Compliant osteosynthesis fixation plate

• US 8,679,164 B2
• Filed: 04/26/2011
• Issued: 03/25/2014
• 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): Philogene, Pedro
• Assistant Examiner(s): COMSTOCK, DAVID C
• Application Number:
  US13/094,673
• Publication Number:
  US 20110218634A1
• Time in Patent Office: 1,064 Days
• Field of Search: 606/280, 606/70, 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
• US Class Current: 606/284
• 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 bendable polymer tissue fixation device for implantation into a living body, said polymer fixation device comprising a laminar body having an first layer, a second layer and an interface, said first layer comprising a porous form of a polymer material, said second layer comprising a non-porous form of said polymer material;

said polymer material comprising a biopolymer, said porous form transitioning to the non-porous form at said interface, wherein at least at room temperature and within a period of time that is from prior to said implantation up through said implantation, said laminar body possesses the following properties;

being capable of being smoothly bent upon application of a bending force, the bending force permanently collapsing a portion of the pores of the porous form to prevent cracking or breaking of the non-porous form, and said laminar body maintaining said bent condition following removal of the bending force.

2. 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.

3. 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.

4. The polymer tissue fixation device of claim 3 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.

5. 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.

6. The polymer tissue fixation device of claim 1 wherein the porous body is capable of being fastened within the living body by one or more means selected from the group consisting of adhesive, wire, staple, suture, pin, nail, tack, screw, and a clamp.

7. 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.

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

9. The polymer tissue fixation device of claim 8 wherein the additional material further comprises biologically active agents.

10. The polymer tissue fixation device of claim 9 wherein at least a portion of said biologically active agent is located within a least a portion of the pores.

11. The polymer tissue fixation device of claim 9 wherein at least a portion of said biologically active agent is located within the polymer of said polymer fixation device.

12. The polymer tissue fixation device of claim 8 wherein the additional material further comprises particulate material, said particulate material having a property selected from the group consisting of biologically active agent delivery, tissue fixation device rigidity enhancement, radiopacity, or microspheres.

13. The polymer tissue fixation device of claim 8 wherein the additional material is one of distributed evenly throughout the device, or distributed unevenly throughout said device.

14. The polymer tissue fixation device of claim 8 wherein the additional material serves to alter the rate of resorption of the polymer fixation device.

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

16. A bendable polymer tissue fixation device for implantation into a living body, said polymer fixation device comprising a laminar body having an first layer, a second layer and an interface, said first layer comprising a porous form of a first polymer material, said second layer comprising a non-porous form of a second polymer material;

said first and second polymer materials comprising biopolymers, said porous form comprising a plurality of pores, said porous form transitioning to the non-porous form at said interface, wherein at least at room temperature and within a period of time that is from prior to said implantation up through said implantation, said laminar body intrinsically is capable of being smoothly bent by a bending force that irreversibly collapses a portion of the pores of the porous form to prevent cracking or breaking of the non-porous form, and wherein said laminar body intrinsically maintains said bent condition following removal of the bending force.

17. The polymer tissue fixation device of claim 16 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.

18. The polymer tissue fixation device of claim 16 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.

19. The polymer tissue fixation device of claim 18 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.

20. The polymer tissue fixation device of claim 16 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.

21. The polymer tissue fixation device of claim 16 wherein the porous body is capable of being fastened within the living body by one or more means selected from the group consisting of adhesive, wire, staple, suture, pin, nail, tack, screw, and a clamp.

22. The polymer tissue fixation device of claim 16 further comprising a plurality of holes extending through the prosthesis, said plurality of holes serving as a fastening location.

23. The polymer tissue fixation device of claim 16 wherein the porous body further comprises additional material.

24. The polymer tissue fixation device of claim 23 wherein the additional material further comprises biologically active agents.

25. The polymer tissue fixation device of claim 24 wherein at least a portion of said biologically active agent is located within a least a portion of the pores.

26. The polymer tissue fixation device of claim 24 wherein at least a portion of said biologically active agent is located within the polymer of said polymer fixation device.

27. The polymer tissue fixation device of claim 23 wherein the additional material further comprises particulate material, said particulate material having a property selected from the group consisting of biologically active agent delivery, tissue fixation device rigidity enhancement, radiopacity, or microspheres.

28. The polymer tissue fixation device of claim 23 wherein the additional material is one of distributed evenly throughout the device, or distributed unevenly throughout said device.

29. The polymer tissue fixation device of claim 23 wherein the additional material serves to alter the rate of resorption of the polymer fixation device.

30. The polymer tissue fixation device of claim 16, wherein the porous body is capable of being smoothly bent without the need for one of heating or special tools.