Orthopedic device of biocompatible polymer with oriented fiber reinforcement

• US 5,192,330 A
• Filed: 08/06/1991
• Issued: 03/09/1993
• Est. Priority Date: 01/20/1987
• Status: Expired due to Fees

• Current Assignee: Smith & Nephew Richards Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Richards Incorporated (Smith & Nephew PLC)
• Inventors: Chang, Fu-Kuo, Georgette, Frederick S., Reifsnider, Kenneth, Davidson, James A.
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): GUALTIERI, GINA
• Application Number:
  US07/740,723
• Time in Patent Office: 581 Days
• Field of Search: 623/16, 623/18, 623/22, 623/23, 623/66
• US Class Current: 623/23.34
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2002/30009 differing in fibre orientations
• CPC Class Codes: A61F 2002/3686 bent
• CPC Class Codes: A61F 2250/0028 differing in fibre orientations
• CPC Class Codes: A61L 27/443 with carbon fillers
• CPC Class Codes: B29C 70/46 using matched moulds, e.g. for deforming sheet moulding compounds [SMC] or prepregs
• CPC Class Codes: B29D 99/0007 having a variable cross-section
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses

Abstract

Orthopedic device of biocompatible polymer with oriented fiber reinforcement. There is provided a device such as a hip stem which has a longitudinally curved body. The reinforcing fibers are continuous filament fiber plies with parallel orienated fibers in each ply. The plies are curved longitudinally to approximately correspond to the curve of the body. In one embodiment, there are longitudinally oriented fiber plies at or near the surfaces of the device and plies with fibers offset at 5°-40° from the longitudinal axis between the surface layers. The fiber orientation is balanced by providing a ply of negatively angled offset fibers of a similar angle for each positively angled offset ply. The device is made by molding plies preimpregnated with polymer (prepregs) simultaneously, by molding a plurality of prepregs into segments which are then molded together, or by molding a segment and incrementally molding additional layers of prepregs thereto in a series of progressively larger molds.

Claims

1. An orthopaedic device, for human implantation having improved axial bending and torque bearing properties, said device comprising:

a curved elongated body having an outer surface and a longitudinal axis, the body comprising a matrix of biocompatible polymeric material defining the shape of the body; and

reinforcing plies embedded within said matrix, said plies being curved in approximate correspondence with the curvature of the device and said plies being formed from fibers, said fibers being continuous and generally parallel to each other within each ply;

wherein a majority of the plies are oriented at a non-zero angle to the longitudinal axis of the curved elongated body.

2. The device of claim 1, wherein the matrix material is selected from the group consisting of:

polysulfone, polyethersulfone, polyarylsulfone, polyphenylene sulfide, polycarbonate, aromatic polyamide, aromatic polyamideimide, thermoplastic polyimide, polyaryletherketone, polyetheretherketone, polyarylethernitrile, aromatic polyhydroxyether, thermosetting phenolics and medical grade epoxies.

3. The device of claim 1, wherein the fibers are selected from the group consisting of carbon fiber, glass fiber, polyolefin fiber, polyetheretherketone fiber and polyethylene terephthalate fiber.

4. The device of claim 1, wherein said matrix material is bioresorbable.

5. The device of claim 1, wherein the fibers are bioresorbable.

6. The device of claim 1 further comprising a biocompatible coating over at least a portion of the surface of the device.

7. The device of claim 6 wherein the coating comprises a radio-opaque composition, osteo-conductive composition or a medicament.

8. The device of claim 1 further comprising:

a sheath of continuous fibers overmolded on at least a portion of the surface of the device.

9. The device of claim 8, wherein said sheath is a mantle adapted to fit over at least a portion of the surface of the device.

10. The device of claim 1 wherein a majority of fibers are oriented at angles of between five and forty degrees.

11. The device of claim 1 wherein the plies comprise, at least in part, a first ply with fibers oriented at a first non-zero angle and a second ply, adjacent the first ply, with fibers oriented at a second non-zero angle, that is greater than the first non-zero angle.

12. The implant of claim 11 wherein the plies comprise at least three consecutive plies stacked in a sequence that includes a first ply with fibers oriented at a first non-zero angle, and a second ply with fibers oriented at a second non-zero angle that is larger than the first non-zero angle, and a third ply with fibers oriented at a third non-zero angle that is different than the first and second angles.

13. The implant of claim 11 wherein the plies comprise at least three consecutive plies stacked in a sequence that includes a first ply with fibers oriented at a first non-zero angle, a second ply with fibers oriented at a second non-zero angle that is greater than the first angle, and a third ply having fibers oriented at a non-zero angle and wherein the third ply fibers are oriented in a negative direction relative to the longitudinal axis.

14. The implant of claim 11 wherein a majority of the fibers are oriented at angles of between five and forty degrees.

15. A composite hip joint for human implantation, comprising:

a) a stem including a distal end, a longitudinal curved body extending from the distal end, said curved body culminating in a neck;

b) said composite hip joint having an outer surface and comprising a biocompatible polymer matrix; and

c) reinforcing plies stacked one atop the other with the matrix, said plies being formed of continuous fibers generally parallel to each other, each of the plies being curved to substantially correspond to the longitudinal curvature of the body;

wherein a majority of the reinforcing plies are oriented at a non-zero angle to a longitudinal axis of the longitudinal curved body of the hip joint stem.

16. The hip joint of claim 15, wherein the matrix material is selected from the group consisting of:

polysulfone, polyethersulfone, polyarylsulfone, polyphenylene sulfide, polycarbonate, aromatic polyamide, aromatic polyamideimide, thermoplastic polyimide, polyaryletherketone, polyetheretherketone, polyarylethernitrile, aromatic polyhydroxyether, thermosetting phenolics and medical grade epoxies.

17. The hip joint of claim 15, wherein the fibers are selected from the group consisting of carbon fiber, glass fiber, polyolefin fiber, polyetheretherketone fiber and polyethylene terephthalate fiber.

18. The hip joint of claim 15, further comprising a sheath of continuous fibers overmolded on at least a portion of the surface of the hip joint.

19. The hip joint of claim 18 wherein the sheath is a mantle adapted to fit over at least a portion of the surface of the hip joint.

20. The hip joint of claim 15 further comprising a coating over at least a portion of the surface of the hip joint.

21. The hip joint of claim 20 wherein the coating comprises a biocompatible polymer.

22. The hip joint of claim 20 wherein the coating further comprises a radio-opaque composition, an osteo-conductive composition or a medicament.

49. The implant of claim 15 wherein the non-zero angle is at least five degrees.

50. The implant of claim 49 wherein the non-zero angle is between five and forty degrees.

51. The implant of claim 15 wherein the plies comprise, at least in part, a first ply with fibers oriented at a first non-zero angle and a second ply adjacent the first play with fibers oriented at a second non-zero angle that is greater than the first non-zero angle.

52. The implant of claim 51 wherein the plies comprise at least three consecutive plies stacked in a sequence that includes a first ply with fibers oriented at a first non-zero angle, and a second ply with fibers oriented at a second non-zero angle that is larger than the first non-zero angle, and a third ply with fibers oriented at a third non-zero angle that is different than the first and second angles.

53. The implant of claim 51 wherein the plies comprise at least three consecutive plies stacked in a sequence that includes a first ply with fibers oriented at a first non-zero angle, a second ply with fibers oriented at a second non-zero angle that is greater than the first angle, and a third ply having fibers oriented at a non-zero angle and wherein the third ply fibers are oriented in a negative direction relative to the longitudinal axis.

54. The implant of claim 51 wherein a majority of the fibers are oriented at angles of between five and forty degrees.

55. The implant of claim 52 wherein a majority of fibers are oriented at angles of between five and forty degrees.

23. An orthopaedic device having improved axial, bending and torque bearing properties for human implantation;

comprising;

a body with a longitudinal curve and a longitudinal axis;

a matrix of biocompatible polymeric material defining the shape of the body and having an outer surface; and

a plurality of planar reinforcing fiber plies embedded within said matrix, said plies each having a longitudinal axis;

wherein the fibers with each ply are continuous and oriented parallel to the longitudinal axis of each ply and a majority of the planar plies are oriented at a non-zero angle to the longitudinal axis of the device.

24. The device of claim 23 wherein the fibers in consecutive plies are stacked in a sequence (0₂ /±

7.5/±

15/±

22.5/±

30)s relative to the longitudinal axis of the device.

25. The device of claim 23 wherein the fibers in consecutive plies are stacked in a sequent (-20, -25, -65)_s relative to the longitudinal axis of the device.

26. The device of claim 23 wherein said fibers are selected from the group consisting of carbon, glass fiber, polyolefin fiber, polyetheretherketone fiber and polyethylene terephthalate fiber.

27. The device of claim 23 wherein said matrix material is bioresorbable.

28. The device of claim 23 wherein said fibers are bioresorbable.

29. The device of claim 23 further comprising a bioresorbable coating over at least a portion of the surface of the device.

30. The device of claim 29 wherein the coating comprises a biocompatible polymer.

31. The device of claim 30 wherein said coating is selected from the group consisting of polysulfone, polyethersulfone, polyarylsulfone, polyphenylene sulfide, polycarbonate, aromatic polyamide, aromatic polyamideimide, thermoplastic polyimide, polyaryletherketone, polyetheretherketone, polyarylethernitrile, aromatic polyhydroxyether, thermosetting phenolics and medical grade epoxies.

32. The device of claim 30 wherein the coating further comprises a radio-opaque composition, osteo-conductive compositions or a medicament.

33. The device of claim 23 further comprising a sheath of continuous fibers overmolded on at least a portion of the outer surface of the device.

34. The device of claim 33 wherein said sheath is a mantle adapted to fit over at least a portion of the outer surface of the device.

35. The device of claim 23, wherein the matrix material is selected from the group consisting of:

polysulfone, polyethersulfone, polyarylsulfone, polyphenylene sulfide, polycarbonate, aromatic polyamide, aromatic polyamideimide, thermoplastic polyimide, polyaryletherketone, polyetheretherketone, polyarylethernitrile, aromatic polyhydroxyether, thermosetting phenolics and medical grade epoxies.

36. The device of claim 23 wherein the fibers are selected from the group consisting of carbon fiber, glass fiber, polyolefin fiber, polyetheretherketone fiber and polyethylene terephthalate fiber.

37. A composite hip joint for human implantation comprising a stem with a distal end, a longitudinal curved body with a longitudinal axis, a neck, and an outer surface, the hip joint comprising:

a longitudinally curved biocompatible polymer matrix; and

reinforcing planar plies embedded in the matrix, said plies being formed of continuous fibers generally parallel to each other;

wherein a majority of the planar plies are oriented at a non-zero angle to the longitudinal axis.

38. The devices of claim 37 wherein the fibers in consecutive plies are stacked in a sequence (0₂ ±

7.5/±

15/±

22.5/±

30)s relative to the longitudinal axis of the device.

39. The device of claim 37 wherein the fibers in consecutive plies are stacked in a sequence (-20, -25, ±

65)_s relative to the longitudinal axis of the device.

40. The device of claim 37 wherein said fibers are selected from the group consisting of carbon, glass fiber, polyolefin fiber, polyetheretherketone fiber and polyethylene terephthalate fiber.

41. The device of claim 37 wherein said matrix material is bioresorbable.

42. The device of claim 37 wherein said fibers are bioresorbable.

43. The device of claim 37 further comprising a bioresorbable coating over at least a portion of the outer surface of the device.

44. The device of claim 43 wherein the coating comprises a biocompatible polymer.

45. The device of claim 44 wherein said coating is selected from the group consisting of polysulfone, polyethersulfone, polyarylsulfone, polyphenylene sulfide, polycarbonate, aromatic polyamide, aromatic polyamideimide, thermoplastic polyimide, polyaryletherketone, polyetheretherketone, polyarylethernitrile, aromatic polyhydroxyether, thermosetting phenholics and medical grade epoxies.

46. The device of claim 44 wherein the coating further comprises a radio-opaque composition, osteo-conductive compositions or a medicament.

47. The device of claim 37 further comprising a sheath of continuous fibers overmolded on at least a portion of the surface of the device.

48. The device of claim 47, wherein said sheath is a mantle adapted to fit over at least a portion of the surface of the device.

56. An orthopedic prosthetic device having improved axial, bending and torque bearing properties, said device comprising:

an elongated prosthesis body formed of a laminated composite having a longitudinal axis;

the laminated composite having an outer surface and being formed of plies, each ply comprising reinforcing fibers imbedded in a matrix of biocompatible polymeric material, the fibers in each ply being generally parallel to each other, the plies being fused together to form said laminate composite;

wherein at least a majority of the plies are oriented at a non-zero angle relative to the longitudinal axis of the prosthetic device.

57. The device of claim 56 wherein a majority of fibers are oriented at angles of between five and forty degrees.

58. The device of claim 56 wherein the fibers in consecutive plies are stacked in a sequence (0₂ /±

7.5/±

15/±

22.5±

30)_s relative to the longitudinal axis of the device.

59. The device of claim 56 wherein the fibers in consecutive plies are stacked in a sequence (0₂ /(±

20)₄)_s relative to the longitudinal axis of the device.

61. The device of claim 56 wherein the biocompatible polymeric material is selected from the group consisting of polysulfone, polyethersulfone, polyarylsulfone, polyphenylene sulfide, polycarbonate, aromatic polyamide, aromatic polyamideimide, thermoplastic polyimide, polyaryletherketone, polyetheretherketone, polyarylethernitrile, aromatic polyhydroxyether, thermosetting phenolics and medical grade epoxies.

62. The device of claim 61 wherein the fibers are selected from the group consisting of carbon fiber, glass fiber, polyolefin fiber, polyetheretherketone fiber and polyethylene fiber.

63. The device of claim 62 further comprising a biocompatible coating over at least a portion of the outer surface of the laminate composite.

64. The device of claim 63 wherein the coating comprises a radio-opaque composition, osteo-conductive compositions, or a medicament.

65. The device of claim 56 further comprising a sheath of continuous fibers over molded on at least a portion of the outer surface of the laminated composite.

66. The device of claim 65 wherein the sheath is a mantle adapted to cover at least a portion of the outer surface of the laminated composite.

60. The device of 56 wherein the fibers in consecutive plies are stacked in a sequence (0₂ /±

20/±

30/±

20/±

30)_s relative to the longitudinal axis of the device.