Compliant osteosynthesis fixation plate

• US 7,931,695 B2
• Filed: 07/15/2003
• Issued: 04/26/2011
• Est. Priority Date: 07/15/2003
• Status: Active Grant

• Current Assignee: DSM IP Assets BV (DSM-Firmenich AG)
• Original Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Inventors: Ringeisen, Timothy A.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): COMSTOCK, DAVID C
• Application Number:
  US10/619,721
• Publication Number:
  US 20050015088A1
• Time in Patent Office: 2,842 Days
• Field of Search: 606/69, 606/70, 606/72, 606/86, 606/280, 606283-286, 606298-300, 606/86.R, 623/11.11, 623/23.51, 623/23.57, 623/23.58, 623/23.61, 623/23.72, 623/23.75, 424/426
• US Class Current: 623/23.72
• 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 17/8061 specially adapted for particular bones A61B17/70 and A61B17/74 take precedence
• CPC Class Codes: A61B 17/8085 with pliable or malleable elements or having a mesh-like structure, e.g. small strips A61B17/8071, A61B17/8076 take precedence
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 31/04 Macromolecular materials
• CPC Class Codes: A61L 31/125 having a macromolecular matrix
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque

Abstract

A bendable polymer tissue fixation device suitable to be implanted into a living body, comprising a highly porous body, the porous body comprising a polymer, the porous body comprising a plurality of pores, the porous body being capable of being smoothly bent, wherein the bending collapses a portion of the pores to form a radius curve, the polymer fixation device being rigid enough to protect a tissue from shifting. In a preferred embodiment the polymer fixation device may be capable of being gradually resorbed by said living body. In one embodiment, the polymer fixation device comprises a plurality of layers distinguishable by various characteristics, such as structural or chemical properties. In another embodiment, the polymer fixation device may comprise additional materials; the additional materials serving to reinforce or otherwise alter the structure or physical characteristics of the device, or alternatively as a method of delivering therapy or other agents to the system of a living being.

Claims

1. A polymer tissue fixation device for implantation into a living body, said polymer fixation device (i) comprising a porous body comprising at least one biopolymer and a plurality of pores, and (ii) being gradually resorbable by said living body, wherein at least at room temperature and within a zone of time that is defined by being from prior to said implantation up through said implantation, said porous body inherently possesses the property of being smoothly bent upon being subjected to a bending force, said bending force at least partially but irreversibly collapsing a portion of the pores to form a radius curve, whereby said porous body (a) inherently maintains said radius curve upon removal of the bending force, and (b) is rigid enough to protect a tissue attached to said device from shifting.

2. The polymer tissue fixation device of claim 1 wherein the porous body can be smoothly bent to conform to a tissue structure.

3. The polymer tissue fixation device of claim 1 wherein the porous body can be smoothly bent to conform to a tissue structure, said smooth bending being capable of occurring at a temperature below the glass transition point of the polymer.

4. The polymer tissue fixation device of claim 1 wherein the porous body comprises a plurality of porous zones, wherein at least one zone of pores is less able to withstand compressive force than other zones.

5. The polymer tissue fixation device of claim 4 wherein the porous body can be compressed against an irregular surface, whereupon less than all of the pores collapse, and the device conforms to the irregular surface.

6. The polymer tissue fixation device of claim 1 wherein the pores are arranged to yield and selectively collapse to allow for placement of a fastening device to fasten the polymer fixation device within the living body.

7. The polymer tissue fixation device of claim 1 wherein the porous body is capable of being fastened within the living body by means of an adhesive.

8. The polymer tissue fixation device of claim 1 wherein the porous body is capable of being fastened within the living body by a fastening device, said fastening device selected from the group consisting of a wire, a staple, a suture, a pin, a nail, a tack, a screw, and a clamp.

9. The polymer tissue fixation device of claim 1 further comprising a plurality of holes extending through the prosthesis, said plurality of holes serving as a fastening location.

10. The polymer tissue fixation device of claim 1 wherein the porous body further comprises additional material.

11. The polymer tissue fixation device of claim 10 wherein the additional material further comprises biologically active agents.

12. The polymer tissue fixation device of claim 11, wherein at least a portion of said biologically active agent is located within at least a portion of said pores.

13. The polymer tissue fixation device of claim 11, wherein at least a portion of said biologically active agent is located within the polymer of said polymer fixation device.

14. The polymer tissue fixation device of claim 10 wherein the additional material further comprises particulate material, said particulate material being arranged to enable the polymer fixation device to deliver biologically active agents.

15. The polymer tissue fixation device of claim 10 wherein the additional material further comprises particulate material, said particulate material being arranged to impart greater rigidity to the tissue fixation device.

16. The polymer tissue fixation device of claim 10 wherein the additional material is radio-opaque.

17. The polymer tissue fixation device of claim 10 wherein the additional material comprises microspheres.

18. The polymer tissue fixation device of claim 10 wherein the additional material is distributed throughout the device.

19. The polymer tissue fixation device of claim 10 wherein the additional material is distributed unevenly throughout said device.

20. The polymer tissue fixation device of claim 10 wherein the additional material serves to alter the rate of resorption of the polymer fixation device.

21. The polymer tissue fixation device of claim 1, further comprising a first layer having a first pore density, a second layer having a second pore density, and a third layer having said first pore density, with a transitional interface between the adjoining layers.

22. The polymer tissue fixation device of claim 1, further comprising a first layer having a first pore density, a second layer having a second pore density, and a third layer having a third pore density, with a transitional interface between the adjoining layers.

23. The polymer tissue fixation device of claim 1, further being capable of being cut using surgical scissors.

24. The polymer tissue fixation device of claim 1, further being capable of being cut out of a large sheet of similar material by a punching operation.

25. The polymer tissue fixation device of claim 1, wherein the porous body is capable of being smoothly bent without the need for heating.

26. The polymer tissue fixation device of claim 1, wherein the porous body is capable of being smoothly bent without the need for special tools.

27. The bendable polymer tissue fixation device of claim 1, wherein said device does not require ingrowth of new tissue of said living body as said device resorbs.

28. A bendable polymer tissue fixation device for implantation into a living body, said polymer fixation device (i) comprising a composite comprising a porous body defining a plurality of pores, and at least one strengthening agent contained within said porous body, and (ii) being capable of being resorbed by said living body, wherein at least at room temperature and within a period of time that is from prior to said implantation up through said implantation, said porous body intrinsically possesses the characteristics of being capable of being smoothly bent upon exposure to a bending force, said bending collapsing a portion of the pores to form a radius curve, whereby said porous body (a) maintains said radius curve upon removal of the bending force, and (b) is rigid enough to protect a tissue fixed to said device from shifting.

29. The polymer tissue fixation device of claim 28 wherein the porous body can be smoothly bent to conform to a tissue structure.

30. The polymer tissue fixation device of claim 28 wherein the porous body can be smoothly bent to conform to a tissue structure, said smooth bending being capable of occurring at a temperature below the glass transition point of the polymer.

31. The polymer tissue fixation device of claim 28 wherein the porous body comprises a plurality of porous zones, where in at least one zone of pores is less able to withstand compressive force than other zones.

32. The polymer tissue fixation device of claim 31 wherein the porous body can be compressed against an irregular surface, whereupon less than all of the pores collapse, and the device conforms to the irregular surface.

33. The polymer tissue fixation device of claim 28 wherein the pores are arranged to yield and selectively collapse to allow for placement of a fastening device to fasten the polymer fixation device within the living body.

34. The polymer tissue fixation device of claim 28 wherein the porous body is capable of being fastened within the living body by means of an adhesive.

35. The polymer tissue fixation device of claim 28 wherein the porous body is capable of being fastened within the living body by a fastening device, said fastening device selected from the group consisting of a wire, a staple, a suture, a pin, a nail, a tack, a screw, and a clamp.

36. The polymer tissue fixation device of claim 28 further comprising a plurality of holes extending through the prosthesis, said plurality of holes serving as a fastening location.

37. The polymer tissue fixation device of claim 28 wherein the porous body further comprises additional material.

38. The porous body of claim 37 wherein the additional material further comprises biologically active agents.

39. The porous body of claim 37 wherein the additional material further comprises particulate material, said particulate material being arranged to enable the polymer fixation device to deliver biologically active agents.

40. The porous body of claim 37 wherein the additional material further comprises particulate material, said particulate material being arranged to impart greater rigidity to the tissue fixation device.

41. The porous body of claim 37 wherein the additional material is radio-opaque.

42. The porous body of claim 37 wherein the additional material comprises microspheres.

43. The porous body of claim 37 wherein the additional material is distributed throughout the device.

44. The porous body of claim 37 wherein the additional material is distributed unevenly throughout said device.

45. The porous body of claim 37 wherein the additional material serves to alter the rate of resorption of the polymer fixation device.

46. The polymer tissue fixation device of claim 28 wherein the strengthening agent is biodegradable.

47. The polymer tissue fixation device of claim 28, wherein the strengthening agent is arranged in the form selected from the group consisting of a mesh, a weave, a knit, and a random arrangement of fibers.

48. The polymer tissue fixation device of claim 28, further comprising a first layer having a first pore density, a second layer having a second pore density, and a third layer having said first pore density, with a transitional interface between the adjoining layers.

49. The polymer tissue fixation device of claim 28, further comprising a first layer having a first pore density, a second layer having a second pore density, and a third layer having a third pore density, with a transitional interface between the adjoining layers.

50. A deformable polymer tissue fixation device for implantation into a living body, said polymer fixation device (a) comprising a porous body comprising at least one biopolymer and a plurality of porous zones, and (b) is resorbable by said living body, wherein at least at room temperature and from prior to said implantation up through said implantation, said porous body inherently possesses the properties of:

at least one of the zones is less able to withstand compressive force than at least one other zone such that the porous body can be compressed against an irregular surface, whereupon less than all of the pores collapse, said collapse not being reversible by said porous body, wherein the device conforms to the irregular shape, wherein the device continues indefinitely to conform to the irregular shape after the compressive force is removed, and further wherein the device is rigid enough to isolate and protect a tissue fastened to said device from shifting.