`
`FILE HISTORY
`US 6,205,411
`
`6,205,411
`PATENT:
`INVENTORS: DiGioia, III, Anthony M.
`Simon, David A.
`Jaramaz, Branislav
`Blackwell, Michael K.
`Morgan, Frederick M.
`O'Toole, Robert V.
`Kanade, Takeo
`
`TITLE:
`
`Computer-assisted surgery planner and
`intra-operative guidance system
`
`APPLICATION
`NO:
`FILED:
`ISSUED:
`
`US1998189914A
`
`12 NOV 1998
`20 MAR 2001
`
`COMPILED:
`
`23 JUL 2014
`
`Mako Exhibit 1002 Page 1
`
`

`

`N.N.
`
`PATENT NUMBER
`
`6205411
`
`6205411
`
`U.S YIJTY PATENT APPLICATION
`PATENI DATE
`OlPE
`A _5__
`MAR 2 0 20?
`aA
`
`SCANNED
`
`4
`
`(Attached In pocket on nght Inade flisp)
`
`(PREPARED AND APPROVED FOR ISSUE
`ISSUING CLASSIFICATION
`CROSS REFERENCE(S)
`SUBCLASS (ONE SUBCLASS PER BLOCK)
`
`Z
`SUBCLASS
`
`Z RINA
`CLASS
`763
`INTERNATIONAL CLASSIFICATION
`
`_4 6 1/ IF__IS
`41
`
`/IF'_Z_A74 I ~El
`
`F TERMINAL
`DICAMRSheets Drwg
`
`CLASS
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`
`22
`
`____ZZ__
`
`____
`
`_
`
`Continued on Issue Slip Inside File Jacket
`
`Print Fig
`
`Total Claims
`
`IS ALLOWED
`Print Claim for 0 G
`
`DhA WINGS
`Figs Drwg
`
`(372t
`
`o a) The term of this patent
`subsequent to _____(date)
`rhas been disclaimed
`
`R1 b) The term
`his patent shall
`not extend beyot J the expiration dat
`of U SPatent No ______/ISSUE
`
`allSSe-eL
`
`(Assistant Examiner)
`
`________
`
`____
`
`
`
`___ ___
`
`___
`___
`
`___
`
`___(Primary
`
`KWVN J T8KAI
`SUPERVISORY
`PATENT EXAMINER
`Examiner)
`
`O c) The terminal ___months of
`this patent have been disclaimed
`
`_________________
`
`V
`
`i
`ta,
`c/
`1
`le~n*rumi&sEximNne)'
`
`NOTICE OF ALLOWANCE MAILED
`-/00~Of
`q11-'JZSt
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`9
`
`Amount Due
`
`FEE
`
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`Date Paid
`
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`
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`
`Dale)
`
`(Date)
`
`ISEBTHNME
`
`40
`
`[WARNING
`The Information disclosed herein may be restricted Unauthorized disclosure may be prohibited by the United States Code Tite 35 Sections 122 181 and 368
`Possession outside the U S Patent & Trademark Office Is restricted to authorized employees and contractors only
`Form PTO 436A
`
`(Rev 6/98)
`
`10g
`0N9(lI
`(LABEL AREA)
`Formai Drawings(...shts)set-
`
`Mako Exhibit 1002 Page 2
`
`

`

`6,205,411
`
`COMPUTER-ASSISTED SURGERY PLANNER AND INTRA-OPERATIVE
`GUIDANCE SYSTEM
`
`TRANSACTION HISTORY
`
`Date
`
`Transaction Description
`11/16/1998
`Initial Exam Team nn
`11/24/1998
`IFW Scan & PACR Auto Security Review
`12/7/1998 Notice Mailed--Application Incomplete--Filing Date Assigned
`1/29/1999
`Information Disclosure Statement (IDS) Filed
`1/29/1999
`Information Disclosure Statement (IDS) Filed
`2/17/1999 Application Is Now Complete
`2/18/1999 Application Dispatched from OIPE
`4/13/1999 Case Docketed to Examiner in GAU
`4/4/2000 Non-Final Rejection
`4/5/2000 Mail Non-Final Rejection
`6/28/2000 Terminal Disclaimer Filed
`8/28/2000 Response after Non-Final Action
`9/11/2000 Terminal Disclaimer Approved in TC
`9/11/2000 Date Forwarded to Examiner
`9/21/2000 Mail Notice of Allowance
`9/21/2000 Notice of Allowance Data Verification Completed
`11/3/2000 Workflow - File Sent to Contractor
`12/21/2000
`Issue Fee Payment Verified
`12/21/2000 Workflow - Drawings Finished
`12/21/2000 Workflow - Drawings Matched with File at Contractor
`12/21/2000 Workflow - Drawings Received at Contractor
`12/21/2000 Workflow - Drawings Sent to Contractor
`1/30/2001 Workflow - Complete WF Records for Drawings
`2/4/200 1 Application Is Considered Ready for Issue
`3/1/2001
`Issue Notification Mailed
`3/20/2001 Recordation of Patent Grant Mailed
`
`Mako Exhibit 1002 Page 3
`
`

`

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`
`Mako Exhibit 1002 Page 4
`
`

`

`ISSUE SLIP STAPLE AREA (for additional cross references)
`
`DATE
`
`2Z
`
`Non elected
`Interference
`Appeal
`Objected
`
`Date
`
`Claim
`
`x--
`
`101 _
`10
`
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`
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`POSITION
`
`INITIALS
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`
`FEE DETERMINATION
`0O1P E CLASSIFIER
`FORMALITY REVIEW
`
`C
`
`d3I
`
`DaQi
`
`1Rejected
`
`-(Through
`
`INDEX OF CLAIMS
`N
`I
`A
`0
`
`Allowed
`numeral) Canceled
`Restricted
`
`Claim
`
`Date
`
`Claim
`
`Date
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`521
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`Mako Exhibit 1002 Page 5
`
`

`

`~
`
`5
`
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`
`I
`
`Class
`--I -
`
`ca0
`
`I2-~
`
`SEARCHED
`
`SubJ DateJ Exmr
`
`SEARCH NOTES
`(INCLUDING SEARCH STRATEGY)
`
`-7
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`
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`
`INTERFERENCE SEARCHED
`Class
`Sub
`Date
`Exmr
`
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`zi
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`I
`
`I
`
`Mako Exhibit 1002 Page 6
`
`

`

`(12) United States Patent
`DiGioia, III et al
`
`US006205411BI
`US 6,205,411 Ri
`*Mar 20, 2001
`
`(10) Patent No
`(45) Date of Patent
`
`(54) COMPUf[ER ASSISTED SURGERY PLANNER
`AND INTRA OPERATIVE GUIDANCE
`SYSTEM
`
`(75)
`
`Inventors Anthony M DiGioia, III Pittsburgh
`PA (US) David A Simon Boulder CO
`(US) Branislav Jaraniaz Michael K
`Blackwell both of Pittsburgh PA (US)
`Frederick M Morgan Quincy Robert
`V O'loole Brookline both of MA
`(US)
`rakeo Kanade Pittsburgh PA
`(US)
`
`(73) Assignee Carnegie Mellon University
`Pittsburgh PA (US)
`
`()Notice
`
`Subject to any disclaimer the term of this
`patent is extended or adjusted under 35
`U SC 154(b) by 0 days
`
`This patent is subject to a terminal dis
`claimer
`
`(21)
`
`(22)
`
`Appl No 09/189,914
`
`Filed
`
`Nov 12, 1998
`
`Related U S Application Data
`
`(63) Continuation ui part of application No 08/803 993 filed on
`Feb 21 1997 now Pat No 5 880 976
`Int Cl 7
`
`(51)
`
`A61F 2/32 A61F 2/34
`A61F 2/36
`703/11 703/7 623/19
`623/20 623/21 623/22
`(58) Field of Search
`703/11 7 606/86
`606/89 90 91 623/11 16 18 19 20
`21 22 23 914
`
`(52) U S Cl
`
`5 007 936
`5 086 401
`5 141 512
`5242455
`5 251 127
`5 299 288
`5 305 203
`5S360 446
`5 383 454
`
`4/1991
`2/1992
`8/1992
`9/1993
`10/1993
`3/1994
`4/1994
`11/1994
`1/1995
`
`Woolson
`Glassman et al
`Farmer et al
`Skeens et at
`Raab
`Glassman et at
`Raab
`Kennedy
`Bucholz
`
`(List continued on next page)
`
`OTHER PUBLICATIONS
`
`128/898
`700/259
`606/87
`606/130
`606/130
`700/245
`606/1
`128/898
`600/429
`
`A M DiGioia M D D A Simon B Jaramaz M Black
`well F Morgan R V 0 Toole B Colgan E Kischell
`HipNav Pre-operative Planning and Intra-operative Navi
`gational Guidance for Acetabular Implant Placement
`in
`Total Hip Replacement Surgery Proceeding of Computer
`Assisted Orthopedic Surgery Bern Switzerland (1996)
`Robert J Krushell M D Denis W Burke M D and Wil
`ham H Harris M D Range of Motion in Contemporary
`Total Hip Arthroplasty pp 97-101 The Journal of Arthro
`plasty vol 6 No 2 Jun 1991
`Robert J Krushell M D Dennis w Burke M D and
`William H Harris M D Elevated-rim Acetabular Compo
`nents pp 1-6 The Journal of Arthiroplasty vol 6 Oct
`1991
`
`(List continued on next page)
`
`Pi intary Examiner-Kevin J Teska
`Assistant Exaniner-Russell W Frejd
`(74) Attorney Agent ot Firm-Kirkpatrick & Lockhart
`LLP
`
`(57)
`
`ABSTRACT
`
`An apparatus for facilitating the implantation of an artificial
`component in one of a hip joint a knee joint a hand and
`wrist joint an elbow joint a shoulder joint and a foot and
`ankle joint The apparatus includes a pre operative geomet
`ric planner and a pre operative kinematic biomechanical
`simulator in communication with the pre operative geomet
`ric planner
`
`(56)
`
`References Cited
`
`U S PATENT DOCUMENTS
`
`4 341 220
`4 905 148
`
`7/1982 Perry
`2/1990 Crawford
`
`606/130
`382/131
`
`17 Claims, 14 Drawing Sheets
`
`Mako Exhibit 1002 Page 7
`
`

`

`US 6,205,411 Bl
`Page 2
`
`U S PATENT DOCUMENTS
`
`T A Maxian T D Brown D R Pederson and J J
`Callaghan Finite Element Modeling of Dislocation Propen
`sity in Total Hip Arthroplasty p 259-44 4 2 n"d Annual
`Meeting Orthopaedic Research Society Feb 19-22 1996
`Atlanta Georgia
`Vincent Dessenne Stephane Lavallee Remi Julliard Rachel
`Orti Sandra Martelli Philippe Cinquin
`Computer-As
`sisted Knee Anterior Cruciate Ligament Reconstruction
`First Clinical Tests Journal of Image Guided Surgery
`1 59-64 (1995)
`AliHamadeh Stephanelavallee Richard Szehiski Philippe
`Cinquin Olivier Peria Anatomy-based Registration for
`Computer-integrated Surgery pp 212-218 Program of 1
`International Conference on Computer Version Virtual Real
`ity Robotics in Medicine 1995 Nice France
`K Rademacher H W Staudte G Rau Computer Assisted
`Orthopedic Surgery by Means of Individual Templates
`Aspects and Analysis of Potential Applications pp 42-48
`Lutz-P Nolte Lucia J Zamorano Zhaowei Jiang Qinghai
`Wang Frank Langlotz Erich Arm Heiko Visarius A Novel
`Approach
`to Computer Assisted Spine Surgery
`pp
`323-328
`Robert Rohling Patrice Munger John M Hollerbach Terry
`Peters Comparison of Relative Accuracy Between a
`Mechanical
`and
`an Optical Position Tracker
`for
`Image-Guided Neurosurgery Journal of Image Guided Sur
`gery 1 30-34 (1995)
`E Grimson T Lozano-Perez W Wells G Ettinger S
`White R Kikinis Automated Registration for Enhanced
`Reality Visualization in Surgery pp 26-29
`S Lavalle P Sautot J Troccaz P Cinquin P Merloz
`Computer-Assisted Spine Surgery A Technique for Accu
`rate Transpedicular Screw Fixation Using CT Data and a
`3-D Optical Localizer Journal of Image Guided Surgery
`1 65-73 (1995)
`Russell H Taylor Brent D Mittelstadt Howard A Paul
`William Hanson Peter Kazanzides Joel F Zuhars Bill
`Williamson Bela L Musits Edward Glassmian William L
`Bargar An Image-Directed Robotic System for Precise
`Orthopaedic Surgery IEEE Transactions on Robotics and
`Automation vol 10 No 3 Jun 1994
`
`* cited by examiner
`
`606/130
`600/407
`600/414
`600/407
`128/898
`703/7
`703/11
`703/11
`
`5 389 101
`5 408 409
`5 517 990
`5 682 886
`5 733 338
`5 880 976
`5 995 738
`6 002 859
`
`2/1995
`4/1995
`5/1996
`11/1997
`3/1998
`3/1999
`11/1999
`12/1999
`
`Heilbrun et al
`Glassman et at
`Kalfas et al
`Delp et at
`Kamnpner
`DiGioia III et at
`DiGioia III et at
`DiGioia III et al
`OTHER PUBLICATIONS
`George E Lewinnek M D
`Jack L Lewis Ph D Richard
`Tarr M S Clinton L Compere M D and Jerald R Zim
`merman B S Dislocations After Tot-id Hip-Replacement
`Arthroplasties pp 217-220 vol 60-A No 2 Mar 1978
`The Journal of Bone and Joint Surgery Incorporated
`Harlan C Amstutz M D R M Lodwig D J Schurnian
`M D and A G Hodgson Range of Motion Studies for Total
`Hip Replacements pp 124-130 Clinical Orthopaedics and
`Related Research #111 Sep 1975
`T K Cobb M D B F Morrey M D and D M Ilstrup
`M S The Elevated-Rim Acetabular Liner in Total Hip
`Arthroplasty Relationship to Postoperative Dislocation pp
`80-86 The Journal of Bone and Joint Surgery 1996
`D A Simon R V 0 Toole M Blackwell F Morgan A M
`DiGioia
`and T Kan-ide Accur-icy Validation
`in
`Image-Guided Orthopaedic Surgery 2 d Annual Sympo
`sium on Medical Robotics and Computer Assisted Surgery
`Baltimore MD Nov 4-7 h 1995
`David A Simon Martial Hebert and Takeo Kanade Tech
`niques for Fast and Accurate Intrasurgical Registration
`Journal of Image Guided Surgery 1 17-29 (1995 )
`Donald E McCollum M D and William J Gray M D
`Dislocation After Total Hip Arthroplasty pp 159-170
`Clinical Orthopaedics and Related Research No 261 Dec
`1990
`David A Simon Martial Hebert and Takeo Kanade
`Redl-time 3-D Pose Estimation Using a High-Speed Range
`Sensor pp 1-14 Carnegie Mellon University Robotics
`Institute Technical Report CMU-RI-TR-93-24 Nov
`1993
`T A Maxian T D Brown D R Pedersen J J Callaghan
`Femoral Head Containment in ltotal Hip Arthroplasty Stan
`dard vs Extended Lip Liners p 420 42 d Annual Meeting
`Orthopaedic Research Society Feb 19-22 Atlanta Geor
`
`Mako Exhibit 1002 Page 8
`
`

`

`U.S. Patent
`
`U.S. Patent
`Mar 20, 2001
`
`US 692059411 BI
`Sheet 1 of 14US62541B
`
`1
`
`Skeletal
`Data
`Source
`
`10
`
`30
`
`FIG. 1
`
`Mako Exhibit 1002 Page 9
`
`

`

`U. S. Patent
`
`U.S. Patent
`Mar 20, 2001
`
`US 692059411 BI
`Sheet 2 of 14US62541R
`
`IObtain Skeletal Structure Geometric Data Of
`I
`A Joint In A Patient
`
`Create Computational Models Of The Skeletal
`Structure Using The Skeletal Geometric Data And
`Computational Models Of The Implant Components
`
`40
`
`042
`
`44
`
`50-
`
`Perform Biomnechanical Simulations Of The Movement
`Of The Joint At Test Positions Using The Models
`
`Claculate A Range Of Motion Of The
`Joint Based On The Simulated Movement
`
`46
`
`( 48
`
`Determine An Implant Position For The Implant
`Components Based On The Calculated Range Of Motion
`
`Identify The Implant Position In The Joint Model
`
`60
`
`Align The Models Of The Skeletal
`Structure With The Patient's Joint
`
`Track The Position Of The Patient's
`Joint, And The Implant Components
`Using The Aligned Models
`
`FIG 2
`
`54
`
`56
`
`Mako Exhibit 1002 Page 10
`
`

`

`Mar 20, 2001
`U.S. Patent Mr2,20
`
`Sheet 3 of 14
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`Mako Exhibit 1002 Page 11
`
`

`

`U.S. Patent
`
`Mar 20, 2001
`
`Sheet 4 of 14
`
`US 6,205,411 BI
`
`20
`
`30
`
`302
`
`300
`
`FIG 3a
`
`Mako Exhibit 1002 Page 12
`
`

`

`U.S. Patent
`
`Mar 20, 2001
`
`Sheet 5 of 14
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`6,205,411 RI
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`Mako Exhibit 1002 Page 13
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`

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`Mar 20, 2001
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`

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`U. S. Patent
`
`Mar 20, 2001
`
`Sheet 7 of 14
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`U.S.Patnt
`6,205,411 Bl
`ar 2, 201 hect7 o 14US
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`90
`
`Mako Exhibit 1002 Page 15
`
`

`

`U.S. Patent
`
`Mar 20, 2001
`
`Sheet 8 of 14
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`U.S.Patnt
`6,205,411 RI
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`Mako Exhibit 1002 Page 16
`
`

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`U.S. Patent
`
`Mar 20, 2001
`
`Sheet 9 of 14
`
`U.S.Patnt
`6,205,411 Bl
`ar 2, 201 hect9 o 14US
`
`70
`
`FIG 8
`
`Mako Exhibit 1002 Page 17
`
`

`

`U.S. Patent
`
`Mar 20, 2001
`
`Sheet 10 of 14
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`US 6,205,411 BI
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`Mako Exhibit 1002 Page 18
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`

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`U.S. Patent
`
`Mar 20, 2001
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`Sheet 11 of 14
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`Mako Exhibit 1002 Page 19
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`

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`U.S. Patent
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`Mar 20, 2001
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`Mako Exhibit 1002 Page 20
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`

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`U. S. Patent
`
`Mar 20, 2001
`
`Sheet 13 of 14
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`US 6,205,411 BI
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`202
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`204
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`Mako Exhibit 1002 Page 21
`
`

`

`U.S. Patent
`
`Mar 20, 2001
`
`Sheet 14 of 14
`
`U.S.Patnt
`6,205,411 Bl
`ar 2,201 Scct 4 o 14US
`
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`Mako Exhibit 1002 Page 22
`
`

`

`US 6,205,411 BI
`
`COMPUTER ASSISTED SURGERY PLANNER
`AND IN fRA OPERATIVE GUIDANCE
`SYSTEM
`
`CROSS REFERENCE TO RELATED
`APPLICArIONS
`This application is a continuation in part application of
`application Ser No 08/803 993 filed Feb 21 1997
`
`STATEMENT REGARDING FEDERALLY
`SPONSORED RESEARCH OR DEVELOPMENT
`
`This work was supported in part by a National Challenge
`grant from the National Science Foundation Award IRI
`9422734
`
`BACKGROUND OF THE INVENTION
`The present invention is directed generally to the implan
`tation of artificial joint components osteochondral grafts
`and osteotomy and more particularly to computer assisted
`surgical implantation of artificial joint components during
`replacement and revision procedures computer assisted
`osteochondral grafts and computer assisted osteotomy
`Total hip replacement (THR) or arthroplasty (THA)
`operations have been performed since the early 1960s to
`repair the acetabulum and the region surrounding it and to
`replace the hip components such as the femoral head that
`have degenerated Currently approximately 200 000 THR
`operations are performed annually
`in the United States
`alone of which approximately 40 000 are redo procedures
`otherwise known as revisions The revisions become nec
`essary due to a number of problems that may arise during the
`lifetime of the implanted components such as dislocation
`component wear and degradation
`-ind loosening of the
`implant from the bone
`Dislocation of the femoral head from
`the acetabular
`component or cup is considered one of the most frequent
`early problems associated with THR because of the sudden
`physical and emotional hardship brought on by the dislo
`cation The incidence of dislocation following the primary
`THR surgery is approximately 2-6% and the percentage is
`even higher for revisions While dislocations can result from
`a variety of causes such as soft tissue laxity and loosening
`of the implant
`the most common cause is impingement of
`the femoral neck with either the rim of an acetabular cup
`implant or the soft tissue or bone surrounding the implant
`Impingement most frequently occurs as a result of the
`malposition of the acetabular cup component within the
`pelvis
`Some clinicians and researchers have found incidence of
`impingement and dislocations can be lessened if the cup is
`oriented specifically to provide for approximately 15 of
`anteversion and 45 of abduction however this incidence is
`also related to the surgical approach For example McCo
`llumn et al cited a comparison of THAs reported in the
`orthopaedic literature that revealed a much higher incidence
`of dislocation in patients who had THAs with a posterolat
`eral approach McCollum D E and W J Gray Disloca
`tion after total hip arthroplasty (causes and prevention)
`Clinical Orthopimedics and Related Research Vol 261
`p 159-170 (1990) McCollum s data showed that when the
`patient is placed in the lateral position for a posterolateral
`THA approach the lumbar lordotic curve is flattened and the
`pelvis rniy be flexed as much as 35
`If the cup was oriented
`at 15-20 of flexion with respect to the longitudinal axis of
`the body when the patient stood up and the postoperative
`
`5
`
`lumbar lordosis was regained
`the cup could be retroverted
`as much as 10 -15 resulting in an unstable cup placement
`Lewinnek et al performed a study taking into account the
`surgical approach utilized and found that the cases falling in
`the zone of 15 ±10 of anteversion and 40 ±10 of abduc
`tion have an instability rate of 1 5% compared with a 6%
`instability rate for the cases falling outside this zone Lewin
`nek G E et al Dislocation after total hip replacement
`arthroplasties
`Journal of Bone and Joint Surgery Vol
`10 60 A No 2 p 217-220 (March 1978) The Lewinnek work
`essentially verifies that dislocations can be correlated with
`the extent of malpositioning as would be expected The
`study does not address other variables such as implant
`design and the anatomy of the individual both of which are
`15 known to greatly affect the performance of the implant
`The design of the implant significantly affects stability as
`well A number of researchers have found that the head to
`neck ratio of the femoral component is the key factor of the
`implant impingement see Ainstutz H C et al Range of
`20 Motion Studies for Total Hip Replacements Clinical
`Orthopaedics and Related Research Vol 111 p 124-130
`(September 1975) Krushell et al additionally found that
`certain long and extra
`long neck designs of modular
`implants can have an adverse effect on the range of motion
`25 Krushell R J Burke D W and Harris W H Range of
`motion in contemporary total hip arthroplasty (the impact of
`modular head neck components)
`The Journal of
`Arthiroplasty Vol 6 p 97-101 (February 1991) Krushell et
`al also found that an optimally oriented elevated rim liner
`30 in an acetabular cup implant may improve the joint stability
`with respect to implant impingement Krushell R J Burke
`D W and Harris W H
`Elevated rim acetabular compo
`nents Effect on range of motion and stability in total hip
`arthroplasty
`The Journal of Arthroplasty Vol 6
`35 Supplement p 1-6 (October 1991) Cobb et al have shown
`a statistically significant reduction of dislocations in the case
`of elevated rim liners compared to standard liners Cobb T
`K Morrey B F Ilstrup D M
`The elevated rim acetabu
`lar liner in total hip arthroplasty Relationship to postopera
`40 tive dislocation
`Journal of Bone and Joint Surgery Vol
`78 A No 1 p 80-86 (January 1996) The two year prob
`ability of dislocation was 2 19% for the elevated liner
`compared with 3 85% for standard liner Initial studies by
`Maxian ct al using a finite element model indicate that the
`45 contact stresses and therefore the polyethylene wear are not
`significantly increased for elevated rim liners however
`points of impingement and subsequent angles of dislocation
`for different liner designs are different as would be expected
`Maxian T A et al Femoral head containment in total hip
`50 arthroplasty Standard vs extended lip liners 42nd Annual
`meeting Orthopaedic Research society p 420 Atlanta Ga
`(Feb 19-22 1996) and Maxian T A et al Finite element
`modeling of dislocation propensity in total hip arthroplasty
`42nd Annual meeting Orthopaedic Research society p
`55 259-64 Atlanta Ga (Feb 19-22 1996)
`An equally important concern in evaluating the disloca
`tion propensity of an implant are variations in individual
`anatomnies As a result of anatomical variations
`there is no
`single optimal design and orientation of hip replacement
`60 components and surgical procedure to minimize the dislo
`cation propensity of the implant For example
`the pelvis can
`assume difterent positions and orientations depending or
`whether an individual is lying supine (as during a CT scan
`or routine X rays) in the lateral decubitis position (as during
`65 surgery) or in critical positions during activities of normal
`daily living (like bending over to tie shoes or during normal
`gait) The relative position of the pelvis and leg when
`
`Mako Exhibit 1002 Page 23
`
`

`

`US 6,205,411BI
`
`10~
`
`3
`defining a neutral plane from which
`the angles of
`movement anteversion abduction etc
`are calculated will
`significantly influence the measured amount of motion per
`mitted before
`impingement and dislocation occurs
`Therefore it is necessary to uniquely define both the neutral 5
`orientation of the femur relative to the pelvis for relevant
`positions and activities and the relations between the femur
`with respect to the pelvis of the patient during each segment
`of leg motion
`Currently most planning for acetabular implant place
`ment and size selection is performed using acetate templates
`and a single anterior posterior x ray of the pelvis Acetabular
`templating is most useful for determining the approximate
`size of the acetabular component however
`it is only of
`limited utility for positioning of the implant because the 15
`x rays provide only a two dimensional image of the pelvis
`Also
`the variations in pelvic orientation can not be more
`fully considered as discussed ibove
`Intra operative positioning devices currently used by sur 2
`geons attempt
`to align
`the acetabular component with 2
`respect to the sagittal and coronal planes of the patient B F
`Morrey editor Reconstructive Surgery of the Joints
`chapter Joint Replacement Arthroplasty pages 605-608
`Churchill Livingston 1996 These devices assume that the 2
`patient s pelvis and trunk are aligned in a known orientation
`2
`and do not take into account individual variations in a
`patient s anatomy or pelvic position on the operating room
`table I1 hese types of positioners can lead to a wide discrep
`ancy between
`the desired and actual implant placement 3
`possibly resulting in reduced range of motion impingement 3
`and subsequent dislocation
`Several attempts have been made to more precisely pre
`pare the -icetabular region for the impl'int components U S
`Pat No 5 007 936 issued to Woolson is directed to estab 3
`lishing a reference plane through which the acetabulumn can
`be reamed and generally prepared to receive the acetabular
`cup implant The method provides for establishing
`the
`reference plane based on selecting three reference points
`preferably the 12 o clock position on the superior rim of the 4
`acetabulum ad two other reference points such as a point
`in the posterior rim and the inner wall that are a known
`distance from the superior rim The location of the superior
`is determined by performing a series of computed
`rim
`tomography (CI) scans that are concentrated near the supe 45
`nior rim and other reference locations in the acetabular
`region
`In the Woolson method calculations are then performed
`to determine a plane in which the rim of the acetabular cup
`should be positioned to allow for a predetermined rotation Of 50
`the femoral head in the cup The distances between the
`points and the plane are calculated and an orientation jig is
`calibrated to define the plane when the jig is mounted on the
`reference points During the surgical procedure
`the surgeon
`must identify the 12 o clock orientation of the superior rim 5
`and the reference points In the preferred mode the jig is
`to the acetabulumn by drilling a hole
`fixed
`through the
`reference point on the inner wall of the acetabulumn and
`affixing the jig to the acetabulum The jig incorporates a drill
`guide to provide for reaming of the acetabulumn in
`the 60
`selected plane
`A number of difficulties exist with the Woolson method
`For example the preferred method requires drilling a hole in
`the -icetabulumn Also visual recognition of the reference
`points must be required and precision placement on the jig 65
`on reference points is performed in a surgical setting In
`addition proper alignment of the reaming device does not
`
`ensure that the implant will be properly positioned thereby
`establishing a more lengthy and costly procedure with no
`guarantees of better results These problems may be a reason
`why the Woolson method has not gained widespread accep
`tance in the medical community
`In U S Pat Nos 5 251 127 and 5 305 203 issued to Raab
`a computer aided surgery apparatus is disclosed in which a
`reference jig is attached to a double self indexing screw
`previously attached to the patient
`to provide for a more
`consistent alignment of the cutting instruments similar to
`that of Woolson However unlike Woolson Raab et al
`employ a digitizer and a computer to determine and relate
`the orientation of the reference jig and the patient during
`surgery with the skeletal shapes determined by tomography
`Similarly U S Pat Nos 5 086 401 5 299 288 and 5 408
`409 issued to Glassman et al disclose an image directed
`surgical robotic system for reaming a human femur to accept
`a femoral stem and head implant using a robot cutter system
`In the system at least three locating pins are inserted in the
`femur and CT scans of the femur in the region containing the
`locating pins are performed During the implanting
`procedure
`the locating pins are identified on the patient as
`discussed in col 9 lines 19-68 of Glassman s 401 patent
`The location of the pins during the surgery are used by a
`5computer to transform CT scan coordinates into the robot
`cutter coordinates which are used to guide the robot cutter
`during reaming operations
`While the Woolson Raab and Glassman patents provide
`methods and apparatuses that further offer the potential for
`)increased accuracy and consistency in the preparation of the
`acetabular region
`to receive
`implant components
`there
`remain a number of difficulties with the procedures A
`significant shortcoming of the methods and apparatuses is
`that when used for implanting components in a joint there
`5are underlying assumptions that the proper position for the
`placement of the components in the joints has been deter
`mined and provided as input to the methods and apparatuses
`that are used to prepare the site As such
`the utility and
`benefit of the methods and apparatuses are based upon the
`)correctness and quality of the implant position provided as
`input to the methods
`In addition both the Raab and Glassman methods and
`apparatuses require that fiducial markers be attached to the
`patient prior to performing
`tomography of the patients
`5Following the tomography the markers must either remain
`attached to the patient until the surgical procedure is per
`formed or the markers must be reattached at the precise
`locations to allow the transformation of the tomographic
`data to the robotic coordinate system either of which is
`)undesirable and/or difficult in practice
`Thus the need exists for apparatuses and methods which
`overcome among others the above discussed problems so
`as to provide for the proper placement and implantation of
`the joint components
`to provide an improved range of
`5motion and usage of the joint following joint reconstruction
`replacement and revision surgery
`BRIEF SUMMARY OF THE INVENTION
`The present invention
`is directed
`to an apparatus for
`)facilitating the implantation of an artificial component in one
`of a hip joint a knee joint a hand and wrist joint an elbow
`joint a shoulder joint and a foot and ankle joint The
`apparatus includes a pre operative geometric planner and a
`pre operative kinematic biomnechanical simulator in com
`5munication with the pre operative geometric planner
`The present invention provides the medical practitioner a
`tool to precisely determine an optimal size and position of
`
`Mako Exhibit 1002 Page 24
`
`

`

`US 6,205,411 Bl
`
`5
`artifi(,ial components in a joint to provide a desired range of
`motion of the joint following surgery and to substantially
`lessen
`the possibility of subsequent dislocation
`Accordingly
`the present invention provides an effective
`solution to problems heretofore encountered with precisely 5
`determining the proper sizing and placement of an artificial
`component to be implanted
`in a joint
`In addition
`the
`practitioner is afforded a less invasive method for executing
`the surgical procedure in accordance with the present inven
`tion These advantages and others will become apparent i0
`from the following detailed description
`
`20
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`A preferred embodiment of the invention will now be 1
`described by way of example only with reference to the
`accompanying figures wherein like members bear like ref
`erence numerals and wherein
`FIG 1 is a system overview of a preferred embodiment of
`the present invention
`FIG 2 is a flow chart illustrating the method of the present
`invention
`FIG 3 is a schematic layout of the apparatus of the present
`invention being used in a hip replacement procedure
`FIG 3A is a diagram illustrating an embodiment of a 25
`system which can be used to find the coordinates of points
`on a bony surface
`FIGS 4(a-c) show the creation of the pelvic model using
`two dimensional scans of the pelvis (a) from which skeletal 3
`geometric data is extracted as shown in (b) and used to 3
`create the pelvic model (c)
`FIGS 5(a-c) show the creation of the femur model using
`two dimensional scans of the femur (a) from which skeletal
`geometric data is extracted as shown in (b) and used to 3
`create the femur model (c)
`FIG 6 shows the sizing of the acetabular cup in the pelvic
`model
`FIGS 7(a-e) show the creation of different sized femoral
`implant models (a) and the fitting of the femoral implant 40
`model into a cut femur (b--e)
`FIG 8 is a schematic drawing showing the range of
`motion of a femoral shaft and the impingement (in dotted
`lines) of a temoral shatt on an acetabular cup
`FIGS 9(a-b) show the range of motion results from 45
`biomechanical simulation of two respective acetabular cup
`orientations
`FIGS 10(a) and (b) show the registration of the pelvis and
`femur
`FIGS 11(a) and (b) show an image guided total knee
`arthroplasty and
`FIGS 12(a-c) show the planning of a femoral osteotomy
`DETAILED DESCRIPTION Of TIL5
`INVENTION
`The apparitus 10 of the present invention will be
`described generally with reference to the drawings for the
`purpose of illustrating the present preferred embodiments of
`the invention only and not for purposes of limiting the same 60
`A system overview
`is provided in FIG 1 and general
`description of the method of the present invention is pre
`sented in flow chart form in FIG