US006978921B2
`
`US 6,978,921 B2
`(10) Patent No.:
`a2 United States Patent
`Shelton, IV et al.
`(45) Date of Patent:
`Dec. 27, 2005
`
`
`(54) SURGICAL STAPLING INSTRUMENT
`INCORPORATING AN E-BEAMFIRING
`MECHANISM
`
`(75)
`
`,
`bk Ea @
`5
`Inventors: Frederick EK. Shelton, IV, Hillsboro,
`OH (US); Michael Earl Setser,
`Burlington, KY (US); William Bruce
`Weisenburgh,II, Maineville, OH (US)
`
`(73) Assignee: Ethicon Endo-Surgery, Inc.,
`Cincinnati, OH (US)
`
`(*) Notice:
`
`Subject to anydisclaimer, the term of this
`patent is extended or adjusted under 35
`US.C. 154(b) by 0 days.
`(21) Appl. No.: 10/443,617
`
`(22)
`
`Filed:
`
`May20, 2003
`
`(65)
`
`Prior Publication Data
`US 2004/0232197 AL
`Nov. 25, 2004
`
`Int. CI? eeecece A61B 17/072,
`(SL)
`(52) US. Ch oo .. 227/176.1; 227/19; 227/180.1
`(58) Field of Search 00... cee 227/175.1, 175.2,
`227/175.4
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`5,031,814 A
`7/1991 Tompkinsetal.
`5,071,052 A
`12/1991 Rodak etal.
`5,137,198 A
`8/1992, Nobis et al.
`ee ‘
`3hoon Savage et ‘ '
`A13,
`olyntjes et al.
`5413268 A
`5/1995 Green et al.
`5,445,304 A
`8/1995 Plyleyetal.
`5,465,895 A
`11/1995 Knodelet al.
`
`5,484,095 A
`1/1996 Greenetal.
`5,535,937 A
`7/1996 Boiarski et al.
`5,584,425 A
`12/1996 Savage et al.
`5,624,452 A *
`4/1997 Yates weccccceccsseeneeeees 606/139
`5,680,983 A
`10/1997 Plyley ct al.
`5,692,668 A * 12/1907 Schulze et ale sess 227/175.
`5,709,334 A
`1/1998. Sorrentinoetal
`5.735,445 4
`4/1998. Vidal et al.
`5,918,791 A
`7/1999 Sorrentinoetal.
`6,010,054 A
`1/2000 Johnsonetal.
`6,032,849 A
`3/2000 Mastri et al.
`6,079,606 A
`6/2000 Millimanctal.
`6,109,500 A
`8/2000 Alli et al.
`6,786,382 B1*
`9/2004 Hoffman ..........06 227/178.1
`2001/0029384 A1
`10/2001 Nicholasetal.
`2001/0030219 A1* 10/2001 Greenetal.
`cited b
`cued
`OY eae
`Primary Examiner—Scott A. Smith
`Assistant Examiner—Gloria R. Weeks
`(74) Attorney, Agent, or Firm—Dean Garner
`
`*
`
`(67)
`
`ABSTRACT
`
`Assurgical severing and stapling instrumentclamps,suitable
`for laparoscopic and endoscopic clinical procedures, clamps
`tissue within an end effector of an elongate channel pivotally
`opposed by an anvil. An E-beam firing bar moves distally
`through the clamped endeffector to sever tissue and to drive
`staples on each side of the cut. The E-beam firing bar
`affirmatively spaces the spaces the anvil from the elongate
`channel to assure properly formed closed staples, especially
`
`
`when an amountof tissue is clamped that is inadequate to
`
`
`space the end effector. In particular, an upperpin ofthe firing
`bar longitudinally moves throughan anvil slot and a channel
`clot is captured between a lower cap and a middle pin of the
`.
`;
`a
`mini
`acing.
`firing bar to assure a minimum spacing
`17 Claims, 17 Drawing Sheets
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`Ethicon Exhibit 2020.001
`Intuitive v. Ethicon
`IPR2018-01247
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`Ethicon Exhibit 2020.001
`Intuitive v. Ethicon
`IPR2018-01247
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`Dec. 27, 2005
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`Sheet 1 of 17
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`US 6,978,921 B2
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`U.S. Patent
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`Ethicon Exhibit 2020.002
`Intuitive v. Ethicon
`IPR2018-01247
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`Ethicon Exhibit 2020.002
`Intuitive v. Ethicon
`IPR2018-01247
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`U.S. Patent
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`Dec.27, 2005
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`Sheet 2 of 17
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`US 6,978,921 B2
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`“
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`FIG. 3
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`Ethicon Exhibit 2020.003
`Intuitive v. Ethicon
`IPR2018-01247
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`Ethicon Exhibit 2020.003
`Intuitive v. Ethicon
`IPR2018-01247
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`U.S. Patent
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`Dec. 27, 2005
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`Sheet 3 of 17
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`Ethicon Exhibit 2020.004
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`IPR2018-01247
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`Ethicon Exhibit 2020.004
`Intuitive v. Ethicon
`IPR2018-01247
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`U.S. Patent
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`Dec. 27, 2005
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`Sheet 4 of 17
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`US 6,978,921 B2
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`Ethicon Exhibit 2020.005
`Intuitive v. Ethicon
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`U.S. Patent
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`Dec.27, 2005
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`Sheet 5 of 17
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`Ethicon Exhibit 2020.006
`Intuitive v. Ethicon
`IPR2018-01247
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`Ethicon Exhibit 2020.006
`Intuitive v. Ethicon
`IPR2018-01247
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`U.S. Patent
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`Dec. 27, 2005
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`Sheet 6 of 17
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`Ethicon Exhibit 2020.007
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`Ethicon Exhibit 2020.007
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`U.S. Patent
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`Dec. 27, 2005
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`Sheet 7 of 17
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`Intuitive v. Ethicon
`IPR2018-01247
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`Ethicon Exhibit 2020.008
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`U.S. Patent
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`Dec.27, 2005
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`Ethicon Exhibit 2020.009
`Intuitive v. Ethicon
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`Ethicon Exhibit 2020.009
`Intuitive v. Ethicon
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`U.S. Patent
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`Dec.27, 2005
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`Sheet 9 of 17
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`Ethicon Exhibit 2020.010
`Intuitive v. Ethicon
`IPR2018-01247
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`Ethicon Exhibit 2020.010
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`U.S. Patent
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`Dec.27, 2005
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`Sheet 10 of 17
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`Ethicon Exhibit 2020.011
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`Sheet 11 of 17
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`Dec. 27, 2005
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`Ethicon Exhibit 2020.012
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`Ethicon Exhibit 2020.012
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`U.S. Patent
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`Dec.27, 2005
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`Dec.27, 2005
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`Intuitive v. Ethicon
`IPR2018-01247
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`Ethicon Exhibit 2020.014
`Intuitive v. Ethicon
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`U.S. Patent
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`Dec. 27, 2005
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`Sheet 14 of 17
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`Ethicon Exhibit 2020.015
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`Sheet 15 of 17
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`Ethicon Exhibit 2020.016
`Intuitive v. Ethicon
`IPR2018-01247
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`Ethicon Exhibit 2020.016
`Intuitive v. Ethicon
`IPR2018-01247
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`U.S. Patent
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`Dec. 27, 2005
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`Sheet 16 of 17
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`Ethicon Exhibit 2020.017
`Intuitive v. Ethicon
`IPR2018-01247
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`Ethicon Exhibit 2020.017
`Intuitive v. Ethicon
`IPR2018-01247
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`U.S. Patent
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`Dec. 27, 2005
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`Sheet 17 of 17
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`US 6,978,921 B2
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`Ethicon Exhibit 2020.018
`Intuitive v. Ethicon
`IPR2018-01247
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`Ethicon Exhibit 2020.018
`Intuitive v. Ethicon
`IPR2018-01247
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`US 6,978,921 B2
`
`1
`SURGICAL STAPLING INSTRUMENT
`INCORPORATINGAN E-BEAM FIRING
`MECHANISM
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`
`The present application is related to four co-pending and
`commonly-ownedapplications filed on even date herewith,
`the disclosure of cach is hercby incorporated by reference in
`their cntircty,
`these four applications being respectively
`entitled:
`(1) “SURGICAL STAPLING INSTRUMENT HAVING A
`SINGLE LOCKOUT MECHANISM FOR PREVEN-
`TION OF FIRING” io Frederick E. Shelton IV, Mike
`Setser, and Bruce Weisenburgh;
`(2) “SURGICAL STAPLING INSTRUMENT HAVING
`SEPARATE DISTINCT CLOSING & FIRING SYS-
`TEMS?”to Frederick E. Shelton, Mike Setser, and Brian J.
`Hemmelgarn;
`(3) “SURGICAL STAPLING INSTRUMENT HAVING A
`SPENT CARTRIDGE LOCKOUT”to Frederick E. Shel-
`ton IV, Mike Setser, Bruce Weisenburgh; and
`(4) “SURGICAL STAPLING INSTRUMENT HAVING A
`FIRING LOCKOUT FOR AN UNCLOSED ANVIL”to
`Frederick E. Shelton IV, Mike Setser, and Bruce Weisen-
`burgh.
`
`FIELD OF THE INVENTION
`
`The present invention relates in general to surgical stapler
`instruments that are capable of applying lines of staples to
`tissue while cutting the tissue betweenthose staple lines and,
`more particularly, to improvementsrelating to stapler instru-
`ments and improvements in processes for forming various
`components of such stapler instruments.
`
`BACKGROUND OF THE INVENTION
`
`
`
`to
`Surgical staplers have been used in the prior art
`simultaneously make a longitudinal incision in tissue and
`applylines of staples on opposing sidesof the incision. Such
`instruments commonlyinclude a pair of cooperating jaw
`members that, if the instrumentis intended Lor endoscopic or
`laparoscopic applications, are capable of passing through a
`cannula passageway. 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 instrument includes a plurality of recip-
`rocating wedges which, when driven distally, pass through
`openings in the staple cartridge and engage drivers support-
`
`ing the staples to effect the firing of the staples toward the
`anvil.
`The simultaneous severing of tissue while forming rows
`of staples on each side of the cut reduces bleeding and
`simplifies the surgical procedure. However, an appropriate
`amount of Uissue should be clamped between the jaws so that
`proper staple formation is achieved and so that a cutting
`member does oot bind or otherwise fail to fully cut the
`clampedtissue.
`Astapling and severing instrument that maintains a maxi-
`mumjaw spacing is described in U.S. Pat. No. 4,429,695. In
`particular, a central knife carrier has an upper shoe that
`enters an upper passagewaythrough an opening when the
`upper jaw is closed and has a lower shoe that is received
`within a lower passageway of the lower jaw. Thus, as the
`
`Laa
`
`aa
`
`5
`
`2
`knife carrier is advanced distally, the shoes vertically and
`laterally position the upper and lower jaws. U.S. Pat. No.
`4,429,695 teaches thal the shoes are allached to the central
`kmile carrier to resist vertical deflection (opening) of the
`Jaws during ejection and forming of staples. As taught, the
`forces tend to vertically open the jaws during stapling.
`However, no mention is made ofresisting forces that might
`be applied to vertically close the jaws. Additionally, this
`reference teaches that
`the device described thercin is
`assembled from two separate, unconnected clementsthat are
`brought together and clamped ontotissuc. The two elements
`form a device suitable only for an open procedure that has
`no size limitations.
`Increasingly, endoscopic and laparoscopic procedures are
`preferred over open procedures due to their reduced post-
`operative recovery times and other advantages. Endoscopic
`stapling and severing instruments use a long slender jaw
`member that tends to deflect upwardly when clamped onto
`thick tissues. On thick tissue, this upward deflection of the
`free (distal) end of the jaw can cause differencesin height of
`the formed staples as the distal gap between the anvil and
`cartridge is larger than the proximal gap. To cnsure more
`uniform proximal to distal staple formation,
`the anvil is
`frequently cambered or bent
`inwardly toward the staple
`cartridge. This camberis better for thick tissue and can cause
`tighter staple forms at
`the distal end when used on thin
`tissue. ‘To overcomethis tight distal closure, pins or bumps
`have been added to the clamping surface of the cartridge
`adjacentto the distal end of the cartridge. The closure of the
`anvil onto the pin ensures a minimum gap at the distal end.
`However, surgeons were concerned aboutthe pins or bumps
`causing tissue trauma. What is needed is a mechanism for
`maintaining a minimal gap between the anvil and cartridge
`and a mechanism for maintaining a maximum gap between
`the anvil and cartridge.
`An example of a surgical stapler suitable for endoscopic
`applications is described in U.S. Pat. No. 5,465,895, which
`advantageously provides distinct closing and liring 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, thereby
`severing and stapling the tissue. The simultaneous severing
`and stapling avoids complications that may arise when
`performing such actions scquentially with different surgical
`tools that respectively only sever orstaple.
`Onespecific advantage of being able to close upon tissue
`before firing is that the clinician is able to verify via an
`endoscope that a sullicient amount of tissue has been cap-
`tured between opposing jaws. Otherwise, opposing jaws
`maybe drawntoo close together, especially pinching attheir
`distal ends, and thus not effectively forming closed staples
`in the severed tissue. Moreover, a firing bar that traverses
`between opposing jaws to sever the tissue and to drive the
`wedgesthat drive the staples may encounter resistance due
`to the pinched opposing jaws.
`Thus, while such surgical staplers have been a significant
`advance in surgical procedures, an opportunity has been
`recognized for enhancing their effectiveness. In particular, it
`would be desirable to affirmatively maintain proper spacing
`between the opposing jaws during firing, both opening and
`closing deflections. In particular, endoscopic devices need to
`fit into an access device such a trocar, and must maintain a
`small shaft diameter. To date, no endoscopic stapling device
`has been provided that has roomfor a pair for longitudinal
`passageways for shoes on a cutter that resists both tensile
`and compressive jawloadings.
`
`Ethicon Exhibit 2020.019
`Intuitive v. Ethicon
`IPR2018-01247
`
`Ethicon Exhibit 2020.019
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US 6,978,921 B2
`
`4
`FIG. 3 depicts an enlarged side elevation viewofthe firing
`bar of the surgical stapling and severing instrument of FIG.
`2.
`
`3
`Furthermore, it is desirable to maintain other advantages
`of ULS. Pat. No. 5,465,895 to include a wedgesled integral
`to a staple cartridge, rather than having camming surfaces
`allached to a cutter. ‘Thereby, fabrication of the cutter is
`simplified, as is iostallation of the staple cartridge. Signifi-
`cantly, an integral wedge sled may be designed specifically
`for each size and application of a staple cartridge, allowing
`the stapling and severing instrument increased number of
`uses. In particular, the thickness of the staple cartridge may
`be based on the desired tissuc thickness. Also, the number
`and spacing of rows of staples may vary.
`Consequently, a significant need exists for an improved
`surgical stapling and severing instrument
`that maintains
`proper spacing in ils end eflector to achieve properstapling
`of the severed Ussue, yel retains the advantages of a staple
`cartridge having an integral wedge sled.
`BRIEF SUMMARY OF THE INVENTION
`
`TIG. 4 depicts an enlarged front view ofthe firing bar of
`the surgical stapling and severing instrument of FIG. 2.
`FIG. 5 depicts a cross-sectional side elevation detail view
`of an alternative end effector for the surgical stapling and
`severing instrumentof F'IG. 1, incorporating a firing bar that
`lacks a middle pin for preventing pinching of the end
`effector.
`FIG. 6 depicts a side elevational view of a handle portion
`of a proximal end of the surgical stapling and severing
`instrument of FIG. 1 with a left side removed to expose
`interior parts in an unclamped, unfired (“start”) position.
`FIG. 7 depicts a perspective, exploded view of the handle
`portion of the proximal end of the surgical stapling and
`severing instrument of FIG. 1.
`FIG. 8 depicts a side elevational view of the handle
`The invention overcomes the above-noted and otherdefi-
`portion of the proximal end of the surgical stapling and
`
`ciencies ofthe prior art by providingafiring mechanism that severing instrument of FIG. 1 with the left side removed to
`affirmatively vertically spaces an end effector of a surgical
`expose interior parts in the closed (“clamped”) position.
`stapling and severing instrument. Thus, the instrument struc-
`FIG. 9 depicts a side elevational view of the handle
`turally assures adequate spacing to achieve proper stapling,
`portion of proximal cnd of surgical stapling and scvering
`evenin instances wheretoolittle tissue is clamped in the end
`instrument of FIG. 1 with the Icft side removed to cxpose
`effector.
`intcrior parts in the stapled and scvered (“fired”) position.
`In one aspect of the invention, a surgical instrument
`FIG. 10 depicts an isometric view of the end effectorat the
`includes a handle portion operable to produce a firing
`distal end of the surgical stapling and severing instrument of
`motion that actuates an implement portion. This implement
`FIG. 1 with the anvil io the up or open position exposing the
`portion has an elongate channel
`that
`receives a staple
`staple cartridge and cutting edge of the firing bar.
`cartridge opposed by a pivotally attached anvil. A firing
`FIG. 11 depicts an isomctric, exploded vicw of the
`device includes a distally presented cutting edge longitudi-
`implement portion of the surgical stapling and severing
`oally received between the elongate channel and the anvil,
`instrument of FIG. 1.
`ao upper member engageable to the anvil channel, a lower
`member engaging the channel slot, and a middle member
`operable to actuate the wedge sled, which is integral to the
`
`staple
`
`cartridge. The middle member
`advantageously
`
`opposes pinching of the end effector, assuring properstaple
`formation even when an otherwise too small amount of
`tissue has been clamped.
`In another aspect of the invention, a surgical instrument is
`provided that is suitable for endo-surgical and laparoscopic
`procedures by have a diametrically sized end effector and
`shalt of the implement portion. A handle portion produces
`both a closing motion and firing motion that are transferred
`distally through the shaft of the implement portion. The
`
`firing mechanismrespondsto the firing motion by engaging
`
`
`
`both the anvil and the elongate channelto effect severing of
`clamped tissue and to affirmatively space the anvil and
`elongate channel to assure proper staple formation.
`These and other objccts and advantages of the prescnt
`invention shall be made apparent from the accompanying
`drawings and the description thereof.
`BRIEI’ DESCRIPTION OF TIE FIGURES
`
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`FIG. 12 depicts an isometric view of the end effectorat the
`distal end ofthe surgical stapling and severing instrumentof
`FIG. 1 with the anvil in the up or open position with the
`cartridge largely removed exposing a single staple driver
`and a double staple driver as exemplary and the wedge sled
`in its start position against a middle pin of the firing bar.
`FIG. 13 depicts an isometric view of the distal end of the
`surgical stapling and severing instrument of FIG. 1 with the
`anvil in the up or open position with the staple cartridge
`completely removed and a portion of an elongate channel
`removed to expose a lowermost pin of the firing bar.
`FIG. 14 depicts a side clevation vicw in section showing
`a mechanicalrelationship between the anvil, elongate chan-
`nel, and staple cartridge in the closed position ofthe surgical
`stapling and severing instrument of FIG. 1,
`the section
`generally taken along lines 14—14 of FIG. 10 to expose
`wedge sled, slaple drivers and staples but also depicting the
`firing bar along the longitudinal centerline.
`TIG. 15 depicts a section view of the end effector of the
`surgical stapling and scvering instrument with the cartridge
`and firing bar in the start position taken along line 15—15
`of FIG. 10.
`
`FIG. 16 depicts a section viewtaken along line 16—16 of
`FIG. 15 showing the cross-sectional relationship between
`the firing bar, elongate channel, wedge sled, staple drivers,
`staples and staple cartridge.
`FIG. 17 depicts a side elevation section view of the
`surgical stapling and severing instrument of FIG. 1 taken
`along the longitudinal centerline of the end effector in a
`partially closed but unclamped position gripping Ussue.
`FIG. 18 depicts a partially cut-awayside elevational view
`of the surgical stapling and severing instrument of FIG. 1 in
`the closed or clamped position.
`
`Ethicon Exhibit 2020.020
`Intuitive v. Ethicon
`IPR2018-01247
`
`The accompanying drawings, which are incorporated in
`and constitute a part of this specification, illustrate embodi-
`ments of the invention, and,
`together with the general
`description of the invention given above, and the detailed
`description of the embodiments given below, serve to
`explain the principles of the present invention.
`FIG. 1 depicts a partially cut-away side elevation view of
`a surgical stapling and severing instrument
`in an open
`position.
`FIG. 2 depicts a cross-sectional side elevation detail view
`along the line 2—2 of TIG. 1 of an end effector of the
`surgical stapling and severing instrument.
`
`Ethicon Exhibit 2020.020
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US 6,978,921 B2
`
`5
`FIG. 19 depicts a side elevation viewin centerline section
`of the distal end of the surgical stapling and severing
`instrument of FIG. 1 in the closed or clamped position with
`tissue properly compressed.
`FIG. 20 depicts a partially cut-awayside clevation vicw
`of the surgical stapling and severing instrument of FIG. 1 in
`a partially fired position.
`FIG. 21 depicts a view in centerline section of the distal
`end ofthe surgical stapling and severing instrument of FIG.
`1 in a partially fired position.
`FIG. 22 depicts a partially cut-away side elevation view
`of the surgical stapling and severing instrumentof FIG. 1 in
`a fullyfired position.
`TIG. 23 depicts a view in centerline section of the distal
`end of the surgical stapling and scvcring instrument of FIG.
`1 in a fully fired position.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`
`
`Turning to the Drawings, wherein like numerals denote
`like components throughout the several views, FIGS. 1 and
`2 depict a surgical stapling and severing instrument 10 that
`is capable of practicing the unique benefits of the present
`invention. ‘The surgical stapling and severing instrument 10
`incorporates an end effector 12 having an E-beamfiring
`
`
`mechanism(“firing bar”) 14 that advantageously controls
`
`
`the spacing of the end effector 12. In particular, an elongate
`
`channel 16 and a pivotally translatable anvil 18 are main-
`
`tained at a spacing that assures effective stapling and sev-
`ering. The problems are avoided associated with varying
`amounts of tissue being captured in the end effector 12.
`The surgical and stapling and severing instrument 10
`includes a handle portion 20 connected to an implement
`portion 22, the latter further comprising a shaft 23 distally
`terminating in the end effector 12. The handle portion 20
`includes a pistol grip 24 toward which a closure trigger 26
`is pivotally drawn bythe clinician to cause clamping, or
`closing, of the anvil 18 toward the elongate channel 16 of the
`end effector 12. A firing trigger 28 is farther outboard of the
`closure trigger 26 and is pivotally drawn by the clinician to
`cause the stapling and severing of clampedtissue in the end
`effector 12.
`
`the terms “proximal” and
`It will be appreciated that
`“distal” are used herein with referenceto a clinician gripping
`a handle of an instrument. Thus, the end effector 12 is distal
`with respect to the more proximal handle portion 20. It will
`be [urther appreciated that for convenience and clarity,
`spatial terms such as “vertical” and “horizontal” are used
`herein with respect
`to the drawings. However, surgical
`instruments are used in many orientations and positions, and
`these terms are not intended to be limiting and absolute.
`Closure trigger 26 is actuated first. Once the clinician is
`satisficd with the positioning of the end cffector 12,
`the
`clinician may drawback the closure trigger 26 to its fully
`clased, locked pasition proximateta the pistol grip 24. Then,
`the firing trigger 28 is actuated. The firing trigger 28
`springedly returns when the clinician removes pressure. A
`release button 30 when depressed on the proximal end of the
`handle portion 20 releases any locked closure trigger 26.
`A closure sleeve 32 encloses a frame 34, which in turn
`encloses a firing drive member 36 that is positioned by the
`firing trigger 28. The frame 34 connects the handle portion
`20 to the end effector 12. With the closure sleeve 32
`withdrawn proximally by the closure trigger 26 as depicted,
`
`w
`
`10
`
`40
`
`60
`
`6
`the anvil 18 springedly opens, pivoting away from the
`elongate channel 16 and translating proximally with the
`closure sleeve 32.
`‘The elongate channel 16 receives a staple cartridge 37 that
`is responsiveto the firing bar 14 to drive staples into forming,
`contact with the anvil 18. It will appreciated that although a
`readily replaceable staple cartridge 37 is advantageously
`described herein, a staple cartridge 37 consistent with
`aspects of the present invention may be permanently affixed
`or intcgral to the clongate channel 16, for instance when a
`larger portion of the end effector 12 is replaced aftcr cach
`firing.
`E-Beam Firing Mechanism
`With particular reference to FIGS. 2-4,the firing bar 14
`includes three vertically spaced pins that control the spacing
`of the end effector 12 during firing. In particular, an upper
`pin 38 is staged to enter an anvil pocket 40 near the pivot
`between the anvil 18 and elongate channel 16. When fired
`with the anvil 18 closed, the upper pin 38 advancesdistally
`within a longitudinal anvil slot 42 extending distally through
`anvil 18. Any minor upward deficction in the anvil 18 is
`overcome by a downward force imparted by the upper pin
`38.
`Firing, bar 14 also includes a lower mostpin,orfiring bar
`cap, 44 that upwardly engages a channel slot 45 in the
`elongate channel 16, thereby cooperating with the upper pin
`38 to draw the anvil 18 and the elongate channel 16 slightly
`closer together in the event of excess tissue clamped ther-
`ebetween.
`Thefiring bar 14 advantageously includes a middle pin 46
`that passes through a firing drive slot 47 formed in a lower
`surface of the cartridge 37 and an upward surface of the
`clongate channel 16, thercby driving the staples therein as
`described below. The middle pin 46, bysliding against the
`elongate channel 16, advantageously resists any tendency
`for the end effector 12 to be pinched shut at its distal end. To
`illustrate an advantage of the middle pin 46, FIG. 5 depicts
`an allernalive end elfector 12! that lacks a middle pin on a
`firing bar 14". In this depiction,
`the end effector 12'
`is
`allowed to pinch shutat its distal end, which tends to impair
`desired staple formation.
`Returning to FIGS. 2-4, a distally presented cutting edge
`48 between the upper and middle pins 38, 46 on the firing
`bar 14 traverses through a proximally presented, vertical slot
`49 in the cartridge 37 to sever clamped tissuc. The affirma-
`
`tive positioning of the firing bar 14 with regard to the
`elongate channel 16 and anvil 18 assure that an effective cut
`is performed.
`Cambered Anvil with Selected Cartridge Gap
`‘The allirmative vertical spacing provided by the E-Beam
`firing bar 14 is suitable for the limited size available for
`endoscopic devices. Moreover, the E-Beamfiring bar 14
`enables fabrication of an anvil 16 with a camber imparting
`a vertical deflection at its distal end, similar to the position
`depicted in FIG. 5, This cambered anvil 16 advantageously
`assists in achicving the desired gap in the end cffector 12
`even with an anvil 16 reduced thickness, which is thus more
`suited to the size limitations of an endoscopic device.
`The E-Beam firing bar 14 further enables increased appli-
`cations, especially in combination with a range of configu-
`ralions of staple cartridges. Kor instance, a clinician may
`select a pray staple cartridge yielding a 0.02 mm tissue gap,
`a white staple cartridge yielding a 0.04 mmtissue gap, a blue
`cartridge yielding a 0.06 mmtissue gap, or a green cartridge
`yielding a 0.10 mmtissue gap. The vertical height of each
`respective staple cartridge in combination with the length of
`staples and an integral wedge sled (described in more detail
`
`
`
`Ethicon Exhibit 2020.021
`Intuitive v. Ethicon
`IPR2018-01247
`
`Ethicon Exhibit 2020.021
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US 6,978,921 B2
`
`7
`below) predetermines this desired tissue thickness with the
`anvil 18 appropriately vertically spaced by the E-Beam
`firing bar 14.
`Two-Axis Handle
`
`With reference to FIGS. 6-9, the handle portion 20 is
`comprised offirst and second base sections 50 and 52, which
`are molded from a polymeric material such as a glass-filled
`polycarbonate. The first base section 50 is provided with a
`plurality of cylindrical-shaped pins 54. The second base
`section 52 includes a plurality of extending members 56,
`each having a hexagonal-shaped opening 58. The cylindri-
`cal-shaped pins 54 are received within the hexagonal-shaped
`openings 58 andare frictionally held therein for maintaining
`the first and second base sections 50 and 52 in assembly.
`A rotating knob 60 has a bore 62 extending completely
`through it for engaging and rotating the implement portion
`22 about its longitudinal axis. The rotating knob 60 includes
`an inwardly protruding boss 64 extending along at least a
`portion of the bore 62. The protruding boss 64 is received 2
`within a longitudinal slot 66 formed at a proximal portion of
`the closure sleeve 32 such that rotation of the rotating knob
`60 effects rotation of the closure sleeve 32.
`It will be
`appreciated that the boss 64 further extends through frame
`34 and into contact with a portion ofthe firing drive member
`36 to effect their rotation as well. Thus, the end effector 12
`(not shownin FIGS. 6-9) rotates with the rotating knob 60.
`A proximal end 68 of the frame 34 passes proximally
`through the rotating knob 60 and is provided with a circum-
`ferential notch 70 that
`is engaged by opposing channel
`securement members 72 extending respectively from the
`basc sections 50 and 52. Only the channel sccurement
`member 72 of the second base section 52 is shown. The
`channel securement members 72 extending from the base
`sections 50, 52 serve to secure the frame 34 to the handle
`portion 20 such that the frame 34 does not move longitu-
`dinally relative to the handle portion 20.
`‘The closure trigger 26 has a handle section 74, a gear
`segment section 76, and an intermediate section 78. A bore
`80 extends through the intermediate section 78. Acylindrical
`support member 82 extending from the second base section
`52 passes through the bore 80 for pivotably mounting the
`closure trigger 26 on the handle portion 20. A second
`cylindrical support member 83 extending from the sccond
`base section 52 passes through a bore 81 offiring trigger 28
`for pivotally mounting on the handle portion 20. A hexago-
`nal opening 84 is provided in the cylindrical support mem-
`ber 83 for receiving a securement pin (not shown) extending
`from the first base section 50.
`
`Laa
`
`wna
`
`Aclosure yoke 86 is housed within the handle portion 20
`for reciprocating movement therein and serves to transfer
`motion from the closure trigger 26 to the closure sleeve 32.
`Support members 88 extending from the second base section
`52 and securement member 72, which extends through a
`recess 89 in the yokc 86, support the yokc 86 within the
`handlc portion 20.
`A proximal end 90 of the closure sleeve 32 is provided
`with a flange 92 that is snap-fitted into a receiving recess 94
`formed in a distal end 96 of the yoke 86. A proximal end 98
`of the yoke 86 has a gear rack 100 that is engaged by the gear
`segment section 76 of the closure trigger 26. When the
`closure trigger 26 is moved toward the pistol gp 24 of the
`handle portion 20, the yoke 86 and, hence, the closure sleeve
`32 move distally, compressing a spring 102 that biases the
`yoke 86 proximally. Distal movementof the closure sleeve
`32 effects pivotal translation movement of the anvil 18
`
`8
`distally and toward the elongate channel 16 of the end
`effector 12 and proximal movement effects closing, as
`discussed below.
`The closure trigger 26 is forward biased to an open
`position by a front surface 130 interacting with an engaging
`surface 128of the firing trigger 28. Clampfirst hook 104 that
`pivots top to rear in the handle portion 20 about a pin 106
`restrains movementof the firing trigger 28 toward the pistol
`grip 24 until the closure trigger 26 is clamped to its closed
`position. Hook 104 restrains firing trigger 28 motion by
`engaging a lockoutpin 107 in firing trigger 28. The hook 104
`is also in contact with the closure trigger 26. In particular, a
`forward projection 108 of the hook 104 engages a member
`110 on the intermediate section 78 of the closure trigger 26,
`the member 110 being outward of the bore 80 toward the
`handle section 74. Hook 104 is biased toward contact with
`member 110 of the closure trigger 26 and engagement with
`lockout pin 107 infiring trigger 28 by a release