Methods and compositions for fusing bone during endoscopy procedures

• US 20040167244A1
• Filed: 12/19/2003
• Published: 08/26/2004
• Est. Priority Date: 08/18/2000
• Status: Abandoned Application

• Current Assignee: Nuortho Surgical Inc.
• Original Assignee: Nuortho Surgical Inc.
• Inventors: Auge, Wayne K. II
• Application Number:
  US10/741,753
• Publication Number:
  US 20040167244A1
• Time in Patent Office: Days
• US Class Current: 523/115
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/88 Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices A61B17/7074 takes precedence
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2018/00619 Welding
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/4644 Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material bone material A61F2/28; disintegrating or milling devices B02C
• CPC Class Codes: A61F 2002/2821 Bone stimulation by electromagnetic fields or electric current for enhancing ossification
• CPC Class Codes: A61F 2002/30451 soldered or brazed or welded
• CPC Class Codes: A61F 2002/30622 Implant for fusing a joint or bone material
• CPC Class Codes: A61F 2002/30668 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2002/4649 Bone graft or bone dowel harvest sites
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61L 24/0005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/365 Bones
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation

Abstract

A method of and compositions for fusing or welding bones in vivo and in a fluid medium wherein an implant bone is provided, the implant bone and/or a receiving bone is treated to expose organic component and to de-fat, an interfacing agent is added between receiving bone segments to be fused or welded, and the implant and receiving bone are fused or welded in vivo, in a fluid medium, utilizing electromagnetic energy. The interfacing agent may include collagen, a hydrophilic polymer and a therapeutic agent.

Claims

1. An interfacing agent for use in welding or fusing adjacent bone segments in a fluid medium by application of electromagnetic energy thereto, the interfacing agent comprising collagen, a hydrophilic polymer and a therapeutic agent.

2. The interfacing agent of claim 1, wherein the collagen is bone-derived collagen.

3. The interfacing agent of claim 1, wherein the source of bone-derived collagen is acid treated bone-derived graft material.

4. The interfacing agent of claim 3, wherein the acid treated bone-derived graft material is derived from autologous bone of the patient to be treated.

5. The interfacing agent of claim 1, wherein the collagen is made by synthetic or recombinant means.

6. The interfacing agent of claim 1, wherein the hydrophilic polymeric material is a hydrogel, wax or biopolymer.

7. The interfacing agent of claim 6, wherein the hydrophilic polymeric material is agar, gelatin, carboxymethylcellulose, hyaluronan, alginic acid or polyacrylonitrile gel.

8. The interfacing agent of claim 1, wherein the therapeutic agent is demineralized bone, hydroxyapetite or tricalcium phosphate.

9. The interfacing agent of claim 1, wherein the therapeutic agent is a bone morphogenic protein.

10. The interfacing agent of claim 9, wherein the bone morphogenic protein is osteogenic protein-1.

11. The interfacing agent of claim 1, wherein the therapeutic agent is a growth factor.

12. The interfacing agent of claim 1, wherein the therapeutic agent is a metal.

13. The interfacing agent of claim 12, wherein the metal is tantalum.

14. The interfacing agent of claim 1, wherein the therapeutic agent is a gene sequence including a delivery vector.

15. A method of fusing or welding bone in vivo and in a fluid medium, the method comprising the steps of:

providing an implant bone;

treating one or more bones selected from the group consisting of the implant bone and a receiving bone to expose organic component;

treating one or more bones selected from the group consisting of the implant bone and the receiving bone by de-fatting;

providing an interfacing agent comprising at least one compound selected from group consisting of acid treated bone-derived graft material and a synthetic bone material;

adding the interfacing agent between receiving bone segments to be fused or welded; and

fusing or welding in vivo, in a fluid medium, utilizing electromagnetic energy.

16. The method of claim 15 wherein the step of providing a piece of implant bone comprises harvesting a piece of autologous implant bone.

17. The method of claim 16 wherein the piece of autologous bone and receiving bone segments comprise cgncellous bone.

18. The method of claim 15 wherein in the fusing or welding step, electromagnetic energy is applied to bone or bone-derived organic tissue to achieve tissue changes.

19. The method of claim 18 wherein in the fusing or welding step, radio frequency energy is applied to bone or bone-derived organic tissue to achieve tissue changes.

20. The method of claim 15 wherein the treating steps comprise one or more steps from the group consisting of chemically and mechanically treating bone or bone-derived tissue to alter the mineral matrix and to de-fat and thereby provide a good fusing or welding surface.

21. The method of claim 20 wherein the chemically treating step comprises treating the bone or bone-derived tissue with acid.

22. The method of claim 20 wherein the mechanically treating step comprises treating the bone or bone-derived tissue to conform it to a shape of another bone.

23. The method of claim 15 additionally comprising the step of compressing the bone segments and interfacing agent during the fusing or welding step.

24. The method of claim 15 wherein the fusing or welding step comprises fusing or welding by one or more means selected from the group consisting of heating and electromagnetic energy means.

25. The method of claim 24 wherein the fusing or welding step comprises employing a means selected from the group consisting of lasers and radio frequency generators

26. The method of claim 24 wherein the fusing or welding step comprises employing an electromagnetic instrument probe with broadcast emission capability and scaled reflector geometry of active electrode design to generate radio frequency energy.

27. The method of claim 26 wherein the fusing or welding step occurs in an electrically conductive medium.

28. The method of claim 23 wherein the compressing step ceases after the fusing or welding step is completed.

29. The method of claim 16 additionally comprising the step of repeating the harvesting and fusing or welding steps with a second piece of bone in a place previously occupied by a temporary provisional fixation device.

30. The method of claim 15 additionally comprising the step of introducing prior to the fusing or welding step a hydrophilic, lipophilic carrier paste-gel, interfadng agent.

31. The method of claim 30 wherein the introducing step comprises impacting the paste-gel interfacing agent complex into porosity of a bone.

32. The method of claim 30 wherein the introducing step comprises impacting the paste-gel interfacing agent into both the implant bone and the receiving bone.

33. The method of claim 30 wherein in the fusing or welding step the paste-gel operates to direct radio frequency energy into portions of bone to be fused or welded together.

34. The method of claim 30 wherein in the fusing or welding step the paste-gel additionally operates to insulate against the radio frequency energy portions of bone other than the portions to be fused or welded together.

35. The method of claim 15 wherein the interfacing agent comprises one or more components selected from the group consisting of osteoconductive, osteoinductive, and osteogenic components designed to augment bone healing.

36. The method of claim 35 wherein the one or more components are activated, released, or induced by the application of electromagnetic energy.

37. A fused or welded bone structure prepared by the method of claim 15.