az United States Patent
`US 7,473,258 B2
`(10) Patent No.:
`Clauson etal.
`Jan. 6, 2009(45) Date of Patent:
`
`
`US007473258B2
`
`
`
`(73)
`
`(*)
`
`(21)
`
`(22)
`
`(65
`
`(51)
`
`(58)
`
`(56
`
`‘Int. Cl.
`(2006.01)
`AGIB 17/072
`(52) US. Ch we 606/139: 227/19; 227/176.1;
`227/82; 606/219
`Field of Classification Search .............. 227/176.1,
`227/175.1, 19, 82, 88; 606/139, 219
`See application file for complete search history.
`
`(54) SURGICAL STAPLER
`
`(75)
`
`Inventors: Luke W. Clauson, Redwood City, CA
`(US); Bryan D. Knodel, Flagstaff, A7,
`(US); Benjamin J. Matthias, San
`Mateo, CA (US); Matthew B. Newell,
`Portola Valley, CA (US)
`
`Assignee: Cardica, Inc., Redwood City, CA (US)
`
`Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 34 days.
`
`Appl. No.: 11/672,858
`
`Filed:
`
`Mar. 8, 2007
`
`Prior Publication Data
`US 2008/0217376 Al
`Sep. 11, 2008
`
`References Cited
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`
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`
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`
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
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`
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`
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`
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`
`(Continued)
`
`
`OTHER PUBLICATIONS
`
`“Closure and Assisted-Compression Device Update”, Endovascular
`Today. (Apr. 2004),22.
`
`(Continued)
`
`Primary Examiner—Scott A. Smith
`(74) Attorney, Agent, or Firm—Brian A. Schar
`
`(57)
`
`ABSTRACT
`
`Amethod for surgically stapling tissue may include providing
`staples in a first configuration, plastically deforming at least
`one staple to a second configuration different from thefirst
`configuration; and then plastically deforming at least one
`staple to a third configuration different from the first configu-
`ration and the second configuration. The deformation of a
`staple fromthefirst configurationto the second configuration
`maybe performed bysplayingthe staple. The staple may be
`splayed by a splay arm or other suitable structure or mecha-
`nism.
`
`13 Claims, 7 Drawing Sheets
`
`
`
`Ethicon Exhibit 2004.001
`Intuitive v. Ethicon
`IPR2018-01247
`
`Ethicon Exhibit 2004.001
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US 7,473,258 B2
`
`Page 2
`
`
`
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`”
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`
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`6,942,674 B2
`7,056,330 B2*
`2001/0007077 Al
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`
`wo
`wo
`i
`WO
`wo
`
`
`
`7/2004 Kanneretal.
`8/2004 Knodcl
`ctal.
`8/2004 Roe etal.
`9/2005 Belef
`6/2006 Gayton .....eee 606/219
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`9/2001 Levinson
`6/2002 Ginn
`6/2002. Ginnet al.
`9/2002 Ginnet al.
`10/2002 Kanner
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`5/2003. Akin et al.
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`9/2006. Brenzelet al.
`;
`;
`
`
`TOREIGN PATINT DOCUMIINTS
`W0.99/62408
`12/1999
`Wo.00/07640
`5000
`ne
`WO-00/56223
`9/2000
`WO.00/56207
`9/2000
`an
`,
`‘
`
`OTHER PUBLICATIONS
`
`“Summary of Safety and Effectiveness Data (EVS (1M) Vascular
`Closure System)”, (Nov. 3, 2004).
`“The EVS(TM) Vascular Closure System by Angiolink”, Business
`Briefing: US Cardiology2004, (2004).
`“VasoStasis (TM) Vascular Closure System 510(k) Notification”
`(Oct. 22, 2004).
`“Notification of Transmittal of the International Scarch Report and.
`Written Opinion of the ISA”, PCT/US2008/056328, (ul. 28, 2008).
`“Written Opinion of the International Search Authority’, PCT/
`opelnierenin. ethRony, » PCTILIS2008/056328 (ul. 28
`soo
`ternational
`Search
`Report",
`PC1/US2008/056528, (Jul. 28,
`).
`* cited by examiner
`
`Ethicon Exhibit 2004.002
`Intuitive v. Ethicon
`IPR2018-01247
`
`Ethicon Exhibit 2004.002
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`U.S. Patent
`
`Jan. 6, 2009
`
`Sheet 1 of 7
`
`US 7,473,258 B2
`
`FIG. 1
`
`Ethicon Exhibit 2004.003
`Intuitive v. Ethicon
`IPR2018-01247
`
`Ethicon Exhibit 2004.003
`Intuitive v. Ethicon
`IPR2018-01247
`
`
`

`

`U.S. Patent
`
`Jan. 6, 2009
`
`Sheet 2 of 7
`
`US 7,473,258 B2
`
`
`
`FIG. 2A
`
`Ethicon Exhibit 2004.004
`Intuitive v. Ethicon
`IPR2018-01247
`
`Ethicon Exhibit 2004.004
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`U.S. Patent
`
`Jan. 6, 2009
`
`Sheet 3 of 7
`
`US 7,473,258 B2
`
`
`
`FIG. 3
`
`C
`"
`
` wori! i
`Ci
`
`58
`
`56
`
`
`
`FIG.4
`
`Ethicon Exhibit 2004.005
`Intuitive v. Ethicon
`IPR2018-01247
`
`Ethicon Exhibit 2004.005
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`U.S. Patent
`
`Jan. 6, 2009
`
`Sheet 4 of 7
`
`US 7,473,258 B2
`
`44
`
`48
`
`46
`
`)
`
`44
`
`48
`
`42
`
`43
`
`43
`
`{ 28
`
`42
`
`FIG.5
`
`Ethicon Exhibit 2004.006
`Intuitive v. Ethicon
`IPR2018-01247
`
`Ethicon Exhibit 2004.006
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`U.S. Patent
`
`Jan. 6, 2009
`
`Sheet 5 of 7
`
`US 7,473,258 B2
`
`
`
`FIG.6
`
`
`
`FIG. 7
`
`Ethicon Exhibit 2004.007
`Intuitive v. Ethicon
`IPR2018-01247
`
`Ethicon Exhibit 2004.007
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`U.S. Patent
`
`Jan. 6, 2009
`
`Sheet 6 of 7
`
`US 7,473,258 B2
`
`
`
`FIG.9
`
`Ethicon Exhibit 2004.008
`Intuitive v. Ethicon
`IPR2018-01247
`
`Ethicon Exhibit 2004.008
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`U.S. Patent
`
`Jan. 6, 2009
`
`Sheet 7 of 7
`
`US 7,473,258 B2
`
`FIG. 10
`
`
`
`Ethicon Exhibit 2004.009
`Intuitive v. Ethicon
`IPR2018-01247
`
`Ethicon Exhibit 2004.009
`Intuitive v. Ethicon
`IPR2018-01247
`
`
`

`

`1
`SURGICAL STAPLER
`
`FIELD OF THE INVENTION
`
`US 7,473,258 B2
`
`2
`
`
`DETAILED DESCRIPTION
`
`The present invention relates gencrally to a surgical stapler
`and a method for surgical stapling.
`
`BACKGROUND
`
`Traditionally, suture has been utilized to close wounds and
`incisions, to attach separate tissue structures to one another,
`and to perform other medical and. surgical functions. How-
`ever, suturing requires skill to perform, particularly suturing
`procedures that are complex, time-consuming and/or diffi-
`cull. Further, suturing may be impractical or unleasible in
`certain situations. For example, in a minimally-invasive sur-
`gical procedure through a small opening (often referred to as
`an accessport) in the patient’s body, that port may notbe large
`enough to allow suturing to be performed throughit. If the
`port were enlarged to allow suturing, the benefits of mini-
`mally-invasive surgery through a small access port would be
`reduced or climinated altogether. Indeed, as surgical technol-
`ogyprogresses, the size of the access ports required in the
`bodyto perform minimally-invasive surgery decreases. For
`example, micro-laparoscopy utilizes instruments having a
`diameter of only 2-3 millimeters to perform procedures such
`as laparoscopic cholecystectomy and inguinal hernia repair.
`Wheninstruments of such small diameter are used, the ports
`in the bodythrough which theyare inserted need be only 2-3
`millimeters in diameter as well, resulting in minimal or no
`scarring ofthe patient after the procedure is completed. Ilow-
`ever, itis difficult or impossible to perform suturing within the
`patient’s body through ports of such small size.
`
`
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`['IG. 1 is a side view of an exemplary surgical stapler.
`FIG. 2 is a culaway perspective view from above of an
`exemplary effector of the surgical stapler of FIG.1.
`FIG. 2A is the cutawayperspective view of FIG.2, includ-
`ing an anti-backup rack.
`FIG. 3 is a cutaway perspective view from below of an
`exemplary effector of the surgical stapler of FIG.1.
`FIG. 4 is a cutawayside viewof an exemplaryeffector of
`the surgical stapler of FIG. 1.
`FIG. 5 is a lop view ofan exemplarystaple deployed bythe
`surgical stapler of FIG.1.
`FIG. 6 is a bottomview of an exemplary uppercase half of
`the surgical stapler of FIG. 1.
`FIG. 7 is a perspective view of the distal end of an exem-
`plary effector ofthe surgical stapler of FIG. 1, without the
`upper case half, showing an exemplary lower case half.
`FIG. 8 is a cutaway perspective view of an exemplary
`effector ofthe surgical stapler of FIG. 1, where the effector is
`in an initial configuration.
`FIG. 9 is a perspective view of the distal end of an exem-
`plary effector of the surgical stapler of FIG.1.
`FIG. 10 is a cutaway perspective view of an exemplary
`effector ofthe surgical stapler of TIG. 1, where the effector is
`in a second configuration.
`FIG. 11 is a cutaway perspective view of an exemplary
`eflector ofthe surgical stapler of FIG. 1, where the eflector is
`in a third configuration.
`The use of the same reference symbols in differentfigures
`indicates similar or identical items.
`
`
`
`
`
`
`
`w
`
`— wn
`
`20
`
`in a
`
`Relerring to FIG.1, a surgical stapler 2 includes a handle 4
`connectedto an effector 6. Allernately, the surgical stapler 2
`maybe configured differently. For example, the effector 6
`maybe indirectly connected to the handle 4 via an interme-
`diate structure, such as a rigid, articulated or flexible shaft
`(not shown). The handle 4 may have anysuitable configura-
`tion, as described in greater detail below. The effector 6 may
`be sized to pass through an accessport in a patient for use in
`a minimally-invasive surgical procedure. The effector 6 may
`be sized. and shaped to allowit to be inserted through an
`access port in a patient of 5 mmin diameter or less. Alter-
`nately, the efector 6 maybe sized and/or shaped dillerently.
`The eflector 6 maybe substantially rigid, substantially flex-
`ible, or a combination of both. The handle 4 mayinclude one
`or moretriggers, levers, knobs, buttons or other input features
`used to actuate and/or control the effector 6.
`Referring to FIGS. 2-3, the effector 6 mayinclude a driver
`8, a pusher 10, a splay arm 12, an anvil 14, an anti-backup rack
`16, an uppercase half 18, and a lower case half 20. The terms
`“upper,” “lower,” “upward,” “downward,” “up,” “down,”
`“below,” “above”and thelike are used solely for convenience
`in this document; such termsrefer to directions an the printed
`s page and do notlimit the orientation of the effector 6 in use.
`The effector 6 mayinclude additional, or fewer, components.
`An exemplary driver 8 may be generally elongated im the
`longitudinal direction, and may be thin. The driver 8 may be
`stamped froma thin sheet of metal or other material, or may
`be otherwise fabricated. The driver 8 mayinclude a longitu-
`dinally-extending bar 22 located at the proximal end of the
`driver 8. The driver 8 maybe forked or otherwise configured
`at its distal end. As one example,the driver 8 mayinclude two
`prongs 24 atits distal end. The proximal end of each prong 24
`maybe connected to a crossbar 26that in turn is connected to
`the bar 22. The crossbar 26 maybe substantially perpendicu-
`lar to the prongs 24 and to the crossbar 26, or maybe oriented
`differently relative to the bar 22. ‘The crossbar 26 may be
`substantially square. However, the crossbar 26 may berect-
`angular, oval, cylindrical, or have any other suitable shape.
`Alternately, the prongs 24 may be connected directly to the
`bar 22, without the use of the crossbar 26. Alternately, more
`than two prongs 24, or a single prong 24, maybe utilized.
`Lach prong 24 may be shaped in any suitable manner. The
`distal end of one prong 24 or both prongs 24 maybe curved or
`angled downward. As one example, a distal portion of at least
`one prong 24 may be below and substantially parallel to the
`bar 22, where that prong 24 curves upward proximally to that
`distal portion to connect to the crossbar 26. Alternately, the
`distal end ofal least one prong 24 may be substantially in the
`sameplane as the remainderofthe prong 24, or maybe curved
`or angled upward.
`The pusher 10 may be located directly belowthe driver 8.
`Alternately, the pusher 10 may be positioneddifferently rela-
`tive to the driver 8. The pusher 10 is oriented relative to the
`driver 8 such that the longitudinal centerlines ofthe pusher 10
`and driver 8 are substantially parallel. Alternately, the pusher
`10 and the driver 8 maybe oriented differentlyrelative to one
`another. The pusher10 andthe crossbar 26 ofthe driver 8 may
`each have substantially the same width, but they may have
`different widths if desired. An exemplary pusher 10 may be
`generally elongated in the longitudinal direction, and may be
`thin. The pusher 10 may be stamped froma thinsheet ofmetal
`or other material, or may be otherwise fabricated. The pusher
`10 holds and advances one or more staples 28. The pusher 10
`includes a substantially flat base 30 with one or more tabs 32
`extending upward therefrom, such that the distal end of each
`
`Ethicon Exhibit 2004.010
`Intuitive v. Ethicon
`IPR2018-01247
`
`Ethicon Exhibit 2004.010
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US 7,473,258 B2
`
`ran °
`
`— wa
`
`°
`
`No wa
`
`w 2
`
`3
`tab 32 is located above the base 30 and the proximal end of
`each tab 32 is connected to the base 30. Alternately, the tabs
`32 may be configured differently. The tabs 32 are biased
`upward from the base 30. ‘lhe base 30 may include one or
`more apertures 34 defined therein, where a tab 32 extends
`upward from the proximal end of a corresponding aperture
`34. The use of such apertures 34 allows the tabs 32 to be
`formedbycutting the base 30, suchas bylaser cutting, result-
`ing in an aperture 34 around and undera corresponding tab
`32. However, the apertures 34 need not be present in the base
`30, and the pusher 10 maybe fabricated in any suitable
`manner. Referring also to FIG. 4, acamming bump 36 extends
`downward from the pusher 10 nearthe distal end ofthe pusher
`10. The function of the camming bump 36 is described in
`grealer detail below. The camming bump 36 may be shaped,
`sized and fabricated in any suitable manner. As one example,
`the camming bump 36 maybe created bydimpling the pusher
`10.
`2
`The anvil 14 maybe fixed to the pusher 10. Advanta-
`geously, the anvil 14 is integral with the pusher 10, and 2
`extends from the distal end of the pusher 10. Alternately, the
`anvil 14 may be connected to the pusher 10 in a different way,
`or may be connected to a different part of the effector 6. The
`proximal end of the anvil 14 may be located at the distal end
`of the pusher 10, or at a different location on the pusher 10.
`The anvil 14 maycurve or angle upward [rom the distal end of
`the pusher 10. Alternately, the anvil 14 may be substantially in
`the same plane as the pusher 10. Advantageously, the distal
`end of the anvil 14 is substantially blunt. The anvil 14 may
`include a notch 40 defined in its upper and lateral surfaces,
`wherethe notch 40 is oriented upward andis substantially as
`deep as the thickness of the staple or staples 28. Alternately,
`the notch 40 maybe deeperor shallower, or may be defined in
`a different surface or surfaces of the anvil 14 or oriented
`differently. The notch 40 is substantially as long in the longi-
`tudinal direction as the corresponding dimension ofthe staple
`28, such that the notch 40 holds the staple 28 securely. Alter-
`nately,
`the notch 40 may be dimensioned dillerently. ‘The
`notch 40 holds a staple 28 both as it is being splayed and
`closed, as described in greater detail below.
`Referring also to FIG. 5, a staple 28 is positioneddistal to
`eachtab 32 of the pusher 10, and may be in contact with the
`corresponding tab 32. At least one staple 28 may be config-
`ured substantially as described in U.S. patent application Ser.
`No. 11/093,003, filed on Mar. 28, 2005, which is hereby
`incorporated byreferencein its entirety. Alternately, at least
`one staple 28 maybe sized and shaped in any different and
`suitable manner. As one example, the staple 28 may have a
`curved M- or W-shape. However, the staple 28 may have any
`other suitable shape. ‘The staple 28 may have two tines 42,
`each extending at least partially in the distal direction. ‘The
`tines 42 maybe curved, and may eachhave a shape andradius
`of curvature suchthat the tines 42 are generally not parallel to
`one another. The radius of curvature may be substantially
`coincident with the path of travel of the tines 42 during
`
`closureofthe staple 28. Each tine 42 has an innersurface 43.
`The staple 28 may be substantially bilaterally symmetrical,
`althoughit may be asymmetricalifdesired. The staple 28 may
`bea substantially continuoussolid. As used in this document,
`the term “solid” means that a structure has no slots, holes,
`apertures or other enclosed or bounded openings defined
`therein. However, the staple 28 need not be a substantially
`continuoussolid.
`The distal end of each tine 42 may have a substantially
`pointed or sharpened distal end. However, the distal ends of
`the tines 42 need not be pointed or sharpened,particularly if
`the cross-sectional area of each tine 42 is small. Advanta-
`
`3
`
`ACSo
`
`fsa
`
`a °
`
`in a
`
`Dp2
`
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`4
`geously, each tine 42 has a single distal end that is not bifur-
`cated or otherwise forkedorsplit. However, the distal end of
`al least one tine 42 maybe bifurcated, forked, split or other-
`wise configured. he body ofthe staple 28 extends proxi-
`mally fromthe distal end of one tine 42 and curves or angles
`relative to the longitudinal centerline of the staple 28. This
`curve may extend outward fromthe longitudinal centerline of
`the staple 28, then toward the longitudinal centerline of the
`staple 28. Alternately, the tine 42 maycurve differently. The
`bodyof the staple 28 reaches a peak 44, then extendsdistally
`and toward the longitudinal centerline of the staple 28. The
`badyof the staple 28 then reaches a trough 46, then extends
`proximally and away from the longitudinal centerline of the
`staple to a second peak 44. The bodyofthe staple 28 contin-
`ues distally to form the second tine 42, whichcurvesor angles
`relative to the longitudinal centerline of the staple 28. This
`curve may extend outward fromthe longitudinal centerline of
`the staple 28, then toward the longitudinal centerline of the
`staple 28. The staple 28 endsat the distal end of the second
`tine 42. Alternately, the staple 28 maybe shaped differently.
`For example, the staple 28 may have more than twotines 42.
`A valley 48 is the area on the staple 28 on the other side of the
`staple 28 from a peak 44. For example, where a peak 44 of the
`staple 28 includes a convex curve oriented proximally,
`the
`corresponding valley 48 is a concave curve opening distally.
`Advantageously, the staple 28 is substantially solid.
`‘The staple 28 mayle substantially in a single plane. ‘That
`is, the staple 28 is shaped such that a single plane extends
`through and substantially bisects the entire staple 28. Alter-
`nately, the staple 28 does not lie substantially in a single
`plane. The longitudinal and lateral dimensionsofthe staple
`28 overall may both be substantially larger than the height of
`the staple 28. Alternately, the staple 28 may be sized differ-
`ently.
`Advantageously, the staple 28 may be plastically deform-
`able. Thatis, the staple 28 may undergo a permanent defor-
`mation when subjectedto a stress exceedingits yield value. In
`other words, plastic deformation is deformation that remains
`afier the load that caused il is removed, or that would remain
`if the load were removed.If so, the staple 28 may be fabri-
`cated fromstainless steel, titaniumor any other suitable plas-
`tically-deformable material. Alternately, the staple 28 may be
`elastically deformable. If so, the staple 28 may be fabricated
`from nickel-titanium alloy or any other suitable elastic or
`superelastic material. The staple 28 may be fabricated from a
`single wire or other piece of material, having a rectangular,
`circularor other cross-section. However, the staple 28 may be
`fabricated in any suitable manner. The cross-section of the
`staple 28 maybe substantially constant along the entire staple
`28, or mayvary al diflerentlocations along the staple 28. For
`example, the cross-sectional area of the staple 28 at certain
`locations may be less than at other locations, in order to
`promote bending in those locations having a lesser cross-
`sectional area. The cross-sectional shapeofthe staple 28 may
`be square, rectangular, circular, oval or any other suitable
`shape, and may be substantially constant along the entire
`staple 28 or vary at different locations along the staple 28.
`Referring back to FIGS. 2-3, the splay arm 12 ofthe effec-
`tor 6 may be located directly below the pusher 10. Alternately,
`the splay arm 12 mayhepositioned differently relative to the
`pusher 10. ‘The splay arm 12 is orientedrelative to the pusher
`10 suchthat the longitudinal centerlines of the splay arm 12
`and pusher10 are substantially parallel. Alternately, the splay
`arm 12 and pusher 10 maybe oriented differently relative to
`one another. The splay arm 12 maybe generally elongated in
`the longitudinal direction, and maybethin. The splay arm 12
`may be stamped from a thin sheet of metal or other material,
`
`Ethicon Exhibit 2004.011
`Intuitive v. Ethicon
`IPR2018-01247
`
`Ethicon Exhibit 2004.011
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US 7,473,258 B2
`
`w
`
`ran °
`
`5
`or maybe otherwise fabricated. The splay arm 12 may include
`a longitudinally-extending har 52 located at the proximal end
`ofthe splay ann 12. An aperture 54 may be defined in the
`splay arm 12 al or near the distal end ofthe bar 52, or ala
`different location on the splay arm 12. The aperture 54 may
`extend completely through the splay arm 12, or may simply
`be a recessed area in the upper surface of the splay arm 12.
`Alternately, the aperture 54 maybe omitted. One or more ears
`56 mayextendlaterally from the splay arm 12, each at a
`longitudinal location on the splay arm 12 substantially even
`with the distal end of the aperture 54. Alternately, the ears 56
`maybe located at a different location an the splay arm 12. The
`splay arm 12 maybe forked or otherwise configured at its
`distal end. As one example,the splay arm 12 mayinclude two
`splay fingers 58 at ils distal end. Each splay finger 58 may
`extend distally from a location on the splay arm 12 distal to
`the ears 56 and the aperture 54. Alternately, at least one splay
`finger 58 extends in a differentdirection and/or froma differ-
`ent part of the splay arm 12. Alternately, more than two splay
`fingers 58, or a single splayfinger 58, may be utilized. Each 2
`splay finger 58 may be shaped in any suitable manner. The
`distal end of one splay finger 58 or both splay fingers 58 may
`include a splay tip 60 that is oriented substantially vertically
`or in any other suitable direction. Each splay tip 60 is posi-
`tioned suchthatit can splay a staple 28, as described .in greater
`detail below. The portion ofthe splay finger 58 between the
`splay lip 60 and the remainderofthe splay arm 12 maybe
`shaped and oriented in anysuitable manner. At least one splay
`finger 58 may be curved or angled upwardinthe distal direc-
`tion. Alternately, at least one splay finger 58 maylie in sub-
`stantially the same plane as a remainder of the splay arm 12.
`The splay arm 12 may be biased proximally. Such biasing
`maybe performed in any suitable manner, with any suitable
`structure or mechanism, such as a coil spring, compression
`spring or tension spring.
`Referring to FIG. 2A, an anti-backup rack 16 may be
`positioned belowthe driver 8. Alternately, the anti-hackup
`rack 16 maybe positioned differentlyrelative to the driver8.
`‘The anti-backup rack 16 is oriented relative to the driver 8
`suchthat the longitudinal centerlines of the anti-backup rack
`16 and driver 8 are generally parallel. Alternately, the anti-
`backup rack 16 and driver 8 may be oriented differently
`relative to one another. The anti-backup rack 16 may be
`generally elongated in the longitudinal direction. The anti-
`backup rack 16 may be stamped froma thin sheet of metal or
`other material, or may be otherwise fabricated. The anti-
`backup rack 16 mayinclude a spine 62 that is oriented sub-
`stantially longitudinally, and one or moretines 64 extending
`from the spine 62. Each tine 64 extends in a downward and
`distal direction. Altemately, al least one tine 64 is oriented
`differently. Advantageously, at least one pair of tines 64
`extends fromthe spine 62, where eachtine 64 ina pair extends
`from substantially the same longitudinal position along the
`spine 62, The distal end of eachtine 64 is positioned substan-
`tially proximal to a corresponding staple 28, such that contact
`between thestaple 28 and thedistal end of at least one tine 64
`prevents the staple 28 from backing up,as described in greater
`detail below. Advantagcously, cach tine 64 of a pair contacts
`a different peak 44 of the staple 28.
`Referring to FIGS. 2-4 and6, the uppercase half 18 may be
`shaped in any suitable manner and [abricated from any suil-
`able material. A ramp 76 may be definedin the inner surface
`ofthe upper case half 18, where that ramp is angled or curved
`downward in the distal direction. Alternately, the ramp 76
`need not be defined in the upper case half 18, but may be a
`componentthat is connectedto the upper case half 18 or other
`part ofthe effector 6. Referring also to FIG. 7, the lower case
`
`6
`half 20 maybe shaped in any suitable manner and fabricated
`from anysuitable material. At least one ramp 74 may be
`defined in the lower case half'20, where that rampis angled or
`curved downward in the distal direction. ‘lhe ramp 74 may be
`defined all the way throughthe lower case half 20, or may be
`defined into the lower case half 20 without creating an open-
`ing in the lower case half 20. Advantageously, two ramps 74
`are defined in the lower case half20, one ramp 74 correspond-
`ing to each ear 56 ofthe splay arm 12. Alternately, the ramp 74
`need not be defined in the lower case half 20, but may be a
`componentthat is connected to the lower case half20 or other
`part ofthe cffector 6. The upper case half 18 may be attached
`to the lower case half 20 in any suitable manner. The case
`halves 18, 20 may be referred to collectively as the housing of
`the stapler 2. Advantageously, the housing is 5 millimeters in
`diameter or less. Alternately, the housing may have a larger
`diameter. Alternately, the case halves 18, 20 are each con-
`nected to the handle 4 but not to eachother.
`The handle 4 may include any mechanism, mechanisms,
`structure orstructures configuredto actuate the effector 6. As
`describedlater in this document, the handle 4 may be config-
`ured to control the motion of the driver 8 and pusher 10,
`and/or other components of the effector 6. The handle 4 may
`provide this control in any suitable manner. As one example,
`a cable extending fromthe handle 4 may be connectedto the
`driver 8, and another cable extending from the handle 4 may
`be connected to the pusher 10. As another example, a rod or
`other substantiallyrigid structure extending from the handle
`4 maybe connected to the driver 8, and another rod or other
`substantially rigid structure extending from the handle 4 may
`be connected to the pusher 10. As another example,the driver
`8 and the pusher 10 may be pneumatically coupled, or other-
`wise coupled, to the handle 4. As another example,the proxi-
`mal end of the driver 8 and/or the pusher 10 may extend
`proximally to the handle 4 and coupledirectly to the handle 4.
`Alternately, the driver 8 and pusher 10 maybe controllable in
`a different manner, or maybe passive components. The driver
`8, pusher 10 and/or other componentsofthe effector 6 may be
`biased proximally ordistally as well, or not biased atall.
`The handle 4 may include any suitable mechanism or
`mechanismsthat provide for control ofthe driver 8 and pusher
`10, and may include a source of stored energy for actuating
`the end effector 4. The source of stored energy may be
`mechanical (such as a spring), electrical (such as a battery),
`pneumatic (such as a cylinderofpressurized gas) or any other
`suitable sourceof stored energy. The source ofstored energy,
`its regulation, and its usc in actuating an effector 6 may be as
`described in U.S. patent application Ser. No. 10/392,336,
`filed on Mar. 19, 2003, or U.S. patent application Ser. No.
`11/054,265,filed on Feb. 9, 2005, which are herein incorpo-
`rated by reference in their entirety. The handle 8 mayinstead,
`or also, include a connector or connectors suitable for receiv-
`ing stored energy from an external source, such as a hose
`connectedto a hospital utility source of pressurized gas or of
`vacuum,or an electrical cord connectable to a power source.
`Optionally, the effector 6 may include a cutaway, trough,
`lumen, ring or other feature (not shown)to allow the effector
`6 to follow a guidewireto a treatmentsite. If so, the surgical
`stapler 2 may include a flexible shaft (not shown) that con-
`nects the handle 4 to the effector 6, such that the handle 4
`transmits control input and/or force to the effector 6 via that
`flexible shaft.
`
`Opcration—Staple Deployment
`The operation of the surgical stapler 2 is described with
`regard to a generic surgical procedure. The surgical stapler 2
`maybe usedin the course of anysuitable surgical procedure,
`
`Ethicon Exhibit 2004.012
`Intuitive v. Ethicon
`IPR2018-01247
`
`No wa
`
`3 2
`
`a wa
`
`40
`
`a °
`
`60
`
`Ethicon Exhibit 2004.012
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US 7,473,258 B2
`
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`3
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`7
`whether that surgical procedure is minimally-invasive or
`open. For example, the surgical stapler 2 may be usedto staple
`woundsor incisionsin the skin together, lor cardiac surgery,
`for hernia repair, lor abdominal wall closure, [or anti-reflux or
`otherbariatric procedures, for intestinal repair, for dura mater
`surgery or other brain surgery, for aneurysm closure, for
`anastomosis, or for any other suitable medical use.
`The distal end ofthe effector 6 maybe placed in proximity
`to the tissue to be stapled. For clarity in describing the opera-
`tion of the stapler 2, that tissue is not shown in the figures.
`Referring to FIGS. 2 and 8, at this time the effector 6 may be
`in an initial state. The user then actuates the handle 4 and/or
`other componentof the surgical stapler 2 to begin the deplay-
`ment sequence, As described above, the handle 4 or other
`mechanism controls the motion of the components ofthe
`effector 6 in any suitable manner. First, the pusher 10 is
`advanceddistally, while the splay arm 12 is maintained in
`substantially the same location. Thus, t