U.S. patent application number 14/479108 was filed with the patent office on 2016-03-10 for local display of tissue parameter stabilization.
The applicant listed for this patent is Ethicon Endo-Surgery, Inc.. Invention is credited to Daniel L. Baber, Andrew T. Beckman, Frederick E. Shelton, IV, Jeffrey S. Swayze.
Application Number | 20160066913 14/479108 |
Document ID | / |
Family ID | 63914669 |
Filed Date | 2016-03-10 |
United States Patent
Application |
20160066913 |
Kind Code |
A1 |
Swayze; Jeffrey S. ; et
al. |
March 10, 2016 |
LOCAL DISPLAY OF TISSUE PARAMETER STABILIZATION
Abstract
A staple cartridge for use with a surgical stapler and surgical
stapling systems are disclosed. The staple cartridge comprises a
cartridge body having a tissue-contacting surface. One or more
light emitting diodes (LEDs) are positioned at the edges of the
tissue-contacting surface. A plurality of staple drivers is located
within the cartridge body each supporting a staple.
Inventors: |
Swayze; Jeffrey S.;
(Hamilton, OH) ; Shelton, IV; Frederick E.;
(Hillsboro, OH) ; Baber; Daniel L.; (Liberty
Township, OH) ; Beckman; Andrew T.; (Cincinnati,
OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ethicon Endo-Surgery, Inc. |
Cincinnati |
OH |
US |
|
|
Family ID: |
63914669 |
Appl. No.: |
14/479108 |
Filed: |
September 5, 2014 |
Current U.S.
Class: |
227/176.1 |
Current CPC
Class: |
A61B 17/07292 20130101;
A61B 2090/0808 20160201; A61B 5/1076 20130101; A61B 5/6885
20130101; A61B 17/00 20130101; A61B 2017/07271 20130101; A61B
2090/0814 20160201; A61B 2505/05 20130101; A61B 2090/0807 20160201;
A61B 2562/0257 20130101; H02H 11/002 20130101; A61B 2017/00115
20130101; A61B 2017/00734 20130101; H02H 7/20 20130101; A61B 17/072
20130101; A61B 2017/07214 20130101; A61B 2017/07257 20130101; A61B
2017/00876 20130101; A61B 2017/07285 20130101; A61B 2017/00022
20130101; G06F 1/3215 20130101; H02H 3/06 20130101; A61B 2090/0818
20160201; H02H 3/087 20130101; A61B 5/067 20130101; A61B 2562/0261
20130101; A61B 2562/043 20130101; A61B 2017/00075 20130101; A61B
17/1155 20130101; A61B 2562/0223 20130101; G06F 1/305 20130101;
H02J 1/10 20130101; G06F 1/3287 20130101; A61B 5/6847 20130101;
G06F 1/28 20130101; A61B 17/105 20130101; A61B 2017/00725 20130101;
A61B 2090/0803 20160201; A61B 2090/0806 20160201; A61B 2090/0811
20160201; A61B 17/068 20130101; A61B 90/96 20160201; A61B 2090/061
20160201; A61B 2090/064 20160201; A61B 2562/06 20130101; A61B
17/07207 20130101; A61B 17/32 20130101; A61B 2017/00199 20130101;
A61B 90/70 20160201; A61B 90/98 20160201; A61B 2017/00477 20130101;
A61B 2090/065 20160201; A61B 2090/081 20160201; A61B 2090/304
20160201; A61B 2017/0046 20130101; H02H 3/202 20130101; H02H 3/243
20130101; A61B 90/06 20160201; A61B 2017/00039 20130101; A61B
2090/702 20160201; G06F 1/266 20130101; H02H 1/06 20130101; H02H
3/207 20130101; A61B 17/0644 20130101; A61B 2017/00393 20130101;
A61B 2017/00398 20130101; A61B 2018/00648 20130101; A61B 8/12
20130101; A61B 2017/00026 20130101; A61B 2562/223 20130101; A61B
8/4483 20130101; A61B 2017/00061 20130101; A61B 2017/00066
20130101; A61B 2017/00119 20130101; A61B 2017/00123 20130101; G01R
33/072 20130101; H02J 1/001 20200101; A61B 90/90 20160201; A61B
2017/00017 20130101; A61B 2090/309 20160201; A61B 90/92 20160201;
A61B 90/94 20160201; A61B 2017/00106 20130101; A61B 2017/2927
20130101; G06F 1/30 20130101; H02H 3/04 20130101; A61B 2090/037
20160201; A61B 2562/0247 20130101; H02H 3/18 20130101; A61B
2562/029 20130101; H02H 3/02 20130101; H02J 7/0068 20130101; Y02D
10/00 20180101 |
International
Class: |
A61B 17/072 20060101
A61B017/072 |
Claims
1. A staple cartridge for use with a surgical stapler, the staple
cartridge comprising: a cartridge body having a tissue-contacting
surface; one or more LEDs positioned at the edges of the
tissue-contacting surface; and a plurality of staple drivers within
the cartridge body each supporting a staple.
2. The staple cartridge of claim 1, wherein the one or more LEDs
emit ultraviolet light.
3. The staple cartridge of claim 2, wherein the staples are coated
in a fluorescing dye.
4. The staple cartridge of claim 1, wherein the one or more LEDs
emit infrared light.
5. A surgical stapling system comprising: an elongated shaft
assembly configured to transmit actuation motions from an actuator;
and an end effector for compressing and stapling tissue, the end
effector operably coupled to the elongated shaft, the end effector
comprising: an elongated channel; an anvil having a staple forming
surface thereon, the anvil moveable relative to the elongated
channel between an open position and a closed position; and a
staple cartridge removably positioned within the elongated channel,
the staple cartridge comprising: a cartridge body having a
tissue-contacting surface in a confronting relationship with the
anvil's staple forming surface when the anvil is in the closed
position; one or more LEDs positioned to be visible when the anvil
is in the closed position; and a plurality of staple drivers within
the cartridge body each supporting a staple.
6. The system of claim 5, wherein the one or more LEDs indicate
that the compressed tissue is stable.
7. The system of claim 6, wherein at least one LED is visible from
either the left or the right side of the end effector, the at least
one LED configured to flash at the rate of the tissue's
stabilization and further configured to maintain a lit condition
when the tissue is stable.
8. The system of claim 6, wherein more than one LED is visible from
either the left or the right side of the end effector.
9. The system of claim 8, wherein the more than one LEDs light in
sequence at the rate of the tissue's stabilization, such that when
all the LEDs indicates that the tissue is stable.
10. The system of claim 8, wherein the more than one LEDs light in
sequence, the speed of the sequence indicating the rate of the
tissue's stabilization, and wherein all the LEDs flash
simultaneously when the tissue is stable.
11. The system of claim 5, wherein the one or more LEDs indicate
which portions of the end effector are in sufficient contact with
the tissue.
12. The system of claim 5, the system further comprising a
processor, the processor configured to compare the tissue's
parameters against the acceptable parameters for all staple
cartridges.
13. The system of claim 12, wherein the processor is further
configured to compare the tissue's parameters against the
acceptable parameters for the staple cartridge currently present in
the elongated channel.
14. The system of claim 12, wherein the LEDs indicate that the
staple cartridge is appropriate for the tissue.
15. The system of claim 5, wherein the one or more LEDs indicate
that the staple cartridge is not compatible with the stapling
system.
16. The system of claim 5, wherein the one or more LEDs indicate
that the end effector is enclosing more tissue than is suitable for
the staple cartridge.
17. A surgical stapling system comprising: an elongated shaft
assembly configured to transmit actuation motions from an actuator;
and an end effector for compressing and stapling tissue, the end
effector operably coupled to the elongated shaft, the end effector
comprising: an elongated channel; an anvil having a staple forming
surface thereon, the anvil moveable relative to the elongated
channel between an open position and a closed position; and a
staple cartridge removably positioned within the elongated channel,
the staple cartridge comprising: a cartridge body having an upper
surface in a confronting relationship with the anvil's staple
forming surface when the anvil is in a closed position; one or more
LEDs positioned to provide illumination to the area between the
anvil and the staple cartridge when the anvil is in a closed
position; and a plurality of staple drivers within the cartridge
body each supporting a staple.
18. The system of claim 17, wherein the one or more LEDs emit
ultraviolet light.
19. The system of claim 18, wherein the staples are coated in a
fluorescing dye.
20. The system of claim 17, wherein the one or more LEDs emit
infrared light.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is related to Application Docket Nos.:
END7420USNP/140125 entitled CIRCUITRY AND SENSORS FOR POWERED
MEDICAL DEVICE, END7421USNP/140126 entitled ADJUNCT WITH INTEGRATED
SENSORS TO QUANTIFY TISSUE COMPRESSION, END7422USNP/140127 entitled
MONITORING DEVICE DEGRADATION BASED ON COMPONENT EVALUATION,
END7423USNP/140128 entitled MULTIPLE SENSORS WITH ONE SENSOR
AFFECTING A SECOND SENSOR'S OUTPUT OR INTERPRETATION,
END7424USNP/140129 entitled POLARITY OF HALL MAGNET TO DETECT
MISLOADED CARTRIDGE, END7425USNP/140130 entitled SMART CARTRIDGE
WAKE UP OPERATION AND DATA RETENTION, and END7426USNP/140131
entitled MULTIPLE MOTOR CONTROL FOR POWERED MEDICAL DEVICE, each of
which is filed concurrently herewith and each of which is
incorporated herein by reference in its entirety.
BACKGROUND
[0002] The present embodiments of the invention relate 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.
SUMMARY
[0003] In one embodiment, a staple cartridge for use with a
surgical stapler is provided. The staple cartridge comprises a
cartridge body having a tissue-contacting surface; one or more LEDs
positioned at the edges of the tissue-contacting surface; and a
plurality of staple drivers within the cartridge body each
supporting a staple. In one embodiment the one or more LEDs emit
ultraviolet light or infrared light. In one embodiment, the staples
are coated in a fluorescing dye.
[0004] In one embodiment, a surgical stapling system is provided.
The surgical stapling system comprises an elongated shaft assembly
configured to transmit actuation motions from an actuator; and an
end effector for compressing and stapling tissue, the end effector
operably coupled to the elongated shaft, the end effector
comprising: an elongated channel; an anvil having a staple forming
surface thereon, the anvil moveable relative to the elongated
channel between an open position and a closed position; and a
staple cartridge removably positioned within the elongated channel,
the staple cartridge comprising: a cartridge body having a
tissue-contacting surface in a confronting relationship with the
anvil's staple forming surface when the anvil is in the closed
position; one or more LEDs positioned to be visible when the anvil
is in the closed position; and a plurality of staple drivers within
the cartridge body each supporting a staple. In one embodiment, the
one or more LEDs indicate that the compressed tissue is stable. In
one embodiment, at least one LED is visible from either the left or
the right side of the end effector, the at least one LED configured
to flash at the rate of the tissue's stabilization and further
configured to maintain a lit condition when the tissue is stable.
In one embodiment, more than one LED is visible from either the
left or the right side of the end effector. In one embodiment, the
more than one LEDs light in sequence at the rate of the tissue's
stabilization, such that when all the LEDs indicates that the
tissue is stable. In one embodiment, the more than one LEDs light
in sequence, the speed of the sequence indicating the rate of the
tissue's stabilization, and wherein all the LEDs flash
simultaneously when the tissue is stable. In one embodiment, the
one or more LEDs indicate which portions of the end effector are in
sufficient contact with the tissue.
[0005] In one embodiment, the system further comprises a processor,
the processor configured to compare the tissue's parameters against
the acceptable parameters for all staple cartridges. In one
embodiment, the processor is further configured to compare the
tissue's parameters against the acceptable parameters for the
staple cartridge currently present in the elongated channel. In one
embodiment, the LEDs indicate that the staple cartridge is
appropriate for the tissue. In one embodiment, the one or more LEDs
indicate that the staple cartridge is not compatible with the
stapling system. In one embodiment, the one or more LEDs indicate
that the end effector is enclosing more tissue than is suitable for
the staple cartridge. In one embodiment, a surgical stapling system
is provided. The surgical stapling system comprises: an elongated
shaft assembly configured to transmit actuation motions from an
actuator; and an end effector for compressing and stapling tissue,
the end effector operably coupled to the elongated shaft, the end
effector comprising: an elongated channel; an anvil having a staple
forming surface thereon, the anvil moveable relative to the
elongated channel between an open position and a closed position;
and a staple cartridge removably positioned within the elongated
channel, the staple cartridge comprising: a cartridge body having
an upper surface in a confronting relationship with the anvil's
staple forming surface when the anvil is in a closed position; one
or more LEDs positioned to provide illumination to the area between
the anvil and the staple cartridge when the anvil is in a closed
position; and a plurality of staple drivers within the cartridge
body each supporting a staple. In one embodiment, the one or more
LEDs emit ultraviolet light or infrared light. In one embodiment,
the staples are coated in a fluorescing dye.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] The features and advantages of the various embodiments of
the invention, and the manner of attaining them, will become more
apparent and the embodiment of the invention itself will be better
understood by reference to the following description of embodiments
of the embodiment of the invention taken in conjunction with the
accompanying drawings, wherein:
[0007] FIG. 1 is a perspective view of a surgical instrument that
has an interchangeable shaft assembly operably coupled thereto;
[0008] FIG. 2 is an exploded assembly view of the interchangeable
shaft assembly and surgical instrument of FIG. 1;
[0009] FIG. 3 is another exploded assembly view showing portions of
the interchangeable shaft assembly and surgical instrument of FIGS.
1 and 2;
[0010] FIG. 4 is an exploded assembly view of a portion of the
surgical instrument of FIGS. 1-3;
[0011] 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;
[0012] 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;
[0013] FIG. 7 is an exploded assembly view of one form of an
interchangeable shaft assembly;
[0014] FIG. 8 is another exploded assembly view of portions of the
interchangeable shaft assembly of FIG. 7;
[0015] FIG. 9 is another exploded assembly view of portions of the
interchangeable shaft assembly of FIGS. 7 and 8;
[0016] FIG. 10 is a cross-sectional view of a portion of the
interchangeable shaft assembly of FIGS. 7-9;
[0017] FIG. 11 is a perspective view of a portion of the shaft
assembly of FIGS. 7-10 with the switch drum omitted for
clarity;
[0018] FIG. 12 is another perspective view of the portion of the
interchangeable shaft assembly of FIG. 11 with the switch drum
mounted thereon;
[0019] 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;
[0020] FIG. 14 is a right side elevational view of the
interchangeable shaft assembly and surgical instrument of FIG.
13;
[0021] FIG. 15 is a left side elevational view of the
interchangeable shaft assembly and surgical instrument of FIGS. 13
and 14;
[0022] 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;
[0023] FIG. 17 is a right side elevational view of the
interchangeable shaft assembly and surgical instrument of FIG.
16;
[0024] FIG. 18 is a left side elevational view of the
interchangeable shaft assembly and surgical instrument of FIGS. 16
and 17;
[0025] 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;
[0026] 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;
[0027] FIG. 20 is an exploded view of one embodiment of an end
effector of the surgical instrument of FIG. 1;
[0028] FIGS. 21A-21B is a circuit diagram of the surgical
instrument of FIG. 1 spanning two drawings sheets;
[0029] 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;
[0030] FIG. 23 illustrates one embodiment of a process for
sequentially energizing a segmented circuit;
[0031] FIG. 24 illustrates one embodiment of a power segment
comprising a plurality of daisy chained power converters;
[0032] FIG. 25 illustrates one embodiment of a segmented circuit
configured to maximize power available for critical and/or power
intense functions;
[0033] FIG. 26 illustrates one embodiment of a power system
comprising a plurality of daisy chained power converters configured
to be sequentially energized;
[0034] FIG. 27 illustrates one embodiment of a segmented circuit
comprising an isolated control section;
[0035] FIG. 28 illustrates one embodiment of an end effector
comprising a first sensor and a second sensor;
[0036] FIG. 29 is a logic diagram illustrating one embodiment of a
process for adjusting the measurement of the first sensor based on
input from the second sensor of the end effector illustrated in
FIG. 28;
[0037] FIG. 30 is a logic diagram illustrating one embodiment of a
process for determining a look-up table for a first sensor based on
the input from a second sensor;
[0038] FIG. 31 is a logic diagram illustrating one embodiment of a
process for calibrating a first sensor in response to an input from
a second sensor;
[0039] FIG. 32A is a logic diagram illustrating one embodiment of a
process for determining and displaying the thickness of a tissue
section clamped between an anvil and a staple cartridge of an end
effector;
[0040] FIG. 32B is a logic diagram illustrating one embodiment of a
process for determining and displaying the thickness of a tissue
section clamped between the anvil and the staple cartridge of the
end effector;
[0041] FIG. 33 is a graph illustrating an adjusted Hall effect
thickness measurement compared to an unmodified Hall effect
thickness measurement;
[0042] FIG. 34 illustrates one embodiment of an end effector
comprising a first sensor and a second sensor;
[0043] FIG. 35 illustrates one embodiment of an end effector
comprising a first sensor and a plurality of second sensors;
[0044] FIG. 36 is a logic diagram illustrating one embodiment of a
process for adjusting a measurement of a first sensor in response
to a plurality of secondary sensors;
[0045] FIG. 37 illustrates one embodiment of a circuit configured
to convert signals from a first sensor and a plurality of secondary
sensors into digital signals receivable by a processor;
[0046] FIG. 38 illustrates one embodiment of an end effector
comprising a plurality of sensors;
[0047] FIG. 39 is a logic diagram illustrating one embodiment of a
process for determining one or more tissue properties based on a
plurality of sensors;
[0048] FIG. 40 illustrates one embodiment of an end effector
comprising a plurality of sensors coupled to a second jaw
member;
[0049] FIG. 41 illustrates one embodiment of a staple cartridge
comprising a plurality of sensors formed integrally therein;
[0050] FIG. 42 is a logic diagram illustrating one embodiment of a
process for determining one or more parameters of a tissue section
clamped within an end effector;
[0051] FIG. 43 illustrates one embodiment of an end effector
comprising a plurality of redundant sensors;
[0052] FIG. 44 is a logic diagram illustrating one embodiment of a
process for selecting the most reliable output from a plurality of
redundant sensors;
[0053] FIG. 45 illustrates one embodiment of an end effector
comprising a sensor comprising a specific sampling rate to limit or
eliminate false signals;
[0054] FIG. 46 is a logic diagram illustrating one embodiment of a
process for generating a thickness measurement for a tissue section
located between an anvil and a staple cartridge of an end
effector;
[0055] FIG. 47 illustrates one embodiment of a circular
stapler;
[0056] FIGS. 48A-48D illustrate a clamping process of the circular
stapler illustrated in FIG. 47, where FIG. 48A illustrates the
circular stapler in an initial position with the anvil and the body
in a closed configuration, FIG. 48B illustrates that the anvil is
moved distally to disengage with the body and create a gap
configured to receive a tissue section therein, once the circular
stapler 3400 is positioned, FIG. 48C illustrates the tissue section
compressed to a predetermined compression between the anvil and the
body, and FIG. 48D illustrates the circular stapler in position
corresponding to staple deployment;
[0057] FIG. 49 illustrates one embodiment of a circular staple
anvil and an electrical connector configured to interface
therewith;
[0058] FIG. 50 illustrates one embodiment of a surgical instrument
comprising a sensor coupled to a drive shaft of the surgical
instrument;
[0059] FIG. 51 is a flow chart illustrating one embodiment of a
process for determining uneven tissue loading in an end
effector;
[0060] FIG. 52 illustrates one embodiment of an end effector
configured to determine one or more parameters of a tissue section
during a clamping operation;
[0061] FIGS. 53A and 53B illustrate an embodiment of an end
effector configured to normalize a Hall effect voltage irrespective
of a deck height of a staple cartridge;
[0062] FIG. 54 is a logic diagram illustrating one embodiment of a
process for determining when the compression of tissue within an
end effector, such as, for example, the end effector illustrated in
FIGS. 53A-53B, has reached a steady state;
[0063] FIG. 55 is a graph illustrating various Hall effect sensor
readings;
[0064] FIG. 56 is a logic diagram illustrating one embodiment of a
process for determining when the compression of tissue within an
end effector, such as, for example, the end effector illustrated in
FIGS. 53A-53B, has reached a steady state;
[0065] FIG. 57 is a logic diagram illustrating one embodiment of a
process for controlling an end effector to improve proper staple
formation during deployment;
[0066] FIG. 58 is a logic diagram illustrating one embodiment of a
process for controlling an end effector to allow for fluid
evacuation and provide improved staple formation;
[0067] FIGS. 59A-59B illustrate one embodiment of an end effector
comprising a pressure sensor;
[0068] FIG. 60 illustrates one embodiment of an end effector
comprising a second sensor located between a staple cartridge and a
second jaw member;
[0069] FIG. 61 is a logic diagram illustrating one embodiment of a
process for determining and displaying the thickness of a tissue
section clamped in an end effector, according to FIGS. 59A-59B or
FIG. 60;
[0070] FIG. 62 illustrates one embodiment of an end effector
comprising a plurality of second sensors located between a staple
cartridge and an elongated channel;
[0071] FIGS. 63A and 63B further illustrate the effect of a full
versus partial bite of tissue;
[0072] FIG. 64 illustrates one embodiment of an end effector
comprising a coil and oscillator circuit for measuring the gap
between the anvil and the staple cartridge;
[0073] FIG. 65 illustrates and alternate view of the end effector.
As illustrated, in some embodiments external wiring may supply
power to the oscillator circuit;
[0074] FIG. 66 illustrates examples of the operation of a coil to
detect eddy currents in a target;
[0075] FIG. 67 illustrates a graph of a measured quality factor,
the measured inductance, and measure resistance of the radius of a
coil as a function of the coil's standoff to a target;
[0076] FIG. 68 illustrates one embodiment of an end effector
comprising an emitter and sensor placed between the staple
cartridge and the elongated channel;
[0077] FIG. 69 illustrates an embodiment of an emitter and sensor
in operation;
[0078] FIG. 70 illustrates the surface of an embodiment of an
emitter and sensor comprising a MEMS transducer;
[0079] FIG. 71 illustrates a graph of an example of the reflected
signal that may be measured by the emitter and sensor of FIG.
69;
[0080] FIG. 72 illustrates an embodiment of an end effector that is
configured to determine the location of a cutting member or
knife;
[0081] FIG. 73 illustrates an example of the code strip in
operation with red LEDs and an infrared LEDs;
[0082] FIG. 74 illustrates a partial perspective view of an end
effector of a surgical instrument comprising a staple cartridge
according to various embodiments described herein;
[0083] FIG. 75 illustrates a elevational view of a portion of the
end effector of FIG. 74 according to various embodiments described
herein;
[0084] FIG. 76 illustrates a logic diagram of a module of the
surgical instrument of FIG. 74 according to various embodiments
described herein;
[0085] FIG. 77 illustrates a partial view of a cutting edge, an
optical sensor, and a light source of the surgical instrument of
FIG. 74 according to various embodiments described herein;
[0086] FIG. 78 illustrates a partial view of a cutting edge, an
optical sensor, and a light source of the surgical instrument of
FIG. 74 according to various embodiments described herein;
[0087] FIG. 79 illustrates a partial view of a cutting edge, an
optical sensor, and a light source of the surgical instrument of
FIG. 74 according to various embodiments described herein;
[0088] FIG. 80 illustrates a partial view of a cutting edge,
optical sensors, and light sources of the surgical instrument of
FIG. 74 according to various embodiments described herein;
[0089] FIG. 81 illustrates a partial view of a cutting edge, an
optical sensor, and a light source of the surgical instrument of
FIG. 74 according to various embodiments described herein;
[0090] FIG. 82 illustrates a partial view of a cutting edge between
cleaning blades of the surgical instrument of FIG. 74 according to
various embodiments described herein;
[0091] FIG. 83 illustrates a partial view of a cutting edge between
cleaning sponges of the surgical instrument of FIG. 74 according to
various embodiments described herein;
[0092] FIG. 84 illustrates a perspective view of a staple cartridge
including a sharpness testing member according to various
embodiments described herein;
[0093] FIG. 85 illustrates a logic diagram of a module of a
surgical instrument according to various embodiments described
herein;
[0094] FIG. 86 illustrates a logic diagram of a module of a
surgical instrument according to various embodiments described
herein;
[0095] FIG. 87 illustrates a logic diagram outlining a method for
evaluating sharpness of a cutting edge of a surgical instrument
according to various embodiments described herein;
[0096] FIG. 88 illustrates a chart of the forces applied against a
cutting edge of a surgical instrument by the sharpness testing
member of FIG. 84 at various sharpness levels according to various
embodiments described herein;
[0097] FIG. 89 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 described herein;
and
[0098] FIG. 90 illustrates a table showing predefined tissue
thicknesses and corresponding predefined threshold forces according
to various embodiments described herein.
[0099] FIG. 91 illustrates a perspective view of a surgical
instrument including a handle, a shaft assembly, and an end
effector;
[0100] FIG. 92 illustrates a logic diagram of a common control
module for use with a plurality of motors of the surgical
instrument of FIG. 91;
[0101] FIG. 93 illustrates a partial elevational view of the handle
of the surgical instrument of FIG. 91 with a removed outer
casing;
[0102] FIG. 94 illustrates a partial elevational view of the
surgical instrument of FIG. 91 with a removed outer casing.
[0103] FIG. 95A illustrates a side angle view of an end effector
with the anvil in a closed position, illustrating one located on
either side of the cartridge deck;
[0104] FIG. 95B illustrates a three-quarter angle view of the end
effector with the anvil in an open position, and one LED located on
either side of the cartridge deck;
[0105] FIG. 96A illustrates a side angle view of an end effector
with the anvil in a closed position and a plurality of LEDs located
on either side of the cartridge deck;
[0106] FIG. 96B illustrates a three-quarter angle view of the end
effector with the anvil in an open position, and a plurality of
LEDs located on either side of the cartridge deck;
[0107] FIG. 97A illustrates a side angle view of an end effector
with the anvil in a closed position, and a plurality of LEDs from
the proximal to the distal end of the staple cartridge, on either
side of the cartridge deck; and
[0108] FIG. 97B illustrates a three-quarter angle view of the end
effector with the anvil in an open position, illustrating a
plurality of LEDs from the proximal to the distal end of the staple
cartridge, and on either side of the cartridge deck.
[0109] FIG. 98A illustrates an embodiment wherein the tissue
compensator is removably attached to the anvil portion of the end
effector;
[0110] FIG. 98B illustrates a detail view of a portion of the
tissue compensator shown in FIG. 98A;
[0111] FIG. 99 illustrates various example embodiments that use the
layer of conductive elements and conductive elements in the staple
cartridge to detect the distance between the anvil and the upper
surface of the staple cartridge;
[0112] FIGS. 100A and 100B illustrate an embodiment of the tissue
compensator comprising a layer of conductive elements in
operation;
[0113] FIGS. 101A and 101B illustrate an embodiment of an end
effector comprising a tissue compensator further comprising
conductors embedded within;
[0114] FIGS. 102A and 102B illustrate an embodiment of an end
effector comprising a tissue compensator further comprising
conductors embedded therein;
[0115] FIG. 103 illustrates an embodiment of a staple cartridge and
a tissue compensator wherein the staple cartridge provides power to
the conductive elements that comprise the tissue compensator;
[0116] FIGS. 104A and 104B illustrate an embodiment of a staple
cartridge and a tissue compensator wherein the staple cartridge
provides power to the conductive elements that comprise the tissue
compensator;
[0117] FIGS. 105A and 105B illustrate an embodiment of an end
effector comprising position sensing elements and a tissue
compensator;
[0118] FIGS. 106A and 106B illustrate an embodiment of an end
effector comprising position sensing elements and a tissue
compensator;
[0119] FIGS. 107A and 107B illustrate an embodiment of a staple
cartridge and a tissue compensator that is operable to indicate the
position of a cutting member or knife bar;
[0120] FIG. 108 illustrates one embodiment of an end effector
comprising a magnet and a Hall effect sensor wherein the detected
magnetic field can be used to identify a staple cartridge;
[0121] FIG. 109 illustrates on embodiment of an end effector
comprising a magnet and a Hall effect sensor wherein the detected
magnetic field can be used to identify a staple cartridge;
[0122] FIG. 110 illustrates a graph of the voltage detected by a
Hall effect sensor located in the distal tip of a staple cartridge,
such as is illustrated in FIGS. 108 and 109, in response to the
distance or gap between a magnet located in the anvil and the Hall
effect sensor in the staple cartridge, such as illustrated in FIGS.
108 and 109;
[0123] FIG. 111 illustrates one embodiment of the housing of the
surgical instrument, comprising a display;
[0124] FIG. 112 illustrates one embodiment of a staple retainer
comprising a magnet;
[0125] FIGS. 113A and 113B illustrate one embodiment of an end
effector comprising a sensor for identifying staple cartridges of
different types;
[0126] FIG. 114 is a partial view of an end effector with sensor
power conductors for transferring power and data signals between
the connected components of the surgical instrument according to
one embodiment.
[0127] FIG. 115 is a partial view of the end effector shown in FIG.
114 showing sensors and/or electronic components located in an end
effector.
[0128] FIG. 116 is a block diagram of a surgical instrument
electronic subsystem comprising a short circuit protection circuit
for the sensors and/or electronic components according to one
embodiment.
[0129] FIG. 117 is a short circuit protection circuit comprising a
supplementary power supply circuit 7014 coupled to a main power
supply circuit, according to one embodiment.
[0130] FIG. 118 is a block diagram of a surgical instrument
electronic subsystem comprising a sample rate monitor to provide
power reduction by limiting sample rates and/or duty cycle of the
sensor components when the surgical instrument is in a non-sensing
state, according to one embodiment.
[0131] FIG. 119 is a block diagram of a surgical instrument
electronic subsystem comprising an over current/voltage protection
circuit for sensors and/or electronic components of a surgical
instrument, according to one embodiment.
[0132] FIG. 120 is an over current/voltage protection circuit for
sensors and electronic components for a surgical instrument,
according to one embodiment.
[0133] FIG. 121 is a block diagram of a surgical instrument
electronic subsystem with a reverse polarity protection circuit for
sensors and/or electronic components according to one
embodiment.
[0134] FIG. 122 is a reverse polarity protection circuit for
sensors and/or electronic components for a surgical instrument
according to one embodiment.
[0135] FIG. 123 is a block diagram of a surgical instrument
electronic subsystem with power reduction utilizing a sleep mode
monitor for sensors and/or electronic components according to one
embodiment.
[0136] FIG. 124 is a block diagram of a surgical instrument
electronic subsystem comprising a temporary power loss circuit to
provide protection against intermittent power loss for sensors
and/or electronic components in modular surgical instruments.
[0137] FIG. 125 illustrates one embodiment of a temporary power
loss circuit implemented as a hardware circuit.
[0138] FIG. 126A illustrates a perspective view of one embodiment
of an end effector comprising a magnet and a Hall effect sensor in
communication with a processor;
[0139] FIG. 126B illustrates a sideways cross-sectional view of one
embodiment of an end effector comprising a magnet and a Hall effect
sensor in communication with processor;
[0140] FIG. 127 illustrates one embodiment of the operable
dimensions that relate to the operation of the Hall effect
sensor;
[0141] FIG. 128A illustrates an external side view of an embodiment
of a staple cartridge;
[0142] FIG. 128B illustrates various dimensions possible between
the lower surface of the push-off lug and the top of the Hall
effect sensor;
[0143] FIG. 128C illustrates an external side view of an embodiment
of a staple cartridge;
[0144] FIG. 128D illustrates various dimensions possible between
the lower surface of the push-off lug and the upper surface of the
staple cartridge above the Hall effect sensor;
[0145] FIG. 129A further illustrates a front-end cross-sectional
view 10054 of the anvil 10002 and the central axis point of the
anvil;
[0146] FIG. 129B is a cross sectional view of a magnet shown in
FIG. 129A;
[0147] FIGS. 130A-130E illustrate one embodiment of an end effector
that comprises a magnet where FIG. 130A illustrates a front-end
cross-sectional view of the end effector, FIG. 130B illustrates a
front-end cutaway view of the anvil and the magnet in situ, FIG.
130C illustrates a perspective cutaway view of the anvil and the
magnet, FIG. 130D illustrates a side cutaway view of the anvil and
the magnet, and FIG. 130E illustrates a top cutaway view of the
anvil and the magnet;
[0148] FIGS. 131A-131E illustrate another embodiment of an end
effector that comprises a magnet where FIG. 131A illustrates a
front-end cross-sectional view of the end effector, FIG. 131B
illustrates a front-end cutaway view of the anvil and the magnet,
in situ, FIG. 131C illustrates a perspective cutaway view of the
anvil and the magnet, FIG. 131D illustrates a side cutaway view of
the anvil and the magnet, and FIG. 131E illustrates a top cutaway
view of the anvil and magnet;
[0149] FIG. 132 illustrates contact points between the anvil and
either the staple cartridge and/or the elongated channel;
[0150] FIGS. 133A and 133B illustrate one embodiment of an end
effector that is operable to use conductive surfaces at the distal
contact point to create an electrical connection;
[0151] FIGS. 134A-134C illustrate one embodiment of an end effector
that is operable to use conductive surfaces to form an electrical
connection where FIG. 134A illustrates an end effector comprising
an anvil, an elongated channel, and a staple cartridge, FIG. 134B
illustrates the inside surface of the anvil further comprising
first conductive surfaces located distally from the staple-forming
indents, and FIG. 134C illustrates the staple cartridge comprising
a cartridge body and first conductive surfaces located such that
they can come into contact with a second conductive surface located
on the staple cartridge;
[0152] FIGS. 135A and 135B illustrate one embodiment of an end
effector that is operable to use conductive surfaces to form an
electrical connection where FIG. 135A illustrates an end effector
comprising an anvil, an elongated channel, and a staple cartridge
and FIG. 109B 135B is a close-up view of the staple cartridge
illustrating the first conductive surface located such that it can
come into contact with second conductive surfaces;
[0153] FIGS. 136A and 136B illustrate one embodiment of an end
effector that is operable to use conductive surfaces to form an
electrical connection where FIG. 136A illustrates an end effector
comprising an anvil, an elongated channel, and a staple cartridge
and FIG. 136B is a close-up view of the staple cartridge
illustrating the anvil further comprising a magnet and an inside
surface, which further comprises a number of staple-forming
indents;
[0154] FIGS. 137A-137C illustrate one embodiment of an end effector
that is operable to use the proximal contact point to form an
electrical connection where FIG. 137A illustrates the end effector,
which comprises an anvil, an elongated channel, and a staple
cartridge, FIG. 137B is a close-up view of a pin as it rests within
an aperture defined in the elongated channel for that purpose, and
FIG. 137C illustrates an alternate embodiment, with an alternate
location for a second conductive surface on the surface of the
aperture;
[0155] FIG. 138 illustrates one embodiment of an end effector with
a distal sensor plug;
[0156] FIG. 139A illustrates the end effector shown in FIG. 138
with the anvil in an open position;
[0157] FIG. 139B illustrates a cross-sectional view of the end
effector shown in FIG. 139A with the anvil in an open position;
[0158] FIG. 139C illustrates the end effector shown in FIG. 138
with the anvil in a closed position;
[0159] FIG. 139D illustrates a cross sectional view of the end
effector shown in FIG. 139C with the anvil in a closed
position;
[0160] FIG. 140 provides a close-up view of the cross section of
the distal end of the end effector;
[0161] FIG. 141 illustrates a close-up top view of the staple
cartridge that comprises a distal sensor plug;
[0162] FIG. 142A is a perspective view of the underside of a staple
cartridge that comprises a distal sensor plug;
[0163] FIG. 142B illustrates a cross sectional view of the distal
end of the staple cartridge;
[0164] FIGS. 143A-143C illustrate one embodiment of a staple
cartridge that comprises a flex cable connected to a Hall effect
sensor and processor where FIG. 143A is an exploded view of the
staple cartridge, FIG. 143B illustrates the assembly of the staple
cartridge and the flex cable in greater detail, and FIG. 143C
illustrates a cross sectional view of the staple cartridge to
illustrate the placement of the Hall effect sensor, processor, and
conductive coupling within the distal end of the staple cartridge,
in accordance with the present embodiment;
[0165] FIG. 144A-144F illustrate one embodiment of a staple
cartridge that comprises a flex cable connected to a Hall effect
sensor and a processor where FIG. 144A is an exploded view of the
staple cartridge, FIG. 144B illustrates the assembly of the staple
cartridge, FIG. 144C illustrates the underside of an assembled
staple cartridge, and also illustrates the flex cable in greater
detail, FIG. 144D illustrates a cross sectional view of the staple
cartridge to illustrate the placement of the Hall effect sensor,
processor, and conductive coupling, FIG. 144E illustrates the
underside of the staple cartridge without the cartridge tray and
including the wedge sled, in its most distal position, and FIG.
144F illustrates the staple cartridge without the cartridge tray in
order to illustrate a possible placement for the cable traces;
[0166] FIGS. 145A and 145B illustrates one embodiment of a staple
cartridge that comprises a flex cable, a Hall effect sensor, and a
processor where FIG. 145A is an exploded view of the staple
cartridge and FIG. 145B illustrates the assembly of the staple
cartridge and the flex cable in greater detail;
[0167] FIG. 146A illustrates a perspective view of an end effector
coupled to a shaft assembly;
[0168] FIG. 146B illustrates a perspective view of an underside of
the end effector and shaft assembly shown in FIG. 146A;
[0169] FIG. 146C illustrates the end effector shown in FIGS. 146A
and 146B with a flex cable and without the shaft assembly;
[0170] FIGS. 146D and 146E illustrate an elongated channel portion
of the end effector shown in FIGS. 146A and 146B without the anvil
or the staple cartridge, to illustrate how the flex cable shown in
FIG. 146C can be seated within the elongated channel;
[0171] FIG. 146F illustrates the flex cable, shown in FIGS.
146C-120E 146C-146E, alone;
[0172] FIG. 147 illustrates a close up view of the elongated
channel shown in FIGS. 146D and 146E with a staple cartridge
coupled thereto;
[0173] FIGS. 148A-148D further illustrate one embodiment of a
staple cartridge operative with the present embodiment of an end
effector where FIG. 148A illustrates a close up view of the
proximal end of the staple cartridge, FIG. 148B illustrates a
close-up view of the distal end of the staple cartridge, with a
space for a distal sensor plug, FIG. 148C further illustrates the
distal sensor plug, and FIG. 148D illustrates the proximal-facing
side of the distal sensor plug;
[0174] FIGS. 149A and 149B illustrate one embodiment of a distal
sensor plug where FIG. 149A illustrates a cutaway view of the
distal sensor plug and FIG. 149B further illustrates the Hall
effect sensor and the processor operatively coupled to the flex
board such that they are capable of communicating;
[0175] FIG. 150 illustrates an embodiment of an end effector with a
flex cable operable to provide power to sensors and electronics in
the distal tip of the anvil portion;
[0176] FIGS. 151A-151C illustrate the operation of the articulation
joint and flex cable of the end effector where FIG. 151A
illustrates a top view of the end effector with the end effector
pivoted -45 degrees with respect to the shaft assembly, FIG. 151B
illustrates a top view of the end effector, and FIG. 151C
illustrates a top view of the end effector with the end effector
pivoted +45 degrees with respect to the shaft assembly;
[0177] FIG. 152 illustrates cross-sectional view of the distal tip
of an embodiment of an anvil with sensors and electronics; and
[0178] FIG. 153 illustrates a cutaway view of the distal tip of the
anvil.
DESCRIPTION
[0179] Certain example embodiments will now be described to provide
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 embodiments 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 example embodiments. The features illustrated or
described in connection with one example embodiment may be combined
with the features of other embodiments. Such modifications and
variations are intended to be included within the scope of the
present embodiment of the invention.
[0180] Reference throughout the specification to "various
embodiments," "some embodiments," "one embodiment," or "an
embodiment", or the like, means that a particular feature,
structure, or characteristic described in connection with the
embodiment is included in at least one embodiment. Thus,
appearances of the phrases "in various embodiments," "in some
embodiments," "in one embodiment", or "in an embodiment", or the
like, in places throughout the specification are not necessarily
all referring to the same embodiment. Furthermore, the particular
features, structures, or characteristics may be combined in any
suitable manner in one or more embodiments. Thus, the particular
features, structures, or characteristics illustrated or described
in connection with one embodiment may be combined, in whole or in
part, with the features structures, or characteristics of one or
more other embodiments without limitation. Such modifications and
variations are intended to be included within the scope of the
present embodiment of the invention.
[0181] 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.
[0182] 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.
[0183] FIGS. 1-6 depict a motor-driven surgical cutting and
fastening instrument 10 that may or may not be reused. In the
illustrated embodiment, the instrument 10 includes a housing 12
that comprises a handle 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
may also be effectively employed in connection with
robotically-controlled surgical systems. Thus, the term "housing"
may also 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" may also 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.
Patent Application Publication No. US 2012/0298719. U.S. patent
application Ser. No. 13/118,241, entitled SURGICAL STAPLING
INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS, now U.S.
Patent Application Publication No. US 2012/0298719, is incorporated
by reference herein in its entirety.
[0184] 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 may also 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.
[0185] 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 14. As shown in FIG. 4, the handle
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 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.
[0186] Referring now to FIG. 4, the handle 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 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 may also be referred to
herein as an "attachment member" and include a transverse
attachment pin 37.
[0187] 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 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 may also be employed.
[0188] 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 embodiment, a Hall effect sensor 65, for
example, can be mounted to the bottom surface of the circuit board
100. The Hall effect sensor 65 can be configured to detect changes
in a magnetic field surrounding the Hall effect sensor 65 caused by
the movement of the magnetic element 63. The Hall effect 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.
[0189] In at least one form, the handle 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 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.
[0190] 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 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 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.
[0191] Actuation of the motor 82 can be controlled by a firing
trigger 130 that is pivotally supported on the handle 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 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.
[0192] As discussed above, the handle 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 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 Hall effect sensor 803 and a second Hall
effect sensor 804, for example, which can be configured to track
the position of the magnet 802. 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 Hall
effect sensor 803 and a second position adjacent the second Hall
effect sensor 804. 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 Hall effect 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.
[0193] 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 142
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 142 to ratchet the drive member
120 in the proximal direction "PD". U.S. Patent Application
Publication No. US 2010/0089970 discloses bailout arrangements and
other components, arrangements and systems that may also 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, now
U.S. Patent Application Publication No. 2010/0089970, is hereby
incorporated by reference in its entirety.
[0194] 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. 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 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. 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.
[0195] 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 14.
[0196] 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 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.
[0197] 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. 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.
[0198] 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 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 may also be articulated relative to the
closure tube 260 by an articulation driver 230.
[0199] 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 may also 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.
[0200] 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.
[0201] 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.
[0202] 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.
[0203] 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,
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, 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.
[0204] As discussed above, the shaft assembly 200 can include a
proximal portion which is fixably mounted to the handle 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 Hall effect
sensor 605, for example, and the switch drum 500 can comprise a
magnetic element, such as permanent magnet 505, for example. The
Hall effect 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 Hall effect sensor 605. In
various instances, Hall effect sensor 605 can detect changes in a
magnetic field created when the permanent magnet 505 is moved. The
Hall effect 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 Hall effect 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.
[0205] 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 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. See FIGS. 3 and 6.
[0206] Various shaft assembly embodiments 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 embodiment, 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.
[0207] 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.
[0208] 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.
[0209] Attachment of the interchangeable shaft assembly 200 to the
handle 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.
[0210] 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 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
14. Another system can comprise a closure drive system 30 which can
operably connect the closure trigger 32 of the handle 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 14
with the intermediate firing shaft 222 of the shaft assembly
200.
[0211] 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 14, such as
microcontroller, for example, that a shaft assembly, such as shaft
assembly 200, for example, has been operably engaged with the
handle 14 and/or, two, conduct power and/or communication signals
between the shaft assembly 200 and the handle 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, 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 14.
[0212] Referring again to FIGS. 2 and 3, the handle 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 embodiment
utilizes six contacts, other embodiments are envisioned which may
utilize more than six contacts or less than six contacts.
[0213] 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 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 14, the electrical
contacts 1401a-1401f may not communicate with each other. When a
shaft assembly is not assembled to the handle 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 14 may be
unpowered when a shaft assembly, such as shaft assembly 200, for
example, is not attached to the handle 14.
[0214] 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 14. Even though
the microcontroller 1500 may be supplied with power to operate
other functionalities of the handle 14 in such circumstances, the
handle 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 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 14 is in a powered-up or a powered-down state.
[0215] 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
14, for example, to the first electrical contact 1401a regardless
of whether the handle 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 14. In
certain circumstances, further to the below, a Hall effect 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 14 and powered up when a shaft assembly
is installed to the handle 14.
[0216] In various circumstances, referring again to FIG. 19, the
handle 14 can include the Hall effect 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 14. The Hall effect 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 Hall
effect 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
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 Hall effect sensor 1402 can detect the magnetic element
1407. While a Hall effect 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 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 14 and powered up when a
shaft assembly is installed to the handle 14.
[0217] In various embodiments, any number of magnetic sensing
elements may be employed to detect whether a shaft assembly has
been assembled to the handle 14, for example. For example, the
technologies used for magnetic field sensing include 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.
[0218] 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.
[0219] 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.
[0220] As discussed above, the handle 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 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 embodiment depicted
in FIG. 3, the shaft contacts 1411a-1411f can comprise male
contacts. In at least one embodiment, 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 embodiment, 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 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 14. In various alternative embodiments, the
handle contacts 1401a-1401f can comprise male contacts and the
shaft contacts 1411a-1411f can comprise female contacts. In certain
alternative embodiments, the handle contacts 1401a-1401f and the
shaft contacts 1411a-1411f can comprise any suitable arrangement of
contacts.
[0221] In various instances, the handle 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 embodiment, 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.
[0222] 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 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 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.
[0223] 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.
[0224] 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 embodiment, 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 embodiments, 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.
[0225] 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).
[0226] Having described a surgical instrument 10 in general terms,
the description now turns to a detailed description of various
electrical/electronic component of the surgical instrument 10.
Turning now to FIGS. 21A-21B, where one embodiment 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.
[0227] In one embodiment, 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 embodiment, 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 embodiment, 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.
[0228] 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.
[0229] In one embodiment, 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
embodiments, 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 embodiments,
the acceleration segment 2002c is coupled to the safety processor
2004 and/or the primary processor 2006.
[0230] In one embodiment, 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 embodiments, the display segment 2002d is
coupled to the safety processor 2004.
[0231] In some embodiments, 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 embodiments, 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 embodiments, 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.
[0232] In some embodiments, 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 embodiments, the magnetic
rotary position encoders 2040a-2040b may be coupled to the safety
processor 2004 and/or the primary processor 2006.
[0233] In some embodiments, 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 embodiments, the motor 2048 is
coupled to a motor electromagnetic interference (EMI) filter
2050.
[0234] 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
embodiments, 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 embodiments, 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.
[0235] In some embodiments, 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 embodiments, one or more components may be
shared between two or more circuit segments 2002a-2002g.
[0236] In some embodiments, 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 embodiments, 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 embodiments, a firing switch 2066, a clamp release switch
2068, and a shaft engaged switch 2070 are coupled to the primary
processor 2006.
[0237] 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 embodiments, 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 embodiments, 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 embodiment, one or more of the left
side and/or right side articulation switches 2058a-2064b may be
combined into a single multi-position switch.
[0238] In one embodiment, 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 embodiments, 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 embodiments,
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.
[0239] In one embodiment, 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 embodiment, the safety processor 2004 is coupled
to at least a first sensor. The first sensor measures a first
property of the surgical instrument 10. In some embodiments, the
safety processor 2004 is configured to compare the measured
property of the surgical instrument 10 to a predetermined value.
For example, in one embodiment, 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
embodiments, 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.
[0240] In some embodiments, 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 embodiment 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.
[0241] 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 embodiments, 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 embodiments, 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.
[0242] In some embodiments, 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 embodiment, 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.
[0243] In some embodiments, 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.
[0244] In one embodiment, 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 embodiment, 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 embodiments, 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.
[0245] In some embodiments, 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 embodiments,
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.
[0246] 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.
[0247] 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.
[0248] 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.
[0249] 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.
[0250] 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.
[0251] 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.
[0252] 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.
[0253] 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.
[0254] In some instances, the use indicator 2106 comprises a time
constant that approximates the single patient procedure time. In
one embodiment, 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 embodiment, 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.
[0255] Referring back to FIG. 2, 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.
[0256] 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.
[0257] 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.
[0258] 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.
[0259] 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.
[0260] 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.
[0261] 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.
[0262] 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.
[0263] 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.
[0264] 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.
[0265] 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.
[0266] 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.
[0267] In some embodiments, 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
embodiment 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 embodiments, the segmented
circuit 2000 transitions from sleep mode following a similar
sequential power-up process 11250.
[0268] FIG. 24 illustrates one embodiment 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 embodiment, 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 illustrated in FIGS. 69-71. 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 embodiments, the boost converter 2318 is coupled directly one
or more circuit components, such as, for example, an OLED display
2388.
[0269] 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 embodiment, 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 embodiments, 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
embodiments, however, are not limited to the particular voltage
range(s) described in the context of this specification.
[0270] FIG. 25 illustrates one embodiment 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 embodiments, however, are not
limited to the particular voltage range(s) described in the context
of this specification.
[0271] 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 embodiments, however, are not
limited to the particular voltage range(s) described in the context
of this specification.
[0272] 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 embodiments, however, are not limited to
the particular voltage range(s) described in the context of this
specification.
[0273] 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 embodiments, 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 embodiments, 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.
[0274] 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 embodiments, the current monitor 2447 may
be coupled to the safety processor 2404.
[0275] In some embodiments, 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
embodiment, 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.
[0276] In some embodiments, 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
embodiment, 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.
[0277] FIG. 26 illustrates one embodiment 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 embodiment, 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 embodiments, 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
embodiments, this signal is provided by the safety processor. The
embodiments, however, are not limited to the particular voltage
range(s) described in the context of this specification.
[0278] 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 embodiments, 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
embodiments, however, are not limited to the particular voltage
range(s) described in the context of this specification.
[0279] In one embodiment, 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.
[0280] FIG. 27 illustrates one embodiment 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 embodiments, 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 embodiments, the rechargeable
battery 2608 provides a stepped-down voltage to the primary
processor, such as, for example, 3.3V. The embodiments, however,
are not limited to the particular voltage range(s) described in the
context of this specification.
[0281] Use of Multiple Sensors with One Sensor Affecting a Second
Sensor's Output or Interpretation
[0282] FIG. 28 illustrates one embodiment of an end effector 3000
comprising a first sensor 3008a and a second sensor 3008b. The end
effector 3000 is similar to the end effector 300 described above.
The end effector 3000 comprises a first jaw member, or anvil, 3002
pivotally coupled to a second jaw member 3004. The second jaw
member 3004 is configured to receive a staple cartridge 3006
therein. The staple cartridge 3006 comprises a plurality of staples
(not shown). The plurality of staples is deployable from the staple
cartridge 3006 during a surgical operation. The end effector 3000
comprises a first sensor 3008a. The first sensor 3008a is
configured to measure one or more parameters of the end effector
3000. For example, in one embodiment, the first sensor 3008a is
configured to measure the gap 3010 between the anvil 3002 and the
second jaw member 3004. The first sensor 3008a may comprise, for
example, a Hall effect sensor configured to detect a magnetic field
generated by a magnet 3012 embedded in the second jaw member 3004
and/or the staple cartridge 3006. As another example, in one
embodiment, the first sensor 3008a is configured to measure one or
more forces exerted on the anvil 3002 by the second jaw member 3004
and/or tissue clamped between the anvil 3002 and the second jaw
member 3004.
[0283] The end effector 3000 comprises a second sensor 3008b. The
second sensor 3008b is configured to measure one or more parameters
of the end effector 3000. For example, in various embodiments, the
second sensor 3008b may comprise a strain gauge configured to
measure the magnitude of the strain in the anvil 3002 during a
clamped condition. The strain gauge provides an electrical signal
whose amplitude varies with the magnitude of the strain. In various
embodiments, the first sensor 3008a and/or the second sensor 3008b
may comprise, for example, a magnetic sensor such as, for example,
a Hall effect 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 3000. The first sensor 3008a and the
second sensor 3008b may be arranged in a series configuration
and/or a parallel configuration. In a series configuration, the
second sensor 3008b may be configured to directly affect the output
of the first sensor 3008a. In a parallel configuration, the second
sensor 3008b may be configured to indirectly affect the output of
the first sensor 3008a.
[0284] In one embodiment, the one or more parameters measured by
the first sensor 3008a are related to the one or more parameters
measured by the second sensor 3008b. For example, in one
embodiment, the first sensor 3008a is configured to measure the gap
3010 between the anvil 3002 and the second jaw member 3004. The gap
3010 is representative of the thickness and/or compressibility of a
tissue section clamped between the anvil 3002 and the staple
cartridge 3006. The first sensor 3008a may comprise, for example, a
Hall effect sensor configured to detect a magnetic field generated
by a magnet 3012 coupled to the second jaw member 3004 and/or the
staple cartridge 3006. Measuring at a single location accurately
describes the compressed tissue thickness for a calibrated full bit
of tissue, but may provide inaccurate results when a partial bite
of tissue is placed between the anvil 3002 and the second jaw
member 3004. A partial bite of tissue, either a proximal partial
bite or a distal partial bite, changes the clamping geometry of the
anvil 3002.
[0285] In some embodiments, the second sensor 3008b is configured
to detect one or more parameters indicative of a type of tissue
bite, for example, a full bite, a partial proximal bite, and/or a
partial distal bite. The measurement of the second sensor 3008b may
be used to adjust the measurement of the first sensor 3008a to
accurately represent a proximal or distal positioned partial bite's
true compressed tissue thickness. For example, in one embodiment,
the second sensor 3008b comprises a strain gauge, such as, for
example, a micro-strain gauge, configured to monitor the amplitude
of the strain in the anvil during a clamped condition. The
amplitude of the strain of the anvil 3002 is used to modify the
output of the first sensor 3008a, for example, a Hall effect
sensor, to accurately represent a proximal or distal positioned
partial bite's true compressed tissue thickness. The first sensor
3008a and the second sensor 3008b may be measured in real-time
during a clamping operation. Real-time measurement allows time
based information to be analyzed, for example, by the primary
processor 2006, and used to select one or more algorithms and/or
look-up tables to recognize tissue characteristics and clamping
positioning to dynamically adjust tissue thickness
measurements.
[0286] In some embodiments, the thickness measurement of the first
sensor 3008a may be provided to an output device of a surgical
instrument 10 coupled to the end effector 3000. For example, in one
embodiment, the end effector 3000 is coupled to the surgical
instrument 10 comprising a display 2028. The measurement of the
first sensor 3008a is provided to a processor, for example, the
primary processor 2006. The primary processor 2006 adjusts the
measurement of the first sensor 3008a based on the measurement of
the second sensor 3008b to reflect the true tissue thickness of a
tissue section clamped between the anvil 3002 and the staple
cartridge 3006. The primary processor 2006 outputs the adjusted
tissue thickness measurement and an indication of full or partial
bite to the display 2028. An operator may determine whether or not
to deploy the staples in the staple cartridge 3006 based on the
displayed values.
[0287] In some embodiments, the first sensor 3008a and the second
sensor 3008b may be located in different environments, such as, for
example, the first sensor 3008a being located within a patient at a
treatment site and the second sensor 3008b being located externally
to the patient. The second sensor 3008b may be configured to
calibrate and/or modify the output of the first sensor 3008a. The
first sensor 3008a and/or the second sensor 3008b may comprise, for
example, an environmental sensor. Environmental sensors may
comprise, for example, temperature sensors, humidity sensors,
pressure sensors, and/or any other suitable environmental
sensor.
[0288] FIG. 29 is a logic diagram illustrating one embodiment of a
process 3020 for adjusting the measurement of a first sensor 3008a
based on input from a second sensor 3008b. A first signal is
captured 3022a by the first sensor 3008a. The first signal 3022a
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 3022b by the second sensor 3008b. The second signal 3022b
may be conditioned based on one or more predetermined conditioning
parameters. The first signal 3022a and the second signal 3022b are
provided to a processor, such as, for example, the primary
processor 2006. The processor 2006 adjusts the measurement of the
first sensor 3022a, as represented by the first signal 3022a, based
on the second signal 3022b from the second sensor. For example, in
one embodiment, the first sensor 3022a comprises a Hall effect
sensor and the second sensor 3022b comprises a strain gauge. The
distance measurement of the first sensor 3022a is adjusted by the
amplitude of the strain measured by the second sensor 3022b to
determine the fullness of the bite of tissue in the end effector
3000. The adjusted measurement is displayed 3026 to an operator by,
for example, a display 2026 embedded in the surgical instrument
10.
[0289] FIG. 30 is a logic diagram illustrating one embodiment of a
process 3030 for determining a look-up table for a first sensor
3008a based on the input from a second sensor 3008b. The first
sensor 3008a captures 3022a a signal indicative of one or more
parameters of the end effector 3000. The first signal 3022a 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
3022b by the second sensor 3008b. The second signal 3022b may be
conditioned based on one or more predetermined conditioning
parameters. The first signal 3022a and the second signal 3022b are
provided to a processor, such as, for example, the primary
processor 2006. The processor 2006 selects a look-up table from one
or more available look-up tables 3034a, 3034b based on the value of
the second signal. The selected look-up table is used to convert
the first signal into a thickness measurement of the tissue located
between the anvil 3002 and the staple cartridge 3006. The adjusted
measurement is displayed 3026 to an operator by, for example, a
display 2026 embedded in the surgical instrument 10.
[0290] FIG. 31 is a logic diagram illustrating one embodiment of a
process 3040 for calibrating a first sensor 3008a in response to an
input from a second sensor 3008b. The first sensor 3008a is
configured to capture 3022a a signal indicative of one or more
parameters of the end effector 3000. The first signal 3022a 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
3022b by the second sensor 3008b. The second signal 3022b may be
conditioned based on one or more predetermined conditioning
parameters. The first signal 3022a and the second signal 3022b are
provided to a processor, such as, for example, the primary
processor 2006. The primary processor 2006 calibrates 3042 the
first signal 3022a in response to the second signal 3022b. The
first signal 3022a is calibrated 3042 to reflect the fullness of
the bite of tissue in the end effector 3000. The calibrated signal
is displayed 3026 to an operator by, for example, a display 2026
embedded in the surgical instrument 10.
[0291] FIG. 32A is a logic diagram illustrating one embodiment of a
process 3050 for determining and displaying the thickness of a
tissue section clamped between the anvil 3002 and the staple
cartridge 3006 of the end effector 3000. The process 3050 comprises
obtaining a Hall effect voltage 3052, for example, through a Hall
effect sensor located at the distal tip of the anvil 3002. The Hall
effect voltage 3052 is provided to an analog to digital convertor
3054 and converted into a digital signal. The digital signal is
provided to a processor, such as, for example, the primary
processor 2006. The primary processor 2006 calibrates 3056 the
curve input of the Hall effect voltage 3052 signal. A strain gauge
3058, such as, for example, a micro-strain gauge, is configured to
measure one or more parameters of the end effector 3000, such as,
for example, the amplitude of the strain exerted on the anvil 3002
during a clamping operation. The measured strain is converted 3060
to a digital signal and provided to the processor, such as, for
example, the primary processor 2006. The primary processor 2006
uses one or more algorithms and/or lookup tables to adjust the Hall
effect voltage 3052 in response to the strain measured by the
strain gauge 3058 to reflect the true thickness and fullness of the
bite of tissue clamped by the anvil 3002 and the staple cartridge
3006. The adjusted thickness is displayed 3026 to an operator by,
for example, a display 2026 embedded in the surgical instrument
10.
[0292] In some embodiments, the surgical instrument can further
comprise a load cell or sensor 3082. The load sensor 3082 can be
located, for instance, in the shaft assembly 200, described above,
or in the housing 12, also described above. FIG. 32B is a logic
diagram illustrating one embodiment of a process 3070 for
deteimining and displaying the thickness of a tissue section
clamped between the anvil 3002 and the staple cartridge 3006 of the
end effector 3000. The process comprises obtaining a Hall effect
voltage 3072, for example, through a Hall effect sensor located at
the distal tip of the anvil 3002. The Hall effect voltage 3072 is
provided to an analog to digital convertor 3074 and converted into
a digital signal. The digital signal is provided to a processor,
such as, for example, the primary processor 2006. The primary
processor 2006 applies calibrates 3076 the curve input of the Hall
effect voltage 3072 signal. A strain gauge 3078, such as, for
example, a micro-strain gauge, is configured to measure one or more
parameters of the end effector 3000, such as, for example, the
amplitude of the strain exerted on the anvil 3002 during a clamping
operation. The measured strain is converted 3080 to a digital
signal and provided to the processor, such as, for example, the
primary processor 2006. The load sensor 3082 measures the clamping
force of the anvil 3002 against the staple cartridge 3006. The
measured clamping force is converted 3084 to a digital signal and
provided to the processor, such as for example, the primary
processor 2006. The primary processor 2006 uses one or more
algorithms and/or lookup tables to adjust the Hall effect voltage
3072 in response to the strain measured by the strain gauge 3078
and the clamping force measured by the load sensor 3082 to reflect
the true thickness and fullness of the bite of tissue clamped by
the anvil 3002 and the staple cartridge 3006. The adjusted
thickness is displayed 3026 to an operator by, for example, a
display 2026 embedded in the surgical instrument 10.
[0293] FIG. 33 is a graph 3090 illustrating an adjusted Hall effect
thickness measurement 3094 compared to an unmodified Hall effect
thickness measurement 3092. As shown in FIG. 33, the unmodified
Hall effect thickness measurement 3092 indicates a thicker tissue
measurement, as the single sensor is unable to compensate for
partial distal/proximal bites that result in incorrect thickness
measurements. The adjusted thickness measurement 3094 is generated
by, for example, the process 3050 illustrated in FIG. 32A. The Hall
effect thickness measurement 3092 is calibrated based on input from
one or more additional sensors, such as, for example, a strain
gauge. The adjusted Hall effect thickness 3094 reflects the true
thickness of the tissue located between an anvil 3002 and a staple
cartridge 3006.
[0294] FIG. 34 illustrates one embodiment of an end effector 3100
comprising a first sensor 3108a and a second sensor 3108b. The end
effector 3100 is similar to the end effector 3000 illustrated in
FIG. 28. The end effector 3100 comprises a first jaw member, or
anvil, 3102 pivotally coupled to a second jaw member 3104. The
second jaw member 3104 is configured to receive a staple cartridge
3106 therein. The end effector 3100 comprises a first sensor 3108a
coupled to the anvil 3102. The first sensor 3108a is configured to
measure one or more parameters of the end effector 3100, such as,
for example, the gap 3110 between the anvil 3102 and the staple
cartridge 3106. The gap 3110 may correspond to, for example, a
thickness of tissue clamped between the anvil 3102 and the staple
cartridge 3106. The first sensor 3108a may comprise any suitable
sensor for measuring one or more parameters of the end effector.
For example, in various embodiments, the first sensor 3108a may
comprise a magnetic sensor, such as a Hall effect sensor, a strain
gauge, a pressure sensor, an inductive sensor, such as an eddy
current sensor, a resistive sensor, a capacitive sensor, an optical
sensor, and/or any other suitable sensor.
[0295] In some embodiments, the end effector 3100 comprises a
second sensor 3108b. The second sensor 3108b is coupled to second
jaw member 3104 and/or the staple cartridge 3106. The second sensor
3108b is configured to detect one or more parameters of the end
effector 3100. For example, in some embodiments, the second sensor
3108b is configured to detect one or more instrument conditions
such as, for example, a color of the staple cartridge 3106 coupled
to the second jaw member 3104, a length of the staple cartridge
3106, a clamping condition of the end effector 3100, the number of
uses/number of remaining uses of the end effector 3100 and/or the
staple cartridge 3106, and/or any other suitable instrument
condition. The second sensor 3108b may comprise any suitable sensor
for detecting one or more instrument conditions, such as, for
example, a magnetic sensor, such as a Hall effect sensor, a strain
gauge, a pressure sensor, an inductive sensor, such as an eddy
current sensor, a resistive sensor, a capacitive sensor, an optical
sensor, and/or any other suitable sensor.
[0296] The end effector 3100 may be used in conjunction with any of
the processes shown in FIGS. 29-33. For example, in one embodiment,
input from the second sensor 3108b may be used to calibrate the
input of the first sensor 3108a. The second sensor 3108b may be
configured to detect one or more parameters of the staple cartridge
3106, such as, for example, the color and/or length of the staple
cartridge 3106. The detected parameters, such as the color and/or
the length of the staple cartridge 3106, may correspond to one or
more properties of the cartridge, such as, for example, the height
of the cartridge deck, the thickness of tissue useable/optimal for
the staple cartridge, and/or the pattern of the staples in the
staple cartridge 3106. The known parameters of the staple cartridge
3106 may be used to adjust the thickness measurement provided by
the first sensor 3108a. For example, if the staple cartridge 3106
has a higher deck height, the thickness measurement provided by the
first sensor 3108a may be reduced to compensate for the added deck
height. The adjusted thickness may be displayed to an operator, for
example, through a display 2026 coupled to the surgical instrument
10.
[0297] FIG. 35 illustrates one embodiment of an end effector 3150
comprising a first sensor 3158 and a plurality of second sensors
3160a, 3160b. The end effector 3150 comprises a first jaw member,
or anvil, 3152 and a second jaw member 3154. The second jaw member
3154 is configured to receive a staple cartridge 3156. The anvil
3152 is pivotally moveable with respect to the second jaw member
3154 to clamp tissue between the anvil 3152 and the staple
cartridge 3156. The anvil comprises a first sensor 3158. The first
sensor 3158 is configured to detect one or more parameters of the
end effector 3150, such as, for example, the gap 3110 between the
anvil 3152 and the staple cartridge 3156. The gap 3110 may
correspond to, for example, a thickness of tissue clamped between
the anvil 3152 and the staple cartridge 3156. The first sensor 3158
may comprise any suitable sensor for measuring one or more
parameters of the end effector. For example, in various
embodiments, the first sensor 3158 may comprise a magnetic sensor,
such as a Hall effect sensor, a strain gauge, a pressure sensor, an
inductive sensor, such as an eddy current sensor, a resistive
sensor, a capacitive sensor, an optical sensor, and/or any other
suitable sensor.
[0298] In some embodiments, the end effector 3150 comprises a
plurality of secondary sensors 3160a, 3160b. The secondary sensors
3160a, 3160b are configured to detect one or more parameters of the
end effector 3150. For example, in some embodiments, the secondary
sensors 3160a, 3160b are configured to measure an amplitude of
strain exerted on the anvil 3152 during a clamping procedure. In
various embodiments, the secondary sensors 3160a, 3160b may
comprise a magnetic sensor, such as a Hall effect sensor, a strain
gauge, a pressure sensor, an inductive sensor, such as an eddy
current sensor, a resistive sensor, a capacitive sensor, an optical
sensor, and/or any other suitable sensor. The secondary sensors
3160a, 3160b may be configured to measure one or more identical
parameters at different locations of the anvil 3152, different
parameters at identical locations on the anvil 3152, and/or
different parameters at different locations on the anvil 3152.
[0299] FIG. 36 is a logic diagram illustrating one embodiment of a
process 3170 for adjusting a measurement of a first sensor 3158 in
response to a plurality of secondary sensors 3160a, 3160. In one
embodiment, a Hall effect voltage is obtained 3172, for example, by
a Hall effect sensor. The Hall effect voltage is converted 3174 by
an analog to digital convertor. The converted Hall effect voltage
signal is calibrated 3176. The calibrated curve represents the
thickness of a tissue section located between the anvil 3152 and
the staple cartridge 3156. A plurality of secondary measurements
are obtained 3178a, 3178b by a plurality of secondary sensors, such
as, for example, a plurality of strain gauges. The input of the
strain gauges is converted 3180a, 3180b 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. The primary
processor utilizes the secondary measurements to adjust 3182 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 3152 and the staple cartridge 3156. The
adjusted thickness is displayed 3026 to an operator by, for
example, a display 2026 embedded in the surgical instrument 10.
[0300] FIG. 37 illustrates one embodiment of a circuit 3190
configured to convert signals from the first sensor 3158 and the
plurality of secondary sensors 3160a, 3160b into digital signals
receivable by a processor, such as, for example, the primary
processor 2006. The circuit 3190 comprises an analog-to-digital
convertor 3194. In some embodiments, the analog-to-digital
convertor 3194 comprises a 4-channel, 18-bit analog to digital
convertor. Those skilled in the art will recognize that the
analog-to-digital convertor 3194 may comprise any suitable number
of channels and/or bits to convert one or more inputs from analog
to digital signals. The circuit 3190 comprises one or more level
shifting resistors 3196 configured to receive an input from the
first sensor 3158, such as, for example, a Hall effect sensor. The
level shifting resistors 3196 adjust the input from the first
sensor, shifting the value to a higher or lower voltage depending
on the input. The level shifting resistors 3196 provide the
level-shifted input from the first sensor 3158 to the
analog-to-digital convertor.
[0301] In some embodiments, a plurality of secondary sensors 3160a,
3160b are coupled to a plurality of bridges 3192a, 3192b within the
circuit 3190. The plurality of bridges 3192a, 3192b may provide
filtering of the input from the plurality of secondary sensors
3160a, 3160b. After filtering the input signals, the plurality of
bridges 3192a, 3192b provide the inputs from the plurality of
secondary sensors 3160a, 3160b to the analog-to-digital convertor
3194. In some embodiments, a switch 3198 coupled to one or more
level shifting resistors may be coupled to the analog-to-digital
convertor 3194. The switch 3198 is configured to calibrate one or
more of the input signals, such as, for example, an input from a
Hall effect sensor. The switch 3198 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
Hall effect sensor. In some embodiments, the adjustment is not
necessary, and the switch 3198 is left in the open position to
decouple the level shifting resistors. The switch 3198 is coupled
to the analog-to-digital convertor 3194. The analog-to-digital
convertor 3194 provides an output to one or more processors, such
as, for example, the primary processor 2006. The primary processor
2006 calculates one or more parameters of the end effector 3150
based on the input from the analog-to-digital convertor 3194. For
example, in one embodiment, the primary processor 2006 calculates a
thickness of tissue located between the anvil 3152 and the staple
cartridge 3156 based on input from one or more sensors 3158, 3160a,
3160b.
[0302] FIG. 38 illustrates one embodiment of an end effector 3200
comprising a plurality of sensors 3208a-3208d. The end effector
3200 comprises an anvil 3202 pivotally coupled to a second jaw
member 3204. The second jaw member 3204 is configured to receive a
staple cartridge 3206 therein. The anvil 3202 comprises a plurality
of sensors 3208a-3208d thereon. The plurality of sensors
3208a-3208d is configured to detect one or more parameters of the
end effector 3200, such as, for example, the anvil 3202. The
plurality of sensors 3208a-3208d may comprise one or more identical
sensors and/or different sensors. The plurality of sensors
3208a-3208d may comprise, for example, magnetic sensors, such as a
Hall effect 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. For example, in one embodiment, the
plurality of sensors 3208a-3208d may comprise a plurality of strain
gauges.
[0303] In one embodiment, the plurality of sensors 3208a-3208d
allows a robust tissue thickness sensing process to be implemented.
By detecting various parameters along the length of the anvil 3202,
the plurality of sensors 3208a-3208d allow a surgical instrument,
such as, for example, the surgical instrument 10, to calculate the
tissue thickness in the jaws regardless of the bite, for example, a
partial or full bite. In some embodiments, the plurality of sensors
3208a-3208d comprises a plurality of strain gauges. The plurality
of strain gauges is configured to measure the strain at various
points on the anvil 3202. The amplitude and/or the slope of the
strain at each of the various points on the anvil 3202 can be used
to determine the thickness of tissue in between the anvil 3202 and
the staple cartridge 3206. The plurality of strain gauges may be
configured to optimize maximum amplitude and/or slope differences
based on clamping dynamics to determine thickness, tissue
placement, and/or material properties of the tissue. Time based
monitoring of the plurality of sensors 3208a-3208d during clamping
allows a processor, such as, for example, the primary processor
2006, to utilize algorithms and look-up tables to recognize tissue
characteristics and clamping positions and dynamically adjust the
end effector 3200 and/or tissue clamped between the anvil 3202 and
the staple cartridge 3206.
[0304] FIG. 39 is a logic diagram illustrating one embodiment of a
process 3220 for determining one or more tissue properties based on
a plurality of sensors 3208a-3208d. In one embodiment, a plurality
of sensors 3208a-3208d generate 3222a-3222d a plurality of signals
indicative of one or more parameters of the end effector 3200. The
plurality of generated signals is converted 3224a-3224d to digital
signals and provided to a processor. For example, in one embodiment
comprising a plurality of strain gauges, a plurality of electronic
.mu.Strain (micro-strain) conversion circuits convert 3224a-3224d
the strain gauge signals to digital signals. The digital signals
are provided to a processor, such as, for example, the primary
processor 2006. The primary processor 2006 determines 3226 one or
more tissue characteristics based on the plurality of signals. The
processor 2006 may determine the one or more tissue characteristics
by applying an algorithm and/or a look-up table. The one or more
tissue characteristics are displayed 3026 to an operator, for
example, by a display 2026 embedded in the surgical instrument
10.
[0305] FIG. 40 illustrates one embodiment of an end effector 3250
comprising a plurality of sensors 3260a-3260d coupled to a second
jaw member 3254. The end effector 3250 comprises an anvil 3252
pivotally coupled to a second jaw member 3254. The anvil 3252 is
moveable relative to the second jaw member 3254 to clamp one or
more materials, such as, for example, a tissue section 3264,
therebetween. The second jaw member 3254 is configured to receive a
staple cartridge 3256. A first sensor 3258 is coupled to the anvil
3252. The first sensor is configured to detect one or more
parameters of the end effector 3150, such as, for example, the gap
3110 between the anvil 3252 and the staple cartridge 3256. The gap
3110 may correspond to, for example, a thickness of tissue clamped
between the anvil 3252 and the staple cartridge 3256. The first
sensor 3258 may comprise any suitable sensor for measuring one or
more parameters of the end effector. For example, in various
embodiments, the first sensor 3258 may comprise a magnetic sensor,
such as a Hall effect sensor, a strain gauge, a pressure sensor, an
inductive sensor, such as an eddy current sensor, a resistive
sensor, a capacitive sensor, an optical sensor, and/or any other
suitable sensor.
[0306] A plurality of secondary sensors 3260a-3260d is coupled to
the second jaw member 3254. The plurality of secondary sensors
3260a-3260d may be formed integrally with the second jaw member
3254 and/or the staple cartridge 3256. For example, in one
embodiment, the plurality of secondary sensors 3260a-3260d is
disposed on an outer row of the staple cartridge 3256 (see FIG.
41). The plurality of secondary sensors 3260a-3260d are configured
to detect one or more parameters of the end effector 3250 and/or a
tissue section 3264 clamped between the anvil 3252 and the staple
cartridge 3256. The plurality of secondary sensors 3260a-3260d may
comprise any suitable sensors for detecting one or more parameters
of the end effector 3250 and/or the tissue section 3264, such as,
for example, magnetic sensors, such as a Hall effect 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.
The plurality of secondary sensors 3260a-3260d may comprise
identical sensors and/or different sensors.
[0307] In some embodiments, the plurality of secondary sensors
3260a-3260d comprises dual purpose sensors and tissue stabilizing
elements. The plurality of secondary sensors 3260a-3260d comprise
electrodes and/or sensing geometries configured to create a
stabilized tissue condition when the plurality of secondary sensors
3260a-3260d are engaged with a tissue section 3264, such as, for
example, during a clamping operation. In some embodiments, one or
more of the plurality of secondary sensors 3260a-3260d may be
replaced with non-sensing tissue stabilizing elements. The
secondary sensors 3260a-3260d create a stabilized tissue condition
by controlling tissue flow, staple formation, and/or other tissue
conditions during a clamping, stapling, and/or other treatment
process.
[0308] FIG. 41 illustrates one embodiment of a staple cartridge
3270 comprising a plurality of sensors 3272a-3272h formed
integrally therein. The staple cartridge 3270 comprises a plurality
of rows containing a plurality of holes for storing staples
therein. One or more of the holes in the outer row 3278 are
replaced with one of the plurality of sensors 3272a-3272h. A
cut-away section 3274 is shown to illustrate a sensor 3272f coupled
to a sensor wire 3276b. The sensor wires 3276a, 3276b may comprise
a plurality of wires for coupling the plurality of sensors
3272a-3272h to one or more circuits of a surgical instrument, such
as, for example, the surgical instrument 10. In some embodiments,
one or more of the plurality of sensors 3272a-3272h comprise dual
purpose sensor and tissue stabilizing elements having electrodes
and/or sensing geometries configured to provide tissue
stabilization. In some embodiments, the plurality of sensors
3272a-3272h may be replaced with and/or co-populated with a
plurality of tissue stabilizing elements. Tissue stabilization may
be provided by, for example, controlling tissue flow and/or staple
formation during a clamping and/or stapling process. The plurality
of sensors 3272a-3272h provide signals to one or more circuits of
the surgical instrument 10 to enhance feedback of stapling
performance and/or tissue thickness sensing.
[0309] FIG. 42 is a logic diagram illustrating one embodiment of a
process 3280 for determining one or more parameters of a tissue
section 3264 clamped within an end effector, such as, for example,
the end effector 3250 illustrated in FIG. 40. In one embodiment, a
first sensor 3258 is configured to detect one or more parameters of
the end effector 3250 and/or a tissue section 3264 located between
the anvil 3252 and the staple cartridge 3256. A first signal is
generated 3282 by the first sensors 3258. The first signal is
indicative of the one or more parameters detected by the first
sensor 3258. One or more secondary sensors 3260 are configured to
detect one or more parameters of the end effector 3250 and/or the
tissue section 3264. The secondary sensors 3260 may be configured
to detect the same parameters, additional parameters, or different
parameters as the first sensor 3258. Secondary signals 3284 are
generated by the secondary sensors 3260. The secondary signals 3284
are indicative of the one or more parameters detected by the
secondary sensors 3260. The first signal and the secondary signals
are provided to a processor, such as, for example, a primary
processor 2006. The processor 2006 adjusts 3286 the first signal
generated by the first sensor 3258 based on input generated by the
secondary sensors 3260. The adjusted signal may be indicative of,
for example, the true thickness of a tissue section 3264 and the
fullness of the bite. The adjusted signal is displayed 3026 to an
operator by, for example, a display 2026 embedded in the surgical
instrument 10.
[0310] FIG. 43 illustrates one embodiment of an end effector 3300
comprising a plurality of redundant sensors 3308a, 3308b. The end
effector 3300 comprises a first jaw member, or anvil, 3302
pivotally coupled to a second jaw member 3304. the second jaw
member 3304 is configured to receive a staple cartridge 3306
therein. The anvil 3302 is moveable with respect to the staple
cartridge 3306 to grasp a material, such as, for example, a tissue
section, between the anvil 3302 and the staple cartridge 3306. A
plurality of sensors 3308a, 3308b is coupled to the anvil. The
plurality of sensors 3308a, 3308b are configured to detect one or
more parameters of the end effector 3300 and/or a tissue section
located between the anvil 3302 and the staple cartridge 3306. In
some embodiments, the plurality of sensors 3308a, 3308b are
configured to detect a gap 3310 between the anvil 3302 and the
staple cartridge 3306. The gap 3310 may correspond to, for example,
the thickness of tissue located between the anvil 3302 and the
staple cartridge 3306. The plurality of sensors 3308a, 3308b may
detect the gap 3310 by, for example, detecting a magnetic field
generated by a magnet 3312 coupled to the second jaw member
3304.
[0311] In some embodiments, the plurality of sensors 3308a, 3308b
comprise redundant sensors. The redundant sensors are configured to
detect the same properties of the end effector 3300 and/or a tissue
section located between the anvil 3302 and the staple cartridge
3306. The redundant sensors may comprise, for example, Hall effect
sensors configured to detect the gap 3310 between the anvil 3302
and the staple cartridge 3306. The redundant sensors provide
signals representative of one or more parameters allowing a
processor, such as, for example, the primary processor 2006, to
evaluate the multiple inputs and determine the most reliable input.
In some embodiments, the redundant sensors are used to reduce
noise, false signals, and/or drift. Each of the redundant sensors
may be measured in real-time during clamping, allowing time-based
information to be analyzed and algorithms and/or look-up tables to
recognize tissue characteristics and clamping positioning
dynamically. The input of one or more of the redundant sensors may
be adjusted and/or selected to identify the true tissue thickness
and bite of a tissue section located between the anvil 3302 and the
staple cartridge 3306.
[0312] FIG. 44 is a logic diagram illustrating one embodiment of a
process 3320 for selecting the most reliable output from a
plurality of redundant sensors, such as, for example, the plurality
of sensors 3308a, 3308b illustrated in FIG. 43. In one embodiment,
a first signal is generated by a first sensor 3308a. The first
signal is converted 3322a by an analog-to-digital convertor. One or
more additional signals are generated by one or more redundant
sensors 3308b. The one or more additional signals are converted
3322b by an analog-to-digital convertor. The converted signals are
provided to a processor, such as, for example, the primary
processor 2006. The primary processor evaluates 3324 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
3302 and the staple cartridge 3306. The adjusted most reliable
output is displayed 3026 to an operator by, for example, a display
2026 embedded in the surgical instrument 10.
[0313] FIG. 45 illustrates one embodiment of an end effector 3350
comprising a sensor 3358 comprising a specific sampling rate to
limit or eliminate false signals. The end effector 3350 comprises a
first jaw member, or anvil, 3352 pivotably coupled to a second jaw
member 3354. The second jaw member 3354 is configured to receive a
staple cartridge 3356 therein. The staple cartridge 3356 contains a
plurality of staples that may be delivered to a tissue section
located between the anvil 3352 and the staple cartridge 3356. A
sensor 3358 is coupled to the anvil 3352. The sensor 3358 is
configured to detect one or more parameters of the end effector
3350, such as, for example, the gap 3364 between the anvil 3352 and
the staple cartridge 3356. The gap 3364 may correspond to the
thickness of a material, such as, for example, a tissue section,
and/or the fullness of a bite of material located between the anvil
3352 and the staple cartridge 3356. The sensor 3358 may comprise
any suitable sensor for detecting one or more parameters of the end
effector 3350, such as, for example, a magnetic sensor, such as a
Hall effect sensor, a strain gauge, a pressure sensor, an inductive
sensor, such as an eddy current sensor, a resistive sensor, a
capacitive sensor, an optical sensor, and/or any other suitable
sensor.
[0314] In one embodiment, the sensor 3358 comprises a magnetic
sensor configured to detect a magnetic field generated by an
electromagnetic source 3360 coupled to the second jaw member 3354
and/or the staple cartridge 3356. The electromagnetic source 3360
generates a magnetic field detected by the sensor 3358. 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 anvil 3352 and the staple cartridge 3356. In some
embodiments, the electromagnetic source 3360 generates a signal at
a known frequency, such as, for example, 1 MHz. In other
embodiments, the signal generated by the electromagnetic source
3360 may be adjustable based on, for example, the type of staple
cartridge 3356 installed in the second jaw member 3354, one or more
additional sensor, an algorithm, and/or one or more parameters.
[0315] In one embodiment, a signal processor 3362 is coupled to the
end effector 3350, such as, for example, the anvil 3352. The signal
processor 3362 is configured to process the signal generated by the
sensor 3358 to eliminate false signals and to boost the input from
the sensor 3358. In some embodiments, the signal processor 3362 may
be located separately from the end effector 3350, such as, for
example, in the handle 14 of a surgical instrument 10. In some
embodiments, the signal processor 3362 is formed integrally with
and/or comprises an algorithm executed by a general processor, such
as, for example, the primary processor 2006. The signal processor
3362 is configured to process the signal from the sensor 3358 at a
frequency substantially equal to the frequency of the signal
generated by the electromagnetic source 3360. For example, in one
embodiment, the electromagnetic source 3360 generates a signal at a
frequency of 1 MHz. The signal is detected by the sensor 3358. The
sensor 3358 generates a signal indicative of the detected magnetic
field which is provided to the signal processor 3362. The signal is
processed by the signal processor 3362 at a frequency of 1 MHz to
eliminate false signals. The processed signal is provided to a
processor, such as, for example, the primary processor 2006. The
primary processor 2006 correlates the received signal to one or
more parameters of the end effector 3350, such as, for example, the
gap 3364 between the anvil 3352 and the staple cartridge 3356.
[0316] FIG. 46 is a logic diagram illustrating one embodiment of a
process 3370 for generating a thickness measurement for a tissue
section located between an anvil and a staple cartridge of an end
effector, such as, for example, the end effector 3350 illustrated
in FIG. 45. In one embodiment of the process 3370, a signal is
generated 3372 by a modulated electromagnetic source 3360. The
generated signal may comprise, for example, a 1 MHz signal. A
magnetic sensor 3358 is configured to detect 3374 the signal
generated by the electromagnetic source 3360. The magnetic sensor
3358 generates a signal indicative of the detected magnetic field
and provides the signal to a signal processor 3362. The signal
processor 3362 processes 3376 the signal to remove noise, false
signals, and/or to boost the signal. The processed signal is
provided to an analog-to-digital convertor for conversion 3378 to a
digital signal. The digital signal may be calibrated 3380, for
example, by application of a calibration curve input algorithm
and/or look-up table. The signal processing 3376, conversion 3378,
and calibration 3380 may be performed by one or more circuits. The
calibrated signal is displayed 3026 to a user by, for example, a
display 2026 formed integrally with a surgical instrument 10.
[0317] Although the various embodiments so far described comprise
an end effector having first and second jaw members pivotally
coupled, the described embodiments are not so limited. For example,
in one embodiment, the end effector may comprise a circular stapler
end effector. FIG. 47 illustrates one embodiment of a circular
stapler 3400 configured to implement one or more of the processes
described in FIGS. 28-46. The circular stapler 3400 comprises a
body 3402. The body 3402 may be coupled to a shaft, such as, for
example, the shaft assembly 200 of the surgical instrument 10. The
body 3402 is configured to receive a staple cartridge and/or one or
more staples therein (not shown). An anvil 3404 is moveably coupled
to the body 3402. The anvil 3404 may be coupled to the body 3402
by, for example, a shaft 3406. The shaft 3406 is receivable within
a cavity within the body (not shown). In some embodiments, a
breakaway washer 3408 is coupled to the anvil 3404. The breakaway
washer 3408 may comprise a buttress or reinforcing material during
stapling.
[0318] In some embodiments, the circular stapler 3400 comprises a
plurality of sensors 3410a, 3410b. The plurality of sensor 3410a,
3410b is configured to detect one or more parameters of the
circular stapler 3400 and/or a tissue section located between the
body 3402 and the anvil 3404. The plurality of sensors 3410a, 3410b
may be coupled to any suitable portion of the anvil 3404, such as,
for example, being positioned under the breakaway washer 3408. The
plurality of sensors 3410a, 3410b may be arranged in any suitable
arrangement, such as, for example, being equally spaced about the
perimeter of the anvil 3404. The plurality of sensors 3410a, 3410b
may comprise any suitable sensors for detecting one or more
parameters of the end effector 3400 and/or a tissue section located
between the body 3402 and the anvil 3404. For example, the
plurality of sensors 3410a, 3410b may comprise magnetic sensors,
such as a Hall effect sensor, strain gauges, pressure sensors,
inductive sensors, such as an eddy current sensor, resistive
sensors, capacitive sensors, optical sensors, any combination
thereof, and/or any other suitable sensor.
[0319] In one embodiment, the plurality of sensors 3410a, 3410b
comprise a plurality of pressure sensors positioned under the
breakaway washer 3408. Each of the sensors 3410a, 3410b is
configured to detect a pressure generated by the presence of
compressed tissue between the body 3402 and the anvil 3404. In some
embodiments the plurality of sensors 3410a, 3410b are configured to
detect the impedance of a tissue section located between the anvil
3404 and the body 3402. The detected impedance may be indicative of
the thickness and/or fullness of tissue located between the anvil
3404 and the body 3402. The plurality of sensors 3410a, 3410b
generate a plurality of signals indicative of the detected
pressure. The plurality of generated signals is provided to a
processor, such as, for example, the primary processor 2006. The
primary processor 2006 applies one or more algorithms and/or
look-up tables based on the input from the plurality of sensors
3410a, 3410b to determine one or more parameters of the end
effector 3400 and/or a tissue section located between the body 3402
and the anvil 3404. For example, in one embodiment comprising a
plurality of pressure sensors, the processor 2006 is configured to
apply an algorithm to quantitatively compare the output of the
plurality of sensors 3410a, 3410b with respect to each other and
with respect to a predetermined threshold. In one embodiment, if
the delta, or difference, between the outputs of the plurality of
sensors 3410a, 3410b is greater than a predetermined threshold,
feedback is provided to the operator indicating a potential uneven
loading condition. In some embodiments, the end effector 3400 may
be coupled to a shaft comprising one or more additional sensors,
such as, for example, the drive shaft 3504 described in connection
to FIG. 50 below.
[0320] FIGS. 48A-48D illustrate a clamping process of the circular
stapler 3400 illustrated in FIG. 47. FIG. 48A illustrates the
circular stapler 3400 in an initial position with the anvil 3404
and the body 3402 in a closed configuration. The circular stapler
3400 is positioned at a treatment site in the closed configuration.
Once the circular stapler 3400 is positioned, the anvil 3404 is
moved distally to disengage with the body 3402 and create a gap
configured to receive a tissue section 3412 therein, as illustrated
in FIG. 48B. The tissue section 3412 is compressed to a
predetermined compression 3414 between the anvil 3404 and the body
3402, as shown in FIG. 48C. The tissue section 3412 is further
compressed between the anvil 3404 and the body 3402. The additional
compression deploys one or more staples from the body 3402 into the
tissue section 3412. The staples are shaped by the anvil 3404. FIG.
48D illustrates the circular stapler 3400 in position corresponding
to staple deployment. Proper staple deployment is dependent on
obtaining a proper bite of tissue between the body 3402 and the
anvil 3404. The plurality of sensors 3410a, 3410b disposed on the
anvil 3404 allow a processor to determine that a proper bite of
tissue is located between the anvil 3404 and the body 3402 prior to
deployment of the staples.
[0321] FIG. 49 illustrates one embodiment of a circular staple
anvil 3452 and an electrical connector 3466 configured to interface
therewith. The anvil 3452 comprises an anvil head 3454 coupled to
an anvil shaft 3456. A breakaway washer 3458 is coupled to the
anvil head 3452. A plurality of pressure sensors 3460a, 3460b are
coupled to the anvil head 3452 between the anvil head 3452 and the
breakaway washer 3458. A flex circuit 3462 is formed on the shaft
3456. The flex circuit 3462 is coupled to the plurality of pressure
sensors 3460a, 3460b. One or more contacts 3464 are formed on the
shaft 3456 to couple the flex circuit 3462 to one or more circuits,
such as, for example, the control circuit 2000 of the surgical
instrument 10. The flex circuit 3462 may be coupled to the one or
more circuits by an electrical connector 3466. The electrical
connector 3466 is coupled to the anvil 3454. For example, in one
embodiment, the shaft 3456 is hollow and configured to receive the
electrical connector 3466 therein. The electrical connector 3466
comprises a plurality of contacts 3468 configured to interface with
the contacts 3464 formed on the anvil shaft 3456. The plurality of
contacts 3468 on the electrical connector 3466 are coupled to a
flex circuit 3470 which is coupled the one or more circuits, such
as, for example, a control circuit 2000.
[0322] FIG. 50 illustrates one embodiment of a surgical instrument
3500 comprising a sensor 3506 coupled to a drive shaft 3504 of the
surgical instrument 3500. The surgical instrument 3500 may be
similar to the surgical instrument 10 described above. The surgical
instrument 3500 comprises a handle 3502 and a drive shaft 3504
coupled to a distal end of the handle. The drive shaft 3504 is
configured to receive an end effector (not shown) at the distal
end. A sensor 3506 is fixedly mounted in the drive shaft 3504. The
sensor 3506 is configured to detect one or more parameters of the
drive shaft 3504. The sensor 3506 may comprise any suitable sensor,
such as, for example, a magnetic sensor, such as a Hall effect
sensor, a strain gauge, a pressure sensor, an inductive sensor,
such as an eddy current sensor, a resistive sensor, a capacitive
sensor, an optical sensor, and/or any other suitable sensor.
[0323] In some embodiments, the sensor 3506 comprises a magnetic
Hall effect sensor. A magnet 3508 is located within the drive shaft
3504. The sensor 3506 is configured to detect a magnetic field
generated by the magnet 3508. The magnet 3508 is coupled to a
spring-backed bracket 3510. The spring-backed bracket 3510 is
coupled to the end effector. The spring-backed bracket 3510 is
moveable in response to an action of the end effector, for example,
compression of an anvil towards a body and/or second jaw member.
The spring-backed bracket 3510 moves the magnet 3508 in response to
the movement of the end effector. The sensor 3506 detects the
change in the magnetic field generated by the magnet 3508 and
generates a signal indicative of the movement of the magnet 3508.
The movement of the magnet 3508 may correspond to, for example, the
thickness of tissue clamped by the end effector. The thickness of
the tissue may be displayed to an operator by, for example, a
display 3512 embedded in the handle 3502 of the surgical instrument
3500. In some embodiments, the Hall effect sensor 3508 may be
combined with one or more additional sensors, such as, for example,
the pressure sensors illustrated in FIG. 47.
[0324] FIG. 51 is a flow chart illustrating one embodiment of a
process 3550 for determining uneven tissue loading in an end
effector, for example, the end effector 3400 illustrated in FIG. 47
coupled to the surgical instrument 3500 illustrated in FIG. 50. In
one embodiment, the process 3550 comprises utilizing one or more
first sensors 3552, such as, for example, a plurality of pressure
sensors, to detect 3554 the presence of tissue within an end
effector. During a clamping operation of the end effector 3400, the
input from the pressure sensors, P, is analyzed to determine the
value of P. If P is less 3556 than a predetermined threshold, the
end effector 3400 continues 3558 the clamping operation. If P is
greater than or equal to 3560 the predetermined threshold, clamping
is stopped. The delta (difference) between the plurality of sensors
3552 is compared 3562. If the delta is greater than a predetermined
delta, the surgical instrument 3500 displays 3564 a warning to the
user. The warning may comprise, for example, a message indicating
that there is uneven clamping in the end effector. If the delta is
less than or equal to the predetermined delta, the input of the one
or more sensors 3552 is compared to an input from an additional
sensor 3566.
[0325] In some embodiments, a second sensor 3566 is configured to
detect one or more parameters of the surgical instrument 3500. For
example, in one some embodiments, a magnetic sensor, such as, for
example, a Hall effect sensor, is located in a shaft 3504 of the
surgical instrument 3500. The second sensor 3566 generates a signal
indicative of the one or more parameters of the surgical instrument
3500. A preset calibration curve is applied 3568 to the input from
the second sensor 3566. The preset calibration curve may adjust
3568 a signal generated by the second sensor 3566, such as, for
example, a Hall voltage generated by a Hall effect sensor. For
example, in one embodiment, the Hall effect voltage is adjusted
such that the generated Hall effect voltage is set at a
predetermined value when the gap between the anvil 3404 and the
body 3402, X1, is equal to zero. The adjusted sensor 3566 input is
used to calculate 3570 a distance, X3, between the anvil 3404 and
the body 3402 when the pressure threshold P is met. The clamping
process is continued 3572 to deploy a plurality of staples into the
tissue section clamped in the end effector 3400. The input from the
second sensor 3566 changes dynamically during the clamping
procedure and is used to calculate the distance, X2, between the
anvil 3404 and the body 3402 in real-time. A real-time percent
compression is calculated 3574 and displayed to an operator. In one
embodiment, the percent compression is calculated as:
[((X3-X2)/X3)*100].
[0326] In some embodiments, one or more of the sensors illustrated
in FIGS. 28-50 are used to indicate: whether the anvil is attached
to the body of the surgical device; the compressed tissue gap;
and/or whether the anvil is in a proper position for removing the
device, or any combination of these indicators.
[0327] In some embodiments, one or more of the sensors illustrated
in FIGS. 28-50 are used to affect device performance. One or more
control parameters of a surgical device 10 may be adjusted by at
least one sensor output. For example, in some embodiments, the
speed control of a firing operation may be adjusted by the output
of one or more sensors, such as, for example, a Hall effect sensor.
In some embodiments, one or more the sensors may adjust a closure
and/or clamping operation based on load and/or tissue type. In some
embodiments, multiple stage compression sensors allow the surgical
instrument 10 to stop closure at a predetermined load and/or a
predeteimined displacement. The control circuit 2000 may apply one
or more predetermined algorithms to apply varying compression to a
tissue section to determine a tissue type, for example, based on a
tissue response. The algorithms may be varied based on closure rate
and/or predetermined tissue parameters. In some embodiments, one or
more sensors are configured to detect a tissue property and one or
more sensors are configured to detect a device property and/or
configuration parameter. For example, in one embodiment, capacitive
blocks may be formed integrally with a staple cartridge to measure
skew.
[0328] Circuitry and Sensors for Powered Medical Device
[0329] FIG. 52 illustrates one embodiment of an end effector 3600
configured to determine one or more parameters of a tissue section
during a clamping operation. The end effector 3600 comprises a
first jaw member, or anvil, 3602 pivotally coupled to a second jaw
member 3604. The second jaw member 3604 is configured to receive a
staple cartridge 3606 therein. The staple cartridge 3606 contains a
plurality of staples (not shown) configured to be deployed into a
tissue section during a clamping and stapling operation. The staple
cartridge 3606 comprises a staple cartridge deck 3622 having a
predetermined height. The staple cartridge 3606 further comprises a
slot 3624 defined within the body of the staple cartridge, similar
to slot 193 described above. A Hall effect sensor 3608 is
configured to detect the distance 3616 between the Hall effect
sensor 3608 and a magnet 3610 coupled to the second jaw member
3604. The distance 3616 between the Hall effect sensor 3608 and the
magnet 3610 is indicative of a thickness of tissue located between
the anvil 3602 and the staple cartridge deck 3622.
[0330] The second jaw member 3604 is configured to receive a
plurality of staple cartridge 3606 types. The types of staple
cartridge 3606 may vary by, for example, containing different
length staples, comprising a buttress material, and/or containing
different types of staples. In some embodiments, the height 3618 of
the staple cartridge deck 3622 may vary based on the type of staple
cartridge 3606 coupled to the second jaw member 3604. The varying
cartridge height 3618 may result in an inaccurate thickness
measurement by the Hall effect sensor 3608. For example, in one
embodiment, a first cartridge comprises a first cartridge deck
height X and a second cartridge comprises a second cartridge deck
height Y, where Y>X. A fixed Hall effect sensor 3608 and fixed
magnet will produce an accurate thickness measurement only for one
of the two cartridge deck heights. In some embodiments, an
adjustable magnet is used to compensate for various deck
heights.
[0331] In some embodiments, the second jaw member 3604 and the
staple cartridge 3606 comprise a magnet cavity 3614. The magnet
cavity 3614 is configured to receive the magnet 3610 therein. The
magnet is coupled to a spring-arm 3612. The spring-arm 3612 is
configured to bias the magnet towards the upper surface of the
magnet cavity 3614. A depth 3620 of the magnet cavity 3614 varies
depending on the deck height 3618 of the staple cartridge 3606. For
example, each staple cartridge 3606 may define a cavity depth 3620
such that the upper surface of the cavity 3614 is a set distance
from the plane of the deck 3622. The magnet 3610 is biased against
the upper surface of the cavity 3614. The magnetic reference of the
magnet 3610, as viewed by the Hall effect sensor 3608, is
consistent relative to all cartridge decks but variable relative to
the slot 3624. For example, in some embodiments, the upper-biased
magnet 3610 and the cavity 3614 provide a set distance 3616 from
the Hall effect sensor 3608 to the magnet 3610, regardless of the
staple cartridge 3606 inserted into the second jaw member 3604. The
set distance 3616 allows the Hall effect sensor 3608 to generate an
accurate thickness measurement irrespective of the staple cartridge
3606 type. In some embodiments, the depth 3620 of the cavity 3614
may be adjusted to calibrate the Hall effect sensor 3608 for one or
more surgical procedures.
[0332] FIGS. 53A and 53B illustrate an embodiment of an end
effector 3650 configured to normalize a Hall effect voltage
irrespective of a deck height of a staple cartridge 3656. FIG. 53A
illustrates one embodiment of the end effector 3650 comprising a
first cartridge 3656a inserted therein. The end effector 3650
comprises a first jaw member, or anvil, 3652 pivotally coupled to a
second jaw member 3654 to grasp tissue therebetween. The second jaw
member 3654 is configured to receive a staple cartridge 3656a. The
staple cartridge 3656a may comprise a variety of staple lengths,
buttress materials, and/or deck heights. A magnetic sensor 3658,
such as, for example, a Hall effect sensor, is coupled to the anvil
3652. The magnetic sensor 3658 is configured to detect a magnetic
field generated by a magnet 3660. The detected magnetic field
strength is indicative of the distance 3664 between the magnetic
sensor 3658 and the magnet 3660, which may be indicative of, for
example, a thickness of a tissue section grasped between the anvil
3652 and the staple cartridge 3656. As noted above, various staple
cartridges 3656a may comprise varying deck heights which create
differences in the calibrated compression gap 3664.
[0333] In some embodiments, a magnetic attenuator 3662 is coupled
to the staple cartridge 3656a. The magnetic attenuator 3662 is
configured to attenuate the magnetic flux generated to by the
magnet 3660. The magnetic attenuator 3662 is calibrated to produce
a magnetic flux based on the height of the staple cartridge 3656a.
By attenuating the magnet 3660 based on the staple cartridge 3656
type, the magnetic attenuator 3662 normalizes the magnetic sensor
3658 signal to the same calibration level for various deck heights.
The magnetic attenuator 3662 may comprise any suitable magnet
attenuator, such as, for example, a ferrous metallic cap. The
magnetic attenuator 3662 is molded into the staple cartridge 3656a
such that the magnetic attenuator 3662 is positioned above the
magnet 3660 when the staple cartridge 3656 is inserted into the
second jaw member 3654.
[0334] In some embodiments, attenuation of the magnet 3660 is not
required for the deck height of the staple cartridge. FIG. 53B
illustrates one embodiment of the end effector 3650 comprising a
second staple cartridge 3656b coupled to the second jaw member
3654. The second staple cartridge 3656b comprises a deck height
matching the calibration of the magnet 3660 and the Hall effect
sensor 3658, and therefore does not require attenuation. As shown
in FIG. 53B, the second staple cartridge 3656b comprises a cavity
3666 in place of the magnetic attenuator 3662 of the first staple
cartridge 3656a. In some embodiments, larger and/or smaller
attenuation members are provided depending on the height of the
cartridge deck. The design of the attenuation member 3662 shape may
be optimized to create features in the response signal generated by
the Hall effect sensor 3658 that allow for the distinction of one
or more additional cartridge attributes.
[0335] FIG. 54 is a logic diagram illustrating one embodiment of a
process 3670 for determining when the compression of tissue within
an end effector, such as, for example, the end effector 3650
illustrated in FIGS. 53A-53B, has reached a steady state. In some
embodiments, a clinician initiates 3672 a clamping procedure to
clamp tissue within the end effector, for example, between an anvil
3652 and staple cartridge 3656. The end effector engages 3674 with
tissue during the clamping procedure. Once the tissue has been
engaged 3674, the end effector begins 3676 real time gap
monitoring. The real time gap monitoring monitors the gap between,
for example, the anvil 3652 and the staple cartridge 3656 of the
end effector 3650. The gap may be monitored by, for example, a
sensor 3658, such as a Hall effect sensor, coupled to the end
effector 3650. The sensor 3658 may be coupled to a processor, such
as, for example, the primary processor 2006. The processor
determines 3678 when tissue clamping requirements of the end
effector 3650 and/or the staple cartridge 3656 have been met. Once
the processor determines that the tissue has stabilized, the
process indicates 3680 to the user that the tissue has stabilized.
The indication may be provided by, for example, a display embedded
within a surgical instrument 10.
[0336] In some embodiments, the gap measurement is provided by a
Hall effect sensor. The Hall effect sensor may be located, for
example, at the distal tip of an anvil 3652. The Hall effect sensor
is configured to measure the gap between the anvil 3652 and a
staple cartridge 3656 deck at the distal tip. The measured gap may
be used to calculate a jaw closure gap and/or to monitor a change
in tissue compression of a tissue section clamped in the end
effector 3650. In one embodiment, the Hall effect sensor is coupled
to a processor, such as, for example, the primary processor 2006.
The processor is configured to receive real time measurements from
the Hall effect sensor and compare the received signal to a
predetermined set of criteria. For example, in one embodiment, a
logic equation at equally spaced intervals, such as one second, is
used to indicate stabilization of a tissue section to the user when
a gap reading remains unchanged for a predetermined interval, such
as, for example, 3.0 seconds. Tissue stabilization may also be
indicated after a predetermined time period, such as, for example,
15.0 seconds. As another example, tissue stabilization may be
indicated when yn=yn+1=yn+2, where y equals a gap measurement of
the Hall effect sensor and n is a predetermined measurement
interval. A surgical instrument 10 may display an indication to a
user, such as, for example, a graphical and/or numerical
representation, when stabilization has occurred.
[0337] FIG. 55 is a graph 3690 illustrating various Hall effect
sensor readings 3692a-3692d. As shown in graph 3690, a thickness,
or compression, of a tissue section stabilizes after a
predetermined time period. A processor, such as, for example, the
primary processor 2006, may be configured to indicate when the
calculated thickness from a sensor, such as a Hall effect sensor,
is relatively consistent or constant over a predetermined time
period. The processor 2006 may indicate to a user, for example,
through a number display, that the tissue has stabilized.
[0338] FIG. 56 is a logic diagram illustrating one embodiment of a
process 3700 for determining when the compression of tissue within
an end effector, such as, for example, the end effector 3650
illustrated in FIGS. 53A-53B, has reached a steady state. In some
embodiments, a clinician initiates 3702 a clamping procedure to
clamp tissue within the end effector, for example, between an anvil
3652 and staple cartridge 3656. The end effector engages 3704 with
tissue during the clamping procedure. Once the tissue has been
engaged 3704, the end effector begins 3706 real time gap
monitoring. The real time gap monitoring technique monitors 3706
the gap between, for example, the anvil 3652 and the staple
cartridge 3656 of the end effector 3650. The gap may be monitored
3706 by, for example, a sensor 3658, such as a Hall effect sensor,
coupled to the end effector 3650. The sensor 3658 may be coupled to
a processor, such as, for example, the primary processor 2006. The
processor is configured to execute one or more algorithms determine
when tissue section compressed by the end effector 3650 has
stabilized.
[0339] For example, in the embodiment illustrated in FIG. 56, the
process 3700 is configured to utilize a slop calculation to
determine stabilization of tissue. The processor calculates 3708
the slope, S, of an input from a sensor, such as a Hall effect
sensor. The slope may be calculated 3708 by, for example, the
equation S=((V.sub.--1-V.sub.--2))/((T.sub.--1-T.sub.--2)). The
processor compares 3710 the calculated slope to a predetermined
value, such as, for example, 0.005 volts/sec. If the value of the
calculated slope is greater than the predetermined value, the
processor resets 3712 a count, C, to zero. If the calculated slope
is less than or equal to the predetermined value, the processor
increments 3714 the value of the count C. The count, C, is compared
3716 to a predetermined threshold value, such as, for example, 3.
If the value of the count C is greater than or equal to the
predetermined threshold value, the processor indicates 3718 to the
user that the tissue section has stabilized. If the value of the
count C is less than the predetermined threshold value, the
processor continues monitoring the sensor 3658. In various
embodiments, the slope of the sensor input, the change in the
slope, and/or any other suitable change in the input signal may be
monitored.
[0340] In some embodiments, an end effector, such as for example,
the end effectors 3600, 3650 illustrated in FIGS. 52, 53A, and 53B
may comprise a cutting member deployable therein. The cutting
member may comprise, for example, an I-Beam configured to
simultaneously cut a tissue section located between an anvil 3602
and a staple cartridge 3608 and to deploy staples from the staple
cartridge 3608. In some embodiments, the I-Beam may comprise only a
cutting member and/or may only deploy one or more staples. Tissue
flow during firing may affect the proper formation of staples. For
example, during I-Beam deployment, fluid in the tissue may cause
the thickness of tissue to temporarily increase, causing improper
deployment of staples.
[0341] FIG. 57 is a logic diagram illustrating one embodiment of a
process 3730 for controlling an end effector to improve proper
staple formation during deployment. The control process 3730
comprises generating 3732 a sensor measurement indicative of the
thickness of a tissue section within the end effector 3650, such as
for example, a Hall effect voltage generated by a Hall effect
sensor. The sensor measurement is converted 3734 to a digital
signal by an analog-to-digital convertor. The digital signal is
calibrated 3736. The calibration 3736 may be performed by, for
example, a processor and/or a dedicated calibration circuit. The
digital signal is calibrated 3736 based on one or more calibration
curve inputs. The calibrated digital signal is displayed 3738 to an
operator by, for example, a display 2026 embedded in a surgical
instrument 10. The calibrated signal may be displayed 3738 as a
thickness measurement of a tissue section grasped between the anvil
3652 and the staple cartridge 3656 and/or as a unit-less range.
[0342] In some embodiments, the generated 3732 Hall effect voltage
is used to control an I-beam. For example, in the illustrated
embodiment, the Hall effect voltage is provided to a processor
configured to control deployment of an I-Beam within an end
effector, such as, for example, the primary processor 2006. The
processor receives the Hall effect voltage and calculates the
voltage rate of change over a predetermined time period. The
processor compares 3740 the calculated rate of change to a
predetermined value, x1. If the calculated rate of change is
greater than the predetermined value, x1, the processor slows 3742
the speed of the I-Beam. The speed may be reduced by, for example,
decrementing a speed variable by a predeteimined unit. If the
calculated voltage rate of change is less than or equal to the
predetermine value, x1, the processor maintains 3744 the current
speed of the I-Beam.
[0343] In some embodiments, the processor may temporarily reduce
the speed of the I-Beam to compensate, for example, for thicker
tissue, uneven loading, and/or any other tissue characteristic. For
example, in one embodiment, the processor is configured to monitor
3740 the rate of voltage change of a Hall effect sensor. If the
rate of change monitored 3740 by the processor exceeds a first
predetermine value, x1, the processor slows down or stops
deployment of the I-Beam until the rate of change is less than a
second predetermined value, x2. When the rate of change is less
than the second predetermined value, x2, the processor may return
the I-beam to normal speed. In some embodiments, the sensor input
may be generated by for example, a pressure sensor, a strain gauge,
a Hall effect sensor, and/or any other suitable sensor. In some
embodiments, the processor may implement one or more pause points
during deployment of an I-Beam. For example, in some embodiments,
the processor may implement three predetermined pause points, at
which the processor pauses deployment of the I-Beam for a
predetermined time period. The pause points are configured to
provide optimized tissue flow control.
[0344] FIG. 58 is a logic diagram illustrating one embodiment of a
process 3750 for controlling an end effector to allow for fluid
evacuation and provide improved staple formation. The process 3750
comprises generating 3752 a sensor measurement, such as, for
example, a Hall effect voltage. The sensor measurement may be
indicative of, for example, the thickness of a tissue section
grasped between an anvil 3652 and a staple cartridge 3656 of an end
effector 3650. The generated signal is provided to an
analog-to-digital convertor for conversion 3754 to a digital
signal. The converted signal is calibrated 3756 based on one or
more inputs, such as, for example, a second sensor input and/or a
predetermined calibration curve. The calibrated signal is
representative of one or more parameters of the end effector 3650,
such as, for example, the thickness of a tissue section grasped
therein. The calibrated thickness measurement may be displayed to a
user as a thickness and/or as a unit-less range. The calibrated
thickness may be displayed by, for example, a display 2026 embedded
in a surgical instrument 10 coupled to the end effector 3650.
[0345] In some embodiments, the calibrated thickness measurement is
used to control deployment of an I-Beam and/or other firing member
within the end effector 3650. The calibrated thickness measurement
is provided to a processor. The processor compares 3760 the change
in the calibrated thickness measurement to a predetermined
threshold percentage, x. If the rate of change of the thickness
measurement is greater than x, the processor slows 3762 the speed,
or rate of deployment, of the I-Beam within the end effector. The
processor may slow 3762 the speed of the I-Beam by, for example,
decrementing a speed variable by a predetermined unit. If the rate
of change of the thickness measurement is less than or equal to x,
the processor maintains 3764 the speed of the I-Beam within the end
effector 3650. The real time feedback of tissue thickness and/or
compression allows the surgical instrument 10 to affect the firing
speed to allow for fluid evacuation and/or provide improved staple
form.
[0346] In some embodiments, the sensor reading generated 3752 by
the sensor, for example, a Hall effect voltage, may be adjusted by
one or more additional sensor inputs. For example, in one
embodiment, a generated 3752 Hall effect voltage may be adjusted by
an input from a micro-strain gauge sensor on the anvil 3652. The
micro-strain gauge may be configured to monitor the strain
amplitude of the anvil 3652. The generated 3752 Hall effect voltage
may be adjusted by the monitored strain amplitude to indicate, for
example, partial proximal or distal tissue bites. Time based
monitoring of the micro-strain and Hall effect sensor output during
clamping allows one or more algorithms and/or look-up tables to
recognize tissue characteristics and clamping positioning and
dynamically adjust tissue thickness measurements to control firing
speed of, for example, an I-Beam. In some embodiments, the
processor may implement one or more pause points during deployment
of an I-Beam. For example, in some embodiments, the processor may
implement three predetermined pause points, at which the processor
pauses deployment of the I-Beam for a predetermined time period.
The pause points are configured to provide optimized tissue flow
control.
[0347] FIGS. 59A-59B illustrate one embodiment of an end effector
3800 comprising a pressure sensor. The end effector 3800 comprises
a first jaw member, or anvil, 3802 pivotally coupled to a second
jaw member 3804. The second jaw member 3804 is configured to
receive a staple cartridge 3806 therein. The staple cartridge 3806
comprises a plurality of staples. A first sensor 3808 is coupled to
the anvil 3802 at a distal tip. The first sensor 3808 is configured
to detect one or more parameters of the end effector, such as, for
example, the distance, or gap 3814, between the anvil 3802 and the
staple cartridge 3806. The first sensor 3808 may comprise any
suitable sensor, such as, for example, a magnetic sensor. A magnet
3810 may be coupled to the second jaw member 3804 and/or the staple
cartridge 3806 to provide a magnetic signal to the magnetic
sensor.
[0348] In some embodiments, the end effector 3800 comprises a
second sensor 3812. The second sensor 3812 is configured to detect
one or more parameters of the end effector 3800 and/or a tissue
section located therebetween. The second sensor 3812 may comprise
any suitable sensor, such as, for example, one or more pressure
sensors. The second sensor 3812 may be coupled to the anvil 3802,
the second jaw member 3804, and/or the staple cartridge 3806. A
signal from the second sensor 3812 may be used to adjust the
measurement of the first sensor 3808 to adjust the reading of the
first sensor to accurately represent proximal and/or distal
positioned partial bites true compressed tissue thickness. In some
embodiments, the second sensor 3812 may be surrogate with respect
to the first sensor 3808.
[0349] In some embodiments, the second sensor 3812 may comprise,
for example, a single continuous pressure sensing film and/or an
array of pressure sensing films. The second sensor 3812 is coupled
to the deck of the staple cartridge 3806 along the central axis
covering, for example, a slot 3816 configured to receive a cutting
and/or staple deployment member. The second sensor 3812 provides
signals indicate of the amplitude of pressure applied by the tissue
during a clamping procedure. During firing of the cutting and/or
deployment member, the signal from the second sensor 3812 may be
severed, for example, by cutting electrical connections between the
second sensor 3812 and one or more circuits. In some embodiments, a
severed circuit of the second sensor 3812 may be indicative of a
spent staple cartridge 3806. In other embodiments, the second
sensor 3812 may be positioned such that deployment of a cutting
and/or deployment member does not sever the connection to the
second sensor 3812.
[0350] FIG. 60 illustrates one embodiment of an end effector 3850
comprising a second sensor 3862 located between a staple cartridge
3806 and a second jaw member 3804. The end effector 3850 comprises
a first jaw member, or anvil, 3852 pivotally coupled to a second
jaw member 3854. The second jaw member 3854 is configured to
receive a staple cartridge 3856 therein. A first sensor 3858 is
coupled to the anvil 3852 at a distal tip. The first sensor 3858 is
configured to detect one or more parameters of the end effector
3850, such as, for example, the distance, or gap 3864, between the
anvil 3852 and the staple cartridge 3856. The first sensor 3858 may
comprise any suitable sensor, such as, for example, a magnetic
sensor. A magnet 3860 may be coupled to the second jaw member 3854
and/or the staple cartridge 3856 to provide a magnetic signal to
the magnetic sensor. In some embodiments, the end effector 3850
comprises a second sensor 3862 similar in all respect to the second
sensor 3812 of FIGS. 59A-59B, except that it is located between the
staple cartridge 3856 and the second jaw member 3864.
[0351] FIG. 61 is a logic diagram illustrating one embodiment of a
process 3870 for determining and displaying the thickness of a
tissue section clamped in an end effector 3800 or 3850, according
to FIGS. B59A-59B or FIG. 60. The process comprises obtaining a
Hall effect voltage 3872, for example, through a Hall effect sensor
located at the distal tip of the anvil 3802. The Hall effect
voltage 3872 is proved to an analog to digital converter 3874 and
converted into a digital signal. the digital signal is provided to
a process, such as for example the primary processor 2006. The
primary processor 2006 calibrates 3874 the curve input of the Hall
effect voltage 3872 signal. Pressure sensors, such as for example
second sensor 3812, is configured to measure 3880 one or more
parameters of, for example, the end effector 3800, such as for
example the amount of pressure being exerted by the anvil 3802 on
the tissue clamped in the end effector 3800. In some embodiments
the pressure sensors may comprise a single continuous pressure
sensing film and/or array of pressure sensing films. The pressure
sensors may thus be operable determine variations in the measure
pressure at different locations between the proximal and distal
ends of the end effector 3800. The measured pressure is provided to
the processor, such as for example the primary processor 2006. The
primary processor 2006 uses one or more algorithms and/or lookup
tables to adjust 3882 the Hall effect voltage 3872 in response to
the pressure measured by the pressure sensors 3880 to more
accurately reflect the thickness of the tissue clamped between, for
example, the anvil 3802 and the staple cartridge 3806. The adjusted
thickness is displayed 3878 to an operator by, for example, a
display 2026 embedded in the surgical instrument 10.
[0352] FIG. 62 illustrates one embodiment of an end effector 3900
comprising a plurality of second sensors 3192a-3192b located
between a staple cartridge 3906 and an elongated channel 3916. The
end effector 3900 comprises a first jaw member or anvil 3902
pivotally coupled to a second jaw member or elongated channel 3904.
The elongated channel 3904 is configured to receive a staple
cartridge 3906 therein. The anvil 3902 further comprises a first
sensor 3908 located in the distal tip. The first sensor 3908 is
configured to detect one or more parameters of the end effector
3900, such as, for example, the distance, or gap, between the anvil
3902 and the staple cartridge 3906. The first sensor 3908 may
comprise any suitable sensor, such as, for example, a magnetic
sensor. A magnet 3910 may be coupled to the elongated channel 3904
and/or the staple cartridge 3906 to provide a magnetic signal to
the first sensor 3908. In some embodiments, the end effector 3900
comprises a plurality of second sensors 3912a-3912c located between
the staple cartridge 3906 and the elongated channel 3904. The
second sensors 3912a-3912c may comprise any suitable sensors, such
as for instance piezo-resistive pressure film strips. In some
embodiments, the second sensors 3912a-3912c may be uniformly
distributed between the distal and proximal ends of the end
effector 3900.
[0353] In some embodiments, signals from the second sensors
3912a-3912c may be used to adjust the measurement of the first
sensor 3908. For instance, the signals from the second sensors
3912a-3912c may be used to adjust the reading of the first sensor
3908 to accurately represent the gap between the anvil 3908 and the
staple cartridge 3906, which may vary between the distal and
proximal ends of the end effector 3900, depending on the location
and/or density of tissue 3920 between the anvil 3902 and the staple
cartridge 3906. FIG. 11 illustrates an example of a partial bite of
tissue 3920. As illustrated for purposes of this example, the
tissue is located only in the proximal area of the end effector
3900, creating a high pressure 3918 area near the proximal area of
the end effector 3900 and a corresponding low pressure 3916 area
near the distal end of the end effector.
[0354] FIGS. 63A and 63B further illustrate the effect of a full
versus partial bite of tissue 3920. FIG. 63A illustrates the end
effector 3900 with a full bite of tissue 3920, where the tissue
3920 is of uniform density. With a full bite of tissue 3920 of
uniform density, the measured first gap 3914a at the distal tip of
the end effector 3900 may be approximately the same as the measured
second gap 3922a in the middle or proximal end of the end effector
3900. For example, the first gap 3914a may measure 2.4 mm, and the
second gap may measure 2.3 mm FIG. 63B illustrates an end effector
3900 with a partial bite of tissue 3920, or alternatively a full
bit of tissue 3920 of non-uniform density. In this case, the first
gap 3914b will measure less than the second gap 3922b measured at
the thickest or densest portion of the tissue 3920. For example,
the first gap may measure 1.0 mm, while the second gap may measure
1.9 mm. In the conditions illustrated in FIGS. 63A and 63B, signals
from the second sensors 3912a-3912c, such as for instance measured
pressure at different points along the length of the end effector
3900, may be employed by the instrument to determine tissue 3920
placement and/or material properties of the tissue 3920. The
instrument may further be operable to use measured pressure over
time to recognize tissue characteristics and tissue position, and
dynamically adjust tissue thickness measurements.
[0355] FIG. 64 illustrates one embodiment of an end effector 3950
comprising a coil 3958 and oscillator circuit 3962 for measuring
the gap between the anvil and the staple cartridge 3956. The end
effector 3950 comprises a first jaw member or anvil 3952 pivotally
coupled to a second jaw member or elongated channel 3954. The
elongated channel 3954 is configured to receive a staple cartridge
3956 therein. In some embodiments the staple cartridge 3954 further
comprises a coil 3958 and an oscillator circuit 3962 located at the
distal end. The coil 3958 and oscillator circuit 3962 are operable
as eddy current sensors and/or inductive sensors. The coil 3958 and
oscillator circuit 3962 can detect eddy currents and/or induction
as a target 3960, such as for instance the distal tip of the anvil
3952, approaches the coil 3958. The eddy current and/or induction
detected by the coil 3958 and oscillator circuit 3962 can be used
to detect the distance or gap between the anvil 3952 and staple
cartridge 3956.
[0356] FIG. 65 illustrates and alternate view of the end effector
3950. As illustrated, in some embodiments external wiring 3964 may
supply power to the oscillator circuit 3962. The external wiring
3964 may be placed along the outside of the elongated channel
3954.
[0357] FIG. 66 illustrates examples of the operation of a coil 3958
to detect eddy currents 3972 in a target 3960. Alternating current
flowing through the coil 3958 at a chose frequency generates a
magnetic field 3970 around the coil 3958. When the coil 3958 is at
is position 3976a a certain distance away from the target 3960, the
coil 3958 will not induce an eddy current 3972. When the coil 3958
is at a position 3976b close to an electrically conductive target
3960 and eddy current 3972 is produced in the target 3960. When the
coil 3958 is at a position 3976c near a flaw in the target 3960,
the flaw may disrupt the eddy current circulation; in this case,
the magnetic coupling with the coil 3958 is changed and a defect
signal 3974 can be read by measuring the coil impedance
variation.
[0358] FIG. 67 illustrates a graph 3980 of a measured quality
factor 3984, the measured inductance 3986, and measure resistance
3988 of the radius of a coil 3958 as a function of the coil's 3958
standoff 3978 to a target 3960. The quality factor 3984 depends on
the standoff 3978, while both the inductance 3986 and resistance
3988 are functions of displacement. A higher quality factor 3984
results in a more purely reactive sensor. The specific value of the
inductance 3986 is constrained only by the need for a
manufacturable coil 3958 and a practical circuit design that burns
a reasonable amount of energy at a reasonable frequency. Resistance
3988 is a parasitic effect.
[0359] The graph 3980 illustrates how inductance 3986, resistance
3988, and the quality factor 3984 depend on the target standoff
3978. As the standoff 3978 increases, the inductance 3986 increases
by a factor of four, the resistance 3988 decreases slightly and as
a consequence the quality factor 3984 increases. The change in all
three parameters is highly nonlinear and each curve tends to decay
roughly exponentially as standoff 3978 increases. The rapid loss of
sensitivity with distance strictly limits the range of an eddy
current sensor to approximately 1/2 the coil diameter.
[0360] FIG. 68 illustrates one embodiment of an end effector 4000
comprising an emitter and sensor 4008 placed between the staple
cartridge 4006 and the elongated channel 4004. The end effector
4000 comprises a first jaw member or anvil 4002 pivotally coupled
to a second jaw member or elongated channel 4004. The elongated
channel 3904 is configured to receive a staple cartridge 4006
therein. In some embodiments, the end effector 4000 further
comprises an emitter and sensor 4008 located between the staple
cartridge 4006 and the elongated channel 4004. The emitter and
sensor 4008 can be any suitable device, such as for instance a MEMS
ultrasonic transducer. In some embodiments, the emitter and sensor
may be placed along the length of the end effector 4000.
[0361] FIG. 69 illustrates an embodiment of an emitter and sensor
4008 in operation. The emitter and sensor 4008 may be operable to
emit a pulse 4014 and sense the reflected signal 4016 of the pulse
4014. The emitter and sensor 4008 may further be operable to
measure the time of flight 4018 between the issuance of the pulse
4014 and the reception of the reflected signal 4016. The measured
time of flight 4018 can be used to determine the thickness of
tissue compressed in the end effector 4000 along the entire length
of the end effector 4000. In some embodiments, the emitter and
sensor 4008 may be coupled to a processor, such as for instance the
primary processor 2006. The processor 2006 may be operable to use
the time of flight 4018 to determine additional information about
the tissue, such as for instance whether the tissue was diseased,
bunched, or damaged. The surgical instrument can further be
operable to convey this information to the operator of the
instrument.
[0362] FIG. 70 illustrates the surface of an embodiment of an
emitter and sensor 4008 comprising a MEMS transducer.
[0363] FIG. 71 illustrates a graph 4020 of an example of the
reflected signal 4016 that may be measured by the emitter and
sensor 4008 of FIG. 69. FIG. 71 illustrates the amplitude 4022 of
the reflected signal 4016 as a function of time 4024. As
illustrated, the amplitude of the transmitted pulse 4026 is greater
than the amplitude of the reflected pulses 4028a-4028c. The
amplitude of the transmitted pulse 4026 may be of a known or
expected value. The first reflected pulse 4028a may be, for
example, from the tissue enclosed by the end effector 4000. The
second reflected pulse 4028b may be, for example, from the lower
surface of the anvil 4002. The third reflected pulse 4028c may be,
for example, from the upper surface of the anvil 4002.
[0364] FIG. 72 illustrates an embodiment of an end effector 4050
that is configured to determine the location of a cutting member or
knife 4058. The end effector 4050 comprises a first jaw member or
anvil 4052 pivotally coupled to a second jaw member or elongated
channel 4054. The elongated channel 4054 is configured to receive a
staple cartridge 4056 therein. The staple cartridge 4056 further
comprises a slot 4058 (not shown) and a cutting member or knife
4062 located therein. The knife 4062 is operably coupled to a knife
bar 4064. The knife bar 4064 is operable to move the knife 4062
from the proximal end of the slot 4058 to the distal end. The end
effector 4050 may further comprise an optical sensor 4060 located
near the proximal end of the slot 4058. The optical sensor may be
coupled to a processor, such as for instance the primary processor
2006. The optical sensor 4060 may be operable to emit an optical
signal towards the knife bar 4064. The knife bar 4064 may further
comprise a code strip 4066 along its length. The code strip 4066
may comprise cut-outs, notches, reflective pieces, or any other
configuration that is optically readable. The code strip 4066 is
placed such that the optical signal from the optical sensor 4060
will reflect off or through the code strip 4066. As the knife 4062
and knife bar 4064 move 4068 along the slot 4058, the optical
sensor 4060 will detect the reflection of the emitted optical
signal coupled to the code strip 4066. The optical sensor 4060 may
be operable to communicate the detected signal to the processor
2006. The processor 2006 may be configured to use the detected
signal to determine the position of the knife 4062. The position of
the knife 4062 may be sensed more precisely by designing the code
strip 4066 such that the detected optical signal has a gradual rise
and fall.
[0365] FIG. 73 illustrates an example of the code strip 4066 in
operation with red LEDs 4070 and infrared LEDs 4072. For purposes
of this example only, the code strip 4066 comprises cut-outs. As
the code strip 4066 moves 4068, the light emitted by the red LEDs
4070 will be interrupted as the cut-outs passed before it. The
infrared LEDs 4072 will therefore detect the motion 4068 of the
code strip 4066, and therefore, by extension, the motion of the
knife 4062.
[0366] Monitoring Device Degradation Based on Component
Evaluation
[0367] FIG. 74 depicts a partial view of the end effector 300 of
the surgical instrument 10. In the example form depicted in FIG.
74, the end effector 300 comprises a staple cartridge 1100 which is
similar in many respects to the staple cartridge 304 (FIG. 20).
Several parts of the end effector 300 are omitted to enable a
clearer understanding of the present disclosure. In certain
instances, the end effector 300 may include a first jaw such as,
for example, the anvil 306 (FIG. 20) and a second jaw such as, for
example, the channel 198 (FIG. 20). In certain instances, as
described above, the channel 198 may accommodate a staple cartridge
such as, for example, the staple cartridge 304 or the staple
cartridge 1100, for example. At least one of the channel 198 and
the anvil 306 may be movable relative to the other one of the
channel 198 and the anvil 306 to capture tissue between the staple
cartridge 1100 and the anvil 306. Various actuation assemblies are
described herein to facilitation motion of the channel 198 and/or
the anvil 306 between an open configuration (FIG. 1) and a closed
configuration (FIG. 75), for example
[0368] In certain instances, as described above, the E-beam 178 can
be advanced distally to deploy the staples 191 into the captured
tissue and/or advance the cutting edge 182 between a plurality of
positions to engage and cut the captured tissue. As illustrated in
FIG. 74, the cutting edge 182 can be advanced distally along a path
defined by the slot 193, for example. In certain instances, the
cutting edge 182 can be advanced from a proximal portion 1102 of
the staple cartridge 1100 to a distal portion 1104 of the staple
cartridge 1100 to cut the captured tissue, as illustrated in FIG.
74. In certain instances, the cutting edge 182 can be retracted
proximally from the distal portion 1104 to the proximal portion
1102 by retraction of the E-beam 178 proximally, for example.
[0369] In certain instances, the cutting edge 182 can be employed
to cut tissue captured by the end effector 300 in multiple
procedures. The reader will appreciate that repetitive use of the
cutting edge 182 may affect the sharpness of the cutting edge 182.
The reader will also appreciate that as the sharpness of the
cutting edge 182 decreases, the force required to cut the captured
tissue with the cutting edge 182 may increase. Referring to FIGS.
74-76, in certain instances, the surgical instrument 10 may
comprise a module 1106 (FIG. 76) for monitoring the sharpness of
the cutting edge 182 during, before, and/or after operation of the
surgical instrument 10 in a surgical procedure, for example. In
certain instances, the module 1106 can be employed to test the
sharpness of the cutting edge 182 prior to utilizing the cutting
edge 182 to cut the captured tissue. In certain instances, the
module 1106 can be employed to test the sharpness of the cutting
edge 182 after the cutting edge 182 has been used to cut the
captured tissue. In certain instances, the module 1106 can be
employed to test the sharpness of the cutting edge 182 prior to and
after the cutting edge 182 is used to cut the captured tissue. In
certain instances, the module 1106 can be employed to test the
sharpness of the cutting edge 1106 at the proximal portion 1102
and/or at the distal portion 1104.
[0370] Referring to FIGS. 74-76, the module 1106 may include one or
more sensors such as, for example, an optical sensor 1108; the
optical sensor 1108 of the module 1106 can be employed to test the
reflective ability of the cutting edge 182, for example. In certain
instances, the ability of the cutting edge 182 to reflect light may
correlate with the sharpness of the cutting edge 182. In other
words, a decrease in the sharpness of the cutting edge 182 may
result in a decrease in the ability of the cutting edge 182 to
reflect the light. Accordingly, in certain instances, the dullness
of the cutting edge 182 can be evaluated by monitoring the
intensity of the light reflected from the cutting edge 182, for
example. In certain instances, the optical sensor 1108 may define a
light sensing region. The optical sensor 1108 can be oriented such
that the optical sensing region is disposed in the path of the
cutting edge 182, for example. The optical sensor 1108 may be
employed to sense the light reflected from the cutting edge 182
while the cutting edge 182 is in the optical sensing region, for
example. A decrease in intensity of the reflected light beyond a
threshold can indicate that the sharpness of the cutting edge 182
has decreased beyond an acceptable level.
[0371] Referring again to FIGS. 74-76, the module 1106 may include
one or more lights sources such as, for example, a light source
1110. In certain instances, the module 1106 may include a
microcontroller 1112 ("controller") which may be operably coupled
to the optical sensor 1108, as illustrated in FIG. 76. In certain
instances, the controller 1112 may include a microprocessor 1114
("processor") and one or more computer readable mediums or memory
units 1116 ("memory"). In certain instances, the memory 1116 may
store various program instructions, which when executed may cause
the processor 1114 to perform a plurality of functions and/or
calculations described herein. In certain instances, the memory
1116 may be coupled to the processor 1114, for example. A power
source 1118 can be configured to supply power to the controller
1112, the optical sensors 1108, and/or the light sources 1110, for
example. In certain instances, the power source 1118 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 for supplying
power to the surgical instrument 10. A number of battery cells
connected in series may be used as the power source 4428. In
certain instances, the power source 1118 may be replaceable and/or
rechargeable, for example.
[0372] The controller 1112 and/or other controllers of the present
disclosure 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, ASICs,
PLDs, DSPs, FPGAs, logic gates, registers, semiconductor devices,
chips, microchips, chip sets, microcontrollers, SoC, and/or 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 controller 1112 may include a
hybrid circuit comprising discrete and integrated circuit elements
or components on one or more substrates, for example.
[0373] In certain instances, the controller 1112 and/or other
controllers of the present disclosure 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 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. Other microcontrollers
may be readily substituted for use with the present disclosure.
Accordingly, the present disclosure should not be limited in this
context.
[0374] In certain instances, the light source 1110 can be employed
to emit light which can be directed at the cutting edge 182 in the
optical sensing region, for example. The optical sensor 1108 may be
employed to measure the intensity of the light reflected from the
cutting edge 182 while in the optical sensing region in response to
exposure to the light emitted by the light source 1110. In certain
instances, the processor 1114 may receive one or more values of the
measured intensity of the reflected light and may store the one or
more values of the measured intensity of the reflected light on the
memory 1116, for example. The stored values can be detected and/or
recorded before, after, and/or during a plurality of surgical
procedures performed by the surgical instrument 10, for
example.
[0375] In certain instances, the processor 1114 may compare the
measured intensity of the reflected light to a predefined threshold
values that may be stored on the memory 1116, for example. In
certain instances, the controller 1112 may conclude that the
sharpness of the cutting edge 182 has dropped below an acceptable
level if the measured light intensity exceeds the predefined
threshold value by 1%, 5%, 10%, 25%, 50%, 100% and/or more than
100%, for example. In certain instances, the processor 1114 can be
employed to detect a decreasing trend in the stored values of the
measured intensity of the light reflected from the cutting edge 182
while in the optical sensing region.
[0376] In certain instances, the surgical instrument 10 may include
one or more feedback systems such as, for example, the feedback
system 1120. In certain instances, the processor 1114 can employ
the feedback system 1120 to alert a user if the measured light
intensity of the light reflected from cutting edge 182 while in the
optical sensing region is beyond the stored threshold value, for
example. In certain instances, the feedback system 1120 may
comprise one or more visual feedback systems such as display
screens, backlights, and/or LEDs, for example. In certain
instances, the feedback system 1120 may comprise one or more audio
feedback systems such as speakers and/or buzzers, for example. In
certain instances, the feedback system 1120 may comprise one or
more haptic feedback systems, for example. In certain instances,
the feedback system 1120 may comprise combinations of visual,
audio, and/or tactile feedback systems, for example.
[0377] In certain instances, the surgical instrument 10 may
comprise a firing lockout mechanism 1122 which can be employed to
prevent advancement of the cutting edge 182. Various suitable
firing lockout mechanisms are described in greater detail in U.S.
Patent Publication No. 2014/0001231, entitled FIRING SYSTEM LOCKOUT
ARRANGEMENTS FOR SURGICAL INSTRUMENTS, and filed Jun. 28, 2012,
which is hereby incorporated by reference herein in its entirety.
In certain instances, as illustrated in FIG. 76, the processor 1114
can be operably coupled to the lockout mechanism 1122; the
processor 1114 may employ the lockout mechanism 1122 to prevent
advancement of the cutting edge 182 in the event it is determined
that the measured intensity of the light reflected from the cutting
edge 182 is beyond the stored threshold, for example. In other
words, the processor 1114 may activate the lockout mechanism 1122
if the cutting edge is not sufficiently sharp to cut the tissue
captured by the end effector 300.
[0378] In certain instances, the optical sensor 1108 and the light
source 1110 can be housed at a distal portion of the shaft assembly
200. In certain instances, the sharpness of cutting edge 182 can be
evaluated by the optical sensor 1108, as described above, prior to
transitioning the cutting edge 182 into the end effector 300. The
firing bar 172 (FIG. 20) may advance the cutting edge 182 through
the optical sensing region defined by the optical sensor 1108 while
the cutting edge 182 is in the shaft assembly 182 and prior to
entering the end effector 300, for example. In certain instances,
the sharpness of cutting edge 182 can be evaluated by the optical
sensor 1108 after retracting the cutting edge 182 proximally from
the end effector 300. The firing bar 172 (FIG. 20) may retract the
cutting edge 182 through the optical sensing region defined by the
optical sensor 1108 after retracting the cutting edge 182 from the
end effector 300 into the shaft assembly 200, for example.
[0379] In certain instances, the optical sensor 1108 and the light
source 1110 can be housed at a proximal portion of the end effector
300 which can be proximal to the staple cartridge 1100, for
example. The sharpness of cutting edge 182 can be evaluated by the
optical sensor 1108 after transitioning the cutting edge 182 into
the end effector 300 but prior to engaging the staple cartridge
1100, for example. In certain instances, the firing bar 172 (FIG.
20) may advance the cutting edge 182 through the optical sensing
region defined by the optical sensor 1108 while the cutting edge
182 is in the end effector 300 but prior to engaging the staple
cartridge 1100, for example.
[0380] In various instances, the sharpness of cutting edge 182 can
be evaluated by the optical sensor 1108 as the cutting edge 182 is
advanced by the firing bar 172 through the slot 193. As illustrated
in FIG. 74, the optical sensor 1108 and the light source 1110 can
be housed at the proximal portion 1102 of the staple cartridge
1100, for example; and the sharpness of cutting edge 182 can be
evaluated by the optical sensor 1108 at the proximal portion 1102,
for example. The firing bar 172 (FIG. 20) may advance the cutting
edge 182 through the optical sensing region defined by the optical
sensor 1108 at the proximal portion 1102 before the cutting edge
182 engages tissue captured between the staple cartridge 1100 and
the anvil 306, for example. In certain instances, as illustrated in
FIG. 74, the optical sensor 1108 and the light source 1110 can be
housed at the distal portion 1104 of the staple cartridge 1100, for
example. The sharpness of cutting edge 182 can be evaluated by the
optical sensor 1108 at the distal portion 1104. In certain
instances, the firing bar 172 (FIG. 20) may advance the cutting
edge 182 through the optical sensing region defined by the optical
sensor 1108 at the distal portion 1104 after the cutting edge 182
has passed through the tissue captured between the staple cartridge
1100 and the anvil 306, for example.
[0381] Referring again to FIG. 74, the staple cartridge 1100 may
comprise a plurality of optical sensors 1108 and a plurality of
corresponding light sources 1110, for example. In certain
instances, a pair of the optical sensor 1108 and the light source
1110 can be housed at the proximal portion 1102 of the staple
cartridge 1100, for example; and a pair of the optical sensor 1108
and the light source 1110 can be housed at the distal portion 1104
of the staple cartridge 1100, for example. In such instances, the
sharpness of the cutting edge 182 can be evaluated a first time at
the proximal portion 1102 prior to engaging the tissue, for
example, and a second time at the distal portion 1104 after passing
through the captured tissue, for example.
[0382] The reader will appreciate that an optical sensor 1108 may
evaluate the sharpness of the cutting edge 182 a plurality of times
during a surgical procedure. For example, the sharpness of the
cutting edge can be evaluated a first time during advancement of
the cutting edge 182 through the slot 193 in a firing stroke, and a
second time during retraction of the cutting edge 182 through the
slot 193 in a return stroke, for example. In other words, the light
reflected from the cutting edge 182 can be measured by the same
optical sensor 1108 once as the cutting edge is advanced through
the optical sensing region, and once as the cutting edge 182 is
retracted through the optical sensing region, for example.
[0383] The reader will appreciate that the processor 1114 may
receive a plurality of readings of the intensity of the light
reflected from the cutting edge 182 from one or more of the optical
sensors 1108. In certain instances, the processor 1114 may be
configured to discard outliers and calculate an average reading
from the plurality of readings, for example. In certain instances,
the average reading can be compared to a threshold stored in the
memory 1116, for example. In certain instances, the processor 1114
may be configured to alert a user through the feedback system 1120
and/or activate the lockout mechanism 1122 if it is determined that
the calculated average reading is beyond the threshold stored in
the memory 1116, for example.
[0384] In certain instances, as illustrated in FIGS. 75, 77, and
78, a pair of the optical sensor 1108 and the light source 1110 can
be positioned on opposite sides of the staple cartridge 1100. In
other words, the optical sensor 1108 can be positioned on a first
side 1124 of the slot 193, for example, and the light source 1110
can be positioned on a second side 1126, opposite the first side
1124, of the slot 193, for example. In certain instances, the pair
of the optical sensor 1108 and the light source 1110 can be
substantially disposed in a plane transecting the staple cartridge
1100, as illustrated in FIG. 75. The pair of the optical sensor
1108 and the light source 1110 can be oriented to define an optical
sensing region that is positioned, or at least substantially
positioned, on the plane transecting the staple cartridge 1100, for
example. Alternatively, the pair of the optical sensor 1108 and the
light source 1110 can be oriented to define an optical sensing
region that is positioned proximal to the plane transecting the
staple cartridge 1100, for example, as illustrated in FIG. 78.
[0385] In certain instances, a pair of the optical sensor 1108 and
the light source 1110 can be positioned on a same side of the
staple cartridge 1100. In other words, as illustrated in FIG. 79,
the pair of the optical sensor 1108 and the light source 1110 can
be positioned on a first side of the cutting edge 182, e.g. the
side 1128, as the cutting edge 182 is advanced through the slot
193. In such instances, the light source 1110 can be oriented to
direct light at the side 1128 of the cutting edge 182; and the
intensity of the light reflected from the side 1128, as measured by
the optical sensor 1108, may represent the sharpness of the side
1128.
[0386] In certain instances, as illustrated in FIG. 80, a second
pair of the optical sensor 1108 and the light source 1110 can be
positioned on a second side of the cutting edge 182, e.g. the side
1130, for example. The second pair can be employed to evaluate the
sharpness of the side 1130. For example, the light source 1110 of
the second pair can be oriented to direct light at the side 1130 of
the cutting edge 182; and the intensity of the light reflected from
the side 1130, as measured by the optical sensor 1108 of the second
pair, may represent the sharpness of the side 1130. In certain
instances, the processor can be configured to assess the sharpness
of the cutting edge 182 based upon the measured intensities of the
light reflected from the sides 1128 and 1130 of the cutting edge
182, for example.
[0387] In certain instances, as illustrated in FIG. 75, a pair of
the optical sensor 1108 and the light source 1110 can be housed at
the distal portion 1104 of the staple cartridge 1100. As
illustrated in FIG. 81, the light source 1108 can be positioned, or
at least substantially positioned, on an axis LL which extends
longitudinally along the path of the cutting edge 182 through the
slot 193, for example. In addition, the light source 1110 can be
positioned distal to the cutting edge 182 and oriented to direct
light at the cutting edge 182 as the cutting edge is advanced
toward the light source 1110, for example. Furthermore, the optical
sensor 1108 can be positioned, or at least substantially
positioned, along an axis AA that intersects the axis LL, as
illustrated in FIG. 81. In certain instances, the axis AA may be
perpendicular to the axis LL, for example. In any event, the
optical sensor 1108 can be oriented to define an optical sensing
region at the intersection of the axis LL and the axis AA, for
example.
[0388] The reader will appreciate that the position, orientation
and/or number of optical sensors and corresponding light sources
described herein in connection with the surgical instrument 10 are
example embodiments intended for illustration purposes. Various
other arrangements of optical sensors and light sources can be
employed by the present disclosure to evaluate the sharpness of the
cutting edge 182.
[0389] The reader will appreciate that advancement of the cutting
edge 182 through the tissue captured by the end effector 300 may
cause the cutting edge to collect tissue debris and/or bodily
fluids during each firing of the surgical instrument 10. Such
debris may interfere with the ability of the module 1106 to
accurately evaluate the sharpness of the cutting edge 182. In
certain instances, the surgical instrument 10 can be equipped with
one or more cleaning mechanisms which can be employed to clean the
cutting edge 182 prior to evaluating the sharpness of the cutting
edge 182, for example. In certain instances, as illustrated in FIG.
82, a cleaning mechanism 1131 may comprise one or more cleaning
members 1132, for example. In certain instances, the cleaning
members 1132 can be disposed on opposite sides of the slot 193 to
receive the cutting edge 182 therebetween (See FIG. 82) as the
cutting edge 182 is advanced through the slot 193, for example. In
certain instances, as illustrated in FIG. 82, the cleaning members
1132 may comprise wiper blades, for example. In certain instances,
as illustrated in FIG. 830, the cleaning members 1132 may comprise
sponges, for example. The reader will appreciate that various other
cleaning members can be employed to clean the cutting edge 182, for
example.
[0390] Referring to FIG. 74, in certain instances, the staple
cartridge 1100 may include a first pair of the optical sensor 1108
and the light source 1110, which can be housed in the proximal
portion 1102 of the staple cartridge 1100, for example.
Furthermore, as illustrated in FIG. 74, the staple cartridge 1100
may include a first pair of the cleaning members 1132, which can be
housed in the proximal portion 1102 on opposite sides of the slot
193. The first pair of the cleaning members 1132 can be positioned
distal to the first pair of the optical sensor 1108 and the light
source 1110, for example. As illustrated in FIG. 74, the staple
cartridge 1100 may include a second pair of the optical sensor 1108
and the light source 1110, which can be housed in the distal
portion 1104 of the staple cartridge 1100, for example. As
illustrated in FIG. 74, the staple cartridge 1100 may include a
second pair of the cleaning members 1132, which can be housed in
the distal portion 1104 on opposite sides of the slot 193. The
second pair of the cleaning members 1132 can be positioned proximal
to the second pair of the optical sensor 1108 and the light source
1110.
[0391] Further to the above, as illustrated in FIG. 74, the cutting
edge 182 may be advanced distally in a firing stroke to cut tissue
captured by the end effector 300. As the cutting edge is advanced,
a first evaluation of the sharpness of the cutting edge 182 can be
performed by the first pair of the optical sensor 1108 and the
light source 1110 prior to tissue engagement by the cutting edge
182, for example. A second evaluation of the sharpness of the
cutting edge 182 can be performed by the second pair of the optical
sensor 1108 and the light source 1110 after the cutting edge 182
has transected the captured tissue, for example. The cutting edge
182 may be advanced through the second pair of the cleaning members
1132 prior to the second evaluation of the sharpness of the cutting
edge 182 to remove any debris collected by the cutting edge 182
during the transection of the captured tissue.
[0392] Further to the above, as illustrated in FIG. 74, the cutting
edge 182 may be retracted proximally in a return stroke. As the
cutting edge is retracted, a third evaluation of the sharpness of
the cutting edge 182 can be performed by the first pair of the
optical sensor 1108 and the light source 1110 during the return
stroke. The cutting edge 182 may be retracted through the first
pair of the cleaning members 1132 prior to the third evaluation of
the sharpness of the cutting edge 182 to remove any debris
collected by the cutting edge 182 during the transection of the
captured tissue, for example.
[0393] In certain instances, one or more of the lights sources 1110
may comprise one or more optical fiber cables. In certain
instances, one or more flex circuits 1134 can be employed to
transmit energy from the power source 1118 to the optical sensors
1108 and/or the light sources 1110. In certain instances, the flex
circuits 1134 may be configured to transmit one or more of the
readings of the optical sensors 1108 to the controller 1112, for
example.
[0394] Referring now to FIG. 84, a staple cartridge 4300 is
depicted; the staple cartridge 4300 is similar in many respects to
the staple cartridge 304 (FIG. 20). For example, the staple
cartridge 4300 can be employed with the end effector 300. In
certain instances, as illustrated in FIG. 84, the staple cartridge
4300 may comprise a sharpness testing member 4302 which can be
employed to test the sharpness of the cutting edge 182. In certain
instances, the sharpness testing member 4302 can be attached to
and/or integrated with the cartridge body 194 of the staple
cartridge 4300, for example. In certain instances, the sharpness
testing member 4302 can be disposed in the proximal portion 1102 of
the staple cartridge 4300, for example. In certain instances, as
illustrated in FIG. 84, the sharpness testing member 4302 can be
disposed onto a cartridge deck 4304 of the staple cartridge 4300,
for example.
[0395] In certain instances, as illustrated in FIG. 84, the
sharpness testing member 4302 can extend across the slot 193 of the
staple cartridge 4300 to bridge, or at least partially bridge, the
gap defined by the slot 193, for example. In certain instances, the
sharpness testing member 4302 may interrupt, or at least partially
interrupt, the path of the cutting edge 182. The cutting edge 182
may engage, cut, and/or pass through the sharpness testing member
4302 as the cutting edge 182 is advanced during a firing stroke,
for example. In certain instances, the cutting edge 182 may be
configured to engage, cut, and/or pass through the sharpness
testing member 4302 prior to engaging tissue captured by the end
effector 300 in a firing stroke, for example. In certain instances,
the cutting edge 182 may be configured to engage the sharpness
testing member 4302 at a proximal end 4306 of the sharpness testing
member 4302, and exit and/or disengage the sharpness testing member
4302 at a distal end 4308 of the sharpness testing member 4302, for
example. In certain instances, the cutting edge 182 can travel
and/or cut through the sharpness testing member 4302 a distance (D)
between the proximal end 4306 and the distal end 4308, for example,
as the cutting edge 182 is advanced during a firing stroke.
[0396] Referring primarily to FIGS. 84 and 85, the surgical
instrument 10 may comprise a sharpness testing module 4310 for
testing the sharpness of the cutting edge 182, for example. In
certain instances, the module 4310 can evaluate the sharpness of
the cutting edge 182 by testing the ability of the cutting edge 182
to be advanced through the sharpness testing member 4302. For
example, the module 4310 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 the
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.
[0397] In certain instances, the module 4310 may include a
microcontroller 4312 ("controller") which may include a
microprocessor 4314 ("processor") and one or more computer readable
mediums or memory units 4316 ("memory"). In certain instances, the
memory 4316 may store various program instructions, which when
executed may cause the processor 4314 to perform a plurality of
functions and/or calculations described herein. In certain
instances, the memory 4316 may be coupled to the processor 4314,
for example. A power source 4318 can be configured to supply power
to the controller 4312, for example. In certain instances, the
power source 4138 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 4318. In certain instances,
the power source 4318 may be replaceable and/or rechargeable, for
example.
[0398] In certain instances, the processor 4313 can be operably
coupled to the feedback system 1120 and/or the lockout mechanism
1122, for example.
[0399] Referring to FIGS. 84 and 85, the module 4310 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, the disclosure of
which is hereby incorporated by reference herein in its entirety.
In certain instances, the module 4310 may include a first position
sensor 4320 and a second position sensor 4322. In certain
instances, the first position sensor 4320 can be employed to detect
a first position of the cutting edge 182 at the proximal end 4306
of the sharpness testing member 4302, for example; and the second
position sensor 4322 can be employed to detect a second position of
the cutting edge 182 at the distal end 4308 of the sharpness
cutting member 4302, for example.
[0400] In certain instances, the position sensors 4320 and 4322 can
be employed to provide first and second position signals,
respectively, to the microcontroller 4312. It will be appreciated
that the position signals may be analog signals or digital values
based on the interface between the microcontroller 4312 and the
position sensors 4320 and 4322. In one embodiment, the interface
between the microcontroller 4312 and the position sensors 4320 and
4322 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.
[0401] Further to the above, the processor 4314 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 to advance
through the sharpness testing member 4302 from the first position
at the proximal end 4306 of the sharpness testing member 4302, for
example, to the second position at the distal end 4308 of the
sharpness testing member 4302, for example. In at least one
example, the controller 4312 may include a time element which can
be activated by the processor 4314 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.
[0402] In various instances, the controller 4312 can compare the
time period it takes the cutting edge 182 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 4312 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.
[0403] Referring to FIG. 86, in various instances, an electric
motor 4330 can drive the firing bar 172 (FIG. 20) to advance the
cutting edge 182 during a firing stroke and/or to retract the
cutting edge 182 during a return stroke, for example. A motor
driver 4332 can control the electric motor 4330; and a
microcontroller such as, for example, the microcontroller 4312 can
be in signal communication with the motor driver 4332. As the
electric motor 4330 advances the cutting edge 182, the
microcontroller 4312 can determine the current drawn by the
electric motor 4330, for example. In such instances, the force
required to advance the cutting edge 182 can correspond to the
current drawn by the electric motor 4330, for example. Referring
still to FIG. 86, the microcontroller 4312 of the surgical
instrument 10 can determine if the current drawn by the electric
motor 4330 increases during advancement of the cutting edge 182
and, if so, can calculate the percentage increase of the
current.
[0404] In certain instances, the current drawn by the electric
motor 4330 may increase significantly while the cutting edge 182 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 4330 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 4330 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.
[0405] In certain instances, the determined value of the percentage
increase of the current drawn by the motor 4330 can be the maximum
detected percentage increase of the current drawn by the motor
4330. In various instances, the microcontroller 4312 can compare
the determined value of the percentage increase of the current
drawn by the motor 4330 to a predefined threshold value of the
percentage increase of the current drawn by the motor 4330. If the
determined value exceeds the predefined threshold value, the
microcontroller 4312 may conclude that the sharpness of the cutting
edge 182 has dropped below an acceptable level, for example.
[0406] In certain instances, as illustrated in FIG. 86, the
processor 4314 can be in communication with the feedback system
1120 and/or the lockout mechanism 1122, for example. In certain
instances, the processor 4314 can employ the feedback system 1120
to alert a user if the determined value of the percentage increase
of the current drawn by the motor 4330 exceeds the predefined
threshold value, for example. In certain instances, the processor
4314 may employ the lockout mechanism 1122 to prevent advancement
of the cutting edge 182 if the determined value of the percentage
increase of the current drawn by the motor 4330 exceeds the
predefined threshold value, for example.
[0407] In various instances, the microcontroller 43312 can utilize
an algorithm to determine the change in current drawn by the
electric motor 4330. For example, a current sensor can detect the
current drawn by the electric motor 4330 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.
[0408] Referring to FIG. 87, a method is depicted for evaluating
the sharpness of the cutting edge 182 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 4312 can be configured to implement the method
depicted in FIG. 87. In certain instances, the surgical instrument
10 may include a load cell 4334 (FIG. 86); as illustrated in FIG.
86, the microcontroller 4312 may be in communication with the load
cell 4334. In certain instances, the load cell 4334 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 4312 may employ the load cell 4334
to monitor the force (Fx) applied to the cutting edge 182 as the
cutting edge 182 is advanced during a firing stroke.
[0409] In certain instances, as illustrated in FIG. 88, the load
cell 4334 can be configured to monitor the force (Fx) applied to
the cutting edge 182 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. For example, as illustrated in FIG.
88, graphs 4336, 4338, and 4340 represent 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 4340 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.
[0410] In certain instances, the microcontroller 4312 may compare a
maximum value of the monitored force (Fx) applied to the cutting
edge 182 to one or more predefined threshold values. In certain
instances, as illustrated in FIG. 88, 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. 88, the monitored force (Fx) can be less than the
alert threshold (F1), for example. In such instances, as
illustrated in FIG. 87, the sharpness of the cutting edge 182 is at
a good level and the microcontroller 4312 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.
[0411] In certain instances, as illustrated in the graph 4338 of
FIG. 88, 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. 87, the
sharpness of the cutting edge 182 can be dulling but still within
an acceptable level. The microcontroller 4312 may take no action to
alert a user as to the status of the cutting edge 182.
Alternatively, the microcontroller 4312 may inform the user that
the sharpness of the cutting edge 182 is within an acceptable
range. Alternatively or additionally, the microcontroller 4312 may
determine or estimate the number of cutting cycles remaining in the
lifecycle of the cutting edge 182 and may alert the user
accordingly.
[0412] In certain instances, the memory 4316 may include a database
or a table that correlates the number of cutting cycles remaining
in the lifecycle of the cutting edge 182 to predetermined values of
the monitored force (Fx). The processor 4314 may access the memory
4316 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.
[0413] In certain instances, as illustrated in the graph 4340 of
FIG. 88, the monitored force (Fx) can be more than the high
severity threshold (F2), for example. In such instances, as
illustrated in FIG. 87, the sharpness of the cutting edge 182 can
be below an acceptable level In response, the microcontroller 4312
may employ the feedback system 1120 to warn the user that the
cutting edge 182 is too dull for safe use, for example. In certain
instances, the microcontroller 4312 may employ the lockout
mechanism 1122 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 4312 may employ the feedback system 1122 to provide
instructions to the user for overriding the lockout mechanism 1122,
for example.
[0414] Referring to FIG. 89, a method is depicted for determining
whether a cutting edge such as, for example, the cutting edge 182
is sufficiently sharp to be employed in transecting a tissue of a
particular tissue thickness that is captured by the end effector
300, for example. In certain instances, the microcontroller 4312
can be implemented to perform the method depicted in FIG. 16, 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 may also 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.
[0415] In certain instances, the cutting edge 182 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, as
illustrated in FIG. 90, the memory 4316 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, if 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.
[0416] In certain instances, the predefined threshold forces and
their corresponding predefined ranges of tissue thicknesses can be
stored in a database and/or a table on the memory 4316 such as, for
example, a table 4342, as illustrated in FIG. 90. In certain
instances, the processor 4314 can be configured to receive a
measured value of the force (Fx) required for the cutting edge 182
to transect a captured tissue and a measured value of the tissue
thickness (Tx) of the captured tissue. The processor 4314 may
access the table 4342 to determine the predefined range of tissue
thicknesses that encompasses the measured tissue thickness (Tx). In
addition, the processor 4314 may compare the measured force (Fx) to
the predefined threshold force associated with the predefined range
of tissue thicknesses that encompasses the tissue thickness (Tx).
In certain instances, if the measured force (Fx) exceeds the
predefined threshold force, the processor 4314 may conclude that
the cutting edge 182 may not be sufficiently sharp to transect the
captured tissue, for example.
[0417] Further to the above, the processor 4314 may employ one or
more tissue thickness sensing modules such as, for example, a
tissue thickness sensing module 4336 to determine the thickness of
the captured tissue. Various suitable tissue thickness sensing
modules are described in the present disclosure. In addition,
various tissue thickness sensing devices and methods, which are
suitable for use with the present disclosure, are disclosed in U.S.
Publication No. US 2011/0155781, entitled SURGICAL CUTTING
INSTRUMENT THAT ANALYZES TISSUE THICKNESS, and filed Dec. 24, 2009,
the entire disclosure of which is hereby incorporated by reference
herein.
[0418] In certain instances, the processor 4314 may employ the load
cell 4334 to measure the force (Fx) required for the cutting edge
182 to transect a captured tissue comprising a tissue thickness
(Tx). The reader will appreciate that that the force applied to the
cutting edge 182 by the captured tissue, while the cutting edge 182
is engaged and/or in contact with the captured tissue, may increase
as the cutting edge 182 is advanced against the captured tissue up
to the force (Fx) at which the cutting edge 182 may transect the
captured tissue. In certain instances, the processor 4314 may
employ the load cell 4334 to continually monitor the force applied
by the captured tissue against the cutting edge 182 as the cutting
edge 182 is advanced against the captured tissue. The processor
4314 may continually compare the monitored force to the predefined
threshold force associated with the predefined tissue thickness
range encompassing the tissue thickness (Tx) of the captured
tissue. In certain instances, if the monitored force exceeds the
predefined threshold force, the processor 4314 may conclude that
the cutting edge is not sufficiently sharp to safely transect the
captured tissue, for example.
[0419] The method described in FIG. 89 outline various example
actions that can be taken by the processor 4313 in the event it is
determined that the cutting edge 182 is not be sufficiently sharp
to safely transect the captured tissue, for example. In certain
instances, the microcontroller 4312 may warn the user that the
cutting edge 182 is too dull for safe use, for example, through the
feedback system 1120, for example. In certain instances, the
microcontroller 4312 may employ the lockout mechanism 1122 to
prevent advancement of the cutting edge 182 upon concluding that
the cutting edge 182 is not sufficiently sharp to safely transect
the captured tissue, for example. In certain instances, the
microcontroller 4312 may employ the feedback system 1122 to provide
instructions to the user for overriding the lockout mechanism 1122,
for example.
[0420] Multiple Motor Control for Powered Medical Device
[0421] FIGS. 91-93 illustrate various embodiments of an apparatus,
system, and method for employing a common control module with a
plurality of motors in connection with a surgical instrument such
as, for example, a surgical instrument 4400. The surgical
instrument 4400 is similar in many respects to other surgical
instruments described by the present disclosure such as, for
example, the surgical instrument 10 of FIG. 1 which is described in
greater detail above. For example, as illustrated in FIG. 91, the
surgical instrument 4400 includes the housing 12, the handle 14,
the closure trigger 32, the shaft assembly 200, and the surgical
end effector 300. Accordingly, for conciseness and clarity of
disclosure, a detailed description of certain features of the
surgical instrument 4400, which are common with the surgical
instrument 10, will not be repeated here.
[0422] Referring primarily to FIG. 92, the surgical instrument 4400
may include a plurality of motors which can be activated to perform
various functions in connection with the operation of the surgical
instrument 4400. In certain instances, a first motor can be
activated to perform a first function; a second motor can be
activated to perform a second function; and a third motor can be
activated to perform a third function. In certain instances, the
plurality of motors of the surgical instrument 4400 can be
individually activated to cause articulation, closure, and/or
firing motions in the end effector 300. The articulation, closure,
and/or firing motions can be transmitted to the end effector 300
through the shaft assembly 200, for example.
[0423] In certain instances, as illustrated in FIG. 92, the
surgical instrument 4400 may include a firing motor 4402. The
firing motor 4402 may be operably coupled to a firing drive
assembly 4404 which can be configured to transmit firing motions
generated by the motor 4402 to the end effector 300. In certain
instances, the firing motions generated by the motor 4402 may cause
the staples 191 to be deployed from the staple cartridge 304 into
tissue captured by the end effector 300 and/or the cutting edge 182
to be advanced to cut the captured tissue, for example.
[0424] In certain instances, as illustrated in FIG. 92, the
surgical instrument 4400 may include an articulation motor 4406,
for example. The motor 4406 may be operably coupled to an
articulation drive assembly 4408 which can be configured to
transmit articulation motions generated by the motor 4406 to the
end effector 300. In certain instances, the articulation motions
may cause the end effector 300 to articulate relative to the shaft
assembly 200, for example. In certain instances, the surgical
instrument 4400 may include a closure motor, for example. The
closure motor may be operably coupled to a closure drive assembly
which can be configured to transmit closure motions to the end
effector 300. In certain instances, the closure motions may cause
the end effector 300 to transition from an open configuration to an
approximated configuration to capture tissue, for example. The
reader will appreciate that the motors described herein and their
corresponding drive assemblies are intended as examples of the
types of motors and/or driving assemblies that can be employed in
connection with the present disclosure. The surgical instrument
4400 may include various other motors which can be utilized to
perform various other functions in connection with the operation of
the surgical instrument 4400.
[0425] As described above, the surgical instrument 4400 may include
a plurality of motors which may be configured to perform various
independent functions. In certain instances, the plurality of
motors of the surgical instrument 4400 can be individually or
separately activated to perform one or more functions while the
other motors remain inactive. For example, the articulation motor
4406 can be activated to cause the end effector 300 to be
articulated while the firing motor 4402 remains inactive.
Alternatively, the firing motor 4402 can be activated to fire the
plurality of staples 191 and/or advance the cutting edge 182 while
the articulation motor 4406 remains inactive.
[0426] In certain instances, the surgical instrument 4400 may
include a common control module 4410 which can be employed with a
plurality of motors of the surgical instrument 4400. In certain
instances, the common control module 4410 may accommodate one of
the plurality of motors at a time. For example, the common control
module 4410 can be separably couplable to the plurality of motors
of the surgical instrument 4400 individually. In certain instances,
a plurality of the motors of the surgical instrument 4400 may share
one or more common control modules such as the module 4410. In
certain instances, a plurality of motors of the surgical instrument
4400 can be individually and selectively engaged the common control
module 4410. In certain instances, the module 4410 can be
selectively switched from interfacing with one of a plurality of
motors of the surgical instrument 4400 to interfacing with another
one of the plurality of motors of the surgical instrument 4400.
[0427] In at least one example, the module 4410 can be selectively
switched between operable engagement with the articulation motor
4406 and operable engagement with the firing motor 4402. In at
least one example, as illustrated in FIG. 92, a switch 4414 can be
moved or transitioned between a plurality of positions and/or
states such as a first position 4416 and a second position 4418,
for example. In the first position 4416, the switch 4414 may
electrically couple the module 4410 to the articulation motor 4406;
and in the second position 4418, the switch 4414 may electrically
couple the module 4410 to the firing motor 4402, for example. In
certain instances, the module 4410 can be electrically coupled to
the articulation motor 4406, while the switch 4414 is in the first
position 4416, to control the operation of the motor 4406 to
articulate the end effector 300 to a desired position. In certain
instances, the module 4410 can be electrically coupled to the
firing motor 4402, while the switch 4414 is in the second position
4418, to control the operation of the motor 4402 to fire the
plurality of staples 191 and/or advance the cutting edge 182, for
example. In certain instances, the switch 4414 may be a mechanical
switch, an electromechanical switch, a solid state switch, or any
suitable switching mechanism.
[0428] Referring now to FIG. 93, an outer casing of the handle 14
of the surgical instrument 4400 is removed and several features and
elements of the surgical instrument 4400 are also removed for
clarity of disclosure. In certain instances, as illustrated in FIG.
93, the surgical instrument 4400 may include an interface 4412
which can be selectively transitioned between a plurality of
positions and/or states. In a first position and/or state, the
interface 4412 may couple the module 4410 to a first motor such as,
for example, the articulation motor 4406; and in a second position
and/or state, the interface 4412 may couple the module 4410 to a
second motor such as, for example, the firing motor 4402.
Additional positions and/or states of the interface 4412 are
contemplated by the present disclosure.
[0429] In certain instances, the interface 4412 is movable between
a first position and a second position, wherein the module 4410 is
coupled to a first motor in the first position and a second motor
in the second position. In certain instances, the module 4410 is
decoupled from first motor as the interface 4412 is moved from the
first position; and the module 4410 is decoupled from second motor
as the interface 4412 is moved from the second position. In certain
instances, a switch or a trigger can be configured to transition
the interface 4412 between the plurality of positions and/or
states. In certain instances, a trigger can be movable to
simultaneously effectuate the end effector and transition the
control module 4410 from operable engagement with one of the motors
of the surgical instrument 4400 to operable engagement with another
one of the motors of the surgical instrument 4400.
[0430] In at least one example, as illustrated in FIG. 93, the
closure trigger 32 can be operably coupled to the interface 4412
and can be configured to transition the interface 4412 between a
plurality of positions and/or states. As illustrated in FIG. 93,
the closure trigger 32 can be movable, for example during a closure
stroke, to transition the interface 4412 from a first position
and/or state to a second position and/or state while transitioning
the end effector 300 to an approximated configuration to capture
tissue by the end effector, for example.
[0431] In certain instances, in the first position and/or state,
the module 4410 can be electrically coupled to a first motor such
as, for example, the articulation motor 4406, and in the second
position and/or state, the module 4410 can be electrically coupled
to a second motor such as, for example, the firing motor 4402. In
the first position and/or state, the module 4410 may be engaged
with the articulation motor 4406 to allow the user to articulate
the end effector 300 to a desired position; and the module 4410 may
remain engaged with the articulation motor 4406 until the trigger
32 is actuated. As the user actuates the closure trigger 32 to
capture tissue by the end effector 300 at the desired position, the
interface 4412 can be transitioned or shifted to transition the
module 4410 from operable engagement with the articulation motor
4406, for example, to operable engagement with the firing motor
4402, for example. Once operable engagement with the firing motor
4402 is established, the module 4410 may take control of the firing
motor 4402; and the module 4410 may activate the motor 4402, in
response to user input, to fire the plurality of staples 191 and/or
advance the cutting edge 182, for example.
[0432] In certain instances, as illustrated in FIG. 93, the module
4410 may include a plurality of electrical and/or mechanical
contacts 4411 adapted for coupling engagement with the interface
4412. The plurality of motors of the surgical instrument 4400,
which share the module 4410, may each comprise one or more
corresponding electrical and/or mechanical contacts 4413 adapted
for coupling engagement with the interface 4412, for example.
[0433] In various instances, the motors of the surgical instrument
4400 can be electrical motors. In certain instances, one or more of
the motors of the surgical instrument 4400 can be a DC brushed
driving motor having a maximum rotation of, approximately, 25,000
RPM, for example. In other arrangements, the motors of the surgical
instrument 4400 may include one or more motors selected from a
group of motors comprising a brushless motor, a cordless motor, a
synchronous motor, a stepper motor, or any other suitable electric
motor.
[0434] In various instances, as illustrated in FIG. 92, the common
control module 4410 may comprise a motor driver 4426 which may
comprise one or more H-Bridge field-effect transistors (FETs). The
motor driver 4426 may modulate the power transmitted from a power
source 4428 to a motor coupled to the module 4410 based on input
from a microcontroller 4420 ("controller"), for example. In certain
instances, the controller 4420 can be employed to determine the
current drawn by the motor, for example, while the motor is coupled
to the module 4410, as described above.
[0435] In certain instances, the controller 4420 may include a
microprocessor 4422 ("processor") and one or more computer readable
mediums or memory units 4424 ("memory"). In certain instances, the
memory 4424 may store various program instructions, which when
executed may cause the processor 4422 to perform a plurality of
functions and/or calculations described herein. In certain
instances, one or more of the memory units 4424 may be coupled to
the processor 4422, for example.
[0436] In certain instances, the power source 4428 can be employed
to supply power to the controller 4420, for example. In certain
instances, the power source 4428 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 for supplying power to
the surgical instrument 4400. A number of battery cells connected
in series may be used as the power source 4428. In certain
instances, the power source 4428 may be replaceable and/or
rechargeable, for example.
[0437] In various instances, the processor 4422 may control the
motor driver 4426 to control the position, direction of rotation,
and/or velocity of a motor that is coupled to the module 4410. In
certain instances, the processor 4422 can signal the motor driver
4426 to stop and/or disable a motor that is coupled to the module
4410. It should be understood that the term processor as used
herein includes any suitable 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.
[0438] In one instance, the processor 4422 may be any single core
or multicore processor such as those known under the trade name ARM
Cortex by Texas Instruments. In certain instances, the
microcontroller 4420 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 microcontrollers
may be readily substituted for use with the module 4410.
Accordingly, the present disclosure should not be limited in this
context.
[0439] In certain instances, the memory 4424 may include program
instructions for controlling each of the motors of the surgical
instrument 4400 that are couplable to the module 4410. For example,
the memory 4424 may include program instructions for controlling
the articulation motor 4406. Such program instructions may cause
the processor 4422 to control the articulation motor 4406 to
articulate the end effector 300 in accordance with user input while
the articulation motor 4406 is coupled to the module 4410. In
another example, the memory 4424 may include program instructions
for controlling the firing motor 4402. Such program instructions
may cause the processor 4422 to control the firing motor 4402 to
fire the plurality of staples 191 and/or advance the cutting edge
182 in accordance with user input while the firing motor 4402 is
coupled to the module 4410.
[0440] In certain instances, one or more mechanisms and/or sensors
such as, for example, sensors 4430 can be employed to alert the
processor 4422 to the program instructions that should be used in a
particular setting. For example, the sensors 4430 may alert the
processor 4422 to use the program instructions associated with
articulation of the end effector 300 while the module 4410 is
coupled to the articulation motor 4406; and the sensors 4430 may
alert the processor 4422 to use the program instructions associated
with firing the surgical instrument 4400 while the module 4410 is
coupled to the firing motor 4402. In certain instances, the sensors
4430 may comprise position sensors which can be employed to sense
the position of the switch 4414, for example. Accordingly, the
processor 4422 may use the program instructions associated with
articulation of the end effector 300 upon detecting, through the
sensors 4430 for example, that the switch 4414 is in the first
position 4416; and the processor 4422 may use the program
instructions associated with firing the surgical instrument 4400
upon detecting, through the sensors 4430 for example, that the
switch 4414 is in the second position 4418.
[0441] Referring now to FIG. 94, an outer casing of the surgical
instrument 4400 is removed and several features and elements of the
surgical instrument 4400 are also removed for clarity of
disclosure. As illustrated in FIG. 94, the surgical instrument 4400
may include a plurality of sensors which can be employed to perform
various functions in connection with the operation of the surgical
instrument 4400. For example, as illustrated in FIG. 94, the
surgical instrument 4400 may include sensors A, B, and/or C. In
certain instances, the sensor A can be employed to perform a first
function, for example; the sensor B can be employed to perform a
second function, for example; and the sensor C can be employed to
perform a third function, for example. In certain instances, the
sensor A can be employed to sense a thickness of the tissue
captured by the end effector 300 during a first segment of a
closure stroke; the sensor B can be employed to sense the tissue
thickness during a second segment of the closure stroke following
the first segment; and the sensor C can be employed to sense the
tissue thickness during a third segment of the closure stroke
following the second segment, for example. In certain instances,
the sensors A, B, and C can be disposed along the end effector 300,
for example.
[0442] In certain instances, the sensors A, B, and C can be
arranged, as illustrated in FIG. 94, such that the sensor A is
disposed proximal to the sensor B, and the sensor C is disposed
proximal to the sensor B, for example. In certain instances, as
illustrated in FIG. 94, the sensor A can sense the tissue thickness
of the tissue captured by the end effector 300 at a first position;
the sensor B can sense the tissue thickness of the tissue captured
by the end effector 300 at a second position distal to the first
position; and the sensor C can sense the tissue thickness of the
tissue captured by the end effector 300 at a third position distal
to the second position, for example. The reader will appreciate
that the sensors described herein are intended as examples of the
types of sensors which can be employed in connection with the
present disclosure. Other suitable sensors and sensing arrangements
can be employed by the present disclosure.
[0443] In certain instances, the surgical instrument 4400 may
include a common control module 4450 which can be similar in many
respects to the module 4410. For example, the module 4450, like the
module 4410, may comprise the controller 4420, the processor 4422,
and/or the memory 4424. In certain instances, the power source 4428
can supply power to the module 4450, for example. In certain
instances, the surgical instrument 4400 may include a plurality of
sensors such as the sensors A, B, and C, for example, which can
activated to perform various functions in connection with the
operation of the surgical instrument 4400. In certain instances,
one of the sensors A, B, and C, for example, can be individually or
separately activated to perform one or more functions while the
other sensors remain inactive. In certain instances, a plurality of
sensors of the surgical instrument 4400 such as, for example, the
sensors A, B, and C may share the module 4450. In certain
instances, only one of the sensors A, B, and C can be coupled to
the module 4450 at a time. In certain instances, the plurality of
sensors of the surgical instrument 4400 can be individually and
separately couplable to the module 4450, for example. In at least
one example, the module 4450 can be selectively switched between
operable engagement with sensor A, Sensor B, and/or Sensor C.
[0444] In certain instances, as illustrated in FIG. 94, the module
4450 can be disposed in the handle 14, for example, and the sensors
that share the module 4450 can be disposed in the end effector 300,
for example. The reader will appreciate that the module 4450 and/or
the sensors that share the module 4450 are not limited to the above
identified positions. In certain instances, the module 4450 and the
sensors that share the module 4450 can be disposed in the end
effector 300, for example. Other arrangements for the positions of
the module 4450 and/or the sensors that share the module 4450 are
contemplated by the present disclosure.
[0445] In certain instances, as illustrated in FIG. 94, an
interface 4452 can be employed to manage the coupling and/or
decoupling of the sensors of the surgical instrument 4400 to the
module 4450. In certain instances, the interface 4452 can be
selectively transitioned between a plurality of positions and/or
states. In a first position and/or state, the interface 4452 may
couple the module 4450 to the sensor A, for example; in a second
position and/or state, the interface 4452 may couple the module
4450 to the sensor B, for example; and in a third position and/or
state, the interface 4452 may couple the module 4450 to the sensor
C, for example. Additional positions and/or states of the interface
4452 are contemplated by the present disclosure.
[0446] In certain instances, the interface 4452 is movable between
a first position, a second position, and/or a third position, for
example, wherein the module 4450 is coupled to a first sensor in
the first position, a second sensor in the second position, and a
third sensor in the third position. In certain instances, the
module 4450 is decoupled from first sensor as the interface 4452 is
moved from the first position; the module 4450 is decoupled from
second sensor as the interface 4452 is moved from the second
position; and the module 4450 is decoupled from third sensor as the
interface 4452 is moved from the third position. In certain
instances, a switch or a trigger can be configured to transition
the interface 4452 between the plurality of positions and/or
states. In certain instances, a trigger can be movable to
simultaneously effectuate the end effector and transition the
control module 4450 from operable engagement with one of the
sensors that share the module 4450 to operable engagement with
another one of the sensors that share the module 4450, for
example.
[0447] In at least one example, as illustrated in FIG. 94, the
closure trigger 32 can be operably coupled to the interface 4450
and can be configured to transition the interface 4450 between a
plurality of positions and/or states. As illustrated in FIG. 94,
the closure trigger 32 can be moveable between a plurality of
positions, for example during a closure stroke, to transition the
interface 4450 between a first position and/or state wherein the
module 4450 is electrically coupled to the sensor A, for example, a
second position and/or state wherein the module 4450 is
electrically coupled to the sensor B, for example, and/or a third
position and/or state wherein the module 4450 is electrically
coupled to the sensor C, for example.
[0448] In certain instances, a user may actuate the closure trigger
32 to capture tissue by the end effector 300. Actuation of the
closure trigger may cause the interface 4452 to be transitioned or
shifted to transition the module 4450 from operable engagement with
the sensor A, for example, to operable engagement with the sensor
B, for example, and/or from operable engagement with sensor B, for
example, to operable engagement with sensor C, for example.
[0449] In certain instances, the module 4450 may be coupled to the
sensor A while the trigger 32 is in a first actuated position. As
the trigger 32 is actuated past the first actuated position and
toward a second actuated position, the module 4450 may be decoupled
from the sensor A. Alternatively, the module 4450 may be coupled to
the sensor A while the trigger 32 is in an unactuated position. As
the trigger 32 is actuated past the unactuated position and toward
a second actuated position, the module 4450 may be decoupled from
the sensor A. In certain instances, the module 4450 may be coupled
to the sensor B while the trigger 32 is in the second actuated
position. As the trigger 32 is actuated past the second actuated
position and toward a third actuated position, the module 4450 may
be decoupled from the sensor B. In certain instances, the module
4450 may be coupled to the sensor C while the trigger 32 is in the
third actuated position.
[0450] In certain instances, as illustrated in FIG. 94, the module
4450 may include a plurality of electrical and/or mechanical
contacts 4451 adapted for coupling engagement with the interface
4452. The plurality of sensors of the surgical instrument 4400,
which share the module 4450, may each comprise one or more
corresponding electrical and/or mechanical contacts 4453 adapted
for coupling engagement with the interface 4452, for example.
[0451] In certain instances, the processor 4422 may receive input
from the plurality of sensors that share the module 4450 while the
sensors are coupled to the module 4452. For example, the processor
4422 may receive input from the sensor A while the sensor A is
coupled to the module 4450; the processor 4422 may receive input
from the sensor B while the sensor B is coupled to the module 4450;
and the processor 4422 may receive input from the sensor C while
the sensor C is coupled to the module 4450. In certain instances,
the input can be a measurement value such as, for example, a
measurement value of a tissue thickness of tissue captured by the
end effector 300. In certain instances, the processor 4422 may
store the input from one or more of the sensors A, B, and C on the
memory 4426. In certain instances, the processor 4422 may perform
various calculations based on the input provided by the sensors A,
B, and C, for example.
[0452] Local Display of Tissue Parameter Stabilization
[0453] FIGS. 95A and 1B illustrate one embodiment of an end
effector 5300 comprising a staple cartridge 5306 that further
comprises two light-emitting diodes (LEDs) 5310. The end effector
5300 is similar to the end effector 300 described above. The end
effector comprises a first jaw member or anvil 5302, pivotally
coupled to a second jaw member or elongated channel 5304. The
elongated channel 5304 is configured to receive the staple
cartridge 5306 therein. The staple cartridge 5306 comprises a
plurality of staples (not shown). The plurality of staples are
deployable from the staple cartridge 5306 during a surgical
operation. The staple cartridge 5306 further comprises two LEDs
5310 mounted on the upper surface, or cartridge deck 5308 of the
staple cartridge 5306. The LEDs 5310 are mounted such that they
will be visible when the anvil 5304 is in a closed position.
Furthermore, the LEDs 5310 can be sufficiently bright to be visible
through any tissue that may be obscuring a direct view of the LEDs
5310. Additionally, one LED 5310 can be mounted on either side of
the staple cartridge 5306 such that at least one LED 5310 is
visible from either side of the end effector 5300. The LED 5310 can
be mounted near the proximal end of the staple cartridge 530, as
illustrated, or may be mounted at the distal end of the staple
cartridge 5306.
[0454] The LEDs 5310 may be in communication with a processor or
microcontroller, such as for instance microcontroller 1500 of FIG.
19. The microcontroller 1500 can be configured to detect a property
of tissue compressed by the anvil 5304 against the cartridge deck
5308. Tissue that is enclosed by the end effector 5300 may change
height as fluid within the tissue is exuded from the tissue's
layers. Stapling the tissue before it has sufficiently stabilized
may affect the effectiveness of the staples. Tissue stabilization
is typically communicates as a rate of change, where the rate of
change indicates how rapidly the tissue enclosed by the end
effector is changing height.
[0455] The LEDs 5310 mounted to the staple cartridge 5306, in the
view of the operator of the instrument, can be used to indicate
rate at which the enclosed tissue is stabilizing and/or whether the
tissue has reached a stable state. The LEDs 5310 can, for example,
be configured to flash at a rate that directly correlates to the
rate of stabilization of the tissue, that is, can flash quickly
initially, flash slower as the tissue stabilizes, and remain steady
when the tissue is stable. Alternatively, the LEDs 5310 can flash
slowly initially, flash more quickly as the tissue stabilizes, and
turn off when the tissue is stable.
[0456] The LEDs 5310 mounted on the staple cartridge 5306 can be
used additionally or optionally to indicate other information.
Examples of other information include, but are not limited to:
whether the end effector 5300 is enclosing a sufficient amount of
tissue, whether the staple cartridge 5306 is appropriate for the
enclosed tissue, whether there is more tissue enclosed than is
appropriate for the staple cartridge 5306, whether the staple
cartridge 5306 is not compatible with the surgical instrument, or
any other indicator that would be useful to the operator of the
instrument. The LEDs 5310 can indicate information by either
flashing at a particular rate, turning on or off at a particular
instance, lighting in different colors for different information.
The LEDs 5310 can alternatively or additionally be used to
illuminate the area of operation. In some embodiments the LEDs 5310
can be selected to emit ultraviolet or infrared light to illuminate
information not visible under normal light, where that information
is printed on the staple cartridge 5300 or on a tissue compensator
(not illustrated). Alternatively or additionally, the staples can
be coated with a fluorescing dye and the wavelength of the LEDs
5310 chosen so that the LEDs 5310 cause the fluorescing dye to
glow. By illuminating the staples with the LEDs 5310 allows the
operator of the instrument to see the staples after they have been
driven.
[0457] Returning to FIGS. 95A and 95B, FIG. 95A illustrates a side
angle view of the end effector 5300 with the anvil 5304 in a closed
position. The illustrated embodiment comprises, by way of example,
one LED 5310 located on either side of the cartridge deck 5308.
FIG. 95B illustrates a three-quarter angle view of the end effector
5300 with the anvil 5304 in an open position, and one LED 5310
located on either side of the cartridge deck 5308.
[0458] FIGS. 96A and 96B illustrate one embodiment of the end
effector 5300 comprising a staple cartridge 5356 that further
comprises a plurality of LEDs 5360. The staple cartridge 5356
comprises a plurality of LEDs 5360 mounted on the cartridge deck
5358 of the staple cartridge 5356. The LEDs 5360 are mounted such
that they will be visible when the anvil 5304 is in a closed
position. Furthermore, the LEDs6 530 can be sufficiently bright to
be visible through any tissue that may be obscuring a direct view
of the LEDs 5360. Additionally, the same number of LEDs 5360 can be
mounted on either side of the staple cartridge 5356 such that the
same number of LEDs 5360 is visible from either side of the end
effector 5300. The LEDs 5360 can be mounted near the proximal end
of the staple cartridge 5356, as illustrated, or may be mounted at
the distal end of the staple cartridge 5356.
[0459] The LEDs 5360 may be in communication with a processor or
microcontroller, such as for instance microcontroller 1500 of FIG.
15. The microcontroller 1500 can be configured to detect a property
of tissue compressed by the anvil 5304 against the cartridge deck
5358, such as the rate of stabilization of the tissue, as described
above. The LEDs 5360 can be used to indicate the rate at which the
enclose tissue is stabilizing and/or whether the tissue has reached
a stable state. The LEDs 5360 can be configured, for instance, to
light in sequence starting at the proximal end of the staple
cartridge 5356 with each subsequent LED 5360 lighting at the rate
at which the enclosed tissue is stabilizing; when the tissue is
stable, all the LEDs 5360 can be lit. Alternatively, the LEDs 5360
can light in sequence beginning at the distal end of the staple
cartridge 5356. Yet another alternative is for the LEDs 5360 to
light in a sequential, repeating sequence, with the sequence
starting at either the proximal or distal end of the LEDs 5360. The
rate at which the LEDs 5360 light and/or the speed of the repeat
can indicate the rate at which the enclosed tissue is stabilizing.
It is understood that these are only examples of how the LEDs 5360
can indicate information about the tissue, and that other
combinations of the sequence in which the LEDs 5360 light, the rate
at which they light, and or their on or off state are possible. It
is also understood that the LEDs 5360 can be used to communicate
some other information to the operator of the surgical instrument,
or to light the work area, as described above.
[0460] Returning to FIGS. 96A and 96B, FIG. 96A illustrates a side
angle view of the end effector 5300 with the anvil 5304 in a closed
position. The illustrated embodiment comprises, by way of example,
a plurality of LEDs 5360 located on either side of the cartridge
deck 5358. FIG. 96B illustrates a three-quarter angle view of the
end effector 5300 with the anvil 5304 in an open position,
illustrating a plurality of LEDs 5360 located on either side of the
cartridge deck 5358.
[0461] FIGS. 97A and 97B illustrate one embodiment of the end
effector 5300 comprising a staple cartridge 5406 that further
comprises a plurality of LEDs 5410. The staple cartridge 5406
comprises a plurality of LEDs 5410 mounted on the cartridge deck
5408 of the staple cartridge 5406, with the LEDs 5410 placed
continuously from the proximal to the distal end of the staple
cartridge 5406. The LEDs 5410 are mounted such that they will be
visible when the anvil 5302 is in a closed position. The same
number of LEDs 5410 can be mounted on either side of the staple
cartridge 5406 such that the same number of LEDs 5410 is visible
from either side of the end effector 5300.
[0462] The LEDs 5410 can be in communication with a processor or
microcontroller, such as for instance microcontroller 1500 of FIG.
15. The microcontroller 1500 can be configured to detect a property
of tissue compressed by the anvil 5304 against the cartridge deck
5408, such as the rate of stabilization of the tissue, as described
above. The LEDs 5410 can be configured to be turned on or off in
sequences or groups as desired to indicate the rate of
stabilization of the tissue and/or that the tissue is stable. The
LEDs 5410 can further be configured communicate some other
information to the operator of the surgical instrument, or to light
the work area, as described above. Additionally or alternatively,
the LEDs 5410 can be configured to indicate which areas of the end
effector 5300 contain stable tissue, and or what areas of the end
effector 5300 are enclosing tissue, and/or if those areas are
enclosing sufficient tissue. The LEDs 5410 can further be
configured to indicate if any portion of the enclosed tissue is
unsuitable for the staple cartridge 5406.
[0463] Returning to FIGS. 97A and 97B, FIG. 97A illustrates a side
angle view of the end effector 5300 with the anvil 5304 in a closed
position. The illustrated embodiment comprises, by way of example,
a plurality of LEDs 5410 from the proximal to the distal end of the
staple cartridge 5406, on either side of the cartridge deck 5408.
FIG. 97B illustrates a three-quarter angle view of the end effector
5300 with the anvil 5304 in an open position, illustrating a
plurality of LEDs 5410 from the proximal to the distal end of the
staple cartridge 5406, and on either side of the cartridge deck
5408.
[0464] Adjunct with Integrated Sensors to Quantify Tissue
Compression
[0465] FIG. 98A illustrates an embodiment of an end effector 5500
comprising a tissue compensator 5510 that further comprises a layer
of conductive elements 5512. The end effector 5500 is similar to
the end effector 300 described above. The end effector 5500
comprises a first jaw member, or anvil, 5502 pivotally coupled to a
second jaw member 5504 (not shown). The second jaw member 5504 is
configured to receive a staple cartridge 5506 therein (not shown).
The staple cartridge 5506 comprises a plurality of staples (not
shown). The plurality of staples 191 is deployable from the staple
cartridge 3006 during a surgical operation. In some embodiments,
the end effector 5500 further comprises a tissue compensator 5510
removably positioned on the anvil 5502 or on the staple cartridge
5506. FIG. 98B illustrates a detail view of a portion of the tissue
compensator 5510 shown in FIG. 98A.
[0466] As described above, the plurality of staples 191 can be
deployed between an unfired position and a fired position, such
that staple legs 5530 move through and penetrate tissue 5518
compressed between the anvil 5502 and the staple cartridge 5506,
and contact the anvil's 5502 staple-forming surface. In embodiments
that include a tissue compensator 5510, the staple legs 5530 also
penetrate and puncture the tissue compensator 5510. As the staple
legs 5530 are deformed against the anvil's staple-forming surface,
each staple 191 can capture a portion of the tissue 5518 and the
tissue compensator 5510 and apply a compressive force to the tissue
5518. The tissue compensator 5510 thus remains in place with the
staples 191 after the surgical instrument 10 is withdrawn from the
patient's body. Because they are to be retained by the patient's
body, the tissue compensators 5510 are composed of biodurable
and/or biodegradable materials. The tissue compensators 5510 are
described in further detail in U.S. Pat. No. 8,657,176, entitled
TISSUE THICKNESS COMPENSATOR FOR SURGICAL STAPLER, which is
incorporated herein by reference in its entirety.
[0467] Returning to FIG. 98A, in some embodiments, the tissue
compensator 5510 comprises a layer of conductive elements 5512. The
conductive elements 5512 can comprise any combination of conductive
materials in any number of configurations, such as for instance
coils of wire, a mesh or grid of wires, conductive strips,
conductive plates, electrical circuits, microprocessors, or any
combination thereof. The layer containing conductive elements 5512
can be located on the anvil-facing surface 5514 of the tissue
compensator 5510. Alternatively or additionally, the layer of
conductive elements 5512 can be located on the staple
cartridge-facing surface 5516 of the tissue compensator 5510.
Alternatively or additionally, the layer of conductive elements
5512 can be embedded within the tissue compensator 5510.
Alternatively, the layer of conductive elements 5512 can comprise
all of the tissue compensator 5510, such as when a conductive
material is uniformly or non-uniformly distributed in the material
comprising the tissue compensator 5510.
[0468] FIG. 98A illustrates an embodiment wherein the tissue
compensator 5510 is removably attached to the anvil 5502 portion of
the end effector 5500. The tissue compensator 5510 would be so
attached before the end effector 5500 would be inserted into a
patient's body. Additionally or alternatively, a tissue compensator
5610 can be attached to a staple cartridge 5506 (not illustrated)
after or before the staple cartridge 5506 is applied to the end
effector 6600 and before the device is inserted into a patient's
body
[0469] FIG. 99 illustrates various example embodiments that use the
layer of conductive elements 5512 and conductive elements 5524,
5526, and 5528 in the staple cartridge 5506 to detect the distance
between the anvil 5502 and the upper surface of the staple
cartridge 5506. The distance between the anvil 5502 and the staple
cartridge 5506 indicates the amount and/or density of tissue 5518
compressed therebetween. This distance can additionally or
alternatively indicate which areas of the end effector 5500 contain
tissue. The tissue 5518 thickness, density, and/or location can be
communicated to the operator of the surgical instrument 10.
[0470] In the illustrated example embodiments, the layer of
conductive elements 5512 is located on the anvil-facing surface
5514 of the tissue compensator 5510, and comprises one or more
coils of wire 5522 in communication with a microprocessor 5520. The
microprocessor 5500 can be located in the end effector 5500 or any
component thereof, or can be located in the housing 12 of the
instrument, or can comprise any microprocessor or microcontroller
previously described. In the illustrated example embodiments, the
staple cartridge 5506 also includes conductive elements, which can
be any one of: one or more coils of wire 5524, one or more
conductive plates 5526, a mesh of wires 5528, or any other
convenient configuration, or any combination thereof. The staple
cartridge's 5506 conductive elements can be in communication with
the same microprocessor 5520 or some other microprocessor in the
instrument.
[0471] When the anvil 5502 is in a closed position and thus is
compressing tissue 5518 against staple cartridge 5506, the layer of
conductive elements 5512 of the tissue compensator 5510 can
capacitively couple with the conductors in staple cartridge 5506.
The strength of the capacitive field between the layer of
conductive elements 5512 and the conductive elements of the staple
cartridge 5506 can be used to determine the amount of tissue 5518
being compressed. Alternatively, the staple cartridge 5506 can
comprise eddy current sensors in communication with a
microprocessor 5520, wherein the eddy current sensors are operable
to sense the distance between the anvil 5502 and the upper surface
of the staple cartridge 5506 using eddy currents.
[0472] It is understood that other configurations of conductive
elements are possible, and that the embodiments of FIG. 99 are by
way of example only, and not limitation. For example, in some
embodiments the layer of conductive elements 5512 can be located on
the staple cartridge-facing surface 5516 of the tissue compensator
5510. Also, in some embodiments the conductive elements 5524, 5526,
and/or 5528 can be located on or within the anvil 5502. Thus in
some embodiments, the layer of conductive elements 5512 can
capacitively couple with conductive elements in the anvil 5502 and
thereby sense properties of tissue 5518 enclosed within the end
effector.
[0473] It can also be recognized that tissue compensator 5512 can
comprise a layer of conductive elements 5512 on both the
anvil-facing surface 5514 and the cartridge-facing surface 5516. A
system to detect the amount, density, and/or location of tissue
5518 compressed by the anvil 5502 against the staple cartridge 5506
can comprise conductors or sensors either in the anvil 5502, the
staple cartridge 5506, or both. Embodiments that include conductors
or sensors in both the anvil 5502 and the staple cartridge 5506 can
optionally achieve enhanced results by allowing differential
analysis of the signals that can be achieved by this
configuration.
[0474] FIGS. 100A and 100B illustrate an embodiment of the tissue
compensator 5510 comprising a layer of conductive elements 5512 in
operation. FIG. 100A illustrates one of the plurality of staples
191 after it has been deployed. As illustrated, the staple 191 has
penetrated both the tissue 5518 and the tissue compensator 5510.
The layer of conductive elements 5512 may comprise, for example,
mesh wires. Upon penetrating the layer of conductive elements 5512,
the staple legs 5530 may puncture the mesh of wires, thus altering
the conductivity of the layer of conductive elements 5512. This
change in the conductivity can be used to indicate the locations of
each of the plurality of staples 191. The location of the staples
191 can compared against the expected location of the staples, and
this comparison can be used to determine if any staples did not
fire or if any staples are not where they are expected to be.
[0475] FIG. 100A also illustrates staple legs 5530 that failed to
completely deform. FIG. 100B illustrates staple legs 5530 that have
properly and completely deformed. As illustrated in FIG. 100B, the
layer of conductive elements 5512 can be punctured by the staple
legs 5530 a second time, such as when the staple legs 5530 deform
against the staple-forming surface of the anvil 5502 and turn back
towards the tissue 5518. The secondary breaks in the layer of
conductive elements 5512 can be used to indicate complete staple
191 formation, as illustrated in FIG. 100B, or incomplete staple
191 formation, as in FIG. 100A.
[0476] FIGS. 101A and 101B illustrate an embodiment of an end
effector 5600 comprising a tissue compensator 5610 further
comprising conductors 5620 embedded within. The end effector 5600
comprises a first jaw member, or anvil, 5602 pivotally coupled to a
second jaw member 5604. The second jaw member 5604 is configured to
receive a staple cartridge 5606 therein. In some embodiments, the
end effector 5600 further comprises a tissue compensator 5610
removably positioned on the anvil 5602 or the staple cartridge
5606.
[0477] Turning first to FIG. 4B, FIG. 4B illustrates a cutaway view
of the tissue compensator 5610 removably positioned on the staple
cartridge 5606. The cutaway view illustrates an array of conductors
5620 embedded within the material that comprises the tissue
compensator 5610. The array of conductors 5620 can be arranged in
an opposing configuration, and the opposing elements can be
separated by insulating material. The array of conductors 5620 are
each coupled to one or more conductive wires 5622. The conductive
wires 5622 allow the array of conductors 5620 to communicate with a
microprocessor, such as for instance microprocessor 1500. The array
of conductors 5620 may span the width of the tissue compensator
5610 such that they will be in the path of a cutting member or
knife bar 280. As the knife bar 280 advances, it will sever,
destroy, or otherwise disable the conductors 5620, and thereby
indicate its position within the end effector 5600. The array of
conductors 5610 can comprise conductive elements, electric
circuits, microprocessors, or any combination thereof.
[0478] Turning now to FIG. 101A, FIG. 101A illustrates a close-up
cutaway view of the end effector 5600 with the anvil 5602 in a
closed position. In a closed position, the anvil 5602 can compress
tissue 5618 and the tissue compensator 5610 against the staple
cartridge 5606. In some cases, only a part of the end effector 5600
may be enclosing the tissue 5618. In areas of the end effector 5600
that are enclosing tissue 5618, the tissue compensator 5610 may be
compressed 5624 a greater amount than areas that do not enclose
tissue 5618, where the tissue compensator 5618 may remain
uncompressed 5626 or be less compressed. In areas of greater
compression 5624, the array of conductors 5620 will also be
compressed, while in uncompressed 5626 areas, the array of
conductors 5620 will be further apart. Hence, the conductivity,
resistance, capacitance, and/or some other electrical property
between the array of conductors 5620 can indicate which areas of
the end effector 5600 contain tissue.
[0479] FIGS. 102A and 102B illustrate an embodiment of an end
effector 5650 comprising a tissue compensator 5660 further
comprising conductors 5662 embedded therein. The end effector 5650
comprises a first jaw member, or anvil, 5652 pivotally coupled to a
second jaw member 5654. The second jaw member 5654 is configured to
receive a staple cartridge 5656 therein. In some embodiments, the
end effector 5650 further comprises a tissue compensator 5660
removably positioned on the anvil 5652 or the staple cartridge
5656.
[0480] FIG. 102A illustrates a cutaway view of the tissue
compensator 5660 removably positioned on the staple cartridge 5656.
The cutaway view illustrates conductors 5670 embedded within the
material that comprises the tissue compensator 5660. Each of the
conductors 5672 is coupled to a conductive wire 5672. The
conductive wires 5672 allow the array of conductors 5672 to
communicate with a microprocessor, such as for instance
microprocessor 1500. The conductors 5672 may comprise conductive
elements, electric circuits, microprocessors, or any combination
thereof.
[0481] FIG. 102A illustrates a close-up side view of the end
effector 5650 with the anvil 5652 in a closed position. In a closed
position, the anvil 5652 can compress tissue 5658 and the tissue
compensator 5660 against the staple cartridge 5656. The conductors
5672 embedded within the tissue compensator 5660 can be operable to
apply pulses of electrical current 5674, at predetermined
frequencies, to the tissue 5658. The same or additional conductors
5672 ca detect the response of the tissue 5658 and transmit this
response to a microprocessor or microcontroller located in the
instrument. The response of the tissue 5658 to the electrical
pulses 5674 can be used to determine a property of the tissue 5658.
For example, the galvanic response of the tissue 5658 indicates the
tissue's 5658 moisture content. As another example, measurement of
the electrical impedance through the tissue 5658 could be used to
determine the conductivity of the tissue 5648, which is an
indicator of the tissue type. Other properties that can be
determined include by way of example and not limitation: oxygen
content, salinity, density, and/or the presence of certain
chemicals. By combining data from several sensors, other properties
could be determined, such as blood flow, blood type, the presence
of antibodies, etc.
[0482] FIG. 103 illustrates an embodiment of a staple cartridge
5706 and a tissue compensator 5710 wherein the staple cartridge
5706 provides power to the conductive elements 5720 that comprise
the tissue compensator 5710. As illustrated, the staple cartridge
5706 comprises electrical contacts 5724 in the form of patches,
spokes, bumps, or some other raised configuration. The tissue
compensator 5710 comprises mesh or solid contact points 5722 that
can electrically couple to the contacts 5724 on the staple
cartridge 5706.
[0483] FIGS. 104A and 104B illustrate an embodiment of a staple
cartridge 5756 and a tissue compensator 5760 wherein the staple
cartridge provides power to the conductive elements 5770 that
comprise the tissue compensator 5710. As illustrated in FIG. 104A,
the tissue compensator 5760 comprises an extension or tab 5772
configured to come into contact with the staple cartridge 5756. The
tab 5772 may contact and adhere to an electrical contact (not
shown) on the staple cartridge 5756. The tab 5772 further comprises
a break point 5774 located in a wire comprising the conductive
elements 5770 of the tissue compensator 5760. When the tissue
compensator 5760 is compressed, such as when an anvil is in a
closed position towards the staple cartridge 5756, the break point
5774 will break, thus allowing the tissue compensator 5756 to
become free from the staple cartridge 5756. FIG. 104B illustrates
another embodiment employing a break point 5774 positioned in the
tab 5772.
[0484] FIGS. 105A and F8B illustrate an embodiment of an end
effector 5800 comprising position sensing elements 5824 and a
tissue compensator 5810. The end effector 5800 comprises a first
jaw member, or anvil, 5802 pivotally coupled to a second jaw member
5804 (not shown). The second jaw member 5804 is configured to
receive a staple cartridge 5806 (not shown) therein. In some
embodiments, the end effector 5800 further comprises a tissue
compensator 5810 removably positioned on the anvil 5802 or the
staple cartridge 5806.
[0485] FIG. 105A illustrates the anvil 5804 portion of the end
effector 5800. In some embodiments the anvil 5804 comprises
position sensing elements 5824. The position sensing elements 5824
can comprise, for example, electrical contacts, magnets, RF
sensors, etc. The position sensing elements 5824 can be located in
key locations, such as for instance the corner points where the
tissue compensator 5810 will be attached, or along the exterior
edges of the anvil's 5802 tissue-facing surface. In some
embodiments, the tissue compensator 5810 can comprise position
indicating elements 5820. The position indicating elements 5820 can
be located in corresponding locations to the position sensing
elements 5824 on the anvil 5802, or in proximal locations, or in
overlapping locations. The tissue compensator 5810 optionally
further comprises a layer of conductive elements 5812. The layer of
conductive elements 5812 and/or the position indicating elements
5820 can be electrically coupled to conductive wires 5822. The
conductive wires 5822 can provide communication with a
microprocessor, such as for instance microprocessor 1500.
[0486] FIG. F8B illustrates an embodiment the position sensing
elements 5824 and position indicating elements 5820 in operation.
When the tissue compensator 5810 is positioned, the anvil 5802 can
sense 5826 that the tissue compensator 5810 is properly position.
When the tissue compensator 5810 is misaligned or missing entirely,
the anvil 5802 (or some other component) can sense 5826 that the
tissue compensator 5810 is misaligned. If the misalignment is above
a threshold magnitude, a warning can be signaled to the operator of
the instrument, and/or a function of the instrument can be disabled
to prevent the staples from being fired.
[0487] In FIGS. 105A and 105B the position sensing elements 5824
are illustrated as a part of the anvil 5804 by way of example only.
It is understood that the position sensing elements 5824 can be
located instead or additionally on the staple cartridge 5806. It is
also understood that the location of the position sensing elements
5824 and the position indicating elements 5820 can be reversed,
such that the tissue compensator 5810 is operable to indicate
whether it is properly aligned.
[0488] FIGS. 106A and F9B illustrate an embodiment of an end
effector 5850 comprising position sensing elements 5874 and a
tissue compensator 5860. The end effector 5850 comprises a first
jaw member, or anvil, 5852 pivotally coupled to a second jaw member
5854 (not shown). The second jaw member 5854 is configured to
receive a staple cartridge 5856 (not show) therein. In some
embodiments, the end effector 5850 further comprises a tissue
compensator 5860 removably positioned on the anvil 5852 or the
staple cartridge 5856.
[0489] FIG. 106A illustrates the anvil 5852 portion of the end
effector 5850. In some embodiments, the anvil 5854 comprises an
array of conductive elements 5474. The array of conductive elements
5474 can comprise, for example, electrical contacts, magnets, RF
sensors, etc. The array of conductive elements 5474 are arrayed
along the length of the tissue-facing surface of the anvil 5852. In
some embodiments, the tissue compensator 5860 can comprise a layer
of conductive elements 5862, wherein the conductive elements
comprise a grid or mesh of wires. The layer of conductive elements
5862 may be coupled to conductive wires 5876. The conductive wires
5862 can provide communication with a microprocessor, such as for
instance microprocessor 1500.
[0490] FIG. 106A illustrates an embodiment wherein of the
conductive elements 5474 of the anvil 5852 and the layer of
conductive elements 5862 are operable to indicate whether the
tissue compensator 5860 is misaligned or missing. As illustrated,
the array of conductive elements 5874 is operable to electrically
couple with the layer of conductive elements 5862. When the tissue
compensator 5860 is misaligned or missing, the electrical coupling
will be incomplete. If the misalignment is above a threshold
magnitude, a warning can be signaled to the operator of the
instrument, and/or a function of the instrument can be disabled to
prevent the staples from being fired.
[0491] It is understood that the array of conductive elements 5874
may additionally or alternatively be located on the staple
cartridge 5856. It is also understood that the any of the anvil
5852, staple cartridge 5856, and/or tissue compensator 5860 may be
operable to indicate misalignment of the tissue compensator
5860.
[0492] FIGS. 107A and 107B illustrate an embodiment of a staple
cartridge 5906 and a tissue compensator 5910 that is operable to
indicate the position of a cutting member or knife bar 280. FIG.
107A is a top-down view of the staple cartridge 5906 that has a
tissue compensator 5920 placed on its upper surface 5916. The
staple cartridge 5906 further comprises a cartridge channel 5918
operable to accept a cutting member or knife bar 280. FIG. 107A
illustrates only the layer of conductive elements 5922 of the
tissue compensator 5910, for clarity. As illustrated, the layer of
conductive elements 5922 comprises a lengthwise segment 5930 that
is located off-center. The lengthwise segment 5930 is coupled to
conductive wires 5926. The conductive wires 5926 allow the layer of
conductive elements 5922 to communicate with a microprocessor, such
as for instance microprocessor 1500. The layer of conductive
elements 5922 further comprises horizontal elements 5932 coupled to
the lengthwise segment 5930 and spanning the width of the tissue
compensator 5910, and thus crossing the path of the knife bar 280.
As the knife bar 280 advances, it will sever the horizontal
elements 5932 and thereby alter an electrical property of the layer
of conductive elements 5922. For example, the advancing of the
knife bar 280 may alter the resistance, capacitance, conductivity,
or some other electrical property of the layer of conductive
elements 5922. As each horizontal element 5932 is severed by the
knife bar 280, the change in the electrical properties of the layer
of conductive elements 5922 will indicate the position of the knife
bar 280.
[0493] FIG. 107B illustrates an alternate configuration for the
layer of conductive elements 5922. As illustrated, the layer of
conductive elements 5922 comprises a lengthwise segment 5934 on
either side of the cartridge channel 5918. The layer of conductive
elements 5922 further comprises horizontal elements 5936 coupled to
both of the lengthwise segments 5934, thus spanning the path of the
knife bar 280. As the knife bar 280, the resistance, for example
between the knife bar and the horizontal elements 5396 can be
measured and used to determine the location of the knife bar 280.
Other configurations of the layer of conductive elements 5922 can
be used to accomplish the same result, such as for instance any of
the arrangements illustrated in FIGS. 98A through 102B. For
example, the layer of conductive elements 5922 can comprise a wire
mesh or grid, such that as the knife bar 280 advances it can sever
the wire mesh and thereby change the conductivity in the wire mesh.
This change in conductivity can be used to indicate the position of
the knife bar 280.
[0494] Other uses for the layer of conductive elements 5922 can be
imagined. For example, a specific resistance can be created in the
layer of conductive elements 592, or a binary ladder of resistors
or conductors can be implemented, such that simple data can be
stored in the tissue compensator 5910. This data can be extracted
from the tissue compensator 5910 by conductive elements in the
anvil and/or staple cartridge when either electrically couple with
the layer of conductive elements 5922. The data can represent, for
example, a serial number, a "use by" date, etc.
[0495] Polarity of Hall Magnet to Detect Misloaded Cartridge
[0496] FIG. 108 illustrates one embodiment of an end effector 6000
comprising a magnet 6008 and a Hall effect sensor 6010 wherein the
detected magnetic field 6016 can be used to identify a staple
cartridge 6006. The end effector 6000 is similar to the end
effector 300 described above. The end effector 6000 comprises a
first jaw member or anvil 6002, pivotally coupled to a second jaw
member or elongated channel 6004. The elongated channel 6004 is
configured to operably support a staple cartridge 6006 therein. The
staple cartridge 6006 is similar to the staple cartridge 304
described above. The anvil 6002 further comprises a magnet 6008.
The staple cartridge 6006 further comprises a Hall effect sensor
6010 and a processor 6012. The Hall effect sensor 6010 is operable
to communicate with the processor 6012 through a conductive
coupling 6014. The Hall effect sensor 6010 is positioned within the
staple cartridge 6006 to operatively couple with the magnet 6008
when the anvil 6002 is in a closed position. The Hall effect sensor
6010 can be operable to detect the magnetic field 6016 produced by
the magnet 6008. The polarity of the magnetic field 6016 can be one
of north or south depending on the orientation of the magnet 6008
within the anvil 6002. In the illustrated embodiment of FIG. 108,
the magnet 6008 is oriented such that its south pole is directed
towards the staple cartridge 6006. The Hall effect sensor 6010 can
be operable to detect the magnetic field 6016 produced by a south
pole. If the Hall effect sensor 6010 detects a magnetic south pole,
then the staple cartridge 6006 can be identified as of a first
type.
[0497] FIG. 109 illustrates on embodiment of an end effector 6050
comprising a magnet 6058 and a Hall effect sensor 6060 wherein the
detected magnetic field 6066 can be used to identify a staple
cartridge 6056. The end effector 6050 comprises a first jaw member
or anvil 6052, pivotally coupled to a second jaw member or
elongated channel 6054. The elongated channel 6054 is configured to
operably support a staple cartridge 6056 therein. The anvil 6052
further comprises a magnet 6058. The staple cartridge 6056 further
comprises a Hall effect sensor 6060 in communication with a
processor 6062 over a conductive coupling 6064. The Hall effect
sensor 6060 is positioned such that it will operatively couple with
the magnet 6058 when the anvil 6052 is in a closed position. The
Hall effect sensor 6060 can be operable to detect the magnetic
field 6066 produced by the magnet 6058. In the illustrated
embodiment, the magnet 6058 is oriented such that its north
magnetic pole is directed towards the staple cartridge 6056. The
Hall effect sensor 6060 can be operable to detect the magnetic
field 6066 produced by a north pole. If the Hall effect sensor 6060
detects a north magnetic pole, then the staple cartridge 6056 an be
identified as a second type.
[0498] It can be recognized that the second type staple cartridge
6056 of FIG. 109 can be substituted for the first type staple
cartridge 6006 of FIG. 108, and vice versa. In FIG. 108, the second
type staple cartridge 6056 would be operable to detect a magnetic
north pole, but will detect a magnetic south pole instead. In this
case, end effector 6000 will identify the staple cartridge 6056 as
being of the second type. If the end effector 6000 did not expect a
staple cartridge 6056 of the second type, the operator of the
instrument can be alerted, and/or a function of the instrument can
be disabled. The type of the staple cartridge 6056 can additionally
or alternatively be used to identify some parameter of the staple
cartridge 6056, such as for instance the length of the cartridge
and/or the height and length of the staples.
[0499] Similarly, as shown in FIG. 109, the first type staple
cartridge 6006 can be substituted for the second staple cartridge
6056. The first type staple cartridge 6006 would be operable to
detect a south magnetic pole, but will instead detect a north
magnetic pole. In this case, the end effector 6050 will identify
the staple cartridge 6006 as being of the first type.
[0500] FIG. 110 illustrates a graph 6020 of the voltage 6022
detected by a Hall effect sensor located in the distal tip of a
staple cartridge, such as is illustrated in FIGS. 108 and 109, in
response to the distance or gap 6024 between a magnet located in
the anvil and the Hall effect sensor in the staple cartridge, such
as illustrated in FIGS. 108 and 109. As illustrated FIG. 110, when
the magnet in the anvil is oriented such that its north pole is
towards the staple cartridge, the voltage will tend towards a first
value as the magnet comes in proximity to the Hall effect sensor;
when the magnet is oriented with its south pole towards the staple
cartridge, the voltage will tend towards a second, different value.
The measured voltage can be used by the instrument to identify the
staple cartridge.
[0501] FIG. 111 illustrates one embodiment of the housing 6100 of
the surgical instrument, comprising a display 6102. The housing
6100 is similar to the housing 12 described above. The display 6102
can be operable to convey information to the operator of the
instrument, such as for instance, that the staple cartridge coupled
to the end effector is inappropriate for the present application.
Additionally or alternatively, the display 6102 can display the
parameters of the staple cartridge, such as the length of the
cartridge and/or the height and length of the staples.
[0502] FIG. 112 illustrates one embodiment of a staple retainer
6160 comprising a magnet 6162. The staple retainer 6160 can be
operably coupled to a staple cartridge 6156 and functions to
prevent staples from exiting of the staple cartridge 6156. The
staple retainer 6160 can be left in place when the staple cartridge
6156 is applied to an end effector. In some embodiments, the staple
retainer 6160 comprises a magnet 6162 located in the distal area of
the staple retainer 6160. The anvil of the end effector can
comprise a Hall effect sensor operable to couple with the magnet
6162 in the staple retainer 6160. The Hall effect sensor can be
operable to detect the properties of the magnet 6162, such as for
instance the magnetic field strength and magnetic polarity. The
magnetic field strength can be varied by, for example, placing the
magnet 6162 in different locations and/or depths on or in the
staple retainer 6160, or by selecting magnets 6162 of different
compositions. The different properties of the magnet 6162 can be
used to identify staple cartridges of different types.
[0503] FIGS. 113A and 113B illustrate one embodiment of an end
effector 6200 comprising a sensor 6208 for identifying staple
cartridges 6206 of different types. The end effector 6200 comprises
a first jaw member or anvil 6202, pivotally coupled to a second jaw
member or elongated channel 6204. The elongated channel 6204 is
configured to operably support a staple cartridge 6206 therein. The
end effector 6200 further comprises a sensor 6208 located in the
proximal area. The sensor 6208 can be any of an optical sensor, a
magnetic sensor, an electrical sensor, or any other suitable
sensor.
[0504] The sensor 6208 can be operable to detect a property of the
staple cartridge 6206 and thereby identify the staple cartridge
6206 type. FIG. 113B illustrates an example where the sensor 6208
is an optical emitter and detector 6210. The body of the staple
cartridge 6206 can be different colors, such that the color
identifies the staple cartridge 6206 type. An optical emitter and
detector 6210 can be operable to interrogate the color of the
staple cartridge 6206 body. In the illustrated example, the optical
emitter and detector 6210 can detect white 6212 by receiving
reflected light in the red, green, and blue spectrums in equal
intensity. The optical emitter and detector 6210 can detect red
6214 by receiving very little reflected light in the green and blue
spectrums while receiving light in the red spectrum in greater
intensity.
[0505] Alternately or additionally, the optical emitter and
detector 6210, or another suitable sensor 6208, can interrogate and
identify some other symbol or marking on the staple cartridge 6206.
The symbol or marking can be any one of a barcode, a shape or
character, a color-coded emblem, or any other suitable marking. The
information read by the sensor 6208 can be communicated to a
microcontroller in the surgical device 10, such as for instance
microcontroller 1500. The microcontroller 1500 can be configured to
communicate information about the staple cartridge 6206 to the
operator of the instrument. For instance, the identified staple
cartridge 6206 may not be appropriate for a given application; in
such case, the operator of the instrument can be informed, and/or a
function of the instrument s inappropriate. In such instance,
microcontroller 1500 can optionally be configured to disable a
function of surgical instrument can be disabled. Alternatively or
additionally, microcontroller 1500 can be configured to inform the
operator of the surgical instrument 10 of the parameters of the
identified staple cartridge 6206 type, such as for instance the
length of the staple cartridge 6206, or information about the
staples, such as the height and length.
[0506] Smart Cartridge Wake Up Operation and Data Retention
[0507] In one embodiment the surgical instrument described herein
comprises short circuit protection techniques for sensors and/or
electronic components. To enable such sensors and other electronic
technology both power and data signals are transferred between
modular components of the surgical instrument. During assembly of
modular sensor components electrical conductors that when connected
are used to transfer power and data signals between the connected
components are typically exposed.
[0508] FIG. 114 is a partial view of an end effector 7000 with
electrical conductors 7002, 7004 for transferring power and data
signals between the connected components of the surgical instrument
according to one embodiment. There is potential for these
electrical conductors 7002, 7004 to become shorted and thus damage
critical system electronic components. FIG. 115 is a partial view
of the end effector 7000 shown in FIG. 114 showing sensors and/or
electronic components 7005 located in the end effector. With
reference now to both FIGS. 114 and 115, in various embodiments the
surgical instruments disclosed throughout the present disclosure
provide real time feedback about the compressibility and thickness
of tissue using electronic sensors. Modular architectures will
enable the configuration of custom modular shafts to employ job
specific technologies. To enable sensors and other electronic
circuit components in surgical instruments it is necessary to
transfer both power and data signals between a secondary circuit
comprising the modular sensor and/or electronic circuit components
7005. During the assembly of the modular sensors and/or electronic
components 7005 the electrical conductors 7002, 7004 are exposed
such that when connected, they are used to transfer power and data
signals between the connected sensors and/or electronic components
7005. Because there is a potential for these electrical conductors
7002, 7004 to become short circuited during the assembly process
and thus damage other system electronic circuits, various
embodiments of the surgical instruments described herein comprise
short circuit protection techniques for the sensors and/or
electronic components 7005
[0509] In one embodiment, the present disclosure provides a short
circuit protection circuit 7012 for the sensors and/or electronic
components 7005 of the secondary circuits of the surgical
instrument. FIG. 116 is a block diagram of a surgical instrument
electronic subsystem 7006 comprising a short circuit protection
circuit 7012 for the sensors and/or electronic components 7005
according to one embodiment. A main power supply circuit 7010 is
connected to a primary circuit comprising a microprocessor and
other electronic components 7008 (processor 7008 hereinafter)
through main power supply terminals 7018, 7020. The main power
supply circuit 7010 also is connected to a short circuit protection
circuit 7012. The short circuit protection circuit 7012 is coupled
to a supplementary power supply circuit 7014, which supplies power
to the sensors and/or electronic components 7005 via the electrical
conductors 7002, 7004.
[0510] To reduce damage to the processor 7008 connected to the main
power supply terminals 7018, 7020, during a short circuit between
the electrical conductors 7002, 7004 of the power supply terminals
feeding the sensors and/or electronic components 7005, a self
isolating/restoring short circuit protection circuit 7012 is
provided. In one embodiment, the short circuit protection circuit
7012 may be implemented by coupling a supplementary power supply
circuit 7014 to the main power supply circuit 7010. In
circumstances when the supplementary power supply circuit 7014
power conductors 7002, 7004 are shorted, the supplementary power
supply circuit 7014 isolates itself from the main power supply
circuit 7010 to prevent damage to the processor 7008 of the
surgical instrument. Thus, there is virtually no effect to the
processor 7008 and other electronic circuit components coupled to
the main power supply terminals 7018, 7020 when a short circuit
occurs in the electrical conductors 7002, 7004 of the supplementary
power supply circuit 7014. Accordingly, in the event that a short
circuit occurs between the electrical conductors 7002, 7004 of the
supplementary power supply circuit 7014, the main power supply
circuit 7010 is unaffected and remains active to supply power to
the protected processor 7008 such that the processor 7008 can
monitor the short circuit condition. When the short circuit between
the electrical conductors 7002, 7004 of the supplementary power
supply circuit 7014 is remedied, the supplementary power supply
circuit 7014 rejoins the main power supply circuit 7010 and is
available once again to supply power to the sensor components 7005.
The short circuit protection circuit 7012 also may be monitored to
indicate one or more short circuit conditions to the end user of
the surgical instrument. The short circuit protection circuit 7012
also may be monitored to lockout the firing of the surgical
instrument when a short circuit event is indicated. Many
supplementary protection circuits may be networked together to
isolate, detect, or protect other circuit functions.
[0511] Accordingly, in one aspect, the present disclosure provides
a short circuit protection circuit 7012 for electrical conductors
7002, 7004 in the end effector 7000 (FIGS. 114 and 115) or other
elements of the surgical instrument. In one embodiment, the short
circuit protection circuit 7012 employs a supplementary
self-isolating/restoring power supply circuit 7014 coupled to the
main power supply circuit 7010. The short circuit protection
circuit 7012 may be monitored to indicate one or more short circuit
conditions to the end user of the surgical instrument. In the event
of a short circuit, the short circuit protection circuit 7012 may
be employed to lock-out the surgical instrument from being fired or
other device operations. Many other supplementary protection
circuits may be networked together to isolate, detect, or protect
other circuit functions.
[0512] FIG. 117 is a short circuit protection circuit 7012
comprising a supplementary power supply circuit 7014 coupled to a
main power supply circuit 7010, according to one embodiment. The
main power supply circuit 7010 comprises a transformer 7023 (X1)
coupled to a full wave rectifier 7025 implemented with diodes
91-94. The full wave rectifier 7025 is coupled to the voltage
regulator 7027. The output (OUT) of the voltage regulator 7027 is
coupled to both the output terminals 7018, 7020 of the main power
supply circuit 7010 (OP1) and the supplementary power supply
circuit 7014. An input capacitor C1 filters the input voltage in
the voltage regulator 7027 and one or more capacitors C2 filter the
output the of the voltage regulator 7027.
[0513] In the embodiment illustrated in FIG. 117, the supplementary
power supply circuit 7014 comprises a pair of transistors T1, T2
configured to control the power supply output OP2 between the
electrical conductors 7002, 7004. During normal operation when the
electrical conductors 7002, 7004 are not shorted, the output OP2
supplies power to the sensor components 7005. Once the transistors
T1 and T2 are turned ON (activated) and begin conducting current,
the current from the output of the voltage regulator 7027 is
shunted by the first transistor T1 such that no current flows
through R1 and i.sub.R1=0. The output voltage of the regulator+V is
applied at the node such the V.sub.n.about.+V, which is then the
output voltage OP2 of the supplementary power supply circuit 7014
and the first transistor T1 drives the current to the sensor
components 7005 through the output terminal 7002, where output
terminal 7004 is the current return path. A portion of the output
current i.sub.R5 is diverted through R5 to drive the output
indicator LED2. The current though the LED2 is i.sub.R5. As long as
the node voltage V.sub.n is above the threshold necessary to turn
ON (activate) the second transistor T2, the supplementary power
supply circuit 7014 operates as a power supply circuit to feed the
sensors and/or electronic components 7005.
[0514] When the electrical conductors 7002, 7004 of the secondary
circuit are shorted, the node voltage V.sub.n drops to ground or
zero and the second transistor T2 turns OFF and stops conducting,
which turns OFF the first transistor T1. When the first transistor
T1 is cut-OFF, the output voltage +V of the voltage regulator 7027
causes current i.sub.R1 to flow through the short circuit indicator
LED1 and through to ground via the short circuit between the
electrical conductors 7002, 7004. Thus, no current flows through R5
and i.sub.R5=OA and +V.sub.OP2=0V. The supplementary power supply
circuit 7014 isolates itself from the main power supply circuit
7010 until the short circuit is removed. During the short circuit
only the short circuit indicator LED 1 is energized while the
output indicator LED2 is not. When the short circuit between the
electrical conductors 7002, 7004 is removed, the node voltage
V.sub.n rises until T2 turns ON and subsequently turning. T1 ON.
When T1 and T2 are turned ON (are biased in a conducting state such
as saturation), until the node voltage V.sub.n reaches+V.sub.OP2
and the supplementary power supply circuit 7014 resumes its power
supply function for the sensor components 7005. Once the
supplementary power supply circuit 7014 restores its power supply
function, the short circuit indicator LED 1 turns OFF and the
output indicator LED2 turns ON. The cycle is repeated in the event
of another short circuit between the supplementary power supply
circuit 7014 electrical conductors 7002, 7004.
[0515] In one embodiment, a sample rate monitor is provided to
enable power reduction by limiting sample rates and/or duty cycle
of the sensor components when the surgical instrument is in a
non-sensing state. FIG. 118 is a block diagram of a surgical
instrument electronic subsystem 7022 comprising a sample rate
monitor 7024 to provide power reduction by limiting sample rates
and/or duty cycle of the sensors and/or electronic components 7005
of the secondary circuit when the surgical instrument is in a
non-sensing state, according to one embodiment. As shown in FIG.
118, the surgical instrument electronic subsystem 7022 comprises a
processor 7008 coupled to a main power supply circuit 7010. The
main power supply circuit 7010 is coupled to a sample rate monitor
circuit 7024. A supplementary power supply circuit 7014 is coupled
to the sample rate 7024 as powers the sensors and/or electronic
components 7005 via the electrical conductors 7002, 7004. The
primary circuit comprising the processor 7008 is coupled to a
device state monitor 7026. In various embodiments, the surgical
instrument electronic subsystem 7022 provides real time feedback
about the compressibility and thickness of tissue using the sensors
and/or electronic components 7005 as previously described herein.
The modular architecture of the surgical instrument enables the
configuration of custom modular shafts to employ function job
specific technologies. To enable such additional functionality,
electronic connection points and components are employed to
transfer both power and signal between modular components of the
surgical instrument. An increase in the number of sensors and/or
electronic components 7005 increases the power consumption of the
surgical instrument system 7022 and creates the need for various
techniques for reducing power consumption of the surgical
instrument system 7022.
[0516] In one embodiment, to reduce power consumption, a surgical
instrument configured with sensors and/or electronic components
7005 (secondary circuit) comprises a sample rate monitor 7024,
which can be implemented as a hardware circuit or software
technique to reduce the sample rate and/or duty cycle for the
sensors and/or electronic components 7005. The sample rate monitor
7024 operates in conjunction with the device state monitor 7026.
The device state monitor 7026 senses the state of various
electrical/mechanical subsystems of the surgical instrument. In the
embodiment illustrated in FIG. 118, the device state monitor 7026
whether the state of the end effector is in an unclamped (State 1),
a clamping (State 2), or a clamped (State 3) state of
operation.
[0517] The sample rate monitor 7024 sets the sample rate and/or
duty cycle for the sensor components 7005 based on the state of the
end effector determined by the device state monitor 7026. In one
aspect, the sample rate monitor 7024 may set the duty cycle to
about 10% when the end effector is in State 1, to about 50% when
the end effector is in State 2, or about 20% when the end effector
is in State 3. In various other embodiments, the duty cycle and/or
sample rate set by the sample rate monitor 7024 may take on ranges
of values. For example, in another aspect, the sample rate monitor
7024 may set the duty cycle to a value between about 5% to about
15% when the end effector is in State 1, to a value of about 45% to
about 55% when the end effector is in State 2, or to a value of
about 15% to about 25% when the end effector is in State 3. In
various other embodiments, the duty cycle and/or sample rate set by
the sample rate monitor 7024 may take on additional ranges of
values. For example, in another aspect, the sample rate monitor
7024 may set the duty cycle to a value between about 1% to about
20% when the end effector is in State 1, to a value of about 20% to
about 80% when the end effector is in State 2, or to a value of
about 1% to about 50% when the end effector is in State 3. In
various other embodiments, the duty cycle and/or sample rate set by
the sample rate monitor 7024 may take on additional ranges of
values.
[0518] In one aspect, the sample rate monitor 7024 may be
implemented by creating a supplementary circuit/software coupled to
a main circuit/software. When the supplementary circuit/software
determines that the surgical instrument system 7022 is in a
non-sensing condition, the sample rate monitor 7024 enters the
sensors and/or electronic components 7005 into a reduced sampling
or duty cycle mode reducing the power load on the main circuit. The
main power supply circuit 7010 will still be active to supply
power, so that the protected processor 7008 of the primary circuit
can monitor the condition. When the surgical instrument system 7022
enters a condition requiring more rigorous sensing activity the
sample rate monitor 7024 increases the supplementary circuit sample
rate or duty cycle. The circuit could utilize a mixture of
integrated circuits, solid state components, microprocessors, and
firmware. The reduced sample rate or duty cycle mode circuit also
may be monitored to indicate the condition to the end user of the
surgical instrument system 7022. The circuit/software might also be
monitored to lockout the firing or function of the device in the
event the device is in the power saving mode.
[0519] In one embodiment, the sample rate monitor 7024 hardware
circuit or software technique reduce the sample rate and/or duty
cycle for the sensors and/or electronic components 7005 to reduce
power consumption of the surgical instrument. The reduced sample
rate and/or duty cycle may be monitored to indicate one or more
conditions to the end user of the surgical instrument. In the event
of a reduced sample rate and/or duty cycle condition in the
surgical instrument the protection circuit/software may be
configured to lock-out the surgical instrument from being fired or
otherwise operated.
[0520] In one embodiment, the present disclosure provides an over
current and/or a voltage protection circuit for sensors and/or
electronic components of a surgical instrument. FIG. 119 is a block
diagram of a surgical instrument electronic subsystem 7028
comprising an over current and/or over voltage protection circuit
7030 for sensors and/or electronic components 7005 of the secondary
circuit of a surgical instrument, according to one embodiment. In
various embodiments, the surgical instrument electronic subsystem
7028 provides real time feedback about the compressibility and
thickness of tissue using the sensors and/or electronic components
7005 of the secondary circuit as previously described herein. The
modular architecture of the surgical instrument enables the
configuration of custom modular shafts to employ function job
specific technologies. To enable the sensors and/or electronic
components 7005, additional electronic connection points and
components to transfer both power and signal between modular
components are added. There is potential for these additional
conductors for the sensors and/or electronic components 7005 from
the modular pieces to be shorted and or damaged causing large draws
of current that could damage fragile processor 7008 circuits or and
other electronic components of the primary circuit. In one
embodiment, the over current/voltage protection circuit 7030
protects the conductors for the sensors and/or electronic
components 7005 on a surgical instrument using a supplementary
self-isolating/restoring circuit 7014 coupled to the main power
supply circuit 7010. The operation of one embodiment of the
supplementary self-isolating/restoring circuit 7014 is described in
connection with FIG. 117 and will not be repeated here for
conciseness and clarity of disclosure.
[0521] In one embodiment, to reduce electronic damage during large
current draws in a sensing surgical instrument, the electronic
subsystem 7028 of the surgical instrument comprises an over
current/voltage protection circuit 7030 for the conductors for the
sensors and/or electronic components 7005. The over current/voltage
protection circuit 7030 may be implemented by creating a
supplementary circuit coupled to a main power supply circuit 7010
circuit. In the case that the supplementary circuit electrical
conductors 7002, 7004 experience higher levels of current than
expected, the over current/voltage protection circuit 7030 isolates
the current from the main power supply circuit 7010 circuit to
prevent damage. The main power supply circuit 7010 circuit will
still be active to supply power, so that the protected main
processor 7008 can monitor the condition. When a large current draw
in the supplementary power supply circuit 7014 is remedied, the
supplementary power supply circuit 7014 rejoins the main power
supply circuit 7010 and is available to supply power to the sensors
and/or electronic components 7005 (e.g., the secondary circuit).
The over current/voltage protection circuit 7030 may utilize a
mixture of integrated circuits, solid state components,
micro-processors, firmware, circuit breaker, fuses, or PTC
(positive temperature coefficient) type technologies.
[0522] In various embodiments, the over current/voltage protection
circuit 7030 also may be monitored to indicate the over
current/voltage condition to the end user of the device. The over
current/voltage protection circuit 7030 also may be monitored to
lockout the firing of the surgical instrument when the over
current/voltage condition event is indicated. The over
current/voltage protection circuit 7030 also may be monitored to
indicate one or more over current/voltage conditions to the end
user of the device. In the event of over current/voltage condition
in the device the over current/voltage protection circuit 7030 may
lock-out the surgical instrument from being fired or lock-out other
operations of the surgical instrument.
[0523] FIG. 120 is an over current/voltage protection circuit 7030
for sensors and electronic components 7005 (FIG. 119) of the
secondary circuit of a surgical instrument, according to one
embodiment. The over current/voltage protection circuit 7030
provides a current path during a hard short circuit (SHORT) at the
output of the over current/voltage protection circuit 7030, and
also provides a path for follow-through current through a bypass
capacitor C.sub.BYPASS driven by stray inductance L.sub.STRAY.
[0524] In one embodiment, the over current/voltage protection
circuit 7030 comprises a current limited switch 7032 with
autoreset. The current limited switch 7032 comprises a current
sense resistor R.sub.CS coupled to an amplifier A. When the
amplifier A senses a surge current above a predetermined threshold,
the amplifier activates a circuit breaker CB to open the current
path to interrupt the surge current. In one embodiment, the current
limited switch 7032 with autoreset may be implemented with a MAX
1558 integrated circuit by Maxim. The current limited switch 7032
with autoreset. Autoreset latches the switch 7032 off if it is
shorted for more than 20 ms, saving system power. The shorted
output (SHORT) is then tested to determine when the short is
removed to automatically restart the channel. Low quiescent supply
current (45 .mu.A) and standby current (3 .mu.A) conserve battery
power in the surgical instrument. The current limited switch 7032
with autoreset safety features ensure that the surgical instrument
is protected. Built-in thermal-overload protection limits power
dissipation and junction temperature. Accurate, programmable
current-limiting circuits, protects the input supply against both
overload and short-circuit conditions. Fault blanking of 20 ms
duration enables the circuit to ignore transient faults, such as
those caused when hot swapping a capacitive load, preventing false
alarms to the host system. In one embodiment, the current limited
switch 7032 with autoreset also features a reverse-current
protection circuitry to block current flow from the output to the
input when the switch 7032 is off.
[0525] In one embodiment, the present disclosure provides a reverse
polarity protection for sensors and/or electronic components in a
surgical instrument. FIG. 121 is a block diagram of a surgical
instrument electronic subsystem 7040 with a reverse polarity
protection circuit 7042 for sensors and/or electronic components
7005 of the secondary circuit according to one embodiment. Reverse
polarity protection is provided for exposed leads (electrical
conductors 7002, 7004) of a surgical instrument using a
supplementary self-isolating/restoring circuit referred to herein
as a supplementary power supply circuit 7014 coupled to the main
power supply circuit 7010. The reverse polarity protection circuit
7042 may be monitored to indicate one or more reverse polarity
conditions to the end user of the device. In the event of reverse
polarity applied to the device the protection circuit 7042 might
lock-out the device from being fired or other device critical
operations.
[0526] In various embodiments, the surgical instruments described
herein provide real time feedback about the compressibility and
thickness of tissue using sensors and/or electronic components
7005. The modular architecture of the surgical instrument enables
the configuration of custom modular shafts to employ job specific
technologies. To enable sensors and/or electronic components 7005,
both power and data signals are transferred between the modular
components. During the assembly of modular components there are
typically exposed electrical conductors that when connected are
used to transfer power and data signals between the connected
components. There is potential for these conductors to become
powered with reverse polarity.
[0527] Accordingly, in one embodiment, the surgical instrument
electronic subsystem 7040 is configured to reduce electronic damage
during the application of a reverse polarity connection 7044 in a
sensing surgical instrument. The surgical instrument electronic
subsystem 7040 employs a polarity protection circuit 7042 inline
with the exposed electrical conductors 7002, 7004. In one
embodiment, the polarity protection circuit 7042 may be implemented
by creating a supplementary power supply circuit 7014 coupled to a
main power supply circuit 7010. In the case that the supplementary
power supply circuit 7014 electrical conductors 7002, 7004 become
powered with reverse polarity it isolates the power from the main
power supply circuit 7010 to prevent damage. The main power supply
circuit 7010 will still be active to supply power, so that the
protected processor 7008 of the main circuit can monitor the
condition. When the reverse polarity in the supplementary power
supply circuit 7014 is remedied, the supplementary power supply
circuit 7014 rejoins the main power supply circuit 7010 and is
available to supply power to the secondary circuit. The reverse
polarity protection circuit 7042 also may be monitored to indicate
that the reverse polarity condition to the end user of the device.
The reverse polarity protection circuit 7042 also may be monitored
to lockout the firing of the device if a reverse polarity event is
indicated.
[0528] FIG. 122 is a reverse polarity protection circuit 7042 for
sensors and/or electronic components 7005 of the secondary circuit
of a surgical instrument according to one embodiment. During normal
operation, the relay switch S1 comprises output contacts in the
normally closed (NC) position and the battery voltage B.sub.1 of
the main power supply circuit 7010 (FIG. 121) is applied to
V.sub.OUT coupled to the secondary circuit. The diode D.sub.1
blocks current from flowing through the coil 7046 (inductor) of the
relay switch S.sub.1. When the polarity of the battery B.sub.1 is
reversed, diode D.sub.1 conducts and current flows through the coil
7046 of the relay switch S.sub.1 energizing the relay switch S1 to
place the output contacts in the normally open (NO) position and
thus disconnecting the reverse voltage from V.sub.OUT coupled to
the secondary circuit. Once the switch S.sub.1 is in the NO
position, current from the positive terminal of the battery B.sub.1
flows through LED D.sub.3 and resistor R.sub.1 to prevent the
battery B.sub.1 from shorting out. Diode D.sub.2 is a clamping
diode to protect from spikes generated by the coil 7046 during
switching.
[0529] In one embodiment, the surgical instruments described herein
provide a power reduction technique utilizing a sleep mode for
sensors on a modular device. FIG. 123 is a block diagram of a
surgical instrument electronic subsystem 7050 with power reduction
utilizing a sleep mode monitor 7052 for sensors and/or electronic
components 7005 according to one embodiment. In one embodiment, the
sleep mode monitor 7052 for the sensors and/or electronic
components 7005 of the secondary circuit may be implemented as a
circuit and/or as a software routine to reduce the power
consumption of a surgical instrument. The sleep mode monitor 7052
protection circuit may be monitored to indicate one or more sleep
mode conditions to the end user of the device. In the event of a
sleep mode condition in the device, the sleep mode monitor 7052
protection circuit/software may be configured to lock-out the
device from being fired or operated by the user.
[0530] In various embodiments, the surgical instruments described
herein provide real time feedback about the compressibility and
thickness of tissue using electronic sensors 7005. The modular
architecture enables the surgical instrument to be configured with
custom modular shafts to employ job specific technologies. To
enable sensors and/or electronic components 7005, additional
electronic connection points and components may be employed to
transfer both power and data signal between the modular components.
As the number of sensors and/or electronic components 7005
increases, the power consumption of the surgical instrument
increases, thus creating a need for techniques to reduce the power
consumption of the surgical instrument.
[0531] In one embodiment, the electronic subsystem 7050 comprises a
sleep mode monitor 7052 circuit and/or software for the sensors
7005 to reduce power consumption of the sensing surgical
instrument. The sleep mode monitor 7052 may be implemented by
creating a supplementary power supply circuit 7014 coupled to a
main power supply circuit 7010. A device state monitor 7054
monitors whether the surgical instrument is in a 1=Unclamped State,
2=Clamping State, or a 3=Clamped State. When the sleep mode monitor
7052 software determines that the surgical instrument is in a
non-sensing (1=Unclamped State) condition the sleep mode monitor
7052 enters the sensors and/or electronic components 7005 of the
secondary circuit into a sleep mode to reduce the power load on the
main power supply circuit 7010. The main power supply circuit 7010
will still be active to supply power, so that the protected
processor 7008 of the primary circuit can monitor the condition.
When the surgical instrument enters a condition requiring sensor
activity the supplementary power supply circuit 7014 is awakened
and rejoins the main power supply circuit 7010. The sleep mode
monitor 7051 circuit can utilize a mixture of integrated circuits,
solid state components, micro-processors, and/or firmware. The
sleep mode monitor 7051 circuit also may be monitored to indicate
the condition to the end user of the device. The sleep mode monitor
7051 circuit may also be monitored to lockout the firing or
function of the device in the event the device is in a sleep
mode.
[0532] In one embodiment the present disclosure provides protection
against intermittent power loss for sensors and/or electronic
components in modular surgical instruments. FIG. 124 is a block
diagram of a surgical instrument electronic subsystem 7060
comprising a temporary power loss circuit 7062 to provide
protection against intermittent power loss for sensors and/or
electronic components 7005 of the secondary circuit in modular
surgical instruments.
[0533] In various embodiments, the surgical instruments described
herein provide real time feedback about the compressibility and
thickness of tissue using sensors and/or electronic components
7005. The modular architecture enables the surgical instrument to
be configured with custom modular shafts to employ job specific
technologies. To enable sensors and/or electronic components 7005
additional electronic connection points and components may be
employed to transfer both power and signal between the modular
components. As the number of electrical connection points increase,
the potential for sensors and/or electronic components 7005 to
experience short term intermittent power loss increases.
[0534] In accordance with one embodiment, the temporary power loss
circuit 7062 is configured to reduce device operation error from
short term intermittent power loss in a sensing surgical
instrument. The temporary power loss circuit 7062 has the capacity
to deliver continuous power for short periods of time in the event
the power from the main power supply circuit 7010 is interrupted.
The temporary power loss circuit 7062 may comprises capacitive
elements, batteries, and/or other electronic elements capable of
leveling, detecting, or storing power.
[0535] As shown in FIG. 124, the temporary power loss circuit 7062
may be implemented by creating a supplementary circuit/software
coupled to a main circuit/software. In the case that the
supplementary circuit/software experiences a sudden power loss from
the main power source, the sensors and/or electronic components
7005 powered by the supplementary power supply circuit 7014 would
be unaffected for short period times. During the power loss the
supplementary power supply circuit 7014 may be powered by
capacitive elements, batteries, and/or other electronic elements
that are capable of leveling or storing power. The temporary power
loss circuit 7062 implemented either in hardware or software also
may be monitored to lockout the firing or function of the surgical
instrument in the event the device is in the power saving mode. In
the event of an intermittent power loss condition in the surgical
instrument the temporary power loss circuit 7062 implemented either
in hardware or software may lock-out the surgical instrument from
being fired or operated.
[0536] FIG. 125 illustrates one embodiment of a temporary power
loss circuit 7062 implemented as a hardware circuit. The temporary
power loss circuit 7062 hardware circuit is configured to reduce
surgical instrument operation error from short term intermittent
power loss. The temporary power loss circuit 7062 has the capacity
to deliver continuous power for short periods of time in the event
the power from the main power supply circuit 7010 (FIG. 124) is
interrupted. The temporary power loss circuit 7062 employs
capacitive elements, batteries, and/or other electronic elements
that are capable of leveling, detecting, or storing power. The
temporary power loss circuit 7062 may be monitored to indicate one
or more conditions to the end user of the surgical instrument. In
the event of an intermittent power loss condition in the surgical
instrument, the temporary power loss circuit 7062 protection
circuit/software might lock-out the device from being fired or
operated.
[0537] In the illustrated embodiment, the temporary power loss
circuit 7062 comprises an analog switch integrated circuit U1. In
one embodiment, the analog switch integrated circuit U1 is a
single-pole/single-throw (SPST), low-voltage, single-supply, CMOS
analog switch such as the MAX4501 provided by Maxim. In one
embodiment, the analog switch integrated circuit U1 is normally
open (NO). In other embodiments, the analog switch integrated
circuit U1 may be normally closed (NC). The input IN activates the
NO analog switch 7064 to connect the output of a step-up DC-DC
converter U3 to the input of a linear regulator U2 via a standby
"RESERVE CAPACITOR." The output of the linear regulator U2 is
coupled to the input of the DC-DC converter U3. The linear
regulator U2 maximizes battery life by combining ultra-low supply
currents and low dropout voltages. In one embodiment, the linear
regulator U2 is a MAX882 integrated circuit provided by Maxim.
[0538] The batteries are also coupled to the input of the step-up
DC-DC converter U3. The step-up DC-DC converter U3 may be a
compact, high-efficiency, step-up DC-DC converter with a built-in
synchronous rectifier to improve efficiency and reduce size and
cost by eliminating the need for an external Schottky diode. In one
embodiment, the step-up DC-DC converter U3 is a MAX1674 integrated
circuit by Maxim.
[0539] Smart Cartridge Technology
[0540] FIGS. 126A and 126B illustrate one embodiment of an end
effector 10000 comprising a magnet 10008 and a Hall effect sensor
10010 in communication with a processor 10012. The end effector
10000 is similar to the end effector 300 described above. The end
effector comprises a first jaw member, or anvil 10002, pivotally
coupled to a second jaw member, or elongated channel 10004. The
elongated channel 10004 is configured to operably support a staple
cartridge 10006 therein. The staple cartridge 10006 is similar to
the staple cartridge 304 described above. The anvil 10008 comprises
a magnet 10008. The staple cartridge comprises a Hall effect sensor
10010 and a processor 10012. The Hall effect sensor 10010 is
operable to communicate with the processor 10012 through a
conductive coupling 10014. The Hall effect sensor 10010 is
positioned within the staple cartridge 10006 to operatively couple
with the magnet 10008 when the anvil 10002 is in a closed position.
The Hall effect sensor 10010 can be configured to detect changes in
the magnetic field surrounding the Hall effect sensor 10010 caused
by the movement of or location of magnet 10008.
[0541] FIG. 127 illustrates one embodiment of the operable
dimensions that relate to the operation of the Hall effect sensor
10010. A first dimension 10020 is between the bottom of the center
of the magnet 10008 and the top of the staple cartridge 10006. The
first dimension 10020 can vary with the size and shape of the
staple cartridge 10006, such as for instance between 0.0466 inches,
0.0325 inches, 0.0154 inches, or 0.0154 inches, or any reasonable
value. A second dimension 10022 is between the bottom of the center
of the magnet 10008 and the top of the Hall effect sensor 10010.
The second dimension can also vary with the size and shape of the
staple cartridge 10006, such as for instance 0.0666 inches, 0.0525
inches, 0.0354 inches, 0.0347 inches, or any reasonable value. A
third dimension 10024 is between the top of the processor 10012 and
the lead-in surface 10028 of the staple cartridge 10006. The third
dimension can also vary with the size and the shape of the staple
cartridge, such as for instance 0.0444 inches, 0.0440 inches,
0.0398 inches, 0.0356 inches, or any reasonable value. An angle
10026 is the angle between the anvil 10002 and the top of the
staple cartridge 10006. The angle 10026 also can vary with the size
and shape of the staple cartridge 10006, such as for instance 0.91
degrees, 0.68 degrees, 0.62 degrees, 0.15 degrees, or any
reasonable value.
[0542] FIGS. 128A through 128D further illustrate dimensions that
can vary with the size and shape of a staple cartridge 10006 and
effect the operation of the Hall effect sensor 10010. FIG. 128A
illustrates an external side view of an embodiment of a staple
cartridge 10006. The staple cartridge 10006 comprises a push-off
lug 10036. When the staple cartridge 10006 is operatively coupled
with the end effector 10000 as illustrated in FIG. 126A, the
push-off lug 10036 rests on the side of the elongated channel
10004.
[0543] FIG. 128B illustrates various dimensions possible between
the lower surface 10038 of the push-off lug 10036 and the top of
the Hall effect sensor 10010 (not pictured). A first dimension
10030a is possible with black, blue, green or gold staple
cartridges 10006, where the color of the body of the staple
cartridge 10006 may be used to identify various aspects of the
staple cartridge 10006. The first dimension 10030a can be, for
instance, 0.005 inches below the lower surface 10038 of the
push-off lug 10036. A second dimension 10030b is possible with gray
staple cartridges 10006, and can be 0.060 inches above the lower
surface 10038 of the push-off lug 10036. A third dimension 10030c
is possible with white staple cartridges 10006, and can be 0.030
inches above the lower-surface 10038 of the push-off lug 10036.
[0544] FIG. 128C illustrates an external side view of an embodiment
of a staple cartridge 10006. The staple cartridge 10006 comprises a
push-off lug 10036 with a lower surface 10038. The staple cartridge
10006 further comprises an upper surface 10046 immediately above
the Hall effect sensor 10010 (not pictured). FIG. 128D illustrates
various dimensions possible between the lower surface 10038 of the
push-off lug 10038 and the upper surface 10046 of the staple
cartridge 10006 above the Hall effect sensor 10010. A first
dimension 10040 is possible for black, blue, green or gold staple
cartridges 10006, and can be, for instance, 0.015 inches above the
lower surface 10038 of the push-off lug 10036. A second dimension
10042 is possible for gray staple cartridges 10006, and can be, for
instance, 0.080 inches. A third dimension 10044 is possible for
white staple cartridges 10006, and can be, for instance, 0.050.
[0545] It is understood that the references to the color of the
body of a staple cartridge 10006 is for convenience and by way of
example only. It is understood that other staple cartridge 10006
body colors are possible. It is also understood that the dimensions
given for FIGS. 128A through 128D are also example and
non-limiting.
[0546] FIG. 129A illustrates various embodiments of magnets
10058a-10058d of various sizes, according to how each magnet
10058a-10058d may fit in the distal end of an anvil, such as anvil
10002 illustrated in FIGS. 126A-126B. A magnet 10058a-10058d can be
positioned in the distal tip of the anvil 10002 at a given distance
10050 from the anvil's pin or pivot point 10052. It is understood
that this distance 10050 may vary with the construction of the end
effector and staple cartridge and/or the desired position of the
magnet. FIG. 129B further illustrates a front-end cross-sectional
view 10054 of the anvil 10002 and the central axis point of the
anvil 10002. FIG. 129A also illustrates an example 10056 of how
various embodiments of magnets 10058a-10058d may fit within the
same anvil 10002.
[0547] FIGS. 130A-130E illustrate one embodiment of an end effector
10100 that comprises, by way of example, a magnet 10058a as
illustrated in FIGS. 129A-129B. FIG. 130A illustrates a front-end
cross-sectional view of the end effector 10100. The end effector
10100 is similar to the end effector 300 described above. The end
effector 10100 comprises a first jaw member or anvil 10102, a
second jaw member or elongated channel 10104, and a staple
cartridge 10106 operatively coupled to the elongated channel 10104.
The anvil 10102 further comprises the magnet 10058a. The staple
cartridge 10106 further comprises a Hall effect sensor 10110. The
anvil 10102 is here illustrated in a closed position. FIG. 130B
illustrates a front-end cutaway view of the anvil 10102 and the
magnet 10058a, in situ. FIG. 130C illustrates a perspective cutaway
view of the anvil 10102 and the magnet 10058a, in an optional
location. FIG. 130D illustrates a side cutaway view of the anvil
10102 and the magnet 10058a, in an optional location. FIG. 130E
illustrates a top cutaway view of the anvil 10102 and the magnet
10058a, in an optional location.
[0548] FIGS. 131A-131E illustrate one embodiment of an end effector
10150 that comprises, by way of example, a magnet 10058d as
illustrated in FIGS. 129A-129B. FIG. 131A illustrates a front-end
cross-sectional view of the end effector 10150. The end effector
10150 comprises an anvil 10152, an elongated channel 10154, and a
staple cartridge 10156. The anvil 10152 further comprises magnet
10058d. The staple cartridge 10156 further comprises a Hall effect
sensor 10160. FIG. 131B illustrates a front-end cutaway view of the
anvil 10150 and the magnet 10058d, in situ. FIG. 131C illustrates a
perspective cutaway view of the anvil 10152 and the magnet 10058d
in an optional location. FIG. 131D illustrates a side cutaway view
of the anvil 10152 and the magnet 10058d in an optional location.
FIG. 131E illustrates a top cutaway view of the anvil 10152 and
magnet 10058d in an optional location.
[0549] FIG. 132 illustrates an end effector 300 as described above,
and illustrates contact points between the anvil 306 and either the
staple cartridge 304 and/or the elongated channel 302. Contact
points between the anvil 306 and the staple cartridge 304 and/or
the elongated channel 302 can be used to determine the position of
the anvil 306 and/or provide a point for an electrical contact
between the anvil 306 and the staple cartridge 304, and/or the
anvil 306 and the elongated channel 302. Distal contact point 10170
can provide a contact point between the anvil 306 and the staple
cartridge 304. Proximal contact point 10172 can provide a contact
point between the anvil 306 and the elongated channel 302.
[0550] FIGS. 133A and 133B illustrate one embodiment of an end
effector 10200 that is operable to use conductive surfaces at the
distal contact point to create an electrical connection. The end
effector 10200 is similar to the end effector 300 described above.
The end effector comprises an anvil 10202, an elongated channel
10204, and a staple cartridge 10206. The anvil 10202 further
comprises a magnet 10208 and an inside surface 10210, which further
comprises a number of staple-forming indents 10212. In some
embodiments, the inside surface 10210 of the anvil 10202 further
comprises a first conductive surface 10214 surrounding the
staple-forming indents 10212. The first conductive surface 10214
can come into contact with second conductive surfaces 10222 on the
staple cartridge 10206, as illustrated in FIG. 107B. FIG. 107B
illustrates a close-up view of the cartridge body 10216 of the
staple cartridge 10206. The cartridge body 10216 comprises a number
of staple cavities 10218 designed to hold staples (not pictured).
In some embodiments the staple cavities 10218 further comprise
staple cavity extensions 10220 that protrude above the surface of
the cartridge body 10216. The staple cavity extensions 10220 can be
coated with the second conductive surfaces 10222. Because the
staple cavity extensions 10222 protrude above the surface of the
cartridge body 10216, the second conductive surfaces 10222 will
come into contact with the first conductive surfaces 10214 when the
anvil 10202 is in a closed position. In this manner the anvil 10202
can form an electrical contact with the staple cartridge 10206.
[0551] FIGS. 134A-134C illustrate one embodiment of an end effector
10250 that is operable to use conductive surfaces to form an
electrical connection. FIG. 134A illustrates the end effector 10250
comprises an anvil 10252, an elongated channel 10254, and a staple
cartridge 10256. The anvil further comprises a magnet 10258 and an
inside surface 10260, which further comprises staple-forming
indents 10262. In some embodiments the inside surface 10260 of the
anvil 10250 can further comprise first conductive surfaces 10264,
located, by way of example, distally from the staple-forming
indents 10262, as illustrated in FIG. 134B. The first conductive
surfaces 10264 are located such that they can come into contact
with a second conductive surface 10272 located on the staple
cartridge 10256, as illustrated in FIG. 134C. FIG. 134C illustrates
the staple cartridge 10256, which comprises a cartridge body 10266.
The cartridge body 10266 further comprises an upper surface 10270,
which in some embodiments can be coated with the second conductive
surface 10272. The first conductive surfaces 10264 are located on
the inside surface 10260 of the anvil 10252 such that they come
into contact with the second conductive surface 10272 when the
anvil 10252 is in a closed position. In this manner the anvil 10250
can form an electrical contact with the staple cartridge 10256.
[0552] FIGS. 135A and 135B illustrate one embodiment of an end
effector 10300 that is operable to use conductive surfaces to form
an electrical connection. The end effector 10300 comprises an anvil
10302, an elongated channel 10304, and a staple cartridge 10306.
The anvil 10302 further comprises a magnet 10308 and an inside
surface 10310, which further comprises a number of staple-forming
indents 10312. In some embodiments the inside surface 10310 further
comprises a first conductive surface 10314 surrounding some of the
staple-forming indents 10312. The first conductive surface is
located such that it can come into contact with second conductive
surfaces 10322 as illustrated in FIG. 109B. FIG. 109B illustrates a
close-up view of the staple cartridge 10306. The staple cartridge
10306 comprises a cartridge body 10316 which further comprises an
upper surface 10320. In some embodiments, the leading edge of the
upper surface 10320 can be coated with second conductive surfaces
10322. The first conductive surface 10312 is positioned such that
it will come into contact with the second conductive surfaces 10322
when the anvil 10302 is in a closed position. In this manner the
anvil 10302 can form an electrical connection with the staple
cartridge 10306.
[0553] FIGS. 136A and 136B illustrate one embodiment of an end
effector 10350 that is operable to use conductive surfaces to form
an electrical connection. FIG. 136A illustrates an end effector
10350 comprising an anvil 10352, an elongated channel 10354, and a
staple cartridge 10356. The anvil 10352 further comprises a magnet
10358 and an inside surface 10360, which further comprises a number
of staple-forming indents 10362. In some embodiments the inside
surface 10360 further comprises a first conductive surface 10364
surrounding some of the staple-forming indents 10362. The first
conductive surface is located such that it can come into contact
with second conductive surfaces 10372 as illustrated in FIG. 136B.
FIG. 136B illustrates a close-up view of the staple cartridge
10356. The staple cartridge 10356 comprises a cartridge body 10366
which further comprises an upper surface 10370. In some
embodiments, the leading edge of the upper surface 10327 can be
coated with second conductive surfaces 10372. The first conductive
surface 10362 is positioned such that it will come into contact
with the second conductive surfaces 10372 when the anvil 10352 is
in a closed position. In this manner the anvil 10352 can form an
electrical connection with the staple cartridge 10356.
[0554] FIGS. 137A-137C illustrate one embodiment of an end effector
10400 that is operable to use the proximal contact point 10408 to
form an electrical connection. FIG. 137A illustrate the end
effector 10400, which comprises an anvil 10402, an elongated
channel 10404, and a staple cartridge 10406. The anvil 10402
further comprises pins 10410 that extend from the anvil 10402 and
allow the anvil to pivot between an open and a closed position
relative to the elongated channel 10404 and the staple cartridge
10406. FIG. 137B is a close-up view of a pin 10410 as it rests
within an aperture 10418 defined in the elongated channel 10404 for
that purpose. In some embodiments, pin 10410 further comprises a
first conductive surface 10412 located on the exterior of the pin
10410. In some embodiments the aperture 10418 further comprises a
second conductive surface 10141 on its outside surface. As the
anvil 10402 moves between a closed and an open position, the first
conductive surface 10412 on the pin 10410 rotates and comes into
contact with the second conductive surface 10414 on the surface of
the aperture 10418, thus forming an electrical contact. FIG. 137C
illustrates an alternate embodiment, with an alternate location for
a second conductive surface 10416 on the surface of the aperture
10418.
[0555] FIG. 138 illustrates one embodiment of an end effector 10450
with a distal sensor plug 10466. End effector 10450 comprises a
first jaw member or anvil 10452, a second jaw member or elongated
channel 10454, and a staple cartridge 10466. The staple cartridge
10466 further comprises the distal sensor plug 10466, located at
the distal end of the staple cartridge 10466.
[0556] FIG. 139A illustrates the end effector 10450 with the anvil
10452 in an open position. FIG. 139B illustrates a cross-sectional
view of the end effector 10450 with the anvil 10452 in an open
position. As illustrated, the anvil 10452 may further comprise a
magnet 10458, and the staple cartridge 10456 may further comprise
the distal sensor plug 10466 and a wedge sled, 10468, which is
similar to the wedge sled 190 described above. FIG. 139C
illustrates the end effector 10450 with the anvil 10452 in a closed
position. FIG. 139D illustrates a cross sectional view of the end
effector 10450 with the anvil 10452 in a closed position. As
illustrated, the anvil 10452 may further comprise a magnet 10458,
and the staple cartridge 10456 may further comprise the distal
sensor plug 10466 and a wedge sled 10468. As illustrated, when the
anvil 10452 is in a closed position relative to the staple
cartridge 10456, the magnet 10458 is in proximity to the distal
sensor plug 10466.
[0557] FIG. 140 provides a close-up view of the cross section of
the distal end of the end effector 10450. As illustrated, the
distal sensor plug 10466 may further comprise a Hall effect sensor
10460 in communication with a processor 10462. The Hall effect
sensor 10460 can be operatively connected to a flex board 10464.
The processor 10462 can also be operatively connect to the flex
board 10464, such that the flex board 10464 provides a
communication path between the Hall effect sensor 10460 and the
processor 10462. The anvil 10452 is illustrated in a closed
position, and as illustrated, when the anvil 10452 is in a closed
position the magnet 10458 is in proximity to the Hall effect sensor
10460.
[0558] FIG. 141 illustrates a close-up top view of the staple
cartridge 10456 that comprises a distal sensor plug 10466. Staple
cartridge 10456 further comprises a cartridge body 10470. The
cartridge body 10470 further comprises electrical traces 10472.
Electrical traces 10472 provide power to the distal sensor plug
10466, and are connected to a power source at the proximal end of
the staple cartridge 10456 as described in further detail below.
Electrical traces 10472 can be placed in the cartridge body 10470
by various methods, such as for instance laser etching.
[0559] FIGS. 142A and 142B illustrate one embodiment of a staple
cartridge 10506 with a distal sensor plug 10516. FIG. 142A is a
perspective view of the underside of the staple cartridge 10506.
The staple cartridge 10506 comprises a cartridge body 10520 and a
cartridge tray 10522. The staple cartridge 10506 further comprises
a distal sensor cover 10524 that encloses the lower area of the
distal end of the staple cartridge 10506. The cartridge tray 10522
further comprises an electrical contact 10526. FIG. 142B
illustrates a cross sectional view of the distal end of the staple
cartridge 10506. As illustrated, the staple cartridge 10506 can
further comprise a distal sensor plug 10516 located within the
cartridge body 10520. The distal sensor plug 10516 further
comprises a Hall effect sensor 10510 and a processor 10512, both
operatively connected to a flex board 10514. The distal sensor plug
10516 can be connected to the electrical contact 10526, and can
thus use conductivity in the cartridge tray 10522 as a source of
power. FIG. 142B further illustrates the distal sensor cover 10524,
which encloses the distal sensor plug 10516 within the cartridge
body 10520.
[0560] FIGS. 143A-143C illustrate one embodiment of a staple
cartridge 10606 that comprises a flex cable 10630 connected to a
Hall effect sensor 10610 and processor 10612. The staple cartridge
10606 is similar to the staple cartridge 10606 is similar to the
staple cartridge 306 described above. FIG. 143A is an exploded view
of the staple cartridge 10606. The staple cartridge comprises 10606
a cartridge body 10620, a wedge sled 10618, a cartridge tray 10622,
and a flex cable 10630. The flex cable 10630 further comprises
electrical contacts 10632 at the proximal end of the staple
cartridge 10606, placed to make an electrical connection when the
staple cartridge 10606 is operatively coupled with an end effector,
such as end effector 10800 described below. The electrical contacts
10632 are integrated with cable traces 10634, which extend along
some of the length of the staple cartridge 10606. The cable traces
10634 connect 10636 near the distal end of the staple cartridge
10606 and this connection 10636 joins with a conductive coupling
10614. A Hall effect sensor 10610 and a processor 10612 are
operatively coupled to the conductive coupling 10614 such that the
Hall effect sensor 10610 and the processor 10612 are able to
communicate.
[0561] FIG. 143B illustrates the assembly of the staple cartridge
10606 and the flex cable 10630 in greater detail. As illustrated,
the cartridge tray 10622 encloses the underside of the cartridge
body 10620, thereby enclosing the wedge sledge 10618. The flex
cable 10630 can be located on the exterior of the cartridge tray
10622, with the conductive coupling 10614 positioned within the
distal end of the cartridge body 10620 and the electrical contacts
10632 located on the outside near the proximal end. The flex cable
10630 can be placed on the exterior of the cartridge tray 10622 by
any appropriate means, such as for instance bonding or laser
etching.
[0562] FIG. 143C illustrates a cross sectional view of the staple
cartridge 10606 to illustrate the placement of the Hall effect
sensor 10610, processor 10612, and conductive coupling 10614 within
the distal end of the staple cartridge, in accordance with the
present embodiment.
[0563] FIG. 144A-144F illustrate one embodiment of a staple
cartridge 10656 that comprises a flex cable 10680 connected to a
Hall effect sensor 10660 and a processor 10662. FIG. 144A is an
exploded view of the staple cartridge 10656. The staple cartridge
comprises a cartridge body 10670, a wedge sled 10668, a cartridge
tray 10672, and a flex cable 10680. The flex cable 10680 further
comprises cable traces 10684 that extend along some of the length
of the staple cartridge 10656. Each of the cable traces 10684 have
an angle 10686 near their distal end, and connect therefrom to a
conductive coupling 10664. A Hall effect sensor 10660 and a
processor 10662 are operatively coupled to the conductive coupling
10664 such that the Hall effect sensor 10660 and the processor
10662 are able to communicate.
[0564] FIG. 144B illustrates the assembly of the staple cartridge
10656. The cartridge tray 10672 encloses the underside of the
cartridge body 10670, thereby enclosing the wedge sled 10668. The
flex cable 10680 is located between the cartridge body 10670 and
the cartridge tray 10672. As such, in the illustration only the
angle 10686 and the conductive coupling 10664 are visible.
[0565] FIG. 144C illustrates the underside of an assembled staple
cartridge 10656, and also illustrates the flex cable 10680 in
greater detail. In an assembled staple cartridge 10656, the
conductive coupling 10664 is located in the distal end of the
staple cartridge 10656. Because the flex cable 10680 can be located
between the cartridge body 10670 and the cartridge tray 10672, only
the angle 10686 ends of the cable traces 10684 would be visible
from the underside of the staple cartridge 10656, as well as the
conductive coupling 10664.
[0566] FIG. 144D illustrates a cross sectional view of the staple
cartridge 10656 to illustrate the placement of the Hall effect
sensor 10660, processor 10662, and conductive coupling 10664. Also
illustrated is an angle 10686 of a cable trace 10684, to illustrate
where the angle 10686 could be placed. The cable traces 10684 are
not pictured.
[0567] FIG. 144E illustrates the underside of the staple cartridge
10656 without the cartridge tray 10672 and including the wedge sled
10668, in its most distal position. The staple cartridge 10656 is
illustrated without the cartridge tray 10672 in order to illustrate
a possible placement for the cable traces 10684, which are
otherwise obscured by the cartridge tray 10672. As illustrated, the
cable traces 10684 can be placed inside the cartridge body 10670.
The angle 10686 optionally allows the cable traces 10684 to occupy
a narrower space in the distal end of the cartridge body 10670.
[0568] FIG. 144F also illustrates the staple cartridge 10656
without the cartridge tray 10672 in order to illustrate a possible
placement for the cable traces 10684. As illustrated the cable
traces 10684 can be placed along the length of the exterior of
cartridge body 10670. Furthermore, the cable traces 10684 can form
an angle 10686 to enter the interior of the distal end of the
cartridge body 10670.
[0569] FIGS. 145A and 145B illustrates one embodiment of a staple
cartridge 10706 that comprises a flex cable 10730, a Hall effect
sensor 10710, and a processor 10712. FIG. 145A is an exploded view
of the staple cartridge 10706. The staple cartridge 10706 comprises
a cartridge body 10720, a wedge sled 10718, a cartridge tray 10722,
and a flex cable 10730. The flex cable 10730 further comprises
electrical contacts 10732 placed to make an electrical connection
when the staple cartridge 10706 is operatively coupled with an end
effector. The electrical contacts 10732 are integrated with cable
traces 10734. The cable traces connect 10736 near the distal end of
the staple cartridge 10706, and this connection 10736 joins with a
conductive coupling 10714. A Hall effect sensor 10710 and a
processor 10712 are operatively connected to the conductive
coupling 10714 such that the are able to communicate.
[0570] FIG. 145B illustrates the assembly of the staple cartridge
10706 and the flex cable 10730 in greater detail. As illustrated,
the cartridge tray 10722 encloses the underside of the cartridge
body 10720, thereby enclosing the wedge sled 10718. The flex cable
10730 can be located on the exterior of the cartridge tray 10722
with the conductive coupling 10714 positioned within the distal end
of the cartridge body 10720. The flex cable 10730 can be placed on
the exterior of the cartridge tray 10722 by any appropriate means,
such as for instance bonding or laser etching.
[0571] FIGS. 146A-146F illustrate one embodiment of an end effector
10800 with a flex cable 10840 operable to provide power to a staple
cartridge 10806 that comprises a distal sensor plug 10816. The end
effector 10800 is similar to the end effector 300 described above.
The end effector 10800 comprises a first jaw member or anvil 10802,
a second jaw member or elongated channel 10804, and a staple
cartridge 10806 operatively coupled to the elongated channel 10804.
The end effector 10800 is operatively coupled to a shaft assembly
10900. The shaft assembly 10900 is similar to shaft assembly 200
described above. The shaft assembly 10900 further comprises a
closure tube 10902 that encloses the exterior of the shaft assembly
10900. In some embodiments the shaft assembly 10900 further
comprises an articulation joint 10904, which includes a double
pivot closure sleeve assembly 10906. The double pivot closure
sleeve assembly 10906 includes an end effector closure sleeve
assembly 10908 that is operable to couple with the end effector
10800.
[0572] FIG. 146A illustrates a perspective view of the end effector
10800 coupled to the shaft assembly 10900. In various embodiments,
the shaft assembly 10900 further comprises a flex cable 10830 that
is configured to not interfere with the function of the
articulation joint 10904, as described in further detail below.
FIG. 146B illustrates a perspective view of the underside of the
end effector 10800 and shaft assembly 10900. In some embodiments,
the closure tube 10902 of the shaft assembly 10900 further
comprises a first aperture 10908, through which the flex cable
10908 can extend. The close sleeve assembly 10908 further comprises
a second aperture 10910, through which the flex cable 10908 can
also pass.
[0573] FIG. 146C illustrates the end effector 10800 with the flex
cable 10830 and without the shaft assembly 10900. As illustrated,
in some embodiments the flex cable 10830 can include a single coil
10832 operable to wrap around the articulation joint 10904, and
thereby be operable to flex with the motion of the articulation
joint 10904.
[0574] FIGS. 146D and 146E illustrate the elongated channel 10804
portion of the end effector 10800 without the anvil 10802 or the
staple cartridge 10806, to illustrate how the flex cable 10830 can
be seated within the elongated channel 10804. In some embodiments,
the elongated channel 10804 further comprises a third aperture
10824 for receiving the flex cable 10830. Within the body of the
elongated channel 10804 the flex cable splits 10834 to form
extensions 10836 on either side of the elongated channel 10804.
FIG. 146E further illustrates that connectors 10838 can be
operatively coupled to the flex cable extensions 10836.
[0575] FIG. 146F illustrates the flex cable 10830 alone. As
illustrated, the flex cable 10830 comprises a single coil 10832
operative to wrap around the articulation joint 10904, and a split
10834 that attaches to extensions 10836. The extensions can be
coupled to connectors 10838 that have on their distal facing
surfaces prongs 10840 for coupling to the staple cartridge 10806,
as described below.
[0576] FIG. 147 illustrates a close up view of the elongated
channel 10804 with a staple cartridge 10806 coupled thereto. The
staple cartridge 10804 comprises a cartridge body 10822 and a
cartridge tray 10820. In some embodiments the staple cartridge
10806 further comprises electrical traces 10828 that are coupled to
proximal contacts 10856 at the proximal end of the staple cartridge
10806. The proximal contacts 10856 can be positioned to form a
conductive connection with the prongs 10840 of the connectors 10838
that are coupled to the flex cable extensions 10836. Thus, when the
staple cartridge 10806 is operatively coupled with the elongated
channel 10804, the flex cable 10830, through the connectors 10838
and the connector prongs 10840, can provide power to the staple
cartridge 10806.
[0577] FIGS. 148A-148D further illustrate one embodiment of a
staple cartridge 10806 operative with the present embodiment of an
end effector 10800. FIG. 148A illustrates a close up view of the
proximal end of the staple cartridge 10806. As discussed above, the
staple cartridge 10806 comprises electrical traces 10828 that, at
the proximal end of the staple cartridge 10806, form proximal
contacts 10856 that are operable to couple with the flex cable
10830 as described above. FIG. 148B illustrates a close-up view of
the distal end of the staple cartridge 10806, with a space for a
distal sensor plug 10816, described below. As illustrated, the
electrical traces 10828 can extend along the length of the staple
cartridge body 10822 and, at the distal end, form distal contacts
10856. FIG. 148C further illustrates the distal sensor plug 10816,
which in some embodiments is shaped to be received by the space
formed for it in the distal end of the staple cartridge 10806. FIG.
148D illustrates the proximal-facing side of the distal sensor plug
10816. As illustrated, the distal sensor plug 10816 has sensor plug
contacts 10854, positioned to couple with the distal contacts 10858
of the staple cartridge 10806. Thus, in some embodiments the
electrical traces 10828 can be operative to provide power to the
distal sensor plug 10816.
[0578] FIGS. 149A and 149B illustrate one embodiment of a distal
sensor plug 10816. FIG. 149A illustrates a cutaway view of the
distal sensor plug 10816. As illustrated, the distal sensor plug
10816 comprises a Hall effect sensor 10810 and a processor 10812.
The distal sensor plug 10816 further comprises a flex board 10814.
As further illustrated in FIG. 149B, the Hall effect sensor 10810
and the processor 10812 are operatively coupled to the flex board
10814 such that they are capable of communicating.
[0579] FIG. 150 illustrates an embodiment of an end effector 10960
with a flex cable 10980 operable to provide power to sensors and
electronics 10972 in the distal tip of the anvil 19052 portion. The
end effector 10950 comprises a first jaw member or anvil 10962, a
second jaw member or elongated channel 10964, and a staple
cartridge 10956 operatively coupled to the elongated channel 10952.
The end effector 10960 is operatively coupled to a shaft assembly
10960. The shaft assembly 10960 further comprises a closure tube
10962 that encloses the shaft assembly 10960. In some embodiments
the shaft assembly 10960 further comprises an articulation joint
10964, which includes a double pivot closure sleeve assembly
10966.
[0580] In various embodiments, the end effector 10950 further
comprises a flex cable 19080 that is configured to not interfere
with the function of the articulation joint 10964. In some
embodiments, the closure tube 10962 comprises a first aperture
10968 through which the flex cable 10980 can extend. In some
embodiments, flex cable 10980 further comprises a loop or coil
10982 that wraps around the articulation joint 10964 such that the
flex cable 10980 does not interfere with the operation of the
articulation joint 10964, as further described below. In some
embodiments, the flex cable 10980 extends along the length of the
anvil 10951 to a second aperture 10970 in the distal tip of the
anvil 10951.
[0581] FIGS. 151A-151C illustrate the operation of the articulation
joint 10964 and flex cable 19080 of the end effector 10950. FIG.
151A illustrates a top view of the end effector 10952 with the end
effector 109650 pivoted -45 degrees with respect to the shaft
assembly 10960. As illustrated, the coil 10982 of the flex cable
10980 flexes with the articulation joint 10964 such that the flex
cable 10980 does not interfere with the operation of the
articulation joint. 10964. FIG. 151B illustrates a top view of the
end effector 10950. As illustrated, the coil 10982 wraps around the
articulation joint 10964 once. FIG. 151C illustrates a top view of
the end effector 10950 with the end effector 10950 pivoted +45
degrees with respect to the shaft assembly 10960. As illustrated,
the coil 10982 of the flex cable 10980 flexes with the articulation
joint 10964 such that the flex cable 10980 does not interfere with
the operation of the articulation joint 10964.
[0582] FIG. 152 illustrates cross-sectional view of the distal tip
of an embodiment of an anvil 10952 with sensors and electronics
10972. The anvil 10952 comprises a flex cable 10980, as described
with respect to FIGS. 150 and 151A-151C. As illustrated in FIG.
152, the anvil 10952 further comprises a second aperture 10970
through which the flex cable 10980 can pass such that the flex
cable 10980 can enter a housing 10974 in the within the anvil
10952. Within the housing 10974 the flex cable 10980 can operably
couple to sensors and electronics 10972 located within the housing
10974 and thereby provide power to the sensors and electronics
10972.
[0583] FIG. 153 illustrates a cutaway view of the distal tip of the
anvil 10952. FIG. 153 illustrates an embodiment of the housing
10974 that can contain sensors and electronics 10972 as illustrated
by FIG. 152.
[0584] In accordance with various embodiments, 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.
[0585] 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).
[0586] 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.
[0587] In various embodiments, 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 embodiments, the operating logic may be
further configured to receive information from and provide feedback
to a hosting computer. In alternate embodiments, 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.
[0588] In various embodiments, 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 embodiments, the operating logic may
be implemented in hardware such as a gate array.
[0589] In various embodiments, 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 embodiments, 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.
[0590] For various embodiments, the processor may be packaged
together with the operating logic. In various embodiments, the
processor may be packaged together with the operating logic to form
a SiP. In various embodiments, the processor may be integrated on
the same die with the operating logic. In various embodiments, the
processor may be packaged together with the operating logic to form
a System on Chip (SoC).
[0591] Various embodiments 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 embodiments 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.
[0592] Although some embodiments 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 embodiments, 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.
[0593] 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 an
embodiment 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.
[0594] 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).
[0595] In some cases, various embodiments 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 embodiments. In various embodiments, 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 embodiments, however, are not
limited in this context.
[0596] The functions of the various functional elements, logical
blocks, modules, and circuits elements described in connection with
the embodiments 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 embodiments 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.
[0597] Additionally, it is to be appreciated that the embodiments
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 embodiments. 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 embodiments 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.
[0598] It is worthy to note that any reference to "one embodiment"
or "an embodiment" means that a particular feature, structure, or
characteristic described in connection with the embodiment is
comprised in at least one embodiment. The appearances of the phrase
"in one embodiment" or "in one aspect" in the specification are not
necessarily all referring to the same embodiment.
[0599] 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.
[0600] It is worthy to note that some embodiments 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 embodiments 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.
[0601] 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.
[0602] The disclosed embodiments have application in conventional
endoscopic and open surgical instrumentation as well as application
in robotic-assisted surgery.
[0603] Embodiments 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. Embodiments 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, embodiments 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,
embodiments 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.
[0604] By way of example only, embodiments 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 may also be sterilized using any other
technique known in the art, including but not limited to beta or
gamma radiation, ethylene oxide, or steam.
[0605] 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.
[0606] 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.
[0607] 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 mateable and/or
physically interacting components, and/or wirelessly interactable,
and/or wirelessly interacting components, and/or logically
interacting, and/or logically interactable components.
[0608] 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.
[0609] 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.
[0610] 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.
[0611] 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."
[0612] 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.
[0613] In summary, numerous benefits have been described which
result from employing the concepts described herein. The foregoing
description of the one or more embodiments 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 embodiments 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 embodiments
and with various modifications as are suited to the particular use
contemplated. It is intended that the claims submitted herewith
define the overall scope.
* * * * *