-1-
`
`Smith & Nephew Ex. 1071
`IPR Petition - USP 9,295,482
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 1 of 44
`
`US 2004/0133276 A1
`
`24
`
`Obtain
`Measurement of
`Target Joint
`
`25
`
`,
`
`Generate Model
`Representation of
`Target Joint
`
`25
`
`Projected Model
`Representation
`of Target Joint
`
`32
`
`
`
`
`
`, Select Suitable Joint
`Replacement Implant
`50
`
`
`
`-2-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 2 0f 44
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`US 2004/0133276 A1
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`42
`
`. Obtain
`Measurement of
`Target Joint
`
`43
`
`Generate Model
`Representation of
`Target Joint
`
`44
`
`Projected Model
`Representation
`of Target Joint
`40
`
`38
`
`Design Suitable Joint
`Replacement Implant
`
`-3-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 3 of 44
`
`US 2004/0133276 A1
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`-4-
`
`

`
`Patent Application Publication
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`Jul. 8, 2004 Sheet 4 of 44
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`US 2004/0133276 A1
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`-5-
`
`

`
`Patent Application Publication
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`Jul. 8, 2004 Sheet 5 of 44
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`US 2004/0133276 A1
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`-6-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 6 of 44
`
`US 2004/0133276 A1
`
`65
`
`66
`
`, __ .. ‘ \
`Optional \
`‘ 61
`,4I
`\ 2:»?
`
`Obtain
`Measurement of
`Target Joint
`60
`
`
`Measure Joint Defect
`
`Identify Device
`Suitable to
`Repair Defect
`
`57
`
`(fptional ‘
`
`38
`
`
`
`
`
`Select Device to
`Repair Defect
`90
`
`'
`
`
`
`-7-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 7 Of 44
`
`US 2004/0133276 A1
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`76.
`
`Obtain
`
`Measurement of
`
`Target Joint
`
`77
`
`"Measure Joint Defect
`
`78
`
`Identify Device
`Suitable to
`
`Repair Defect
`80
`
`39
`
`Manufacture Device to
`Repair Defect
`
`-8-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 8 of 44
`
`US 2004/0133276 A1
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`104
`
`102
`
`/00
`
`106
`
`FIG. 8A
`
`c
`
`D
`
`E
`
`106
`
`P ’/ 100
`
`
`
`E
`
`L
`
`L2
`
`108
`
`c
`
`D
`
`w
`
`FIG. 8B
`
`-9-
`
`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 9 of 44
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`US 2004/0133276 A1
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`L
`
`t1
`
`/100
`
`102
`
`FIG. 8C
`
`/100
`
`102
`
`FIG. 8D
`
`/100
`
`102
`
`FIG. 8E
`
`-10-
`
`-10-
`
`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 10 of 44
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`US 2004/0133276 A1
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`108
`102 /
`*~~I hz
`
`/
`
`110
`
`100
`
`l
`
`T
`
`104
`
`FIG. 8F
`
`120
`
`FIG. 8G
`
`124
`
`102
`
`100
`
`122
`
`-11-
`
`

`
`Patent Application Publication
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`Jul. 8, 2004 Sheet 11 of 44
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`US 2004/0133276 A1
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`122
`
`FIG. 31
`
`1 22
`
`FIG. 8J
`
`-12-
`
`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 12 of 44
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`US 2004/0133276 A1
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`/100
`
`112
`
`‘104
`
`FIG. 8K
`
`112
`
`w /W
`
`1 14
`
`FIG. BL
`
`.13.
`
`-13-
`
`

`
`Patent Application Publication
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`Jul. 8, 2004 Sheet 13 of 44
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`US 2004/0133276 A1
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`Lateral
`
`Frontal
`
`%
`
`FIG. 8M
`
`Lateral
`
`Frontal
`
`-14-
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`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 14 of 44
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`US 2004/0133276 A1
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`154
`
`156
`
`152
`
`..___ 150
`
`154 156
`
`
`-15-
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`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 15 of 44
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`US 2004/0133276 A1
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`
`
`FIG. 9D
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`1 56
`
`154
`
`-16-
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`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 16 of 44
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`US 2004/0133276 A1
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`-17-
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`-17-
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`

`
`Patent Application Publication
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`Jul. 8, 2004 Sheet 17 of 44
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`US 2004/0133276 A1
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`200"””'
`
`202
`
`204
`
`-18-
`
`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 18 of 44
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`US 2004/0133276 A1
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`‘X 220
`
`222
`
`224
`
`FIG. 10C
`
`226
`
`Q-“J
`
`/ 220
`
`FIG. 1 OD
`
`-19-
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`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 19 of 44
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`US 2004/0133276 A1
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`/ 220
`
`23
`
`222
`
`FIG. 1 1A
`
`FIG. 11B
`
`FIG. 11C
`
`7 F
`
`FIG. 11E
`
`IG. 11D
`
`-20-
`
`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 20 of 44
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`US 2004/0133276 A1
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`232
`
`224
`
`22g
`
`FIG. 12A
`
`FIG. 12B
`
`FIG. 12C
`
`FIG. 12D
`
`FIG. 12E
`
`-21-
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`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 21 of 44
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`US 2004/0133276 A1
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`230
`
`231
`
`221
`
`‘Z
`
`FIG. 13A
`
`FIG. 133
`
`FIG. 13C
`
`FlG- 13D
`
`
`
`-22-
`
`

`
`Patent Application Publication
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`Jul. 8, 2004 Sheet 22 of 44
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`US 2004/0133276 A1
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`i 3
`
`FIG. 13G
`
`FIG. 13H
`
`FIG. 13!
`
`FIG. 13J
`
`-23-
`
`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 23 of 44
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`US 2004/0133276 A1
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`242
`
`246
`
`242
`
`-X
`
`240
`
`FIG. 14B
`
`FIG. 14C
`
`-24-
`
`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 24 of 44
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`US 2004/0133276 A1
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`242
`
`244
`
`24
`
`243
`
`FIG. 15A
`
`FIG. 15B
`
`FIG. 15C
`
`-25-
`
`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 25 of 44
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`US 2004/0133276 A1
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`254
`
`255
`
`255
`
`_,/«”25°
`
`253
`
`252
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`FIG. 16/-\
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`
`FIG. 163
`
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`
`FIG. 16C
`
`FIG. 16D
`
`-26-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 26 of 44
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`US 2004/0133276 A1
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`262
`
`242
`
`244
`
`FIG. 17A
`
`242
`
`262
`
`262
`
`242
`
`FIG. 17B
`
`FIG. 17C
`
`-27-
`
`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 27 of 44
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`US 2004/0133276 A1
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`264
`
`24
`
`240
`
`FIG. 18A
`
`264
`
`_
`264
`
`264'"
`
`264"
`
`FIG. 18B
`
`-28-
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`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 28 of 44
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`US 2004/0133276 A1
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`242
`
`/ 240
`
`264
`
`/ 240
`
`FIG. 19A
`
`242
`
`25
`
`256
`
`244
`
`244
`
`266
`
`FIG. 19B
`
`-29-
`
`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 29 of 44
`
`US 2004/0133276 A1
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`FIG. 203
`
`%
`
`FIG. 2oc
`
`FIG. 20D
`
`-30-
`
`-30-
`
`

`
`Patent Application Publication
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`Jul. 8, 2004 Sheet 30 of 44
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`US 2004/0133276 A1
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`FIG. 21B
`
`-31-
`
`-31-
`
`

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`Patent Application Publication
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`Jul. 8, 2004 Sheet 31 of 44
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`US 2004/0133276 A1
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`313
`
`320
`
`324
`
`306
`
`322
`
`FIG. 21C
`
`320
`
`324
`
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`
`FIG. 21D
`
`FIG. 21E
`
`316
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`
`306
`
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`
`
`
`FIG. 21F
`
`FlG- 216
`
`-32-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 32 of 44
`
`US 2004/0133276 A1
`
`320
`
`340
`
`313
`
`324
`
`306
`
`FIG. 21H
`
`340
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`344
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`
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`
`FIG. 21J
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`
`354
`
`FIG. 21L
`
`FIG. 21M
`
`-33-
`
`-33-
`
`

`
`Patent Application Publication
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`Jul. 8, 2004 Sheet 33 of 44
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`US 2004/0133276 A1
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`360
`
`374
`
`363
`
`372
`
`FIG 21N
`
`FIG 210
`
`312
`
`312
`
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`
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`
`FIG. 21P
`
`FIG. 210
`
`502
`
`603
`
`620
`
`607
`
`604
`
`605
`
`608
`
`606
`
`//
`
`610
`
`FIG. 22
`
`-34-
`
`-34-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 34 of 44
`
`US 2004/0133276 A1
`
`706
`
`
`
`ma Q9/2°
`
`702
`
`704
`
`FIG. 23B
`
`-35-
`
`-35-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 35 of 44
`
`US 2004/0133276 A1
`
`/
`730
`i 732
`
`700
`
`702
`
`704
`
`FIG. 23C
`
`-35-
`
`-36-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 36 of 44
`
`US 2004/0133276 A1
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`700
`
`\ Q00 } 0
`
`53
`
`755
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`/
`702
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`
`FIG. 23E
`
`754
`
`764
`
`762
`
`74
`
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`
`766
`
`FIG. 23F
`
`-37-
`
`-37-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 37 of 44
`
`US 2004/0133276 A1
`
`800
`
`Cfl??
`
`804
`
`824
`
`820
`
`822
`
`802
`
`FIG. 24
`
`1024
`
`1000
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`/////”//
`
`1022
`
`1002
`
`1020
`
`FIG. 26
`
`-33-
`
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`<:::::)(::::::>
`
`1004
`
`-38-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 38 of 44
`
`US 2004/0133276 A1
`
`902
`
`/
`
`900
`
`904'
`
`904
`
`920
`
`6
`
`906
`
`FIG. 25A
`
`908 T...‘930
`
`904'
`
`904
`
`FIG. 25B
`
`-39-
`
`-39-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 39 of 44
`
`US 2004/0133276 A1
`
`944
`
`904
`
`908
`
`952
`
`900
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`902 »V’//
`
`940
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`942
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`FVGi.25E7
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`-40-
`
`902
`
`950
`
`"904
`
`-40-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 40 of 44
`
`US 2004/0133276 A1
`
`2651
`
`Joint
`2610
`
`,1
`
`2652
`
`Prepare Joint Surface
`Using Implant Guide
`2620
`
`fiptional ‘
`\\ 2621 /4
`
`«.--3-V
`
`
`2653
`2650
`
`lnstall Implant
`on Surface of
`
`Joint
`
`2640
`
`Close Wound
`
`FIG. 27A
`
`-41-
`
`-41-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 41 of 44
`
`US 2004/0133276 A1
`
`2663
`_
`
`2664
`
`2665
`
`Make Incision to
`Acce6s_ Target
`Joint
`
`2610
`
`‘ Cfpligrial‘
`xx 2611’;J
`
`--.—f
`
`‘Apply Frame to Joint
`2660
`
`
`
`/6-piiarlal‘
`x‘ 2661 / ,4
`
`2662
`
`Install Implant
`on Surface of
`Joint
`
`
`
`2640
`
`-—q—_.
`dptional ‘
`Vxx 2641,,‘
`
`‘pg...-
`
`Close Wound
`
`2650
`
`-42-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 42 of 44
`
`US 2004/0133276 A1
`
`fa-—u.__
`I ’OptionaT \
`\\ 2611 /4
`
`
`
`Make Incision to
`Access Target
`Joint
`
`2673
`
`2674
`
`’
`
`2675
`
`
`
`
`Install Implant
`on Surface of
`
`Joint
`
`2640
`
`Remove" Diseased
`
`Cartilage
`2670
`
`?c-—.__.
`Optional ‘
`xx 2641 (,4
`
`—-1-'
`
`Close Wound
`
`2650
`
`FIG. 27C
`
`-43-
`
`-43-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 43 of 44
`
`US 2004/0133276 A1
`
`Make ‘Incision to
`
`Access Target
`Joint
`
` 2640
`
` ‘ ©’p—t-ion§al\
`x\ 2641 /,4
`-1?
`
`
`’()’p.t.io-n‘aT‘
` ‘
`
`\\ 2681 I
`
`
`
`Position lmplant
`2680
`
`Install lrnplant
`
`
`
`
`
`~ Adjust Implant Profile
`2684 an-—.,__
`'0'-ptionaT\
`x‘ 2682/4 L
`
`—-—-f
`
`
`
`Close Wound
`
`2650
`
`FIG. 27D
`
`-44-
`
`-44-
`
`

`
`Patent Application Publication
`
`Jul. 8, 2004 Sheet 44 of 44
`
`US 2004/0133276 A1
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`FIG. 29B
`
`-45-
`
`-45-
`
`

`
`US 2004/0133276 A1
`
`Jul. 8, 2004
`
`MINIMALLY INVASIVE JOINT IMPLANT WITH
`3-DIMENSIONAL GEOMETRY MATCHING THE
`ARTICULAR SURFACES
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`[0001] This application claims priority to U.S. Provisional
`Patent Application 60/416,601 filed by Philipp Lang on Oct.
`7, 2002 for “Minimally Invasive Joint Implant with 3-Di-
`mensional Geometry Matching the Articular Surfaces” and
`U.S. Provisional Patent Application 60/467,686 filed by
`Philipp Lang, Daniel Steines, Hacene Bouadi, David Miller,
`Barry J. Linder, and Cecily Anne Snyder
`for “Joint
`Implants” on May 2, 2003.
`
`FIELD OF THE INVENTION
`
`[0002] This invention is directed to orthopedic implants
`and systems. The implants can be joint implants and/or
`interpositional joint implants. The invention also relates to
`methods of implant design, manufacture, modeling and
`implantation as well as to surgical
`tools and kits used
`therewith. This invention also relates to a self-expandable
`orthopedic implant amendable to arthroscopic insertion and
`profile alteration. Finally, this invention is related to joint
`implants that are shaped such that the implants re-establish
`normal, or near normal, 3D articular geometry or alignment
`and facilitate joint movement that exceeds from 60 to 99.9%
`of the normal range of motion for the joint and which are
`capable of withstanding up to 100% of the normal shear
`force exerted on the joint during motion.
`
`BACKGROUND OF THE INVENTION
`
`[0003] There are various types of cartilage, e.g., hyaline
`cartilage and fibrocartilage. Hyaline cartilage is found at the
`articular surfaces of bones, e.g., in the joints, and is respon-
`sible for providing the smooth gliding motion characteristic
`of moveable joints. Articular cartilage is firmly attached to
`the underlying bones and measures typically less than 5 mm
`in thickness in human joints, with considerable variation
`depending on the joint and more particularly the site within
`the joint. In addition, articular cartilage is aneural, avascular,
`and alymphatic. In adult humans, this cartilage derives its
`nutrition by a double diffusion system through the synovial
`membrane and through the dense matrix of the cartilage to
`reach the chondrocyte,
`the cells that are found in the
`connective tissue of cartilage.
`
`[0004] Adult cartilage has a limited ability of repair; thus,
`damage to cartilage produced by disease, such as rheuma-
`toid arthritis and/or osteoarthritis, or trauma can lead to
`serious physical deformity and debilitation. Furthermore, as
`human articular cartilage ages, its tensile properties change.
`Thus,
`the tensile stiffness and strength of adult cartilage
`decreases markedly over time as a result of the aging
`process.
`
`the superficial zone of the knee
`[0005] For example,
`articular cartilage exhibits an increase in tensile strength up
`to the third decade of life, after which it decreases markedly
`with age as detectable damage to type II collagen occurs at
`the articular surface. The deep zone cartilage also exhibits a
`progressive decrease in tensile strength with increasing age,
`although collagen content does not appear to decrease.
`These observations indicate that
`there are changes in
`
`mechanical and, hence, structural organization of cartilage
`with aging that, if sufficiently developed, can predispose
`cartilage to traumatic damage.
`
`[0006] Usually, severe damage or loss of cartilage is
`treated by replacement of the joint with a prosthetic material,
`for example, silicone, e.g. for cosmetic repairs, or suitable
`metal alloys. See, e.g., U.S. Pat. No. 6,383,228 to
`Schmotzer, issued May 7, 2002; U.S. Pat. No. 6,203,576 to
`Afriat, et al., issued Mar. 20, 2001; U.S. Pat. No. 6,126,690
`to Ateshian et al., issued Oct. 3, 2000. Implantation of these
`prosthetic devices is usually associated with loss of under-
`lying tissue and bone without recovery of the full function
`allowed by the original cartilage and, with some devices,
`serious long-term complications associated with the loss of
`significant amount of tissue and bone can include infection,
`osteolysis and also loosening of the implant.
`
`[0007] As can be appreciated, joint arthroplasties are
`highly invasive and require surgical resection of the entire,
`or a majority of the, articular surface of one or more bones
`involved in the repair. Typically with these procedures, the
`marrow space is fairly extensively reamed in order to fit the
`stem of the prosthesis within the bone. Reaming results in a
`loss of the patient’s bone stock and over time osteolysis will
`frequently lead to loosening of the prosthesis. Further, the
`area where the implant and the bone mate degrades over
`time requiring the prosthesis to eventually be replaced.
`Since the patient’s bone stock is limited,
`the number of
`possible replacement surgeries is also limited for joint
`arthroplasty. In short, over the course of 15 to 20 years, and
`in some cases even shorter time periods, the patient can run
`out of therapeutic options ultimately resulting in a painful,
`non-functional joint.
`
`[0008] The use of matrices, tissue scaffolds or other car-
`riers implanted with cells (e.g., chondrocyte, chondrocyte
`progenitors, stromal cells, mesenchymal stem cells, etc.) has
`also been described as a potential treatment for cartilage
`repair. See, also, International Publications WO 99/51719 to
`Fofonoff published Oct. 14, 1999; WO 01/91672 to Simon
`et al., published Dec. 6, 2001; and WO 01/17463 to Mans-
`mann, published Mar. 15, 2001; and U.S. Pat. No. 6,283,980
`B1 to Vibe-Hansen, et al., issued Sep. 4, 2001; U.S. Pat. No.
`5,842,477 to Naughton, et al., issued Dec. 1, 1998; U.S. Pat.
`No. 5,769,899 to Schwartz, issued Jun. 23, 1998; U.S. Pat.
`No. 4,609,551 to Caplan et al., issued Sep. 2, 1986; U.S. Pat.
`No. 5,041,138 to Vacanti et al., issued Aug. 20, 1991; U.S.
`Pat. No. 5,197,985 to Caplan et al., issued Mar. 30, 1993;
`U.S. Pat. No. 5,226,914 to Caplan, et al., issued Jul. 13,
`1993; U.S. Pat. No. 6,328,765 to Hardwick et al., issued
`Dec. 11, 2001; U.S. Pat. No. 6,281,195 to Rueger et al.,
`issued Aug. 28, 2001; and U.S. Pat. No. 4,846,835 to
`Grande, issued Jul. 11, 1989. However, clinical outcomes
`with biologic replacement materials such as allograft and
`autograft systems and tissue scaffolds have been uncertain
`since most of these materials cannot achieve a morphologic
`arrangement or structure similar to or identical to that of the
`normal, disease-free human tissue it is intended to replace.
`Moreover,
`the mechanical durability of these biologic
`replacement materials remains uncertain.
`
`[0009] U.S. Pat. No. 6,206,927 to Fell, et al., issued Mar.
`21, 2001, and U.S. Pat. No. 6,558,421 to Fell, et al., issued
`May 6, 2003, disclose a surgically implantable knee pros-
`thesis that does not require bone resection. This prosthesis is
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`described as substantially elliptical in shape with one or
`more straight edges. Accordingly,
`these devices are not
`designed to substantially conform to the actual shape (con-
`tour) of the remaining cartilage in vivo and/or the underlying
`bone. Thus, integration of the implant can be extremely
`difficult due to differences in thickness and curvature
`
`between the patient’s surrounding cartilage and/or
`underlying subchondral bone and the prosthesis.
`
`the
`
`there remains a need for a system and
`[0010] Thus,
`method for replicating the natural geography of a joint using
`one or more implant parts that can be implanted using
`minimally invasive techniques and tools for making those
`repairs and implants and methods that recreate natural or
`near natural
`three-dimensional geometric relationships
`between two articular surfaces of the joint.
`
`SUMMARY OF THE INVENTION
`
`[0011] The present invention provides methods and com-
`positions for
`repairing joints, particularly devices and
`implants useful for repairing articular cartilage and for
`facilitating the integration of a wide variety of cartilage and
`bone repair materials into a subject. Among other things, the
`techniques described herein allow for the production of
`devices that substantially or completely conform to the
`contour of a particular subject’s underlying cartilage and/or
`bone and/or other articular structures.
`In addition,
`the
`devices also preferably substantially or completely conform
`to the shape (size) of the cartilage. When the shape (e.g.,
`size, thickness and/or curvature) of the articular cartilage
`surface is an anatomic or near anatomic fit with the non-
`
`damaged cartilage, with the subject’s original cartilage,
`and/or with the underlying bone, the success of repair is
`enhanced.
`
`[0012] The repair material can be shaped prior to implan-
`tation and such shaping can be based, for example, on
`electronic images that provide information regarding curva-
`ture or thickness of any “normal” cartilage surrounding a
`defect or area of diseased cartilage and/or on curvature of the
`bone underlying or surrounding the defect or area of dis-
`eased cartilage, as well as bone and/or cartilage comprising
`the opposing mating surface for the joint.
`
`invention provides, among other
`[0013] The current
`things, for minimally invasive methods for partial joint
`replacement. The methods can result in little or no loss in
`bone stock resulting from the procedure. Additionally, the
`methods described herein help to restore the integrity of the
`articular surface by achieving an anatomic or near anatomic
`fit between the implant and the surrounding or adjacent
`cartilage and/or subchondral bone.
`
`In most cases, joint mobility for the repaired joint
`[0014]
`will range from 60 to 99.9% of normal mobility. The range
`of motion is
`improved to 85-99.9%, more preferably
`between 90-99.9%, most preferably between 95-99.9% and
`ideally between 98-99.9%.
`
`the
`the incisions required to implant
`[0015] Further,
`devices of the invention typically are less than 50% of the
`incision required to implant currently available implants.
`For example, a total knee replacement typically employs an
`incision of from 6-12 inches (15-30 cm) while a unicom-
`partmental knee replacement requires an incision of 3 inches
`(7 cm). An implant according to this invention designed to
`
`repair the tibial surface requires only a 3 cm incision
`(approximately 1.5 inches), while a combination of implants
`for repairing both the tibial surface and the femoral condyles
`requires an incision of 3 inches (7 cm). In another example,
`a traditional hip replacement surgery requires a single inci-
`sion of between 6 and 12 inches (15-30 cm), or in the less
`invasive technique two incisions of 1.5-4 inches (3-9.5 cm).
`An implant according to this invention designed to repair the
`acetabulum requires a single incision of from 1.5 inches (3
`cm) to 6 inches (30 cm), depending upon whether single or
`dual surface correction is desired.
`
`[0016] Advantages of the present invention can include,
`but are not limited to,
`customization of joint repair to an
`individual patient (e.g. patient specific design or solution),
`thereby enhancing the efficacy and comfort level following
`the repair procedure; (ii) eliminating the need for a surgeon
`to measure the defect to be repaired intraoperatively in some
`embodiments; (iii) eliminating the need for a surgeon to
`shape the material during the implantation procedure; (iv)
`providing methods of evaluating curvature or shape of the
`repair material based on bone, cartilage or tissue images or
`based on intraoperative probing techniques; (v) providing
`methods of repairing joints with only minimal or, in some
`instances, no loss in bone stock; and (vi) improving post-
`operative joint congruity.
`
`[0017] Thus, the design and use of joint repair material
`that more precisely fits the defect (e.g., site of implantation)
`and, accordingly, provides improved repair of the joint is
`described herein.
`
`[0018] As can be appreciated by those of skill in the art an
`implant
`is described that
`is an interpositional articular
`implant, cartilage defect conforming implant, cartilage pro-
`jected implant,
`and/or
`subchondral bone
`conforming
`implant. The implant has a superior surface and an inferior
`surface. The superior surface opposes a first articular surface
`of a joint and the inferior surface opposes a second articular
`surface of the joint and further wherein at least one of the
`superior or inferior surfaces has a three-dimensional shape
`that substantially matches the shape of one of the first and
`second articular surfaces. The implant is suitable for place-
`ment within any joint, including the knee, hip, shoulder,
`elbow, wrist, finger, toe, and ankle. The superior surface and
`the inferior surface of the implant typically have a three
`dimensional shape that substantially matches the shape of at
`least one of the articular surface that the superior surface of
`the implant abuts and the inferior surface of the articular
`surface that the implant abuts. The implant is designed to
`have a thickness of the cartilage defect in a patient, or a
`fraction thereof, typically between 65% and 99.9%.
`
`[0019] The implant can be manufactured from a variety of
`suitable materials, including biocompatible materials, met-
`als, metal alloys, biologically active materials, polymers,
`and the like. Additionally, the implant can be manufactured
`from a plurality of materials, including coatings.
`
`[0020] The implant can further have a mechanism for
`attachment
`to a joint. Suitable attachment mechanisms
`include ridges, pegs, pins, cross-members, teeth and protru-
`sions. Additional mechanisms for stabilization of the joint
`can be provided such as ridges, lips, and thickening along all
`or a portion of a peripheral surface.
`
`[0021] The implant can also be designed such that it has
`two or more components. These components can be inte-
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`grally formed, indivisibly formed, interconnectedly formed,
`and interdependently formed, depending on the desired
`functionality. In the multiple component scenario, the joint
`contacting components can be designed to engage the joint
`slideably or rotatably, or a combination thereof. Alterna-
`tively, either or both of the joint contacting components can
`be fixed to the joint. Any additional components can be
`integrally formed,
`indivisibly formed,
`interconnectedly
`formed or interdependently formed with any other compo-
`nent that it engages.
`
`[0022] Each component of the implant, or the implant
`itself can have a shape formed along its periphery or
`perimeter that is circular, elliptical, ovoid, kidney shaped,
`substantially circular, substantially elliptical, substantially
`ovoid, and substantially kidney shaped. Additionally, each
`component of the implant, or the implant itself can have a
`cross-sectional
`shape
`that
`is
`spherical, hemispherical,
`aspherical, convex, concave, substantially convex, and sub-
`stantially concave.
`
`[0023] The design of the implant is such that it is condu-
`cive for implantation using an incision of 10 cm or less.
`Further,
`the implant is designed to restore the range of
`motion of the joint to between 80-99.9% of normal joint
`motion.
`
`[0024] The implant, or any component thereof, can have a
`variety of shapes such that the periphery of the implant can
`be of greater thickness than a central portion of the implant.
`Alternatively, the implant, or any component thereof, can be
`designed so that the central portion of the implant is of
`greater thickness than a periphery. Looking at the implant
`from a plurality of directions, such as an anterior portion,
`posterior portion,
`lateral portion and medial portion,
`the
`implant, or any component thereof, can have a thickness
`along the posterior portion of the device that is equal to or
`greater than a thickness of at least one of the lateral, medial
`and anterior portion of the implant. Alternatively,
`the
`implant, or any component thereof, can have a thickness
`along a posterior portion of the device that is equal to or less
`than a thickness of at least one of the lateral, medial and
`anterior portion of the implant. In yet another alternative, the
`implant, or any component thereof, can have a thickness
`along a medial portion of the device that is equal to or less
`than a thickness of at
`least one of an anterior portion,
`posterior portion, and lateral portion. In another alternative,
`the implant can have a thickness along a medial portion of
`the device that is equal to or greater than a thickness of at
`least one of an anterior portion, posterior portion, and lateral
`portion.
`
`[0025] Procedures for repairing a joint using the implant
`described below includes the step of arthroscopically
`implanting an implant having a superior and inferior surface
`wherein at least one of the superior or inferior surfaces has
`a three-dimensional shape that substantially matches the
`shape of an articular surface. The image can be analyzed
`prior to implantation. Typically the image is an MRI, CT,
`x-ray, or a combinations thereof.
`
`[0026] The method of making an implant according to this
`invention includes: determining three-dimensional shapes of
`one or more articular surface of the joint; and producing an
`implant having a superior surface and an inferior surface,
`wherein the superior surface and inferior surface oppose a
`first and second articular surface of the joint and further
`
`wherein at least one of the superior or inferior surfaces
`substantially matches the three-dimensional shape of the
`articular surface.
`
`invention provides novel
`the present
`[0027] Further,
`devices and methods for replacing a portion (e.g., diseased
`area and/or area slightly larger than the diseased area) of a
`joint (e.g., cartilage and/or bone) with an implant material,
`where the implant achieves an anatomic or near anatomic fit
`with at least one surface of the surrounding structures and
`tissues and restores joint mobility to between 60-99.9% of
`the normal range of motion for the joint. Further,
`the
`implants can withstand up to 100% of the shear force exerted
`on the joint during motion. In cases where the devices and/or
`methods include an element associated with the underlying
`articular bone, the invention also provides that the bone-
`associated element can achieve an anatomic or near ana-
`
`tomic alignment with the subchondral bone. The invention
`also enables the preparation of an implantation site with a
`single cut. These devices can be interpositional. The devices
`can be single component, dual component, or have a plu-
`rality of components.
`
`[0028] A method of the invention comprises the steps of
`(a) measuring one or more dimensions (e.g.,
`thickness
`and/or curvature and/or size) of the intended implantation
`site or the dimensions of the area surrounding the intended
`implantation site; and (b) providing cartilage replacement or
`material that conforms to the measurements obtained in step
`(a). In certain aspects, step (a) comprises measuring the
`thickness of the cartilage surrounding the intended implan-
`tation site and measuring the curvature of the cartilage
`surrounding the intended implantation site. Alternatively,
`step (a) can comprise measuring the size of the intended
`implantation site and measuring the curvature of the carti-
`lage surrounding the intended implantation site; or measur-
`ing the thickness of the cartilage surrounding the intended
`implantation site, measuring the size of the intended implan-
`tation site, and measuring the curvature of the cartilage
`surrounding the intended implantation site; or reconstructing
`the shape of healthy cartilage surface at the intended implan-
`tation site; or measuring the size of the intended implanta-
`tion site and/or measuring the curvature or geometry of the
`subchondral bone at the or surrounding the intended implan-
`tation site. In addition, the thickness, curvature or surface
`geometry of the remaining cartilage at the implantation site
`can be measured and can, for example, be compared with the
`thickness, curvature or surface geometry of the surrounding
`cartilage. This comparison can be used to derive the shape
`of a cartilage replacement or material more accurately.
`
`[0029] The dimensions of the replacement material can be
`selected
`following
`intraoperative measurements,
`for
`example measurements made using imaging techniques
`such as ultrasound, MRI, CT scan, x-ray imaging obtained
`with x-ray dye and fluoroscopic imaging. A mechanical
`probe (with or without imaging capabilities) can also be
`used to selected dimensions, for example an ultrasound
`probe, a laser, an optical probe, an indentation probe, and a
`deformable material.
`
`includes a
`[0030] One or more implantable device(s)
`three-dimensional body. In a knee, the implant can be used
`in one (unicompartmental) or more (multicompartmental)
`compartments. In the knee, the implant is not elliptical in
`shape, but follows the 3D geometry of the articular cartilage,
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`intra-articular structures. The
`subchondral bone and/or
`implant has a pair of opposed faces. The contours of one face
`of the implant matches or substantially match the underlying
`cartilage and/or bone contour; while the contour of the
`opposing face of the implant creates a surface for a mating
`joint surface to interface with. For example, the surface of
`the opposing face can be projected using modeling to
`optimize the surface for mating with the joint. In addition,
`the opposed faces can be connected using a rounded inter-
`face. The interface can also extend beyond the articular
`surface. The implants of the invention can also be self-
`expandable and amendable to arthroscopic insertion.
`
`[0031] Each face of the device is not necessarily uniform
`in dimension. The length D across one axis taken at any
`given point is variable along that axis. Similarly the length
`2D across the second axis (perpendicular to the first axis) is
`also variable along that axis as well. The ratio between any
`D length along a first axis and any D length along a second
`axis can have any ratio that is suitable for the physical
`anatomy being corrected and would be appreciated by those
`of skill in the art.
`
`[0032] As will be appreciated by those of skill in the art,
`any of the implantable joint prostheses described herein can
`comprise multiple (e.g., two or more pieces) body compo-
`nents that are engageable (e.g., slideably) and/or separable
`without departing from the scope of the invention. For
`example, a two-piece component can be provided where
`each component has a face whose contour conforms, par-
`tially or substantially,
`to the underlying cartilage and/or
`bone. In certain embodiments, the opposing surfaces of the
`components that are engageable are curved. The curvature
`can be selected to be similar to that or mirror that of at least
`
`one articular surface for that joint. In other embodiments, the
`opposing surfaces of the components that are engageable are
`flat. In other embodiments,
`the opposing surfaces of the
`components that are engageable are a combination of flat
`and curved. The opposing surfaces of the components that
`are engageable can also be irregular. In this case, they are
`preferably designed to mate with each other in at least one
`or more positions.
`[0033]
`In any of the methods described herein, the replace-
`ment material can be selected (for example, from a pre-
`existing library of repair systems). Thus, the replacement
`material can be produced pre-, intra- or post-operatively.
`Furthermore, in any of the methods described herein the
`replacement material can also be shaped using appropriate
`techniques known in the art; either pre-operatively, intra-
`operatively, or post-operatively. Techniques include: manu-
`ally, automatically or by machine; using mechanical abra-
`sion including polishing,
`laser ablation,
`radiofrequency
`ablation, extrusion, injection, molding, compression mold-
`ing and/or machining techniques, or the like. Finally, the
`implants can comprise one or more biologically active
`materials such as drug(s), cells, acellular material, pharma-
`cological agents, biological agents, and the like.
`[0034] The invention includes a method of repairing car-
`tilage in a subject,
`the method comprising the step of
`implanting cartilage repair material prepared according to
`any of the methods described herein. Implantation is typi-
`cally arthroscopic and can be accomplished via a relatively
`small incision.
`
`[0035] The invention also provides a method of determin-
`ing the curvature of an articular surface, the method com-
`
`prising the step of intraoperatively measuring the curvature
`of the articular surface using a mechanical probe or a
`surgical mechanical navigation system. The articular surface
`can comprise cartilage and/or
`subchondral bone. The
`mechanical probe (with or without imaging capabilities) can
`include, for example an ultrasound probe, a laser, a mechani-
`cal arm (such as the Titanium FARO arm) an optical probe
`and/or a deformable material or device