U.S. patent application number 14/141563 was filed with the patent office on 2016-12-22 for electrically self-powered surgical instrument with manual release.
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 Thomas O. Bales, JR., Derek Dee Deville, Matthew A. Palmer, Carlos Rivera, Kevin W. Smith.
Application Number | 20160367244 14/141563 |
Document ID | / |
Family ID | 57799356 |
Filed Date | 2016-12-22 |
United States Patent
Application |
20160367244 |
Kind Code |
A9 |
Smith; Kevin W. ; et
al. |
December 22, 2016 |
ELECTRICALLY SELF-POWERED SURGICAL INSTRUMENT WITH MANUAL
RELEASE
Abstract
A surgical instrument comprising a surgical end effector having
an actuation assembly operable to effect a surgical procedure when
actuated, a part of the actuation assembly being movable between a
first position and second position, and a handle connected to the
end effector for actuating the actuation assembly, the handle
having a power supply disposed within the handle, a motor disposed
within the handle and electrically powered by the power supply, a
transmission connecting the motor to the moving part and
operational to displace the moving part anywhere between the first
and second positions when the motor is operated, and a manual
release mechanism that selectively interrupts the transmission and,
during interruption, displaces the moving part towards the first
position independent of operation of the motor.
Inventors: |
Smith; Kevin W.; (Coral
Gables, FL) ; Bales, JR.; Thomas O.; (Coral Gables,
FL) ; Deville; Derek Dee; (Coral Gables, FL) ;
Rivera; Carlos; (Cooper City, FL) ; Palmer; Matthew
A.; (Miami, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ethicon Endo-Surgery, Inc. |
Cincinnati |
OH |
US |
|
|
Assignee: |
Ethicon Endo-Surgery, Inc.
Cincinnati
OH
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20140175149 A1 |
June 26, 2014 |
|
|
Family ID: |
57799356 |
Appl. No.: |
14/141563 |
Filed: |
December 27, 2013 |
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Feb 12, 2007 |
8028885 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/2931 20130101;
A61B 17/07207 20130101; A61B 17/1114 20130101; A61B 2017/00017
20130101; A61B 2017/00398 20130101; A61B 2017/320052 20130101; A61B
90/90 20160201; A61B 17/068 20130101; A61B 90/98 20160201; A61B
17/1155 20130101; A61B 17/115 20130101; A61B 2017/0046 20130101;
A61B 2017/2927 20130101; A61B 2017/00734 20130101 |
International
Class: |
A61B 17/068 20060101
A61B017/068 |
Claims
1. A surgical instrument, comprising: a surgical end effector
having an actuation assembly operable to effect a surgical
procedure when actuated, a part of the actuation assembly being
movable between a first position and second position; and a handle
connected to the end effector for actuating the actuation assembly,
the handle having: a power supply disposed within the handle; a
motor disposed within the handle and electrically powered by the
power supply; a transmission connecting the motor to the moving
part and operational to displace the moving part anywhere between
the first and second positions when the motor is operated; and a
manual release mechanism that selectively interrupts the
transmission and, during interruption, displaces the moving part
towards the first position independent of operation of the
motor.
2. The instrument according to claim 1, wherein: the first position
is a starting position; and the second position is a fully actuated
position.
3. The instrument according to claim 1, further comprising a
controller electrically connected to the power supply and to the
motor and selectively operating the motor.
4. The instrument according to claim 1, wherein the manual release
mechanism is mechanically coupled to the transmission.
5. The instrument according to claim 1, wherein the manual release
mechanism is mechanically disposed in the transmission.
6. The instrument according to claim 1, wherein: the surgical end
effector is an endoscopic surgical stapler and tissue cutter; and
the moving part is comprised of at least a staple-actuating and
tissue-cutting slide.
7. The instrument according to claim 1, wherein the power supply is
a removable battery.
8. The instrument according to claim 3, wherein the controller
comprises a multi-state switch that causes rotation of the motor in
a forward direction when the switch is in a first state and causes
rotation of the motor in a reverse direction when the switch is in
a second state.
9. The instrument according to claim 3, wherein the transmission
has a motor drive side and an actuation side and the manual release
mechanism is coupled therebetween.
10. The instrument according to claim 9, wherein: the motor drive
side has a series of rotation-reducing gears including a last gear;
the actuation side has: at least one gear; and a rack-and-pinion
assembly coupled to the at least one gear and directly connected to
at least a portion of the moving part; and the manual release
mechanism is mechanically coupled between the at least one gear and
the last gear.
11. The instrument according to claim 10, wherein: the motor has an
output gear; and the series of gears has a first stage coupled to
the output gear.
12. The instrument according to claim 11, wherein: the series of
rotation-reducing gears includes first, second, and third stages,
and a cross-over gear with a shaft crossing from the motor drive
side to the actuation side; and the cross-over gear is coupled to
the third stage.
13. The instrument according to claim 10, wherein: the series of
rotation-reducing gears has a cross-over gear with a cross-over
shaft crossing from the motor drive side to the actuation side; the
cross-over gear is coupled to the series of rotation-reducing
gears; a castle gear is rotationally fixedly coupled about the
cross-over shaft and longitudinally translatable thereon, the
castle gear having castellations extending towards the actuation
side; the at least one gear of the actuation side includes a first
pinion having castellation slots shaped to mate with the
castellations; a bias device is disposed between the cross-over
gear and the castle gear and imparts a bias upon the castle gear
towards the actuation side to permit selective engagement of the
castle gear with the first pinion and, thereby, cause a
corresponding rotation of the first pinion with rotation of the
cross-over shaft when so engaged; and the manual release mechanism
has a release part shaped and positioned to provide an opposing
force to overcome the bias on the castle gear and disengage the
castle gear from the first pinion when the manual release mechanism
is at least partially actuated.
14. The instrument according to claim 13, wherein the at least one
gear of the actuation side includes a second pinion stage having: a
second pinion shaft; a second pinion gear coupled to the first
pinion and rotationally fixedly to the second pinion shaft; and a
third pinion rotationally fixed to the second pinion shaft, the
third pinion being a pinion of the rack-and-pinion assembly and
longitudinally moving a rack thereof when rotated.
15. The instrument according to claim 13, wherein the manual
release mechanism has: a rest state in which the release part
provides the opposing force at a magnitude less than the bias to
the castle gear; a first partially actuated state in which the
release part provides the opposing force at a magnitude greater
than the bias to the castle gear and move the castellations out
from the castellation slots; and a second partially actuated state
in which the manual release mechanism rotates the first pinion to
move a rack longitudinally in a withdrawing direction.
16. The instrument according to claim 13, wherein: the at least one
gear of the actuation side includes at least one release gear; and
the first pinion is directly connected to the at least one release
gear to rotate the at least one release gear when rotated.
17. The instrument according to claim 13, wherein: the at least one
gear of the actuation side includes first and second stage release
gears; and the first pinion is directly connected to the first
stage release gear to rotate the first and second stage release
gears when rotated.
18. The instrument according to claim 16, wherein: the manual
release mechanism includes a manual release lever: rotatably
connected to the handle; and having a one-way ratchet assembly; and
the at least one release gear has an axle directly connected to the
ratchet assembly to rotate in a corresponding manner with the
manual release lever when the manual release lever is at least
partially actuated and to rotate independent of the manual release
lever when the manual release lever is not actuated.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is: [0002] a divisional of U.S. patent
application Ser. No. 13/089,041, filed on Apr. 18, 2011; and [0003]
a divisional of U.S. patent application Ser. No. 12/245,017, now
U.S. Pat. No. 7,959,050, filed on Oct. 3, 2008 (which application
claims the priority of U.S. Provisional Patent Application Ser. No.
60/977,489, filed on Oct. 4, 2007); [0004] is a continuation in
part of U.S. patent application Ser. No. 12/034,320, filed Feb. 20,
2008; [0005] is a continuation in part of U.S. patent application
Ser. No. 13/847,971, filed on Mar. 20, 2013; [0006] is a
continuation in part of U.S. patent application Ser. No.
13/798,369, filed on Mar. 13, 2013; [0007] is a continuation in
part of U.S. patent application Ser. No. 13/743,179, filed on Jan.
16, 2013; [0008] is a continuation in part of U.S. patent
application Ser. No. 13/622,819, filed on Sep. 19, 2012; [0009] is
a continuation in part of U.S. patent application Ser. No.
13/611,881, filed on Sep. 12, 2012; [0010] is a continuation in
part of U.S. patent application Ser. No. 13/229,076, filed on Sep.
9, 2011, now U.S. Pat. No. 8,292,157; [0011] is a continuation in
part of U.S. patent application Ser. No. 12/793,962, filed on Jun.
4, 2010; [0012] is a continuation in part of U.S. patent
application Ser. No. 12/612,525, filed on Nov. 4, 2009; [0013] is a
continuation in part of U.S. patent application Ser. No.
12/102,464, filed on Apr. 14, 2008, now U.S. Pat. No. 8,286,846;
[0014] is a continuation in part of U.S. patent application Ser.
No. 12/102,181, filed on Apr. 14, 2008, now U.S. Pat. No.
8,573,459; [0015] is a continuation in part of U.S. patent
application Ser. No. 11/705,381, filed on Feb. 12, 2007, now U.S.
Pat. No. 8,038,046 (which application claims the priority, under 35
U.S.C. .sctn.119, of U.S. Provisional Patent Application Ser. Nos.
60/858,112, filed on Nov. 9, 2006, 60/810,272, filed on Jun. 2,
2006, and 60/801,989 filed on May 19, 2006); [0016] is a
continuation in part of U.S. patent application Ser. No.
11/705,344, filed on Feb. 12, 2007, now U.S. Pat. No. 7,936,210
(which application claims the priority, under 35 U.S.C. .sctn.119,
of U.S. Provisional Patent Application Ser. Nos. 60/858,112, filed
on Nov. 9, 2006, 60/810,272, filed on Jun. 2, 2006, and 60/801,989
filed on May 19, 2006); [0017] is a continuation in part of U.S.
patent application Ser. No. 11/705,246, filed on Feb. 12, 2007, now
U.S. Pat. No. 8,028,885 (which application claims the priority,
under 35 U.S.C. .sctn.119, of U.S. Provisional Patent Application
Ser. Nos. 60/858,112, filed on Nov. 9, 2006, 60/810,272, filed on
Jun. 2, 2006, and 60/801,989 filed on May 19, 2006); [0018] is a
continuation in part of U.S. patent application Ser. No.
13/654,073, filed on Oct. 17, 2012; [0019] is a continuation in
part of U.S. patent application Ser. No. 13/547,968, filed on Jul.
12, 2012; [0020] is a continuation in part of U.S. patent
application Ser. No. 13/228,933, filed on Sep. 9, 2011; [0021] is a
continuation in part of U.S. patent application Ser. No.
12/633,292, filed on Dec. 8, 2009, now U.S. Pat. No. 8,034,077;
[0022] is a continuation in part of U.S. patent application Ser.
No. 12/139,142, filed on Jun. 13, 2008, now U.S. Pat. No.
8,245,898; [0023] is a continuation in part of U.S. patent
application Ser. No. 11/844,406, filed on Aug. 24, 2007, now U.S.
Pat. No. 7,419,080; [0024] is a continuation in part of U.S. patent
application Ser. No. 11/541,105, filed on Sep. 29, 2006 (which
application claims the priority, under 35 U.S.C. .sctn.119, of U.S.
Provisional Patent Application Ser. Nos. 60/811,950, filed on Jun.
8, 2006, 60/760,000, filed on Jan. 8, 2006, and 60/702,643, filed
on Jul. 25, 2005); [0025] is a continuation in part of U.S. patent
application Ser. No. 11/540,255, filed on Sep. 29, 2006, now U.S.
Pat. No. 7,404,508 (which application claims the priority, under 35
U.S.C. .sctn.119, of U.S. Provisional Patent Application Ser. Nos.
60/811,950, filed on Jun. 8, 2006, 60/760,000, filed on Jan. 8,
2006, and 60/702,643, filed on Jul. 25, 2005); [0026] is a
continuation in part of U.S. patent application Ser. No.
11/491,626, filed on Jul. 24, 2006, now U.S. Pat. No. 8,579,176
(which application claims the priority, under 35 U.S.C. .sctn.119,
of U.S. Provisional Patent Application Ser. Nos. 60/811,950, filed
on Jun. 8, 2006, 60/760,000, filed on Jan. 8, 2006, and 60/702,643,
filed on Jul. 25, 2005) the entire disclosures of all of these
applications are hereby incorporated herein by reference in their
entireties.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0027] Not Applicable
COMPUTER PROGRAM LISTING APPENDIX
[0028] A computer program listing appendix is included with this
application on a single compact disc, the entire contents of which
are incorporated herein by reference. The file name, date of
creation, and size for the file submitted on the compact disc
are:
Elec Stap Man Rel Div 2 Comp Prog Listing f.pdf, Mar. 7, 2014, 28
KB.
FIELD OF THE INVENTION
[0029] The present invention lies in the field of surgical
instruments, in particular but not necessarily, stapling devices.
The stapling device described in the present application is a
hand-held, fully electrically self-powered and controlled surgical
stapler with a manual release.
BACKGROUND OF THE INVENTION
[0030] Medical stapling devices exist in the art. Ethicon
Endo-Surgery, Inc. (a Johnson & Johnson company; hereinafter
"Ethicon") manufactures and sells such stapling devices. Circular
stapling devices manufactured by Ethicon are referred to under the
trade names PROXIMATE.RTM. PPH, CDH, and ILS and linear staplers
are manufactured by Ethicon under the trade names CONTOUR and
PROXIMATE. In each of these exemplary surgical staplers, tissue is
compressed between a staple cartridge and an anvil and, when the
staples are ejected, the compressed tissue is also cut. Depending
upon the particular tissue engaged by the physician, the tissue can
be compressed too little (where blood color is still visibly
present in the tissue), too much (where tissue is crushed), or
correctly (where the liquid is removed from the tissue, referred to
as dessicating or blanching).
[0031] Staples to be delivered have a given length and the
cartridge and anvil need to be within an acceptable staple firing
distance so that the staples close properly upon firing. Therefore,
these staplers have devices indicating the relative distance
between the two planes and whether or not this distance is within
the staple length firing range. Such an indicator is mechanical and
takes the form of a sliding bar behind a window having indicated
thereon a safe staple-firing range. These staplers are all
hand-powered, in other words, they require physical actuations by
the user/physician to position the anvil and stapler cartridge
about the tissue to be stapled and/or cut, to close the anvil and
stapler cartridge with respect to one another, and to fire and
secure the staples at the tissue (and/or cut the tissue). No prior
art staplers are electrically powered to carry out each of these
operations because the longitudinal force necessary to effect
staple firing is typically on the order of 250 pounds at the staple
cartridge. Further, such staplers do not have any kind of active
compression indicator that would optimizes the force acting upon
the tissue that is to be stapled so that tissue degradation does
not occur.
[0032] One hand-powered, intraluminal anastomotic circular stapler
is depicted, for example, in U.S. Pat. No. 5,104,025 to Main et
al., and assigned to Ethicon. Main et al. is hereby incorporated
herein by reference in its entirety. As can be seen most clearly in
the exploded view of FIG. 7 in Main et al., a trocar shaft 22 has a
distal indentation 21, some recesses 28 for aligning the trocar
shaft 22 to serrations 29 in the anvil and, thereby, align the
staples with the anvils 34. A trocar tip 26 is capable of
puncturing through tissue when pressure is applied thereto. FIGS. 3
to 6 in Main et al. show how the circular stapler 10 functions to
join two pieces of tissue together. As the anvil 30 is moved closer
to the head 20, interposed tissue is compressed therebetween, as
particularly shown in FIGS. 5 and 6. If this tissue is
overcompressed, the surgical stapling procedure might not succeed.
Thus, it is desirable to not exceed the maximum acceptable tissue
compression force. The interposed tissue can be subject to a range
of acceptable compressing force during surgery. This range is known
and referred to as optimal tissue compression or OTC, and is
dependent upon the type of tissue being stapled. While the stapler
shown in Main et al. does have a bar indicator that displays to the
user a safe staple-firing distance between the anvil and the staple
cartridge, it cannot indicate to the user any level of compressive
force being imparted upon the tissue prior to stapling. It would be
desirable to provide such an indication so that over-compression of
the tissue can be avoided.
SUMMARY OF THE INVENTION
[0033] The invention overcomes the above-noted and other
deficiencies of the prior art by providing a electrically
self-powered surgical device that uses the self-power to effect a
medical procedure. For example, in a linear endocutter, the
electric on-board power can position an anvil and stapler cartridge
with respect to one another about tissue to be stapled and/or cut,
and, after closing the anvil and stapler cartridge with respect to
one another, firing and securing the staples at the tissue (and/or
cutting the tissue). Further, the electrically self-powered
surgical device can indicate to the user a user-pre-defined level
of compressive force being imparted upon the tissue prior to firing
the staples. The present invention also provides methods for
operating the electric surgical stapling device to staple when
optimal tissue compression (OTC) exists. Further provided is a
manual release device that allows recovery from a partial actuation
or a jam.
[0034] An offset-axis configuration for the two anvil and staple
firing sub-assemblies creates a device that can be sized to
comfortably fit into a user's hand. It also decreases manufacturing
difficulty by removing previously required nested (co-axial) hollow
shafts. With the axis of the anvil sub-assembly being offset from
the staple firing sub-assembly, the length of the threaded rod for
extending and retracting the anvil can be decreased by
approximately two inches, thereby saving in manufacturing cost and
generating a shorter longitudinal profile.
[0035] An exemplary method for using the electric stapler includes
a power-on feature that permits entry into a manual mode for
testing purposes. In a surgical procedure, the stapler is a one-way
device. In the test mode, however, the user has the ability to move
the trocar back and forth as desired. This test mode can be
disengaged and the stapler reset to the use mode for packaging and
shipment. For packaging, it is desirable (but not necessary) to
have the anvil be at a distance from the staple cartridge.
Therefore, a homing sequence can be programmed to place the anvil 1
cm (for example) away from the staple cartridge before powering
down for packaging and shipment. Before use, the trocar is extended
and the anvil is removed. If the stapler is being used to dissect a
colon, for example, the trocar is retracted back into the handle
and the handle is inserted trans-anally into the colon to
downstream side of the dissection while the anvil is inserted
through a laparoscopic incision to an upstream side of the
dissection. The anvil is attached to the trocar and the two parts
are retracted towards the handle until a staple ready condition
occurs. The staple firing sequence is started, which can be
aborted, to staple the dissection and simultaneously cut tissue at
the center of the dissection to clear an opening in the middle of
the circular ring of staples. The staple firing sequence includes
an optimal tissue compression (OTC) measurement and feedback
control mechanism that causes staples to be fired only when the
compression is in a desired pressure range, referred to as the OTC
range. This range or value is known beforehand based upon known
characteristics of the tissue to be compressed between the anvil
and staple cartridge.
[0036] Some exemplary procedures in which the electric stapler can
be used include colon dissection and gastric bypass surgeries.
There are many other uses for the electric stapler in various
different technology areas.
[0037] With the foregoing and other objects in view, there is
provided, a surgical instrument comprising a surgical end effector
having an actuation assembly operable to effect a surgical
procedure when actuated, a part of the actuation assembly being
movable between a first position and second position, and a handle
connected to the end effector for actuating the actuation assembly,
the handle having a power supply disposed within the handle, a
motor disposed within the handle and electrically powered by the
power supply, a transmission connecting the motor to the moving
part and operational to displace the moving part anywhere between
the first and second positions when the motor is operated, and a
manual release mechanism that selectively interrupts the
transmission and, during interruption, displaces the moving part
towards the first position independent of operation of the
motor.
[0038] In accordance with another mode of the invention, the first
position is a starting position and the second position is a fully
actuated position.
[0039] In accordance with a further mode of the invention, there is
also provided a controller electrically connected to the power
supply and to the motor and selectively operating the motor.
[0040] In accordance with an additional mode of the invention, the
manual release is mechanically coupled to the transmission.
[0041] In accordance with yet another mode of the invention, the
manual release is mechanically disposed in the transmission.
[0042] In accordance with yet a further mode of the invention, the
surgical end effector is an endoscopic surgical stapler and tissue
cutter and the moving part is comprised of at least a
staple-actuating and tissue-cutting slide.
[0043] In accordance with yet an added mode of the invention, the
power supply is a removable battery.
[0044] In accordance with yet an additional mode of the invention,
the controller comprises a multi-state switch that causes rotation
of the motor in a forward direction when the switch is in a first
state and causes rotation of the motor in a reverse direction when
the switch is in a second state.
[0045] In accordance with again another mode of the invention, the
transmission has a motor drive side and an actuation side and the
manual release is coupled therebetween.
[0046] In accordance with a further mode of the invention, the
motor drive side has a series of rotation-reducing gears including
a last gear, the actuation side has at least one gear and a
rack-and-pinion assembly coupled to the at least one gear and
directly connected to at least a portion of the moving part, and
the manual release is mechanically coupled between the at least one
gear and the last gear.
[0047] In accordance with again an added mode of the invention, the
motor has an output gear and the series of gears has a first stage
coupled to the output gear.
[0048] In accordance with again an additional mode of the
invention, the series of rotation-reducing gears includes first,
second, and third stages, and a cross-over gear with a shaft
crossing from the motor drive side to the actuation side and the
cross-over gear is coupled to the third stage.
[0049] In accordance with still another mode of the invention, the
series of rotation-reducing gears has a cross-over gear with a
cross-over shaft crossing from the motor drive side to the
actuation side, the cross-over gear is coupled to the series of
rotation-reducing gears, a castle gear is rotationally fixedly
coupled about the cross-over shaft and longitudinally translatable
thereon, the castle gear having castellations extending towards the
actuation side, the at least one gear of the actuation side
includes a first pinion having castellation slots shaped to mate
with the castellations, a bias device is disposed between the
cross-over gear and the castle gear and imparts a bias upon the
castle gear towards the actuation side to permit selective
engagement of the castle gear with the first pinion and, thereby,
cause a corresponding rotation of the first pinion with rotation of
the shaft when so engaged, and the manual release has a release
part shaped and positioned to provide an opposing force to overcome
the bias on the castle gear and disengage the castle gear from the
first pinion when the manual release is at least partially
actuated.
[0050] In accordance with still a further mode of the invention,
the at least one gear of the actuation side includes a second
pinion stage having a second pinion shaft, a second pinion gear
coupled to the first pinion and rotationally fixedly to the second
pinion shaft, and a third pinion rotationally fixed to the second
pinion shaft, the third pinion being a pinion of the
rack-and-pinion assembly and longitudinally moving a rack thereof
when rotated.
[0051] In accordance with still an added mode of the invention, the
manual release has a rest state in which the release part provides
the opposing force at a magnitude less than the bias to the castle
gear, a first partially actuated state in which the release part
provides the opposing force at a magnitude greater than the bias to
the castle gear and move the castellations out from the
castellation slots, and a second partially actuated state in which
the manual release rotates the pinion to move the rack
longitudinally in a withdrawing direction.
[0052] In accordance with still an additional mode of the
invention, the at least one gear of the actuation side includes at
least one release gear and the first pinion is directly connected
to the at least one release gear to rotate the at least one release
gear when rotated.
[0053] In accordance with an additional mode of the invention, the
at least one gear of the actuation side includes first and second
stage release gears and the first pinion is directly connected to
the first stage release gear to rotate the first and second release
gears when rotated.
[0054] In accordance with a concomitant feature of the invention,
the manual release includes a manual release lever rotatably
connected to the handle and having a one-way ratchet assembly, and
the at least one release gear has an axle directly connected to the
ratchet assembly to rotate in a corresponding manner with the lever
when the lever is at least partially actuated and to rotate
independent of the lever when the lever is not actuated.
[0055] Other features that are considered as characteristic for the
invention are set forth in the appended claims.
[0056] Although the invention is illustrated and described herein
as embodied in an electrically self-powered surgical instrument
with manual release, it is, nevertheless, not intended to be
limited to the details shown because various modifications and
structural changes may be made therein without departing from the
spirit of the invention and within the scope and range of
equivalents of the claims.
[0057] The construction and method of operation of the invention,
however, together with additional objects and advantages thereof,
will be best understood from the following description of specific
embodiments when read in connection with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0058] Advantages of embodiments of the present invention will be
apparent from the following detailed description of the preferred
embodiments thereof, which description should be considered in
conjunction with the accompanying drawings in which:
[0059] FIG. 1 is a perspective view from a side of an exemplary
embodiment of an electric stapler according to the invention;
[0060] FIG. 2 is a fragmentary side elevational view of the stapler
of FIG. 1 with a right half of a handle body and with a proximal
backbone plate removed;
[0061] FIG. 3 is an exploded, perspective view of an anvil control
assembly of the stapler of FIG. 1;
[0062] FIG. 4 is an enlarged, fragmentary, exploded, perspective
view of the anvil control assembly of FIG. 3;
[0063] FIG. 5 is a fragmentary, perspective view of a staple firing
control assembly of the stapler of FIG. 1 from a rear side
thereof;
[0064] FIG. 6 is an exploded, perspective view of the staple firing
control assembly of the stapler of FIG. 1;
[0065] FIG. 7 is an enlarged, fragmentary, exploded, perspective
view of the staple firing control assembly of FIG. 6;
[0066] FIG. 8 is a fragmentary, horizontally cross-sectional view
of the anvil control assembly from below the handle body portion of
the stapler of FIG. 1;
[0067] FIG. 9 is a fragmentary, enlarged, horizontally
cross-sectional view from below a proximal portion of the anvil
control assembly FIG. 8;
[0068] FIG. 10 is a fragmentary, enlarged, horizontally
cross-sectional view from below an intermediate portion of the
anvil control assembly of FIG. 8;
[0069] FIG. 11 is a fragmentary, enlarged, horizontally
cross-sectional view from below a distal portion of the anvil
control assembly of FIG. 8;
[0070] FIG. 12 is a fragmentary, vertically cross-sectional view
from a right side of a handle body portion of the stapler of FIG.
1;
[0071] FIG. 13 is a fragmentary, enlarged, vertically
cross-sectional view from the right side of a proximal handle body
portion of the stapler of FIG. 12;
[0072] FIG. 14 is a fragmentary, enlarged, vertically
cross-sectional view from the right side of an intermediate handle
body portion of the stapler of FIG. 12;
[0073] FIG. 15 is a fragmentary, further enlarged, vertically
cross-sectional view from the right side of the intermediate handle
body portion of the stapler of FIG. 14;
[0074] FIG. 16 is a fragmentary, enlarged, vertically
cross-sectional view from the right side of a distal handle body
portion of the stapler of FIG. 12;
[0075] FIG. 17 is a perspective view of a portion of an anvil of
the stapler of FIG. 1;
[0076] FIG. 18 is a fragmentary, cross-sectional view of a
removable stapling assembly including the anvil, a stapler
cartridge, a force switch, and a removable cartridge connecting
assembly of the stapler of FIG. 1;
[0077] FIG. 19 is a fragmentary, horizontally cross-sectional view
of the anvil control assembly from above the handle body portion of
the stapler of FIG. 1 with the anvil rod in a fully extended
position;
[0078] FIG. 20 is a fragmentary, side elevational view of the
handle body portion of the stapler of FIG. 1 from a left side of
the handle body portion with the left handle body and the circuit
board removed and with the anvil rod in a fully extended
position;
[0079] FIG. 21 is a fragmentary, side elevational view of the
handle body portion of the stapler of FIG. 20 with the anvil rod in
a 1-cm anvil closure position;
[0080] FIG. 22 is a fragmentary, horizontally cross-sectional view
of the anvil control assembly from above the handle body portion of
the stapler of FIG. 1 with the anvil rod in a safe staple firing
position;
[0081] FIG. 23 is a fragmentary, horizontally cross-sectional view
of the anvil control assembly from above the handle body portion of
the stapler of FIG. 1 with the anvil rod in a fully retracted
position;
[0082] FIG. 24 is a fragmentary, horizontally cross-sectional view
of the firing control assembly from above the handle body portion
of the stapler of FIG. 1;
[0083] FIG. 25 is a fragmentary, enlarged, horizontally
cross-sectional view from above a proximal portion of the firing
control assembly of FIG. 24;
[0084] FIG. 26 is a fragmentary, enlarged, horizontally
cross-sectional view from above an intermediate portion of the
firing control assembly of FIG. 24;
[0085] FIG. 27 is a fragmentary, enlarged, horizontally
cross-sectional view from above a distal portion of the firing
control assembly of FIG. 24;
[0086] FIGS. 28 and 29 are shaded, fragmentary, enlarged, partially
transparent perspective views of a staple cartridge removal
assembly of the stapler of FIG. 1;
[0087] FIG. 30 is a schematic circuit diagram of an exemplary
encryption circuit for interchangeable parts of the medical device
according to the invention;
[0088] FIG. 31 is a bar graph illustrating a speed that a pinion
moves a rack shown in FIG. 32 for various loads;
[0089] FIG. 32 is a fragmentary, perspective view of a simplified,
exemplary portion of a gear train according to the present
invention between a gear box and a rack;
[0090] FIG. 33 is a fragmentary, vertically longitudinal,
cross-sectional view of a distal end of an articulating portion of
an exemplary embodiment of an end effector with the inner tube, the
pushrod-blade support, the anvil, the closure ring, and the near
half of the staple sled removed;
[0091] FIG. 34 is a schematic circuit diagram of an exemplary
switching assembly for a power supply according to the
invention;
[0092] FIG. 35 is a schematic circuit diagram of an exemplary
switching assembly for forward and reverse control of a motor
according to the invention;
[0093] FIG. 36 is a schematic circuit diagram of another exemplary
switching assembly for the power supply and the forward and reverse
control of the motor according to the invention;
[0094] FIG. 37 is a left side elevational view of the device
according to the invention with the outer shell removed;
[0095] FIG. 38 is an enlarged left side elevational view of a
portion the device of FIG. 37 with the left side frame removed;
[0096] FIG. 39 is a right side elevational view of the device of
FIG. 37;
[0097] FIG. 40 is an enlarged right side elevational view of a
portion the device of FIG. 38 with the right side frame
removed;
[0098] FIG. 41 is a perspective view of the device portion of FIG.
40 from the right rear;
[0099] FIG. 42 is a rear elevational view of the device portion of
FIG. 40;
[0100] FIG. 43 is a perspective view of the device portion of FIG.
40 from the left rear with the first to third stage cover
removed;
[0101] FIG. 44 is a perspective view of the device portion of FIG.
40 from above the right side with the power supply removed;
[0102] FIG. 45 is a perspective view of the device portion of FIG.
44 with the manual release lever in a first intermediate position
with the castle gear in the separated position;
[0103] FIG. 46 is a perspective view of the device portion of FIG.
45 with the manual release lever in a second intermediate
position;
[0104] FIG. 47 is a top plan view of the device portion of FIG. 46
with the manual release lever in a third intermediate position;
[0105] FIG. 48 is an enlarged perspective view of the manual
release assembly from the right side with the second stage release
gear, two cam plates, and a pawl spring removed with the pawl in an
upper, unratcheting position;
[0106] FIG. 49 is a perspective view of the manual release lever
from below a right front side;
[0107] FIG. 50 is a perspective view of the manual release lever
from below a right rear side;
[0108] FIG. 51 is a perspective view of the manual release lever
from below a left rear side;
[0109] FIG. 52 is a perspective view of a cam plate from a left
side;
[0110] FIG. 53 is a perspective view of a castle gear from a right
side;
[0111] FIG. 54 is a perspective view of a fourth stage pinion from
the left side;
[0112] FIG. 55 is a perspective view of the device portion of FIG.
44 from above a front right side with a pawl against a pawl
cam;
[0113] FIG. 56 is a perspective view of the device portion of FIG.
55 with the pawl off of the pawl cam and against a ratchet gear and
with the castle gear in the separated position;
[0114] FIG. 57 is a perspective view of the device portion of FIG.
44 from above a front left side with the manual release in an
intermediate position;
[0115] FIG. 58 is a perspective view of the device portion of FIG.
57 with the manual release in another intermediate position;
[0116] FIG. 59 is an enlarged right side elevational view of a
portion of the device of FIG. 40 with the end effector control
handle in an unactuated position;
[0117] FIG. 60 is an enlarged right side elevational view of a the
device portion of FIG. 59 with the end effector control handle in a
partially actuated position;
[0118] FIG. 61 is an enlarged perspective view of a shaft connector
portion of the device of FIG. 37 from above the front right side
with a removable end effector shaft secured in a frame;
[0119] FIG. 62 is an enlarged perspective view of the shaft
connector portion of FIG. 61 with shaft securing device removed to
permit removal of the end effector shaft from the frame;
[0120] FIG. 63 is an elevational view of the interior of a left
half of the outer shell of the device of FIG. 37;
[0121] FIG. 64 is an elevational view of the interior of a right
half of the outer shell of the device of FIG. 37;
[0122] FIG. 65 is an elevational view of the exterior of the right
half of the outer shell of the device of FIG. 37; and
[0123] FIG. 66 is an elevational view of the exterior of the left
half of the outer shell of the device of FIG. 37.
DETAILED DESCRIPTION OF THE INVENTION
[0124] Aspects of the invention are disclosed in the following
description and related drawings directed to specific embodiments
of the invention. Alternate embodiments may be devised without
departing from the spirit or the scope of the invention.
Additionally, well-known elements of exemplary embodiments of the
invention will not be described in detail or will be omitted so as
not to obscure the relevant details of the invention.
[0125] Before the present invention is disclosed and described, it
is to be understood that the terminology used herein is for the
purpose of describing particular embodiments only and is not
intended to be limiting. It must be noted that, as used in the
specification and the appended claims, the singular forms "a,"
"an," and "the" include plural references unless the context
clearly dictates otherwise.
[0126] While the specification concludes with claims defining the
features of the invention that are regarded as novel, it is
believed that the invention will be better understood from a
consideration of the following description in conjunction with the
drawing figures, in which like reference numerals are carried
forward. The figures of the drawings are not drawn to scale.
Further, it is noted that the figures have been created using a
computer-aided design computer program. This program at times
removes certain structural lines and/or surfaces when switching
from a shaded or colored view to a wireframe view. Accordingly, the
drawings should be treated as approximations and be used as
illustrative of the features of the present invention.
[0127] Referring now to the figures of the drawings in detail and
first, particularly to FIGS. 1 to 2 thereof, there is shown an
exemplary embodiment of an electric surgical circular stapler 1.
The present application applies the electrically powered handle to
a circular surgical staple head for ease of understanding only. The
invention is not limited to circular staplers and can be applied to
any surgical stapling head, such as a linear stapling device, for
example. Such an exemplary embodiment is described, in particular,
starting with FIG. 37.
[0128] The powered stapler 1 has a handle body 10 containing three
switches: an anvil open switch 20, an anvil close switch 21, and a
staple firing switch 22. Each of these switches is electrically
connected to a circuit board 500 (see FIG. 12) having circuitry
programmed to carry out the stapling functions of the stapler 1.
The circuit board 500 is electrically connected to a power supply
600 contained within the handle body 10. One exemplary embodiment
utilizes 2 to 6 Lithium CR123 or CR2 cells as the power supply 600.
Other power supply embodiments are possible, such as rechargeable
batteries or a power converter that is connected to an electric
mains (in the latter embodiment, the stapler would not be
self-powered or self-contained). As used herein, the terms
self-powered or self-contained when used with regard to the
electric power supply (600) are interchangeable and mean that the
power supply is a complete and independent unit in and of itself
and can operate under its own power without the use of external
power sources. For example, a power supply having an electric cord
that is plugged into an electric mains during use is not
self-powered or self-contained.
[0129] Insulated conductive wires or conductor tracks on the
circuit board 500 connect all of the electronic parts of the
stapler 1, such as an on/off switch 12, a tissue compression
indicator 14, the anvil and firing switches 20, 21, 22, the circuit
board 500, and the power supply 600, for example. But these wires
and conductors are not shown in the figures of the drawings for
ease of understanding and clarity.
[0130] The distal end of the handle body 10 is connected to a
proximal end of a rigid anvil neck 30. Opposite this connection, at
the distal end of the anvil neck 30, is a coupling device 40 for
removably attaching a staple cartridge 50 and an anvil 60 thereto.
Alternatively, the staple cartridge 50 can be non-removable in a
single-use configuration of the stapler 1. These connections will
be described in further detail below.
[0131] FIG. 2 shows the handle body 10 with the right half 13 of
the handle body 10 and the circuit board 500 removed. As will be
discussed below, a proximal backbone plate 70 is also removed from
the view of FIG. 2 to allow viewing of the internal components
inside the handle body 10 from the right side thereof. What can be
seen from the view of FIG. 2 is that there exist two internal
component axes within the handle body 10. A first of these axes is
the staple control axis 80, which is relatively horizontal in the
view of FIG. 2. The staple control axis 80 is the centerline on
which lie the components for controlling staple actuation. The
second of these axes is the anvil control axis 90 and is disposed
at an angle to the staple control axis 80. The anvil control axis
90 is the centerline on which lie the components for controlling
anvil actuation. It is this separation of axes 80, 90 that allows
the electric stapler 1 to be powered using a handle body 10 that is
small enough to fit in a physician's hand and that does not take up
so much space that the physician becomes restricted from movement
in all necessary directions and orientations.
[0132] Shown inside the handle body 10 is the on/off switch 12
(e.g., a grenade pin) for controlling power (e.g., battery power)
to all of the electrical components and the tissue compression
indicator 14. The tissue compression indicator 14 indicates to the
physician that the tissue being compressed between the anvil 60 and
the staple cartridge 50 has or has not been compressed with greater
than a pre-set compressive force, which will be described in
further detail below. This indicator 14 is associated with a force
switch 400 that has been described in co-pending U.S. Patent
Provisional Application Ser. No. 60/801,989 filed May 19, 2006, and
titled "Force Switch" (the entirety of which is incorporated by
reference herein).
[0133] The components along the anvil control axis 90 make up the
anvil control assembly 100. An anvil control frame 110 is aligned
along the anvil control axis 90 to house and/or fix various part of
the anvil control assembly 100 thereto. The anvil control frame 110
has a proximal mount 112, an intermediate mount 114, and a distal
mount 116. Each of these mounts 112, 114, 116 can be attached to or
integral with the control frame 110. In the exemplary embodiment,
for ease of manufacturing, the proximal mount 112 has two halves
and is separate from the frame 110 and the intermediate mount 114
is separate from the frame 110.
[0134] At the proximal end of the anvil control assembly 100 is an
anvil motor 120. The anvil motor 120 includes the drive motor and
any gearbox that would be needed to convert the native motor
revolution speed to a desired output axle revolution speed. In the
present case, the drive motor has a native speed of approximately
10,000 rpm and the gearbox converts the speed down to between
approximately 50 and 70 rpm at an axle 122 extending out from a
distal end of the anvil motor 120. The anvil motor 120 is secured
both longitudinally and rotationally inside the proximal mount
112.
[0135] A motor-shaft coupler 130 is rotationally fixed to the axle
122 so that rotation of the axle 122 translates into a
corresponding rotation of the motor coupler 130.
[0136] Positioned distal of the coupler 130 is a rotating nut
assembly 140. The nut assembly 140 is, in this embodiment, a two
part device having a proximal nut half 141 and a distal nut half
142 rotationally and longitudinally fixed to the proximal nut half
141. It is noted that these nut halves 141, 142 can be integral if
desired. Here, they are illustrated in two halves for ease of
manufacturing. The proximal end of the nut assembly 140 is
rotationally fixed to the distal end of the coupler 130.
Longitudinal and rotational support throughout the length of these
two connected parts is assisted by the intermediate 114 and distal
116 mounts.
[0137] A proximal nut bushing 150 (see FIG. 3) is interposed
between the intermediate mount 114 and the proximal nut half 141
and a distal nut bushing 160 is interposed between the distal mount
116 and the distal nut half 142 to have these parts spin
efficiently and substantially without friction within the handle
body 10 and the anvil control frame 110. The bushings 150, 160 can
be of any suitable bearing material, for example, they can be of
metal such as bronze or a polymer such as nylon. To further
decrease the longitudinal friction between the rotating nut
assembly 140 and the coupler 130, a thrust washer 170 is disposed
between the proximal bushing 150 and the proximal nut half 141.
[0138] Rotation of the coupler 130 and nut assembly 140 is used to
advance or retract a threaded rod 180, which is the mechanism
through which the anvil 60 is extended or retracted. The threaded
rod 180 is shown in further detail in the exploded view of FIGS. 3
to 4 and is described in further detail below. A rod support 190 is
attached to a distal end of the anvil control frame 110 for
extending the supporting surfaces inside the nut assembly 140 that
keep the rod 180 aligned along the anvil control axis 90. The rod
support 190 has a smooth interior shape corresponding to an
external shape of the portion of the rod 180 that passes
therethrough. This mating of shapes allows the rod 180 to move
proximally and distally through the support 190 substantially
without friction. To improve frictionless movement of the rod 180
through the support 190, in the exemplary embodiment, a cylindrical
rod bushing 192 is disposed between the support 190 and the rod
180. The rod bushing 192 is not visible in FIG. 2 because it rests
inside the support 190. However, the rod bushing 192 is visible in
the exploded view of FIGS. 3 to 4. With the rod bushing 192 in
place, the internal shape of the support 190 corresponds to the
external shape of the rod bushing 192 and the internal shape of the
rod bushing 192 corresponds to the external shape of the portion of
the rod 180 that passes therethrough. The rod bushing 192 can be,
for example, of metal such as bronze or a polymer such as
nylon.
[0139] The components along the staple control axis 80 form the
staple control assembly 200. The staple control assembly 200 is
illustrated in FIG. 5 viewed from a proximal upper and side
perspective. The proximal end of the staple control assembly 200
includes a stapling motor 210. The stapling motor 210 includes the
drive motor and any gearbox that would be needed to convert the
native motor revolution speed to a desired revolution speed. In the
present case, the drive motor has a native speed of approximately
20,000 rpm and the gearbox converts the speed to approximately 200
rpm at an output axle 212 at the distal end of the gearbox. The
axle 212 cannot be seen in the view of FIG. 5 but can be seen in
the exploded view of FIGS. 6 to 7.
[0140] The stapling motor 210 is rotationally and longitudinally
fixed to a motor mount 220. Distal of the motor mount 220 is an
intermediate coupling mount 230. This coupling mount 230 has a
distal plate 232 that is shown, for example in FIG. 6. The distal
plate 232 is removable from the coupling mount 230 so that a
rotating screw 250 can be held therebetween. It is this rotating
screw 250 that acts as the drive for ejecting the staples out of
the staple cartridge 50. The efficiency in transferring the
rotational movement of axle 212 to the rotating screw 250 is a
factor that can substantially decrease the ability of the stapler 1
to deliver the necessary staple ejection longitudinal force of up
to 250 pounds. Thus, an exemplary embodiment of the screw 250 has
an acme profile thread.
[0141] There are two exemplary ways described herein for
efficiently coupling the rotation of the axle 212 to the screw 250.
First, the stapling motor 210 can be housed "loosely" within a
chamber defined by the handle body 10 so that it is rotationally
stable but has play to move radially and so that it is
longitudinally stable but has play to move. In such a
configuration, the stapling motor 210 will "find its own center" to
align the axis of the axle 212 to the axis of the screw 250, which,
in the exemplary embodiment, is also the staple control axis
80.
[0142] A second exemplary embodiment for aligning the axle 212 and
the screw 250 is illustrated in FIGS. 1 to 5, for example. In this
embodiment, a proximal end of a flexible coupling 240 is fixed
(both rotationally and longitudinally) to the axle 212. This
connection is formed by fitting the distal end of the axle 212
inside a proximal bore 241 of the flexible coupling 240. See FIG.
12. The axle 212 is, then, secured therein with a proximal setscrew
213. The screw 250 has a proximal extension 251 that fits inside a
distal bore 242 of the flexible coupling 240 and is secured therein
by a distal setscrew 252. It is noted that the figures of the
drawings show the flexible coupling 240 with ridges in the middle
portion thereof. In an exemplary embodiment of the coupling 240,
the part is of aluminum or molded plastic and has a spiral or
helixed cut-out around the circumference of the center portion
thereof. In such a configuration, one end of the coupling 240 can
move in any radial direction (360 degrees) with respect to the
other end (as in a gimbal), thus providing the desired flex to
efficiently align the central axes of the axle 212 and the screw
250.
[0143] The proximal extension 251 of the screw 250 is substantially
smaller in diameter than the diameter of the bore 231 that exists
in and through the intermediate coupling mount 230. This bore 231
has two increasing steps in diameter on the distal side thereof.
The first increasing step in diameter is sized to fit a proximal
radius screw bushing 260, which is formed of a material that is
softer than the intermediate coupling mount 230. The proximal
radius screw bushing 260 only keeps the screw 250 axially aligned
and does not absorb or transmit any of the longitudinal thrust. The
second increasing step in diameter is sized to fit a proximal
thrust bearing 270 for the screw 250. In an exemplary embodiment of
the thrust bearing 270, proximal and distal plates sandwich a
bearing ball retainer plate and bearing balls therebetween. This
thrust bearing 270 absorbs all of the longitudinal thrust that is
imparted towards the axle 212 while the up to 250 pounds of
longitudinal force is being applied to eject the staples in the
staple cartridge 50. The proximal extension 251 of the screw 250
has different sized diameters for each of the interiors of the
screw bushing 260 and the thrust bearing 270. The motor mount 220
and the coupling mount 230, therefore, form the two devices that
hold the flexible coupling 240 therebetween.
[0144] The rotating screw 250 is held inside the distal plate 232
with a distal radius screw bushing 280 similar to the proximal
radius screw bushing 260. Thus, the screw 250 rotates freely within
the distal plate 232. To translate the rotation of the screw 250
into a linear distal movement, the screw 250 is threaded within a
moving nut 290. Movement of the nut 290 is limited to the amount of
movement that is needed for complete actuation of the staples; in
other words, the nut 290 only needs to move through a distance
sufficient to form closed staples between the staple cartridge 50
and the anvil 60 and to extend the cutting blade, if any, within
the staple cartridge 50, and then retract the same. When the nut
290 is in the proximal-most position (see, e.g., FIG. 12), the
staples are at rest and ready to be fired. When the nut 290 is in
the distal-most position, the staples are stapled through and
around the tissue interposed between the staple cartridge 50 and
the anvil, and the knife, if any, is passed entirely through the
tissue to be cut. The distal-most position of the nut 290 is
limited by the location of the distal plate 232. Thus, the
longitudinal length of the threads of the screw 250 and the
location of the distal plate 232 limit the distal movement of the
nut 290.
[0145] Frictional losses between the screw 250 and the nut 290
contribute to a significant reduction in the total pounds of force
that can be transmitted to the staple cartridge 50 through the
cartridge plunger 320. Therefore, it is desirable to select the
materials of the screw 250 and the nut 290 and the pitch of the
threads of the screw 250 in an optimized way. It has been found
that use of a low-friction polymer for manufacturing the nut 290
will decrease the friction enough to transmit the approximately 250
pounds of longitudinal force to the distal end of the cartridge
plunger 320--the amount of force that is needed to effectively
deploy the staples. Two particular exemplary materials provide the
desired characteristics and are referred to in the art as
DELRIN.RTM. AF Blend Acetal (a thermoplastic material combining
TEFLON.RTM. fibers uniformly dispersed in DELRIN.RTM. acetal resin)
and RULON.RTM. (a compounded form of TFE fluorocarbon) or other
similar low-friction polymers.
[0146] A nut coupling bracket 300 is longitudinally fixed to the
nut 290 so that it moves along with the nut 290. The nut coupling
bracket 300 provides support for the relatively soft, lubricious
nut material. In the exemplary embodiment shown, the bracket 300
has an interior cavity having a shape corresponding to the exterior
shape of the nut 290. Thus, the nut 290 fits snugly into the
coupling bracket 300 and movement of the nut 290 translates into a
corresponding movement of the nut coupling bracket 300. The shape
of the nut coupling bracket 300 is, in the exemplary embodiment,
dictated by the components surrounding it and by the longitudinal
forces that it has to bear. For example, there is an interior
cavity 302 distal of the nut 290 that is shaped to receive the
distal plate 232 therein. The nut coupling bracket 300 also has a
distal housing 304 for receiving therein a stiffening rod 310. The
stiffening rod 310 increases the longitudinal support and forms a
portion of the connection between the nut 290 and a cartridge
plunger 320 (see, i.e., FIG. 5), which is the last moving link
between elements in the handle body 10 and the staple cartridge 50.
A firing bracket 330, disposed between the distal end of the nut
coupling bracket 300 and the stiffening rod 310, strengthens the
connection between the nut coupling bracket 300 and the rod
310.
[0147] Various components of the stapler 1 are connected to one
another to form a backbone or spine. This backbone is a frame
providing multi-directional stability and is made up of four
primary parts (in order from proximal to distal): the anvil control
frame 110, the proximal backbone plate 70 (shown in FIGS. 3 to 4
and 6 to 7), a distal backbone plate 340, and the anvil neck 30.
Each of these four parts is longitudinally and rotationally fixed
to one another in this order and forms the skeleton on which the
remainder of the handle components is attached in some way. Lateral
support to the components is provided by contours on the inside
surfaces of the handle body 10, which in an exemplary embodiment is
formed of two halves, a left half 11 and a right half 13.
Alternatively, support could be single frame, stamped, or
incorporated into the handle halves 11, 13.
[0148] Functionality of the anvil control assembly 100 is described
with regard to FIGS. 17 to 27. To carry out a stapling procedure
with the stapler 1, the anvil 60 is removed entirely from the
stapler 1 as shown in FIG. 17. The anvil open switch 20 is
depressed to extend the distal end of the trocar tip 410 housed
within the staple cartridge and which is longitudinally fixedly
connected to the screw 250. The point of the trocar tip 410 can,
now, be passed through or punctured through tissue that is to be
stapled. The user can, at this point, replace the anvil 60 onto the
trocar tip 410 from the opposite side of the tissue (see FIG. 18)
and, thereby, lock the anvil 60 thereon. The anvil closed switch 22
can be actuated to begin closing the anvil 60 against the staple
cartridge 50 and pinch the tissue therebetween within an
anvil-cartridge gap 62.
[0149] To describe how the trocar tip controlling movement of the
anvil 60 occurs, reference is made to FIGS. 8 to 10, 14 to 15, and
18. As shown in dashed lines in FIG. 15, a rod-guiding pin 143 is
positioned within the central bore 144 of the distal nut half 142.
As the threaded rod 180 is screwed into the rotating nut 140, 141,
142, the pin 143 catches the proximal end of the thread 182 to
surround the pin 143 therein. Thus, rotation of the nut 140 with
the pin 143 inside the thread 182 will cause proximal or distal
movement of the rod 180, depending on the direction of nut
rotation. The thread 182 has a variable pitch, as shown in FIGS. 14
to 15, to move the anvil 60 at different longitudinal speeds. When
the pin 143 is inside the longer (lower) pitched thread portion
183, the anvil 60 moves longitudinally faster. In comparison, when
the pin 143 is inside the shorter (higher) pitched thread portion
184, the anvil 60 moves longitudinally slower. It is noted that the
pin 143 is the only portion contacting the thread 182 when in the
longer pitched thread portion 183. Thus, the pin 143 is exposed to
the entire longitudinal force that is acting on the rod 180 at this
point in time. The pin 143 is strong enough to bear such forces but
may not be sufficient to withstand all longitudinal force that
could occur with anvil 60 closure about interposed tissue.
[0150] As shown in FIG. 14, the rod 180 is provided with a shorter
pitched thread portion 184 to engage in a corresponding internal
thread 145 at the proximal end of the central bore 144 of the
proximal nut half 141. When the shorter pitched thread portion 184
engages the internal thread 145, the entire transverse surface of
the thread portion 184 contacts the internal thread 145. This
surface contact is much larger than the contact between the pin 143
and any portion of the thread 182 and, therefore, can withstand all
the longitudinal force that occurs with respect to anvil 60
closure, especially when the anvil 60 is closing about tissue
during the staple firing state. For example, in the exemplary
embodiment, the pin 143 bears up to approximately 30 to 50 pounds
of longitudinal force. This is compared to the threads, which can
hold up to 400 pounds of longitudinal force--an almost 10-to-1
difference.
[0151] An alternative exemplary embodiment of anvil control
assembly 100 can entirely remove the complex threading of the rod
180. In such a case, the rod 180 has a single thread pitch and the
anvil motor 120 is driven (through corresponding programming in the
circuit board 500) at different speeds dependent upon the
longitudinal position of the single-thread rod 180.
[0152] In any embodiment for driving the motors 120, 210, the
control programming can take many forms. In one exemplary
embodiment, the microcontroller on the battery powered circuit
board 500 can apply pulse modulation (e.g., pulse-width,
pulse-frequency) to drive either or both of the motors. Further,
because the stapler 1 is a device that has a low duty cycle, or is
a one-use device, components can be driven to exceed acceptable
manufacturers' specifications. For example, a gear box can be
torqued beyond its specified rating. Also, a drive motor, for
example, a 6 volt motor, can be overpowered, for example, with 12
volts.
[0153] Closure of the anvil 60 from an extended position to a
position in which the tissue is not compressed or is just slightly
compressed can occur rapidly without causing damage to the
interposed tissue. Thus, the longer-pitched thread portion 183
allows the user to quickly close the anvil 60 to the tissue in a
tissue pre-compressing state. Thereafter, it is desirable to
compress the tissue slowly so that the user has control to avoid
over-compression of the tissue. As such, the shorter pitched thread
portion 184 is used over this latter range of movement and provides
the user with a greater degree of control. During such compression,
the force switch 400 seen in FIG. 18 and described in co-pending
U.S. Patent Provisional Application Ser. No. 60/801,989 can be used
to indicate to the user through the tissue compression indicator 14
(and/or to the control circuitry of the circuit board 500) that the
tissue is being compressed with a force that is greater than the
pre-load of the spring 420 inside the force switch 400. It is noted
that FIG. 18 illustrates the force switch 400 embodiment in the
normally-open configuration described as the first exemplary
embodiment of U.S. Patent Provisional Application Ser. No.
60/801,989. A strain gauge can also be used for measuring tissue
compression.
[0154] FIGS. 19 to 23 illustrate movement of the rod 180 from an
anvil-extended position (see FIGS. 19 to 20), to a
1-cm-closure-distance position (see FIG. 21), to a
staple-fire-ready position (see FIG. 22), and, finally, to an anvil
fully closed position (see FIG. 23). Movement of the rod 180 is
controlled electrically (via the circuit board 500) by contact
between a portion of a cam surface actuator 185 on the rod 180 and
actuating levers or buttons of a series of micro-switches
positioned in the handle body 10.
[0155] A rod-fully-extended switch 610 (see FIG. 19) is positioned
distal in the handle body 10 to have the actuator 185 compress the
activation lever of the rod-fully-extended switch 610 when the rod
180 (and, thereby, the anvil 60) is in the fully extended position.
A 1-cm switch 612 is positioned in an intermediate position within
the handle body 10 (see FIGS. 20 to 21) to prevent a 1-cm cam
surface portion 186 of the rod 180 from pressing the activation
button of the 1-cm switch 612 when the rod 180 (and, thereby, the
anvil 60) is within 1 cm of the fully closed position. After
passing the 1-cm closure distance, as shown in FIG. 22, the cam
surface actuator 185 engages a staple-fire-ready switch 614. The
lower end of the actuator 185 as viewed in FIGS. 22 to 23 has a
bevel on both the forward and rear sides with respect to the button
of the staple-fire-ready switch 614 and the distance between the
portion on the two bevels that actuates the button (or, only the
flat portion thereof) corresponds to the acceptable staple forming
range (i.e., safe firing length) of the staples in the staple
cartridge 50. Thus, when the button of the staple-fire-ready switch
614 is depressed for the first time, the distance between the anvil
60 and the staple cartridge 50 is at the longest range for
successfully firing and closing the staples. While the button is
depressed, the separation distance 62 of the anvil 60 (see FIG. 18)
remains within a safe staple-firing range. However, when the button
of the staple-fire-ready switch 614 is no longer depressed--because
the actuator 185 is positioned proximally of the button, then
staples will not fire because the distance is too short for
therapeutic stapling. FIG. 23 show the rod 180 in the proximal-most
position, which is indicated by the top end of the actuator 185
closing the lever of a rod fully-retracted switch 616. When this
switch 616 is actuated, the programming in the circuit board 500
prevents the motor 120 from turning in a rod-retraction direction;
in other words, it is a stop switch for retracting the rod 180 in
the proximal direction.
[0156] It is noted that FIGS. 2 to 3, 11 to 12, and 16 illustrate
the distal end of the rod 180 not being connected to another device
at its distal end (which would then contact the proximal end of the
force switch 400). The connection band or bands between the distal
end of the rod 180 and the proximal end of the force switch 400 are
not shown in the drawings only for clarity purposes. In an
exemplary embodiment, the pull-bands are flat and flexible to
traverse the curved underside of the cartridge plunger 320 through
the anvil neck 30 and up to the proximal end of the force switch
400. Of course, if the force switch 400 is not present, the bands
would be connected to the proximal end of the trocar tip 410 that
releasably connects to the proximal end of the anvil 60.
[0157] Functionality of the staple control assembly 200 is
described with regard to FIGS. 12 to 16 and 24 to 27, in
particular, to FIG. 24. The stapling motor 210 is held between a
motor bearing 222 and a motor shaft cover 224. The axle 212 of the
stapling motor 210 is rotationally connected to the proximal end of
the flexible coupling 240 and the distal end of the flexible
coupling 240 is rotationally connected to the proximal end of the
screw 250, which rotates on bearings 260, 270, 280 that are
disposed within the intermediate coupling mount 230 and the distal
plate 232. The longitudinally translating nut 290 is threaded onto
the screw 250 between the coupling mount 230 and the distal plate
232. Therefore, rotation of the axle 212 translates into a
corresponding rotation of the screw 250.
[0158] The nut coupling bracket 300 is longitudinally fixed to the
nut 290 and to the stiffening rod 310 and the firing bracket 330.
The firing bracket 330 is longitudinally fixed to the cartridge
plunger 320, which extends (through a non-illustrated staple
driver) up to the staple cartridge 50 (or to the staples). With
such a connection, longitudinal movement of the nut 290 translates
into a corresponding longitudinal movement of the cartridge plunger
320. Accordingly, when the staple firing switch 22 is activated,
the stapling motor 210 is caused to rotate a sufficient number of
times so that the staples are completely fired from the staple
cartridge 50 (and the cutting blade, if present, is extended to
completely cut the tissue between the anvil 60 and the staple
cartridge 50). Programming in the circuitry, as described below,
then causes the cartridge plunger 320 to retract after firing and
remove any portion of the staple firing parts and/or the blade
within the staple cartridge 50 from the anvil-cartridge gap 62.
[0159] Control of this stapling movement, again, occurs through
micro-switches connected to the circuit board 500 through
electrical connections, such as wires. A first of these control
switches, the proximal staple switch 618, controls retraction of
the staple control assembly 200 and defines the proximal-most
position of this assembly 200. To actuate this switch, an actuation
plate 306 is attached, in an adjustable manner, to a side of the
nut coupling bracket 300. See, e.g., FIGS. 6 and 24. As such, when
the nut 290 moves proximally to cause the plate 306 on the nut
coupling bracket 300 to activate the proximal staple switch 618,
power to the stapling motor 210 is removed to stop further
proximally directed movement of the staple control assembly
200.
[0160] A second of the switches for controlling movement of the
staple control assembly 200 is located opposite a distal transverse
surface of the stiffening rod 310. See, e.g. FIG. 27. At this
surface is disposed a longitudinally adjustable cam member 312 that
contacts a distal staple switch 620. In an exemplary embodiment,
the cam member 312 is a screw that is threaded into a distal bore
of the stiffening rod 310. Accordingly, when the nut 290 moves
distally to cause the cam member 312 of the stiffening rod 310 to
activate the distal staple switch 620, power to the stapling motor
210 is removed to stop further distally directed movement of the
staple control assembly 200.
[0161] FIGS. 28 and 29 illustrate a removable connection assembly
to permit replacement of a different staple cartridge 60 on the
distal end of the anvil 30.
[0162] The proximal-most chamber of the handle body 10 defines a
cavity for holding therein a power supply 600. This power supply
600 is connected through the circuit board 500 to the motors 120,
210 and to the other electrical components of the stapler 1.
[0163] The electronic components of the stapler 1 have been
described in general with respect to control through the circuit
board 500. The electric stapler 1 includes, as set forth above in
an exemplary embodiment, two drive motors 120, 210 powered by
batteries and controlled through pushbuttons 20, 21, 22. The ranges
of travel of each motor 120, 210 are controlled by limit switches
610, 616, 618, 620 at the ends of travel and at intermediary
locations 612, 614 along the travel. The logic by which the motors
120, 210 are controlled can be accomplished in several ways. For
example, relay, or ladder logic, can be used to define the control
algorithm for the motors 120, 210 and switches 610, 612, 614, 616,
618, 620. Such a configuration is a simple but limited control
method. A more flexible method employs a microprocessor-based
control system that senses switch inputs, locks switches out,
activates indicator lights, records data, provides audible
feedback, drives a visual display, queries identification devices
(e.g., radio frequency identification devices (RFIDs) or
cryptographic identification devices), senses forces, communicates
with external devices, monitors battery life, etc. The
microprocessor can be part of an integrated circuit constructed
specifically for the purpose of interfacing with and controlling
complex electro-mechanical systems. Examples of such chips include
those offered by Atmel, such as the Mega 128, and by PIC, such as
the PIC 16F684.
[0164] A software program is required to provide control
instructions to such a processor. Once fully developed, the program
can be written to the processor and stored indefinitely. Such a
system makes changes to the control algorithm relatively simple;
changes to the software that are uploaded to the processor adjust
the control and user interface without changing the wiring or
mechanical layout of the device.
[0165] For a disposable device, a power-on event is a one time
occurrence. In this case, the power-on can be accomplished by
pulling a tab or a release that is permanently removed from the
device. The removal enables battery contact, thus powering on the
device.
[0166] In any embodiment of the device, when the device is powered
on, the control program begins to execute and, prior to enabling
the device for use, goes through a routine that ensures awareness
of actual positions of the extend/retract and firing
sub-assemblies, referred to as a homing routine. The homing routine
may be executed at the manufacturer prior to shipping to the user.
In such a case, the homing routine is performed, the positions of
the assemblies are set, and the device is shipped to the user in a
ready-to-use condition. Upon power-up, the device verifies its
positions and is ready to use.
[0167] Visual indicators (e.g., LEDs) are used to provide feedback
to the user. In the case of the pushbutton switches 20, 21, 22,
they can be lit (or backlit) when active and unlit when not active.
The indicators can blink to convey additional information to the
user. In the case of a delayed response after a button press, a
given light can blink at an ever-increasing rate as the response
becomes imminent, for example. The indicators can also light with
different colors to indicate various states.
[0168] Cams are used in various locations at the stapler 1 to
activate limit switches that provide position information to the
processor. By using linear cams of various lengths, position ranges
can be set. Alternatively, encoders can be used instead of limit
switches (absolute and incremental positioning). Limit switches are
binary: off or on. Instead of binary input for position
information, encoders (such as optical encoders) can be used to
provide position information. Another way to provide position
feedback includes mounting pulse generators on the end of the
motors that drive the sub-assemblies. By counting pulses, and by
knowing the ratio of motor turns to linear travel, absolute
position can be derived.
[0169] Use of a processor creates the ability to store data. For
example, vital, pre-loaded information, such as the device serial
number and software revision can be stored. Memory can also be used
to record data while the stapler 1 is in use. Every button press,
every limit switch transition, every aborted fire, every completed
fire, etc., can be stored for later retrieval and diagnosis. Data
can be retrieved through a programming port or wirelessly. In an
exemplary embodiment, the device can be put into diagnostic mode
through a series of button presses. In this diagnostic mode, a
technician can query the stapler 1 for certain data or to
transmit/output certain data. Response from the stapler 1 to such a
query can be in the form of blinking LEDs, or, in the case of a
device with a display, visual character data, or can be electronic
data. As set forth above, a strain gauge can be used for analog
output and to provide an acceptable strain band. Alternatively,
addition of a second spring and support components can set this
band mechanically.
[0170] An exemplary control algorithm for a single fire stapler 1
can include the following steps: [0171] Power on. [0172] Verify
home position and go to home position, if necessary/desired. [0173]
Enable extend/retract buttons (lit) and disable (unlit) staple fire
button. [0174] Enable staple fire button only after full extension
(anvil removal) and subsequent retraction with extend/retract
buttons remaining enabled. [0175] Upon actuation of staple fire
button, retract anvil until force switch is activated. [0176] Begin
countdown by blinking fire button LED and increase blink rate as
firing cycle becomes imminent. Continue monitoring of force switch
and retract anvil so that force switch remains activated. [0177]
During staple fire cycle, any button press aborts staple fire
routine. [0178] If abort occurs before staple firing motor is
activated, firing cycle stops, anvil is extended to home position,
and staple fire button remains active and ready for a re-fire.
[0179] Alternatively, if the abort occurs during movement of firing
motor, firing cycle stops, firing motor is retracted, anvil is
returned to home position, and firing button is rendered inactive.
Accordingly, stapler (or that staple cartridge) cannot be used.
[0180] After countdown to fire is complete, staple range limit
switch is queried for position. If staple range limit switch is
activated--meaning that anvil is within an acceptable staple firing
range--then staple firing motor is activated and firing cycle
proceeds. If staple range limit switch is not activated, then
firing cycle is aborted, anvil is returned to home position, and
staple firing button remains active ready for a re-fire attempt.
[0181] After a completed staple firing, anvil remains in closed
position and only the extend button remains active. Once anvil is
extended to at least the home position, both extend and retract
buttons are made active. Staple fire button remains inactive after
a completed staple firing. Throughout the above exemplary cycle,
button presses, switch positions, aborts, and/or fires can be
recorded.
[0182] In a surgical procedure, the stapler is a one-way device. In
the test mode, however, the test user needs to have the ability to
move the trocar 410 and anvil 60 back and forth as desired. The
power-on feature permits entry by the user into a manual mode for
testing purposes. This test mode can be disengaged and the stapler
reset to the use mode for packaging and shipment.
[0183] For packaging, it is desirable (but not necessary) to have
the anvil 60 be disposed at a distance from the staple cartridge
50. Therefore, a homing sequence can be programmed to place the
anvil 60 one centimeter (for example) away from the staple
cartridge 50 before powering down for packaging and shipment.
[0184] When the electric stapler is unpackaged and ready to be used
for surgery, the user turns the stapler on (switch 12). Staples
should not be allowed to fire at any time prior to being in a
proper staple-firing position and a desired tissue compression
state. Thus, the anvil/trocar extend/retract function is the only
function that is enabled. In this state, the extend and retract
buttons 20, 21 are lit and the staple firing switch 22 is not lit
(i.e., disabled).
[0185] Before use inside the patient, the trocar 410 is extended
and the anvil 60 is removed. If the stapler is being used to
anastomose a colon, for example, the trocar 410 is retracted back
into the anvil neck 30 and the staple cartridge 50 and anvil neck
30 are inserted trans-anally into the colon to a downstream side of
the dissection. The anvil 60, in contrast, is inserted through an
upstream laparoscopic incision and placed at the upstream side of
the dissection. The anvil 60 is attached to the trocar 410 and the
two parts are retracted towards the staple cartridge 50 until a
staple ready condition occurs. As set forth above, the anvil is
moved to a distance that does not substantially compress and,
specifically, does not desiccate, the tissue therebetween. At this
point, staple firing can occur when desired.
[0186] The staple firing sequence is started by activating the
staple fire switch 22. Staple firing can be aborted anytime during
the firing sequence, whether prior to movement (during the
blanching cycle) or during movement (whether the staples have
started to form or not). The software is programmed to begin a
staple firing countdown sequence because it is understood that the
tissue needs to be compressed and allowed to desiccate before
staple firing should occur. Thus, after the staple firing switch 22
is activated, the anvil 60 closes upon the interposed tissue and
begins to compress the tissue. The staple firing sequence includes
an optimal tissue compression (OTC) measurement and a feedback
control mechanism that causes staples to be fired only when the
compression is in a desired pressure range, referred to as the OTC
range, and a sufficient time period has elapsed to allow fluid
removal from the compressed tissue. The OTC range is known
beforehand based upon known characteristics of the tissue that is
to be compressed between the anvil 60 and the staple cartridge 50
(the force switch can be tuned for different tissue OTC ranges). It
is the force switch 400 that provides the OTC measurement and
supplies the microprocessor with information indicating that the
OTC for that particular tissue has been reached. The OTC state can
be indicated to the user with an LED, for example.
[0187] When the firing sequence begins, the staple fire switch 22
can be made to blink at a given rate and then proceed to blink
faster and faster, for example, until firing occurs. If no abort is
triggered during this wait time, the OTC state will remain for the
preprogrammed desiccation duration and staple filing will occur
after the countdown concludes. In the example of colon anastomosis
with a circular stapler, stapling of the dissection occurs
simultaneously with a cutting of tissue at the center of the
dissection. This cutting guarantees a clear opening in the middle
of the circular ring of staples sufficient to create an opening for
normal colon behavior after the surgery is concluded.
[0188] As the liquid from the interposed compressed tissue is
removed, the compressive force on the tissue naturally reduces. In
some instances, this reduction can be outside the OTC range.
Therefore, the program includes closed-loop anvil-compression
control that is dependent upon continuous measurements provided by
the force switch 400. With this feedback, the compressed tissue is
kept within the OTC range throughout the procedure and even after
being desiccated.
[0189] During the staple firing cycle, any actuation of a control
switch by the user can be programmed to abort the staple fire
routine. If an abort occurs before the staple firing motor 210 is
activated, the firing cycle stops, the anvil 60 is extended to a
home position, and the staple fire switch 22 remains active and
ready for a re-fire attempt, if desired. Alternatively, if the
abort occurs during movement of the staple firing motor 210, the
firing cycle stops and the staple firing motor 210 is caused to
extend the anvil 60 to its home position. At this point, the staple
firing switch 22 is rendered inactive. Accordingly, the stapler (or
that particular staple cartridge) can no longer be used (unless the
staple cartridge is replaced).
[0190] It is noted that before a staple firing can occur, a staple
range limit switch is queried for relative position of the staple
cartridge 50 and anvil 60. If the staple range limit switch is
activated--meaning that anvil 60 is within an acceptable staple
firing range--then the staple firing motor 210 can be made active
and the firing cycle can be allowed to proceed. If the staple range
limit switch is not activated, then the firing cycle is aborted,
the anvil 60 is returned to the home position, and the staple
firing switch 22 remains active and ready for a re-fire
attempt.
[0191] Powering (also referred to as actuating, powering,
controlling, or activating) of the motor and/or the drive train of
any portion of the end effector (e.g., anvil or stapler/cutter) is
described herein. It is to be understood that such powering need
not be limited to a single press of an actuation button by the user
nor is the powering of a motor limited to a single energizing of
the motor by the power supply. Control of any motor in the device
can require the user to press an actuation button a number of
times, for example, a first time to actuate a portion of the end
effector for a first third of movement, a second time for a second
third of movement, and a third time for a last third of movement.
More specifically for a surgical stapler, a first exemplary
actuation can move the staple sled or blade past the lock-out, a
second exemplary actuation can move the part up to the tissue, and
a third exemplary actuation can move the sled past all staples to
the end of the staple cartridge. Similarly, powering of a motor
need not be constant, for example, where the motor is energized
constantly from the time that the blade begins movement until it
reaches the end point of its movement. Instead, the motor can be
operated in a pulsed mode, a first example of which includes
periodically switching on and off the power supplied by the power
supply to the motor during actuation of an end effector function.
More specifically for a stapler, the motor can be pulsed ten
times/second as the staple/cutter moves from its proximal/start
position to its distal-most position. This pulsing can be directly
controlled or controlled by microprocessor, either of which can
have an adjustable pulse rate. Alternatively, or additionally, the
motor can be operated with a pulse modulation (pulse-width or
pulse-frequency), with pulses occurring at very short time periods
(e.g., tenths, hundredths, thousandths, or millionths of a second).
Accordingly, when the power supply, the motor, and/or the drive
train are described herein as being powered, any of these and other
possible modes of operation are envisioned and included.
[0192] After a completed staple firing, the anvil 60 remains in the
closed position and only the extend switch 20 remains active (all
other switches are deactivated). Once the anvil 60 is extended to
at least the home position, both the extend and retract switches
20, 21 are made active but the retraction switch 21 does not permit
closure of the anvil 60 past the home position. The staple fire
switch 22 remains inactive after a completed staple firing.
[0193] As set forth above, the anvil neck 30 houses a linear force
switch 400 connected to the trocar 410. This switch 400 is
calibrated to activate when a given tensile load is applied. The
given load is set to correspond to a desired pressure that is to be
applied to the particular tissue before stapling can occur.
Interfacing this switch 400 with the processor can ensure that the
firing of staples only occurs within the OTC range.
[0194] An exemplary embodiment of a program listing for carrying
out the methods according to the invention as described herein is
supplied in the Appendix. The program listing provided in the
Appendix is only submitted as exemplary and those of skill in the
art can appreciate that programming the methods according to the
invention can take many different forms to achieve the same
functionality.
[0195] Also mentioned above is the possibility of using
identification devices with removable and/or interchangeable
portions of the end effector. Such identification devices, for
example, can be used to track usage and inventory.
[0196] One exemplary identification device employs radio-frequency
and is referred to as an RFID. In an exemplary embodiment where a
medical stapler uses re-loadable, interchangeable staple
cartridges, such as the stapler 1 described herein, an RFID can be
placed in the staple cartridge to ensure compatibility with the
particular stapler and an RFID reader for sensing compatible staple
cartridges can be associated with the handle. In such a
configuration, the reader interrogates the RFID mounted in the
cartridge. The RFID responds with a unique code that the stapler
verifies. If the stapler cartridge is labeled as verified, the
stapler becomes active and ready for use. If the cartridge is
rejected, however, the stapler gives a rejected indication (e.g., a
blinking LED, an audible cue, a visual indicator). To avoid
accidental or improper reading of a nearby staple cartridge, the
antenna of the RFID reader can be constructed to only read the RFID
when the staple cartridge is installed in the stapler or is very
nearby (optimally, at the distal end of the device). Use of the
RFID can be combined with a mechanical lockout to ensure that only
one fire cycle is allowed per staple cartridge. RFIDs have
drawbacks because the readers are expensive, the antennas are
required to be relatively large, and the distance for reading is
relatively close, typically measured in centimeters.
[0197] Other wireless authentication measures can be employed.
Active RFIDs can be used. Similarly, infrared (IR) transmission
devices can be used. However, both of these require the generation
of power at the receiving end, which is a cost and size
disadvantage.
[0198] Another exemplary identification device employs encryption.
With encryption comes the need for processing numbers and,
associated with such calculations, is use of processing chips
(e.g., a microprocessor), one of which is to be placed on the
interchangeable part, such as a staple cartridge or a replaceable
end effector shaft. Such encryption chips have certain
characteristics that can be analyzed for optimization with the
surgical instrument of the present invention. First, a separate
power source for the interchangeable part is not desired. Not only
would such a power source add cost, it would also add undesirable
weight and take up space that is needed for other features or is
just not available. Thus, power supply to the part should come from
the already existing power supply within the handle. Also, supply
of power should be insured at all times. Because the
interchangeable part is relatively small, the encryption chip
should be correspondingly small. Further, both the handle and the
interchangeable part are configured to be disposable, therefore,
both encryption processors should have a cost that allows
disposability. Finally, connections between the encryption device
on the interchangeable part and the corresponding encryption device
on the handle should be minimized. As will be discussed below, the
encryption device according to the present invention provides all
of these desirable characteristics and limits the undesirable
ones.
[0199] Devices for encrypted identification are commercially
available. One of such encryption devices is produced by Dallas
Semiconductor and is referred to as the DS2432 chip. The DS2432
chip not only provides encrypted identification between a reader
and a transponder, but it also has a memory that can be used to
store device-specific information, which information and its uses
will be described in further detail below. One beneficial
characteristic of the DS2432 is that it is a 1-wire device. This
means that the power and both of the input and output signals
travel on the same line. With a 1-wire device such as the DS2432,
there is only the need for a single wire to traverse the distance
from the handle body 10 through the anvil neck 30 to the
interchangeable staple cartridge 50 in order to make a connection
between the handle and the end effector. This configuration
satisfies the characteristic of having a minimal amount of
electrical connections and has a correspondingly reduced cost for
manufacture. It is true that the DS2432 chip requires ground,
however, the metallic anvil neck 30 is electrically conducting and
is connected to ground of the device 1, therefore, an exemplary
embodiment for the ground connection of the DS2432 chip is made by
direct electrical contact through a lead to the neck 30 or by
directly connecting the chip's ground to the neck 30.
[0200] One exemplary encryption circuit configuration places a
first encryption chip on the interchangeable part (e.g., the staple
cartridge). Ground for the first encryption chip is electrically
connected to a metallic portion of the interchangeable part which,
in turn, is electrically connected to ground of the device, for
example, to the neck 30. The 1-wire connection of the DS2432 chip
is electrically connected to a contact pad that is somewhere on the
interchangeable part but is electrically disconnected from ground.
For example, if the interchangeable part is a linear 60 mm staple
cartridge, the DS2432 can be attached to or embedded within the
electrically insulated distal end of the cartridge distal of the
last staple set. The encryption chip can be embedded on a side of
the cartridge opposite the staple ejection face so that it is
neither exposed to the working surfaces nor to the exposed tissue
when in use. The ground lead of the DS2432 chip can be electrically
connected to the metallic outer frame of the staple cartridge,
which is electrically connected to ground of the stapler. The
1-wire lead is electrically connected to a first conductive device
(such as a pad, a lead, or a boss) that is electrically insulated
from the metallic frame of the cartridge. A single electrically
conductive but insulated wire is connected at the proximal end to
the circuit board or to the appropriate control electronics within
the handle of the device. This wire is insulated from electrical
contact with any other part of the stapler, especially the grounded
frame, and travels from the handle, through the neck and up to the
receiving chamber for the interchangeable part. At the distal end,
the insulated wire is exposed and electrically connected to a
second conductive device (such as a pad, a lead, or a boss) that is
shaped to positively contact the first conductive device on the
cartridge when the cartridge is locked into place in the end
effector. In such a configuration, the two conductive devices form
a direct electrical connection every time that the interchangeable
part (e.g., the staple cartridge) is inserted within the end
effector; in one particular embodiment, contact can be made only
when the part is correctly inserted.
[0201] The DS2432 is also only a few square millimeters in area,
making the chip easy to install on a small interchangeable part,
such as a staple cartridge, while simultaneously satisfying the
minimal size requirement. It is noted that the DS2432 chip is
relatively inexpensive. To keep all communication with the DS2432
chip hidden from outside examination, a DS2460 (also manufactured
by Dallas Semiconductor) can be used to perform a comparison of an
encrypted transmission received from a DS2432 with an expected
result calculated internally. The characteristics of both of these
chips are explained, for example, by Dallas Semiconductors'
Application Note 3675, which is hereby incorporated by reference
herein in its entirety. The DS2460 chip costs significantly more
than the DS2432 chip, but is still inexpensive enough to be
disposed along with the handle. It is noted that the number of
disposable interchangeable parts of medical devices (such as the
surgical instrument of the present invention) typically outnumber
the handle that receives the interchangeable parts by a significant
amount. Accordingly, if the DS2432 chip is placed in the
interchangeable part and the DS2460 chip is placed in the handle,
the low cost encryption characteristic is satisfied. There exists
an alternative circuit configuration using two DS2432 chips that is
explained in FIG. 2 of Application Note 3675, which circuit
eliminates the need of the more expensive DS2460 chip by performing
the comparison with a local microprocessor (e.g., microprocessor
2000). In such a configuration, the cost for adding encryption into
the device 1 is reduced, however, as explained, the configuration
gives up some aspects of security by making available to inspection
both numbers that are to be compared.
[0202] The process for electronically verifying the identity of an
interchangeable part on a medical device using encryption is
described with an exemplary embodiment having one DS2432 chip and
one DS2460 chip. The exemplary control circuit for the encryption
device is shown in FIG. 30. This exemplary embodiment is described
using a linear stapler having a handle containing therein a circuit
board with a microprocessor 2000. One free I/O pin 2010 of the
microprocessor 2000 is connected to a first lead 2110 of the DS2460
and another I/O pin 2020 is connected to a second lead 2120. Each
interchangeable part 2200 is provided with a DS2432 chip and the
1-wire lead is connected to a third I/O pin 2030 of the
microprocessor 2000.
[0203] To start the process, an interchangeable part 2200 is
connected to the device, making electrical contact with ground and
with the 1-wire lead. When the microprocessor 2000 detects that a
new part 2200 has been connected to the device 1, it runs an
authentication routine. First, the microprocessor 2000 initiates a
random number request to the DS2460 over the first communication
pin 2010. The DS2460 has a pre-programmed secret number that is the
same as the pre-programmed secret numbers stored in each of the
DS2432 chips contained on the interchangeable parts 2200.
Therefore, when the same random number is provided to both the
DS2432 and the DS2460 chips, the output result from each of the two
chips will be identical. The DS2460 generates a random number and
supplies it, via the second pin 2020, to the microprocessor 2000
for forwarding, via pin 2030, on to the DS2432 over the 1-wire
lead. When the DS2432 receives the random number, it applies its
SHA-1 algorithm (developed by the National Institute of Standards
and Technology (NIST)) to cryptographically generate a hash code
reply. This hash code reply is transmitted back over the 1-wire
lead to the microprocessor 2000 and is forwarded, via either pin
2010 or 2020 to the DS2460. During this period of time, the DS2460
is also calculating its own a hash code reply. First, the DS2460
internally applies the same random number sent to the DS2432 to its
own SHA-1 algorithm and stores, internally, the generated hash code
reply. The DS2460 also stores the hash code reply transmitted from
the DS2432 through the microprocessor 2000. Both of the hash code
replies are compared and, if they are identical, the
interchangeable part 2200 is confirmed as authenticated. If there
is a difference between the hash code replies, then the part 2200
is rejected and the device is placed in a state where the part 2200
either cannot be used or can be used, but only after certain
safeguards are met. For example, data regarding the time, date,
environment, etc. and characteristics of the unauthenticated part
can be stored for later or simultaneous transmission to the
manufacturer (or its agent) to inform the manufacturer that the
user is attempting to use or has used an unauthorized part 2200
with the device. If there was no encryption in the messages, the
authentication messages could be intercepted and counterfeit,
pirated, or unauthorized parts 2200 could be used without having to
purchase the parts 2200 from an authorized distributor. In the
exemplary encryption embodiment described herein, the only
information that is transmitted across lines that can be examined
is a single random number and a single hash code reply. It is
understood that it would take hundreds of years to decrypt this
SHA-1-generated reply, thus reducing any incentive for reverse
engineering.
[0204] Because the chips used in this example each have secure
memories that can only be accessed after authentication occurs,
they can be programmed to employ multiple secret keys each stored
within the memory. For example, if the DS2460 has multiple keys
stored therein and the parts 2200 each have only one key selected
from this stored set of multiple keys, the DS2460 can act as a
"master" key to the "general" single keys of the parts 2200.
[0205] By authenticating the interchangeable part of the surgical
instrument of the present invention, many positive results are
obtained. First, the instrument manufacturer can prevent a user
from using unauthorized parts, thereby insuring use of only
authorized parts. Not only does this guarantee that the
manufacturer can receive royalties from sales of the
interchangeable part, but it also allows the manufacture to insure
that the quality of the surgical parts remains high. Having the
encryption circuitry contain memory dramatically enhances the
benefits provided by the present invention. For example, if a
single end effector of a linear stapler can receive 30 mm, 60 mm,
and 120 mm staple cartridges, for example, each size of the
cartridges could be provided with an individualized key and the
handle can be programmed to store and use each of these three keys.
Upon receiving a hash code reply that corresponds to one, but not
the other two internally calculated hash code replies, the handle
would know what kind of cartridge has been inserted in the device.
Each cartridge could also contain in its memory cartridge-specific
parameters, such as staple sled movement length, that are different
among the various sized cartridges and, therefore, cause the handle
to behave differently dependent upon the cartridge detected. The
parameters examined can also account for revision levels in the
particular part. For example, a revision 1 cartridge could have
certain parameters for use and, by detecting that particular
cartridge, programming could cause the handle to not allow use of
revision 1 cartridges but allow use of revision 2 cartridges, or
vice-versa.
[0206] Having memory on the encryption chips can also allow the
cartridge to keep track of other kinds of data. For example, the
cartridge can store the identity of each handle to which it was
connected, the identity of the handle that fired the cartridge, the
time, date and other temporal data when use and/or connection
occurred, how long it took to fire the cartridge, how many times
the firing trigger was actuated during staple firing, and many
other similar parameters. One parameter in particular could record
data when the cartridge misfires. This would allow the manufacturer
to determine if the cartridge was faulty or if user-error occurred,
for example, the latter being investigated to assist the user with
remedial measures or other training. By having memory available at
the handle, other handle-relevant parameters could be stored, for
example, duration of each procedure, speed of each staple firing,
torque generated at each firing, and/or load experienced throughout
each firing. The memory could be powered for years merely from the
lithium-based power cells already present in the handle. Thus,
longevity of handle data can be ensured. The memory can be used to
store all uses of a particular handle, along with relevant calendar
data. For example, if a handle is only certified for use in a
single surgical procedure but the handle has data indicating that
staple cartridges were fired days or weeks apart, then, when it was
finally returned to the manufacturer for recycling, the
manufacturer could detect that the user (hospital, doctor, clinic,
etc.) was improperly and, possibly, unsafely, using the handle.
Encrypted authentication can be used with removable battery packs
as well. Moreover, sensors can be added to any portion of the
device for communicating information to be stored within the memory
of the encryption chips. For example, temperature sensors can
transmit operating room temperature existing when the cartridge was
fired. This temperature reading can be used to determine if later
infection was caused by improper temperature control existing
during the procedure (e.g., in countries where air-conditioning is
not available).
[0207] In the unlikely event that the stapler becomes inoperable
during use, a mechanical override or bail-out is provided to allow
manual removal of the device from the patient. All bailout uses can
be recorded with the memory existing on these encryption chips.
Furthermore, data that could indicate why bailout was necessary
could be stored for later examination. For quality assurance, when
bailout is detected, the handle can be programmed to indicate that
a certified letter should be sent to the customer/user informing
them of the bailout use.
[0208] As described above, the present invention is not limited to
a circular stapler, which has been used as an exemplary embodiment
above, and can be applied to any surgical stapling head, such as a
linear stapling device, for example. Accordingly, a linear stapler
is being used in the text that follows for various exemplary
embodiment. However, use of a linear stapler in this context should
not be considered as limited only thereto.
[0209] Described above are components that exist along the staple
control axis 80 of linear and circular staplers and these
components form the staple control assembly 200. As set forth
therein, the required force for proper staple ejection and tissue
cutting can be over 200 pounds and, possibly, up to 250 pounds. It
has been determined that minimum requirements for carrying out the
desired stapling and cutting functions with a linear electric
surgical stapler for human tissue (such as colon tissue, for
example) are: [0210] 1) delivering approximately 54.5 kg (120
pounds) of force over a stroke of about 60 mm (.about.2.4'') in
approximately 3 seconds; or [0211] 2) delivering approximately 82
kg (180 pounds) of force over a stroke of about 60 mm
(.about.2.4'') in approximately 8 seconds. The electric-powered,
hand-held linear surgical stapling device of the present invention
can meet these requirements because it is optimized in a novel way
as set forth below.
[0212] To generate the force necessary to meet the above-mentioned
requirements, the maximum power (in watts) of the mechanical
assembly needs to be calculated based upon the maximum limits of
these requirements: 82 kg over 60 mm in 3 seconds. Mathematical
conversion of these figures generates an approximate maximum of 16
Watts of mechanical power needed at the output of the drive train.
Conversion of the electrical power into mechanical power is not 1:1
because the motor has less than 100% efficiency and because the
drive train also has less than 100% efficiency. The product of
these two efficiency ratings forms the overall efficiency. The
electrical power required to produce the 16 Watts of mechanical
power is greater than the 16 Watts by an inverse product of the
overall efficiency. Once the required electrical power can be
determined, an examination of available power supplies can be made
to meet the minimum power requirements. Thereafter, an examination
and optimization of the different power supplies can be made. This
analysis is described in detail in the following text.
[0213] Matching or optimizing the power source and the motor
involves looking into the individual characteristics of both. When
examining the characteristics of an electric motor, larger motors
can perform a given amount work with greater efficiency than
smaller motors. Also motors with rare-earth magnets or with
coreless construction can deliver the same power in a smaller size,
but at higher cost. Further, in general, larger motors cost less
than smaller motors if both are designed to deliver the same power
over a given period of time. Larger motors, however, have an
undesirable characteristic when used in surgical stapling devices
because the handle in which they are to be placed is limited by the
size of an operator's hand. Physicians desire to use devices that
are smaller and lighter, not larger and heavier. Based upon these
considerations, cost, size, and weight are factors that can be
optimized for use in the surgical stapler handle of the present
invention.
[0214] Available motors for use within a physician's hand include
motors with relatively inexpensive ceramic magnets and motors with
relatively expensive rare earth (i.e., neodymium) magnets. However,
the power increase of the latter as compared to the former is not
sufficiently large to warrant the substantial increase in cost of
the latter. Thus, ceramic magnet motors can be selected for use in
the handle. Exemplary motors come in standard sizes (diameter) of
27.5 mm or 24 mm, for example. These motors have a rated efficiency
of approximately 60% (which decreases to 30% or below depending
upon the size of the load). Such motors operate at speeds of
approximately 30,000 rpm (between 20,000 and 40,000 rpm) when
unloaded.
[0215] Even though such conventional motors could be used, it would
be desirable to reduce the size even further. To that effect, the
inventors have discovered that coreless, brush-type, DC motors
produce similar power output but with a significant reduction in
size. For example, a 17 mm diameter coreless motor can output
approximately the same power as a standard 24 mm diameter motor.
Unlike a standard motor, the coreless motor can have an efficiency
of up to 80%. Coreless motors almost all use rare earth
magnets.
[0216] With such a limited volume and mechanical power available,
it is desirable to select a mechanical gear train having the
greatest efficiency. Placing a rack and pinion assembly as the
final drive train control stage places a high-efficiency end stage
in the drive train as compared to a screw drive because, in
general, the rack and pinion has an approximate 95% efficiency, and
the screw drive has a maximum of about 80% efficiency. For the
linear electric stapler, there is a 60 mm travel range for the
stapling/cutting mechanism when the stapler has a 60 mm cartridge
(cartridges ranging from 30 mm to 100 mm can be used but 60 mm is
used in this example for illustrative purposes). With this travel
range, a 3-second, full travel duration places the rack and pinion
extension rate at 0.8 inches per second. To accomplish this with a
reasonably sized rack and pinion assembly, a gear train should
reduce the motor output to approximately 60 rpm. With a motor
output speed of approximately 30,000 rpm, the reduction in speed
for the drive train becomes approximately 500:1. To achieve this
reduction with the motor, a 5-stage drive train is selected. It is
known that such drive trains have an approximate 97% efficiency for
each stage. Thus, combined with an approximate 95% efficiency of
the rack and pinion, the overall efficiency of the drive train is
(0.95)(0.97).sup.5 or 82%. Combining the 60% motor efficiency with
the 82% drive train efficiency yields an overall electrical to
final mechanical efficiency of approximately 49.2%. Knowing this
overall efficiency rating, when determining the amount of
electrical power required for operating the stapler within the
desired requirements, the actual electrical power needed is almost
twice the value that is calculated for producing the
stapling/cutting force.
[0217] To generate the force necessary to meet the above-mentioned
requirements, the power (in watts) of the mechanical assembly can
be calculated based upon the 82 kg over 60 mm in 3 seconds to be
approximately 16 Watts. It is known that the overall mechanical
efficiency is 49.2%, so 32.5 Watts is needed from the power supply
(16 mech. watts.apprxeq.32.5 elec. Watts.times.0.492 overall
efficiency.). With this minimum requirement for electrical power,
the kind of cells available to power the stapler can be identified,
which, in this case, include high-power Lithium Primary cells. A
known characteristic of high-power Lithium cells (e.g., CR123 or
CR2 cells) is that they produce about 5 peak watts of power per
cell. Thus, at least six cells in series will generate the required
approximate amount of 32.5 watts of electrical power, which
translates into 16 watts of mechanical power. This does not end the
optimization process because each type of high-power Lithium cell
manufactured has different characteristics for delivering peak
power and these characteristics differ for the load that is to be
applied.
[0218] Various battery characteristics exist that differentiate one
battery of a first manufacturer from another battery of a second
manufacturer. Significant battery characteristics to compare are
those that limit the power that can be obtained from a battery, a
few of which include: [0219] type of electrolyte in the cell;
[0220] electrolyte concentration and chemistry; [0221] how the
anode and cathode are manufactured (both in chemistry and in
mechanical construction); and [0222] type and construction of the
PTC (positive temperature coefficient of resistance) device.
Testing of one or more of these characteristics gives valuable
information in the selection of the most desirable battery for use
in the stapling device. It has been found that an examination of
the last characteristic--PTC device behavior--allows an
optimization of the type of battery to perform the desired
work.
[0223] Most power sources are required to perform, with relative
certainty and efficiency, many times throughout a long period of
time. When designing and constructing a power source, it is not
typical to select the power source for short-duration use combined
with a low number of uses. However, the power source of an electric
stapling device is only used for a short duration and for a small
number of times. In each use, the motor needs to be ready for a
peak load and needs to perform without error. This means that, for
surgical staplers, the stapling/cutting feature will be carried out
during only one medical procedure, which has cycle counts of
between 10 and 20 uses at most, with each use needing to address a
possible peak load of the device. After the one procedure, the
device is taken out of commission and discarded. Therefore, the
power source for the present invention needs to be constructed
unlike any other traditional power supply.
[0224] The device according to the present invention is constructed
to have a limited useful life of a power cell as compared to an
expected useful life of the power cell when not used in the device.
When so configured, the device is intended to work few times after
this defined "life span." It is known that self-contained power
supplies, such as batteries, have the ability to recover after some
kind of use. For optimization with the present invention, the
device is constructed within certain parameters that, for a defined
procedure, will perform accordingly but will be limited or unable
to continue performance if the time of use extends past the
procedure. Even though the device might recover and possibly be
used again in a different procedure, the device is designed to use
the power cells such that they will most likely not be able to
perform at the enhanced level much outside the range of intended
single use periods or outside the range of aggregate use time. With
this in mind, a useful life or clinical life of the power supply or
of the device is defined, which life can also be described as an
intended use. It is understood that this useful/clinical life does
not include periods or occurrences of use during a testing period
thereof to make sure that the device works as intended. The life
also does not include other times that the device is activated
outside the intended procedure, i.e., when it is not activated in
accordance with a surgical procedure.
[0225] Conventional batteries available in the market are designed
to be used in two ways: (1) provide a significant amount of power
for a short duration (such as in a high-drain digital device like
cameras) or (2) provide a small amount of power over a long
duration (such as a computer's clock backup). If either of these
operations is not followed, then the battery begins to heat up. If
left unchecked, the battery could heat to a point where the
chemicals could cause significant damage, such as an explosion. As
is apparent, battery explosion is to be avoided. These extremes are
prevented in conventional batteries with the presence of the PTC
device--a device that is constructed to limit conduction of the
battery as the battery increases in temperature (i.e., a positive
temperature coefficient of resistance). The PTC device protects
batteries and/or circuits from overcurrent and overtemperature
conditions. Significantly, the PTC device protects a battery from
external short circuits while still allowing the battery to
continue functioning after the short circuit is removed. Some
batteries provide short-circuit and/or overtemperature protection
using a one-time fuse. However, an accidental short-circuit of such
a fused battery causes the fuse to open, rendering the battery
useless. PTC-protected batteries have an advantage over fused
batteries because they are able to automatically "reset" when the
short circuit is removed, allowing the battery to resume its normal
operation. Understanding characteristics of the PTC device is
particularly important in the present invention because the motor
will be drawing several times greater current than would ever be
seen in a typical high-drain application.
[0226] The PTC device is provided in series with the anode and
cathode and is made of a partially conducting layer sandwiched
between two conductive layers, for example. The device is in a
low-resistance condition at a temperature during a normal operation
(depending on circuit conditions in which the device is used, for
example, from room temperature to 40.degree. C.). On exposure to
high temperature due to, for example, unusually large current
resulting from the formation of a short circuit or excessive
discharge (depending on circuit conditions in which the device is
used, for example, from 60.degree. to 130.degree. C.), the PTC
device switches into an extremely high-resistance mode. Simply put,
when a PTC device is included in a circuit and an abnormal current
passes through the circuit, the device enters the higher
temperature condition and, thereby, switches into the higher
resistance condition to decrease the current passing through the
circuit to a minimal level and, thus, protect electric elements of
the circuit and the battery/ies. At the minimal level (e.g., about
20% of peak current), the battery can cool off to a "safe" level at
which time greater power can be supplied. The partially conducting
layer of the PTC device is, for example, a composite of carbon
powder and polyolefin plastic. Further description of such devices
is unnecessary, as these devices are described and are well known
in the art.
[0227] Because PTC circuits of different manufacturers operate with
different characteristic behaviors, the present invention takes
advantage of this feature and provides a process for optimizing the
selection of a particular battery to match a particular motor and a
particular use. An examination of the time when the PTC device
switches to the higher resistance condition can be used as this
indicator for optimizing a particular motor and drive train to a
battery. It is desirable to know when the PTC device makes this
switch so that, during normal stapler use, the PTC device does not
make this change.
[0228] Exemplary batteries were loaded with various levels from
approximately 3 amps to approximately 8 amps. At the high end, the
PTC device changed to the high-resistance state almost immediately,
making this current level too high for standard CR123 cells. It was
determined that, for between 4 and 6 amps, one manufacturer's cell
had PTC activation sooner than another manufacturer's cell. The
longest PTC changeover duration for the second manufacturer was
>3 minutes for 4 amps, approximately 2 minutes for 5 amps, and
almost 50 seconds for 6 amps. Each of these durations was
significantly greater than the 8-second peak load requirement.
Accordingly, it was determined that the second manufacturer's cells
would be optimal for use at peak amps as compared to the first
manufacturer's cells.
[0229] Initially, it was surmised that higher amperes with lower or
constant voltage would generate higher power out of the power
cell(s). Based upon the configuration of 6 cells in series, the
peak voltage could be 18 volts with a peak current of only 6 amps.
Placing cells in parallel, in theory, should allow a higher peak
amperage and a 3.times.2 configuration (two parallel set of three
cells in series) could have a 9 volt peak with up to a 12 amp
peak.
[0230] Different single cells were investigated and it was
confirmed that a relatively low voltage (about 1.5 to 2 volts) and
approximately 4 to 6 amperes produces the highest power in Watts.
Two six-cell configurations were examined: a 6.times.1 series
connection and a 3.times.2 parallel connection. The 3.times.2
configuration produced the greatest peak amperes of approximately
10 amps. The 6.times.1 configuration produced about 6 amps peak and
the single cell was able to peak at 5-6 amps before the PTC device
changed state. This information indicated the state at which any
single cell in the series group would be activating its PTC device
and, thus, limiting current through the entire group of cells.
Thus, the tentative conclusion of yielding peak amps at lower
voltage with a 3.times.2 configuration was maintained.
[0231] Three different CR123 battery configurations were tested:
4.times.1, 6.times.1, and 3.times.2, to see how fast the pinion
would move the rack (in inches per second ("IPS")) for the 120# and
180# loads and for a given typical gearing. The results of this
real world dynamic loading test are shown in the chart of FIG. 31,
for both the 120# load: [0232] the 4.times.1 battery pack was able
to move the load at about 0.6 IPS at approximately 2.5 amps but at
approximately 8 volts; [0233] the 6.times.1 battery pack was able
to move the load at about 0.9 IPS at approximately 2.5 amps but at
approximately 13 volts; and [0234] the 3.times.2 battery pack was
able to move the load at about 0.4 IPS at approximately 2.5 amps
but at approximately 6 volts; and the 180# load: [0235] the
4.times.1 battery pack was able to move the load at about 0.65 IPS
at approximately 4 amps but at approximately 7.5 volts; [0236] the
6.times.1 battery pack was able to move the load at about 0.9 IPS
at approximately 4 amps but at approximately 12 volts; and [0237]
the 3.times.2 battery pack was able to move the load at about 0.4
IPS at approximately 4 amps but at approximately 7 volts. Clearly,
the peak current was limited and this limit was dependent upon the
load. This experiment revealed that the motor drew a similar
current regardless of the power supply for a given load but that
the voltage changed depending upon the battery cell configuration.
With respect to either load, the power output was the greatest in
the 6.times.1 configuration and not in the 3.times.2 configuration,
as was expected. From this, it was determined that the total power
of the cell pack is driven by voltage and not by current and,
therefore, the parallel configuration (3.times.2) was not the path
to take in optimizing the power source.
[0238] Traditionally, when designing specifications for a motor,
the windings of the motor are matched to the anticipated voltage at
which the motor will be run. This matching takes into account the
duration of individual cycles and the desired overall life of the
product. In a case of an electric stapling device the motor will
only be used for very short cycles and for a very short life,
traditional matching methods yield results that are below optimal.
Manufacturers of the motors give a voltage rating on a motor that
corresponds to the number of turns of the windings. The lower the
number of turns, the lower the rated voltage. Within a given size
of motor winding, a lower number of turns allows larger wire to be
used, such that a lower number of turns results in a lower
resistance in the windings, and a higher number of turns results in
a higher resistance. These characteristics limit the maximum
current that the motor will draw, which is what creates most of the
heat and damage when the motor is overdriven. For the present
invention, a desirable configuration will have the lowest winding
resistance to draw the most current from the power supply (i.e.,
battery pack). By running the motor at a voltage much higher than
the motor rating, significantly greater power can be drawn from
similarly sized motors. This trait was verified with testing of
nearly identical coreless motors that only varied in winding
resistance (and, hence, the number of turns). For example, 12-volt
and 6-volt rated motors were run with 6 cells (i.e., at 19.2
volts). The motors rated for 12 volts output peak power of 4 Watts
with the battery voltage only falling slightly to 18 volts when
drawing 0.7 amps. In comparison, the motors rated for 6 volts
output 15 Watts of power with the voltage dropping to 15 volts but
drawing 2 amps of current. Therefore, the lower resistance windings
were selected to draw enough power out of the batteries. It is
noted that the motor windings should be balanced to the particular
battery pack so that, in a stall condition, the motor does not draw
current from the cells sufficient to activate the PTC, which
condition would impermissibly delay use of an electric surgical
stapler during an operation.
[0239] The 6.times.1 power cell configuration appeared to be more
than sufficient to meet the requirements of the electric stapling
device. Nonetheless, at this point, the power cell can be further
optimized to determine if six cells are necessary to perform the
required work. Four cells were, then, tested and it was determined
that, under the 120# load, the motor/drive train could not move the
rack over the 60 mm span within 3 seconds. Six cells were tested
and it was determined that, under the 120# load, the motor/drive
train could move the rack over the 60 mm span in 2.1 seconds--much
faster than the 3-second requirement. It was further determined
that, under the 180# load, the motor/drive train could move the
rack over the 60 mm span in less than 2.5 seconds--much quicker
than the 8-second requirement. At this point, it is desirable to
optimize the power source and mechanical layout to make sure that
there is no "runaway" stapling/cutting; in other words, if the load
is significantly less than the required 180# maximum, or even the
120# maximum, then it would not be desirable to have the rack move
too fast.
[0240] The gear reduction ratio and the drive system need to be
optimized to keep the motor near peak efficiency during the firing
stroke. The desired stroke of 60 mm in 3 seconds means a minimum
rack velocity of 20 mm/sec (.about.0.8 inches/second). To reduce
the number of variables in the optimization process, a basic
reduction of 333:1 is set in the gear box. This leaves the final
reduction to be performed by the gears present between the output
shaft 214 of the gear box and the rack 217, which gears include,
for example, a bevel gear 215 and the pinion 216 (which drives the
rack), a simplified example of which is illustrated in FIG. 32.
[0241] These variables can be combined into the number of inches of
rack travel with a single revolution of the output shaft 214 of the
333:1 gearbox. If the gearbox output (in rpm) never changed, it
would be a simple function to match the inches of rack travel per
output shaft revolution ("IPR") to the output rpm to get a desired
velocity as follows:
(60 rpm.fwdarw.1 revolution/second (rps); 1 rps @.fwdarw.0.8 IPR
0.8 in/sec).
In such an idealized case, if the IPR is plotted against velocity,
a straight line would be produced. Velocity over a fixed distance
can be further reduced to Firing Time. Thus, a plot of Firing Time
versus IPR would also be a straight line in this idealized case.
However, output of the motor (in rpm) and, therefore, of the
gearbox, is not fixed because this speed varies with the load. The
degree of load determines the amount of power the motor can put
out. As the load increases, the rpms decrease and the efficiency
changes. Based upon an examination of efficiency with differing
loads, it has been determined that efficiency peaks at just over
60%. However, the corresponding voltage and amperes at this
efficiency peak are not the same as at the point of peak power.
Power continues to increase as the load increases until the
efficiency is falling faster than the power is increasing. As the
IPR increases, an increase in velocity is expected, but a
corresponding increase in IPR lowers the mechanical advantage and,
therefore, increases the load. This increasing load, with the
corresponding decrease in efficiency at progressively higher loads,
means that a point will exist when greater velocity out of the rack
is no longer possible with greater IPR. This behavior is reflected
as a deviation from a predicted straight line in the plot of Firing
Time (in sec) versus IPR. Experimentation of the system of the
present invention reveals that the boundary between unnecessary
mechanical advantage and insufficient mechanical advantage occurs
at approximately 0.4 IPR.
[0242] From this IPR value, it is possible to, now, select the
final gear ratio of the bevel gear 215 to be approximately three
times greater (3:1) than the sprocket of the output shaft. This
ratio translates into an approximate IPR of 0.4.
[0243] Now that the bevel gear 215 has been optimized, the battery
pack can be reexamined to determine if six cells could be reduced
to five or even four cells, which would save cost and considerably
decrease the volume needed for the power supply within the handle.
A constant load of approximately 120# was used with the optimized
motor, drive train, bevel gear, and rack and pinion and it was
discovered that use of 4 cells resulted in an almost 5 second time
period for moving the rack 60 mm. With 5 cells, the time was
reduced to approximately 3.5 seconds. With a 6-cell configuration,
the time was 2.5 seconds. Thus, interpolating this curve resulted
in a minimum cell configuration of 5.5 cells. Due to the fact that
cells only can be supplied in integer amounts, it was discovered
that the 6-cell configuration was needed to meet the requirements
provided for the electric stapling device.
[0244] From this, the minimum power source volume could be
calculated as a fixed value, unless different sized cells could be
used that provided the same electrical power characteristics.
Lithium cells referred as CR2s have similar electrical power
characteristics as have CR123s but are smaller. Therefore, using a
6-cell power supply of CR2s reduced the space requirement by more
than 17%.
[0245] As set forth in detail above, the power source (i.e.,
batteries), drive train, and motor are optimized for total
efficiency to deliver the desired output force within the required
window of time for completing the surgical procedure. The
efficiency of each kind of power source, drive train, and motor was
examined and, thereafter, the type of power source, drive train,
and motor was selected based upon this examination to deliver the
maximum power over the desired time period. In other words, the
maximum-power condition (voltage and current) is examined that can
exist for a given period of time without activating the PTC (e.g.,
approximately 15 seconds). The present invention locates the
voltage-current-power value that optimizes the way in which power
is extracted from the cells to drive the motor. Even after such
optimization, other changes can be made to improve upon the
features of the electric stapler 1.
[0246] Another kind of power supply can be used and is referred to
herein as a "hybrid" cell. In such a configuration, a rechargeable
Lithium-ion or Lithium-polymer cell is connected to one or more of
the optimized cells mentioned above (or perhaps another primary
cell of smaller size but of a similar or higher voltage). In such a
configuration, the Li-ion cell would power the stapling/cutting
motor because the total energy contained within one CR2 cell is
sufficient to recharge the Li ion cell many times, however, the
primary cells are limited as to delivery. Li-ion and Li-Polymer
cells have very low internal resistance and are capable of very
high currents over short durations. To harness this beneficial
behavior, a primary cell (e.g., CR123, CR2, or another cell) could
take 10 to 30 seconds to charge up the secondary cell, which would
form an additional power source for the motor during firing. An
alternative embodiment of the Li-ion cell is the use of a
capacitor; however, capacitors are volume inefficient. Even so, a
super capacitor may be put into the motor powering system; it may
be disconnected electrically therefrom until the operator
determines that additional power is required. At such a time, the
operator would connect the capacitor for an added "boost" of
energy.
[0247] As mentioned above, if the load on the motor increases past
a given point, the efficiency begins to decrease. In such a
situation, a multi-ratio transmission can be used to change the
delivered power over the desired time period. When the load becomes
too great such that efficiency decreases, a multi-ratio
transmission can be used to switch the gear ration to return the
motor to the higher efficiency point, at which, for example, at
least a 180# force can be supplied. It is noted, however, that the
motor of the present invention needs to operate in both forward and
reverse directions. In the latter operating mode, the motor must be
able to disengage the stapling/cutting instrument from out of a
"jammed" tissue clamping situation. Thus, it would be beneficial
for the reverse gearing to generate more force than the forward
gearing.
[0248] With significantly varying loads, e.g., from low pounds up
to 180 pounds, there is the possibility of the drive assembly being
too powerful in the lower end of the load range. Thus, the
invention can include a speed governing device. Possible governing
devices include dissipative (active) governors and passive
governors. One exemplary passive governor is a flywheel, such as
the energy storage element 56, 456 disclosed in U.S. Patent
Application No. 2005/0277955 to Palmer et al. Another passive
governor that can be used is a "fly" paddlewheel. Such an assembly
uses wind resistance to govern speed because it absorbs more force
as it spins faster and, therefore, provides a speed governing
characteristic when the motor is moving too fast. Another kind of
governor can be a compression spring that the motor compresses
slowly to a compressed state. When actuation is desired, the
compressed spring is released, allowing all of the energy to be
transferred to the drive in a relatively short amount of time. A
further exemplary governor embodiment can include a multi-stage
switch having stages that are connected respectively to various
sub-sets of the battery cells. When low force is desired, a first
switch or first part of a switch can be activated to place only a
few of the cells in the power supply circuit. As more power is
desired, the user (or an automated computing device) can place
successive additional cells into the power supply circuit. For
example, in a 6-cell configuration, the first 4 cells can be
connected to the power supply circuit with a first position of a
switch, the fifth cell can be connected with a second position of
the switch, and the sixth cell can be connected with a third
position of the switch.
[0249] Electric motors and the associated gear box produce a
certain amount of noise when used. The stapler of the present
invention isolates the motor and/or the motor drive train from the
handle to decrease both the acoustic and vibration characteristics
and, thereby, the overall noise produced during operation. In a
first embodiment, a dampening material is disposed between the
handle body and both of motor and the drive train. The material can
be foam, such as latex, polyester, plant-based, polyether,
polyetherimide, polyimide, polyolefin, polypropylene, phenolic,
polyisocyanates, polyurethane, silicone, vinyl, ethylene copolymer,
expanded polyethylene, fluoropolymer, or styrofoam. The material
can be an elastomer, such as silicone, polyurethane, chloroprene,
butyl, polybutadiene, neoprene, natural rubber, or isoprene. The
foam can be closed cellular, open cellular, flexible, reticular, or
syntactic, for example. The material can be placed at given
positions between the handle and motor/gear box or can entirely
fill the chamber surrounding the motor/gear box. In a second
embodiment, the motor and drive train are isolated within a nested
box configuration, sometimes referred to as a "Chinese Box" or
"Russian nesting doll." In such a configuration, the dampening
material is placed around the motor/gear box and the two are placed
within a first box with the gear box shaft protruding therefrom.
Then, the first box is mounted within the "second box"--the handle
body--and the dampening material is place between the first box and
the handle interior.
[0250] The electric stapler of the present invention can be used in
surgical applications. Most stapling devices are one-time use. They
can be disposed after one medical procedure because the cost is
relatively low. The electric surgical stapler, however, has a
greater cost and it may be desirable to use at least the handle for
more than one medical procedure. Accordingly, sterilization of the
handle components after use becomes an issue. Sterilization before
use is also significant. Because the electric stapler includes
electronic components that typically do not go through standard
sterilization processes (i.e., steam or gamma radiation), the
stapler needs to be sterilized by other, possibly more expensive,
means such as ethylene-oxide gas. It would be desirable, however,
to make the stapler available to gamma radiation sterilization to
reduce the cost associated with gas sterilization. It is known that
electronics are usable in space, which is an environment where such
electronics are exposed to gamma radiation. In such applications,
however, the electronics need to work while being exposed. In
contrast, the electric stapler does not need to work while being
exposed to the gamma sterilization radiation. When semiconductors
are employed, even if the power to the electronics is turned off,
gamma radiation will adversely affect the stored memory. These
components only need to withstand such radiation and, only after
exposure ceases, need to be ready for use. Knowing this, there are
various measures that can be taken to gamma-harden the electronic
components within the handle. First, instead of use MOSFET memory,
for example, fusable link memories can be used. For such memories,
once the fuses are programmed (i.e., burnt), the memory becomes
permanent and resistant to the gamma sterilization. Second, the
memory can be mask-programmed. If the memory is hard programmed
using masks, gamma radiation at the level for medical sterilization
will not adversely affect the programming. Third, the sterilization
can be performed while the volatile memory is empty and, after
sterilization, the memory can be programmed through various
measures, for example, a wireless link including infrared, radio,
ultrasound, or Bluetooth communication can be used. Alternatively,
or additionally, external electrodes can be contacted in a clean
environment and these conductors can program the memory. Finally, a
radiopaque shield (made from molybdenum or tungsten, for example)
can be provided around the gamma radiation sensitive components to
prevent exposure of these components to the potentially damaging
radiation.
[0251] As set forth herein, characteristics of the battery, drive
train, and motor are examined and optimized for an electric
stapling application. The particular design (i.e., chemistry and
PTC) of a battery will determine the amount of current that can be
supplied and/or the amount of power that can be generated over a
period of time. It has been determined that standard alkaline cells
do not have the ability to generate the high power needed over the
short period of time to effect actuation of the electric stapling
device. It was also determined that some lithium-manganese dioxide
cells also were unable to meet the needs for actuating the stapling
device. Therefore, characteristics of certain lithium-manganese
dioxide cell configurations were examined, such as the electrolyte
and the positive temperature coefficient device.
[0252] It is understood that conventional lithium-manganese dioxide
cells (e.g., CR123 and CR2) are designed for loads over a long
period of time. For example, SUREFIRE.RTM. markets flashlights and
such cells and states that the cells will last for from 20 minutes
to a few hours (3 to 6) at the maximum lumen output of the
flashlight. Load upon the cells(s) during this period of time is
not close to the power capacity of the battery(ies) and, therefore,
the critical current rate of the battery(ies) is not reached and
there is no danger of overheating or explosion. If such use is not
continuous, the batteries can last through many cycles (i.e.,
hundreds) at this same full power output.
[0253] Simply put, such batteries are not designed for loads over a
period of 10 seconds or less, for example, five seconds, and are
also not designed for a small number of uses, for example, ten to
fifteen. What the present invention does is to configure the power
supply, drive train, and motor to optimize the power supply (i.e.,
battery) for a small number of uses with each use occurring over a
period of less than ten seconds and at a load that is significantly
higher than rated.
[0254] All of the primary lithium cells that were examined possess
a critical current rate defined by the respective PTC device and/or
the chemistry and internal construction. If used above the critical
current rate for a period of time, the cells can overheat and,
possibly, explode. When exposed to a very high power demand (close
to the PTC threshold) with a low number of cycles, the voltage and
amperage profiles do not behave the same as in prior art standard
uses. It has been found that some cells have PTC devices that
prevent generation of power required by the stapler of the present
invention, but that other cells are able to generate the desired
power (can supply the current an voltage) for powering the electric
stapling device. This means that the critical current rate is
different depending upon the particular chemistry, construction,
and/or PTC of the cell.
[0255] The present invention configures the power supply to operate
in a range above the critical current rate, referred to herein as
the "Super-Critical Current Rate." It is noted within the
definition of Super-Critical Current Rate also is an averaging of a
modulated current supplied by the power supply that is above the
critical current rate. Because the cells cannot last long while
supplying power at the Super-Critical Current Rate, the time period
of their use is shortened. This shortened time period where the
cells are able to operate at the Super-Critical Current Rate is
referred to herein as the "Super-Critical Pulse Discharge Period,"
whereas the entire time when the power supply is activated is
referred to as a "Pulse Discharge Period." In other words, the
Super-Critical Pulse Discharge Period is a time that is less than
or equal to the Pulse Discharge Period, during which time the
current rate is greater than the critical current rate of the
cells. The Super-Critical Pulse Discharge Period for the present
invention is less than about 16 seconds, in other words, in a range
of about one-half to fifteen seconds, for example, between two and
four seconds and, more particularly, at about three seconds. During
the life of the stapling device, the power supply may be subjected
to the Super-Critical Current Rate over the Pulse Discharge Period
for at least one time and less than twenty times within the time of
a clinical procedure, for example, between approximately five and
fifteen times, in particular, between ten and fifteen times within
a period of five minutes. Therefore, in comparison to the hours of
use for standard applications of the power supply, the present
invention will have an aggregate use, referred to as the Aggregate
Pulse Time, of, at most, approximately 200 to 300 seconds, in
particular, approximately 225 seconds. It is noted that, during an
activation, the device may not be required to exceed or to always
exceed the Super-Critical Current Rate in a given procedure because
the load presented to the instrument is dependent upon the specific
clinical application (i.e., some tissue is denser than others and
increased tissue density will increase load presented to device).
However, the stapler is designed to be able to exceed the
Super-Critical Current Rate for a number of times during the
intended use of the surgical procedure. Acting in this
Super-Critical Pulse Discharge Period, the device can operate a
sufficient amount of times to complete the desired surgical
procedure, but not many more because the power supply is asked to
perform at an increased current.
[0256] When performing in the increased range, the force generated
by the device, e.g., the electric stapler 1, is significantly
greater than existed in a hand-powered stapler. In fact, the force
is so much greater that it could damage the stapler itself. In one
exemplary use, the motor and drive assemblies can be operated to
the detriment of the knife blade lock-out feature--the safety that
prevents the knife blade 1060 from advancing when there is no
staple cartridge or a previously fired staple cartridge in the
staple cartridge holder 1030. This feature is illustrated in FIG.
33. As discussed, the knife blade 1060 should be allowed to move
distally only when the staple sled 102 is present at the
firing-ready position, i.e., when the sled 102 is in the position
illustrated in FIG. 33. If the sled 102 is not present in this
position, this can mean one of two things, either there is no
staple cartridge in the holder 1030 or the sled 102 has already
been moved distally--in other words, a partial or full firing has
already occurred with the loaded staple cartridge. Thus, the blade
1060 should not be allowed to move, or should be restricted in its
movement. Accordingly, to insure that the sled 102 can prop up the
blade 1060 when in a firing state, the sled 102 is provided with a
lock-out contact surface 104 and the blade 1060 is provided with a
correspondingly shaped contact nose 1069. It is noted at this point
that, the lower guide wings 1065 do not rest against a floor 1034
in the cartridge holder 1030 until the blade 1060 has moved
distally past an edge 1035. With such a configuration, if the sled
102 is not present at the distal end of the blade 1060 to prop up
the nose 1069, then the lower guide wings 1065 will follow the
depression 1037 just proximal of the edge 1035 and, instead of
advancing on the floor 1034, will hit the edge 1035 and prevent
further forward movement of the blade 1060. To assist with such
contact when the sled 102 is not present (referred to as a "lock
out"), the staple cartridge 1030 has a plate spring 1090 (attached
thereto by at least one rivet 1036) for biasing the blade 1060.
With the plate spring 1090 flexed upward and pressing downward
against the flange 1067 (at least until the flange 1067 is distal
of the distal end of the plate spring 1090), a downwardly directed
force is imparted against the blade 1060 to press the wings 1065
down into the depression 1037. Thus, as the blade 1060 advances
distally without the sled 102 being present, the wings 1065 follow
the lower curve of the depression 1037 and are stopped from further
distal movement when the distal edge of the wings 1065 hit the edge
1035.
[0257] This safety feature operates as described so long as the
force transmitted by the knife blades 1062 to the blade 1060 is not
great enough to tear off the lower guide wings 1065 from the blade
1060. With the forces able to be generated by the power supply,
motor and drive train of the present invention, the blade 1060 can
be pushed distally so strongly that the wings 1065 are torn away.
If this occurs, there is no way to prevent distal movement of the
blade 1060 or the sled 102. Accordingly, the present invention
provides a way to lower the forces able to be imparted upon the
wings 1065 prior to their passage past the edge 1035. In other
words, the upper limit of force able to be applied to the blade
1060 is reduced in the first part of blade travel (past the edge
1035) and increases after the wings 1065 have cleared the edge 1035
and rest on the floor 1034. More specifically, a first exemplary
embodiment of this two-part force generation limiter takes the form
of a circuit in which only one or a few of the cells in the power
supply are connected to the motor during the first part of the
stapling/cutting stroke and, in the second part of the
stapling/cutting stroke, most or all of the cells in the power
supply are connected to the motor. A first exemplary form of such a
circuit is illustrated in FIG. 34. In this first embodiment, when
the switch 1100 is in the "A" position, the motor (e.g., stapling
motor 210) is only powered with one power cell 602 (of a possible
four in this exemplary embodiment). However, when the switch 1100
is in the "B" position, the motor is powered with all four of the
cells 602 of the power supply 600, thereby increasing the amount of
force that can be supplied to the blade 1060. Control of the switch
1100 between the A and B positions can occur by positioning a
second switch somewhere along the blade control assembly or along
the sled 102, the second switch sending a signal to a controller
after the wings 1065 have passed the edge 1035. It is noted that
this first embodiment of the control circuit is only exemplary and
any similarly performing assembly can provide the lock-out
protection for the device, see, for example, the second exemplary
embodiment illustrated in FIG. 36.
[0258] A first exemplary form of a forward and reverse motor
control circuit is illustrated in FIG. 35. This first exemplary
embodiment uses a double-throw, double pole switch 1200. The switch
1200 is normally spring-biased to a center position in which both
poles are off. The motor M illustrated can, for example, represent
the stapling motor 210 of the present invention. As can be seen,
the power-on switch 1210 must be closed to turn on the device. Of
course, this switch is optional. When a forward movement of the
motor M is desired, the switch 1200 is placed in the right position
as viewed in FIG. 35, in which power is supplied to the motor to
run the motor in a first direction, defined as the forward
direction here because the "+" of the battery is connected to the
"+" of the motor M. In this forward switching position, the motor M
can power the blade 1060 in a distal direction. Placement of an
appropriate sensor or switch to indicate the forward-most desired
position of the blade 1060 or the sled 102 can be used to control a
forward travel limit switch 1220 that interrupts power supply to
the motor M and prevents further forward travel, at least as long
as the switch 1220 remains open. Circuitry can be programmed to
never allow this switch 1220 to close and complete the circuit or
to only allow resetting of the switch 1220 when a new staple
cartridge, for example, is loaded.
[0259] When a reverse movement of the motor M is desired, the
switch 1200 is placed in the left position as viewed in FIG. 35, in
which power is supplied to the motor to run the motor in a second
direction, defined as the reverse direction here because the "-" of
the battery is connected to the "+" of the motor M. In this reverse
switching position, the motor M can power the blade 1060 in a
proximal direction. Placement of an appropriate sensor or switch to
indicate the rearward-most desired position of the blade 1060 or
the sled 102 can be used to control a rearward travel limit switch
1230 that interrupts power supply to the motor M and prevents
further rearward travel, at least as long as the switch 1230
remains open. It is noted that other switches (indicated with
dotted arrows) can be provided in the circuit to selectively
prevent movement in either direction independent of the limit
switches 1220, 1230.
[0260] It is noted that the motor can power the gear train with a
significant amount of force, which translates into a high
rotational inertia. As such, when any switch mentioned with respect
to FIGS. 34 and 35 is used to turn off the motor, the gears may not
just stop. Instead, the rotational inertia continues to propel, for
example, the rack 217 in the direction it was traveling when power
to the motor was terminated. Such movement can be disadvantageous
for many reasons. By configuring the power supply and motor
appropriately, a circuit can be formed to substantially eliminate
such post-termination movement, thereby giving the user more
control over actuation.
[0261] FIG. 36 illustrates an exemplary embodiment where the motor
(for example, stapling motor 210) is arrested from further rotation
when forward or reverse control is terminated. FIG. 36 also
illustrates alternative embodiments of the forward/reverse control
and of the multi-stage power supply. The circuit of FIG. 36 has a
motor arrest sub-circuit utilizing a short-circuit property of an
electrical motor. More specifically, the electrical motor M is
placed into a short-circuit so that an electrically generated
magnetic field is created in opposition to the permanent magnetic
field, thus slowing the still-spinning motor at a rate that
substantially prevents inertia-induced over-stroke. To explain how
the circuit of FIG. 36 can brake the motor M, an explanation of the
forward/reverse switch 1300 is provided. As can be seen, the
forward/reverse switch 1300 has three positions, just like the
switch 1200 of FIG. 35. When placed in the right position, the
motor M is actuated in a forward rotation direction. When placed in
the left position, the motor M is actuated in a rearward rotation
direction. When the switch 1300 is not actuated--as shown in FIG.
36--the motor M is short circuited. This short circuit is
diagrammatically illustrated by the upper portion of the switch
1300. It is noted that the switching processes in a braking switch
is desired to take place in a time-delayed manner, which is also
referred to as a break-before-make switching configuration. When
switching over from operating the motor M to braking the motor M,
the double-pole, double throw portion of the forward/reverse switch
1300 is opened before the motor short circuit is effected.
Conversely, when switching over from braking the motor M to
operating the motor M, the short circuit is opened before the
switch 1300 can cause motor actuation. Therefore, in operation,
when the user releases the 3-way switch 1300 from either the
forward or reverse positions, the motor M is short-circuited and
brakes quickly.
[0262] Other features of the circuit in FIG. 36 have been explained
with regard to FIG. 35. For example, an on/off switch 1210 is
provided. Also present is the power lock-out switch 1100 that only
powers the motor with one power cell 602' in a given portion of the
actuation (which can occur at the beginning or at any other desired
part of the stroke) and powers the motor M with all of the power
cells 602 (here, for example, six power cells) in another portion
of the actuation.
[0263] A new feature of the reverse and forward limit switches
1320, 1330 prevents any further forward movement of the motor M
after the forward limit switch 1320 is actuated. When this limit is
reached, the forward limit switch 1320 is actuated and the switch
moves to the second position. In this state, no power can get to
the motor for forward movement but power can be delivered to the
motor for reverse movement. The forward limit switch can be
programmed to toggle or be a one-time use for a given staple
cartridge. More specifically, the switch 1320 will remain in the
second position until a reset occurs by replacing the staple
cartridge with a new one. Thus, until the replacement occurs, the
motor M can only be powered in the reverse direction. If the switch
is merely a toggle, then power can be restored for additional
further movement only when the movement has retreated the part away
from actuating the switch 1320.
[0264] The reverse limit switch 1330 can be configured similarly.
When the reverse limit is reached, the switch 1330 moves to the
second position and stays there until a reset occurs. It is noted
that, in this position, the motor M is in a short-circuit, which
prevents motor movement in either direction. With such a
configuration, the operation of the stapler can be limited to a
single stroke up to the forward limit and a single retreat up to
the rear limit. When both have occurred, the motor M is disabled
until the two switches 1320 are reset.
[0265] Referring now to the figures of the drawings in detail and
first, particularly to FIGS. 37 to 40 thereof, there is shown an
exemplary embodiment of an electric surgical device 1000 according
to the invention, which, in this embodiment, is an electric
surgical linear stapler. FIG. 37 shows the left side of the device
1000 with the handle's outer shell 1001 and 1002 removed.
Similarly, FIG. 39 shows the right side of the device 1000 with the
handle's outer shell removed. The two halves of the outer shell
1001 and 1002 are only shown in FIGS. 63 to 66 to allow for clear
viewing of the internal assemblies. Also not shown in these and the
subsequent figures is the end effector. An exemplary embodiment of
a linear stapling end effector is described in detail in the family
of co-owned and co-pending patent applications including U.S.
Provisional Patent Application Ser. No. 60/702,643 filed Jul. 26,
2005, 60/760,000 filed Jan. 18, 2006, and 60/811,950 filed Jun. 8,
2006, and U.S. patent application Ser. No. 11/491,626 filed Jul.
24, 2006, Ser. Nos. 11/540,255 and 11/541,105 both filed Sep. 29,
2006, and Ser. No. 11/844,406 filed Aug. 24, 2007. The entire
disclosure of this family of applications is hereby incorporated
herein by reference in its entirety.
[0266] FIG. 38 shows the mechanical assembly of the device 1000
with the left-side frames 1010 removed. FIG. 40, in comparison,
shows the mechanical assembly both the left and right-side frames
1010, 1020 removed.
[0267] FIG. 37 shows the gear cover plate 1105, under which are the
first-, second-, and third-stage gears 1110, 1120, 1130 of the
motor transmission assembly. Also appearing in FIG. 37 is the end
effector closing assembly 1400. This end effector closing assembly
1400 will be explained in greater detail with regard to FIGS. 59 to
60.
[0268] FIGS. 37 to 38 also show the electric power and power
control assemblies. The electric power assembly 1500 in this
exemplary embodiment is a removable battery pack containing one or
more batteries 1510. As set forth above, one exemplary power supply
is a series connection of between four and six CR123 or CR2 power
cells. Here, there are six batteries 1510. One of these batteries
1510a, the one on the upper left in FIG. 37, is placed in an
electrically disconnectable configuration so that power can be
supplied selectively to the motor 1520 through either the single
battery 1510a or the entire set of six batteries 1510. This is
beneficial in applications where only a small amount of power is
needed or where full torque is desired to be prohibited. One such
prohibition is mentioned above with regard to moving the staple
sled or blade past the lock-out. The exemplary circuit only
connects this one cell 1510a to the motor 1520 during the first
part of the stapling/cutting stroke and, in the second part of the
stapling/cutting stroke, all of the cells 1510, 1510a in the power
supply are connected to the motor 1520. See FIG. 34.
[0269] The power supply control assembly 1600 in the exemplary
embodiment takes the form of a rocker switch 1610. In one actuated
direction of the rocker switch 1610, the motor 1520 is caused to
rotate in a first direction, for example, forward, and in the other
actuated direction of the rocker switch 1610, the motor 1520 is
caused to rotate in an opposite second direction, for example,
reverse.
[0270] The electrically powered drive train in the exemplary
embodiment is used to operate one feature of a linear
cutter/stapler. Here, the drive train is being used to actuate the
stapling/cutting feature. To do this, the drive train is connected
to a linear actuator 1700, which, in the present embodiment, is in
the form of a toothed rack that translates distally and proximally
along a rack guide 1720. As shown in FIG. 38, the rack 1700 is in a
relatively proximal position. To minimize the size of the shell
1001, 1002 at the proximal end (right side of FIG. 38), the rack
1700 has a pivoting portion 1710 that pivots freely in the downward
direction (as viewed in FIG. 38) when the pivoting portion 1710 is
not contained within the rack guide 1720. As the rack 1700 moves
distally (to the left in FIG. 38), the bottom of the pivoting
portion 1710 contacts the proximal end of the rack guide 1720 and
is caused to pivot upward to a position that is substantially
coaxial with the remainder of the rack 1700 due to the shape of the
rack guide 1720. The proximal end of the rack guide 1720 is seen in
FIG. 41.
[0271] The teeth 1702 of the rack 1700 are shaped to interact with
a final stage of the drive train in a rack-and-pinion
configuration. While various features of the drive train are
visible in virtually all of FIGS. 37 to 47, the explanation of the
drive train is easily seen with particular reference to FIGS. 43
and 46. It is noted here that some of the transmission stages shown
in many of the figures have no teeth. This is because the gears are
merely diagrammatic representations of a particular exemplary
embodiment. Thus, the lack of teeth, or even the number or size of
teeth present, should not be taken as limiting or fixed.
Additionally, many of the gears illustrated are shown with a
central band located inside the teeth. This band should not be
considered as part of the device 1000 and is, merely, a limitation
of the software used to create the figures of the instant
application.
[0272] The explanation of the drive train starts from the motor
1520. An output gear 1522 of the motor 1520 is connected to the
first, second, and third stages 1110, 1120, 1130 of the
transmission. The third stage 1130 is coupled to the final gear
present on the left side of the device 1000. This couple is
difficult to view in all of the figures because of its interior
location. FIGS. 55 to 56, however, show the coupling of the third
stage 1130 to the fourth stage, cross-over gear 1140. As mentioned
above, the output of the third stage 1130 is only diagrammatically
illustrated--as a cylinder without teeth. Continuing to refer to
FIG. 46, the cross-over gear 1140 is rotationally coupled to a
fourth stage shaft 1142, which shaft 1142 crosses over the rack
1700 from the left side of the device 1000 to the right side. The
right side of the shaft 1142 is not directly coupled in a
rotational manner to any of the gears on the right side. Instead,
it rotates inside a shaft bearing 1144 that fits inside a
corresponding pocket within the right side frame 1020, which frame
1020 is removed from the view of FIG. 46 to allow viewing of the
right side drive train.
[0273] A castle gear 1146 (shown by itself in FIG. 53) is
positioned on the cross-over shaft 1142 to be rotationally fixed
therewith but longitudinally translatable thereon. To permit such a
connection, the shaft 1142 has a non-illustrated interior slot in
which is disposed a non-illustrated pin that passes through two
opposing ports 11462 of the castle gear 1146. By fixedly securing
the pin to the castle gear 1146, rotation of the shaft 1142 will
cause a corresponding rotation of the castle gear 1146 while still
allowing the castle gear 1146 to freely translate along the
longitudinal axis of the shaft 1142, at least to the extent of the
slot in the shaft 1142. As can be seen in FIG. 46, the right-side
castellations 11464 of the castle gear 1146 are shaped to fit
between corresponding castellation slots 11482 on the left-side of
a fourth stage pinion 1148, which is illustrated by itself in FIG.
54. Because the castle gear 1146 is required to mate securely with
the fourth stage pinion 1148, a right-side biasing force F is
needed. To supply this bias, a non-illustrated compression spring,
for example, can be provided to have one end contact the right face
of the cross-over gear 1140 and the other opposing end contact the
left face of a central flange 11468, which projects radially away
from the outer cylindrical surface of the castle gear 1146. (This
flange 11468 will be described in more detail below with respect to
the manual release feature of the device 1000.) Any other similarly
functioning bias device can be used instead of the exemplary
spring. Such a configuration allows the castle gear 1146 to be
selectively rotationally engaged with the fourth stage pinion 1148.
More specifically, when the castle gear 1146 is not acted upon by
any force other than the force F of the bias device, the
castellations 11464 will be mated with the castellation slots 11482
and any rotation of the shaft 1142 will cause a corresponding
rotation of the fourth stage pinion 1148. However, when a force
opposing and overcoming the bias F is applied, the castellations
11464 exit the castellation slots 11482 and any rotation of the
shaft 1142 has no effect on the fourth stage pinion 1148. It is
this selective engagement that allows a manual release to occur.
Before such release is explained, the right side drive train is
described.
[0274] The fourth stage pinion 1148 is directly engaged with a
fifth stage 1150 of the drive train, which has a fifth stage shaft
1152, a fifth stage input gear 1154 rotationally fixed to the fifth
stage shaft 1152, and a fifth stage pinion 1156, also rotationally
fixed to the fifth stage shaft 1152. The teeth of the fifth stage
pinion 1156 are directly coupled to the teeth 1702 of the rack
1700. Thus, any rotation of the fifth stage input gear 1154 causes
a corresponding rotation of the fifth stage pinion and a
longitudinal movement of the rack 1700. As viewed in the exemplary
embodiment of FIG. 46, a clockwise rotation of the fifth stage
input gear 1154 causes a proximally directed movement of the rack
1700 (retract) and a counter-clockwise rotation of the fifth stage
input gear 1154 causes a distally directed movement of the rack
1700 (extend).
[0275] Based upon the above connection of the five stages of the
drive train, rotation of the motor shaft in one direction will
cause a longitudinal movement of the rack 1700, but only when the
castle gear 1146 is engaged with the fourth stage pinion 1148. When
the castle gear 1146 is not engaged with the fourth stage pinion
1148, rotation of the motor has no effect on the rack 1700. It is
in this uncoupled state of the two gears 1146, 1148 that a manual
release of the rack 1700 becomes possible.
[0276] In operation of the device 1000, the rack 1700 moves
distally (extends) to actuate some part of an end effector. In the
embodiment of a linear surgical stapling/cutting device, when the
rack 1700 moves distally, the sled (carrying the stapling actuator
and cutting blade) that causes both stapling and cutting to occur
is moved distally to effect both stapling and cutting. Because the
tissue placed between the jaws of the end effector is different in
virtually every surgical procedure, a physician cannot anticipate
times when the sled will be jammed or stuck for any reason. In a
jammed case, the sled will need to be retracted distally without
use of the motor. There also exists the possibility of a power loss
or the possibility that the motor fails in a catastrophic fashion
rendering the output shaft fixed. If this occurred when the sled
was in a distal position, the jaws of the end effector would be
held shut on the tissue therebetween and, consequently, the sled
would have to be moved proximally before the jaws could be opened
and the tissue could be released. In such a case, the rack 1700
will need to be retracted distally without use of the motor. To
effect this desired function, the invention is provided with a
manual release assembly 1800.
[0277] In each of FIGS. 37 to 44, 55, 59 to 62, the manual release
lever 1810 is in the un-actuated (e.g., down) position. In FIGS. 45
and 57, the manual release lever 1810 is in an intermediate
position. And, in FIGS. 46, 47, 56, and 58, the manual release
lever 1810 is approximately in a fully actuated (e.g., up)
position.
[0278] When the manual release lever 1810 is in the un-actuated
position, as can be seen in FIG. 44, the castle gear 1146 is
engaged with the fourth stage pinion 1148. Thus, any rotation of
the output gear 1522 of the motor 1520 causes movement of the rack
1700. The fourth stage pinion 1148 is not only directly connected
to the fifth stage input gear 1154, however. It is also directly
connected to a first stage release gear 1820, which, in turn, is
directly connected to a second stage release gear 1830. Thus, any
rotation of the fourth stage pinion 1148 necessarily causes a
rotation of the second stage release gear 1830 (the direction of
which being dependent upon the number of gears therebetween). If
the axle of this gear 1830 was directly connected to the manual
release lever 1810, the lever 1810 would rotate every time the
fourth stage pinion 1148 rotated. And, if the fourth stage pinion
1148 rotated more than one revolution, the lever 1810 could
possibly be caused to rotate through a full 360 degree revolution.
As expected, this does not occur due to the presence of a one-way
gear assembly coupling the manual release lever 1810 to the second
stage release gear 1830 (see explanation of FIG. 48 below). It is
noted that the first stage release gear 1820 has a toothed shaft
1822 extending coaxially therefrom. This toothed shaft 1822 is
directly coupled to an indicator wheel 1840. As can be seen on the
right surface of the wheel 1840, there is a curved shape linearly
expanding about the axis of the wheel 1840 and having a different
color from the remainder of the surface. When coupled with the
window 1004 present on the right side shell 1002 (see FIGS. 64 to
65), the colored shape becomes more and more visible in a linear
manner--corresponding to a linear distance of the rack 1700
traveled from the fully proximal (e.g., retracted) position.
[0279] The one-way gear assembly coupling the manual release lever
1810 to the second stage release gear 1830 is shown in FIG. 48.
This assembly is formed by providing a ratchet gear 1850 centered
at a pivot point of the lever 1810 and extending an axle 1852 of
the ratchet gear 1850 into and through a center bore 1832 of the
second stage release gear 1830. With the axle 1852 fixed to the
bore 1832 of the second stage release gear 1830 in this way, any
rotation of the second stage release gear 1830 causes a
corresponding rotation of the ratchet gear 1850. But, merely having
this ratchet gear 1850 rotate with the second stage release gear
1830 does not, by itself, assist with a manual release of the rack
1700 when the motor 1520 is not powering the drive train.
[0280] To create the manual release function, two manual releasing
items are present. The first item is a device that uncouples the
right side gear train from the left side gear train and motor. This
prevents the manual release from having to overcome the resistance
offered by both the motor 1520 and the gears of the left side train
when the manual release is actuated. The uncoupling occurs when the
castle gear 1146 separates from the fourth stage pinion 1148. To
cause this uncoupling, a cam plate 1860 is disposed between the
ratchet gear 1850 and the second stage release gear 1830 and is
rotationally fixed to the axle 1852. The cam plate 1860 is shown by
itself in FIG. 52. The cam plate 1860 is provided with a ramped cam
surface 1862 that is positioned to interact with the central flange
11468 of the castle gear 1146. Interaction of the cam plate 1860
with the central flange 11468 can be seen in the progression of
FIGS. 44 to 47 and in FIGS. 57 to 58.
[0281] In FIG. 44, the manual release lever 1810 is in an
unactuated position, which means that it is desired to have the
castle gear 1146 rotationally coupled with the fourth stage pinion
1148. In this way, any rotation of the motor 1520 will be
translated into a rotation of the fourth stage pinion 1148 and a
movement of the rack 1700. In FIGS. 45 to 47 and 57 to 58, the
manual release lever 1810 is in one of a few actuated positions,
each of which is illustrated as being sufficient to rotate the cam
plate 1860 to have the ramped cam surface 1862 contact the central
flange 11468 of the castle gear 1146 and force the castle gear 1146
towards the left side sufficient to separate the castellations
11464 from the castellation slots 11482 of the fourth stage pinion
1148. In this position, the castle gear 1146 is rotationally
uncoupled from the fourth stage pinion 1148. Thus, any rotation of
the motor 1520 (or the gears of the left side train) will be
entirely independent from the right side gear train, thus
preventing any movement of the rack 1700 based upon rotation of the
motor 1520.
[0282] After the right side gear train become rotationally
independent from the right side motor and gear train, to have a
manual rack release function, the rack 1700 needs to be moved in
the proximal direction. To supply this movement, a second of the
two above-mentioned manual releasing items is provided. This second
item interacts with the teeth 1832 of the ratchet gear 1850 so that
a counter-clockwise rotation of the manual release lever 1810 (when
viewed from the right side of the device 1000) causes the ratchet
gear 1850 to spin in a counter-clockwise direction--this direction
is desired in the illustrated embodiment because such rotation
causes a clockwise rotation of the fifth stage pinion 1156--a
rotation that corresponds to proximal movement (e.g., retraction)
of the rack 1700. To control the ratchet gear 1850 with this
counter-clockwise lever 1810 movement, the invention provides a
ratchet pawl 1870 that is rotatably mounted on a locking boss 1814
of the lever 1810. This configuration is best illustrated in FIG.
48. A non-illustrated leaf spring is secured in a spring channel
1816 of the lever 1810 to bias the pawl 1870 in a direction D
towards the ratchet gear 1850. It is noted that if the pawl 1870
were not restrained in some way, however, the pawl 1870 would
always contact the teeth 1852 of the ratchet gear 1850 and prevent
any clockwise rotation of the gear 1850--which occurs in the
present embodiment when the castle gear 1146 and the fourth stage
pinion 1148 are engaged with one another (see, i.e., FIG. 44) and
rotate together. To prevent this condition, as shown in FIGS. 44
and 55, the distal end of the pawl 1870 has a widened portion 1872
that extends out from the pawl cavity 1818 towards the second stage
release gear 1830. With the presence of a second cam plate 1880
between the second stage release gear 1830 and the cam plate 1870,
a pawl cam 1882 can be positioned to contact the bottom surface of
the widened portion 1872 and retain the pawl 1870 in the pawl
cavity 1818 (by providing a force in a direction opposite to
direction D and against bias of the leaf spring) when the lever
1810 is in a home or unactuated position. This contact between the
pawl 1870 and the pawl cam 1882 is shown in FIGS. 44 and 55. Thus,
when the lever 1810 is not actuated, the pawl 1870 has no contact
with the teeth 1852 of the ratchet gear 1850. In contrast, when the
manual release has rotated past a position sufficient to separate
the ratchet gear 1850 from the fourth stage pinion 1148, the bottom
surface of the pawl 1870 no longer contacts the pawl cam 1882 of
the non-rotating second cam plate 1880 and is, therefore, free to
move in the direction D (caused by the biasing force of the leaf
spring) to engage the teeth 1852 of the ratchet gear 1850 when
rotating counter-clockwise. Thus, when rotating clockwise, the pawl
1870 ratchets against the top surfaces of the teeth 1852.
[0283] After about fifteen degrees of travel of the lever 1810, for
example, the pawl 1870 no longer is in contact with the pawl cam
1882 and the castellations 11464 of the castle gear 1146 are no
longer engaged with the castellation slots 11482 of the fourth
stage pinion 1148. At this point, the pawl 1870 is permitted to
move towards the axle 1852 and engages one of the teeth 1852 of the
ratchet gear 1850. Further counter-clockwise movement of the lever
1810 turns the ratchet gear 1850 correspondingly, which causes a
corresponding counter-clockwise rotation of the second stage
release gear 1830. In turn, rotation of the second stage release
gear 1830 causes clockwise rotation of the first stage release gear
1820, counter-clockwise rotation of the fourth stage pinion 1148,
and clockwise rotation of the fifth stage input gear 1154,
respectively. As indicated above, clockwise rotation of the fifth
stage input gear 1154 causes proximal movement of the rack
1700--the desired direction of movement during a manual release of
the end effector feature connected to the rack 1700. As the lever
1810 is released, a return bias 1890 forces the lever 1810 back to
its unactuated position (see FIG. 44), which causes the pawl cam
1882 to return the pawl 1870 to its upper position in the pawl
cavity 1818 where it is disengaged from the teeth 1852 of the
ratchet gear 1850. It is noted that contact between the pawl cam
1882 and the lower surface of the widened portion 1872 is made
smooth by shaping the respective top front and top rear surfaces of
the pawl cam 1882 and bottom front and bottom rear surfaces of the
widened portion 1872. It is further noted that the return bias 1890
is shown in FIGS. 46, 57, and 58, for example, as a coil spring,
one end of which is wrapped around a bolt secured to the lever 1810
and the other opposing end being a shaft that is secured to a
portion of the shell 1001, 1002, illustrated in FIGS. 63-66. The
opposing shaft of the coil spring 1890 moves in the illustrations
only due to the limitations of the drawing program. This movement
does not occur in the invention.
[0284] As discussed above, one exemplary embodiment of the end
effector for the device 1000 of the present invention includes a
set of jaws that close down upon tissue disposed therebetween and a
stapler/cutter to secure together each of two sides of the tissue
as it is being cut. The manual release described above can be
coupled to the stapler/cutter and the end effector closing assembly
1400 can be coupled to the jaws to close the jaws together when
actuated. FIGS. 59 to 60 illustrate one exemplary embodiment of the
couple between the jaws and the end effector closing assembly 1400.
Here, the end effector closing assembly 1400 is comprised of a
handle 1410 having a lever support 1412 and pivoting about a handle
pivot 1414. The lever support 1412 is pivotally connected to a
first end of a link 1420. A second opposing end of the link 1420 is
pivotally connected to a slider shaft 1430. The end effector shaft
assembly 1900 includes an outer shaft 1910 and an inner shaft 1920.
The inner shaft 1910 is longitudinally fixed to the frames 1010,
1020 and to the lower jaw of the end effector and, therefore, is
the longitudinally fixed component of the end effector. The outer
shaft 1920 is connected about the inner shaft 1910 and
longitudinally translates thereon. The upper jaw of the end
effector pivots in relation to the lower jaw. To cause the
pivoting, the outer shaft 1920 is extended from a proximal
position, shown in FIG. 59, to a distal position, shown in FIG. 60.
Because the outer shaft 1920 surrounds the inner shaft, a portion
(for example, an upper portion) contacts the proximal end of the
open upper jaw, which is at a position proximal of the upper jaw
pivot. As the outer shaft 1920 moves further distal, the upper jaw
cannot translate distally because of the fixed pivot position, but
can rotate about that pivot. Accordingly, the upper jaw closes upon
the lower, longitudinally fixed jaw. Simply put, and as can be seen
in the progression from FIG. 59 to FIG. 60, when the handle 1410 is
moved towards the electric power assembly 1500, the slider 1430
moves in the longitudinal direction from the proximal position of
FIG. 59 to the distal position of FIG. 60. This prior art jaw
assembly is present on a linear stapler manufactured by Ethicon
Endo-Surgery under the trade name Echelon EC60.
[0285] It is noted that this exemplary configuration of the end
effector shaft assembly 1900 is opposite to the end effector
actuation shown in family of co-pending patent applications
mentioned above, including application Ser. No. 11/844,406, filed
Aug. 24, 2007. As shown in this application in FIGS. 39 and 40, as
the lower jaw/staple cartridge holder 1030 is translated in the
proximal direction over gap 1031, the upper anvil 1020 is caused to
pivot downward because the proximal upper edge of the upper anvil
1020 is being pressed against the longitudinally fixed drum sleeve
1040.
[0286] Various prior art linear staplers, such as the Echelon EC60
mentioned above, use the same end effector and shaft. Therefore, it
is desirable to have those prior art end effector shaft assemblies
be able to fit inside the device 1000 of the present invention.
This is accomplished by configuring the left and right side frames
1010, 1020 as shown in FIGS. 61 to 62, for example. The frames
1010, 1020 are formed with one side (the upper side) open as shown
in FIG. 62. In this configuration, the proximal end of the inner
shaft 1910 prior art end effector shaft assembly can simply side in
between respective tabs 1012, 1022 to longitudinally fix the inner
shaft 1910 (and, thus, the entire assembly) therein and
transversely fix the inner shaft 1910 therebetween in all radial
directions except for the direction in which the inner shaft 1910
was inserted into the opening between the frames 1010, 1020. To
close off this opening, a shaft plug 1930 is secured between the
tabs 1012, 1022, for example, with a bolt, as shown in FIG. 61. In
another alternative embodiment, the shaft plug 1930 can be entirely
disregarded by extending the distal ends of the left and right
frames 1010, 1020 and shaping them, in a clam-shell design, to be
secured around the inner shaft 1910 when placed together.
[0287] The foregoing description and accompanying drawings
illustrate the principles, preferred embodiments and modes of
operation of the invention. More specifically, the optimized power
supply, motor, and drive train according to the present invention
has been described with respect to a surgical stapler. However, the
invention should not be construed as being limited to the
particular embodiments discussed above. Additional variations of
the embodiments discussed above will be appreciated by those
skilled in the art as well as for applications, unrelated to
surgical devices, that require an advanced power or current output
for short and limited durations with a power cell having a limited
power or current output. As is shown and described, when optimized
according to the present invention, a limited power supply can
produce lifting, pushing, pulling, dragging, retaining, and other
kinds of forces sufficient to move a substantial amount of weight,
for example, over 82 kg.
[0288] The above-described embodiments should be regarded as
illustrative rather than restrictive. Accordingly, it should be
appreciated that variations to those embodiments can be made by
those skilled in the art without departing from the scope of the
invention as defined by the following claims.
* * * * *