United States Patent (19)
`RobertSOn
`
`54). SURGICAL FASTENERAPPLYING DEVICE
`75 Inventor: John C. Robertson, Cheshire, Conn.
`73 Assignee: United States Surgical Corporation,
`Norwalk, Conn.
`
`21 Appl. No.: 09/076,933
`22 Filed:
`May 13, 1998
`Related U.S. Application Data
`63 Continuation of application No. 08/618,436, Mar. 15, 1996,
`Pat. No. 5,810,240.
`(51) Int. Cl. .............................................. A61B 17/068
`52 U.S. Cl. ..................... 227/176.1; 227/19, 227/1752;
`227/178.1
`58 Field of Search .................................... 227/19, 1751,
`227/176.1, 178.1, 179.1, 180.1, 175.2
`
`56)
`
`References Cited
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`
`US005964394A
`Patent Number:
`11
`(45) Date of Patent:
`
`5,964,394
`Oct. 12, 1999
`
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`(List continued on next page.)
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`2141066 12/1984 United Kingdom.
`OTHER PUBLICATIONS
`Information Booklet for Auto Suture, Poly CS-57, Dispos
`able Surgical Stapler, 1988, USSC.
`Primary Examiner Scott A. Smith
`57
`ABSTRACT
`A fastener applying device for applying Surgical fasteners to
`body tissue is provided. The fastener applying device
`includes an approximation mechanism having a single
`actuator to perform fast closure and incremental approxi
`mation of a cartridge carrier and anvil. The cartridge carrier
`and anvil can be approximated into a multiplicity of prede
`termined firing enabled positions. An adjustment member is
`operably associated with a firing mechanism of the device to
`vary the maximum Stroke of a pusher bar. The adjustment
`member facilitates ejection of multiple size fasteners from
`the device.
`
`9 Claims, 19 Drawing Sheets
`
`Ethicon Exhibit 2001.001
`Intuitive v. Ethicon
`IPR2018-00934
`
`

`

`5,964,394
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`4,741,336
`4,788,978
`4,809,898
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`4,930,503
`4,938.408
`4.941,623
`4,964,559
`
`5/1988
`12/1988
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`4/1990
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`7/1990
`7/1990
`10/1990
`
`Failla et al. .
`Strekopytov et al. .
`Gassner et al. .
`Pruitt.
`Green et al. .
`Isaacs et al. .
`Green.
`Pruitt.
`Bedi et al. .
`Pruitt.
`Deniega et al. .
`
`5,018,657
`5,027,834
`5,071,052
`5,100,042
`5,116,349
`5,137,198
`5,190.203
`5,413,267
`5,458,279
`5,470,006
`5,470,008
`5,470,009
`5,509,596
`
`5/1991
`7/1991
`12/1991
`3/1992
`5/1992
`8/1992
`3/1993
`5/1995
`10/1995
`11/1995
`11/1995
`11/1995
`4/1996
`
`Pedlick et al. .
`Pruitt.
`Rodak et al. .
`Gravener et al. .
`Aranyi.
`Nobis et al. .
`Rodak.
`Solyntjes et al. .
`Plyley.
`Roadk.
`Rodak.
`Rodak.
`Green et al. .
`
`Ethicon Exhibit 2001.002
`Intuitive v. Ethicon
`IPR2018-00934
`
`

`

`U.S.
`US.
`
`
`
`Oct. 12, 1999
`Oct. 12, 1999
`
`Sheet 1 0f 19
`Sheet 1 of 19
`
`5,964,394
`5,964,394
`
`
`
`
`
`Ethicon Exhibit 2001.003
`
`Intuitive v. Ethicon
`
`|PR2018—00934
`
`Ethicon Exhibit 2001.003
`Intuitive v. Ethicon
`IPR2018-00934
`
`

`

`U.S. Patent
`
`Oct. 12, 1999
`
`Sheet 2 of 19
`
`5,964,394
`
`
`
`Ethicon Exhibit 2001.004
`Intuitive v. Ethicon
`IPR2018-00934
`
`

`

`U.S. Patent
`
`Oct. 12, 1999
`
`Sheet 3 of 19
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`5,964,394
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`Ethicon Exhibit 2001.005
`Intuitive v. Ethicon
`IPR2018-00934
`
`

`

`U.S. Patent
`
`Oct. 12, 1999
`
`Sheet 4 of 19
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`5,964,394
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`Ethicon Exhibit 2001.006
`Intuitive v. Ethicon
`IPR2018-00934
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`

`

`U.S. Patent
`
`Oct. 12, 1999
`
`Sheet 5 of 19
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`5,964,394
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`92
`
`Ethicon Exhibit 2001.007
`Intuitive v. Ethicon
`IPR2018-00934
`
`

`

`U.S. Patent
`
`Oct. 12, 1999
`
`Sheet 6 of 19
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`5,964,394
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`Ethicon Exhibit 2001.008
`Intuitive v. Ethicon
`IPR2018-00934
`
`

`

`U.S. Patent
`
`Oct. 12, 1999
`
`Sheet 7 of 19
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`5,964,394
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`Ethicon Exhibit 2001.009
`Intuitive v. Ethicon
`IPR2018-00934
`
`

`

`U.S. Patent
`
`Oct. 12, 1999
`
`Sheet 8 of 19
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`5,964,394
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`Ethicon Exhibit 2001.010
`Intuitive v. Ethicon
`IPR2018-00934
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`

`

`U.S. Patent
`
`Oct. 12, 1999
`
`Sheet 9 of 19
`
`5,964,394
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`
`Ethicon Exhibit 2001.011
`Intuitive v. Ethicon
`IPR2018-00934
`
`

`

`US. Patent
`
`Oct. 12,1999
`
`Sheet 10 0f 19
`
`5,964,394
`
`FIC.14
`
`Ethicon Exhibit 2001.012
`
`Intuitive v. Ethicon
`
`|PR2018—00934
`
`Ethicon Exhibit 2001.012
`Intuitive v. Ethicon
`IPR2018-00934
`
`

`

`U.S. Patent
`
`Oct. 12, 1999
`
`Sheet 11 0f 19
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`5,964,394
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`
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`Ethicon Exhibit 2001.013
`Intuitive v. Ethicon
`IPR2018-00934
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`

`

`U.S. Patent
`
`Oct. 12, 1999
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`Ethicon Exhibit 2001.014
`Intuitive v. Ethicon
`IPR2018-00934
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`

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`Oct. 12, 1999
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`Ethicon Exhibit 2001.015
`Intuitive v. Ethicon
`IPR2018-00934
`
`

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`US. Patent
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`Oct. 12, 1999
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`Ethicon Exhibit 2001.016
`Intuitive v. Ethicon
`IPR2018-00934
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`
`

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`U.S. Patent
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`Oct. 12, 1999
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`IPR2018-00934
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`Oct. 12, 1999
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`Intuitive v. Ethicon
`IPR2018-00934
`
`

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`Oct. 12, 1999
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`Ethicon Exhibit 2001.019
`Intuitive v. Ethicon
`IPR2018-00934
`
`

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`Intuitive v. Ethicon
`
`|PR2018—00934
`
`Ethicon Exhibit 2001.020
`Intuitive v. Ethicon
`IPR2018-00934
`
`
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`U.S. Patent
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`Ethicon Exhibit 2001.021
`Intuitive v. Ethicon
`IPR2018-00934
`
`

`

`1
`SURGICAL FASTENERAPPLYING DEVICE
`
`RELATED APPLICATIONS
`This application is a Continuation of U.S. patent appli
`cation Ser. No. 08/618,436, filed Mar. 15, 1996, now U.S.
`Pat. No. 5,810,240.
`
`BACKGROUND
`
`1. Technical Field
`The present disclosure relates generally to a Surgical
`device. More Specifically, the present disclosure relates to a
`fastener applying device for Simultaneously applying an
`array of fasteners to body tissue.
`2. Background of Related Art
`Surgical fastening devices for Simultaneously applying an
`array of Surgical fasteners, e.g., Staples or other types of
`fasteners are known in the art. Such devices are used for
`joining body tissue Such as, for example, intestinal and
`gastric walls with Spaced parallel rows of longitudinally
`aligned fasteners. These Surgical fastening devices reduce
`the time of wound closure in a Surgical procedure.
`Typically, these devices include a fastener holder dis
`posed on one Side of the tissue to be joined, and an anvil
`assembly parallel to the fastener holder on the other side of
`the tissue to be fastened. The fastener holder is moved
`linearly towards the anvil assembly So that the tissue is
`clamped between them. The fasteners are driven from the
`fastener holder So that the ends of the fasteners pass through
`the tissue and form finished fasteners as they make contact
`with the anvil assembly, thereby producing an array of
`finished fasteners in the tissue. The fasteners can be one or
`two piece and made of metal, non-absorbable polymers, or
`bioabsorbable polymerS Such as plyglycolide, polylactide,
`and copolymers thereof.
`U.S. Pat. No. 5,137,198 to Nobis et al. (“Nobis") discloses
`a fastener applying device including a cartridge that is
`advanced towards an anvil assembly by an advancing
`mechanism. The advancing mechanism includes a first
`actuator member for advancing the cartridge towards the
`anvil assembly at an accelerated rate and a Second actuator
`member Spaced from the first actuator member for incre
`mentally advancing the cartridge towards the anvil assem
`bly.
`One problem associated with Such a device is that a
`Surgeon must be able to move between and manipulate the
`first and Second Spaced actuator members while Simulta
`neously maintaining the fastener applying device in a Sub
`Stantially fixed position with respect to body tissue to be
`repaired. This may be difficult to accomplish during the
`course of a Surgical procedure.
`Typically, fastener applying devices include a pusher bar
`that is advanced over a predetermined Stroke to interact with
`and eject the fasteners from the cartridge. At least one driver
`is positioned within the cartridge between the distal end of
`the pusher bar and the fastenerS Such that the pusher bar
`advances the drivers into engagement with the fasteners. The
`length of the drivers may be varied to facilitate ejection of
`different size fasteners from a fastener applying device
`having a fixed pusher bar Stroke.
`U.S. Pat. No. 3,692,224 to Astafiev et al. describes a
`fastener applying device in which the driver is integrally
`formed with the pusher bar and not housed within the
`cartridge. The pusher bar is movable over a fixed Stroke to
`eject the fasteners from the cartridge. Because the Stroke of
`the pusher bar is fixed, only a single size fastener can be
`
`15
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`25
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`40
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`5,964,394
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`2
`properly ejected from each fastener applying device. If a
`cartridge housing fasteners not sized for use with a particular
`fastener applying device is inserted into the fastener apply
`ing device, advancement of the pusher bar over its fixed
`Stroke will result in either overadvancement or underad
`Vancement of the fasteners into body tissue.
`Accordingly, a need exists for an improved fastener
`applying device which overcomes the above-noted
`disadvantages, is easy to use and provides greater reliability
`when repairing tissue.
`
`SUMMARY
`In accordance with one aspect of the present disclosure, a
`fastener applying device having a single actuator to perform
`fast closure and incremental advancement of a cartridge
`assembly with respect to an anvil assembly is provided. The
`device includes an approximation mechanism including a
`pivotable approximating clamp, a longitudinally extending
`clamp Slide, and a cartridge carrier. The cartridge carrier is
`Supported on the distal end of the clamp Slide and is adapted
`to receive a cartridge housing a plurality of fasteners. The
`clamp slide is restricted to linear movement within the body
`of the fastener applying device by a Series of guide pins. The
`proximal end of the clamp Slide is positioned to engage a
`distal end of the pivotable clamp as the clamp is pivoted to
`advance the clamp Slide and cartridge carrier towards a
`distally located anvil assembly.
`The distal end of the pivotable clamp includes a plurality
`of Vertically aligned detents which are configured to be
`releasably received in a pair of Vertically aligned recesses
`formed in the proximal end of the clamp Slide. The approxi
`mation clamp is pivotable to Sequentially move each one of
`the detents into locking engagement with each of the
`recesses to define a plurality of different Stages of approxi
`mation. The engaging Surfaces of the approximation clamp
`and the clamp Slide are configured to provide fast closure of
`the device as the detents are moved into engagement with
`the bottom receSS and incremental closure of the device as
`the detents are moved into engagement with the upper
`CCCSS.
`The fastener applying device preferably further includes
`an adjustment mechanism that changes the maximum Stroke
`of the pusher bar to facilitate ejection of different size
`fasteners from cartridges housing only fasteners, i.e., the
`drivers are not housed within the cartridge. The adjustment
`mechanism includes an adjustment member having a shaft
`having at least two flats formed at different depths into the
`shaft. The shaft is rotatably supported on the body of the
`device and extends through an adjustment slot formed in the
`pusher bar of the fastener applying device. The shaft is
`movable to align each of the flats with the proximal end of
`the adjustment slot to limit the effective stroke of the pusher
`bar. Each flat is formed to facilitate ejection of a particular
`size fastener from the device. Since each of the flats is
`formed in the adjustment member to a different depth, the
`maximum Stroke of the pusher bar can be changed by
`rotating the adjustment shaft to align a different flat with the
`proximal end of the adjustment Slot.
`To prevent insertion of a cartridge into a fastener applying
`device Set to receive a cartridge housing different size
`fasteners, a cartridge housing particular size fasteners, e.g.,
`4.8 mm fasteners, may include a proximally extending leg.
`When the adjustment member is properly set to eject the
`fasteners, the proximally extending leg will be aligned with
`a receSS in the adjustment Shaft allowing the cartridge to be
`inserted into the cartridge carrier. However, if the adjustment
`
`Ethicon Exhibit 2001.022
`Intuitive v. Ethicon
`IPR2018-00934
`
`

`

`3
`shaft is improperly Set, i.e., Set to eject a different size or
`Smaller fastener, the receSS in the adjustment shaft config
`ured to receive the cartridge leg will not be aligned with the
`leg and the adjustment shaft will obstruct passage of the
`cartridge into the cartridge carrier.
`BRIEF DESCRIPTION OF THE DRAWINGS
`Various embodiments are described herein with reference
`to the drawings wherein:
`FIG. 1 is a perspective view of one embodiment of the
`fastener applying device of the present disclosure;
`FIG. 2 is a perspective view of the distal end of the
`embodiment of the disclosure shown in FIG. 1 with the
`cartridge assembly in an advanced position;
`FIG. 3 is a perspective view with parts separated of the
`device shown in FIG. 1;
`FIG. 4 is a perspective view with parts Separated of a
`portion of the distal end of the device shown in FIG. 1;
`FIG. 5 is a front elevational view of the anvil of the device
`shown in FIG. 1;
`FIG. 6 is a perspective view of the cartridge carrier of the
`device shown in FIG. 1;
`FIG. 7 is a perspective view of a portion of the distal end
`of the device shown in FIG. 1;
`FIG. 8 is a perspective view of the cartridge assembly of
`the device shown in FIG. 1;
`FIG. 9 is a cross-sectional view taken along Section line
`9- 9 of FIG. 8:
`FIG. 10 is a perspective view of the pusher bar and
`proximal portion of the clamp Slide of the device shown in
`FIG. 1;
`FIG. 11 is an enlarged view of the proximal end of the
`pusher bar and clamp slide as shown in FIG. 10;
`FIG. 12 is a perspective view with parts separated of the
`pusher bar, the proximal portion of the clamp Slide, and the
`metal support member of the pusher bar of the device shown
`in FIG. 1;
`FIG. 12A is a perspective view with parts separated of the
`clamp slide and the pusher bar of the device shown in FIG.
`1;
`FIG. 13 is an enlarged view of the indicated area of detail
`shown in FIG. 12;
`FIG. 14 is a perspective view of the set pin of the
`adjustment mechanism of the device shown in FIG. 1;
`FIG. 15 is a perspective view of a portion of the alignment
`mechanism of the device shown in FIG. 1;
`FIG. 15A is an enlarged view of the indicated area of
`detail shown in FIG. 15;
`FIG. 16 is a perspective view of the lateral slide element
`of the alignment mechanism of the device shown in FIG. 1;
`FIG. 16A is an enlarged view of the indicated area of
`detail of FIG. 16;
`FIG. 17 is a side cross-sectional view of the device shown
`in FIG. 1 with the clamp slide in a retracted position;
`FIG. 18 is an enlarged view of the indicated area of detail
`shown in FIG. 17;
`FIG. 19 is an enlarged view of the indicated area of detail
`shown in FIG. 17;
`FIG.20 is a side cross-sectional view of the device shown
`in FIG. 1 at a first Stage of approximation and prior to firing
`the fasteners,
`FIG. 21 is an enlarged view of the indicated area of detail
`of FIG. 20;
`
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`FIG.22 is a side cross-sectional view of the device shown
`in FIG. 1 at a Second Stage of approximation;
`FIG. 23 is an enlarged view of the indicated area of detail
`of FIG.22;
`FIG. 24 is an enlarged view of the indicated area of detail
`of FIG.22;
`FIG.25 is a side cross-sectional view of the device shown
`in FIG. 1 at a third Stage of approximation and prior to firing
`the fasteners,
`FIG. 26 is an enlarged view of the indicated area of detail
`of FIG. 25;
`FIG. 27 is an enlarged view of the indicated area of detail
`of FIG. 25;
`FIG.28 is a side cross-sectional view of the device shown
`in FIG. 1 at a fourth Stage of approximation and prior to
`firing of the fasteners,
`FIG.29 is an enlarged view of the indicated area of detail
`of FIG. 28;
`FIG.30 is an enlarged view of the indicated area of detail
`of FIG. 28;
`FIG.31 is a side cross-sectional view of the device shown
`in FIG. 1 at the third stage of approximation in a fully
`actuated condition;
`FIG.32 is an enlarged view of the indicated area of detail
`of FIG. 31;
`FIG. 33 is a top cross-sectional view of the distal end of
`the device shown in FIG. 1 with the clamp slide in a
`retracted position;
`FIG. 34 is a top cross-sectional view of the distal end of
`the device shown in FIG. 1 with the cartridge and anvil
`assemblies at a fourth stage of approximation;
`FIG. 35 is a top cross-sectional view of the distal end of
`the device shown in FIG. 1 with the pusher bar in an
`advanced position.
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`Preferred embodiments of the presently disclosed fastener
`applying device will now be described in detail with refer
`ence to the drawings, in which like reference numerals
`designate identical or corresponding elements in each of the
`Several views.
`Referring to the drawings, FIGS. 1 and 2 illustrate a first
`embodiment of the fastener applying device shown gener
`ally as 10. Fastener applying device 10 includes a housing
`12 including Stationary handle 14, a distally extending body
`portion 16, and a transverse body portion 15. Transverse
`body portion 15 is configured to receive support frame 18.
`Housing 12 may be constructed from plastic material in the
`form of molded housing half-sections 12a and 12b.
`Preferably, housing 12 is constructed from fiberglass rein
`forced plastic, although other materials having the requisite
`Strength requirements may be used.
`FIG. 3 illustrates a perspective View of fastener applying
`device 10 with the internal components of device 10 sepa
`rated from each other. The device 10 may be is fastened
`together using ScrewS 19 that extend between housing
`half-sections 12a and 12b, although adhesives, ultrasonic
`welding, and other known fastening methods may also be
`used to fasten the components of the device together.
`Referring to FIGS. 4 and 5, an anvil 20 is fastened to a
`first leg 24 of the Support frame 18. Any known fastening
`technique may be used to fasten the anvil 20 to first leg 24.
`Preferably, anvil 20 includes a pair of inwardly converging
`
`Ethicon Exhibit 2001.023
`Intuitive v. Ethicon
`IPR2018-00934
`
`

`

`S
`legs 35 dimensioned to be received on a pair of outwardly
`diverging legs 37 formed on first leg 24. During manufac
`turing of device 10, anvil 20 may be slid onto first leg 24, in
`the direction as indicated by arrow “X”, and secured in
`position Via any known means, e.g., Welding, crimping, etc.
`The anvil 20 may be constructed from any material having
`the requisite Strength requirements, but is preferably formed
`from cold rolled steel.
`The Support frame 18 is substantially U-shaped and
`includes first leg 24, a Second leg 26, and a base portion 28.
`First leg 24 extends Substantially parallel to Second leg 26.
`Second leg 26 is formed with a cam slot 30 and a pair of
`elongated guide nubs 32, which will be discussed in further
`detail below. Base portion 28 extends between first and
`second legs 24 and 26 to define a space 39. The support
`frame 18 may be monolithically formed by bending a sheet
`of material into the desired shape. Preferably, Support frame
`18 is constructed from Stainless Steel, although other mate
`rials having the requisite Strength requirements may be used.
`Referring to FIGS. 6 and 7, cartridge carrier 38 is slidably
`Supported about Second leg 26 of Support frame 18 and is
`movable through the space 39 towards first leg 24. Elon
`gated slots 50 extend through cartridge carrier 38 and are
`configured to receive the guide nubS 32 formed on the
`second leg 26. The guide nubs 32 define a linear path of
`travel for the cartridge carrier 38 as it advances between the
`first and second legs 24 and 26 of support frame 18.
`FIGS. 3, 8 and 9 illustrate cartridge assembly 22. Car
`tridge assembly 22 includes a body 104 having a distal face
`106 which is spaced from an open proximal end 74. A pusher
`bar channel 108 extends from the open end 74 through a
`portion of body 104. A plurality of slots 110 house fasteners
`21 (FIG. 3) and are configured to receive distally extending
`fingers 76 of pusher bar 66. The slots 110 extend between the
`distal end of pusher bar channel 108 and the distal face 106
`of cartridge assembly 22. The outer Surface of cartridge
`body 104 includes a pair of transversely extending flanges
`54.
`Referring temporarily back to FIG. 6, cartridge carrier 38
`is provided with inwardly extending projections 52 which
`define a channel 53 configured to receive cartridge assembly
`22 (FIG. 8). The cartridge assembly 22 can be slid into
`channel 53 Such that projections 52 engage flanges 54 to
`retain cartridge assembly 22 within cartridge carrier 38. The
`open end 74 of cartridge body 104 faces the proximal end of
`the device 10. When the cartridge assembly 22 is properly
`positioned within channel 53, an opening 124 formed in
`cartridge carrier 38 is aligned with an opening 112 formed
`in cartridge assembly 22.
`Referring to FIGS. 3 and 10-12A, the fastener applying
`device 10 has an approximation mechanism for advancing
`cartridge assembly 22 and cartridge carrier 38. An approxi
`mating clamp 34 or lever is pivotably mounted about pivot
`member 40 which is supported between housing half sec
`tions 12a and 12b in the proximal end of housing 12. The
`approximating clamp 34 is movable into engagement with a
`proximal end of clamp Slide 36 to linearly advance the clamp
`slide 36 within body portion 16. A plurality of longitudinal
`slots 42 formed in clamp slide 36 are configured to receive
`guide pins 44 to limit clamp slide 36 to a linear path of
`travel.
`Referring specifically to FIGS. 12 and 12A, the distal end
`of clamp slide 36 includes a pair of projections 46. The
`projections 46 are fastened within a pair of openings 48
`formed in a proximal end of cartridge carrier 38, Such that
`linear movement of clamp Slide 36 is translated to corre
`sponding linear movement of cartridge carrier 38.
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`Referring to FIGS. 3, 10 and 11, approximating clamp 34
`includes an abutment end 62 having a Series of detents
`55-57 which are configured to be received in recesses 58
`and 59 formed in an angled proximal end 60 of clamp slide
`36. The angled proximal end 60 of the clamp slide 36 and the
`abutment end 62 of the approximating clamp 34 (FIG. 3) are
`movable into engagement to advance the cartridge assembly
`22 towards the anvil 20. Preferably, approximating clamp 34
`and clamp Slide 36 are constructed of plastic and cartridge
`carrier 38 is constructed of stainless steel. However, other
`materials meeting the requisite Strength requirements and
`being Suitable for Surgical use may be used to construct each
`of the components of device 10.
`FIGS. 3, 12 and 13 illustrate the firing mechanism for
`applying the fasteners of device 10. The firing mechanism
`includes a trigger actuator 64 and an elongate pusher bar 66
`slidably received in channel 67 formed in clamp slide 36.
`Trigger actuator 64 is pivotable about pivot pin 68 into
`engagement with a proximal end of pusher bar 66 to advance
`pusher bar 66 with respect to cartridge carrier 38. Pivot pin
`68 is supported between housing half-sections 12a and 12b.
`Pusher bar 66 includes a series of longitudinal slots 70.
`The slots 70 slidably receive the guide pins 44. Guide pins
`44 limit pusher bar 66 to a linear path of travel identical to
`that of clamp slide 36.
`The distal end of pusher bar 66 is formed with a head
`portion 72 configured to move through the open proximal
`end 74 of cartridge assembly 22 (FIG. 9) to effect ejection
`of fasteners 21. A plurality of distally extending fingers 76
`are integrally formed on head portion 72. Each finger 76 has
`a concave distal Surface 78 configured to engage the fasten
`ers 21 housed within cartridge assembly 22. Fingers 76
`extend from head portion 72 in a pattern that corresponds to
`the pattern that fastenerS 21 are housed within cartridge
`assembly 22. For example, the pattern may be two staggered
`rows. Other patterns are also contemplated.
`A recess 71 is formed in one side of head portion 72. A
`metal plate 73 is positioned in recess 71 to provide addi
`tional strength to the distal end of pusher bar 66. Due to the
`increase in Strength provided by metal plate 73, pusher bar
`66 may be constructed from plastic and still retain the
`Strength to effect ejection of fastenerS 21 from fastener
`applying device 10.
`Pusher bar 66 has a ledge 86 located proximally of head
`portion 72. Ledge 86 is positioned to engage a distal edge 88
`formed on clamp slide 36, such that distal movement of
`clamp Slide 36 effects corresponding distal movement of
`pusher bar 66. Pusher bar 66 remains free to advance distally
`independently of clamp slide 36 since ledge 86 will be
`disengaged from distal edge 88 when pusher bar 66 is
`advanced distally.
`As illustrated in FIG. 3, the proximal end of pusher bar 66
`has a locking Surface 80 and a contact Surface 82. The trigger
`actuator 64 includes an engagement Surface 84 which pivots
`into engagement with contact Surface 82 of the pusher bar 66
`to advance the pusher bar 66 distally.
`Referring temporarily ahead to FIGS. 17-21, when the
`pusher bar 66 is in a retracted position, locking surface 80
`of the pusher bar 66 is positioned to prevent engagement
`between engagement Surface 84 of the trigger actuator 64
`and contact surface 82 of pusher bar 66. Thus, locking
`surface 80 prevents firing fasteners 21 prior to sufficient
`approximation of cartridge assembly 22 and anvil 20. Before
`trigger actuator 64 can be rotated counter-clockwise, as
`viewed in FIG. 21, to eject fasteners 21 from device 10, the
`approximating clamp 34 must be rotated clockwise from the
`
`Ethicon Exhibit 2001.024
`Intuitive v. Ethicon
`IPR2018-00934
`
`

`

`7
`position of FIG. 17, toward the stationary handle 14 in the
`direction indicated by arrow “A”, to advance clamp slide 36
`distally, Such that distal edge 88 of clamp Slide 36 engages
`and advances distal ledge 86 of pusher bar 66, to move
`locking Surface 80 distally past engagement Surface 84. This
`frees trigger actuator 64 for pivotal movement to fire the
`fasteners.
`Referring now to FIGS. 3 and 14, an adjustment member
`90 is provided in the distal end of the device 10 to facilitate
`ejection of different Size fastenerS 21 from fastener applying
`device 10. Adjustment member 90 includes a cylindrical
`shaft 92 having a pair of diametrically opposed first and
`second flats 94 and 96, respectively. Cylindrical shaft 92
`extends through an opening 100 (FIG. 4) formed in the
`second leg 26 of support member 18 and through the distal
`end of a longitudinal adjustment slot 98 formed in pusher bar
`66. The adjustment member 90 is secured to support mem
`ber 18 by adjustment nut 91. Shaft 92 is rotatable to align
`one of the opposed flats 94 or 96 with a proximal end 102
`of adjustment slot 98 to define a stop surface for the pusher
`bar 66. See FIG. 12A. Since the flats 94 and 96 are formed
`at different depths into the cylindrical shaft 92, shaft 92 may
`be rotated to change the position of the Stop Surface to vary
`the stroke of the pusher bar 66.
`Referring now to FIGS. 4, 7, and 15-16, an alignment
`mechanism is operably connected to the approximation
`mechanism to maintain alignment between cartridge assem
`bly 22 and anvil 20 during approximation of anvil 20 and
`cartridge 22. The alignment mechanism preferably includes
`alignment pin 114, L-shaped link 116, and slide element 118.
`Alignment pin 114 includes a cylindrical shaft 115 having
`a distal tapered nose 120 and an annular groove 122 located
`proximally of nose 120. The pin 114 is configured to pass
`through an opening 112 (FIG. 8) formed in cartridge assem
`bly 122, opening 124 formed in cartridge carrier 38, and
`opening 126 formed in anvil 20. The proximal end of pin 114
`includes an angled portion 128 which is operably connected
`to the L-shaped link 116.
`L-shaped link 116 includes a first leg 130 having an
`elongated slot 132, a Second leg 134 adapted to receive a
`camming pin 142 (FIG. 15), and a central portion 136 having
`a pivot member 138 configured to pivotably engage con
`nector 140. The connector 140 is integrally formed with
`cartridge carrier 38. Elongated slot 132 is dimensioned to
`slidably receive angled portion 128 of alignment pin 114,
`and camming pin 142 is positioned in cam Slot 30 formed in
`support member 18.
`Slide element 118 is slidably received in channel 144
`formed in first leg 24 of support member 18 (FIG. 7) and
`includes a forked tip 146 at one end having a recess 148
`configured to be received in annular groove 122 of align
`ment pin 114 (FIG. 15A). Longitudinal extension 150
`extends from the other end of slide element 118 and is
`dimensioned to be received within opening