Medical device films
View Patent ↗Medical devices described herein include a melt-pressed film having first and second diffusion barrier layers disposed thereon. The melt-pressed film and the barrier layers comprise bioabsorbable copolymers. In a further aspect, a therapeutic agent, such as an analgesic is included in the medical device.
1. A medical device comprising:
a first spray coated diffusion barrier layer,
a second spray coated diffusion barrier layer, and
a melt-pressed film comprising a therapeutic agent disposed therebetween.
2. The medical device of claim 1 , wherein the melt-pressed film comprises a material selected from the group consisting of homopolymers and copolymers of lactide; glycolide; epsilon-caprolactone, p-dioxanone; trimethylene carbonate; alkyl derivatives of trimethylene carbonate; Δ-valerolactone; β-butyrolactone; γ-butyrolactone; ε-decalactone; hydroxybutyrate; hydroxyvalerate; 1,4-dioxepan-2-one; 1,5-dioxepan-2-one; 6,6-dimethyl- 1,4-dioxan-2-one; 2,5-diketomorpholine; pivalolactone; α, α diethylpropiolactone; ethylene carbonate; ethylene oxalate; 3-methyl-1,4-dioxane-2,5-dione; 3,3-diethyl-1,4-dioxan-2,5-dione; and 6,8-dioxabicycloctane-7-one.
3. The medical device of claim 2 , wherein the melt-pressed film comprises glycolide, trimethylene carbonate, epsilon-caprolactone, and lactide.
4. The medical device of claim 2 , wherein the melt-pressed film comprises a random copolymer.
5. The medical device of claim 1 , wherein at least the first or the second diffusion barrier layer comprises a biodegradable material.
6. The medical device of claim 1 , wherein at least the first or second diffusion barrier layer comprises glycolide and caprolactone.
7. The medical device of claim 1 , wherein at least the first diffusion barrier layer or the second diffusion barrier layer is from about 1 micron to about 50 microns thick.
8. The medical device of claim 1 , wherein the melt-pressed film is from about 1 millimeter to about 10 millimeters thick.
9. The medical device of claim 1 , wherein the therapeutic agent is selected from the group consisting of anti-adhesives, antimicrobials, analgesics, and, anesthetics.
10. The medical device of claim 1 , wherein the therapeutic agent is bupivacaine.
11. The medical device of claim 10 , wherein the therapeutic agent is at a concentration of from about 30% to about 50% of the melt-pressed film.
12. A medical device comprising:
a copolymer film including about 69% glycolide, about 7% trimethylene carbonate, about 17% caprolactone, about 7% lactide;
wherein the copolymer film is disposed between a first and second barrier layer; and,
at least one of the first and second barrier layers includes about 90% caprolactone and about 10% glycolide.
13. The medical device according to claim 12 , wherein the copolymer film includes a therapeutic agent at a concentration of from about 40% by weight to about 50% by weight.