Meniscus prosthesis

• US 20050278025A1
• Filed: 06/10/2004
• Published: 12/15/2005
• Est. Priority Date: 06/10/2004
• Status: Abandoned Application

• Current Assignee: Cartiva, Inc. (Stryker Corporation)
• Original Assignee: SaluMedica LLC
• Inventors: Meyer, Ralph A., Sarabia, Xavier R., Ku, David N., Williams, Stephen N.
• Application Number:
  US10/865,238
• Publication Number:
  US 20050278025A1
• Time in Patent Office: Days
• US Class Current: 623/14.120
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/3099 for temporo-mandibular [TM, TMJ] joints endoprostheses for mandibular reconstruction A61F2/2803
• CPC Class Codes: A61F 2/3872 Meniscus for implantation between the natural bone surfaces
• CPC Class Codes: A61F 2/40 for shoulders
• CPC Class Codes: A61F 2/4202 for ankles
• CPC Class Codes: A61F 2002/30069 elastomeric
• CPC Class Codes: A61F 2002/30131 horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30708 Means for distinguishing between left-sided and right-sided devices, Sets comprising both left-sided and right-sided prosthetic parts
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0015 Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0084 Means for distinguishing between left-sided and right-sided devices; Sets comprising both left-sided and right-sided prosthetic parts

Abstract

A prosthesis for placement into a joint space between two or more bones is disclosed. The prosthesis includes a body formed from a pre-formed solid one piece elastomer, wherein the elastomer is formed from a synthetic organic polymer that is biocompatible and has a modulus of elasticity and a mechanical strength between 0.5 MPa and 75 MPa. The body having a shape contoured to fit within a joint space between the femoral condyle, tubercle, and tibial plateau without any means of attachment.

Claims

1. A prosthesis comprising a body formed from an elastomer, wherein the elastomer is formed from an organic polymer that is biocompatible and has a modulus of elasticity and a mechanical strength between 0.5 MPa and 75 MPa enabling said body to provide cushioning and load distribution capabilities within a joint space similar to native articular cartilage and meniscus, said body having a shape contoured to fit with a femoral condyle, a tubercle, and a tibial plateau, said body having a geometry designed to stay within a joint space without any separate means of attachment.

2. The prosthesis of claim 1, wherein the body has a uniform modulus of elasticity throughout.

3. The prosthesis of claim 1, wherein the body includes a superior surface forming a concave groove channel contoured to receive a femoral condyle, an inferior surface forming a convex surface contoured to fit on top a tibial plateau, and having a thickness therebetween.

4. The prosthesis of claim 3, wherein the groove channel has a width that is greater than ½

the width of the body.

5. The prosthesis of claim 1, wherein the body further comprising a cruciate region, an outer region, an anterior region, a posterior region a central region, and an outer wall along the periphery of the cruciate region, outer region, anterior region, and posterior region, said cruciate region including an indentation located proximally to the anterior region and contoured to receive a tubercle.

6. The prosthesis of claim 5, wherein the indentation is generally in the form of a sinusoidal shaped arch.

7. The prosthesis of claim 5, wherein the indentation decreases in size as it extends from the outer wall of the cruciate region to the central region.

8. The prosthesis of claim 3, wherein the groove channel is located within a central region.

9. The prosthesis of claim 1, wherein the body is wide enough to fully receive the width of a femoral condyle.

10. The prosthesis of claim 1, wherein the body has a length that is approximately equal to the anterior-posterior length of a tibial plateau.

11. The prosthesis of claim 5, wherein the posterior region is thicker than the anterior region.

12. The prosthesis of claim 1, wherein the body may be flexed into a joint space.

13. The prosthesis of claim 1, wherein the body is compatible with magnetic resonance imaging.

14. The prosthesis of claim 1, wherein the body is attached to a tissue fixation component.

15. The prosthesis of claim 14, wherein the tissue fixation component is selected from the group consisting of extension tabs, sutures, and mesh.

16. The prosthesis of claim 1, wherein the body is substantially kidney shaped.

17. The prosthesis of claim 1, wherein the body is substantially toroidal in shape.

18. The prosthesis of claim 1, wherein the body is substantially crescent shaped.

19. The prosthesis of claim 5, wherein the anterior region is thicker than the posterior region.

20. The prosthesis of claim 1, wherein the body includes a reinforcing material selected from the group consisting of polymers such as polyester or metals such as titanium.

21. The prosthesis of claim 1, wherein the elastomer is a hydrogel.

22. The prosthesis of claim 1, wherein the elastomer has a modulus of elasticity of from about 0.6 MPa to about 10 MPa.

23. The prosthesis of claim 1, wherein the elastomer has a compressive modulus of elasticity of from about 2 MPa to about 5 MPa.

24. The prosthesis of claim 1, wherein the elastomer has a tensile strength of from about 0.6 MPa to about 10 MPa.

25. The prosthesis of claim 1, wherein the elastomer has a tensile strength of from about 2 MPa to about 5 MPa.

26. The prosthesis of claim 1, wherein the elastomer has a dynamic coefficient of friction from about 0.01 to about 1.

27. The prosthesis of claim 1, wherein the elastomer has a dynamic coefficient of friction from about 0.02 to about 0.1.

28. The prosthesis of claim 1, wherein the elastomer is formed synthetically.

29. The prosthesis of claim 1, wherein the body is formed from a pre-formed solid one piece elastomer.

30. A prosthesis comprising a body formed from a pre-formed solid one piece elastomer, wherein the elastomer is formed from an organic polymer that is biocompatible and has a modulus of elasticity and a mechanical strength between 0.5 MPa and 75 MPa enabling said body to provide cushioning and load distribution capabilities within a joint space similar to native articular cartilage and meniscus, said body including a superior surface forming a concave groove channel contoured to receive a femoral condyle, wherein said groove channel has a width that is greater than ½

the width of the body, an inferior surface forming a convex surface contoured to fit on top of a tibial plateau, and having a thickness therebetween, said body being wide enough to fully receive the width of the femoral condyle, said body further comprising a cruciate region, an outer region, an anterior region, a posterior region, a central region, and an outer wall surrounding the periphery of the cruciate region, outer region, anterior region, and posterior region, said cruciate region including an indentation located proximally to the anterior region and contoured to fit with a tubercle, said indentation generally in the form of a sinusoidal shaped arch decreasing in size as it extends from the outer wall of the cruciate region to the central region, said posterior region being thicker than said anterior region, said body further having a geometry designed to stay within a joint space without any separate means of attachment.

31. A method for placing a prosthesis into a joint space which comprises:

making an incision in the tissue surrounding the joint space of a knee;

inserting a prosthesis into the joint space of a knee, said prosthesis comprising a body formed from a pre-formed solid one piece elastomer, wherein the elastomer is formed from an organic polymer that is biocompatible and has a modulus of elasticity and a mechanical strength between 0.5 MPa and 75 MPa, said body including a superior surface forming a concave groove channel contoured to receive a femoral condyle, wherein said groove channel has a width that is greater than ½

the width of the body, an inferior surface forming a convex surface contoured to fit on top of a tibial plateau, and having a thickness therebetween, said body being wide enough to fully receive the width of the femoral condyle, said body further comprising a cruciate region, an outer region, an anterior region, a posterior region, a central region, and an outer wall surrounding the periphery of the cruciate region, outer region, anterior region, and posterior region, said cruciate region further including an indentation located proximally to the anterior region and contoured to fit with a tubercle, said indentation generally in the form of a sinusoidal shaped arch decreasing in size as it goes from the outer wall of the cruciate region to the central region, said posterior region being thicker than said anterior region, said body further having a geometry designed to stay within a joint space without any separate means of attachment; and

closing said incision.