`5,865,361
`Feb. 2, 1999
`Milliman et al.
`[45] Date of Patent:
`
`
`[11] Patent Number:
`
`USO005865361A
`
`[54] SURGICAL STAPLING APPARATUS
`
`[75]
`
`Inventors: Keith L. Milliman, Bethel; Frank J.
`Viola, Sandy Hook; Joseph Orban,
`Norwalk; Randolph F. Lehn, Stratford,
`all of Conn.
`
`[73] Assignee: United States Surgical Corporation,
`Norwalk, Conn.
`
`[21] Appl. No.: 935,980
`
`Sep. 23, 1997
`
`Filed:
`[22]
`A6LB 17/068
`int. CLS
`51]
`Unt,
`C18 eeeeee eet cette ttc
`[ST]
`[52] U.S. Ch. oe. 227/176.1; 227/19; 227/178.1
`[58] Field of Search 0.0.0.0. 227/19, 175.1,
`227/176.1, 175.3, 178.1, 179.1
`
`[56]
`
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`.
`;
`.
`Primary Examiner—Scott A. Smith
`RA
`[57]
`ABSTRACT
`Asurgical stapling device particularly suited for endoscopic
`procedures is described. The device can be used with both
`articulating and non-articulating disposable loading units
`and has a sensing mechanism for sensing the type of
`disposable loading unit secured to the device.
`
`.
`
`4 Claims, 39 Drawing Shects
`
`
`
`1
`
`IS 1017
`Intuitive Surgical v. Ethicon
`IPR2019-00880
`
`IS 1017
`Intuitive Surgical v. Ethicon
`IPR2019-00880
`
`
`
`5,865,361
`Page 2
`
`U.S. PATENT DOCUMENTS
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`5,474,571
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`5,487,500
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`4/1996
`7/1996
`12/1996
`3/1997
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`TIA997
`
`Young etal. .
`Boiarski et al. oo... eee ceeeeeeee 227/19
`Klieman et al. .
`
`Smith et al. cee eee 227/176.1
`Viola...
`. 227/176.1
`. 227/175.1
`Heaton et al.
`.
`
`2
`
`
`
`U.S. Patent
`
`Feb. 2, 1999
`
`Sheet 1 of 39
`
`5,865,361
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`Feb. 2, 1999
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`1
`SURGICAL STAPLING APPARATUS
`
`BACKGROUND
`
`1. Technical Field
`
`This application relates to a surgical stapling apparatus,
`and more particularly, to an articulating mechanism for use
`with an endoscopic surgical stapling apparatus for sequen-
`tially applying a plurality of surgical fasteners to body tissue
`and optionally incising fastened tissue.
`2. Background of Related Art
`Surgical devices wherein tissue is first grasped or clamped
`between opposing jaw structure and then joined by surgical
`fasteners are well knownin the art. In some instruments a
`knife is provided to cut the tissue which has been joined by
`the fasteners. The fasteners are typically in the form of
`surgical staples but two part polymeric fasteners can also be
`utilized.
`
`Instruments for this purpose can include two elongated
`members which are respectively used to capture or clamp
`tissue. Typically, one of the members carries a staple car-
`tridge which housesa plurality of staples arranged in at least
`two lateral rows while the other member has an anvil that
`defines a surface for forming the 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 and/or open the stapled tissue between
`the rows of staples. Such instruments are disclosed, for
`example,
`in U.S. Pal. No. 3,079,606 and U.S. Pat. No.
`3,490,675.
`A later stapler disclosed in U.S. Pat. No. 3,499,591
`applies a double row of staples on each side of the incision.
`This is accomplished by providing a disposable loading, unit
`in which a cam member moves through an elongate guide
`path between twosets of staggered staple carrying grooves.
`Staple drive membersare located within the grooves and are
`positioned in such a manner so as to be contacted by the
`longitudinally moving cam memberto effect ejection of the
`staples from the staple cartridge of the disposable loading
`unit. Other examples of such staplers are disclosed in U.S.
`Pat. Nos. 4,429,695 and 5,065,929.
`Each of the instruments described above were designed
`for use in conventional surgical procedures wherein sur-
`geons have direct manual access to the operative site.
`However, in endoscopic or laparoscopic procedures, surgery
`is performed through a small incision or through a narrow
`cannula inserted through small entrance woundsin the skin.
`In order to address the specific needs of endoscopic and/or
`laparoscopic surgical procedures, endoscopic surgical sta-
`pling devices have been developed and are disclosed in, for
`example, U.S. Pat. Nos. 5,040,715 (Green,et al.); 5,307,976
`(Olson,et al.); 5,312,023 (Green,et al.); 5,318,221 (Green,
`et al.); 5,326,013 (Green, et al.); and 5,332,142 (Robinson,
`et al.).
`US. Surgical, the assignee of the present application, has
`manufactured and marketed endoscopic stapling
`instruments, such as the Multifire ENDO GIA* 30 and
`Multifire ENDO GIA* 60 instruments, for several years.
`These instruments have provided significant clinical ben-
`efits. Nonetheless, improvements are possible, for example,
`by reducing the cost and complexity of manufacture.
`Current laparoscopic linear stapling devices are config-
`ured to operate with disposable loading units (U.S. Surgical)
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`and staple cartridges (Ethicon) of only one size. For
`example, individual linear staplers are presently available
`tor applying parallel rows of staples measuring 30 mm, 45
`mm and 60 mmin length. Thus, during a normal operation,
`a surgcon may be required to utilize several different sta-
`pling instruments to perform a single laparoscopic surgical
`procedure. Such practices increase the time, complexity and
`overall costs associated with laparoscopic surgical proce-
`dures. In addition, costs are greater in designing and manu-
`facturing multiple stapler sizes, as opposed to creating a
`single, multipurpose stapler.
`It would be extremely beneficial to provide a surgical
`device for use during laparoscopic and/or endoscopic sur-
`gical procedures that can be employed with several different
`sized disposable loading units to reduce the overall costs
`associated with such procedures. It would also be particu-
`larly beneficial if the device could perform multiple tasks,
`using disposable loading units of varying size and of varying
`purpose, such as, for example,
`to staple, clip, cut and/or
`articulate.
`
`In making improvements or modifications to the current
`instruments, it would be highly desirable not to sacrifice any
`of the important benefits of the MULTIFIRE ENDO GIA*
`30 and 60 instruments as compared to other commercially
`available products, e.g., the endoscopic stapling instruments
`manufactured and marketed by Ethicon, Inc. For example,
`any improvement should advantageously provide a fresh
`knife blade for each firing of the instrument and ensure that
`the disposable loading unit
`is securely retained in the
`stapling instrument unless and until
`the operating team
`chooses to remove it. These advantages have historically
`been found in the U.S. Surgical instruments, but not in the
`Ethicon instruments.
`
`SUMMARY
`
`In accordance with the present disclosure, a surgical
`stapling apparatus for scqucntially applying a plurality of
`fasteners to body tissue and simultaneously incising tissue is
`provided. The surgical stapling apparatus is adapted to
`receive disposable loading units having rows of staples
`having a lincar Icngth of between 30 mm and 60 mm. The
`surgical stapling apparatus is also adapted to receive articu-
`lating and non-articulating, disposable loading units.
`The surgical stapling apparatus includes a handle assem-
`bly having a movable handle and a stationary handle. The
`movable handle is movable through an actuation stroke to
`clamp tissue and to effect ejection of staples from the
`disposable loading unit. An elongated body extendsdistally
`from the handle assembly and defines a longitudinal axis. An
`actuation shaft having a toothed rack is operably associated
`with the movable handle by a pawl mechanism. The distal
`end of the actuation shaft is connected to a control rod
`having a distal end adapted to operatively engage an axial
`drive assembly located within a disposable loading unit.
`The stapling apparatus includes an articulation mecha-
`nism having an articulation lever operatively engaged with
`a cam member having a stepped camming channel. The cam
`member is engaged with a translation member which
`includes a pin dimensioned to be received within the stepped
`camming channel such that pivotable movement of the lever
`causes linear movement of the translation member. A first
`articulation link includes a proximal end adapted to engage
`the translation memberand a distal end adapted to engage a
`second articulation link positioned within the disposable
`loading, unit. Linear movement of the translation member
`causes linear movement of the articulation links to cause
`
`articulation of a tool assembly of the disposable loading unit.
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`The surgical stapling apparatus also preferably includes a
`scnsing mechanism for scnsing the type of disposable load-
`ing unit secured to the elongated body of the apparatus. The
`sensing, mechanism includes a sensing tube positioned
`within the elongated body to engage a disposable loading
`unit secured to the elongated body. A sensing cylinder
`connected to the sensing tube engages a locking ring having
`a tab portion configured to engage the articulation mecha-
`nism in a first position to prevent movement of the articu-
`lation lever. The locking ning is moved by the sensing
`cylinder when an articulating disposable loading unit is
`secured to the elongated body of the stapling apparatus to a
`second position to disengage the tab portion from the
`articulation mechanism to permit movement of the articu-
`lation lever. In contrast, a non-articulating disposable load-
`ing unit will not unlock the articulation lever.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Various preferred embodiments are described herein with
`reference to the drawings:
`FIG. 1 is a perspective view of one preferred embodiment
`of the presently disclosed surgical stapling apparatus;
`FIG. 2 is a top view of the surgical apparatus shownin
`FIG. 1;
`FIG. 3 is a side view of the surgical apparatus shown in
`FIG. 1;
`FIG. 4 is a perspective view with parts separated of the
`handle assembly of the surgical apparatus shown in FIG. 1;
`FIG. 5 is a cross-sectional view of a portion of the firing
`lockout mechanism shownin FIG. 4;
`FIG. 6 is a perspective of the slide plate of the anti-reverse
`clutch mechanism of the surgical apparatus;
`FIG. 7 is an enlarged perspective view ofthe anti- reverse
`clutch mechanism shown in FIG. 1;
`FIG. 8 is a side cross-sectional view of the surgical
`stapling apparatus shown in FIG. 1 in the non-actuated
`position with the disposable loading unit removed;
`T'IG. 9 is a perspective view with parts separated of the
`rotation member,the articulation mechanism, and the elon-
`gated body of the surgical stapling apparatus shown in FIG.
`1;
`
`FIG. 10 is an enlarged view of the indicated area of detail
`shown in FIG. 8;
`FIG. 10a is a perspective view of the translation member
`of the articulating mechanism and the proximal end of the
`elongated body of the surgical stapling apparatus shown in
`FIG. 1;
`FIG. 105 is an enlarged cross-sectional view of the
`indicated area of detail of FIG. 8;
`FIG. 10c¢ is a cross-sectional view along section line
`10c-10c of FIG. 8;
`FIG. 11 is a perspective view of the cam member of the
`arliculation mechanism of the surgical stapling apparatus
`shownin FIG. 1;
`FIG. 12 is a top view of the cam member of the articu-
`lation mechanism of the surgical stapling apparatus shown
`in FIG. 1;
`FIG. 124 is a perspective view of a non-articulating
`disposable loading unit usable with the surgical stapling
`apparatus shown in FIG. 1;
`FIG. 126 is a perspective view of the preferred articulat-
`ing disposable loading unit of the surgical stapling apparatus
`shownin FIG. 1;
`FIG. 13 is a cross-sectional view taken along section line
`13—13 of FIG. 10;
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`4
`FIG. 14 is a cross-sectional view taken along section line
`14—14 of FIG. 10;
`VIG. 15 is a cross-sectional view taken along section line
`15—15 of FIG. 10;
`FIG. 16 is an enlarged view of the indicated area of detail
`shown in FIG. 8;
`
`FIG. 17 is a side perspective view of the blocking plate of
`the surgical stapling apparatus shown in FIG. 1;
`FIG. 18 is a top perspective view of the blocking plate of
`the surgical stapling apparatus shown in FIG. 1;
`FIG. 19 is a perspective view of a disposable loading unit
`usable with the surgical stapling apparatus of FIG. 1;
`FIG. 20 is another perspective view of a disposable
`loading unit usable with the surgical stapling apparatus of
`FIG. 1;
`FIG. 21 is a perspective view of the tool assembly of the
`surgical stapling, apparatus of FIG. 1 with parts separated;
`FIG. 22 is an enlarged perspective view of the distal end
`of the anvil assembly showing a plurality of staple deform-
`ing cavities;
`FIG. 23 is an enlarged perspective view of the distal end
`of the staple cartridge of the surgical stapling apparatus
`shownin FIG. 1;
`FIG. 24 is a side cross-sectional view taken along section
`line 24—24 of FIG. 23;
`FIG. 25 is a bottom perspective view of the staple
`cartridge shown in FIG. 21;
`FIG. 26 is an enlarged perspective view of the actuation
`sled, the pushers and the fasteners shown in FIG. 21;
`FIG. 27 is an enlarged perspective view with parts sepa-
`rated of the proximal housing portion and mounting assem-
`bly of the disposable loading unit shown in FIG. 19;
`FIG. 28 is an enlarged perspective view of the mounting
`assembly of the disposable loading unit shown in FIG. 19
`mounted to a distal end portion of the proximal housing,
`portion;
`FIG. 29 is an enlarged perspective view of the proximal
`housing, portion and the mounting assembly of the dispos-
`able loading unit shown in FIG. 19 with the upper housing
`half removed;
`IG. 30 is a perspective view of the proximal housing
`portion and the mounting assembly ofthe disposable loading
`unit shown in FIG. 19 with the upper housing half removed;
`FIG. 31 is a perspective view with parts separated of the
`axial drive assembly;
`FIG. 32 is an enlarged perspective view of the axial drive
`assembly shown in FIG. 31;
`FIG. 33 is an enlarged perspective view of the proximal
`end of the axial drive assembly shownin FIG. 31 including
`the locking device;
`FIG. 34 is an enlarged perspective view of the distal end
`of the axial drive assembly shownin ['IG. 31;
`FIG, 35 is an enlarged perspective view of the distal end
`of the elongated body of the stapling apparatus shown in
`FIG. 1;
`FIG. 36 is an enlarged perspective view of the locking
`device shownin FIG. 33;
`FIG. 37 is an enlarged perspective view of a lower
`housing half of the proximal housing portion of the dispos-
`able loading unit shown in FIG. 27;
`FIG. 38 is a side cross-sectional view of the disposable
`loading, unit shown in FIG. 20;
`FIG. 39 is an enlarged view of the indicated area of detail
`shown in FIG. 38;
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`FIG. 40 is a perspective view of the surgical stapling
`apparatus shown in FIG. 1 with the disposable loading unit
`of FIG. 19 detached from the elongated body;
`FIG. 41 is an enlarged perspective view of the disposable
`loading, unit of FIG. 19 during attachment to the elongated
`body of the surgical stapling apparatus shown in FIG. 1;
`FIG. 42 is another enlarged perspective view of the
`disposable loading unit of FIG. 19 during attachment to the
`clongatcd body of the surgical stapling apparatus shown in
`FIG. 1;
`FIG. 43 is a cross-sectional view taken along section line
`43—43 of FIG. 41;
`FIG. 43a is a side cross-sectional view of the rotation
`knob, articulation mechanism, and sensing mechanism dur-
`ing insertion of a disposable loading unit into the elongated
`body of the surgical stapling apparatus;
`FIG. 44 is a cross-sectional view taken along section line
`4444 of FIG. 42;
`FIG. 45 is a side cross-sectional view of the distal end of
`
`the disposable loading unit of FIG. 1 with tissue positioned
`between the anvil and clamp assemblies;
`FIG. 46 is a side cross-sectional view of the handle
`
`assembly with the movable handle in an actuated position;
`FIG. 47 is an enlarged view of the indicated area of detail
`shown in FIG. 46;
`FIG. 48 is a cross-sectional view of the proximal end of
`the disposable loading unit of FIG. 19 and the distal end of
`the elongated body of the surgical stapling apparatus shown
`in FIG. 1 with the control red in a partially advanced
`position;
`FIG. 49 is a cross-sectional view of the tool assembly of
`the surgical stapling apparatus shown in FIG. 1 positioned
`about tissue in the clamped position;
`FIG. 50 is a cross-sectional view of the handle assembly
`of the stapling apparatus of FIG. 1 during the clamping
`stroke of the apparatus;
`FIG. 51 is a side cross-sectional view of the distal end of
`
`the tool assembly of the stapling apparatus shownin FIG. 1
`during firing of the apparatus;
`FIG. 52 is a side cross-sectional view of the distal end of
`
`the tool assembly of the stapling apparatus shownin FIG. 1
`after firing of the apparatus;
`FIG. 53 is a side cross-sectional view of the handle
`assembly of the apparatus during retraction of the actuation
`shaft;
`FIG. 54 is a side cross-sectional view of the handle
`
`assembly of the stapling apparatus during actuation of the
`emergency release button;
`FIG. 55 is a top view of the articulation mechanism of the
`surgical stapling apparatus;
`FIG. 56 is a side cross-sectional view of the articulation
`mechanism and rotation member of the surgical stapling
`apparatus shown in FIG. 1;
`FIG. 57 is a top view of the distal end of the elongated
`body, the mounting assembly, and the proximal end of the
`tool assembly during articulation of the stapling apparatus;
`FIG. 58 is a perspective view of the surgical stapling
`apparatus during articulation of the tool assembly;
`FIG. 59 is a perspective view of the surgical stapling
`apparatus during articulation and rotation of the tool assem-
`bly;
`FIG. 60 is a top view of the distal end of the disposable
`loading unit immediately prior to articulation;
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`FIG. 61 is a top view of the distal end of the elongated
`body, the mounting assembly, and the proximal cnd of the
`tool assembly during articulation of the stapling apparatus;
`FIG. 62 is a partial cross-sectional view of a portion of the
`disposable loading unit during retraction of the locking
`device; and
`FIG. 63 is a partial cross-sectional view of a portion of the
`disposable loading unit with the locking device in the locked
`position.
`DETAILED DESCRIPTION OF PREFERRED
`EMBODIMENTS
`
`Preferred embodiments of the presently disclosed endo-
`scopic surgical stapling apparatus will now be described in
`detail with reference to the drawings, in whichlike reference
`numerals designate identical or corresponding elements in
`each of the several views.
`
`In the drawings and in the description that follows, the
`term “proximal”, as is traditional, will refer to the end of the
`stapling apparatus whichis closest to the operator, while the
`term distal will refer to the end of the apparatus which is
`furthest from the operator.
`FIGS. 1-3 illustrate one embodiment of the presently
`disclosed surgical stapling apparatus shown generally as 10.
`Briefly, surgical stapling apparatus 10 includes a handle
`assembly 12 and an elongated body 14. A disposable loading,
`unit or DLU 16 is releasably secured to a distal end of
`elongated body 14. Disposable loading unit 16 includes a
`tool assembly 17 having a cartridge assembly 18 housing a
`plurality of surgical staples and an anvil assembly 20 mov-
`ably secured in relation to cartridge assembly 18. Disposable
`loading unit 16 is configured to apply linear rowsofstaples
`measuring from about 30 mm to about 60 mm in length.
`Disposable loading, units having linear rows of staples of
`other lengths are also envisioned, e.g., 45 mm. Handle
`assembly 12 includes a stationary handle member 22, a
`movable handle member 24, and a barrel portion 26. A
`rotatable member 28 is preferably mounted on the forward
`end of barrel portion 26 to facilitate rotation of elongated
`body 14 with respect to handle assembly 12. Anarticulation
`lever 30 is also preferably mounted on the forward end of
`barrel portion 26 adjacent rotatable knob 28 to facilitate
`articulation of tool assembly 17. A pair of retraction knobs
`32 are movably positioned along barrel portion 26 to return
`surgical stapling apparatus 10 to a retracted position, as will
`be described in detail below.
`
`Referring to FIG. 4, handle assembly 12 includes housing
`36, which is preferably formed from molded housing half-
`sections 36a and 36b, which forms stationary handle mem-
`ber 22 and barrel portion 26 of handle assembly 12 (See FIG.
`1). Movable handle member 24 is pivotably supported
`between housing half-sections 36¢@ and 36b about pivot pin
`38. A biasing member 40, which is preferably a torsion
`spring, biases movable handle 24 away from stationary
`handle 22. An actuation shaft 46 is supported within barrel
`portion 26 of housing 36 and includes a toothed rack 48. A
`driving, pawl 42 having a rack engagement finger 43 with
`laterally extending wings 43a and 436 is pivotably mounted
`to one end of movable handle 24 about a pivot pin 44. A
`biasing member 50, which is also preferably a torsion
`spring, is positioned to urge engagementfinger 43 of driving,
`pawl 42 towards toothed rack 48 of actuation shaft 46.
`Movable handle 24 is pivotable to move engagement finger
`43 of driving pawl 42 into contact with toothed rack 48 of
`actuation shaft 46 to advance the actuation shaft linearly in
`the distal direction. The forward end of actuation shaft 46
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`rotatably receives the proximal end 49 of a control rod 52
`such that linear advancement of actuation shaft 46 causes
`corresponding linear advancement of control rod 52. A
`locking, pawl 54 having a rack engagement member 55 is
`pivotably mounted within housing 36 about pivot pin 57 and
`is biased towards toothed rack 48 by biasing member 56,
`which is also preferably a torsion spring. Engagement mem-
`ber 55 of locking pawl 54 is movable into engagement with
`toothed rack 48 to retain actuation shaft 46 in a longitudi-
`nally fixed position.
`A retraction mechanism 58 which includes a pair of
`retractor knobs 32 (See FIG. 1) is connected to the proximal
`end of actuation shaft 46 by a coupling rod 60. Coupling rod
`60 includesright and left engagementportions 62a and 62b
`for receiving retractor knobs 32 and a central portion 62¢
`which is dimensioned and configured to translate within a
`pair of longitudinal slots 34a formed in actuation shaft 46
`adjacent the proximal end thereof. A release plate 64 is
`operatively associated with actuation shaft 46 and is
`mounted for movement with respect thereto in response to
`manipulation of retractor knobs 32. A pair of spaced apart
`pins 66 extend outwardly from a lateral face of actuation
`shaft 46 to engage a pair of corresponding angled cam slots
`68 formed in release plate 64. Upon rearward movement of
`retractor knobs 32, pins 66 canrelease plate 64 downwardly
`with respect to actuation shaft 46 and with respect to toothed
`rack 48 such that the bottom portion of release plate 64
`extends below toothed rack 48 to disengage engagement
`finger 43 of driving pawl 42 from toothed rack 48. A
`transverse slot 70 is formed at the proximal end of release
`plate 64 to accommodate the central portion 62c of coupling
`rod 60, and elongated slots 34 (See FIG. 1) are defined in the
`barrel section 26 of handle assembly 12 to accommodate the
`longitudinal translation of coupling red 60 as retraction
`knobs 32 are pulled rearwardly to retract actuation shaft 46
`and thusretract control rod 52 rearwardly. Actuation shaft 46
`is biased proximally by spring 72 which is secured at one
`end to coupling rod portion 62 via connector 74 and at the
`other end to post 76 on actuation shaft 46.
`Referring also to FIG. 5, handle assembly 12 includes a
`firing lockout assembly 80 which includes a plunger 82 and
`a pivotable locking member 83. Plunger 82 is biased to a
`central position by biasing springs 84 and includes annular
`tapered camming surfaces 85. Each end of plunger 82
`extends through housing 36 (See FIG. 1) adjacent an upper
`end of stationary handle 22. Pivotable locking member 83 is
`pivotably attached at its distal end between housing half-
`sections 36a and 36b about pivot pin 86 and includes a
`locking, surface 88 and proximal extension 90 having a slot
`89 formed therein. Locking member 83 is biased by spring
`92 counter-clockwise (as viewed in FIG. 4) to move locking
`surface 88 to a position to abut the distal end of actuation
`shaft 46 to prevent advancementof shaft 46 and subsequent
`firing of stapling apparatus 10. Annular tapered camming
`surface 85 is positioned to extend into tapered slot 89 in
`proximal extension 90. Lateral movement of plunger 82 in
`either direction against the bias of either spring 84 moves
`tapered camming, surface 85 into engagement with the
`sidewalls of tapered slot 89 to pivot locking member 83
`clockwise about pivot pin 86, as viewed in FIG. 4, to move
`blocking surface 88 to a position to permit advancement of
`actuation shaft 46 and thus firing of stapling apparatus 10.
`Blocking surface 88 is retained in this position by recesses
`87 which receive the tapered tip of camming surface 85 to
`lock locking member 83 in a counter-clockwise position.
`Operation of firing lockout assem