`a2) Patent Application Publication (10) Pub. No.: US 2005/0006432 Al
`(43) Pub. Date: Jan. 13, 2005
`
`Racenet etal.
`
`US 20050006432A1
`
`(54) SURGICAL STAPLING DEVICE
`
`(52) US. Ch.
`
`cecescssssssssnsssesnesnstnassee 227/176.1; 227/19
`
`(76)
`
`Inventors: David C. Racenet, Litchfield, CT (US);
`Ralph Stearns, Bozrah, CT (US); John
`W. Beardsley, Hamden, CT (US);
`Philip Roy, Hamden, CT (US); Lee
`Ann Olson, Wallingford, CT (US)
`
`Correspondence Address:
`Paul R. Audet, Esq.
`U.S. Surgical
`A Division of Tyco Healthcare Group, LP
`150 Glover Avenue
`
`Norwalk, CT 06856 (US)
`
`(21) Appl. No.:
`
`10/871,342
`
`(22)
`
`Filed:
`
`Jun. 17, 2004
`
`Related U.S. Application Data
`
`(60) Provisional application No. 60/479,379,filed on Jun.
`17, 2003.
`
`Publication Classification
`
`(57)
`
`ABSTRACT
`
`A surgical device is disclosed which includes a handle
`portion, a central body portion and a SULU. The SULU
`includes a proximal body portion, an intermediate pivot
`memberand a tool assembly. The intermediate pivot mem-
`ber is pivotally secured to the proximal body portion about
`a first pivot axis and the tool assembly is pivotally secured
`to the intermediate pivot member about a second pivot axis
`which is orthogonal
`to the first pivot axis. The SULU
`includesa plurality of articulation links which are operably
`connected to the tool assembly by non-rigid links. The
`articulation links are adapted to releasably engage articula-
`tion links positioned in the central body portion. The body
`portion articulation links are connected to an articulation
`actuator which is supported for omni-directional movement
`to effect articulation of the tool assembly aboutthe first and
`second axes. The handle portion includes a spindle and
`barrel assembly drive mechanism for advancing andretract-
`ing a drive memberpositioned in the tool assembly. In one
`embodiment, the tool assembly includes a cartridge assem-
`bly having a plurality of staples and an anvil assembly.
`
`10
`
`2
`
`13b
`
`(SL) Ute C07 caacccssssssssnsssssnsssetnesnesnstsee A61B 17/04
`
`1
`
`IS 1021
`Intuitive Surgical v. Ethicon
`IPR2019-00880
`
`1
`
`IS 1021
`Intuitive Surgical v. Ethicon
`IPR2019-00880
`
`
`
`US 2005/0006432 Al
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`
`SURGICAL STAPLING DEVICE
`
`[0001] This application claims priority from U.S. provi-
`sional application Ser. No. 60/479,379 filed Jun. 17, 2003,
`which is incorporated herein by reference in its entirety.
`
`BACKGROUND
`
`[0002]
`
`1. Technical Field
`
`[0003] The present disclosure relates to a surgical stapling
`device and, more particularly,
`to an endoscopic surgical
`stapling device having a tool assembly whichis articulatable
`about first and second perpendicular axes.
`
`[0004]
`
`2. Background Of Related Art
`
`[0005] Surgical devices wherein tissueis first grasped or
`clamped between opposing jaw structure and then joined by
`surgical fasteners are well knownin the art. In someinstru-
`ments a knife is provided to cut the tissue which has been
`joined be the fasteners. The fasteners are typically in the
`form of surgical staples but two part, including polymeric,
`fasteners can also be utilized.
`
`Instruments for this purpose can include twoelon-
`[0006]
`gated members which are respectively used to capture or
`clamp tissue. Typically, one of the memberscarries a staple
`cartridge which houses a plurality of staples arranged, for
`example, in at least two lateral rows while the other member
`has an anvil that defines a surface for formingthe staple legs
`as the staples are driven from the staple cartridge. Generally,
`the stapling operation is effected by cam bars that travel
`longitudinally through the staple cartridge, with the cam
`bars acting upon staple pushers to sequentially eject the
`staples from the staple cartridge. A knife can travel between
`the staple rows to longitudinally cut
`the stapled tissue
`between the rows of staples. Such staplers are disclosed in
`US. Pat. Nos. 6,250,532 and 6,241,139 which are incorpo-
`rated herein be reference in their entirety.
`
`In endoscopic or laparoscopic procedures, surgery
`[0007]
`is performed through small incisions or through small diam-
`eter cannulas inserted through small entrance woundsin the
`skin. Due to the limited degree of motion of an instrument
`when it is positioned through the skin,
`it may be quite
`difficult for a surgeon to manipulate the tool assembly of the
`instrument to access and/or clamp tissue. To overcomethis
`problem,instruments having rotatable endoscopic body por-
`tions and rotatable and/orarticulatable tool assemblies have
`been developed and are commercially available. Although
`these instruments provide significant improvements in the
`endoscopic toolart, further improvements that may decrease
`the time required for surgical procedures by allowing sur-
`geons to more quickly access tissue are desired.
`
`[0008] Accordingly, a continuing need exists for an endo-
`scopic or laparoscopic surgical device having a tool assem-
`bly which can be quickly and easily manipulated to an
`infinite number of orientations to access, clamp and/or cut
`tissue.
`
`SUMMARY
`
`In accordance with the present disclosure, a surgi-
`[0009]
`cal stapling device is provided which includes a handle
`portion, an elongated central body portion and a Single Use
`Loading Unit
`(““SULU”) or Disposable Loading Unit
`(“DLU”). The elongated body portionis rotatably secured to
`
`the handle portion. The SULU includes a proximal body
`portion, an intermediate pivot memberand a tool assembly.
`The intermediate pivot memberis pivotally connected to the
`proximal body portion about a first axis and pivotally
`connected to the tool assembly about a second axis substan-
`tially orthogonalto the first axis. As such, the intermediate
`pivot memberis able to articulate in relation to the proximal
`body portion and tool assembly is able to pivot with respect
`to the intermediate pivot member. Thus, the tool assembly is
`able to be pivoted about multiple axes in relation to the
`elongated central body portion of the device. Since the
`elongated central body portion of the deviceis also rotatable
`in relation to the handle portion of the device, the capability
`of articulation of the tool assembly about multiple axes
`allows a surgeon to quickly and easily position the tool
`assembly at an infinite number of orientations to facilitate
`operation on bodytissue.
`
`the surgical
`In another aspect of the disclosure,
`[0010]
`stapling device includes an articulation actuator which is
`supported on a semi-spherical base member for onmi-
`directional or universal movement. A plurality of articula-
`tion links have a first end operably connected to the articu-
`lation actuator and a second end adapted to be releasably
`connectedto articulation links of the SULU. Thearticulation
`links of the SULU are operably connected to the tool
`assembly by cables or non-rigid links such that the articu-
`lation actuator can be manipulated to articulate the tool
`assembly about either or both of the first and second axes.
`
`the handle
`In another aspect of the invention,
`{0011]
`portion includes a drive mechanism for moving a firing link
`and a retraction link for effecting operation of the tool
`assembly. The drive mechanism includes a spindle sup-
`ported within the handle portion and a barrel assembly
`slidably positioned about the spindle. The spindle includes a
`first guide track for receiving a firing rack and a second
`diametrically disposed guide track for slidably receiving a
`retraction rack. The barrel assembly includes a firing pawl
`which is movable into engagement with the firing rack and
`aretraction pawl which is movable into engagement with the
`retraction rack. A first shift ring assembly is provided to
`selectively position the firing and retraction pawls in relation
`to the firing and retraction racks, respectively. A handle
`portion trigger is provided to move the barrel assembly
`about and along the spindle to selectively move the firing
`rack or retraction rack to operate the tool assembly.
`
`In yet another aspect of the disclosure, the tool
`[0012]
`assembly is a stapling device and the barrel assembly
`includes a grasper pawl which is movable into engagement
`with the firing rack to allow the tool assembly to be operated
`in a grasper mode. More specifically, the grasper pawl is
`controlled by a second shift ring assembly andis selectively
`movable into engagement with the firing rack to allow the
`firing rack to move a distance which will, upon operation of
`the movable trigger, effect approximation of cartridge and
`anvil assemblies of the tool assembly but will not affect
`firing of staples.
`
`In yet another embodiment of the disclosure, the
`[0013]
`tool assembly includes a cartridge assembly and an anvil
`assembly. A drive assembly including a knife bar and an
`actuation sled are translatable through the tool assembly to
`simultaneously staple and cut tissue positioned between the
`cartridge and anvil assemblies. A firing cable and a retract
`
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`cable each havea first portion secured to the drive assembly.
`The firing cable has a proximal end securedto a firing link
`of the SULU whichis adapted to be releasably connected to
`a firing link of the central body portion. Thefiring link of the
`central body portion is operably connected to the firing rack
`such that proximal movementof the firing rack effects distal
`translation of the drive assembly through the cartridge
`assembly. The retract cable has a proximal end connected to
`a retraction link of the SULU. The retraction link of the
`
`SULUis adapted to be connected to the retraction link of the
`central body portion of the device which is operably con-
`nected to the retraction rack such that proximal movementof
`the retraction rack effects proximal movement of the drive
`assembly.
`
`In another aspect of the disclosure, a novel con-
`[0014]
`nection mechanism is provided for securing the SULUto the
`elongated central body portion of the stapling device. The
`connection mechanism facilitates releasable attachmentof a
`
`SULU having a non-rigid cable driven drive assembly to a
`stapling device.
`
`is an object of this disclosure to provide a
`It
`[0015]
`surgical device having a removable SULU which includes
`an articulation and/or drive mechanism having non-rigid
`links.
`
`It is another object of this disclosure to provide a
`[0016]
`surgical stapling device having a rotatable central body
`portion and a tool assembly including a cartridge assembly
`and an anvil assembly whichis pivotal aboutfirst and second
`axes which are substantially orthogonal to each other.
`
`Itis yet another object of this disclosure to provide
`[0017]
`a handle portion having a spindle and barrel assembly which
`facilitates selective operation of an operating member or
`drive memberin a firing or operating mode, a retraction
`mode and a grasping mode.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0026] FIG. 8 is a side perspective view from the distal
`end of the surgical stapling device shownin FIG.4 with the
`SULUseparated from the central portion of the central body
`portion of the surgical stapling device shownin FIG.8 with
`a handle portion half-section, the rotation control member
`and the articulation actuator removed;
`
`[0027] FIG. 9 is a side perspective view from the distal
`end of the surgical stapling device shown in FIG. 8, with
`parts separated and with the SULU not shown;
`
`[0028] FIG. 10 is a side perspective view with parts
`separated of the proximal end of the central body portion,
`one half-section of the articulation actuator and actuator
`base member and one half-section of the rotation control
`
`memberof the surgical stapling device shown in FIG.8;
`
`[0029] FIG. 11 is a side perspective view from the proxi-
`mal end of the handle portion and the proximal portion of the
`central body portion of the surgical stapling device shown in
`FIG. 8 with a handle portion half-section, the articulation
`actuator and rotation control member removed;
`
`[0030] FIG. 12 is a side perspective view from the top of
`the distal portion of the handle portion, rotation control
`member, articulation actuator and proximal portion of the
`central body portion of the surgical stapling device shown in
`FIG.8;
`
`[0031] FIG. 13 is a side perspective view from the distal
`end of the handle portion and the proximal portion of the
`central body portion of the surgical stapling device shown in
`FIG. 8 with a handle portion half-section and a half-section
`of the rotation control member and articulation actuator
`removed;
`
`[0032] FIG. 14 is a side view of the handle portion and the
`proximalportion of the central body portion of the surgical
`stapling device shown in FIG. 8 with a handle portion
`half-section, the rotation control member and the articula-
`tion actuator removed;
`
`[0018] Embodiments of the presently disclosed surgical
`stapling device are disclosed herein with reference to the
`drawings wherein:
`
`[0033] FIG. 15 is a side perspective view from the distal
`end of the spindle and barrel assembly of the surgical
`stapling device shown in FIG. 9;
`
`[0019] FIG. 1 is a side perspective view from the distal
`end of the presently disclosed surgical stapling device;
`
`FIG.2 isa side perspective view from the proximal
`[0020]
`end of the surgical stapling device shown in FIG.1;
`
`FIG.3 isa side view ofthe surgical stapling device
`[0021]
`shown in FIG.2;
`
`FIG.4 is a top view of the surgical stapling device
`[0022]
`shown in FIG.3;
`
`[0023] FIG. 5 is a side perspective view from the distal
`end of the proximal body portion and tool assembly of the
`SULUofthe surgical stapling device shown in FIG.4 with
`the tool assembly in a non-articulated position;
`
`[0024] FIG. 6 is a side perspective view from the distal
`end of the SULU shown in FIG. 5 with the tool assembly
`articulated about a first axis;
`
`[0025] FIG. 7 is a side perspective view from the distal
`end of the SULU shown in FIG. 6 with the tool assembly
`articulated about a second axis transverse to the first axis;
`
`[0034] FIG. 16 is a side perspective view from the distal
`end of the spindle and barrel assembly shown in FIG. 15
`with parts separated;
`
`[0035] FIG. 17 is a side perspective view with parts
`separated of the internal components of the central body
`portion of the surgical stapling shown in FIG.8;
`
`[0036] FIG. 18 is an enlarged view of the indicated area
`of detail shown in FIG. 17;
`
`[0037] FIG. 18a is a side perspective view of the SULU
`of the surgical stapling device shown in FIG. 8 with the
`proximal body portion of the SULU shown with parts
`separated;
`
`[0038] FIG. 185 is a cross-sectional view taken along
`section lines 18b-18b of FIG. 18a;
`
`[0039] FIG. 18c is a cross-sectional view taken along
`section lines 18c-18c of FIG. 18a;
`
`[0040] FIG. 18d is a cross-sectional view taken along
`section lines 18d-18d of FIG. 18a;
`
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`[0041] FIG. 18e is a cross-sectional view of the proximal
`body portion of the SULU shown in FIG. 18 during attach-
`mentof the SULU to the central body portion of a surgical
`stapling device;
`
`[0060] FIG. 33d is a cross-sectional view of the barrel
`assembly and spindle shown in FIG. 30 with the second
`shift ring assembly in its proximal-most position and the
`grasper pawl disengaged with the firing rack;
`
`[0042] FIG. 19 is a side perspective view with parts
`separated of the tool assembly of the SULU shown in FIG.
`18a with mess cables not shown;
`
`[0043] FIG. 20 is an enlarged side perspective view of the
`knife bar of the SULU shownin FIG. 19;
`
`[0044] FIG. 21 is an enlarged side perspective view from
`the distal end of the guide cap of the SULU shown in FIG.
`19;
`
`[0045] FIG. 22 is an enlarged side perspective view from
`aboveof the cartridge assembly of the SULU shownin FIG.
`19, assembled;
`
`[0046] FIG. 23 is an enlarged side perspective view of a
`portion of the distal end of the cartridge assembly shown in
`FIG. 22 with the cartridge and nose cap removed;
`
`FIG.24is a top perspective view from oneside of
`[0047]
`the cartridge assembly shown in FIG. 22 with parts sepa-
`rated and the firing cable and retract cable shown schemati-
`cally;
`
`[0048] FIG. 25 is an enlarged view of the indicated area
`of detail shown in FIG.16;
`
`[0049] FIG. 26 is an enlarged view of the indicated area
`of detail shown in FIG.16;
`
`[0050] FIG. 27 is an enlarged view of the indicated area
`of detail shown in FIG.16;
`
`[0051] FIG. 28 is an enlarged side perspective view from
`the distal end of the barrel assembly body portion of the
`barrel assembly shown in FIG. 15;
`
`[0052] FIG. 29 is a top view of the barrel assembly and
`spindle shown in FIG. 15;
`
`[0053] FIG. 30 is a side view of the barrel assembly and
`spindle shown in FIG.29;
`
`[0054] FIG. 31 is a cross-sectional view taken along
`section lines 31-31 of FIG.30;
`
`[0055] FIG. 32 is a cross-sectional view taken along
`section lines 32-32 of FIG.29;
`
`[0056] FIG. 33 is an enlarged view of the indicated area
`of detail shown in FIG.32;
`
`[0057] FIG. 33a is an enlarged horizontal cross-sectional
`view of a portion of the handle portion of surgical stapling
`device shown in FIG. 1 with the first and second shift ring
`assemblies in their distal-most positions and the firing pawl
`engaged with the firing rack;
`
`[0058] FIG. 33d is a horizontal cross-sectional view with
`portions broken awayof oneside of the handle portion of the
`surgical stapling device shown in FIG. 33a and with the
`second shift ring assembly being moved towards its proxi-
`mal-most position;
`
`[0059] FIG. 33c is a horizontal cross-sectional view ofthe
`handle portion of the surgical stapling device shown in FIG.
`33a with the second shift ring assembly moved to its
`proximal-most position;
`
`[0061] FIG. 33¢eis a side view of a portion of the handle
`portion of the surgical stapling device shown in FIG. 14
`with the second shift ring assembly movedto its proximal-
`most position;
`
`[0062] FIG. 33/ is a horizontal cross-sectional view of the
`handle portion of the surgical stapling device shown in FIG.
`1 with the first and second shift ring assemblies moved to
`their proximal-most positions;
`
`[0063] FIG. 33¢ is a vertical cross-sectional view of the
`barrel assembly and spindle shown in FIG. 30 with the first
`and second shift ring assemblies in their proximal-most
`positions;
`
`[0064] FIG. 34 is a side view of the internal body of a
`handle portion half-section of the handle portion shown in
`FIG. 33e;
`
`[0065] FIG. 34a is an enlarged partial cutaway cross-
`sectional view taken along section lines 34a-34a of FIG.34;
`
`[0066] FIG. 35 is an enlarged side perspective view of a
`portion of the handle portion shown in FIG.34;
`
`[0067] FIG. 36 is an enlarged view of the indicated area
`of detail shown in FIG. 35;
`
`[0068] FIG. 37 is a perspective view from the distal end
`of the proximal portion of the SULU and the distal portion
`of the central body portion of the surgical stapling device
`shown in FIG. 8 prior to attachment of the SULU to the
`central body portion;
`
`[0069] FIG. 38 is a perspective view from the proximal
`end of the proximal portion of the SULU and the distal
`portion of the central body portion shown in FIG. 37;
`
`[0070] FIG. 39 is a perspective view from the distal end
`of an articulation link of the central body portion and an
`articulation link of the SULUprior to attachment;
`
`[0071] FIG. 40 is a side view of the articulation links
`shown in FIG.39;
`
`[0072] FIG. 40a is a cross-sectional view of a firing/
`retract link of the central body portion and a firing/retract
`link of the SULU interconnected by an intermediate link;
`
`[0073] FIG. 41 is a perspective view of the distal end of
`the central body portion of the surgical stapling device
`shown in FIG. 8 with the outer tube removed;
`
`[0074] FIG. 42 is a perspective view from the distal end
`of the central body portion shown in FIG. 41 with the hub
`member removed;
`
`[0075] FIG. 43 is an enlarged view of the indicated area
`of detail shown in FIG.1, prior to attachment of the SULU
`to the device;
`
`[0076] FIG. 44 is an enlarged view of the indicated area
`of detail shown in FIG. 2;
`
`[0077] FIG. 45 is a side perspective view from the distal
`end of the proximal portion of the SULU and the distal
`
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`portion of the central body portion of the surgical stapling
`device shown in FIG. 8 during attachment of the SULU to
`the central body portion;
`
`[0078] FIG. 46 is a side view of a SULUarticulation link
`and a central body portion articulation link during attach-
`ment of one to the other;
`
`[0079] FIG. 47 is a side perspective view of the proximal
`end of the device SULU andthe distal end of the device
`central body portion shown in FIG. 45 just prior to full
`attachment of one to the other;
`
`[0080] FIG. 48is a side perspective view of the proximal
`end of the device SULU and the distal end of the device
`central body portion with the SULU fully attached to the
`central body portion;
`
`[0094] FIG. 62 is a side cutaway view of the handle
`portion and central body portion of the surgical stapling
`device shown in FIG. 59 with the articulation actuator
`moved proximally;
`
`FIG.63 is a side cross-sectional view of the carrier
`[0095]
`portion, intermediate pivot and mounting memberof the
`surgical stapling device shown in FIG. 62;
`
`[0096] FIG. 64is a top cross-sectional view of the carrier
`portion, intermediate pivot and mounting memberof the
`SULUof the surgical stapling device shown in FIG. 62;
`
`[0097] FIG. 65 is a side cutaway view of the carrier
`portion, intermediate pivot and mounting memberof the
`surgical stapling device shown in FIG. 8 showing the
`articulation cables partly in phantom and with the SULU in
`a non-articulated position;
`
`[0081] FIG. 49 is an enlarged view of the indicated area
`of detail shown in FIG.1;
`
`[0098] FIG. 66 is a side view of the handle portion of the
`surgical stapling device shown in FIG. 8 with the articula-
`[0082] FIG. 50 is an enlarged view of the indicated area
`tion actuator moved to a first position to articulate the tool
`of detail shown in FIG.2;
`assembly of the SULU toafirst orientation;
`
`[0083] FIG. 51 is a perspective view from the distal end
`of the proximal end of the cartridge carrier portion,
`the
`intermediate pivot assembly and the mounting memberof
`the surgical stapling device shown in FIG. 8, with parts
`separated;
`
`[0084] FIG. 52 is a bottom perspective view of the proxi-
`mal end of the cartridge carrier portion shown in FIG. 51
`with an articulation cable attached thereto;
`
`[0085] FIG. 53 is a top perspective view of the proximal
`end of the cartridge carrier portion shown in FIG. 52 with
`a pair of rotatable pulleys, and articulation cables thereon;
`
`[0086] FIG. 54 is a top perspective view of the proximal
`end of the cartridge carrier portion shown in FIG. 53 with
`the intermediate pivot and a secondpair of rotatable pulleys
`attached thereto;
`
`[0087] FIG. 55 is a top perspective view of the proximal
`end of the cartridge carrier portion shown in FIG. 54 with
`the mounting membersecured to the intermediate pivot;
`
`[0099] FIG. 67 is a side view of the carrier portion,
`intermediate pivot and mounting member shownin FIG.65
`after the articulation actuator has been movedto the position
`shown in FIG.66;
`
`[0100] FIG. 68is a side view of the handle portion of the
`surgical stapling device shown in FIG. 8 with the articula-
`tion actuator movedto a second positionto articulate the tool
`assembly of the SULU to a second orientation;
`
`[0101] FIG. 69 is a side view of the carrier portion,
`intermediate pivot, and mounting memberas shown in FIG.
`65 after the articulation actuator has been moved to the
`
`position shown in FIG. 68;
`
`[0102] FIG. 70 is a bottom view of the carrier portion,
`intermediate pivot and mounting member shownin FIG.65;
`
`[0103] FIG. 71 is a top view of the handle portion of the
`surgical stapling device shown in FIG. 8 with the articula-
`tion actuator movedto a third position to articulate the tool
`assembly to a third orientation; and
`
`[0088] FIG. 56 is an enlarged side perspective view of the
`distal end of the handle portion and the proximal end of the
`central body portion of the surgical stapling device with a
`half-section of the rotation control member removed;
`
`[0104] FIG. 72 is a bottom view of the carrier portion,
`intermediate pivot and mounting member as shown in FIG.
`70 after the articulation actuator has been moved to the
`position shown in FIG.71.
`
`[0089] FIG. 57 is a side perspective view from the top of
`a snap-fit button of the surgical stapling device shown in
`FIG.56;
`
`[0090] FIG. 58 is a second side perspective view from the
`top of the snap-fit button shown in FIG. 57;
`
`[0091] FIG. 59 is a side cutaway view of the handle
`portion and central body portion of the surgical stapling
`device shown in FIG.8 priorto articulation of the surgical
`stapling device;
`
`FIG.60 is a side cross-sectional view of the carrier
`[0092]
`portion, intermediate pivot assembly and mounting member
`of the surgical stapling device shown in FIG. 59;
`
`[0093] FIG. 61 is a top cross-sectional view of the carrier
`portion, intermediate pivot and mounting member shown in
`FIG.60;
`
`[0105] FIG. 73 is a top view of the handle portion of the
`surgical stapling device shown in FIG. 8 with the articula-
`tion actuator moved to a fourth position to articulate the tool
`assembly to a fourth orientation; and
`
`[0106] FIG. 74 is a bottom view of the carrier portion,
`intermediate pivot and mounting member as shown in FIG.
`70 after the articulation actuator has been moved to the
`
`position shown in FIG.73.
`
`DETAILED DESCRIPTION OF PREFERRED
`EMBODIMENTS
`
`[0107] Preferred embodiments of the presently disclosed
`stapling device will now be descri