i||||||l||||||||||||||||ll||||||||||
`U3005632432A
`
`Umted States Patent
`[19]
`
`Schulze et a].
`
`[11] Patent Number:
`[45] Date of Patent:
`
`5,632,432
`May 27, 1997
`
`
`
`128/4
`6/1965 Stokes ...............
`3,190,286
`6/1966 Tsepelve et a1.
`.. 128/8
`3,256,875
`
`.. 95/11
`9’19“ 6055319
`32701641
`
`..
`ao
`,
`,
`7:;58.7411
`1:;£32:
`:5?“
`gigglggg
`
`3/1971 Bazell eta].
`.. 128/6
`3,572,325
`
`.. 128/4
`6/1971 Tahakashi.
`3,583,393
`
`214/1 BC
`6/1971 Pauly
`3,587.872
`
`1/1974 Hall
`.. 128/4
`3,788,303
`
`3/1974 Fukaumi
`128/6
`3,799.151
`7/1975 Mitsui ..
`.. 128/4
`3,892,228
`3,998,216 12/1976 Hosono
`.. 128/6
`4,054,128 10/1977 Seufen eta].
`.. 128/4
`
`‘
`
`4,078,555
`
`3/1978 Takahaski
`(Llst continued on next page.)
`Primary Examinerfigcott A. Smith
`Attorney, Agent, or Firm—Paul A. Coletti
`
`[57]
`
`ABSTRACT
`
`A surgical instrument for performing endoscopic surgical
`procedures. In one embodiment. the instrument includes a
`knife that remains unexposed until initiation of a cutting
`sequence. and returns to an unexposed position at the
`conclusion of the cutting sequence, minimizing the risk of
`injury to the person handling the instrument. In another
`embodiment. the instrument includes a flexible neck for
`articulating a surgical head assembly with respect to the
`shaft of the instmment. In another embodiment, a device for
`locking the articulated head at an angle of articulation is
`provided. In yet another embodiment, a mechanism for
`opening and closing an anvil assembly is disclosed.
`
`2 Claims, 43 Drawing Sheets
`
`[54] SURGICAL INSTRUMENT
`
`[75]
`
`Inventors: Dale R. Schulze. Lebanon; Joseph
`.
`.
`_
`Paraschac. Cincinnati; William D.
`FMoi’fiéwERlscflimfiffig’fgmg ,
`‘
`S
`’
`gt
`’.
`3’"
`KennF‘h SW31”, M1101" 011101 Mark
`5- 1911191“, Milford» 01110
`.
`’
`[73] Asngnee: Ethicon Endo-Surgery, Inc.
`Cincinnati, Ohio
`
`[21] APPI- No.2 359,107
`[22] Filed:
`Dec. 19, 1994
`[51]
`Int. CL“
`[52] US. Cl.
`
` '
`
`.. A61B 17/068
`227/1761; 227/1801;
`227/19
`
`227/19. 180.1,
`227 175.1, 176.1. 179.1
`
`[58] Field of Search
`
`[56]
`
`.
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`3/1956 Morse ..
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`2,885,686
`5/1959 Giaimo .
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`2,975,785
`3/1961 Sheldon
`
`123/6
`3,060,972
`10/1962 Sheldon
`133/120
`
`3,071,161
`1/1963 Ulrich ..
`133/120
`
`.. 128/4
`3,090,378
`5/1963 Sheldon
`
`
`3,162,214 12/1964 Bazinet
`138/120
`
`
`
`
`
`4"":-
`
`
`
`
`.._-r
`1 u- .5.‘
`
`-Kfifl‘h
`
`
`ISRGETH-300077333
`
`Ethicon Exhibit 2011.001
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.001
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`5,632,432
`____.—__._____________—_______~
`Page 2
`
`us. PATENT DOCUMENTS
`
`3/1973 Tanaka
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`,
`5/1980 Takahashl
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`
`4/1981 Bclyamn e131,
`74/469
`4,259,876
`. 128/6
`6/1981 Tsukaya
`4,273,111
`414/733
`8/1981 Vertut..
`4,283,165
`
`9,1981 Siegmund
`_ 128,6
`4,290,421
`
`. 128/6
`9/1982 Hcsono
`4,347,837
`9/1982 01161116141
`. 128/4
`4,351,323
`
`2/1984 05mm ______
`1 123/4
`4,432,349
`
`9/1984 Noiles et a1.
`. 128/305
`4,473,077
`11/1984 Yamaka etal.
`. 128/4
`4,483,326
`
`74/469
`1/1985 Larson etal,
`4,494,417
`
`. 128/4
`3/1985 Takayama
`4,503,842
`
`.128/4
`4,557,254 12/1985 Yamaguchi
`
`. 128/4
`4,593,679
`6/1986 Collins .....
`8/1986 Coma et 11.
`.
`. 128/305
`4,606,343
`
`9/1986 Rmbfuss et a].
`.
`2917/1801
`4,608,981
`
`
`- 128/4
`4,688,555
`8/1987 Wardle .....
`- 123/4
`4,700,693 10/1987 149914
`4318407
`“1983 011191113 --
`~- 123/4
`417211099
`“1933 Ch‘kam --
`-- 1234
`4,726,355
`2/1988 0km ..
`.. 128/4
`
`
`
`6/1988 Brewer.
`..128/4
`4,753,223
`
`7/1988 Barker et al.
`227/19
`4,754,909
`8/1988 Lia et a1.
`. 128/4
`4,762,118
`
`8/1988 4111681111141.
`. 128/4
`4,762,119
`9/1988 Silversteinetal
`128/661.08
`4,770,185
`. 128/4
`9/1988 Suzuki e1 31.
`4,773,395
`4,779,612 10/1988 Kishi
`.. 128/6
`4,787,369 11/1988 AJde,DIetal.
`. 128/4
`4,790,294 12/1988 41118111111131.
`, 123/4
`4,794,912
`1/1989 Lia ..................
`.. 128/4
`4,796,607
`1/1989 14111611116131.
`. 128/4
`4,805,596
`2/1989 Hatou'
`.............
`.. 128/4
`
`. 414/7
`4,815,911
`3/1989 Bengtson e1a1.
`
`
`
`
`
`5/1989 Umeda
`4,834,069
`128/4
`4,873,965 10/1989 13161611
`128/6
`
`4,905,666
`3/1990 Fukuda
`.. 128/4
`
`,
`,
`osonowskl eta].
`128/6
`4911148
`3,1990 3
`.
`
`,
`,
`Jegmluld ..
`128/4
`4919112
`4,1990 S.
`.
`
`8/1990 Ople e1a1.
`4,947,827
`128/4
`.
`.
`
`4,977,790 12/1990 N1sh1 11111.
`.
`. 74/479
`
`449961974
`3/1991 C1916
`123/4
`
`510024041
`3/1991 Chm“?
`123/4
`... 128/4
`5,005,558
`4/1991 Aomou '..............
`
`5,007,406
`4/1991 Takahashl e111,.
`128/4
`. 60/581
`5014515
`5/1991 Krauter ......
`5,014,685
`5/1991 Takahashi
`128/4
`5,025,804
`6/1991 Kondo
`128/4
`5,042,707
`8/1991 Taheri
`606/213
`5,108,819
`4/1992 Wollschlager eta].
`
`6/1992 Adair .........
`5,125,395
`403,291
`5,143,475
`9/1992 Chikama
`
`. 128/66203
`5,158,086 10/1992 Brown 6121.
`
`5,167,221
`12/1992 Chikama
`128/4
`5,168,864 12/1992 Shockey.
`128/4
`5,174,276 12/1992 Crockard
`128/4
`
`5,174,277 12/1992 Matsumaru
`128/4
`5176126
`1/1993 Chikama
`12m
`
`5’178’129
`1/1993 cum
`128“
`’
`’
`.
`.a
`5479935
`“1993 MW?»
`128"
`511951963
`34993 L‘mdql‘ls‘ 9‘ 31-1
`-604/95
`
`606/205
`5,391,180
`2/1995 Tovey et 231-
`3/1995 Kobayasln etal.
`5,394,864
`128/4
`
`......
`.- 606/207
`5,411,519
`5/1995 Tovey et a1.
`5,417,203
`5/1995 Tovey eta].
`128/4
`5,447,265
`9/1995 Vldal eta].
`22711801
`5,478,003 12/1995 Green et 41.
`227/180.1
`5,485,947
`1/1996 Olson eta],
`227/180.1
`5,489,058
`2/1996 Plyley etal,
`227/19
`
`
`
`ISRGETH-300077334
`
`Ethicon Exhibit 2011.002
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.002
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 1 of 43
`
`5,632,432
`
`FlG-/
`
`ISRGETH-300077335
`
`Ethicon Exhibit 2011.003
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.003
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 2 of 43
`
`5,632,432
`
`
`
`ISRGETH-300077336
`
`Ethicon Exhibit 2011.004
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.004
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 3 of 43
`
`5,632,432
`
`
`
`6‘
`
`ISRGETH-300077337
`
`Ethicon Exhibit 2011.005
`
`Intuitive v. Ethicon
`
`IPR2019-00880
`
`Ethicon Exhibit 2011.005
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`2ay 27, 1997
`
`Sheet 4 of 43
`
`5,632,432
`
`
`
`.t
`
`
`
`
`
`fifl:"
` =‘u'inn—T,II !r
`fl "gag-51%“%5H6
`
`”0 I34
`
`’32-?
`
`FIG-2b
`
`ISRGETH-300077338
`
`Ethicon Exhibit 2011.006
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`I44
`
`!~
`
`
`
`s\="'\\=\
`
`Ethicon Exhibit 2011.006
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 5 of 43
`
`5,632,432
`
`§
`
`‘\
`
`‘
`
`0)
`‘9 g
`
`'
`
`.
`
`\
`____________ \\
`\.......__M 'g
`
`‘
`.J
`
`
`
`
` \
`
`9
`\.
`
`5/”. ~
`
`\..../
`m
`‘3
`g
`
`{HO1/1,.
`
`
`
`
`9
`
`124
`
`3a
`
`ISRGETH-300077339
`
`Ethicon Exhibit 2011.007
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.007
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 6 of 43
`
`5,632,432
`
`
`
`ISRGETH-300077340
`
`Ethicon Exhibit 2011.008
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.008
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 7 0f 43
`
`5,632,432
`
`I92
`
`194
`
`FIG-80
`
`FIG-8
`
`ISRGETH-300077341
`
`Ethicon Exhibit 2011.009
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.009
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 8 of 43
`
`5,632,432
`
`FIG-9
`
`I27!)
`
`I42
`
`FIG-90
`
`ISRGETH-300077342
`
`Ethicon Exhibit 2011.010
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.010
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 9 of 43
`
`5,632,432
`
`
`
`ISRGETH-300077343
`
`.mhtE
`
`Emnn0'
`
`flvmbe
`..m.wm
`xfll
`
`
`
`0E92.1 108new“mm
`
`
`
`
`
`1n0
`
`Ethicon Exhibit 2011.011
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 10 of 43
`
`5,632,432
`
`FIG-ll
`
`[62
`
`FIG-IO
`
`I66
`
`I700
`
`ISRGETH-300077344
`
`Ethicon Exhibit 2011.012
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.012
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 11 of 43
`
`5,632,432
`
`
`
`1"!“
`IV”,
`[Ina-fl
`kR‘--L
`“"'y
`,a'
`
`11‘
`
`I
`
`fl
`
` ‘aA"E"“
`
`0Q
`
`0.2‘
`
`ETQE
`
`ISRGETH-300077345
`
`Ethicon Exhibit 2011.013
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.013
`Intuitive v. Ethicon
`IPR2019-00880
`
`
`
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 12 of 43
`
`5,632,432
`
`FIG-l2
`
`ISRGETH-300077346
`
`Ethicon Exhibit 2011.014
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.014
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 13 of 43
`
`5,632,432
`
`
`
`ISRGETH-300077347
`
`Ethicon Exhibit 2011.015
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.015
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 14 of 43
`
`5,632,432
`
`609On
`
`MTGE
`
`.v
`
`mm{uwm-win]!!!“IJIIIlIIIHIIIIHIHIJIHInflfiwaHuflflflnmmmn‘wilHillIIlillw
`--Fa-.u:nlté00M
`_rallIIIIII‘I.I|I¢I.III
`
`E:-lI.nllllllllEIJu.
`
`
`
`3
`
`ON
`
`.\\m~NM.VbOwmm.OW
`
`ISRGETH-300077348
`
`Ethicon Exhibit 2011.016
`
`Intuitive v. Ethicon
`
`IPR2019-00880
`
`Ethicon Exhibit 2011.016
`Intuitive v. Ethicon
`IPR2019-00880
`
`
`
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 15 of 43
`
`5,632,432
`
`VV 4
`
`7
`
`FIG-l5
`
`
`I%
`
`FIG-160
`
`I20
`
`ISRGETH-300077349
`
`Ethicon Exhibit 2011.017
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.017
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 16 of 43
`
`5,632,432
`
`
`
`ISRGETH-300077350
`
`Ethicon Exhibit 2011.018
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.018
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 17 of 43
`
`5,632,432
`
`
`
`
`
`FIG-190
`
`ISRGETH-300077351
`
`Ethicon Exhibit 2011.019
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.019
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 18 of 43
`
`5,632,432
`
`
`
`ali’QW/I!aii’l’l’r”””'d.I
`
`
`
`
`
`ISRGETH-300077352
`
`.mhtE
`
`Emnnol
`
`flvmbemwm
`xfll
`
`
`
`0E92.1 2080.c%“mm
`
`
`
`
`
`ono
`
`Ethicon Exhibit 2011.020
`Intuitive v. Ethicon
`IPR2019-00880
`
`
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 19 of 43
`
`5,632,432
`
`aoown
`
`“...1.‘-i‘
`
`ISRGETH-300077353
`
`Ethicon Exhibit 2011.021
`
`Intuitive v. Ethicon
`
`IPR2019-00880
`
`Ethicon Exhibit 2011.021
`Intuitive v. Ethicon
`IPR2019-00880
`
`
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 20 of 43
`
`5,632,432
`
`
`
`ISRGETH-300077354
`
`Ethicon Exhibit 2011.022
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.022
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 21 of 43
`
`5,632,432
`
`
`
`ISRGETH-300077355
`
`.mhtE
`
`Emnn0|
`
`flvmbe
`..m.wm
`xfll
`
`
`
`0E92.1 208new“mm
`
`
`
`
`
`3n0
`
`Ethicon Exhibit 2011.023
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 22 of 43
`
`5,632,432
`
`206a
`
`ISRGETH-300077356
`
`Ethicon Exhibit 2011.024
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.024
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 23 of 43
`
`5,632,432
`
` FIG.26
`
`PHOXIMAL
`
`ISRGETH-300077357
`
`Ethicon Exhibit 2011.025
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.025
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 24 of 43
`
`5,632,432
`
`DISTOL
`
`PROXIMAL FIG.27
`
`ISRGETH-300077358
`
`Ethicon Exhibit 2011.026
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.026
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 25 of 43
`
`5,632,432
`
`
`
`ISRGETH-300077359
`
`Ethicon Exhibit 2011.027
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.027
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 26 of 43
`
`5,632,432
`
`650
`
`ISRGETH-300077360
`
`Ethicon Exhibit 2011.028
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.028
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 27 of 43
`
`5,632,432
`
`606 E
`
`FIG. 29A
`
` “\\‘\\\“““‘
`
`
`Ill,“
`
`
`s12
`
`
`
`614
`
`I: v
`
`.
`5
`3 El
`5l
`5I
`
`FIG. 290
`
`ISRGETH-300077361
`
`Ethicon Exhibit 2011.029
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.029
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`~Q’A
`‘s
`
`..‘
`
`V ‘
`
`G
`
`708!)
`
`US. Patent
`
`May 27, 1997
`
`Sheet 23 of 43
`
`5,632,432
`
`’
`rV
`
`5’GI
`
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`Ethicon Exhibit 2011.030
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.030
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 29 of 43
`
`5,632,432
`
`
`
`3;W/s
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`714D
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`
`ISRGETH-300077363
`
`Ethicon Exhibit 2011.031
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.031
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 30 of 43
`
`5,632,432
`
`
`ROTATE
`
`
`H2
`
`
`HOTATE
`
`
`
`
`
`FIG.32A
`
`FIG.32B
`
`ISRGETH-300077364
`
`Ethicon Exhibit 2011.032
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.032
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 31 of 43
`
`5,632,432
`
`QI
`
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`O...
`
` FIG.34C
`
`ISRGETH-300077365
`
`Ethicon Exhibit 2011.033
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.033
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 32 of 43
`
`5,632,432
`
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`ISRGETH-300077366
`
`Ethicon Exhibit 2011.034
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.034
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 33 of 43
`
`5,632,432
`
`
`
`
`
`FIG.35A
`
`ISRGETH-300077367
`
`Ethicon Exhibit 2011.035
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.035
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 34 of 43
`
`5,632,432
`
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`ISRGETH-300077368
`
`Ethicon Exhibit 2011.036
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.036
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 35 of 43
`
`5,632,432
`
`
`
`FIG.36A
`
`1269
`
`1269
` FIG.37
`
`ISRGETH-300077369
`
`Ethicon Exhibit 2011.037
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.037
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 36 of 43
`
`5,632,432
`
`FIG.39
`
`1284
`
`1265
`
`FIG.41
`
`ISRGETH-300077370
`
`Ethicon Exhibit 2011.038
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.038
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 37 of 43
`
`5,632,432
`
`
`
`ISRGETH-300077371
`
`Ethicon Exhibit 2011.039
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.039
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 38 of 43
`
`5,632,432
`
`.OE
`
`Omv
`
`ISRGETH-300077372
`
`Ethicon Exhibit 2011.040
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.040
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 39 of 43
`
`5,632,432
`
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`Ethicon Exhibit 2011.041
`Intuitive v. Ethicon
`IPR2019-00880
`
`
`
`
`
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 40 of 43
`
`5,632,432
`
`mom.
`
`ISRGETH-300077374
`
`Ethicon Exhibit 2011.042
`
`Intuitive v. Ethicon
`
`IPR2019-00880
`
`Ethicon Exhibit 2011.042
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 41 of 43
`
`5,632,432
`
`
`
`ISRGETH-300077375
`
`Ethicon Exhibit 2011.043
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.043
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 42 of 43
`
`5,632,432
`
`mmv
`
`OE
`
`ISRGETH-300077376
`
`Ethicon Exhibit 2011.044
`
`Intuitive v. Ethicon
`
`IPR2019-00880
`
`Ethicon Exhibit 2011.044
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May 27, 1997
`
`Sheet 43 of 43
`
`5,632,432
`
`
`
`ISRGETH-300077377
`
`Ethicon Exhibit 2011.045
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.045
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`5,632,432
`
`1
`SURGICAL INSTRUMENT
`
`FIELD OF THE INVENTION
`
`This invention relates generally to medical engineering,
`and more specifically it relates to laparoscopic or endoscopic
`surgery. Most specifically, it relates to a surgical instrument
`which may be articulating. having improved articulation
`capability.
`including an articulation lock and improved
`articulation connections, may be capable of performing
`clamping. closures and cutting of lumen and tissue. and may
`include a safety wedgdsled that provides a safety for knife
`protection once a cutting sequence is completed This is
`accomplished in a mechanism which can be used
`endoscopically. that is through a trocar cannula or alone.
`through an incision.
`BACKGROUND OF THE INVENTION
`
`In recent years surgery has markedly advanced through
`the performance of laparoscopic and endoscopic surgical
`procedures such as cholecystectorm‘es. gastrostomies.
`appendectomies, and hernia repair. Also, the application of
`endoscopic surgical stapling and suturing instruments has
`been provided in cardiovascular and pulmonary surgery, as
`well as operative inventions in the gastrointestinal tract.
`Such endoscopic instruments are capable of providing
`hemostasis and also of cutting tissue. This reduces operating
`and recuperation time. These stapling procedures are accom-
`plished through a trocar assembly. which is a surgical
`instrument used to puncture a body cavity. The trocar
`contains a sharpened obturator tip and a trocar tube or
`cannula. The trocar cannula is inserted into the skin to access
`the body cavity. by using the obturator tip to penetrate the
`skin. After penetration. the obtnrator is removed and the
`trocar cannula remains in the body. It is through this cannula
`that surgical
`instruments are placed. Specifically.
`it is
`through this trocar cannula that surgical stapling instruments
`with cutting mechanisms are placed. One such trocar is the
`Endopath.
`trocar manufactured by ETI-HCON ENDO-
`SU'RGERY, Cincinnati. Ohio.
`Nonetheless. certain deficiencies in current concepts for
`endosurgical stapling, cutting, clip applying, and grasping
`mechanisms have been recognized. One perceived defi-
`ciency in current surgical articulating instruments is that
`when loaded. the articulating head on the instrument tends
`to move. This movement is usually a combination of piece
`part deflection and slop (or backlash) in the articulation
`mechanism. High loads on the distal tip of the instrument
`(e.g.. tissue clamping and staple firing) are reflected through
`the articulation device into the articulation control near the
`handle and can move (or rotate) the articulation control
`mechanism. In the past. articulation joints were designed
`with the articulation device performing double duty as the
`means for both positioning and locln'ng the articulated head
`of the instrument.
`
`An examination of the force application points for the
`load (tip of the instrument) and the articulation device (near
`the articulation joint) reveals a mechanical disadvantage for
`the articulating device. This disadvantage manifests itself as
`a magnification of tolerances or clearances in the articulating
`device. resulting in significant head movements.
`the rigid
`In existing articulating surgical instruments,
`shaft of the instrument is sometimes pivotally connected to
`the surgical head of the instrument with a pivot mount. such
`as a pin. hinge. or other joint mechanism. While such
`mechanisms otfer the advantage of a precise. tight bend. this
`
`10
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`15
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`20
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`25
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`30
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`45
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`50
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`55
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`60
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`65
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`2
`same advantage creates a perceived disadvantage. in that
`increased transmission force may be required in order to
`drive a surgical tool, such as a knife. around a tight bend,
`which force is magnified as the angle of articulation
`increases.
`
`Wedge sled and knife assemblies are generally known in
`the art. In general. however. such assemblies are not self-
`contained within the staple cartridge, rely on more expen-
`sive metal. as opposed to plastic wedges, present problems
`of curling and stapling in an axis which is not colinear with
`the shaft. present technical difficulty associated with incor-
`porating a spent cartridge lockout in an articulating joint. do
`not provide a new knife for each firing. and may not
`completely contain the sharp edge of the knife within the
`cartridge at the initial and final positions of the linear cutting
`procedure. creating the potential for injury to the user.
`A design criteria in creating a system containing two
`separate mechanisms for clamping and firing tissue is the
`limitation of the human hand. Therefore. it is diflicult to
`properly and conveniently position a pair of triggers or a
`pushbutton mechanism coupled with a trigger mechanism.
`Thus.
`there has been little focus or incentive to create
`stapling mechanisms whereby the user is capable of oper—
`ating a stapler with two strokes. unless both can be accom-
`plished in a one-handed operation without moving that hand
`from the handle of the instrument.
`Naturally. it would be desirable to be able to perform
`these functions in a fully rotational system. This simply
`allows the user to obtain virtually any angle of approach to
`the surgical site without having to contort the arm of wrist
`in order to adequately approach the subject.
`Furthermore. it would be advantageous to provide the
`capability to remotely articulate the surgical. e.g.. clamping
`and stapling end of the instrument. such that the angular
`orientation of the end of the instrument may be adjusted
`even after the instrument has been inserted through the
`cannula.
`
`It is also desirable to have distal contact of the stapling
`jaws. and then proximal clamping. “Distal contact” means
`that the distal or far end of the anvil seats first on the gap
`spacing pin or cartridge. Without such distal contact, the
`surgeon may still be uncertain about the amount of tissue
`clamped. and therefore the firing force necessary to fire the
`mechanism. In this way. once distal contact is effectuated.
`the surgeon realizes and can actually visualize. flirough an
`endoscoplcally placed camera. the amount oftissue clamped
`between the jaws. Also. distal contact helps prevent tissue
`from slipping out of the jaws during a clamping sequence.
`Additionally. it would be advantageous to provide a knife
`assembly that included a safety feature. whereby following
`a cutting sequence. the knife retracts or otherwise is shielded
`from the operator of the instrument. reducing the likelihood
`of an inadvertent cutting of the patient or the operator.
`Also. it would be highly desireable to provide a device for
`locking the head of an articulating stn'gical instrument in an
`articulated position.
`Finally. it would be useful to provide an articulation
`connection having a flexible neck connecting the rigid shaft
`of the surgical instrument to a surgical head as sembly,
`providing for a smoothly radiused bend. allowing smoother
`transmission of force around the bend than is possible with
`sharper bends achieved through an articulation joint.
`SUMMARY OF THE INVENTION
`
`It is an object of the invention to provide a stapling
`mechanism which is able to be used endoscopically. and
`
`ISRGETH-300077378
`
`Ethicon Exhibit 2011.046
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.046
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`5,632,432
`
`10
`
`15
`
`20
`
`4
`the stapling function. The stapling mechanism contains a
`trigger mechanism which contains a double trigger feature.
`One of the triggers causes clamping of tissue. The other
`trigger causes firing of the staples and actuation of the knife.
`Thus, clamping and firing are accomplished separately.
`Because the system contains a safety mechanism, there
`cannot be firing of staples before there is full clamping of
`tissue. In this mechanism, stapling is accomplished in any
`rotatable position, as soon as tissue has been clamped. Yet,
`the clamping trigger locks in position so that it will not
`inadvertently spring open during use of the firing trigger.
`In one of the embodiments described herein. there is
`contained in the endoscopic stapling mechanism a double
`clutch mechanism which allows the user to derive benefits
`from both forward and reverse motion of the clamping and
`firing triggers. During forward motion of the triggers. there
`is clamping and then firing. During reverse motion. there is
`the capability of overriding any jams encountered by the
`stapling mechanism, and then allowng the stapled tissue to
`be removed from the stapling site.
`Furthermore, in this invention there is the capability of
`having distal clamping of tissue, wherein relatively larger
`tissue is held within a larger size device. After this clamping,
`there is then proximal contact of the stapling and closure
`means and thereafter. similar proximal contact of the knife
`mechanism. Thus, while it is easily ascertajnable how much
`tissue is clamped between the clamping mechanisms. it is
`also easy to determine whether clamping and stapling have
`been properly accomplished.
`In a highly preferred embodiment of the invention, a
`mechanism for remotely articulating the stapling and clamp-
`ing portion of the surgical instrument is provided, including
`an articulating coupling device, which may be. for example.
`a ball-in-socket type coupling. a knuckle joint, a flexible
`neck, a flexible band or strap, a hinge and pin coupling, a
`rack and pinion, or other coupling device. In a most highly
`preferred embodiment, a joy stick mounted proximately to
`the handle allows rotational motion of the joy stick to be
`translated into articulational motion of the stapling and
`clamping portion about the aforementioned articulating cou-
`pling.
`In another highly preferred embodiment of the invention,
`the knife mechanism retracts within the staple cartridge at
`the completion of the cutting sequence, and in a most highly
`preferred embodiment. separates from the knife/wedge
`driver and is retained. retracted, in the staple cartridge,
`which is removed and disposed of, to be replaced by a new
`staple cartridge having a new knife, which may be driven by
`It is a further object of the invention to provide a dispos-
`the same knife/wedge that remains in the instrument.
`In yet another highly preferred embodiment of the
`able cartridge assembly which completely encases the firing 50
`invention, an improved locking mechanism for redirecting
`wedges and_knife. such‘that the krufe and wedges do not
`or eliminating deflection in the head of articulating surgical
`return to their start posrtrons at the end of a firing sequence.
`instruments is provided. The locking mechanism may be
`It
`is another object of the invention to provide an
`improved device for 1‘39ng the head 0f 3-11 articulating 55 independently controlled with respect to the articulating
`surgical instrument.
`mechanism, or operationally connected to the articulating
`Finally. it is an object of the invention to provide an
`mechanism. The locking mechanism locks the head of the
`improved articulation connection comprising a flexible
`assembly in an articulated position whenever the articulation
`neck, allowing for a relatively large bend radius and con-
`control is not being used. That is, the articulation lock is
`sequent smooth transmission of forces around the bend.
`50 generally engaged, disengages when the articulation control
`These and other objects of the invention are described in
`is being used, thereby allowing articulation 0f the head. 311d
`an improved surgical instrument, such as an endoscopic
`relocks the head in its new articulated position when the
`stapling mechanism which is capable of clamping, stapling
`articulation step is completed.
`and cutting tissue. The stapling mechanism utilizes a snrgi-
`Finally. in yet another highly preferred embodiment of the
`cal stapling cartridge which contains at least two double 65 invention. a flexible neck connection is provided for articu-
`rows of staples. The stapling cartridge also provides for
`lating a surgical head assembly with respect to a rigid shaft
`to which the head assembly is mounted. The flexible neck
`lmife means to divide the two double rows of staples during
`
`3
`may also be used in non-endoscopic procedures, and pro-
`vides both stapling and cutting to the surgical site. It is
`desired to have tissue clamped between the jaws of the
`stapling mechanism, and it is also desired that the stapling
`mechanism accomplish this clamping and then firing in a
`two-part, sequenced operation.
`It is further an object to provide a stapling and clamping
`mechanism whereby the clamping mechanism causes the
`stapling mechanism to be put into position for firing.
`This novel concept also necessarily requires that one is
`prevented from actuating the firing mechanism before
`clamping is accomplished. Therefore, it is further an object
`to prevent firing of the stapling mechanism before the entire
`clamping procedure is completed or if a cartridge is missing
`or has been previously fired.
`It is further an object to provide a rotational mechanism
`which accommodates stapling and cutting endoscopically.
`It is further an object to provide a closure mechanism so
`that the closure mechanism is not able to inadvertently
`spring open before the firing mechanism has been fully
`actuated. It is yet another object to provide a mechanism
`which allows forward and reverse motion of a clamping
`trigger such that forward motion causes clamping. and then
`permits stapling. and reverse motion permits the jaws of the
`mechanism to be opened, by reversing the functions of the
`clamping mechanism.
`Yet another object is to provide a mechanism for remotely
`articulating the clamping and stapling portion of the
`instrument. before. during. and/or after completion of the
`surgical procedure.
`It is an object to provide a closure mechanism in a surgical
`stapler which accomplishes clamping of the tissue to be
`stapled in a direction opposite that of stapling, that is, from
`the distal toward the proximal end of the stapler. In this way,
`proper amounts of tissue may be adequately clamped, and
`then stapled.
`It is yet another object of the invention to provide a safety
`feature for retracting or otherwise shielding the knife of the
`instrument from the patient and operator prior to and/or
`following the cutting sequence. It is a further object of the
`invention to provide an instrument which can cut and staple
`in an axis which is not colinear with the shaft, to provide a
`self-contained cartridge/wedge assembly to be used in con-
`junction with the handle. to provide lower cost materials of
`construction. such as plastic, for use in wedges for only one
`firing, and to keep the head length of the cartridge to a
`minimum.
`
`30
`
`35
`
`40
`
`45
`
`ISRGETH-300077379
`
`Ethicon Exhibit 2011.047
`
`Intuitive v. Ethicon
`
`lPR2019-00880
`
`Ethicon Exhibit 2011.047
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`5 632,432
`
`5
`may be a flexible material with a plurality of ribs therein,
`which may be articulated with push/pull techniques, or may
`comprise a pre—articulated neck that assumes a curve as it is
`advanced through a linear shafi.
`These and other objects of the invention will be better
`understood from the following attached Detailed Descrip—
`tion of the Drawings, when taken in conjunction with the
`Detailed Description of the Invention.
`
`DETAILED DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a side elevational View of an endoscopic linear
`stapling and cutting mechanism of the present invention;
`FIG. 1a is an exploded perspective view of the instrument
`of FIG. 1;
`FIGS. 2a and 2b are cross-sectional views of the view of
`FIG. 1;
`FIGS. 3 and 3a are individual and closeup views of the
`closure trigger of the present invention;
`FIGS. 4 and 7 are operational views of the closure trigger
`and toggle linkage of the invention;
`FIGS. 5 and 6 are isolated side and top views of the firing
`trigger of the invention;
`FIGS. 8 and 8a are side and bottom isolated views of a
`typical cartridge of the invention;
`FIGS. 9 and 9a are side and bottom isolated views of the
`anvil of the invention;
`FIGS. 9b. 9c and 9d are side operational views of the
`interaction between the stapler shaft. the cartridge, and the
`anvil closing mechanism;
`FIG. 10 is a side isolated view of the knife means with a
`lockout notch;
`FIG. 10a is a side View of an alternate knife means with
`no lockout notch;
`FIG. 11 is a side isolated View of the lockout member
`contained in the cartridge of FIGS. 8 and 8a.
`FIGS. 11:: and 1117 show the motion of the lockout
`member of FIG. 11 when moved by the knife means of FIG.
`10in the cartridge of FIG. 8;
`FIG. 12 is a side elevational view of an alternate preferred
`embodiment of the stapla of the present invention;
`FIG. 12a is an exploded perspective view of the instru-
`ment of FIG. 12
`
`FIG. 13 is a cross-sectional View of the stapler of FIG. 12;
`FIG. 14 is a side View of the closing trigger plate of the
`embodiment as described in FIGS. 12 and 13;
`FIG. 15 is a side View of the firing trigger as seen in FIG.
`13 of the present invention;
`FIG. 15a is a