Smith & Nephew Ex. 1078
`IPR Petition - USP 8,657,827
`
`-i-
`
`

`

`PROVISIONAL APPLICATION COVER SHEET
`Page 2 of 2
`
`PTO/SBI16 (1 0-05)
`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.
`
`No.
`
`The invention was made by an agency of the United States Government or under a contract with an agency of the United States Government.
`
`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 refere ced in a published application or an issued patent (see 37 CFR 1.14). Checks and credit card
`authorization forms
`O-2038 submitted for payment purposes are not retained in the application file and therefore are not
`
`publicly available.
`
` SIGNATURE
`
`Date
`
`31 March 2006
`
`REGISTRATION NO.
`(if appropriate)
`
`47,953
`
`TYPED or PRINTED NAME Alexander]. Smolenski
`
`TELEPHONE $617) 443-9292
`
`Docket Number:
`
`2960/ I30
`
`-11-
`
`-ii-
`
`

`

`22764 U.S.'PTO
`
`lllllllllllllllllllllllllllllll
`033106
`
`Practitioner's Docket No. 2960/130
`
`PATENT
`
`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: O3/3 l/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 EV504304859US
`Date of Deposit 03/31/2006
`
`I hereby state that the following attached paper or fee"
`
`New U.S. 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.
`
`. Smolenski
`
`Alexander V
`
`
`
`
`
`L
`
`
`Signatur of person mailing paper or fee
`
`02960/00001 482312.]
`
`Express Mail Certificaten page I of 1
`
`-iii-
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PROVISIONAL APPLICATION FOR UNITED STATES PATENT
`
`,
`
`FOR
`
`Surgical Tools for Performing Joint Arthroplasty
`
`Inventors:
`
`Philipp Lang
`7 Fair Oaks Terrace
`
`Lexington, MA 02421
`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
`Sunnyvale, CA 94087
`Citizenship: Bolivia
`
`Attorney Docket: 2960/ 1 30
`
`Attorneys:
`BROMBERG & SUNSTEIN LLP
`125 Summer Street
`
`Boston, MA 02110
`(617) 443-9292
`
`_iV_
`
`-iv-
`
`

`

`2960/130
`
`Attorney Docket: 2960/ 130
`
`Surgical Tools for Performing Joint Arthroplasty
`
`Cross Reference to Related Applications
`
`[0001]
`
`This application is related to U.S. Ser. No. 09/953,373 for “Assessing the
`
`Confition of a Joint and Assessing Cartilage Loss” filed September 14, 2001 , which is a
`
`continuation-in-part of U.S. Ser. No. 09/882,363 for “Assessing the Condition of a Joint and
`Preventing Damage” filed June 15, 2001, which in turn claims the benefit of U.S. Ser. No.
`
`60/112,989, filed December 16, 1998, and is a continuation of PCT/US99/30265, filed
`
`December 16, 1999. U.S. Ser. No. 09/953,373 also claims the benefit of U.S. Ser. No.
`
`60/232,637, filed September 14, 2000, and U.S. Ser. No. 60232,639, filed September 14,
`
`2000.
`
`15
`
`20
`
`[0002]
`
`This application is also 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 tum 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.
`
`

`

`2960/ 1 30
`
`[0003]
`
`Each of the above-described applications are hereby incorporated by reference in
`
`their entireties.
`
`Technical Field
`
`[0004]
`
`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.
`
`Background Art
`
`10
`
`15
`
`20
`
`[0005]
`
`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
`
`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, 1991 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, alignment 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 Thornhill et al. issued Feb. 7, 1995 discloses
`
`instrumentation for use in knee revision surgery. Abearing 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
`
`25
`
`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 disclosesan epicondylar axis referencing drill guide for use in resection to prepare a
`
`2
`
`

`

`2960/ 1 30
`
`bone end for prosthetic joint replacement. U.S. Pat. No. 6,296,646 to Williamson issued Oct.
`
`2, 200] 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 alignment. U.S. Pat. No. 6,620,168 to Lombardi et al. issued Sep. 16, 2003
`
`discloses a tool for intermedullary revision surgery along with tibial components.
`
`[0006]
`
`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.
`
`[0007]
`
`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.
`
`[0008]
`
`'
`
`Thus, there remains a need for tools that improve the accuracy of the joint
`
`resurfacing process.
`
`Summagy of the Invention
`
`[0009]
`
`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 surface associated
`
`with a joint. The at least one contact surface substantially conforms with the surface. The
`
`template further includes at least one guide aperture for directing movement of a surgical
`
`instrument.
`
`[0010]
`
`In accordance with related embodiments of the invention, the surface may be an
`
`articular surface, a non-articular surface, a cartilage surface, a weight bearing surface, a non-
`
`weight surface and/or a bone surface. The joint has a joint space, with the surface either
`
`within the joint space or external to the joint space 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
`
`l0
`
`15
`
`20
`
`25
`
`

`

`2960/130
`
`more of the at least one guide apertures. The at least one contact surface may include a
`
`plurality of discrete contact surfaces.
`
`[0011]
`
`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 or semi-transparent, such as a contact surface made of Somos 11120.
`
`[0012] 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 an 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.
`
`[0013] 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 surface associated with a joint. A template is created having at least one
`
`contact surface that confonns with the 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 surface in a predefined orientation.
`
`[0014] In related embodiments of the invention, the joint surface is at least one of an
`
`articular surface, a non-articular surface, a cartilage surface, a weight bearing surface, a non-
`
`weight bearing surface, and a bone surface. The joint has a joint space, wherein the surface
`
`may be within the joint space or external to the joint space. The at least one contact surface
`
`may include a plurality of discrete contact surfaces. Creating the template may include rapid
`
`prototyping and/or creating a mold, the template furthermore may be sterilizable and/or
`
`bicompatible.. 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
`
`10
`
`15
`
`20
`
`25
`
`30
`
`

`

`2960/ l 30
`
`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.
`
`Adding the predefined thickness may be a function of at least one of an anatomic reference
`
`database, an age, a gender , and race matching. Obtaining the imaging may include
`
`performing an ultrasound, a CT, a spiral CT, and/or an MRI.
`
`[0015] 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.
`
`[0016] In still further related 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 an 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
`
`correcting an axis deformity.
`
`[0017] In further related embodiments of the invention, the method further includes
`
`performing at least one of a muscle sparing technique and a bone sparing technique. An
`
`incision for inserting the template may be equal to or less than one of 15 cm, 13 cm, 10cm, 8
`
`cm, and 6cm. At least a portion of the template may be sterilized. Sterilizing may include
`
`heat sterilization and/or sterilizat_ion using gas. The sterilized portion may includes a mold.
`
`[0018] 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 surface associated
`
`with a joint, the at least one contact surface substantially conforming with the surface. The
`
`contact surface is substantially transparent or semi-transparent. The template further
`
`includes at least one guide aperture for directing movement of a surgical instrument.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`

`

`2960/ l 30
`
`[0019] In accordance with another embodiment of the invention, a method ofjoint
`
`arthroplasty is presented. The method includes obtaining an image associated with a joint.
`
`A template is created having at least one contact surface that conforms with a surface
`
`associated with the joint, the template 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 center of an ankle.
`
`[0020] 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 a surface associated 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 surface such that the reference element establishes an axis. The template
`
`may be anchored to the surface. A surgical tool is aligned using the reference element to
`
`correct an axis deformity.
`
`[0021] 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
`
`surface associated with a joint. The at least one contact surface substantially conforms with
`
`the 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. The mold may be
`
`sterilizable and/or substantially transparent or semi-transparent.
`
`[0022] 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
`
`10
`
`IS
`
`20
`
`25
`
`30
`
`

`

`2960/130
`
`sterilization without deforming. The template includes at least one guide aperture for
`
`directing movement of a surgical instrument.
`
`[0023] 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
`
`polyphenylsulfone.
`
`[0024] In accordance with another embodiment of the invention, a method of using a
`
`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.
`
`[0025] 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.
`
`[0026]
`
`In accordance with ‘another embodiment of the invention, a method of performing
`
`joint arthroplasty includes obtaining a first image associated with a first joint, obtaining a
`
`second image of a second joint, and optionally obtaining a third image of a third joint. A
`
`biomechanical axis associated with the first joint and the second joint and optionally the third
`
`joint is determined. A template is provided for enabling surgery to correct an anatomic
`
`abnormality associated with at least one of the first, second and/or third joint.
`
`10
`
`I5
`
`20
`
`25
`
`30
`
`

`

`2960/ l 30
`
`[0027] In another embodiment, gait, loading and other physical activities of a joint may be
`
`simulated using a computer workstation. The template and the resultant surgical procedures,
`
`e.g. cuts, drilling, rasping, can be optimized using this information to achieve an optimal
`
`fimctional result. For example, the template and the resultant implant position may be
`
`optimized for different degrees of flexion and extension, internal or external rotation,
`
`abduction or adduction. Thus, the templates may be used to achieve motion that is optimized
`
`in one, two or more directions.
`
`[0028] In accordance with related embodiments of the invention, the template may include at
`
`least one contact surface for engaging a surface associated with the first joint, the second
`
`joint and/or the third joint, the at least one contact surface substantially confonning with the
`
`surface. The template may include at least one guide aperture for directing movement of a
`
`surgical instrument.
`
`[0029] In further related embodiments of the invention, obtaining the first image may
`
`include imaging one of at least 5 cm, at least 10cm, at least 15cm, at least 20 cm, at least 25
`
`cm, at least 30 cm, and at least 35cm beyond the first joint. Obtaining the first image/and or
`
`second image and/or the third image may include performing a CT or an MRI. Performing
`
`the MRI may include obtaining a plurality of MRI scans.
`
`[0030] In accordance with another embodiment of the invention, a method of performing
`
`joint arthroplasty includes obtaining a computer image of a surface associated with a first
`
`joint. At least one deformity in the computer image is removed pertaining to the surface, so
`
`as to form a modified computer image. The at least one deformity is removed from the
`
`surface to create a modified surface. A template is provided based, at least in part, on the
`
`modified computer image. The template includes at least one contact surface for engaging
`
`the modified surface, the at least one contact surface substantially conforming with the
`
`modified surface.
`
`[003]] In accordance with related embodiments of the invention, the template may be used
`
`in a surgical procedure. The template may include at least one guide aperture, the method
`
`10
`
`15
`
`20
`
`25
`
`30
`
`

`

`2960/I30
`
`further including using the at least one guide aperture to direct movement of a surgical
`
`instrument. The at least one deformity may include a osteophyte, a subchondral cyst, and/or
`
`an arthritic deformation.
`
`[0032]
`
`In accordance with another embodiment of the invention, a method of performing
`
`joint arthroplasty includes obtaining an image of a surface associated with a first joint, the
`
`image including at least one deformity. A template is provided, based at least in part on the
`
`image, the template having at least one contact surface for engaging portions of the surface
`
`free of the deformity. The at least one contact surface substantially conforms with the
`
`portions of the surface. The template is used in a surgical procedure.
`
`[0033] In accordance with related embodiments of the invention, the template may include at
`
`least one guide aperture, the method further including using the at least one guide aperture to
`
`direct movement of a surgical instrument. The at least one deformity may include a
`
`osteophyte, a subchondral cyst, and/or an arthritic deformation.
`
`[0034] In accordance with another embodiment of the invention, a method of performing
`
`joint arthroplasty includes obtaining an image of a surface associated with a joint, the image
`
`including at least subchondral bone. A template is provided, ‘based at least in part on the
`
`image. The template includes at least one contact surface substantially conforming with the
`
`subchondral bone. Residual cartilage is removed from the surface in areas where the at least
`
`one contact surface is to contact the subchondral bone. The template is positioned such that
`
`the at least one contact surface abuts the subchondral bone in a predefined orientation.
`
`[0035] In accordance with another embodiment of the invention, a method of performing
`
`joint arthroplasty includes providing a template. The template is fixated to bone associated
`
`with a joint without performing any cuts to the joint. The template may be used in a surgical
`
`procedure.
`
`[0036] In accordance with related embodiments of the invention, fixating may include
`
`drilling into the bone and leaving a drill bit in the bone. An image of a surface associated
`
`10
`
`15
`
`20
`
`25
`
`30
`
`

`

`2960/I30
`
`with ajoint may be obtained, the template having at least one contact surface that conforms
`
`with the surface.
`
`[0037]
`
`In any of the embodiments and aspects described herein, the joint can be a knee,
`
`shoulder, hip, vertebrae, elbow, ankle, hand, wrist etc.
`
`Brief Description of the Drawings
`
`[0038]
`
`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:
`
`[0039]
`
`FIG. 1A 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
`
`create a cutting plane along with a cut femur and tibia. FIG. IF illustrates the proximal end
`
`of the femur including the head of the femur.
`
`[0040]
`
`FIG. 2 shows an example of a surgical tool having one surface matching the
`
`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
`
`implant having a press-fit design.
`
`[0041]
`
`FIG. 3 is a flow chart depicting various methods of the invention used to create a
`
`mold for preparing a patient's joint for arthroscopic surgery.
`
`[0042]
`
`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
`
`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.
`
`l0
`
`10
`
`I5
`
`20
`
`25
`
`30
`
`

`

`2960/ l 30
`
`[0043]
`
`FIGS. SA-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.
`
`[0044]
`
`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.
`
`[0045]
`
`FIG. 7A-G illustrate patellar cutting blocks and molds used to prepare the patella
`
`for receiving a portion of a knee implant.
`
`[0046]
`
`FIG. 8A-H illustrate femoral head cutting blocks and molds used to create a
`
`surface for receiving the femoral portion of a knee implant.
`
`[0047]
`
`FIG. 9A-D illustrate acetabulum cutting blocks and molds used to create a surface
`
`for a hip implant.
`
`[0048]
`
`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. 10F illustrates a reamer
`
`used to prepare the patella.
`
`[0049]
`
`FIG. 11A illustrates a reamer made for each patella size. FIG. 11B illustrates a
`
`reamed patella ready for patella implantation.
`
`[0050]
`
`FIG. 12A-F illustrate a recessed patella implanted on a patella.
`
`Detailed Description of Specific Embodiments
`
`[0051]
`
`The following description is presented to enable any person skilled in the art to
`
`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
`
`ll
`
`l0
`
`15
`
`20
`
`25
`
`30
`
`

`

`2960/I30
`
`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
`consistent with the principles and features disclosed herein. To the extent necessary to
`
`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.
`
`[0052]
`
`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.
`A
`
`[0053]
`
`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.
`
`I0
`
`15
`
`20
`
`25
`
`30
`
`12
`
`

`

`2960/130
`
`[0054]
`
`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.
`
`[0055]
`
`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 intercondylar 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 0 from the mechanical axis in the valgus, or outward, direction.
`
`, [0056]
`
`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.
`
`[0057]
`
`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 full leg to
`
`ascertain the axis.
`
`[0058]
`
`With disease and malfunction of the knee, aligmnent 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
`
`and to optimize the patient's anatomical and mechanical axis of the lower extremity.
`
`'13
`
`10
`
`15
`
`20
`
`25
`
`30
`
`

`

`2960/ l 30
`
`[0059]
`
`First, the tibia 130 is resected to create a flat surface to accept the tibial
`
`component of the implant. In most cases, the tibial surface is resected perpendicular to the
`
`long axis of the tibia in the coronal plane, but is typically sloped 4-7’ posteriorly in the
`
`sagittal plane