United States Patent
`Olson et al.
`
`1197
`
`[11] Patent Number:
`[45] Date of Patent:
`
`5,307,976
`May 3, 1994
`
`MMWMNWMH
` MWWWMMWWWWWNMH
`Usoosso797eA»
`
`[54] LINEAR STAPLING MECHANISM WITH
`CUTTING MEANS
`
`[75]
`
`Inventors: Todd Olson, Loveland: Dan Meiser,
`Oxford; Gary Steed, Cleves: Eric
`Huffman. Loveland; Matthew Otten,
`Cincinnati; Ronald VanOverloop,
`West Chester; Darrel Powell,
`Cincinnati; Thomas Knodell,
`Loveland; Edward Rhnd, Fairfield;
`Ralph Chen, Cincinnati; Robert Cook,
`West Chester, all of Ohio
`
`[73] Assignee: Ethicon, Inc., Somerville, NJ.
`
`[21] Appi No: 917,636
`
`[22
`
`Filed:
`
`Jul. 20, 1992
`
`[63]
`
`Related U.S. Application Data
`Continuation-impart of Ser. No, 779.436. Oct. 18. 1991.
`abandoned
`
`
` [.1] 111:. cu. ........ A61817/072
`
`[52] L'.S.Cl...
`.. 227/178; 227/19;
`227/180
`227/19. 180, 176. 173
`
`[58] Field of Search
`
`[56]
`
`References Cited
`U.S. PATENT DOCUMENTS
`227/19
`4.754.909
`7/1988 Barker et a].
`.1
`227/19 X
`4,784.137 11/1988 Kulik e1. al.
`227/19 X
`4,892,244
`1/1990 Fox et a1.
`
`4,955,959
`9/1990 Tompkins et a].
`i
`i. 227/180 X
`5.040715
`.. 227/8 X
`8/1991 Green et a1.
`
`227/19 X
`5.071.052 12/1991 Roda};
`227/19 X
`5,170.925 12/1992 Madden ..
`
`Primary ExaminervRinaldi Radn
`Attorney, Agent. or Firm—Paul A. Coletti
`[57]
`ABSTRACT
`A stapler mechanism is described which contains a
`stapling assemb1y, and anvil assembly, firing means and
`knife means, These means are activated by a firing trig-
`ger. The anvil assembly is closed upon the stapling
`assembly by means of a closure triggerv The firing trig—
`ger is inoperable until the closure trigger has been acti»
`vated Another mechanism in the stapler is capable of
`locking the closure trigger after use so it does not spring
`open inadvertently before use of the firing triggeri Aci-
`ditionally, the stapler mechanism allows forward mo-
`tion of both triggers and also is capable of allowing
`reverse motion of the closure trigger to open the mech—
`anism.
`
`22 Claims, 18 Drawing Sheets
`
`
`
`
`
`140
`
`{64
`155
`I50
`
`
`
`
`
`Ethicon Exhibit 2016.001
`
`Intuitive v. Ethicon
`
`lPR2018-01254
`
`Ethicon Exhibit 2016.001
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`US. Patent
`
`May 3, 1994
`
`Sheet 1 of 18
`
`5,307,976
`
`
`
`
`
`
`
`FIG-I
`
`Ethicon Exhibit 2016.002
`
`Intuitive v. Ethicon
`
`lPR2018-01254
`
`Ethicon Exhibit 2016.002
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`US. Patent
`
`May 3, 1994
`
`Sheet 2 of 18
`
`5,307,976
`
`
`
`Ethicon Exhibit 2016.003
`
`Intuitive v. Ethicon
`
`IPR2018-01254
`
`Ethicon Exhibit 2016.003
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`US. Patent
`
`May 3, 1994
`
`Sheet 3 of 18
`
`5,307,976
`
`
`
`Emu/m;mwm/wmmflrmmmmefifiraii:.I.»@5543
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`03
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`09
`
`Ethicon Exhibit 2016.004
`
`Intuitive v. Ethicon
`
`IPR2018-01254
`
`Ethicon Exhibit 2016.004
`Intuitive v. Ethicon
`IPR2018-01254
`
`
`
`

`

`US. Patent
`
`May 3, 1994
`
`Sheet 4 of 18
`
`5,307,976
`
`
`
`FIG-2b
`
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`Ethicon Exhibit 2016.005
`
`Intuitive v. Ethicon
`
`lPR2018-01254
`
`Ethicon Exhibit 2016.005
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`US. Patent
`
`May 3, 1994
`
`Sheet 5 of 18
`
`5,307,976
`
`\m<\
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`Ethicon Exhibit 2016.006
`
`Intuitive v. Ethicon
`
`IPR2018-01254
`
`Ethicon Exhibit 2016.006
`Intuitive v. Ethicon
`IPR2018-01254
`
`
`

`

`US. Patent
`
`May 3, 1994
`
`Sheet 6 of 18
`
`_ 5,307,976
`
`
`
`Ethicon Exhibit 2016.007
`
`Intuitive v. Ethicon
`
`IPR2018-01254
`
`Ethicon Exhibit 2016.007
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`US. Patent
`
`May 3, 1994
`
`Sheet 7 of 18
`
`5,307,976
`
`wfl
`flail
`
`
`
`
`
`
`
`I6!
`
`FIG-8
`
`FIG-80
`
`Ethicon Exhibit 2016.008
`
`Intuitive v. Ethicon
`
`lPR2018-01254
`
`Ethicon Exhibit 2016.008
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`US. Patent
`
`May 3, 1994
`
`Sheet 8 of 18
`
`5,307,976
`
`
`
`
`
`I40/
`
`FIG-9
`
`Ethicon Exhibit 2016.009
`
`Intuitive v. Ethicon
`
`lPR2018-01254
`
`Ethicon Exhibit 2016.009
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`US. Patent
`
`May 3, 1994
`
`Sheet 9 of 18
`
`5,307,976
`
`
`DE
`
`.09
`
`-QE
`
`Ethicon Exhibit 2016.010
`
`Intuitive v. Ethicon
`
`IPR2018-01254
`
`Ethicon Exhibit 2016.010
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`US. Patent
`
`May 3, 1994
`
`Sheet 10 of 18
`
`5,307,976
`
`FIG-l0
`
`F/G-//
`
`[62
`
`I700
`
`Ethicon Exhibit 2016.011
`
`Intuitive v. Ethicon
`
`lPR2018-01254
`
`Ethicon Exhibit 2016.011
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`US. Patent
`
`May 3, 1994
`
`Sheet 11 of 13
`
`5,307,976
`
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`
`Ethicon Exhibit 2016.012
`Intuitive v. Ethicon
`IPR2018-01254
`
`
`
`
`
`
`

`

`U.S. Patent
`
`May 3, 1994
`
`Sheet 12 of 18
`
`, 5,307,976
`
`
`
`
`
`
`
`FIG-[2.
`
`Ethicon Exhibit 2016.013
`
`Intuitive v. Ethicon
`
`lPR2018-01254
`
`Ethicon Exhibit 2016.013
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`US. Patent
`
`May 3, 1994
`
`Sheet 13 of 18
`
`5,307,976
`
`
`
`Ethicon Exhibit 2016.014
`
`Intuitive v. Ethicon
`
`lPR2018-01254
`
`Ethicon Exhibit 2016.014
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`US. Patent
`
`May 3, 1994
`
`Sheet 14 of 18
`
`5,307,976
`
` NM
`
`E8an
`
`OD
`
`Ethicon Exhibit 2016.015
`
`Intuitive v. Ethicon
`
`IPR2018-01254
`
`Ethicon Exhibit 2016.015
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`U.S. Patent
`
`May 3, 1994
`
`Sheet 15 of 18
`
`5,307,976
`
`09
`0E
`
`Ethicon Exhibit 2016.016
`
`Intuitive v. Ethicon
`
`IPR2018-01254
`
`Ethicon Exhibit 2016.016
`Intuitive v. Ethicon
`IPR2018-01254
`
`
`

`

`US. Patent
`
`May 3, 1994
`
`Sheet 16 of 18
`
`5,307,976
`
`
`
`FIG/80
`
`
`
`FIG-l8
`
`Ethicon Exhibit 2016.017
`
`Intuitive v. Ethicon
`
`lPR2018-01254
`
`Ethicon Exhibit 2016.017
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`US. Patent
`
`May 3, 1994
`
`Sheet 17 of 18
`
`5,307,976
`
`
`
`
`
`
`
`FIG—[9
`
`
`
`Ethicon Exhibit 2016.018
`
`Intuitive v. Ethicon
`
`lPR2018-01254
`
`Ethicon Exhibit 2016.018
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`US. Patent
`
`May 3, 1994
`
`Sheet 13 of 18
`
`V 5,307,976
`
`b.
`
`Ethicon Exhibit 2016.019
`
`Intuitive v. Ethicon
`
`IPR2018-01254
`
`Ethicon Exhibit 2016.019
`Intuitive v. Ethicon
`IPR2018-01254
`
`
`

`

`1
`
`LINEAR STAPLING MECHANISM WITH
`CUTTING MEANS
`
`5,307,976
`
`5
`
`This is a continuation in part of application Ser. No.
`07/779,436 filed Oct. 18. l99l now abandoned,
`FIELD OF THE INVENTION
`This invention relates generally to medical engineer-
`ing, and more specifically it relates to laparoscopic or 10
`endoscopic surgery. Most specifically,
`it relates to a
`surgical stapling instrument which is capable of per-
`forming closures and cutting of lumen and tissue. This is
`accomplished in a mechanism which can be used endo-
`scopically, that is through a trocar cannula or alone, 15
`through an incision, to both staple and cut tissue.
`BACKGROUND OF THE INVENTION
`In recent years surgery has markedly advanced
`through the performance of laparosc0pic and endo- 20
`Scopic surgical procedures such as cholecystectomies,
`gastrostomies, appendectomies, and hernia repair. Also,
`the application of endoscopic surgical stapling and su-
`turing instruments has been provided in cardiovascular
`and pulmonary surgery, as well ’as operative inventions 25
`in the gastrointestinal tract. Such endoscopic instru—
`ments are capable of providing hemostasis and also of
`cutting tissue. This reduces operating and recuperation
`time.
`These stapling procedures are accomplished through 30
`a trocar assembly, which is a surgical instrument used to
`puncture a body cavity. The trocar contains a sharp-
`ened obturator tip and a trocar tube or cannula. The
`trocar cannula is inserted into the skin to access the
`body cavity, by using the obturator tip to penetrate the 35
`skin. After penetration. the obturator is removed and
`the trocar cannula remains in the body. It is through this
`cannula that surgical instruments are placed. Specifi-
`cally. it
`is through this trocar cannula that surgical
`stapling instruments with cutting mechanisms are 40
`placed. One such trocar is the Endo-path ®trocar man-
`ufactured by ETHICON ENDO-SURGERY. Cincin-
`nati. Ohio.
`Nonetheless. certain deficiencies in current concepts
`for endosurgical stapling mechanisms have been recog- 4S
`nized. One of the more important deficiencies is the fact
`that current stapling mechanisms can not cause clamp—
`ing of tissue and firing of the stapler, including the knife
`mechanism, with the same position of the hand for the
`forward stroke of an actuator. such as a trigger. Thus. 50
`the user must aim the clamping mechanism to encapture
`the desirable tissue with one hand, and then, while malt—
`ing a forward trigger stroke with the opposite hand,
`cause the tissue to be stapled and out If the stapling
`mechanism provides a ratchet member for the actuator, 55
`this deficiency is really not overcome, for in such a
`mechanism there still must occur simultaneous clamp-
`ing and stapling of the tissue. Then, if it is undesirable to
`staple the tissue in that location, the trigger must be
`fully reversed. This may result in inadvertent jamming 60
`of the system, and in some staplers this alternative is
`simply not capable of being performed.
`Another perceived deficiency is that no current sta-
`pling mechanisms have a safety device in place which
`prevents firing of the stapler before tissue has been 65
`clamped. Typically, the stapling mechanism may begin
`to clamp tissue between an anvil jaw and a stapling jaw.
`However, in some instances, there will be firing of the
`
`»
`
`2
`entirely
`is
`the tissue
`stapling mechanism before
`clamped. The user may have the mechanism partially
`attached to tissue via partially expelled staples before
`the user has ascertained a desirable location of the sta-
`pler. In this way. once again, there is a certain amount
`of instability or uncertainty in applying such a device.
`A design criteria in creating a system containing two
`separate mechanisms for clamping and firing tissue is
`the limitation of the human hand. Therefore, it is diffi-
`cult to properly and conveniently position a pair of
`triggers or a pushbutton mechanism coupled with a
`trigger mechanism. Thus, there has been little focus or
`incentive to create stapling mechanisms whereby the
`user is capable of operating a stapler with two strokes,
`unless both can be accomplished in a one-handed opera-
`tion without moving that hand from the handle of the
`instrument.
`Naturally, it would be desirable to be able to perform
`these functions in a fully rotational system This simply
`allows the user to obtain virtually any angle of ap-
`proach to the surgical site without having to contort the
`arm or wrist in order to adequately approach the sub-
`ject.
`Also, there have been no mechanisms which provide
`opening and closure of a clamping mechanism occur—
`ring during reciprocating motion of a clamping trigger.
`What is desired would be to be able to forwardly or
`rcversedly move a trigger and thereby obtain closure or
`opening.
`it would also be desirable to have distal
`Finally.
`contact of the stapling jaws, and then proximal clamp-
`ing. In this way, once distal contact is effectuated, the
`surgeon realizes and can actually visualize the amount
`of tissue clamped between the jaws. By distal contact is
`meant that the distal or far end of the anvil seats first on
`the gap spacing pin or cartridge. Without such distal
`contact, the surgeon may still be uncertain about the
`amount of tissue clamped, and therefore the firing force
`necessary to fire the mechanism.
`SUMMARY OF THE INVENTION
`It is an object of the invention to provide a stapling
`mechanism which is able to be used endoscopically, and
`may also be used in non-endoscopic procedures, and
`provides both stapling and cutting to the surgical site. It
`is desired to have tissue clamped between the jaws of
`the stapling mechanism, and it is also desired that the
`stapling mechanism accomplish this clamping and then
`firing in a two—part. sequenced operation.
`It is further an object of the invention to provide a
`stapling and clamping mechanism whereby the clamp-
`ing mechanism causes the stapling mechanism to be put
`into position for firing.
`This novel concept also necessarily requires that one
`is prevented from actuating the firing mechanism before
`clamping is accomplished. Therefore, it
`is further an
`object of the invention to prevent firing of the stapling
`mechanism before the entire clamping procedure is
`completed or if a cartridge is missing or has been previ~
`ously fired.
`It is further an object of the invention to provide a
`rotational mechanism which accommodates stapling
`and cutting endoscopically.
`It is further an object of the invention to provide a
`closure mechanism so that the closure mechanism is not
`able to inadvertently spring open before the firing
`mechanism has been fully actuated. It is yet another
`object of the invention to provide a mechanism which
`
`Ethicon Exhibit 2016.020
`
`Intuitive v. Ethicon
`
`lPR2018-01254
`
`Ethicon Exhibit 2016.020
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`5,307,976
`
`3
`allows forward and reverse motion of a clamping trig.
`ger such that forward motion causes clamping. and then
`permits stapling, and reverse motion permits the jaws of
`the mechanism to be opened, by reversing the functions
`of the clamping mechanism.
`Finally, it is an object of the invention to provide a
`closure mechanism in a surgical stapler which accom-
`plishes clamping of the tissue to be stapled in a direction
`opposite that of stapling, that is, from the distal toward
`the proximal end of the stapler. In this way. proper
`amounts of tissue may be adequately clamped, and then
`stapled.
`These and other objects of the invention are de-
`scribed in an endoscopic stapling mechanism which is
`capable of clamping, stapling and cutting tissue. The
`stapling mechanism utilizes a surgical stapling cartridge
`which contains at least two double rows of staples. The
`stapling cartridge also provides for knife means to di-
`vide the two double rows of staples during the stapling
`function. The stapling mechanism contains a unique
`trigger mechanism which contains a double trigger
`feature. One of the triggers causes clamping of tissue.
`The other trigger causes firing of the staples and actua-
`tion of the knife. Thus, clamping and firing are accom»
`plished separately. Because the system contains a
`unique safety mechanism, there cannot be firing of sta-
`ples before there is full clamping oftissue. In this mech-
`anism, stapling is accomplished in any rotatable posi-
`tion, as soon as tissue has been clamped. Yet, the clamp-
`ing trigger locks in position so that it will not inadver-
`tently spring open during use of the firing trigger.
`Uniquely.
`in one of the embodiments described
`herein.
`there is contained in the endoscopic stapling
`mechanism a double clutch mechanism which allows
`the user to derive benefits from both forward and re-
`verse motion of the clamping and firing triggers. Dur-
`ing forward motion of the triggers, there is clamping
`and then firing. During reverse motion, there is the
`capability of overriding any jams encountered by the
`stapling mechanism, and then allowing the stapled tis-
`sue to be removed from the stapling site.
`Finally.
`in this invention there is the capability of
`having distal clamping of tissue, even larger tissue held
`within a larger size device. After this clamping. there is
`then proximal contact of the stapling and closure means
`and thereafter. similar proximal contact of the knife
`mechanism. Thus, while it is easily ascertainable how
`much tissue is clamped between the clamping mecha-
`nisms, it is also easy to determine whether clamping and
`stapling have been properly accomplished.
`These and other objects of the invention will be bet-
`ter understood from the following attached Detailed
`Description of the Drawings, when taken in conjunc-
`tion with the Detailed Description of the Invention.
`DETAILED DESCRIPTION OF THE
`DRAWINGS
`
`FIG. 1 is a side elevational View of an endoscopic
`linear stapling and cutting mechanism of the present
`invention;
`FIG. la is an exploded perspective View of the instru-
`ment of FIG. 1;
`FIGS. 20 and 2b are cross-sectional views of the view
`of FIG. 1:
`FIGS. 3 and 3a are individual and closeup views of
`the closure trigger of the present invention;
`FIGS. 4 and 7 are operational views of the closure
`trigger and toggle linkage of the invention;
`
`4
`FIGS. 5 and 6 are isolated side and top views of the
`firing trigger of the invention;
`FIGS. 8 and 8a are side and bottom isolated views of
`a typical cartridge of the invention:
`FIGS. 9 and 9a are side and bottom isolated views of
`the anvil of the invention;
`FIGS. 91:, 9c and 9d are side operational views of the
`interaction between the stapler shaft, the cartridge, and
`the anvil closing mechanism;
`FIG. 10 is a side isolated view of the knife means with
`a lockout notch;
`FIG. 10a is a side view of an alternate knife means
`with no lockout notch;
`FIG. 11 is a side isolated view of the lookout member
`contained in the cartridge of FIGS. 8 male.
`FIGS. 110 and 11b show the motion of the lockout
`member of FIG. 11 when moved by the knife means of
`FIG. 10 in the cartridge of FIG. 8;
`FIG. 12 is a side elevational view of an alternate
`preferred embodiment of the stapler of the present in-
`vention;
`FIG. 12a is an exploded perspective view of the in-
`strument of FIG. 12
`FIG. 13 is a cross-sectional view of the stapler of
`FIG. 12;
`'
`FIG. 14 is a side View of the closing trigger plate of
`the embodiment as described in FIGS. 12 and 13;
`FIG. 15 is a side view of the firing trigger as seen in
`FIG. 13 of the present invention;
`FIG. 150 is a side View ofthe trigger return linkage of
`the alternate embodiment of this invention;
`FIGS. 16 and 16a are isolated views of the front
`toggle link as seen in FIG. 13 of the present invention;
`FIGS 17 and 17a are isolated plan views of the rear
`toggle link as also described in FIG. 13 of the present
`invention:
`FIGS. 18 and 1811 are isolated side and top views of
`another typical cartridge. as used in the stapler of FIG.
`12:
`FIGS. 19 and 19a are isolated side and bottom views
`of the anvil member used in the stapler of FIG. 12;
`FIG. 20 is a detailed view ofthe knife mechanism and
`lockout notch as used in the cartridge of FIG. 18, as
`seen in the views of FIGS. 12 and 13 describing the
`alternate embodiment of the present invention; and
`FIGS. 20:! and 2017 are views of the lockout mecha-
`nism before and after motion of the knife means of
`FIGS. 19 as in the stapler of FIGS. 12 and 13.
`DETAILED DESCRIPTION OF THE
`INVENTION
`As can be seen from FIGS. 1, la, and 2, in one em-
`bodiment of the surgical stapler of this invention, there
`is described a stapler 100 which contains a handle por-
`tion 110, rotating means 120, a shaft portion 130, anvil
`portion 140, and cartridge assembly 150. A knife means
`160 is slidable within the cartridge assembly 159 to cut
`tissue. In the handle portion 110 there is a first or clo-
`sure trigger (also called a clamping trigger) 112. and
`second or firing trigger 114. The clamping trigger 112
`causes the anvil portion 140 to come into proximity of
`the cartridge assembly 150. The firing trigger 114
`causes the wedges 122 located in the shaft 130 to move
`through the cartridge assembly 150. and also causes the
`knife means 160, also located in the shaft 130 to move
`through the cartridge assembly 150,
`in order to cut
`tissue.
`
`IO
`
`15
`
`20
`
`30
`
`40
`
`50
`
`55
`
`65
`
`Ethicon Exhibit 2016.021
`
`Intuitive v. Ethicon
`
`lPR2018-01254
`
`Ethicon Exhibit 2016.021
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`m
`
`10
`
`l5
`
`20
`
`25
`
`30
`
`35
`
`40
`
`5,307,976
`5
`As can be seen in more detail in FIGS. 1a. 2a. 2b, 3,
`4, 5, 6 and 7 the endoscopic linear stapling mechanism
`100 contains a double trigger mechanism. The first or
`clamping trigger 112 is for closing the jaws 132, 142 of
`the instrument onto tissue, and the second or firing
`trigger 114 is used for firing the stapler 100. The intent
`of the double trigger design is to combine one-handed
`use within a stapling mechanism, and to make such
`one-handed use so that it is impossible to form staples
`unless the instrument is fully closed.
`When the instrument is initially loaded, with car-
`tridge assembly 150 held within shaft portion 130 on
`jaw 132, the firing trigger 114 is flush with the body 116
`of the instrument, so that it is parallel with the shaft
`portion 130, and is for all practical purposes inaccessible
`to the user. During actuation of the clamping trigger
`112, the firing trigger 114 swings into a “ready" position
`preparatory to actuation. This position is 35° to 45‘
`spaced apart from the closure trigger 112, which has
`now moved into position against base 118. As will be
`later described, a multiplier mechanism causes the firing
`trigger 114 to move through a greater are than closure
`trigger 112.
`The closure trigger is spring-loaded. so that an in-
`complete closure results in the closure trigger swinging
`open to its position as seen in FIGS. 1 and 2. once again
`spacing the firing trigger 114 away from the reach of
`the hand operating the mechanism. A closure sequence
`must therefore be completed, with the clamping trigger
`112 locking proximal to the base 118, before the firing
`trigger 114 can be grasped or is Operational by the user.
`As can be seen from the FIGS. 1a. 2. 3, 3a, 4 and 7.
`the closure trigger 112 is attached to a front closure link
`124. at pivot pin 126. Closure trigger 112 is also at-
`tached to a rear closure link 128 which pivots inside the
`handle 110 of the stapler 100. The closure trigger 112
`therefore is capable of pivoting around the handle por-
`tion at pivot 113, so that it moves roughly 25‘—SO‘ . in
`this instance, preferably 35°. The closure trigger 112 is
`spring-loaded at spring 129 so that unless the closure
`trigger 112 is fully rotated toward the base 118, the
`spring 129 causes the closure trigger 11210 reopen to its
`initial position. As will be later explained. it is the mo-
`tion of this closure trigger 112 which causes the anvil
`portion 140 to clamp into proximity of cartridge assem-
`bly 150.
`Furthermore. the closure trigger 112 is connected by
`means of a pin to the firing trigger 114. Thus. as can be
`best seen in FIGS. 2b, 3, 5 and 6, the closure trigger 112
`is linked with the firing trigger 114 by means of a pin
`119 which moves in a guided path along slot 117 away
`from the axis of rotation of the closure trigger 112. This
`pin 119, in turn, moves along a path within slot 117 of
`the firing trigger 114. As better seen in FIGS. :15, 5, 6
`and 7, the rotation of the closure trigger for approxi-
`mately 35n results in rotation of the firing trigger for
`approximately 45“. The control of the pin 119 is accom-
`plished by guide plates placed in the body 116 of handle
`portion 110. Now, closure trigger 112 is in place at the
`base 118 of handle 116. Firing trigger 114 needs to
`travel only 30°—60° to complete a full firing stroke. This
`are is quite manageable for even the smallest human
`hands.
`this guiding pin 119 no
`After its initial rotation,
`longer acts upon the firing trigger 114. That is, this
`guide pin 119 is no longer in contact with the firing
`trigger 114. This allows the firing trigger 114 to com-
`plete its rotation and fire staples without interaction of
`
`6
`guide pin 119 or with the closure trigger 112. Thereby.
`the firing trigger 114 is connected to a spring 121 as seen
`in FIG. 1, which is in turn connected to the handle 110.
`This spring causes the firing trigger 114 to return to the
`45” position so that triggers 112. 114 may be returned
`during opening of the instrument 100,
`As can be seen in FIGS. 1, la and 2b, and especially
`in FIG. 4, there is contained a locking mechanism com-
`prising button 131 which activates leaf spring involu-
`tion 1590 on leaf spring 159 , in order to cause the clo-
`sure trigger 112 to be locked once it reaches base 118 of
`the handle 116. The closure trigger 112 is locked in
`place by leaf spring 159 which seats under front closure
`link 124 thus immobilizing pin 126. This in turn restrains
`closure trigger 112. The safety button 131 is pivotally
`mounted to the proximal top of base 118 and rests upon
`leaf spring 159. As will later be explained, thereafter,
`the firing trigger 114 is free to move alone.
`As further can be seen from FIG. 2!). 43nd 7, motion
`of closure trigger 112 causes motion of front and rear
`closure links 124. 128. These front and rear closure links
`124, 128 cause motion in line with the shaft 130 of a
`closure sliding member 136. This closure sliding mem-
`ber 136 is attached in a rotatable fashion at joint 135 . On
`the distal side ofjoint 135 is closure coupler 134, which
`attaches to the end of a closure channel 138. It is the
`closure channel 138 which is attached to the pin 139 in
`the shaft 130 that connects this mechanism to anvil 140.
`Closure channel 138 causes closure of the anvil por~
`tion 140 into proximity and alignment with the car-
`tridge assembly 150. This is accomplished in that the
`closure links 124, 128 first move parallel to the axis of
`the shaft 130, as in FIG. 7, from their original positions
`in FIG. 4. Closure channel 138 is caused to slide within
`shaft 130. The front top surface 138:: of closure channel
`138 pushes forward and down on the anvil. This causes
`anvil 140 to come parallel to cartridge assembly 150 so
`that there is alignment of cartridge 150 and anvil 140.
`The shaft 130 is formed from a stationary tube, 50 that
`the Closure channel 138 moves within the shaft 130 at
`the distal end of the instrument 100.
`This double trigger mechanism 112. 114 has the fol-
`lowing advantages. The firing trigger 112 cannot be ~
`actuated until the closure trigger 114 has been com-
`pletely snapped into its final position, due to locking of
`the closure trigger 112 inside the handle 110. Therefore,
`one is certain that tissue has been clamped before the
`firing trigger 114 has been placed into motion. The
`firing trigger 114 can be actuatedwithout repositioning
`the hand following closure of the instrument. That is.
`the hand stays stationary, and is once again gripped
`around the firing trigger 114, with closure trigger 112
`maintained at the base 118 of the handle 110. This facili-
`tates rapid completion of the firing sequence without
`requiring the surgeon‘s attention on the stapler away
`from the endoscopic video screen and thereby away
`from the operating arena. In addition. both the closure
`trigger 112 and the firing trigger 114 utilize a mecha-
`nism which is familiar to those who use surgical instru-
`ments. a pistol grip with a trigger type actuation.
`As has earlier been explained, the closure trigger 112
`pushes on the central pivot pin 126 of a toggle linkage
`124, 128. Central pivot pin 126 rides in slot 115. This
`central pivot pin 126 results in relatively large amounts
`of motion in the closure channel 138 (see FIG. 4) which
`results in gross closure of the instrument 100. The me-
`chanical advantage provided by the toggle linkage 124.
`128 during this portion of closure is relatively small.
`
`Ethicon Exhibit 2016.022
`
`Intuitive v. Ethicon
`
`lPR2018-01254
`
`50
`
`55
`
`60
`
`Ethicon Exhibit 2016.022
`Intuitive v. Ethicon
`IPR2018-01254
`
`

`

`5,307,976
`
`7
`This has the advantage of providing the user with high
`tactile feedback. That is, the user is readily able to tell
`whether the system is overloaded with tissue. Near the
`position wherein movement of the toggle linkage 124,
`128, (FIG. 7) is nearly complete, the closure trigger 112
`has moved into place at base 118. and front closure link
`124 and rear closure link 128 have been made generally
`parallel to the shaft 130, relatively little motion of the
`linkage 124, 128 results from any given rotation of the
`trigger 112. Trigger 112 rotation at this point provides
`significantly higher closure force than during the first
`portion of its motion. This is critical in accomplishing
`preloading of anvil 140 during the final portion of clo-
`sure, and is in theory only constrained by the structural
`limitations of the system, as well as the force able to be
`applied by the user.
`As can be seen from FIGS. 2b, 5 and 6, firing is ac-
`complished by a simple rotation of the firing trigger 114
`acting as a lever arm about pivot 113. The firing trigger
`is linked to the firing or driver rod 144 and driver rod
`link 146 by means of firing links 148. These firing links
`are engaged with the firing triggers by means of a
`clutch. This clutch mechanism is better seen in the top
`view of the firing trigger as seen in FIG. 6. This clutch
`mechanism does not engage the firing link 148 until the
`firing trigger 114 is
`in a “ready to fire" position.
`whereby hook 149 engages link 148. This eliminates the
`potential for firing the instrument prior to complete
`closure of the mechanism by closure trigger 112.
`Once the clutch system has engaged the firing link
`148, this causes the driver rod link 146 to be translated
`by pin 145. and moving with link 148 in slot 147. in a
`generally parallel position to the shaft 130 of the mecha~
`nism. This driver rod link 146 is connected to driver rod
`144 which is rotatably connected in nozzle 120 to a
`pusher block 152 contained in the shaft 130. This pusher
`block is connected to firing wedges 122 and knife mech»
`anism 160, as seen at the proximal edge of the shaft 130
`which enters the cartridge assembly 150. The firing
`wedges 122 are able to transversely move staples loaded
`in the cartridge assembly 150 so that they are fired into
`the anvil portion 140, as best seen in F165. 25, 8, Ba. 9
`and 9a. and as well known in the art. The knife mecha~
`nism 160 is capable of cutting tissue between the com-
`pleted pair of double or triple rows(or more) of staples.
`as also is well known in the art.
`After firing has been completed, the firing mecha-
`nism returns by means of a compression spring 156
`placed about driver rod 144 along shaft 130, so that
`spring 156_ is stationary at base 157, which causes the
`driver rod 144 to be moved in a direction reverse from
`firing. Spring 156 itself has a sufficient strength to also
`cause driver rod 144 to move the firing link 148 via
`linkage 146 to return to its ready to fire position. This
`similarly causes the driver rod 144 to pull the wedges
`122 and the knife 160 so that they are removed from the
`cartridge assembly 150. If the wedges 122 or the knife
`160 do not return, that is if they are jammed, the firing
`mechanism comprising the firing trigger 114 contains a
`reverse clutch assembly which allows the firing trigger
`114 to engage with the firing link 148 at hook 151 (FIG.
`6) so that it is capable of causing this assembly to move
`in a reverse or rearward direction. This provides a
`backup to the system. in the event there is a failure in
`the driver return spring 156 or if the instrument has
`inadvertently been misassembled.
`The system also contains a safety mechanism which
`locks the closure trigger 112 in its closed position. This
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`safety mechanism is a leaf spring 159 which interacts
`with the safety button 131 on the rear of the instrument.
`Side plates on the portion of the toggle linkage assembly
`124, 126 cause the leaf spring to remain in a tensioned
`position, and guide the leaf spring during its motion.
`When the front closure link 124 is in its straightened
`position. so that the rear closure link 128 is also rotated
`to be generally parallel with the shaft 130,
`the leaf
`spring 159 has been tensioned to restrain the toggle
`linkage 124, 128 in its parallel position. The safety but-
`ton 131 on the rear of the instrument thereafter urges
`the leaf spring 159 in a forward direction. toward the
`cutting mechanism. This forward motion of the spring
`159 causes the toggle linkages 124, 128 to be freed from
`the restraint of the spring 159. This motion allows free-
`dom of movement for closure trigger 112.
`As has been previously described, and as better seen
`in FIGS. 2a, 8, 9 and 942—91 the jaws 132, 142 of this
`instrument are closed by means of a cam surface 127 on
`the outer surface of the anvil 140. The anvil 14D pivots
`about pin 139 embedded in slot 141 of the closure chan-
`nel 138 in shaft 130. Channel 138 is pushed forward
`With the actuation of the closure trigger 112. Closure
`channel surface 138a bears upon the cam surface 127 of
`the anvil 140. forcing it to pivot and move transversely
`within slot 153 contained in shaft 130. The location of
`the slot 153 as compared to the surface profile of the
`cam 127 determines motion of the anvil 140, such that
`the slot 153 and Slot 141 combination forms a “fixed"
`pivot, which is fixed only with respect to the anvil 140.
`Therefore, anvil 140 is allowed to move transversely
`across the axis of a stationary tube 130. Shaft or station-
`ary tube 130 forms the “ground“ position for the pivot
`pin 139, so that its motion is only transverse compared
`to the shaft 130.
`As better seen in FIGS. 9b—9a’, the motion ofthe anvil
`140 follows a predetermined path. First, the anvil 140 is
`rotated to a position parallel to cartridge 150. Then,
`anvil 140 moves in a direction tra