`
`
`Exhibit 1010
`
`
`Exhibit 1010
`
`Mako Surgical Corp. Ex. 1010
`
`

`

`(12) United States Patent
`DiGioia, III et al.
`
`I lllll llllllll Ill lllll lllll lllll lllll lllll 111111111111111111111111111111111
`US006205411Bl
`US 6,205,411 Bl
`*Mar.20,2001
`
`(10) Patent No.:
`(45) Date of Patent:
`
`(54) COMPUTER-ASSISTED SURGERY PLANNER
`AND INTRA-OPERATIVE GUIDANCE
`SYSTEM
`
`(75)
`
`Inventors: Anthony M. DiGioia, III, Pittsburgh,
`PA (US); David A. Simon, Boulder, CO
`(US); Branislav Jaramaz; Michael K.
`Blackwell, both of Pittsburgh, PA (US);
`Frederick M. Morgan, Quincy; Robert
`V. O'Toole, Brookline, both of MA
`(US); Takeo 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.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`(21) Appl. No.: 09/189,914
`
`(22) Filed:
`
`Nov. 12, 1998
`
`Related U.S. Application Data
`
`( 63) Continuation-in-part of application No. 08/803,993, filed on
`Feb. 21, 1997, now Pat. No. 5,880,976.
`
`(51)
`
`Int. Cl.7 ................................ A61F 2/32; A61F 2/34;
`A61F 2/36
`(52) U.S. Cl. ................................... 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
`
`(56)
`
`References Cited
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`4/1991 Woolson .............................. 128/898
`2/1992 Glassman et al. ................... 700/259
`8/1992 Farmer et al. ......................... 606/87
`9/1993 Skeens et al.
`....................... 606/130
`10/1993 Raab .................................... 606/130
`3/1994 Glassman et al. ................... 700/245
`4/1994 Raab ........................................ 606/1
`11/1994 Kennedy .............................. 128/898
`1/1995 Bucholz ............................... 600/429
`
`(List continued on next page.)
`
`OTHER PUBLICATIONS
`
`A M. DiGioia, M.D., D. A Simon, B. Jaramaz, M. Black(cid:173)
`well, F. Morgan, R. V. O'Toole, B. Colgan, E. Kischell,
`HipNav: Pre-operative Planning and Intra-operative Navi(cid:173)
`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(cid:173)
`liam H. Harris, M.D., Range of Motion in Contemporary
`Total Hip Arthroplasty, pp. 97-101, The Journal of Arthro(cid:173)
`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(cid:173)
`nents, pp. 1-6, The Journal of Arthroplasty, vol. 6, Oct.,
`1991.
`
`(List continued on next page.)
`
`Primary Examiner-Kevin J. Teska
`Assistant Examiner-Russell W. Frejd
`(74) Attorney, Agent, or 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(cid:173)
`ric planner and a pre-operative kinematic biomechanical
`simulator in communication with the pre-operative geomet(cid:173)
`ric planner.
`
`4,341,220
`4,905,148
`
`7 /1982 Perry .................................... 606/130
`2/1990 Crawford ............................. 382/131
`
`17 Claims, 14 Drawing Sheets
`
`Page 1
`
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`

`

`US 6,205,411 Bl
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`2/1995 Heilbrun et al. ..................... 606/130
`5,389,101
`4/1995 Glassman et al. ................... 600/407
`5,408,409
`5/1996 Kalfas et al.
`........................ 600/414
`5,517,990
`11/1997 Delp et al. ........................... 600/407
`5,682,886
`3/1998 Kampner .............................. 128/898
`5,733,338
`5,880,976 * 3/1999 DiGioia, III et al.
`................... 703/7
`5,995,738 * 11/1999 DiGioia, III et al.
`................. 703/11
`6,002,859 * 12/1999 DiGioia, III et al.
`................. 703/11
`
`OIBER PUBLICATIONS
`
`George E. Lewinnek, M.D., Jack L. Lewis, Ph.D., Richard
`Tarr, M.S., Clinton L. Compere, M.D. and Jerald R. Zim(cid:173)
`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. Amstutz, M.D., R. M. Ladwig, 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. O'Toole, M. Blackwell, F. Morgan, A. M.
`DiGioia
`and T. Kanade, Accuracy Validation
`in
`Image-Guided Orthopaedic Surgery, 2nd Annual Sympo(cid:173)
`sium on Medical Robotics and Computer Assisted Surgery,
`Baltimore, MD, Nov. 4-7'h, 1995.
`David A Simon, Martial Hebert and Takeo Kanade, Tech(cid:173)
`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,
`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(cid:173)
`dard vs. Extended Lip Liners, p. 420, 42nd Annual Meeting,
`Orthopaedic Research Society, Feb. 19-22, Atlanta, Geor(cid:173)
`gia.
`
`T. A Maxian, T. D. Brown, D. R. Pederson and J. J.
`Callaghan, Finite Element Modeling of Dislocation Propen(cid:173)
`sity in Total Hip Arthroplasty, p. 259-44, 42nd 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(cid:173)
`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 Peria, Anatomy-based Registration for
`Computer-integrated Surgery, pp. 212-218, Program of 1st
`International Conference on Computer Version Virtual Real(cid:173)
`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, Reiko 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(cid:173)
`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(cid:173)
`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 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.
`
`* cited by examiner
`
`Page 2
`
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`

`U.S. Patent
`
`Mar.20,2001
`
`Sheet 1 of 14
`
`US 6,205,411 Bl
`
`r-13
`.-/
`
`Skeletal
`Data
`Source
`
`,
`
`Pre-Operative
`Geometric
`Planner
`
`12
`
`-
`
`L/14
`
`, I
`
`Pre-Operative
`Kinematic
`Biomechanical
`Simulator
`
`FIG. 1
`
`/16
`
`Intra-Operative
`Navigational
`Software
`
`I
`
`Tracking
`Device
`
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`

`

`U.S. Patent
`
`Mar.20,2001
`
`Sheet 2 of 14
`
`US 6,205,411 Bl
`
`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
`
`40
`
`42
`
`f
`
`•
`Perform Biomechanical Simulations Of The Movement
`Of The Joint At Test Positions Using The Models
`
`4 4
`
`
`J
`
`50
`
`'
`Claculate A Range Of Motion Of The
`Joint Based On The Simulated Movement
`
`46
`Lf
`
`r
`
`48
`
`Determine An Implant Position For The Implant
`Components Based On The Calculated Range Of Motion
`
`I
`
`5 2
`
`Identify The Implant Position In The Joint Model
`
`60
`
`'
`Align The Models Of The Skeletal
`Structure With The Patient's Joint
`
`~54
`
`Track The Position Of The Patient's
`Joint, And The Implant Components
`Using The Aligned Models.
`
`~56
`
`FIG. 2
`
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`U.S. Patent
`
`Mar.20,2001
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`Mar.20,2001
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`Page 6
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`

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`Mar.20,2001
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`
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`
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`
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`

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`U.S. Patent
`
`Mar.20,2001
`
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`Page 9
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`

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`Mar.20,2001
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`
`Mar.20,2001
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`
`Page 11
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`Mar.20,2001
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`Page 14
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`
`Mar.20,2001
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`Page 15
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`U.S. Patent
`
`Mar. 20, 2001
`
`Sheet 14 of 14
`
`US 6,205,411 Bl
`
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`
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`
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`
`34
`
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`US 6,205,411 Bl
`
`1
`COMPUTER-ASSISTED SURGERY PLANNER
`AND INTRA-OPERATIVE GUIDANCE
`SYSTEM
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`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(cid:173)
`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(cid:173)
`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
`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(cid:173)
`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(cid:173)
`llum 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(cid:173)
`eral approach. McCollum, D. E. and W. J. Gray, "Disloca(cid:173)
`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
`patient is placed in the lateral position for a posterolateral
`THA approach, the lumbar lordotic curve is flattened and the
`pelvis may 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
`
`2
`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(cid:173)
`tion have an instability rate of 1.5%, compared with a 6%
`instability rate for the cases falling outside this zone. Lewin(cid:173)
`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(cid:173)
`neck ratio of the femoral component is the key factor of the
`implant impingement, see Amstutz 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
`Arthroplasty, Vol. 6, p. 97-101(February1991). 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(cid:173)
`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(cid:173)
`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(cid:173)
`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
`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(cid:173)
`tion propensity of an implant are variations in individual
`anatomies. 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(cid:173)
`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
`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
`
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`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(cid:173)
`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(cid:173)
`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 above.
`Intra-operative positioning devices currently used by sur(cid:173)
`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. These types of positioners can lead to a wide discrep(cid:173)
`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(cid:173)
`pare the acetabular region for the implant components. U.S.
`Pat. No. 5,007,936 issued to Woolson is directed to estab(cid:173)
`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
`rim is determined by performing a series of computed
`tomography (CT) scans that are concentrated near the supe(cid:173)
`rior 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
`fixed to the acetabulum by drilling a hole 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 60
`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
`
`4
`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
`10 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
`20 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
`25 computer 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
`30 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
`35 are underlying assumptions that the proper position for the
`placement of the components in the joints has been deter(cid:173)
`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
`40 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.
`45 Following the tomography, the markers must either remain
`attached to the patient until the surgical procedure is per(cid:173)
`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
`50 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
`55 motion 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 biomechanical simulator in com-
`65 munication with the pre-operative geometric planner.
`The present invention provides the medical practitioner a
`tool to precisely determine an optimal size and position of
`
`Page 18
`
`Mako Surgical Corp. Ex. 1010
`
`

`

`US 6,205,411 Bl
`
`5
`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 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(cid:173)
`tion. These advantages and others will become apparent 10
`from the following detailed description.
`
`6
`12 is interfaced with a pre-operative kinematic biomechani(cid:173)
`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(cid:173)
`nents. The implant positions are used in conjunction with the
`geometric models in intra-operative navigational software
`16 to guide a medical practitioner in the placement of the
`implant components at the implant positions.
`The pre-operative geometric planner 12, the pre-operative
`kinematic biomechanical simulator 14 and the intra(cid:173)
`operative navigational software are implemented using a
`computer system 20 having at least one display monitor 22,
`as shown in FIG. 3. For example, applicants have found that
`a Silicon Graphics 02 workstation (Mountain View, Calif.)
`can be suitably employed as the computer system 20;
`15 however, the choice of computer system 20 will necessarily
`depend upon the resolution and calculational detail sought in
`practice. During the pre-operative stages of the method, the
`display monitor 22 is used for viewing and interactively
`creating and/or generating models in the pre-operative plan-
`20 ner 12 and displaying the results of the biomechanical
`simulator 14. The pre-operative stages of the method may be
`carried out on a computer (not shown) remote from the
`surgical theater.
`During the intra-operative stages of the method, the
`25 computer system 20 is used to display the relative locations
`of the objects being tracked with a tracking device 30. The
`medical practitioner preferably can control the operation of
`the computer system 20 during the procedure, such as
`through the use of a foot pedal controller 24 connected to the
`30 computer system 20. The tracking device 30 can employ any
`type of tracking method as may be known in the art, for
`example, emitter/detector systems including optic, acoustic
`or other wave forms, shape based recognition tracking
`algorithms, or video-based, mechanical, electromagnetic
`35 and radio frequency (RF) systems. In a preferred
`embodiment, schematically shown in FIG. 3, the tracking
`device 30 is an optical tracking system that includes at least
`one camera 32 that is attached to the computer system 20
`and positioned to detect light emitted from a number of
`40 special light emitting diodes, or targets 34. The targets 34
`can be attached to bones, tools, and other objects in the
`operating room equipment to provide precision tracking of
`the objects. One such device that has been found to be
`suitable for performing the tracking function is the
`45 Optotrak™ 3020 system from Northern Digital Inc.,
`Ontario, Canada, which is advertised as capable of achieving
`accuracies of roughly 0.1 mm at speeds of 100 measure(cid:173)
`ments per second or higher.
`The apparatus 10 of FIG. 1 is operated in accordance with
`50 the method illustrated in FIG. 2. The skeletal structure of the
`joint is determined at step 40 using tomographic data (three
`dimensional) or computed tomographic data (pseudo three
`dimensional data produced from a series of two dimensional
`scans) or other techniques from the skeletal data source 13.
`55 Commonly used tomographic techniques include computed
`tomography (CT), magnetic resonance imaging (MRI),
`positron emission tomographic (PET), or ultrasound scan(cid:173)
`ning of the joint and surround structure. The tomographic
`data from the scanned structure generated by the skeletal
`60 data source 13 is provided to the geometric planner 12 for
`use in producing a model of the skeletal structure. It should
`be noted that, in a preferred embodiment, there is no
`requirement that fiducial markers be attached to the patient
`in the scanned region to provide a reference frame for
`65 relating the tomography scans to intra-operative position of
`the patient, although markers can be used as a cross refer(cid:173)
`ence or for use with other alternative embodiments.
`
`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(cid:173)
`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
`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
`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
`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
`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 femoral shaft o