I lllll llllllll Ill lllll lllll lllll lllll lllll 111111111111111111111111111111111
`US007534263B2
`
`c12) United States Patent
`Burdulis, Jr. et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 7 ,534,263 B2
`*May 19, 2009
`
`(75)
`
`(54) SURGICAL TOOLS FACILITATING
`INCREASED ACCURACY, SPEED AND
`SIMPLICITY IN PERFORMING JOINT
`ARTHROPLASTY
`Inventors: Albert G. Burdulis, Jr., San Francisco,
`CA (US); Wolfgang Fitz, Sherborn, MA
`(US); Rene Vargas-Voracek, Sunnyvale,
`CA (US); Philipp Lang, Lexington, MA
`(US); Daniel Steines, Lexington, MA
`(US); Konstantinos Tsougarakis,
`Sunnyvale, CA (US)
`(73) Assignee: ConforMIS, Inc., Burlington, MA (US)
`( *) Notice:
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 81 days.
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`(21) Appl. No.: 11/002,573
`
`(22) Filed:
`
`Dec. 2, 2004
`
`(65)
`
`Prior Publication Data
`
`US 2005/0234461 Al
`
`Oct. 20, 2005
`
`Related U.S. Application Data
`
`(63) Continuation-in-part of application No. 10/724,010,
`filed on Nov. 25, 2003, which is a continuation-in-part
`of application No. 10/305,652, filed on Nov. 27, 2002,
`which is a continuation-in-part of application No.
`10/160,667, filed on May 28, 2002.
`
`(60) Provisional application No. 60/380,695, filed on May
`14, 2002, provisional application No. 60/380,692,
`filed on May 14, 2002, provisional application No.
`60/363,527, filed on Mar. 12, 2002, provisional appli(cid:173)
`cation No. 60/293,488, filed on May 25, 2001.
`
`(51)
`
`Int. Cl.
`A61F 2108
`(2006.01)
`(2006.01)
`A61B 17158
`(52) U.S. Cl. ...................................... 623/14.12; 606/88
`(58) Field of Classification Search ................... 606/86,
`606/87, 88, 89, 82, 80, 96, 98; 623/14.12
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3,798,679 A
`
`3/1974 Ewald ............................... 3/1
`
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`
`3516743
`
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`
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`
`OTHER PUBLICATIONS
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`Taha et al., "Modeling and design of a custom made cranium implant
`for large skull reconstruction before a tumor removal", Phidias
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`
`(Continued)
`
`Primary Examiner-Pedro Philogene
`(74) Attorney, Agent, or Firm-Bromberg & Sunstein LLP
`
`(57)
`
`ABSTRACT
`
`Disclosed herein are tools for repairing articular surfaces
`repair materials and for repairing an articular surface. The
`surgical tools are designed to be customizable or highly
`selectable by patient to increase the speed, accuracy and
`simplicity of performing total or partial arthroplasty.
`
`80 Claims, 25 Drawing Sheets
`
`-1-
`
`Smith & Nephew Ex. 1001
`IPR Petition - USP 7,534,263
`
`

`
`US 7,534,263 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
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`-2-
`
`

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`US 7,534,263 B2
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`
`-4-
`
`

`
`U.S. Patent
`
`U.S. P a t e n t
`
`M a y 19, 2 0 0 9
`May 19, 2009
`
`S h e e t 1 o f 2 5
`Sheet 1 of 25
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`US 7,534,263 B2
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`V S 7 , 5 3 4 , 2 6 3 B 2
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`F IG . 1A
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`-5-
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`

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`U.S. Patent
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`May 19, 2009
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`Sheet 2of25
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`US 7 ,534,263 B2
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`I
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`U.S. Patent
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`May 19, 2009
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`Sheet 3of25
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`US 7 ,534,263 B2
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`1''
`
`200 ... 'f
`
`FIG. 2
`
`-7-
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`

`
`U.S. Patent
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`May 19, 2009
`
`Sheet 4of25
`
`US 7,534,263 B2
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`Measure Size of Area
`of Diseased Cartilage
`or Cartilage Loss
`300
`
`"o~ti~-~~I'\
`'• 301 _/
`...... -........ ~ .... .,.,.,
`
`Measure Thickness of
`Adjacent Cartilage
`~;?._Q
`
`-------
`,'Optiona-1'\
`_,'-
`321
`........ ___ ,..~ ... ,,,_ ...
`
`Measure Curvature of
`Articular Surface and/
`- orSubchondral Bone
`~-~-Q
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`/Qptiona-1'\
`331
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`Select Best Fitting
`Patient Specific Implant
`Implant in Library
`332
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`......... --......----~-
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`340
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`(
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`-8-
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`

`
`U.S. Patent
`
`May 19, 2009
`
`Sheet 5 of 25
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`US 7 ,534,263 B2
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`FIG. 4A
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`-9-
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`
`U.S. Patent
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`May 19, 2009
`
`Sheet 6 of 25
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`US 7 ,534,263 B2
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`510
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`514 530
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`-10-
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`

`
`U.S. Patent
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`May 19, 2009
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`Sheet 7 of 25
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`US 7 ,534,263 B2
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`512
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`FIG. 5H (2)
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`FIG. 5G
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`FIG. 51
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`FIG. 5K
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`FIG. 5L
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`-11-
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`

`
`U.S. Patent
`
`May 19, 2009
`
`Sheet 8 of 25
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`US 7 ,534,263 B2
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`FIG. 5M
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`FIG. 5N
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`530
`520
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`U.S. Patent
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`May 19, 2009
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`Sheet 9of25
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`US 7 ,534,263 B2
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`614
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`612
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`610
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`FIG. 60
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`-13-
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`

`
`U.S. Patent
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`May 19, 2009
`
`Sheet 10 of 25
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`US 7 ,534,263 B2
`
`FIG. 6F
`
`FIG. 6E
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`648
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`646
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`FIG. 6H
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`-14-
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`

`
`U.S. Patent
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`May 19, 2009
`
`Sheet 11 of 25
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`US 7 ,534,263 B2
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`FIG. 6J
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`FIG. 6K
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`640
`610
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`FIG. 6L
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`613
`666
`FIG. 6N
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`FIG. 60 610
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`-15-
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`U.S. Patent
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`May 19, 2009
`
`Sheet 12 of 25
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`US 7 ,534,263 B2
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`s
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`J ( 797 700
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`FIG. ?A
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`FIG. 78
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`FIG. 70
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`-16-
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`
`U.S. Patent
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`May 19, 2009
`
`Sheet 13 of 25
`
`US 7 ,534,263 B2
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`FIG. 7E
`
`0-732
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`FIG. 7F
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`FIG. 7G
`
`-17-
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`

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`U.S. Patent
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`May 19, 2009
`
`Sheet 14 of 25
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`US 7 ,534,263 B2
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`(
`
`,/~-~
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`820
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`'--822
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`f
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`826-j 824
`
`FIG. 88
`
`FIG. 8C
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`FIG. 80
`
`-18-
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`

`
`U.S. Patent
`
`May 19, 2009
`
`Sheet 15 of 25
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`US 7 ,534,263 B2
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`850
`
`..-852
`
`~uolESo
`
`---------- ~b___._-...._-9_o_o -
`
`FIG. 8E
`
`FIG. BF
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`813 !
`
`FIG. BG
`
`862
`
`----~3
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`FIG. 8H
`
`-19-
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`

`
`U.S. Patent
`
`May 19, 2009
`
`Sheet 16 of 25
`
`US 7 ,534,263 B2
`
`FIG. 98
`
`977
`
`FIG. 9C
`
`FIG. 90
`
`-20-
`
`

`
`U.S. Patent
`
`May 19, 2009
`
`Sheet 17 of 25
`
`US 7 ,534,263 B2
`
`1010
`
`(
`
`1014-
`
`Patellar Faces
`
`t
`\
`10·12
`
`FIG. 1 OA
`
`Articular surface
`matches patella
`
`1020--
`
`FIG. 1 OB
`
`-21-
`
`

`
`U.S. Patent
`
`May 19, 2009
`
`Sheet 18 of 25
`
`US 7 ,534,263 B2
`
`1 02 0 ..____..,...
`
`1030
`
`1032
`
`FIG. 1 OC
`
`Mold-Drill guide fits
`onto articular
`
`1020
`
`~
`
`FIG. 1 OD
`
`-22-
`
`

`
`U.S. Patent
`U.S. Patent
`
`May 19, 2009
`May 19, 2009
`
`Sheet 19 of 25
`Sheet 19 of 25
`
`US 7 ,534,263 B2
`Us 7,534,263 B2
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`muam3%E9:3E32E0a:
`\
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`

`
`U.S. Patent
`U.S. Patent
`
`May 19, 2009
`May 19, 2009
`
`Sheet 20 of 25
`Sheet 20 of 25
`
`US 7 ,534,263 B2
`US 7,534,263 B2
`
`$2.55&3
`
`Efimmm.
`
`0
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`
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`
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`
`U.S. Patent
`
`May 19, 2009
`
`Sheet 21 of 25
`
`US 7 ,534,263 B2
`
`1060
`y/
`
`50mm diarneter
`surrounding portion
`reams excess bone
`from surrounding
`area
`
`30mm diameter
`Patella reaming --+-I'~
`portion
`
`FIG. 11A
`
`-25-
`
`

`
`U.S. Patent
`U.S. Patent
`
`May 19, 2009
`May 19, 2009
`
`Sheet 22 of 25
`Sheet 22 of 25
`
`US 7 ,534,263 B2
`US 7,534,263 B2
`
`MG,118
`
`N
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`-26-
`
`

`
`U.S. Patent
`
`May 19, 2009
`
`Sheet 23 of 25
`
`US 7 ,534,263 B2
`
`Bone sparing 7n1m
`poly thickness w
`3rnm pegs
`(=·1 Omrri) ~
`
`/1200
`)l
`
`FIG. 12A
`
`Three Peg design
`with marker wire
`
`-1210
`
`FIG. 12B
`
`-27-
`
`

`
`U.S. Patent
`
`May 19, 2009
`
`Sheet 24 of 25
`
`US 7,534,263 B2
`
`FIG. 12C
`
`FIG. 120
`
`-28-
`
`

`
`U.S. Patent
`
`M a y 19, 2009
`
`Sheet 25 o f 25
`
`US 7,534,263 B2
`
`FIG~ 12E
`
`FIG~ 12F
`
`-29-
`
`

`
`US 7,534,263 B2
`
`1
`SURGICAL TOOLS FACILITATING
`INCREASED ACCURACY, SPEED AND
`SIMPLICITY IN PERFORMING JOINT
`ARTHROPLASTY
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`SUMMARY OF THE INVENTION
`
`2
`Pat. No. 6, 106,529 to Techiera issuedAug. 22, 2000 discloses
`anepicondylar axis referencing drill guide for use in resection
`to prepare a bone end for prosthetic joint replacement. U.S.
`Pat. No. 6,296,646 to Williamson issued Oct. 2, 2001 dis-
`5 closes a system that allows a practitioner to position the leg in
`the alignment that is directed at the end of the implant proce(cid:173)
`dure and to cut both the femur and tibia while the leg is fixed
`in alignment. U.S. Pat. No. 6,620,168 to Lombardi et al.
`This application is a continuation-in-part of U.S. Ser. No.
`issued Sep. 16, 2003 discloses a tool for intermedullary revi-
`10/724,010 for "PATIENT SELECTABLE JOINT ARTHROPLASTY 10 sion surgery along with tibial components.
`DEVICES AND SURGICAL TOOLS FACILITATING INCREASED ACCURACY,
`U.S. Pat. No. 5,578,037 to Sanders et al. issued Nov. 26,
`SPEED AND SIMPLICITY IN PERFORMING TOTAL AND PARTIAL JoINT
`1996 discloses a surgical guide for femoral resection. The
`ARTHROPLASTY" filed Nov. 25, 2003 which is a continuation(cid:173)
`guide enables a surgeon to resect a femoral neck during a hip
`in-part of U.S. Ser. No. 10/305,652 entitled "METHODS AND
`arthroplasty procedure so that the femoral prosthesis can be
`COMPOSITIONS FOR ARTICULAR REPAIR," filed Nov. 27, 2002,
`15 implanted to preserve or closely approximate the anatomic
`which is a continuation-in-part of U.S. Ser. No. 10/160,667,
`center of rotation of the hip.
`filed May 28, 2002, which in tum claims the benefit of U.S.
`Currently available tools do not always enable the surgeon
`Ser. No. 60/293,488 entitled "METHODS To IMPROVE CARTILAGE
`to make the most accurate cuts on the bone surface in prepar(cid:173)
`REPAIR SYSTEMS", filed May 25, 2001, U.S. Ser. No. 60/363,
`ing the target joint for implantation.
`527, entitled "NoVEL DEVICES FoR CARTILAGE REPAIR, filed M