Curable media for implantable medical device
View Patent ↗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.
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 H 2 N—R—NH 2 , wherein R is a branched or unbranched C 2 -C 10 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.