Prosthesis with a selectively applied bone growth promoting agent

• US 8,241,357 B2
• Filed: 04/25/2007
• Issued: 08/14/2012
• Est. Priority Date: 04/25/2007
• Status: Active Grant

• Current Assignee: Jmea Corporation
• Original Assignee: Jmea Corporation
• Inventors: Bhatnagar, Mohit K., Yeh, Jack Y.
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): Negrelli, Christina
• Application Number:
  US11/740,181
• Publication Number:
  US 20080269893A1
• Time in Patent Office: 1,938 Days
• Field of Search: 606/246, 606264-279, 606300-321, 606/76, 623 1711- 1716, 623 2353- 2355, 623/13.15, 623/11.11, 623/16.11, 623/23.6
• US Class Current: 623/16.11
• CPC Class Codes: A61B 17/7208 Flexible pins, e.g. ENDER pins
• CPC Class Codes: A61B 17/7233 with special means of locking the nail to the bone
• CPC Class Codes: A61B 17/7266 with fingers moving radially outwardly
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2002/0081 directly machined on the prosthetic surface, e.g. holes, grooves A61F2/30771 takes precedence

Abstract

An implantable prosthesis system including a selectively applied bone growth promoting agent is disclosed. The types of prostheses which may include a selectively applied bone growth promoting agent include rods, fracture plates, screws, as well as other types of prostheses. Additionally, the structural composition of many types of prostheses may be modified to help induce bone ingrowth and allow for fusion with the implantable prosthesis.

Claims

1. An implantable prosthesis system, comprising:

a rod configured for implantation into a bone;

the rod including a first portion and a second portion;

a flexible sheet material wrapped around and attached to the rod;

wherein the flexible sheet material and the rod are separate components;

wherein the flexible sheet material includes a bone growth promoting agent; and

wherein the flexible sheet material is disposed over the first portion, leaving the second portion exposed.

2. The implantable prosthesis system according to claim 1, wherein the rod has a solid core.

3. The implantable prosthesis system according to claim 1, wherein the rod includes a third portion and a fourth portion.

4. The implantable prosthesis system according to claim 3, wherein the flexible sheet material comprises a first flexible sleeve, and wherein the implantable prosthesis system further comprises a second flexible sleeve that is a component separate from the first flexible sleeve and the rod, that is configured to receive the rod, that includes a bone growth promoting agent, and that is disposed over the third portion, leaving the second portion and the fourth portion exposed.

5. The implantable prosthesis system according to claim 4, wherein the second portion is disposed longitudinally between the first portion and the third portion, and wherein the third portion is disposed longitudinally between the second portion and the fourth portion.

6. The implantable prosthesis system according to claim 4, wherein the first flexible sleeve and the second flexible sleeve are cylindrical sleeves spaced apart along a longitudinal axis of the rod, with the second portion longitudinally between the first flexible sleeve and the second flexible sleeve.

7. The implantable prosthesis system according to claim 1, wherein the flexible sheet material includes holes.

8. The implantable prosthesis system according to claim 1, wherein the rod comprises a third portion that is exposed and wherein the first portion is disposed longitudinally between the exposed second portion and the exposed third portion.

9. The implantable prosthesis system according to claim 1, wherein the bone growth promoting agent is disposed on the flexible sheet material in a pattern selected from the group consisting essentially of striped patterns, spotted patterns, diagonal patterns, geometric patterns, shapes and any combination thereof.

10. The implantable prosthesis system according to claim 1, wherein the bone growth promoting agent is disposed on the flexible sheet material in a spotted pattern.

11. The implantable prosthesis system according to claim 10, wherein the bone growth promoting agent is disposed on the flexible sheet material in a checkered pattern.

12. The implantable prosthesis system according to claim 1, wherein the bone growth promoting agent is disposed on the flexible sheet material in a geometric pattern.

13. The implantable prosthesis system according to claim 1, wherein the flexible sheet material is configured as a flexible sleeve, wherein the sleeve has an outer surface and an inner surface, wherein the rod has an outer surface, and wherein the outer surface of the rod contacts the inner surface of the sleeve.

14. The implantable prosthesis system according to claim 13, wherein the sleeve comprises a hollow cylinder.

15. The implantable prosthesis system according to claim 14, wherein the rod comprises a hollow cylinder, wherein walls of the sleeve and the rod define aligned holes, and wherein each set of aligned holes extends from an outer surface of the sleeve to an inner core surface of the rod.

16. An implantable prosthesis system, comprising:

a rod configured for implantation into a bone, wherein the rod has a fixed outer surface;

a flexible sheet material including a bone growth promoting agent; and

wherein the flexible sheet material is wrapped around and adhered to a selected portion of the outer surface of the rod, leaving a remaining portion of the outer surface of the rod exposed.

17. The implantable prosthesis system according to claim 16, wherein the sheet material comprises a mesh fabric.

18. The implantable prosthesis system according to claim 16, wherein the sheet material may be cut to a preconfigured size.

19. The implantable prosthesis system according to claim 16, wherein the sheet material may be cut to a preconfigured shape.

20. The implantable prosthesis system according to claim 16, wherein the flexible sheet material is configured as a flexible sleeve that is coupled to the rod by an adhesive.

21. The implantable prosthesis system according to claim 16, wherein the flexible sheet material is configured as a flexible sleeve, and wherein the rod is inserted into the flexible sleeve.

22. The implantable prosthesis system according to claim 16, wherein the sheet material comprises a collagen.

23. The implantable prosthesis system according to claim 16, wherein the sheet material comprises a biologic matrix.

24. The implantable prosthesis system according to claim 16, wherein the sheet material comprises a metallic foil.

25. The implantable prosthesis system according to claim 16, wherein the sheet material comprises a plastic sheet.

26. The implantable prosthesis system according to claim 16, wherein the sheet material is coupled to the rod by hooks.

27. The implantable prosthesis system according to claim 16, wherein the sheet material is coupled to the rod by an interference fit.

28. The implantable prosthesis system according to claim 16, wherein the sheet material is coupled to the rod by a Morris taper.

29. The implantable prosthesis system according to claim 16, wherein the sheet material is magnetically coupled to the rod.

30. The implantable prosthesis system according to claim 16, wherein the rod has a solid core.

31. An implantable prosthesis system, comprising:

a rod configured for implantation into a bone and having a length, wherein the rod has an exterior surface of a fixed dimension before and after implantation;

the rod having a hollow central core along at least a portion of the length;

the rod also having at least one hole placing the hollow central core in fluid communication with an exterior surface of the rod;

a flexible sleeve configured to receive the rod;

wherein the sleeve and the rod are separate components;

wherein the sleeve includes a bone growth promoting agent; and

wherein the sleeve is disposed over the at least a portion of the length of the rod having the hollow central core.

32. The implantable prosthesis system according to claim 31, wherein the rod includes holes along at least a portion of the length.

33. The implantable prosthesis system according to claim 31, wherein the bone growth promoting agent is also applied to an inner surface of the hollow central core.

34. The implantable prosthesis system according to claim 31, wherein the bone growth promoting agent is disposed in at least one wall of the hole.

35. The implantable prosthesis system according to claim 34, wherein the rod includes a plurality of holes.

36. The implantable prosthesis system according to claim 35, wherein the holes are disposed along the entirety of the rod.

37. The implantable prosthesis system according to claim 31, wherein walls of the sleeve and the rod define aligned holes, and wherein each set of aligned holes extends from an outer surface of the sleeve to the hollow central core of the rod.

38. A method of fusing an implantable prosthesis to a bone, comprising:

selecting a rod having an outer surface;

adhering a flexible sheet material to a selected portion of the outer surface of the rod, wherein the flexible sheet material includes bone growth promoting agent, and wherein a remaining portion of the rod is exposed;

implanting the rod inside the bone such that the flexible sheet material at the selected portion of the outer surface of the rod contacts the bone; and

promoting growth of the bone at the selected portion of the outer surface of the rod by virtue of the contact between the flexible sheet material and the bone.

39. The method according to claim 38, wherein the bone is allowed to grow into a hollow central core of the rod.

40. The method according to claim 39, wherein a portion of the bone fuses is allowed to fuse to the rod inside the hollow central core of the rod.

41. The method according to claim 38, wherein the flexible sheet material is configured as a flexible sleeve and wherein adhering the flexible sheet material to a selected portion of the outer surface of the rod comprises inserting the rod into the flexible sleeve.

42. The method according to claim 38, wherein the rod has an inner surface and a set of holes disposed between the outer surface and the inner surface, and wherein the method further comprises positioning the flexible sheet material on the rod over a region of the outer surface in which the set of holes is disposed.

43. The method according to claim 42, wherein a bone growth promoting agent is selectively applied to the inner surface.

44. The method according to claim 38, wherein the flexible sheet material defines a first hole and the rod defines a second hole within the selected portion of the outer surface of the rod, and wherein the method further comprises aligning the first hole of the flexible sheet material with the second hole of the rod.

45. The method according to claim 38, wherein the flexible sheet material is configured as a flexible sleeve, and wherein the method further comprises inserting the rod into the sleeve and coupling the sleeve to the rod with adhesive.

46. The method according to claim 38, wherein the flexible sheet material is configured as a flexible sleeve, and wherein the method further comprises inserting the rod into the sleeve and coupling the sleeve to the rod with hooks.

47. The method according to claim 38, wherein the flexible sheet material is configured as a flexible sleeve, and wherein the method further comprises inserting the rod into the sleeve and coupling the sleeve to the rod with an interference fit.

48. The method according to claim 38, wherein the flexible sheet material is configured as a flexible sleeve, and wherein the method further comprises inserting the rod into the sleeve and coupling the sleeve to the rod with a Morris taper.

49. The method according to claim 38, wherein the flexible sheet material is configured as a flexible sleeve, and wherein the method further comprises inserting the rod into the sleeve and magnetically coupling the sleeve to the rod.

50. The method according to claim 38, wherein the flexible sheet material is one of a mesh fabric, a collagen, a biologic matrix, a metallic foil, and a plastic sheet.

51. The method according to claim 38, further comprising cutting the flexible sheet material to a preconfigured shape matching the selected portion.

52. The method according to claim 38, wherein adhering the flexible sheet material to the rod comprises adhering the flexible sheet material to the rod with an adhesive.

53. The method according to claim 38, wherein adhering the flexible sheet material to the rod comprises mechanically attaching the flexible sheet material to the rod.

54. The method according to claim 53, wherein mechanically attaching the flexible sheet material to the rod comprises attaching the flexible sheet material to the rod with one of hooks, an interference fit, and a Morris taper.

55. The method according to claim 38, wherein adhering the flexible sheet material to the rod comprises wrapping the flexible sheet material around the rod.

56. The method according to claim 38, wherein adhering the flexible sheet material to the rod comprises magnetically coupling the flexible sheet material to the rod.

57. The method according to claim 38, wherein adhering the flexible sheet material to the rod comprises adhering the flexible sheet material to the rod during surgery.