Curable media for implantable medical device

• US 6,875,212 B2
• Filed: 12/20/2002
• Issued: 04/05/2005
• Est. Priority Date: 06/23/2000
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Vertelink Corporation (Medtronic Plc)
• Inventors: Estes, Richard H., Shaolian, Samuel M., Nguyen, Thanh Van, Pham, To V., Teitelbaum, George P.
• Primary Examiner(s): Robert, Eduardo C.
• Application Number:
  US10/327,706
• Publication Number:
  US 20040006341A1
• Time in Patent Office: 837 Days
• Field of Search: 606/61, 606/72, 604/96.01
• US Class Current: 606/86.00A
• 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 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.

2. The bone fixation device of claim 1, wherein said epoxy 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.

3. The bone fixation device of claim 2, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F.

4. The bone fixation device of claim 3, wherein the dialkylamines are according to a formula H₂N—

R—

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

5. The bone fixation device of claim 4, wherein the cycloalkylamines are N-aminoalkylpiperazines.

6. The bone fixation device of claim 2, wherein the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether.

7. The bone fixation device of claim 2, 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.

8. The bone fixation device of claim 1, wherein the hardenable media cures at temperature below about 45°

C.

9. The bone fixation device of claim 1, wherein the hardenable media has a static compression bending value (ASTM F1717) of at least 150 lbs within 12 hours.