[19]
`United States Patent
`Schulze et al.
`
`
`[54] SURGICAL INSTRUMENT
`
`[75]
`
`Inventors: Dale R. Schulze, Lebanon; Joseph
`Paraschace, Cincinnati; William D.
`Fox, New Richmond,all of Ohio;
`.
`.
`:
`Michael E. Setser, Burlington, Ky.;
`|
`Kenneth S. Wales, Mason, Ohio; Mark
`S. Zeiner, Milford, Ohio
`;
`;
`[73] Assignee: Ethicon Endo-Surgery, inc.,
`Cincinnati, Ohio
`
`[21] Appl. No.: 359,107
`122] Filed:
`Dec. 19, 1994
`. A61B 17/068
`[51]
`Int. CLS ...
` .
`[52] U.S. Cl......
`wes 227/476.1; 227/180.1;
`227/19
`
`sasseeseesse 22119, 180.1,
`227/175.1, 176.1, 179.1
`
`[58] Field of Search.
`
`......
`
`[56]
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`Exami
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`Examiner—Scott A. Smi
`Primary
`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 ancther
`embodiment, the instrument includes a flexible neck for
`articulating a surgical head assembly with respect to the
`shaft of the instrument. 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
`
`10
`
`ISRGETH-30007 7333
`
`Ethicon Exhibit 2011.001
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.001
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`5,632,432
`Page 2Snem
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`ISRGETH-30007 7334
`
`Ethicon Exhibit 2011.002
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.002
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

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

`

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

`

`Peereneehg——oadeeeectedhaeWRTe,we(retirementeeeeepinecheenhertrerenbaiatalaeerePyrenean—CS
`
`U.S. Patent
`
`May27, 1997
`
`Sheet 3 of 43
`
`Pol
`
`I]
`
`
`SRarEEan=—nyyeeegeeogrecapgreeomeA
`
`
`5,632,432
`
`ISRGETH-30007 7337
`
`Ethicon Exhibit 2011.005
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.005
`Intuitive v. Ethicon
`IPR2019-00880
`
`
`
`
`

`

`U.S. Patent
`
`May 27, 1997
`
`Sheet 4 of 43
`
`5,632,432
`
`
`
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`
` =13514413614gila148145
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`138130so| 144
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`
`ISRGETH-300077338
`
`Ethicon Exhibit 2011.006
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.006
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`May27, 1997
`
`Sheet 5 of 43
`
`U.S. Patent
`
`5,632,432
`
`ISRGETH-300077339
`
`Ethicon Exhibit 2011.007
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.007
`Intuitive v. Ethicon
`IPR2019-00880
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`

`

`May27, 1997
`
`Sheet 6 of 43
`
`U.S. Patent
`
`5,632,432
`
`ISRGETH-300077340
`
`Ethicon Exhibit 2011.008
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.008
`Intuitive v. Ethicon
`IPR2019-00880
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`

`

`US. Patent
`
`May27, 1997
`
`Sheet 7 of 43
`
`5,632,432
`
`194
`
`FIG-8
`
`192
`
`ISRGETH-300077341
`
`Ethicon Exhibit 2011.009
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.009
`Intuitive v. Ethicon
`IPR2019-00880
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`

`

`May27, 1997
`
`Sheet 8 of 43
`
`5,632,432
`
`U.S. Patent
`
`FIG-9
`
`FIG-9a
`
`ISRGETH-300077342
`
`Ethicon Exhibit 2011.010
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.010
`Intuitive v. Ethicon
`IPR2019-00880
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`

`

`U.S. Patent
`
`May 27, 1997
`
`Sheet 9 of 43
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`eriOr!
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`5,632,432
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`Ethicon Exhibit 2011.011
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`FIG-IlO
`
`May27, 1997
`
`162
`
`Sheet 10 of 43
`
`5,632,432
`
`FIG-If
`
`166
`
`'700
`
`ISRGETH-300077344
`
`Ethicon Exhibit 2011.012
`Intuitive v. Ethicon
`IPR2019-00880
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`Ethicon Exhibit 2011.012
`Intuitive v. Ethicon
`IPR2019-00880
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`

`

`U.S. Patent
`
`May27, 1997
`
`Sheet 11 of 43
`
`5,632,432
`
`WAANa
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`Ethicon Exhibit 2011.013
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.013
`Intuitive v. Ethicon
`IPR2019-00880
`
`
`
`
`

`

`U.S. Patent
`
`May 27, 1997
`
`Sheet 12 of 43
`
`5,632,432
`
`3!
`
`10
`
`FIG-I2
`
`ISRGETH-300077346
`
`Ethicon Exhibit 2011.014
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.014
`Intuitive v. Ethicon
`IPR2019-00880
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`

`

`May27, 1997
`
`Sheet 13 of 43
`
`USS. Patent
`
`5,632,432
`
`ISRGETH-300077347
`
`Ethicon Exhibit 2011.015
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.015
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`U.S. Patent
`
`May27, 1997
`
`Sheet 14 of 43
`
`og,
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`4091O¢6;oeaeWWEelieeMsr=te)Py\h2eaeace.él*OSIofwf/(6e[4!
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`Ethicon Exhibit 2011.016
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.016
`Intuitive v. Ethicon
`IPR2019-00880
`
`
`

`

`5,632,432
`
`FIG-I7a
`
`FIG-i6a
`
`USS. Patent
`
`May27, 1997
`
`Sheet 15 of 43
`
`44
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`
`47
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`
`
`ISRGETH-300077349
`
`Ethicon Exhibit 2011.017
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.017
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`USS. Patent
`
`May27, 1997
`
`Sheet 16 of 43
`
`5,632,432
`
`
`
`FIG-18
`
`94
`
`FIG-i8a
`
`ISRGETH-300077350
`
`Ethicon Exhibit 2011.018
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.018
`Intuitive v. Ethicon
`IPR2019-00880
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`

`

`U.S. Patent
`
`FIG-19
`
`May27, 1997
`
`Sheet 17 of 43
`
`5,632,432
`
`
`
`
`
`FIG-19a
`
`ISRGETH-300077351
`
`Ethicon Exhibit 2011.019
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.019
`Intuitive v. Ethicon
`IPR2019-00880
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`

`

`May 27, 1997
`
`Sheet 18 of 43
`
`5,632,432
`
`U.S. Patent q0¢
`
`|
`
`ISRGETH-30007 7352
`
`Ethicon Exhibit 2011.020
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.020
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`U.S. Patent
`
`May 27, 1997
`
`Sheet 19 of 43
`
`5,632,432
`
`
`
`
`
` iJPePOhtrere|
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`
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`
`ISRGETH-30007 7353
`
`Ethicon Exhibit 2011.021
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.021
`Intuitive v. Ethicon
`IPR2019-00880
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`
`

`

`May27, 1997
`
`Sheet 20 of 43
`
`USS. Patent
`
`5,632,432
`
`ISRGETH-300077354
`
`Ethicon Exhibit 2011.022
`Intuitive v. Ethicon
`IPR2019-00880
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`Ethicon Exhibit 2011.022
`Intuitive v. Ethicon
`IPR2019-00880
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`

`

`May 27, 1997
`
`Sheet 21 of 43
`
`USS. Patent
`
`5,632,432
`
`ISRGETH-300077355
`
`Ethicon Exhibit 2011.023
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.023
`Intuitive v. Ethicon
`IPR2019-00880
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`

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

`5,632,432 FIG.26
`
`US. Patent
`
`PROXIMAL
`
`May27, 1997
`
`Sheet 23 of 43
`
`ISRGETH-300077357
`
`Ethicon Exhibit 2011.025
`Intuitive v. Ethicon
`IPR2019-00880
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`Ethicon Exhibit 2011.025
`Intuitive v. Ethicon
`IPR2019-00880
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`

`May27, 1997
`
`Sheet 24 of 43
`
`5,632,432
`
`US. Patent
`
`DISTOL
`
`PROXIMAL FIG.27
`
`ISRGETH-300077358
`
`Ethicon Exhibit 2011.026
`Intuitive v. Ethicon
`IPR2019-00880
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`Ethicon Exhibit 2011.026
`Intuitive v. Ethicon
`IPR2019-00880
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`

`May 27, 1997
`
`Sheet 25 of 43
`
`U.S. Patent
`
`5,632,432
`
`FIG. 28B
`
`ISRGETH-300077359
`
`Ethicon Exhibit 2011.027
`Intuitive v. Ethicon
`IPR2019-00880
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`Ethicon Exhibit 2011.027
`Intuitive v. Ethicon
`IPR2019-00880
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`

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

`

`US. Patent
`
`May 27, 1997
`
`Sheet 27 of 43
`
`5,632,432
`
`Sheet4]eneene
` 614
`CSSSbhhe.hhehhod
`
`
`FIG. 29C
`
`ISRGETH-300077361
`
`Ethicon Exhibit 2011.029
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.029
`Intuitive v. Ethicon
`IPR2019-00880
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`

`U.S. Patent
`
`May 27, 1997
`
`Sheet 28 of 43
`
`5,632,432
`
`FIG. 30A
`
`ISRGETH-300077362
`
`Ethicon Exhibit 2011.030
`Intuitive v. Ethicon
`IPR2019-00880
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`Ethicon Exhibit 2011.030
`Intuitive v. Ethicon
`IPR2019-00880
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`

`

`USS. Patent
`
`May27, 1997
`
`Sheet 29 of 43
`
`5,632,432
`
`
`
`
`”LS :
`4GVR
`
`
`
`g
`
`fy
`
`FIG. 31B
`
`ISRGETH-300077363
`
`Ethicon Exhibit 2011.031
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.031
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

` R2
`ROTATE “a Ri
`
`
`
`
`
`
`
`FIG.382A
`
`U.S. Patent
`
`May 27, 1997
`
`Sheet 30 of 43
`
`5,632,432
`
`FIG.32B
`
`ISRGETH-300077364
`
`Ethicon Exhibit 2011.032
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.032
`Intuitive v. Ethicon
`IPR2019-00880
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`

`

`U.S. Patent
`
`May 27, 1997
`
`Sheet 31 of 43
`
`5,632,432
`
`——fDG
`
`o=_ FIG.34C
`
`ao
`
`oS
`
`ISRGETH-300077365
`
`Ethicon Exhibit 2011.033
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.033
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`US. Patent
`
`May27, 1997
`
`Sheet 32 of 43
`
`5,632,432
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`ISRGETH-300077366
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`Ethicon Exhibit 2011.034
`Intuitive v. Ethicon
`IPR2019-00880
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`Ethicon Exhibit 2011.034
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`May27, 1997
`
`Sheet 33 of 43
`
`U.S. Patent
`
`5,632,432
`
`ISRGETH-300077367
`
`Ethicon Exhibit 2011.035
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.035
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`i
`jl
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`MTUUOUO
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`1272
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`
`U.S. Patent
`
`May 27, 1997
`
`Sheet 34 of 43
`
`5,632,432
`
`FIG.36
`
`ISRGETH-300077368
`
`Ethicon Exhibit 2011.036
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.036
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`5,632,432
`
`<l
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`ISRGETH-300077369
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`Ethicon Exhibit 2011.037
`Intuitive v. Ethicon
`IPR2019-00880
`
`U.S. Patent
`
`1269
`
`May27, 1997 Sheet 35 of 43
`
`
`Ethicon Exhibit 2011.037
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`USS. Patent
`
`May 27, 1997
`
`Sheet 36 of 43
`
`FIG.41 FIG.39
`
`5,632,432
`
`64
`
`1266
`
`ISRGETH-300077370
`
`Ethicon Exhibit 2011.038
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.038
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`May27, 1997
`
`Sheet 37 of 43
`
`U.S. Patent
`
`5,632,432
`
`ISRGETH-300077371
`
`Ethicon Exhibit 2011.039
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.039
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`U.S. Patent
`
`May27, 1997
`
`Sheet 38 of 43
`
`3,632,432
`
`JerSIs
`
`ISRGETH-30007 7372
`
`Ethicon Exhibit 2011.040
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.040
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

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`May 27, 1997
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`Sheet 39 of 43
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`3,632,432
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`VerDis
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`ISRGETH-30007 7373
`
`Ethicon Exhibit 2011.041
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.041
`Intuitive v. Ethicon
`IPR2019-00880
`
`
`
`
`
`
`

`

`May 27, 1997
`
`Sheet 40 of 43
`
`U.S. Patent
`
`5,632,432
`
`ISRGETH-30007 7374
`
`Ethicon Exhibit 2011.042
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.042
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`U.S. Patent
`
`May 27, 1997
`
`Sheet 41 of 43
`
`5,632,432
`
`
`
`FIG. 48
`
`
`
`ISRGETH-300077375
`
`Ethicon Exhibit 2011.043
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.043
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`U.S. Patent
`
`May 27, 1997
`
`FIG.49
`
`Sheet 42 of 43
`
`5,632,432
`
`5Gea1380b
`
`FIG.49B
`
`FRsss va FIG.49
`
`ISRGETH-300077376
`
`Ethicon Exhibit 2011.044
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.044
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`U.S. Patent
`
`May 27, 1997
`
`Sheet 43 of 43
`
`5,632,432
`
`sss
`
`1470
`
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`
`1468
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`
`FIG. 50
`
`ISRGETH-300077377
`
`Ethicon Exhibit 2011.045
`Intuitive v. Ethicon
`IPR2019-00880
`
`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 itrelates 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 andtissue, and may
`include a safety wedge/sled 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 cholecystectomies, 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 cannvla is inserted into the skin to access
`the body cavity, by using the obturator tip to penetrate the
`skin. After penetration, the obturator is removed and the
`trocar cannula remainsin 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 ETHICON ENDO-
`SURGERY, 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
`whenloaded, the articulating head on the instrument tends
`to move. This movementis usually a combination of piece
`part deflection and slop (or backlash) in the articulation
`mechanism. High loads on the distal tip of the instrument
`(c.g., tissue clamping andstaple 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
`meansfor both positioning and locking 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 manifestsitself as
`a magnification of tolerances or clearancesin 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 offer the advantageof a precise,tight bend,this
`
`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 knownin
`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 cutting andstapling 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
`cartridgeat the initial and final positionsof 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 andfiring tissue is the
`limitation of the human hand. Therefore, it is difficult 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 maystill be uncertain about the amount oftissue
`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, through an
`endoscopically placed camera, the amountoftissue clamped
`between the jaws. Also, distal contact helps preventtissue
`from slipping out of the jaws during a clamping sequence.
`Additionally. it would be advantageousto 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 headof an articulating surgical instrument in an
`articulated position.
`Finally, it would be useful to provide an articulation
`connection havinga fiexible neck connecting the rigid shaft
`of the surgical instrument to a surgical head assembly,
`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
`
`65
`
`ISRGETH-300077378
`
`Ethicon Exhibit 2011.046
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.046
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`5,632,432
`
`4
`3
`the stapling function. The stapling mechanism contains a
`may also be used in non-endoscopic procedures, and pro-
`trigger mechanism which contains a double trigger feature.
`vides both stapling and cutting to the surgical site. It is
`One of the triggers causes clamping of tissue. The other
`desired to have tissue clamped between the jaws of the
`trigger causesfiring of the staples and actuation ofthe knife.
`stapling mechanism,andit is also desired that the stapling
`mechanism accomplish this clamping and then firing in a 5 Thus, clamping and firing are accomplished separately.
`two-part, sequenced operation.
`Because the system contains a safety mechanism, there
`It is further an object to provide a stapling and clamping
`Cannotbefiring of staples before there is full clamping of
`mechanism whereby the clamping mechanism causes the_tissue. In this mechanism,stapling is accomplished in any
`stapling mechanism to be put into position for firing.
`rotatable position, as soon as tissue has been clamped. Yet,
`This novel concept also necessarily requires that one is 1° the clamping trigger locks in Position so that it will not
`prevented from actuating the firing mechanism before
` i2advertently spring open during use of the firingtrigger.
`clamping is accomplished. Therefore, it is further an object
`In ‘one of the embodiments described herein, there is
`to preventfiring of the stapling mechanism before the entire©contained in the endoscopic stapling mechanism a double
`clamping procedure is completed orif a cartridge is missing
`clutch mechanism which allows the user to derive benefits
`or has been previously fired.
`15 from both forward and reverse motion of the clamping and.
`It is further an object to provide a rotational mechanism
`firing trigger8. During forward motion of the trigger:8. there
`which accommodates stapling and cutting endoscopically.
`is clamping and then firing. During reverse motion,there is
`:
`.
`.
`.
`the capability of overriding any jams encountered by the
`it is further an object to provide a closure mechanism so
`stapling mechanism, andthenallowingthestapled tissue to
`that the closure mechanism is not able to inadvertently 5,
`be removed from the stapling site.
`spring open before the firing mechanism has been fully
`Furthermore, in this invention there is the capability of
`actuated. It is yet another object to provide a mechanism
`having distal clamping of tissue, wherein relatively larger
`which allows forward and reverse motion of a clamping
`tissue is held within a larger size device. After this clamping,
`trigger such that forward motion causes clamping, and then
`there is then proximal contact of the stapling and closure
`permits stapling, and reverse motion permits the jaws of the
`means and thereafter, similar proximal contact of the knife
`mechanism to be opened, by reversing the functions of the
`mechanism. Thus, while it is easily ascertainable how much
`clamping mechanism.
`tissue is clamped between the clamping mechanisms,it is
`Yet another object is to provide a mechanism for remotely
`also easy to determine whether clamping and stapling have
`articulating the clamping and stapling portion of the
`been properly accomplished.
`instrument, before, during, and/or after completion of the
`Tn a highly preferred embodiment of the invention, a
`surgical procedure.
`mechanism for remotely articulating the stapling and clamp-
`It is an object to provide a closure mechanism in a surgical
`ing portion of the surgical instrumentis provided, including
`stapler which accomplishes clamping of the tissue to be
`an articulating coupling device, which may be, for example,
`stapled in a direction opposite that of stapling, that is, from
`a ball-in-socket type coupling, a knuckle joint, a flexible
`the distal toward the proximal endof the stapler. In this way,
`neck, a flexible band or strap, a hinge and pin coupling, a
`proper amounts of tissue may be adequately clamped, and
`rack and pinion, or other coupling device. In a mosthighly
`then stapled.
`preferred embodiment, a joy stick mounted proximately to
`It is yet another object of the invention to provide a safety
`the handle allows rotational motion of the joy stick to be
`feature for retracting or otherwise shielding the knife of the
`translated into articulational motion of the stapling and
`instrument from the patient and operator prior to and/or
`clamping portion aboutthe aforementioned articulating cou-
`following the cutting sequence. It is a further object of the
`pling.
`invention to provide an instrument which can cut and staple
`Tn another highly preferred embodimentof the invention,
`in an axis whichis not colinear with the shaft, to provide a
`the knife mechanism retracts within the staple cartridge at
`self-contained cartridge/wedge assembly to be used in con-
`the completion of the cutting sequence, and in a most highly
`junction with the handle, to provide lower cost materials of
`preferred embodiment. separates from the knife/wedge
`construction, such asplastic, for use in wedges for only one
`driver and is retained, retracted, in the staple cartridge,
`firing. and to keep the head length of the cartridge to a
`which is removed and disposed of, to be replaced by a new
`minimum.
`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 encasesthe firing %0
`invention, an improved locking mechanism for redirecting
`wedges and knife, suchthat the knife and wedges do not
`or eliminating deflection in the headof articulating surgical
`return to their start positions at the endof a firing sequence.
`instruments is provided. The locking mechanism may be
`It
`is another object of the invention to provide an
`independently controlled with respect to the articulating
`improved device for locking the head of an articulating 5;
`mechanism, or operationally connected to the articulating
`surgical instrument.
`mechanism. The locking mechanism locks the head of the
`Finally, it is an object of the invention to provide an
`assemblyin an articulated position wheneverthe articulation
`improved articulation connection comprising a flexible
`control is not being used. That is, the articulation lock is
`neck, allowing for a relatively large bend radius and con-
`¢q generally engaged, disengages when the articulation control
`sequent smooth transmission of forces around the bend.
`is being used,thereby allowingarticulation of the head, and
`These and other objects of the invention are described in
`relocks the head in its new articulated position when the
`an improved surgical instrument, such as an endoscopic
`articulation step is completed.
`stapling mechanism which is capable of clamping, stapling
`Finally, in yet another highly preferred embodimentof the
`and cutting tissue. The stapling mechanism utilizes a surgi-
`cal stapling cartridge which contains at least two double 65 invention,a flexible neck connection is providedfor articu-
`tows 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
`knife means to divide the two double rowsof staples during
`
`ISRGETH-300077379
`
`Ethicon Exhibit 2011.047
`Intuitive v. Ethicon
`IPR2019-00880
`
`Ethicon Exhibit 2011.047
`Intuitive v. Ethicon
`IPR2019-00880
`
`

`

`FIG. 1 is a side elevational view of an endoscopic linear
`stapling and cutting mechanism ofthe present invention;
`FIG. 12 is an exploded perspective view of the instrament
`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;
`FIG.27 is an overhead view of another preferred articu-
`FIGS.5 and6are isolated side and top viewsof thefiring
`lation locking device of the present invention.
`trigger of the invention;
`FIG. 28A is an isometric view of another preferred
`FIGS.8 and 8a are side and bottom isolated views of a
`articulation locking device of the present invention.
`typical cartridge of the invention;
`FIG. 28B is a top plan view of the device of FIG. 28A.
`FIGS.9 and 9a are side and bottom isolated viewsof the
`FIG. 29 is an isometric, exploded view of another pre-
`anvil of the invention;
`ferred articulation locking device of the present invention.
`FIGS. 9b, 9c and 9d are side operational views of the
`FIG.294Ais a top plan view of the distal end of the device
`interaction between the stapler shaft, the cartridge. and the
`of FIG. 29, showing the head in a locked unarticulated
`anvil closing mechanism;
`position.
`FIG. 10 is a side isolated view of the knife means with a
`FIG.29B is a top plan view of the distal end of the device
`lockout notch;
`of FIG. 29, showing the head in an articulated position, and
`FIG. 10a is a side view of an alternate knife means with
`the locking device in an unlocked position.
`no lockout notch;
`FIG. 29C is a top plan view of the distal end of the devices
`FIG. 11 is a side isolated view of the lockout member
`of FIG. 29, showing the head in a locked articulated posi-
`tion.
`contained in the cartridge of FIGS. 8 and 8a.
`FIGS. 1a and 116 show the motion of the lockout
`member of FIG. 11 when moved by the knife means of FIG.
`10 in the cartridge of FIG. 8;
`FIG,12 is a side elevational view of an alternate preferred
`embodiment of the stapler of the present invention;
`FIG. 12a is an exploded perspective view of the instru-
`ment of FIG. 12
`
`15
`
`45
`
`FIG.13 is a cross-sectional view ofthe 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 side view of the trigger return linkage of the
`alternate embodimentof this invention;
`FIGS. 16 and 16a are isolated views of the front toggle
`link as seen in FIG. 13 of the present invention;
`FIGS. 17 and 17a are isolated plan views of the rear
`toggle link as also described in FIG