Curable media for implantable medical device

• US 20040006341A1
• Filed: 12/20/2002
• Published: 01/08/2004
• Est. Priority Date: 06/23/2000
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: Shaolian, Samuel M., Nguyen, Thanh Van, Pham, To V., Teitelbaum, George P., Estes, Richard H.
• Granted Patent: US 6,875,212 B2
• Time in Patent Office: Days
• US Class Current: 606/61
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1697 specially adapted for wire insertion
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/1796 for holes for sutures or flexible wires
• CPC Class Codes: A61B 17/60 for external osteosynthesis, e.g. distractors, contractors
• CPC Class Codes: A61B 17/7001 Screws or hooks combined with longitudinal elements which do not contact vertebrae A61B17/7058 takes precedence
• CPC Class Codes: A61B 17/7002 Longitudinal elements, e.g. rods
• CPC Class Codes: A61B 17/7008 with parts of, or attached to, the longitudinal elements, bearing against an outside of the screw or hook heads, e.g. nuts on threaded rods A61B17/7007 takes precedence
• CPC Class Codes: A61B 17/7013 the shape of the element being adjustable before use adjustable length plates A61B17/7014
• CPC Class Codes: A61B 17/7049 Connectors, not bearing on the vertebrae, for linking longitudinal elements together A61B17/7055, A61B17/7053, A61B17/7019 take precedence
• CPC Class Codes: A61B 17/7083 Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 17/8863 Apparatus for shaping or cutting osteosynthesis equipment by medical personnel
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61F 2/4611 of spinal prostheses

Abstract

A subcutaneously formed in place orthopedic fixation device is provided, such as for fixation of the spine or other bone or bones. The device comprises an inflatable member, such as a tubular balloon. The balloon is positioned at a treatment site in the body while in a flexible, low crossing profile configuration. The balloon is thereafter inflated with a hardenable epoxy media comprising one or more epoxy compounds and one or more amine curing compounds that cures rapidly in place with low to moderate exotherm. Methods and delivery structures are also disclosed.

Claims

1. A formed in place orthopedic device, comprising:

an outer wall, defining a cavity therein; and

a hardenable media within the cavity to form the orthopedic device, said hardenable media comprising a resin and hardener mixture that is substantially cured at a temperature below about 45°

C. in about 90 minutes or less;

wherein the hardenable media is hardened while the device is positioned within the body of a patient to create the formed in place orthopedic device.

2. The formed in place orthopedic device of claim 1, wherein said hardenable media comprises an epoxy resin.

3. The formed in place orthopedic device of claim 2, wherein said epoxy resin comprises a total of about 65-75% by weight of one or more diepoxide resins and a total of about 25-35% by weight of one or more amine curing agents.

4. The formed in place orthopedic device of claim 2, wherein said epoxy resin comprises about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines.

5. The formed in place orthopedic device of claim 4, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F.

6. The formed in place orthopedic device of claim 4, wherein the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether.

7. The formed in place orthopedic device of claim 4, wherein the dialkylamines are according to the formula H₂N—

R—

NH₂, wherein R is a branched or unbranched C₂-C₁₀ alkyl group.

8. The formed in place orthopedic device of claim 4, wherein the cycloalkylamines are N-aminoalkylpiperazines.

9. The formed in place orthopedic device of claim 4, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A, the aliphatic diepoxide resin comprises butane diol of glycidyl ether, the dialkylamine comprises 1,3-diaminopropane, and the cycloalkylamine comprises N-aminoethylpiperazine.

10. The formed in place orthopedic device of claim 1, wherein said hardenable media cures to a hardened form having a static compression bending value (ASTM F1717) of at least 100 lbs.

11. A bone fixation device, comprising:

a delivery catheter;

comprising an inflatable member;

a hardenable media contained within the inflatable member, said hardenable media comprising an epoxy that cures to a hardened form having a static compression bending value (ASTM F1717) of at least 90 lbs in about 90 minutes or less; and

at least two anchors having portals,

wherein said inflatable member extends through said portals of said at least two anchors.

12. The bone fixation device of claim 11, wherein said epoxy resin comprises about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines.

13. The bone fixation device of claim 12, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F.

15. The bone fixation device of claim 13, wherein the dialkylamines are according to the formula H₂N—

R—

NH₂, wherein R is a branched or unbranched C₂-C₁₀ alkyl group.

16. The bone fixation device of claim 15, wherein the cycloalkylamines are N-aminoalkylpiperazines.

17. The bone fixation device of claim 12, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A, the aliphatic diepoxide resin comprises butane diol of glycidyl ether, the dialkylamine comprises 1,3-diaminopropane, and the cycloalkylamine comprises N-aminoethylpiperazine.

18. The bone fixation device of claim 11, wherein the hardenable media cures at temperature below about 45°

C.

19. The bone fixation device of claim 11, wherein the hardenable media has a static compression bending value (ASTM F1717) of at least 150 lbs within 12 hours.

14. The bone fixation device of claim 14, wherein the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether.

20. An orthopedic fixation device, comprising:

an elongate, flexible tubular body having a distal end and a proximal end, said body forming a central lumen;

a manifold at the proximal end of the tubular body comprising at least one port;

an inflatable member having a proximal end, a distal end, and an interior, removably attached to the distal end of the tubular body;

a hardenable media for inflating said inflatable member, said hardenable media comprising about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines; and

a valve, provided at the proximal end of the inflatable member.

21. The orthopedic fixation device of claim 20, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F;

the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether;

the cycloalkylamines are N-aminoalkylpiperazines; and

the dialkylamines are according to the formula H₂N—

R—

NH₂, wherein R is a branched or unbranched C₂-C₁₀ alkyl group.

22. The orthopedic fixation device of claim 21, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A, the aliphatic diepoxide resin comprises butane diol of glycidyl ether, the dialkylamine comprises 1,3-diaminopropane, and the cycloalkylamine comprises N-aminoethylpiperazine.

23. The orthopedic fixation device of claim 20, wherein said hardenable media, when cured, has a static compression bending value of at least 100 lbs (ASTM F1717).

24. The orthopedic fixation device of claim 20, wherein the media is substantially cured in about 90 minutes or less.

25. The orthopedic fixation device of claim 20, wherein the media cures at a temperature of about 45°

C. or less.

26. A method of forming an orthopedic device at a treatment site within the body of a patient, comprising the steps of:

positioning an outer wall at the treatment site within the patient, the outer wall defining a chamber therein; and

introducing a hardenable media into the chamber, wherein the hardenable media cures from a liquid form to a hardened form having a static compression bending value of at least 90 lbs (ASTM F1717) in about 90 minutes or less.

27. A method of forming an orthopedic device as in claim 26, wherein the positioning step comprises positioning the outer wall between two bone anchors.

28. The method of claim 26, wherein said hardenable media comprises about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines.

29. The method of claim 28, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F;

the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether;

the cycloalkylamines are N-aminoalkylpiperazines; and

the dialkylamines are according to the formula H₂N—

R—

NH₂, wherein R is a branched or unbranched C₂-C₁₀ alkyl group.

30. The method of claim 28, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A, the aliphatic diepoxide resin comprises butane diol of glycidyl ether, the dialkylamine comprises 1,3-diaminopropane, and the cycloalkylamine comprises N-aminoethylpiperazine.

31. The method of claim 26, wherein the hardenable media cures at temperature below about 45°

C.

32. The method of claim 26, wherein the hardenable media has a static compression bending value (ASTM F1717) of at least 150 lbs within 12 hours.

33. A method of stabilizing an orthopedic fracture, comprising:

inserting at least two anchors having portals into a bone;

delivering an orthopedic device comprising an inflatable balloon to the bone; and

inflating said balloon with a hardenable media comprising about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines;

wherein said orthopedic device extends through said portals, such that said inflating fixes said anchors in relation to one another.

34. The method of claim 33, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F;

the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether;

the cycloalkylamines are N-aminoalkylpiperazines; and

the dialkylamines are according to the formula H₂N—

R—

NH₂, wherein R is a branched or unbranched C₂-C₁₀ alkyl group.

35. The method of claim 33, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A, the aliphatic diepoxide resin comprises butane diol of glycidyl ether, the dialkylamine comprises 1,3-diaminopropane, and the cycloalkylamine comprises N-aminoethylpiperazine.

36. The method of claim 33, wherein said hardenable media, when cured, has a static compression bending value of at least 100 lbs. (ASTM F1717).

37. The method of claim 33, wherein the media is substantially cured in about 90 minutes or less.

38. The method of claim 33, wherein the media cures at a temperature of about 45°

C. or less.

39. A method of stabilizing an orthopedic fracture, comprising:

inserting at least two anchors having portals into a bone;

delivering an orthopedic device comprising an inflatable balloon through the portals; and

inflating said balloon with a liquid curable material;

wherein the inflating step fixes said anchors in relation to one another and the curable material is substantially cured at a temperature below about 45°

C. in about 90 minutes or less.

40. The method of claim 39, wherein said curable material comprises about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines.

41. The method of claim 40, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F;

the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether;

the cycloalkylamines are N-aminoalkylpiperazines; and

the dialkylamines are according to the formula H₂N—

R—

NH₂, wherein R is a branched or unbranched C₂-C₁₀ alkyl group.

42. The method of claim 40, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A, the aliphatic diepoxide resin comprises butane diol of glycidyl ether, the dialkylamine comprises 1,3-diaminopropane, and the cycloalkylamine comprises N-aminoethylpiperazine.

43. The method of claim 39, wherein said hardenable media, when cured, has a static compression bending value of at least 100 lbs. (ASTM F1717).

44. A formed in place medical device, comprising:

an outer wall, defining a cavity therein; and

a hardenable media within the cavity to form the medical device, said hardenable media comprising a resin and hardener mixture that cures at a temperature below about 45°

C. wherein said cured media has a static compression bending value (ASTM F1717) of at least 150 lbs;

wherein the hardenable media is hardened while the device is positioned within the body of a patient to create the formed in place medical device.