`
`(12) United States Patent
`US 7,490,749 B2
`(10) Patent No.:
`Schall et al.
`(45) Date of Patent:
`*Feb. 17, 2009
`
`(54) SURGICAL STAPLING AND CUTTING
`INSTRUMENT WITH MANUALLY
`RETRACTABLE FIRING MEMBER
`
`(75)
`
`Inventors: Christopher J. Schall, Cincinnati, OH
`(US); Chad P. Boudreaux, Cincinnati,
`OH (US)
`
`4,396,139 A
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`(73) Assignee: Ethicon Endo-Surgery, Inc., Cincinnati,
`OH (US)
`
`(Continued)
`FOREIGN PATENT DOCUMENTS
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 19 days.
`
`CA
`
`2458946 Al
`
`3/2003
`
`This patent is subject to a terminal dis-
`claimer.
`
`(Continued)
`OTHER PUBLICATIONS
`
`(21) Appl.No.: 11/729,355
`
`(22)
`
`Filed:
`
`Mar. 28, 2007
`
`(65)
`
`Prior Publication Data
`
`US 2008/0237298 A1
`
`Oct. 2, 2008
`
`(51)
`
`Int. Cl.
`(2006.01)
`A6IB 17/068
`(52) US. Cl.
`................... 227/176.1; 227/19; 227/180.1;
`606/139; 606/219
`(58) Field of Classification Search ................... 227/19,
`227/1761,175.1,175.2,180.1,178.1; 606/139,
`606/219
`
`See application file for complete search history.
`
`(56)
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`References Cited
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`Primary ExamineriScott A. Smith
`
`(57)
`
`ABSTRACT
`
`A surgical stapling and severing instrument particularly
`suited to endoscopic procedures incorporates a handle that
`produces separate closing and firing motions to actuate an end
`effector. In particular, the handle produces multiple firing
`strokes in order to reduce the required amount of force
`required to fire (i.e., staple and sever) the end effector. A
`linked transmission reduces the required handle longitudinal
`length, yet achieves a rigid, strong configuration when
`straightened for firing. A traction biased firing mechanism
`avoids binding in driving this straightened linked rack. The
`instrument further has a manually actuatable retraction sys-
`tem that does not require the use of additional springs or other
`mechanisms to generate retraction forces which must be over-
`come when generating the forces necessary to fire the device.
`In various embodiments, the retraction system provides a
`visual indication to the surgeon as to how far firing has pro-
`gressed.
`
`19 Claims, 25 Drawing Sheets
`
`
`
`2X
`
`16
`
`IS 1001
`
`IS 1001
`
`1
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`
`US 7,490,749 B2
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`
`FOREIGN PATENT DOCUMENTS
`
`CA
`CA
`DE
`DE
`DE
`DE
`DE
`DE
`EP
`
`2512960 A1
`2514274 A1
`273689 C
`9412228 U
`69328576 T2
`20112837 U1
`20121753 U1
`10314072 A1
`0122046 A1
`
`1/2006
`1/2006
`5/ 1914
`9/1994
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`EP
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`EP
`EP
`EP
`EP
`FR
`GB
`GB
`JP
`JP
`JP
`JP
`JP
`JP
`
`0033548 B1
`0639349 A2
`0593920 A1
`0600182 A2
`0630612 B1
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`0646356 A2
`0646357 A1
`0669104 A1
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`0392547 B1
`0685204 A1
`0699418 A1
`0702937 A1
`0705571 A1
`0484677 B2
`0541987 B1
`0667119 B1
`0770355 A1
`0503662 B1
`0625335 B1
`0552423 B1
`0592244 B1
`0648476 B1
`0603472 B1
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`0760230 B1
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`0552050 B1
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`1129665 B1
`1256317 B1
`1728473 A1
`1728475 A2
`1479346 B1
`1484024 Bl
`1300117 B1
`1112936 A
`939929 A
`2336214 A
`6007357 A
`7051273 A
`8033641 A
`8229050 A
`2001286477 A
`2002369820 A
`
`5/1986
`2/1994
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`4
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`W0
`W0
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`W0
`W0
`W0
`W0
`W0
`
`W0
`
`2005505322 T
`2005103293 A
`2187249 C2
`2225170 C2
`1377053 A1
`1561964 A1
`1722476 A1
`WO 93/08755 A1
`WO 95/18572 A1
`WO 95/29639 A1
`WO 96/35464 A1
`WO 98/30153 A1
`WO 99/12483 A1
`WO 99/15086 A1
`WO 99/34744 A1
`WO 00/57796 A1
`WO 00/64365 A1
`WO 00/72762 A1
`WO 00/72765 A1
`WO 01/05702 A1
`WO 01/10482 A1
`WO 01/62158 A2
`WO 01/62162 A1
`WO 01/62164 A2
`WO 01/91646 A1
`WO 02/17799 A1
`WO 02/19920 A1
`WO 02/30297 A2
`WO 02/32322 A2
`WO 02/43571 A2
`W0 02/067785 A2
`W0 02/098302 A1
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`W0 03/001329 A2
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`W0 03/063694 A1
`W0 03/077769 A1
`W0 03/082126 A1
`W0 03/088845 A2
`W0 03/090630 A2
`W0 03/094743 A1
`W0 03/094745 A1
`W0 03/094746 A1
`W0 03/094747 A1
`W0 03/101313 A1
`W0 03/105702 A2
`WO 2004/006980 A2
`WO 2004/032754 A2
`WO 2004/032760 A2
`WO 2004/032762 A1
`WO 2004/032763 A2
`WO 2004/047653 A2
`WO 2004/049956 A2
`WO 2004/086987 A1
`WO 2004/096057 A2
`WO 2004/112618 A2
`WO 2004/112652 A2
`WO 2005/027983 A2
`WO 2005/096954 A2
`WO 2005/115251 A2
`WO 2006/044490 A2
`WO 2006/044581 A2
`WO 2006/044810 A2
`WO 2006/083748 A1
`WO 2006/132992 A1
`WO 2007/016290 A2
`
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`4/2006
`4/2006
`8/2006
`12/2006
`2/2007
`
`OTHER PUBLICATIONS
`
`Disclosed Anonymously, “Motor-Driven Surgical Stapler Improve-
`ments ” Research Disclosure Database No 526041 Published' Feb
`'
`2008.,
`'
`’
`'
`C.C. Thompson et al., “Peroral Endoscopic Reduction of Dilated
`'
`'
`lAn t
`' After Roux-en-Y Gastric B assAPos-
`Clamojejuna
`. as “no“.
`.
`.
`.
`,,yp
`'
`s1ble New Option for Patients With Weight Regain, Surg Endosc
`(2006) vol. 20 pp 1744-1748
`’
`'
`'
`
`* cited by examiner
`
`5
`
`
`
`US. Patent
`
`Feb. 17, 2009
`
`Sheet 1 0f 25
`
`US 7,490,749 B2
`
`IG.
`
`1 F
`
`6
`
`
`
`U.S. Patent
`
`Feb.17,2009
`
`Sheet20f25
`
`US 7,490,749 B2
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`
`
`7
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`
`
`US. Patent
`
`Feb. 17, 2009
`
`Sheet 3 0f 25
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`US 7,490,749 B2
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`
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`8
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`US. Patent
`
`Feb. 17, 2009
`
`Sheet 4 0f 25
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`US 7,490,749 B2
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`9
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`
`
`U.S. Patent
`
`Feb.17,2009
`
`Sheet50f25
`
`US 7,490,749 B2
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`US 7,490,749 B2
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`11
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`Feb.17,2009
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`Sheet70f25
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`US 7,490,749 B2
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`12
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`Feb.17,2009
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`US 7,490,749 B2
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`Feb. 17, 2009
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`US 7,490,749 B2
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`Feb. 17, 2009
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`Feb. 17, 2009
`
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`U.S. Patent
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`Feb.17,2009
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`US 7,490,749 B2
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`US 7,490,749 B2
`
`1
`SURGICAL STAPLING AND CUTTING
`INSTRUMENT WITH MANUALLY
`RETRACTABLE FIRING MEMBER
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`
`The present application is related to commonly-owned
`US. patent application Ser. No. 11/729,013, to Chad P. Bou-
`dreaux and Christopher J. Schall, filed Mar. 28, 2007, entitled
`“Surgical Stapling and Cutting Instrument With Side
`Mounted Refraction Member”, the disclosure of which is
`hereby incorporated by reference in its entirety.
`
`FIELD OF THE INVENTION
`
`The present invention relates in general to endoscopic sur-
`gical instruments including, but not limited to, surgical sta-
`pler instruments that are capable of applying lines of staples
`to tissue while cutting the tissue between those staple lines
`and, more particularly, to improvements relating to surgical
`stapler instruments and improvements in processes for form-
`ing various components of such surgical stapler instruments
`that have manual retraction capabilities.
`
`BACKGROUND OF THE INVENTION
`
`Endoscopic surgical instruments are often preferred over
`traditional open surgical devices since a smaller incision
`tends to reduce the post-operative recovery time and compli-
`cations. Consequently, significant development has gone into
`a range of endoscopic surgical instruments that are suitable
`for precise placement of a distal end effector at a desired
`surgical site through a cannula of a trocar. These distal end
`effectors engage the tissue in a number of ways to achieve a
`diagnostic or therapeutic effect (e. g., endocutter, grasper, cut-
`ter, staplers, clip applier, access device, drug/gene therapy
`delivery device, and energy device using ultrasound, RF,
`laser, etc.).
`Known surgical staplers include an end effector that simul-
`taneously makes a longitudinal incision in tissue and applies
`lines of staples on opposing sides of the incision. The end
`effector includes a pair of cooperating jaw members that, if
`the instrument is intended for endoscopic or laparoscopic
`applications, are capable of passing through a cannula pas-
`sageway. One of the jaw members receives a staple cartridge
`having at least two laterally spaced rows of staples. The other
`jaw member defines an anvil having staple-forming pockets
`aligned with the rows of staples in the cartridge. The instru-
`ment commonly includes a plurality of reciprocating wedges
`which, when driven distally, pass through openings in the
`staple cartridge and engage drivers supporting the staples to
`effect the firing of the staples toward the anvil.
`An example of a surgical stapler suitable for endoscopic
`applications is described in US. Pat. No. 5,465,895 to Brian
`D. Knodel, Richard P. Nuchols, and Warren P. Williamson,
`IV, which advantageously provides distinct closing and firing
`actions. Thereby, a clinician is able to close the jaw members
`upon tissue to position the tissue prior to firing. Once the
`clinician has determined that the jaw members are properly
`gripping tissue, the clinician can then fire the surgical stapler
`with a single firing stroke, thereby severing and stapling the
`tissue. The simultaneous severing and stapling avoids com-
`plications that may arise when performing such actions
`sequentially with different surgical tools that respectively
`only sever or staple.
`
`2
`
`One specific advantage of being able to close upon tissue
`before firing is that the clinician is able to verify via an
`endoscope that the desired location for the cut has been
`achieved, including that a sufficient amount oftissue has been
`captured between opposing jaws. Otherwise, opposing jaws
`may be drawn too close together, especially pinching at their
`distal ends, and thus not effectively forming closed staples in
`the severed tissue. At the other extreme, an excessive amount
`of clamped tissue may cause binding and an incomplete fir-
`1ng.
`Generally, a single closing stroke followed by a single
`firing stroke is a convenient and efficient way to perform
`severing and stapling. However, in some instances, it would
`be desirable for multiple firing strokes to be required. For
`example, surgeons are able to select a length of staple car-
`tridge for the desired length of cut from a range ofjaw sizes.
`Longer staple cartridges require a longer firing stroke. Thus,
`to effect the firing, a hand-squeezed trigger is required to exert
`a larger force for these longer staple cartridges in order to
`sever more tissue and drive more staples as compared to a
`shorter staple cartridge. It would be desirable for the amount
`offorce to be lower and comparable to shorter cartridges so as
`not to exceed the hand strength of some surgeons. In addition,
`some surgeons, not familiar with the larger staple cartridges,
`may become concerned that binding or other malfunction has
`occurred when an unexpectedly higher force is required.
`One approach for lowering the required force for a firing
`stroke is a ratcheting mechanism that allows a firing trigger to
`be stroked multiple times, as described in US. Pat. Nos.
`5,762,256 and 6,330,965, the disclosures ofwhich are herein
`incorporated by reference. These known surgical stapling
`instruments with multiple-stroke firing mechanisms do not
`have the advantages of a separate closure and firing actions.
`Other ratcheting surgical instruments are disclosed in com-
`monly-owned US. Pat. No. 7,083,075, issuedAug. 1, 2006 to
`Jeffrey S. Swayze, Frederick E. Shelton, IV, Kevin Ross Doll,
`and Douglass B. Hoffman, entitled Multi-Stroke Mechanism
`With Automatic End of Stroke Retraction, which is hereby
`incorporated by reference. Various embodiments disclosed
`therein employ a handle that produces separate closing and
`firing motions to actuate an end effector. In particular, the
`handle is configured to generate the firing force necessary to
`staple and sever the tissue clamped within the end effector
`through multiple actuations of a firing trigger. The device may
`further employ a linked transmission which reduces the
`required handle length, yet achieves a rigid, strong configu-
`ration when straightened for firing. A traction biased firing
`mechanism avoids binding in driving this straightened linked
`rack in cooperation with an anti-backup mechanism, with a
`lockout mechanism that prevents releasing the closure trigger
`during firing. Furthermore, an external indicator gives feed-
`back to the surgeon as to how far firing has progressed, as well
`as providing a manual retraction capability. These embodi-
`ments also generally employ a relatively strong spring to
`automatically retract the cutting member after the end effec-
`tor has been fired. While such designs are extremely effective,
`the use ofthe retraction spring requires additional firing force
`to be generated to overcome the opposing spring force during
`firing. This problem can also be somewhat exacerbated when
`using articulating end effectors. In particular, when an articu-
`lating end effector is employed, a larger return spring must
`generally be employed to retract the articulating firing mem-
`ber. Use of such larger spring further increases the amount of
`firing forces that must be generated to overcome the spring
`force and fire the end effector components.
`Consequently, a significant need exists for a surgical sta-
`pling instrument having a multiple stroke or other type of
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`US 7,490,749 B2
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`3
`firing mechanism that is equipped with a manually actuatable
`retraction mechanism and does not employ an additional
`retraction means such as a spring or the like that generates
`forces that must be overcome during the firing stroke.
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`These and other objects and advantages of the present
`invention shall be made apparent from the accompanying
`drawings and the description thereof.
`
`BRIEF DESCRIPTION OF THE FIGURES
`
`SUMMARY
`
`In one aspect of the invention, there is provided a surgical
`instrument has a handle assembly and an end effector for
`performing a surgical operation. The end effector is operably
`coupled to the handle assembly and may operably support a
`firing member that is movable from a retracted position to a
`fired position in response to a longitudinal firing motion
`applied thereto. The instrument may also include a firing
`drive that is supported by the handle assembly and is config-
`ured to selectively generate the longitudinal firing motion
`upon actuation of a firing trigger operably coupled to the
`handle assembly. A retraction assembly may be supported by
`the handle assembly and interface with the firing drive such
`that manual actuation of the retraction assembly causes the
`firing drive to apply a sole retraction motion which is com-
`municated to the firing member to cause the firing member to
`move from the fired position to the retracted position.
`In another general aspect of various embodiments of the
`present invention there is provided a surgical instrument that
`has a handle assembly that is coupled to an end effector for
`performing a surgical operation. The end effector may oper-
`ably support a firing member that is movable from a retracted
`position to a fired position in response to a longitudinal firing
`motion applied thereto. A linked rack may be operably sup-
`ported by the handle assembly and a firing rod may commu-
`nicate with the linked rack and the end effector for transmit-
`
`ting the firing and retraction motions from the linked rack to
`the end effector. A firing trigger may be operably supported
`by the handle assembly and may be configured to interface
`with the linked rack such that actuation of the firing trigger
`causes the linked rack to apply the firing motion to the firing
`rod. A first gear may be in meshing engagement with the
`linked rack and a retraction lever may be movably supported
`by the handle assembly and may be configured to interface
`with the first gear such that actuation of the retraction lever
`applies the sole retraction motion or force to the first gear
`which thereby transfers the sole retraction motion to the
`linked rack.
`
`In still another general aspect of various embodiments of
`the present invention there is provided a surgical instrument
`that has a handle assembly that is coupled to an end effector.
`The end effector may operably support a firing member that is
`movable from a retracted position to a fired position in
`response to a longitudinal firing motion applied thereto. A
`first linked rack may be operably supported by the handle
`assembly. A firing rod may communicate with the linked rack
`and the end effector for transmitting the firing and retraction
`motions from the linked rack to the end effector. A firing
`trigger may be operably supported by the handle assembly
`and may be configured to selectively interface with the linked
`rack such that actuation of the firing trigger causes the linked
`rack to apply the firing motion to the firing rod. A second gear
`rack may be operably supported by the handle assembly. A
`drive gear may be in meshing engagement with the first linked
`rack and the second gear rack. A retraction lever may be
`movably coupled to the handle assembly and the second gear
`rack such that actuation ofthe retraction lever applies the sole
`retraction motion to the drive gear which thereby transfers the
`sole retraction motion to the linked rack.
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`The accompanying drawings, which are incorporated in
`and constitute a part of this specification, illustrate embodi-
`ments ofthe invention, and, together with the general descrip-
`tion ofthe invention