U.S. patent application number 16/916575 was filed with the patent office on 2021-01-21 for powered surgical instrument.
The applicant listed for this patent is Ethicon LLC. Invention is credited to Jason L. Harris, Jerome R. Morgan, Frederick E. Shelton, IV, David C. Yates.
Application Number | 20210015480 16/916575 |
Document ID | / |
Family ID | 1000005134582 |
Filed Date | 2021-01-21 |
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United States Patent
Application |
20210015480 |
Kind Code |
A1 |
Shelton, IV; Frederick E. ;
et al. |
January 21, 2021 |
POWERED SURGICAL INSTRUMENT
Abstract
A method of operating a surgical instrument is disclosed. The
surgical instrument includes an electronic system comprising an
electric motor coupled to the end effector; a motor controller
coupled to the motor; a parameter threshold detection module
configured to monitor multiple parameter thresholds; a sensing
module configured to sense tissue compression; a processor coupled
to the parameter threshold detection module and the motor
controller; and a memory coupled to the processor. The memory
stores executable instructions that when executed by the processor
cause the processor to monitor multiple levels of action thresholds
and monitor speed of the motor and increment a drive unit of the
motor, sense tissue compression, and provide rate and control
feedback to the user of the surgical instrument.
Inventors: |
Shelton, IV; Frederick E.;
(Hillsboro, OH) ; Yates; David C.; (Morrow,
OH) ; Harris; Jason L.; (Lebanon, OH) ;
Morgan; Jerome R.; (Cincinnati, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ethicon LLC |
Guaynabo |
PR |
US |
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|
Family ID: |
1000005134582 |
Appl. No.: |
16/916575 |
Filed: |
June 30, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16146885 |
Sep 28, 2018 |
10729432 |
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16916575 |
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15459546 |
Mar 15, 2017 |
10524787 |
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16146885 |
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14640746 |
Mar 6, 2015 |
9808246 |
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15459546 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/068 20130101;
A61B 2090/0818 20160201; A61B 2017/0019 20130101; A61B 2090/034
20160201; A61B 2018/1455 20130101; A61B 2017/07257 20130101; A61B
2090/066 20160201; A61B 2560/0475 20130101; A61B 2017/00411
20130101; A61B 2017/00022 20130101; A61B 2018/00607 20130101; A61B
2017/07278 20130101; A61B 2090/065 20160201; A61B 17/072 20130101;
A61B 17/07207 20130101; A61B 2090/0803 20160201; A61B 2017/00367
20130101; A61B 2017/00119 20130101; A61B 2017/00398 20130101; A61B
2017/00017 20130101; A61B 2017/07271 20130101; A61B 2017/00026
20130101; A61B 90/98 20160201; A61B 2017/00734 20130101; A61B
2090/0814 20160201; A61B 2017/2927 20130101; A61B 2017/07285
20130101; A61B 2017/0046 20130101; A61B 17/295 20130101; A61B
2090/0807 20160201; A61B 18/1445 20130101; A61B 2090/0808
20160201 |
International
Class: |
A61B 17/068 20060101
A61B017/068; A61B 18/14 20060101 A61B018/14; A61B 17/072 20060101
A61B017/072; A61B 17/295 20060101 A61B017/295 |
Claims
1-20. (canceled)
21. A surgical instrument, comprising: a motor; a motor controller
configured to control the motor; a processor coupled to the motor
controller; and a memory coupled to the processor, wherein the
memory stores: a plurality of set parameters associated with the
surgical instrument; an ultimate threshold associated with each of
the set parameters; and a marginal threshold associated with each
of the set parameters; wherein the processor is configured to:
monitor, by the processor, a parameter of the plurality of set
parameters during use of the surgical instrument; compare, by the
processor, the monitored parameter to an ultimate threshold
associated with the parameter; adjust, by the motor controller, an
operation of the motor based on a result of the comparison of the
monitored parameter and the ultimate threshold; compare, by the
processor, the monitored parameter to a marginal threshold
associated with the parameter; and adjust, by the motor controller,
an operation of the motor based on a result of the comparison of
the monitored parameter and the marginal threshold.
22. The surgical instrument of claim 21, wherein the processor is
configured to compare the monitored parameter to the marginal
threshold based on the monitored parameter not reaching or
exceeding the ultimate threshold.
23. The surgical instrument of claim 21, wherein the processor is
configured to adjust a speed of the motor based on the monitored
parameter reaching or exceeding the ultimate threshold.
24. The surgical instrument of claim 23, wherein the processor is
configured to adjust the speed of the motor to zero based on the
monitored parameter reaching or exceeding the ultimate
threshold.
25. The surgical instrument of claim 21, wherein the processor is
further configured to set, by the processor, a new marginal
threshold for the parameter based on the monitored parameter
reaching or exceeding the ultimate threshold.
26. The surgical instrument of claim 21, wherein the processor is
configured to set, by the processor, a linear progression function
to the motor controller based on the monitored parameter reaching
or exceeding the marginal threshold.
27. The surgical instrument of claim 21, wherein the processor is
configured to set, by the processor, a non-linear progression
function to the motor controller based on the monitored parameter
reaching or exceeding the marginal threshold.
28. The surgical instrument of claim 21, wherein the parameter
comprises a current draw of the motor.
29. The surgical instrument of claim 21, wherein the parameter
comprises a number of sterilization cycles of the surgical
instrument.
30. The surgical instrument of claim 21, wherein the surgical
instrument further comprises a firing drive system, and wherein the
parameter comprises a velocity of the firing drive system.
31. The surgical instrument of claim 21, wherein the surgical
instrument further comprises a firing drive system, and wherein the
parameter comprises a firing force experienced by the firing drive
system.
32. A surgical instrument, comprising: a motor; a motor controller
configured to control the motor; a processor coupled to the motor
controller; and a memory coupled to the processor; wherein the
processor is configured to: monitor, by the processor, a speed of
the motor; predict, by the processor, a future motor speed based on
the speed of the motor increasing; compare, by the processor, the
predicted future motor speed to a threshold motor speed; and
adjust, by the motor controller, the speed of the motor based on a
result of the comparison.
33. The surgical instrument of claim 32, wherein the processor is
configured to divert the speed of the motor away from an expected
speed curve based on the result of the comparison.
34. A surgical system, comprising: a motor; a motor control circuit
configured to control the motor; a processing circuit coupled to
the motor control circuit; and a memory coupled to the processing
circuit, wherein the memory stores: a plurality of set parameters
associated with the surgical system; an ultimate threshold
associated with each of the set parameters; and a marginal
threshold associated with each of the set parameters; wherein the
processing circuit is configured to: monitor, by the processing
circuit, a parameter of the plurality of set parameters during use
of the surgical system; compare, by the processing circuit, the
monitored parameter to an ultimate threshold associated with the
parameter; adjust, by the motor control circuit, an operation of
the motor based on a result of the comparison of the monitored
parameter and the ultimate threshold; compare, by the processing
circuit, the monitored parameter to a marginal threshold associated
with the parameter based on the monitored parameter not reaching or
exceeding the ultimate threshold; and adjust, by the motor control
circuit, an operation of the motor based on a result of the
comparison of the monitored parameter and the marginal
threshold.
35. The surgical system of claim 34, wherein the processing circuit
is configured to set, by the processing circuit, a new marginal
threshold for the parameter based on the monitored parameter
reaching or exceeding the ultimate threshold.
36. The surgical system of claim 34, wherein the processing circuit
is configured to adjust a speed of the motor based on the monitored
parameter reaching or exceeding the ultimate threshold.
37. The surgical system of claim 34, wherein the parameter
comprises a current draw of the motor of the surgical system.
38. The surgical system of claim 34, wherein the parameter
comprises a number of sterilization cycles of the surgical
system.
39. The surgical system of claim 34, further comprising a firing
drive system, and wherein the parameter comprises a velocity of the
firing drive system.
40. The surgical system of claim 34, further comprising a firing
drive system, and wherein the parameter comprises a firing force
experienced by the firing drive system.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application claiming
priority under 35 U.S.C. .sctn. 120 to U.S. patent application Ser.
No. 16/146,885, entitled POWERED SURGICAL INSTRUMENT, filed Sep.
28, 2018, now U.S. Patent Application Publication No. 2019/0029678,
which is a continuation application claiming priority under 35
U.S.C. .sctn. 120 to U.S. patent application Ser. No. 15/459,546,
entitled POWERED SURGICAL INSTRUMENT, filed Mar. 15, 2017, which
issued on Jan. 7, 2020 as U.S. Pat. No. 10,524,787, which is a
continuation application claiming priority under 35 U.S.C. .sctn.
120 to U.S. patent application Ser. No. 14/640,746, entitled
POWERED SURGICAL INSTRUMENT, filed Mar. 6, 2015, which issued on
Nov. 7, 2017 as U.S. Pat. No. 9,808,246, the entire disclosures of
which are hereby incorporated by reference herein.
BACKGROUND
[0002] The present disclosure relates to surgical instruments and,
in various circumstances, to surgical stapling and cutting
instruments and staple cartridges therefor that are designed to
staple and cut tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0003] The features and advantages of the present disclosure, and
the manner of attaining them, will become more apparent and the
present disclosure will be better understood by reference to the
following description of the present disclosure taken in
conjunction with the accompanying drawings, wherein:
[0004] FIG. 1 is a perspective view of a surgical instrument that
has an interchangeable shaft assembly operably coupled thereto;
[0005] FIG. 2 is an exploded assembly view of the interchangeable
shaft assembly and surgical instrument of FIG. 1;
[0006] FIG. 3 is another exploded assembly view showing portions of
the interchangeable shaft assembly and surgical instrument of FIGS.
1 and 2;
[0007] FIG. 4 is an exploded assembly view of a portion of the
surgical instrument of FIGS. 1-3;
[0008] FIG. 5 is a cross-sectional side view of a portion of the
surgical instrument of FIG. 4 with the firing trigger in a fully
actuated position;
[0009] FIG. 6 is another cross-sectional view of a portion of the
surgical instrument of FIG. 5 with the firing trigger in an
unactuated position;
[0010] FIG. 7 is an exploded assembly view of one form of an
interchangeable shaft assembly;
[0011] FIG. 8 is another exploded assembly view of portions of the
interchangeable shaft assembly of FIG. 7;
[0012] FIG. 9 is another exploded assembly view of portions of the
interchangeable shaft assembly of FIGS. 7 and 8;
[0013] FIG. 10 is a cross-sectional view of a portion of the
interchangeable shaft assembly of FIGS. 7-9;
[0014] FIG. 11 is a perspective view of a portion of the shaft
assembly of FIGS. 7-10 with the switch drum omitted for
clarity;
[0015] FIG. 12 is another perspective view of the portion of the
interchangeable shaft assembly of FIG. 11 with the switch drum
mounted thereon;
[0016] FIG. 13 is a perspective view of a portion of the
interchangeable shaft assembly of FIG. 11 operably coupled to a
portion of the surgical instrument of FIG. 1 illustrated with the
closure trigger thereof in an unactuated position;
[0017] FIG. 14 is a right side elevational view of the
interchangeable shaft assembly and surgical instrument of FIG.
13;
[0018] FIG. 15 is a left side elevational view of the
interchangeable shaft assembly and surgical instrument of FIGS. 13
and 14;
[0019] FIG. 16 is a perspective view of a portion of the
interchangeable shaft assembly of FIG. 11 operably coupled to a
portion of the surgical instrument of FIG. 1 illustrated with the
closure trigger thereof in an actuated position and a firing
trigger thereof in an unactuated position;
[0020] FIG. 17 is a right side elevational view of the
interchangeable shaft assembly and surgical instrument of FIG.
16;
[0021] FIG. 18 is a left side elevational view of the
interchangeable shaft assembly and surgical instrument of FIGS. 16
and 17;
[0022] FIG. 18A is a right side elevational view of the
interchangeable shaft assembly of FIG. 11 operably coupled to a
portion of the surgical instrument of FIG. 1 illustrated with the
closure trigger thereof in an actuated position and the firing
trigger thereof in an actuated position;
[0023] FIG. 19 is a schematic of a system for powering down an
electrical connector of a surgical instrument handle when a shaft
assembly is not coupled thereto;
[0024] FIG. 20 is an exploded view of one aspect of an end effector
of the surgical instrument of FIG. 1;
[0025] FIGS. 21A-21B is a circuit diagram of the surgical
instrument of FIG. 1 spanning two drawings sheets;
[0026] FIG. 22 illustrates one instance of a power assembly
comprising a usage cycle circuit configured to generate a usage
cycle count of the battery back;
[0027] FIG. 23 illustrates one aspect of a process for sequentially
energizing a segmented circuit;
[0028] FIG. 24 illustrates one aspect of a power segment comprising
a plurality of daisy chained power converters;
[0029] FIG. 25 illustrates one aspect of a segmented circuit
configured to maximize power available for critical and/or power
intense functions;
[0030] FIG. 26 illustrates one aspect of a power system comprising
a plurality of daisy chained power converters configured to be
sequentially energized;
[0031] FIG. 27 illustrates one aspect of a segmented circuit
comprising an isolated control section;
[0032] FIG. 28, which is divided into FIGS. 28A and 28B, is a
circuit diagram of the surgical instrument of FIG. 1;
[0033] FIG. 29 is a block diagram the surgical instrument of FIG. 1
illustrating interfaces between the handle assembly 14 and the
power assembly and between the handle assembly 14 and the
interchangeable shaft assembly;
[0034] FIG. 30 illustrates one aspect of a process for utilizing
thresholds to modify operations of a surgical instrument;
[0035] FIG. 31 illustrates an example graph showing modification of
operations of a surgical instrument describing a linear
function;
[0036] FIG. 32 illustrates an example graph showing modification of
operations of a surgical instrument describing a non-linear
function;
[0037] FIG. 33 illustrates an example graph showing modification of
operations of a surgical instrument based on an expected user input
parameter;
[0038] FIG. 34 illustrates an example graph showing modification of
velocity of a drive based on detection of a threshold;
[0039] FIG. 35 illustrates an example graph showing modification in
connection with operations based on battery current based on
detection of a threshold;
[0040] FIG. 36 illustrates an example graph showing modification in
connection with operations based on battery voltage based on
detection of a threshold;
[0041] FIG. 37 illustrates an example graph showing modification of
knife speed based on detection of a cycle threshold;
[0042] FIG. 38 illustrates a logic diagram of a system for
evaluating sharpness of a cutting edge of a surgical instrument
according to various aspects;
[0043] FIG. 39 illustrates a logic diagram of a system for
determining the forces applied against a cutting edge of a surgical
instrument by a sharpness testing member at various sharpness
levels according to various aspects;
[0044] FIG. 40 illustrates a flow chart of a method for determining
whether a cutting edge of a surgical instrument is sufficiently
sharp to transect tissue captured by the surgical instrument
according to various aspects;
[0045] FIG. 41 illustrates a chart of the forces applied against a
cutting edge of a surgical instrument by a sharpness testing member
at various sharpness levels according to various embodiments.
[0046] FIG. 42 illustrates a flow chart outlining a method for
determining whether a cutting edge of a surgical instrument is
sufficiently sharp to transect tissue captured by the surgical
instrument according to various embodiments.
[0047] FIG. 43 illustrates one aspect of a process for adapting
operations of a surgical instrument;
[0048] FIG. 44 illustrates one aspect of a process for adapting
operations of a surgical instrument;
[0049] FIG. 45 illustrates one aspect of a mechanism for adapting
operations of a surgical instrument in the context of closure
motion and tissue pressure;
[0050] FIG. 46 illustrates one aspect of a mechanism for adapting
speed associated with a parameter of a surgical instrument in the
context of tissue modification and sensor modification;
[0051] FIG. 47 illustrates one aspect of a mechanism for adapting
firing rate associated with a parameter of a surgical instrument in
the context of tissue modification and sensor modification;
[0052] FIG. 48 illustrates one aspect of a mechanism for adapting
operations associated with a surgical instrument in the context of
tissue compression during a clamping phase;
[0053] FIG. 49 illustrates one aspect of a mechanism for adapting
operations associated with a surgical instrument in the context of
tissue compression during a firing phase;
[0054] FIG. 50 illustrates one aspect of a mechanism for adapting
operations associated with a surgical instrument in the context of
slowing a firing event where a peak is predicted above a limit;
[0055] FIG. 51 illustrates a portion of tissue having a disparity
in thickness;
[0056] FIG. 52 depicts an example medical device that can include
one or more aspects of the present disclosure;
[0057] FIG. 53A depicts an example end-effector of a medical device
surrounding tissue in accordance with one or more aspects of the
present disclosure;
[0058] FIG. 53B depicts an example end-effector of a medical device
compressing tissue in accordance with one or more aspects of the
present disclosure;
[0059] FIG. 54A depicts example forces exerted by an end-effector
of a medical device compressing tissue in accordance with one or
more aspects of the present disclosure;
[0060] FIG. 54B also depicts example forces exerted by an
end-effector of a medical device compressing tissue in accordance
with one or more aspects of the present disclosure;
[0061] FIG. 55 depicts an example tissue compression sensor system
in accordance with one or more aspects of the present
disclosure;
[0062] FIG. 56 also depicts an example tissue compression sensor
system in accordance with one or more aspects of the present
disclosure;
[0063] FIG. 57 also depicts an example tissue compression sensor
system in accordance with one or more aspects of the present
disclosure;
[0064] FIG. 58 depicts an example end-effector channel frame in
accordance with one or more aspects of the present disclosure;
[0065] FIG. 59 depicts an example end-effector in accordance with
one or more aspects of the present disclosure;
[0066] FIG. 60 also depicts an example end-effector channel frame
in accordance with one or more aspects of the present
disclosure;
[0067] FIG. 61 also depicts an example end-effector channel frame
in accordance with one or more aspects of the present
disclosure;
[0068] FIG. 62 also depicts an example end-effector channel frame
in accordance with one or more aspects of the present
disclosure;
[0069] FIG. 63 depicts an example electrode in accordance with one
or more aspects of the present disclosure;
[0070] FIG. 64 depicts an example electrode wiring system in
accordance with one or more aspects of the present disclosure;
[0071] FIG. 65 also depicts an example end-effector channel frame
in accordance with one or more aspects of the present
disclosure;
[0072] FIG. 66 is an example circuit diagram in accordance with one
or more aspects of the present disclosure;
[0073] FIG. 67 is also an example circuit diagram in accordance
with one or more aspects of the present disclosure;
[0074] FIG. 68 is also an example circuit diagram in accordance
with one or more aspects of the present disclosure;
[0075] FIG. 69 is graph depicting an example frequency modulation
in accordance with one or more aspects of the present
disclosure;
[0076] FIG. 70 is graph depicting a compound RF signal in
accordance with one or more aspects of the present disclosure;
[0077] FIG. 71 is graph depicting filtered RF signals in accordance
with one or more aspects of the present disclosure;
[0078] FIG. 72 is a plan view of a speed sensor assembly for a
surgical instrument power train;
[0079] FIG. 73 is a longitudinal cross section through plane A of
FIG. 71;
[0080] FIG. 74 is a perspective view of a speed sensor assembly for
a brushless motor;
[0081] FIG. 75 is a transverse cross section through plane B of
FIG. 73;
[0082] FIG. 76 is a perspective view of a surgical instrument with
an articulable, interchangeable shaft;
[0083] FIG. 77 is a side view of the tip of the surgical instrument
shown in FIG. 76;
[0084] FIGS. 78A-78E are graphs plotting gap size over time (FIG.
78A), firing current over time (FIG. 78B), tissue compression over
time (FIG. 78C), anvil strain over time (FIG. 78D), and trigger
force over time (FIG. 78E);
[0085] FIG. 79 is a graph plotting tissue displacement as a
function of tissue compression for normal tissues;
[0086] FIG. 80 is a graph plotting tissue displacement as a
function of tissue compression to distinguish normal and diseased
tissues;
[0087] FIG. 81 illustrates a perspective view of a surgical
instrument in accordance with one aspect;
[0088] FIG. 82 illustrates an exploded view of the end effector of
the surgical instrument of FIG. 81 in accordance with one
aspect;
[0089] FIG. 83 illustrates a partial side view of a handle of the
surgical instrument of FIG. 81 in accordance with one aspect;
[0090] FIG. 84 illustrates a cross-sectional view of an end
effector of the surgical instrument of FIG. 81 in accordance with
one aspect;
[0091] FIG. 85 illustrates a logic diagram of a process in
accordance with one aspect;
[0092] FIG. 86 illustrates a logic diagram of a feedback system in
accordance with one aspect;
[0093] FIG. 87 illustrates a logic diagram of a feedback system in
accordance with one aspect;
[0094] FIG. 88 illustrates a feedback indicator of a feedback
system in accordance with one aspect;
[0095] FIG. 89 illustrates a feedback indicator of a feedback
system in accordance with one aspect;
[0096] FIG. 90 illustrates a feedback indicator of a feedback
system in accordance with one aspect;
[0097] FIG. 91 illustrates a feedback indicator of a feedback
system in accordance with one aspect;
[0098] FIG. 92 illustrates a feedback indicator of a feedback
system in accordance with one aspect;
[0099] FIG. 93 illustrates a feedback indicator of a feedback
system in accordance with one aspect;
[0100] FIG. 94 illustrates a feedback indicator of a feedback
system in accordance with one aspect;
[0101] FIG. 95 illustrates a feedback indicator of a feedback
system in accordance with one aspect;
[0102] FIG. 96 illustrates a feedback indicator of a feedback
system in accordance with one aspect;
[0103] FIG. 97 is a schematic depicting control systems of the
modular surgical instrument system of FIG. 1, according to various
aspects of the present disclosure;
[0104] FIG. 98 is a logic diagram of a method for implementing a
surgical function with the modular surgical instrument system of
FIG. 1, according to various aspects of the present disclosure;
[0105] FIG. 99 depicts an example medical device that can include
one or more aspects of the present disclosure;
[0106] FIG. 100 depicts an example end-effector of a medical device
that can include one or more aspects of the present disclosure;
[0107] FIG. 101 also depicts an example end-effector of a medical
device that can include one or more aspects of the present
disclosure;
[0108] FIG. 102 is a diagram of a smart sensor component in
accordance with an aspect the present disclosure;
[0109] FIG. 103 is a logic diagram illustrating one aspect of a
process for calibrating a first sensor in response to an input from
a second sensor;
[0110] FIG. 104 is a logic diagram illustrating one aspect of a
process for adjusting a measurement of a first sensor in response
to a plurality of secondary sensors;
[0111] FIG. 105 illustrates one aspect of a circuit configured to
convert signals from a first sensor and a plurality of secondary
sensors into digital signals receivable by a processor;
[0112] FIG. 106 is a logic diagram illustrating one aspect of a
process for selecting the most reliable output from a plurality of
redundant sensors;
[0113] FIG. 107 illustrates a sideways cross-sectional view of one
aspect of an end effector comprising a magnet and a magnetic field
sensor in communication with processor;
[0114] FIGS. 108-110 illustrate one aspect of an end effector that
comprises a magnet where FIG. 108 illustrates a perspective cutaway
view of the anvil and the magnet, FIG. 109 illustrates a side
cutaway view of the anvil and the magnet, and FIG. 110 illustrates
a top cutaway view of the anvil and the magnet;
[0115] FIG. 111 illustrates one aspect of an end effector that is
operable to use conductive surfaces at the distal contact point to
create an electrical connection;
[0116] FIG. 112 illustrates one aspect of an exploded view of a
staple cartridge that comprises a flex cable connected to a
magnetic field sensor and processor;
[0117] FIG. 113 illustrates the end effector shown in FIG. 112 with
a flex cable and without the shaft assembly;
[0118] FIGS. 114 and 115 illustrate an elongated channel portion of
an end effector without the anvil or the staple cartridge, to
illustrate how the flex cable shown in FIG. 113 can be seated
within the elongated channel;
[0119] FIG. 116 illustrates a flex cable, shown in FIGS. 113-115,
alone;
[0120] FIG. 117 illustrates a close up view of the elongated
channel shown in FIGS. 114 and 115 with a staple cartridge coupled
thereto;
[0121] FIGS. 118 and 119 illustrate one aspect of a distal sensor
plug where FIG. 118 illustrates a cutaway view of the distal sensor
plug and FIG. 119 further illustrates the magnetic field sensor and
the processor operatively coupled to the flex board such that they
are capable of communicating;
[0122] FIG. 120 illustrates an aspect of an end effector with a
flex cable operable to provide power to sensors and electronics in
the distal tip of the anvil portion;
[0123] FIGS. 121-123 illustrate the operation of the articulation
joint and flex cable of the end effector where FIG. 121 illustrates
a top view of the end effector with the end effector pivoted -45
degrees with respect to the shaft assembly, FIG. 122 illustrates a
top view of the end effector, and FIG. 123 illustrates a top view
of the end effector with the end effector pivoted +45 degrees with
respect to the shaft assembly;
[0124] FIG. 124 illustrates cross-sectional view of the distal tip
of an aspect of an anvil with sensors and electronics; and
[0125] FIG. 125 illustrates a cutaway view of the distal tip of the
anvil.
[0126] FIG. 126 is a partial cross-sectional view of a handle of a
surgical instrument comprising a battery and a battery lock in
accordance with at least one embodiment;
[0127] FIG. 127 is partial cross-sectional view of the handle of
FIG. 126 illustrating the battery lock in an unlocked
configuration;
[0128] FIG. 128 is a partial cross-sectional view of the handle of
FIG. 126 illustrating the battery lock in a locked
configuration;
[0129] FIG. 129 is a partial cross-sectional view of a handle of a
surgical instrument comprising a battery lockout in accordance with
at least one embodiment illustrated in an unlocked
configuration;
[0130] FIG. 130 is a partial cross-sectional view of the handle of
FIG. 129 illustrating the battery lockout in a locked-out
configuration;
[0131] FIG. 131 is a partial cross-sectional view of a battery
lockout in accordance with an alternative embodiment illustrated in
a locked-out configuration;
[0132] FIG. 132 depicts a surgical instrument system comprising a
motor including a shaft, a gear train, an output shaft operably
coupled to the motor shaft, and power generation means mounted to
the motor shaft in accordance with at least one embodiment;
[0133] FIG. 133 depicts the motor shaft of FIG. 132 which includes
a strain gauge and means for transmitting information from the
motor shaft, i.e., a rotating plane, to a stationary plane mounted
to the motor shaft and, in addition, means for interpreting the
information being transmitted from the motor shaft;
[0134] FIG. 134 is a perspective view of an end effector of a
surgical stapling instrument including a cartridge channel, a
staple cartridge positioned in the cartridge channel, and an
anvil;
[0135] FIG. 135 is a cross-sectional elevational view of the
surgical stapling instrument of FIG. 134 illustrating a sled and a
firing member in an unfired position;
[0136] FIG. 136 is a detail view depicting the sled of FIG. 135 in
a partially advanced position and the firing member in its unfired
position;
[0137] FIG. 137 is a perspective view of the staple cartridge of
FIG. 134 prior to being inserted into the cartridge channel of FIG.
134;
[0138] FIG. 138 is a perspective view of the staple cartridge of
FIG. 134 fully seated in the cartridge channel of FIG. 134;
[0139] FIG. 139 is a schematic of the staple cartridge and
cartridge channel of FIG. 134 and the sled and the firing member of
FIG. 135 depicting a mis-insertion of the staple cartridge into the
cartridge channel and the effect on the sled that such a
mis-insertion can cause;
[0140] FIG. 140 is a partial perspective view of an end effector of
a surgical stapling instrument in accordance with at least one
embodiment including a sensor configured to sense whether a staple
cartridge has been mis-inserted in the manner depicted in FIG.
139;
[0141] FIG. 141 is a partial perspective view of an end effector of
a surgical stapling instrument in accordance with at least one
embodiment including a sensor configured to detect whether the sled
has been unintentionally advanced;
[0142] FIG. 142 is a partial perspective view of the end effector
of FIG. 141 illustrating the sled in an unintentionally advanced
position;
[0143] FIG. 143 is a cross-sectional view of the sensor of FIG. 141
in accordance with at least one embodiment; and
[0144] FIG. 144 is a cross-sectional view of the sensor of FIG. 141
in accordance with at least one alternative embodiment.
DESCRIPTION
[0145] Applicant of the present application owns the following
patent applications that were filed on Mar. 6, 2015 and which are
each herein incorporated by reference in their respective
entireties:
[0146] U.S. patent application Ser. No. 14/640,795, entitled
MULTIPLE LEVEL THRESHOLDS TO MODIFY OPERATION OF POWERED SURGICAL
INSTRUMENTS, now U.S. Pat. No. 10,441,279;
[0147] U.S. patent application Ser. No. 14/640,832, entitled
ADAPTIVE TISSUE COMPRESSION TECHNIQUES TO ADJUST CLOSURE RATES FOR
MULTIPLE TISSUE TYPES, now U.S. Pat. No. 10,687,806;
[0148] U.S. patent application Ser. No. 14/640,935, entitled
OVERLAID MULTI SENSOR RADIO FREQUENCY (RF) ELECTRODE SYSTEM TO
MEASURE TISSUE COMPRESSION, now U.S. Pat. No. 10,548,504;
[0149] U.S. patent application Ser. No. 14/640,831, entitled
MONITORING SPEED CONTROL AND PRECISION INCREMENTING OF MOTOR FOR
POWERED SURGICAL INSTRUMENTS, now U.S. Pat. No. 9,895,148;
[0150] U.S. patent application Ser. No. 14/640,859, entitled TIME
DEPENDENT EVALUATION OF SENSOR DATA TO DETERMINE STABILITY, CREEP,
AND VISCOELASTIC ELEMENTS OF MEASURES, now U.S. Pat. No.
10,052,044;
[0151] U.S. patent application Ser. No. 14/640,817, entitled
INTERACTIVE FEEDBACK SYSTEM FOR POWERED SURGICAL INSTRUMENTS, now
U.S. Pat. No. 9,924,961;
[0152] U.S. patent application Ser. No. 14/640,844, entitled
CONTROL TECHNIQUES AND SUB-PROCESSOR CONTAINED WITHIN MODULAR SHAFT
WITH SELECT CONTROL PROCESSING FROM HANDLE, now U.S. Pat. No.
10,045,776;
[0153] U.S. patent application Ser. No. 14/640,837, entitled SMART
SENSORS WITH LOCAL SIGNAL PROCESSING, now U.S. Pat. No.
9,993,248;
[0154] U.S. patent application Ser. No. 14/640,780, entitled
SURGICAL INSTRUMENT COMPRISING A LOCKABLE BATTERY HOUSING, now U.S.
Pat. No. 10,245,033;
[0155] U.S. patent application Ser. No. 14/640,765, entitled SYSTEM
FOR DETECTING THE MIS-INSERTION OF A STAPLE CARTRIDGE INTO A
SURGICAL STAPLER, now U.S. Pat. No. 10,617,412; and
[0156] U.S. patent application Ser. No. 14/640,799, entitled SIGNAL
AND POWER COMMUNICATION SYSTEM POSITIONED ON A ROTATABLE SHAFT, now
U.S. Pat. No. 9,901,342.
[0157] Applicant of the present application owns the following
patent applications that were filed on Feb. 27, 2015, and which are
each herein incorporated by reference in their respective
entireties:
[0158] U.S. patent application Ser. No. 14/633,576, entitled
SURGICAL INSTRUMENT SYSTEM COMPRISING AN INSPECTION STATION, now
U.S. Pat. No. 10,045,779;
[0159] U.S. patent application Ser. No. 14/633,546, entitled
SURGICAL APPARATUS CONFIGURED TO ASSESS WHETHER A PERFORMANCE
PARAMETER OF THE SURGICAL APPARATUS IS WITHIN AN ACCEPTABLE
PERFORMANCE BAND, now U.S. Pat. No. 10,180,463;
[0160] U.S. patent application Ser. No. 14/633,560, entitled
SURGICAL CHARGING SYSTEM THAT CHARGES AND/OR CONDITIONS ONE OR MORE
BATTERIES, now U.S. Patent Application Publication No.
2016/0249910;
[0161] U.S. patent application Ser. No. 14/633,566, entitled
CHARGING SYSTEM THAT ENABLES EMERGENCY RESOLUTIONS FOR CHARGING A
BATTERY, now U.S. Pat. No. 10,182,816;
[0162] U.S. patent application Ser. No. 14/633,555, entitled SYSTEM
FOR MONITORING WHETHER A SURGICAL INSTRUMENT NEEDS TO BE SERVICED,
now U.S. Pat. No. 10,321,907;
[0163] U.S. patent application Ser. No. 14/633,542, entitled
REINFORCED BATTERY FOR A SURGICAL INSTRUMENT, now U.S. Pat. No.
9,931,118;
[0164] U.S. patent application Ser. No. 14/633,548, entitled POWER
ADAPTER FOR A SURGICAL INSTRUMENT, now U.S. Pat. No.
10,245,028;
[0165] U.S. patent application Ser. No. 14/633,526, entitled
ADAPTABLE SURGICAL INSTRUMENT HANDLE, now U.S. Pat. No.
9,993,258;
[0166] U.S. patent application Ser. No. 14/633,541, entitled
MODULAR STAPLING ASSEMBLY, now U.S. Pat. No. 10,226,250; and
[0167] U.S. patent application Ser. No. 14/633,562, entitled
SURGICAL APPARATUS CONFIGURED TO TRACK AN END-OF-LIFE PARAMETER,
now U.S. Pat. No. 10,159,483.
[0168] Applicant of the present application owns the following
patent applications that were filed on Dec. 18, 2014 and which are
each herein incorporated by reference in their respective
entireties:
[0169] U.S. patent application Ser. No. 14/574,478, entitled
SURGICAL INSTRUMENT SYSTEMS COMPRISING AN ARTICULATABLE END
EFFECTOR AND MEANS FOR ADJUSTING THE FIRING STROKE OF A FIRING
MEMBER, now U.S. Pat. No. 9,844,374;
[0170] U.S. patent application Ser. No. 14/574,483, entitled
SURGICAL INSTRUMENT ASSEMBLY COMPRISING LOCKABLE SYSTEMS, now U.S.
Pat. No. 10,188,385;
[0171] U.S. patent application Ser. No. 14/575,139, entitled DRIVE
ARRANGEMENTS FOR ARTICULATABLE SURGICAL INSTRUMENTS, now U.S. Pat.
No. 9,844,375;
[0172] U.S. patent application Ser. No. 14/575,148, entitled
LOCKING ARRANGEMENTS FOR DETACHABLE SHAFT ASSEMBLIES WITH
ARTICULATABLE SURGICAL END EFFECTORS, now U.S. Pat. No.
10,085,748;
[0173] U.S. patent application Ser. No. 14/575,130, entitled
SURGICAL INSTRUMENT WITH AN ANVIL THAT IS SELECTIVELY MOVABLE ABOUT
A DISCRETE NON-MOVABLE AXIS RELATIVE TO A STAPLE CARTRIDGE, now
U.S. Pat. No. 10,245,027;
[0174] U.S. patent application Ser. No. 14/575,143, entitled
SURGICAL INSTRUMENTS WITH IMPROVED CLOSURE ARRANGEMENTS, now U.S.
Pat. No. 10,004,501;
[0175] U.S. patent application Ser. No. 14/575,117, entitled
SURGICAL INSTRUMENTS WITH ARTICULATABLE END EFFECTORS AND MOVABLE
FIRING BEAM SUPPORT ARRANGEMENTS, now U.S. Pat. No. 9,943,309;
[0176] U.S. patent application Ser. No. 14/575,154, entitled
SURGICAL INSTRUMENTS WITH ARTICULATABLE END EFFECTORS AND IMPROVED
FIRING BEAM SUPPORT ARRANGEMENTS, now U.S. Pat. No. 9,968,355;
[0177] U.S. patent application Ser. No. 14/574,493, entitled
SURGICAL INSTRUMENT ASSEMBLY COMPRISING A FLEXIBLE ARTICULATION
SYSTEM, now U.S. Pat. No. 9,987,000; and
[0178] U.S. patent application Ser. No. 14/574,500, entitled
SURGICAL INSTRUMENT ASSEMBLY COMPRISING A LOCKABLE ARTICULATION
SYSTEM, now U.S. Pat. No. 10,117,649.
[0179] Applicant of the present application owns the following
patent applications that were filed on Mar. 1, 2013 and which are
each herein incorporated by reference in their respective
entireties:
[0180] U.S. patent application Ser. No. 13/782,295, entitled
ARTICULATABLE SURGICAL INSTRUMENTS WITH CONDUCTIVE PATHWAYS FOR
SIGNAL COMMUNICATION, now U.S. Pat. No. 9,700,309;
[0181] U.S. patent application Ser. No. 13/782,323, entitled ROTARY
POWERED ARTICULATION JOINTS FOR SURGICAL INSTRUMENTS, now U.S. Pat.
No. 9,782,169;
[0182] U.S. patent application Ser. No. 13/782,338, entitled
THUMBWHEEL SWITCH ARRANGEMENTS FOR SURGICAL INSTRUMENTS, now U.S.
Patent Application Publication No. 2014/0249557;
[0183] U.S. patent application Ser. No. 13/782,499, entitled
ELECTROMECHANICAL SURGICAL DEVICE WITH SIGNAL RELAY ARRANGEMENT,
now U.S. Pat. No. 9,358,003;
[0184] U.S. patent application Ser. No. 13/782,460, entitled
MULTIPLE PROCESSOR MOTOR CONTROL FOR MODULAR SURGICAL INSTRUMENTS,
now U.S. Pat. No. 9,554,794;
[0185] U.S. patent application Ser. No. 13/782,358, entitled
JOYSTICK SWITCH ASSEMBLIES FOR SURGICAL INSTRUMENTS, now U.S. Pat.
No. 9,326,767;
[0186] U.S. patent application Ser. No. 13/782,481, entitled SENSOR
STRAIGHTENED END EFFECTOR DURING REMOVAL THROUGH TROCAR, now U.S.
Pat. No. 9,468,438;
[0187] U.S. patent application Ser. No. 13/782,518, entitled
CONTROL METHODS FOR SURGICAL INSTRUMENTS WITH REMOVABLE IMPLEMENT
PORTIONS, now U.S. Patent Application Publication No.
2014/0246475;
[0188] U.S. patent application Ser. No. 13/782,375, entitled ROTARY
POWERED SURGICAL INSTRUMENTS WITH MULTIPLE DEGREES OF FREEDOM, now
U.S. Pat. No. 9,398,911; and
[0189] U.S. patent application Ser. No. 13/782,536, entitled
SURGICAL INSTRUMENT SOFT STOP, now U.S. Pat. No. 9,307,986.
[0190] Applicant of the present application also owns the following
patent applications that were filed on Mar. 14, 2013 and which are
each herein incorporated by reference in their respective
entireties:
[0191] U.S. patent application Ser. No. 13/803,097, entitled
ARTICULATABLE SURGICAL INSTRUMENT COMPRISING A FIRING DRIVE, now
U.S. Pat. No. 9,687,230;
[0192] U.S. patent application Ser. No. 13/803,193, entitled
CONTROL ARRANGEMENTS FOR A DRIVE MEMBER OF A SURGICAL INSTRUMENT,
now U.S. Pat. No. 9,332,987;
[0193] U.S. patent application Ser. No. 13/803,053, entitled
INTERCHANGEABLE SHAFT ASSEMBLIES FOR USE WITH A SURGICAL
INSTRUMENT, now U.S. Pat. No. 9,883,860;
[0194] U.S. patent application Ser. No. 13/803,086, entitled
ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK,
now U.S. Patent Application Publication No. 2014/0263541;
[0195] U.S. patent application Ser. No. 13/803,210, entitled SENSOR
ARRANGEMENTS FOR ABSOLUTE POSITIONING SYSTEM FOR SURGICAL
INSTRUMENTS, now U.S. Pat. No. 9,808,244;
[0196] U.S. patent application Ser. No. 13/803,148, entitled
MULTI-FUNCTION MOTOR FOR A SURGICAL INSTRUMENT, now U.S. Pat. No.
10,470,762;
[0197] U.S. patent application Ser. No. 13/803,066, entitled DRIVE
SYSTEM LOCKOUT ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS, now
U.S. Pat. No. 9,629,623;
[0198] U.S. patent application Ser. No. 13/803,117, entitled
ARTICULATION CONTROL SYSTEM FOR ARTICULATABLE SURGICAL INSTRUMENTS,
now U.S. Pat. No. 9,351,726;
[0199] U.S. patent application Ser. No. 13/803,130, entitled DRIVE
TRAIN CONTROL ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS, now
U.S. Pat. No. 9,351,727; and
[0200] U.S. patent application Ser. No. 13/803,159, entitled METHOD
AND SYSTEM FOR OPERATING A SURGICAL INSTRUMENT, now U.S. Pat. No.
9,888,919.
[0201] Applicant of the present application also owns the following
patent application that was filed on Mar. 7, 2014 and is herein
incorporated by reference in its entirety:
[0202] U.S. patent application Ser. No. 14/200,111, entitled
CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS, now U.S. Pat. No.
9,629,629.
[0203] Applicant of the present application also owns the following
patent applications that were filed on Mar. 26, 2014 and are each
herein incorporated by reference in their respective
entireties:
[0204] U.S. patent application Ser. No. 14/226,106, entitled POWER
MANAGEMENT CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS, now U.S.
Patent Application Publication No. 2015/0272582;
[0205] U.S. patent application Ser. No. 14/226,099, entitled
STERILIZATION VERIFICATION CIRCUIT, now U.S. Pat. No.
9,826,977;
[0206] U.S. patent application Ser. No. 14/226,094, entitled
VERIFICATION OF NUMBER OF BATTERY EXCHANGES/PROCEDURE COUNT, now
U.S. Patent Application Publication No. 2015/0272580;
[0207] U.S. patent application Ser. No. 14/226,117, entitled POWER
MANAGEMENT THROUGH SLEEP OPTIONS OF SEGMENTED CIRCUIT AND WAKE UP
CONTROL, now U.S. Pat. No. 10,013,049;
[0208] U.S. patent application Ser. No. 14/226,075, entitled
MODULAR POWERED SURGICAL INSTRUMENT WITH DETACHABLE SHAFT
ASSEMBLIES, now U.S. Pat. No. 9,743,929;
[0209] U.S. patent application Ser. No. 14/226,093, entitled
FEEDBACK ALGORITHMS FOR MANUAL BAILOUT SYSTEMS FOR SURGICAL
INSTRUMENTS, now U.S. Pat. No. 10,028,761;
[0210] U.S. patent application Ser. No. 14/226,116, entitled
SURGICAL INSTRUMENT UTILIZING SENSOR ADAPTATION, now U.S. Patent
Application Publication No. 2015/0272571;
[0211] U.S. patent application Ser. No. 14/226,071, entitled
SURGICAL INSTRUMENT CONTROL CIRCUIT HAVING A SAFETY PROCESSOR, now
U.S. Pat. No. 9,690,362;
[0212] U.S. patent application Ser. No. 14/226,097, entitled
SURGICAL INSTRUMENT COMPRISING INTERACTIVE SYSTEMS, now U.S. Pat.
No. 9,820,738;
[0213] U.S. patent application Ser. No. 14/226,126, entitled
INTERFACE SYSTEMS FOR USE WITH SURGICAL INSTRUMENTS, now U.S. Pat.
No. 10,004,497;
[0214] U.S. patent application Ser. No. 14/226,133, entitled
MODULAR SURGICAL INSTRUMENT SYSTEM, now U.S. Patent Application
Publication No. 2015/0272557;
[0215] U.S. patent application Ser. No. 14/226,081, entitled
SYSTEMS AND METHODS FOR CONTROLLING A SEGMENTED CIRCUIT, now U.S.
Pat. No. 9,804,618;
[0216] U.S. patent application Ser. No. 14/226,076, entitled POWER
MANAGEMENT THROUGH SEGMENTED CIRCUIT AND VARIABLE VOLTAGE
PROTECTION, now U.S. Pat. No. 9,733,663;
[0217] U.S. patent application Ser. No. 14/226,111, entitled
SURGICAL STAPLING INSTRUMENT SYSTEM, now U.S. Pat. No. 9,750,499;
and
[0218] U.S. patent application Ser. No. 14/226,125, entitled
SURGICAL INSTRUMENT COMPRISING A ROTATABLE SHAFT, now U.S. Pat. No.
10,201,364.
[0219] Applicant of the present application also owns the following
patent applications that were filed on Sep. 5, 2014 and which are
each herein incorporated by reference in their respective
entireties:
[0220] U.S. patent application Ser. No. 14/479,103, entitled
CIRCUITRY AND SENSORS FOR POWERED MEDICAL DEVICE, now U.S. Pat. No.
10,111,679;
[0221] U.S. patent application Ser. No. 14/479,119, entitled
ADJUNCT WITH INTEGRATED SENSORS TO QUANTIFY TISSUE COMPRESSION, now
U.S. Pat. No. 9,724,094;
[0222] U.S. patent application Ser. No. 14/478,908, entitled
MONITORING DEVICE DEGRADATION BASED ON COMPONENT EVALUATION, now
U.S. Pat. No. 9,737,301;
[0223] U.S. patent application Ser. No. 14/478,895, entitled
MULTIPLE SENSORS WITH ONE SENSOR AFFECTING A SECOND SENSOR'S OUTPUT
OR INTERPRETATION, now U.S. Pat. No. 9,757,128;
[0224] U.S. patent application Ser. No. 14/479,110, entitled USE OF
POLARITY OF HALL MAGNET DETECTION TO DETECT MISLOADED CARTRIDGE,
now U.S. Pat. No. 10,016,199;
[0225] U.S. patent application Ser. No. 14/479,098, entitled SMART
CARTRIDGE WAKE UP OPERATION AND DATA RETENTION, now U.S. Pat. No.
10,135,242;
[0226] U.S. patent application Ser. No. 14/479,115, entitled
MULTIPLE MOTOR CONTROL FOR POWERED MEDICAL DEVICE, now U.S. Pat.
No. 9,788,836; and
[0227] U.S. patent application Ser. No. 14/479,108, entitled LOCAL
DISPLAY OF TISSUE PARAMETER STABILIZATION, now U.S. Patent
Application Publication No. 2016/0066913.
[0228] Applicant of the present application also owns the following
patent applications that were filed on Apr. 9, 2014 and which are
each herein incorporated by reference in their respective
entireties:
[0229] U.S. patent application Ser. No. 14/248,590, entitled MOTOR
DRIVEN SURGICAL INSTRUMENTS WITH LOCKABLE DUAL DRIVE SHAFTS, now
U.S. Pat. No. 9,826,976;
[0230] U.S. patent application Ser. No. 14/248,581, entitled
SURGICAL INSTRUMENT COMPRISING A CLOSING DRIVE AND A FIRING DRIVE
OPERATED FROM THE SAME ROTATABLE OUTPUT, now U.S. Pat. No.
9,649,110;
[0231] U.S. patent application Ser. No. 14/248,595, entitled
SURGICAL INSTRUMENT SHAFT INCLUDING SWITCHES FOR CONTROLLING THE
OPERATION OF THE SURGICAL INSTRUMENT, now U.S. Pat. No.
9,844,368;
[0232] U.S. patent application Ser. No. 14/248,588, entitled
POWERED LINEAR SURGICAL STAPLER, now U.S. Pat. No. 10,405,857;
[0233] U.S. patent application Ser. No. 14/248,591, entitled
TRANSMISSION ARRANGEMENT FOR A SURGICAL INSTRUMENT, now U.S. Pat.
No. 10,149,680;
[0234] U.S. patent application Ser. No. 14/248,584, entitled
MODULAR MOTOR DRIVEN SURGICAL INSTRUMENTS WITH ALIGNMENT FEATURES
FOR ALIGNING ROTARY DRIVE SHAFTS WITH SURGICAL END EFFECTOR SHAFTS,
now U.S. Pat. No. 9,801,626;
[0235] U.S. patent application Ser. No. 14/248,587, entitled
POWERED SURGICAL STAPLER, now U.S. Pat. No. 9,867,612;
[0236] U.S. patent application Ser. No. 14/248,586, entitled DRIVE
SYSTEM DECOUPLING ARRANGEMENT FOR A SURGICAL INSTRUMENT, now U.S.
Pat. No. 10,136,887; and
[0237] U.S. patent application Ser. No. 14/248,607, entitled
MODULAR MOTOR DRIVEN SURGICAL INSTRUMENTS WITH STATUS INDICATION
ARRANGEMENTS, now U.S. Pat. No. 9,814,460.
[0238] Applicant of the present application also owns the following
patent applications that were filed on Apr. 16, 2013 and which are
each herein incorporated by reference in their respective
entireties:
[0239] U.S. Provisional Patent Application Ser. No. 61/812,365,
entitled SURGICAL INSTRUMENT WITH MULTIPLE FUNCTIONS PERFORMED BY A
SINGLE MOTOR;
[0240] U.S. Provisional Patent Application Ser. No. 61/812,376,
entitled LINEAR CUTTER WITH POWER;
[0241] U.S. Provisional Patent Application Ser. No. 61/812,382,
entitled LINEAR CUTTER WITH MOTOR AND PISTOL GRIP;
[0242] U.S. Provisional Patent Application Ser. No. 61/812,385,
entitled SURGICAL INSTRUMENT HANDLE WITH MULTIPLE ACTUATION MOTORS
AND MOTOR CONTROL; and
[0243] U.S. Provisional Patent Application Ser. No. 61/812,372,
entitled SURGICAL INSTRUMENT WITH MULTIPLE FUNCTIONS PERFORMED BY A
SINGLE MOTOR.
[0244] The present disclosure provides an overall understanding of
the principles of the structure, function, manufacture, and use of
the devices and methods disclosed herein. One or more examples of
these aspects are illustrated in the accompanying drawings. Those
of ordinary skill in the art will understand that the devices and
methods specifically described herein and illustrated in the
accompanying drawings are non-limiting examples. The features
illustrated or described in connection with one example may be
combined with the features of other examples. Such modifications
and variations are intended to be included within the scope of the
present disclosure.
[0245] Reference throughout the specification to "various aspects,"
"some aspects," "one aspect," or "an aspect", or the like, means
that a particular feature, structure, or characteristic described
in connection with the aspect is included in at least one aspect.
Thus, appearances of the phrases "in various aspects," "in some
aspects," "in one aspect", or "in an aspect", or the like, in
places throughout the specification are not necessarily all
referring to the same aspect. Furthermore, the particular features,
structures, or characteristics may be combined in any suitable
manner in one or more aspects. Thus, the particular features,
structures, or characteristics illustrated or described in
connection with one aspect may be combined, in whole or in part,
with the features structures, or characteristics of one or more
other aspects without limitation. Such modifications and variations
are intended to be included within the scope of the present
disclosure.
[0246] The terms "proximal" and "distal" are used herein with
reference to a clinician manipulating the handle portion of the
surgical instrument. The term "proximal" referring to the portion
closest to the clinician and the term "distal" referring to the
portion located away from the clinician. It will be further
appreciated that, for convenience and clarity, spatial terms such
as "vertical," "horizontal," "up," and "down" may be used herein
with respect to the drawings. However, surgical instruments are
used in many orientations and positions, and these terms are not
intended to be limiting and/or absolute.
[0247] Various example devices and methods are provided for
performing laparoscopic and minimally invasive surgical procedures.
However, the person of ordinary skill in the art will readily
appreciate that the various methods and devices disclosed herein
can be used in numerous surgical procedures and applications
including, for example, in connection with open surgical
procedures. As the present Detailed Description proceeds, those of
ordinary skill in the art will further appreciate that the various
instruments disclosed herein can be inserted into a body in any
way, such as through a natural orifice, through an incision or
puncture hole formed in tissue, etc. The working portions or end
effector portions of the instruments can be inserted directly into
a patient's body or can be inserted through an access device that
has a working channel through which the end effector and elongated
shaft of a surgical instrument can be advanced.
[0248] FIGS. 1-6 depict a motor-driven surgical cutting and
fastening instrument 10 that may or may not be reused. In the
illustrated examples, the instrument 10 includes a housing 12 that
comprises a handle assembly 14 that is configured to be grasped,
manipulated and actuated by the clinician. The housing 12 is
configured for operable attachment to an interchangeable shaft
assembly 200 that has a surgical end effector 300 operably coupled
thereto that is configured to perform one or more surgical tasks or
procedures. As the present Detailed Description proceeds, it will
be understood that the various unique and novel arrangements of the
various forms of interchangeable shaft assemblies disclosed herein
also may be effectively employed in connection with
robotically-controlled surgical systems. Thus, the term "housing"
also may encompass a housing or similar portion of a robotic system
that houses or otherwise operably supports at least one drive
system that is configured to generate and apply at least one
control motion which could be used to actuate the interchangeable
shaft assemblies disclosed herein and their respective equivalents.
The term "frame" may refer to a portion of a handheld surgical
instrument. The term "frame" also may represent a portion of a
robotically controlled surgical instrument and/or a portion of the
robotic system that may be used to operably control a surgical
instrument. For example, the interchangeable shaft assemblies
disclosed herein may be employed with various robotic systems,
instruments, components and methods disclosed in U.S. patent
application Ser. No. 13/118,241, entitled SURGICAL STAPLING
INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS, now U.S.
Pat. No. 9,072,535. U.S. patent application Ser. No. 13/118,241,
entitled SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE
DEPLOYMENT ARRANGEMENTS, now U.S. Pat. No. 9,072,535, is
incorporated by reference herein in its entirety.
[0249] The housing 12 depicted in FIGS. 1-3 is shown in connection
with an interchangeable shaft assembly 200 that includes an end
effector 300 that comprises a surgical cutting and fastening device
that is configured to operably support a surgical staple cartridge
304 therein. The housing 12 may be configured for use in connection
with interchangeable shaft assemblies that include end effectors
that are adapted to support different sizes and types of staple
cartridges, have different shaft lengths, sizes, and types, etc. In
addition, the housing 12 also may be effectively employed with a
variety of other interchangeable shaft assemblies including those
assemblies that are configured to apply other motions and forms of
energy such as, for example, radio frequency (RF) energy,
ultrasonic energy and/or motion to end effector arrangements
adapted for use in connection with various surgical applications
and procedures. Furthermore, the end effectors, shaft assemblies,
handles, surgical instruments, and/or surgical instrument systems
can utilize any suitable fastener, or fasteners, to fasten tissue.
For instance, a fastener cartridge comprising a plurality of
fasteners removably stored therein can be removably inserted into
and/or attached to the end effector of a shaft assembly.
[0250] FIG. 1 illustrates the surgical instrument 10 with an
interchangeable shaft assembly 200 operably coupled thereto. FIGS.
2 and 3 illustrate attachment of the interchangeable shaft assembly
200 to the housing 12 or handle assembly 14. As shown in FIG. 4,
the handle assembly 14 may comprise a pair of interconnectable
handle housing segments 16 and 18 that may be interconnected by
screws, snap features, adhesive, etc. In the illustrated
arrangement, the handle housing segments 16, 18 cooperate to form a
pistol grip portion 19 that can be gripped and manipulated by the
clinician. As will be discussed in further detail below, the handle
assembly 14 operably supports a plurality of drive systems therein
that are configured to generate and apply various control motions
to corresponding portions of the interchangeable shaft assembly
that is operably attached thereto.
[0251] Referring now to FIG. 4, the handle assembly 14 may further
include a frame 20 that operably supports a plurality of drive
systems. For example, the frame 20 can operably support a "first"
or closure drive system, generally designated as 30, which may be
employed to apply closing and opening motions to the
interchangeable shaft assembly 200 that is operably attached or
coupled thereto. In at least one form, the closure drive system 30
may include an actuator in the form of a closure trigger 32 that is
pivotally supported by the frame 20. More specifically, as
illustrated in FIG. 4, the closure trigger 32 is pivotally coupled
to the housing 14 by a pin 33. Such arrangement enables the closure
trigger 32 to be manipulated by a clinician such that when the
clinician grips the pistol grip portion 19 of the handle assembly
14, the closure trigger 32 may be easily pivoted from a starting or
"unactuated" position to an "actuated" position and more
particularly to a fully compressed or fully actuated position. The
closure trigger 32 may be biased into the unactuated position by
spring or other biasing arrangement (not shown). In various forms,
the closure drive system 30 further includes a closure linkage
assembly 34 that is pivotally coupled to the closure trigger 32. As
shown in FIG. 4, the closure linkage assembly 34 may include a
first closure link 36 and a second closure link 38 that are
pivotally coupled to the closure trigger 32 by a pin 35. The second
closure link 38 also may be referred to herein as an "attachment
member" and include a transverse attachment pin 37.
[0252] Still referring to FIG. 4, it can be observed that the first
closure link 36 may have a locking wall or end 39 thereon that is
configured to cooperate with a closure release assembly 60 that is
pivotally coupled to the frame 20. In at least one form, the
closure release assembly 60 may comprise a release button assembly
62 that has a distally protruding locking pawl 64 formed thereon.
The release button assembly 62 may be pivoted in a counterclockwise
direction by a release spring (not shown). As the clinician
depresses the closure trigger 32 from its unactuated position
towards the pistol grip portion 19 of the handle assembly 14, the
first closure link 36 pivots upward to a point wherein the locking
pawl 64 drops into retaining engagement with the locking wall 39 on
the first closure link 36 thereby preventing the closure trigger 32
from returning to the unactuated position. See FIG. 18. Thus, the
closure release assembly 60 serves to lock the closure trigger 32
in the fully actuated position. When the clinician desires to
unlock the closure trigger 32 to permit it to be biased to the
unactuated position, the clinician simply pivots the closure
release button assembly 62 such that the locking pawl 64 is moved
out of engagement with the locking wall 39 on the first closure
link 36. When the locking pawl 64 has been moved out of engagement
with the first closure link 36, the closure trigger 32 may pivot
back to the unactuated position. Other closure trigger locking and
release arrangements also may be employed.
[0253] Further to the above, FIGS. 13-15 illustrate the closure
trigger 32 in its unactuated position which is associated with an
open, or unclamped, configuration of the shaft assembly 200 in
which tissue can be positioned between the jaws of the shaft
assembly 200. FIGS. 16-18 illustrate the closure trigger 32 in its
actuated position which is associated with a closed, or clamped,
configuration of the shaft assembly 200 in which tissue is clamped
between the jaws of the shaft assembly 200. Upon comparing FIGS. 14
and 17, the reader will appreciate that, when the closure trigger
32 is moved from its unactuated position (FIG. 14) to its actuated
position (FIG. 17), the closure release button 62 is pivoted
between a first position (FIG. 14) and a second position (FIG. 17).
The rotation of the closure release button 62 can be referred to as
being an upward rotation; however, at least a portion of the
closure release button 62 is being rotated toward the circuit board
100. Referring to FIG. 4, the closure release button 62 can include
an arm 61 extending therefrom and a magnetic element 63, such as a
permanent magnet, for example, mounted to the arm 61. When the
closure release button 62 is rotated from its first position to its
second position, the magnetic element 63 can move toward the
circuit board 100. The circuit board 100 can include at least one
sensor configured to detect the movement of the magnetic element
63. In at least one aspect, a magnetic field sensor 65, for
example, can be mounted to the bottom surface of the circuit board
100. The magnetic field sensor 65 can be configured to detect
changes in a magnetic field surrounding the magnetic field sensor
65 caused by the movement of the magnetic element 63. The magnetic
field sensor 65 can be in signal communication with a
microcontroller 1500 (FIG. 19), for example, which can determine
whether the closure release button 62 is in its first position,
which is associated with the unactuated position of the closure
trigger 32 and the open configuration of the end effector, its
second position, which is associated with the actuated position of
the closure trigger 32 and the closed configuration of the end
effector, and/or any position between the first position and the
second position.
[0254] As used throughout the present disclosure, a magnetic field
sensor may be a Hall effect sensor, search coil, fluxgate,
optically pumped, nuclear precession, SQUID, Hall-effect,
anisotropic magnetoresistance, giant magnetoresistance, magnetic
tunnel junctions, giant magnetoimpedance,
magnetostrictive/piezoelectric composites, magnetodiode,
magnetotransistor, fiber optic, magnetooptic, and
microelectromechanical systems-based magnetic sensors, among
others.
[0255] In at least one form, the handle assembly 14 and the frame
20 may operably support another drive system referred to herein as
a firing drive system 80 that is configured to apply firing motions
to corresponding portions of the interchangeable shaft assembly
attached thereto. The firing drive system may 80 also be referred
to herein as a "second drive system". The firing drive system 80
may employ an electric motor 82, located in the pistol grip portion
19 of the handle assembly 14. In various forms, the motor 82 may be
a DC brushed driving motor having a maximum rotation of,
approximately, 25,000 RPM, for example. In other arrangements, the
motor may include a brushless motor, a cordless motor, a
synchronous motor, a stepper motor, or any other suitable electric
motor. The motor 82 may be powered by a power source 90 that in one
form may comprise a removable power pack 92. As shown in FIG. 4,
for example, the power pack 92 may comprise a proximal housing
portion 94 that is configured for attachment to a distal housing
portion 96. The proximal housing portion 94 and the distal housing
portion 96 are configured to operably support a plurality of
batteries 98 therein. Batteries 98 may each comprise, for example,
a Lithium Ion ("LI") or other suitable battery. The distal housing
portion 96 is configured for removable operable attachment to a
control circuit board assembly 100 which is also operably coupled
to the motor 82. A number of batteries 98 may be connected in
series may be used as the power source for the surgical instrument
10. In addition, the power source 90 may be replaceable and/or
rechargeable.
[0256] As outlined above with respect to other various forms, the
electric motor 82 can include a rotatable shaft (not shown) that
operably interfaces with a gear reducer assembly 84 that is mounted
in meshing engagement with a with a set, or rack, of drive teeth
122 on a longitudinally-movable drive member 120. In use, a voltage
polarity provided by the power source 90 can operate the electric
motor 82 in a clockwise direction wherein the voltage polarity
applied to the electric motor by the battery can be reversed in
order to operate the electric motor 82 in a counter-clockwise
direction. When the electric motor 82 is rotated in one direction,
the drive member 120 will be axially driven in the distal direction
"DD". When the motor 82 is driven in the opposite rotary direction,
the drive member 120 will be axially driven in a proximal direction
"PD". The handle assembly 14 can include a switch which can be
configured to reverse the polarity applied to the electric motor 82
by the power source 90. As with the other forms described herein,
the handle assembly 14 can also include a sensor that is configured
to detect the position of the drive member 120 and/or the direction
in which the drive member 120 is being moved.
[0257] Actuation of the motor 82 can be controlled by a firing
trigger 130 that is pivotally supported on the handle assembly 14.
The firing trigger 130 may be pivoted between an unactuated
position and an actuated position. The firing trigger 130 may be
biased into the unactuated position by a spring 132 or other
biasing arrangement such that when the clinician releases the
firing trigger 130, it may be pivoted or otherwise returned to the
unactuated position by the spring 132 or biasing arrangement. In at
least one form, the firing trigger 130 can be positioned "outboard"
of the closure trigger 32 as was discussed above. In at least one
form, a firing trigger safety button 134 may be pivotally mounted
to the closure trigger 32 by pin 35. The safety button 134 may be
positioned between the firing trigger 130 and the closure trigger
32 and have a pivot arm 136 protruding therefrom. See FIG. 4. When
the closure trigger 32 is in the unactuated position, the safety
button 134 is contained in the handle assembly 14 where the
clinician cannot readily access it and move it between a safety
position preventing actuation of the firing trigger 130 and a
firing position wherein the firing trigger 130 may be fired. As the
clinician depresses the closure trigger 32, the safety button 134
and the firing trigger 130 pivot down wherein they can then be
manipulated by the clinician.
[0258] As discussed above, the handle assembly 14 can include a
closure trigger 32 and a firing trigger 130. Referring to FIGS.
14-18A, the firing trigger 130 can be pivotably mounted to the
closure trigger 32. The closure trigger 32 can include an arm 31
extending therefrom and the firing trigger 130 can be pivotably
mounted to the arm 31 about a pivot pin 33. When the closure
trigger 32 is moved from its unactuated position (FIG. 14) to its
actuated position (FIG. 17), the firing trigger 130 can descend
downwardly, as outlined above. After the safety button 134 has been
moved to its firing position, referring primarily to FIG. 18A, the
firing trigger 130 can be depressed to operate the motor of the
surgical instrument firing system. In various instances, the handle
assembly 14 can include a tracking system, such as system 800, for
example, configured to determine the position of the closure
trigger 32 and/or the position of the firing trigger 130. With
primary reference to FIGS. 14, 17, and 18A, the tracking system 800
can include a magnetic element, such as permanent magnet 802, for
example, which is mounted to an arm 801 extending from the firing
trigger 130. The tracking system 800 can comprise one or more
sensors, such as a first magnetic field sensor 803 and a second
magnetic field sensor 804, for example, which can be configured to
track the position of the magnet 802.
[0259] Upon comparing FIGS. 14 and 17, the reader will appreciate
that, when the closure trigger 32 is moved from its unactuated
position to its actuated position, the magnet 802 can move between
a first position adjacent the first magnetic field sensor 803 and a
second position adjacent the second magnetic field sensor 804.
[0260] Upon comparing FIGS. 17 and 18A, the reader will further
appreciate that, when the firing trigger 130 is moved from an
unfired position (FIG. 17) to a fired position (FIG. 18A), the
magnet 802 can move relative to the second magnetic field sensor
804. The sensors 803 and 804 can track the movement of the magnet
802 and can be in signal communication with a microcontroller on
the circuit board 100. With data from the first sensor 803 and/or
the second sensor 804, the microcontroller can determine the
position of the magnet 802 along a predefined path and, based on
that position, the microcontroller can determine whether the
closure trigger 32 is in its unactuated position, its actuated
position, or a position therebetween. Similarly, with data from the
first sensor 803 and/or the second sensor 804, the microcontroller
can determine the position of the magnet 802 along a predefined
path and, based on that position, the microcontroller can determine
whether the firing trigger 130 is in its unfired position, its
fully fired position, or a position therebetween.
[0261] As indicated above, in at least one form, the longitudinally
movable drive member 120 has a rack of teeth 122 formed thereon for
meshing engagement with a corresponding drive gear 86 of the gear
reducer assembly 84. At least one form also includes a
manually-actuatable "bailout" assembly 140 that is configured to
enable the clinician to manually retract the longitudinally movable
drive member 120 should the motor 82 become disabled. The bailout
assembly 140 may include a lever or bailout handle assembly 14 that
is configured to be manually pivoted into ratcheting engagement
with teeth 124 also provided in the drive member 120. Thus, the
clinician can manually retract the drive member 120 by using the
bailout handle assembly 14 to ratchet the drive member 120 in the
proximal direction "PD". U.S. Patent Application Publication No.
2010/0089970, now U.S. Pat. No. 8,608,045 discloses bailout
arrangements and other components, arrangements and systems that
also may be employed with the various instruments disclosed herein.
U.S. patent application Ser. No. 12/249,117, entitled POWERED
SURGICAL CUTTING AND STAPLING APPARATUS WITH MANUALLY RETRACTABLE
FIRING SYSTEM, U.S. Patent Application Publication No.
2010/0089970, now U.S. Pat. No. 8,608,045, is hereby incorporated
by reference in its entirety.
[0262] Turning now to FIGS. 1 and 7, the interchangeable shaft
assembly 200 includes a surgical end effector 300 that comprises an
elongated channel 302 that is configured to operably support a
staple cartridge 304 therein. The end effector 300 may further
include an anvil 306 that is pivotally supported relative to the
elongated channel 302. The interchangeable shaft assembly 200 may
further include an articulation joint 270 and an articulation lock
350 (FIG. 8) which can be configured to releasably hold the end
effector 300 in a desired position relative to a shaft axis SA-SA.
Details regarding the construction and operation of the end
effector 300, the articulation joint 270 and the articulation lock
350 are set forth in U.S. patent application Ser. No. 13/803,086,
filed Mar. 14, 2013, entitled ARTICULATABLE SURGICAL INSTRUMENT
COMPRISING AN ARTICULATION LOCK, now U.S. Patent Application
Publication No. 2014/0263541. The entire disclosure of U.S. patent
application Ser. No. 13/803,086, filed Mar. 14, 2013, entitled
ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK,
now U.S. Patent Application Publication No. 2014/0263541, is hereby
incorporated by reference herein. As shown in FIGS. 7 and 8, the
interchangeable shaft assembly 200 can further include a proximal
housing or nozzle 201 comprised of nozzle portions 202 and 203. The
interchangeable shaft assembly 200 can further include a closure
tube 260 which can be utilized to close and/or open the anvil 306
of the end effector 300. Primarily referring now to FIGS. 8 and 9,
the shaft assembly 200 can include a spine 210 which can be
configured to fixably support a shaft frame portion 212 of the
articulation lock 350. See FIG. 8. The spine 210 can be configured
to, one, slidably support a firing member 220 therein and, two,
slidably support the closure tube 260 which extends around the
spine 210. The spine 210 can also be configured to slidably support
a proximal articulation driver 230. The articulation driver 230 has
a distal end 231 that is configured to operably engage the
articulation lock 350. The articulation lock 350 interfaces with an
articulation frame 352 that is adapted to operably engage a drive
pin (not shown) on the end effector frame (not shown). As indicated
above, further details regarding the operation of the articulation
lock 350 and the articulation frame may be found in U.S. patent
application Ser. No. 13/803,086, now U.S. Patent Application
Publication No. 2014/0263541. In various circumstances, the spine
210 can comprise a proximal end 211 which is rotatably supported in
a chassis 240. In one arrangement, for example, the proximal end
211 of the spine 210 has a thread 214 formed thereon for threaded
attachment to a spine bearing 216 configured to be supported within
the chassis 240. See FIG. 7. Such an arrangement facilitates
rotatable attachment of the spine 210 to the chassis 240 such that
the spine 210 may be selectively rotated about a shaft axis SA-SA
relative to the chassis 240.
[0263] Referring primarily to FIG. 7, the interchangeable shaft
assembly 200 includes a closure shuttle 250 that is slidably
supported within the chassis 240 such that it may be axially moved
relative thereto. As shown in FIGS. 3 and 7, the closure shuttle
250 includes a pair of proximally-protruding hooks 252 that are
configured for attachment to the attachment pin 37 that is attached
to the second closure link 38 as will be discussed in further
detail below. A proximal end 261 of the closure tube 260 is coupled
to the closure shuttle 250 for relative rotation thereto. For
example, a U shaped connector 263 is inserted into an annular slot
262 in the proximal end 261 of the closure tube 260 and is retained
within vertical slots 253 in the closure shuttle 250. See FIG. 7.
Such an arrangement serves to attach the closure tube 260 to the
closure shuttle 250 for axial travel therewith while enabling the
closure tube 260 to rotate relative to the closure shuttle 250
about the shaft axis SA-SA. A closure spring 268 is journaled on
the closure tube 260 and serves to bias the closure tube 260 in the
proximal direction "PD" which can serve to pivot the closure
trigger into the unactuated position when the shaft assembly is
operably coupled to the handle assembly 14.
[0264] In at least one form, the interchangeable shaft assembly 200
may further include an articulation joint 270. Other
interchangeable shaft assemblies, however, may not be capable of
articulation. As shown in FIG. 7, for example, the articulation
joint 270 includes a double pivot closure sleeve assembly 271.
According to various forms, the double pivot closure sleeve
assembly 271 includes an end effector closure sleeve assembly 272
having upper and lower distally projecting tangs 273, 274. An end
effector closure sleeve assembly 272 includes a horseshoe aperture
275 and a tab 276 for engaging an opening tab on the anvil 306 in
the various manners described in U.S. patent application Ser. No.
13/803,086, filed Mar. 14, 2013, entitled ARTICULATABLE SURGICAL
INSTRUMENT COMPRISING AN ARTICULATION LOCK, now U.S. Patent
Application Publication No. 2014/0263541, which has been
incorporated by reference herein. As described in further detail
therein, the horseshoe aperture 275 and tab 276 engage a tab on the
anvil when the anvil 306 is opened. An upper double pivot link 277
includes upwardly projecting distal and proximal pivot pins that
engage respectively an upper distal pin hole in the upper
proximally projecting tang 273 and an upper proximal pin hole in an
upper distally projecting tang 264 on the closure tube 260. A lower
double pivot link 278 includes upwardly projecting distal and
proximal pivot pins that engage respectively a lower distal pin
hole in the lower proximally projecting tang 274 and a lower
proximal pin hole in the lower distally projecting tang 265. See
also FIG. 8.
[0265] In use, the closure tube 260 is translated distally
(direction "DD") to close the anvil 306, for example, in response
to the actuation of the closure trigger 32. The anvil 306 is closed
by distally translating the closure tube 260 and thus the shaft
closure sleeve assembly 272, causing it to strike a proximal
surface on the anvil 360 in the manner described in the
aforementioned reference U.S. patent application Ser. No.
13/803,086, now U.S. Patent Application Publication No.
2014/0263541. As was also described in detail in that reference,
the anvil 306 is opened by proximally translating the closure tube
260 and the shaft closure sleeve assembly 272, causing tab 276 and
the horseshoe aperture 275 to contact and push against the anvil
tab to lift the anvil 306. In the anvil-open position, the shaft
closure tube 260 is moved to its proximal position.
[0266] As indicated above, the surgical instrument 10 may further
include an articulation lock 350 of the types and construction
described in further detail in U.S. patent application Ser. No.
13/803,086, now U.S. Patent Application Publication No.
2014/0263541, which can be configured and operated to selectively
lock the end effector 300 in position. Such arrangement enables the
end effector 300 to be rotated, or articulated, relative to the
shaft closure tube 260 when the articulation lock 350 is in its
unlocked state. In such an unlocked state, the end effector 300 can
be positioned and pushed against soft tissue and/or bone, for
example, surrounding the surgical site within the patient in order
to cause the end effector 300 to articulate relative to the closure
tube 260. The end effector 300 also may be articulated relative to
the closure tube 260 by an articulation driver 230.
[0267] As was also indicated above, the interchangeable shaft
assembly 200 further includes a firing member 220 that is supported
for axial travel within the shaft spine 210. The firing member 220
includes an intermediate firing shaft portion 222 that is
configured for attachment to a distal cutting portion or knife bar
280. The firing member 220 also may be referred to herein as a
"second shaft" and/or a "second shaft assembly". As shown in FIGS.
8 and 9, the intermediate firing shaft portion 222 may include a
longitudinal slot 223 in the distal end thereof which can be
configured to receive a tab 284 on the proximal end 282 of the
distal knife bar 280. The longitudinal slot 223 and the proximal
end 282 can be sized and configured to permit relative movement
therebetween and can comprise a slip joint 286. The slip joint 286
can permit the intermediate firing shaft portion 222 of the firing
drive 220 to be moved to articulate the end effector 300 without
moving, or at least substantially moving, the knife bar 280. Once
the end effector 300 has been suitably oriented, the intermediate
firing shaft portion 222 can be advanced distally until a proximal
sidewall of the longitudinal slot 223 comes into contact with the
tab 284 in order to advance the knife bar 280 and fire the staple
cartridge positioned within the channel 302 As can be further seen
in FIGS. 8 and 9, the shaft spine 210 has an elongate opening or
window 213 therein to facilitate assembly and insertion of the
intermediate firing shaft portion 222 into the shaft frame 210.
Once the intermediate firing shaft portion 222 has been inserted
therein, a top frame segment 215 may be engaged with the shaft
frame 212 to enclose the intermediate firing shaft portion 222 and
knife bar 280 therein. Further description of the operation of the
firing member 220 may be found in U.S. patent application Ser. No.
13/803,086, now U.S. Patent Application Publication No.
2014/0263541.
[0268] Further to the above, the shaft assembly 200 can include a
clutch assembly 400 which can be configured to selectively and
releasably couple the articulation driver 230 to the firing member
220. In one form, the clutch assembly 400 includes a lock collar,
or sleeve 402, positioned around the firing member 220 wherein the
lock sleeve 402 can be rotated between an engaged position in which
the lock sleeve 402 couples the articulation driver 360 to the
firing member 220 and a disengaged position in which the
articulation driver 360 is not operably coupled to the firing
member 200. When lock sleeve 402 is in its engaged position, distal
movement of the firing member 220 can move the articulation driver
360 distally and, correspondingly, proximal movement of the firing
member 220 can move the articulation driver 230 proximally. When
lock sleeve 402 is in its disengaged position, movement of the
firing member 220 is not transmitted to the articulation driver 230
and, as a result, the firing member 220 can move independently of
the articulation driver 230. In various circumstances, the
articulation driver 230 can be held in position by the articulation
lock 350 when the articulation driver 230 is not being moved in the
proximal or distal directions by the firing member 220.
[0269] Referring primarily to FIG. 9, the lock sleeve 402 can
comprise a cylindrical, or an at least substantially cylindrical,
body including a longitudinal aperture 403 defined therein
configured to receive the firing member 220. The lock sleeve 402
can comprise diametrically-opposed, inwardly-facing lock
protrusions 404 and an outwardly-facing lock member 406. The lock
protrusions 404 can be configured to be selectively engaged with
the firing member 220. More particularly, when the lock sleeve 402
is in its engaged position, the lock protrusions 404 are positioned
within a drive notch 224 defined in the firing member 220 such that
a distal pushing force and/or a proximal pulling force can be
transmitted from the firing member 220 to the lock sleeve 402. When
the lock sleeve 402 is in its engaged position, the second lock
member 406 is received within a drive notch 232 defined in the
articulation driver 230 such that the distal pushing force and/or
the proximal pulling force applied to the lock sleeve 402 can be
transmitted to the articulation driver 230. In effect, the firing
member 220, the lock sleeve 402, and the articulation driver 230
will move together when the lock sleeve 402 is in its engaged
position. On the other hand, when the lock sleeve 402 is in its
disengaged position, the lock protrusions 404 may not be positioned
within the drive notch 224 of the firing member 220 and, as a
result, a distal pushing force and/or a proximal pulling force may
not be transmitted from the firing member 220 to the lock sleeve
402. Correspondingly, the distal pushing force and/or the proximal
pulling force may not be transmitted to the articulation driver
230. In such circumstances, the firing member 220 can be slid
proximally and/or distally relative to the lock sleeve 402 and the
proximal articulation driver 230.
[0270] As shown in FIGS. 8-12, the shaft assembly 200 further
includes a switch drum 500 that is rotatably received on the
closure tube 260. The switch drum 500 comprises a hollow shaft
segment 502 that has a shaft boss 504 formed thereon for receive an
outwardly protruding actuation pin 410 therein. In various
circumstances, the actuation pin 410 extends through a slot 267
into a longitudinal slot 408 provided in the lock sleeve 402 to
facilitate axial movement of the lock sleeve 402 when it is engaged
with the articulation driver 230. A rotary torsion spring 420 is
configured to engage the boss 504 on the switch drum 500 and a
portion of the nozzle housing 203 as shown in FIG. 10 to apply a
biasing force to the switch drum 500. The switch drum 500 can
further comprise at least partially circumferential openings 506
defined therein which, referring to FIGS. 5 and 6, can be
configured to receive circumferential mounts 204, 205 extending
from the nozzle halves 202, 203 and permit relative rotation, but
not translation, between the switch drum 500 and the proximal
nozzle 201. As shown in those Figures, the mounts 204 and 205 also
extend through openings 266 in the closure tube 260 to be seated in
recesses 211 in the shaft spine 210. However, rotation of the
nozzle 201 to a point where the mounts 204, 205 reach the end of
their respective slots 506 in the switch drum 500 will result in
rotation of the switch drum 500 about the shaft axis SA-SA.
Rotation of the switch drum 500 will ultimately result in the
rotation of eth actuation pin 410 and the lock sleeve 402 between
its engaged and disengaged positions. Thus, in essence, the nozzle
201 may be employed to operably engage and disengage the
articulation drive system with the firing drive system in the
various manners described in further detail in U.S. patent
application Ser. No. 13/803,086, now U.S. Patent Application
Publication No. 2014/0263541.
[0271] As also illustrated in FIGS. 8-12, the shaft assembly 200
can comprise a slip ring assembly 600 which can be configured to
conduct electrical power to and/or from the end effector 300 and/or
communicate signals to and/or from the end effector 300, for
example. The slip ring assembly 600 can comprise a proximal
connector flange 604 mounted to a chassis flange 242 extending from
the chassis 240 and a distal connector flange 601 positioned within
a slot defined in the shaft housings 202, 203. The proximal
connector flange 604 can comprise a first face and the distal
connector flange 601 can comprise a second face which is positioned
adjacent to and movable relative to the first face. The distal
connector flange 601 can rotate relative to the proximal connector
flange 604 about the shaft axis SA-SA. The proximal connector
flange 604 can comprise a plurality of concentric, or at least
substantially concentric, conductors 602 defined in the first face
thereof. A connector 607 can be mounted on the proximal side of the
connector flange 601 and may have a plurality of contacts (not
shown) wherein each contact corresponds to and is in electrical
contact with one of the conductors 602. Such an arrangement permits
relative rotation between the proximal connector flange 604 and the
distal connector flange 601 while maintaining electrical contact
therebetween. The proximal connector flange 604 can include an
electrical connector 606 which can place the conductors 602 in
signal communication with a shaft circuit board 610 mounted to the
shaft chassis 240, for example. In at least one instance, a wiring
harness comprising a plurality of conductors can extend between the
electrical connector 606 and the shaft circuit board 610. The
electrical connector 606 may extend proximally through a connector
opening 243 defined in the chassis mounting flange 242. See FIG. 7.
U.S. patent application Ser. No. 13/800,067, entitled STAPLE
CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, filed on Mar. 13, 2013,
now U.S. Patent Application Publication No. 2014/0263552, is
incorporated by reference in its entirety. U.S. patent application
Ser. No. 13/800,025, entitled STAPLE CARTRIDGE TISSUE THICKNESS
SENSOR SYSTEM, filed on Mar. 13, 2013, now U.S. Pat. No. 9,345,481,
is incorporated by reference in its entirety. Further details
regarding slip ring assembly 600 may be found in U.S. patent
application Ser. No. 13/803,086, now U.S. Patent Application
Publication No. 2014/0263541.
[0272] As discussed above, the shaft assembly 200 can include a
proximal portion which is fixably mounted to the handle assembly 14
and a distal portion which is rotatable about a longitudinal axis.
The rotatable distal shaft portion can be rotated relative to the
proximal portion about the slip ring assembly 600, as discussed
above. The distal connector flange 601 of the slip ring assembly
600 can be positioned within the rotatable distal shaft portion.
Moreover, further to the above, the switch drum 500 can also be
positioned within the rotatable distal shaft portion. When the
rotatable distal shaft portion is rotated, the distal connector
flange 601 and the switch drum 500 can be rotated synchronously
with one another. In addition, the switch drum 500 can be rotated
between a first position and a second position relative to the
distal connector flange 601. When the switch drum 500 is in its
first position, the articulation drive system may be operably
disengaged from the firing drive system and, thus, the operation of
the firing drive system may not articulate the end effector 300 of
the shaft assembly 200. When the switch drum 500 is in its second
position, the articulation drive system may be operably engaged
with the firing drive system and, thus, the operation of the firing
drive system may articulate the end effector 300 of the shaft
assembly 200. When the switch drum 500 is moved between its first
position and its second position, the switch drum 500 is moved
relative to distal connector flange 601. In various instances, the
shaft assembly 200 can comprise at least one sensor configured to
detect the position of the switch drum 500. Turning now to FIGS. 11
and 12, the distal connector flange 601 can comprise a magnetic
field sensor 605, for example, and the switch drum 500 can comprise
a magnetic element, such as permanent magnet 505, for example. The
magnetic field sensor 605 can be configured to detect the position
of the permanent magnet 505. When the switch drum 500 is rotated
between its first position and its second position, the permanent
magnet 505 can move relative to the magnetic field sensor 605. In
various instances, magnetic field sensor 605 can detect changes in
a magnetic field created when the permanent magnet 505 is moved.
The magnetic field sensor 605 can be in signal communication with
the shaft circuit board 610 and/or the handle circuit board 100,
for example. Based on the signal from the magnetic field sensor
605, a microcontroller on the shaft circuit board 610 and/or the
handle circuit board 100 can determine whether the articulation
drive system is engaged with or disengaged from the firing drive
system.
[0273] Referring again to FIGS. 3 and 7, the chassis 240 includes
at least one, and preferably two, tapered attachment portions 244
formed thereon that are adapted to be received within corresponding
dovetail slots 702 formed within a distal attachment flange portion
700 of the frame 20. Each dovetail slot 702 may be tapered or,
stated another way, be somewhat V-shaped to seatingly receive the
attachment portions 244 therein. As can be further seen in FIGS. 3
and 7, a shaft attachment lug 226 is formed on the proximal end of
the intermediate firing shaft 222. As will be discussed in further
detail below, when the interchangeable shaft assembly 200 is
coupled to the handle assembly 14, the shaft attachment lug 226 is
received in a firing shaft attachment cradle 126 formed in the
distal end 125 of the longitudinal drive member 120 as shown in
FIGS. 3 and 6, for example.
[0274] Various shaft assemblies employ a latch system 710 for
removably coupling the shaft assembly 200 to the housing 12 and
more specifically to the frame 20. As shown in FIG. 7, for example,
in at least one form, the latch system 710 includes a lock member
or lock yoke 712 that is movably coupled to the chassis 240. In the
illustrated example, for example, the lock yoke 712 has a U-shape
with two spaced downwardly extending legs 714. The legs 714 each
have a pivot lug 716 formed thereon that are adapted to be received
in corresponding holes 245 formed in the chassis 240. Such
arrangement facilitates pivotal attachment of the lock yoke 712 to
the chassis 240. The lock yoke 712 may include two proximally
protruding lock lugs 714 that are configured for releasable
engagement with corresponding lock detents or grooves 704 in the
distal attachment flange 700 of the frame 20. See FIG. 3. In
various forms, the lock yoke 712 is biased in the proximal
direction by spring or biasing member (not shown). Actuation of the
lock yoke 712 may be accomplished by a latch button 722 that is
slidably mounted on a latch actuator assembly 720 that is mounted
to the chassis 240. The latch button 722 may be biased in a
proximal direction relative to the lock yoke 712. As will be
discussed in further detail below, the lock yoke 712 may be moved
to an unlocked position by biasing the latch button the in distal
direction which also causes the lock yoke 712 to pivot out of
retaining engagement with the distal attachment flange 700 of the
frame 20. When the lock yoke 712 is in "retaining engagement" with
the distal attachment flange 700 of the frame 20, the lock lugs 716
are retainingly seated within the corresponding lock detents or
grooves 704 in the distal attachment flange 700.
[0275] When employing an interchangeable shaft assembly that
includes an end effector of the type described herein that is
adapted to cut and fasten tissue, as well as other types of end
effectors, it may be desirable to prevent inadvertent detachment of
the interchangeable shaft assembly from the housing during
actuation of the end effector. For example, in use the clinician
may actuate the closure trigger 32 to grasp and manipulate the
target tissue into a desired position. Once the target tissue is
positioned within the end effector 300 in a desired orientation,
the clinician may then fully actuate the closure trigger 32 to
close the anvil 306 and clamp the target tissue in position for
cutting and stapling. In that instance, the first drive system 30
has been fully actuated. After the target tissue has been clamped
in the end effector 300, it may be desirable to prevent the
inadvertent detachment of the shaft assembly 200 from the housing
12. One form of the latch system 710 is configured to prevent such
inadvertent detachment.
[0276] As can be most particularly seen in FIG. 7, the lock yoke
712 includes at least one and preferably two lock hooks 718 that
are adapted to contact corresponding lock lug portions 256 that are
formed on the closure shuttle 250. Referring to FIGS. 13-15, when
the closure shuttle 250 is in an unactuated position (i.e., the
first drive system 30 is unactuated and the anvil 306 is open), the
lock yoke 712 may be pivoted in a distal direction to unlock the
interchangeable shaft assembly 200 from the housing 12. When in
that position, the lock hooks 718 do not contact the lock lug
portions 256 on the closure shuttle 250. However, when the closure
shuttle 250 is moved to an actuated position (i.e., the first drive
system 30 is actuated and the anvil 306 is in the closed position),
the lock yoke 712 is prevented from being pivoted to an unlocked
position. See FIGS. 16-18. Stated another way, if the clinician
were to attempt to pivot the lock yoke 712 to an unlocked position
or, for example, the lock yoke 712 was in advertently bumped or
contacted in a manner that might otherwise cause it to pivot
distally, the lock hooks 718 on the lock yoke 712 will contact the
lock lugs 256 on the closure shuttle 250 and prevent movement of
the lock yoke 712 to an unlocked position.
[0277] Attachment of the interchangeable shaft assembly 200 to the
handle assembly 14 will now be described with reference to FIG. 3.
To commence the coupling process, the clinician may position the
chassis 240 of the interchangeable shaft assembly 200 above or
adjacent to the distal attachment flange 700 of the frame 20 such
that the tapered attachment portions 244 formed on the chassis 240
are aligned with the dovetail slots 702 in the frame 20. The
clinician may then move the shaft assembly 200 along an
installation axis IA that is perpendicular to the shaft axis SA-SA
to seat the attachment portions 244 in "operable engagement" with
the corresponding dovetail receiving slots 702. In doing so, the
shaft attachment lug 226 on the intermediate firing shaft 222 will
also be seated in the cradle 126 in the longitudinally movable
drive member 120 and the portions of pin 37 on the second closure
link 38 will be seated in the corresponding hooks 252 in the
closure yoke 250. As used herein, the term "operable engagement" in
the context of two components means that the two components are
sufficiently engaged with each other so that upon application of an
actuation motion thereto, the components may carry out their
intended action, function and/or procedure.
[0278] As discussed above, at least five systems of the
interchangeable shaft assembly 200 can be operably coupled with at
least five corresponding systems of the handle assembly 14. A first
system can comprise a frame system which couples and/or aligns the
frame or spine of the shaft assembly 200 with the frame 20 of the
handle assembly 14. Another system can comprise a closure drive
system 30 which can operably connect the closure trigger 32 of the
handle assembly 14 and the closure tube 260 and the anvil 306 of
the shaft assembly 200. As outlined above, the closure tube
attachment yoke 250 of the shaft assembly 200 can be engaged with
the pin 37 on the second closure link 38. Another system can
comprise the firing drive system 80 which can operably connect the
firing trigger 130 of the handle assembly 14 with the intermediate
firing shaft 222 of the shaft assembly 200.
[0279] As outlined above, the shaft attachment lug 226 can be
operably connected with the cradle 126 of the longitudinal drive
member 120. Another system can comprise an electrical system which
can signal to a controller in the handle assembly 14, such as
microcontroller, for example, that a shaft assembly, such as shaft
assembly 200, for example, has been operably engaged with the
handle assembly 14 and/or, two, conduct power and/or communication
signals between the shaft assembly 200 and the handle assembly 14.
For instance, the shaft assembly 200 can include an electrical
connector 1410 that is operably mounted to the shaft circuit board
610. The electrical connector 1410 is configured for mating
engagement with a corresponding electrical connector 1400 on the
handle control board 100. Further details regaining the circuitry
and control systems may be found in U.S. patent application Ser.
No. 13/803,086, now U.S. Patent Application Publication No.
2014/0263541, the entire disclosure of which was previously
incorporated by reference herein. The fifth system may consist of
the latching system for releasably locking the shaft assembly 200
to the handle assembly 14.
[0280] Referring again to FIGS. 2 and 3, the handle assembly 14 can
include an electrical connector 1400 comprising a plurality of
electrical contacts. Turning now to FIG. 19, the electrical
connector 1400 can comprise a first contact 1401a, a second contact
1401b, a third contact 1401c, a fourth contact 1401d, a fifth
contact 1401e, and a sixth contact 1401f, for example. While the
illustrated example utilizes six contacts, other examples are
envisioned which may utilize more than six contacts or less than
six contacts.
[0281] As illustrated in FIG. 19, the first contact 1401a can be in
electrical communication with a transistor 1408, contacts
1401b-1401e can be in electrical communication with a
microcontroller 1500, and the sixth contact 1401f can be in
electrical communication with a ground. In certain circumstances,
one or more of the electrical contacts 1401b-1401e may be in
electrical communication with one or more output channels of the
microcontroller 1500 and can be energized, or have a voltage
potential applied thereto, when the handle 1042 is in a powered
state. In some circumstances, one or more of the electrical
contacts 1401b-1401e may be in electrical communication with one or
more input channels of the microcontroller 1500 and, when the
handle assembly 14 is in a powered state, the microcontroller 1500
can be configured to detect when a voltage potential is applied to
such electrical contacts. When a shaft assembly, such as shaft
assembly 200, for example, is assembled to the handle assembly 14,
the electrical contacts 1401a-1401f may not communicate with each
other. When a shaft assembly is not assembled to the handle
assembly 14, however, the electrical contacts 1401a-1401f of the
electrical connector 1400 may be exposed and, in some
circumstances, one or more of the contacts 1401a-1401f may be
accidentally placed in electrical communication with each other.
Such circumstances can arise when one or more of the contacts
1401a-1401f come into contact with an electrically conductive
material, for example. When this occurs, the microcontroller 1500
can receive an erroneous input and/or the shaft assembly 200 can
receive an erroneous output, for example. To address this issue, in
various circumstances, the handle assembly 14 may be unpowered when
a shaft assembly, such as shaft assembly 200, for example, is not
attached to the handle assembly 14.
[0282] In other circumstances, the handle 1042 can be powered when
a shaft assembly, such as shaft assembly 200, for example, is not
attached thereto. In such circumstances, the microcontroller 1500
can be configured to ignore inputs, or voltage potentials, applied
to the contacts in electrical communication with the
microcontroller 1500, i.e., contacts 1401b-1401e, for example,
until a shaft assembly is attached to the handle assembly 14. Even
though the microcontroller 1500 may be supplied with power to
operate other functionalities of the handle assembly 14 in such
circumstances, the handle assembly 14 may be in a powered-down
state. In a way, the electrical connector 1400 may be in a
powered-down state as voltage potentials applied to the electrical
contacts 1401b-1401e may not affect the operation of the handle
assembly 14. The reader will appreciate that, even though contacts
1401b-1401e may be in a powered-down state, the electrical contacts
1401a and 1401f, which are not in electrical communication with the
microcontroller 1500, may or may not be in a powered-down state.
For instance, sixth contact 1401f may remain in electrical
communication with a ground regardless of whether the handle
assembly 14 is in a powered-up or a powered-down state.
[0283] Furthermore, the transistor 1408, and/or any other suitable
arrangement of transistors, such as transistor 1410, for example,
and/or switches may be configured to control the supply of power
from a power source 1404, such as a battery 90 within the handle
assembly 14, for example, to the first electrical contact 1401a
regardless of whether the handle assembly 14 is in a powered-up or
a powered-down state. In various circumstances, the shaft assembly
200, for example, can be configured to change the state of the
transistor 1408 when the shaft assembly 200 is engaged with the
handle assembly 14. In certain circumstances, further to the below,
a magnetic field sensor 1402 can be configured to switch the state
of transistor 1410 which, as a result, can switch the state of
transistor 1408 and ultimately supply power from power source 1404
to first contact 1401a. In this way, both the power circuits and
the signal circuits to the connector 1400 can be powered down when
a shaft assembly is not installed to the handle assembly 14 and
powered up when a shaft assembly is installed to the handle
assembly 14.
[0284] In various circumstances, referring again to FIG. 19, the
handle assembly 14 can include the magnetic field sensor 1402, for
example, which can be configured to detect a detectable element,
such as a magnetic element 1407 (FIG. 3), for example, on a shaft
assembly, such as shaft assembly 200, for example, when the shaft
assembly is coupled to the handle assembly 14. The magnetic field
sensor 1402 can be powered by a power source 1406, such as a
battery, for example, which can, in effect, amplify the detection
signal of the magnetic field sensor 1402 and communicate with an
input channel of the microcontroller 1500 via the circuit
illustrated in FIG. 19. Once the microcontroller 1500 has a
received an input indicating that a shaft assembly has been at
least partially coupled to the handle assembly 14, and that, as a
result, the electrical contacts 1401a-1401f are no longer exposed,
the microcontroller 1500 can enter into its normal, or powered-up,
operating state. In such an operating state, the microcontroller
1500 will evaluate the signals transmitted to one or more of the
contacts 1401b-1401e from the shaft assembly and/or transmit
signals to the shaft assembly through one or more of the contacts
1401b-1401e in normal use thereof. In various circumstances, the
shaft assembly 200 may have to be fully seated before the magnetic
field sensor 1402 can detect the magnetic element 1407. While a
magnetic field sensor 1402 can be utilized to detect the presence
of the shaft assembly 200, any suitable system of sensors and/or
switches can be utilized to detect whether a shaft assembly has
been assembled to the handle assembly 14, for example. In this way,
further to the above, both the power circuits and the signal
circuits to the connector 1400 can be powered down when a shaft
assembly is not installed to the handle assembly 14 and powered up
when a shaft assembly is installed to the handle assembly 14.
[0285] In various examples, as may be used throughout the present
disclosure, any suitable magnetic field sensor may be employed to
detect whether a shaft assembly has been assembled to the handle
assembly 14, for example. For example, the technologies used for
magnetic field sensing include Hall effect sensor, search coil,
fluxgate, optically pumped, nuclear precession, SQUID, Hall-effect,
anisotropic magnetoresistance, giant magnetoresistance, magnetic
tunnel junctions, giant magnetoimpedance,
magnetostrictive/piezoelectric composites, magnetodiode,
magnetotransistor, fiber optic, magnetooptic, and
microelectromechanical systems-based magnetic sensors, among
others.
[0286] Referring to FIG. 19, the microcontroller 1500 may generally
comprise a microprocessor ("processor") and one or more memory
units operationally coupled to the processor. By executing
instruction code stored in the memory, the processor may control
various components of the surgical instrument, such as the motor,
various drive systems, and/or a user display, for example. The
microcontroller 1500 may be implemented using integrated and/or
discrete hardware elements, software elements, and/or a combination
of both. Examples of integrated hardware elements may include
processors, microprocessors, microcontrollers, integrated circuits,
application specific integrated circuits (ASIC), programmable logic
devices (PLD), digital signal processors (DSP), field programmable
gate arrays (FPGA), logic gates, registers, semiconductor devices,
chips, microchips, chip sets, microcontrollers, system-on-chip
(SoC), and/or system-in-package (SIP). Examples of discrete
hardware elements may include circuits and/or circuit elements such
as logic gates, field effect transistors, bipolar transistors,
resistors, capacitors, inductors, and/or relays. In certain
instances, the microcontroller 1500 may include a hybrid circuit
comprising discrete and integrated circuit elements or components
on one or more substrates, for example.
[0287] Referring to FIG. 19, the microcontroller 1500 may be an LM
4F230H5QR, available from Texas Instruments, for example. In
certain instances, the Texas Instruments LM4F230H5QR is an ARM
Cortex-M4F Processor Core comprising on-chip memory of 256 KB
single-cycle flash memory, or other non-volatile memory, up to 40
MHz, a prefetch buffer to improve performance above 40 MHz, a 32 KB
single-cycle serial random access memory (SRAM), internal read-only
memory (ROM) loaded with StellarisWare.RTM. software, 2 KB
electrically erasable programmable read-only memory (EEPROM), one
or more pulse width modulation (PWM) modules, one or more
quadrature encoder inputs (QEI) analog, one or more 12-bit
Analog-to-Digital Converters (ADC) with 12 analog input channels,
among other features that are readily available. Other
microcontrollers may be readily substituted for use with the
present disclosure. Accordingly, the present disclosure should not
be limited in this context.
[0288] As discussed above, the handle assembly 14 and/or the shaft
assembly 200 can include systems and configurations configured to
prevent, or at least reduce the possibility of, the contacts of the
handle electrical connector 1400 and/or the contacts of the shaft
electrical connector 1410 from becoming shorted out when the shaft
assembly 200 is not assembled, or completely assembled, to the
handle assembly 14. Referring to FIG. 3, the handle electrical
connector 1400 can be at least partially recessed within a cavity
1409 defined in the handle frame 20. The six contacts 1401a-1401f
of the electrical connector 1400 can be completely recessed within
the cavity 1409. Such arrangements can reduce the possibility of an
object accidentally contacting one or more of the contacts
1401a-1401f. Similarly, the shaft electrical connector 1410 can be
positioned within a recess defined in the shaft chassis 240 which
can reduce the possibility of an object accidentally contacting one
or more of the contacts 1411a-1411f of the shaft electrical
connector 1410. With regard to the particular example depicted in
FIG. 3, the shaft contacts 1411a-1411f can comprise male contacts.
In at least one example, each shaft contact 1411a-1411f can
comprise a flexible projection extending therefrom which can be
configured to engage a corresponding handle contact 1401a-1401f,
for example. The handle contacts 1401a-1401f can comprise female
contacts. In at least one example, each handle contact 1401a-1401f
can comprise a flat surface, for example, against which the male
shaft contacts 1401a-1401f can wipe, or slide, against and maintain
an electrically conductive interface therebetween. In various
instances, the direction in which the shaft assembly 200 is
assembled to the handle assembly 14 can be parallel to, or at least
substantially parallel to, the handle contacts 1401a-1401f such
that the shaft contacts 1411a-1411f slide against the handle
contacts 1401a-1401f when the shaft assembly 200 is assembled to
the handle assembly 14. In various alternative examples, the handle
contacts 1401a-1401f can comprise male contacts and the shaft
contacts 1411a-1411f can comprise female contacts. In certain
alternative examples, the handle contacts 1401a-1401f and the shaft
contacts 1411a-1411f can comprise any suitable arrangement of
contacts.
[0289] In various instances, the handle assembly 14 can comprise a
connector guard configured to at least partially cover the handle
electrical connector 1400 and/or a connector guard configured to at
least partially cover the shaft electrical connector 1410. A
connector guard can prevent, or at least reduce the possibility of,
an object accidentally touching the contacts of an electrical
connector when the shaft assembly is not assembled to, or only
partially assembled to, the handle. A connector guard can be
movable. For instance, the connector guard can be moved between a
guarded position in which it at least partially guards a connector
and an unguarded position in which it does not guard, or at least
guards less of, the connector. In at least one example, a connector
guard can be displaced as the shaft assembly is being assembled to
the handle. For instance, if the handle comprises a handle
connector guard, the shaft assembly can contact and displace the
handle connector guard as the shaft assembly is being assembled to
the handle. Similarly, if the shaft assembly comprises a shaft
connector guard, the handle can contact and displace the shaft
connector guard as the shaft assembly is being assembled to the
handle. In various instances, a connector guard can comprise a
door, for example. In at least one instance, the door can comprise
a beveled surface which, when contacted by the handle or shaft, can
facilitate the displacement of the door in a certain direction. In
various instances, the connector guard can be translated and/or
rotated, for example. In certain instances, a connector guard can
comprise at least one film which covers the contacts of an
electrical connector. When the shaft assembly is assembled to the
handle, the film can become ruptured. In at least one instance, the
male contacts of a connector can penetrate the film before engaging
the corresponding contacts positioned underneath the film.
[0290] As described above, the surgical instrument can include a
system which can selectively power-up, or activate, the contacts of
an electrical connector, such as the electrical connector 1400, for
example. In various instances, the contacts can be transitioned
between an unactivated condition and an activated condition. In
certain instances, the contacts can be transitioned between a
monitored condition, a deactivated condition, and an activated
condition. For instance, the microcontroller 1500, for example, can
monitor the contacts 1401a-1401f when a shaft assembly has not been
assembled to the handle assembly 14 to determine whether one or
more of the contacts 1401a-1401f may have been shorted. The
microcontroller 1500 can be configured to apply a low voltage
potential to each of the contacts 1401a-1401f and assess whether
only a minimal resistance is present at each of the contacts. Such
an operating state can comprise the monitored condition. In the
event that the resistance detected at a contact is high, or above a
threshold resistance, the microcontroller 1500 can deactivate that
contact, more than one contact, or, alternatively, all of the
contacts. Such an operating state can comprise the deactivated
condition. If a shaft assembly is assembled to the handle assembly
14 and it is detected by the microcontroller 1500, as discussed
above, the microcontroller 1500 can increase the voltage potential
to the contacts 1401a-1401f. Such an operating state can comprise
the activated condition.
[0291] The various shaft assemblies disclosed herein may employ
sensors and various other components that require electrical
communication with the controller in the housing. These shaft
assemblies generally are configured to be able to rotate relative
to the housing necessitating a connection that facilitates such
electrical communication between two or more components that may
rotate relative to each other. When employing end effectors of the
types disclosed herein, the connector arrangements must be
relatively robust in nature while also being somewhat compact to
fit into the shaft assembly connector portion.
[0292] Referring to FIG. 20, a non-limiting form of the end
effector 300 is illustrated. As described above, the end effector
300 may include the anvil 306 and the staple cartridge 304. In this
non-limiting example, the anvil 306 is coupled to an elongate
channel 198. For example, apertures 199 can be defined in the
elongate channel 198 which can receive pins 152 extending from the
anvil 306 and allow the anvil 306 to pivot from an open position to
a closed position relative to the elongate channel 198 and staple
cartridge 304. In addition, FIG. 20 shows a firing bar 172,
configured to longitudinally translate into the end effector 300.
The firing bar 172 may be constructed from one solid section, or in
various examples, may include a laminate material comprising, for
example, a stack of steel plates. A distally projecting end of the
firing bar 172 can be attached to an E-beam 178 that can, among
other things, assist in spacing the anvil 306 from a staple
cartridge 304 positioned in the elongate channel 198 when the anvil
306 is in a closed position. The E-beam 178 can also include a
sharpened cutting edge 182 which can be used to sever tissue as the
E-beam 178 is advanced distally by the firing bar 172. In
operation, the E-beam 178 can also actuate, or fire, the staple
cartridge 304. The staple cartridge 304 can include a molded
cartridge body 194 that holds a plurality of staples 191 resting
upon staple drivers 192 within respective upwardly open staple
cavities 195. A wedge sled 190 is driven distally by the E-beam
178, sliding upon a cartridge tray 196 that holds together the
various components of the replaceable staple cartridge 304. The
wedge sled 190 upwardly cams the staple drivers 192 to force out
the staples 191 into deforming contact with the anvil 306 while a
cutting surface 182 of the E-beam 178 severs clamped tissue.
[0293] Further to the above, the E-beam 178 can include upper pins
180 which engage the anvil 306 during firing. The E-beam 178 can
further include middle pins 184 and a bottom foot 186 which can
engage various portions of the cartridge body 194, cartridge tray
196 and elongate channel 198. When a staple cartridge 304 is
positioned within the elongate channel 198, a slot 193 defined in
the cartridge body 194 can be aligned with a slot 197 defined in
the cartridge tray 196 and a slot 189 defined in the elongate
channel 198. In use, the E-beam 178 can slide through the aligned
slots 193, 197, and 189 wherein, as indicated in FIG. 20, the
bottom foot 186 of the E-beam 178 can engage a groove running along
the bottom surface of channel 198 along the length of slot 189, the
middle pins 184 can engage the top surfaces of cartridge tray 196
along the length of longitudinal slot 197, and the upper pins 180
can engage the anvil 306. In such circumstances, the E-beam 178 can
space, or limit the relative movement between, the anvil 306 and
the staple cartridge 304 as the firing bar 172 is moved distally to
fire the staples from the staple cartridge 304 and/or incise the
tissue captured between the anvil 306 and the staple cartridge 304.
Thereafter, the firing bar 172 and the E-beam 178 can be retracted
proximally allowing the anvil 306 to be opened to release the two
stapled and severed tissue portions (not shown).
[0294] Having described a surgical instrument 10 (FIGS. 1-4) in
general terms, the description now turns to a detailed description
of various electrical/electronic components of the surgical
instrument 10. Turning now to FIGS. 21A-21B, where one example of a
segmented circuit 2000 comprising a plurality of circuit segments
2002a-2002g is illustrated. The segmented circuit 2000 comprising
the plurality of circuit segments 2002a-2002g is configured to
control a powered surgical instrument, such as, for example, the
surgical instrument 10 illustrated in FIGS. 1-18A, without
limitation. The plurality of circuit segments 2002a-2002g is
configured to control one or more operations of the powered
surgical instrument 10. A safety processor segment 2002a (Segment
1) comprises a safety processor 2004. A primary processor segment
2002b (Segment 2) comprises a primary processor 2006. The safety
processor 2004 and/or the primary processor 2006 are configured to
interact with one or more additional circuit segments 2002c-2002g
to control operation of the powered surgical instrument 10. The
primary processor 2006 comprises a plurality of inputs coupled to,
for example, one or more circuit segments 2002c-2002g, a battery
2008, and/or a plurality of switches 2058a-2070. The segmented
circuit 2000 may be implemented by any suitable circuit, such as,
for example, a printed circuit board assembly (PCBA) within the
powered surgical instrument 10. It should be understood that the
term processor as used herein includes any microprocessor,
microcontroller, or other basic computing device that incorporates
the functions of a computer's central processing unit (CPU) on an
integrated circuit or at most a few integrated circuits. The
processor is a multipurpose, programmable device that accepts
digital data as input, processes it according to instructions
stored in its memory, and provides results as output. It is an
example of sequential digital logic, as it has internal memory.
Processors operate on numbers and symbols represented in the binary
numeral system.
[0295] In one aspect, the main processor 2006 may be any single
core or multicore processor such as those known under the trade
name ARM Cortex by Texas Instruments. In one example, the safety
processor 2004 may be a safety microcontroller platform comprising
two microcontroller-based families such as TMS570 and RM4x known
under the trade name Hercules ARM Cortex R4, also by Texas
Instruments. Nevertheless, other suitable substitutes for
microcontrollers and safety processor may be employed, without
limitation. In one example, the safety processor 2004 may be
configured specifically for IEC 61508 and ISO 26262 safety critical
applications, among others, to provide advanced integrated safety
features while delivering scalable performance, connectivity, and
memory options.
[0296] In certain instances, the main processor 2006 may be an LM
4F230H5QR, available from Texas Instruments, for example. In at
least one example, the Texas Instruments LM4F230H5QR is an ARM
Cortex-M4F Processor Core comprising on-chip memory of 256 KB
single-cycle flash memory, or other non-volatile memory, up to 40
MHz, a prefetch buffer to improve performance above 40 MHz, a 32 KB
single-cycle SRAM, internal ROM loaded with StellarisWare.RTM.
software, 2 KB EEPROM, one or more PWM modules, one or more QEI
analog, one or more 12-bit ADC with 12 analog input channels, among
other features that are readily available for the product
datasheet. Other processors may be readily substituted and,
accordingly, the present disclosure should not be limited in this
context.
[0297] In one aspect, the segmented circuit 2000 comprises an
acceleration segment 2002c (Segment 3). The acceleration segment
2002c comprises an acceleration sensor 2022. The acceleration
sensor 2022 may comprise, for example, an accelerometer. The
acceleration sensor 2022 is configured to detect movement or
acceleration of the powered surgical instrument 10. In some
examples, input from the acceleration sensor 2022 is used, for
example, to transition to and from a sleep mode, identify an
orientation of the powered surgical instrument, and/or identify
when the surgical instrument has been dropped. In some examples,
the acceleration segment 2002c is coupled to the safety processor
2004 and/or the primary processor 2006.
[0298] In one aspect, the segmented circuit 2000 comprises a
display segment 2002d (Segment 4). The display segment 2002d
comprises a display connector 2024 coupled to the primary processor
2006. The display connector 2024 couples the primary processor 2006
to a display 2028 through one or more display driver integrated
circuits 2026. The display driver integrated circuits 2026 may be
integrated with the display 2028 and/or may be located separately
from the display 2028. The display 2028 may comprise any suitable
display, such as, for example, an organic light-emitting diode
(OLED) display, a liquid-crystal display (LCD), and/or any other
suitable display. In some examples, the display segment 2002d is
coupled to the safety processor 2004.
[0299] In some aspects, the segmented circuit 2000 comprises a
shaft segment 2002e (Segment 5). The shaft segment 2002e comprises
one or more controls for a shaft 2004 coupled to the surgical
instrument 10 and/or one or more controls for an end effector 2006
coupled to the shaft 2004. The shaft segment 2002e comprises a
shaft connector 2030 configured to couple the primary processor
2006 to a shaft PCBA 2031. The shaft PCBA 2031 comprises a first
articulation switch 2036, a second articulation switch 2032, and a
shaft PCBA EEPROM 2034. In some examples, the shaft PCBA EEPROM
2034 comprises one or more parameters, routines, and/or programs
specific to the shaft 2004 and/or the shaft PCBA 2031. The shaft
PCBA 2031 may be coupled to the shaft 2004 and/or integral with the
surgical instrument 10. In some examples, the shaft segment 2002e
comprises a second shaft EEPROM 2038. The second shaft EEPROM 2038
comprises a plurality of algorithms, routines, parameters, and/or
other data corresponding to one or more shafts 2004 and/or end
effectors 2006 which may be interfaced with the powered surgical
instrument 10.
[0300] In some aspects, the segmented circuit 2000 comprises a
position encoder segment 2002f (Segment 6). The position encoder
segment 2002f comprises one or more magnetic rotary position
encoders 2040a-2040b. The one or more magnetic rotary position
encoders 2040a-2040b are configured to identify the rotational
position of a motor 2048, a shaft 2004, and/or an end effector 2006
of the surgical instrument 10. In some examples, the magnetic
rotary position encoders 2040a-2040b may be coupled to the safety
processor 2004 and/or the primary processor 2006.
[0301] In some aspects, the segmented circuit 2000 comprises a
motor segment 2002g (Segment 7). The motor segment 2002g comprises
a motor 2048 configured to control one or more movements of the
powered surgical instrument 10. The motor 2048 is coupled to the
primary processor 2006 by an H-Bridge driver 2042 and one or more
H-bridge field-effect transistors (FETs) 2044. The H-bridge FETs
2044 are coupled to the safety processor 2004. A motor current
sensor 2046 is coupled in series with the motor 2048 to measure the
current draw of the motor 2048. The motor current sensor 2046 is in
signal communication with the primary processor 2006 and/or the
safety processor 2004. In some examples, the motor 2048 is coupled
to a motor electromagnetic interference (EMI) filter 2050.
[0302] In some aspects, the segmented circuit 2000 comprises a
power segment 2002h (Segment 8). A battery 2008 is coupled to the
safety processor 2004, the primary processor 2006, and one or more
of the additional circuit segments 2002c-2002g. The battery 2008 is
coupled to the segmented circuit 2000 by a battery connector 2010
and a current sensor 2012. The current sensor 2012 is configured to
measure the total current draw of the segmented circuit 2000. In
some examples, one or more voltage converters 2014a, 2014b, 2016
are configured to provide predetermined voltage values to one or
more circuit segments 2002a-2002g. For example, in some examples,
the segmented circuit 2000 may comprise 3.3V voltage converters
2014a-2014b and/or 5V voltage converters 2016. A boost converter
2018 is configured to provide a boost voltage up to a predetermined
amount, such as, for example, up to 13V. The boost converter 2018
is configured to provide additional voltage and/or current during
power intensive operations and prevent brownout or low-power
conditions.
[0303] In some aspects, the safety segment 2002a comprises a motor
power interrupt 2020. The motor power interrupt 2020 is coupled
between the power segment 2002h and the motor segment 2002g. The
safety segment 2002a is configured to interrupt power to the motor
segment 2002g when an error or fault condition is detected by the
safety processor 2004 and/or the primary processor 2006 as
discussed in more detail herein. Although the circuit segments
2002a-2002g are illustrated with all components of the circuit
segments 2002a-2002h located in physical proximity, one skilled in
the art will recognize that a circuit segment 2002a-2002h may
comprise components physically and/or electrically separate from
other components of the same circuit segment 2002a-2002g. In some
examples, one or more components may be shared between two or more
circuit segments 2002a-2002g.
[0304] In some aspects, a plurality of switches 2056-2070 are
coupled to the safety processor 2004 and/or the primary processor
2006. The plurality of switches 2056-2070 may be configured to
control one or more operations of the surgical instrument 10,
control one or more operations of the segmented circuit 2000,
and/or indicate a status of the surgical instrument 10. For
example, a bail-out door switch 2056 is configured to indicate the
status of a bail-out door. A plurality of articulation switches,
such as, for example, a left side articulation left switch 2058a, a
left side articulation right switch 2060a, a left side articulation
center switch 2062a, a right side articulation left switch 2058b, a
right side articulation right switch 2060b, and a right side
articulation center switch 2062b are configured to control
articulation of a shaft 2004 and/or an end effector 2006. A left
side reverse switch 2064a and a right side reverse switch 2064b are
coupled to the primary processor 2006. In some examples, the left
side switches comprising the left side articulation left switch
2058a, the left side articulation right switch 2060a, the left side
articulation center switch 2062a, and the left side reverse switch
2064a are coupled to the primary processor 2006 by a left flex
connector 2072a. The right side switches comprising the right side
articulation left switch 2058b, the right side articulation right
switch 2060b, the right side articulation center switch 2062b, and
the right side reverse switch 2064b are coupled to the primary
processor 2006 by a right flex connector 2072b. In some examples, a
firing switch 2066, a clamp release switch 2068, and a shaft
engaged switch 2070 are coupled to the primary processor 2006.
[0305] In some aspects, the plurality of switches 2056-2070 may
comprise, for example, a plurality of handle controls mounted to a
handle of the surgical instrument 10, a plurality of indicator
switches, and/or any combination thereof. In various examples, the
plurality of switches 2056-2070 allow a surgeon to manipulate the
surgical instrument, provide feedback to the segmented circuit 2000
regarding the position and/or operation of the surgical instrument,
and/or indicate unsafe operation of the surgical instrument 10. In
some examples, additional or fewer switches may be coupled to the
segmented circuit 2000, one or more of the switches 2056-2070 may
be combined into a single switch, and/or expanded to multiple
switches. For example, in one example, one or more of the left side
and/or right side articulation switches 2058a-2064b may be combined
into a single multi-position switch.
[0306] In one aspect, the safety processor 2004 is configured to
implement a watchdog function, among other safety operations. The
safety processor 2004 and the primary processor 2006 of the
segmented circuit 2000 are in signal communication. A
microprocessor alive heartbeat signal is provided at output 2096.
The acceleration segment 2002c comprises an accelerometer 2022
configured to monitor movement of the surgical instrument 10. In
various examples, the accelerometer 2022 may be a single, double,
or triple axis accelerometer. The accelerometer 2022 may be
employed to measures proper acceleration that is not necessarily
the coordinate acceleration (rate of change of velocity). Instead,
the accelerometer sees the acceleration associated with the
phenomenon of weight experienced by a test mass at rest in the
frame of reference of the accelerometer 2022. For example, the
accelerometer 2022 at rest on the surface of the earth will measure
an acceleration g=9.8 m/s.sup.2 (gravity) straight upwards, due to
its weight. Another type of acceleration that accelerometer 2022
can measure is g-force acceleration. In various other examples, the
accelerometer 2022 may comprise a single, double, or triple axis
accelerometer. Further, the acceleration segment 2002c may comprise
one or more inertial sensors to detect and measure acceleration,
tilt, shock, vibration, rotation, and multiple degrees-of-freedom
(DoF). A suitable inertial sensor may comprise an accelerometer
(single, double, or triple axis), a magnetometer to measure a
magnetic field in space such as the earth's magnetic field, and/or
a gyroscope to measure angular velocity.
[0307] In one aspect, the safety processor 2004 is configured to
implement a watchdog function with respect to one or more circuit
segments 2002c-2002h, such as, for example, the motor segment
2002g. In this regards, the safety processor 2004 employs the
watchdog function to detect and recover from malfunctions of the
primary processor 2006. During normal operation, the safety
processor 2004 monitors for hardware faults or program errors of
the primary processor 2004 and to initiate corrective action or
actions. The corrective actions may include placing the primary
processor 2006 in a safe state and restoring normal system
operation. In one example, the safety processor 2004 is coupled to
at least a first sensor. The first sensor measures a first property
of the surgical instrument 10 (FIGS. 1-4). In some examples, the
safety processor 2004 is configured to compare the measured
property of the surgical instrument 10 to a predetermined value.
For example, in one example, a motor sensor 2040a is coupled to the
safety processor 2004. The motor sensor 2040a provides motor speed
and position information to the safety processor 2004. The safety
processor 2004 monitors the motor sensor 2040a and compares the
value to a maximum speed and/or position value and prevents
operation of the motor 2048 above the predetermined values. In some
examples, the predetermined values are calculated based on
real-time speed and/or position of the motor 2048, calculated from
values supplied by a second motor sensor 2040b in communication
with the primary processor 2006, and/or provided to the safety
processor 2004 from, for example, a memory module coupled to the
safety processor 2004.
[0308] In some aspects, a second sensor is coupled to the primary
processor 2006. The second sensor is configured to measure the
first physical property. The safety processor 2004 and the primary
processor 2006 are configured to provide a signal indicative of the
value of the first sensor and the second sensor respectively. When
either the safety processor 2004 or the primary processor 2006
indicates a value outside of an acceptable range, the segmented
circuit 2000 prevents operation of at least one of the circuit
segments 2002c-2002h, such as, for example, the motor segment
2002g. For example, in the example illustrated in FIGS. 21A-21B,
the safety processor 2004 is coupled to a first motor position
sensor 2040a and the primary processor 2006 is coupled to a second
motor position sensor 2040b. The motor position sensors 2040a,
2040b may comprise any suitable motor position sensor, such as, for
example, a magnetic angle rotary input comprising a sine and cosine
output. The motor position sensors 2040a, 2040b provide respective
signals to the safety processor 2004 and the primary processor 2006
indicative of the position of the motor 2048.
[0309] The safety processor 2004 and the primary processor 2006
generate an activation signal when the values of the first motor
sensor 2040a and the second motor sensor 2040b are within a
predetermined range. When either the primary processor 2006 or the
safety processor 2004 to detect a value outside of the
predetermined range, the activation signal is terminated and
operation of at least one circuit segment 2002c-2002h, such as, for
example, the motor segment 2002g, is interrupted and/or prevented.
For example, in some examples, the activation signal from the
primary processor 2006 and the activation signal from the safety
processor 2004 are coupled to an AND gate. The AND gate is coupled
to a motor power switch 2020. The AND gate maintains the motor
power switch 2020 in a closed, or on, position when the activation
signal from both the safety processor 2004 and the primary
processor 2006 are high, indicating a value of the motor sensors
2040a, 2040b within the predetermined range. When either of the
motor sensors 2040a, 2040b detect a value outside of the
predetermined range, the activation signal from that motor sensor
2040a, 2040b is set low, and the output of the AND gate is set low,
opening the motor power switch 2020. In some examples, the value of
the first sensor 2040a and the second sensor 2040b is compared, for
example, by the safety processor 2004 and/or the primary processor
2006. When the values of the first sensor and the second sensor are
different, the safety processor 2004 and/or the primary processor
2006 may prevent operation of the motor segment 2002g.
[0310] In some aspects, the safety processor 2004 receives a signal
indicative of the value of the second sensor 2040b and compares the
second sensor value to the first sensor value. For example, in one
aspect, the safety processor 2004 is coupled directly to a first
motor sensor 2040a. A second motor sensor 2040b is coupled to a
primary processor 2006, which provides the second motor sensor
2040b value to the safety processor 2004, and/or coupled directly
to the safety processor 2004. The safety processor 2004 compares
the value of the first motor sensor 2040 to the value of the second
motor sensor 2040b. When the safety processor 2004 detects a
mismatch between the first motor sensor 2040a and the second motor
sensor 2040b, the safety processor 2004 may interrupt operation of
the motor segment 2002g, for example, by cutting power to the motor
segment 2002g.
[0311] In some aspects, the safety processor 2004 and/or the
primary processor 2006 is coupled to a first sensor 2040a
configured to measure a first property of a surgical instrument and
a second sensor 2040b configured to measure a second property of
the surgical instrument. The first property and the second property
comprise a predetermined relationship when the surgical instrument
is operating normally. The safety processor 2004 monitors the first
property and the second property. When a value of the first
property and/or the second property inconsistent with the
predetermined relationship is detected, a fault occurs. When a
fault occurs, the safety processor 2004 takes at least one action,
such as, for example, preventing operation of at least one of the
circuit segments, executing a predetermined operation, and/or
resetting the primary processor 2006. For example, the safety
processor 2004 may open the motor power switch 2020 to cut power to
the motor circuit segment 2002g when a fault is detected.
[0312] In one aspect, the safety processor 2004 is configured to
execute an independent control algorithm. In operation, the safety
processor 2004 monitors the segmented circuit 2000 and is
configured to control and/or override signals from other circuit
components, such as, for example, the primary processor 2006,
independently. The safety processor 2004 may execute a
preprogrammed algorithm and/or may be updated or programmed on the
fly during operation based on one or more actions and/or positions
of the surgical instrument 10. For example, in one example, the
safety processor 2004 is reprogrammed with new parameters and/or
safety algorithms each time a new shaft and/or end effector is
coupled to the surgical instrument 10. In some examples, one or
more safety values stored by the safety processor 2004 are
duplicated by the primary processor 2006. Two-way error detection
is performed to ensure values and/or parameters stored by either of
the processors 2004, 2006 are correct.
[0313] In some aspects, the safety processor 2004 and the primary
processor 2006 implement a redundant safety check. The safety
processor 2004 and the primary processor 2006 provide periodic
signals indicating normal operation. For example, during operation,
the safety processor 2004 may indicate to the primary processor
2006 that the safety processor 2004 is executing code and operating
normally. The primary processor 2006 may, likewise, indicate to the
safety processor 2004 that the primary processor 2006 is executing
code and operating normally. In some examples, communication
between the safety processor 2004 and the primary processor 2006
occurs at a predetermined interval. The predetermined interval may
be constant or may be variable based on the circuit state and/or
operation of the surgical instrument 10.
[0314] FIG. 22 illustrates one example of a power assembly 2100
comprising a usage cycle circuit 2102 configured to monitor a usage
cycle count of the power assembly 2100. The power assembly 2100 may
be coupled to a surgical instrument 2110. The usage cycle circuit
2102 comprises a processor 2104 and a use indicator 2106. The use
indicator 2106 is configured to provide a signal to the processor
2104 to indicate a use of the battery back 2100 and/or a surgical
instrument 2110 coupled to the power assembly 2100. A "use" may
comprise any suitable action, condition, and/or parameter such as,
for example, changing a modular component of a surgical instrument
2110, deploying or firing a disposable component coupled to the
surgical instrument 2110, delivering electrosurgical energy from
the surgical instrument 2110, reconditioning the surgical
instrument 2110 and/or the power assembly 2100, exchanging the
power assembly 2100, recharging the power assembly 2100, and/or
exceeding a safety limitation of the surgical instrument 2110
and/or the battery back 2100.
[0315] In some instances, a usage cycle, or use, is defined by one
or more power assembly 2100 parameters. For example, in one
instance, a usage cycle comprises using more than 5% of the total
energy available from the power assembly 2100 when the power
assembly 2100 is at a full charge level. In another instance, a
usage cycle comprises a continuous energy drain from the power
assembly 2100 exceeding a predetermined time limit. For example, a
usage cycle may correspond to five minutes of continuous and/or
total energy draw from the power assembly 2100. In some instances,
the power assembly 2100 comprises a usage cycle circuit 2102 having
a continuous power draw to maintain one or more components of the
usage cycle circuit 2102, such as, for example, the use indicator
2106 and/or a counter 2108, in an active state.
[0316] The processor 2104 maintains a usage cycle count. The usage
cycle count indicates the number of uses detected by the use
indicator 2106 for the power assembly 2100 and/or the surgical
instrument 2110. The processor 2104 may increment and/or decrement
the usage cycle count based on input from the use indicator 2106.
The usage cycle count is used to control one or more operations of
the power assembly 2100 and/or the surgical instrument 2110. For
example, in some instances, a power assembly 2100 is disabled when
the usage cycle count exceeds a predetermined usage limit. Although
the instances discussed herein are discussed with respect to
incrementing the usage cycle count above a predetermined usage
limit, those skilled in the art will recognize that the usage cycle
count may start at a predetermined amount and may be decremented by
the processor 2104. In this instance, the processor 2104 initiates
and/or prevents one or more operations of the power assembly 2100
when the usage cycle count falls below a predetermined usage
limit.
[0317] The usage cycle count is maintained by a counter 2108. The
counter 2108 comprises any suitable circuit, such as, for example,
a memory module, an analog counter, and/or any circuit configured
to maintain a usage cycle count. In some instances, the counter
2108 is formed integrally with the processor 2104. In other
instances, the counter 2108 comprises a separate component, such
as, for example, a solid state memory module. In some instances,
the usage cycle count is provided to a remote system, such as, for
example, a central database. The usage cycle count is transmitted
by a communications module 2112 to the remote system. The
communications module 2112 is configured to use any suitable
communications medium, such as, for example, wired and/or wireless
communication. In some instances, the communications module 2112 is
configured to receive one or more instructions from the remote
system, such as, for example, a control signal when the usage cycle
count exceeds the predetermined usage limit.
[0318] In some instances, the use indicator 2106 is configured to
monitor the number of modular components used with a surgical
instrument 2110 coupled to the power assembly 2100. A modular
component may comprise, for example, a modular shaft, a modular end
effector, and/or any other modular component. In some instances,
the use indicator 2106 monitors the use of one or more disposable
components, such as, for example, insertion and/or deployment of a
staple cartridge within an end effector coupled to the surgical
instrument 2110. The use indicator 2106 comprises one or more
sensors for detecting the exchange of one or more modular and/or
disposable components of the surgical instrument 2110.
[0319] In some instances, the use indicator 2106 is configured to
monitor single patient surgical procedures performed while the
power assembly 2100 is installed. For example, the use indicator
2106 may be configured to monitor firings of the surgical
instrument 2110 while the power assembly 2100 is coupled to the
surgical instrument 2110. A firing may correspond to deployment of
a staple cartridge, application of electrosurgical energy, and/or
any other suitable surgical event. The use indicator 2106 may
comprise one or more circuits for measuring the number of firings
while the power assembly 2100 is installed. The use indicator 2106
provides a signal to the processor 2104 when a single patient
procedure is performed and the processor 2104 increments the usage
cycle count.
[0320] In some instances, the use indicator 2106 comprises a
circuit configured to monitor one or more parameters of the power
source 2114, such as, for example, a current draw from the power
source 2114. The one or more parameters of the power source 2114
correspond to one or more operations performable by the surgical
instrument 2110, such as, for example, a cutting and sealing
operation. The use indicator 2106 provides the one or more
parameters to the processor 2104, which increments the usage cycle
count when the one or more parameters indicate that a procedure has
been performed.
[0321] In some instances, the use indicator 2106 comprises a timing
circuit configured to increment a usage cycle count after a
predetermined time period. The predetermined time period
corresponds to a single patient procedure time, which is the time
required for an operator to perform a procedure, such as, for
example, a cutting and sealing procedure. When the power assembly
2100 is coupled to the surgical instrument 2110, the processor 2104
polls the use indicator 2106 to determine when the single patient
procedure time has expired. When the predetermined time period has
elapsed, the processor 2104 increments the usage cycle count. After
incrementing the usage cycle count, the processor 2104 resets the
timing circuit of the use indicator 2106.
[0322] In some instances, the use indicator 2106 comprises a time
constant that approximates the single patient procedure time. In
one example, the usage cycle circuit 2102 comprises a
resistor-capacitor (RC) timing circuit 2506. The RC timing circuit
comprises a time constant defined by a resistor-capacitor pair. The
time constant is defined by the values of the resistor and the
capacitor. In one example, the usage cycle circuit 2552 comprises a
rechargeable battery and a clock. When the power assembly 2100 is
installed in a surgical instrument, the rechargeable battery is
charged by the power source. The rechargeable battery comprises
enough power to run the clock for at least the single patient
procedure time. The clock may comprise a real time clock, a
processor configured to implement a time function, or any other
suitable timing circuit.
[0323] Referring still to FIG. 22, in some instances, the use
indicator 2106 comprises a sensor configured to monitor one or more
environmental conditions experienced by the power assembly 2100.
For example, the use indicator 2106 may comprise an accelerometer.
The accelerometer is configured to monitor acceleration of the
power assembly 2100. The power assembly 2100 comprises a maximum
acceleration tolerance. Acceleration above a predetermined
threshold indicates, for example, that the power assembly 2100 has
been dropped. When the use indicator 2106 detects acceleration
above the maximum acceleration tolerance, the processor 2104
increments a usage cycle count. In some instances, the use
indicator 2106 comprises a moisture sensor. The moisture sensor is
configured to indicate when the power assembly 2100 has been
exposed to moisture. The moisture sensor may comprise, for example,
an immersion sensor configured to indicate when the power assembly
2100 has been fully immersed in a cleaning fluid, a moisture sensor
configured to indicate when moisture is in contact with the power
assembly 2100 during use, and/or any other suitable moisture
sensor.
[0324] In some instances, the use indicator 2106 comprises a
chemical exposure sensor. The chemical exposure sensor is
configured to indicate when the power assembly 2100 has come into
contact with harmful and/or dangerous chemicals. For example,
during a sterilization procedure, an inappropriate chemical may be
used that leads to degradation of the power assembly 2100. The
processor 2104 increments the usage cycle count when the use
indicator 2106 detects an inappropriate chemical.
[0325] In some instances, the usage cycle circuit 2102 is
configured to monitor the number of reconditioning cycles
experienced by the power assembly 2100. A reconditioning cycle may
comprise, for example, a cleaning cycle, a sterilization cycle, a
charging cycle, routine and/or preventative maintenance, and/or any
other suitable reconditioning cycle. The use indicator 2106 is
configured to detect a reconditioning cycle. For example, the use
indicator 2106 may comprise a moisture sensor to detect a cleaning
and/or sterilization cycle. In some instances, the usage cycle
circuit 2102 monitors the number of reconditioning cycles
experienced by the power assembly 2100 and disables the power
assembly 2100 after the number of reconditioning cycles exceeds a
predetermined threshold.
[0326] The usage cycle circuit 2102 may be configured to monitor
the number of power assembly 2100 exchanges. The usage cycle
circuit 2102 increments the usage cycle count each time the power
assembly 2100 is exchanged. When the maximum number of exchanges is
exceeded the usage cycle circuit 2102 locks out the power assembly
2100 and/or the surgical instrument 2110. In some instances, when
the power assembly 2100 is coupled the surgical instrument 2110,
the usage cycle circuit 2102 identifies the serial number of the
power assembly 2100 and locks the power assembly 2100 such that the
power assembly 2100 is usable only with the surgical instrument
2110. In some instances, the usage cycle circuit 2102 increments
the usage cycle each time the power assembly 2100 is removed from
and/or coupled to the surgical instrument 2110.
[0327] In some instances, the usage cycle count corresponds to
sterilization of the power assembly 2100. The use indicator 2106
comprises a sensor configured to detect one or more parameters of a
sterilization cycle, such as, for example, a temperature parameter,
a chemical parameter, a moisture parameter, and/or any other
suitable parameter. The processor 2104 increments the usage cycle
count when a sterilization parameter is detected. The usage cycle
circuit 2102 disables the power assembly 2100 after a predetermined
number of sterilizations. In some instances, the usage cycle
circuit 2102 is reset during a sterilization cycle, a voltage
sensor to detect a recharge cycle, and/or any suitable sensor. The
processor 2104 increments the usage cycle count when a
reconditioning cycle is detected. The usage cycle circuit 2102 is
disabled when a sterilization cycle is detected. The usage cycle
circuit 2102 is reactivated and/or reset when the power assembly
2100 is coupled to the surgical instrument 2110. In some instances,
the use indicator comprises a zero power indicator. The zero power
indicator changes state during a sterilization cycle and is checked
by the processor 2104 when the power assembly 2100 is coupled to a
surgical instrument 2110. When the zero power indicator indicates
that a sterilization cycle has occurred, the processor 2104
increments the usage cycle count.
[0328] A counter 2108 maintains the usage cycle count. In some
instances, the counter 2108 comprises a non-volatile memory module.
The processor 2104 increments the usage cycle count stored in the
non-volatile memory module each time a usage cycle is detected. The
memory module may be accessed by the processor 2104 and/or a
control circuit, such as, for example, the control circuit 200.
When the usage cycle count exceeds a predetermined threshold, the
processor 2104 disables the power assembly 2100. In some instances,
the usage cycle count is maintained by a plurality of circuit
components. For example, in one instance, the counter 2108
comprises a resistor (or fuse) pack. After each use of the power
assembly 2100, a resistor (or fuse) is burned to an open position,
changing the resistance of the resistor pack. The power assembly
2100 and/or the surgical instrument 2110 reads the remaining
resistance. When the last resistor of the resistor pack is burned
out, the resistor pack has a predetermined resistance, such as, for
example, an infinite resistance corresponding to an open circuit,
which indicates that the power assembly 2100 has reached its usage
limit. In some instances, the resistance of the resistor pack is
used to derive the number of uses remaining.
[0329] In some instances, the usage cycle circuit 2102 prevents
further use of the power assembly 2100 and/or the surgical
instrument 2110 when the usage cycle count exceeds a predetermined
usage limit. In one instance, the usage cycle count associated with
the power assembly 2100 is provided to an operator, for example,
utilizing a screen formed integrally with the surgical instrument
2110. The surgical instrument 2110 provides an indication to the
operator that the usage cycle count has exceeded a predetermined
limit for the power assembly 2100, and prevents further operation
of the surgical instrument 2110.
[0330] In some instances, the usage cycle circuit 2102 is
configured to physically prevent operation when the predetermined
usage limit is reached. For example, the power assembly 2100 may
comprise a shield configured to deploy over contacts of the power
assembly 2100 when the usage cycle count exceeds the predetermined
usage limit. The shield prevents recharge and use of the power
assembly 2100 by covering the electrical connections of the power
assembly 2100.
[0331] In some instances, the usage cycle circuit 2102 is located
at least partially within the surgical instrument 2110 and is
configured to maintain a usage cycle count for the surgical
instrument 2110. FIG. 22 illustrates one or more components of the
usage cycle circuit 2102 within the surgical instrument 2110 in
phantom, illustrating the alternative positioning of the usage
cycle circuit 2102. When a predetermined usage limit of the
surgical instrument 2110 is exceeded, the usage cycle circuit 2102
disables and/or prevents operation of the surgical instrument 2110.
The usage cycle count is incremented by the usage cycle circuit
2102 when the use indicator 2106 detects a specific event and/or
requirement, such as, for example, firing of the surgical
instrument 2110, a predetermined time period corresponding to a
single patient procedure time, based on one or more motor
parameters of the surgical instrument 2110, in response to a system
diagnostic indicating that one or more predetermined thresholds are
met, and/or any other suitable requirement. As discussed above, in
some instances, the use indicator 2106 comprises a timing circuit
corresponding to a single patient procedure time. In other
instances, the use indicator 2106 comprises one or more sensors
configured to detect a specific event and/or condition of the
surgical instrument 2110.
[0332] In some instances, the usage cycle circuit 2102 is
configured to prevent operation of the surgical instrument 2110
after the predetermined usage limit is reached. In some instances,
the surgical instrument 2110 comprises a visible indicator to
indicate when the predetermined usage limit has been reached and/or
exceeded. For example, a flag, such as a red flag, may pop-up from
the surgical instrument 2110, such as from the handle, to provide a
visual indication to the operator that the surgical instrument 2110
has exceeded the predetermined usage limit. As another example, the
usage cycle circuit 2102 may be coupled to a display formed
integrally with the surgical instrument 2110. The usage cycle
circuit 2102 displays a message indicating that the predetermined
usage limit has been exceeded. The surgical instrument 2110 may
provide an audible indication to the operator that the
predetermined usage limit has been exceeded. For example, in one
instance, the surgical instrument 2110 emits an audible tone when
the predetermined usage limit is exceeded and the power assembly
2100 is removed from the surgical instrument 2110. The audible tone
indicates the last use of the surgical instrument 2110 and
indicates that the surgical instrument 2110 should be disposed or
reconditioned.
[0333] In some instances, the usage cycle circuit 2102 is
configured to transmit the usage cycle count of the surgical
instrument 2110 to a remote location, such as, for example, a
central database. The usage cycle circuit 2102 comprises a
communications module 2112 configured to transmit the usage cycle
count to the remote location. The communications module 2112 may
utilize any suitable communications system, such as, for example,
wired or wireless communications system. The remote location may
comprise a central database configured to maintain usage
information. In some instances, when the power assembly 2100 is
coupled to the surgical instrument 2110, the power assembly 2100
records a serial number of the surgical instrument 2110. The serial
number is transmitted to the central database, for example, when
the power assembly 2100 is coupled to a charger. In some instances,
the central database maintains a count corresponding to each use of
the surgical instrument 2110. For example, a bar code associated
with the surgical instrument 2110 may be scanned each time the
surgical instrument 2110 is used. When the use count exceeds a
predetermined usage limit, the central database provides a signal
to the surgical instrument 2110 indicating that the surgical
instrument 2110 should be discarded.
[0334] The surgical instrument 2110 may be configured to lock
and/or prevent operation of the surgical instrument 2110 when the
usage cycle count exceeds a predetermined usage limit. In some
instances, the surgical instrument 2110 comprises a disposable
instrument and is discarded after the usage cycle count exceeds the
predetermined usage limit. In other instances, the surgical
instrument 2110 comprises a reusable surgical instrument which may
be reconditioned after the usage cycle count exceeds the
predetermined usage limit. The surgical instrument 2110 initiates a
reversible lockout after the predetermined usage limit is met. A
technician reconditions the surgical instrument 2110 and releases
the lockout, for example, utilizing a specialized technician key
configured to reset the usage cycle circuit 2102.
[0335] In some aspects, the segmented circuit 2000 is configured
for sequential start-up. An error check is performed by each
circuit segment 2002a-2002g prior to energizing the next sequential
circuit segment 2002a-2002g. FIG. 23 illustrates one example of a
process for sequentially energizing a segmented circuit 2270, such
as, for example, the segmented circuit 2000. When a battery 2008 is
coupled to the segmented circuit 2000, the safety processor 2004 is
energized 2272. The safety processor 2004 performs a self-error
check 2274. When an error is detected 2276a, the safety processor
stops energizing the segmented circuit 2000 and generates an error
code 2278a. When no errors are detected 2276b, the safety processor
2004 initiates 2278b power-up of the primary processor 2006. The
primary processor 2006 performs a self-error check. When no errors
are detected, the primary processor 2006 begins sequential power-up
of each of the remaining circuit segments 2278b. Each circuit
segment is energized and error checked by the primary processor
2006. When no errors are detected, the next circuit segment is
energized 2278b. When an error is detected, the safety processor
2004 and/or the primary process stops energizing the current
segment and generates an error 2278a. The sequential start-up
continues until all of the circuit segments 2002a-2002g have been
energized. In some examples, the segmented circuit 2000 transitions
from sleep mode following a similar sequential power-up process
11250.
[0336] FIG. 24 illustrates one aspect of a power segment 2302
comprising a plurality of daisy chained power converters 2314,
2316, 2318. The power segment 2302 comprises a battery 2308. The
battery 2308 is configured to provide a source voltage, such as,
for example, 12V. A current sensor 2312 is coupled to the battery
2308 to monitor the current draw of a segmented circuit and/or one
or more circuit segments. The current sensor 2312 is coupled to an
FET switch 2313. The battery 2308 is coupled to one or more voltage
converters 2309, 2314, 2316. An always on converter 2309 provides a
constant voltage to one or more circuit components, such as, for
example, a motion sensor 2322. The always on converter 2309
comprises, for example, a 3.3V converter. The always on converter
2309 may provide a constant voltage to additional circuit
components, such as, for example, a safety processor (not shown).
The battery 2308 is coupled to a boost converter 2318. The boost
converter 2318 is configured to provide a boosted voltage above the
voltage provided by the battery 2308. For example, in the
illustrated example, the battery 2308 provides a voltage of 12V.
The boost converter 2318 is configured to boost the voltage to 13V.
The boost converter 2318 is configured to maintain a minimum
voltage during operation of a surgical instrument, for example, the
surgical instrument 10 (FIGS. 1-4). Operation of a motor can result
in the power provided to the primary processor 2306 dropping below
a minimum threshold and creating a brownout or reset condition in
the primary processor 2306. The boost converter 2318 ensures that
sufficient power is available to the primary processor 2306 and/or
other circuit components, such as the motor controller 2343, during
operation of the surgical instrument 10. In some examples, the
boost converter 2318 is coupled directly one or more circuit
components, such as, for example, an OLED display 2388.
[0337] The boost converter 2318 is coupled to one or more step-down
converters to provide voltages below the boosted voltage level. A
first voltage converter 2316 is coupled to the boost converter 2318
and provides a first stepped-down voltage to one or more circuit
components. In the illustrated example, the first voltage converter
2316 provides a voltage of 5V. The first voltage converter 2316 is
coupled to a rotary position encoder 2340. A FET switch 2317 is
coupled between the first voltage converter 2316 and the rotary
position encoder 2340. The FET switch 2317 is controlled by the
processor 2306. The processor 2306 opens the FET switch 2317 to
deactivate the position encoder 2340, for example, during power
intensive operations. The first voltage converter 2316 is coupled
to a second voltage converter 2314 configured to provide a second
stepped-down voltage. The second stepped-down voltage comprises,
for example, 3.3V. The second voltage converter 2314 is coupled to
a processor 2306. In some examples, the boost converter 2318, the
first voltage converter 2316, and the second voltage converter 2314
are coupled in a daisy chain configuration. The daisy chain
configuration allows the use of smaller, more efficient converters
for generating voltage levels below the boosted voltage level. The
examples, however, are not limited to the particular voltage
range(s) described in the context of this specification.
[0338] FIG. 25 illustrates one aspect of a segmented circuit 2400
configured to maximize power available for critical and/or power
intense functions. The segmented circuit 2400 comprises a battery
2408. The battery 2408 is configured to provide a source voltage
such as, for example, 12V. The source voltage is provided to a
plurality of voltage converters 2409, 2418. An always-on voltage
converter 2409 provides a constant voltage to one or more circuit
components, for example, a motion sensor 2422 and a safety
processor 2404. The always-on voltage converter 2409 is directly
coupled to the battery 2408. The always-on converter 2409 provides
a voltage of 3.3V, for example. The examples, however, are not
limited to the particular voltage range(s) described in the context
of this specification.
[0339] The segmented circuit 2400 comprises a boost converter 2418.
The boost converter 2418 provides a boosted voltage above the
source voltage provided by the battery 2408, such as, for example,
13V. The boost converter 2418 provides a boosted voltage directly
to one or more circuit components, such as, for example, an OLED
display 2488 and a motor controller 2443. By coupling the OLED
display 2488 directly to the boost converter 2418, the segmented
circuit 2400 eliminates the need for a power converter dedicated to
the OLED display 2488. The boost converter 2418 provides a boosted
voltage to the motor controller 2443 and the motor 2448 during one
or more power intensive operations of the motor 2448, such as, for
example, a cutting operation. The boost converter 2418 is coupled
to a step-down converter 2416. The step-down converter 2416 is
configured to provide a voltage below the boosted voltage to one or
more circuit components, such as, for example, 5V. The step-down
converter 2416 is coupled to, for example, a FET switch 2451 and a
position encoder 2440. The FET switch 2451 is coupled to the
primary processor 2406. The primary processor 2406 opens the FET
switch 2451 when transitioning the segmented circuit 2400 to sleep
mode and/or during power intensive functions requiring additional
voltage delivered to the motor 2448. Opening the FET switch 2451
deactivates the position encoder 2440 and eliminates the power draw
of the position encoder 2440. The examples, however, are not
limited to the particular voltage range(s) described in the context
of this specification.
[0340] The step-down converter 2416 is coupled to a linear
converter 2414. The linear converter 2414 is configured to provide
a voltage of, for example, 3.3V. The linear converter 2414 is
coupled to the primary processor 2406. The linear converter 2414
provides an operating voltage to the primary processor 2406. The
linear converter 2414 may be coupled to one or more additional
circuit components. The examples, however, are not limited to the
particular voltage range(s) described in the context of this
specification.
[0341] The segmented circuit 2400 comprises a bailout switch 2456.
The bailout switch 2456 is coupled to a bailout door on the
surgical instrument 10. The bailout switch 2456 and the safety
processor 2404 are coupled to an AND gate 2419. The AND gate 2419
provides an input to a FET switch 2413. When the bailout switch
2456 detects a bailout condition, the bailout switch 2456 provides
a bailout shutdown signal to the AND gate 2419. When the safety
processor 2404 detects an unsafe condition, such as, for example,
due to a sensor mismatch, the safety processor 2404 provides a
shutdown signal to the AND gate 2419. In some examples, both the
bailout shutdown signal and the shutdown signal are high during
normal operation and are low when a bailout condition or an unsafe
condition is detected. When the output of the AND gate 2419 is low,
the FET switch 2413 is opened and operation of the motor 2448 is
prevented. In some examples, the safety processor 2404 utilizes the
shutdown signal to transition the motor 2448 to an off state in
sleep mode. A third input to the FET switch 2413 is provided by a
current sensor 2412 coupled to the battery 2408. The current sensor
2412 monitors the current drawn by the circuit 2400 and opens the
FET switch 2413 to shut-off power to the motor 2448 when an
electrical current above a predetermined threshold is detected. The
FET switch 2413 and the motor controller 2443 are coupled to a bank
of FET switches 2445 configured to control operation of the motor
2448.
[0342] A motor current sensor 2446 is coupled in series with the
motor 2448 to provide a motor current sensor reading to a current
monitor 2447. The current monitor 2447 is coupled to the primary
processor 2406. The current monitor 2447 provides a signal
indicative of the current draw of the motor 2448. The primary
processor 2406 may utilize the signal from the motor current 2447
to control operation of the motor, for example, to ensure the
current draw of the motor 2448 is within an acceptable range, to
compare the current draw of the motor 2448 to one or more other
parameters of the circuit 2400 such as, for example, the position
encoder 2440, and/or to determine one or more parameters of a
treatment site. In some examples, the current monitor 2447 may be
coupled to the safety processor 2404.
[0343] In some aspects, actuation of one or more handle controls,
such as, for example, a firing trigger, causes the primary
processor 2406 to decrease power to one or more components while
the handle control is actuated. For example, in one example, a
firing trigger controls a firing stroke of a cutting member. The
cutting member is driven by the motor 2448. Actuation of the firing
trigger results in forward operation of the motor 2448 and
advancement of the cutting member. During firing, the primary
processor 2406 closes the FET switch 2451 to remove power from the
position encoder 2440. The deactivation of one or more circuit
components allows higher power to be delivered to the motor 2448.
When the firing trigger is released, full power is restored to the
deactivated components, for example, by closing the FET switch 2451
and reactivating the position encoder 2440.
[0344] In some aspects, the safety processor 2404 controls
operation of the segmented circuit 2400. For example, the safety
processor 2404 may initiate a sequential power-up of the segmented
circuit 2400, transition of the segmented circuit 2400 to and from
sleep mode, and/or may override one or more control signals from
the primary processor 2406. For example, in the illustrated
example, the safety processor 2404 is coupled to the step-down
converter 2416. The safety processor 2404 controls operation of the
segmented circuit 2400 by activating or deactivating the step-down
converter 2416 to provide power to the remainder of the segmented
circuit 2400.
[0345] FIG. 26 illustrates one aspect of a power system 2500
comprising a plurality of daisy chained power converters 2514,
2516, 2518 configured to be sequentially energized. The plurality
of daisy chained power converters 2514, 2516, 2518 may be
sequentially activated by, for example, a safety processor during
initial power-up and/or transition from sleep mode. The safety
processor may be powered by an independent power converter (not
shown). For example, in one example, when a battery voltage
V.sub.BATT is coupled to the power system 2500 and/or an
accelerometer detects movement in sleep mode, the safety processor
initiates a sequential start-up of the daisy chained power
converters 2514, 2516, 2518. The safety processor activates the 13V
boost section 2518. The boost section 2518 is energized and
performs a self-check. In some examples, the boost section 2518
comprises an integrated circuit 2520 configured to boost the source
voltage and to perform a self check. A diode D prevents power-up of
a 5V supply section 2516 until the boost section 2518 has completed
a self-check and provided a signal to the diode D indicating that
the boost section 2518 did not identify any errors. In some
examples, this signal is provided by the safety processor. The
examples, however, are not limited to the particular voltage
range(s) described in the context of this specification.
[0346] The 5V supply section 2516 is sequentially powered-up after
the boost section 2518. The 5V supply section 2516 performs a
self-check during power-up to identify any errors in the 5V supply
section 2516. The 5V supply section 2516 comprises an integrated
circuit 2515 configured to provide a step-down voltage from the
boost voltage and to perform an error check. When no errors are
detected, the 5V supply section 2516 completes sequential power-up
and provides an activation signal to the 3.3V supply section 2514.
In some examples, the safety processor provides an activation
signal to the 3.3V supply section 2514. The 3.3V supply section
comprises an integrated circuit 2513 configured to provide a
step-down voltage from the 5V supply section 2516 and perform a
self-error check during power-up. When no errors are detected
during the self-check, the 3.3V supply section 2514 provides power
to the primary processor. The primary processor is configured to
sequentially energize each of the remaining circuit segments. By
sequentially energizing the power system 2500 and/or the remainder
of a segmented circuit, the power system 2500 reduces error risks,
allows for stabilization of voltage levels before loads are
applied, and prevents large current draws from all hardware being
turned on simultaneously in an uncontrolled manner. The examples,
however, are not limited to the particular voltage range(s)
described in the context of this specification.
[0347] In one aspect, the power system 2500 comprises an over
voltage identification and mitigation circuit. The over voltage
identification and mitigation circuit is configured to detect a
monopolar return current in the surgical instrument and interrupt
power from the power segment when the monopolar return current is
detected. The over voltage identification and mitigation circuit is
configured to identify ground floatation of the power system. The
over voltage identification and mitigation circuit comprises a
metal oxide varistor. The over voltage identification and
mitigation circuit comprises at least one transient voltage
suppression diode.
[0348] FIG. 27 illustrates one aspect of a segmented circuit 2600
comprising an isolated control section 2602. The isolated control
section 2602 isolates control hardware of the segmented circuit
2600 from a power section (not shown) of the segmented circuit
2600. The control section 2602 comprises, for example, a primary
processor 2606, a safety processor (not shown), and/or additional
control hardware, for example, a FET Switch 2617. The power section
comprises, for example, a motor, a motor driver, and/or a plurality
of motor MOSFETS. The isolated control section 2602 comprises a
charging circuit 2603 and a rechargeable battery 2608 coupled to a
5V power converter 2616. The charging circuit 2603 and the
rechargeable battery 2608 isolate the primary processor 2606 from
the power section. In some examples, the rechargeable battery 2608
is coupled to a safety processor and any additional support
hardware. Isolating the control section 2602 from the power section
allows the control section 2602, for example, the primary processor
2606, to remain active even when main power is removed, provides a
filter, through the rechargeable battery 2608, to keep noise out of
the control section 2602, isolates the control section 2602 from
heavy swings in the battery voltage to ensure proper operation even
during heavy motor loads, and/or allows for real-time operating
system (RTOS) to be used by the segmented circuit 2600. In some
examples, the rechargeable battery 2608 provides a stepped-down
voltage to the primary processor, such as, for example, 3.3V. The
examples, however, are not limited to the particular voltage
range(s) described in the context of this specification.
[0349] FIGS. 28A and 28B illustrate another aspect of a control
circuit 3000 configured to control the powered surgical instrument
10, illustrated in FIGS. 1-18A. As shown in FIGS. 18A, 28B, the
handle assembly 14 may include a motor 3014 which can be controlled
by a motor driver 3015 and can be employed by the firing system of
the surgical instrument 10. In various forms, the motor 3014 may be
a DC brushed driving motor having a maximum rotation of,
approximately, 25,000 RPM, for example. In other arrangements, the
motor 3014 may include a brushless motor, a cordless motor, a
synchronous motor, a stepper motor, or any other suitable electric
motor. In certain circumstances, the motor driver 3015 may comprise
an H-Bridge FETs 3019, as illustrated in FIGS. 28A and 28B, for
example. The motor 3014 can be powered by a power assembly 3006,
which can be releasably mounted to the handle assembly 14. The
power assembly 3006 is configured to supply control power to the
surgical instrument 10. The power assembly 3006 may comprise a
battery which may include a number of battery cells connected in
series that can be used as the power source to power the surgical
instrument 10. In such configuration, the power assembly 3006 may
be referred to as a battery pack. In certain circumstances, the
battery cells of the power assembly 3006 may be replaceable and/or
rechargeable. In at least one example, the battery cells can be
Lithium-Ion batteries which can be separably couplable to the power
assembly 3006.
[0350] Examples of drive systems and closure systems that are
suitable for use with the surgical instrument 10 are disclosed in
U.S. Provisional Patent Application Ser. No. 61/782,866, entitled
CONTROL SYSTEM OF A SURGICAL INSTRUMENT, and filed Mar. 14, 2013,
the entire disclosure of which is incorporated by reference herein
in its entirety. For example, the electric motor 3014 can include a
rotatable shaft (not shown) that may operably interface with a gear
reducer assembly that can be mounted in meshing engagement with a
set, or rack, of drive teeth on a longitudinally-movable drive
member. In use, a voltage polarity provided by the battery can
operate the electric motor 3014 to drive the longitudinally-movable
drive member to effectuate the end effector 300. For example, the
motor 3014 can be configured to drive the longitudinally-movable
drive member to advance a firing mechanism to fire staples into
tissue captured by the end effector 300 from a staple cartridge
assembled with the end effector 300 and/or advance a cutting member
to cut tissue captured by the end effector 300, for example.
[0351] As illustrated in FIGS. 28A and 28B and as described below
in greater detail, the power assembly 3006 may include a power
management controller which can be configured to modulate the power
output of the power assembly 3006 to deliver a first power output
to power the motor 3014 to advance the cutting member while the
interchangeable shaft 200 is coupled to the handle assembly 14
(FIG. 1) and to deliver a second power output to power the motor
3014 to advance the cutting member while the interchangeable shaft
assembly 200 is coupled to the handle assembly 14, for example.
Such modulation can be beneficial in avoiding transmission of
excessive power to the motor 3014 beyond the requirements of an
interchangeable shaft assembly that is coupled to the handle
assembly 14.
[0352] In certain circumstances, the interface 3024 can facilitate
transmission of the one or more communication signals between the
power management controller 3016 and the shaft assembly controller
3022 by routing such communication signals through a main
controller 3017 residing in the handle assembly 14 (FIG. 1), for
example. In other circumstances, the interface 3024 can facilitate
a direct line of communication between the power management
controller 3016 and the shaft assembly controller 3022 through the
handle assembly 14 while the shaft assembly 200 (FIG. 1) and the
power assembly 3006 are coupled to the handle assembly 14.
[0353] In one instance, the main microcontroller 3017 may be any
single core or multicore processor such as those known under the
trade name ARM Cortex by Texas Instruments. In one instance, the
surgical instrument 10 (FIGS. 1-4) may comprise a power management
controller 3016 such as, for example, a safety microcontroller
platform comprising two microcontroller-based families such as
TMS570 and RM4x known under the trade name Hercules ARM Cortex R4,
also by Texas Instruments. Nevertheless, other suitable substitutes
for microcontrollers and safety processor may be employed, without
limitation. In one instance, the safety processor 2004 (FIG. 21A)
may be configured specifically for IEC 61508 and ISO 26262 safety
critical applications, among others, to provide advanced integrated
safety features while delivering scalable performance,
connectivity, and memory options.
[0354] In certain instances, the microcontroller 3017 may be an LM
4F230H5QR, available from Texas Instruments, for example. In at
least one example, the Texas Instruments LM4F230H5QR is an ARM
Cortex-M4F Processor Core comprising on-chip memory of 256 KB
single-cycle flash memory, or other non-volatile memory, up to 40
MHz, a prefetch buffer to improve performance above 40 MHz, a 32 KB
single-cycle serial random access memory (SRAM), internal read-only
memory (ROM) loaded with StellarisWare.RTM. software, 2 KB
electrically erasable programmable read-only memory (EEPROM), one
or more pulse width modulation (PWM) modules, one or more
quadrature encoder inputs (QEI) analog, one or more 12-bit
Analog-to-Digital Converters (ADC) with 12 analog input channels,
among other features that are readily available for the product
datasheet. The present disclosure should not be limited in this
context.
[0355] FIG. 29 is a block diagram the surgical instrument of FIG. 1
illustrating interfaces between the handle assembly 14 (FIG. 1) and
the power assembly and between the handle assembly 14 and the
interchangeable shaft assembly. As shown in FIG. 29, the power
assembly 3006 may include a power management circuit 3034 which may
comprise the power management controller 3016, a power modulator
3038, and a current sense circuit 3036. The power management
circuit 3034 can be configured to modulate power output of the
battery 3007 based on the power requirements of the shaft assembly
200 (FIG. 1) while the shaft assembly 200 and the power assembly
3006 are coupled to the handle assembly 14. For example, the power
management controller 3016 can be programmed to control the power
modulator 3038 of the power output of the power assembly 3006 and
the current sense circuit 3036 can be employed to monitor power
output of the power assembly 3006 to provide feedback to the power
management controller 3016 about the power output of the battery
3007 so that the power management controller 3016 may adjust the
power output of the power assembly 3006 to maintain a desired
output.
[0356] It is noteworthy that the power management controller 3016
and/or the shaft assembly controller 3022 each may comprise one or
more processors and/or memory units which may store a number of
software modules. Although certain modules and/or blocks of the
surgical instrument 14 (FIG. 1) may be described by way of example,
it can be appreciated that a greater or lesser number of modules
and/or blocks may be used. Further, although various instances may
be described in terms of modules and/or blocks to facilitate
description, such modules and/or blocks may be implemented by one
or more hardware components, e.g., processors, Digital Signal
Processors (DSPs), Programmable Logic Devices (PLDs), Application
Specific Integrated Circuits (ASICs), circuits, registers and/or
software components, e.g., programs, subroutines, logic and/or
combinations of hardware and software components.
[0357] In certain instances, the surgical instrument 10 (FIGS. 1-4)
may comprise an output device 3042 which may include one or more
devices for providing a sensory feedback to a user. Such devices
may comprise, for example, visual feedback devices (e.g., an LCD
display screen, LED indicators), audio feedback devices (e.g., a
speaker, a buzzer) or tactile feedback devices (e.g., haptic
actuators). In certain circumstances, the output device 3042 may
comprise a display 3043 which may be included in the handle
assembly 14 (FIG. 1). The shaft assembly controller 3022 and/or the
power management controller 3016 can provide feedback to a user of
the surgical instrument 10 through the output device 3042. The
interface 3024 can be configured to connect the shaft assembly
controller 3022 and/or the power management controller 3016 to the
output device 3042. The reader will appreciate that the output
device 3042 can instead be integrated with the power assembly 3006.
In such circumstances, communication between the output device 3042
and the shaft assembly controller 3022 may be accomplished through
the interface 3024 while the shaft assembly 200 is coupled to the
handle assembly 14.
[0358] Having described a surgical instrument 10 (FIGS. 1-4) and
various control circuits 2000, 3000 for controlling the operation
thereof, the disclosure now turns to various specific
configurations of the surgical instrument 10 and control circuits
2000 (or 3000).
[0359] In various aspects the present disclosure provides
techniques for data storage and usage. In one aspect, data storage
and usage is based on multiple levels of action thresholds. Such
thresholds include upper and lower ultimate threshold limits,
ultimate threshold that shuts down motor or activates return is
current, pressure, firing load, torque is exceeded, and
alternatively, while running within the limits the device
automatically compensates for loading of the motor.
[0360] In one aspect, the instrument 10 (described in connection
with FIGS. 1-29) can be configured to monitor upper and lower
ultimate threshold limits to maintain minimum and maximum closure
clamp loads within acceptable limits. If a minimum is not achieved
the instrument 10 cannot start or if it drops below minimum a user
action is required. If the clamp load is at a suitable level but
drops under minimum during firing, the instrument 10 can adjust the
speed of the motor or warn the user. If the minimum limit is
breached during operation the unit could give a warning that the
firing may not be completely as anticipated. The instrument 10 also
can be configured to monitor when the battery voltage drops below
the lower ultimate limit the remaining battery power is only direct
able towards returning the device to the I-beam parked state. The
opening force on the anvil can be employed to sense jams in the end
effector. Alternatively, the instrument 10 can be configured to
monitor when the motor current goes up or the related speed goes
down, then the motor control increases pulse width or frequency
modulation to keep speed constant.
[0361] In another aspect, the instrument 10 can (FIG. 1) be
configured to detect an ultimate threshold of current draw,
pressure, firing load, torque such that when any of these
thresholds are exceeded, the instrument 10 shuts down the motor or
causes the motor to return the knife to a pre-fired position. A
secondary threshold, which is less than the ultimate threshold, may
be employed to alter the motor control program to accommodate
changes in conditions by changing the motor control parameters. A
marginal threshold can be configured as a step function or a ramp
function based on a proportionate response to another counter or
input. For example, in the case of sterilization, no changes
between 0-200 sterilization cycles, slow motor 1% per use from
201-400 sterilization cycles, and prevent use over 400
sterilization cycles. The speed of the motor also can be varied
based on tissue gap and current draw.
[0362] There are many parameters that could influence the ideal
function of a powered reusable stapler device. Most of these
parameters have an ultimate maximum and/or minimum threshold beyond
which the device should not be operated. Nevertheless, there are
also marginal limits that may influence the functional operation of
the device. These multiple limits, from multiple parameters may
provide an overlying and cumulative effect on the operations
program of the device.
[0363] Accordingly, the present disclosure relates to surgical
instruments and, in various circumstances, to surgical stapling and
cutting instruments and staple cartridges therefor that are
designed to staple and cut tissue.
[0364] Efficient performance of an electromechanical device depends
on various factors. One is the operational envelope, i.e., range of
parameters, conditions and events in which the device carries out
its intended functions. For example, for a device powered by a
motor driven by electrical current, there may be an operational
region above a certain electrical current threshold where the
device runs more inefficiently than desired. Put another way, there
may be an upper "speed limit" above which there is decreasing
efficiency. Such an upper threshold may have value in preventing
substantial inefficiencies or even device degradation.
[0365] There may be thresholds within an operational envelope,
however, that may form regions exploitable to enhance efficiency
within operational states. In other words, there may be regions
where the device can adjust and perform better within a defined
operational envelope (or sub-envelope). Such a region can be one
between a marginal threshold and an ultimate threshold. In
addition, these regions may comprise "sweet spots" or a
predetermined optional range or point. These regions also may
comprise a large range within which performance is judged to be
adequate.
[0366] An ultimate threshold can be defined, above which or below
which an action or actions could be taken (or refrained from being
taken) such as stopping the device. In addition, a marginal
threshold or thresholds can be defined, above which or below which
an action or actions could be taken (or refrained from being
taken). By way of non-limiting example, a marginal threshold can be
set to define where the current draw of the motor exceeds 75% of an
ultimate threshold. Exceeding the marginal threshold can result,
for example, in the device's beginning to slow motor speed at an
increasing rate as it continues to climb toward the ultimate
threshold.
[0367] Various mechanisms can be employed to carry out the
adjustment(s) taken as a result of exceeding a threshold. For
example, the adjustment can reflect a step function. It can also
reflect a ramped function. Other functions can be utilized.
[0368] In various aspects, to enhance performance by additional
mechanisms, an overlaying threshold can be defined. An overlaying
threshold can comprise one or more thresholds defined by multiple
parameters. An overlaying threshold can result in one or more
thresholds being an input into the generation of another threshold
or thresholds. An overlaying threshold can be predetermined or
dynamically generated such as at runtime. The overlaying threshold
may come into effect when you the threshold is defined by multiple
inputs. For example, as the number of sterilization cycles exceeds
300 (the marginal threshold) but not 500 (the ultimate threshold)
the device runs the motor slower. Then as the current draw exceeds
its 75% marginal threshold it multiples the slow down going even
slower.
[0369] FIG. 30 is a logic diagram disclosing aspects of a
multiple-level threshold system wherein a threshold rules framework
4000. Parameters can be identified 4010, such parameters
representing quantities, amounts, states, events or more. For
example, parameters identified can include one or more of current,
voltage, tissue pressure, tissue thickness, jaw closure rate,
tissue creep rate, firing load, knife thickness, torque, or battery
usage. An ultimate threshold or thresholds for these parameters can
be identified 4012. For instance, a predetermined current draw can
be identified. As but one example, an ultimate electrical current
draw threshold may be defined as 100% of a selected current
magnitude. There can be an upper ultimate threshold, a lower
ultimate threshold, multiple lower or upper ultimate thresholds
depending on the circumstances, or a range defining an ultimate
threshold. It will be appreciated that an "ultimate" threshold can
be defined and/or calibrated in such a way as to remain essentially
a unitary threshold but embody various action triggers. A marginal
threshold or thresholds can be identified 4014. If the marginal
threshold is exceeded, a motor control program can alter operations
to accommodate change.
[0370] One or more thresholds can be monitored an acted on during a
single surgical procedure, wherein the thresholds are independent
of each other with no interaction. In addition, there can be an
interactive association between thresholds of two or more
parameters. For example, a marginal threshold for a parameter based
on current draw can be 75% of the ultimate threshold. In addition,
in connection with a parameter based on number of sterilization
cycles, a marginal threshold may be set at 200 sterilization
cycles, and an ultimate threshold at sterilization 400 cycles.
Motor use can proceed normally from 0-199 cycles, and then slow by
1% from 200 cycles to 399. At cycle 400, motor use can be
prevented. It will be appreciated, however, that there can be an
interactive effect. In other words, because motor speed is reduced
by 1% due to exceeding the sterilization cycle threshold, the
current draw threshold can be correspondingly adjusted. This
interactive effect can result in the motor running more slowly than
it would if either input were considered independently.
[0371] Thus, the value of one threshold can be an input into the
value of another threshold, or one threshold can be completely
independent of another threshold. Where two or more thresholds are
activated, it can be considered that there can be an overlaying
threshold. As a result, multiple thresholds, defining multiple
boundaries and limits, can have an overlaying or cumulative effect
on operations of instrument 10 (FIGS. 1-4). And, one threshold in a
multiple-threshold operation scenario can have a cause-and-effect
with another threshold, or there may be no cause-and-effect and the
thresholds may exist independent of each other.
[0372] In addition, a threshold can be dynamically set and/or reset
depending on conditions experienced during surgery or other
conditions. In other words, prior to a given surgical procedure, a
module or modules can be preprogrammed into instrument 10 (FIGS.
1-4) or uploaded as needed. Also, a threshold can be dynamically
determined, or uploaded, during a surgical procedure.
[0373] Turning briefly now to FIG. 1, numerous parameters can be
assigned thresholds. Thus, in examples thresholds may be assigned
based on tissue gap between the anvil 306 and staple cartridge 304,
or anvil 306 and second jaw member 302, of an end effector 300, and
motor speed varied thereby. In addition, in example thresholds
based on current can vary motor speed control. Further, in various
examples ultimate, marginal and overlaying thresholds can be
established in connection with closure clamp loads in furtherance
of an acceptable operating range. Plus, in various examples opening
force on an anvil 306 can help to detect a jam. Further, in various
examples if a minimum threshold is not achieved, the system may be
prevented from starting or if it drops below a minimum then a user
action can be required.
[0374] Still with reference to FIG. 1, in various aspects, it can
be determined whether clamp load is acceptable and when clamp load
drops under a minimum threshold during firing the speed of the
motor can be adjusted and/or the clinician warned. In various
examples, when a minimum threshold is exceeded during operation,
instrument 10 can give a warning that the firing may not be
completely as anticipated. Moreover, in various examples thresholds
can be assigned wherein if battery charge falls below a threshold
then remaining battery charge can be used to return the device to a
parked state with respect to the I-beam.
[0375] However, thresholds can be referenced even during operations
that do not exceed a threshold. Thus, for example, instrument 10
can, while running "within limits", compensate for the loading of
the motor. For instance, if current goes up or related speed goes
down, then motor control can increase pulse width or frequency
modulation to help to maintain a constant speed. In other words,
measures can be taken to improve and/or optimize operations of
instrument 10 even while running "within limits."
[0376] In addition, dynamically during a surgical procedure, a
threshold can be modified, or a new threshold generated. This can
occur after several events including adjusting operations of the
instrument 10.
[0377] Turning now back to FIG. 30, in various aspects a parameter
or parameters are identified 4010. Further, an ultimate threshold
or thresholds for a given parameter(s) are identified 4012. In
addition, a marginal threshold or thresholds for a given
parameter(s) are identified 4014. Measures 4010, 4012, and 4014 can
be accomplished prior to the procedure, during the procedure, or
both.
[0378] Measurements of a parameter(s) are obtained 4016. It can be
determined whether the measurement of a given parameter exceeds an
upper or lower ultimate threshold for the parameter 4018. When the
answer is no, it can be determined whether the measurement of a
given parameter exceeds an upper or lower marginal threshold for
the parameter 4020. When the answer is no, operations can be
continued 4026. And, measurements of a given parameter(s) can be
again obtained.
[0379] When, however, the answer is yes to whether the measurement
of a given parameter exceeds an upper or lower ultimate threshold
for the parameter 4018, control can pass to where operations can be
adjusted 4022. Many types of adjustments can be made. One example
is to vary motor speed. It can be determined whether to modify a
given threshold and/or generate a new threshold 4024. This can
occur after operations have been adjusted 4022.
[0380] After operations are adjusted, it can be determined whether
to modify a threshold or generate a new threshold. For example, a
marginal threshold initially set at 75% can be set to a different
value. In addition, a new threshold on the same parameter, or a new
threshold on a new parameter, can be generated if desired.
[0381] Upon determining whether to modify a threshold or generate a
new one, control can pass back to step 4016 where measurement of a
parameter(s) is obtained. In addition, control can proceed to
identify 4010 parameters.
[0382] When the answer to whether the measurement exceeds an upper
or lower ultimate threshold is no, however, then it can be
determined when the measurement exceeds an upper or lower marginal
threshold. When the answer is yes, then operations can be adjusted
4022 and control proceed as above. When the answer is no,
operations can be continued 4026 and control proceed to measuring a
parameter(s).
[0383] It will be appreciated that the sequence of steps can be
varied and is not limited to that specifically disclosed in FIG.
30. As just one example, after obtaining measurement of a
parameter(s) 4016, it can then be determined whether a marginal
threshold is exceeded 4020. In addition, an overlaying threshold
can expressly be identified and considered in the course of the
flow.
[0384] FIG. 31 is a graphical representation 4100 of instrument
system parameters versus time depicting how, in one aspect,
instrument system parameters can be adjusted in the event that a
threshold is reached. Time (t) is shown along a horizontal (x) axis
4102 and the instrument System Parameter is shown along a vertical
(y) axis 4104, marginal threshold 4104 and ultimate threshold 4106.
In the graphical representation 4100 depicted in FIG. 34, the
y-axis parameter 4102 is the one to which a threshold of instrument
system parameter is assigned and the x-axis 4102 represents time.
At a certain time during operation of instrument 10 (FIGS. 1-4), as
evidenced by function 4110, a measurement can indicate that
marginal threshold 4106 is reached. At this point, operations of
the instrument 10 (FIGS. 1-4) can be adjusted. For example, when
the y-axis 4104 parameter is electrical current draw by a motor, a
function can be imposed on the subsequent electrical current draw
and limit current in some fashion. In one example, the function can
represent a linear progression 4112. At a certain time in the
course of operation, an ultimate threshold 4108 can be reached. At
this point, electrical current can be discontinued 4114.
Accordingly, an adjustment mechanism can be accomplished via a
linear function. An additional perspective with which to view the
operational adjustment is that there can be a square-wave
multiplier change.
[0385] FIG. 32 is a graphical representation 4120 of instrument
system parameter depicting how, in another aspect, a system
parameter can be adjusted in the event that a threshold is reached.
Time (t) is shown along a horizontal (x) axis 4122 and the number
of Instrument Operations is shown along a vertical (y) axis 4124,
marginal threshold 4126 and ultimate threshold 4128. Here the
y-axis 4124 parameter is the one to which a threshold is assigned.
At a certain time during operation of instrument 10 (FIGS. 1-4), a
measurement can indicate that the marginal threshold 4126 is
reached during the course of operation 4130. At this point,
operations of the instrument 10 can be adjusted. For example, when
the y-axis 4124 parameter is electrical current draw by a motor, a
limit can be placed on the subsequent current draw representing a
non-linear progression 4132. At a certain time after this, an
ultimate threshold 4128 can be reached. At this point, current can
be discontinued 4134. Accordingly, an adjustment mechanism can be
accomplished via a non-linear function 4132, with a variable slope.
An additional perspective with which to view the operational
adjustment is that there is an exponential multiplier change; here,
the closer the y-axis 4124 parameter comes to the ultimate
threshold 4128, the rate at which current increases diminishes.
[0386] FIG. 33 is a graphical representation 4140 that represents
one aspect wherein a response by instrument 10 (FIGS. 1-4) to
clinician input (User Input) is detected and then a modification is
made. Time (t) is shown along a horizontal (x) axis 4142 and User
Input is represented along a vertical (y) axis 4144. In other
words, a clinician, in performing a procedure, can actuate a
response by instrument 10 such as depressing closure trigger 32
(FIG. 1) which may for example cause motor operation 4146. As motor
speed increases there may or not be a threshold reached. At a
certain point, however, here represented by the divergence point
4148 of curves 4150 and 4152, it can be determined that motor speed
has reached an actual level, or a future level be predicted, that
is or will be suboptimal or otherwise undesirable. At this point,
rather than following the actual or expected speed curve 4150,
instrument 10 can employ a control measure such as an algorithm to
adapt or otherwise modify the output, thus regulating the motor. At
a certain point, motor actuation can be discontinued 4154. In other
words, instrument 10 can take an actual or expected y-axis
parameter and, determining that such actual or expected measurement
is excessive, employ an algorithm to modify such parameter. Put
another way, measured clinician behavior can comprise a value for a
threshold or thresholds.
[0387] FIG. 34 is a graphical representation 4160 of instrument
system parameters that represents one aspect wherein instrument 10
(FIGS. 1-4) detects whether a marginal threshold 4166 or ultimate
threshold 4168 is reached, and responds accordingly. Time (t) is
shown along the horizontal (x) axis 4162 and instrument System
Parameters is shown along the vertical (y) axis 4164. For example,
here the vertical (y) axis 4154 parameter can be the velocity of a
drive, such as a closure drive system 30 (FIG. 1) or firing drive
system 80 (FIG. 1). Instrument 10 can check whether during the
course of operation 4170 a marginal threshold 4166 velocity is
reached. When the marginal threshold 4166 is reached, a control
measure such as an algorithm can be used to adapt or otherwise
modify the velocity 4172. The modified velocity 4172 can be given
by a linear or non-linear function. And, at an ultimate threshold,
power to the motor can be discontinued 4174.
[0388] It will be appreciated that where FIG. 33 can represent a
situation where an actual or predicted value is evaluated, whether
or not an express threshold is provided, FIG. 34 is a graphical
representation where thresholds are provided. It can be
appreciated, however, that a threshold or thresholds can be
implicitly given to FIG. 33 with equivalent results, insofar as a
predetermined or dynamically determined value can serve as a
functional equivalent of a threshold, or trigger actions associated
with a threshold or thresholds. There may be two or more ceiling or
floor values that can serve as such threshold functional
equivalents.
[0389] Turning to another example using thresholds, FIG. 35 is a
graphical representation 4180 of battery current versus time, where
Time (t) is shown along the horizontal (x) axis 4182 and battery
current I.sub.BAT is shown along the vertical (y) axis 4184. In one
example battery current I.sub.BAT 4184 is monitored under varying
operational conditions. As motor speed increases, current drawn
4186 from a battery 90 (FIG. 4) increases. Current drawn can
increase in a non-linear manner depending on several factors;
however, instrument 10 (FIGS. 1-4) can resolve the current drawn
into a linear function 4188. The linear function can be based on
(1) averaging overall current, (2) be based on a prediction of
future current based on past and/or present current, both (1) and
(2), or another function. Linear function 4188 can be extended out
theoretically to linear function 4190, which is an extrapolated
extension with the same slope as linear function 4188.
[0390] Once linear function 4188 reaches a marginal threshold 4192,
instrument 10 (FIGS. 1-4) can take action to modify the response.
Here the marginal threshold is given as 75% of an ultimate
threshold 4194 wherein the ultimate threshold represents a motor
stall; however, it will be appreciated that the selection of the
marginal threshold or ultimate threshold can be made based on
multiple factors. In other words, marginal threshold 4192 can be
reached at time "a" 4196. If adjustments are not made, it is
expected that motor stall would occur at time "b1" 4198. However,
due to adjustments made by instrument 10, the actual motor stall
will not occur until time "b2" 4200. It is possible that a stall
might not occur at all, because the more graduated rise may help to
prevent such an event. Function 4202, which is implemented via a
control measure, can be based on slowing the motor, or another
adjustment. It can manifest as a stepped, ramped or further
function.
[0391] Employing the thresholds herein can give the clinician
greater time to react and adapt, maintain a desired efficiency of
the instrument, and prolong battery life. Thus, utilizing
thresholds can provide multiple benefits in connection with ease of
clinician use and protection of the instrument itself.
[0392] Turning to another aspect, FIG. 36 is a graphical
representation 4210 of battery voltage that shows Time (t) along
the horizontal (x) axis 4212 and battery voltage V.sub.BAT along
the vertical (y) axis 4214. In one example a threshold can be set
in connection with battery voltage V.sub.BAT 4214. Here a marginal
threshold 4216 can be set at 8.1V. Additionally, an ultimate
threshold 4218 can be set at 7.0V. During the course of operation
of instrument 10 (FIGS. 1-4), voltage can decrease over time. The
curve described by measuring the voltage decrease 4220 is not
necessarily linear. However, instrument 10 can resolve the voltage
decrease into a linear function 4222. The linear function can be
based on (1) averaging overall voltage, (2) be based on a
prediction of future voltage based on past and/or present voltage,
both (1) and (2), or another function. Linear function 4222 can be
extrapolated out theoretically to linear function 4224, which has
the same slope as linear function 4222.
[0393] Once linear function 4222 reaches a marginal threshold 4216,
instrument 10 can take action to modify the response. Marginal
threshold 4216 is reached at time "a" 4226. If adjustments are not
made, it is expected that a depleted battery condition would occur
at time "b1" 4228. However, due to adjustments made by instrument
10 (FIGS. 1-4), the actual depleted battery condition will not
occur until time "b2" 4230. Again, it is possible that it may not
occur at all. Function 4232, which can be implemented via a control
measure, can be based on slowing the motor, or another adjustment.
It can manifest as a stepped, ramped or further function.
[0394] FIG. 37 is a graphical representation 4240 of knife speed
versus number of cycles where and Cycles is shown along the
horizontal (x) axis 4242 and Knife Speed is shown along the
vertical (y) axis 4244. As shown in the example illustrated by FIG.
37, thresholds can be employed to adjust speed of a knife 280 (FIG.
8) based on the number of cycles. Relevant cycles can refer to an
amount of firings performed by instrument 10 (FIGS. 1-4),
sterilization cycles performed by instrument 10, or other measured
events. An objective of managing instrument operation by this
threshold mechanism is to maximize the likelihood that an incision
will be effective, taking into account potential blunting of the
knife 280 edge after multiple uses. In this example, firing of the
knife can be initialized based on an expected speed. However, once
a marginal threshold 4246 is reached based on number of cycles,
speed can be reduced from speed 4248 to 4252, such as in a stepped
manner 4250. Thus, once marginal threshold 4760 is exceeded, knife
280 will fire at a progressively lower speed. This will occur for a
given number of cycles 4246 until ultimate threshold 4254 is
reached. At this point, knife speed will be stepped down 4256 even
more or of course instrument 10 can alert the clinician that it may
be undesirable to incise with the knife, and can lock out firing.
It will be understood that function 4248 shows employing a stepped
function once a threshold 4246 is reached, and function 4258 shows
employing a ramped function 4260 once a threshold 4246 is reached.
Additional functions can be employed.
[0395] Further, it will be appreciated that the thresholds given in
FIG. 37 have been defined on the x-axis 4711, whereas prior figures
have shown thresholds on the y-axis 4712. It will also be
appreciated that there can be an additional axis or axes taken into
account, i.e., a z-axis or further axes, wherein the
interrelationship of multiple variables can be considered. Further,
thresholds from a first parameter can be considered along with
thresholds from a second parameter, and one threshold can comprise
an input into another threshold, and vice versa.
[0396] When a threshold is exceeded, the clinician can be notified.
This can be based on a feedback system. In certain instances, the
feedback system may comprise one or more visual feedback systems
such as display screens, backlights, and/or LEDs, for example. In
certain instances, the feedback system may comprise one or more
audio feedback systems such as speakers and/or buzzers, for
example. In certain instances, the feedback system may comprise one
or more haptic feedback systems, for example. In certain instances,
the feedback system may comprise combinations of visual, audio,
and/or tactile feedback systems, for example. Such feedback can
serve to alert or warn the clinician.
[0397] FIG. 38 illustrates a logic diagram of a system 4311 for
evaluating sharpness of a cutting edge 182 (FIG. 20) of a surgical
instrument 10 (FIGS. 1-4) according to various examples. FIG. 38
illustrates a sharpness testing system 4311 for evaluating
sharpness of a cutting edge of a surgical instrument 10 according
to various examples. In certain instances, the system 4311 can
evaluate the sharpness of the cutting edge 182 by testing the
ability of the cutting edge 182 to be advanced through a sharpness
testing member 4302. For example, the system 4311 can be configured
to observe the time period the cutting edge 182 takes to fully
transect and/or completely pass through at least a predetermined
portion of a sharpness testing member 4302. If the observed time
period exceeds a predetermined threshold, the module 4310 may
conclude that the sharpness of the cutting edge 182 has dropped
below an acceptable level, for example.
[0398] In one aspect, the sharpness testing member 4302 can be
employed to test the sharpness of the cutting edge 182 (FIG. 20).
In certain instances, the sharpness testing member 4302 can be
attached to and/or integrated with the cartridge body 194 (FIG. 20)
of the staple cartridge 304 (FIGS. 1, 2, and 20), for example. In
certain instances, the sharpness testing member 4302 can be
disposed in the proximal portion of the staple cartridge 304, for
example. In certain instances, the sharpness testing member 4302
can be disposed onto a cartridge deck or cartridge body 194 of the
staple cartridge 304, for example.
[0399] In certain instances, a load cell 4335 can be configured to
monitor the force (Fx) applied to the cutting edge 182 (FIG. 20)
while the cutting edge 182 is engaged and/or in contact with the
sharpness testing member 4302, for example. The reader will
appreciate that the force (Fx) applied by the sharpness testing
member 4302 to the cutting edge 182 while the cutting edge 182 is
engaged and/or in contact with the sharpness testing member 4302
may depend, at least in part, on the sharpness of the cutting edge
182. In certain instances, a decrease in the sharpness of the
cutting edge 182 can result in an increase in the force (Fx)
required for the cutting edge 182 to cut or pass through the
sharpness testing member 4302. The load cell 4335 of the sharpness
testing member 4302 may be employed to measure the force (Fx)
applied to the cutting edge 182 while the cutting edge 182 travels
a predefined distance (D) through the sharpness testing member 4302
may be employed to determine the sharpness of the cutting edge
182.
[0400] In certain instances, the module 4311 may include a
microcontroller 4313 ("controller") which may include a
microprocessor 4315 ("processor") and one or more computer readable
mediums or memory units 4317 ("memory"). In certain instances, the
memory 4317 may store various program instructions, which when
executed may cause the processor 4315 to perform a plurality of
functions and/or calculations described herein. In certain
instances, the memory 4317 may be coupled to the processor 4315,
for example. A power source 4319 can be configured to supply power
to the controller 4313, for example. In certain instances, the
power source 4319 may comprise a battery (or "battery pack" or
"power pack"), such as a Li ion battery, for example. In certain
instances, the battery pack may be configured to be releasably
mounted to the handle 14. A number of battery cells connected in
series may be used as the power source 4319. In certain instances,
the power source 4319 may be replaceable and/or rechargeable, for
example.
[0401] In certain instances, the processor 4313 can be operably
coupled to the feedback system and/or the lockout mechanism 4123,
for example.
[0402] The module 4311 may comprise one or more position sensors.
Example position sensors and positioning systems suitable for use
with the present disclosure are described in U.S. patent
application Ser. No. 13/803,210, entitled SENSOR ARRANGEMENTS FOR
ABSOLUTE POSITIONING SYSTEM FOR SURGICAL INSTRUMENTS, and filed
Mar. 14, 2013, now U.S. Pat. No. 9,808,244, the disclosure of which
is hereby incorporated by reference herein in its entirety. In
certain instances, the module 4311 may include a first position
sensor 4321 and a second position sensor 4323. In certain
instances, the first position sensor 4321 can be employed to detect
a first position of the cutting edge 182 (FIG. 20) at a proximal
end of a sharpness testing member 4302, for example; and the second
position sensor 4323 can be employed to detect a second position of
the cutting edge 182 at a distal end of a sharpness testing member
4302, for example.
[0403] In certain instances, the position sensors 4321 and 4323 can
be employed to provide first and second position signals,
respectively, to the microcontroller 4313. It will be appreciated
that the position signals may be analog signals or digital values
based on the interface between the microcontroller 4313 and the
position sensors 4321 and 4323. In one example, the interface
between the microcontroller 4313 and the position sensors 4321 and
4323 can be a standard serial peripheral interface (SPI), and the
position signals can be digital values representing the first and
second positions of the cutting edge 182, as described above.
[0404] Further to the above, the processor 4315 may determine the
time period between receiving the first position signal and
receiving the second position signal. The determined time period
may correspond to the time it takes the cutting edge 182 (FIG. 20)
to advance through a sharpness testing member 4302 from the first
position at a proximal end of the sharpness testing member 4302,
for example, to a second position at a distal end of the sharpness
testing member 4302, for example. In at least one example, the
controller 4313 may include a time element which can be activated
by the processor 4315 upon receipt of the first position signal,
and deactivated upon receipt of the second position signal. The
time period between the activation and deactivation of the time
element may correspond to the time it takes the cutting edge 182 to
advance from the first position to the second position, for
example. The time element may comprise a real time clock, a
processor configured to implement a time function, or any other
suitable timing circuit.
[0405] In various instances, the controller 4313 can compare the
time period it takes the cutting edge 182 (FIG. 20) to advance from
the first position to the second position to a predefined threshold
value to assess whether the sharpness of the cutting edge 182 has
dropped below an acceptable level, for example. In certain
instances, the controller 4313 may conclude that the sharpness of
the cutting edge 182 has dropped below an acceptable level if the
measured time period exceeds the predefined threshold value by 1%,
5%, 10%, 25%, 50%, 100% and/or more than 100%, for example.
[0406] FIG. 39 illustrates a logic diagram of a system 4340 for
determining the forces applied against a cutting edge of a surgical
instrument 10 (FIGS. 1-4) by a sharpness testing member 4302 at
various sharpness levels according to various aspects. Referring to
FIG. 39, in various instances, an electric motor 4331 can drive the
firing bar 172 (FIG. 20) to advance the cutting edge 182 (FIG. 20)
during a firing stroke and/or to retract the cutting edge 182
during a return stroke, for example. A motor driver 4333 can
control the electric motor 4331; and a microcontroller such as, for
example, the microcontroller 4313 can be in signal communication
with the motor driver 4333. As the electric motor 4331 advances the
cutting edge 182, the microcontroller 4313 can determine the
current drawn by the electric motor 4331, for example. In such
instances, the force required to advance the cutting edge 182 can
correspond to the current drawn by the electric motor 4331, for
example. Referring still to FIG. 39, the microcontroller 4313 of
the surgical instrument 10 can determine if the current drawn by
the electric motor 4331 increases during advancement of the cutting
edge 182 and, if so, can calculate the percentage increase of the
current.
[0407] In certain instances, the current drawn by the electric
motor 4331 may increase significantly while the cutting edge 182
(FIG. 20) is in contact with the sharpness testing member 4302 due
to the resistance of the sharpness testing member 4302 to the
cutting edge 182. For example, the current drawn by the electric
motor 4331 may increase significantly as the cutting edge 182
engages, passes and/or cuts through the sharpness testing member
4302. The reader will appreciate that the resistance of the
sharpness testing member 4302 to the cutting edge 182 depends, in
part, on the sharpness of the cutting edge 182; and as the
sharpness of the cutting edge 182 decreases from repetitive use,
the resistance of the sharpness testing member 4302 to the cutting
edge 182 will increase. Accordingly, the value of the percentage
increase of the current drawn by the motor 4331 while the cutting
edge is in contact with the sharpness testing member 4302 can
increase as the sharpness of the cutting edge 182 decreases from
repetitive use, for example.
[0408] In certain instances, the determined value of the percentage
increase of the current drawn by the motor 4331 can be the maximum
detected percentage increase of the current drawn by the motor
4331. In various instances, the microcontroller 4313 can compare
the determined value of the percentage increase of the current
drawn by the motor 4331 to a predefined threshold value of the
percentage increase of the current drawn by the motor 4331. If the
determined value exceeds the predefined threshold value, the
microcontroller 4313 may conclude that the sharpness of the cutting
edge 182 has dropped below an acceptable level, for example.
[0409] In certain instances, as illustrated in FIG. 39, the
processor 4315 can be in communication with the feedback system
and/or the lockout mechanism for example. In certain instances, the
processor 4315 can employ the feedback system to alert a user if
the determined value of the percentage increase of the current
drawn by the motor 4331 exceeds the predefined threshold value, for
example. In certain instances, the processor 4315 may employ the
lockout mechanism to prevent advancement of the cutting edge 182
(FIG. 20) if the determined value of the percentage increase of the
current drawn by the motor 4331 exceeds the predefined threshold
value, for example. In certain instances, the system 4311 may
include a first position sensor 4321 and a second position sensor
4323. The surgical instrument 10 (FIGS. 1-4) may include a load
cell 4335.
[0410] In various instances, the microcontroller 4313 can utilize
an algorithm to determine the change in current drawn by the
electric motor 4331. For example, a current sensor can detect the
current drawn by the electric motor 4331 during the firing stroke.
The current sensor can continually detect the current drawn by the
electric motor and/or can intermittently detect the current draw by
the electric motor. In various instances, the algorithm can compare
the most recent current reading to the immediately proceeding
current reading, for example. Additionally or alternatively, the
algorithm can compare a sample reading within a time period X to a
previous current reading. For example, the algorithm can compare
the sample reading to a previous sample reading within a previous
time period X, such as the immediately proceeding time period X,
for example. In other instances, the algorithm can calculate the
trending average of current drawn by the motor. The algorithm can
calculate the average current draw during a time period X that
includes the most recent current reading, for example, and can
compare that average current draw to the average current draw
during an immediately proceeding time period time X, for
example.
[0411] FIG. 40 illustrates a logic diagram 4350 of a method for
determining whether a cutting edge of a surgical instrument 10
(FIGS. 1-4) is sufficiently sharp to transect tissue captured by
the surgical instrument 10 according to various aspects. Referring
to FIG. 40, the logic diagram 4350 depicts a method for evaluating
the sharpness of the cutting edge 182 (FIG. 20) of the surgical
instrument 10; and various responses are outlined in the event the
sharpness of the cutting edge 182 drops to and/or below an alert
threshold and/or a high severity threshold, for example. In various
instances, a microcontroller such as, for example, the
microcontroller 4313 can be configured to implement the method 4350
depicted in FIG. 40. In certain instances, the surgical instrument
10 may include a load cell 4335, as illustrated in FIGS. 38 and 39,
and the microcontroller 4313 may be in communication with the load
cell 4335. In certain instances, the load cell 4335 may include a
force sensor such as, for example, a strain gauge, which can be
operably coupled to the firing bar 172, for example. In certain
instances, the microcontroller 4313 may employ the load cell 4335
to monitor the force (Fx) applied to the cutting edge 182 as the
cutting edge 182 is advanced during a firing stroke.
[0412] In various instances, the method 4350 begins by initiating
4352 firing of the surgical instrument 10 (FIGS. 1-4). Before,
during, and/or after firing of the surgical instrument 10 is
initiated 4352, a system checks 4354 the dullness of the cutting
edge 182 by monitoring a force (Fx). The reader will appreciate
that the force (Fx) is applied by the sharpness testing member 4302
to the cutting edge 182 while the cutting edge 182 is engaged
and/or in contact with the sharpness testing member 4302, and, the
force (Fx) may depend, at least in part, on the sharpness of the
cutting edge 182. In certain instances, a decrease in the sharpness
of the cutting edge 182 can result in an increase in the force (Fx)
required for the cutting edge 182 to cut or pass through the
sharpness testing member 4302.
[0413] The system senses 4356 the force (Fx) applied by the
sharpness testing member 4302 to the cutting edge 182 (FIG. 20).
When the force (Fx) sensed 4356 stays within an alert threshold
range a display will display 4358 nothing and firing 4360 of the
surgical instrument 10 (FIGS. 1-4) will proceed. When the force
(Fx) sensed 4356 is outside the alert threshold range, the system
4354 will then determine if the force (Fx) is outside a high
severity threshold range. The display will display 4364 an alert to
the user of the surgical instrument 10 that the cutting edge 182 is
dulling. At this stage, the user is aware that the cutting edge 182
is dulling and may need replaced. When the force (Fx) is sensed
4362 to be greater than the high severity threshold range, the
display displays 4366 a warning indicating the force (Fx) applied
to the cutting edge 182 is greater than the high severity threshold
and that the cutting edge 182 is dull. If the cutting edge is
determined to be dull, a firing lockout system may be engaged. The
display may display 4368 an optional display sequence to allow the
user of the surgical instrument 10 to override the firing lockout
system and continue firing 4360 this surgical instrument 10.
[0414] In certain instances, the load cell 4335 (FIGS. 38, 39) can
be configured to monitor the force (Fx) applied to the cutting edge
182 (FIG. 20) while the cutting edge 182 is engaged and/or in
contact with the sharpness testing member 4302 (FIGS. 38, 39), for
example. The reader will appreciate that the force (Fx) applied by
the sharpness testing member 4302 to the cutting edge 182 while the
cutting edge 182 is engaged and/or in contact with the sharpness
testing member 4302 may depend, at least in part, on the sharpness
of the cutting edge 182. In certain instances, a decrease in the
sharpness of the cutting edge 182 can result in an increase in the
force (Fx) required for the cutting edge 182 to cut or pass through
the sharpness testing member 4302. For example, as illustrated
graphically in FIG. 41, graphs 4336, 4338, and 4342 represent,
respectively, the force (Fx) applied to the cutting edge 182 while
the cutting edge 182 travels a predefined distance (D) through
three identical, or at least substantially identical, sharpness
testing members 4302. The graph 4336 corresponds to a first
sharpness of the cutting edge 182; the graph 4338 corresponds to a
second sharpness of the cutting edge 182; and the graph 4342
corresponds to a third sharpness of the cutting edge 182. The first
sharpness is greater than the second sharpness, and the second
sharpness is greater than the third sharpness.
[0415] In certain instances, the microcontroller 4313 (FIGS. 38,
39) may compare a maximum value of the monitored force (Fx) applied
to the cutting edge 182 (FIG. 20) to one or more predefined
threshold values. In certain instances, as illustrated in FIG. 41,
the predefined threshold values may include an alert threshold (F1)
and/or a high severity threshold (F2). In certain instances, as
illustrated in the graph 4336 of FIG. 41, the monitored force (Fx)
can be less than the alert threshold (F1), for example. In such
instances, as illustrated in FIG. 41, the sharpness of the cutting
edge 182 is at a good level and the microcontroller 4313 may take
no action to alert a user as to the status of the cutting edge 182
or may inform the user that the sharpness of the cutting edge 182
is within an acceptable range.
[0416] In certain instances, as illustrated in the graph 4338 of
FIG. 41, the monitored force (Fx) can be more than the alert
threshold (F1) but less than the high severity threshold (F2), for
example. In such instances, as illustrated in FIG. 40, the
sharpness of the cutting edge 182 (FIG. 2) can be dulling but still
within an acceptable level. The microcontroller 4313 may take no
action to alert a user as to the status of the cutting edge 182.
Alternatively, the microcontroller 4313 (FIGS. 38, 39) may inform
the user that the sharpness of the cutting edge 182 is within an
acceptable range. Alternatively or additionally, the
microcontroller 4313 may determine or estimate the number of
cutting cycles remaining in the lifecycle of the cutting edge 182
and may alert the user accordingly.
[0417] In certain instances, the memory 4317 (FIGS. 38, 39) may
include a database or a table that correlates the number of cutting
cycles remaining in the lifecycle of the cutting edge 182 (FIG. 20)
to predetermined values of the monitored force (Fx). The processor
4315 (FIGS. 38, 39) may access the memory 4317 to determine the
number of cutting cycles remaining in the lifecycle of the cutting
edge 182 which correspond to a particular measured value of the
monitored force (Fx) and may alert the user to the number of
cutting cycles remaining in the lifecycle of the cutting edge 182,
for example.
[0418] In certain instances, as illustrated in the graph 4342 of
FIG. 41, the monitored force (Fx) can be more than the high
severity threshold (F2), for example. In such instances, as
illustrated in FIG. 40, the sharpness of the cutting edge 182 can
be below an acceptable level. In response, the microcontroller 4313
may employ the feedback system to warn the user that the cutting
edge 182 is too dull for safe use, for example. In certain
instances, the microcontroller 4313 may employ the lockout
mechanism to prevent advancement of the cutting edge 182 upon
detection that the monitored force (Fx) exceeds the high severity
threshold (F2), for example. In certain instances, the
microcontroller 4313 may employ the feedback system to provide
instructions to the user for overriding the lockout mechanism, for
example.
[0419] Referring now to FIG. 42, a method 4370 is depicted for
determining whether a cutting edge such as, for example, the
cutting edge 182 (FIG. 20) is sufficiently sharp to be employed in
transecting a tissue of a particular tissue thickness that is
captured by the end effector 300 (FIG. 1), for example. In certain
instances, the microcontroller 4313 can be implemented to perform
the method 4370 depicted in FIG. 42, for example. As described
above, repetitive use of the cutting edge 182 may dull or reduce
the sharpness of the cutting edge 182 which may increase the force
required for the cutting edge 182 to transect the captured tissue.
In other words, the sharpness level of the cutting edge 182 can be
defined by the force required for the cutting edge 182 to transect
the captured tissue, for example. The reader will appreciate that
the force required for the cutting edge 182 to transect a captured
tissue also may depend on the thickness of the captured tissue. In
certain instances, the greater the thickness of the captured
tissue, the greater the force required for the cutting edge 182 to
transect the captured tissue at the same sharpness level, for
example.
[0420] In certain instances, the cutting edge 182 (FIG. 20) may be
sufficiently sharp for transecting a captured tissue comprising a
first thickness but may not be sufficiently sharp for transecting a
captured tissue comprising a second thickness greater than the
first thickness, for example. In certain instances, a sharpness
level of the cutting edge 182, as defined by the force required for
the cutting edge 182 to transect a captured tissue, may be adequate
for transecting the captured tissue if the captured tissue
comprises a tissue thickness that is in a particular range of
tissue thicknesses, for example. In certain instances, the memory
4317 (FIGS. 38, 39) can store one or more predefined ranges of
tissue thicknesses of tissue captured by the end effector 300; and
predefined threshold forces associated with the predefined ranges
of tissue thicknesses. In certain instances, each predefined
threshold force may represent a minimum sharpness level of the
cutting edge 182 that is suitable for transecting a captured tissue
comprising a tissue thickness (Tx) encompassed by the range of
tissue thicknesses that is associated with the predefined threshold
force. In certain instances, when the force (Fx) required for the
cutting edge 182 to transect the captured tissue, comprising the
tissue thickness (Tx), exceeds the predefined threshold force
associated with the predefined range of tissue thicknesses that
encompasses the tissue thickness (Tx), the cutting edge 182 may not
be sufficiently sharp to transect the captured tissue, for
example.
[0421] The method 4370 shown in FIG. 42 begins with clamping 4372
the tissue. Once the tissue to be transected is clamped, the
thickness of the tissue is sensed 4374. After the tissue thickness
is sensed 4374, firing of the surgical instrument can be initiated
4376 by the user. Once the surgical instrument begins firing, the
force (Fx) applied to the cutting edge 182 (FIG. 20) is sensed
4378. The force (Fx) and the tissue thickness (Tx) is then compared
4380 to predetermined tissue thickness ranges and force ranges
required to adequately transect the predetermined tissue
thicknesses. For example, if the force (Fx) sensed is greater than
a predetermined force range required to adequately transect tissue
at the tissue thickness (Tx) that was sensed for the tissue
clamped, a display will display 4386 an alert to the user that the
cutting edge 182 is dulling. When the force (Fx) sensed is within
the predetermined force range required to adequately transect
tissue at the tissue thickness (Tx) that was sensed for the tissue
clamped, the display may display 4382 nothing. In both instances,
the surgical instrument continues 4384 firing to transect the
tissue.
[0422] In various aspects, the present disclosure provides
techniques for determining tissue compression and additional
techniques to control the operation of the instrument 10 (described
in connection with FIGS. 1-29) in response to the tissue
compression. In one example, the cartridges may be configured to
define variable compression algorithm which drives instrument 10 to
close differently based on intended tissue type and thickness. In
another example, the instrument 10 learns from surgeon use and
original tissue compression profile to adapt closure based on load
experienced during firing. When the instrument 10 experiences
tissue compression loads that are dramatically different that those
experienced for this cartridge type the instrument highlights this
to the user.
[0423] Active adjustment of a motor control algorithm over time as
the instrument become acclimated to the hospital's usage can
improve the life expectancy of a rechargeable battery as well as
adjust to tissue/procedure requirements of minimizing tissue flow,
thus improving staple formation in the tissue seal.
[0424] Accordingly, the present disclosure relates to surgical
instruments and, in various circumstances, to surgical stapling and
cutting instruments and staple cartridges therefor that are
designed to staple and cut tissue. For example, in various aspects
the present disclosure provides an endosurgical instrument
configured to sense the cartridge type or tissue gap to enable the
handle to adjust the closure and firing algorithms to adjust for
intended tissue properties. This adaptive algorithm adjustment can
"learn" from the user's operations allowing the device to react and
benefit two different systems. The first benefit provided by the
disclosed adaptive algorithm includes tissue flow and staple
formation. As the device learns the users' basic habits and step
timings, the device can adjust the closure speed and firing speed
to provide a more consistent and reliable output. The second
benefit provided by the disclosed adaptive algorithm is related to
the battery pack. As the device learns how many firings and what
conditions the instrument was used, the device can adjust motor
current needs/speed in a predefined manner to prolong battery life.
There is a substantially small likelihood that a device used in a
hospital that performs predominantly bariatric procedures would be
operated in a manner similar to a device used in a hospital that
performs mostly colorectal or thoracic procedures. Thus, when the
device is used to perform substantially similar procedure, over
time, the device is configured to learn and adjust its operational
algorithm to maintain within the "ideal" discharge and tissue flow
envelopes.
[0425] Safe and effective surgery requires due knowledge of, and
respect for, the tissue involved. Clinicians are mindful that
adjustments made during surgery may be beneficial. These
adjustments include mechanisms to detect and promote desirable
staple formation.
[0426] Endosurgical instruments can generate, monitor and process a
substantial amount of data during their use in connection with a
surgical procedure. Such data can be obtained from the surgical
instrument itself, including battery usage. Additionally, data can
be obtained from the properties of the tissue with which the
surgical instrument interacts, including properties such as tissue
compression. Further, data can be obtained from the clinician's
interaction with the surgical instrument itself. The repository of
data so obtained can be processed and, where desired, the surgical
instrument can be designed to adapt to circumstances so as to
promote a safe and effective outcome to the current surgical
procedure, as well as lay the foundation for more generalized
productive use by multiple clinicians. Such adaptive
adjustments--both during a surgical procedure, and wherein the
instrument "learns" based on usage patterns drawn from multiple
surgical procedures--can provide numerous mechanisms to enhance the
overall patient-care environment.
[0427] FIG. 43 illustrates one aspect of a process for adapting
operations of a surgical instrument. As shown in FIG. 43, in
various examples, an adaptive algorithm framework 5000 is provided.
A staple cartridge can be identified 5060. Control measures, such
as algorithms, can be selected 5062 based on the cartridge
identified. These algorithms may include one or more variable
compression algorithms that drives instrument 10 (FIGS. 1-4) to
close in a different manner based on an expected tissue type and/or
thickness. Tissue properties can be identified 5064 as an aid to
selection of control measures. The clinician can operate 5066
instrument 10 to carry out a surgical procedure, including but not
limited to stapling and/or incising tissue. Control measures can be
modified 5068, with or without reference to data observed or
generated during the course of a surgical procedure.
[0428] A surgical procedure can entail generating a significant
amount of data on parameters. By way of non-limiting example, these
parameters can include those associated with surgical instrument 10
(FIGS. 1-4) itself and its functionality, including but not limited
to: speed of closure of the anvil 306 (FIG. 1) and staple cartridge
304 (FIG. 1), or speed of closure of anvil 306 and second jaw
member 302 (FIG. 1); gap (e.g., distance) between anvil 306 and
staple cartridge 304, or anvil 306 and second jaw member 302;
voltage; current; motor(s') speed; power management, e.g., battery
use; or sensor operation and accuracy.
[0429] Additional parameters that may be generated and observed in
connection with a surgical procedure can also include those derived
from the tissue being operated upon, including but not limited to:
tissue compression; tissue thickness; tissue flow; tissue creep;
tissue pressure; tissue stabilization; whether end effector 300
(FIG. 1) clamps a full or partial bite of tissue, and whether such
partial bite is proximal or distal; speed of closure drive system
30 (FIG. 1); speed of firing drive system 80 (FIG. 4); staple
performance; and/or determination if the tissue profile is
consistent with healthy tissue or diseased tissue.
[0430] Further parameters that may be generated and observed in
connection with a surgical procedure can also include those derived
from the clinician, such as frequency of actuating closure trigger
32 (FIG. 1) by clinician; force applied on closure trigger 32 by
clinician; frequency of actuating firing trigger 130 (FIG. 4) by
clinician; force applied on firing trigger 130 by clinician; and/or
step timing by clinician.
[0431] Even more, parameters can include to what extent the
instrument 10: experiences tissue compression loads different from
those expected for the cartridge type; experiences a wait period
(such as for tissue creep) different from that expected;
experiences a firing speed different from that expected; has
undergone one or more sterilization cycles; and/or experiences
different or similar patterns of use based on the clinical setting.
For example, there may be meaningful differences among use of the
instrument in a setting directed primarily to bariatric,
colorectal, or thoracic procedures respectively.
[0432] On top of these, parameters can include accuracy and
appropriateness of control measures themselves, such as algorithms,
used in connection with operating the instrument. Feedback loops
and/or logic paths can be developed that include one or more of
algorithms, data based on instrument operation 5070, data based on
the treatment site 5072, data based on clinician conduct 5074, and
more. Added parameters can be considered and developed.
[0433] It will be apparent that there are numerous data resources
that can be derived from a single surgical procedure. These data
resources can be analyzed in various manners including as a single
data point, a plurality of data points, a range or ranges, as a
range or ranges, or based on added metrics such as rate of change
of current, voltage, speed, or other parameter. Taking into account
one, or many, of these data resources can enhance the safety and
effectiveness of a single procedure.
[0434] In addition, these data resources can enhance the safety and
effectiveness of future procedures by the same clinician to the
extent that the surgical instrument can "learn" the basic habits
and step timings of the clinician. In addition, data can be
aggregated from multiple clinicians, further enabling the
successful calibration of the surgical instrument in the context of
the surgical procedure. It can be appreciated that the hospital or
health center in which the data is compiled can develop a unique
profile that can further enhance health outcomes. In addition,
battery life can be prolonged, as it is learned how many firings
and under what conditions the surgical instrument 10 is used. Thus,
arrangements to adapt to numerous battery usage metrics are
contemplated in examples.
[0435] Instrument 10 (FIGS. 1-4) can determine whether, based on
data obtained 5070, 5072, 5074, a control measure is appropriate or
not by various mechanisms. One mechanism is by identifying a
predetermined value or values. Such value or values can comprise an
acceptable, or expected, parameter. If data obtained 5070, 5072,
5074 leads to a determination that an acceptable range has been
exceeded, then a new control measure(s) can be identified 5076 and
control measures can be modified 5078 including setting forth a new
acceptable value. Exceeding a range can be considered to mean going
above a range, below or range, or otherwise going beyond a range.
The second control measure can be a minor adaptation of the first
control measure, or it can be an entirely new control measure. It
will also be appreciated that the predetermined acceptable range
can be a single data point, multiple data points, a function or
other calculable equation, or any mechanism by which it can be
determined that a measurement, property or other metric that can be
resolvable into a calculable value differs from an actual, expected
or predicted value. It is also understood that a control measure
can be compared with another control measure, and the differential
effectiveness of each determined, thus forming an input into
another determination of whether and which control measures to
adopt. Put another way, success of control measures can represent
an input.
[0436] In addition, expected values for parameters can be embedded
in control measures. In other words, an expected set of values for
a tissue property can be embedded in a control measure that has
been associated with instrument 10 (FIGS. 1-4). Thus, it will be
evident that numerous expected values for numerous parameters can
be populated into numerous control measures. These expected values
can be referenced during operations of the instrument in order to
determine control measures carried out by instrument 10. Further,
observed values can be detected and analyzed by instrument 10
during operation. These observed values can be referenced and help
determine the course of selection of current and future control
measures of the instrument 10 during the procedure, and also
programmed into instrument 10 to set new or modified benchmarks to
help determine an acceptable range or ranges of control measures.
Further predictions can be made during operation of the instrument
10. The predictions can inform the processing and analysis of
measurements, can lead to modifying control measures, and generally
adapting to operational circumstances.
[0437] Thus, data can be obtained from multiple sources. One source
is data based on operation of the instrument (e.g., closure speed)
5070. Another source of data can be that derived from the treatment
site 5072 (e.g., tissue thickness). A further source of data can be
that based on clinician conduct 5074 (e.g., firing habits). Once
this data 5070, 5072, 5074 is obtained, the appropriateness of
control measures can be assessed 5076. For example, a certain
tissue type may have been expected, and this tissue type was
experienced during the procedure. However, it may be that the
exudation resulting from clamping was heavier than anticipated.
Also, it may be that the clinician has a habit of applying more
pressure than may be desirable on the firing trigger 130 (FIG. 1).
In short, there may be many data sources that can be consulted to
analyze, improve on and potentially optimize efficacy of current
and future uses of the instrument. As a result, control measures
can be modified 5078 during and/or after a procedure for maximum
success.
[0438] In one aspect, surgical instrument 10 (FIGS. 1-4) can
comprise a plurality of modules, based on control mechanisms
configurable from a controller and/or other processor, memory, and
other systems therein for transmission, communication and
processing of data. One of multiple possible modules can be based
on a feedback system, as generalized and/or customized for a
specific purpose or system. In addition, it will be apparent that
there will be a processor 4315 (FIGS. 38, 39) and memory 4317
(FIGS. 38, 39) in operative communication with the surgical
instrument 10 that can permit the functionality discussed
herein.
[0439] FIG. 44 illustrates one aspect of a process for adapting
operations of a surgical instrument. As depicted in FIG. 44, a
module can be attached 5160 or otherwise loaded to instrument 10
(FIGS. 1-4). The module can contain a program that is selected or
uploaded 5162. Controls can be activated 5164 such that they can be
ready to operate instrument 10. During or after usage of instrument
10, a program, including control measures, can be adapted 5166. For
example, this can include adjusting the data rate within the
instrument 10 or with respect to remote operation of the instrument
10. This can include adjusting speed, such as speed by which anvil
306 (FIG. 1) and cartridge 304 (FIG. 1) engage in a closure motion.
This can also include a pulse from an emitter and sensor or to
apply a pulse of electrical current to tissue, and the timing of
such pulse. This can include adjusting a program to adapt to
acceleration, such as acceleration of the instrument 10 if dropped,
or transition from a sleep mode. A program can be adapted to handle
an actual and/or expected load based on clamping force.
[0440] Instrument 10 (FIGS. 1-4) can be employed to complete an
action 5168, for example to carry out a stapling procedure. Data
can be recorded 5170 in appropriate memory locations of instrument
10. Sensor behavior 5172 can be assessed, such as to what extent a
sensor accurately measured and/or measures a parameter. Anticipated
data can be assessed 5174, including but not limited to tissue
properties, wait period and firing speed. Foregoing mechanisms
disclosed herein can provide an input to adapt a program 5166
further. In addition, a tissue identification 5178 can be
performed, based on historical, actual or expected tissue
properties, and this can provide an input to adapt a program 5166
further. In addition, tissue identification 5178 properties can be
updated. Moreover, measured sensor input 5176 during a procedure
can be used as an additional input to adapt a program 5166 further;
such sensor measurements can include those of the gap between anvil
306 and cartridge 304, obtaining a derivative measurement including
a derivative of a function, current, or torque.
[0441] FIG. 45 illustrates one aspect of a mechanism for adapting
operations of a surgical instrument in the context of closure
motion and tissue pressure. In various aspects, closure motion 5216
can be adjusted based on a parameter. An example parameter can be
average tissue pressure 5218. FIG. 45 is a diagram that illustrates
three phases of carrying out a procedure with instrument 10 (FIGS.
1-4). Time (t) is shown along a bottom horizontal axis 5220, a
bottom vertical axis represents average tissue pressure 5218
applied to tissue clamped between the jaw members of the end
effector. A top vertical axis represents closure motion 5216 of the
anvil 306 (FIG. 1) towards the cartridge 304 (FIG. 1) to engage
tissue therebetween in a closure motion. A top horizontal axis
represents closing 5210 of the anvil 306 (FIG. 1) of end effector
to engage a cartridge 304 (FIG. 1) or second jaw member 302 (FIG.
1), tissue creep 5212 wherein material is allowed to exudate from
the tissue section held within end effector 300 (FIG. 1), and
firing 5214, which can comprise deploying a staple cartridge 304,
applying electrosurgical energy, incising tissue, or other suitable
surgical event. An anvil 306 can begin to close on a second jaw
member 302, which is configured to receive a staple cartridge 304
therein. As anvil 306 closes toward cartridge 304 during a clamping
operation, tissue pressure is determined by one or more mechanisms,
such as by reference to one or more sensors. A plurality of sensors
may comprise one or more identical sensors and/or different
sensors. The plurality of sensors may comprise, for example,
magnetic sensors, such as a magnetic field sensor, strain gauges,
pressure sensors, inductive sensors, such as an eddy current
sensor, resistive sensors, capacitive sensors, optical sensors,
and/or any other suitable sensors or combination thereof.
[0442] During the closing phase 5210, the closure motion 5216
versus time of the jaw members is compared with average tissue
pressure 5218 versus time. A first average tissue pressure versus
time curve, represented by a dashed line includes three segments,
includes a first segment 5286 during the closing phase 5210 of the
anvil 306 (FIG. 1) towards the cartridge 304 (FIG. 1) to apply
pressure against the tissue grasped therebetween. A second segment
5260 represents the tissue pressure during the tissue creep 5212
phase where the anvil 304 has stopped moving and the tissue is
given an opportunity to creep. A third segment represents the
tissue pressure during the firing phase during which the staples
are deployed to seal the tissue ahead of advancement of the cutting
member to cut the tissue.
[0443] A second average tissue pressure versus time curve,
represented by a dashed-dot line, represents a typical curve
observed when the anvil 306 (FIG. 1) is closing too fast 5254. This
is represented by the first segment 5152 where the slope P2 of the
average tissue pressure 5218 versus time is too steep during the
closure motion curve segment 5230 during the acceleration of the
closure motion and curve segment 5234 when the closure motion 5216
remains steady until a threshold 5236 average tissue slope 5218 is
detected at which time the closure motion drops to a lower constant
value shown by curve segment 5238 at which time the slope of the
average tissue pressure 5216 curve segment 5256 decreases to
reflect the slower closure motion 5216.
[0444] A third "ideal" tissue pressure versus time curve 5258
having an ideal slope is represented by a solid line curve segment
5250.
[0445] The tissue creep 5212 phase is entered after the tissue is
grasped and the average tissue pressure reaches a predetermined
threshold and the closure motion 5216 stops such that the jaw
members, e.g., anvil 306 (FIG. 1) and cartridge 304 (FIG. 1), hold
the tissue therebetween for a predetermined time before initiating
the firing 5214 phase in which the staples and knife are deployed.
During the tissue creep 5212 phase the average tissue pressure
drops over the time period between closing 5210 and firing 5214
phases. The dashed-dot curve (adjusted closing too fast curve) and
solid curve (ideal closing speed) segments 5262 overlap.
[0446] At a predetermined time 5248, the firing 5214 phase
initiates. A typical firing 5214 cycle, is represented by the
dashed line average tissue pressure curve segment 5266. An ideal
firing 5214 cycle is represented by the solid line average tissue
pressure curve segment 5264 where the slope P1 increases 5270,
reaches a peak 5272, and then gently decreases 5276. When the
firing 5214 phase moves too rapidly as indicated by curve segment
5240, the slope P2 of the dashed-dot line average tissue pressure
curve 5266 rises too steeply. When a predetermined slope threshold
is detected, the firing speed is maintained constant as represented
by firing curve speed segment 5242 and the slope 5270 of the
dashed-dot line average tissue pressure curve 5266 decreases. After
a predetermined time, the firing speed drops to a lower speed as
represented by the firing speed curve segment 5246. After allowing
for system response times, the dashed-dot line coincides with the
solid line during the lower firing speed 5246.
[0447] Closure motion 5216, such as speed of closure, or another
measured rate related to closure, can be determined. As the
clamping operation progresses, and a parameter increases 5230,
average tissue pressure is being measured. The parameter in
question can be but is not limited to speed. Average tissue
pressure can be plotted graphically. A curve 5252 described by such
graph can be plotted. At a certain point closure motion 5216 can be
steady 5232. However, a tissue pressure reading can suggest that
the closure motion rate is too fast 5254 as indicated by, for
example, the slope of curve 5252. It can also be the case that the
closure motion rate was too fast, or is predicted to be too fast in
the future. This can occur during a period where closure rate is
steady 5232, or during a period where closure rate drops 5234 such
as where thick, fluid-filled or unexpectedly dense tissue is
encountered, among other reasons. Fluid in tissue could cause
thickness to increase temporarily, causing undesirable staple
deployment. To the extent that it is detected that the slope of
average tissue pressure curve 5218 is growing too steep,
adjustments can be made. It will also be appreciated that,
independent of or in conjunction with slope, a secondary
calculation can be made based on the observed parameters suggesting
that the closure rate is too fast. An adjustment can be made, such
as by decreasing the rate of change of closure motion 5216. For
example, an ideal closing speed can be referenced based on stored
control measures or dynamically obtained control measures, or both.
An average tissue pressure curve reflecting such ideal closing
speed 5258 can be referenced.
[0448] Accordingly, curve 5258 can influence closure motion 5216
such that the rate of closure is decreased 5238 or otherwise
modified to adapt to circumstances encountered during a surgical
procedure. It will be understood that an ideal closing speed can
represent an optimal closing speed, or one within a range of
adequate closing speeds.
[0449] Compression of clamped tissue can precede the firing 5214
phase. It may be desired that compression reach a certain average
tissue pressure, and/or that the tissue is considered stabilized
such that firing 5214 can be warranted. A measured tissue pressure
can be reached at a point, for example, representing the
intersection of curve 5252 and 5250. Upon reaching this point, the
tissue can be allowed to stabilize and the exudate seep from the
tissue. Tissue, in part because it is composed of solid and liquid
material, tends to elongate when compressed; one way to account for
this property is "tissue creep". When tissue is compressed, a
certain amount of tissue creep 5212 can occur. Affording the
compressed tissue an adequate amount of time under certain
circumstances to accomplish tissue creep can therefore produce
benefits. One benefit can be adequate staple formation. This can
contribute to a consistent staple line. Accordingly, a certain time
can be given to enable tissue creep 5212 prior to firing 5214.
[0450] Upon reaching a desirable point, firing 5214 can be
commenced. Firing 5214 can comprise one or more actions or events,
including deployment of an I-beam and/or other firing member
towards and/or within end effector 300 (FIG. 1). An I-beam can
comprise a cutting member deployable therein. The cutting member
can comprise, for example, an I-Beam configured for simultaneously
cutting of a tissue section located between an anvil 306 (FIG. 1)
and a staple cartridge 304 (FIG. 1) and deploying staples from the
staple cartridge 304.
[0451] During firing 5214, average tissue pressure can ascend along
curve 5266, comparable with the rate of closure motion 5216. A
slope can be calculated for average tissue pressure during firing
5214. The slope can be evaluated to be steeper than desired,
perhaps due to an increasing rate of average tissue pressure change
in combination with a stable firing rate 5242. If this condition or
another condition provided for is detected, instrument 10 (FIGS.
1-4) can have the capability to adapt. Measures can be implemented
to modify the firing curve 5268 such that a peak can be reached
that would be similar to or identical to that obtainable from a
more desirable tissue pressure curve 5274.
[0452] Accordingly, similar to adaptive mechanisms employed in
connection with closing 5210, adaptive measures can be employed in
connection with firing 5214.
[0453] Tissue-pressure curve 5286 can be referenced which can track
a desired tissue-creep rate after reference to an ideal closing
speed. Tissue-pressure curve 5286 can be programmed to operate in
conjunction with, or be extrapolated from, the closing phase 5210
or firing phase 5214. Additionally, a given tissue type can be
referenced that would give certain characteristics when surgical
operations are carried out thereon, such characteristics embodying
curve 5286. It will be appreciated that various purposes can be
fulfilled by referencing tissue-pressure curve 5286, or another
tissue-pressure curve, that might be considered an "ideal",
desired, or otherwise "reference curve". Such a reference curve can
assist in improving closing 5210, tissue creep 5212, and/or firing
5214. Such a reference curve or curves can be stored in instrument
10 (FIGS. 1-4) or be developed dynamically, or both, and can
account for varying thickness of a tissue portion, and many other
factors.
[0454] In accordance with aspects, FIG. 46 illustrates adaptive
mechanisms that can influence actual behavior of instrument 10
(FIGS. 1-4) in the process of carrying out a surgical procedure.
Speed 5310 can be enumerated on the vertical (y) axis and time 5311
(t) is represented along the horizontal axis. Speed 5310 can
represent speed of the motor, speed of closure of end effector 300
(FIG. 1), speed of firing rate, or another speed. As speed
increases 5312, sensors can obtain measurements of various
parameters. Based on control measures derived from stored
algorithms, or dynamically generated algorithms, or both, one or
more modifications can be made. One modification can be a tissue
modification 5320 that will influence operation of instrument 10
such that speed is upwardly or downwardly adjusted in order to
obtain a more desirable set of conditions. An additional
modification can be a sensor modification 5330. Sensor modification
5330 can influence the characteristics or values of data
transmitted to microcontroller 1500 (FIG. 19) and operatively
associated memory units. Microcontroller 1500 can monitor and
obtain data from sensors associated with for example end effector
300. Sensor modification can also influence parameter readings at
one or more added sensor(s). For example, a primary sensor such as
a magnetic field sensor located for example at a distal portion of
anvil 306 (FIG. 1) can indicate a certain thickness of a bite of
tissue; however, reference to a secondary sensor such as a strain
gauge can be factored in such that the measured Hall effect voltage
can be adjusted. As a result, inputs such as tissue modification
5320 and sensor modification 5330 can influence an actual speed
5340 that is adjusted to take into account one or both.
[0455] Additionally, in accordance with aspects, FIG. 47
illustrates adaptive mechanisms that can influence actual behavior
of a firing rate 5410 in the process of carrying out a surgical
procedure. Firing rate 5410 can be enumerated on the vertical (y)
axis and time 5412 (t) is represented along the horizontal (x)
axis. Firing rate 5410 can represent a rate at which a firing
member 220 (FIGS. 1 and 7) is longitudinally deployed, a rate at
which tissue is incised, and/or a rate at which staples are
deployed. In various examples, a firing rate 5410 value can ascend,
upon actuation of a firing mechanism. Based on control measures
derived from predetermined algorithms, or dynamically generated
algorithms, or both, one or more modifications can be made to an
original program in the memory that can define the firing rate
(here, a steady firing rate 5420). One modification can be a tissue
modification 5430 that can influence operation of instrument such
that speed is upwardly or downwardly adjusted in order to obtain a
more desirable set of conditions. An additional modification can be
a sensor modification 5440. Sensor modification 5440 can influence
the characteristics or values of data transmitted to
microcontroller 1500 from sensors associated with for example end
effector 300 (FIG. 1). Sensor modification 5440 can also influence
parameter readings at one or more added sensor(s). For example, a
primary sensor such as a magnetic field sensor on end effector 300
can indicate a certain thickness of a bite of tissue; however,
reference to a secondary sensor such as a strain gauge can be
factored in such that the measured Hall effect voltage can be
adjusted. As a result, inputs such as tissue modification 5430 and
sensor modification 5440 can influence an actual speed 5450 that is
adjusted to take into account one or both.
[0456] Inputs can be given their actual weight, i.e., without
selective weighting. However, in various aspects one or more inputs
may not be weighted equally. Certain inputs may be given more
weight than other inputs.
[0457] Adequate staple formation is a key consideration. Factors
that influence staple formation include finding desirable
operational envelopes based on tissue compression. FIGS. 48 and 49
illustrate example scenarios where a parameter such as differential
tissue compression, as measured by impedance sensors, can result in
adaptive firing procedures. FIG. 48 illustrates clamping 5510
operations where tissue compression 5514 is shown along the
vertical (y) axis and staple cartridge size 5532 (mm) is shown
along the horizontal (x) axis. Measurements from an end effector
300 (FIG. 1) can embrace a tissue portion of length up to 60 mm in
this example, though it can be of a greater length in other
examples. Tissue compression within the clamping end effector 300
can be measured by impedance sensors positioned, for example, every
6 mm, such as from 6 mm-60 mm. An impedance measurement can be
taken at each sensor. During a surgical procedure, tissue can be
compressed within end effector 300. Impedance measurements can be
taken at times t1 5516 and t2 5518. At time t1 5516, a curve 5522
can be described toward 5520 by monitoring impedance measurements
from one more of the impedance sensors (including impedance sensors
5526, 5528 and 5530). It will be appreciated that there may be ten
impedance sensors as shown in the example, but there may be more or
fewer. At a second time, t2 5518, a curve 5524 can be described
toward 5523 by monitoring the same impedance measurements from one
more of the impedance sensors (including impedance sensors 5526,
5528 and 5530). Impedance can be measured based on values from one
or more of the impedance sensors, along a curve toward 5524.
Comparing the impedance values for a given sensor from t1 and t2
can reveal a differential based on staple line length 5512. There
may be multiple reasons. One reason can be that the clamped tissue
exhibits different compression properties at different locations
along staple line length 5512. An additional reason can be that
there is a different tissue thickness; in other words, the tissue
may exhibit pre-clamping thickness of a profile seen in FIG. 51.
Further, tissue creep may have played a role. It is possible that
all these reasons contribute to the observed properties, or there
are other reasons. In any event, differential tissue compression
over time can be observed.
[0458] FIG. 49 can illustrate a firing operation 5610, including
but not limited to a firing operation based on FIG. 48. In FIG. 49,
tissue compression 5612 is shown along a vertical (y) axis and
staple cartridge size 5622 (mm) is shown along the horizontal (x)
axis. As the I-beam traverses the tissue, tissue compression 5612
measurements are taken by monitoring impedance measurements from
one more of the impedance sensors (including impedance sensors
5618, 5620 and 5624). During firing, tissue compression 5612 can
rise to a threshold 5630 and then peak at time t3 5670 relative to
I-beam location 5614. Subsequently, tissue compression falls
between t3 5670 and t4 5672 (e.g., 1 second 5660) relative to
I-beam location 5616. This operation can describe a rising curve
5640 and a falling curve 5642. It also may be observed that under
certain circumstances a rising curve 5640 can exhibit a convex
complexion, and a falling curve a concave complexion 5642. It may
be predicted that an I-beam may take more time to traverse tissue
with certain characteristics, e.g., thicker tissue, diseased
tissue, etc. Accordingly, a different tissue compression profile
may be prescribed such that tissue compression measurements observe
a second curve 5650, 5652. In addition, second curve 5650, 5652 may
result where there is a differential thickness of the pre-clamped
tissue, such as that seen in FIG. 51. Portion 5810 is thinner than
portion 5812. Traversing thicker tissue can act to slow the
relative speed of the I-Beam, leading to different tissue
compression measurements over time, and accordingly variable tissue
profiles.
[0459] Accordingly, a differential in tissue compression
measurements between t1 and t2 can lead to an adaptive response
whereby control measures adjust a curve of tissue compression
during a firing phase 5610. It will be appreciated, then, that the
curve peaking at t4 can represent an adaptive curve based on tissue
properties that can lead to improved results from the surgical
procedure, battery usage, and other operations where an adaptive
response can be used.
[0460] The shape of the curve can have significance. For example, a
convex curve can reflect a rising tissue compression profile during
a firing phase 5610. A concave curve can reflect a falling tissue
compression profile during a firing phase 5610. A peak tissue
compression measurement 5670, 5672 can fall between respective
concave and convex curves. (For purposes of this disclosure, a
perspective based on which concavity or convexity is found is based
on viewing from a higher value on the y-axis than the peak of the
curve.)
[0461] In conjunction with FIGS. 48 and 49, or as independent
examples, control measures can wholly or partially adjust firing in
order to prevent a parameter from rising above a certain limit.
FIG. 50 shows an example scenario. A first curve 5730, 5732 can be
a predicted firing profile stored by instrument 10 (FIGS. 1-4) for
a given type of tissue. It will be seen that the vertical (y) axis
parameter, such as tissue compression, over time (t) along the
horizontal (x) axis 5172 can rise as in curve 5730, then fall as in
curve 5732. However, it is possible that the values associated with
the predicted firing profile diverge, during operation, from values
actually observed during the surgical procedure. As a result,
instrument 10 can take measures to adapt. For example, the observed
measurements can fall along curve 5720, with a slower rate of rise
but projected higher peak. Thus, the y-axis parameter can continue
to rise. Under certain circumstances, it can be predicted that the
curve for the y-axis parameter could breach predetermined, or
dynamically determined, limit 5710 prior to reaching its peak. This
prediction can be made based on a slope 5722 of the curve, in
combination or not with input from the x-axis 5172 parameter (e.g.,
time). If it is determined that the peak is predicted to be above
the limit 5726, or other portions of curve 5724 will breach the
limit 5710, instrument 10 could adapt firing in order to provide
for a slower firing rate. Doing so can result in the y-axis
measurement falling along an adaptive curve 5728 based on slower
firing. The adaptive curve can rise above the limit, or be
constrained from doing by adapting operations accordingly.
[0462] FIG. 51 illustrates a portion of tissue prior to clamping.
It can be seen that one end of the tissue 5810 is thinner than the
other end 5812. In such circumstances, there can be differential
forces and timings exerted by end effector 300 (FIG. 1) on the
tissue, and by the tissue on end effector 300. The thickness
disparity can be taken into account by instrument 10 (FIGS. 1-4) in
adapting to such thickness. It may be the case that this tissue
portion is similar to the one considered in connection with FIGS.
48-49. It also may be the case that another tissue portion is
illustrated in connection with FIGS. 48-49, to show more general
applicability. It may further be the case that FIG. 50 is a
graphical representation of adaptive operations performed in
connection with a tissue portion like that in FIG. 51; again, it
also may be the case that FIG. 50 can show more generally adaptive
operations in response to detecting measurement of certain
parameters during the course of a surgical procedure and adjusting
accordingly.
[0463] In various aspects, the present disclosure provides an
instrument 10 (described in connection with FIGS. 1-29) configured
to sense tissue compression when tissue is clamped between the jaw
members of the end effector, such as, for example, between the
anvil and the staple cartridge. In one example, the instrument 10
(FIGS. 1-4) can be configured to sense tissue contact in one of the
jaw members such as the anvil and/or the staple cartridge. In
another example, the instrument 10 can be configured to sense the
pressure applied to the tissue by the jaw members. In yet another
example, the instrument 10 can be configured to measure the
electrical impedance (resistance) through the tissue between the
jaw members. This may be achieved by embedding micro electrodes in
at least one of the jaw members to drive a low amplitude, low
energy, RF signal through the tissue to enable a nontherapeutic
measurement of tissue impedance. The energy level is kept low
enough to avoid therapeutic tissue effects such as coagulation,
sealing, welding, or cautery. Further, the instrument 10 can
include devices to produce two distinct measures from a single set
of energized and return paths. In one example, multiple frequency
signals can be overlaid to measure impedance in different places
simultaneously. This can include a single active electrode with the
channel and the anvil grounded through isolated paths with filters
for different frequency RF signals. Otherwise, two isolated return
paths with independent filters, which are part of the handle
electronics system can be used. In another example, the sequential
impedance measurements would be multiplexed at variable RF
frequencies.
[0464] RF technology has been used in endocutters for some time.
The challenge in employing the technology is in the delivery of
high density RF energy and shorting between the jaw members of the
end effector. Despite the shortcomings of using RF energy
therapeutically, RF technology can be effectively employed
sub-therapeutically to sense tissue compression rather than
actually coagulating, sealing, or cauterizing tissue. In the
sub-therapeutic sense, the endosurgical device can employ RF energy
to sense internal tissue parameters and adjust the deployment of
staples rather and being employed as an adjunct to the stapling
operation to assist in sealing the tissue prior to cutting the
tissue with a knife.
[0465] RF technology used in endosurgical medical devices, and for
example, in RF endocutters, may introduce the challenges of
handling high densities of energy and dealing with shorting.
However, RF technology may be less challenging if used merely to
sense tissue compression rather than, for example, cauterizing
tissue. RF technology may be used as a way for medical devices,
such as endocutters, to sense internal tissue parameters such as
compression, and adjust stapling deployment in response. RF
electrode and cautery devices may utilize the same electrodes for
sensing tissue impedance as they do to melt tissue. These same
electrodes may be implemented with significantly less electrical
and power requirements as a tissue compression sensor system.
[0466] RF electrodes and cautery devices can utilize the same
electrodes for sensing tissue impedance as they do to weld the
tissue by applying energy thereto. Nevertheless, in the an
endocutter instrument context, the RF electrodes can be employed to
as a tissue compression sensor system with significantly less
electronics and power needs relative to a fully equipped
electrosurgical device. A single energized electrode on the
cartridge, for example, or perhaps an isolated knife, can be used
to make multiple tissue compression measurements simultaneously. If
multiple RF signals are overlaid or multiplexed they can be
transmitted down the single power conductor and then allowed to
return on either the channel frame or the anvil of the device. If a
filter is provided in the anvil and channel contacts before they
join the common return path, the tissue impedance for both paths
can be differentiated. This would provide a measure of through
tissue versus lateral tissue compression. This filtered approach
may be implemented proximal and distal as opposed to vertical and
lateral depending on the placement of the filters and the location
of the metallic electrically conductive return paths. The smaller
frequency generator and signal processor may be implemented in a
small package form factor on an existing circuit board or a sub
circuit board without the need for extensive extra cost associated
with an RF sealing/cauterization system.
[0467] Referring to FIG. 52, an endocutter 6000 may include a
handle component 6002, a shaft component 6004, and an end-effector
component 6006. The endocutter 6000 is similarly constructed and
equipped as the motor-driven surgical cutting and fastening
instrument 10 described in connection with FIGS. 1-29. Accordingly,
for conciseness and clarity the details of operation and
construction will not be repeated here. The end-effector 6006 may
be used to compress, cut, or staple tissue. Referring now to FIG.
53A, an end-effector 6030 may be positioned by a physician to
surround tissue 6032 prior to compression, cutting, or stapling. As
shown in FIG. 53A, no compression may be applied to the tissue
while preparing to use the end-effector. Referring now to FIG. 53B,
by engaging the handle (e.g., handle 6002) of the endocutter, the
physician may use the end-effector 6030 to compress the tissue
6032. In one aspect, the tissue 6032 may be compressed to its
maximum threshold, as shown in FIG. 53B.
[0468] Referring to FIG. 54A, various forces may be applied to the
tissue 6032 by the end-effector 6030. For example, vertical forces
F1 and F2 may be applied by the anvil 6034 and the channel frame
6036 of the end-effector 6030 as tissue 6032 is compressed between
the two. Referring now to FIG. 54B, various diagonal and/or lateral
forces also may be applied to the tissue 6032 when compressed by
the end-effector 6030. For example, force F3 may be applied. For
the purposes of operating a medical device such as endocutter 6000,
it may be desirable to sense or calculate the various forms of
compression being applied to the tissue by the end-effector. For
example, knowledge of vertical or lateral compression may allow the
end-effector to more precisely or accurately apply a staple
operation or may inform the operator of the endocutter such that
the endocutter can be used more properly or safely.
[0469] The compression through tissue 6032 may be determined from
an impedance of tissue 6032. At various levels of compression, the
impedance Z of tissue 6032 may increase or decrease. By applying a
voltage V and a current I to the tissue 6032, the impedance Z of
the tissue 6032 may be determined at various levels of compression.
For example, impedance Z may be calculated by dividing the applied
voltage V by the current I.
[0470] Referring now to FIG. 55, in one aspect, an RF electrode
6038 may be positioned on the end-effector 6030 (e.g., on a staple
cartridge, knife, or channel frame of the end-effector 6030).
Further, an electrical contact 6040 may be positioned on the anvil
6034 of the end-effector 6030. In one aspect, the electrical
contact may be positioned on the channel frame of the end-effector.
As the tissue 6032 is compressed between the anvil 6034 and, for
example, the channel frame 6036 of the end-effector 6030, an
impedance Z of the tissue 6032 changes. The vertical tissue
compression 6042 caused by the end-effector 6030 may be measured as
a function of the impedance Z of the tissue 6032.
[0471] Referring now to FIG. 56, in one aspect, an electrical
contact 6044 may be positioned on an opposite end of the anvil 6034
of the end-effector 6030 as the RF electrode 6038 is positioned. As
the tissue 6032 is compressed between the anvil 6034 and, for
example, the channel frame 6036 of the end-effector 6030, an
impedance Z of the tissue 6032 changes. The lateral tissue
compression 6046 caused by the end-effector 6030 may be measured as
a function of the impedance Z of the tissue 6032.
[0472] Referring now to FIG. 57, in one aspect, electrical contact
6050 may be positioned on the anvil 6034 and electrical contact
6052 may be positioned on an opposite end of the end-effector 6030
at channel frame 6036. RF electrode 6048 may be positioned
laterally to the central to the end-effector 6030. As the tissue
6032 is compressed between the anvil 6034 and, for example, the
channel frame 6036 of the end-effector 6030, an impedance Z of the
tissue 6032 changes. The lateral compression or angular
compressions 6054 and 6056 on either side of the RF electrode 6048
may be caused by the end-effector 6030 and may be measured as a
function of different impedances Z of the tissue 6032, based on the
relative positioning of the RF electrode 6048 and electrical
contacts 6050 and 6052.
[0473] In accordance with one or more of the techniques and
features described in the present disclosure, and as discussed
above, an RF electrode may be used as an RF sensor. Referring now
to FIG. 58, in one aspect, an RF sensor 6062 may be positioned on a
staple cartridge 6060 inserted into a channel frame 6066 an
end-effector. The RF electrode may run from a power line 6064 which
may be powered by a power source in a handle (e.g., handle 6002) of
an endocutter.
[0474] Referring now to FIG. 59, in one aspect, RF electrodes 6074
and 6076 may be positioned on a staple cartridge 6072 inserted into
a channel frame 6078 of end-effector 6070. As shown, RF electrode
6074 may be placed in a proximal position of the end-effector
relative to an endocutter handle. Further, RF electrode 6076 may be
placed in a distal position of the end-effector relative to the
endocutter handle. RF electrodes 6074 and 6076 may be utilized to
measure vertical, lateral, proximal, or distal compression at
different points in a tissue based on the position of one or more
electrical contacts on the end-effector.
[0475] Referring now to FIG. 60, in one aspect, RF electrodes
6084-6116 may be positioned on staple cartridge 6082 inserted into
the channel frame 6080 (or other component of an end-effector)
based on various points for which compression information is
desired. Referring now to FIG. 61, in one aspect, RF electrodes
6122-6140 may be positioned on staple cartridge 6120 at discrete
points for which compression information is desired. Referring now
to FIG. 62, RF electrodes 6152-6172 may be positioned at different
points in multiple zones of a staple cartridge based on how
accurate or precise the compression measurements should be. For
example, RF electrodes 6152-6156 may be positioned in zone 6158 of
staple cartridge 6150 depending on how accurate or precise the
compression measurements in zone 6158 should be. Further, RF
electrodes 6160-6164 may be positioned in zone 6166 of staple
cartridge 6150 depending on how accurate or precise the compression
measurements in zone 6166 should be. Additionally, RF electrodes
6168-6172 may be positioned in zone 6174 of staple cartridge 6150
depending on how accurate or precise the compression measurements
in zone 6174 should be.
[0476] The RF electrodes discussed herein may be wired through a
staple cartridge inserted in the channel frame. Referring now to
FIG. 63, in one aspect, an RF electrode may have a stamped
"mushroom head" 6180 of about 1.0 mm in diameter. While the RF
electrode may have the stamped "mushroom head" of about 1.0 mm in
diameter, this is intended to be a non-limiting example and the RF
electrode may be differently shaped and sized depending on each
particular application or design. The RF electrode may be connected
to, fastened to, or may form, a conductive wire 6182. The
conductive wire 182 may be about 0.5 mm in diameter, or may have a
larger or smaller diameter based on a particular application or
design. Further, the conductive wire may have an insulative coating
6184. In one example, the RF electrode may protrude through a
staple cartridge, channel frame, knife, or other component of an
end-effector.
[0477] Referring now to FIG. 64, the RF electrodes may be wired
through a single wall or through multiple walls of a staple
cartridge or channel frame of an end-effector. For example, RF
electrodes 6190-6194 may be wired through wall 6196 of the staple
cartridge or channel frame of an end-effector. One or more of wires
6198 may be connected to, fastened to, or be part of, RF electrodes
6190-6194 and may run through wall 6196 from a power source in,
e.g., a handle of an endocutter.
[0478] Referring now to FIG. 65, the power source may be in
communication with the RF electrodes or may provide power to the RF
electrodes through a wire or cable. The wire or cable may join each
individual wire and lead to the power source. For example, RF
electrodes 6204-6212 may receive power from a power source through
wire or cable 6202, which may run through staple cartridge 6200 or
a channel frame of an end-effector. In one example, each of RF
electrodes 6204-6212 may have its own wire that runs to or through
wire or cable 6202. The staple cartridge 6200 or channel frame also
may include a controller 6214, such as the controller 2006 shown in
connection with FIGS. 21A, 21B, or other controllers 2606 or 3017
shown in connection with FIGS. 27-29, for example. It will be
appreciated that the controller 6214 should be suitably sized to
fit in the staple cartridge 6200 or channel frame form factor.
Also, the controller
[0479] In various aspects, the tissue compression sensor system
described herein for use with medical devices may include a
frequency generator. The frequency generator may be located on a
circuit board of the medical device, such as an endocutter. For
example the frequency generator may be located on a circuit board
in a shaft or handle of the endocutter. Referring now to FIG. 66,
an example circuit diagram 6220 in accordance with one example of
the present disclosure is shown. As shown, frequency generator 6222
may receive power or current from a power source 6221 and may
supply one or more RF signals to one or more RF electrodes 6224. As
discussed above, the one or more RF electrodes may be positioned at
various locations or components on an end-effector or endocutter,
such as a staple cartridge or channel frame. One or more electrical
contacts, such as electrical contacts 6226 or 6228 may be
positioned on a channel frame or an anvil of an end-effector.
Further, one or more filters, such as filters 6230 or 6232 may be
communicatively coupled to the electrical contacts 6226 or 6228 as
shown in FIG. 66. The filters 6230 and 6232 may filter one or more
RF signals supplied by the frequency generator 6222 before joining
a single return path 6234. A voltage V and a current I associated
with the one or more RF signals may be used to calculate an
impedance Z associated with a tissue that may be compressed and/or
communicatively coupled between the one or more RF electrodes 6224
and the electrical contacts 6226 or 6228.
[0480] Referring now to FIG. 67, various components of the tissue
compression sensor system described herein may be located in a
handle 6236 of an endocutter. For example, as shown in circuit
diagram 6220a, frequency generator 6222 may be located in the
handle 6236 and receives power from power source 6221. Also,
current I1 and current I2 may be measured on a return path
corresponding to electrical contacts 6228 and 6226. Using a voltage
V applied between the supply and return paths, impedances Z1 and Z2
may be calculated. Z1 may correspond to an impedance of a tissue
compressed and/or communicatively coupled between one or more of RF
electrodes 6224 and electrical contact 6228. Further, Z2 may
correspond to an impedance of a tissue compressed and/or
communicatively coupled between one or more of RF electrodes 6224
and electrical contact 6226. Applying the formulas Z1=V/I1 and
Z2=V/I2, impedances Z1 and Z2 corresponding to different
compression levels of a tissue compressed by an end-effector may be
calculated.
[0481] Referring now to FIG. 68, one or more aspects of the present
disclosure are described in circuit diagram 6250. In an
implementation, a power source at a handle 6252 of an endocutter
may provide power to a frequency generator 6254. The frequency
generator 6254 may generate one or more RF signals. The one or more
RF signals may be multiplexed or overlaid at a multiplexer 6256,
which may be in a shaft 6258 of the endocutter. In this way, two or
more RF signals may be overlaid (or, e.g., nested or modulated
together) and transmitted to the end-effector. The one or more RF
signals may energize one or more RF electrodes 6260 at an
end-effector 6262 (e.g., positioned in a staple cartridge) of the
endocutter. A tissue (not shown) may be compressed and/or
communicatively coupled between the one or more of RF electrodes
6260 and one or more electrical contacts. For example, the tissue
may be compressed and/or communicatively coupled between the one or
more RF electrodes 6260 and the electrical contact 6264 positioned
in a channel frame of the end-effector 6262 or the electrical
contact 6266 positioned in an anvil of the end-effector 6262. A
filter 6268 may be communicatively coupled to the electrical
contact 6264 and a filter 6270 may be communicatively coupled to
the electrical contact 6266.
[0482] A voltage V and a current I associated with the one or more
RF signals may be used to calculate an impedance Z associated with
a tissue that may be compressed between the staple cartridge (and
communicatively coupled to one or more RF electrodes 6260) and the
channel frame or anvil (and communicatively coupled to one or more
of electrical contacts 6264 or 6266).
[0483] In one aspect, various components of the tissue compression
sensor system described herein may be located in a shaft 6258 of
the endocutter. For example, as shown in circuit diagram 6250 (and
in addition to the frequency generator 6254), an impedance
calculator 6272, a controller 6274, a non-volatile memory 6276, and
a communication channel 6278 may be located in the shaft 6258. In
one example, the frequency generator 6254, impedance calculator
6272, controller 6274, non-volatile memory 6276, and communication
channel 6278 may be positioned on a circuit board in the shaft
6258.
[0484] The two or more RF signals may be returned on a common path
via the electrical contacts. Further, the two or more RF signals
may be filtered prior to the joining of the RF signals on the
common path to differentiate separate tissue impedances represented
by the two or more RF signals. Current I1 and current I2 may be
measured on a return path corresponding to electrical contacts 6264
and 6266. Using a voltage V applied between the supply and return
paths, impedances Z1 and Z2 may be calculated. Z1 may correspond to
an impedance of a tissue compressed and/or communicatively coupled
between one or more of RF electrodes 6260 and electrical contact
6264. Further, Z2 may correspond to an impedance of the tissue
compressed and/or communicatively coupled between one or more of RF
electrodes 6260 and electrical contact 6266. Applying the formulas
Z1=V/I1 and Z2=V/I2, impedances Z1 and Z2 corresponding to
different compressions of a tissue compressed by an end-effector
6262 may be calculated. In example, the impedances Z1 and Z2 may be
calculated by the impedance calculator 6272. The impedances Z1 and
Z2 may be used to calculate various compression levels of the
tissue.
[0485] Referring now to FIG. 69, a frequency graph 6290 is shown.
The frequency graph 6290 shows a frequency modulation to nest two
RF signals. The two RF signals may be nested before reaching RF
electrodes at an end-effector as described above. For example, an
RF signal with Frequency 1 and an RF signal with Frequency 2 may be
nested together. Referring now to FIG. 70, the resulting nested RF
signal is shown in frequency graph 6300. The compound signal shown
in frequency graph 6300 includes the two RF signals of frequency
graph 6290 compounded. Referring now to FIG. 71, a frequency graph
6310 is shown. Frequency graph 6310 shows the RF signals with
Frequencies 1 and 2 after being filtered (by, e.g., filters 6268
and 6270). The resulting RF signals can be used to make separate
impedance calculations or measurements on a return path, as
described above.
[0486] In one aspect, filters 6268 and 6270 may be High Q filters
such that the filter range may be narrow (e.g., Q=10). Q may be
defined by the Center frequency (Wo)/Bandwidth (BW) where Q=Wo/BW.
In one example, Frequency 1 may be 150 kHz and Frequency 2 may be
300 kHz. A viable impedance measurement range may be 100 kHz-20
MHz. In various examples, other sophisticated techniques, such as
correlation, quadrature detection, etc., may be used to separate
the RF signals.
[0487] Using one or more of the techniques and features described
herein, a single energized electrode on a staple cartridge or an
isolated knife of an end-effector may be used to make multiple
tissue compression measurements simultaneously. If two or more RF
signals are overlaid or multiplexed (or nested or modulated), they
may be transmitted down a single power side of the end-effector and
may return on either the channel frame or the anvil of the
end-effector. If a filter were built into the anvil and channel
contacts before they join a common return path, the tissue
impedance represented by both paths could be differentiated. This
may provide a measure of vertical tissue vs lateral tissue
compression. This approach also may provide proximal and distal
tissue compression depending on placement of the filters and
location of the metallic return paths. A frequency generator and
signal processor may be located on one or more chips on a circuit
board or a sub board (which may already exist in an
endocutter).
[0488] In various aspects, the present disclosure provides
techniques for monitoring the speed and precision incrementing of
the drive motor in the instrument 10 (described in connection with
FIGS. 1-29). In one example, a magnet can be placed on a planet
frame of one of the stages of gear reduction with an inductance
sensor on the gear housing. In another example, placing the magnet
and magnetic field sensor on the last stage would provide the most
precise incremental movement monitoring.
[0489] Conventional motor control systems employ encoders to detect
the location and speed of the motor in hand held battery powered
endosurgical instruments such as powered endocutter/stapler
devices. Precision operation of endocutter/stapler devices relies
in part on the ability to verify the motor operation under load.
Simple sensor implementations may be employed to achieve verify the
motor operation under load.
[0490] Accordingly, the present disclosure includes a magnetic body
on one of the planetary carriers of a gear reduction system or
employ brushless motor technology. Both approaches involve the
placement of an inductance sensor on the outside housing of the
motor or planetary gear system. In the case of a brushless motor
there are electromagnetic field coils (windings, inductors, etc.)
arrayed radially around the center magnetic shaft of the motor. The
coils are sequentially activated and deactivated to drive the
central motor shaft. One or more inductance sensors can be placed
outside of the motor and adjacent to at least some of the coils to
sense the activation/deactivation cycles of the motor windings to
determine the number times the shaft has been rotated.
Alternatively, a permanent magnet can be placed on one of the
planetary carriers and the inductance sensor can be placed adjacent
to the radial path of the planetary carrier to measure the number
of times that stage of the gear train is rotated. This
implementation can be applied to any rotational components in the
system with increasingly more resolution possible in regions with a
relatively large number of rotations during function, or as the
rotational components become closer (in terms of number of
connections) to the end effector depending on the design. The gear
train sensing method may be preferred since it actually measures
rotation of one of the stages whereas the motor sensing method
senses the number of times the motor has been commanded to
energize, rather than the actual shaft rotation. For example, if
the motor is stalled under high load, the motor sensing method
would not be able to detect the lack of rotation because it senses
only the energizing cycles not shaft rotation. Nevertheless, both
techniques can be employed in a cost effective manner to sense
motor rotation.
[0491] During stapling, for example, tissue is firmly clamped
between opposing jaws before a staple is driven into the clamped
tissue. Tissue compression during clamping can cause fluid to be
displaced from the compressed tissue, and the rate or amount of
displacement varies depending on tissue type, tissue thickness, the
surgical operation (e.g., clamping pressure and clamping time). In
various instances, fluid displacement between the opposing jaws of
an end effector may contribute to malformation (e.g., bending) of
staples between the opposing jaws. Accordingly, in various
instances, it may be desirable to control the firing stroke, e.g.,
to control the firing speed, in relationship to the detected fluid
flow, or lack thereof, intermediate opposing jaws of a surgical end
effector.
[0492] Accordingly, also provided herein are methods, devices, and
systems for monitoring speed and incremental movement of a surgical
instrument drive train, which in turn provides information about
the operational velocity of the device (e.g., jaw closure,
stapling). In accordance with the present examples, the instrument
10 (FIGS. 1-4) does not include a motor encoder. Rather, the
instrument 10 is equipped with a motor 7012 shown in FIG. 72, which
illustrates a speed sensor assembly for a power train 7010 of the
motor 7012, in accordance with an illustrative example. The speed
sensor assembly can include a motor 7012 having an output shaft
7014 that is coupled directly or indirectly to a drive shaft. In
some examples, the output shaft is connected to a gear reduction
assembly, such as the planetary gear train 7020 shown in FIG.
72.
[0493] With continued reference to FIG. 72, the speed sensor
assembly further includes at least one sensor 7016 that detects the
rotational speed of any suitable component of the system. For
example, the sensor may be a proximity sensor, such as an induction
sensor, which detects movement of one or more detectable elements
7018 affixed to any rotating part of the gear reduction assembly.
In FIG. 72, which is exemplary, the detectable element is affixed
to the last stage annular gear 7034c and the sensor is positioned
adjacent the radial path of the detectable element so as to detect
movement of the detectable element. FIG. 72 is exemplary
only--rotating components vary depending on design--and the
sensor(s) can be affixed to any rotating component of the gear
reduction assembly. For example, in another example, a detectable
element is associated with the carrier gear of the final stage or
even the drive gear. In some examples, a detectable element is
located outside of the gear reduction assembly, such as on the
driveshaft between gear reduction assembly and the end effector. In
some example, a detectable element is located on a rotating
component in the final gear reduction at the end effector.
[0494] With continued reference to FIG. 72, in one aspect motor
7012 is rotationally coupled to a gear reduction assembly, such as
a planetary gear train 7020. However, any suitable gear reduction
or transmission can be used and/or the motor can be coupled
directly to a drive shaft (e.g., direct drive). The planetary gear
train can include 1, 2, 3, 4, 5, or more stages. The planetary gear
train illustrated in FIG. 72 has three stages. The planetary gear
train is driven by a sun gear (7042 in FIG. 73) attached directly
or indirectly to the motor output shaft 7014. The sun gear drives
one or more first stage planet gears 7032a, which in turn engage a
first stage annular gear 7034a. Any number of planet gears can be
used such as, for example, 1, 2, 3, 4, 5 or more planet gears.
First stage planet gears 7032a communicate with a first stage
carrier 7036a, which includes or connects to a second stage sun
gear (7038a in FIG. 73) that drives the second stage.
[0495] Similar to the first stage, the second stage includes one or
more planet gears 7032b, an annular gear 7034b, and a carrier 7036b
that includes or connects to a third stage sun gear (7038b in FIG.
73) that drives the third stage. Likewise, the third stage includes
one or more planet gears 7032c, an annular gear 7034c, and a
carrier 7036c. The final stage in the planetary gear train assembly
is connected to a drive gear 7040, which can be the final effector
in the gear reduction assembly, depending on design. The use of
three planetary gear stages is exemplary only. Any suitable type of
gear reduction assembly can be used in accordance with the present
disclosure.
[0496] The sensor 7016 can be mounted in or near the gear reduction
assembly in, near, or adjacent the radial path of detectable
element 7018. The sensor can be any suitable sensor type capable of
detecting rotational speed without an encoder. The sensor is used
in conjunction with a detectable element capable of being detected
by the sensor. For example, in some examples, the sensor is an
inductance sensor and the detectable element is a metallic element.
The inductance sensor can be configured to detect a change in
inductance caused by a metallic object or magnet passing adjacent
the inductive sensor. In some examples, the sensor is a magnetic
field sensor, and the detectable element is a magnetic element. A
magnetic field sensor can be configured to detect changes in a
magnetic field surrounding the magnetic field sensor caused by the
movement of the magnetic element.
[0497] Detectable elements can be affixed or integral with any
rotating part or particular stage of the gear reduction assembly to
measure the number of times that the part or stage rotates. For
example, a single detectable element could be placed on drive gear
7040. Each complete rotation of the drive gear would cause the
detectable element to pass the sensor one time, resulting in one
detected rotation. In some examples, multiple detectable elements
7018 can be used within the same gear reduction assembly, by
placing a plurality of detectable elements (e.g., 2, 3, 4, 5 or
more) on the same component (e.g., a gear) and/or by placing one or
more detectable elements on a plurality of different components
(e.g., on two different gears). Placing multiple sensors equally
spaced on a single component can provide refined information about
incremental rotations. Similarly, resolution of speed monitoring
can be increased by placing a detectable element(s) on a component
that rotates more quickly relative to other components and/or by
placing the detectable element closer (in terms of number of
connections) to the end effector depending on the design. Using
multiple detectable elements on different components provides a
redundant, fail-safe system should one sensor or detectable element
fail.
[0498] Sensors should be located close enough to detectable
elements to ensure that each revolution of a detectable element is
captured by its associated sensor. Multiple sensors can be placed
in the same radial path of a detectable element. In addition, if
detectable elements are placed on a plurality of different
components (e.g., two different gears), a sensor can be placed
adjacent the radial path of each detectable element. The sensor
7016 is in data communication with a controller 7011 such as the
microcontroller 1500 (FIG. 19) or microcontroller 2006 (FIGS. 21A,
21B), processor 2104 (FIG. 22), or controller 2606 and 3017 shown
in FIGS. 27-29, which is programmed to translate the number and/or
rate of detection events into a speed reading useful to the user,
such as using the speed indicator display shown in FIGS. 88-90.
[0499] FIG. 73 shows a longitudinal cross section through plane A
of FIG. 72. Clearly visible in FIG. 73 is sun gear 7042 coupled to
output shaft 7014.
[0500] FIG. 74 illustrates a speed sensor assembly for 7050 for
directly sensing the rotational speed of a brushless motor 7060, in
accordance with an illustrative aspect. A brushless motor typically
comprises electromagnetic field coils 7062, 7064 arrayed radially
around a central magnetic shaft (7066 in FIG. 75). Negative 7062
and positive 7064 coils are alternately arranged around the central
magnetic shaft, and these coils are sequentially activated and
deactivated to drive the central magnetic shaft. One or more
sensors 7016 can be placed adjacent these coils on the outside of
the motor to monitor motor speed. The sensor induction field 7068
is affected each time an electromagnetic field coil passes the
sensor. The sensor is in data communication with a controller 7011,
such as the microcontroller 1500 (FIG. 19) or microcontroller 2006
(FIGS. 21A, 21B), processor 2104 (FIG. 22), or controller 2606 and
3017 shown in FIGS. 27-29, for example, which is programmed to
translate the number and/or rate of detection events into a speed
reading useful to the user, such as using a speed indicator display
shown in FIGS. 88-90.
[0501] If the motor stalls, for example under high load, the sensor
7016 may still detect activation of the coils, which the sensor
7016 would interpret as motor rotation even though the motor is
stalled. As a result, under certain operational circumstances,
motor speed could be an inaccurate readout for operational tool
speed. In one example, speed is measured using one or more sensors
7016 on the gear reduction assembly because this measures the
actual speed of the gear assembly, or a stage of the gear assembly,
rather than the speed of the motor. In addition, the closer the
detectable element(s) and associated sensor(s) are to the end
effector, the more likely the sensed speed accurately reflects
operational tool speed. The ability to verify motor operation under
load is important for precision operation of surgical instruments,
such as staplers.
[0502] FIG. 75 illustrates a transverse cross section through plane
B of the motor assembly shown in FIG. 74. The central magnetic
shaft 7066 is visible in FIG. 75.
[0503] Sensor 7016 is in data communication with a controller 7011,
such as the microcontroller 1500 (FIG. 19) or microcontroller 2006
(FIGS. 21A, 21B), processor 2104 (FIG. 22), or controller 2606 and
3017 shown in FIGS. 27-29, which is programmed to translate the
number and/or rate of detection events into a speed reading useful
to the user. The controller 7011 also can regulate motor speed to
ensure safe operating parameters and/or to ensure that a constant
speed and/or acceleration are maintained for particular surgical
applications.
[0504] Various functions may be implemented utilizing the circuitry
previously described, For example, the motor may be controlled with
a motor controller 7011 similar those described in connection with
FIGS. 21A, 21B, 24, 25, 28A, 28B, and 29, where the encoder is
replaced with the monitoring speed control and precision
incrementing of motor systems for powered surgical instruments
described in connection with FIGS. 72-75. For example, the position
encoder 2340 shown in FIG. 24 can be replaced with the sensor 7016
shown in FIGS. 72-75 coupled to the microcontroller 2306 in FIG.
24. Similarly, the position encoder 2440 shown in FIG. 25 can be
replaced with the sensor 7016 shown in FIGS. 72-75 coupled to the
microcontroller 2406 in FIG. 25.
[0505] In one aspect, the present disclosure provides an instrument
10 (described in connection with FIGS. 1-29) configured with
various sensing systems. Accordingly, for conciseness and clarity
the details of operation and construction will not be repeated
here. In one aspect, the sensing system includes a
viscoelasticity/rate of change sensing system to monitor knife
acceleration, rate of change of impedance, and rate of change of
tissue contact. In one example, the rate of change of knife
acceleration can be used as a measure of for tissue type. In
another example, the rate of change of impedance can be measures
with a pulse sensor ad can be employed as a measure for
compressibility. Finally, the rate of change of tissue contact can
be measured with a sensor based on knife firing rate to measure
tissue flow.
[0506] The rate of change of a sensed parameter or stated
otherwise, how much time is necessary for a tissue parameter to
reach an asymptotic steady state value, is a separate measurement
in itself and may be more valuable than the sensed parameter it was
derived from. To enhance measurement of tissue parameters such as
waiting a predetermined amount of time before making a measurement,
the present disclosure provides a novel technique for employing the
derivate of the measure such as the rate of change of the tissue
parameter.
[0507] The derivative technique or rate of change measure becomes
most useful with the understanding that there is no single
measurement that can be employed alone to dramatically improve
staple formation. It is the combination of multiple measurements
that make the measurements valid. In the case of tissue gap it is
helpful to know how much of the jaw is covered with tissue to make
the gap measure relevant. Rate of change measures of impedance may
be combined with strain measurements in the anvil to relate force
and compression applied to the tissue grasped between the jaw
members of the end effector such as the anvil and the staple
cartridge. The rate of change measure can be employed by the
endosurgical device to determine the tissue type and not merely the
tissue compression. Although stomach and lung tissue sometimes have
similar thicknesses, and even similar compressive properties when
the lung tissue is calcified, an instrument may be able to
distinguish these tissue types by employing a combination of
measurements such as gap, compression, force applied, tissue
contact area, and rate of change of compression or rate of change
of gap. If any of these measurements were used alone, the
endosurgical it may be difficult for the endosurgical device to
distinguish one tissue type form another. Rate of change of
compression also may be helpful to enable the device to determine
if the tissue is "normal" or if some abnormality exists. Measuring
not only how much time has passed but the variation of the sensor
signals and determining the derivative of the signal would provide
another measurement to enable the endosurgical device to measure
the signal. Rate of change information also may be employed in
determining when a steady state has been achieved to signal the
next step in a process. For example, after clamping the tissue
between the jaw members of the end effector such as the anvil and
the staple cartridge, when tissue compression reaches a steady
state (e.g., about 15 seconds), an indicator or trigger to start
firing the device can be enabled.
[0508] Also provided herein are methods, devices, and systems for
time dependent evaluation of sensor data to determine stability,
creep, and viscoelastic characteristics of tissue during surgical
instrument operation. A surgical instrument 10, such as the stapler
illustrated in FIG. 1, can include a variety of sensors for
measuring operational parameters, such as jaw gap size or distance,
firing current, tissue compression, the amount of the jaw that is
covered by tissue, anvil strain, and trigger force, to name a few.
These sensed measurements are important for automatic control of
the surgical instrument and for providing feedback to the
clinician.
[0509] The examples shown in connection with FIGS. 52-71 may be
employed to measure the various derived parameters such as gap
distance versus time, tissue compression versus time, and anvil
strain versus time. Motor current may be monitored employing the
current sensor 2312 in series with the battery 2308 as described in
connection with FIG. 24, the current sensor 2412 in series with the
battery 2408 shown in FIG. 25, or the current sensor 3026 in FIG.
29.
[0510] Turning now to FIG. 76, a motor-driven surgical cutting and
fastening instrument 8010 is depicted that may or may not be
reused. The motor-driven surgical cutting and fastening instrument
8010 is similarly constructed and equipped as the motor-driven
surgical cutting and fastening instrument 10 described in
connection with FIGS. 1-29. In the example illustrated in FIG. 76,
the instrument 8010 includes a housing 8012 that comprises a handle
assembly 8014 that is configured to be grasped, manipulated and
actuated by the clinician. The housing 8012 is configured for
operable attachment to an interchangeable shaft assembly 8200 that
has a surgical end effector 8300 operably coupled thereto that is
configured to perform one or more surgical tasks or procedures.
Since the motor-driven surgical cutting and fastening instrument
8010 is similarly constructed and equipped as the motor-driven
surgical cutting and fastening instrument 10 described in
connection with FIGS. 1-29, for conciseness and clarity the details
of operation and construction will not be repeated here.
[0511] The housing 8012 depicted in FIG. 76 is shown in connection
with an interchangeable shaft assembly 8200 that includes an end
effector 8300 that comprises a surgical cutting and fastening
device that is configured to operably support a surgical staple
cartridge 8304 therein. The housing 8012 may be configured for use
in connection with interchangeable shaft assemblies that include
end effectors that are adapted to support different sizes and types
of staple cartridges, have different shaft lengths, sizes, and
types, etc. In addition, the housing 8012 also may be effectively
employed with a variety of other interchangeable shaft assemblies
including those assemblies that are configured to apply other
motions and forms of energy such as, for example, radio frequency
(RF) energy, ultrasonic energy and/or motion to end effector
arrangements adapted for use in connection with various surgical
applications and procedures. Furthermore, the end effectors, shaft
assemblies, handles, surgical instruments, and/or surgical
instrument systems can utilize any suitable fastener, or fasteners,
to fasten tissue. For instance, a fastener cartridge comprising a
plurality of fasteners removably stored therein can be removably
inserted into and/or attached to the end effector of a shaft
assembly.
[0512] FIG. 76 illustrates the surgical instrument 8010 with an
interchangeable shaft assembly 8200 operably coupled thereto. In
the illustrated arrangement, the handle housing forms a pistol grip
portion 8019 that can be gripped and manipulated by the clinician.
The handle assembly 8014 operably supports a plurality of drive
systems therein that are configured to generate and apply various
control motions to corresponding portions of the interchangeable
shaft assembly that is operably attached thereto. Trigger 8032 is
operably associated with the pistol grip for controlling various of
these control motions.
[0513] With continued reference to FIG. 76, the interchangeable
shaft assembly 8200 includes a surgical end effector 8300 that
comprises an elongated channel 8302 that is configured to operably
support a staple cartridge 8304 therein. The end effector 8300 may
further include an anvil 8306 that is pivotally supported relative
to the elongated channel 8302.
[0514] The inventors have discovered that derived parameters can be
even more useful for controlling a surgical instrument, such as the
instrument illustrated in FIG. 76, than the sensed parameter(s)
upon which the derived parameter is based. Non-limiting examples of
derived parameters include the rate of change of a sensed parameter
(e.g., jaw gap distance) and how much time elapses before a tissue
parameter reaches an asymptotic steady state value (e.g., 15
seconds). Derived parameters, such as rate of change, are
particularly useful because they dramatically improve measurement
accuracy and also provide information not otherwise evident
directly from sensed parameters. For example, impedance (i.e.,
tissue compression) rate of change can be combined with strain in
the anvil to relate compression and force, which enables the
microcontroller to determine the tissue type and not merely the
amount of tissue compression. This example is illustrative only,
and any derived parameters can be combined with one or more sensed
parameters to provide more accurate information about tissue types
(e.g., stomach vs. lung), tissue health (calcified vs. normal), and
operational status of the surgical device (e.g., clamping
complete). Different tissues have unique viscoelastic properties
and unique rates of change, making these and other parameters
discussed herein useful indicia for monitoring and automatically
adjusting a surgical procedure.
[0515] FIGS. 78A-78E show exemplary sensed parameters as well as
parameters derived therefrom. FIG. 78A is an illustrative graph
showing gap distance over time, where the gap is the space between
the jaws being occupied by clamped tissue. The vertical (y) axis is
distance and the horizontal (x) axis is time. Specifically,
referring to FIGS. 76 and 77, the gap distance 8040 is the distance
between the anvil 8306 and the elongate channel 8302 of the end
effector. In the open jaw position, at time zero, the gap 8040
between the anvil 8306 and the elongate member is at its maximum
distance. The width of the gap 8040 decreases as the anvil 8306
closes, such as during tissue clamping. The gap distance rate of
change can vary because tissue has non-uniform resiliency. For
example, certain tissue types may initially show rapid compression,
resulting in a faster rate of change. However, as tissue is
continually compressed, the viscoelastic properties of the tissue
can cause the rate of change to decrease until the tissue cannot be
compressed further, at which point the gap distance will remain
substantially constant. The gap decreases over time as the tissue
is squeezed between the anvil 8306 and the staple cartridge 8304 of
the end effector 8040. The one or more sensors described in
connection with FIGS. 50-68 and FIG. 84 may be adapted and
configured to measure the gap distance "d" between the anvil 8306
and the staple cartridge 8304 over time "t" as represented
graphically in FIG. 78A. The rate of change of the gap distance "d"
over time "t" is the Slope of the curve shown in FIG. 78A, where
Slope=.DELTA.d/.DELTA.t.
[0516] FIG. 78B is an illustrative graph showing firing current of
the end effector jaws. The vertical (y) axis is current and the
horizontal (x) axis is time. As discussed herein, the surgical
instrument and/or the microcontroller, as shown in FIGS. 21-29,
thereof can include a current sensor that detects the current
utilized during various operations, such as clamping, cutting,
and/or stapling tissue. For example, when tissue resistance
increases, the instrument's electric motor can require more current
to clamp, cut, and/or staple the tissue. Similarly, if resistance
is lower, the electric motor can require less current to clamp,
cut, and/or staple the tissue. As a result, firing current can be
used as an approximation of tissue resistance. The sensed current
can be used alone or more preferably in conjunction with other
measurements to provide feedback about the target tissue. Referring
still to FIG. 78B, during some operations, such as stapling, firing
current initially is high at time zero but decreases over time.
During other device operations, current may increase over time if
the motor draws more current to overcome increasing mechanical
load. In addition, the rate of change of firing current is can be
used as an indicator that the tissue is transitioning from one
state to another state. Accordingly, firing current and, in
particular, the rate of change of firing current can be used to
monitor device operation. The firing current decreases over time as
the knife cuts through the tissue. The rate of change of firing
current can vary if the tissue being cut provides more or less
resistance due to tissue properties or sharpness of the knife 8305
(FIG. 77). As the cutting conditions vary, the work being done by
the motor varies and hence will vary the firing current over time.
A current sensor may be may be employed to measure the firing
current over time while the knife 8305 is firing as represented
graphically in FIG. 78B. For example, the motor current may be
monitored employing the current sensor 2312 in series with the
battery 2308 as described in connection with FIG. 24, the current
sensor 2412 in series with the battery 2408 shown in FIG. 25, or
the current sensor 3026 shown in FIG. 29. The current sensors 2312,
2314, 3026 may be adapted and configured to measure the motor
firing current "i" over time "t" as represented graphically in FIG.
78B. The rate of change of the firing current "i" over time "t" is
the Slope of the curve shown in FIG. 78B, where
Slope=.DELTA.i/.DELTA.t.
[0517] FIG. 78C is an illustrative graph of impedance over time.
The vertical (y) axis is impedance and the horizontal (x) axis is
time. At time zero, impedance is low but increases over time as
tissue pressure increases under manipulation (e.g., clamping and
stapling). The rate of change varies over time as because as the
tissue between the anvil 8306 and the staple cartridge 8304 of the
end effector 8040 is severed by the knife or is sealed using RF
energy between electrodes located between the anvil 8306 and the
staple cartridge 8304 of the end effector 8040. For example, as the
tissue is cut the electrical impedance increases and reaches
infinity when the tissue is completely severed by the knife. Also,
if the end effector 8040 includes electrodes coupled to an RF
energy source, the electrical impedance of the tissue increases as
energy is delivered through the tissue between the anvil 8306 and
the staple cartridge 8304 of the end effector 8040. The electrical
impedance increase as the energy through the tissue dries out the
tissue by vaporizing moistures in the tissue. Eventually, when a
suitable amount of energy is delivered to the tissue, the impedance
increases to a very high value or infinity when the tissue is
severed. In addition, as illustrated in FIG. 78C, different tissues
can have unique compression properties, such as rate of
compression, that distinguish tissues. The tissue impedance can be
measured by driving a sub-therapeutic RF current through the tissue
grasped between the first and second jaw members 9014, 9016. One or
more electrodes can be positioned on either or both the anvil 8306
and the staple cartridge 8304. The tissue compression/impedance of
the tissue between the anvil 8306 and the staple cartridge 8304 can
be measured over time as represented graphically in FIG. 78C. The
sensors described in connection with FIGS. 50-68 and 84 may be
adapted and configured to measure tissue compression/impedance. The
sensors may be adapted and configured to measure tissue impedance
"Z" over time "t" as represented graphically in FIG. 78C. The rate
of change of the tissue impedance "Z" over time "t" is the Slope of
the curve shown in FIG. 78C, where Slope=.DELTA.Z/.DELTA.t.
[0518] FIG. 78D is an illustrative graph of anvil 8306 (FIGS. 76,
77) strain over time. The vertical (y) axis is strain and the
horizontal (x) axis is time. During stapling, for example, anvil
8306 strain initially is high but decreases as the tissue reaches a
steady state and exerts less pressure on the anvil 8306. The rate
of change of anvil 8306 strain can be measured by a pressure sensor
or strain gauge positioned on either or both the anvil 8306 and the
staple cartridge 8304 (FIGS. 76, 77) to measure the pressure or
strain applied to the tissue grasped between the anvil 8306 and the
staple cartridge 8304. The anvil 8306 strain can be measured over
time as represented graphically in FIG. 78D. The rate of change of
strain "S" over time "t" is the Slope of the curve shown in FIG.
78D, where Slope=.DELTA.S/.DELTA.t.
[0519] FIG. 78E is an illustrative graph of trigger force over
time. The vertical (y) axis is trigger force and the horizontal (x)
axis is time. In certain examples, trigger force is progressive, to
provide the clinician tactile feedback. Thus, at time zero, trigger
8020 (FIG. 76) pressure may be at its lowest and trigger pressure
may increase until completion of an operation (e.g., clamping,
cutting, or stapling). The rate of change trigger force can be
measured by a pressure sensor or strain gauge positioned on the
trigger 8302 of the handle 8019 of the instrument 8010 (FIG. 76) to
measure the force required to drive the knife 8305 (FIG. 77)
through the tissue grasped between the anvil 8306 and the staple
cartridge 8304. The trigger 8032 force can be measured over time as
represented graphically in FIG. 78E. The rate of change of strain
trigger force "F" over time "t" is the Slope of the curve shown in
FIG. 78E, where Slope=.DELTA.F/.DELTA.t.
[0520] For example, stomach and lung tissue can be differentiated
even though these tissue can have similar thicknesses, and can have
similar compressive properties if the lung tissue is calcified.
Stomach and lung tissues can be distinguished by analyzing jaw gap
distance, tissue compression, force applied, tissue contact area,
compression rate of change, and jaw gap rate of change. For
example, FIG. 79 shows a graph of tissue pressure "P" versus tissue
displacement for various tissues. The vertical (y) axis is tissue
pressure and the horizontal (x) axis is tissue displacement. When
tissue pressure reaches a predetermined threshold, such as 50-100
pounds per square inch (psi), the amount of tissue displacement as
well as the rate of tissue displacement before reaching the
threshold can be used to differentiate tissues. For instance, blood
vessel tissue reaches the predetermined pressure threshold with
less tissue displacement and with a faster rate of change than
colon, lung, or stomach tissue. In addition, the rate of change
(tissue pressure over displacement) for blood vessel tissue is
nearly asymptotic at a threshold of 50-100 psi, whereas the rate of
change for colon, lung, and stomach is not asymptotic at a
threshold of 50-100 psi. As will be appreciated, any pressure
threshold can be used such as, for example, between 1 and 1000 psi,
more preferably between 10 and 500 psi, and more preferably still
between 50 and 100 psi. In addition, multiple thresholds or
progressive thresholds can be used to provide further resolution of
tissue types that have similar viscoelastic properties.
[0521] Compression rate of change also can enable the
microcontroller to determine if the tissue is "normal" or if some
abnormality exists, such as calcification. For example, referring
to FIG. 80, compression of calcified lung tissue follows a
different curve than compression of normal lung tissue. Tissue
displacement and rate of change of tissue displacement therefore
can be used to diagnose and/or differentiate calcified lung tissue
from normal lung tissue.
[0522] In addition, certain sensed measurements may benefit from
additional sensory input. For example, in the case of jaw gap,
knowing how much of the jaw is covered with tissue can make the gap
measurement more useful and accurate. If a small portion of the jaw
is covered in tissue, tissue compression may appear to be less than
if the entire jaw is covered in tissue. Thus, the amount of jaw
coverage can be taken into account by the microcontroller when
analyzing tissue compression and other sensed parameters.
[0523] In certain circumstances, elapsed time also can be an
important parameter. Measuring how much time has passed, together
with sensed parameters, and derivative parameters (e.g., rate of
change) provides further useful information. For example, if jaw
gap rate of change remains constant after a set period of time
(e.g., 5 seconds), then the parameter may have reached its
asymptotic value.
[0524] Rate of change information also is useful in determining
when a steady state has been achieved, thus signaling a next step
in a process. For example, during clamping, when tissue compression
reaches a steady state--e.g., no significant rate of change occurs
after a set period of time--the microcontroller can send a signal
to the display alerting the clinician to start the next step in the
operation, such as staple firing. Alternatively, the
microcontroller can be programmed to automatically start the next
stage of operation (e.g., staple firing) once a steady state is
reached.
[0525] Similarly, impedance rate of change can be combined with
strain in the anvil to relate force and compression. The rate of
change would allow the device to determine the tissue type rather
than merely measure the compression value. For example, stomach and
lung sometimes have similar thicknesses, and even similar
compressive properties if the lung is calcified.
[0526] The combination of one or more sensed parameters with
derived parameters provides more reliable and accurate assessment
of tissue types and tissue health, and allows for better device
monitoring, control, and clinician feedback.
[0527] Turning briefly to FIG. 84, the end effector 9012 is one
aspect of the end effector 8300 (FIG. 76) that may be adapted to
operate with surgical instrument 8010 (FIG. 76) to measure the
various derived parameters such as gap distance versus time, tissue
compression versus time, and anvil strain versus time. Accordingly,
the end effector 9012 shown in FIG. 84 may include one or more
sensors configured to measure one or more parameters or
characteristics associated with the end effector 9012 and/or a
tissue section captured by the end effector 9012. In the example
illustrated in FIG. 84, the end effector 9012 comprises a first
sensor 9020 and a second sensor 9026. In various examples, the
first sensor 9020 and/or the second sensor 9026 may comprise, for
example, a magnetic sensor such as, for example, a magnetic field
sensor, a strain gauge, a pressure sensor, a force sensor, an
inductive sensor such as, for example, an eddy current sensor, a
resistive sensor, a capacitive sensor, an optical sensor, and/or
any other suitable sensor for measuring one or more parameters of
the end effector 9012.
[0528] In certain instances, the first sensor 9020 and/or the
second sensor 9026 may comprise, for example, a magnetic field
sensor embedded in the first jaw member 9014 and configured to
detect a magnetic field generated by a magnet 9024 embedded in the
second jaw member 9016 and/or the staple cartridge 9018. The
strength of the detected magnetic field may correspond to, for
example, the thickness and/or fullness of a bite of tissue located
between the jaw members 9014, 9016. In certain instances, the first
sensor 9020 and/or the second sensor 9026 may comprise a strain
gauge, such as, for example, a micro-strain gauge, configured to
measure the magnitude of the strain in the anvil 9014 during a
clamped condition. The strain gauge provides an electrical signal
whose amplitude varies with the magnitude of the strain.
[0529] In some aspects, one or more sensors of the end effector
9012 such as, for example, the first sensor 9020 and/or the second
sensor 9026 may comprise a pressure sensor configured to detect a
pressure generated by the presence of compressed tissue between the
jaw members 9014, 9016. In some examples, one or more sensors of
the end effector 9012 such as, for example, the first sensor 9020
and/or the second sensor 9026 are configured to detect the
impedance of a tissue section located between the jaw members 9014,
9016. The detected impedance may be indicative of the thickness
and/or fullness of tissue located between the jaw members 9014,
9016.
[0530] In one aspect, one or more of the sensors of the end
effector 9012 such as, for example, the first sensor 9012 is
configured to measure the gap 9022 between the anvil 9014 and the
second jaw member 9016. In certain instances, the gap 9022 can be
representative of the thickness and/or compressibility of a tissue
section clamped between the jaw members 9014, 9016. In at least one
example, the gap 9022 can be equal, or substantially equal, to the
thickness of the tissue section clamped between the jaw members
9014, 9016. In one example, one or more of the sensors of the end
effector 9012 such as, for example, the first sensor 9020 is
configured to measure one or more forces exerted on the anvil 9014
by the second jaw member 9016 and/or tissue clamped between the
anvil 9014 and the second jaw member 9016. The forces exerted on
the anvil 9014 can be representative of the tissue compression
experienced by the tissue section captured between the jaw members
9014, 9016. In one embodiment, the gap 9022 between the anvil 9014
and the second jaw member 9016 can be measured by positioning a
magnetic field sensor on the anvil 9014 and positioning a magnet on
the second jaw member 9016 such that the gap 9022 is proportional
to the signal detected by the magnetic field sensor and the signal
is proportional to the distance between the magnet and the magnetic
field sensor. It will be appreciated that the location of the
magnetic field sensor and the magnet may be swapped such that the
magnetic field sensor is positioned on the second jaw member 9016
and the magnet is placed on the anvil 9014.
[0531] One or more of the sensors such as, for example, the first
sensor 9020 and/or the second sensor 9026 may be measured in
real-time during a clamping operation. Real-time measurement allows
time based information to be analyzed, for example, by a processor,
and used to select one or more algorithms and/or look-up tables for
the purpose of assessing, in real-time, a manual input of an
operator of the surgical instrument 9010. Furthermore, real-time
feedback can be provided to the operator to assist the operator in
calibrating the manual input to yield a desired output.
[0532] In various aspects, the present disclosure provides an
instrument 10 (as described in connection with FIGS. 1-29)
configured to provide rate and control feedback to the surgeon. In
one example, the instrument 10 (FIGS. 1-4) comprises an energy
device to provide rate/impedance feedback. In another example, the
instrument 10 provides time dependency such as time between steps
and/or rate of firing. In another example, the instrument 10 is
configured with a display that the surgeon can monitor for error
resolution. In one implementation, the display may be a flexible
roll up display is contained within handle (no external display) in
the event of failure user unrolls display to determine steps to
release.
[0533] The present disclosure provides a novel feedback system for
surgical instruments to enable the surgeon to balance the motor
controlled speed of knife actuation with the thickness and
stiffness of the tissue grasped between the jaw members of the end
effector such as the anvil and the staple cartridge. The present
technique for adjusting the knife actuation speed based on the
thickness of the tissue and tissue flow can improve the consistency
of staple formation to form a stapled seal.
[0534] Accordingly, the present disclosure provides the surgeon a
feedback mechanism on the shaft or the handle of the endosurgical
device. The feedback comprises a combination of the speed of the
advancement of the knife, the tissue compression (impedance), the
tissue gap (d), and force to advance (motor current draw). This
combination can be displayed on an indicator comprising multiple
zones, such as 5-9 zones, for example, with the mid zone indicating
the most ideal speed for the force and tissue compression being
handled. The more compression the slower the speed to keep the
indicator balanced in the center. This would provide a surgeon a
repeatable relative measure to judge thickness and tissue flow and
the surgeon could then decide how far out of balance the
endosurgical device can be operated within certain conditions in
order to achieve overall good results. The present feedback
mechanism also would provide the surgeon a good evaluation when the
tissue and/or firing conditions are out of the ordinary to enable
the surgeon to proceed cautiously with the operation during that
particular firing. The feedback mechanism also can enable the
surgeon to learn the best technique for firing the endosurgical
device with limited to no in servicing.
[0535] Turning to the figures, FIG. 81 illustrates a surgical
instrument 9010. The surgical instrument 9010 is similar in many
respects to other surgical instruments described in the present
disclosure. For example, the surgical instrument 9010 is similarly
constructed and equipped as the motor-driven surgical cutting and
fastening instrument 10 described in connection with FIGS. 1-29.
Therefore, for conciseness and clarity the details of operation and
construction will not be repeated here. Accordingly, the surgical
instrument 9010, like other surgical instruments described in the
present disclosure, comprises an end effector 9012. In the example
illustrated in FIGS. 81-82, the end effector 9012 comprises a first
jaw member, or anvil, 9014 pivotally coupled to a second jaw member
9016 to capture tissue between the first jaw member 9014 and the
second jaw member 9016. The second jaw member 9016 is configured to
receive a staple cartridge 9018 therein. The staple cartridge 9018
comprises a plurality of staples 9042. The plurality of staples
9402 is deployable from the staple cartridge 9018 during a surgical
operation.
[0536] In alternative aspects, the end effector 9012 can be
configured to seal tissue captured between the first jaw member
9014 and the second jaw member 9016. For example, the first jaw
member 9014 and the second jaw member 9016 may each include an
electrically conductive member. The electrically conductive members
may cooperate to transmit energy through tissue captured
therebetween to treat and/or seal the tissue. A power source such
as, for example, a battery can be configured to provide the
energy.
[0537] In certain instances, as illustrated in FIG. 81, the
surgical instrument 9010 can be a motor-driven surgical cutting and
fastening instrument that may or may not be reused. In the
illustrated example, the instrument 9010 includes a housing 9028
that comprises a handle 9030 that is configured to be grasped,
manipulated and actuated by the clinician. In the example
illustrated in FIG. 81, the housing 9028 is operably coupled to a
shaft assembly 9032 that has a surgical end effector 9012
configured to perform one or more surgical tasks or procedures.
[0538] The housing 9028 depicted in FIG. 81 is shown in connection
with a shaft assembly 9032 that includes an end effector 9012 that
comprises a surgical cutting and fastening device that is
configured to operably support a surgical staple cartridge 9018
therein. The housing 9028 may be configured for use in connection
with shaft assemblies that include end effectors that are adapted
to support different sizes and types of staple cartridges, have
different shaft lengths, sizes, and types, etc. In addition, the
housing 9028 also may be effectively employed with a variety of
other shaft assemblies including those assemblies that are
configured to apply other motions and forms of energy such as, for
example, radio frequency (RF) energy, ultrasonic energy and/or
motion to end effector arrangements adapted for use in connection
with various surgical applications and procedures.
[0539] Referring to FIG. 82, a non-limiting form of the end
effector 9012 is illustrated. As described above, the end effector
9012 may include the anvil 9014 and the staple cartridge 9018. In
this non-limiting example, the anvil 9014 is coupled to an elongate
channel 9034. In addition, FIG. 82 shows a firing bar 9036,
configured to longitudinally translate into the end effector 9012.
A distally projecting end of the firing bar 9036 can be attached to
an E-beam 9038 that can, among other things, assist in spacing the
anvil 9014 from a staple cartridge 9018 positioned in the elongate
channel 9034 when the anvil 9014 is in a closed position. The
E-beam 9038 can also include a sharpened cutting member 9040 which
can be used to sever tissue as the E-beam 9038 is advanced distally
by the firing bar 9036. In operation, the E-beam 9038 can also
actuate, or fire, the staple cartridge 9018. The staple cartridge
9018 can include a plurality of staples 9042. A wedge sled 9044 is
driven distally by the E-beam 9038 to force out the staples 9042
into deforming contact with the anvil 9012 while a cutting member
9040 of the E-beam 9038 severs clamped tissue.
[0540] In one aspect, as illustrated in FIGS. 81-83, a motor can be
operably coupled to the firing bar 9036. The motor can be powered
by a power source such as, for example, a battery 9039. The battery
9039 may supply power to the motor 9082 to motivate the firing bar
9036 to advance the E-beam 9038 to fire the staples 9042 into
tissue captured between the anvil 9014 and the staple cartridge
9018 and/or advance the cutting member 9040 to sever the captured
tissue. Actuation of the motor 9082 can be controlled by a firing
trigger 9094 that is pivotally supported on the handle 9030. The
firing trigger 9094 can be depressed by an operator of the surgical
instrument 9010 to activate the motor 9082.
[0541] In one instance, the firing trigger 9094 can be depressed or
actuated between a plurality of positions each yielding a different
output value. For example, actuating the firing trigger 9094 to a
first position may yield a first output value, and actuating the
firing trigger 9094 to a second position after the first position
may yield a second output value greater than the first output
value. In certain instances, the greater the firing trigger 9094 is
depressed or actuated, the greater the output value. In certain
instances, the output is a characteristic of motion of the firing
bar 9036 and/or the cutting member 9040. In one instance, the
output can be the speed of the cutting member 9040 during
advancement of the cutting member 9040 in a firing stroke. In such
instance, actuating the firing trigger 9094 to a first position may
cause the cutting member 9040 to travel at a first speed, and
actuating the firing trigger 9094 to a second position may cause
the cutting member 9040 to travel at a second speed different from
the first speed. In certain instances, the greater the firing
trigger 9094 is depressed or actuated, the greater the speed of
travel of the cutting member 9040.
[0542] In the aspect illustrated in FIG. 83, a tracking system 9080
is configured to determine the position of the firing trigger 9094.
The tracking system 9080 can include a magnetic element, such as
permanent magnet 9086, for example, which is mounted to an arm 9084
extending from the firing trigger 9094. The tracking system 9080
can comprise one or more sensors, such as a first magnetic field
sensor 9088 and a second magnetic field sensor 9090, for example,
which can be configured to track the position of the magnet 9086.
The sensors 9088 and 9090 can track the movement of the magnet 9086
and can be in signal communication with a microcontroller such as,
for example, the microcontroller 9061 (FIG. 87). With data from the
first sensor 9088 and/or the second sensor 9090, the
microcontroller 9061 can determine the position of the magnet 9086
along a predefined path and, based on that position, the
microcontroller 9061 can determine an output of the motor 9082. In
certain instances, a motor driver 9092 can be in communication with
the microcontroller 9061, and can be configured to drive the motor
9082 in accordance with an operator's manual input as detected by
the tracking system 9080.
[0543] In certain instances, the magnetic field sensors can be
configured to detect movement of the firing trigger 9094 through a
firing stroke instead of, or in addition to, detecting discrete
positions along the firing stroke. The strength of the magnetic
field generated by the permanent magnet, as detected by the
magnetic field sensors, changes as the permanent magnet 9086 is
moved with the firing trigger 9094 through the firing stroke. The
change in the strength of the magnetic field can be indicative of a
characteristic of motion of the firing trigger 9094, which can
detected by a microcontroller as a manual input.
[0544] The end effector 9012 may include one or more sensors
configured to measure one or more parameters or characteristics
associated with the end effector 9012 and/or a tissue section
captured by the end effector 9012. In the example illustrated in
FIG. 84, the end effector 9012 comprises a first sensor 9020 and a
second sensor 9026. In various examples, the first sensor 9020
and/or the second sensor 9026 may comprise, for example, a magnetic
sensor such as, for example, a magnetic field sensor, a strain
gauge, a pressure sensor, a force sensor, an inductive sensor such
as, for example, an eddy current sensor, a resistive sensor, a
capacitive sensor, an optical sensor, and/or any other suitable
sensor for measuring one or more parameters of the end effector
9012.
[0545] In certain instances, the first sensor 9020 and/or the
second sensor 9026 may comprise, for example, a magnetic field
sensor embedded in the first jaw member 9014 and configured to
detect a magnetic field generated by a magnet 9024 embedded in the
second jaw member 9016 and/or the staple cartridge 9018. The
strength of the detected magnetic field may correspond to, for
example, the thickness and/or fullness of a bite of tissue located
between the jaw members 9014, 9016. In certain instances, the first
sensor 9020 and/or the second sensor 9026 may comprise a strain
gauge, such as, for example, a micro-strain gauge, configured to
measure the magnitude of the strain in the anvil 9014 during a
clamped condition. The strain gauge provides an electrical signal
whose amplitude varies with the magnitude of the strain.
[0546] In some aspects, one or more sensors of the end effector
9012 such as, for example, the first sensor 9020 and/or the second
sensor 9026 may comprise a pressure sensor configured to detect a
pressure generated by the presence of compressed tissue between the
jaw members 9014, 9016. In some examples, one or more sensors of
the end effector 9012 such as, for example, the first sensor 9020
and/or the second sensor 9026 are configured to detect the
impedance of a tissue section located between the jaw members 9014,
9016. The detected impedance may be indicative of the thickness
and/or fullness of tissue located between the jaw members 9014,
9016.
[0547] In one aspect, one or more of the sensors of the end
effector 9012 such as, for example, the first sensor 9012 is
configured to measure the gap 9022 between the anvil 9014 and the
second jaw member 9016. In certain instances, the gap 9022 can be
representative of the thickness and/or compressibility of a tissue
section clamped between the jaw members 9014, 9016. In at least one
example, the gap 9022 can be equal, or substantially equal, to the
thickness of the tissue section clamped between the jaw members
9014, 9016. In one example, one or more of the sensors of the end
effector 9012 such as, for example, the first sensor 9020 is
configured to measure one or more forces exerted on the anvil 9014
by the second jaw member 9016 and/or tissue clamped between the
anvil 9014 and the second jaw member 9016. The forces exerted on
the anvil 9014 can be representative of the tissue compression
experienced by the tissue section captured between the jaw members
9014, 9016. In one embodiment, the gap 9022 between the anvil 9014
and the second jaw member 9016 can be measured by positioning a
magnetic field sensor on the anvil 9014 and positioning a magnet on
the second jaw member 9016 such that the gap 9022 is proportional
to the signal detected by the magnetic field sensor and the signal
is proportional to the distance between the magnet and the magnetic
field sensor. It will be appreciated that the location of the
magnetic field sensor and the magnet may be swapped such that the
magnetic field sensor is positioned on the second jaw member 9016
and the magnet is placed on the anvil 9014.
[0548] One or more of the sensors such as, for example, the first
sensor 9020 and/or the second sensor 9026 may be measured in
real-time during a clamping operation. Real-time measurement allows
time based information to be analyzed, for example, by a processor,
and used to select one or more algorithms and/or look-up tables for
the purpose of assessing, in real-time, a manual input of an
operator of the surgical instrument 9010. Furthermore, real-time
feedback can be provided to the operator to assist the operator in
calibrating the manual input to yield a desired output.
[0549] FIG. 85 is a logic diagram illustrating one aspect of a
process 9046 for assessing, in real-time, a manual input of an
operator of the surgical instrument 9010 and providing real-time
feedback to the operator as to the adequacy of the manual input. In
the example illustrated in FIG. 85, the process starts at step or
block 9050 where one or more parameters of the end effector 9012
are measured. Next at step 9052, a manual input of an operator of
the surgical instrument 9010 is assessed. In one example, a value
representative of the manual input is determined. Next at step
9054, the determined value is evaluated or assessed for a position,
rank, and/or status with respect to a desired zone or range. The
measurement of the parameters of the end effector 9012 and the
determined value can be employed to select or determine the
position, rank, and/or status associated with the determined value.
In a following step 9056 of the process 9046, the position, rank,
and/or status associated with the determined value is reported to
the operator of the surgical instrument 9010. The real-time
feedback allows the operator to adjust the manual input until a
position, rank, and/or status within the desired zone or range is
achieved. For example, the operator may change the manual input by
increasing or decreasing the manual input while monitoring the
real-time feedback until the position, rank, and/or status
associated with a determined value that corresponds to a present
manual input is within the desired zone or range.
[0550] FIG. 86 is a logic diagram illustrating one aspect of a
real-time feedback system 9060 for assessing, in real-time, a
manual input 9064 of an operator of the surgical instrument 9010
and providing to the operator real-time feedback as to the adequacy
of the manual input 9064. With reference to FIGS. 81-86, in the
example illustrated in FIG. 86, the real-time feedback system 9060
is comprised of a circuit. The circuit includes a microcontroller
9061 comprising a processor 9062. A sensor such as, for example,
the sensor 9020 is employed by the processor 9062 to measure a
parameter of the end effector 9012. In addition, the processor 9062
can be configured to determine or receive a value representative of
a manual input 9064 of an operator of the surgical instrument 9010.
The manual input 9064 can be continuously assessed by the processor
9062 for as long as the manual input 9064 is being provided by the
operator. The processor 9062 can be configured to monitor a value
representative of the manual input 9064. Furthermore, the processor
9062 is configured to assign, select, or determine a position,
rank, and/or status for the determined value with respect to a
desired zone or range. The measurement of the parameter of the end
effector 9012 and the determined value can be employed by the
processor 9062 to select or determine the position, rank, and/or
status associated with the determined value, as described in
greater detail below. A change in the manual input 9064 yields a
change in the determined value which, in turn, yields a change in
the position, rank, and/or status assigned to the determined value
with respect to the desired zone or range.
[0551] As illustrated in FIG. 86, the real-time feedback system
9060 may further include a feedback indicator 9066 which can be
adjusted between a plurality of positions, ranks, and/or statuses
inside and outside a desired zone or range. In one example, the
processor 9062 may select a first position (P1), rank, and/or
status that characterizes the manual input 9064 based on a
measurement (M1) of a parameter of the end effector 9012 and a
first determined value (V1) representing a first manual input (I1).
In certain instances, the first position (P1), rank, and/or status
may fall outside the desired zone or range. In such instances, the
operator may change the manual input 9064 from the first manual
input (I1) to a second manual input (I2) by increasing or
decreasing the manual input 9064, for example. In response, the
processor 9062 may adjust the feedback indicator 9066 from the
first position (P1), rank, and/or status to a second position (P2),
rank, and/or status, which characterizes the change to the manual
input 9064. The processor 9062 may select the second position (P2),
rank, and/or status based on the measurement (M1) of the parameter
of the end effector 9012 and a second determined value (V2)
representing a second manual input (I2). In certain instances, the
second position (P2), rank, and/or status may fall inside the
desired zone or range. In such instances, the operator may maintain
the second manual input (I2) for a remainder of a treatment cycle
or procedure, for example.
[0552] In the aspect illustrated in FIG. 86, the microcontroller
9061 includes a storage medium such as, for example, a memory unit
9068. The memory unit 9068 may be configured to store correlations
between measurements of one or more parameters of the end effector
9012, values representing manual inputs, and corresponding
positions, ranks, and/or statuses characterizing the manual input
9064 with respect to a desired zone or range. In one example, the
memory unit 9068 may store the correlation between the measurement
(M1), the first determined value (V1), and the first manual input
(I1), and the correlation between the measurement (M1), the second
determined value (V2), and the second manual input (I2). In one
example, the memory unit 9068 may store an algorism, an equation,
or a look-up table for determining correlations between
measurements of one or more parameters of the end effector 9012,
values representing manual inputs, and corresponding positions,
ranks, or statuses with respect to a desired zone or range. The
processor 9062 may employ such algorism, equation, and/or look-up
table to characterize a manual input 9064 provided by an operator
of the surgical instrument 9010 and provide feedback to the
operator as to the adequacy of the manual input 9064.
[0553] FIG. 87 is a logic diagram illustrating one aspect of a
real-time feedback system 9070. The system 9070 is similar in many
respects to the system 9060. For example, like the system 9060, the
system 9070 is configured for assessing, in real-time, a manual
input of an operator of the surgical instrument 9010 and providing
to the operator real-time feedback as to the adequacy of the manual
input. Furthermore, like the system 9060, the system 9070 is
comprised of a circuit that may include the microcontroller
9061.
[0554] In the aspect illustrated in FIG. 87, a strain gauge 9072,
such as, for example, a micro-strain gauge, is configured to
measure one or more parameters of the end effector 9012, such as,
for example, the amplitude of the strain exerted on the anvil 9014
during a clamping operation, which can be indicative of the tissue
compression. The measured strain is converted to a digital signal
and provided to the processor 9062. A load sensor 9074 can measure
the force to advance the cutting member 9040 to cut tissue captured
between the anvil 9014 and the staple cartridge 9018.
Alternatively, a current sensor (not shown) can be employed to
measure the current drawn by the motor 9082. The force required to
advance the firing bar 9036 can correspond to the current drawn by
the motor 9082, for example. The measured force is converted to a
digital signal and provided to the processor 9062. A magnetic field
sensor 9076 can be employed to measure the thickness of the
captured tissue, as described above. The measurement of the
magnetic field sensor 9076 is also converted to a digital signal
and provided to the processor 9062.
[0555] In the aspect illustrated in FIG. 87, the system 9070
further includes the tracking system 9080 which can be configured
to determine the position of the firing trigger 9094 (FIG. 83). As
described above, the firing trigger 9094 can be depressed or
actuated by moving the firing trigger 9094 between a plurality of
positions, each corresponding to one of a plurality of values of a
characteristic of motion of the firing bar 9036 and/or the cutting
member 9040 during a firing stroke. As describe above, a
characteristic of motion can be a speed of advancement of the
firing bar 9036 and/or the cutting member 9040 during the firing
stroke. In certain instances, a motor driver 9092 can be in
communication with the microcontroller 9061, and can be configured
to drive the motor 9082 in accordance with an operator's manual
input as detected by the tracking system 9080.
[0556] Further to the above, the system 9070 may include a feedback
indicator 9066. In one aspect, the feedback indicator 9066 can be
disposed in the handle 9030. Alternatively, the feedback indicator
can be disposed in the shaft assembly 9032, for example. In any
event, the microcontroller 9061 may employ the feedback indicator
9066 to provide feedback to an operator of the surgical instrument
9010 with regard to the adequacy of a manual input such as, for
example, a selected position of the firing trigger 9094. To do so,
the microcontroller 9061 may assess the selected position of the
firing trigger 9094 and/or the corresponding value of the speed of
the firing bar 9036 and/or the cutting member 9040. The
measurements of the tissue compression, the tissue thickness,
and/or the force required to advance the firing bar 9036, as
respectively measured by the sensors 9072, 9074, and 9076, can be
used by the microcontroller 9061 to characterize the selected
position of the firing trigger 9094 and/or the corresponding value
of the speed of the firing bar 9036 and/or the cutting member 9040.
In one instance, the memory 9068 may store an algorism, an
equation, and/or a look-up table which can be employed by the
microcontroller 9061 in the assessment. In one example, the
measurements of the sensors 9072, 9074, and/or 9076 can be used to
select or determine a position, rank, and/or a status that
characterizes the selected position of the firing trigger 9094
and/or the corresponding value of the speed of the firing bar 9036
and/or the cutting member 9040. The determined position, rank,
and/or status can be communicated to the operator via the feedback
indicator 9066.
[0557] The reader will appreciate that an optimal speed of the
firing bar 9036 and/or the cutting member 9040 during a firing
stroke can depend on several parameters of the end effector 9012
such as, for example, the thickness of the tissue captured by the
end effector 9012, the tissue compression, and/or the force
required to advance the firing bar 9036 and, in turn, the cutting
member 9040. As such, measurements of these parameters can be
leveraged by the microcontroller 9061 in assessing whether a
current speed of advancement of the cutting member 9040 through the
captured tissue is within an optimal zone or range.
[0558] In one aspect, as illustrated in FIGS. 88-90, the feedback
indicator 9066 includes a dial 9096 and a pointer 9098 movable
between a plurality positions relative to the dial 9096. The dial
9096 is divided to define an optimal zone, a so-called "TOO FAST"
zone, and a so-called "TOO SLOW" zone. The pointer 9098 can be set
to one of a plurality of positions within the three zones. In one
example, as illustrated in FIG. 88, the pointer is set to a
position in the "TOO SLOW" zone to alert the operator that a
selected speed of advancement of the cutting member 9040 through
the tissue captured by the end effector 9012 is below an optimal or
a desired zone. As described above, such a characterization of the
selected speed can be performed by the microcontroller 9061 based
on one or more measurements of one or more parameters of the end
effector 9012. In another example, perhaps after the operator
increases the speed of the cutting member 9040 in response to the
previous alert, the pointer is moved to a new position in the "TOO
FAST" zone, as illustrated in FIG. 89, to alert the operator that a
newly selected speed of the cutting member 9040 exceeds the optimal
zone. The operator may continue to adjust the speed of the cutting
member 9040 by adjusting the position of the firing trigger 9094
until the pointer lands in the optimal zone, as illustrated in FIG.
90. At such point, the operator may maintain the current position
of the firing trigger 9094 for the remainder of the firing
stroke.
[0559] In certain instances, the dial 9096 and the pointer 9098 can
be replaced with a digital indicator. In one example, the digital
indicator includes a screen that illustrates the above-identified
three zones. A digital pointer can be transitioned between a
plurality of positions on the screen to provide feedback to the
operator in accordance with the present disclosure. In certain
instances, as illustrated in FIGS. 91-93, the feedback indicator
9066 includes a plurality of zones with a middle zone indicating an
optimal or ideal speed of the cutting member 9040. In the example
illustrated in FIG. 91, nine zones are illustrated. However, in
alternative examples, the feedback indicator 9066 may include five
or seven zones, for example. As illustrated in FIG. 91, the
plurality of zones can be color coded. For example, the middle zone
can be in green. The first two zones to the right and the first two
zones to the left of the middle zone can be in yellow. The
remaining zones can be in red. In certain instances, as illustrated
in FIG. 91, the nine zones can be numbered with the numbers -4, -3,
-2, 0, +1, +2, +3, and +4, respectively from left to right. In at
least one example, the plurality of zones can be numbered and color
coded.
[0560] In any event, as illustrated in FIGS. 92-95, a pointer 9100
is movable between a plurality of positions to point to one of the
nine zones. An operator of the surgical instrument 9010 may squeeze
the firing trigger 9094 while monitoring the position of the
pointer 9100. Depending on the position taken by the pointer 9100,
the operator may reduce or increase the pressure on the trigger
9094 until the pointer 9100 rests in the middle or optimal zone. At
such point, the operator may maintain the current pressure on the
firing trigger 9094 for the remainder of the firing stroke. In
certain instances, as illustrated in FIG. 96, the feedback
indicator 9066 may alert the operator that the firing stroke is
completed.
[0561] In certain instances, as described above, the jaw members
9014, 9016 include electrically conductive layers configured to
deliver energy to tissue captured between the jaw members 9014,
9016. An energy trigger or actuator can be moved or depressed
between a plurality of positions or settings, in a similar manner
to the firing trigger 9094, to deliver the energy to the tissue.
The level or intensity of the energy delivered to the tissue may
depend on the selected position. For example, depressing the energy
trigger to a first position may yield a first energy level, and
depressing the energy trigger to a second position, different from
the first position, may yield a second energy level different from
the first energy level. A tracking system, like the tracking system
9080, can track the position of the energy trigger and report such
manual input to the microcontroller 9061. Alternatively, the
resulting energy level can be monitored and reported to the
microcontroller 9061. A current sensor or a voltage sensor, for
example, can be employed to monitor the resulting energy level.
[0562] In any event, the microcontroller 9061 may be configured to
characterize the selected position of the energy trigger and/or the
resulting energy level in view of one or more measured parameters
of the end effector 9012 and/or one or more characteristics of the
captured tissue such as tissue thickness, tissue compression,
and/or tissue impedance. One or more sensors can be employed to
obtain measurements of one or parameters of the end effector and/or
one or more characteristics of the captured tissue, which can be
reported in real-time to the microcontroller 9061. In response, the
microcontroller 9061 may characterize the selected position of the
energy trigger and/or the resulting energy level by selecting or
determining a position, rank, and/or status of the selected
position of the energy trigger and/or the resulting energy level
with respect to a desired zone or range. As described above, the
memory unit 9068 can include an algorism, equation, and/or look-up
table for determining the position, rank, and/or status of the
selected position of the energy trigger and/or the resulting energy
level. Furthermore, the position, rank, and/or status can be
reported to the operator of the energy trigger in real-time via a
feedback indicator, similar to the feedback indicator 9066, for
example.
[0563] One of the advantages of the feedback methods and systems of
the present disclosure is that they reduce the number of variables
that an operator need to consider while providing a manual input
such as, for example, actuating the firing trigger 9094. As such,
the operator is relieved from having to manually consider each of
the measured parameters of the end effector 9012 to estimate the
adequacy of a manual input and/or an output value resulting from
the manual input such as the speed of the cutting member 9040.
Instead, a current manual input and/or an output value of the
manual input can be automatically characterized by the
microcontroller 9061 in view of all the measured parameters of the
end effector 9012 to provide the operator with one consolidated
real-time feedback through the feedback indicator 9066. The
operator may then focus on such feedback and adjust the manual
input to achieve an optimal result.
[0564] Further to the above, the feedback methods and systems of
the present disclosure would give the operator a repeatable
relative measure to judge the adequacy of a manual input. In
addition, the operator could decide for themselves how far beyond
an optimal zone, with respect to such relative measure, they are
willing to reach comfortably to achieve a good outcome.
Furthermore, the feedback methods and systems of the present
disclosure would also give the operator a warning if the firing was
out of the ordinary so that additional caution may be exercised.
Furthermore, by focusing on the one consolidated real-time
feedback, an operator can learn quicker the best way to fire a
surgical instrument.
[0565] The present disclosure also provides novel techniques for
modular reload to identify itself and define a program of operation
of a motor controller to actuate the module.
[0566] One technique includes defining a table of programs and
configuring a module to communicate to the handle which software
programs (or other machine executable instructions) to select and
execute. By way of contrast, other techniques are contemplated that
do not include no operating programs in the handle portion of the
endosurgical device and instead store the program in the module
itself and uploads the program at the time of attachment for the
handle to execute. In another technique, no programs would be
executed in the handle. The handle would contain the motor
controller, the actuation buttons, and even the power controller,
but not the operating programs. The module would contain all the
upper level logic and a sub-processor to execute the program such
that each module includes a main processor and the program specific
to that reload. When the shaft is attached to the handle, the
processor becomes energized and it identifies the handle to which
it is attached. Once identified the handle is slaved to the modular
reload with the module giving and processing all commands. When a
button is depressed, for example, the module responds and
determines the next action and then communicates to the slaved
motor controller how far and how fast to move and when to stop.
With the inclusion of the master processor in the module there also
should be a relatively high bandwidth communication bus between the
module and the handle to enable the necessary communication
traffic. This can be accomplished by holding the rotary shaft
component of the modular attachment within a station frame
attachment component such that the stationary part houses the
processor and control program. Therefore, the communication bus
does not have to also serve as a slip ring contact set.
[0567] As described herein, a surgical system can include modular
components, which can be attached and/or combined together to form
a surgical instrument. Such modular components can be configured to
communicate and interact to affect surgical functions. Referring
again to the surgical instrument 10 (FIGS. 1-4), the surgical
instrument 10 includes a first modular component 14 (FIG. 1), e.g.,
a handle assembly 14, and a second modular component 200 (FIG. 1),
e.g., an attachment assembly that includes an elongate shaft 260
(FIG. 1) and an end effector 300 (FIG. 1), which are described
herein. The handle assembly 14 and the attachment assembly 200 can
be assembled together to form the modular surgical instrument 10 or
at least a portion thereof. Optionally, a different modular
component may be coupled to the handle assembly 14, such as an
attachment having different dimensions and/or features than those
of the attachment assembly 200 (FIG. 1), for example. For example,
alternative attachments can be interchangeable with the attachment
assembly 200. In various instances, the surgical instrument 10 can
include additional modular components, such as a modular battery 90
(FIG. 4), for example.
[0568] The modular surgical instrument 10 (FIGS. 1-4) can include a
control system that is designed and configured to control various
elements and/or functions of the surgical instrument 10. For
example, the handle assembly 14 (FIG. 1) and the attachment
assembly 200 (FIG. 1) can each comprise a circuit board 100 (FIG.
4), 610 (FIG. 7), respectively, having at least one control system.
The control systems of the modular components 14, 200 can
communicate and/or cooperate. In certain instances, a table of
control modules can be accessible to the controller in the handle
assembly 14 of the surgical system 10. The controller in the
attachment assembly 200 can instruct the handle assembly 14 to
select and implement at least one of the control module(s) from the
table. In such instances, the controller in the handle assembly 14
can access and run the control module(s). In other instances, the
controller in the attachment assembly 200 can include at least one
control module. The appropriate control module(s) can be uploaded
to the controller in the handle assembly 14, which can run the
control module(s). In such instances, the controller in the handle
assembly 14 can also access and run the control module(s).
Additionally or alternatively, various control module(s) in the
handle assembly 14 and/or the attachment assembly 200 can be
updated. For example, the controller in the handle assembly 14 can
be configured to download updated and/or modified control module(s)
from the controller in the attachment assembly 200. U.S. patent
application Ser. No. 14/226,133, entitled MODULAR SURGICAL
INSTRUMENT SYSTEM, filed Mar. 26, 2014, now U.S. Patent Application
Publication No. 2015/0272557, which describes various surgical
systems and control systems thereof, is hereby incorporated by
reference herein in its entirety.
[0569] In still other instances, a processor of the surgical
instrument 10 (FIGS. 1-4) can comprise a master processor, and
another processor of the surgical instrument 10 can comprise a
slave processor. An operating system and/or a plurality of control
modules can be accessible to the master processor. The operating
system and/or the control modules can affect at least one surgical
function with and/or by an element or subsystem of the surgical
instrument 10, for example. A control module can comprise software,
firmware, a program, a module, and/or a routine, for example,
and/or can include multiple software, firmware, programs, control
modules, and/or routines, for example. The control modules can
affect a surgical function based on a pre-programmed routine,
operator input, and/or system feedback, for example. In various
instances, the master processor can be configured to direct
information and/or commands to the slave processor. Moreover, the
slave processor can be configured to receive information and/or
commands from the master processor. The slave processor can act in
response to the commands from the master processor. In various
instances, the slave processor may not include a control module(s)
and/or operating system, and the actions of the slave processor can
be attributed to command(s) from the master processor and the
control module(s) accessible to the master processor. As described
herein, the control system in the attachment assembly 200 (FIG. 1)
of the surgical instrument system 10 can include a master
processor, and the control system in the handle assembly 14 (FIG.
1) of the surgical instrument system 10 can include at least one
slave processor, for example.
[0570] Referring again to the surgical instrument 10 (FIGS. 1-4),
the handle assembly 14 can be compatible with different
attachments, which can be configured to affect different surgical
functions. The various attachments can be interchangeable, and the
different surgical functions can correspond to different tissue
types and/or different surgical procedures, for example. Because
different attachments can be configured to affect different
surgical functions, control modules specific to the particular
attachments can be stored on the respective attachments. For
example, the attachment assembly 200 (FIG. 1) can store the
specific control module(s) for operating the attachment assembly
200. Additionally, the attachment assembly 200 can include the
upper level logic and sub-processor to run the control module(s).
In such instances, the processor in the attachment assembly 200 can
comprise a master control system and/or master processor that is
configured to command a slave processor in the handle assembly 14
to implement the control module(s) stored on the attachment
assembly 200.
[0571] Because each attachment includes the specific control
module(s) for its operation and because the processor in the
attachment comprises the master processor, the modular surgical
instrument 10 is configured to run the most appropriate and
up-to-date control module(s) for the particular attachment.
Additionally, as updated and/or revised attachments and/or control
module(s) therefor and designed and implemented, the updated and/or
revised attachments are designed to properly work with handle
assemblies that have less recent updates and/or revisions. In other
words, updated and/or revised attachments can be retrofit to
operate properly with existing and/or out-of-date handle
assemblies.
[0572] As described herein, the handle assembly 14 (FIG. 1)
includes a firing drive system 80 that includes a motor 82 (FIG.
4). The handle assembly 14 also includes a battery 90 (FIG. 90), a
handle circuit board 100 (FIG. 4), and an electrical connector 1400
(FIG. 4). A motor controller, such as the motor controller 2043
(FIGS. 21A and 21B), for example, which is described herein, can be
configured to control the operation of the motor 82. For example,
the motor controller 2043 can initiate rotation of the motor 82
and/or can control the direction and/or speed of motor
rotation.
[0573] As described herein, the attachment assembly 200 (FIG. 1)
can include a shaft circuit board 610 and an electrical connector
1410 (FIG. 7). The electrical connector 1410 (FIG. 3) on the
attachment assembly 200 can be configured to engage the electrical
connector 1400 (FIG. 4) on the handle assembly 14 (FIG. 1) to
provide a conduit and/or conductive pathway for transferring power
and/or information between the handle assembly 14 and the
attachment assembly 200. The electrical connectors 1400, 1410 can
be mounted to stationary components of the surgical instrument 10
(FIGS. 1-4). Referring to FIG. 3, for example, the electrical
connection 1410 in the attachment assembly 200 is mounted to the
shaft chassis 244, which remains stationary relative to the
intermediate firing shaft 222. Because the electrical connections
1400, 1410 are stationary relative to each other, the connections
1400, 1410 can provide a high bandwidth communication bus to enable
traffic between the connections 1400, 1410.
[0574] In various instances, when the attachment assembly 200 (FIG.
1) is attached to the handle assembly 14 (FIG. 1), the electrical
connectors 1400 (FIG. 3), 1410 (FIG. 3) can be engaged and the
battery 90 (FIG. 4) in the handle assembly 14 can power the handle
assembly 14 and the attachment assembly 200. For example, the
battery 90 can provide power to the shaft circuit board 610 (FIG.
7) when the attachment assembly 200 is coupled to the handle
assembly 14. In various instances, the battery 90 can automatically
power the shaft circuit board 610 and/or components thereof when
the attachment assembly 200 is connected to the handle assembly
14.
[0575] Referring now to FIG. 97, a schematic depicting the various
control systems for a modular surgical instrument system, such as
the surgical instrument 10 (FIGS. 1-4), for example, is depicted. A
first control system 10000 can be positioned in a modular
attachment, such as the attachment assembly 200 (FIG. 1), and a
second control system 10014 can be positioned in a modular handle,
such as the handle assembly 14 (FIG. 1). The attachment control
system 10000 includes a master processor 10012, which is configured
to issue commands to a slave processor. For example, the handle
control system 10014 includes a slave processor 10018, which can be
slaved to the master processor 10012 in the modular attachment 200.
In various instances, the slave processor 10018 can correspond to a
motor controller, such as the motor controller 2043 (FIGS. 21A and
21B), for example. In such instances, the motor controller 2043 in
the handle assembly 14 of the surgical instrument 10 can be slaved
to the master processor 10012 in the modular attachment 200. For
example, the master processor 10012 can issue commands to the motor
controller 2043, which can affect actuation of the motor 82 (FIG.
4), for example, and can control the direction and/or speed of
motor rotation.
[0576] Referring still to FIG. 97, the control system 10000 in the
modular attachment 200 can also include at least one sensor 10010,
which can be in communication with the master processor 10012 in
the modular attachment 200 (FIG. 1). Various exemplary sensors for
detecting conditions within the shaft 260, within the end effector
300 (FIGS. 1 and 2), and/or at the surgical site are described
herein. In certain instances, the master processor 10012 can select
a control module and/or program to run based on feedback from the
sensors 10010. For example, the thickness, density, and/or
temperature of tissue detected by one of the sensors 10010 can be
communicated to the master processor 10012 and the operating
module(s) and/or program selected by the master processor 10012 can
account for the detected condition(s) within the end effector
300.
[0577] The handle control system 10014 depicted in FIG. 97 also
includes a display processor 10016, which can be similar to the
display segment 2002d of segmented circuit 2000 (FIGS. 21A and
21B), for example. In certain instances, the display processor
10016 can be configured to control the information provided to and
presented by a display. In various examples, the display can be
integrally formed on the handle assembly 14 (FIG. 1) of the
surgical instrument system 10 (FIG. 1). In still other instances,
the display can be separate and/or remote from the handle assembly
14 and the attachment assembly 200 (FIG. 1). In at least one
instance, the display processor 10016 is a slave to the master
processor 10012 in the attachment assembly 200. For example, the
master processor 10012 can send commands to the display processor
10016 and the display processor 10016 can implement the
commands.
[0578] Referring still to FIG. 97, the control system 10014 in the
handle assembly 14 (FIG. 1) can include a safety coprocessor 10020,
which can be similar to the safety processor 2004 (FIGS. 21A and
21B), for example. In various instances, the safety coprocessor
10020 can be in signal communication with the master processor
10012 in the modular attachment 200 (FIG. 1). The master processor
10012 can issue commands to the safety coprocessor 10020, which can
be specific to the modular attachment and/or the surgical functions
performed by the particular modular attachment. For example, the
master processor 10012 can initiate the safety operations of the
safety coprocessor 10020. In various instances, after the safety
operations of the safety coprocessor 10020 have been initiated, the
safety coprocessor 10020 can run independently and can notify the
master processor 10012 if a triggering event occurs.
[0579] The control system 10014 in the handle assembly 14 (FIG. 1)
can be coupled to a battery 10022, which can be similar to the
battery 90 (FIG. 4) positioned in the handle assembly 14 and the
battery 2008 (FIGS. 21A and 21B) in the power segment 2002h (FIGS.
21A and 21B) of the segmented circuit 2000, which are described
herein. The battery 10022 can power the control system 10014 in the
handle assembly 14. Moreover, when the attachment assembly 200 is
connected to the handle assembly 14, the battery 10022 can power
the master control system 10000 in the attachment assembly 200
(FIG. 1). For example, the battery 10022 can power the master
processor 10012 in the attachment assembly 200. In various
instances, when the attachment assembly 200 is attached to the
handle assembly 14, the battery 10022 can automatically power the
master processor 10012. For example, current can flow to the master
processor 10012 via the electrical connector 1400 (FIGS. 3 and 4)
in the handle assembly 14 and the electrical connector 1410 (FIG.
7) in the attachment assembly 200.
[0580] In various instances, the master processor 10012 can include
a plurality of control modules, which are specific to the surgical
functions and/or components of the attachment assembly 200 (FIG.
1). The control modules can be accessible to and/or integral with
the master processor 10012. In various circumstances, the master
processor 10012 can include multiple tiers and/or levels of command
and the control modules can be organized into multiple tiers. For
example, the master processor 10012 can include a first tier of
control modules, a second tier of control modules, and/or a third
tier of control modules. Control modules of the first tier can be
configured to issue commands to the control modules of the second
tier, for example, and the control modules of the second tier can
be configured to issue commands to the control modules of the third
tier. In various instances, the master processor 10012 can include
less than three tiers and/or more than three tiers, for
example.
[0581] The control module(s) in the first tier can comprise
high-level software, or a clinical algorithm. Such a clinical
algorithm can control the high-level functions of the surgical
instrument 10 (FIGS. 1-4), for example. In certain instances, the
control module(s) in the second tier can comprise intermediate
software, or framework module(s), which can control the
intermediate-level functions of the surgical instrument 10, for
example. In certain instances, the clinical algorithm of the first
tier can issue abstract commands to the framework module(s) of the
second tier to control the surgical instrument 10. Furthermore, the
control modules in the third tier can comprise firmware modules,
for example, which can be specific to a particular hardware
component, or components, of the surgical instrument 10. For
example, the firmware modules can correspond to a particular
cutting element, firing bar, trigger, sensor, and/or motor of the
surgical instrument 10, and/or can correspond to a particular
subsystem of the surgical instrument 10, for example. In various
instances, a framework module can issue commands to a firmware
module to implement a surgical function with the corresponding
hardware component. Accordingly, the various control modules of the
surgical system 10 can communicate and/or cooperate during a
surgical procedure.
[0582] The master processor 10012 can include and/or access the
control modules of various tiers, which can affect different
surgical functions. In certain instances, the motor controller
10018 may not include any control modules, and control modules may
not be accessible to the motor controller 10018. For example, the
motor controller 10018 may not include an operating system,
framework module, and/or firmware module. In such instances, the
motor controller 10018 can be slaved to the master processor 10012,
and the motor controller 10018 can be configured to implement the
commands issued by the master processor 10012.
[0583] As described herein, the master control system 1000 in the
attachment assembly 200 can communicate with the control system
10014 in the handle assembly 14 (FIG. 1) to affect a surgical
function. In use, referring primarily now to FIG. 98, modular
components of a surgical instrument, such as the handle assembly 14
and the attachment assembly 200 (FIG. 1), can be attached 11000.
Thereafter, at least one function can be initiated by a master
processor, such as the master processor 10012 (FIG. 97), for
example, which can include the control module(s) and/or operating
program(s) specific to the attachment assembly 200 (FIG. 1) and the
surgical function(s) to be performed by the attachment assembly
200.
[0584] With reference primarily to both FIGS. 97 and 98, a battery,
such as the battery 10022 can power 11010 the master processor
10012. As described herein, when the attachment assembly 200 (FIG.
1) is properly coupled to the handle assembly 14 (FIG. 1), the
battery 10022 in the handle assembly 14 can power the master
processor 10012. The powered master processor 10012 can identify
11016 at least one slave processor, such as the slave processors
10016 and 10018, for example. After the master processor 10012
identifies 11016 at least one of the slave processor(s) 10016,
10018, the master processor 10012 can issue commands to the slave
processor(s) 10016, 10018. The commands can be based on a
pre-programmed routine found in a control module accessible to the
master processor 10012.
[0585] In various instances, the master processor 10012 can request
information from other systems and/or controllers in the surgical
instrument 10 (FIGS. 1-4). For example, the master processor 10012
can request information from a slaved processor. In certain
instances, the master processor 10012 can request information from
an input system, such as an actuation button and/or trigger on the
handle assembly 14 (FIG. 1). Additionally or alternatively, the
master processor 10012 can request information from a sensor and/or
feedback system. For example, the master processor 10012 can
communicate with at least one sensor 10010 to obtain information on
at least one condition in the surgical instrument 10 and/or
surgical site. The master processor 10012 can receive 11012
information and/or inputs.
[0586] The master processor 10012 can issue at least one command to
at least one slave processor 10016, 10018 at step 11018. In certain
instances, the command(s) can be based on the control module(s)
accessible to the master processor 10012 and/or the feedback and/or
input received at step 11012. For example, the master processor
10012 can command the slaved motor controller 10018 to operate the
motor 82 (FIG. 4) in the handle assembly 14 at a particular power
level, in a particular direction, and/or for a particular duration.
The control sequence of the motor 82 can be determined and provided
by a control module in the attachment assembly 200 (FIG. 1). As a
result, the control sequence can correspond to the particular
attachment assembly 200 and the surgical function to be performed
by that attachment assembly 200.
[0587] At step 11014, the slaved processors 10016 and/or 10018 can
implement the command(s) from the master processor 10012. In
various instances, the master processor 10012 can request
information from various slaved systems during and/or throughout
implementation of the control sequence. In certain instances, based
on the updated information, the master processor 10012 can issue a
new and/revised command and/or commands. Additionally or
alternatively, the master processor 10012 can issue additional
commands to the slaved processor(s) throughout the operation of the
surgical instrument 10 (FIGS. 1-4).
[0588] The present disclosure provides additional techniques to
overcome challenges with conventional modular endosurgical devices.
Two of these techniques, in the context of modular endocutters,
include wire contacts to transmit power and receive signals from an
end effector shaft configured to rotate, and the ability to upgrade
the modular attachment with new tech and sensors while allowing the
handle to readily accept the new tech.
[0589] The ability for the sensors in the end-effector to have the
signal processing capability built into the sensor itself helps
improve both of these issues. In one aspect, the sensor can be
configured to supply the handle with processed information rather
than supplying the handle with raw data to minimize the impact of
newer sensors and the number of wires necessary to run them. In one
aspect, a series of smart sensors can be placed in parallel along a
single power line with the shaft of the device as the return path
and using current draw "signal" the handle to stop, or start, or
end etc. In accordance with this technique, the handle does not
need to know what the sensor actually is or how to interpret the
processed information being fed back to the controller. Likewise,
the current draw can be monitored using a standard Morse Code like
encoding technique on the power line to enable the handle to know
what the issue is and which sensor identified the issue without any
pairing or other couple communication requirement.
[0590] Medical devices may be modular devices that include several
separate components. For example, an endocutter such as endocutter
12010 as shown in FIG. 99 may include several large and small
separate components. The endocutter 12010 is similarly constructed
and equipped as the motor-driven surgical cutting and fastening
instrument 10 described in connection with FIGS. 1-29. Accordingly,
for conciseness and clarity the details of operation and
construction will not be repeated here. Endocutter 12010 may
include a handle component 12012, a shaft component 12014, and an
end-effector component 12016. Each of the handle, the shaft, and
the end-effector may include smaller but separate components such
as sensors, transducers, motors, switches, controllers, processors
etc., which may be programmable and interoperable with one another.
In this way, endocutter 12010 may be a modular medical device.
[0591] In general, modular devices may have several challenges to
overcome. For example, modular endocutter 12010 may require
multiple wire contacts configured to transmit power and receive
signals. A power source, such as a battery 90 (FIG. 4), may
transfer power to one or more sensors, transducers, motors,
switches, controllers, processors, or other modular components of
the endocutter through various wires and wire contacts. One or more
of these modular components may receive signals from one another in
order to perform various calculations, processes, or actions to
operate the endocutter. For example, a sensor in end-effector 12016
may be powered from a battery in handle 12012 through a wire in
shaft 12014 and may send back signals or data to a microprocessor
or microcontroller in handle 12012 through a different wire in
shaft 12014. The shaft 12014 may be only a half inch in diameter
and may have the ability to rotate, which may lead to challenges
when swapping or upgrading modular components such as sensors.
[0592] In some systems, a sensor in the end-effector may send data
to the handle. The data may require signal processing or other
processing by one or more components in the handle in order to be
used to operate the endocutter. Adding a new sensor or upgrading an
existing sensor may require new wires to enable communication with
the one or more components (e.g., a microprocessor) in the handle.
Having to add new wires or wire contacts may negatively impact the
ability to use new sensors or upgrade existing sensors and may be
undesirable. The ability to upgrade the modular components (e.g.,
sensors) in, for example, the end-effector 12016, with new
technology such as more advanced sensors, while allowing components
in the handle 12012 (e.g., a microcontroller 12024) to readily
accept output from the new sensors without adding new wires or new
wire contacts may be desirable.
[0593] In one aspect of the present disclosure, one or more sensors
in the end-effector (e.g., end-effector 12016) may have local or
built-in signal processing capability. These sensors may be
referred to as smart sensors. Rather than supplying the handle or
one or more components therein with data that may require further
processing, smart sensors with local signal processing may supply
the handle with already processed data or information that can be
used to operate the endocutter while minimizing or eliminating
further processing.
[0594] For example, the end-effector 12016 may include a sensor
12020 and signal processing component 12022. The signal processing
component 12022 may correspond to the sensor 12020 (i.e., may be
configured to process data from sensor 12020). In one example, the
signal processing component 12022 may be specially designed or
configured to process signals or data received from the sensor
12020. Further, the signal processing component 12022 may generate
processed information based on the signals or data received from
sensor 12020. In this way, the signal processing component 12022
may process data received from the sensor 12020 of a surgical
instrument (i.e., the endocutter 12010) locally to the sensor and
into information usable by the surgical instrument.
[0595] The handle 12012 (or a component therein) may be configured
to receive the processed information from the signal processing
component 12022. For example, the signal processing component 12022
may transmit the processed information to handle 12012 via shaft
12014 (through, e.g., one or more wires). In this way, the
processed information may be transmitted from the signal processing
component 12022 to a controller 12024 (e.g., a microcontroller) of
the surgical instrument (e.g., the endocutter 12010). Further, the
surgical instrument (e.g., the endocutter 12010) may be controlled
based on the processed information from the signal processing
component 12022. For example, the end-effector 12016 may be stopped
or started or a process of the endocutter 12010 may be ended based
on the processed information. In one example, the controller 12024
may stop or start the end-effector based on the processed
information.
[0596] The signal processing component 12022 and the sensor 12020
may be part of a single module 12018. The single module 12018 may
be positioned in the end-effector 12016 and may be a modular
component easily swapped into or out of the end-effector 12016. The
sensor 12020 may be, for example, a magnetic field sensor, a
magnetic sensor, an inductive sensor, a capacitive sensor, or
another type of sensor used in medical devices or endocutters. The
signal processing component 12022 may be the microcontroller 2006
(FIGS. 21A, 21B) or microcontroller 3017 (FIGS. 28A, 28B).
[0597] In one aspect, the signal processing component may be a
sensor circuit 12036 as shown in FIG. 100. The sensor circuit 12036
may be any suitable circuit configured to read signals from a
sensor component such as an inductive coil 12032. The sensor
circuit 12036 may be in communication with or be communicatively
coupled to a sensor component in the end-effector 12030. For
example, the sensor circuit 12036 may be communicatively coupled to
an inductive coil 12032 via a wire or cable 12038. The inductive
coil 12032 may produce a magnetic field 12034 and may be located at
a distal end of an anvil 12040 of the end-effector 12030. The
sensor circuit 12036 may receive data or signals from the sensor
component (e.g., inductive coil 12032) and may process the data or
signals to generate processed information which may be used to
operate the end-effector 12030.
[0598] While the sensor circuit 12036 is shown outside of the
end-effector 12030 and the anvil 12040 in FIG. 100 for ease of
disclosure, the sensor circuit 12036 may be local to the sensor
component (e.g., inductive coil 12032) or may be part of a single
module including the sensor component and the sensor circuit, such
as single module 12018 of FIG. 99. For example, as shown in FIG.
101, a sensor circuit 12052 also may be positioned at a distal end
of an anvil 12056 of an end-effector 12050. The sensor circuit
12052 may be local to, and in communication with, a sensing
component such as magnet 12054.
[0599] Referring back to FIG. 99, the handle 12012 may include a
controller 12024 which may be configured to control or otherwise
operate the endocutter 12010. In one example, the controller 12012
may be a microcontroller and may be configured to receive the
processed information from the signal processing component 12022 or
the single module 12018. For example the shaft 12014 may be
configured to communicatively couple the signal processing
component 12022 of the end-effector 12016 and the handle 12012. The
microcontroller 12024 in the handle 12012 may be in wired
communication with the signal processing component 12022 via shaft
12014. In one example, the signal processing component 12022 may be
in wireless communication with the microcontroller 12024 or with
another component in handle 12012. While the controller 12024 may
be configured to receive the processed information from the signal
processing component 12022 or the single module 12018, this is not
intended to be a limitation of the present disclosure as various
other components (e.g., a microprocessor, display, interface,
switch, etc.) in handle 12012 may be configured to receive the
processed information from the signal processing component 12022 or
the single module 12018.
[0600] In one aspect, a plurality of smart sensors may be
positioned on a power line of an end-effector and may be
communicatively coupled to a handle of an endocutter. The smart
sensors may be positioned in series or parallel with respect to the
power line. Referring now to FIG. 14, smart sensors 12060 and 12062
may be in communication with a signal processing component or a
microprocessor 12064 which may be local to the smart sensors. Both
the smart sensors 12060 and 12062 and the microprocessor 12064 may
be located at the end-effector (represented by dashed-box 12066).
For example, smart sensor 12060 may output signals or data to an
operational amplifier 12068 and an ADC converter 12070, which may
condition the signals or data for input into microprocessor 12064.
Similarly, smart sensor 12062 may output signals or data to an
operational amplifier 12072 and an ADC converter 12074, which may
condition the signals or data for input into microprocessor
12064.
[0601] Smart sensors 12060 and/or 12062 may be different types of
sensors or the same type of sensor, which may be, for example,
magnetic field sensors, magnetic sensors, inductive sensors,
capacitive sensors, or other types of sensors used in medical
devices or endocutters. Component 12064, previously referred to as
a microprocessor, also may be a computational core, FPGA (field
programmable gate array), logic unit (e.g., logic processor or
logic controller), signal processing unit, or other type of
processor. The microprocessor 12064 may be in communication with a
memory, such as non-volatile memory 12076, which may store
calculation data, equipment information such as a type of cartridge
inserted in the end-effector 12066, tabular data, or other
reference data that may enable the microprocessor 12064 to process
signals or data received from one or more of the smart sensors
12060 or 12062 for use in operating the end-effector 12066 or an
endocutter.
[0602] Further, a shaft 12078 may include a return path through
which at least one of the plurality of smart sensors (e.g., smart
sensors 12060 or 12062) and the handle 12080 are communicatively
coupled. The shaft may include one or more wires which may transfer
information from the microprocessor 12064 to the handle 12080 for
operation of the end-effector 12066 or endocutter. In one example,
the information from the microprocessor 12064 may be communicated
to the handle 12080 (by way of shaft 12078 or directly without use
of shaft 12078) over one or more of: a wired-line, a single-wired
line, a multi-wired line, a wireless communication protocol such as
Bluetooth, an optical line, or an acoustic line.
[0603] In one aspect, at least one of a plurality of smart sensors
positioned at an end-effector may include a signal processing
component. For example, the signal processing component may be
built into the smart sensor or may be locally coupled to the smart
sensor as shown in single module 12018 of FIG. 99. The signal
processing component may be configured to process data received
from a sensor component (e.g., sensor component 12020) of at least
one of the plurality of smart sensors. A controller 12024 (e.g., a
microcontroller) at the handle may be communicatively coupled to at
least one of the plurality of smart sensors.
[0604] In one aspect, a smart sensor may be configured for local
signal processing in a medical device. The smart sensor may include
at least one sensor component (e.g., sensor component 12020) and at
least one processing component (e.g., processing component 12022).
The processing component may be configured to receive data from the
at least one sensor component and to process the data into
information for use by the medical device. The medical device may
be, for example, an endocutter, however this is not intended to be
a limitation of the present disclosure. It should be understood
that the techniques and features discussed herein for smart sensors
with local signal processing may be used in any medical device
where processing of sensor signals or data is used for operation of
the medical device.
[0605] Further, a controller (e.g., controller 12024,
microcontroller) in the medical device may be configured to receive
the information (i.e., processed signals or data) from the at least
one processing component (e.g., processing component 12022). As
discussed above, the medical device may be a surgical instrument
such as an endocutter and the smart sensor may be configured for
local signal processing in the surgical instrument. Local signal
processing may refer to, for example, processing signals or data
from a sensor component at a processing component coupled to the
sensor, where the resulting processed information may be used by a
separate component. For example, the controller 12024 may be
positioned in the handle 12012 of the surgical instrument (i.e.,
the endocutter 12010) and the smart sensor may be configured to be
positioned in a separate component (i.e., the end-effector 12016)
of the surgical instrument (i.e., the endocutter 12010), separate
from the handle 12012. Thus, the controller 12024 may be positioned
at the handle 12012 of the surgical instrument and the signal
processing component 12022 and the sensor 12020 may be located in a
component separate from the handle 12012 (e.g., end-effector
12016).
[0606] In this way, the handle or controller 12024 need not have
information about the smart sensor, knowledge of what the smart
sensor is doing, or capability to interpret data feed back from the
smart sensor. This is because the processing component 12022 may
transform or condition the data from the smart sensor and generate
information from the data directly usable by the handle or
controller 12024. The information generated by the processing
component may be used directly, without the data from the smart
sensor needing to be processed in another part of the medical
device (e.g., near the handle 12012 or controller 12024). Thus, the
surgical instrument may be controlled based on the (processed)
information from the signal processing component local to the
sensor.
[0607] In one aspect, a current draw on a power line
communicatively coupled to the signal processing component 12022
(i.e., local to the sensor 12020) may be monitored. The current
draw may be monitored by a microprocessor or other monitoring
device at the shaft 12014 or the handle 12012, or at another
microprocessor or other monitoring device separate from the signal
processing component 12022. For example, the monitoring may be a
standard Morse Code type monitoring of the current draw on the
power line. An issue with the surgical instrument based on the
current draw and a particular sensor may be determined by the
separate microprocessor at, e.g., the handle 12012. In this way,
the monitoring may allow the handle (or a processor or controller
therein) to be informed of various issues related to signals or
data received by one or more sensor and which particular sensor
identified the issue, without a further communication requirement
(e.g., pairing, or other coupled communication).
[0608] Turning now to FIG. 103, which is a logic diagram
illustrating one aspect of a process 13040 for calibrating a first
sensor 13008a in response to an input from a second sensor 13008b.
The first sensor 13008a is configured to capture 13022a a signal
indicative of one or more parameters of the end effector 13000. The
first signal 13022a may be conditioned based on one or more
predetermined parameters, such as, for example, a smoothing
function, a look-up table, and/or any other suitable conditioning
parameters. A second signal is captured 13022b by the second sensor
13008b. The second signal 13022b may be conditioned based on one or
more predetermined conditioning parameters. The first signal 13022a
and the second signal 13022b are provided to a processor, such as,
for example, the primary processor 2006 (FIGS. 21A-21B). The
primary processor 2006 calibrates 13042 the first signal 13022a in
response to the second signal 13022b. The first signal 13022a is
calibrated 13042 to reflect the fullness of the bite of tissue in
the end effector 13000. The calibrated signal is displayed 13026 to
an operator by, for example, a display 12026 embedded in the
surgical instrument 10 (FIGS. 1-6).
[0609] FIG. 104 is a logic diagram illustrating one aspect of a
process 13170 for adjusting a measurement of a first sensor 13158
in response to a plurality of secondary sensors 13160a, 13160. In
one example, a Hall effect voltage is obtained 13172, for example,
by a magnetic field sensor. The Hall effect voltage is converted
13174 by an analog to digital convertor. The converted Hall effect
voltage signal is calibrated 13176. The calibrated curve represents
the thickness of a tissue section located between the anvil 13152
and the staple cartridge 13156. A plurality of secondary
measurements are obtained 13178a, 13178b by a plurality of
secondary sensors, such as, for example, a plurality of strain
gauges. The input of the strain gauges is converted 13180a, 13180b
into one or more digital signals, for example, by a plurality of
electronic .mu.Strain conversion circuits. The calibrated Hall
effect voltage and the plurality of secondary measurements are
provided to a processor, such as, for example, the primary
processor 2006 (FIGS. 21A-21B). The primary processor utilizes the
secondary measurements to adjust 13182 the Hall effect voltage, for
example, by applying an algorithm and/or utilizing one or more
look-up tables. The adjusted Hall effect voltage represents the
true thickness and fullness of the bite of tissue clamped by the
anvil 13152 and the staple cartridge 13156. The adjusted thickness
is displayed 13026 to an operator by, for example, a display 12026
embedded in the surgical instrument 10 (FIGS. 1-6).
[0610] FIG. 105 illustrates one aspect of a circuit 13190
configured to convert signals from the first sensor 13158 and the
plurality of secondary sensors 13160a, 13160b into digital signals
receivable by a processor, such as, for example, the primary
processor 2006 (FIGS. 21A-21B). The circuit 13190 comprises an
analog-to-digital convertor 13194. In some examples, the
analog-to-digital convertor 13194 comprises a 4-channel, 18-bit
analog to digital convertor. Those skilled in the art will
recognize that the analog-to-digital convertor 13194 may comprise
any suitable number of channels and/or bits to convert one or more
inputs from analog to digital signals. The circuit 13190 comprises
one or more level shifting resistors 13196 configured to receive an
input from the first sensor 13158, such as, for example, a magnetic
field sensor. The level shifting resistors 13196 adjust the input
from the first sensor, shifting the value to a higher or lower
voltage depending on the input. The level shifting resistors 13196
provide the level-shifted input from the first sensor 13158 to the
analog-to-digital convertor.
[0611] In some aspects, a plurality of secondary sensors 13160a,
13160b are coupled to a plurality of bridges 13192a, 13192b within
the circuit 13190. The plurality of bridges 13192a, 13192b may
provide filtering of the input from the plurality of secondary
sensors 13160a, 13160b. After filtering the input signals, the
plurality of bridges 13192a, 13192b provide the inputs from the
plurality of secondary sensors 13160a, 13160b to the
analog-to-digital convertor 13194. In some examples, a switch 13198
coupled to one or more level shifting resistors may be coupled to
the analog-to-digital convertor 13194. The switch 13198 is
configured to calibrate one or more of the input signals, such as,
for example, an input from a magnetic field sensor. The switch
13198 may be engaged to provide one or more level shifting signals
to adjust the input of one or more of the sensors, such as, for
example, to calibrate the input of a magnetic field sensor. In some
examples, the adjustment is not necessary, and the switch 13198 is
left in the open position to decouple the level shifting resistors.
The switch 13198 is coupled to the analog-to-digital convertor
13194. The analog-to-digital convertor 13194 provides an output to
one or more processors, such as, for example, the primary processor
2006 (FIGS. 21A-21B). The primary processor 2006 calculates one or
more parameters of the end effector 13150 based on the input from
the analog-to-digital convertor 13194. For example, in one example,
the primary processor 2006 calculates a thickness of tissue located
between the anvil 13152 and the staple cartridge 13156 based on
input from one or more sensors 13158, 13160a, 13160b.
[0612] FIG. 106 is a logic diagram illustrating one aspect of a
process 13320 for selecting the most reliable output from a
plurality of redundant sensors, such as, for example, the plurality
of sensors 13308a, 13308b. In one example, a first signal is
generated by a first sensor 13308a. The first signal is converted
13322a by an analog-to-digital convertor. One or more additional
signals are generated by one or more redundant sensors 13308b. The
one or more additional signals are converted 13322b by an
analog-to-digital convertor. The converted signals are provided to
a processor, such as, for example, the primary processor 2006
(FIGS. 21A-21B). The primary processor 2006 evaluates 13324 the
redundant inputs to determine the most reliable output. The most
reliable output may be selected based on one or more parameters,
such as, for example, algorithms, look-up tables, input from
additional sensors, and/or instrument conditions. After selecting
the most reliable output, the processor may adjust the output based
on one or more additional sensors to reflect, for example, the true
thickness and bite of a tissue section located between the anvil
13302 and the staple cartridge 13306. The adjusted most reliable
output is displayed 13026 to an operator by, for example, a display
2026 embedded in the surgical instrument 10 (FIGS. 1-6).
[0613] FIG. 107 illustrates one aspect of an end effector 13000
comprising a magnet 13008 and a magnetic field sensor 13010 in
communication with a processor 13012. The end effector 13000 is
similar to the end effector 300 (FIG. 1) described above in
connection with surgical instrument 10 (FIGS. 1-6). The end
effector 13000 comprises a first jaw member, or anvil 13002,
pivotally coupled to a second jaw member, or elongated channel
13004. The elongated channel 13004 is configured to operably
support a staple cartridge 13006 therein. The staple cartridge
13006 is similar to the staple cartridge 304 (FIG. 1) described
above in connection with surgical instrument 10 (FIGS. 1-6). The
anvil 13008 comprises a magnet 13008. The staple cartridge
comprises a magnetic field sensor 13010 and a processor 13012. The
magnetic field sensor 13010 is operable to communicate with the
processor 13012 through a conductive coupling 13014. The magnetic
field sensor 13010 is positioned within the staple cartridge 13006
to operatively couple with the magnet 13008 when the anvil 13002 is
in a closed position. The magnetic field sensor 13010 can be
configured to detect changes in the magnetic field surrounding the
magnetic field sensor 13010 caused by the movement of or location
of magnet 13008.
[0614] FIGS. 108-110 illustrate one aspect of an end effector that
comprises a magnet where FIG. 108 illustrates a perspective cutaway
view of the anvil 13102 and the magnet 13058a, in an optional
location. FIG. 109 illustrates a side cutaway view of the anvil
13102 and the magnet 13058a, in an optional location. FIG. 110
illustrates a top cutaway view of the anvil 13102 and the magnet
13058a, in an optional location.
[0615] FIG. 111 illustrates one aspect of an end effector 13200
that is operable to use conductive surfaces at the distal contact
point to create an electrical connection. The end effector 13200 is
similar to the end effector 300 (FIG. 1) described above in
connection with surgical instrument 10 (FIGS. 1-6). The end
effector 13200 comprises an anvil 13202, an elongated channel
13204, and a staple cartridge 13206. The anvil 13202 further
comprises a magnet 13208 and an inside surface 13210, which further
comprises a number of staple-forming indents 13212. In some
examples, the inside surface 13210 of the anvil 13202 further
comprises a first conductive surface 13214 surrounding the
staple-forming indents 13212. The first conductive surface 13214
can come into contact with second conductive surfaces 13222 on the
staple cartridge 13206. The cartridge body comprises a number of
staple cavities designed to hold staples (not pictured). In some
examples the staple cavities further comprise staple cavity
extensions that protrude above the surface of the cartridge body.
The staple cavity extensions can be coated with the second
conductive surfaces. Because the staple cavity extensions protrude
above the surface of the cartridge body, the second conductive
surfaces will come into contact with the first conductive surfaces
13214 when the anvil 13202 is in a closed position. In this manner
the anvil 13202 can form an electrical contact with the staple
cartridge 13206.
[0616] FIG. 112 illustrates one aspect of a staple cartridge 13606
that comprises a flex cable 13630 connected to a magnetic field
sensor 13610 and processor 13612. The staple cartridge 13606 is
similar to the staple cartridge 13606 is similar to the staple
cartridge 306 (FIG. 1) described above in connection with surgical
instrument 10 (FIGS. 1-6). FIG. 112 is an exploded view of the
staple cartridge 13606. The staple cartridge comprises 13606 a
cartridge body 13620, a wedge sled 13618, a cartridge tray 13622,
and a flex cable 13630. The flex cable 13630 further comprises
electrical contacts 13632 at the proximal end of the staple
cartridge 13606, placed to make an electrical connection when the
staple cartridge 13606 is operatively coupled with an end effector,
such as end effector 13800 described below. The electrical contacts
13632 are integrated with cable traces 13634, which extend along
some of the length of the staple cartridge 13606. The cable traces
13634 connect 13636 near the distal end of the staple cartridge
13606 and this connection 13636 joins with a conductive coupling
13614. A magnetic field sensor 13610 and a processor 13612 are
operatively coupled to the conductive coupling 13614 such that the
magnetic field sensor 13610 and the processor 13612 are able to
communicate.
[0617] FIG. 113 illustrates one aspect of an end effector 13800
with a flex cable 13830 operable to provide power to a staple
cartridge 13806 that comprises a distal sensor plug 13816. The end
effector 13800 is similar to the end effector 300 (FIG. 1)
described above in connection with surgical instrument 10 (FIGS.
1-6). The end effector 13800 comprises a first jaw member or anvil
13802, a second jaw member or elongated channel 13804, and a staple
cartridge 13806 operatively coupled to the elongated channel 13804.
The end effector 13800 is operatively coupled to a shaft assembly.
The shaft assembly is similar to shaft assembly 200 (FIG. 1)
described above in connection with surgical instrument 10 (FIGS.
1-6). The shaft assembly further comprises a closure tube that
encloses the exterior of the shaft assembly. In some examples the
shaft assembly further comprises an articulation joint 13904, which
includes a double pivot closure sleeve assembly. The double pivot
closure sleeve assembly includes an end effector closure sleeve
assembly that is operable to couple with the end effector
13800.
[0618] FIGS. 114 and 115 illustrate the elongated channel 13804
portion of the end effector 13800 without the anvil 13802 or the
staple cartridge, to illustrate how the flex cable 13830 can be
seated within the elongated channel 13804. In some examples, the
elongated channel 13804 further comprises a third aperture 13824
for receiving the flex cable 13830. Within the body of the
elongated channel 13804 the flex cable splits 13834 to form
extensions 13836 on either side of the elongated channel 13804.
FIG. 115 further illustrates that connectors 13838 can be
operatively coupled to the flex cable extensions 13836.
[0619] FIG. 116 illustrates the flex cable 13830 alone. As
illustrated, the flex cable 13830 comprises a single coil 13832
operative to wrap around the articulation joint 13904 (FIG. 113),
and a split 13834 that attaches to extensions 13836. The extensions
can be coupled to connectors 13838 that have on their distal facing
surfaces prongs 13840 for coupling to the staple cartridge 13806,
as described below.
[0620] FIG. 117 illustrates a close up view of the elongated
channel 13804 shown in FIGS. 114 and 115 with a staple cartridge
13804 coupled thereto. The staple cartridge 13804 comprises a
cartridge body 13822 and a cartridge tray 13820. In some examples
the staple cartridge 13806 further comprises electrical traces
13828 that are coupled to proximal contacts 13856 at the proximal
end of the staple cartridge 13806. The proximal contacts 13856 can
be positioned to form a conductive connection with the prongs 13840
of the connectors 13838 that are coupled to the flex cable
extensions 13836. Thus, when the staple cartridge 13806 is
operatively coupled with the elongated channel 13804, the flex
cable 13830, through the connectors 13838 and the connector prongs
13840, can provide power to the staple cartridge 13806.
[0621] FIGS. 118 and 119 illustrate one aspect of a distal sensor
plug 13816. FIG. 118 illustrates a cutaway view of the distal
sensor plug 13816. As illustrated, the distal sensor plug 13816
comprises a magnetic field sensor 13810 and a processor 13812. The
distal sensor plug 13816 further comprises a flex board 13814. As
further illustrated in FIG. 119, the magnetic field sensor 13810
and the processor 13812 are operatively coupled to the flex board
13814 such that they are capable of communicating.
[0622] FIG. 120 illustrates one aspect of an end effector 13950
with a flex cable 13980 operable to provide power to sensors and
electronics in the distal tip 13952 of the anvil 13961 portion. The
end effector 13950 comprises a first jaw member or anvil 13961, a
second jaw member or elongated channel 13954, and a staple
cartridge 13956 operatively coupled to the elongated channel. The
end effector 13950 is operatively coupled to a shaft assembly
13960. The shaft assembly 13960 further comprises a closure tube
13962 that encloses the shaft assembly 13960. In some examples the
shaft assembly 13960 further comprises an articulation joint 13964,
which includes a double pivot closure sleeve assembly 13966.
[0623] In various aspects, the end effector 13950 further comprises
a flex cable 13980 that is configured to not interfere with the
function of the articulation joint 13964. In some examples, the
closure tube 13962 comprises a first aperture 13968 through which
the flex cable 13980 can extend. In some examples, flex cable 13980
further comprises a loop or coil 13982 that wraps around the
articulation joint 13964 such that the flex cable 13980 does not
interfere with the operation of the articulation joint 13964, as
further described below. In some examples, the flex cable 13980
extends along the length of the anvil 13961 to a second aperture
13970 in the distal tip of the anvil 13961.
[0624] FIGS. 121-123 illustrate the operation of the articulation
joint 13964 and flex cable 13980 of the end effector 13950. FIG.
121 illustrates a top view of the end effector 13952 with the end
effector 13950 pivoted -45 degrees with respect to the shaft
assembly 13960. As illustrated, the coil 13982 of the flex cable
13980 flexes with the articulation joint 13964 such that the flex
cable 13980 does not interfere with the operation of the
articulation joint 13964. FIG. 122 illustrates a top view of the
end effector 13950. As illustrated, the coil 13982 wraps around the
articulation joint 13964 once. FIG. 123 illustrates a top view of
the end effector 13950 with the end effector 13950 pivoted +45
degrees with respect to the shaft assembly 13960. As illustrated,
the coil 13982 of the flex cable 13980 flexes with the articulation
joint 13964 such that the flex cable 13980 does not interfere with
the operation of the articulation joint 13964.
[0625] FIG. 124 illustrates cross-sectional view of the distal tip
of one aspect of an anvil 13961 with sensors and electronics 13972.
The anvil 13961 comprises a flex cable 13980, as described with
respect to FIGS. 121-123. As illustrated in FIG. 124, the anvil
13961 further comprises a second aperture 13970 through which the
flex cable 13980 can pass such that the flex cable 13980 can enter
a housing 13974 in the within the anvil 13961. Within the housing
13974 the flex cable 13980 can operably couple to sensors and
electronics 13972 located within the housing 13974 and thereby
provide power to the sensors and electronics 13972.
[0626] FIG. 125 illustrates a cutaway view of the distal tip of the
anvil 13961. FIG. 125 illustrates one aspect of the housing 13974
that can contain sensors and electronics 13972 as illustrated by
FIG. 124.
[0627] A surgical instrument can be powered by a battery. In at
least one embodiment, the handle of the surgical instrument
comprises a battery cavity and the battery can be inserted into and
removed from the battery cavity. In certain embodiments, the
surgical instrument can comprise a shaft assembly which includes a
battery cavity and a battery removably positioned in the battery
cavity. When the battery is seated in the battery cavity, the
battery can supply power to the handle. The battery and/or the
handle, for example, can comprise a releasable lock which
releasably holds the battery in the battery cavity. In various
instances, the releasable lock comprises a latch which can be
depressed by the user of the surgical instrument to unlock the
battery and permit the battery to be removed from the battery
cavity. In various instances, the battery can be removed from the
handle and replaced with another battery. U.S. Patent Application
Publication No. 2012/0071711, entitled SURGICAL INSTRUMENTS AND
BATTERIES FOR SURGICAL INSTRUMENTS, which was filed on Sep. 17,
2010, now U.S. Pat. Nos. 9,289,212, and 8,632,525, entitled POWER
CONTROL ARRANGEMENTS FOR SURGICAL INSTRUMENTS AND BATTERIES, which
was filed on Sep. 17, 2010 are incorporated by reference herein in
their respective entireties.
[0628] Referring now to FIGS. 126-128, a surgical instrument 14000
comprises a handle 14010 including a housing 14011 and a battery
cavity 14012 defined in the housing 14011. The surgical instrument
14000 further comprises an end effector configured to deploy
staples from a staple cartridge; however, the surgical instrument
14000 can comprise any suitable end effector. The handle 14010
further comprises a firing member 14050 which is movable proximally
and distally to articulate the end effector of the surgical
instrument 14000 about an articulation joint. The firing member
14050 is also movable distally to fire staples from the staple
cartridge and retractable proximally after the staples have been
fired. FIGS. 126-128 depict the firing member 14050 in an unfired
position. The firing member 14050 is movable proximally and
distally by an electric motor and/or a hand crank, for example, and
is translatable within a proximally-extending chamber 14016. The
chamber 14016 comprises a proximal end 14013 which encloses the
firing member 14050 and extends proximally into the battery cavity
14012. The chamber 14016 is sized and configured to provide a
clearance gap 14055 for the firing member 14050 which, in at least
one instance, permits the firing member 14050 to be retracted
proximally from its unfired position in order to articulate the end
effector. In other instances, as discussed in greater detail
further below, the chamber 14016 comprises an open proximal
end.
[0629] The surgical instrument 14000 further comprises a battery
14020 which is positionable in the battery cavity 14012 to supply
power to the handle 14010. The battery 14020 comprises a battery
housing 14021 having an outer surface 14022. The battery cavity
14012 and the outer surface 14022 of the battery 14020 are
configured such that the battery 14020 is closely received in the
battery cavity 14012. In at least one instance, the battery cavity
14012 and the outer surface 14022 are configured such that the
battery 14020 can be inserted into the battery cavity 14012 in only
one orientation, or in a limited number of orientations. The
battery 14020 comprises a clearance aperture 14026 defined therein
configured to receive the chamber 14016 when the battery 14020 is
positioned in the battery cavity 14012. The handle 14010 further
comprises one or more electrical contacts 14014 (FIG. 131) which
are engaged by corresponding electrical contacts 14024 (FIG. 131)
defined on the battery 14020 when the battery 14020 is fully seated
in the battery cavity 14012. Moreover, a proximal end 14025 of the
battery 14020 is flush, or at least substantially flush, with the
handle housing 14011 when the battery 14020 is fully seated in the
battery cavity 14012. When the battery 14020 is not fully seated in
the battery cavity 14012, the battery contacts 14024 may not be
engaged with the handle contacts 14014 and, in such a position, the
battery 14020 cannot supply power to the handle 14010.
[0630] In various embodiments, the battery 14020 is the only power
source available to the handle 14010. In other embodiments, more
than one power source is available to the handle 14010. In at least
one such embodiment, the battery 14020 is the primary power source
for the handle 14010. Regardless of the embodiment utilized, the
battery 14020 can provide a large portion of, if not all of, the
power needed by the handle 14010. In the event that the battery
14020 were to be disconnected from the handle 14010 and/or removed
from the battery cavity 14012 during a surgical procedure, the
handle 14010 would become unpowered and/or underpowered. In some
instances, removing the battery 14020 from the battery cavity 14012
may be preferred or required to replace a depleted battery 14020
with a fully-charged battery 14020, for instance. In other
instances, removing the battery 14020 from the battery cavity 14012
during a critical point of the surgical procedure may not be
preferred, such as when the firing member 14050 is being advanced
distally to fire the staples from the staple cartridge, for
example. In at least one such instance, a sudden loss of power may
render a control circuit 14015 and/or display screen 14040 of the
handle 14010 inoperable, for example. In light of the above, the
handle 14010 includes a battery lock, or means which can prevent
the battery 14020 from becoming electrically de-coupled from the
handle 14010 and/or removed from the battery cavity 14012 at
certain points during the operation of the handle 14010. There are
other reasons for locking the battery 14020 in the handle 14010.
For instance, the battery 14020 can be locked to the handle 14010
so that the handle 14010 and/or battery 14020 can be disposed of
safely.
[0631] Referring again to FIGS. 126-128, the handle 14010 comprises
one or more deployable locks 14017. Each lock 14017 is movable
between an undeployed, or unlocked, position (FIG. 127) and a
deployed, or locked, position (FIGS. 126 and 128). Each lock 14017
comprises a cantilever beam extending from a sidewall of the
chamber 14016; however, any suitable configuration could be
utilized. Each lock 14017 comprises a proximal end mounted to a
sidewall of the chamber 14016 and a distal end which is movable
relative to the proximal end. The proximal end of each lock 14017
can be pivotably attached to a sidewall of the chamber 14016. The
locks 14017, and/or the sidewalls of the chamber 14016, can be
comprised of a resilient material and can be configured to deflect
when a biasing force is applied thereto. Each lock 14017 comprises
a cam surface 14018 defined on the distal end thereof.
[0632] The handle 14010 further includes a lock actuator 14030
configured to move the locks 14017 between their undeployed
position (FIG. 127) to their deployed position (FIG. 128). The lock
actuator 14030 comprises a solenoid; however, the lock actuator
14030 could comprise any suitable actuator, such as an electric
motor, for example. The lock actuator 14030 comprises a wire coil
14034 mounted in the handle housing 14011 and, in addition, an
armature 14032 movable relative to the wire coil 14034. The
armature 14032 comprises an elongate aperture 14031 defined therein
which is sized and configured to permit the firing member 14050 to
slide therein. In various instances, a clearance gap can be present
between the firing member 14050 and the armature 14032.
[0633] The armature 14032 is comprised of a ferrous material, for
example, and the wire coil 14034 is comprised of a conductive wire,
such as copper wire, for example. When electrical current flows
through the wire coil 14034 in a first direction, the field
generated by the flowing current pushes the armature 14032 from a
first, or distal, position (FIG. 127) to a second, or proximal,
position (FIG. 128). The armature 14032 comprises a proximal end
14038 configured to engage the cam surfaces 14018 of the locks
14017 when the armature 14032 is moved proximally and deflect the
locks 14017 outwardly, as illustrated in FIG. 128. When electrical
current flows through the wire coil 14034 in a second, or opposite,
direction, the field generated by the flowing current pushes the
armature 14032 from its second, or proximal, position (FIG. 128) to
its first, or distal, position (FIG. 127). When the armature 14032
is moved distally, the proximal end 14038 of the armature 14032 is
disengaged from the cam surfaces 14018 of the locks 14017 and the
locks 14017 can then resiliently deflect inwardly back to their
undeployed positions. The locks 14017 can comprise any suitable
configuration and, in at least one instance, the locks 14017 are
integrally-molded with the chamber 14016 and can be attached to the
chamber 14016 in a living-hinge arrangement, for example. In other
instances, the locks 14017 can comprise separate components which
are mounted to the chamber 14016, for example.
[0634] Further to the above, each lock 14017 comprises a lock
shoulder 14019 which is displaced outwardly when the locks 14017
are displaced outwardly, as described above. When the locks 14017
are moved into their deployed positions, as illustrated in FIG.
128, the lock shoulders 14019 of the locks 14017 are moved behind
lock shoulders 14029 defined in the battery housing 14021. When the
lock shoulders 14019 are positioned behind the lock shoulders 14029
of the battery 14020 by the lock actuator 14030, the battery 14020
cannot be disengaged from the handle 14010. As a result, the
battery contacts 14024 remain engaged with the handle contacts
14014 and the power supplied to the handle 14010 by the battery
14020 may not be interrupted. In the event that the user of the
surgical instrument 14000 pulls on the battery 14020 when the
battery lock 14030 has been actuated, the lock shoulders 14029 of
the battery 14020 can abut the lock shoulders 14019 of the lock
arms 14017. Moreover, the armature 14032 can buttress and support
the lock arms 14017 in their deployed positions such that battery
contacts 14024 do not break contact with the handle contacts 14014.
It is envisioned that some relative movement between the battery
14020 and the handle 14010 may occur even though the battery lock
14030 has been actuated; however, such movement is insufficient to
electrically decouple the battery 14020 from the handle 14010.
[0635] The armature 14032 comprises a stop 14033 defined on the
distal end thereof which is configured to limit the proximal travel
of the armature 14032. In at least one embodiment, the stop 14033
is configured to contact the wire coil 14034, as illustrated in
FIG. 128. In various instances, the wire coil 14034 can remain
energized to hold the armature 14032 in its proximal, or locked,
position (FIG. 128). In certain instances, the armature 14032 can
be held in place by friction forces between the armature 14032 and
the walls of the chamber 14026, for example, even though the wire
coil 14034 is not being energized. Similar to the above, the handle
14010 can include a distal stop configured to limit the distal
movement of the armature 14032. As mentioned above, the wire coil
14034 of the lock actuator 14030 can be energized to actively move
the armature 14032 proximally and distally; however, the lock
actuator 14030 can include a biasing member, such as a spring, for
example, which can be configured to bias the armature 14032 in
either the proximal direction or the distal direction. For
instance, in at least one embodiment, the wire coil 14034 is
energized to move the armature 14032 proximally and a return spring
is configured to move the armature 14032 distally after the wire
coil 14034 is no longer energized. Alternatively, in at least one
embodiment, the wire coil 14034 is energized to move the armature
14032 distally and a return spring is configured to move the
armature 14032 proximally after the wire coil 14034 is no longer
energized.
[0636] As discussed above, the lock actuator 14030 can be
selectively actuated to deploy the locks 14017 and de-actuated to
retract the locks 14017. The lock actuator 14030 is in signal
communication with the control circuit 14015 which can control the
actuation of the lock actuator 14030. The control circuit 14015 can
include a microprocessor which can determine when to activate and
de-activate the lock actuator 14030. The microprocessor can be
configured to evaluate one or more operating parameters of the
surgical instrument 14000 to determine whether to activate or
de-activate the lock actuator 14030. For instance, the
microprocessor can be configured to evaluate the voltage and/or
current of the battery 14020 to determine whether the battery 14020
is sufficiently charged to operate the handle 14010 and, if the
battery 14020 has a sufficient charge, activate the lock actuator
14030 to deploy the locks 14017, or, if the battery 14020 does not
have a sufficient charge, de-activate the lock actuator 14030 to
permit the battery 14020 to be removed from the handle 14010.
[0637] Alternatively, the control circuit 14015 can utilize the
lock actuator 14030 to prevent the battery 14020 from being removed
from the handle 14010 in the event that the control circuit 14015
determines that the handle 14010 has exceeded its useful life. The
control circuit 14015 can determine that the handle 14010 has
exceeded its useful life if the firing system of the handle 14010
has been operated a certain number of times and/or if the handle
14010 has been sterilized a certain number of times, for example.
In certain instances, the lock actuator 14030 can prevent the
battery 14020 from being moved relative to the handle 14010. In at
least one such instance, the control circuit 14015 of the handle
14010 can utilize the display screen 14040 to indicate to the user
that the battery 14020 has been locked in position and that the
handle 14010 should be either disposed of or serviced. In certain
instances, the battery 14020 can include indicia thereon and the
lock actuator 14030 can be configured to permit the battery 14020
to be translated a limited distance to expose the indicia when a
clinician pulls on the battery 14020. The indicia can be on the
side of the battery housing 14021 and can visible above the handle
housing 14011 after the battery 14020 has been displaced. The
indicia can have a contrasting color to other portions of the
battery housing 14021, for example, and/or written instructions to
the user of the surgical instrument 14000 such as the word
"dispose" and/or "service", for example. In certain instances, the
battery housing 14021 can include detention features which can
engage the handle housing 14011 and hold the battery 14020 in its
displaced position.
[0638] In certain embodiments, further to the above, a battery
housing can comprise a two-part housing--a first portion which
includes the battery cells 14023 and the electrical contacts 14024
and a second portion which is separable from the first portion, for
example. In ordinary use, the first portion and the second portion
of the battery housing are connected together and are unmovable
relative to one another. The first portion can include a gripping
portion, such as the proximal end 14025, for example, which allows
the user of the surgical instrument 14000 to grab the battery
housing and remove both portions of the battery housing
simultaneously. If the control circuit 14015 has determined that
the handle 14010 has reached its end of life, the control circuit
14015 can actuate a lock actuator which engages and holds the
second portion of the battery housing. When the user of the
surgical instrument 14000 attempts to remove the battery 14020 from
the battery cavity 14012 of the handle 14010 after the lock
actuator has been actuated, the first portion of the battery
housing can separate from the second portion thereby leaving the
second portion behind in the battery cavity 14012. As a result of
the second portion being locked within and unremovable from the
battery cavity 14012, a new battery 14020 is not positionable in
the battery cavity 14012. In various instances, the first portion
and/or the second portion of such a battery housing can include
indicia thereon explaining to the user of the surgical instrument
14000 that the handle 14010 is no longer usable. Such indicia may
only be visible after the first housing portion has separated from
the second housing portion. In certain instances, the first housing
portion and the second housing portion can be connected by a ribbon
which is exposed, or unfurled, when the first housing portion
detaches from the second housing portion. The ribbon can include
instructions thereon for handling, disposing, and/or refurbishing
the handle 14010. When the handle 14010 is refurbished, the lock
actuator can be reset and the second housing portion can be removed
from the battery cavity 14012.
[0639] Further to the above, the handle and/or the battery can
comprise an exposable portion which can be exposed by the control
system when the control system determines that the handle and/or
the battery is no longer suitable for use. The exposable portion
can be displaced and/or otherwise exposed by an actuator operated
by the control system. The exposable portion can include indicia,
such as words and/or a contrasting color, for example, which only
become visible when the control system has deactivated the handle
and/or the battery in at least one way.
[0640] In various embodiments, the handle 14010 can include an
override button in communication with the microprocessor which,
when actuated, can instruct the microprocessor to deactivate the
lock actuator and permit the battery to be removed. Other
embodiments may not include such an override button.
[0641] In various instances, a surgical instrument may become
unsuitable for use in a surgical procedure. A handle of a surgical
instrument can become unsuitable for use when the handle has
exceeded its intended number of uses, for example. A handle of a
surgical instrument may also become unsuitable for use when it
experiences excessive force loading and/or electrical faults, for
example. Moreover, a handle of a surgical instrument may become
unsuitable for use when another component of the surgical
instrument is incorrectly attached to the handle and/or an
incorrect component is attached to the handle. When the control
system of the handle determines that the handle may be unsuitable
for use, the control system may employ a battery lockout which can
prevent a battery from being operably coupled to the handle, as
described in greater detail further below.
[0642] A handle 14110 is depicted in FIGS. 129 and 130. The handle
14110 is similar to the handle 14010 in many respects. The handle
14110 comprises a handle housing 14111 which includes a battery
cavity 14012 configured to receive a battery 14020, as described
above. The handle housing 14111 further comprises a chamber 14116
configured to receive the firing member 14050 which, similar to the
chamber 14016, extends into the battery cavity 14012. The handle
14110 further comprises one or more deployable lockout arms 14117.
Each lockout 14117 is movable between an undeployed position (FIG.
129) and a deployed position (FIG. 130). Each lockout 14117
comprises a cantilever beam extending from a sidewall of the
chamber 14116; however, any suitable configuration could be
utilized. Each lockout 14117 comprises a distal end mounted to a
sidewall of the chamber 14116 and a proximal end which is movable
relative to the distal end. The distal end of each lockout 14117
can be pivotably attached to a sidewall of the chamber 14116. The
lockouts 14117, and/or the sidewalls of the chamber 14116, can be
comprised of a resilient material and can be configured to deflect
when a biasing force is applied thereto. Each lockout 14117
comprises a cam surface 14118 defined on the proximal end
thereof.
[0643] The handle 14110 further includes a lock actuator 14030
configured to move the lockouts 14117 from their undeployed
position (FIG. 129) to their deployed position (FIG. 130). The lock
actuator 14030 comprises a solenoid; however, the lock actuator
14030 could comprise any suitable actuator, such as a motor, for
example. The lock actuator 14030 comprises a wire coil 14034
mounted in the handle housing 14111 and, in addition, an armature
14032 movable relative to the wire coil 14034. The armature 14032
comprises an elongate aperture 14031 defined therein which is sized
and configured to permit the firing member 14050 to slide therein.
In various instances, a clearance gap can be present between the
firing member 14050 and the armature 14032.
[0644] The armature 14032 is comprised of a ferrous material, for
example, and the wire coil 14034 is comprised of a conductive wire,
such as copper wire, for example. When electrical current flows
through the wire coil 14034 in a first direction, the field
generated by the flowing current pushes the armature 14032 from a
first, or distal, position (FIG. 129) to a second, or proximal,
position (FIG. 130). The armature 14032 comprises a proximal end
14038 configured to engage the cam surfaces 14118 of the lockouts
14117 when the armature 14032 is moved proximally and deflect the
lockouts 14117 outwardly, as illustrated in FIG. 130. When
electrical current flows through the wire coil 14034 in a second,
or opposite, direction, the field generated by the flowing current
pushes the armature 14032 from its second, or proximal, position
(FIG. 130) to its first, or distal, position (FIG. 129). When the
armature 14032 is moved distally, the proximal end 14038 of the
armature 14032 is disengaged from the cam surfaces 14118 of the
lockouts 14117 and the lockouts 14117 can then resiliently deflect
inwardly back to their undeployed positions.
[0645] Further to the above, each lockout 14117 comprises a lock
shoulder 14119 which is displaced outwardly when the lockouts 14117
are displaced outwardly, as described above. When the lockouts
14117 are moved into their deployed positions, as illustrated in
FIG. 130, the lock shoulders 14119 of the lockouts 14117 are moved
in front of lock shoulders 14028 defined in the battery housing
14021. When the lock shoulders 14119 are positioned in front of the
lock shoulders 14028 of the battery 14020 by the lock actuator
14030, the battery 14020 cannot be fully seated in the handle
14110. As a result, the battery contacts 14024 cannot engage the
handle contacts 14014 and the battery 14020 cannot supply power to
the handle 14110. In the event that the user of the handle 14100
pushes on the battery 14020 when the battery lockout 14130 has been
actuated, the armature 14032 can buttress and support the lockouts
14117 in their deployed positions.
[0646] A handle 14210 is depicted in FIG. 131. The handle 14210 is
similar to the handle 14010 and/or the handle 14110 in many
respects. The handle 14210 comprises a handle housing 14211
including a battery cavity 14012 configured to receive a battery
14020. The handle housing 14211 further comprises a chamber 14216
configured to receive the firing member 14050 which, similar to the
chamber 14016 and the chamber 14116, extends into the battery
cavity 14012. The chamber 14216 of the handle 14210, however,
comprises an open proximal end 14213. As illustrated in FIG. 131,
the open proximal end 14213 is sized and configured to permit the
firing member 14050 to extend therethrough. When the control system
of the handle 14210 has determined that the handle 14210 is not
suitable for use, further to the above, the control system can
operate the electric motor which advances and retracts the firing
member 14050 to position the firing member 14050 in a lockout
position, i.e., a position in which the firing member 14050
prevents the electrical contacts 14024 of the battery 14020 from
engaging the electrical contacts 14014 of the handle 14210. As
illustrated in FIG. 131, the firing member 14050 can be retracted
to a position in which the proximal end 14025 of the battery 14020,
for example, contacts the firing member 14050 before the battery
14020 is sufficiently seated enough in the battery cavity 14012 to
supply power to the handle 14210.
[0647] In at least one alternative embodiment, a handle of a
surgical instrument system can include a battery cavity and at
least one first electrical contact and at least one second
electrical contact positioned in the battery cavity which are in
communication with the control system of the handle. When the
battery is fully seated in the battery cavity, the battery is
electrically coupled with the first electrical contact and can
fully power the handle. Similar to the above, the handle can
include a battery lockout system which can be activated to prevent
the battery from being fully seated in the battery cavity.
Moreover, the battery lockout system can prevent the battery from
being electrically coupled with the first electrical contact when
the battery lockout system is activated. In contrast to the battery
lockout systems described above, however, the battery lockout
system of the current embodiment can permit the battery to be
electrically coupled with the second electrical contact eventhough
the battery lockout has been activated. In such instances, the
control system of the handle can utilize the power supplied to the
second electrical contact by the battery to operate the handle in a
limited function mode.
[0648] In a limited function mode, further to the above, the
control system may only be able to perform diagnostic functions to
assess the condition of the handle and/or communicate the condition
of the handle to the user. In at least one limited function mode,
the control system may not be able to operate the electric motor to
advance the firing member 14050 distally but it may be able to
operate the electric motor to retract the firing member 14050
proximally, for example. The control system may also operate the
display and/or permit the control buttons which interface with the
display to be operated when the handle is being operated in a
limited function mode, for example.
[0649] In at least one embodiment, further to the above, the first
handle contact can be positioned deeper in the battery cavity than
the second handle contact. In at least one such instance, the
battery can include a battery contact which can engage the first
handle contact or the second handle contact, depending on the depth
in which the battery is inserted into the battery cavity. In at
least one instance, the battery can comprise a first battery
contact configured to engage the first handle contact when the
battery is inserted to a first depth and a second battery contact
configured to engage the second handle contact when the battery is
inserted to a second depth which is different than the first
depth.
[0650] In certain embodiments, further to the above, the firing
member 14050 can be pushed proximally into the battery cavity 14012
to displace the battery 14020 proximally and electrically decouple
the battery 14020 from the handle 14210. In such instances, the
firing member 14050 can displace the battery 14020 proximally such
that the battery contacts 14024 are no longer engaged with the
handle contacts 14014. The control system of the handle can
decouple the battery 14020 from the handle when the control system
has determined that the handle is no longer suitable for use. In
certain other embodiments, further to the above, the firing member
14050 can push a battery from a first position in which the battery
is electrically coupled to a first electrical contact to a second
position in which the battery is electrically decoupled from the
first electrical contact and electrically coupled to a second
electrical contact. Similar to the above, the control system of the
handle may only use the power supplied to the second electrical
contact to perform a limited number of functions. In such
instances, the control system can switch itself between a
fully-functional operating mode and a limited-function operating
mode. In various instances, the handle housing can include a catch
feature which can prevent the battery from being electrically
decoupled from the second electrical contact and/or pushed entirely
out of the battery cavity in the handle housing.
[0651] As discussed herein, the firing member 14050 can enter into
a battery cavity to prevent a battery from being fully installed
into a handle and/or contact a battery to at least partially
displace the battery out of the battery cavity. In various other
instances, the firing member 14050 itself may not block a battery
cavity and/or push a battery proximally; rather, the proximal
movement of the firing member 14050 out of its ordinary range of
motion can trip a spring-loaded mechanism which can block a battery
cavity and/or push a battery proximally, for example. In at least
one instance, the spring-loaded mechanism can include at least one
pre-stretched and/or at least one pre-compressed spring member that
is released when tripped by the firing member 14050, for example.
Such a spring-loaded mechanism can also deploy an indicator, for
example, when it is tripped which can indicate to the user that the
handle has entered into a different operating mode. In certain
embodiments, the control system of a handle may actuate a
spring-loaded mechanism directly without using the firing member
14050 to trip the spring-loaded mechanism. While a spring could be
utilized to store energy and deliver that energy to a cocked
actuator to perform the functions discussed herein, any suitable
device capable of storing and releasing energy could be utilized.
In various instances, the device can be pre-energized or pre-loaded
when the handle is supplied to the user.
[0652] In addition to or in lieu of the above, the control system
of a handle can move the firing member 14050, either proximally or
distally, to an inoperative position to render the handle unusable
if the control system detects a defect in the handle and/or
otherwise determines that the handle should not be used. In at
least one instance, the firing member 14050 can be moved, either
proximally or distally, to a position in which the electric motor
becomes mechanically decoupled from the firing member 16050 and the
electric motor can no longer move the firing member 14050
proximally or distally, for example. In another instance, the
firing member 14050 can be moved, either proximally or distally, to
a position in which the firing member 14050 impedes the operability
of another system of the handle, such as a closing system used to
close an end effector of the surgical instrument. In certain
instances, the firing member 14050 can be moved, either proximally
or distally, to a position in which a modular shaft assembly cannot
be operably coupled to the handle and/or the firing member 14050.
In some instances, the firing member 14050 can be moved, either
proximally or distally, to a position in which a modular shaft
assembly cannot be operably de-coupled from the handle and/or the
firing member 14050. In view of the above, the firing member 14050
of a handle can be moved out of a typical operating range of
positions to render the handle inoperable in at least one
capacity.
[0653] Further to the above, the firing member 14050 is movable
within a firing operating range to fire staples from a staple
cartridge and/or an articulation operating range to articulate the
end effector of the surgical instrument. In certain embodiments,
the firing member 14050 is movable within a clamping operating
range to close an end effector and/or clamp tissue within the end
effector. The firing operating range, the articulation operating
range, and/or the clamping operating range can comprise the typical
operating range of positions discussed above. As also discussed
above, the firing member 14050 can be moved out of this typical
operating range to change the operating state of the handle in some
manner. In at least one embodiment, the firing member 14050 can be
moved proximally out of its typical operating range to cycle or
index a use counter after every time that the handle has been used.
The use counter can be cycled mechanically and/or electronically.
The use counter can be in communication with the processor of the
handle which can utilize data from the use counter to determine
whether the handle is still suitable for use. The control system of
the handle, including the handle microprocessor, the use counter,
and/or one or more sensors configured to monitor the electric motor
which drives the firing member 14050, for example, can be part of a
diagnostic system which determines whether the handle is suitable
for use.
[0654] The exemplary embodiments illustrated in FIGS. 126-131
depict two lock arms or two lockout arms, as the case may be;
however, one lock arm, or lockout arm, could be used. Moreover,
more than two lock arms, or lockout arms, could be used. The lock
arms, or lockout arms, of the exemplary embodiments are deployed
simultaneously; however, other embodiments are envisioned in which
they are deployed sequentially. Furthermore, the embodiment of
FIGS. 126-128, which comprises a battery lock system, could be
combined with the embodiment of FIGS. 129 and 130 and/or the
embodiment of FIG. 131, which comprise battery lockout systems. In
various embodiments, a single system can perform the battery lock
and battery lockout functions described herein.
[0655] As discussed above, a surgical instrument can include a
handle, a shaft assembly, and an end effector. The handle can
include an electric motor having a rotatable output shaft which is
operably coupled to a drive shaft in the shaft assembly. The output
shaft can rotate the drive shaft or, alternatively, the rotary
motion of the output shaft can be converted to translational motion
before being transmitted to the drive shaft. In either event, a
property of the output shaft can be measured while it is driving
the drive shaft. Various embodiments can include one or more
sensors, for example, positioned relative to the output shaft which
can measure the motion of the drive shaft, for example. Such
sensors are positioned off-board with respect to the shaft. Such
embodiments can be useful; however, the off-board positioning of
the sensors can limit the properties of the drive shaft which can
be detected and/or the manner in which the properties of the drive
shaft are detected. Various embodiments are discussed below which
comprise one or more sensors which are positioned on the output
shaft which can detect a property of the drive shaft. Such sensors
are positioned on-board with respect to the shaft. Also discussed
below are embodiments which can include a control circuit mounted
to the shaft and/or means for transmitting power to the control
circuit.
[0656] Referring now to FIGS. 132 and 133, a surgical instrument
system 15000 comprises an electric motor 15010 including a
rotatable shaft 15020. The electric motor 15010 can comprise any
suitable electric motor, such as a direct current (DC) electric
motor, for example. The electric motor 15010 is mounted in a handle
of a surgical instrument; however, the electric motor 15010 can be
mounted in any suitable portion of a surgical instrument, such as
the shaft assembly extending from the handle, for example. In
certain other embodiments, the electric motor 15010 can be part of
a robotically-controlled assembly. In any event, the motor shaft
15020 is rotatably supported by any suitable number of bearings
such that the shaft 15020 is rotatable by the electric motor 15010
about a longitudinal axis 15021.
[0657] Referring primarily to FIG. 132, the surgical instrument
system 15000 further comprises a drive system 15030 operably
coupled with the motor shaft 15020. The drive system 15030 is
positioned in the handle of the surgical instrument; however, the
drive system 15030 may be positioned in any suitable portion of the
surgical instrument, such as the shaft assembly extending from the
handle, for example. In certain other embodiments, the drive system
15030 can be part of a robotically-controlled assembly. In any
event, the drive system 15030 comprises a transmission 15031 and an
output shaft 15032. The transmission 15031 is configured to
transmit rotary motion between the motor shaft 15020 to the output
shaft 15032. The transmission 15031 comprises a plurality of
intermeshed gears, for example. In various instances, the gears of
the transmission 15031 are configured such that the rotational
velocity of the output shaft 15032 is different than the rotational
velocity of the motor shaft 15020. In at least one such instance,
the rotational velocity of the output shaft 15032 is less than the
rotational velocity of the motor shaft 15020. In various
alternative embodiments, the gears of the transmission 15031 are
configured such that the rotational velocity of the output shaft
15032 is the same as the rotational velocity of the motor shaft
15020.
[0658] Referring again to FIGS. 132 and 133, the surgical
instrument system 15000 further comprises a sensor 15050 mounted to
the output shaft 15020. The sensor 15050 comprises a strain gauge;
however, any suitable sensor could be utilized. For instance, the
sensor 15050 could comprise an accelerometer, for example. The
strain gauge 15050 is mounted to the outside surface 15023 of the
output shaft 15020. The strain gauge 15050 comprises a substrate,
or backing, 15052 comprised of an insulative material which is
flexible and conformable to the outside surface 15023 of the shaft
15020. The backing 15052 is attachable to the outside surface 15023
of the shaft 15020 by any suitable adhesive, such as cyanoacrylate,
for example. The strain gauge 15050 further comprises a metallic
wire 15053 mounted to the substrate 15052. When the shaft 15020
experiences a load and is elastically and/or plastically deformed
by the load, the metallic wire 15053 is also deformed by the load
and, as a result, the electrical resistance of the metallic wire
15053 changes. This change in resistance, usually measured using a
Wheatstone bridge, is related to the strain, or deformation, being
experienced by the shaft 15020 by a ratio known as a gauge
factor.
[0659] When an electrical conductor, such as the metallic wire
15053, for example, is stretched within the limits of its
elasticity such that it does not break or permanently deform, the
electrical conductor will become narrower and longer which
increases its electrical resistance from end-to-end. Conversely,
when the electrical conductor is compressed such that it does not
buckle, it will broaden and shorten which decreases its electrical
resistance from end-to-end. The electrical conductor of a resistive
strain gauge often comprises a long, thin conductive strip arranged
in a continuous zig-zag pattern of parallel lines. These parallel
lines of the conductive strip are usually spaced close together
such that a large length of the conductive strip is positioned over
a small area. Owing to the large length of the conductive strip, a
small amount of stress in the direction of the orientation of the
parallel lines results in a multiplicatively larger strain
measurement over the effective length of the conductor--and hence a
multiplicatively larger change in resistance--than would be
observed with a single straight-line conductive wire. From the
measured electrical resistance of the strain gauge 15050, the
amount of stress being applied to the motor shaft 15020 may be
inferred.
[0660] The surgical instrument system 15000 further comprises a
control system 15040 which is positioned on the motor shaft 15020.
The control system 15040 includes a circuit board 15046 mounted to
the motor shaft 15020. The circuit board 15046 can be comprised of
a printed circuit board and/or a flexible laminate, for example,
and can be attached to the outside surface 15023 of the shaft 15020
utilizing one or more adhesives, for example. The control system
15040 can include a control circuit on the circuit board 15046. The
control circuit comprises, among other things, a microprocessor
15047 and at least one memory chip 15048 in signal communication
with the microprocessor 15047. The strain gauge 15050 is also in
signal communication with the microprocessor 15047 which is
configured to detect the resistance change in the metallic wire
15053 of the strain gauge 15050, as discussed above. When the shaft
15020 is rotated to operate the end effector articulation system,
the tissue-clamping system, and/or the staple-firing system of a
surgical instrument, for example, the shaft 15020 will experience
forces and/or torques T that create strain within the shaft 15020
which is detected by the strain gauge 15050 and the microprocessor
15047, as discussed in greater detail further below. The
microprocessor 15047 can include the Wheatstone bridge discussed
above.
[0661] The strain gauge 15050, further to the above, can comprise
any suitable strain gauge. For instance, the strain gauge 15050 can
comprise a semiconductor strain gauge, a piezoresistor, a
nano-particle based strain gauge, a fiber optic strain gauge,
and/or a capacitive strain gauge, for example. Certain strain
gauges are configured to measure strain along one axis while other
strain gauges are configured to measure strain along more than one
axis, such as two axes or three axes, for example. More than one
strain gauge can be used to assess the strain of the shaft 5020.
For example, a first strain gauge can be used to assess the strain
of the shaft 5020 along a first axis and a second strain gauge can
be used to assess the strain of the shaft 5020 along a second axis.
In at least one such instance, a first strain gauge can be
positioned and arranged to measure the strain along the
longitudinal axis 5021 of the shaft 5020 and a second strain gauge
can be positioned and arranged to measure the strain around the
circumference of the shaft 5020. The strain measured along the
circumferential axis of the shaft 5020 is orthogonal to the strain
measured along the longitudinal axis; however, other embodiments
are envisioned in which the first axis and the second axis are
transverse, but not orthogonal to one another. In various
instances, one or more strain gauges can be utilized to evaluate
the total, or overall, strain being experienced by the shaft 15020
at a particular location on the shaft 15020. In certain instances,
a plurality of strain gauges can be utilized to evaluate the strain
of the shaft 15020 at a plurality of locations on the shaft
15020.
[0662] The strain gauge 15050 can be utilized to evaluate the
strain, and the stress, being experienced by the shaft 15020. When
the shaft 15020 is being utilized to drive an articulation system,
a large increase in strain can indicate that the end effector of
the surgical instrument may not be articulating properly.
Similarly, a large increase in strain can indicate that the firing
member of the surgical instrument may have become stuck when the
shaft 15020 is being utilized to drive a firing system. The
microprocessor 15047, and/or any other microprocessor of the
surgical instrument, can be programmed to interpret the strain data
and utilize the strain data to interpret whether the operation of
the surgical instrument should be modified. For example, a strain
reading supplied by the strain gauge 15050 to the microprocessor
15047 when the shaft 15020 is being utilized to articulate an end
effector may exceed a maximum articulation strain threshold and, in
such instances, the microprocessor 15047, for example, can be
programmed to interrupt the operation of the motor 15010 driving
the shaft 15020 when the strain reading exceeds the maximum
articulation strain threshold. The same strain reading, if provided
when the shaft 15020 is being utilized to fire staples from the end
effector, may or may not exceed a maximum firing strain threshold.
If the strain reading does not exceed the maximum firing strain
threshold, then the microprocessor 15047 may not interrupt the
operation of the electric motor 15010. If the strain reading
exceeds the maximum firing strain threshold, then the
microprocessor 15047 may interrupt the operation of the motor
15010. In certain instances, the maximum firing strain threshold is
different than the maximum articulation strain threshold while, in
other instances, they may be the same.
[0663] In some instances, further to the above, interrupting the
motor 15010 may mean that the microprocessor 15047, and/or any
other microprocessor of the surgical instrument, immediately pauses
the motor 15010 until receiving an input from the user of the
surgical instrument. Such an input can be a command to reverse the
operation of the motor 15010 or a command to override the
interruption of the motor 15010 and restart the motor 15010 to
complete the articulation or firing process, as the case may be. In
certain instances, interrupting the motor 15010 may mean slowing
the motor 15010 down which can give the microprocessor 15047, for
example, a longer period of time to evaluate the loading conditions
being experienced by the shaft 15020. If the increase in strain
represents a transient, or temporary, increase and the measured
strain drops back below the relevant threshold, the microprocessor
15047 may not interrupt the motor 15010. If the microprocessor
15047 has slowed the motor 15010 in response to an elevated strain
reading, the microprocessor 15047 may restore the original speed of
the motor 15010 after the strain drops back below the relevant
threshold. In other instances, the microprocessor 15047 may
continue to operate the motor 15010 at the slower speed even though
the strain has dropped back below the relevant threshold. If,
however, the elevated strain reading above the relevant threshold
persists, the microprocessor 15047 can operate the motor 15010 at
the slower speed and/or pause the motor 15010 after a predetermined
period of time has elapsed. In the event that the measured strain
continues to increase over the threshold, the microprocessor 15047
can be programmed to stop the motor 15010.
[0664] As discussed above, the microprocessor 15047 is positioned
on the shaft 5020. In order for the microprocessor 15047 to control
the motor 15010 driving the shaft 15020, the microprocessor 15047
needs to be able to communicate with the motor 15010. In at least
one instance, a slip ring system can be utilized to transmit one or
more signals from the microprocessor 15047 to the motor 15010. The
slip ring system can also be utilized to transmit and/or one or
more signals from the motor 15010, and/or sensors monitoring the
motor 15010, to the microprocessor 15047. In certain instances, a
transmitter 15060 can be utilized to transmit data between the
microprocessor 15047 and the motor 15010. The transmitter 15060 is
mounted to the shaft 15020 and rotates with the shaft 15020. The
transmitter 15060 is in signal communication with the
microprocessor 15047 and, in at least one instance, can comprise a
wireless frequency emitter configured to generate a wireless signal
utilizing data provided by the microprocessor 15047. The frequency
emitter can be in communication with the microprocessor 15047 via
one or more power wires and/or one or more signal wires which are
mounted to the shaft 15020. Alternatively, as described in greater
detail further below, the transmitter 15060 can comprise an
impendence field generator.
[0665] When the transmitter 15060 comprises a wireless frequency
emitter, the surgical instrument can comprise a wireless frequency
receiver 15070 configured to receive the signal emitted by the
frequency emitter. The frequency receiver 15070 is positioned in
the handle of the surgical instrument; however, the frequency
receiver 15070 can be positioned in any suitable location in the
surgical instrument. In various instances, the frequency receiver
15070 is in signal communication with the motor 15010 such that the
data transmitted within the wireless signal and received by the
frequency receiver 15070 can directly control the motor 15010. In
other instances, the frequency receiver 15070 is in signal
communication with a second microprocessor 15080 in the surgical
instrument. The second microprocessor 15080 is positioned in the
handle of the surgical instrument; however, the second
microprocessor 15080 can be positioned in any suitable location in
the surgical instrument. The second microprocessor 15080 can
utilize the data transmitted from the microprocessor 15047, and/or
any other data from one or more suitable inputs, to control the
motor 15010. The second microprocessor 15080 is in signal
communication with the motor 15010 via one or more signal and/or
power wires 15082, for example. The second microprocessor 15080 can
also be programmed to control the motor 15010 in the manner
described above. In various instances, the microprocessors 15047
and 15080 can co-operate to control the motor 15010.
[0666] The control system 15040, the sensor 15050, and the
transmitter 15060 comprise an on-board detection system configured
to detect and evaluate one or more conditions of the shaft 15020.
In the embodiment described above, the condition of the shaft 15020
is the operating load being experienced by the shaft 15020 and the
sensor 15050 comprises a strain gauge configured to detect the
operating load; however, any suitable condition of the shaft 15020
can be detected by one or more on-board sensors positioned on the
shaft 15020. Moreover, the microprocessor 15047 can be configured
to arrange the data provided to the microprocessor 15047 from a
plurality of sensors into two or more signals and the wireless
frequency emitter can be configured to emit those signals to the
frequency receiver 15070. Such signals can then be provided to the
microprocessor 15080 which can control the motor 15010 in response
to the signals that it has received. One or more signal
multiplexers and demultiplexers could be utilized.
[0667] While a wireless frequency emitter can be useful to
communicate data between a rotating plane, i.e., the shaft 15020,
and a fixed plane, i.e., the handle of the surgical instrument, for
example, the transmitter 15060 can be configured to communicate
data in any suitable manner. In at least one embodiment, as
mentioned above, the transmitter 15060 can comprise an impedance
field generator. In at least one instance, the impedance field
generator can comprise an impedance coil mounted to the outside
surface 15023 of the shaft 15020. The impedance field generator can
be configured to generate a field which can be sensed by a field
sensor 15070 positioned in the handle, for example. Similar to the
above, the impedance field generator moves within a rotating plane
and the field sensor is positioned within a fixed plane.
[0668] Further to the above, the magnitude of the field generated
by the impedance field generator corresponds to the magnitude of
the strain detected by the strain gauge 15050. For instance, higher
emitted field intensities can be associated with larger strains
while lower emitted field intensities can be associated with
smaller strains. In at least one instance, the magnitude of the
field emitted by the impedance field generator can be directly
proportional to the magnitude of the strain detected by the strain
gauge 15050. In such an embodiment, the field sensor can measure
the intensity of the field created by the impedance field generator
and communicate such information to the microprocessor 15080, for
example. The microprocessor 15080 can comprise a calibration table
which relates the data received from the field sensor to the load
being experienced by the motor shaft 15020. The microprocessor
15080 can also be configured to adjust the speed of the electric
motor 15010 in response to the data received from the strain gauge
15050 and the impedance field generator. For instance, the
microprocessor 15080 can slow the electric motor 15010 when the
measured strain is high. The microprocessor 15080 can also utilize
any other suitable data to adjust the performance characteristics
of the electric motor 15010. Such data could include the current
draw of the motor 15010, the impedance of the tissue being stapled,
the tissue gap between the anvil and the staple cartridge, and/or
the strain that the anvil is experiencing, for example.
[0669] The impedance field generator described above transmits data
between a moving shaft 15020 and the handle without the use of
electrical contacts. As a result, it can be said that the impedance
field generator communicates data from the shaft 15020 to the
handle `wirelessly`; however, it can also be stated that the
impedance field generator is being used to affect a measurement
that is being made adjacent to the moving shaft 15020 which is then
turned into a data stream and interpreted.
[0670] As the reader will appreciate, the control system 15040, the
sensor 15050, and the transmitter 15060 may require electrical
power to operate. In at least one instance, one or more batteries
can be mounted to shaft 15020 which can supply power to the control
system 15040, the sensor 15050, and/or the transmitter 15060, for
example. In addition to or in lieu of a battery, power can be
supplied to the control system 15040, the sensor 15050, and/or the
transmitter 15060, for example, via a slip ring system, such as the
one described above, for example. In addition to or in lieu of the
above, power can be transmitted wirelessly to the control system
15040, the sensor 15050, and/or the transmitter 15060, for example.
In at least one such instance, the surgical instrument can include
a magnet 15041 configured to generate a magnetic field 15042 which
induces a current in a wire coil 15043 wound around the shaft 15020
when the shaft 15020 is rotated by the electric motor 15010. The
wire coil 15043 is in electrical communication with the control
system 15040 such that the current induced within the wire coil
15043 can supply power to the microprocessor 15047, the strain
gauge sensor 15050, and/or the transmitter 15060, for example. In
at least one such instance, the wire coil 15043 comprises a first
end 15044 and a second end 15045 mounted to contacts on the board
15046.
[0671] The magnet 15041 comprises a permanent magnet; however, the
magnet 15041 can comprise any suitable magnet, such as an
electromagnet, for example. When the magnet 15041 comprises a
permanent magnet, the magnet 15041 can continuously generate the
magnetic field 15042. The permanent magnet 15041 is securely
positioned in the surgical instrument such that the orientation
and/or magnitude of the magnetic field 15042 does not change. The
wire coil 15043 comprises a copper, or copper alloy, wire wrapped
around the outside surface 15023 of the shaft 15020; however, the
wire coil 15043 can be comprised of any suitable conductive
material, such as aluminum, for example. The wire coil 15043 can be
wrapped around the shaft 15020 any suitable number of times.
Moreover, the wire coil 15043 can be positioned on the shaft 15020
at a location in which the intensity of the magnetic field 15042 is
high, or at its highest. In at least one instance, the wire coil
15043 can be wrapped around the shaft 15020 such that the wire coil
15043 is aligned, or at least substantially aligned, with a polar
axis of the magnetic field 15042. Generally, the current that is
generated within the wire coil 15043 is directly proportional to
the number of times that the wire coil 15043 is wound around the
shaft 15020. Moreover, the current that is generated within the
wire coil 15043 is directly proportional to the speed in which the
shaft 15020 is rotated.
[0672] As discussed above, the magnet 15041 can comprise an
electromagnet. The electromagnet 15041 can be powered by a battery
of the surgical instrument, for example, to generate the magnetic
field 15042. The electromagnet 15041 can be selectively activated,
or energized, to selectively generate the magnetic field 15042. For
instance, the electromagnet 15041 can be energized only when the
shaft 15020 is being rotated by the motor 15010. In such instances,
the electromagnet 15041 will not be energized when the shaft 15020
is not rotating. Such instances may be useful when prolonged pauses
in the operation of the shaft 15020 are anticipated or are in the
process of occurring. In at least one instance, the electromagnet
15041 may be energized prior to shaft 15020 being rotated by the
motor 15010. In certain instances, the electromagnet 15041 may be
de-energized after the shaft 15020 has stopped rotating. Such
approaches can assure that the motion of the shaft 15020 can be
fully utilized to induce current within the wire coil 15043. In
various instances, the electromagnet 15041 may be energized whether
or not the shaft 15020 is rotating. Such instances may be useful
when only short pauses in the operation of the shaft 15020 are
anticipated or are in the process of occurring.
[0673] When the shaft 15020 is not rotating, further to the above,
the magnetic field 15042 does not induce a current within the wire
coil 15043 and, as a result, the control system 15040, the sensor
15050, and the transmitter 15060 are not being powered by the
magnetic field 15042. In at least one such instance, the
microprocessor 15047 can enter into a sleep mode. When the motor
15010 begins to rotate the shaft 15020, the wire coil 15043 is
rotated within the magnetic field 15042 and a current is generated
within the wire coil 15043. The wire coil 15043 can be in
electrical communication with an input gate in the microprocessor
15047 and can apply a voltage potential to the input gate which
can, one, power the microprocessor 15047 and, two, cause the
microprocessor 15047 to awaken from its sleep mode. In such an
embodiment, as a result, the control system 15040 can be in a sleep
mode when the shaft 15020 is not rotating and an active, or
fully-powered, operating mode when the shaft 15020 is rotating.
[0674] In various instances, the control system 15040 can include
and/or can have access to a power source when the shaft 15020 is
not rotating. In such instances, the microprocessor 15047 can enter
a low-power mode. In at least one instance, the control system
15040 can include one or more capacitive elements, such as
supercapacitors, for example, that can be configured to store
electrical power when the shaft 15020 is being rotated and current
from the wire coil 15043 is being supplied to the control system
15040. When the shaft 15020 is no longer rotating and current from
the wire coil 15043 is no longer being supplied to the control
circuit 15040, the capacitive elements can supply electrical power
to the microprocessor 15047, and/or any other portion of the
control system 15040, and prevent the microprocessor 15047, and/or
control system 15040, from entering into a completely unpowered
state, at least for a period of time. Such capacitive elements
could also release power to the microprocessor 15047, and/or any
other portion of the control system 15040, the strain gauge 15050,
and/or the transmitter 15060 when the shaft 15020 is rotating at a
slow speed, i.e., a speed which is insufficient to generate the
power necessary to operate such components in their fully-powered
operating mode. In addition to or in lieu of the above, a battery
mounted to the shaft 15020 can supply power to the microprocessor
15047, and/or any other portion of the control system 15040, the
strain gauge 15050, and/or the wireless transmitter 15060 when the
shaft 15020 is not rotating. Such a battery could also provide
power to the microprocessor 15047, and/or any other portion of the
control system 15040, the strain gauge 15050, and/or the
transmitter 15060 when the shaft 15020 is rotating slowly and/or
when such components are otherwise underpowered, for example.
[0675] Further to the above, the shaft 15020 may be stopped for a
multitude of reasons. For instance, the user of the surgical
instrument may choose to pause or stop the advancement of a firing
member to assess whether the firing stroke of the firing member
could or should be completed and, in such circumstances, the shaft
15020, which advances the firing member, may be paused or stopped.
As discussed above, a current is not induced in the wire coil 15043
when the shaft 15020 is not rotating; however, it may be desirable
to power the control system 15040, the sensor 15050, and/or the
transmitter 15060 in order to collect, evaluate, and/or transmit
data from the sensor 15050 while the shaft 15020 is not being
rotated. A secondary power source described above is capable of
facilitating such an operating state of the surgical instrument. In
at least one alternative embodiment, a current can be induced in
the wire coil 15043 even though the shaft 15020 is not rotating.
For instance, a plurality of electromagnets 15041 can be positioned
around the wire coil 15043 which can be selectively energized to
create a rotating magnetic field 15042. In such an embodiment, the
magnetic field 15042 can be rotated relative to the wire coil 15043
to induce a current in the wire coil 15043 and power the control
system 15040, the sensor 15050, and/or the transmitter 15060 even
though the shaft 15020 has been stopped.
[0676] In use, further to the above, a power source, such as a
battery, for example, can be utilized to power the electric motor
15010 and rotate the shaft 15020. As described above, the rotation
of the wire coil 15043 within a magnetic field 15042 generates a
current within the wire coil 15043 which supplies power to the
control circuit 15040, the sensor 15050, and/or the transmitter
15060 positioned on the shaft 15020. In such instances, this
on-board shaft system re-captures a portion of the energy expended
to rotate the shaft 15020 and utilizes that energy to sense,
evaluate, and/or monitor the performance of the shaft 15020.
[0677] Various examples disclosed herein have been discussed in
connection with the motor shaft 15020; however, such examples could
be applied to any rotatable shaft and/or rotatable system, such as
the shaft 15032, for example. Moreover, the examples disclosed
herein could be applied to the rotatable shaft and/or rotatable
system of any suitable surgical instrument. For instance, the
examples disclosed herein could be applied to a robotic system,
such as the DAVINCI robotic surgical system manufactured by
Intuitive Surgical, Inc., for example. The entire disclosure of
U.S. patent application Ser. No. 13/118,241, entitled SURGICAL
STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS,
now U.S. Pat. No. 9,072,535, is incorporated by reference herein.
The examples disclosed herein could also be applied to non-surgical
applications, such as the crankshaft and/or camshaft of a motor,
for example.
[0678] A portion of a surgical stapling instrument 16000 is
illustrated in FIGS. 134-139. The stapling instrument 16000 is
usable with a manually-operated system and/or a
robotically-controlled system, for example. The stapling instrument
16000 comprises a shaft 16010 and an end effector 16020 extending
from the shaft 16010. The end effector 16020 comprises a cartridge
channel 16030 and a staple cartridge 16050 positioned in the
cartridge channel 16030. Referring primarily to FIGS. 137 and 138,
the staple cartridge 16050 comprises a cartridge body 16051 and a
retainer 16057 attached to the cartridge body 16051. The cartridge
body 16051 is comprised of a plastic material, for example, and the
retainer 16057 is comprised of metal, for example; however, the
cartridge body 16051 and the retainer 16057 can be comprised of any
suitable material. The cartridge body 16051 comprises a deck 16052
configured to support tissue, a longitudinal slot 16056, and a
plurality of staple cavities 16053 defined in the deck 16052.
Referring primarily to FIGS. 135 and 136, staples 16055 are
removably positioned in the staple cavities 16053 and are supported
by staple drivers 16054 which are also movably positioned in the
staple cavities 16053. The retainer 16057 extends around the bottom
of the cartridge body 16051 to keep the staple drivers 16054 and/or
the staples 16055 from falling out of the bottom of the staple
cavities 16053. The staple drivers 16054 and the staples 16055 are
movable between an unfired position (FIG. 135) and a fired position
by a sled 16060. The sled 16060 is movable between a proximal,
unfired position (FIG. 135) toward a distal, fired position to
eject the staples 16055 from the staple cartridge 16050, as
illustrated in FIG. 136. The sled 16060 comprises one or more
ramped surfaces 16064 which are configured to slide under the
staple drivers 16054. The end effector 16020 further comprises an
anvil 16040 configured to deform the staples 16055 when the staples
16055 are ejected from the staple cartridge 16050. In various
instances, the anvil 16040 can comprise forming pockets 16045
defined therein which are configured to deform the staples
16055.
[0679] The shaft 16010 comprises a frame 16012 and an outer sleeve
16014 which is movable relative to the frame 16012. The cartridge
channel 16030 is mounted to and extends from the shaft frame 16012.
The outer sleeve 16014 is operably engaged with the anvil 16040 and
is configured to move the anvil 16040 between an open position
(FIG. 134) and a closed position (FIG. 135). In use, the anvil
16040 is movable toward a staple cartridge 16050 positioned in the
cartridge channel 16030 to clamp tissue against the deck 16052 of
the staple cartridge 16050. In various alternative embodiments, the
cartridge channel 16030 and the staple cartridge 16050 are movable
relative to the anvil 16040 to clamp tissue therebetween. In either
event, the shaft 16010 further comprises a firing member 16070
configured to push the sled 16060 distally. The firing member 16070
comprises a knife edge 16076 which is movable within the
longitudinal slot 16056 and is configured to incise the tissue
positioned intermediate the anvil 16040 and the staple cartridge
16050 as the firing member 16070 is advanced distally to eject the
staples 16055 from the staple cartridge 16050. The firing member
16070 further comprises a first cam 16071 configured to engage the
cartridge channel 16030 and a second cam 16079 configured to engage
the anvil 16040 and hold the anvil 16040 in position relative to
the staple cartridge 16050. The first cam 16071 is configured to
slide under the cartridge channel 16030 and the second cam 16079 is
configured to slide within an elongate slot 16049 defined in the
anvil 16040.
[0680] Further to the above, the staple cartridge 16050 is a
replaceable staple cartridge. When a staple cartridge 16050 has
been at least partially used, it can be removed from the cartridge
channel 16030 and replaced with another staple cartridge 16050, or
any other suitable staple cartridge. Each new staple cartridge
16050 comprises a cartridge body 16051, staple drivers 16054,
staples 16055, and a sled 16060. The firing member 16070 is part of
the shaft 16010. When a staple cartridge 16050 is removed from the
cartridge channel 16030, the firing member 16070 remains with the
shaft 16010. That said, the shaft 16010 itself may be replaceable
as well; however, such a replacement shaft 16010 could still be
used in the manner described herein. In at least one such instance,
the surgical instrument system 16000 could comprise a handle, a
shaft 16010 replaceably attached to the handle, and a staple
cartridge 16050 replaceably positioned in the cartridge channel
16030 extending from the shaft 16010, for example. FIG. 137 depicts
a staple cartridge 16050 positioned over an opening 16031 defined
in the cartridge channel 16030 and FIG. 138 depicts the staple
cartridge 16050 fully seated in the cartridge channel 16030;
however, it should be appreciated that several components of the
end effector 16020, such as the anvil 16040, for example, and the
firing member 16070 have been removed from FIGS. 137 and 138 to
demonstrate the general premise of a staple cartridge 16050 being
inserted into the cartridge channel 16030. It should be
appreciated, however, that a staple cartridge 16050 is often
inserted into the cartridge channel 16030 through the distal end
16038 of the channel 16030. In such instances, the proximal end
16059 of the staple cartridge 16050 is aligned with the distal end
16038 of the cartridge channel 16030 and the staple cartridge 16050
is then moved proximally to align the proximal end 16059 of the
staple cartridge 16050 with the proximal end 16039 of the cartridge
channel 16030 and, correspondingly, align the distal end 16058 of
the staple cartridge 16050 with the distal end 16038 of the
cartridge channel 16030. The cartridge channel 16030 comprises a
datum 16033 configured to stop the proximal insertion of the staple
cartridge 16050. More particularly, the cartridge body 16051
comprises a datum shoulder 16034 defined thereon configured to abut
the datum 16033 when the staple cartridge 16050 has been inserted
to the proper depth; however, it is possible for the staple
cartridge 16050 to be inserted into the cartridge channel 16030 in
a number of ways which can prevent the datum shoulder 16034 from
contacting the datum 16033.
[0681] Regardless of the manner used to position a staple cartridge
16050 in the cartridge channel 16030, it is desired to position the
sled 16060 of the staple cartridge 16050 directly in front of the
firing member 16070 when the staple cartridge 16050 is positioned
in the cartridge channel 16030. When the sled 16060 is positioned
directly in front of the firing member 16070, the sled 16060 can
keep the firing member 16070 from falling into a lockout when the
firing member 16070 is advanced distally. More specifically,
referring to FIG. 135, the sled 16060 includes a support shoulder
16067 which is configured to support a support tab 16077 extending
distally from the firing member 16070 and hold a lock shoulder
16078 of the firing member 16070 above a lockout window 16037 (FIG.
137) defined in the cartridge channel 16030. If the sled 16060 has
been advanced distally prior to the staple cartridge 16050 being
fully seated in the cartridge channel 16030, as illustrated in FIG.
136, the support tab 16077 of the firing member 16070 will not be
supported, or supportable, by the support shoulder 16067 of the
sled 16060 and, as a result, the lock shoulder 16078 of the firing
member 16070 will enter the lockout window 16037 when the firing
member 16070 is advanced distally. In fact, the shaft 16010
includes a biasing spring 16018 resiliently engaged with a top
surface 16072 of the firing member 16070 which biases the firing
member 16070 toward the lockout window 16037. The entire
disclosures of U.S. Pat. No. 7,143,923, entitled SURGICAL STAPLING
INSTRUMENT HAVING A FIRING LOCKOUT FOR AN UNCLOSED ANVIL, which
issued on Dec. 5, 2006; U.S. Pat. No. 7,044,352, SURGICAL STAPLING
INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FOR PREVENTION OF
FIRING, which issued on May 16, 2006; U.S. Pat. No. 7,000,818,
SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND
FIRING SYSTEMS, which issued on Feb. 21, 2006; U.S. Pat. No.
6,988,649, SURGICAL STAPLING INSTRUMENT HAVING A SPENT CARTRIDGE
LOCKOUT, which issued on Jan. 24, 2006; and U.S. Pat. No.
6,978,921, SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM
FIRING MECHANISM, which issued on Dec. 27, 2005, are incorporated
by reference herein. The above being said, it may be difficult for
the clinician inserting the staple cartridge 16050 into the
cartridge channel 16030 to determine whether the sled 16060 has
been accidentally, or prematurely, pushed forward prior to
inserting, and/or during the insertion of, the staple cartridge
16050 into the cartridge channel 16030. As described in detail
further below, the surgical instrument system 16000 comprises means
for assessing whether the sled 16060 has been prematurely advanced
when the staple cartridge 16050 is positioned in the cartridge
channel 16030.
[0682] When moving a staple cartridge 16050 proximally to insert
the staple cartridge 16050 in the cartridge channel 16030, as
described above, the sled 16060 can be accidentally or
unintentionally bumped and pushed distally from its unfired
position (FIG. 135) to a partially-fired position (FIG. 136). More
particularly, referring now to FIG. 139, the sled 16060 in the
staple cartridge 16050 can contact the firing member 16070 in the
shaft 16010 in the event that the staple cartridge 16050 is
mis-inserted into the cartridge channel 16030, i.e., inserted too
far proximally into the cartridge channel 16030, which can move the
sled 16060 distally a distance X. Eventhough the clinician may
subsequently place the staple cartridge 16050 in its proper
position in the cartridge channel 16030, the sled 16060 will have
already been pushed out of its proper position in the staple
cartridge 16050 and, as a result, the firing member 16070 will
enter the lockout when the firing member 16070 is advanced
distally. Accordingly, the surgical instrument system 16000 will be
unable to fire the staple cartridge 16050. Turning now to FIG. 140,
the surgical instrument system 16000 comprises a mis-insertion
sensor 16090 configured to detect when a staple cartridge 16050 has
been over-inserted, or moved too far proximally within the end
effector 16020, at some point during the process of inserting the
staple cartridge 16050 into the cartridge channel 16030.
[0683] Further to the above, the mis-insertion sensor 16090 is in
signal communication with a control system of the surgical
instrument system 16000. The control system can include a
microprocessor and the mis-insertion sensor 16090 can be in signal
communication with the microprocessor via at least one signal wire
16092 and/or a wireless signal transmitter and receiver system, for
example. The mis-insertion sensor 16090 can comprise any suitable
sensor. In at least one instance, the mis-insertion sensor 16090
can comprise a contact switch which is in an open condition when a
staple cartridge 16050 is not in contact with the sensor 16090 and
a closed condition when a staple cartridge 16050 is in contact with
the sensor 16090. The mis-insertion sensor 16090 is positioned in
the cartridge channel 16030 such that, if the staple cartridge
16050 is inserted properly in the cartridge channel 16030, the
staple cartridge 16050 will not contact the mis-insertion sensor
16090. In various instances, the control system of the surgical
instrument system 16000 can include an indicator which can indicate
to the user of the surgical instrument system 16000 that the
mis-insertion sensor 16090 and the microprocessor have not detected
a mis-insertion of a staple cartridge 16050.
[0684] In the event that the staple cartridge 16050 is
over-inserted into the cartridge channel 16030 and the staple
cartridge 16050 contacts the mis-insertion sensor 16090, further to
the above, the microprocessor can detect the closure of the sensor
16090 and take an appropriate action. Such an appropriate action
may include warning the user of the surgical instrument system
16000 that the staple cartridge 16050 has been over-inserted and
that the sled 16060 of the staple cartridge 16050 may have been
moved distally pre-maturely. In at least one instance, the surgical
instrument system 16000 can include an indicator which, when
illuminated, can indicate to the user that the condition of the
staple cartridge 16050 positioned in the cartridge channel 16030 is
unreliable and that it should be removed and replaced with another
staple cartridge 16050. In addition to or in lieu of the above, the
surgical instrument system 16000 can include a display screen, for
example, which could communicate this information to the user of
the surgical instrument system 16000. In addition to or in lieu of
the above, the microprocessor can deactivate the closure system of
the surgical instrument system 16000 to prevent the anvil 16040
from being moved into a closed position when the microprocessor has
determined that a staple cartridge 16050 has been over-inserted
into the cartridge channel 16030 and/or that the condition of the
staple cartridge 16050 positioned in the cartridge channel 16030 is
unreliable. By preventing the anvil 16040 from closing, in the
embodiments where the surgical instrument system 16000 comprises an
endoscopic surgical stapler, for example, the end effector 16020 of
the surgical instrument system 16000 cannot be inserted through a
trocar into a patient and, thus, the surgical instrument system
16000 can require the user to replace the staple cartridge 16050
before the surgical instrument 16000 can be used.
[0685] When the mis-insertion sensor 16090 comprises a contact
switch, further to the above, the sensor 16090 can be positioned in
any suitable location in the cartridge channel 16030 in which a
staple cartridge 16050 would make contact with the sensor 16090 if
the staple cartridge 16050 is mis-inserted. As illustrated in FIG.
140, the mis-insertion sensor 16090 can be positioned on either
side of a longitudinal slot 16036 extending through the cartridge
channel 16030, for example. As discussed above, however, the
mis-insertion sensor 16090 can comprise any suitable type of sensor
and, as a result, the sensor 16090 can be positioned in any
suitable position in the end effector 16020 and/or shaft 16010,
depending on the type of sensor that is being used. For instance,
the mis-insertion sensor 16090 can comprise a Hall Effect sensor,
for example, which can emit a magnetic field and detect changes to
that magnetic field when the staple cartridge 16050 is inserted
into the cartridge channel 16030. In various instances, a large
disturbance to the magnetic field can indicate that the staple
cartridge 16050 is close to the sensor 16090. If the disturbance to
the magnetic field exceeds a threshold level, then the
microprocessor can determine that the staple cartridge 16050 was
positioned too close to the sensor 16090 during the insertion of
the staple cartridge 16050 into the cartridge channel 16030 and, as
a result, the staple cartridge 16050 has been over-inserted into
the cartridge channel 16030 at some point. In at least one
instance, the cartridge body 16051, the retainer 16057, and/or the
sled 16060 can include one or more magnetic elements which can be
configured to disturb the magnetic field of the sensor 16090, for
example.
[0686] In addition to or in lieu of the above, referring now to
FIGS. 141 and 142, the surgical instrument system 16000 can
comprise a sensor 16080 configured to directly detect whether the
sled 16060 is in its correct, or unfired, position when the staple
cartridge 16050 is positioned in the cartridge channel 16030. The
sensor 16080 is positioned in a recess 16032 defined in the
cartridge channel 16030; however, the sensor 16080 can be
positioned in any suitable location. The sensor 16080 is aligned
with the proximal end of the sled 16060 when the sled 16060 is in
its unfired position, as illustrated in FIG. 141. In such
instances, the sled 16060 is positioned over the sensor 16080 and
is in contact with the sensor 16080. The sensor 16080 comprises a
contact switch which is in a closed condition when the sled 16060
is engaged with the sensor 16080, for example. In various
instances, the sensor 16080 can comprise a continuity sensor, for
example. When the sled 16060 is advanced distally, the sled 16060
is no longer aligned with or in contact with the sensor 16080. In
such instances, the contact switch of the sensor 16080 is in an
open condition. The sensor 16080 is in signal communication with
the microprocessor of the control system of the surgical instrument
system 16000 via at least one signal wire 16082 and/or a wireless
signal transmitter and receiver system, for example. When a staple
cartridge 16050 is inserted into the channel, the sensor 16080 and
the microprocessor can evaluate whether the sled 16060 is in its
unfired position and, if it is not, take an appropriate action,
such as the appropriate actions discussed above, for example.
[0687] Referring now to FIG. 143, the sensor 16080 comprises a
first contact 16084 and a second contact 16085. The second contact
16085 comprises a free end positioned over the first contact 16084
which is movable between an open position in which a gap 16086 is
present between the second contact 16085 and the first contact
16084 and a closed position in which the second contact 16085 is
deflected into contact with the first contact 16084. The first
contact 16084 and the second contact 16085 are comprised of an
electrically conductive material, such as copper, for example, and,
when the second contact 16085 is in contact with the first contact
16084, the sensor 16080 closes a circuit which permits current to
flow therethrough. The sensor 16080 further comprises a flexible
housing 16083 which surrounds the ends of the first contact 16084
and the second contact 16085. The housing 16083 comprises a sealed
deformable membrane; however, any suitable configuration could be
used. The housing 16083 is comprised of an electrically insulative
material, such as plastic, for example. When the sled 16060
contacts the sensor 16080, as discussed above, the sled 16060 can
push the housing 16083 downwardly and deflect the second contact
16085 toward the first contact 16084 to close the sensor 16080. If
the sled 16060 has been advanced distally prior to the staple
cartridge 16050 being fully seated in the cartridge channel 16030,
the sled 16060 will not deflect the housing 16083 and the second
contact 16085 downwardly. As a result of the above, the sensor
16080 can not only detect whether a staple cartridge 16050 is
present in the cartridge channel 16030, but it can also detect
whether the staple cartridge 16050 has been at least partially
fired.
[0688] In addition to or in lieu of the above, the sensor 16080 can
comprise any suitable sensor, such as a Hall Effect sensor, for
example, which is configured to emit a magnetic field and detect
changes to the magnetic field. The sled 16060 can include a
magnetic element mounted thereto, such as on the bottom of the sled
16060, for example, and, when the staple cartridge 16050 is
positioned in the cartridge channel 16030, the magnetic element can
disrupt the magnetic field emitted by the sensor 16080. The sensor
16080 and the microprocessor of the surgical instrument control
system can be configured to evaluate the magnitude in which the
magnetic field has been disrupted and correlate the disruption of
the magnetic field with the position of the sled 16060. Such an
arrangement may be able to determine whether the sled 16060 is in
an acceptable range of positions. For instance, the microprocessor
may assess whether the disturbance of the magnetic field has
exceeded a threshold and, if it has, the microprocessor can
indicate to the user that the staple cartridge 16050 is suitable
for use and, if the threshold has not been exceeded, the
microprocessor can take a suitable action, as described above.
[0689] In addition to or in lieu of assessing whether a staple
cartridge has been inserted to its proper depth in the cartridge
channel 16030, the sensor 16080 can be configured to assess whether
a staple cartridge 16050 has been fully seated in the cartridge
channel 16030. For instance, referring again to FIG. 143, the sled
16060 may deflect the second contact 16085 enough to contact the
first contact 16084 only when the staple cartridge 16050 is fully
seated in the staple channel 16030. When the sensor 16080 comprises
a Hall Effect sensor, for example, the threshold disturbance that
the sled 16060 must create to indicate that the staple cartridge
16050 is suitable for use may not only require that the staple
cartridge 16050 be inserted to its proper depth in the cartridge
channel 16030 and that the sled 16060 be in its unfired position
but it may also require that the staple cartridge 16050 be in its
fully seated condition. Referring now to FIG. 144, an alternative
sensor 16080' is depicted which comprises a pressure sensitive
switch. The sensor 16080' comprises a variable resistive element
16086' positioned intermediate the first contact 16084 and the
second contact 16085. In at least one instance, the variable
resistive element 16086' can comprise a semi-conductive spacer, for
example. The resistance of the variable resistive element 16086' is
a function of the pressure, or force, being applied to it. For
instance, if a low pressure is applied to the variable resistive
element 16086' then the variable resistive element 16086' will have
a low resistance and, correspondingly, if a high pressure is
applied to the resistive element 16086' then the resistive element
16086' will have a high resistance. The microprocessor can be
configured to correlate the resistance of the resistive element
16086' with the pressure being applied to the sensor 16080' and,
ultimately, correlate the pressure being applied to the sensor
16080' with the height in which the staple cartridge 16050 is
seated in the cartridge channel 16030. Once the resistance of the
resistive element 16086' has exceeded a threshold resistance, the
microprocessor can determine that the staple cartridge 16050 is
ready to be fired. If, however, the resistance of the resistive
element 16086' is below the threshold resistance, the
microprocessor can determine that the staple cartridge 16050 has
not been fully seated in the cartridge channel 16030 and take an
appropriate action.
[0690] The present disclosure will now be described in connection
with various examples and various combinations of such examples as
described hereinbelow.
[0691] 1. One example provides an electronic system for a surgical
instrument, the electronic system comprising: an electric motor
coupled to the end effector; a motor controller coupled to the
motor; a parameter threshold detection module configured to monitor
multiple parameter thresholds; a sensing module configured to sense
tissue compression; a processor coupled to the parameter threshold
detection module and the motor controller; and a memory coupled to
the processor, the memory storing executable instructions that when
executed by the processor cause the processor to monitor multiple
levels of action thresholds and monitor speed of the motor and
increment a drive unit of the motor, sense tissue compression, and
provide rate and control feedback to the user of the surgical
instrument.
[0692] 2. Another example provides the electronic system of example
1, wherein the processor provides automatic compensation for motor
load when thresholds detected by the parameter threshold detection
module are within acceptable limits.
[0693] 3. Another example provides the electronic system of example
1 or 2, wherein the parameter threshold detection module is
configured to detect battery current and speed of the motor such
that when the battery current increases or the speed of the motor
decreases the motor controller increase a pulse width or frequency
modulation to maintain the speed of the motor constant.
[0694] 4. Another example provides the electronic system of any one
of examples 1-3, wherein the parameter threshold detection module
is configured to detect minimum and maximum threshold limits to
control operation of the surgical instrument.
[0695] 5. Another example provides the electronic system of example
4, wherein the parameter threshold detection module is configured
to detect end effector closing force, end effector opening force,
and speed of the motor.
[0696] 6. Another example provides the electronic system of example
5, wherein when the end effector closing force decreases while a
knife is translating through a knife channel in the end effector,
the processor is configured to control the speed of the motor.
[0697] 7. Another example provides the electronic system of example
5 or 6, wherein when the end effector closing force decreases while
a knife is translating through a knife channel, the processor is
configured to activate an alarm.
[0698] 8. Another example provides the electronic system of any one
of examples 4-7, wherein the processor is configured to activate
the motor only after a minimum parameter threshold is detected.
[0699] 9. Another example provides the electronic system of any one
of examples 1-8, wherein the parameter threshold detection module
is configured to detect an ultimate threshold associated with
current draw, end effector pressure applied to tissue, firing load,
or torque, wherein when the ultimate threshold is exceeded, the
processor is configured to shut down the motor or cause the motor
to retract the knife.
[0700] 10. Another example provides the electronic system of
example 9, wherein the parameter threshold detection module is
configured to detect a secondary threshold which is less than the
ultimate threshold, wherein control parameters are changed by the
processor to accommodate the change in operation.
[0701] 11. Another example provides the electronic system of
example 9 or 10, wherein the parameter threshold detection module
is configured to detect a marginal threshold in the form of either
a step function or ramp function based on a proportional response
to another input to the parameter threshold detection module.
[0702] 12. Yet another example provides an electronic system for a
surgical instrument, the electronic system comprising: an electric
motor coupled to the end effector; a motor controller coupled to
the motor; a sensing module configured to sense tissue compression;
a processor coupled to the parameter threshold detection module and
the motor controller; and a memory coupled to the processor, the
memory storing executable instructions that when executed by the
processor cause the processor to monitor the sensing module,
wherein the sensing module is configured to sense multiple tissue
parameters.
[0703] 13. Another example provides the electronic system of
example 12, wherein the sensing module is configured to sense
tissue compression.
[0704] 14. Another example provides the electronic system of
example 12 or 13, wherein the sensing module is configured to sense
tissue impedance.
[0705] 15. Another example provides the electronic system of
example 14, wherein the sensing module is coupled to electrodes to
measure tissue impedance via sub-therapeutic RF energy.
[0706] 16. Another example provides the electronic system of
example 15, wherein the sensing module is configured to read
overlaid multiple frequency signals to measure impedance in
different locations simultaneously.
[0707] 17. Another example provides the electronic system of
example 15 or 16, wherein the sensing module comprises a
multiplexor to measure impedance at variable RF frequencies
sequentially.
[0708] 18. Another example provides the electronic system of any
one of examples 12-17, wherein the sensing module is configured to
sense tissue pressure.
[0709] 19. Another example provides the electronic system of any
one of examples 12-18, wherein the sensing module is configured to
sense tissue contact.
[0710] 20. Another example provides the electronic system of any
one of examples 12-19, wherein the sensing module is configured to
sense viscoelasticity rate of change.
[0711] 21. Yet another example provides an electronic system for a
surgical instrument, the electronic system comprising: an electric
motor coupled to the end effector; a motor controller coupled to
the motor; a sensing module configured to sense tissue compression;
a feedback module configured to provide rate and control feedback
to a user of the surgical instrument; a processor coupled to the
parameter threshold detection module and the motor controller; and
a memory coupled to the processor, the memory storing executable
instructions that when executed by the processor cause the
processor to monitor the sensing module, wherein the sensing module
is configured to sense multiple tissue parameters and provide
feedback over the feedback module to a user of the instrument.
[0712] In accordance with various examples, the surgical
instruments described herein may comprise one or more processors
(e.g., microprocessor, microcontroller) coupled to various sensors.
In addition, to the processor(s), a storage (having operating
logic) and communication interface, are coupled to each other.
[0713] As described earlier, the sensors may be configured to
detect and collect data associated with the surgical device. The
processor processes the sensor data received from the
sensor(s).
[0714] The processor may be configured to execute the operating
logic. The processor may be any one of a number of single or
multi-core processors known in the art. The storage may comprise
volatile and non-volatile storage media configured to store
persistent and temporal (working) copy of the operating logic.
[0715] In various aspects, the operating logic may be configured to
perform the initial processing, and transmit the data to the
computer hosting the application to determine and generate
instructions. For these examples, the operating logic may be
further configured to receive information from and provide feedback
to a hosting computer. In alternate examples, the operating logic
may be configured to assume a larger role in receiving information
and determining the feedback. In either case, whether determined on
its own or responsive to instructions from a hosting computer, the
operating logic may be further configured to control and provide
feedback to the user.
[0716] In various aspects, the operating logic may be implemented
in instructions supported by the instruction set architecture (ISA)
of the processor, or in higher level languages and compiled into
the supported ISA. The operating logic may comprise one or more
logic units or modules. The operating logic may be implemented in
an object oriented manner. The operating logic may be configured to
be executed in a multi-tasking and/or multi-thread manner. In other
examples, the operating logic may be implemented in hardware such
as a gate array.
[0717] In various aspects, the communication interface may be
configured to facilitate communication between a peripheral device
and the computing system. The communication may include
transmission of the collected biometric data associated with
position, posture, and/or movement data of the user's body part(s)
to a hosting computer, and transmission of data associated with the
tactile feedback from the host computer to the peripheral device.
In various examples, the communication interface may be a wired or
a wireless communication interface. An example of a wired
communication interface may include, but is not limited to, a
Universal Serial Bus (USB) interface. An example of a wireless
communication interface may include, but is not limited to, a
Bluetooth interface.
[0718] For various aspects, the processor may be packaged together
with the operating logic. In various examples, the processor may be
packaged together with the operating logic to form a SiP. In
various examples, the processor may be integrated on the same die
with the operating logic. In various examples, the processor may be
packaged together with the operating logic to form a System on Chip
(SoC).
[0719] Various aspects may be described herein in the general
context of computer executable instructions, such as software,
program modules, and/or engines being executed by a processor.
Generally, software, program modules, and/or engines include any
software element arranged to perform particular operations or
implement particular abstract data types. Software, program
modules, and/or engines can include routines, programs, objects,
components, data structures and the like that perform particular
tasks or implement particular abstract data types. An
implementation of the software, program modules, and/or engines
components and techniques may be stored on and/or transmitted
across some form of computer-readable media. In this regard,
computer-readable media can be any available medium or media
useable to store information and accessible by a computing device.
Some examples also may be practiced in distributed computing
environments where operations are performed by one or more remote
processing devices that are linked through a communications
network. In a distributed computing environment, software, program
modules, and/or engines may be located in both local and remote
computer storage media including memory storage devices. A memory
such as a random access memory (RAM) or other dynamic storage
device may be employed for storing information and instructions to
be executed by the processor. The memory also may be used for
storing temporary variables or other intermediate information
during execution of instructions to be executed by the
processor.
[0720] Although some aspects may be illustrated and described as
comprising functional components, software, engines, and/or modules
performing various operations, it can be appreciated that such
components or modules may be implemented by one or more hardware
components, software components, and/or combination thereof. The
functional components, software, engines, and/or modules may be
implemented, for example, by logic (e.g., instructions, data,
and/or code) to be executed by a logic device (e.g., processor).
Such logic may be stored internally or externally to a logic device
on one or more types of computer-readable storage media. In other
examples, the functional components such as software, engines,
and/or modules may be implemented by hardware elements that may
include processors, microprocessors, circuits, circuit elements
(e.g., transistors, resistors, capacitors, inductors, and so
forth), integrated circuits, ASICs, PLDs, DSPs, FPGAs, logic gates,
registers, semiconductor device, chips, microchips, chip sets, and
so forth.
[0721] Examples of software, engines, and/or modules may include
software components, programs, applications, computer programs,
application programs, system programs, machine programs, operating
system software, middleware, firmware, software modules, routines,
subroutines, functions, methods, procedures, software interfaces,
application program interfaces (API), instruction sets, computing
code, computer code, code segments, computer code segments, words,
values, symbols, or any combination thereof. Determining whether
one example is implemented using hardware elements and/or software
elements may vary in accordance with any number of factors, such as
desired computational rate, power levels, heat tolerances,
processing cycle budget, input data rates, output data rates,
memory resources, data bus speeds and other design or performance
constraints.
[0722] One or more of the modules described herein may comprise one
or more embedded applications implemented as firmware, software,
hardware, or any combination thereof. One or more of the modules
described herein may comprise various executable modules such as
software, programs, data, drivers, application APIs, and so forth.
The firmware may be stored in a memory of the controller and/or the
controller which may comprise a nonvolatile memory (NVM), such as
in bit-masked ROM or flash memory. In various implementations,
storing the firmware in ROM may preserve flash memory. The NVM may
comprise other types of memory including, for example, programmable
ROM (PROM), erasable programmable ROM (EPROM), EEPROM, or battery
backed RAM such as dynamic RAM (DRAM), Double-Data-Rate DRAM
(DDRAM), and/or synchronous DRAM (SDRAM).
[0723] In some cases, various aspects may be implemented as an
article of manufacture. The article of manufacture may include a
computer readable storage medium arranged to store logic,
instructions and/or data for performing various operations of one
or more examples. In various examples, for example, the article of
manufacture may comprise a magnetic disk, optical disk, flash
memory or firmware containing computer program instructions
suitable for execution by a general purpose processor or
application specific processor. The examples, however, are not
limited in this context.
[0724] The functions of the various functional elements, logical
blocks, modules, and circuits elements described in connection with
the examples disclosed herein may be implemented in the general
context of computer executable instructions, such as software,
control modules, logic, and/or logic modules executed by the
processing unit. Generally, software, control modules, logic,
and/or logic modules comprise any software element arranged to
perform particular operations. Software, control modules, logic,
and/or logic modules can comprise routines, programs, objects,
components, data structures and the like that perform particular
tasks or implement particular abstract data types. An
implementation of the software, control modules, logic, and/or
logic modules and techniques may be stored on and/or transmitted
across some form of computer-readable media. In this regard,
computer-readable media can be any available medium or media
useable to store information and accessible by a computing device.
Some examples also may be practiced in distributed computing
environments where operations are performed by one or more remote
processing devices that are linked through a communications
network. In a distributed computing environment, software, control
modules, logic, and/or logic modules may be located in both local
and remote computer storage media including memory storage
devices.
[0725] Additionally, it is to be appreciated that the aspects
described herein illustrate example implementations, and that the
functional elements, logical blocks, modules, and circuits elements
may be implemented in various other ways which are consistent with
the described examples. Furthermore, the operations performed by
such functional elements, logical blocks, modules, and circuits
elements may be combined and/or separated for a given
implementation and may be performed by a greater number or fewer
number of components or modules. As will be apparent to those of
skill in the art upon reading the present disclosure, each of the
individual examples described and illustrated herein has discrete
components and features which may be readily separated from or
combined with the features of any of the other several aspects
without departing from the scope of the present disclosure. Any
recited method can be carried out in the order of events recited or
in any other order which is logically possible.
[0726] It is worthy to note that any reference to "one example" or
"an example" means that a particular feature, structure, or
characteristic described in connection with the example is
comprised in at least one example. The appearances of the phrase
"in one example" or "in one aspect" in the specification are not
necessarily all referring to the same example.
[0727] Unless specifically stated otherwise, it may be appreciated
that terms such as "processing," "computing," "calculating,"
"determining," or the like, refer to the action and/or processes of
a computer or computing system, or similar electronic computing
device, such as a general purpose processor, a DSP, ASIC, FPGA or
other programmable logic device, discrete gate or transistor logic,
discrete hardware components, or any combination thereof designed
to perform the functions described herein that manipulates and/or
transforms data represented as physical quantities (e.g.,
electronic) within registers and/or memories into other data
similarly represented as physical quantities within the memories,
registers or other such information storage, transmission or
display devices.
[0728] It is worthy to note that some aspects may be described
using the expression "coupled" and "connected" along with their
derivatives. These terms are not intended as synonyms for each
other. For example, some aspects may be described using the terms
"connected" and/or "coupled" to indicate that two or more elements
are in direct physical or electrical contact with each other. The
term "coupled," however, also may mean that two or more elements
are not in direct contact with each other, but yet still co-operate
or interact with each other. With respect to software elements, for
example, the term "coupled" may refer to interfaces, message
interfaces, API, exchanging messages, and so forth.
[0729] It should be appreciated that any patent, publication, or
other disclosure material, in whole or in part, that is said to be
incorporated by reference herein is incorporated herein only to the
extent that the incorporated material does not conflict with
existing definitions, statements, or other disclosure material set
forth in this disclosure. As such, and to the extent necessary, the
disclosure as explicitly set forth herein supersedes any
conflicting material incorporated herein by reference. Any
material, or portion thereof, that is said to be incorporated by
reference herein, but which conflicts with existing definitions,
statements, or other disclosure material set forth herein will only
be incorporated to the extent that no conflict arises between that
incorporated material and the existing disclosure material.
[0730] The present disclosure applies to conventional endoscopic
and open surgical instrumentation as well as application in
robotic-assisted surgery.
[0731] Aspects of the devices disclosed herein can be designed to
be disposed of after a single use, or they can be designed to be
used multiple times. Examples may, in either or both cases, be
reconditioned for reuse after at least one use. Reconditioning may
include any combination of the steps of disassembly of the device,
followed by cleaning or replacement of particular pieces, and
subsequent reassembly. In particular, examples of the device may be
disassembled, and any number of the particular pieces or parts of
the device may be selectively replaced or removed in any
combination. Upon cleaning and/or replacement of particular parts,
examples of the device may be reassembled for subsequent use either
at a reconditioning facility, or by a surgical team immediately
prior to a surgical procedure. Those skilled in the art will
appreciate that reconditioning of a device may utilize a variety of
techniques for disassembly, cleaning/replacement, and reassembly.
Use of such techniques, and the resulting reconditioned device, are
all within the scope of the present application.
[0732] By way of example only, aspects described herein may be
processed before surgery. First, a new or used instrument may be
obtained and when necessary cleaned. The instrument may then be
sterilized. In one sterilization technique, the instrument is
placed in a closed and sealed container, such as a plastic or TYVEK
bag. The container and instrument may then be placed in a field of
radiation that can penetrate the container, such as gamma
radiation, x-rays, or high-energy electrons. The radiation may kill
bacteria on the instrument and in the container. The sterilized
instrument may then be stored in the sterile container. The sealed
container may keep the instrument sterile until it is opened in a
medical facility. A device also may be sterilized using any other
technique known in the art, including but not limited to beta or
gamma radiation, ethylene oxide, plasma peroxide, or steam.
[0733] One skilled in the art will recognize that the herein
described components (e.g., operations), devices, objects, and the
discussion accompanying them are used as examples for the sake of
conceptual clarity and that various configuration modifications are
contemplated. Consequently, as used herein, the specific exemplars
set forth and the accompanying discussion are intended to be
representative of their more general classes. In general, use of
any specific exemplar is intended to be representative of its
class, and the non-inclusion of specific components (e.g.,
operations), devices, and objects should not be taken limiting.
[0734] With respect to the use of substantially any plural and/or
singular terms herein, those having skill in the art can translate
from the plural to the singular and/or from the singular to the
plural as is appropriate to the context and/or application. The
various singular/plural permutations are not expressly set forth
herein for sake of clarity.
[0735] The herein described subject matter sometimes illustrates
different components contained within, or connected with, different
other components. It is to be understood that such depicted
architectures are merely examples and that in fact many other
architectures may be implemented which achieve the same
functionality. In a conceptual sense, any arrangement of components
to achieve the same functionality is effectively "associated" such
that the desired functionality is achieved. Hence, any two
components herein combined to achieve a particular functionality
can be seen as "associated with" each other such that the desired
functionality is achieved, irrespective of architectures or
intermedial components. Likewise, any two components so associated
can also be viewed as being "operably connected," or "operably
coupled," to each other to achieve the desired functionality, and
any two components capable of being so associated can also be
viewed as being "operably couplable," to each other to achieve the
desired functionality. Specific examples of operably couplable
include but are not limited to physically matable and/or physically
interacting components, and/or wirelessly interactable, and/or
wirelessly interacting components, and/or logically interacting,
and/or logically interactable components.
[0736] Some aspects may be described using the expression "coupled"
and "connected" along with their derivatives. It should be
understood that these terms are not intended as synonyms for each
other. For example, some aspects may be described using the term
"connected" to indicate that two or more elements are in direct
physical or electrical contact with each other. In another example,
some aspects may be described using the term "coupled" to indicate
that two or more elements are in direct physical or electrical
contact. The term "coupled," however, also may mean that two or
more elements are not in direct contact with each other, but yet
still co-operate or interact with each other.
[0737] In some instances, one or more components may be referred to
herein as "configured to," "configurable to," "operable/operative
to," "adapted/adaptable," "able to," "conformable/conformed to,"
etc. Those skilled in the art will recognize that "configured to"
can generally encompass active-state components and/or
inactive-state components and/or standby-state components, unless
context requires otherwise.
[0738] While particular aspects of the present subject matter
described herein have been shown and described, it will be apparent
to those skilled in the art that, based upon the teachings herein,
changes and modifications may be made without departing from the
subject matter described herein and its broader aspects and,
therefore, the appended claims are to encompass within their scope
all such changes and modifications as are within the true scope of
the subject matter described herein. It will be understood by those
within the art that, in general, terms used herein, and especially
in the appended claims (e.g., bodies of the appended claims) are
generally intended as "open" terms (e.g., the term "including"
should be interpreted as "including but not limited to," the term
"having" should be interpreted as "having at least," the term
"includes" should be interpreted as "includes but is not limited
to," etc.). It will be further understood by those within the art
that when a specific number of an introduced claim recitation is
intended, such an intent will be explicitly recited in the claim,
and in the absence of such recitation no such intent is present.
For example, as an aid to understanding, the following appended
claims may contain usage of the introductory phrases "at least one"
and "one or more" to introduce claim recitations. However, the use
of such phrases should not be construed to imply that the
introduction of a claim recitation by the indefinite articles "a"
or "an" limits any particular claim containing such introduced
claim recitation to claims containing only one such recitation,
even when the same claim includes the introductory phrases "one or
more" or "at least one" and indefinite articles such as "a" or "an"
(e.g., "a" and/or "an" should typically be interpreted to mean "at
least one" or "one or more"); the same holds true for the use of
definite articles used to introduce claim recitations.
[0739] In addition, even when a specific number of an introduced
claim recitation is explicitly recited, those skilled in the art
will recognize that such recitation should typically be interpreted
to mean at least the recited number (e.g., the bare recitation of
"two recitations," without other modifiers, typically means at
least two recitations, or two or more recitations). Furthermore, in
those instances where a convention analogous to "at least one of A,
B, and C, etc." is used, in general such a construction is intended
in the sense one having skill in the art would understand the
convention (e.g., "a system having at least one of A, B, and C"
would include but not be limited to systems that have A alone, B
alone, C alone, A and B together, A and C together, B and C
together, and/or A, B, and C together, etc.). In those instances
where a convention analogous to "at least one of A, B, or C, etc."
is used, in general such a construction is intended in the sense
one having skill in the art would understand the convention (e.g.,
"a system having at least one of A, B, or C" would include but not
be limited to systems that have A alone, B alone, C alone, A and B
together, A and C together, B and C together, and/or A, B, and C
together, etc.). It will be further understood by those within the
art that typically a disjunctive word and/or phrase presenting two
or more alternative terms, whether in the description, claims, or
drawings, should be understood to contemplate the possibilities of
including one of the terms, either of the terms, or both terms
unless context dictates otherwise. For example, the phrase "A or B"
will be typically understood to include the possibilities of "A" or
"B" or "A and B."
[0740] With respect to the appended claims, those skilled in the
art will appreciate that recited operations therein may generally
be performed in any order. Also, although various operational flows
are presented in a sequence(s), it should be understood that the
various operations may be performed in other orders than those
which are illustrated, or may be performed concurrently. Examples
of such alternate orderings may include overlapping, interleaved,
interrupted, reordered, incremental, preparatory, supplemental,
simultaneous, reverse, or other variant orderings, unless context
dictates otherwise. Furthermore, terms like "responsive to,"
"related to," or other past-tense adjectives are generally not
intended to exclude such variants, unless context dictates
otherwise.
[0741] In summary, numerous benefits have been described which
result from employing the concepts described herein. The foregoing
disclosure has been presented for purposes of illustration and
description. It is not intended to be exhaustive or limiting to the
precise form disclosed. Modifications or variations are possible in
light of the above teachings. The one or more examples were chosen
and described in order to illustrate principles and practical
application to thereby enable one of ordinary skill in the art to
utilize the various examples and with various modifications as are
suited to the particular use contemplated. It is intended that the
claims submitted herewith define the overall scope.
* * * * *