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

• US 9,393,032 B2
• Filed: 02/23/2015
• Issued: 07/19/2016
• Est. Priority Date: 03/17/2000
• Status: Expired due to Fees

• 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:
  US14/629,374
• Publication Number:
  US 20150164521A1
• Time in Patent Office: 512 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: 1/1
• 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 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 kit for use during an implant procedure, the kit comprising:

a knee prosthesis configured to substantially allow the original kinematics of a particular patient'"'"'s knee; and

an instrument comprising;

a body, the body including a femoral contacting side, the femoral contacting side comprising a three-dimensional shape substantially custom formed based on preoperative data obtained from the particular patient to match and fit at least a portion of a distal-anterior portion of a femur of the particular patient; and

a surgical tool guide, the surgical tool guide being customized for the particular patient, wherein the surgical tool guide is in a predetermined position with respect to the three dimensional shape of the femoral contacting side.

2. The kit according to claim 1, wherein the knee prosthesis is a custom replacement device formed based on the preoperative data.

3. The kit according to claim 2, wherein the custom replacement device is configured to maintain the original articulating movement of the particular patient'"'"'s knee.

4. The kit according to claim 2, wherein the femoral contacting side of the instrument is customized to match at least a portion of a surface area of the particular patient'"'"'s trochlear groove, the femoral contacting side being substantially defined by four boundary conditions, and wherein the first boundary condition is defined relative to the particular patient'"'"'s anterior cruciate ligament, the second boundary condition is defined approximately at or near a superior edge of an end of a natural cartilage, the third boundary condition is approximately at a top ridge of a lateral condyle, and the fourth boundary condition is approximately at a top ridge of medial condyle.

5. The kit of claim 1, wherein the knee prosthesis is configured to substantially maintain the original kinematics of the particular patient'"'"'s knee after removal of at least some bone from the knee.

6. The kit of claim 1, wherein the femoral contacting side of the instrument is configured to align with at least a portion of the particular patient'"'"'s trochlear groove.

7. A kit for facilitating surgery of a particular patient'"'"'s femur, the kit comprising:

a femoral implant, the femoral implant comprising an articular surface configured to substantially preserve the original kinematics of a particular patient'"'"'s knee; and

an instrument for use during an implant procedure and customized for the particular patient based on preoperative data obtained from the particular patient, the instrument comprising;

a body and a surgical tool guide, the body comprising a femoral contacting side, the femoral contacting side substantially custom formed to match in shape and size at least a portion of a distal-anterior portion of a femur of the particular patient and the surgical tool guide being in a predetermined position with respect to the three dimensional shape of the femoral contacting side.

8. The kit according to claim 7, wherein the femoral implant is a custom replacement device formed based on the preoperative data.

9. The kit according to claim 8, wherein the custom replacement device is configured to maintain the particular patient'"'"'s original articulating movement of the knee.

10. The kit according to claim 8, wherein the femoral contacting side of the instrument is customized to match at least a portion of a surface area of a trochlear groove of the particular patient, the femoral contacting side being substantially defined by four boundary conditions, and wherein the first boundary condition is defined relative to the particular patient'"'"'s anterior cruciate ligament, the second boundary condition is defined approximately at or near a superior edge of an end of a natural cartilage, the third boundary condition is approximately at a top ridge of a lateral condyle, and the fourth boundary condition is approximately at a top ridge of a medial condyle.

11. The kit of claim 7, wherein the femoral implant is configured to substantially preserve the original kinematics of the particular patient'"'"'s knee after removal of at least some bone from the knee.

12. The kit of claim 7, wherein the femoral contacting side of the instrument is configured to align with at least a portion of the particular patient'"'"'s trochlear groove.

13. A kit for use during an implant procedure for a particular patient, the kit comprising:

a knee joint prosthesis configured to substantially preserve the original kinematics of the particular patient'"'"'s knee joint; and

an instrument formed based on preoperative data obtained from the particular patient, the instrument comprising;

a body including a tissue contacting side and a surgical tool guide, the tissue contacting side including an anterior-femoral referencing portion configured to the particular patient'"'"'s anterior femur, the anterior-femoral referencing portion including at least three contacting portions;

a first contacting portion configured to contact a trochlear groove of the anterior femur of the particular patient;

a second contacting portion configured to contact a portion of the anterior femur to a first side of the trochlear groove; and

a third contacting portion configured to contact a portion of the anterior femur to a second side of the trochlear groove opposite the first side of the trochlear groove;

wherein the first contacting portion is offset relative to the second and third contacting portions.

14. The kit of claim 13, wherein the first, second, and third contacting portions are a continuous contact surface.

15. The kit of claim 14, wherein the continuous contact surface matches the anterior femur of the particular patient.

16. The kit of claim 14, wherein the continuous contact surface comprises at least one undulation matching at least one undulation of the anterior femur of the particular patient.

17. The kit of claim 13, wherein the surgical tool guide comprises at least two cylindrical drill guides configured to guide the formation of pin receiving openings in the femur of the particular patient.

18. The kit of claim 13, wherein the surgical tool guide is at least one of a hole or a slot.

19. The kit of claim 13, wherein the body defines an outer boundary surface configured to indicate a portion of an outer boundary of the knee joint prosthesis.

20. The kit of claim 13, wherein the first, second, and third contacting surfaces are configured to facilitate positioning the instrument in a predefined position relative to an axis of the particular patient.

21. The kit of claim 13, wherein at least one of the first, second, or third contacting surfaces is configured to contact at least a portion of a subchondral bone surface of the anterior femur of the particular patient.

22. The kit of claim 13, wherein the body has a bone contacting surface area, the bone contacting surface area being substantially defined by four boundary conditions, and wherein the first boundary condition is defined relative to the particular patient'"'"'s anterior cruciate ligament, the second boundary condition is defined approximately at or near a superior edge of an end of a natural cartilage, the third boundary condition is approximately at a top ridge of a lateral condyle, and the fourth boundary condition is approximately at a top ridge of medial condyle.

23. The kit of claim 13, wherein the knee joint prosthesis is configured to substantially preserve the original kinematics of the particular patient'"'"'s knee joint after removal of at least some bone from the knee joint.

24. The kit of claim 13, wherein the knee joint prosthesis is formed based on the preoperative data.

25. An kit for knee surgery, the kit comprising:

a femoral implant configured to substantially replicate as closely as possible the original kinematics of a knee joint of a particular patient; and

an instrument formed based on preoperative data obtained from the particular patient, the instrument comprising;

a bone contacting surface area, at least a portion of the bone contacting surface area customized to match at least a portion of a surface area of a trochlear groove of the particular patient, the bone contacting surface area being substantially defined by four boundary conditions, and wherein the first boundary condition is defined relative to the particular patient'"'"'s anterior cruciate ligament, the second boundary condition is defined approximately at or near a superior edge of an end of a natural cartilage, the third boundary condition is approximately at a top ridge of a medial condyle, and the fourth boundary condition is approximately at a top ridge of a lateral condyle.

26. The kit of claim 25, wherein the first boundary condition is approximately 3 to 5 mm from a point of attachment of the anterior cruciate ligament to a femur.

27. The kit of claim 25, wherein the first boundary condition is of sufficient distance above a groove where the anterior cruciate ligament exits so as not to result in impingement upon the tibial surface.

28. The kit of claim 25, further comprising a tool guide.

29. The kit of claim 25, wherein the femoral implant is configured to replicate the original kinematics of the knee joint after removal of at least some bone from the knee joint.

30. The kit of claim 25, wherein the femoral implant is formed based on the preoperative data.