`
`FILE HISTORY
`US 5,880,976
`
`5,880,976
`PATENT:
`INVENTORS: DiGioia III, Anthony M.
`Simon, David A.
`Jaramaz, Branislav
`Blackwell, Michael K.
`Morgan, Frederick M.
`O'Toole, Robert V.
`Kanade, Takeo
`
`TITLE:
`
`Apparatus and method for facilitating the
`implantation of artificial components in
`joints
`
`APPLICATION
`NO:
`FILED:
`ISSUED:
`
`US1997803993A
`
`21 FEB 1997
`09 MAR 1999
`
`COMPILED:
`
`03 SEP 2014
`
`Mako Exhibit 1003 Page 1
`
`

`

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`DEPT OF COMMJ PAT & TM-PO4L(Rv29)
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`-----
`
`FT-M (OV 1-04
`
`PARTS OF APPLICATION
`FILED SEPARATELYplia
`
`NOTICE OF ALLOWANCE MAILED
`
`~-Total
`
`o
`
`m
`
`CLAIMS ALLOWED
`Claims
`Print Claim
`
`LAssistant Examiner/
`ISSUE FEE,4-A &.L u
`-Q7>
`Dat Paid
`Amount Due
`
`T
`P'RI ARYEAfj
`
`DRAWING
`Sheets Drwg Figs Drwg
`
`Print Fig-
`
`Label
`Area
`
`Formn rO436A
`(Rev 8/92)
`
`I UE
`BATCH
`TPmary Examiner NUMBER
`PREPARED FOR ISSUE
`
`WARNING
`
`The information disclosed herein may be restnicted U
`thorized disclosure may be prohibited
`by the United States Code Title 35 Sections 122 1 and 368 Possessl6n outside the U S
`Patent & Trademark Office is restricted to authorize employees and contractors only
`
`MOE Fff MOLE
`
`Mako Exhibit 1003 Page 2
`
`

`

`51880,976
`
`APPARATUS AND METHOD FOR FACILITATING THE IMPLANTATION OF
`ARTIFICIAL COMPONENTS IN JOINTS
`
`Transaction History
`
`3/24/1997
`Initial Exam Team nn
`6/5/ 1997 Notice Maiied Appiication Incompiete Fiiing Date Assigned
`9/8/1997 Appiication Is Now Complete
`9/12/1997 Application Dispatched from OIPE
`IFW Scan & PACR Auto Security Review
`9/12/1997
`11/4/1997 Case Docketed to Examiner in GAU
`5/13/1998 Case Docketed to Examiner in GAUI
`6/24/1998 Mail Notice of Allowance
`6/24/1998 Notice of Allowance Data Verification Completed
`9/22/1998
`Issue Fee Payment Verified
`9/22/1998 Mailroom Date of Drawing(s)
`9/30/1998 Application Ordered to Match Drawing(s)
`9/30/1998 Drawing(s) Received at Publications
`12/14/1998 Application Received to Match Drawing(s)
`12/14/1998 Preexamination Location Change
`12/23/1998 Drawing(s) Matched to Application
`12/29/1998 Drawing(s) Processing Completed
`2/1/1999
`Issue Notification Mailed
`3/9/1999 Recordation of Patent Grant Mailed
`Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with
`10/7/1999 37 CFR 1 27
`
`Mako Exhibit 1003 Page 3
`
`

`

`AP)PROVED FORIICENSE F
`
`WIIA%-APRO 19 7,94
`
`08803993
`
`____
`__
`
`CONTENTS
`
`
`
`____ ____
`
`
`
`_ ____
`
`___Date
`
`Received
`or
`Mailed
`
`Application
`
`.
`
`/papers
`
`& OzciT
`
`PYU GH~ANI MAR 0 9
`
`(FRONT)
`
`Rik~
`
`Date
`Entered
`orCounted
`
`2 3 4 5 6
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
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`20
`
`21
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`22
`
`-23
`24
`
`25
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`26
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`27
`
`29
`
`30
`
`___ __
`
`__
`
`__28
`
`Mako Exhibit 1003 Page 4
`
`

`

`PATENT NUMBER
`
`4t
`
`4'
`
`ORIGINAL CtkSII
`
`MM
`
`[CLAS
`
`I
`~APPq(CATION SERIAN6ME
`
`r
`
`-dr-
`
`~ APPLICANT S NAME (PLEASE PRINT)
`
`I
`
`CROSSREFENCE()
`SBLASS
`I__ I
`(imr6BCLASS PER BLOCK)
`
`CLASS F'
`~z3
`zz2
`
`~IF REISSUE ORIGINAL PATENT NUMBER
`
`4
`
`INTERNATIONAL CLASSIFIC
`ICATION
`
`GROUP
`ART UNIT
`
`1 1
`
`1-1
`
`-SU
`iPTO 270
`5REV0")
`
`f
`
`~
`
`ISU
`
`[A=SSIST4N EXAMINER (PLEASe STAM.WRINT FULL NAME)
`sice-44 V
`76 RMARY EXAMINER (PLEAS
`LSIIAINSI
`'LPPATENT
`LSIICTO
`
`TAMP OR PRINT FULL NAME
`. ~USDPRMN FCMEC
`AND TRAGEMARK OFfla
`
`.
`
`Mako Exhibit 1003 Page 5
`
`

`

`POSITION
`CLASSIFIER
`EXAMINER
`TYPIST
`VERIFIER
`CORPS CORR
`SPEC_HAND
`FILE MAINT
`DRAFTING
`
`Staple Issue Slip Here
`
`ID NO
`
`DATE
`
`_47h_
`
`___
`
`___
`
`___
`
`___
`
`___
`
`_
`
`_
`
`_
`
`_
`
`_
`
`_
`
`_
`
`_
`
`_
`
`_
`
`__
`
`_
`
`_
`
`_
`
`_
`
`INDEX OF CLAIMS
`
`Claim
`
`Date
`
`Claim
`
`Date
`
`-
`
`q9
`10 10
`
`12
`13
`Iq 14
`
`_
`
`_
`
`1*7 17_
`
`Z21_
`
`ZJ241__
`25
`26
`27
`. 28-
`291
`30
`31
`32
`33
`34j
`351
`361
`.371
`381
`391
`40
`.41
`42
`43
`44
`45
`46
`.47.
`48
`
`- 501
`
`-
`
`-
`
`-
`
`-
`
`-
`
`-
`
`(Through numberal)
`
`SYMBOLS
`Rejected
`Allowed
`Canceled
`Restricted
`Non-elected
`Interference
`Appeal
`Objected
`
`1
`
`0
`151 1
`52
`53
`54
`55
`56
`57
`58
`59
`-60.
`161 1
`62
`63
`64
`65
`166 1_
`1671
`68
`69
`70
`71
`72
`73
`74
`.75.
`1761
`771
`78
`79
`80
`81
`821
`831
`841
`85
`86
`87
`1881
`89
`90
`91
`92,
`93
`94
`95
`96
`97
`98
`99
`1001
`
`Mako Exhibit 1003 Page 6
`
`

`

`___SEARCHED
`Class
`
`Sub
`
`Date
`
`Exmr
`
`5-7 6111
`
`r
`
`/
`
`SEARCH NOTES
`Date
`
`Exmr
`
`INTERFERENCE SEARCHED
`Class
`Sub
`Date
`Exmr
`
`61zlzoe
`
`Mako Exhibit 1003 Page 7
`
`

`

`United States Patent [19]
`DiGioia III et al
`
`[54] APPARATUS AND METHOD FOR
`FACILITATING THE IMPLANTATION OF
`ARTIFICIAL COMPONENTS IN JOINTS
`
`[75]
`
`Inventors Anthony M DiGioia III Pittsburgh
`Pa David A Simon Boulder Colo
`Branislav Jaramaz Mi(-hael K
`Blackwell both of Pittsburgh Pa
`Frederick M Morgan Quincy Robert
`V O'Toole Brookline both of Mass
`Takeo Kanade Pittsburgh Pa
`
`[73] Assignee Carnegie Mellon University
`Pittsburgh Pa
`
`[21] Appl No 803,993
`
`[22] Filed
`
`Feb 21, 1997
`
`[51]
`
`Int Cl 6
`
`[52] U S CI
`[58] Field of Search
`
`A61F 2/32 A61F 2/34
`A61F 2/36
`364/578 623/22
`1
`364/578 606/86
`606/89 90 91 623/11 22 23
`
`[56]
`
`R
`
`eferences Cited
`
`TENT DOCUMENTS
`
`U S PA]
`7/1982
`4 341 220
`2/1990
`4 905 148
`5007936
`4/1991
`5 086 401
`2/1992
`9/1993
`5 242 455
`5 251 127 10/1993
`3/1994
`5 299 288
`5 305 203
`4/1994
`1/1995
`5 383 454
`5 389 101
`2/1995
`5 408 409
`4/1995
`5 517 990
`5/1996
`
`Perry
`Crawford
`Woolson
`Glassmnan et al
`Skeens et al
`Raab
`Glassman et al
`Raab
`Bucholz
`Heilbrun et al
`Glassmnan et al
`Kalfas et al
`OTHER PUBLICATIONS
`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
`
`128/630
`364/413 1
`623/23
`395/94
`606/130
`364/413 13
`395/80
`364/413 13
`128/653 1
`606/130
`364/413 13
`128/653 1
`
`III1101111111ll111101 H 111111
`i1101111111111
`
`US005880976A
`[11] Patent Number
`[45] Date of Patent
`
`5,880,976
`Mar 9, 1999
`
`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
`hamn H Harris M D Range of Motion in Contemporary
`Total Hip Arthiroplasty 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 Coin
`pontents pp 1-6 The Journal of Arthroplasty vol 6 Oct
`1991
`
`(List continued on next page)
`Pi inary Exaniner-Vincent N Trans
`Assistant Examiner-Russell W Frejd
`Attorney Agent oi Fuin-Kirkpatrick & Lockhart LLP
`
`ABSTRACT
`
`[57]
`Apparatuses and methods are disclosed for determining an
`implant position for at least one artificial component in a
`joint and facilitating the implantation thereof The appara
`tuses and methods include creating a joint model of a
`patient s joint into which an artificial component is to be
`implanted and creating a component model of the artificial
`component The joint and artificial component models are
`used to simulate movement in the patient s joint with the
`artificial component in a test position The component model
`and the joint model are used to calculate a range of motion
`in the joint for at least one test position based on the
`simulated motion An implant position
`including angular
`orientation
`in the patient s joint is determined based on a
`predetermined range of motion and the calculated range of
`motion In a preferred embodiment
`the implant position can
`be identified in the joint model and the joint model aligned
`with the joint by registering positional data from discrete
`points on the joint with the joint model Such registration
`also allows for tracking of the joint during surgical proce
`dures A current preferred application of the invention is for
`determining the implant position and sizing of an acetabular
`cup and femoral implant for use in total hip replacement
`surgery
`
`24 Claims, 11 Drawing Sheets
`
`Ob ISkletal Str t
`AJ 11 AP t
`
`eWil0StahOf
`
`40
`
`C C p toal Mo IO01Th SkOh
`Smmo oU ITh S lIGeo nc D And
`IodelOf Th I pltCompo
`Co pol
`Is
`
`1
`FpePd -B hom Is. 1. 0OITh. M
`0Th iI A T Posftnos U gTh ode
`
`I
`
`44
`
`-F
`Cacuat A R g OfIM I tl h
`
`46
`
`te0.1e I ApLanoP bF Th Ip
`
`Id hfy Theol plan P s48oI Th Join M 0e
`
`41
`
`52
`
`60-,
`
`tgnTh Mo IO The SkI
`Srw IWthTheP mot Jo
`
`106
`T ckTh Pos OTh Paten
`J Int Arid T
`op C pone
`A gTh ApaodModel
`
`Mako Exhibit 1003 Page 8
`
`

`

`5,880,976
`Page 2
`
`OTHER PUBLICATI7ONS
`
`George E Lewinnek M D Jack L Lewis Ph D Richard
`Tarr M S Clinton L Compere M D and Jerald R Zimn
`merman B S Dislocations After Total Hip-Replacement
`Arthroplasties pp 217-220 vol 60-A No 2 Mar 1978
`The Journal of Bone and Joint Surgery Incorporated
`Harlan C Arnstutz M D R M Lodwig D J Schurman
`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 Kanade Accuracy Validation
`in
`Image-Guided Orthopaedic Surgery 2 d Annual Sympo
`sium on Medical Robotics and Computer Assisted Surgery
`Baltimore MD Nov 4-71 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 Arthroplasty pp 159-170 Clinical
`Orthopaedics and Related Research No 261 Dec 1990
`David A Simon Martial Hebert and Takeo Kanade Real-
`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 Total Hip Arthroplasty Stan
`dard vs Exended Lip Liners p 420 42 d Annual Meeting
`Orthopaedic Research Society Feb 19-22 Atlanta Geor
`gia
`T A Maxian T D Brown D R Pedersen and J J
`Callaghan Finite Element Modeling of Dislocation Propen
`sity in Total Hip Arthroplasty pp 259-344 42 d Annual
`Meeting 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)
`Ali Hamadeh Stephane Lavallee Richard Szeliski Philippe
`Cinquin Olivier Penia 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 Visanus A Novel
`pp
`Approach
`to Computer Assisted Spine Surgery
`323-328
`
`Robert Rohlmng 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)
`'laylor Brent D Mittelstadt Howard A Paul
`Russell H
`William Hanson Peter Kazanzides Joel F Zuhars Bill
`Williamson Bela L Musits Edward Glassman William L
`Bargar An Image-Directed Robotic System for Precise
`Orthopaedic Surgery IEEE Transactions on Robotics and
`Automation vol 10 No 3 Jun 1994
`
`Mako Exhibit 1003 Page 9
`
`

`

`Mar 9, 1999
`U.S. PatentMa9,19She1of158097
`
`Sheet I of 11
`
`598809976
`
`,.,30
`
`FIGi1
`
`Mako Exhibit 1003 Page 10
`
`

`

`Mar 9, 1999
`U.S. PatentMa9,19She2of158097
`
`Sheet 2 of 11
`
`598809976
`
`40
`
`Obtain Skeletal Structure Geometric Data Of
`A Joint In A Patient
`
`Create Computational Models Of The Skeletal
`Structure Using The Skeletal Geometric Data And
`Computational Models Of The Implant Components
`
`50 ,
`
`Perform Biomechanical 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
`
`42
`
`44
`
`46
`
`Determine An Implant Position For The Implant
`
`Components Based On The Calculated Range Of MotionV
`
`(1"48
`
`52
`
`Identify The Implant Position In The Joint Mode]l
`
`54
`
`56
`
`Track The Position Of The Patient's
`Joint, And The Implant Components
`Using The Aligned Models
`
`60O-
`
`FIG 2
`
`Mako Exhibit 1003 Page 11
`
`

`

`U. S. Patent
`
`Mar 9, 1999
`
`Sheet 3 of 11
`
`5,880,976
`
`co)
`0
`
`Mako Exhibit 1003 Page 12
`
`

`

`Mar 9, 1999
`U.S. PatentMa9,19She4of158097
`
`Sheet 4 of 11
`
`598809976
`
`C.)
`
`0L
`
`L
`
`.0
`
`0
`
`7
`
`0D
`
`(0
`
`Mako Exhibit 1003 Page 13
`
`

`

`U.S. Patent
`
`Mar 9, 1999
`
`Sheet 5 of 11
`
`5,880,976
`
`C\~j
`0)
`
`(0c CC
`
`106O
`
`0
`
`13
`
`I
`
`Mako Exhibit 1003 Page 14
`
`

`

`Mar 9, 1999
`U.S. PatentMa9,19She6of158097
`
`Sheet 6 of 11
`
`598809976
`
`90
`
`FIG 6
`
`Mako Exhibit 1003 Page 15
`
`

`

`U.S. Patent
`
`Mar 9, 1999
`
`Sheet 7 of 11
`
`5,880,976
`
`~0
`
`0
`
`cz.
`
`0L
`
`0 L
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`0
`
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`
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`Mako Exhibit 1003 Page 16
`
`

`

`U.S. Patent
`
`U.S. PatentMar
`9, 1999
`Sheet 8 of 115,897
`
`598809976
`
`70
`
`FIG 8
`
`Mako Exhibit 1003 Page 17
`
`

`

`U.S. Patent
`
`Mar 9, 1999
`
`Sheet 9 of 11
`
`5,880,976
`
`~0U.
`
`cr)
`0
`
`Mako Exhibit 1003 Page 18
`
`

`

`U.S. Patent
`
`Mar 9, 1999
`
`Sheet 10 of 11
`
`5,880,976
`
`3DI
`
`cz
`
`LL
`
`x
`
`/
`
`Mako Exhibit 1003 Page 19
`
`

`

`U.S. Patent
`
`Mar 9, 1999
`
`Sheet 11 of 11
`
`5,880,976
`
`43
`
`'4
`
`92
`
`FIG 10b
`
`Mako Exhibit 1003 Page 20
`
`

`

`5,880,976
`
`APPARATUS AND METHOD FOR
`FACILITATING THE IMPLANTATION OF
`ARTIFICIAL COMPONENTS IN JOINTS
`
`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
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`
`Not Applicable
`
`BACKGROUND OF THE INVENTION
`
`5
`
`10
`
`15
`
`30
`
`The present invention is directed generally to the implan
`tation of artifici'il joint components and more particularly
`to computer assisted surgical implantation of artificial 2
`acetabular and femoral components during total hip replace
`2
`ment and revision procedures
`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 25
`replace the hip components such as the femoral head that
`have degenerated Currently approximately 200 000 THR
`in the United States
`operations are performed annually
`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 and loosening of the
`implant from the bone
`Dislocation of the femoral head from
`the acetabular 35
`is considered one of the most frequent
`component or cup
`early problems associated with THR because ot 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 40
`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 rum ot an acetabular cup
`implant or the soft tissue or bone surrounding the implant 45
`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 50
`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
`Ilum et al cited a comparison of THAs reported in the
`orthopaedic literature that revealed a much higher incidence 55
`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 Orthopaedics and Related Research Vol 261
`p 159-170 (1990) McCollum s data showed that when the 60
`patient is placed in the lateral position for a posterolateral
`THA aipproach the lumbar lordotic curve is flattened and the
`pelvis may be flexed as much as 35
`It the cup was oriented
`at 15 -20 of flexion with respect to the longitudinal axis of
`the body when the p)atient stood up and the postoperative 65
`lumbar lordosis was regained the cup could be retroverted
`as much as 10 -15
`resulting in an unstable cup placement
`
`2
`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
`Journal of Bone and Joint Surgery Vol
`arthroplasties
`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
`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 Amstutz H C et al Range of
`Clinical
`Motion Studies for Total Hip Replacements
`Orthopaedics and Related Research Vol 111 p 124-130
`(September 1975) Krushell et al additionally found that
`long and extra long neck designs of modular
`certain
`implants can have an adverse effect on the range of motion
`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
`Arthroplasty Vol 6 p 97-101 (February 1991) Krushell et
`al also found that an optimally oriented elevated rim liner
`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
`The Journal of Arthroplasty Vol 6
`arthroplasty
`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
`Journal of Bone and Joint Surgery Vol
`tive dislocation
`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 et al using a finite element model indicate that the
`contact stresses and therefore the polyethylene wear are not
`increased for elevated rim liners however
`significantly
`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
`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
`259-64 Atlanta Ga (Feb 19-22 1996)
`An equally important concern in evaluating the disloca
`5tion propensity of an implant are variations in individual
`there is no
`anatomies As a result of anatomical variations
`single optimal design and orientation of hip replacement
`components and surgical procedure to minimize the dislo
`cation propensity of the implant For example the pelvis can
`)assume different 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
`surgery) or in critical positions during activities of normal
`daily living (like bending over to tie shoes or during normal
`5gait) The relative position of the pelvis and leg when
`defining a neutral plane from which the angles of
`movement anteversion abduction etc are calculated will
`
`Mako Exhibit 1003 Page 21
`
`

`

`5,880,976
`
`3
`significantly influence the measured amount of motion per
`mitted before impingement and dislocation occurs
`Therefore
`it is necessary to uniquely define both the neutral
`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
`x rays provide only a two dimensional image of the pelvis
`the variations in pelvic orientation can not be more
`Also
`fully considered as discussed above
`Intra operative positioning devices currently used by sur
`geons attempt
`to align
`the acetabular component with
`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
`patient s pelvis and trunk are aligned in a known orientation
`and do not
`take into account individual variations in a
`patient s anatomy or pelvic position on the operating room
`table I hese types of positioners can lead to a wide discrep
`ancy between
`the desired and actual implant placement
`possibly resulting in reduced range of motion impingement
`and subsequent dislocation
`Several attempts have been made to more precisely pre
`pare the acetabular region for the implant components U S
`Pat No 5 007 936 issued to Woolson is directed to estab
`lishing a reference plane through which the acetabulum 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
`acetabulum and 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
`tomograiphy (CT) scans that are concentrated near the supe
`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
`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
`and the reference points In the preferred mode the jig is
`the acetabulum by drilling a hole
`fixed to
`through the
`reference point on the inner wall of the acetabulum and
`affixing the jig to the acetabulum The jig incorporates a drill
`guide to provide for reaming of the acetabulum
`in the
`selected plane
`A number of difficulties exist with the Woolson method
`For example the preferred method requires drilling a hole in
`the acetabulum Also visual recognition of the reference
`points must be required and precision placement on the jig
`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
`
`4
`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
`5a 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
`10 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
`15409 issued to Glassman et al disclose an image directed
`Ssurgical 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
`2locating pins are performed During the implanting
`the locating pins are identified on the patient as
`20procedure
`discussed in col 9 lines 19-68 of Glassman s 401 patent
`The location of the pins duning the surgery are used by a
`computer to transform CT scan coordinates into the robot
`25cutter coordinates which are used to guide the robot cutter
`25during 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
`there
`implant components
`30 acetabular region to receive
`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
`are underlying assumptions that the proper position for the
`35 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
`Following the tomography
`the markers must either remain
`45 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
`motion and usage of the joint following joint reconstruction
`replacement and revision surgery
`
`50
`
`40
`
`55
`
`BRIEF SUMMARY OF THE INVENTION
`The above objectives and others are accomplished by
`methods and apparatuses in accordance with the present
`60 invention The apparatuses and methods include creating a
`joint model of a patient s joint into which an artificial
`component is to be implanted and creating a component
`model of the artificial component The joint and artificial
`component models are used to simulate movement of the
`65 p)atient s jnint with the artificial component in a test position
`The component model and the joint model are used to
`calculate a range of motion of the joint for at least one test
`
`Mako Exhibit 1003 Page 22
`
`

`

`5,880,976
`
`5
`position based on the simulated movement An implant
`position
`including angular orientation
`for the artificial
`component is determined based on a predetermined range of
`motion and the calculated range of motion A goal of the
`simulation process is to find the implant position which
`optimizes the calculated range of motion using the prede
`termined range of motion as a basis for optimization In
`practice
`the predetermined range of motion is determined
`based on desired functional motions selected by a medical
`practitioner on a patient specific basis (e g sitting requires
`flexion of 90 )
`In a preferred embodiment
`the implant
`position can be identified in the joint model During surgery
`the joint model can be aligned with the joint by registering
`positional data from discrete points on the joint with the joint
`model Such registration also allows for tracking of the joint
`during the surgical procedures
`A current preferred application of the invention is for
`determining the implant position and sizing of an acetabular
`cup and femorail implant for use in total hip replacement
`surgery Also mn a preferred embodiment alignment of the
`joint model with the patient s joint is performed using
`surface based registration techniques The tracking of the
`pelvis
`the acetabular cup femoral implant and surgical
`instrument is preferably performed using an emitter/detector
`optical tracking system
`The present invention provides the medical practitioner a
`tool to precisely determine an optimal size and position of
`artificial 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
`determining the proper sizing and pla(,ement 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 advantaiges and others will become apparent
`from the following detailed description
`BRIEF DESCRIPTION OF THE DRAWINGS
`A preferred embodiment of the invention will now be
`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 preterred 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
`FIGS 4(a-c) show the creation of the pelvic model using
`two dimensional scans of the pelvis (a) from which skeletal
`geometric data is extracted as shown in (b) and used to
`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
`cre,ite the femur model (c)
`FIG 6 shows the sizing of the acetabular cup mn the pelvic
`model
`FIGS 7(a-e) show the creation of different sized femoral
`implant models (a) and the fitting of the femoral implant
`model into a cut femur (L--e)
`FIG 8 is a schematic drawing showing the range of
`motion of a femoral shaft and the impingement (in dotted
`lines) of a femordl shaft on an acetabular cup
`
`FIGS 9(a-b) shows the range of motion results from
`biomnechanical simulation of two respective acetabular cup
`orientations and
`FIGS 10 (a) and (b) show the registration of the pelvis
`5 and femur
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`10 The apparatus 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
`A system overview is provided in FIG 1 and general
`15 description of the method of the present invention is pre
`sented in flow chart form in FIG 2 The apparatus 10
`includes a geometric pre operative planner 12 that is used to
`create geometric models of the joint and the components to
`be implanted based on geometric data received from a
`20 skeletal structure data source 13 The pre operative planner
`12 is interfaced with a pre operative kinematic biomnechani
`cal simulator 14 that simulates movement of the joint using
`the geometric models for use
`in determining
`implant
`positions
`including angular orientations
`for the compo
`25 nents The implant positions are used in conj