USOO7473258B2
`
`(12) United States Patent
`(10) Patent N0.:
`US 7,473,258 32
`Clauson et a].
`
`Jan. 6, 2009(45) Date of Patent:
`
`(54) SURGICAL STAPLER
`
`(75)
`
`Inventors: Luke W. Clauson, Redwood City, CA
`(US); Bryan I). Knodel, Flagstaff, A7.
`(US); Benjamin J. Matthias, San
`Mateo, CA (US); Matthew B. Newell,
`Portola Valley, CA (US)
`
`................ 606/143
`9/1991 Simon et al.
`5,049,152 A *
`2/1992 Green ........................ 606/219
`5,089,009 A *
`3/1992 Storace .
`. 227/19
`5,100,041 A *
`
`5,170,926 A * 12/1992 Ruckdeschel et a1.
`227/177.1
`4/1993 Tayot et 211
`5,201,745 A
`5,207,692 A
`5/1993 Kraus etal.
`
`(21 Appl.No.: 11/672,858
`
`(73
`
`( *
`
`(22
`
`(65
`
`(51
`
`(52
`
`(58
`
`(56
`
`
`
`Assignee: C ardica, Inc., Redwood City, CA (US)
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U,S.C. 154(b) by 34 days.
`
`Filed:
`
`Mar. 8, 2007
`
`Prior Publication Data
`US 2008/0217376 A1
`Sep. 11, 2008
`
`Int. Cl.
`(2006.01)
`A613 17/072
`U.S. Cl.
`...................... 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.
`
`References Cited
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`*
`
`(Continued)
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`FOREIGN PATENT DOCUMENTS
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`(Continued)
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`OTHER PUBLICATIONS
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`“Closure and Assisted-Compression Device Update", Endovascu/ar
`deay. (Apr. 2004:).22.
`
`(Continued)
`
`Primary Examiner7Scott A. Smith
`(74) Attorney, Agent, or FirmiBrian A. Schar
`
`(57)
`
`ABSTRACT
`
`A method for surgically stapling tissue may include providing
`staples in a first configuration, plastically deforming at least
`one staple to a second configuration different from the first
`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 from the first configuration to the second configuration
`may be performed by splaying the 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
`
`lPR2018-01247
`
`Ethicon Exhibit 2004.001
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US 7,473,258 B2
`Page 2
`
`227/108
`
`227/177.1
`
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`
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`7
`7
`
`
`FOREIGN PATENT DOCUMENTS
`
`WO
`wo
`5
`wo
`wo
`
`12,1999
`WO-99/62408
`2,2000
`wo 00/07640
`'
`'
`9/2000
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`9,2000
`wo 00/5622,
`‘
`'
`“
`I
`
`OTHER PUBLICATIONS
`
`“Summaly of Safety and Effectiveness Data (LVS (TM) Vascular
`Closure System)”, (Nov. 3-, 2004)-
`“The EVS(TM) Vascular Closure Systeln by Angiolink”, Business
`Briefing: US Cardiology 2004, (2004)
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`(Oct. 22. 2004).
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`W'l'itten Opinion Of 1118 ISA". PCT/USZOOB/056328. (Jul. 28. 2008).
`“Written Opinion of the International Search Authority”, PCT/
`EEégofi/OSBB’ (313281111208) ,, PCT,US,008,0563,8 Jul ,8
`2008
`temmona em epo“ ’
`/
`2
`/
`2 "x
`'5 5
`)’
`* cited by examiner
`
`Ethicon Exhibit 2004.002
`
`Intuitive v. Ethicon
`
`IPR2018-01247
`
`Ethicon Exhibit 2004.002
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US. Patent
`
`n.aJ
`
`90026,
`
`7f01,
`
`S
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`2
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`w1hoSG
`
`H
`
`Um
`
`Bm0%“fl2,bn.m4,X7E
`
`.mhtE
`
`3o0.M
`
`Intuitive v. Ethicon
`
`IPR2018-01247
`
`Ethicon Exhibit 2004.003
`Intuitive v. Ethicon
`IPR2018-01247
`
`
`

`

`US. Patent
`
`n.aJ
`
`90026,
`
`7f02
`
`S
`
`2
`
`tAw2h.SG
`
`
`H
`
`Um
`
`Bm0%“fl2,bn.m4,X7E
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`.mhtE
`
`4o0.M
`
`Intuitive v. Ethicon
`
`IPR2018-01247
`
`Ethicon Exhibit 2004.004
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US. Patent
`
`Jan. 6, 2009
`
`Sheet 3 of7
`
`US 7,473,258 B2
`
`
`
`FIG.3
`
`(
`2s
`
`
`
`¥‘_\
`
`
`
`
`
`
`58
`
`56
`
`FIG.4
`
`Ethicon Exhibit 2004.005
`
`Intuitive v. Ethicon
`
`lPR2018-01247
`
`Ethicon Exhibit 2004.005
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US. Patent
`
`Jan. 6, 2009
`
`Sheet 4 of7
`
`US 7,473,258 B2
`
`46
`
`\7
`
`48
`
`48
`
`42
`
`42
`
`43
`
`43
`
`FIG. 5
`
`Ethicon Exhibit 2004.006
`
`Intuitive v. Ethicon
`
`lPR2018-01247
`
`Ethicon Exhibit 2004.006
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US. Patent
`
`Jan. 6, 2009
`
`Sheet 5 of7
`
`US 7,473,258 B2
`
`
`
`FIG.6
`
`
`
`FIG.7
`
`Ethicon Exhibit 2004.007
`
`Intuitive v. Ethicon
`
`lPR2018-01247
`
`Ethicon Exhibit 2004.007
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US. Patent
`
`Jan. 6, 2009
`
`Sheet 6 of7
`
`US 7,473,258 B2
`
`
`
`19
`
`FIG.9
`
`Ethicon Exhibit 2004.008
`
`Intuitive v. Ethicon
`
`lPR2018-01247
`
`Ethicon Exhibit 2004.008
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US. Patent
`
`Jan.6,2009
`
`Sheet7of7
`
`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 generally to a surgical stapler
`and a method for surgical stapling.
`
`BACKGROUND
`
`m
`
`Referring to FIG. 1, a surgical stapler 2 includes a handle 4
`connected to an effector 6. Alternately, the surgical stapler 2
`may be configured differently. For examole, the effector 6
`may be indirectly connected to the handle 4 via an intemie-
`diate structure, such as a rigid, articulated or flexible shaft
`(not shown). The handle 4 may have any suitable configura-
`tion. as described in greater detail below. The effector 6 may
`be sized to pass through an access port in a patient for use in
`a minimally-invasive surgical procedure. The effector 6 may
`be sized and shaped to allow it to be inserted through an
`access port in a patient of 5 mm in diameter or less. Alter—
`nately, the effector 6 may be sized and/or shaped differently.
`The effector 6 may be substantially rigid, substantially flex—
`ible, or a combination of both. The handle 4 may include one
`or more triggers, levers, knobs, buttons or other input features
`used to actuate and/or control the effector 6.
`Referring to FIGS. 2-3, the effector 6 may include a driver
`8, a pusher 10, a splay arm 12, an anvil 14, an anti-backup rack
`16, an upper case half 18, and a lower case half 20. The terms
`“upper,” “lower,” “upward,” “downward,” “up.” “down,”
`“below,” “above” and the like are used solely for convenience
`in this document; such terms refer to directions on the printed
`Iv Ji
`, page and do not limit the orientation of the effector 6 in use.
`The effector 6 may include additional, or fewer, components.
`An exemplary driver 8 may be generally elongated in the
`longitudinal direction, and may be thin. The driver 8 may be
`stamped from a thin sheet of metal or other material, or may
`be otherwise fabricated. The driver 8 may include a longitu-
`dinally-extending bar 22 located at the proximal end of the
`driver 8. The driver 8 may be forked or otherwise configured
`at its distal end. As one example, the driver 8 may include two
`prongs 24 at its distal end. The proximal end of each prong 24
`may be connected to a crossbar 26 that in turn is comiected to
`the bar 22. The crossbar 26 may be substantially perpendicu—
`lar to the prongs 24 and to the crossbar 26, or may be oriented
`differently relative to the bar 22. The crossbar 26 may be
`substantially square. However, the crossbar 26 may be rect—
`angular, ovaf, 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. may be utilized.
`Each prong 24 may be shaped in any suitable maimer. The
`distal end of one prong 24 or both prongs 24 may be 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. Altemately, the
`distal end of at least one prong 24 may be substantially in the
`same plane as the remainder ofthe prong 24, or may be curved
`or angled upward.
`The pusher 10 may be located directly below the driver 8.
`Alternately, the pusher 10 may be positioned differently 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 may be oriented differently relative to one
`another. Thepusher10 and the crossbar 26 ofthe driver 8 may
`each have substantially the same width, but they may have
`different widths if desired. A11 exemplary pusher 10 may be
`generally elongated in the longitudinal direction, and may be
`thin. The pusher 10 may be stamped from a thin sheet 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
`
`lPR2018-01247
`
`10
`
`20
`
`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—
`cult. Further, suturing may be impractical or unfeasible in
`certain situations. For example, in a minirnally—invasive sur—
`gical procedure through a small opening (often referred to as
`an access port) in the patient’ s body, that port may not be large
`enough to allow suturing to be performed through it. If the
`port were enlarged to allow suturing. the benefits of mini-
`mally-invasive surgery through a small access port would be
`reduced or eliminated altogether. Indeed. as surgical technol-
`ogy progresses, the size of the access ports required in the
`body to 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 cholecystectorny and inguinal hernia repair.
`When instruments of such small diameter are used, the ports
`in the body through which they are inserted need be only 2-3
`millimeters in diameter as well, resulting in minimal or no ,
`scarring ofthe patient after the procedure is completed. How-
`ever. it is difficult or impossible to perform suturing within the
`patient’s body through ports of such small size.
`
`
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`71G. 1 is a side view of an exemplary surgical stapler.
`41G. 2 is a cutaway perspective view from above of an
`exemplary effector of the surgical stapler of FIG. 1.
`jIG. 2A is the cutaway perspective view of FIG. 2, includ-
`ing an anti-backup rack.
`31G. 3 is a cutaway perspective view from below of an
`exemplary effector of the surgical stapler of FIG. 1.
`3IG. 4 is a cutaway side view of an exemplary effector of
`the surgical stapler of FIG. 1.
`41G. Sis a top view ofan exemolary staple deployedby the
`surgical stapler of FIG. 1.
`:10. 6 is a bottom View of an exemplary upper case half of
`the surgical stapler of FIG. 1.
`31G. 7 is a perspective view 0 'the distal end of an exem—
`plary effector of the surgical stapler of FIG. 1, without the
`up aer case half, showing an exemplary lower case half.
`:10. 8 is a cutaway perspective View of an exemplary
`effector ofthe surgical stapler of 3IG. 1, where the effector is
`in an initial configuration.
`31G. 9 is a perspective view 0 'the distal end of an exem—
`plary effector of the surgical stapler of FIG. 1.
`:10. 10 is a cutaway perspective view of an exemplary
`effector ofthe surgical stapler of 71G. 1, where the effector is
`in a second configuration.
`31G. 11 is a cutaway perspective View of an exemplary
`effector of the surgical stapler of :IG. 1, where the effector is
`in a third configuration.
`The use of the same reference symbols in different figures
`inc icates similar or identical items.
`
`
`
`
`
`40
`
`m v.
`
`60
`
`Ethicon Exhibit 2004.010
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US 7,473,258 B2
`
`3
`tab 32 is located above the base 30 and the proximal end of
`each tab 32 is connected to the base 30. Altemately, the tabs
`32 may be configured differently. The tabs 32 are biased
`upward from the base 30. The 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
`formed by cutting the base 30, such as by laser cutting, result-
`ing in an aperture 34 around and under a corresponding tab
`32. However, the apertures 34 need not be present in the base
`30. and the pusher 10 may be fabricated in any suitable
`manner. Referring also to FIG. 4, a camming bump 3 6 extends
`downward from the pusher 10 near the distal end ofthe pusher
`10. The function of the camming bump 36 is described in
`greater detail below. The camming bump 36 may be shaped,
`sized and fabricated in any suitable manner. As one example,
`the camming bump 36 may be created by dimpling the pusher
`10.
`The anvil 14 may be fixed to the pusher 10. Advanta-
`geously, the anvil 14 is integral with the pusher 10, and
`extends from the distal end of the pusher 10. Altemately, the
`anvil 14 may be c01mected 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 may curve or angle upward from the distal end of
`the pusher 1 0. 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,
`where the notch 40 is oriented upward and is substantially as
`deep as the thickness of the staple or staples 28. Altemately,
`the notch 40 may be deeper or 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 differently. 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 positioned distal to
`each tab 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 US. patent application Ser.
`No. 11/093,003, filed 011 Mar. 28, 2005, which is hereby
`incorporated by reference in its entirety. Alternatcly, at least
`one staple 28 may be 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 may be curved, and may each have a shape and radius
`of curvature such that 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
`
`closure ofthe staple 28. Each tine 42 has an iimer surface 43.
`The staple 28 may be substantially bilaterally symmetrical,
`although it may be asymmetrical ifdesired. The staple 28 may
`be a substantially continuous solid. 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
`continuous solid.
`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-
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`geously, each tine 42 has a single distal end that is not bifur—
`cated or otherwise forked or split. However, the distal end of
`at least one line 42 may be bifurcated, forked, split or other—
`wise configured. The body of the staple 28 extends proxi—
`mally from the distal end of one tine 42 and curves or angles
`relative to the longitudinal centerline of the staple 28. This
`curve may extend outward from the longitudinal centerline of
`the staple 28, then toward the longitudinal centerline of the
`staple 28. Altemately. the tine 42 may curve differently. The
`body of the staple 28 reaches a peak 44, then extends distally
`and toward the longitudinal centerline of the staple 28. The
`body of 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 body of the staple 28 contin—
`ues distally to form the second line 42, which curves or angles
`relative to the longitudinal centerline of the staple 28. This
`curve may extend outward from the longitudinal centerline of
`the staple 28, then toward the longitudinal centerline of he
`staple 28. The staple 28 ends at the distal end of the second
`tine 42. Altemately, the staple 28 may be shaped differently.
`For example, the staple 28 may have more than two tines 42.
`A valley 48 is the area on the staple 28 on the other side of he
`staple 28 from a peak 44. For example, where a peak 44 of he
`staple 28 includes a convex curve oriented proximally, he
`corresponding valley 48 is a concave curve opening distally.
`Advantageously, the staple 28 is substantially solid.
`The staple 28 may lie substantially in a single plane. Tiat
`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 dimensions of the staole
`28 overall may both be substantially larger than the height of
`the staple 28. Alternately, the staple 28 may be sized differ-
`ently.
`Advantageou sly, the staple 28 may be plastically deform—
`able. That is, the staple 28 may undergo a permanent defor—
`mation when subjected to a stress exceeding its yieldvalue. in
`other words, plastic deformation is deformation that remains
`after the load that caused it is removed, or that would remain
`if the load were removed. If so, the staple 28 may be fabri-
`cated from stainless steel, titanium or any other suitable plas-
`tically-deformable material. Altemately, 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,
`circular or other cross —section. However, the staple 28 may be
`fabricated in any suitable manner. The cross—section of the
`staple 28 may be substantially constant along the entire staple
`28, or may vary at different locations 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 shape of the 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 1 0. Alternately,
`the splay arm 12 may be positioned differently relative to the
`pusher 10. The splay arm 12 is oriented relative to the pusher
`10 such that the longitudinal centerlines of the splay arm 12
`and pusher 10 are substantially parallel. Altemately, the splay
`ann 12 and pusher 10 may be oriented differently relative to
`one another. The splay arm 12 may be generally elongated in
`the longitudinal direction. and may be thin. The splay arm 12
`may be stamped from a thin sheet of metal or other material,
`
`Ethicon Exhibit 2004.011
`
`Intuitive v. Ethicon
`
`lPR2018-01247
`
`Ethicon Exhibit 2004.011
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US 7,473,258 B2
`
`5
`or may be otherwise fabricated. The splay arm 12 may include
`a longitudinally—extending bar 52 located at the proximal end
`of the splay arm 12. An aperture 54 may be delined in the
`splay arm 12 at or near the distal end of the bar 52, or at a
`different location on the splay arm 12. The aperture 54 may
`extend completely through the splay ann 12, or may simply
`be a recessed area in the upper surface of the splay arm 12.
`Alternately, the aperture 54 may be omitted. One or more ears
`56 may extend laterally 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
`may be located at a different location on the splay arm 12. The
`splay arm 12 may be forked or otherwise configured at its
`distal end. As one example, the splay arm 12 may include two
`splay lingers 58 at its distal end. Each splay linger 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 different direction and/or from a differ-
`ent part of the splay arm 12. Alternately, more than two splay
`fingers 58, or a single splay finger 58, may be utilized. Each
`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 such that it can splay a staple 28, as described in greater
`detail below. The portion of the splay linger 58 between the
`splay tip 60 and the remainder of the splay arm 12 may be
`shaped and oriented in any suitable manner. At least one splay
`finger 58 may be curved or angled upward in the distal direc-
`tion. Alternately, at least one splay finger 58 may lie in sub-
`stantially the same plane as a remainder of the splay arm 12.
`The splay arm 12 may be biased proximally. Such biasing
`may be performed in any suitable mamrer, 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 below the driver 8. Alternately, the anti—backup
`rack 16 may be positioned dill‘erently relative to the driver 8.
`The anti—backup rack 16 is oriented relative to the driver 8
`such that 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 from a thin sheet of metal or
`other material, or may be otherwise fabricated. The anti-
`backup rack 16 may include a spine 62 that is oriented sub—
`stantially longitudinally, and one or more tines 64 extending
`from the spine 62. Each line 64 extends in a downward and
`distal direction. Altemately, at least one tine 64 is oriented
`differently. Advantageously, at least one pair of tines 64
`extends from the spine 62, where each tine 64 in a pair extends
`from substantially the same longitudinal position along the
`spine 62. The distal end of each tine 64 is positioned substan-
`tially proximal to a corresponding staple 28, such that contact
`between the staple 28 and the distal end of at least one tine 64
`prevents the staple 28 from backing up, as described in greater
`detail below. Advantageously, each tine 64 of a pair contacts
`a different peak 44 of the staple 28.
`Referring to FIGS. 2—4 and 6, the uppercase half18 may be
`shaped in any suitable manner and fabricated from any suit—
`able material. A ramp 76 may be defined in the inner surface
`ofthe ripper 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 ripper case half 18, but may be a
`component that is connected to the upper case half 18 or other
`part ofthe effector 6. Referring also to FIG. 7. the lower case
`
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`half 20 may be shaped in any suitable manner and fabricated
`from any suitable material. At least one ramp 74 may be
`delined in the lower case hall'20, where that ramp is angled or
`curved downward in the distal direction. The ramp 74 may be
`defined all the way through the 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 car 56 ofthe splay arm 12. Altemately, the ramp 74
`need not be defined in the lower case half 20, but may be a
`component that is connected to the lower case half20 or other
`part ofthe effector 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 each other.
`The handle 4 may include any mechanism, mechanisms,
`structure or structures configured to actuate the effector 6. As
`described later in this document, the handle 4 may be config—
`ured to control the motion of the driver 8 and pusher 1 0,
`and/or other components of the effector 6. The handle 4 may
`provide this control in any suitable mamier. As one example,
`a cable extending from the handle 4 may be connected to 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 substantially rigid structure extending from the handle
`4 may be connected to the driver 8, and another rod or other
`substantially rigid structure extending from the handle 4 may
`be connected to the pusher 1 0. 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 couple directly to the handle 4.
`Alternately, the driver 8 and pusher 10 may be controllable in
`a different mamrer, or may be passive components. The driver
`8, pusher l 0 and/or other components ofthe effector 6 may be
`biased proximally or distally as well, or not biased at all.
`The handle 4 may include any suitable mechanism or
`mechanisms that 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 cylinder ofpres surized gas) or any other
`suitable source of stored energy. The source of stored energy,
`its regulation, and its use in actuating an effector 6 may be as
`described in US. patent application Ser. No. 10/392,336,
`filed on Mar. 19, 2003, or US patent application Ser. No.
`11/054,265, filed on Feb. 9, 2005, which are herein incorpo—
`rated by reference irr their entirety. The handle 8 may instead,
`or also, include a connector or connectors suitable for receiv-
`ing stored energy from an external source, such as a hose
`connected to 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 guidewire to a treatment site. 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.
`
`Operation Staple Deployment
`The operation of the surgical stapler 2 is described with
`regard to a generic surgical procedure. The surgical stapler 2
`may be used in the course of any suitable surgical procedure,
`
`Ethicon Exhibit 2004.012
`
`Intuitive v. Ethicon
`
`lPR2018-01247
`
`Ethicon Exhibit 2004.012
`Intuitive v. Ethicon
`IPR2018-01247
`
`

`

`US 7,473,258 B2
`
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`whether that surgical procedure is minimally—inva sive or
`open. For example, the surgical stapler 2 may be used to staple
`wounds or incisions in the skin together, for cardiac surgery,
`for hernia repair, for abdominal wall closure, for anti—reflux or
`other bariatric 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 may be 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 c