# US 8,343,218 B2 · Methods and compositions for articular repair

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- Number: US 8,343,218 B2
- Document ID: US8343218B2
- Status: Granted
- Kind: B2
- Application number: 12/317,416
- Filed: 2008-12-22
- Published: 2009-12-17
- Granted: 2013-01-01
- Earliest claimed: 2001-05-25
- Assignees: ConforMIS, Inc.
- Inventors: Philipp Lang; Daniel Steines; Konstantinos Tsourgarakis
- Web page: https://patentgrep.com/patent/US8343218B2

## CPC

- A61F 2/30756: {Cartilage endoprostheses (A61F2/3603 takes precedence)}
- A61B 17/1662: {for particular parts of the body}
- A61F 2/30942: {for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques}
- A61F 2/389: {Tibial components (A61F2/3868 takes precedence)}
- G06F 30/00: Computer-aided design [CAD]
- A61B 5/4504: {Bones (A61B5/4547 takes precedence)}
- A61B 5/4514: {Cartilage}
- A61B 5/4528: {Joints (A61B5/4533, A61B5/4538 take precedence)}
- A61B 17/8805: {for introducing fluid filler into bone or extracting it (A61B17/7097, A61B17/8833 take precedence)}
- A61F 2/30767: {Special external or bone-contacting surface, e.g. coating for improving bone ingrowth}
- A61F 2/3859: {Femoral components}
- A61F 2002/30062: {(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive}
- A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body}
- A61F 2002/30787: {inclined obliquely with respect to each other}
- A61F 2002/30948: {using computerized tomography, i.e. CT scans}
- A61F 2002/30957: {using a positive or a negative model, e.g. moulds}
- A61F 2002/3097: {using laser}
- A61F 2002/4631: {the prosthesis being specially adapted for being cemented}
- A61F 2210/0004: bioabsorbable
- A61F 2310/00011: Metals or alloys
- A61F 2310/00017: Iron- or Fe-based alloys, e.g. stainless steel
- A61F 2310/00023: Titanium or titanium-based alloys, e.g. Ti-Ni alloys
- A61F 2310/00029: Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
- A61F 2310/00047: Aluminium or Al-based alloys
- A61F 2310/00065: Manganese or Mn-based alloys
- A61F 2310/00071: Nickel or Ni-based alloys
- A61F 2310/00077: Copper or Cu-based alloys
- A61F 2310/00083: Zinc or Zn-based alloys
- A61F 2310/00107: Palladium or Pd-based alloys
- A61F 2310/00113: Silver or Ag-based alloys
- A61F 2310/00119: Tin or Sn-based alloys
- A61F 2310/00131: Tantalum or Ta-based alloys
- A61F 2310/00149: Platinum or Pt-based alloys
- A61F 2310/00155: Gold or Au-based alloys
- A61F 2310/00293: containing a phosphorus-containing compound, e.g. apatite
- A61F 2310/00383: Gelatin
- A61F 2310/00395: Coating or prosthesis-covering structure made of metals or of alloys
- A61F 2310/00592: Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
- B33Y 80/00: Products made by additive manufacturing
- Y10T 29/49: Method of mechanical manufacture
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

Disclosed herein are methods and compositions for producing articular repair materials and for repairing an articular surface. In particular, methods for providing articular repair systems. Also provided are articular surface repair systems designed to replace a selected area cartilage, for example, and surgical tools for repairing articular surfaces.

## Claims

### Claim 1

A method of fitting an articular implant to a knee joint of a patient, the method comprising:
deriving a model from anatomical image data including articular anatomy of the patient's knee joint;
selecting an articular implant from a catalog of existing articular implants having a range of sizes, wherein the articular implant includes a planar surface for abutting a resected bone surface;
adapting the shape of the selected articular implant to fit the articular implant to the articular anatomy of the patient's knee joint; and
designing a surgical cutting or drilling tool having a surface that substantially conforms to a surface of the knee joint and having one or more guides defining a cutting or drilling path with a predetermined position relative to the surface of the knee joint, wherein the tool facilitates the placement of the implant in a preferred position.

### Claim 2 (depends on 1)

The method of claim 1, further comprising superimposing the anatomical image data and one or more images or projections of the articular implant to determine the fit of the articular implant in the knee joint.

### Claim 3 (depends on 1)

The method of claim 1, wherein the anatomical image data of the knee joint and one or more images of the articular implant are merged into a common coordinate system.

### Claim 4 (depends on 2)

The method of claim 2, wherein the anatomical image data and one or more images or projections of the articular implant are three-dimensional.

### Claim 5 (depends on 4)

The method of claim 4, wherein the images comprise three-dimensional representations of at least one articular structure and at least one articular implant.

### Claim 6 (depends on 5)

The method of claim 5, wherein the three-dimensional representations are generated using a parametric surface representation.

### Claim 7 (depends on 1)

The method of claim 1, wherein the anatomical image data comprises one or more cross-sectional 2-D images.

### Claim 8 (depends on 7)

The method of claim 7, wherein the 2-D cross-sectional images are reconstructed in multiple planes.

### Claim 9 (depends on 1)

The method of claim 1, wherein the selection step is performed by computer.

### Claim 10 (depends on 1)

The method of claim 1, wherein the selection step is performed by manual visual inspection.

### Claim 11 (depends on 1)

The method of claim 1, wherein the anatomical image data of the joint is obtained using a C-arm system.

### Claim 12 (depends on 11)

The method of claim 11, wherein the anatomical image data of the joint is obtained using radiographic contrast.

### Claim 13 (depends on 1)

The method of claim 1, wherein the selected articular implant includes a surface that replaces at least a portion of the patient's natural articular cartilage.

### Claim 14 (depends on 1)

The method of claim 1, wherein the selected articular implant includes a first surface portion that replaces at least a portion of the patient's natural subchondral bone surface.

### Claim 15 (depends on 14)

The method of claim 14, wherein the selected articular implant includes a second surface portion that replaces at least a portion of the patient's natural articular cartilage.

### Claim 16 (depends on 1)

The method of claim 1, wherein the step of further shaping the implant comprises altering at least a portion of the size of the implant.

### Claim 17 (depends on 1)

The method of claim 1, wherein the step of further shaping the implant comprises altering at least a portion of the thickness of the implant.

### Claim 18 (depends on 1)

The method of claim 1, wherein the step of shaping the implant is performed utilizing Computer Aided Design or Computer Aided Manufacturing (CAD/CAM) techniques.

### Claim 19 (depends on 1)

The method of claim 1, wherein the anatomical image data and one or more images or projections of the articular implant are two-dimensional.

### Claim 20 (depends on 1)

The method of claim 1, wherein the step of further shaping the articular implant comprises subtracting material from the selected articular implant.

### Claim 21 (depends on 20)

The method of claim 20, wherein the step of subtracting material from the selected articular implant comprises mechanically removing material from the selected articular implant.

### Claim 22 (depends on 1)

The method of claim 1, wherein the step of selecting an articular implant comprising selecting an implant having the closest shape and size to the articular anatomy of the patient's joint.

### Claim 23 (depends on 1)

The method of claim 1, wherein the articular anatomy includes a portion of a shape of a femoral condyle of the patient's knee joint.

### Claim 24 (depends on 1)

The method of claim 1, wherein the model is a three-dimensional representation.

### Claim 25 (depends on 1)

The method of claim 1, further comprising aligning the selected implant relative to the model to determine the preferred position of the implant in the joint.

### Claim 26 (depends on 1)

The method of claim 1, further comprising aligning the selected implant relative to a mechanical axis of the patient's knee joint.

### Claim 27 (depends on 1)

The method of claim 1, further comprising aligning the selected implant relative to an anatomical axis of the patient's knee joint.

### Claim 28 (depends on 1)

The method of claim 1, further comprising aligning the selected implant relative to an articular surface of the patient's knee joint.

### Claim 29

A method for optimizing the fit of an implant for a knee joint of a patient, the method comprising:
obtaining anatomical image data including articular anatomy of the patient's knee joint;
deriving a model of at least a portion of the knee joint from the anatomical image data including articular anatomy of the patient's knee joint;
selecting a implant of appropriate shape or size from a database of articular implants having a range of sizes, wherein the implant includes a planar surface for abutting a resected bone surface;
adapting the size or shape of the selected implant by manipulating the size or shape of the implant to fit the implant to the articular anatomy of the patient's knee joint; and
designing a surgical cutting or drilling tool having a surface that substantially conforms to a surface of the knee joint and having guides defining a cutting or drilling path with a predetermined position relative to the surface of the knee joint to facilitate the placement of the implant in a preferred position.

### Claim 30 (depends on 29)

The method of claim 29, further comprising the step of superimposing an image of the implant on the anatomical image data of the patient's knee joint.

### Claim 31 (depends on 29)

The method of claim 29, wherein the step of manipulating the size or shape of the implant is performed utilizing Computer Aided Design or Computer Aided Manufacturing (CAD/CAM) techniques.

### Claim 32 (depends on 29)

The method of claim 29, further comprising utilizing the anatomical image data to manufacture a surgical tool for preparing the joint to receive the further shaped implant.

### Claim 33 (depends on 32)

The method of claim 32, wherein the surgical tool is an alignment guide.

### Claim 34 (depends on 29)

The method of claim 29, further comprising the step of modifying a surface of the implant to achieve a near anatomic fit with a subchondral bone of the joint.

### Claim 35 (depends on 26)

The method of claim 26, further comprising the step of implanting the implant into the patient's joint.

### Claim 36 (depends on 35)

The method of claim 35, wherein the implanting step comprises utilizing bone cement during implantation of the implant into the patient's joint.

### Claim 37 (depends on 35)

The method of claim 35, wherein the implanting step comprises utilizing a liquid attachment material during implantation of the implant into the patient's joint.

### Claim 38 (depends on 26)

The method of claim 26, wherein at least a portion of a surface of the implant comprises a bone ingrowth surface.

### Claim 39 (depends on 26)

The method of claim 26, wherein the implant comprises a synthetic material.

### Claim 40 (depends on 26)

The method of claim 26, wherein the selecting and manipulating steps are performed automatically.

### Claim 41 (depends on 26)

The method of claim 26, wherein at least one of the obtaining, selecting or manipulating steps requires human intervention.

### Claim 42 (depends on 26)

The method of claim 26, further comprising performing one or more measurements or deriving representations of external articular geometry or dimensions upon which the selection of the implant is based.

### Claim 43 (depends on 32)

The method of claim 32, wherein at least a portion of the surgical tool comprises a surface that is formed to match a natural or surgically resected surface of the joint.

### Claim 44 (depends on 32)

The method of claim 32, wherein the surgical tool comprises at least one guide for aligning surgical tools used to prepare the joint for receiving the further shaped implant.

### Claim 45 (depends on 29)

The method of claim 29, further comprising the step of modifying a surface of the implant to achieve a near anatomic fit with a cartilage surface of the joint.

### Claim 46 (depends on 29)

The method of claim 29, wherein the articular anatomy includes a portion of a shape of a femoral condyle of the patient's knee joint.

### Claim 47 (depends on 29)

The method of claim 29, wherein the model is a three-dimensional representation.

### Claim 48 (depends on 29)

The method of claim 29, further comprising aligning the selected implant relative to the model to determine the preferred position of the implant in the joint.

### Claim 49 (depends on 29)

The method of claim 29, further comprising aligning the selected implant relative to a mechanical axis of the patient's knee joint.

### Claim 50 (depends on 29)

The method of claim 29, further comprising aligning the selected implant relative to an anatomical axis of the patient's knee joint.

### Claim 51 (depends on 29)

The method of claim 29, further comprising aligning the selected implant relative to an articular surface of the patient's knee joint.
