# US 8,771,281 B2 · Marking template for installing a custom replacement device for resurfacing a femur and associated installation method

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- Number: US 8,771,281 B2
- Document ID: US8771281B2
- Status: Granted
- Kind: B2
- Application number: 13/096,868
- Filed: 2011-04-28
- Published: 2011-11-10
- Granted: 2014-07-08
- Earliest claimed: 2000-03-17
- Assignees: Kinamed, Inc.
- Applicants: Roger Carignan; Clyde R. Pratt
- Inventors: Roger Carignan; Clyde R. Pratt
- Web page: https://patentgrep.com/patent/US8771281B2

## CPC

- A61F 2/3859: {Femoral components}
- A61B 17/1764: {for the knee}
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- 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 2/3877: {Patellae or trochleae}
- A61F 2/461: {of knees}
- A61F 2/4657: {Measuring instruments used for implanting artificial joints (for surgical instruments A61B90/06)}
- A61B 17/00491: {Surgical glue applicators}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- A61F 2/30767: {Special external or bone-contacting surface, e.g. coating for improving bone ingrowth}
- A61F 2002/30125: {elliptical or oval}
- A61F 2002/30594: {slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots}
- A61F 2002/30685: {Means for reducing or preventing the generation of wear particulates}
- A61F 2002/30892: {parallel}
- A61F 2002/30948: {using computerized tomography, i.e. CT scans}
- A61F 2002/30952: {using CAD-CAM techniques or NC-techniques}
- A61F 2002/30957: {using a positive or a negative model, e.g. moulds}
- A61F 2002/4658: {for measuring dimensions, e.g. length}
- A61F 2230/0008: elliptical or oval
- 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 2310/00203: containing alumina or aluminium oxide
- A61F 2310/00239: containing zirconia or zirconium oxide ZrO2
- A61F 2310/00407: Coating made of titanium or of Ti-based alloys
- A61F 2310/00796: Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
- Y10S 623/901: Method of manufacturing prosthetic device
- Y10T 29/49764: with testing or indicating
- 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)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A replacement device for resurfacing a joint surface of a femur and a method of making and installing such a device is provided. The custom replacement device is designed to substantially fit the trochlear groove surface, of an individual femur. Thereby creating a “customized” replacement device for that individual femur and maintaining the original kinematics of the joint. The replacement device may be defined by four boundary points, and a first and a second surface. The first of four points is 3 to 5 mm from the point of attachment of the anterior cruciate ligament to the femur. The second point is near the bottom edge of the end of the natural articulatar cartilage. The third point is at the top ridge of the right condyle and the fourth point at the top ridge of the left condyle of the femur. The top surface is designed so as to maintain centrally directed tracking of the patella perpendicular to the plane established by the distal end of the femoral condyles and aligned with the center of the femoral head.

## Claims

### Claim 1

A method of facilitating a knee implant procedure for a particular patient, the method comprising:
(a) providing a knee implant, wherein the knee implant includes a tissue contacting surface which is substantially custom formed based on pre-operative data to match and fit the natural contour of a portion of the particular patient's knee joint in a pre-defined spatial arrangement; and
(b) providing an instrument, wherein the instrument includes a tissue contacting surface and a surgical tool guide for guiding a surgical tool, wherein the tissue contacting surface is substantially custom formed based on the pre-operative data to match and fit a portion of the particular patient's knee joint in a pre-defined spatial arrangement.

### Claim 2 (depends on 1)

The method of claim 1, wherein providing the knee implant and the instrument comprise providing a knee implant and an instrument that are configured based on pre-operative imaging data of the particular patient's knee joint.

### Claim 3 (depends on 2)

The method of claim 2, wherein providing the knee implant and the instrument comprise providing a knee implant and an instrument that are configured based on computer tomography imaging data.

### Claim 4 (depends on 2)

The method of claim 2, wherein providing the knee implant comprises providing a knee implant that is configured based on imaging data of a cartilage surface of the particular patient's knee joint.

### Claim 5 (depends on 2)

The method of claim 2, wherein providing the knee implant comprises providing a knee implant that is configured based on imaging data of a subchondral bone surface of the particular patient's knee joint.

### Claim 6 (depends on 5)

The method of claim 5, wherein providing the instrument comprises providing an instrument that is configured based on the imaging data of the subchondral bone surface to match at least a portion of the subchondral bone surface of the particular patient.

### Claim 7 (depends on 5)

The method of claim 5, wherein providing the knee implant comprises providing a knee implant that is configured based on the imaging data of the subchondral bone surface to include an inner non-articular surface matching at least a portion of the subchondral bone surface of the particular patient.

### Claim 8 (depends on 1)

The method of claim 1, further comprising receiving the pre-operative data, the preoperative data comprising a computer model of the knee implant and a computer model of the instrument, the computer models configured based on pre-operative imaging data of the particular patient's knee joint.

### Claim 9 (depends on 1)

The method of claim 1, wherein providing the knee implant comprises providing a knee implant configured to replace at least a portion of an anterior articular surface of a distal femur of the particular patient.

### Claim 10 (depends on 1)

The method of claim 1, wherein providing the knee implant comprises providing a knee implant configured to replace at least a portion of a trochlea of a distal femur of the particular patient.

### Claim 11 (depends on 1)

The method of claim 1, wherein providing the instrument comprises providing an instrument configured to match at least a portion of an anterior portion of a distal femur of the particular patient.

### Claim 12 (depends on 11)

The method of claim 11, wherein the tissue contacting surface includes at least one contour matching the portion of the anterior portion of the particular patient's distal femur.

### Claim 13 (depends on 1)

The method of claim 1, wherein providing the instrument comprises providing an instrument configured to match at least a portion of a trochlea of a distal femur of the particular patient.

### Claim 14 (depends on 1)

The method of claim 1, wherein providing the instrument comprises providing a marking template.

### Claim 15 (depends on 1)

The method of claim 1, wherein providing the instrument comprises providing a drill guide.

### Claim 16 (depends on 1)

The method of claim 1, wherein providing the knee implant comprises providing a knee implant configured based on cartilage surface pre-operative data for the particular patient; and
wherein providing the instrument comprises providing an instrument configured based on subchondral surface pre-operative data for the particular patient.

### Claim 17 (depends on 1)

The method of claim 1, further comprising receiving imaging data concerning a damaged cartilage surface of the particular patient's knee joint; and wherein providing the knee implant comprises providing a knee implant configured based on the imaging data of the damaged cartilage surface to substantially mimic at least a portion of a healthy cartilage surface of the particular patient's knee joint.

### Claim 18 (depends on 1)

The method of claim 1, further comprising receiving data relating to an axis of a femur of the particular patient; and wherein providing the instrument comprises providing an instrument configured based on the data relating to the axis of the femur to contact the particular patient's knee joint in a pre-defined position relative to the axis.

### Claim 19 (depends on 1)

The method of claim 1, wherein providing the knee implant and the instrument comprise manufacturing the knee implant and the instrument.

### Claim 20

A method of facilitating a knee implant procedure for a particular patient, the method comprising:
(a) providing a knee implant, wherein the knee implant comprises an articular surface at least a portion of which matches a natural kinematic contour of a knee joint of the particular patient and a tissue contacting surface that is substantially custom formed based on the pre-operative data to fit a portion of the particular patient's knee joint in a pre-defined spatial arrangement; and
(b) providing an instrument, wherein the instrument includes a tissue contacting surface and a surgical tool guide for guiding a surgical tool, wherein the tissue contacting surface is substantially custom formed based on the pre-operative data to match and fit a portion of the particular patient's knee joint in a pre-defined spatial arrangement.

### Claim 21

A method of facilitating a knee implant procedure for a particular patient, the method comprising:
(a) providing a knee implant, wherein the knee implant comprises at least one surface that is custom formed based on pre-operative data to match a natural contour of a portion of a particular patient's knee joint such that the knee implant permits desired kinematics for the patient's knee after implantation; and
(b) providing an instrument, wherein the instrument includes a tissue contacting surface and a surgical tool guide for guiding a surgical tool, wherein the tissue contacting surface is substantially custom formed based on the pre-operative data to match and fit a portion of the particular patient's knee joint in a pre-defined spatial arrangement.
