Composite femoral implant having increased neck strength

• US 5,522,904 A
• Filed: 10/13/1993
• Issued: 06/04/1996
• Est. Priority Date: 10/13/1993
• Status: Expired due to Term

• Current Assignee: Hercules Incorporated (Ashland Global Holdings, Inc.), Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Hercules Incorporated (Ashland Global Holdings, Inc.)
• Inventors: Moran, James M., Daniel, Isaac M., Cairns, Douglas S., Smith, Daniel B., Salzstein, Richard A.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): ZUTTARELLI, ANTHONY
• Application Number:
  US08/135,484
• Time in Patent Office: 965 Days
• Field of Search: 623/11, 623/16, 623/18, 623/22-23, 623/901
• US Class Current: 623/23.34
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/3609 Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts A61F2/3601 takes precedence
• CPC Class Codes: A61F 2/3662 Femoral shafts
• CPC Class Codes: A61F 2002/30009 differing in fibre orientations
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30332 Conically- or frustoconically-shaped protrusion and recess
• 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 2002/3611 Heads or epiphyseal parts of femur
• CPC Class Codes: A61F 2002/3625 Necks
• CPC Class Codes: A61F 2002/365 Connections of heads to necks
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0028 differing in fibre orientations
• CPC Class Codes: A61L 27/443 with carbon fillers
• CPC Class Codes: B29C 2793/009 after shaping
• CPC Class Codes: B29C 70/202 arranged in parallel planes or structures of fibres crossing at substantial angles, e.g. cross-moulding compound [XMC] B29C70/207 takes precedence
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses

Abstract

A femoral implant for a hip prosthesis includes a shaft oriented in a longitudinal direction and a neck extending from said shaft at an acute angle θ to the longitudinal direction. The implant includes a plurality of layers of fibers in a matrix, wherein the fibers are substantially unidirectional in each respective layer. The implant is made from a stack of layers of the matrix so that the direction of fibers is unbalanced. At least 50% of the fibers are oriented in the θ direction and the remainder of said fibers are oriented in directions other than the θ angle.

Claims

1. A femoral implant for a hip prosthesis comprising:

a shaft oriented in a longitudinal direction;

a neck extending from said shaft at an acute angle θ

to the longitudinal direction;

said implant comprises a plurality of layers of fibers in a matrix, wherein said fibers are substantially unidirectional in each respective layer;

wherein at least 50% of said fibers of the implant are oriented in the θ

direction and the remainder of said fibers of the implant are oriented in directions other than the θ

angle.

2. The implant according to claim 1, wherein about 50 to about 60% of said fibers are oriented in the θ

direction.

3. The implant according to claim 1, wherein about 40 to about 50% of said fibers are oriented in the longitudinal direction.

4. The implant according to claim 1, wherein said acute angle θ

is about 25°

-55°

.

5. The implant according to claim 1, wherein said matrix comprises a biocompatible matrix.

6. The implant according to claim 1, wherein said matrix comprises a polymeric matrix.

7. The implant according to claim 1, wherein said matrix is selected from the group consisting of polysulfone, polyethersulphone, polyarylsulfone, polyphenylene sulfide, polycarbonates, aromatic polyamides, aromatic polyamideimides, thermoplastic polyimides, polyaryletherketones, polyetheretherketones, polyarylethernitriles, aromatic polyhydroxyethers, and mixtures thereof.

8. The implant according to claim 1, wherein said matrix is selected from the group consisting of ceramics, metals, carbon, epoxies, acrylics, and mixtures thereof.

9. The implant according to claim 1, wherein said matrix comprises polysulfone resin.

10. The implant according to claim 1, wherein said fibers comprise carbon.

11. The implant according to claim 1, wherein said fibers comprise a ceramic material.

12. The implant according to claim 1, wherein said fibers comprise boron.

13. The implant according to claim 1, wherein said fibers comprise metal.

14. The implant according to claim 1, wherein said fibers comprise a polymer.

15. The implant according to claim 1, wherein said fibers comprise aramid fibers.

16. The implant according to claim 1, wherein said fibers comprise fiberglass.

17. The implant according to claim 1, wherein said remainder of said fibers are oriented in the longitudinal direction.

18. The implant according to claim 1, wherein the number of layers is at least 100.

19. The implant according to claim 1, wherein the number of layers is about 100-300.

20. The implant according to claim 1, wherein the compressive strength of the neck is at least about 80 ksi.

21. The implant according to claim 1, wherein said acute angle θ

is about 25°

-55°

, said layers are flat, said matrix comprises a biocompatible matrix, and said fibers are selected from the group consisting of carbon, ceramic, boron, metal, aramid and fiberglass fibers.

22. The implant according to claim 1, wherein said acute angle θ

is about 35°

-45°

, said layers are flat, said matrix comprises a biocompatible polymeric matrix, said fibers comprise carbon and the number of layers is about 100-300.

23. A femoral implant as in claim 1 wherein the remainder of the fibers are oriented within ±

10°

from the longitudinal direction.

24. The implant according to claim 1, wherein said acute angle θ

is about 35°

-45°

.

25. The implant according to claim 24, wherein said acute angle θ

is about 40°

.

26. A femoral implant for a hip prosthesis comprising:

a shaft oriented in a longitudinal-direction and a neck extending from said shaft at an acute angle θ

to the longitudinal direction;

wherein said implant comprises a plurality of layers of fibers in a matrix, wherein said fibers are substantially unidirectional in each respective layer; and

wherein more of said fibers of the implant are oriented in the θ

direction than are fibers of the implant oriented in directions other than the θ

angle.

27. The implant according to claim 26, wherein more of said fibers are oriented in the θ

direction than in the longitudinal direction.

28. The implant according to claim 26, wherein said acute angle θ

is about 25°

-55°

, said layers are flat, said matrix comprises a biocompatible matrix, and said fibers are selected from the group consisting of carbon, ceramic, boron, metal, aramid and fiberglass fibers.

29. The implant according to claim 26, wherein said acute angle θ

is about 35°

-45°

, said layers are flat, said matrix comprises a biocompatible polymeric matrix, said fibers comprise carbon and the number of layers is about 100-300.

30. A femoral implant for a hip prosthesis comprising:

a shaft oriented in a longitudinal direction and a neck extending from said shaft at an acute angle θ

to the longitudinal direction;

wherein said implant comprises a plurality of layers of fibers in a matrix, wherein said fibers are substantially unidirectional in each respective layer; and

wherein more of said layers contain fibers oriented in the θ

direction than said layers contain fibers oriented in the shaft direction.

31. The implant according to claim 30, wherein said acute angle θ

is about 25°

-55°

, said layers are flat, said matrix comprises a biocompatible matrix, and said fibers are selected from the group consisting of carbon, ceramic, boron, metal, aramid and fiberglass fibers.

32. The implant according to claim 30, wherein said acute angle θ

is about 35°

-45°

, said layers are flat, said matrix comprises a biocompatible polymeric matrix, said fibers comprise carbon and the number of layers is about 100-300.

33. A method of making a femoral implant for a hip prosthesis having a shaft oriented in a longitudinal direction and a neck extending from said shaft at an acute angle θ

to said longitudinal direction comprising the steps of;

forming a plurality of individual layers of substantially unidirectional fibers in a matrix;

stacking said layers such that at least 50% of said fibers of the implant are oriented at said angle θ and

the remainder are oriented in directions other than the θ

angle;

heating the stacked layers under pressure to melt said matrix;

cooling said matrix to form a composite block; and

machining said stacked layers into the form of the implant.

34. The method according to claim 33, wherein said acute angle θ

is about 25°

-55°

, said layers are flat, said matrix comprises a biocompatible matrix, and said fibers are selected from the group consisting of carbon, ceramic, boron, metal, aramid and fiberglass fibers.

35. The method according to claim 33, wherein said acute angle θ

is about 35°

-45°

, said layers are flat, said matrix comprises a biocompatible polymeric matrix, said fibers comprise carbon and the number of layers is about 100-300.

36. A method of performing hip-joint replacement surgery comprising implanting a femoral implant comprising a shaft oriented in a longitudinal direction and a neck extending from said shaft at an acute angle θ

to the longitudinal direction;

wherein said implant comprises a plurality of layers of fibers in a matrix wherein said fibers are unidirectional in each respective layer; and

wherein at least 50% of said layers have fibers oriented in the θ

direction and the remainder of said layers have fibers oriented in directions other than the θ

angle.

37. The method according to claim 36, wherein said acute angle θ

is about 25°

-55°

, said layers are flat, said matrix comprises a biocompatible matrix, and said fibers are selected from the group consisting of carbon, ceramic, boron, metal, aramid and fiberglass fibers.

38. The method according to claim 36, wherein said acute angle θ

is about 35°

-45°

, said layers are flat, said matrix comprises a biocompatible polymeric matrix, said fibers comprise carbon and the number of layers is about 100-300.

39. A femoral implant for a hip prosthesis comprising a shaft oriented in a longitudinal direction and a neck extending from said shaft at an acute angle θ

to the longitudinal direction;

wherein said implant comprises a plurality of layers of fibers in a matrix, and said fibers are substantially unidirectional in each respective layer; and

wherein at least 50% of the layers have fibers oriented in the θ

direction and the remainder of the layers have fibers oriented in directions other than the θ

angle.

40. A femoral implant for a hip prosthesis as claimed in claim 39 wherein the implant is made from a stack of layers of fibers and matrix so that the direction of the fibers is unbalanced.

41. A femoral implant as in claim 39 wherein more of the fibers may he oriented in the θ

direction than are fibers oriented in directions other that the θ

angle.

42. A femoral implant as in claim 39 wherein at least as much of the fibers are oriented in the θ

direction as are fibers oriented in the shaft direction, the number of fibers oriented in the θ

direction being different than the number of fibers oriented in the shaft direction.

43. A femoral implant according to claim 39, wherein said acute angle θ

is about 25°

-55°

, said layers are flat, said matrix comprises a biocompatible matrix, and said fibers are selected from the group consisting of carbon, ceramic, boron, metal, aramid and fiberglass fibers.

44. A femoral implant according to claim 39, wherein said acute angle θ

is about 35°

-45°

, said layers are flat, said matrix comprises a biocompatible polymeric matrix, said fibers comprise carbon and the number of layers is about 100-300.

45. A femoral implant as in claim 39 wherein the remainder of the fibers are oriented within ±

10°

from the longitudinal direction.

46. A femoral implant according to claim 45, wherein said acute angle θ

is about 25°

-55°

, said layers are flat, said matrix comprises a biocompatible matrix, and said fibers are selected from the group consisting of carbon, ceramic, boron, metal, aramid and fiberglass fibers.

47. A femoral implant according to claim 45, wherein said acute angle θ

is about 35°

-45°

, said layers are flat, said matrix comprises a biocompatible polymeric matrix, said fibers comprise carbon and the number of layers is about 100-300.

48. A method of making a femoral implant for hip prosthesis having a shaft oriented in a longitudinal direction and a neck extending from said shaft at an acute angle θ

to said longitudinal direction comprising the steps of;

forming a plurality of individual layers of substantially unidirectional fibers in a matrix;

stacking the layers such that at least 50% of the layers have fibers oriented in the θ

direction and the remainder of the layers have fibers oriented in directions other than the θ

angle;

heating the stacked layers under pressure to melt said matrix;

cooling said matrix to form a composite block; and

machining said stacked layers into the form of the implant.

49. A method of making a femoral implant for hip prosthesis as claimed in claim 48 wherein said heating step is carried out prior to said maching step.

50. A method of making a femoral implant for hip prosthesis as claimed in claim 48 comprising sequentially said machining the stacked layers into the form of the implant and then said heating the stacked layers under pressure to melt said matrix.

51. The method according to claim 48, wherein said layers are flat, said acute angle θ

is about 25°

-55°

, said matrix comprises a biocompatible matrix, and said fibers are selected from the group consisting of carbon, ceramic, boron, metal, aramid and fiberglass fibers.

52. The method according to claim 48, wherein said acute angle θ

is about 35°

-45°

, said layers are flat, said matrix comprises a biocompatible polymeric matrix, said fibers comprise carbon and the number of layers is about 100-300.

53. The method according to claim 48, wherein said acute angle θ

is about 25°

-55°

, said layers are flat, said matrix comprises a biocompatible matrix, and said fibers are selected from the group consisting of carbon, ceramic, boron, metal, aramid and fiberglass fibers.

54. The method according to claim 48, wherein said acute angle θ

is about 35°

-45°

, said layers are flat, said matrix comprises a biocompatible polymeric matrix, said fibers comprise carbon and the number of layers is about 100-300.

55. A method of performing hip-joint replacement surgery comprising implanting a femoral implant comprising a shaft oriented in a longitudinal direction and a neck extending from said shaft at an acute angle θ

to the longitudinal direction;

wherein said implant comprises a plurality of layers of fibers in a matrix and said fibers are unidirectional in each respective layer; and

wherein at least 50% of said layers have fibers oriented in the θ

direction and the remainder of said layers have fibers oriented in directions other than the θ

angle.