Surgically implantable knee prothesis

• US 6,206,927 B1
• Filed: 05/10/1999
• Issued: 03/27/2001
• Est. Priority Date: 04/02/1999
• Status: Expired due to Term

• Current Assignee: Centerpulse Orthopedics Incorporated
• Original Assignee: Barry M. Fell, Richard H. Hallock
• Inventors: Fell, Barry M., Hallock, Richard H.
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US09/297,943
• Time in Patent Office: 687 Days
• Field of Search: 623/20.23, 623/20.26, 623/20.24, 623/20.29, 623/20.31, 623/20.14
• US Class Current: 623/20.29
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/3868 with sliding tibial bearing
• CPC Class Codes: A61F 2/3872 Meniscus for implantation between the natural bone surfaces
• CPC Class Codes: A61F 2002/30065 thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30324 differing in thickness
• 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 2002/30962 using stereolithography
• CPC Class Codes: A61F 2002/3895 unicompartimental
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2210/0071 thermoplastic
• CPC Class Codes: A61F 2230/0015 Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00179 Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

A self-centering meniscal prosthesis device suitable for minimally invasive, surgical implantation into the cavity between a femoral condyle and the corresponding tibial plateau is composed of a hard, high modulus material shaped such that the contour of the device and the natural articulation of the knee exerts a restoring force on the free-floating device.

Claims

1. A meniscal load distribution device suitable for an arthroscopically assisted implantation into a meniscal cavity of one compartment of a knee joint between a femoral condyle and the respective tibial plateau, said meniscal device comprising a high modulus material having a hardness greater than about Shore D 60, said meniscal device being substantially elliptical in plan, and having a concave femoral meniscal surface, a convex tibial meniscal surface, and a periphery defined by lateral, medial, anterior, and posterior portions, the periphery being on average of greater thickness than a central portion of the meniscal device, said femoral meniscal surface having a contour such that the contour angle of said femoral meniscal surface is approximately the same as the contour angle of said femoral condyle, relative to the contour angle of the tibial plateau, said tibial meniscal surface having a contour such that the contour angle is substantially the same as the contour angle of said tibial plateau.

2. The meniscal load distribution device of claim 1, wherein said meniscal device in plan is kidney-shaped.

3. The meniscal load distribution device of claim 1 wherein said device has a thickness along the posterior portion is equal to or greater than the thickness at the lateral, medial and anterior portions.

4. The meniscal load distribution device of claim 1 wherein said device is constructed of a material selected from the group consisting of a biocompatible ceramic, a biocompatible metal, or composites thereof.

5. The meniscal load distribution device of claim 1 wherein said device is constructed of a material comprising a thermoset polymer or a thermoplastic polymer.

6. The meniscal load distribution device of claim 5 wherein said polymer contains fibrous reinforcement.

7. The meniscal load distribution device of claim 1 wherein the contour angle of the femoral meniscal surface as referenced by the tibial contour angle is different from the contour angle of the tibial plateau by up to about 35°

.

8. The meniscal load distribution device of claim 1 wherein the contour angle of the femoral meniscal surface is different from the contour angle of the tibial plateau from about 10°

to about 20°

.

9. The meniscal load distribution device of claim 1 wherein the contour angle of the femoral meniscal surface of the device is offset from the contour angle of the femoral condyle from +0.20 inches to −

0.20 inches relative to the CSO of the device.

10. The meniscal load distribution device of claim 1 wherein the contour angle of the tibial meniscal surface of the device is offset from the contour angle of the tibial plateau from +0.40 inches to −

0.20 inches relative to the CSO of the device.

11. The meniscal load distribution device of claim 1 wherein the surface area of the femoral surface is smaller than the surface area of the tibial surface resulting in an increasing taper of the edge of the device from the femoral surface to the tibial surface.

12. The meniscal load distribution device of claim 1 wherein the device contains one or more areas of reverse curvature at the extreme anterior-lateral and/or posterior/lateral portions.

13. A procedure for unicompartmental correction of knee joint injury, degeneration, or injury and degeneration, said procedure comprising:

a) creating an incision in the anterior portion of tissue surrounding a knee joint compartment;

b) optionally arthroscopically altering the condition of bone, meniscal cartilage, articular cartilage, or other tissue located in said compartment or adjacent thereto;

c) inserting into said compartment a device of claim 1; and

d) closing off said incision.

14. The procedure of claim 13 wherein said meniscal cartilage is left substantially intact.

15. The procedure of claim 13 wherein said device is the device of claim 14.

16. The meniscal load distribution device of claim 1, said meniscal device having an active material coated thereon, contained as part of or contained therein.

17. The meniscal load distribution device of claim 14, wherein said meniscal load distribution device has a surface contour such that the device bridges a damaged or degenerated portion of tissue, said surface contour optionally containing, or producing an active material which encourages tissue regrowth or which decreases inflammation.

18. A process for the regeneration of tissue in a bearing surface of a knee joint compartment, comprising coating said surface with an active material which encourages tissue regeneration;

inserting into said knee joint compartment a meniscal load distribution device of claim 1, said device having a recessed portion or non-contacting portion which, following insertion of said device into said knee joint compartment, is proximate said surface such that said surface is protected from abrasion and wear at least during the period of tissue regeneration at said surface.

19. A method for correcting a varus or valgus deformity in the alignment of the knee joint, inserting into said knee joint compartment a meniscal load distribution device of claim 1, said device having a shape and thickness which, following insertion of said device into said knee joint compartment, is able to correct a varus or valgus deformity in the knee joint.

20. The meniscal load distribution device of claim 1, said meniscal device having surfaces of varying radii.

21. The meniscal load distribution device of claim 1, said meniscal device having surfaces of substantially constant radii.

22. A bicompartmental meniscal device suitable for bicompartmental implantation, comprising a medial meniscal device in accordance with claim 1 and a lateral meniscal device in accordance with claim 1, said medial and lateral meniscal devices mechanically but non-rigidly linked.

32. The prosthetic device of claim 1, wherein said prosthetic device has a surface contour such that the device bridges a damaged or degenerated portion of tissue, said surface contour optionally containing, or producing an active material which encourages tissue regrowth or which decreases inflammation.

33. The prosthetic device of claim 32, wherein said active material is contained in a composition which releases said active material in a timed release manner.

34. The prosthetic device of claim 33 wherein said composition comprises a gel, a paste, or a polymer.

23. A process for the preparation of a unicompartmental meniscal load distribution device suitable for implantation into a knee joint, between a femoral condyle and its corresponding tibial plateau, said process comprising:

a) determining the geometry of said femoral condyle by a non-invasive imaging technique;

b) determining the geometry of said corresponding tibial plateau;

c) molding a meniscal load distribution device which is dimensioned to fit within the compartment defined on its top and bottom surfaces by the geometry of said femoral condyle and said tibial plateau, said device being substantially elliptical in shape, and having a concave femoral meniscal surface, a convex tibial meniscal surface, and a posterior thickness which is equal to or greater than a lateral and an anterior thickness, said femoral meniscal surface having a contour angle which is substantially equal to the contour angle of said femoral condyle relative to the tibial plateau.

24. A prosthetic device suitable for unicompartmental implantation into the knee joint of a patient, said device comprising a hard, rigid device substantially elliptical in plan with a periphery whose average thickness is greater than the portion of the central portion of said device of lowest thickness, said device having an uppermost concave femoral meniscal surface having generally the contour of the femoral condyle of the knee compartment into which said device is to be inserted, a lowermost convex tibial meniscal surface, said periphery defined by lateral, medial, anterior, and posterior portions, said device free of anchoring devices attached to bone, cartilage, ligaments, or other tissue, said device thus being capable of translation, rotation, or both translation and rotation in the compartment cavity, the femoral meniscal surface and tibial meniscal surface contoured such that the device is self-centering between the femoral condyle and tibial plateau of said compartment.

25. The device of claim 24 wherein said posterior portion of said periphery is on average equal to or of greater thickness than the average thickness of said lateral, medial and anterior portions of said periphery.

26. The device of claim 24 wherein the geometry of said device renders said device substantially immune from spitting from said compartment upon flexing of the knee joint.

27. The device of claim 24 wherein said device in plan is kidney-shaped.

28. The device of claim 24 wherein the contour angle of the femoral meniscal surface of the device is equal to or different from the contour angle of said femoral condyle within ±

15°

, and less than 20°

, of the contour angle of the femoral condyle relative to the contour angle of the tibial plateau.

29. The device of claim 24 wherein the contour angle of said femoral meniscal surface is different from the contour angle of said tibial plateau by from about 10°

to about 35°

.

30. The device of claim 24 wherein said device is constructed of one or more fiber reinforced and non-fiber reinforced biocompatible materials selected from the group consisting of thermoset polymers, thermoplastic polymers, metals, and ceramics.

31. The prosthetic device of claim 24, said prosthetic device having an active material coated thereon, contained as part of or contained therein.