Vascular closure device
View Patent ↗A biocompatible material may be configured into any number of implantable medical devices including a vascular closure device. The vascular closure device includes a fibrous structure formed from at least one randomly oriented fiber, the randomly oriented fiber comprising at least one polymer, and at least one agent, in therapeutic dosage, incorporated into at least one of the fibrous structure and the at least one randomly oriented fiber.
1. A vascular closure device comprising:
a preshaped, cylindrical fibrous plug formed prior to delivery from a non-woven fabric of at least one randomly oriented and entangled fiber, the thickness of the nonwoven fabric ranging from about 0.25 to 2 mm, the basis weight of the nonwoven fabric ranging from about 0.01 to 0.2 g/in 2 , the at least one randomly oriented fiber having a density from about 120 to about 150 denier and a tenacity from about 3 to about 7 g/denier, the cylindrical fibrous plug being configured for occluding blood flow from a puncture and sealing a wound in a tract of a puncture wound, the fibrous plug having a definite cylindrical shape and volume ex vivo, the randomly oriented fiber comprising at least one polymer; and
at least one agent, in therapeutic dosage, dispersed in the fiber matrix of the at least one randomly oriented fiber, and configured for controlled elution therefrom.
2. The implantable medical device according to claim 1 , wherein the at least one polymer comprises a blend of one or more polymers.
3. The implantable medical device according to claim 1 , wherein the at least one polymer comprises a blend of at least one polymer and at least one plasticizer.
4. The implantable medical device according to claim 1 , wherein the at least one polymer comprises a bioabsorbable polymer.
5. The implantable medical device according to claim 4 , wherein the bioabsorbable polymer comprises poly (alpha hydroxy esters).
6. The implantable medical device according to claim 1 , wherein the at least one agent comprises anti-proliferative agents.
7. The implantable medical device according to claim 1 , wherein the at least one agent comprises anti-thrombogenic agents.
8. The implantable medical device according to claim 1 , wherein the at least one agent comprises anti-restenotic agents.
9. The implantable medical device according to claim 1 , wherein the at least one agent comprises anti-infective agents.
10. The implantable intraluminal medical device according to claim 1 , wherein the at least one agent comprises anti-viral agents.
11. The implantable intraluminal medical device according to claim 1 , wherein the at least one agent comprises anti-bacterial agents.
12. The implantable medical device according to claim 1 , wherein the at least one agent comprises anti-fungal agents.
13. The implantable medical device according to claim 1 , wherein the at least one agent comprises anti-inflammatory agents.
14. The implantable medical device according to claim 1 , wherein the at least one agent comprises cytostatic agents.
15. The implantable medical device according to claim 1 , wherein the at least one agent comprises cytotoxic agents.
16. The implantable medical device according to claim 1 , wherein the at least one agent comprises immunosuppressive agents.
17. The implantable medical device according to claim 1 , wherein the at least one agent comprises anti-microbial agents.
18. The implantable medical device according to claim 1 , wherein the at least one agent comprises anti-calcification agents.
19. The implantable medical device according to claim 1 , wherein the at least one agent comprises anti-encrustation agents.
20. The implantable medical device according to claim 1 , wherein the at least one agent comprises statins.
21. The implantable medical device according to claim 1 , wherein the at least one agent comprises hormones.
22. The implantable medical device according to claim 1 , wherein the at least one agent comprises anti-cancer agents.
23. The implantable medical device according to claim 1 , wherein the at least one agent comprises anti-coagulants.
24. The implantable medical device according to claim 1 , wherein the at least one agent comprises anti-migratory agents.
25. The implantable medical device according to claim 1 , wherein the at least one agent comprises tissue growth promoting agents.
26. The implantable medical device according to claim 23 , wherein the anti-coagulant comprises heparin.
27. A vascular closure device for sealing a wound in a body comprising:
a bioabsorbable, preshaped, cylindrical porous plug formed prior to delivery from a non-woven fabric of a plurality of randomly oriented bonded fibers prior to delivery, the thickness of the nonwoven fabric ranging from about 0.25 to 2 mm, the basis weight of the nonwoven fabric ranging from about 0.01 to 0.2 g/in 2 , the randomly oriented fibers each having a density from about 120 to about 150 denier and a tenacity from about 3 to about 7 g/denier, the cylindrical porous plug being configured for occluding blood flow from a puncture and sealing a wound in a tissue tract, the porous plug having a definite cylindrical shape and volume ex vivo, each of the plurality of bonded fibers comprising at least one polymer interspersed with therapeutic amounts of an agent.
28. A vascular closure device for sealing a wound in a body comprising:
a bioabsorbable, preshaped, cylindrical porous plug formed prior to delivery from a non-woven fabric of a plurality of randomly oriented bonded core fibers, the thickness of the nonwoven fabric ranging from about 0.25 to 2 mm, the basis weight of the nonwoven fabric ranging from about 0.01 to 0.2 g/in 2 , the randomly oriented fibers each having a density from about 120 to about 150 denier and a tenacity from about 3 to about 7 g/denier, the cylindrical porous plug being configured for occluding blood flow from a puncture and sealing a wound in a tissue tract, the porous plug having a definite cylindrical shape and volume ex vivo, each of the plurality of core fibers covered by a polymer layer forming a sheath over the core fiber, wherein the sheath includes at least one agent, in therapeutic amounts, dispersed in the fiber matrix of the polymer layer.
29. A vascular closure device for sealing a wound in a body comprising:
a bioabsorbable, cylindrical porous plug formed prior to delivery from a non-woven fabric of a plurality of randomly oriented bonded fibers oriented to form interstitial spaces between adjacent fibers, the thickness of the nonwoven fabric ranging from about 0.25 to 2 mm, the basis weight of the nonwoven fabric ranging from about 0.01 to 0.2 g/in 2 , the randomly oriented fibers each having a density from about 120 to about 150 denier and a tenacity from about 3 to about 7 g/denier, the cylindrical porous plug being configured for occluding blood flow from a puncture and sealing a wound in a tissue tract, the porous plug having a definite cylindrical shape and volume ex vivo, each fiber comprising at least one polymer, and therapeutic amounts of an agent dispersed within at least the interstitial space.
30. The medical device of claim 1 wherein the at least one agent is uniformly dispersed in the fiber.