Smith & Nephew Ex. 1076
`IPR Petition - USP 8,657,827
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`PROVISIONAL APPLICATION COVER SHEET
`Page 2 of 2
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`PTO/SB/16 (10-05)
`Approved for use through 07/31/2006. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`
`The invention was made by an agency of the United States Government or under a contract with an agency of the United States Government.
`
`,
`
`No.
`D Yes, the name of the U.S. Government agency and the Government contract number are:
`
`WARNING:
`
`Petitioner/applicant is cautioned to avoid submitting personal information in documents filed in a patent application that may
`contribute to identity theft. Personal information such as social security numbers, bank account numbers, or credit card
`numbers (other than a check or credit card authorization form PTO-2038 submitted for payment purposes) is never required by
`the USPTO to support a petition or an application.
`If this type of personal information is included in documents submitted to
`the USPTO, petitioners/applicants should consider redacting such personal information from the documents before submitting
`them to the USPTO. Petitioner/applicant is advised that the record of a patent application is available to the public after
`publication of the application (unless a non—pub|ication request in compliance with 37 CFR 1.213(a) is made in the application)
`or issuance of a patent. Furthermore, the record from an abandoned application may also be available to the public if the
`application is referenced in a published application or an issued patent (see 37 CFR 1.14). Checks and credit card
`authorization forms PT -2038 submitted for payment purposes are not retained in the application file and therefore are not
`publicly available.
`
`SIGNATURE
`
` Date
`
`E6 February 2006
`
`_
`
`TYPED or PRINTED NAME Alexander J - Smolenski
`
`REGISTRATION NO.
`(if appropriate)
`
`V
`
`47,953
`
`
`TELEPHONE 617-443-9292
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`Docket Number:
`
`.
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`2960/126
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`-11-
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`Practitioner's Docket No. 2960/126
`
`PA TENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re application of:
`
`Philipp Lang, Albert G. Burdulis, Wolfgang Fitz, Daniel Steines and Rene
`Vargas-Voracek
`
`Application No.: Not Yet Assigned
`Filed: 02/06/2006
`
`Group No.: N/A
`Examiner: N/A
`
`For: Surgical Tools for Performing Joint Arthroplasty
`
`Commissioner for Patents
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`EXPRESS MAIL CERTIFICATE
`
`"Express Mail" label number EV504305465US
`Date of Deposit 02/06/2006
`
`I hereby state that the following attached paper or fee
`
`New Provisional Patent Application, transmittal and documents referenced therein
`
`is being deposited with the United States Postal Service "Express Mail Post Office to Addressee" service
`under 37 C.F.R. § 1.10, on the date indicated above and is addressed to the Commissioner for Patents,
`P.O. Box 1450, Alexandria, VA 22313-1450.
`
`Alexander J.
`
`olenski
`
`
`
`Signature of person mailing paper or fee
`
`02960/00126 465578.]
`
`l\
`
`Express Mail Certificate" page 1 of 1
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`._‘.
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PROVISIONAL APPLICATION FOR UNITED STATES PATENT
`
`FOR
`
`Surgical Tools for Performing Joint Arthroplasty
`
`Inventors:
`
`Philipp Lang
`36 Fairlawn Lane
`
`Lexington, MA 02420
`Citizenship: Germany
`
`Albert G. Burdulis
`
`935 Rockdale Drive
`
`San Francisco, CA 94127
`Citizenship: U.S.
`
`Wolfgang Fitz
`53 Lake Street
`
`‘ Sherbom, MA 01770
`Citizenship: Germany
`
`Daniel Steines
`
`3619 Park Boulevard
`
`Palo Alto, CA 94306
`
`Citizenship: Germany
`
`Rene Vargas-Voracek
`1119 Lorne Way
`Surmyvale, CA 94087
`Citizenship: Bolivia
`
`Attorney Docket: 2960/ 126
`
`Attorneys:
`BROMBERG & SUNSTEIN LLP
`125 Summer Street
`
`Boston, MA 02110
`
`(617) 443-9292
`
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`2960/126
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`Attorney Docket: 2960/ 126
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`Surgical Tools for Performing Joint Arthroplasty
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`Cross Reference to Related Applications
`
`[0001]
`
`This application is related to U.S Ser. No. 11/002,573 for “SURGICAL TOOLS
`
`FACILITATING INCREASED ACCURACY, SPEED AND SIMPLICITY IN
`
`PERFORMING JOINT ARTHROPLASTY” filed December 2, 2004 which is a
`
`continuation-in-part of U.S. Ser. No. 10/724,010 for “PATIENT SELECTABLE JOINT
`
`ARTHROPLASTY DEVICES AND SURGICAL TOOLS FACILITATING INCREASED
`
`ACCURACY, SPEED AND SIMPLICITY IN PERFORMING TOTAL AND PARTIAL
`JOINT ARTHROPLASTY” filed Nov. 25, 2003 which is a continuation-in-part of U.S. Ser.
`
`No. 10/305,652 entitled “METHODS AND COMPOSITIONS FOR ARTICULAR
`
`REPAIR,” filed Nov. 27, 2002, which is a continuation-in-part of U.S. Ser. No. 10/160,667,
`
`filed May 28, 2002, which in turn claims the benefit of U.S. Ser. No. 60/293,488 entitled
`
`“METHODS TO IMPROVE CARTILAGE REPAIR SYSTEMS”, filed May 25, 2001, U.S.
`
`Ser. No. 60/363,527, entitled “NOVEL DEVICES FOR CARTILAGE REPAIR,” filed Mar.
`
`12, 2002 and U.S. Ser. Nos. 60/380,695 and 60/380,692, entitled “METHODS AND
`
`COMPOSITIONS FOR CARTILAGE REPAIR,” and “METHODS FOR JOINT REPAIR,”
`
`filed May 14, 2002, all of which applications are hereby incorporated by reference in their
`
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`entireties.
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`Technical Field
`
`[0002]
`
`The present invention relates to methods, systems and devices for articular
`
`resurfacing. The present invention includes surgical molds designed to achieve optimal cut
`
`planes in a joint in preparation for installation of a joint implant.
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`Background Art
`
`[0003]
`
`A variety of tools are available to assist surgeons in performing joint surgery. In
`
`the knee, for example, U.S. Pat. No. 4,501,266 to McDaniel issued Feb. 26, 1985 discloses a
`
`knee distraction device that facilitates knee arthroplasty. The device has an adjustable force
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`2960/ 126
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`calibration mechanism that enables the device to accommodate controlled selection of the
`
`ligament-tensioning force to be applied to the respective, opposing sides of the knee. U.S.
`
`Pat. No. 5,002,547 to Poggie et al. issued Mar. 26, 199] discloses a modular apparatus for
`
`use in preparing the bone surface for implantation of a modular total knee prosthesis. The
`
`apparatus has cutting guides, templates, aligmnent devices along with a distractor and
`
`clamping instruments that provide modularity and facilitate bone resection and prosthesis
`
`implantation. U.S. Pat. No. 5,250,050 to Poggie et al. issued Oct. 5, 1993 is also directed to a
`
`modular apparatus for use in preparing a bone surface for the implantation of a modular total
`
`knee prosthesis. U.S. Pat. No. 5,387,216 to Thomhill et al. issued Feb. 7, 1995 discloses
`
`instrumentation for use in knee revision surgery. A bearing sleeve is provided that is inserted
`
`into the damaged canal in order to take up additional volume. The rod passes through the
`
`sleeve and is positioned to meet the natural canal of the bone. The rod is then held in a fixed
`
`position by the bearing sleeve. A cutting guide can then be mounted on the rod for cutting
`
`the bone and to provide a mounting surface for the implant. U.S. Pat. No. 6,056,756 to Eng
`
`et al. issued May 2, 2000 discloses a tool for preparing the distal femoral end for a prosthetic
`
`implant. The tool lays out the resection for prosthetic replacement and includes a jack for
`
`pivotally supporting an opposing bone such that the jack raises the opposing bone in flexion
`
`to the spacing of the intended prosthesis. U.S. Pat. No. 6,106,529 to Techiera issued Aug. 22,
`
`2000 discloses an epicondylar axis referencing drill guide for use in resection to prepare a
`
`bone end» for prosthetic joint replacement. U.S. Pat. No. 6,296,646 to Williamson issued Oct.
`
`2, 2001 discloses a system that allows a practitioner to position the leg in the alignment that
`
`is directed at the end of the implant procedure and to cut both the femur and tibia while the
`
`leg is fixed in aligmnent. U.S. Pat. No. 6,620,168 to Lombardi et al. issued Sep. 16, 2003.
`
`discloses a tool for interrnedullary revision surgery along with tibial components.
`
`[0004]
`
`U.S. Pat. No. 5,578,037 to Sanders et al. issued Nov. 26, 1996 discloses a surgical
`
`guide for femoral resection. The guide enables a surgeon to resect a femoral neck during a
`
`hip arthroplasty procedure so that the femoral prosthesis can be implanted to preserve or
`
`closely approximate the anatomic center of rotation of the hip.
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`[0005]
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`Currently available tools do not always enable the surgeon to make the most
`
`accurate cuts on the bone surface in preparing the target joint for implantation.
`
`[0006]
`
`Thus, there remains a need for tools that improve the accuracy of the joint
`
`resurfacing process.
`
`Summary of the Invention
`
`[0007]
`
`In accordance with one embodiment of the invention, a surgical tool includes a
`
`template. The template has at least one contact surface for engaging a joint surface. The at
`
`least one contact surface substantially conforms with the joint surface. The template further
`
`includes at least one guide aperture for directing movement of a surgical instrument.
`
`[0008]
`
`In accordance with related embodiments of the invention, the joint surface may be
`
`an articular cartilage surface and/or a bone surface. The template may include a mold. The
`
`template may include at least two pieces,
`
`the at least two pieces including a first piece that
`
`includes one or more of the at least one contact surfaces, the second piece including one or
`
`more of the at least one guide apertures. The at least one contact surface may include a
`
`plurality of discrete contact surfaces.
`
`[0009]
`
`In accordance with further related embodiments of the invention, the contact
`
`surface may be made of a biocompatible material, such as acylonitrile butadiene styrene,
`
`polyphenylsulfone, and polycarbonate. The contact surface may be capable of heat
`
`sterilization without deforming. For example, the contact surface may be capable of heat
`
`sterilization without deforming at temperatures lower than 207 degrees Celsius, such as a
`
`contact surface made of polyphenylsulfone. The contact surface may be substantially
`
`transparent, such as a contact surface made of Somos 11120.
`
`[0010] In still further embodiments of the invention, the template may include a reference
`
`element, such as a pin, for establishing a reference plane relative to at least one of a
`
`biomechanical axis and a anatomical axis of a limb. In other embodiments, the reference
`
`element may be used for establishing an axis to assist in correcting an axis deformity.
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`[0011] In accordance with another embodiment of the invention, a method ofjoint
`
`arthroplasty is provided. The method includes obtaining an image of a joint, wherein the
`
`image includes a joint surface. A template is created having at least one contact surface that
`
`conforms with the joint surface. The template includes at least one guide aperture for
`
`directing movement of a surgical instrument. The template is positioned such that the contact
`
`surface abuts the joint surface in a predefined orientation.
`
`[0012] In related embodiments of the invention, the joint surface is at least one of an
`
`articular cartilage surface and a bone surface. Creating the template may include rapid
`
`prototyping and/or creating a mold. The rapid prototyping may include laying down
`
`successive layers of plastic. The template may be a multi-piece template. The multi-piece
`
`template may include a first piece that includes one or more of the at least one contact
`
`surfaces, and a second piece that includes one or more of the at least one guide apertures.
`
`Obtaining the image may include determining dimensions of bone underlying the cartilage,
`
`and adding a predefined thickness to the bone dimensions, the predefined thickness
`
`representing the cartilage thickness. Obtaining the imaging may include performing a spiral
`
`CT.
`
`[0013] In further related embodiments of the invention, the method may further include
`
`anchoring the contact surface to the cartilage. The anchoring may include using at least one
`
`of k-wire and adhesive. The anchoring may include drilling a bit through the cartilage, and
`
`leaving the bit in place.
`
`[0014] In still further embodiments of the invention, the template may include a reference
`
`element. The method may include establishing, via the reference element, a reference plane
`
`relative to at least one of a biomechanical axis and a anatomical axis of a limb. The
`
`biomechanical axis may extend from a center of a hip to a center of an ankle. Alternatively,
`
`an axis may be established via the reference element that is used to align surgical tools in
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`correcting an axis deformity.
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`[0015] In accordance with another embodiment of the invention, a surgical tool includes a
`
`template. The template has at least one contact surface for engaging a joint surface, the at
`
`least one contact surface substantially conforming with the joint surface. The contact surface
`
`is substantially transparent. The template further includes at least one guide aperture for
`
`directing movement of a surgical instrument.
`
`[0016] In accordance with another embodiment of the invention, a method ofjoint
`
`arthroplasty is presented. The method includes obtaining an image of a joint. A template is
`
`created having at least one contact surface that conforms with the joint, the template
`
`l0
`
`including a reference element and at least one guide aperture for directing movement of a
`
`surgical instrument. The template is aligned in an orientation on the joint such that the
`reference element establishes a reference plane relative to a biomechanical axis of a limb.
`
`The template is anchored to the joint such that the contact surface abuts the joint in said
`
`orientation. The biomechanical axis may extend, for example, from a center of a hip to a
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`15
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`center of an ankle.
`
`[0017] In accordance with another embodiment of the invention, a method ofjoint
`
`arthroplasty includes obtaining an image of a joint. A template is created having at least one
`
`contact surface that conforms with the joint, the template including a reference element and
`
`at least one guide aperture for directing movement of a surgical instrument, the template
`
`including a reference element. The template is aligned in an orientation on the joint such that
`
`the reference element establishes an axis. The template is anchored to the joint such that the
`
`contact surface abuts the joint in said orientation. A surgical tool is aligned using the
`
`reference element to correct an axis deformity.
`
`[0018] In accordance with another embodiment of the invention, a surgical tool includes a
`
`template. The template includes a mold having at least one contact surface for engaging a
`
`joint surface. The at least one contact surface substantially conforms with the joint
`
`surface.The mold is made of a biocompatible material. The template further includes at least
`
`one guide aperture for directing movement of a surgical instrument.
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`[0019] In accordance with still another embodiment of the invention, a surgical tool includes
`
`a template. The template includes a mold having at least one contact surface for engaging a
`
`joint surface. The at least one contact surface substantially conforms with the joint surface.
`
`The mold is made of a biocompatible material. Furthermore, the mold is capable of heat
`
`sterilization without deforming. The template includes at least one guide aperture for
`
`directing movement of a surgical instrument.
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`[0020] In accordance with related embodiments of the invention, the mold may be capable of
`
`heat sterilization without deformation. The contact surface may be made of
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`polyphenylsulfone.
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`[0021] In accordance with another embodiment of the invention, a method of using a
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`surgical tool is presented. The surgical tool includes a first template removably attached to a
`
`second template. The method includes anchoring the first template to a femoral joint
`
`surface, the first template having a first contact surface for engaging the femoral joint
`
`surface. The second template is anchored to a tibial joint surface, the second template having
`
`a second contact surface for engaging a tibial joint surface. After anchoring the first
`
`template and the second template, the second template is released from the first template,
`
`such that the second template is capable of moving independent of the first template.
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`[0022] In accordance with related embodiments of the invention, the method may further
`
`include using the second template to direct a surgical cut on the tibia. Anchoring the second
`template may occur subsequent or prior to anchoring the first template. At least one of the
`
`first and second templates may include a mold. The first contact surface may substantially
`
`conform with the femoral joint surface. The second contact surface may substantially
`
`conform with the tibial joint surface.
`
`[0023]
`
`In any of the embodiments and aspects described herein, the joint can be a knee,
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`shoulder, hip, vertebrae, elbow, ankle, hand, wrist etc.
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`Brief Description of the Drawings
`
`[0024]
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`The foregoing features of the invention will be more readily understood by
`
`reference to the following detailed description, taken with reference to the accompanying
`
`drawings, in which:
`
`[0025]
`
`FIG. IA illustrates a femur, tibia and fibula along with the mechanical and
`
`anatomic axes. FIGS. 1B-E illustrate the tibia with the anatomic and mechanical axis used to
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`create a cutting plane along with a cut femur and tibia. FIG. 1F illustrates the proximal end
`
`of the femur including the head of the femur.
`
`[0026]
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`FIG. 2 shows an example of a surgical tool having one surface matching the
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`geometry of an articular surface of the joint. Also shown is an aperture in the tool capable of
`
`controlling drill depth and width of the hole and allowing implantation of an insertion of
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`implant having a press-fit design.
`
`[0027]
`
`FIG. 3 is a flow chart depicting various methods of the invention used to create a
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`mold for preparing a patient's joint for arthroscopic surgery.
`
`[0028]
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`FIG. 4A depicts, in cross-section, an example of a surgical tool containing an
`
`aperture through which a surgical drill or saw can fit. The aperture guides the drill or saw to
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`make the proper hole or cut in the underlying bone. Dotted lines represent where the cut
`
`corresponding to the aperture will be made in bone. FIG. 4B depicts, in cross-section, an
`
`example of a surgical tool containing apertures through which a surgical drill or saw can fit
`
`and which guide the drill or saw to make cuts or holes in the bone. Dotted lines represent
`
`_where the cuts corresponding to the apertures will be made in bone.
`
`[0029]
`
`FIGS. 5A—R illustrate tibial cutting blocks and molds used to create a surface
`
`perpendicular to the anatomic axis for receiving the tibial portion of a knee implant.
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`[0030]
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`FIGS. 6A-O illustrate femur cutting blocks and molds used to create a surface for
`
`receiving the femoral portion of a knee implant. FIGS. 6P and 6Q illustrate a surgical tool
`
`that includes both a femoral and tibial component.
`
`[0031]
`
`FIG. 7A—G illustrate patellar cutting blocks and molds used to prepare the patella
`
`for receiving a portion of a knee implant.
`
`[0032]
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`FIG. 8A—H illustrate femoral head cutting blocks and molds used to create a
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`surface for receiving the femoral portion of a knee implant.
`
`[0033]
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`FIG. 9A-D illustrate acetabulum cutting blocks and molds used to create a surface
`
`for a hip implant.
`
`[0034]
`
`FIG. 10A illustrates a patella modeled from CT data. FIGS. 10B-D illustrate a
`
`mold guide, and then the mold guide placed on an articular surface of the patella. FIG. 10E
`
`illustrates a drill placed into a patella through mold drill guide. FIG. l0F illustrates a reamer
`
`used to prepare the patella.
`
`[0035]
`
`FIG. 11A illustrates a reamer made for each patella size. FIG. 1 1B illustrates a
`
`reamed patella ready for patella implantation.
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`[0036]
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`FIG. 12A-F illustrate a recessed patella implanted on a patella.
`
`Detailed Description of Specific Embodiments
`
`[0037]
`
`The following description is presented to enable any person skilled in the art to
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`25
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`make and use the invention. Various modifications to the embodiments described will be
`
`readily apparent to those skilled in the art, and the generic principles defined herein can be
`
`applied to other embodiments and applications without departing from the spirit and scope of
`
`the present invention as defined by the appended claims. Thus, the present invention is not
`
`intended to be limited to the embodiments shown, but is to be accorded the widest scope
`
`30
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`consistent with the principles and features disclosed herein. To the extent necessary to
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`2960/126
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`achieve a complete understanding of the invention disclosed, the specification and drawings
`
`of all issued patents, patent publications, and patent applications cited in this application are
`
`incorporated herein by reference.
`
`[0038]
`
`As will be appreciated by those of skill in the art, the practice of the present
`
`invention employs, unless otherwise indicated, conventional methods of x-ray imaging and
`
`processing, x-ray tomosynthesis, ultrasound including A—scan, B-scan and C-scan, computed
`
`tomography (CT scan), magnetic resonance imaging (MRI), optical coherence tomography,
`
`single photon emission tomography (SPECT) and positron emission tomography (PET)
`
`within the skill of the art. Such techniques are explained fully in the literature and need not
`
`be described herein. See, e.g., X-Ray Structure Determination: A Practical Guide, 2nd
`
`Edition, editors Stout and Jensen, 1989, John Wiley & Sons, publisher; Body CT: A Practical
`
`Approach, editor Slone, 1999, McGraw-Hill publisher; X-ray Diagnosis: A Physician's
`
`Approach, editor Lam, 1998 Springer-Verlag, publisher; and Dental Radiology:
`
`Understanding the X-Ray Image, editor Laetitia Brocklebank 1997, Oxford University Press
`
`publisher. See also, The Essential Physics of Medical Imaging (2.sup.nd Ed.), Jerrold T.
`
`Bushberg, et al.
`
`[0039]
`
`As described herein, repair systems, including surgical instruments, templates,
`
`guides and/or molds, of various sizes, curvatures and thicknesses can be obtained. These
`
`repair systems, including surgical instruments, guides, templates, and/or molds, can be
`
`catalogued and stored to create a library of systems from which an appropriate system for an
`
`individual patient can then be selected. In other words, a defect, or an articular surface, is
`
`assessed in a particular subject and a pre-existing repair system, including surgical
`
`instruments, guides, templates, and/or molds, having a suitable shape and size is selected
`
`from the library for further manipulation (e.g., shaping) and implantation.
`
`[0040]
`
`Performing a total knee arthroplasty is a complicated procedure. In replacing the
`
`knee with an artificial knee, it is important to get the anatomical and mechanical axes of the
`
`lower extremity aligned correctly to ensure optimal functioning of the implanted knee.
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`[0041]
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`As shown in FIG. 1A, the center of the hip 102 (located at the head 130 of the
`
`femur 132), the center of the knee 104 (located at the notch where the intercondular tubercle
`
`134 of the tibia 136 meet the femur) and ankle 106 lie approximately in a straight line 110
`
`which defines the mechanical axis of the lower extremity. The anatomic axis 120 aligns 5-7.
`
`offset 6 from the mechanical axis in the valgus, or outward, direction.
`
`[0042]
`
`The long axis of the tibia 136 is collinear with the mechanical axis of the lower
`
`extremity 110. From a three-dimensional perspective, the lower extremity of the body ideally
`
`functions within a single plane known as the median anterior-posterior plane (MAP-plane)
`
`throughout the flexion-extension arc. In order to accomplish this, the femoral head 130, the
`
`mechanical axis of the femur, the patellar groove, the intercondylar notch, the patellar
`
`articular crest, the tibia and the ankle remain within the MAP—plane during the flexion-
`
`extension movement. During movement, the tibia rotates as the knee flexes and extends in
`
`the epicondylar axis which is perpendicular to the MAP-plane.
`
`[0043]
`
`A variety of image slices can be taken at each individual joint, e.g., the knee joint
`
`150-150", and the hip joint 152-150“. These image slices can be used as described above in
`
`Section I U.S Patent Application Ser. No. 11/002,573, along with an image of the f11ll leg to
`
`ascertain the axis.
`
`[0044]
`
`With disease and malfunction of the knee, alignment of the anatomic axis is
`
`altered. Performing a total knee arthroplasty is one solution for correcting a diseased knee.
`
`Implanting a total knee joint, such as the PFC Sigma RP Knee System by Johnson &
`
`Johnson, requires that a series of resections be made to the surfaces forming the knee joint in
`
`order to facilitate installation of the artificial knee. The resections should be made to enable
`
`the installed artificial knee to achieve flexion-extension movement within the MAP-plane
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`and to optimize the patient's anatomical and mechanical axis of the lower extremity.
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`[0045]
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`First, the tibia 130 is resected to create a flat surface to accept the tibial
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`component of the implant. In most cases, the tibial surface is resected perpendicular to the
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`long axis of the tibia in the coronal plane, but is typically sloped 4-7’ posteriorly in the
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`sagittal plane to match the normal slope of the tibia. As will be appreciated by those of skill
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`in the art, the sagittal slope can be 0' where the device to be implanted does not require a
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`sloped tibial cut. The resection line 158 is perpendicular to the mechanical axis 110, but the
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`angle between the resection line and the surface plane of the plateau 160 varies depending on
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`the amount of damage to the knee.
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`[0046]
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`FIGS. 1B-D illustrate an anterior view of a resection of an anatomically normal
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`tibial component, a tibial component in a varus knee, and a tibial component in a valgus
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`knee, respectively. In each figure, the mechanical axis 110 extends vertically through the
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`bone and the resection line 158 is perpendicular to the mechanical axis 110 in the coronal
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`plane, varying from the surface line formed by the joint depending on the amount of damage
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`to the joint. FIG. 1B illustrates a normal knee wherein the line corresponding to the surface
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`of the joint 160 is parallel to the resection line 158. FIG. 1C illustrates a varus knee wherein
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`the line corresponding to the surface of the joint 160 is not parallel to the resection line 158.
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`FIG. 1D illustrates a valgus knee wherein the line corresponding to the surface of the joint
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`160 is not parallel to the resection line 158.
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`[0047]
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`Once the tibial surface has been prepared, the surgeon turns to preparing the
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`femoral condyle.
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`[0048]
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`The plateau of the femur 170 is resected to provide flat surfaces that communicate
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`with the interior of the femoral prosthesis. The cuts made to the femur are based on the
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`overall height of the gap to be created between the tibia and the femur. Typically, a 20 mm
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`gap is desirable to provide the implanted prosthesis adequate room to achieve full range of
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`motion. The bone is resected at a 5-7’ valgus to the mechanical axis of the femur. Resected
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`surface 172 forms a flat plane with an angular relationship to adjoining surfaces 174, 176.
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`The angle 0', 6" between the surfaces 172-174, and 172-176 varies according to the design
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`of the implant.
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`[0049]
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`As illustrated in FIG. IF, the external geometry of the proximal femur includes
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`the head 180, the neck 182, the lesser trochanter 184, the greater trochanter 186 and the
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`proximal femoral diaphysis. The relative positions of the trochanters 184, 186, the femoral
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`head center 102 and the femoral shaft 188 are correlated with the inclination of the neck-
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`shaft angle. The mechanical axis 110 and anatomic axis 120 are also shown. Assessment of
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`these relationships can change the reaming direction to achieve neutral alignment of the
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`prosthesis with the femoral canal.
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`[0050]
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`Using anteroposterior and lateral radiographs, measurements are made of the
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`proximal and distal geometry to determine the size and optimal design of the implant.
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`[0051]
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`Typically, after obtaining surgical access to the hip joint, the femoral neck 182 is
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`resected, e. g. along the line 190. Once the neck is resected, the medullary canal is reamed.
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`Reaming can be accomplished, for example, with a conical or straight reamer, or a flexible
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`reamer. The depth of reaming is dictated by the specific design of the implant. Once the
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`canal has been reamed, the proximal reamer is prepared by serial rasping, with the rasp
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`directed down into the canal.
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`[0052]
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`Further, surgical assistance can be provided by using a device applied to the outer
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`surface of the articular cartilage or the bone, including the subchondral bone, in order to
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`match the alignment of the articular repair system and the recipient site or the joint. The
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`device can be round, circular, oval, ellipsoid, curved or irregular in shape. The shape can be
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`selected or adjusted to match or enclose an area of diseased cartilage or an area slightly
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`larger than the area of diseased cartilage or substantially larger than the diseased cartilage.
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`The area can encompass the entire articular surface or the weight bearing surface. Such
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`devices are typically preferred when replacement of a majority or an entire articular surface
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`is contemplated.
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`[0053]
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`Mechanical devices can be used for surgical assistance (e.g., surgical tools such
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`as a template), for example using gels, molds, plastics or metal. One or more electronic
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`images or intraoperative measurements can be obtained providing object coordinates that
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`define the articular cartilage and/or bone surface and shape. These objects’ coordinates can
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`be utilized to either shape the device, e.g. using a CAD/CAM technique, to be adapted to a
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`patient's articular anatomy or, alternatively, to select a typically pre-made device that has a
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`good fit with a patient's articular anatomy. The device can have a surface and shape that will
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`match all or portions of the articular cartilage, or bone surface and shape, e.g. similar to a
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`“mirror image.” The device can be, without limitation, a template that includes apertures,
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`slots and/or holes to accommodate surgical instruments such as drills, reamers, curettes, k-
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`wires, screws and saws.
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`[0054]
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`Typically, a position will be chosen that will result in an anatomically desirable
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`cut plane, drill hole, or general instrument orientation for subsequent placement of an
`articular repair system or for facilitating placement of the articular repair system. Moreover,
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`the device can be designed so that the depth of the drill, reamer or other surgical instrument
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`can be controlled, e.g., the drill carmot go any deeper into the tissue than defined by the K
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`device, and the size of the hole in the block can be designed to essentially match the size of
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`the implant. Information about other joints or axis and alignment information of a joint or
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`extremity can be included when selecting the position of these slots or holes. Alternatively,
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`the openings in the device can be made larger than needed to accommodate these
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`instruments. The device can also be configured to conform to the articular shape. The
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`apertures, or openings, provided can be wide enough to allow for varying the position or
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`angle of the surgical instrument, e.g., reamers, saws, drills, curettes and other surgical
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`instruments. An instrument guide, typically comprised of a relatively hard material, can then
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`be applied to the device. The device helps orient the instrument guide relative to the three-
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`dimensional anatomy of the joint.
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`[0055]
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`The surgeon can, optionally, make fine adjustments between the alignment device
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`and the instrument guide. In this manner, an optimal compromise can be found, for example,
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`between biomechanical alignment and joint laxity or biomechanical alignment and joint
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`function, e.g. in a knee joint flexion gap and extension gap. By oversizing the openings in the
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`alignment guide, the surgeon can utilize the instruments and insert them in the instrument
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`guide without damaging the alignment guide. Thus, in particular if the alignment guide is
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`made of plastic, debris will not be introduced into the joint. The position and orientation
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`between the alignment guide and the instrument guide can be also be optimized with the use
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`'
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`‘
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`of, for example, interposed spacers, wedges, screws a