Marking template for installing a custom replacement device for resurfacing a femur and associated installation method

• US 8,771,281 B2
• Filed: 04/28/2011
• Issued: 07/08/2014
• Est. Priority Date: 03/17/2000
• Status: Active Grant

• Current Assignee: Kinamed Inc (VME Acquisition Corp)
• Original Assignee: Kinamed Inc (VME Acquisition Corp)
• Inventors: Carignan, Roger, Pratt, Clyde R.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US13/096,868
• Publication Number:
  US 20110276145A1
• Time in Patent Office: 1,167 Days
• Field of Search: 623/18.11, 623/16.11, 623/11.11, 623/22.42, 623/20.35, 623/20.14, 623/20.19, 623/20.18, 623 203- 2032, 606/88, 606/87, 606/86.R, 606/89, 606/96, 606/80, 606/53, 606/85
• US Class Current: 606/88
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/1764 for the knee
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/30942 for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/3877 Patellae or trochleae
• CPC Class Codes: A61F 2/461 of knees
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2002/30125 elliptical or oval
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30685 Means for reducing or preventing the generation of wear particulates
• CPC Class Codes: A61F 2002/30892 parallel
• CPC Class Codes: A61F 2002/30948 using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30952 using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/4658 for measuring dimensions, e.g. length
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00203 : containing alumina or aluminium oxide
• CPC Class Codes: A61F 2310/00239 : containing zirconia or zirconium oxide ZrO2
• CPC Class Codes: A61F 2310/00407 : Coating made of titanium or of Ti-based alloys
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: Y10S 623/901 : Method of manufacturing prosthetic device
• CPC Class Codes: Y10T 29/49764 : with testing or indicating

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

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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

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

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

16. 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.

17. 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.

18. 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.

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

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.

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.