U.S. patent application number 13/627246 was filed with the patent office on 2013-01-24 for surgical instrument.
This patent application is currently assigned to ETHICON ENDO-SURGERY, INC.. The applicant listed for this patent is Ethicon Endo-Surgery, Inc.. Invention is credited to Jerome R. Morgan, John N. Ouwerkerk, Frederick E. Shelton, IV, Jeffrey S. Swayze.
Application Number | 20130020376 13/627246 |
Document ID | / |
Family ID | 38063732 |
Filed Date | 2013-01-24 |
United States Patent
Application |
20130020376 |
Kind Code |
A1 |
Shelton, IV; Frederick E. ;
et al. |
January 24, 2013 |
SURGICAL INSTRUMENT
Abstract
A surgical instrument. The surgical instrument has an end
effector and a trigger in communication with the end effector. The
surgical instrument also has a first sensor and an externally
accessible memory device in communication with the first sensor.
The first sensor has an output that represents a first condition of
either the trigger or the end effector. The memory device is
configured to record the output of the first sensor. In various
embodiments, memory device may include an output port and/or a
removable storage medium.
Inventors: |
Shelton, IV; Frederick E.;
(Hillsboro, OH) ; Ouwerkerk; John N.; (Staunton,
VA) ; Morgan; Jerome R.; (Cincinnati, OH) ;
Swayze; Jeffrey S.; (Hamilton, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ethicon Endo-Surgery, Inc.; |
Cincinnati |
OH |
US |
|
|
Assignee: |
ETHICON ENDO-SURGERY, INC.
Cincinnati
OH
|
Family ID: |
38063732 |
Appl. No.: |
13/627246 |
Filed: |
September 26, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13424648 |
Mar 20, 2012 |
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13627246 |
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12949099 |
Nov 18, 2010 |
8167185 |
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13424648 |
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11343803 |
Jan 31, 2006 |
7845537 |
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12949099 |
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Current U.S.
Class: |
227/176.1 ;
227/175.1; 606/167 |
Current CPC
Class: |
A61B 5/4836 20130101;
A61B 2090/064 20160201; A61B 2017/07257 20130101; A61B 34/30
20160201; A61B 2017/07271 20130101; A61B 34/71 20160201; A61B
2017/07214 20130101; A61B 2017/0042 20130101; A61B 17/00234
20130101; A61B 34/76 20160201; A61B 2017/07285 20130101; A61B 34/74
20160201; A61B 2090/0811 20160201; A61B 17/115 20130101; A61B
2017/00221 20130101; A61B 2090/0803 20160201; A61B 2017/00017
20130101; A61B 2017/00734 20130101; A61B 2017/2943 20130101; A61B
17/00 20130101; A61B 17/105 20130101; A61B 17/068 20130101; A61B
2017/00353 20130101; A61B 17/072 20130101; A61B 17/1155 20130101;
A61B 2017/00398 20130101; A61B 17/07207 20130101; A61B 17/1114
20130101; A61B 2090/033 20160201; A61B 2090/065 20160201; A61B
2017/00199 20130101; A61B 2017/00685 20130101; A61B 2017/07278
20130101; A61B 2090/069 20160201 |
Class at
Publication: |
227/176.1 ;
227/175.1; 606/167 |
International
Class: |
A61B 17/068 20060101
A61B017/068; A61B 17/32 20060101 A61B017/32 |
Claims
1-20. (canceled)
21. A surgical instrument, comprising: an end effector comprising a
moveable firing member; a drive shaft connected to the end
effector; a drive train operably coupled with the firing member; a
motor for actuating the drive train; and a handle, wherein the
handle comprises a firing trigger for actuating the motor, wherein
the firing trigger is operably connected to the drive train such
that the loading force on the firing trigger is related to the
loading force experienced by the firing member in the end
effector.
22. The surgical instrument of Claim 21, further comprising a
staple cartridge positioned within the end effector, wherein the
staple cartridge comprises a plurality of staples removably stored
therein, and wherein the firing member is configured to eject the
staples from the staple cartridge.
23. The surgical instrument of Claim 22, wherein the staple
cartridge comprises a plurality of staple cavities positioned along
a path, wherein a said staple is positioned in each staple cavity,
and wherein the firing member is configured to deploy the staples
sequentially.
24. The surgical instrument of Claim 21, further comprising a
battery operably couplable with the motor for powering the
motor.
25. The surgical instrument of Claim 21, further comprising a
closure trigger, separate from the firing trigger, which is
actuatable to cause the end effector to clamp an object positioned
in the end effector.
26. The surgical instrument of Claim 21, further comprising a run
motor sensor for sensing the actuation of the firing trigger,
wherein, when the actuation of the firing trigger is sensed by the
run motor sensor, the motor is signaled to forward rotate to cause
cutting of an object positioned in the end effector by the firing
member.
27. The surgical instrument of Claim 26, wherein the run motor
sensor comprises a proportional switch, and wherein the rate of
rotation of the motor is proportional to the retraction force
applied to the firing trigger.
28. The surgical instrument of Claim 26, wherein the run motor
sensor comprises an on/off switch.
29. The surgical instrument of Claim 21, wherein the motor and the
firing trigger are meshingly engaged with the drive train.
30. A surgical instrument, comprising: a shaft connectable to an
end effector, wherein the shaft includes a drive member for at
least one of firing fasteners from a fastener cartridge positioned
in the end effector or cutting an object captured within the end
effector; a drive train operably engaged with drive member; a motor
for actuating the drive member via the drive train; and a handle
connected to the shaft, wherein the handle comprises: a firing
trigger for actuating the motor; and means for applying a loading
force to the firing trigger such that the loading force on the
firing trigger is related to the loading force experienced by the
drive member.
31. The surgical instrument of Claim 30, further comprising the
fastener cartridge, wherein the fastener cartridge comprises a
plurality of fasteners removably stored therein, and wherein the
drive member is configured to eject the fasteners from the fastener
cartridge.
32. The surgical instrument of Claim 31, wherein the fastener
cartridge comprises a plurality of fastener cavities positioned
along a path, wherein a said fastener is positioned in each
fastener cavity, and wherein the drive member is configured to
deploy the fasteners sequentially.
33. The surgical instrument of Claim 30, further comprising a
battery operably couplable with the motor for powering the
motor.
34. The surgical instrument of Claim 30, further comprising a
closure trigger, separate from the firing trigger, which is
actuatable to cause the end effector to clamp the object positioned
in the end effector.
35. The surgical instrument of Claim 30, further comprising a run
motor sensor for sensing the actuation of the firing trigger,
wherein, when the actuation of the firing trigger is sensed by the
run motor sensor, the motor is signaled to forward rotate to cause
cutting of the object positioned in the end effector by the drive
member.
36. The surgical instrument of Claim 35, wherein the run motor
sensor comprises a proportional switch, and wherein the rate of
rotation of the motor is proportional to the actuation force
applied to the firing trigger.
37. The surgical instrument of Claim 35, wherein the run motor
sensor comprises an on/off switch.
38. The surgical instrument of Claim 30, wherein the motor and the
firing trigger are meshingly engaged with the drive train.
39. A surgical instrument, comprising: a shaft connectable to an
end effector, wherein the shaft includes a drive member for at
least one of firing fasteners from a fastener cartridge positioned
in the end effector or cutting an object captured within the end
effector; a motor for actuating the drive member; and a handle,
wherein the handle comprises: a firing trigger for actuating the
motor; and means for applying a loading force to the firing trigger
which is determined by the loading force experienced by the drive
member.
40. The surgical instrument of Claim 39, further comprising the
fastener cartridge.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is related to the following
concurrently-filed U.S. patent applications, which are incorporated
herein by reference: [0002] MOTOR-DRIVEN SURGICAL CUTTING AND
FASTENING INSTRUMENT WITH USER FEEDBACK SYSTEM [0003] Inventors:
Frederick E. Shelton, IV, John Ouwerkerk and Jerome R. Morgan
(K&LNG 050519/END5687USNP) [0004] MOTOR-DRIVEN SURGICAL CUTTING
AND FASTENING INSTRUMENT WITH LOADING FORCE FEEDBACK [0005]
Inventors: Frederick E. Shelton, IV, John N. Ouwerkerk, Jerome R.
Morgan, and Jeffrey S. Swayze (K&LNG 050516/END5692USNP) [0006]
MOTOR-DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH TACTILE
POSITION FEEDBACK [0007] Inventors: Frederick E. Shelton, IV, John
N. Ouwerkerk, Jerome R. Morgan, and Jeffrey S. Swayze (K&LNG
050515/END5693USNP) [0008] MOTOR-DRIVEN SURGICAL CUTTING AND
FASTENING INSTRUMENT WITH ADAPTIVE USER FEEDBACK [0009] Inventors:
Frederick E. Shelton, IV, John N. Ouwerkerk, and Jerome R. Morgan
(K&LNG 050513/END5694USNP) [0010] MOTOR-DRIVEN SURGICAL CUTTING
AND FASTENING INSTRUMENT WITH ARTICULATABLE END EFFECTOR [0011]
Inventors: Frederick E. Shelton, IV and Christoph L. Gillum
(K&LNG 050692/END5769USNP) [0012] MOTOR-DRIVEN SURGICAL CUTTING
AND FASTENING INSTRUMENT WITH MECHANICAL CLOSURE SYSTEM [0013]
Inventors: Frederick E. Shelton, IV and Christoph L. Gillum
(K&LNG 050693/END5770USNP) [0014] SURGICAL CUTTING AND
FASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM [0015]
Inventors: Frederick E. Shelton, IV and Kevin R. Doll (K&LNG
050694/END5771USNP) [0016] GEARING SELECTOR FOR A POWERED SURGICAL
CUTTING AND FASTENING STAPLING INSTRUMENT [0017] Inventors:
Frederick E. Shelton, IV, Jeffrey S. Swayze, Eugene L. Timperman
(K&LNG 050697/END5772USNP) [0018] SURGICAL INSTRUMENT HAVING A
REMOVABLE BATTERY [0019] Inventors: Frederick E. Shelton, IV, Kevin
R. Doll, Jeffrey S. Swayze and Eugene Timperman (K&LNG
050699/END5774USNP) [0020] ELECTRONIC LOCKOUTS AND SURGICAL
INSTRUMENT INCLUDING SAME [0021] Inventors: Jeffrey S. Swayze,
Frederick E. Shelton, IV, Kevin R. Doll (K&LNG
050700/END5775USNP) [0022] ENDOSCOPIC SURGICAL INSTRUMENT WITH A
HANDLE THAT CAN ARTICULATE WITH RESPECT TO THE SHAFT [0023]
Inventors: Frederick E. Shelton, IV, Jeffrey S. Swayze, Mark S.
Ortiz, and Leslie M. Fugikawa (K&LNG 050701/END5776USNP) [0024]
ELECTRO-MECHANICAL SURGICAL CUTTING AND FASTENING INSTRUMENT HAVING
A ROTARY FIRING AND CLOSURE SYSTEM WITH PARALLEL CLOSURE AND ANVIL
ALIGNMENT COMPONENTS [0025] Inventors: Frederick E. Shelton, IV,
Stephen J. Balek and Eugene L. Timperman (K&LNG
050702/END5777USNP) [0026] DISPOSABLE STAPLE CARTRIDGE HAVING AN
ANVIL WITH TISSUE LOCATOR FOR USE WITH A SURGICAL CUTTING AND
FASTENING INSTRUMENT AND MODULAR END EFFECTOR SYSTEM THEREFOR
[0027] Inventors: Frederick E. Shelton, IV, Michael S. Cropper,
Joshua M. Broehl, Ryan S. Crisp, Jamison J. Float, Eugene L.
Timperman (K&LNG 050703/END5778USNP) [0028] SURGICAL INSTRUMENT
HAVING A FEEDBACK SYSTEM [0029] Inventors: Frederick E. Shelton,
IV, Jerome R. Morgan, Kevin R. Doll, Jeffrey S. Swayze and Eugene
Timperman (K&LNG 050705/EDN5780USNP)
BACKGROUND
[0030] The present invention relates in general to surgical
instruments, and more particularly to minimally invasive surgical
instruments capable of recording various conditions of the
instrument.
[0031] Endoscopic surgical instruments are often preferred over
traditional open surgical devices because a smaller incision tends
to reduce the post-operative recovery time and complications.
Consequently, significant development has gone into a range of
endoscopic surgical instruments that are suitable for precise
placement of a distal end effector at a desired surgical site
through a cannula of a trocar. These distal end effectors engage
the tissue in a number of ways to achieve a diagnostic or
therapeutic effect (e.g., endocutter, grasper, cutter, staplers,
clip applier, access device, drug/gene therapy delivery device, and
energy device using ultrasound, RF, laser, etc.).
[0032] Known surgical staplers include an end effector that
simultaneously makes a longitudinal incision in tissue and applies
lines of staples on opposing sides of the incision. The end
effector includes a pair of cooperating jaw members that, if the
instrument is intended for endoscopic or laparoscopic applications,
are capable of passing through a cannula passageway. One of the jaw
members receives a staple cartridge having at least two laterally
spaced rows of staples. The other jaw member defines an anvil
having staple-forming pockets aligned with the rows of staples in
the cartridge. The instrument includes a plurality of reciprocating
wedges which, when driven distally, pass through openings in the
staple cartridge and engage drivers supporting the staples to
effect the firing of the staples toward the anvil.
[0033] An example of a surgical stapler suitable for endoscopic
applications is described in U.S. Pat. No. 5,465,895, entitled
"SURGICAL STAPLER INSTRUMENT" to Knodel et al., which discloses an
endocutter with distinct closing and firing actions. A clinician
using this device is able to close the jaw members upon tissue to
position the tissue prior to firing. Once the clinician has
determined that the jaw members are properly gripping tissue, the
clinician can then fire the surgical stapler with a single firing
stroke, or multiple firing strokes, depending on the device. Firing
the surgical stapler causes severing and stapling of the tissue.
The simultaneous severing and stapling avoids complications that
may arise when performing such actions sequentially with different
surgical tools that respectively only sever and staple.
[0034] One specific advantage of being able to close upon tissue
before firing is that the clinician is able to verify via an
endoscope that the desired location for the cut has been achieved,
including a sufficient amount of tissue has been captured between
opposing jaws. Otherwise, opposing jaws may be drawn too close
together, especially pinching at their distal ends, and thus not
effectively forming closed staples in the severed tissue. At the
other extreme, an excessive amount of clamped tissue may cause
binding and an incomplete firing.
[0035] When endoscopic surgical instruments fail, they are often
returned to the manufacturer, or other entity, for analysis of the
failure. If the failure resulted in a critical class of defect in
the instrument, it is necessary for the manufacturer to determine
the cause of the failure and determine whether a design change is
required. In that case, the manufacturer may spend many hundreds of
man-hours analyzing a failed instrument and attempting to
reconstruct the conditions under which it failed based only on the
damage to the instrument. It can be expensive and very challenging
to analyze instrument failures in this way. Also, many of these
analyses simply conclude that the failure was due to improper use
of the instrument.
SUMMARY
[0036] In one general aspect, the present invention is directed to
a surgical instrument. The surgical instrument has an end effector
and a trigger in communication with the end effector. The surgical
instrument also has a first sensor and an externally accessible
memory device in communication with the first sensor. The first
sensor has an output that represents a first condition of either
the trigger or the end effector. The memory device is configured to
record the output of the first sensor. In various embodiments,
memory device may include an output port and/or a removable storage
medium.
[0037] Also, in various embodiments, the output of the first sensor
represents a condition of the end effector and the instrument
further comprises a second sensor with an output representing a
condition of the trigger. The memory device is configured to record
the output of the first sensor and the second sensor.
[0038] In another general aspect, the present invention is directed
to a method of recording the state of a surgical instrument. The
method comprises the step of monitoring outputs of a plurality of
sensors. The outputs represent conditions of the surgical
instrument. The method also comprises the step of recording the
outputs to a memory device when at least one of the conditions of
the surgical instrument changes. In various embodiments, the method
may also comprise the step of providing the recorded outputs of the
plurality of sensors to an outside device.
DRAWINGS
[0039] Various embodiments of the present invention are described
herein by way of example in conjunction with the following figures,
wherein
[0040] FIGS. 1 and 2 are perspective views of a surgical cutting
and fastening instrument according to various embodiments of the
present invention;
[0041] FIGS. 3-5 are exploded views of an end effector and shaft of
the instrument according to various embodiments of the present
invention;
[0042] FIG. 6 is a side view of the end effector according to
various embodiments of the present invention;
[0043] FIG. 7 is an exploded view of the handle of the instrument
according to various embodiments of the present invention;
[0044] FIGS. 8 and 9 are partial perspective views of the handle
according to various embodiments of the present invention;
[0045] FIG. 10 is a side view of the handle according to various
embodiments of the present invention;
[0046] FIGS. 10A and 10B illustrate a proportional sensor that may
be used according to various embodiments of the present
invention;
[0047] FIG. 11 is a schematic diagram of a circuit used in the
instrument according to various embodiments of the present
invention;
[0048] FIGS. 12-13 are side views of the handle according to other
embodiments of the present invention;
[0049] FIGS. 14-22 illustrate different mechanisms for locking the
closure trigger according to various embodiments of the present
invention;
[0050] FIGS. 23A-B show a universal joint ("u-joint") that may be
employed at the articulation point of the instrument according to
various embodiments of the present invention;
[0051] FIGS. 24A-B shows a torsion cable that may be employed at
the articulation point of the instrument according to various
embodiments of the present invention;
[0052] FIGS. 25-31 illustrate a surgical cutting and fastening
instrument with power assist according to another embodiment of the
present invention;
[0053] FIGS. 32-36 illustrate a surgical cutting and fastening
instrument with power assist according to yet another embodiment of
the present invention;
[0054] FIGS. 37-40 illustrate a surgical cutting and fastening
instrument with tactile feedback to embodiments of the present
invention;
[0055] FIG. 41 illustrates an exploded view of an end effector and
shaft of the instrument according to various embodiments of the
present invention;
[0056] FIG. 42 illustrates a side view of the handle of a
mechanically instrument according to various embodiments of the
present invention;
[0057] FIG. 43 illustrates an exploded view of the handle of the
mechanically actuated instrument of FIG. 42;
[0058] FIG. 44 illustrates a block diagram of a recording system
for recording various conditions of the instrument according to
various embodiments of the present invention;
[0059] FIGS. 45-46 illustrate cut away side views of a handle of
the instrument showing various sensors according to various
embodiments of the present invention;
[0060] FIG. 47 illustrates the end effector of the instrument
showing various sensors according to various embodiments of the
present invention;
[0061] FIG. 48 illustrates a firing bar of the instrument including
a sensor according to various embodiments of the present
invention;
[0062] FIG. 49 illustrates a side view of the handle, end effector,
and firing bar of the instrument showing a sensor according to
various embodiments of the present invention;
[0063] FIG. 50 illustrates an exploded view of the staple channel
and portions of a staple cartridge of the instrument showing
various sensors according to various embodiments of the present
invention;
[0064] FIG. 51 illustrates a top down view of the staple channel of
the instrument showing various sensors according to various
embodiments of the present invention;
[0065] FIGS. 52A and 52B illustrate a flow chart showing a method
for operating the instrument according to various embodiments;
and
[0066] FIG. 53 illustrates a memory chart showing exemplary
recorded conditions of the instrument according to various
embodiments of the present invention.
DETAILED DESCRIPTION
[0067] FIGS. 1 and 2 depict a surgical cutting and fastening
instrument 10 according to various embodiments of the present
invention. The illustrated embodiment is an endoscopic surgical
instrument 10 and in general, the embodiments of the instrument 10
described herein are endoscopic surgical cutting and fastening
instruments. It should be noted, however, that according to other
embodiments of the present invention, the instrument 10 may be a
non-endoscopic surgical cutting instrument, such as a laproscopic
instrument.
[0068] The surgical instrument 10 depicted in FIGS. 1 and 2
comprises a handle 6, a shaft 8, and an articulating end effector
12 pivotally connected to the shaft 8 at an articulation pivot 14.
An articulation control 16 may be provided adjacent to the handle 6
to effect rotation of the end effector 12 about the articulation
pivot 14. It will be appreciated that various embodiments may
include a non-pivoting end effector, and therefore may not have an
articulation pivot 14 or articulation control 16. Also, in the
illustrated embodiment, the end effector 12 is configured to act as
an endocutter for clamping, severing and stapling tissue, although,
in other embodiments, different types of end effectors may be used,
such as end effectors for other types of surgical devices, such as
graspers, cutters, staplers, clip appliers, access devices,
drug/gene therapy devices, ultrasound, RF or laser devices,
etc.
[0069] The handle 6 of the instrument 10 may include a closure
trigger 18 and a firing trigger 20 for actuating the end effector
12. It will be appreciated that instruments having end effectors
directed to different surgical tasks may have different numbers or
types of triggers or other suitable controls for operating the end
effector 12. The end effector 12 is shown separated from the handle
6 by a preferably elongate shaft 8. In one embodiment, a clinician
or operator of the instrument 10 may articulate the end effector 12
relative to the shaft 8 by utilizing the articulation control 16,
as described in more detail in pending U.S. patent application Ser.
No. 11/329,020, filed Jan. 10, 2006, entitled "Surgical Instrument
Having An Articulating End Effector," by Geoffrey C. Hueil et al.,
which is incorporated herein by reference.
[0070] The end effector 12 includes in this example, among other
things, a staple channel 22 and a pivotally translatable clamping
member, such as an anvil 24, which are maintained at a spacing that
assures effective stapling and severing of tissue clamped in the
end effector 12. The handle 6 includes a pistol grip 26 toward
which a closure trigger 18 is pivotally drawn by the clinician to
cause clamping or closing of the anvil 24 towards the staple
channel 22 of the end effector 12 to thereby clamp tissue
positioned between the anvil 24 and channel 22. The firing trigger
20 is farther outboard of the closure trigger 18. Once the closure
trigger 18 is locked in the closure position as further described
below, the firing trigger 20 may rotate slightly toward the pistol
grip 26 so that it can be reached by the operator using one hand.
Then the operator may pivotally draw the firing trigger 20 toward
the pistol grip 26 to cause the stapling and severing of clamped
tissue in the end effector 12. In other embodiments, different
types of clamping members besides the anvil 24 could be used, such
as, for example, an opposing jaw, etc.
[0071] It will be appreciated that the terms "proximal" and
"distal" are used herein with reference to a clinician gripping the
handle 6 of an instrument 10. Thus, the end effector 12 is distal
with respect to the more proximal handle 6. It will be further
appreciated that, for convenience and clarity, spatial terms such
as "vertical" and "horizontal" are 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 absolute.
[0072] The closure trigger 18 may be actuated first. Once the
clinician is satisfied with the positioning of the end effector 12,
the clinician may draw back the closure trigger 18 to its fully
closed, locked position proximate to the pistol grip 26. The firing
trigger 20 may then be actuated. The firing trigger 20 returns to
the open position (shown in FIGS. 1 and 2) when the clinician
removes pressure, as described more fully below. A release button
on the handle 6, when depressed may release the locked closure
trigger 18. The release button may be implemented in various forms
such as, for example, release button 30 shown in FIGS. 42-43, slide
release button 160 shown in FIG. 14, and/or button 172 shown in
FIG. 16.
[0073] FIGS. 3-6 show embodiments of a rotary-driven end effector
12 and shaft 8 according to various embodiments. FIG. 3 is an
exploded view of the end effector 12 according to various
embodiments. As shown in the illustrated embodiment, the end
effector 12 may include, in addition to the previously-mentioned
channel 22 and anvil 24, a cutting instrument 32, a sled 33, a
staple cartridge 34 that is removably seated in the channel 22, and
a helical screw shaft 36. The cutting instrument 32 may be, for
example, a knife. The anvil 24 may be pivotably opened and closed
at pivot pins 25 connected to the proximate end of the channel 22.
The anvil 24 may also include a tab 27 at its proximate end that is
inserted into a component of the mechanical closure system
(described further below) to open and close the anvil 24. When the
closure trigger 18 is actuated, that is, drawn in by a user of the
instrument 10, the anvil 24 may pivot about the pivot pins 25 into
the clamped or closed position. If clamping of the end effector 12
is satisfactory, the operator may actuate the firing trigger 20,
which, as explained in more detail below, causes the knife 32 and
sled 33 to travel longitudinally along the channel 22, thereby
cutting tissue clamped within the end effector 12. The movement of
the sled 33 along the channel 22 causes the staples (not shown) of
the staple cartridge 34 to be driven through the severed tissue and
against the closed anvil 24, which turns the staples to fasten the
severed tissue. In various embodiments, the sled 33 may be an
integral component of the cartridge 34. U.S. Pat. No. 6,978,921,
entitled "SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM
FIRING MECHANISM" to Shelton, IV et al., which is incorporated
herein by reference, provides more details about such two-stroke
cutting and fastening instruments. The sled 33 may be part of the
cartridge 34, such that when the knife 32 retracts following the
cutting operation, the sled 33 does not retract.
[0074] It should be noted that although the embodiments of the
instrument 10 described herein employ an end effector 12 that
staples the severed tissue, in other embodiments different
techniques for fastening or sealing the severed tissue may be used.
For example, end effectors that use RF energy or adhesives to
fasten the severed tissue may also be used. U.S. Pat. No. 5,709,680
entitled "ELECTROSURGICAL HEMOSTATIC DEVICE" to Yates et al., and
U.S. Pat. No. 5,688,270 entitled "ELECTOSURGICAL HEMOSTATIC DEVICE
WITH RECESSED AND/OR OFFSET ELECTRODES" to Yates et al. which are
incorporated herein by reference, disclose an endoscopic cutting
instrument that uses RF energy to seal the severed tissue. U.S.
patent application Ser. No. 11/267,811 to Jerome R. Morgan, et. al,
and U.S. patent application Ser. No. 11/267,383 to Frederick E.
Shelton, IV, et. al, which are also incorporated herein by
reference, disclose cutting instruments that uses adhesives to
fasten the severed tissue. Accordingly, although the description
herein refers to cutting/stapling operations and the like below, it
should be recognized that this is an exemplary embodiment and is
not meant to be limiting. Other tissue fastening techniques may
also be used.
[0075] FIGS. 4 and 5 are exploded views and FIG. 6 is a side view
of the end effector 12 and shaft 8 according to various
embodiments. As shown in the illustrated embodiment, the shaft 8
may include a proximate closure tube 40 and a distal closure tube
42 pivotably linked by a pivot link 44. The distal closure tube 42
includes an opening 45 into which the tab 27 on the anvil 24 is
inserted in order to open and close the anvil 24, as further
described below. Disposed inside the closure tubes 40, 42 may be a
proximate spine tube 46. Disposed inside the proximate spine tube
46 may be a main rotational (or proximate) drive shaft 48 that
communicates with a secondary (or distal) drive shaft 50 via a
bevel gear assembly 52. The secondary drive shaft 50 is connected
to a drive gear 54 that engages a proximate drive gear 56 of the
helical screw shaft 36. The vertical bevel gear 52b may sit and
pivot in an opening 57 in the distal end of the proximate spine
tube 46. A distal spine tube 58 may be used to enclose the
secondary drive shaft 50 and the drive gears 54, 56. Collectively,
the main drive shaft 48, the secondary drive shaft 50, and the
articulation assembly (e.g., the bevel gear assembly 52a-c) are
sometimes referred to herein as the "main drive shaft
assembly."
[0076] A bearing 38, positioned at a distal end of the staple
channel 22, receives the helical drive screw 36, allowing the
helical drive screw 36 to freely rotate with respect to the channel
22. The helical screw shaft 36 may interface a threaded opening
(not shown) of the knife 32 such that rotation of the shaft 36
causes the knife 32 to translate distally or proximately (depending
on the direction of the rotation) through the staple channel 22.
Accordingly, when the main drive shaft 48 is caused to rotate by
actuation of the firing trigger 20 (as explained in more detail
below), the bevel gear assembly 52a-c causes the secondary drive
shaft 50 to rotate, which in turn, because of the engagement of the
drive gears 54, 56, causes the helical screw shaft 36 to rotate,
which causes the knife driving member 32 to travel longitudinally
along the channel 22 to cut any tissue clamped within the end
effector 12. The sled 33 may be made of, for example, plastic, and
may have a sloped distal surface. As the sled 33 traverses the
channel 22, the sloped forward surface may push up or drive the
staples in the staple cartridge through the clamped tissue and
against the anvil 24. The anvil 24 turns the staples, thereby
stapling the severed tissue. When the knife 32 is retracted, the
knife 32 and sled 33 may become disengaged, thereby leaving the
sled 33 at the distal end of the channel 22.
[0077] As described above, because of the lack of user feedback for
the cutting/stapling operation, there is a general lack of
acceptance among physicians of motor-driven endocutters where the
cutting/stapling operation is actuated by merely pressing a button.
In contrast, embodiments of the present invention provide a
motor-driven endocutter with user-feedback of the deployment, force
and/or position of the cutting instrument 32 in end effector
12.
[0078] FIGS. 7-10 illustrate an exemplary embodiment of a
motor-driven endocutter, and in particular the handle thereof, that
provides user-feedback regarding the deployment and loading force
of the cutting instrument 32 in the end effector 12. In addition,
the embodiment may use power provided by the user in retracting the
firing trigger 20 to power the device (a so-called "power assist"
mode). The embodiment may be used with the rotary driven end
effector 12 and shaft 8 embodiments described above. As shown in
the illustrated embodiment, the handle 6 includes exterior lower
side pieces 59, 60 and exterior upper side pieces 61, 62 that fit
together to form, in general, the exterior of the handle 6. A
battery 64, such as a Li ion battery, may be provided in the pistol
grip portion 26 of the handle 6. The battery 64 powers a motor 65
disposed in an upper portion of the pistol grip portion 26 of the
handle 6. According to various embodiments, the motor 65 may be a
DC brushed driving motor having a maximum rotation of,
approximately, 5000 RPM. The motor 65 may drive a 90.degree. bevel
gear assembly 66 comprising a first bevel gear 68 and a second
bevel gear 70. The bevel gear assembly 66 may drive a planetary
gear assembly 72. The planetary gear assembly 72 may include a
pinion gear 74 connected to a drive shaft 76. The pinion gear 74
may drive a mating ring gear 78 that drives a helical gear drum 80
via a drive shaft 82. A ring 84 may be threaded on the helical gear
drum 80. Thus, when the motor 65 rotates, the ring 84 is caused to
travel along the helical gear drum 80 by means of the interposed
bevel gear assembly 66, planetary gear assembly 72 and ring gear
78.
[0079] The handle 6 may also include a run motor sensor 110 (see
FIG. 10) in communication with the firing trigger 20 to detect when
the firing trigger 20 has been drawn in (or "closed") toward the
pistol grip portion 26 of the handle 6 by the operator to thereby
actuate the cutting/stapling operation by the end effector 12. The
sensor 110 may be a proportional sensor such as, for example, a
rheostat or variable resistor. When the firing trigger 20 is drawn
in, the sensor 110 detects the movement, and sends an electrical
signal indicative of the voltage (or power) to be supplied to the
motor 65. When the sensor 110 is a variable resistor or the like,
the rotation of the motor 65 may be generally proportional to the
amount of movement of the firing trigger 20. That is, if the
operator only draws or closes the firing trigger 20 in a little
bit, the rotation of the motor 65 is relatively low. When the
firing trigger 20 is fully drawn in (or in the fully closed
position), the rotation of the motor 65 is at its maximum. In other
words, the harder the user pulls on the firing trigger 20, the more
voltage is applied to the motor 65, causing greater rates of
rotation.
[0080] The handle 6 may include a middle handle piece 104 adjacent
to the upper portion of the firing trigger 20. The handle 6 also
may comprise a bias spring 112 connected between posts on the
middle handle piece 104 and the firing trigger 20. The bias spring
112 may bias the firing trigger 20 to its fully open position. In
that way, when the operator releases the firing trigger 20, the
bias spring 112 will pull the firing trigger 20 to its open
position, thereby removing actuation of the sensor 110, thereby
stopping rotation of the motor 65. Moreover, by virtue of the bias
spring 112, any time a user closes the firing trigger 20, the user
will experience resistance to the closing operation, thereby
providing the user with feedback as to the amount of rotation
exerted by the motor 65. Further, the operator could stop
retracting the firing trigger 20 to thereby remove force from the
sensor 100, to thereby stop the motor 65. As such, the user may
stop the deployment of the end effector 12, thereby providing a
measure of control of the cutting/fastening operation to the
operator.
[0081] The distal end of the helical gear drum 80 includes a distal
drive shaft 120 that drives a ring gear 122, which mates with a
pinion gear 124. The pinion gear 124 is connected to the main drive
shaft 48 of the main drive shaft assembly. In that way, rotation of
the motor 65 causes the main drive shaft assembly to rotate, which
causes actuation of the end effector 12, as described above.
[0082] The ring 84 threaded on the helical gear drum 80 may include
a post 86 that is disposed within a slot 88 of a slotted arm 90.
The slotted arm 90 has an opening 92 its opposite end 94 that
receives a pivot pin 96 that is connected between the handle
exterior side pieces 59, 60. The pivot pin 96 is also disposed
through an opening 100 in the firing trigger and an opening 102 in
the middle handle piece 104.
[0083] In addition, the handle 6 may include a reverse motor sensor
(or end-of-stroke sensor) 130 and a stop motor (or
beginning-of-stroke) sensor 142. In various embodiments, the
reverse motor sensor 130 may be a limit switch located at the
distal end of the helical gear drum 80 such that the ring 84
threaded on the helical gear drum 80 contacts and trips the reverse
motor sensor 130 when the ring 84 reaches the distal end of the
helical gear drum 80. The reverse motor sensor 130, when activated,
sends a signal to the motor 65 to reverse its rotation direction,
thereby withdrawing the knife 32 of the end effector 12 following
the cutting operation.
[0084] The stop motor sensor 142 may be, for example, a
normally-closed limit switch. In various embodiments, it may be
located at the proximate end of the helical gear drum 80 so that
the ring 84 trips the switch 142 when the ring 84 reaches the
proximate end of the helical gear drum 80.
[0085] In operation, when an operator of the instrument 10 pulls
back the firing trigger 20, the sensor 110 detects the deployment
of the firing trigger 20 and sends a signal to the motor 65 to
cause forward rotation of the motor 65, for example, at a rate
proportional to how hard the operator pulls back the firing trigger
20. The forward rotation of the motor 65 in turn causes the ring
gear 78 at the distal end of the planetary gear assembly 72 to
rotate, thereby causing the helical gear drum 80 to rotate, causing
the ring 84 threaded on the helical gear drum 80 to travel distally
along the helical gear drum 80. The rotation of the helical gear
drum 80 also drives the main drive shaft assembly as described
above, which in turn causes deployment of the knife 32 in the end
effector 12. That is, the knife 32 and sled 33 are caused to
traverse the channel 22 longitudinally, thereby cutting tissue
clamped in the end effector 12. Also, the stapling operation of the
end effector 12 is caused to happen in embodiments where a
stapling-type end effector 12 is used.
[0086] By the time the cutting/stapling operation of the end
effector 12 is complete, the ring 84 on the helical gear drum 80
will have reached the distal end of the helical gear drum 80,
thereby causing the reverse motor sensor 130 to be tripped, which
sends a signal to the motor 65 to cause the motor 65 to reverse its
rotation. This in turn causes the knife 32 to retract, and also
causes the ring 84 on the helical gear drum 80 to move back to the
proximate end of the helical gear drum 80.
[0087] The middle handle piece 104 includes a backside shoulder 106
that engages the slotted arm 90 as best shown in FIGS. 8 and 9. The
middle handle piece 104 also has a forward motion stop 107 that
engages the firing trigger 20. The movement of the slotted arm 90
is controlled, as explained above, by rotation of the motor 65.
When the slotted arm 90 rotates counter clockwise as the ring 84
travels from the proximate end of the helical gear drum 80 to the
distal end, the middle handle piece 104 will be free to rotate
counter clockwise. Thus, as the user draws in the firing trigger
20, the firing trigger 20 will engage the forward motion stop 107
of the middle handle piece 104, causing the middle handle piece 104
to rotate counter clockwise. Due to the backside shoulder 106
engaging the slotted arm 90, however, the middle handle piece 104
will only be able to rotate counter clockwise as far as the slotted
arm 90 permits. In that way, if the motor 65 should stop rotating
for some reason, the slotted arm 90 will stop rotating, and the
user will not be able to further draw in the firing trigger 20
because the middle handle piece 104 will not be free to rotate
counter clockwise due to the slotted arm 90.
[0088] FIGS. 10A and 10B illustrate two states of a variable sensor
that may be used as the run motor sensor 110 according to various
embodiments of the present invention. The sensor 110 may include a
face portion 280, a first electrode (A) 282, a second electrode (B)
284, and a compressible dielectric material 286 between the
electrodes 282, 284, such as, for example, an electoactive polymer
(EAP). The sensor 110 may be positioned such that the face portion
280 contacts the firing trigger 20 when retracted. Accordingly,
when the firing trigger 20 is retracted, the dielectric material
286 is compressed, as shown in FIG. 10B, such that the electrodes
282, 284 are closer together. Since the distance "b" between the
electrodes 282, 284 is directly related to the impedance between
the electrodes 282, 284, the greater the distance the more
impedance, and the closer the distance the less impedance. In that
way, the amount that the dielectric 286 is compressed due to
retraction of the firing trigger 20 (denoted as force "F" in FIG.
42) is proportional to the impedance between the electrodes 282,
284, which can be used to proportionally control the motor 65.
[0089] Components of an exemplary closure system for closing (or
clamping) the anvil 24 of the end effector 12 by retracting the
closure trigger 18 are also shown in FIGS. 7-10. In the illustrated
embodiment, the closure system includes a yoke 250 connected to the
closure trigger 18 by a pivot pin 251 inserted through aligned
openings in both the closure trigger 18 and the yoke 250. A pivot
pin 252, about which the closure trigger 18 pivots, is inserted
through another opening in the closure trigger 18 which is offset
from where the pin 251 is inserted through the closure trigger 18.
Thus, retraction of the closure trigger 18 causes the upper part of
the closure trigger 18, to which the yoke 250 is attached via the
pin 251, to rotate counterclockwise. The distal end of the yoke 250
is connected, via a pin 254, to a first closure bracket 256. The
first closure bracket 256 connects to a second closure bracket 258.
Collectively, the closure brackets 256, 258 define an opening in
which the proximate end of the proximate closure tube 40 (see FIG.
4) is seated and held such that longitudinal movement of the
closure brackets 256, 258 causes longitudinal motion by the
proximate closure tube 40. The instrument 10 also includes a
closure rod 260 disposed inside the proximate closure tube 40. The
closure rod 260 may include a window 261 into which a post 263 on
one of the handle exterior pieces, such as exterior lower side
piece 59 in the illustrated embodiment, is disposed to fixedly
connect the closure rod 260 to the handle 6. In that way, the
proximate closure tube 40 is capable of moving longitudinally
relative to the closure rod 260. The closure rod 260 may also
include a distal collar 267 that fits into a cavity 269 in
proximate spine tube 46 and is retained therein by a cap 271 (see
FIG. 4).
[0090] In operation, when the yoke 250 rotates due to retraction of
the closure trigger 18, the closure brackets 256, 258 cause the
proximate closure tube 40 to move distally (i.e., away from the
handle end of the instrument 10), which causes the distal closure
tube 42 to move distally, which causes the anvil 24 to rotate about
the pivot pins 25 into the clamped or closed position. When the
closure trigger 18 is unlocked from the locked position, the
proximate closure tube 40 is caused to slide proximately, which
causes the distal closure tube 42 to slide proximately, which, by
virtue of the tab 27 being inserted in the window 45 of the distal
closure tube 42, causes the anvil 24 to pivot about the pivot pins
25 into the open or unclamped position. In that way, by retracting
and locking the closure trigger 18, an operator may clamp tissue
between the anvil 24 and channel 22, and may unclamp the tissue
following the cutting/stapling operation by unlocking the closure
trigger 20 from the locked position.
[0091] FIG. 11 is a schematic diagram of an electrical circuit of
the instrument 10 according to various embodiments of the present
invention. When an operator initially pulls in the firing trigger
20 after locking the closure trigger 18, the sensor 110 is
activated, allowing current to flow there through. If the
normally-open reverse motor sensor switch 130 is open (meaning the
end of the end effector stroke has not been reached), current will
flow to a single pole, double throw relay 132. Since the reverse
motor sensor switch 130 is not closed, the inductor 134 of the
relay 132 will not be energized, so the relay 132 will be in its
non-energized state. The circuit also includes a cartridge lockout
sensor 136. If the end effector 12 includes a staple cartridge 34,
the sensor 136 will be in the closed state, allowing current to
flow. Otherwise, if the end effector 12 does not include a staple
cartridge 34, the sensor 136 will be open, thereby preventing the
battery 64 from powering the motor 65.
[0092] When the staple cartridge 34 is present, the sensor 136 is
closed, which energizes a single pole, single throw relay 138. When
the relay 138 is energized, current flows through the relay 136,
through the variable resistor sensor 110, and to the motor 65 via a
double pole, double throw relay 140, thereby powering the motor 65
and allowing it to rotate in the forward direction.
[0093] When the end effector 12 reaches the end of its stroke, the
reverse motor sensor 130 will be activated, thereby closing the
switch 130 and energizing the relay 134. This causes the relay 134
to assume its energized state (not shown in FIG. 13), which causes
current to bypass the cartridge lockout sensor 136 and variable
resistor 110, and instead causes current to flow to both the
normally-closed double pole, double throw relay 142 and back to the
motor 65, but in a manner, via the relay 140, that causes the motor
65 to reverse its rotational direction.
[0094] Because the stop motor sensor switch 142 is normally-closed,
current will flow back to the relay 134 to keep it closed until the
switch 142 opens. When the knife 32 is fully retracted, the stop
motor sensor switch 142 is activated, causing the switch 142 to
open, thereby removing power from the motor 65.
[0095] In other embodiments, rather than a proportional-type sensor
110, an on-off type sensor could be used. In such embodiments, the
rate of rotation of the motor 65 would not be proportional to the
force applied by the operator. Rather, the motor 65 would generally
rotate at a constant rate. But the operator would still experience
force feedback because the firing trigger 20 is geared into the
gear drive train.
[0096] FIG. 12 is a side-view of the handle 6 of a power-assist
motorized endocutter according to another embodiment. The
embodiment of FIG. 12 is similar to that of FIGS. 7-10 except that
in the embodiment of FIG. 12, there is no slotted arm connected to
the ring 84 threaded on the helical gear drum 80. Instead, in the
embodiment of FIG. 12, the ring 84 includes a sensor portion 114
that moves with the ring 84 as the ring 84 advances down (and back)
on the helical gear drum 80. The sensor portion 114 includes a
notch 116. The reverse motor sensor 130 may be located at the
distal end of the notch 116 and the stop motor sensor 142 may be
located at the proximate end of the notch 116. As the ring 84 moves
down the helical gear drum 80 (and back), the sensor portion 114
moves with it. Further, as shown in FIG. 12, the middle piece 104
may have an arm 118 that extends into the notch 12.
[0097] In operation, as an operator of the instrument 10 retracts
in the firing trigger toward the pistol grip 26, the run motor
sensor 110 detects the motion and sends a signal to power the motor
65, which causes, among other things, the helical gear drum 80 to
rotate. As the helical gear drum 80 rotates, the ring 84 threaded
on the helical gear drum 80 advances (or retracts, depending on the
rotation). Also, due to the pulling in of the firing trigger 20,
the middle piece 104 is caused to rotate counter clockwise with the
firing trigger due to the forward motion stop 107 that engages the
firing trigger 20. The counter clockwise rotation of the middle
piece 104 cause the arm 118 to rotate counter clockwise with the
sensor portion 114 of the ring 84 such that the arm 118 stays
disposed in the notch 116. When the ring 84 reaches the distal end
of the helical gear drum 80, the arm 118 will contact and thereby
trip the reverse motor sensor 130. Similarly, when the ring 84
reaches the proximate end of the helical gear drum 80, the arm will
contact and thereby trip the stop motor sensor 142. Such actions
may reverse and stop the motor 65, respectively as described
above.
[0098] FIG. 13 is a side-view of the handle 6 of a power-assist
motorized endocutter according to another embodiment. The
embodiment of FIG. 13 is similar to that of FIGS. 7-10 except that
in the embodiment of FIG. 13, there is no slot in the arm 90.
Instead, the ring 84 threaded on the helical gear drum 80 includes
a vertical channel 126. Instead of a slot, the arm 90 includes a
post 128 that is disposed in the channel 126. As the helical gear
drum 80 rotates, the ring 84 threaded on the helical gear drum 80
advances (or retracts, depending on the rotation). The arm 90
rotates counter clockwise as the ring 84 advances due to the post
128 being disposed in the channel 126, as shown in FIG. 13.
[0099] As mentioned above, in using a two-stroke motorized
instrument, the operator first pulls back and locks the closure
trigger 18. FIGS. 14 and 15 show one embodiment of a way to lock
the closure trigger 18 to the pistol grip portion 26 of the handle
6. In the illustrated embodiment, the pistol grip portion 26
includes a hook 150 that is biased to rotate counter clockwise
about a pivot point 151 by a torsion spring 152. Also, the closure
trigger 18 includes a closure bar 154. As the operator draws in the
closure trigger 18, the closure bar 154 engages a sloped portion
156 of the hook 150, thereby rotating the hook 150 upward (or
clockwise in FIGS. 14-15) until the closure bar 154 completely
passes the sloped portion 156 passes into a recessed notch 158 of
the hook 150, which locks the closure trigger 18 in place. The
operator may release the closure trigger 18 by pushing down on a
slide button release 160 on the back or opposite side of the pistol
grip portion 26. Pushing down the slide button release 160 rotates
the hook 150 clockwise such that the closure bar 154 is released
from the recessed notch 158.
[0100] FIG. 16 shows another closure trigger locking mechanism
according to various embodiments. In the embodiment of FIG. 16, the
closure trigger 18 includes a wedge 160 having an arrow-head
portion 161. The arrow-head portion 161 is biased downward (or
clockwise) by a leaf spring 162. The wedge 160 and leaf spring 162
may be made from, for example, molded plastic. When the closure
trigger 18 is retracted, the arrow-head portion 161 is inserted
through an opening 164 in the pistol grip portion 26 of the handle
6. A lower chamfered surface 166 of the arrow-head portion 161
engages a lower sidewall 168 of the opening 164, forcing the
arrow-head portion 161 to rotate counter clockwise. Eventually the
lower chamfered surface 166 fully passes the lower sidewall 168,
removing the counter clockwise force on the arrow-head portion 161,
causing the lower sidewall 168 to slip into a locked position in a
notch 170 behind the arrow-head portion 161.
[0101] To unlock the closure trigger 18, a user presses down on a
button 172 on the opposite side of the closure trigger 18, causing
the arrow-head portion 161 to rotate counter clockwise and allowing
the arrow-head portion 161 to slide out of the opening 164.
[0102] FIGS. 17-22 show a closure trigger locking mechanism
according to another embodiment. As shown in this embodiment, the
closure trigger 18 includes a flexible longitudinal arm 176 that
includes a lateral pin 178 extending therefrom. The arm 176 and pin
178 may be made from molded plastic, for example. The pistol grip
portion 26 of the handle 6 includes an opening 180 with a laterally
extending wedge 182 disposed therein. When the closure trigger 18
is retracted, the pin 178 engages the wedge 182, and the pin 178 is
forced downward (i.e., the arm 176 is rotated clockwise) by the
lower surface 184 of the wedge 182, as shown in FIGS. 17 and 18.
When the pin 178 fully passes the lower surface 184, the clockwise
force on the arm 176 is removed, and the pin 178 is rotated counter
clockwise such that the pin 178 comes to rest in a notch 186 behind
the wedge 182, as shown in FIG. 19, thereby locking the closure
trigger 18. The pin 178 is further held in place in the locked
position by a flexible stop 188 extending from the wedge 184.
[0103] To unlock the closure trigger 18, the operator may further
squeeze the closure trigger 18, causing the pin 178 to engage a
sloped backwall 190 of the opening 180, forcing the pin 178 upward
past the flexible stop 188, as shown in FIGS. 20 and 21. The pin
178 is then free to travel out an upper channel 192 in the opening
180 such that the closure trigger 18 is no longer locked to the
pistol grip portion 26, as shown in FIG. 22.
[0104] FIGS. 23A-B show a universal joint ("u-joint") 195. The
second piece 195-2 of the u-joint 195 rotates in a horizontal plane
in which the first piece 195-1 lies. FIG. 23A shows the u-joint 195
in a linear (180.degree.) orientation and FIG. 23B shows the
u-joint 195 at approximately a 150.degree. orientation. The u-joint
195 may be used instead of the bevel gears 52a-c (see FIG. 4, for
example) at the articulation point 14 of the main drive shaft
assembly to articulate the end effector 12. FIGS. 24A-B show a
torsion cable 197 that may be used in lieu of both the bevel gears
52a-c and the u-joint 195 to realize articulation of the end
effector 12.
[0105] FIGS. 25-31 illustrate another embodiment of a motorized,
two-stroke surgical cutting and fastening instrument 10 with power
assist according to another embodiment of the present invention.
The embodiment of FIGS. 25-31 is similar to that of FIGS. 6-10
except that instead of the helical gear drum 80, the embodiment of
FIGS. 23-28 includes an alternative gear drive assembly. The
embodiment of FIGS. 25-31 includes a gear box assembly 200
including a number of gears disposed in a frame 201, wherein the
gears are connected between the planetary gear 72 and the pinion
gear 124 at the proximate end of the drive shaft 48. As explained
further below, the gear box assembly 200 provides feedback to the
user via the firing trigger 20 regarding the deployment and loading
force of the end effector 12. Also, the user may provide power to
the system via the gear box assembly 200 to assist the deployment
of the end effector 12. In that sense, like the embodiments
described above, the embodiment of FIGS. 23-32 is another power
assist motorized instrument 10 that provides feedback to the user
regarding the loading force experienced by the instrument.
[0106] In the illustrated embodiment, the firing trigger 20
includes two pieces: a main body portion 202 and a stiffening
portion 204. The main body portion 202 may be made of plastic, for
example, and the stiffening portion 204 may be made out of a more
rigid material, such as metal. In the illustrated embodiment, the
stiffening portion 204 is adjacent to the main body portion 202,
but according to other embodiments, the stiffening portion 204
could be disposed inside the main body portion 202. A pivot pin 207
may be inserted through openings in the firing trigger pieces 202,
204 and may be the point about which the firing trigger 20 rotates.
In addition, a spring 222 may bias the firing trigger 20 to rotate
in a counter clockwise direction. The spring 222 may have a distal
end connected to a pin 224 that is connected to the pieces 202, 204
of the firing trigger 20. The proximate end of the spring 222 may
be connected to one of the handle exterior lower side pieces 59,
60.
[0107] In the illustrated embodiment, both the main body portion
202 and the stiffening portion 204 includes gear portions 206, 208
(respectively) at their upper end portions. The gear portions 206,
208 engage a gear in the gear box assembly 200, as explained below,
to drive the main drive shaft assembly and to provide feedback to
the user regarding the deployment of the end effector 12.
[0108] The gear box assembly 200 may include as shown, in the
illustrated embodiment, six (6) gears. A first gear 210 of the gear
box assembly 200 engages the gear portions 206, 208 of the firing
trigger 20. In addition, the first gear 210 engages a smaller
second gear 212, the smaller second gear 212 being coaxial with a
large third gear 214. The third gear 214 engages a smaller fourth
gear 216, the smaller fourth gear being coaxial with a fifth gear
218. The fifth gear 218 is a 90.degree. bevel gear that engages a
mating 90.degree. bevel gear 220 (best shown in FIG. 31) that is
connected to the pinion gear 124 that drives the main drive shaft
48.
[0109] In operation, when the user retracts the firing trigger 20,
a run motor sensor (not shown) is activated, which may provide a
signal to the motor 65 to rotate at a rate proportional to the
extent or force with which the operator is retracting the firing
trigger 20. This causes the motor 65 to rotate at a speed
proportional to the signal from the sensor. The sensor is not shown
for this embodiment, but it could be similar to the run motor
sensor 110 described above. The sensor could be located in the
handle 6 such that it is depressed when the firing trigger 20 is
retracted. Also, instead of a proportional-type sensor, an on/off
type sensor may be used.
[0110] Rotation of the motor 65 causes the bevel gears 68, 70 to
rotate, which causes the planetary gear 72 to rotate, which causes,
via the drive shaft 76, the ring gear 122 to rotate. The ring gear
122 meshes with the pinion gear 124, which is connected to the main
drive shaft 48. Thus, rotation of the pinion gear 124 drives the
main drive shaft 48, which causes actuation of the cutting/stapling
operation of the end effector 12.
[0111] Forward rotation of the pinion gear 124 in turn causes the
bevel gear 220 to rotate, which causes, by way of the rest of the
gears of the gear box assembly 200, the first gear 210 to rotate.
The first gear 210 engages the gear portions 206, 208 of the firing
trigger 20, thereby causing the firing trigger 20 to rotate counter
clockwise when the motor 65 provides forward drive for the end
effector 12 (and to rotate counter clockwise when the motor 65
rotates in reverse to retract the end effector 12). In that way,
the user experiences feedback regarding loading force and
deployment of the end effector 12 by way of the user's grip on the
firing trigger 20. Thus, when the user retracts the firing trigger
20, the operator will experience a resistance related to the load
force experienced by the end effector 12. Similarly, when the
operator releases the firing trigger 20 after the cutting/stapling
operation so that it can return to its original position, the user
will experience a clockwise rotation force from the firing trigger
20 that is generally proportional to the reverse speed of the motor
65.
[0112] It should also be noted that in this embodiment the user can
apply force (either in lieu of or in addition to the force from the
motor 65) to actuate the main drive shaft assembly (and hence the
cutting/stapling operation of the end effector 12) through
retracting the firing trigger 20. That is, retracting the firing
trigger 201 causes the gear portions 206, 208 to rotate counter
clockwise, which causes the gears of the gear box assembly 200 to
rotate, thereby causing the pinion gear 124 to rotate, which causes
the main drive shaft 48 to rotate.
[0113] Although not shown in FIGS. 25-31, the instrument 10 may
further include reverse motor and stop motor sensors. As described
above, the reverse motor and stop motor sensors may detect,
respectively, the end of the cutting stroke (full deployment of the
knife 32) and the end of retraction operation (full retraction of
the knife 32). A similar circuit to that described above in
connection with FIG. 11 may be used to appropriately power the
motor 65.
[0114] FIGS. 32-36 illustrate a two-stroke, motorized surgical
cutting and fastening instrument 10 with power assist according to
another embodiment. The embodiment of FIGS. 32-36 is similar to
that of FIGS. 25-31 except that in the embodiment of FIGS. 32-36,
the firing trigger 20 includes a lower portion 228 and an upper
portion 230. Both portions 228, 230 are connected to and pivot
about a pivot pin 207 that is disposed through each portion 228,
230. The upper portion 230 includes a gear portion 232 that engages
the first gear 210 of the gear box assembly 200. The spring 222 is
connected to the upper portion 230 such that the upper portion is
biased to rotate in the clockwise direction. The upper portion 230
may also include a lower arm 234 that contacts an upper surface of
the lower portion 228 of the firing trigger 20 such that when the
upper portion 230 is caused to rotate clockwise the lower portion
228 also rotates clockwise, and when the lower portion 228 rotates
counter clockwise the upper portion 230 also rotates counter
clockwise. Similarly, the lower portion 228 includes a rotational
stop 238 that engages a shoulder of the upper portion 230. In that
way, when the upper portion 230 is caused to rotate counter
clockwise the lower portion 228 also rotates counter clockwise, and
when the lower portion 228 rotates clockwise the upper portion 230
also rotates clockwise.
[0115] The illustrated embodiment also includes the run motor
sensor 110 that communicates a signal to the motor 65 that, in
various embodiments, may cause the motor 65 to rotate at a speed
proportional to the force applied by the operator when retracting
the firing trigger 20. The sensor 110 may be, for example, a
rheostat or some other variable resistance sensor, as explained
herein. In addition, the instrument 10 may include reverse motor
sensor 130 that is tripped or switched when contacted by a front
face 242 of the upper portion 230 of the firing trigger 20. When
activated, the reverse motor sensor 130 sends a signal to the motor
65 to reverse direction. Also, the instrument 10 may include a stop
motor sensor 142 that is tripped or actuated when contacted by the
lower portion 228 of the firing trigger 20. When activated, the
stop motor sensor 142 sends a signal to stop the reverse rotation
of the motor 65.
[0116] In operation, when an operator retracts the closure trigger
18 into the locked position, the firing trigger 20 is retracted
slightly (through mechanisms known in the art, including U.S. Pat.
No. 6,978,921 to Frederick Shelton, IV et. al and U.S. Pat. No.
6,905,057 to Jeffery S. Swayze et. al, which are incorporated
herein by reference) so that the user can grasp the firing trigger
20 to initiate the cutting/stapling operation, as shown in FIGS. 32
and 33. At that point, as shown in FIG. 33, the gear portion 232 of
the upper portion 230 of the firing trigger 20 moves into
engagement with the first gear 210 of the gear box assembly 200.
When the operator retracts the firing trigger 20, according to
various embodiments, the firing trigger 20 may rotate a small
amount, such as five degrees, before tripping the run motor sensor
110, as shown in FIG. 34. Activation of the sensor 110 causes the
motor 65 to forward rotate at a rate proportional to the retraction
force applied by the operator. The forward rotation of the motor 65
causes, as described above, the main drive shaft 48 to rotate,
which causes the knife 32 in the end effector 12 to be deployed
(i.e., begin traversing the channel 22). Rotation of the pinion
gear 124, which is connected to the main drive shaft 48, causes the
gears 210-220 in the gear box assembly 200 to rotate. Since the
first gear 210 is in engagement with the gear portion 232 of the
upper portion 230 of the firing trigger 20, the upper portion 232
is caused to rotate counter clockwise, which causes the lower
portion 228 to also rotate counter clockwise.
[0117] When the knife 32 is fully deployed (i.e., at the end of the
cutting stroke), the front face 242 of the upper portion 230 trips
the reverse motor sensor 130, which sends a signal to the motor 65
to reverse rotational directional. This causes the main drive shaft
assembly to reverse rotational direction to retract the knife 32.
Reverse rotation of the main drive shaft assembly also causes the
gears 210-220 in the gear box assembly to reverse direction, which
causes the upper portion 230 of the firing trigger 20 to rotate
clockwise, which causes the lower portion 228 of the firing trigger
20 to rotate clockwise until the lower portion 228 trips or
actuates the stop motor sensor 142 when the knife 32 is fully
retracted, which causes the motor 65 to stop. In that way, the user
experiences feedback regarding deployment of the end effector 12 by
way of the user's grip on the firing trigger 20. Thus, when the
user retracts the firing trigger 20, the operator will experience a
resistance related to the deployment of the end effector 12 and, in
particular, to the loading force experienced by the knife 32.
Similarly, when the operator releases the firing trigger 20 after
the cutting/stapling operation so that it can return to its
original position, the user will experience a clockwise rotation
force from the firing trigger 20 that is generally proportional to
the reverse speed of the motor 65.
[0118] It should also be noted that in this embodiment the user can
apply force (either in lieu of or in addition to the force from the
motor 65) to actuate the main drive shaft assembly (and hence the
cutting/stapling operation of the end effector 12) through
retracting the firing trigger 20. That is, retracting the firing
trigger 20 causes the gear portion 232 of the upper portion 230 to
rotate counter clockwise, which causes the gears of the gear box
assembly 200 to rotate, thereby causing the pinion gear 124 to
rotate, which causes the main drive shaft assembly to rotate.
[0119] The above-described embodiments employed power-assist user
feedback systems, with or without adaptive control (e.g., using a
sensor 110, 130, and 142 outside of the closed loop system of the
motor 65, gear drive train, and end effector 12) for a two-stroke,
motorized surgical cutting and fastening instrument. That is, force
applied by the user in retracting the firing trigger 20 may be
added to the force applied by the motor 65 by virtue of the firing
trigger 20 being geared into (either directly or indirectly) the
gear drive train between the motor 65 and the main drive shaft 48.
In other embodiments of the present invention, the user may be
provided with tactile feedback regarding the position of the knife
32 in the end effector, but without having the firing trigger 20
geared into the gear drive train. FIGS. 37-40 illustrate a
motorized surgical cutting and fastening instrument with such a
tactile position feedback system.
[0120] In the illustrated embodiment of FIGS. 37-40, the firing
trigger 20 may have a lower portion 228 and an upper portion 230,
similar to the instrument 10 shown in FIGS. 32-36. Unlike the
embodiment of FIG. 32-36, however, the upper portion 230 does not
have a gear portion that mates with part of the gear drive train.
Instead, the instrument includes a second motor 265 with a threaded
rod 266 threaded therein. The threaded rod 266 reciprocates
longitudinally in and out of the motor 265 as the motor 265
rotates, depending on the direction of rotation. The instrument 10
also includes an encoder 268 that is responsive to the rotations of
the main drive shaft 48 for translating the incremental angular
motion of the main drive shaft 48 (or other component of the main
drive assembly) into a corresponding series of digital signals, for
example. In the illustrated embodiment, the pinion gear 124
includes a proximate drive shaft 270 that connects to the encoder
268.
[0121] The instrument 10 also includes a control circuit (not
shown), which may be implemented using a microcontroller or some
other type of integrated circuit, that receives the digital signals
from the encoder 268. Based on the signals from the encoder 268,
the control circuit may calculate the stage of deployment of the
knife 32 in the end effector 12. That is, the control circuit can
calculate if the knife 32 is fully deployed, fully retracted, or at
an intermittent stage. Based on the calculation of the stage of
deployment of the end effector 12, the control circuit may send a
signal to the second motor 265 to control its rotation to thereby
control the reciprocating movement of the threaded rod 266.
[0122] In operation, as shown in FIG. 37, when the closure trigger
18 is not locked into the clamped position, the firing trigger 20
rotated away from the pistol grip portion 26 of the handle 6 such
that the front face 242 of the upper portion 230 of the firing
trigger 20 is not in contact with the proximate end of the threaded
rod 266. When the operator retracts the closure trigger 18 and
locks it in the clamped position, the firing trigger rotates
slightly towards the closure trigger 20 so that the operator can
grasp the firing trigger 20, as shown in FIG. 38. In this position,
the front face 242 of the upper portion 230 contacts the proximate
end of the threaded rod 266.
[0123] As the user then retracts the firing trigger 20, after an
initial rotational amount (e.g. 5 degrees of rotation) the run
motor sensor 110 may be activated such that, as explained above,
the sensor 110 sends a signal to the motor 65 to cause it to rotate
at a forward speed proportional to the amount of retraction force
applied by the operator to the firing trigger 20. Forward rotation
of the motor 65 causes the main drive shaft 48 to rotate via the
gear drive train, which causes the knife 32 and sled 33 to travel
down the channel 22 and sever tissue clamped in the end effector
12. The control circuit receives the output signals from the
encoder 268 regarding the incremental rotations of the main drive
shaft assembly and sends a signal to the second motor 265 to cause
the second motor 265 to rotate, which causes the threaded rod 266
to retract into the motor 265. This allows the upper portion 230 of
the firing trigger 20 to rotate counter clockwise, which allows the
lower portion 228 of the firing trigger to also rotate counter
clockwise. In that way, because the reciprocating movement of the
threaded rod 266 is related to the rotations of the main drive
shaft assembly, the operator of the instrument 10, by way of
his/her grip on the firing trigger 20, experiences tactile feedback
as to the position of the end effector 12. The retraction force
applied by the operator, however, does not directly affect the
drive of the main drive shaft assembly because the firing trigger
20 is not geared into the gear drive train in this embodiment.
[0124] By virtue of tracking the incremental rotations of the main
drive shaft assembly via the output signals from the encoder 268,
the control circuit can calculate when the knife 32 is fully
deployed (i.e., fully extended). At this point, the control circuit
may send a signal to the motor 65 to reverse direction to cause
retraction of the knife 32. The reverse direction of the motor 65
causes the rotation of the main drive shaft assembly to reverse
direction, which is also detected by the encoder 268. Based on the
reverse rotation detected by the encoder 268, the control circuit
sends a signal to the second motor 265 to cause it to reverse
rotational direction such that the threaded rod 266 starts to
extend longitudinally from the motor 265. This motion forces the
upper portion 230 of the firing trigger 20 to rotate clockwise,
which causes the lower portion 228 to rotate clockwise. In that
way, the operator may experience a clockwise force from the firing
trigger 20, which provides feedback to the operator as to the
retraction position of the knife 32 in the end effector 12. The
control circuit can determine when the knife 32 is fully retracted.
At this point, the control circuit may send a signal to the motor
65 to stop rotation.
[0125] According to other embodiments, rather than having the
control circuit determine the position of the knife 32, reverse
motor and stop motor sensors may be used, as described above. In
addition, rather than using a proportional sensor 110 to control
the rotation of the motor 65, an on/off switch or sensor can be
used. In such an embodiment, the operator would not be able to
control the rate of rotation of the motor 65. Rather, it would
rotate at a preprogrammed rate.
[0126] FIGS. 41-43 illustrate an exemplary embodiment of a
mechanically actuated endocutter, and in particular the handle 6,
shaft 8 and end effector 12 thereof. Further details of a
mechanically actuated endocutter may be found in U.S. patent
application Ser. No. 11/052,632 entitled, "Surgical Stapling
Instrument Incorporating A Multi-Stroke Firing Mechanism With
Automatic End Of Firing Travel Retraction," which is incorporated
herein by reference. With reference to FIG. 41, the end effector 12
responds to the closure motion from the handle 6 (not depicted in
FIG. 41) first by including an anvil face 1002 connecting to an
anvil proximal end 1004 that includes laterally projecting anvil
pivot pins 25 that are proximal to a vertically projecting anvil
tab 27. The anvil pivot pins 25 translate within kidney shaped
openings 1006 in the staple channel 22 to open and close anvil 24
relative to channel 22. The tab 27 engages a bent tab 1007
extending inwardly in tab opening 45 on a distal end 1008 of the
closure tube 1005, the latter distally terminating in a distal edge
1008 that pushes against the anvil face 1002. Thus, when the
closure tube 1005 moves proximally from its open position, the bent
tab 1007 of the closure tube 1005 draws the anvil tab 27
proximally, and the anvil pivot pins 25 follow the kidney shaped
openings 1006 of the staple channel 22 causing the anvil 24 to
simultaneously translate proximally and rotate upward to the open
position. When the closure tube 1005 moves distally, the bent tab
1007 in the tab opening 45 releases from the anvil tab 27 and the
distal edge 1008 pushes on the anvil face 1002, closing the anvil
24.
[0127] With continued reference to FIG. 41, the shaft 8 and end
effector 12 also include components that respond to a firing motion
of a firing rod 1010. In particular, the firing rod 1010 rotatably
engages a firing trough member 1012 having a longitudinal recess
1014. Firing trough member 1012 moves longitudinally within frame
1016 in direct response to longitudinal motion of firing rod 1010.
A longitudinal slot 1018 in the closure tube 1005 operably couples
with the right and left exterior side handle pieces 61, 62 of the
handle 6 (not shown in FIG. 41). The length of the longitudinal
slot 1018 in the closure tube 1005 is sufficiently long to allow
relative longitudinal motion with the handle pieces 61, 62 to
accomplish firing and closure motions respectively with the
coupling of the handle pieces 61, 62 passing on through a
longitudinal slot 1020 in the frame 1016 to slidingly engage the
longitudinal recess 1014 in the frame trough member 1012.
[0128] The distal end of the frame trough member 1012 is attached
to a proximal end of a firing bar 1022 that moves within the frame
1016, specifically within a guide 1024 therein, to distally project
the knife 32 into the end effector 12. The end effector 12 includes
a staple cartridge 34 that is actuated by the knife 32. The staple
cartridge 34 has a tray 1028 that holds a staple cartridge body
1030, a wedge sled driver 33, staple drivers 1034 and staples 1036.
It will be appreciated that the wedge sled driver 33 longitudinally
moves within a firing recess (not shown) located between the
cartridge tray 1028 and the cartridge body 1030. The wedge sled
driver 33 presents camming surfaces that contact and lift the
staple drivers 1034 upward, driving the staples 1036. The staple
cartridge body 1030 further includes a proximally open, vertical
slot 1031 for passage of the knife 32. Specifically, a cutting
surface 1027 is provided along a distal end of knife 32 to cut
tissue after it is stapled.
[0129] It should be appreciated that the shaft 8 is shown in FIG. 4
as a non-articulating shaft. Nonetheless, applications of the
present invention may include instruments capable of articulation,
for example, as such shown above with reference to FIGS. 1-4 and
described in the following U.S. patents and patent applications,
the disclosure of each being hereby incorporated by reference in
their entirety: (1) "SURGICAL INSTRUMENT INCORPORATING AN
ARTICULATION MECHANISM HAVING ROTATION ABOUT THE LONGITUDINAL
AXIS", U.S. Patent Application Publication No. 2005/0006434, by
Frederick E. Shelton IV, Brian J. Hemmelgarn, Jeffrey S. Swayze,
Kenneth S. Wales, filed 9 Jul. 2003; (2) "SURGICAL STAPLING
INSTRUMENT INCORPORATING AN ARTICULATION JOINT FOR A FIRING BAR
TRACK", U.S. Pat. No. 6,786,382, to Brian J. Hemmelgarn; (3) "A
SURGICAL INSTRUMENT WITH A LATERAL-MOVING ARTICULATION CONTROL",
U.S. Pat. No. 6,981,628, to Jeffrey S. Swayze; (4) "SURGICAL
STAPLING INSTRUMENT INCORPORATING A TAPERED FIRING BAR FOR
INCREASED FLEXIBILITY AROUND THE ARTICULATION JOINT", U.S. Pat. No.
6,964,363, to Frederick E. Shelton IV, Michael Setser, Bruce
Weisenburgh II; and (5) "SURGICAL STAPLING INSTRUMENT HAVING
ARTICULATION JOINT SUPPORT PLATES FOR SUPPORTING A FIRING BAR",
U.S. Patent Application Publication No. 2005/0006431, by Jeffrey S.
Swayze, Joseph Charles Hueil, filed 9 Jul. 2003.
[0130] FIGS. 42-43 show an embodiment of the handle 6 that is
configured for use in a mechanically actuated endocutter along with
the embodiment of the shaft 8 and end effector 12 as shown above in
FIG. 41. It will be appreciated that any suitable handle design may
be used to mechanically close and fire the end effector 12. In
FIGS. 42-43, the handle 6 of the surgical stapling and severing
instrument 10 includes a linked transmission firing mechanism 1060
that provides features such as increased strength, reduced handle
size, minimized binding, etc.
[0131] Closure of the end effector 12 (not shown in FIGS. 42-43) is
caused by depressing the closure trigger 18 toward the pistol grip
26 of handle 6. The closure trigger 18 pivots about a closure pivot
pin 252 that is coupled to right and left exterior lower side
pieces 59, 60 the handle 6, causing an upper portion 1094 of the
closure trigger 18 to move forward. The closure tube 1005 receives
this closure movement via the closure yoke 250 that is pinned to a
closure link 1042 and to the upper portion 1094 of the closure
trigger 18 respectively by a closure yoke pin 1044 and a closure
link pin 1046.
[0132] In the fully open position of FIG. 42, the upper portion
1094 of the closure trigger 18 contacts and holds a locking arm
1048 of the pivoting closure release button 30 in the position
shown. When the closure trigger 18 reaches its fully depressed
position, the closure trigger 18 releases the locking arm 1048 and
an abutting surface 1050 rotates into engagement with a distal
rightward notch 1052 of the pivoting locking arm 1048, holding the
closure trigger 18 in this clamped or closed position. A proximal
end of the locking arm 1048 pivots about a lateral pivotal
connection 1054 with the pieces 59, 60 to expose the closure
release button 30. An intermediate, distal side 1056 of the closure
release button 30 is urged proximally by a compression spring 1058,
which is compressed between a housing structure 1040 and closure
release button 30. The result is that the closure release button 30
urges the locking arm 1048 counterclockwise (when viewed from the
left) into locking contact with the abutting surface 1050 of
closure trigger 18, which prevents unclamping of closure trigger 18
when the linked transmission firing system 1040 is in an
un-retracted condition.
[0133] With the closure trigger 18 retracted and fully depressed,
the firing trigger 20 is unlocked and may be depressed toward the
pistol grip 26, multiple times in this embodiment, to effect firing
of the end effector 12. As depicted, the linked transmission firing
mechanism 1060 is initially retracted, urged to remain in this
position by a combination tension/compression spring 1062 that is
constrained within the pistol grip 26 of the handle 6, with its
nonmoving end 1063 connected to the pieces 59, 60 and a moving end
1064 connected to a downwardly flexed and proximal, retracted end
1067 of a steel band 1066.
[0134] A distally-disposed end 1068 of the steel band 1066 is
attached to a link coupling 1070 for structural loading, which in
turn is attached to a front link 1072a of a plurality of links
1072a-1072d that form a linked rack 1074. Linked rack 1074 is
flexible yet has distal links that form a straight rigid rack
assembly that may transfer a significant firing force through the
firing rod 1010 in the shaft 6, yet readily retract into the pistol
grip 26 to minimize the longitudinal length of the handle 6. It
should be appreciated that the combination tension/compression
spring 1062 increases the amount of firing travel available while
essentially reducing the minimum length by half over a single
spring.
[0135] The firing trigger 20 pivots about a firing trigger pin 96
that is connected to the handle pieces 59, 60. An upper portion 228
of the firing trigger 20 moves distally about the firing trigger
pin 96 as the firing trigger 20 is depressed towards pistol grip
26, stretching a proximally placed firing trigger tension spring
222 proximally connected between the upper portion 228 of the
firing trigger 20 and the pieces 59, 60. The upper portion 228 of
the firing trigger 20 engages the linked rack 1074 during each
firing trigger depression by a traction biasing mechanism 1078 that
also disengages when the firing trigger 20 is released. Firing
trigger tension spring 222 urges the firing trigger 20 distally
when released and disengages the traction biasing mechanism
1078.
[0136] As the linked transmission firing mechanism 1040 actuates,
an idler gear 1080 is rotated clockwise (as viewed from the left
side) by engagement with a toothed upper surface 1082 of the linked
rack 1074. This rotation is coupled to an indicator gear 1084,
which thus rotates counterclockwise in response to the idler gear
1080. Both the idler gear 1080 and indicator gear 1084 are
rotatably connected to the pieces 59, 60 of the handle 6. The gear
relationship between the linked rack 1074, idler gear 1080 and
indicator gear 1084 may be advantageously selected so that the
toothed upper surface 1082 has tooth dimensions that are suitably
strong and that the indicator gear 1084 makes no more than one
revolution during the full firing travel of the linked transmission
firing mechanism 1060.
[0137] As described in greater detail below, the indicator gear
1084 performs at least four functions. First, when the linked rack
1074 is fully retracted and both triggers 18, are open as shown in
FIG. 42, an opening 1086 in a circular ridge 1088 on the left side
of the indicator gear 1084 is presented to an upper surface 1090 of
the locking arm 1048. Locking arm 1048 is biased into the opening
1086 by contact with the closure trigger 18, which in turn is urged
to the open position by a closure tension spring 1092. Closure
trigger tension spring 1092 is connected proximally to the upper
portion 1094 of the closure trigger 18 and the handle pieces 59,
60, and thus has energy stored during closing of the closure
trigger 18 that urges the closure trigger 18 distally to its
unclosed position.
[0138] A second function of the indicator gear 1084 is that it is
connected to the indicating retraction knob 1096 externally
disposed on the handle 6. Thus, the indicator gear 1084
communicates the relative position of the firing mechanism 1060 to
the indicating retraction knob 1096 so that the surgeon has a
visual indication of how many strokes of the firing trigger 20 are
required to complete firing.
[0139] A third function of the indicator gear 1084 is to
longitudinally and angularly move an anti-backup release lever 1098
of an anti-backup mechanism (one-way clutch mechanism) 1097 as the
surgical stapling and severing instrument 10 is operated. During
the firing strokes, proximal movement of anti-backup release lever
1098 by indicator gear 1084 activates the anti-backup mechanism
1097 that allows distal movement of firing bar 1010 and prevents
proximal motion of firing bar 1010. This movement also extends the
anti-backup release button 1100 from the proximal end of the handle
pieces 59, 60 for the operator to actuate should the need arise for
the linked transmission firing mechanism 1060 to be retracted
during the firing strokes. After completion of the firing strokes,
the indicator gear 1084 reverses direction of rotation as the
firing mechanism 1060 retracts. The reversed rotation deactivates
the anti-backup mechanism 1097, withdraws the anti-backup release
button 1100 into the handle 6, and rotates the anti-backup release
lever 1098 laterally to the right to allow continued reverse
rotation of the indicator gear 1084.
[0140] A fourth function of the indicator gear 1084 is to receive a
manual rotation from the indicating retraction knob 1096 (clockwise
in the depiction of FIG. 42) to retract the firing mechanism 1060
with anti-backup mechanism 1097 unlocked, thereby overcoming any
binding in the firing mechanism 1060 that is not readily overcome
by the combination tension/compression spring 1062. This manual
retraction assistance may be employed after a partial firing of the
firing mechanism 1060 that would otherwise be prevented by the
anti-backup mechanism 1097 that withdraws the anti-backup release
button 1100 so that the latter may not laterally move the
anti-backup release lever 1098.
[0141] Continuing with FIGS. 42-43, anti-backup mechanism 1097
consists of the operator accessible anti-backup release lever 1098
operably coupled at the proximal end to the anti-backup release
button 1100 and at the distal end to an anti-backup yoke 1102. In
particular, a distal end 1099 of the anti-backup release lever 1098
is engaged to the anti-backup yoke 1102 by an anti-backup yoke pin
1104. The anti-backup yoke 1102 moves longitudinally to impart a
rotation to an anti-backup cam slot tube 1106 that is
longitudinally constrained by the handle pieces 59, 90 and that
encompasses the firing rod 1010 distally to the connection of the
firing rod 1010 to the link coupling 1070 of the linked rack 1074.
The anti-backup yoke 1102 communicates the longitudinal movement
from the anti-backup release lever 1098 via a cam slot tube pin
1108 to the anti-backup cam slot tube 1106. That is, longitudinal
movement of cam slot tube pin 1108 in an angled slot in the
anti-backup cam slot tube 1106 rotates the anti-backup cam slot
tube 1106.
[0142] Trapped between a proximal end of the frame 1016 and the
anti-backup cam slot tube 1106 respectively are an anti-backup
compression spring 1110, an anti-backup plate 1112, and an
anti-backup cam tube 1114. As depicted, proximal movement of the
firing rod 1010 causes the anti-backup plate 1112 to pivot top to
the rear, presenting an increased frictional contact to the firing
rod 1010 that resists further proximal movement of the firing rod
1010.
[0143] This anti-backup plate 1112 pivots in a manner similar to
that of a screen door lock that holds open a screen door when the
anti-backup cam slot tube 1106 is closely spaced to the anti-backup
cam tube 1114. Specifically, the anti-backup compression spring
1110 is able to act upon a top surface of the plate 1112 to tip the
anti-backup plate 1112 to its locked position. Rotation of the
anti-backup cam slot tube 1106 causes a distal camming movement of
the anti-backup cam tube 1114 thereby forcing the top of the
anti-backup plate 1112 distally, overcoming the force from the
anti-backup compression spring 1110, thus positioning the
anti-backup plate 1112 in an untipped (perpendicular), unlocked
position that allows proximal retraction of the firing rod
1010.
[0144] With particular reference to FIG. 43, the traction biasing
mechanism 1078 is depicted as being composed of a pawl 1116 that
has a distally projecting narrow tip 1118 and a rightwardly
projecting lateral pin 1120 at its proximal end that is rotatably
inserted through a hole 1076 in the upper portion 230 of the firing
trigger 20. On the right side of the firing trigger 20 the lateral
pin 1120 receives a biasing member, depicted as biasing wheel 1122.
As the firing trigger 20 translates fore and aft, the biasing wheel
1122 traverses an arc proximate to the right half piece 59 of the
handle 6, overrunning at its distal portion of travel a biasing
ramp 1124 integrally formed in the right half piece 59. The biasing
wheel 1122 may advantageously be formed from a resilient,
frictional material that induces a counterclockwise rotation (when
viewed from the left) into the lateral pin 1120 of the pawl 1116,
thus traction biasing the distally projecting narrow tip 1118
downward into a ramped central track 1075 of the nearest link
1072a-d to engage the linked rack 1074.
[0145] As the firing trigger 20 is released, the biasing wheel 1122
thus tractionally biases the pawl 1116 in the opposite direction,
raising the narrow tip 1118 from the ramped central track 1075 of
the linked rack 1074. To ensure disengagement of the tip 1118 under
high load conditions and at nearly full distal travel of the pawl
1116, the right side of the pawl 1116 ramps up onto a proximally
and upwardly facing beveled surface 1126 on the rightside of the
closure yoke 250 to disengage the narrow tip 1118 from the ramped
central track 1075. If the firing trigger 20 is released at any
point other than full travel, the biasing wheel 1122 is used to
lift the narrow tip 1118 from the ramped central track 1075.
Whereas a biasing wheel 1122 is depicted, it should be appreciated
that the shape of the biasing member or wheel 1122 is illustrative
and may be varied to accommodate a variety of shapes that use
friction or traction to engage or disengage the firing of the end
effector 12.
[0146] Various embodiments of the surgical instrument 10 have the
capability to record instrument conditions at one or more times
during use. FIG. 44 shows a block diagram of a system 2000 for
recording conditions of the instrument 10. It will be appreciated
that the system 2000 may be implemented in embodiments of the
instrument 10 having motorized or motor-assisted firing, for
example, as described above with reference to FIGS. 1-40, as well
as embodiments of the instrument 10 having mechanically actuated
firing, for example, as described above with reference to FIGS.
41-43.
[0147] The system 2000 may include various sensors 2002, 2004,
2006, 2008, 2010, 2012 for sensing instrument conditions. The
sensors may be positioned, for example, on or within the instrument
10. In various embodiments, the sensors may be dedicated sensors
that provide output only for the system 2000, or may be dual-use
sensors that perform other functions with in the instrument 10. For
example, sensors 110, 130, 142 described above may be configured to
also provide output to the system 2000.
[0148] Directly or indirectly, each sensor provides a signal to the
memory device 2001, which records the signals as described in more
detail below. The memory device 2001 may be any kind of device
capable of storing or recording sensor signals. For example, the
memory device 2001 may include a microprocessor, an Electrically
Erasable Programmable Read Only Memory (EEPROM), or any other
suitable storage device. The memory device 2001 may record the
signals provided by the sensors in any suitable way. For example,
in one embodiment, the memory device 2001 may record the signal
from a particular sensor when that signal changes states. In
another embodiment, the memory device 2001 may record a state of
the system 2000, e.g., the signals from all of the sensors included
in the system 2000, when the signal from any sensor changes states.
This may provide a snap-shot of the state of the instrument 10. In
various embodiments, the memory device 2001 and/or sensors may be
implemented to include 1-WIRE bus products available from DALLAS
SEMICONDUCTOR such as, for example, a 1-WIRE EEPROM.
[0149] In various embodiments, the memory device 2001 is externally
accessible, allowing an outside device, such as a computer, to
access the instrument conditions recorded by the memory device
2001. For example, the memory device 2001 may include a data port
2020. The data port 2020 may provide the stored instrument
conditions according to any wired or wireless communication
protocol in, for example, serial or parallel format. The memory
device 2001 may also include a removable medium 2021 in addition to
or instead of the output port 2020. The removable medium 2021 may
be any kind of suitable data storage device that can be removed
from the instrument 10. For example, the removable medium 2021 may
include any suitable kind of flash memory, such as a Personal
Computer Memory Card International Association (PCMCIA) card, a
COMPACTFLASH card, a MULTIMEDIA card, a FLASHMEDIA card, etc. The
removable medium 2021 may also include any suitable kind of
disk-based storage including, for example, a portable hard drive, a
compact disk (CD), a digital video disk (DVD), etc.
[0150] The closure trigger sensor 2002 senses a condition of the
closure trigger 18. FIGS. 45 and 46 show an exemplary embodiment of
the closure trigger sensor 2002. In FIGS. 45 and 46, the closure
trigger sensor 2002 is positioned between the closure trigger 18
and closure pivot pin 252. It will be appreciated that pulling the
closure trigger 18 toward the pistol grip 26 causes the closure
trigger 18 to exert a force on the closure pivot pin 252. The
sensor 2002 may be sensitive to this force, and generate a signal
in response thereto, for example, as described above with respect
to sensor 110 and FIGS. 10A and 10B. In various embodiments, the
closure trigger sensor 2002 may be a digital sensor that indicates
only whether the closure trigger 18 is actuated or not actuated. In
other various embodiments, the closure trigger sensor 2002 may be
an analog sensor that indicates the force exerted on the closure
trigger 18 and/or the position of the closure trigger 18. If the
closure trigger sensor 2002 is an analog sensor, an
analog-to-digital converter may be logically positioned between the
sensor 2002 and the memory device 2001. Also, it will be
appreciated that the closure trigger sensor 2002 may take any
suitable form and be placed at any suitable location that allows
sensing of the condition of the closure trigger.
[0151] The anvil closure sensor 2004 may sense whether the anvil 24
is closed. FIG. 47 shows an exemplary anvil closure sensor 2004.
The sensor 2004 is positioned next to, or within the kidney shaped
openings 1006 of the staple channel 22 as shown. As the anvil 24 is
closed, anvil pivot pins 25 slides through the kidney shaped
openings 1006 and into contact with the sensor 2004, causing the
sensor 2004 to generate a signal indicating that the anvil 24 is
closed. The sensor 2004 may be any suitable kind of digital or
analog sensor including a proximity sensor, etc. It will be
appreciated that when the anvil closure sensor 2004 is an analog
sensor, an analog-to-digital converter may be included logically
between the sensor 2004 and the memory device 2001.
[0152] Anvil closure load sensor 2006 is shown placed on an inside
bottom surface of the staple channel 22. In use, the sensor 2006
may be in contact with a bottom side of the staple cartridge 34
(not shown in FIG. 46). As the anvil 24 is closed, it exerts a
force on the staple cartridge 34 which is transferred to the sensor
2006. In response, the sensor 2006 generates a signal. The signal
may be an analog signal proportional to the force exerted on the
sensor 2006 by the staple cartridge 34 and due to the closing of
the anvil 24. Referring the FIG. 44, the analog signal may be
provided to an analog-to-digital converter 2014, which converts the
analog signal to a digital signal before providing it to the memory
device 2001. It will be appreciated that embodiments where the
sensor 2006 is a digital or binary sensor may not include
analog-to-digital converter 2014.
[0153] The firing trigger sensor 110 senses the position and/or
state of the firing trigger 20. In motorized or motor-assisted
embodiments of the instrument, the firing trigger sensor may double
as the run motor sensor 110 described above. In addition, the
firing trigger sensor 110 may take any of the forms described
above, and may be analog or digital. FIGS. 45 and 46 show an
additional embodiment of the firing trigger sensor 110. In FIGS. 45
and 46, the firing trigger sensor is mounted between firing trigger
20 and firing trigger pivot pin 96. When firing trigger 20 is
pulled, it will exert a force on firing trigger pivot pin 96 that
is sensed by the sensor 110. Referring to FIG. 44, In embodiments
where the output of the firing trigger sensor 110 is analog,
analog-to-digital converter 2016 is included logically between the
firing trigger sensor 110 and the memory device 2001.
[0154] The knife position sensor 2008 senses the position of the
knife 32 or cutting surface 1027 within the staple channel 22.
FIGS. 47 and 48 show embodiments of a knife position sensor 2008
that are suitable for use with the mechanically actuated shaft 8
and end effector 12 shown in FIG. 41. The sensor 2008 includes a
magnet 2009 coupled to the firing bar 1022 of the instrument 10. A
coil 2011 is positioned around the firing bar 1022, and may be
installed; for example, along the longitudinal recess 1014 of the
firing trough member 1012 (see FIG. 41). As the knife 32 and
cutting surface 1027 are reciprocated through the staple channel
22, the firing bar 1022 and magnet 2009 may move back and forth
through the coil 2011. This motion relative to the coil induces a
voltage in the coil proportional to the position of the firing rod
within the coil and the cutting edge 1027 within the staple channel
22. This voltage may be provided to the memory device 2001, for
example, via analog-to-digital converter 2018.
[0155] In various embodiments, the knife position sensor 2008 may
instead be implemented as a series of digital sensors (not shown)
placed at various positions on or within the shaft 8. The digital
sensors may sense a feature of the firing bar 1022 such as, for
example, magnet 2009, as the feature reciprocates through the shaft
8. The position of the firing bar 1022 within the shaft 8, and by
extension, the position of the knife 32 within the staple channel
22, may be approximated as the position of the last digital sensor
tripped.
[0156] It will be appreciated that the knife position may also be
sensed in embodiments of the instrument 10 having a rotary driven
end effector 12 and shaft 8, for example, as described above, with
reference to FIGS. 3-6. An encoder, such as encoder 268, may be
configured to generate a signal proportional to the rotation of the
helical screw shaft 36, or any other drive shaft or gear. Because
the rotation of the shaft 36 and other drive shafts and gears is
proportional to the movement of the knife 32 through the channel
22, the signal generated by the encoder 268 is also proportional to
the movement of the knife 32. Thus, the output of the encoder 268
may be provided to the memory device 2001.
[0157] The cartridge present sensor 2010 may sense the presence of
the staple cartridge 34 within the staple channel 22. In motorized
or motor-assisted instruments, the cartridge present sensor 2010
may double as the cartridge lock-out sensor 136 described above
with reference to FIG. 11. FIGS. 50 and 51 show an embodiment of
the cartridge present sensor 2010. In the embodiment shown, the
cartridge present sensor 2010 includes two contacts, 2011 and 2013.
When no cartridge 34 is present, the contacts 2011, 2013 form an
open circuit. When a cartridge 34 is present, the cartridge tray
1028 of the staple cartridge 34 contacts the contacts 2011, 2013, a
closed circuit is formed. When the circuit is open, the sensor 2010
may output a logic zero. When the circuit is closed, the sensor
2010 may output a logic one. The output of the sensor 2010 is
provided to memory device 2001, as shown in FIG. 44.
[0158] The cartridge condition sensor 2012 may indicate whether a
cartridge 34 installed within the staple channel 22 has been fired
or spent. As the knife 32 is translated through the end effector
12, it pushes the sled 33, which fires the staple cartridge. Then
the knife 32 is translated back to its original position, leaving
the sled 33 at the distal end of the cartridge. Without the sled 33
to guide it, the knife 32 may fall into lock-out pocket 2022.
Sensor 2012 may sense whether the knife 32 is present in the
lock-out pocket 2022, which indirectly indicates whether the
cartridge 34 has been spent. It will be appreciated that in various
embodiments, sensor 2012 may directly sense the present of the sled
at the proximate end of the cartridge 34, thus eliminating the need
for the knife 32 to fall into the lock-out pocket 2022.
[0159] FIGS. 52A and 52B depict a process flow 2200 for operating
embodiments of the surgical instrument 10 configured as an
endocutter and having the capability to record instrument
conditions according to various embodiments. At box 2202, the anvil
24 of the instrument 10 may be closed. This causes the closure
trigger sensor 2002 and or the anvil closure sensor 2006 to change
state. In response, the memory device 2001 may record the state of
all of the sensors in the system 2000 at box 2203. At box 2204, the
instrument 10 may be inserted into a patient. When the instrument
is inserted, the anvil 24 may be opened and closed at box 2206, for
example, to manipulate tissue at the surgical site. Each opening
and closing of the anvil 24 causes the closure trigger sensor 2002
and/or the anvil closure sensor 2004 to change state. In response,
the memory device 2001 records the state of the system 2000 at box
2205.
[0160] At box 2208, tissue is clamped for cutting and stapling. If
the anvil 24 is not closed at decision block 2210, continued
clamping is required. If the anvil 24 is closed, then the sensors
2002, 2004 and/or 2006 may change state, prompting the memory
device 2001 to record the state of the system at box 2213. This
recording may include a closure pressure received from sensor 2006.
At box 2212, cutting and stapling may occur. Firing trigger sensor
110 may change state as the firing trigger 20 is pulled toward the
pistol grip 26. Also, as the knife 32 moves through the staple
channel 22, knife position sensor 2008 will change state. In
response, the memory device 2001 may record the state of the system
2000 at box 2013.
[0161] When the cutting and stapling operations are complete, the
knife 32 may return to a pre-firing position. Because the cartridge
34 has now been fired, the knife 32 may fall into lock-out pocket
2022, changing the state of cartridge condition sensor 2012 and
triggering the memory device 2001 to record the state of the system
2000 at box 2015. The anvil 24 may then be opened to clear the
tissue. This may cause one or more of the closure trigger sensor
2002, anvil closure sensor 2004 and anvil closure load sensor 2006
to change state, resulting in a recordation of the state of the
system 2000 at box 2017. After the tissue is cleared, the anvil 24
may be again closed at box 2220. This causes another state change
for at least sensors 2002 and 2004, which in turn causes the memory
device 2001 to record the state of the system at box 2019. Then the
instrument 10 may be removed from the patient at box 2222.
[0162] If the instrument 10 is to be used again during the same
procedure, the anvil may be opened at box 2224, triggering another
recordation of the system state at box 2223. The spent cartridge 34
may be removed from the end effector 12 at box 2226. This causes
cartridge present sensor 2010 to change state and cause a
recordation of the system state at box 2225. Another cartridge 34
may be inserted at box 2228. This causes a state change in the
cartridge present sensor 2010 and a recordation of the system state
at box 2227. If the other cartridge 34 is a new cartridge,
indicated at decision block 2230, its insertion may also cause a
state change to cartridge condition sensor 2012. In that case, the
system state may be recorded at box 2231.
[0163] FIG. 53 shows an exemplary memory map 2300 from the memory
device 2001 according to various embodiments. The memory map 2300
includes a series of columns 2302, 2304, 2306, 2308, 2310, 2312,
2314, 2316 and rows (not labeled). Column 2302 shows an event
number for each of the rows. The other columns represent the output
of one sensor of the system 2000. All of the sensor readings
recorded at a given time may be recorded in the same row under the
same event number. Hence, each row represents an instance where one
or more of the signals from the sensors of the system 2000 are
recorded.
[0164] Column 2304 lists the closure load recorded at each event.
This may reflect the output of anvil closure load sensor 2006.
Column 2306 lists the firing stroke position. This may be derived
from the knife position sensor 2008. For example, the total travel
of the knife 32 may be divided into partitions. The number listed
in column 2306 may represent the partition where the knife 32 is
currently present. The firing load is listed in column 2308. This
may be derived from the firing trigger sensor 110. The knife
position is listed at column 2310. The knife position may be
derived from the knife position sensor 2008 similar to the firing
stroke. Whether the anvil 24 is open or closed may be listed at
column 2312. This value may be derived from the output of the anvil
closure sensor 2004 and/or the anvil closure load sensor 2006.
Whether the sled 33 is present, or whether the cartridge 34 is
spent, may be indicated at column 2314. This value may be derived
from the cartridge condition sensor 2012. Finally, whether the
cartridge 34 is present may be indicated a column 2316. This value
may be derived from cartridge present sensor 2010. It will be
appreciated that various other values may be stored at memory
device 2001 including, for example, the end and beginning of firing
strokes, for example, as measured by sensors 130, 142.
[0165] While the present invention has been illustrated by
description of several embodiments and while the illustrative
embodiments have been described in considerable detail, it is not
the intention of the applicant to restrict or in any way limit the
scope of the appended claims to such detail. Additional advantages
and modifications may readily appear to those skilled in the
art.
[0166] For example, although the embodiments described above have
advantages for an endoscopically employed surgical severing and
stapling instrument 100, a similar embodiments may be used in other
clinical procedures. It is generally accepted that endoscopic
procedures are more common than laparoscopic procedures.
Accordingly, the present invention has been discussed in terms of
endoscopic procedures and apparatus. However, use herein of terms
such as "endoscopic", should not be construed to limit the present
invention to a surgical instrument for use only in conjunction with
an endoscopic tube (i.e., trocar). On the contrary, it is believed
that the present invention may find use in any procedure where
access is limited to a small incision, including but not limited to
laparoscopic procedures, as well as open procedures.
[0167] Any patent, publication, or information, 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 document. As such
the disclosure as explicitly set forth herein supersedes any
conflicting material incorporated herein by reference.
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