Inflatable porous implants and methods for drug delivery

• US 7,803,178 B2
• Filed: 01/30/2004
• Issued: 09/28/2010
• Est. Priority Date: 01/30/2004
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Trivascular Incorporated
• Inventors: Whirley, Robert G., Shapiro, James M.
• Primary Examiner(s): SWEET, THOMAS
• Application Number:
  US10/769,532
• Publication Number:
  US 20050171593A1
• Time in Patent Office: 2,433 Days
• Field of Search: 623/1.42, 623/1.43
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0023 differing in porosity
• CPC Class Codes: A61F 2250/0035 differing in release or diffusion time
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

The present invention provides inflatable porous implants, such as grafts, stent-grafts, and bladders, as well as methods and kits for drug delivery. In particular, the grafts and stent-grafts of the present invention provide for the delivery of a therapeutic agent into a flow conduit in the body. The inflatable porous implants provide for direct delivery of larger, more precise dosages of drugs over longer administration periods into the body. Moreover, these inflatable porous implants are often flexible when inserted and have a low profile delivery configuration for easy placement. The implants of the present invention further provide a mechanical or structural function in addition to drug delivery in a single integrated structure.

Claims

1. A graft comprising:

a graft body section having a proximal end, a distal end, and defining at least one inflatable porous channel;

at least one inflatable porous cuff disposed at the proximal or distal end of the graft body section and in fluid communication with the at least one channel, wherein the at least one inflatable porous cuff is disposed in an axisymmetric cylindrical manner around the proximal or distal end of the graft body section; and

an inflation medium including at least one therapeutic agent configured to be introduced into the inflatable channel;

wherein the inflation medium comprises a curable liquid comprising a therapeutic agent-carrying host polymer.

2. The graft of claim 1 wherein the agent is capable of being transported from the inflation medium through a wall of the porous channel and released into a body lumen.

3. The graft of claim 2 wherein the agent is configured to be released into the body lumen from a luminal or abluminal surface of the graft body section.

4. The graft of claim 2 wherein the porous channel has varying levels of porosity.

5. The graft of claim 2 wherein the graft body section comprises one or more materials selected from the group consisting of a fluoropolymer, a polyethyleneterephthalate, a polyvinylchloride, a polyurethane, a polyolefin, and a polyamide.

6. The graft of claim 2 wherein the graft body section comprises expanded or perforated polytetrafluoroethylene.

7. The graft of claim 2 wherein a quantity of the agent releasable into the body lumen ranges from about 10 micrograms to about 100 milligrams.

8. The graft of claim 2 wherein the therapeutic agent is configured to be transported into the body lumen in a time period ranging from about seven days to about twelve months.

9. The graft of claim 2 wherein the at least one therapeutic agent comprises one or more agents selected from the group consisting of an endothelialization promoting agent, an angiogenesis promoting agent, an anti-thrombotic agent, an anti-aneurysmal agent, an anti-infection agent, an anti-inflammatory agent, an anti-restenosis agent, a chemotherapeutic agent, and an anti-cancer agent.

10. The graft of claim 1 wherein the therapeutic agent is capable of being released by diffusion through the host polymer.

11. The graft of claim 1 wherein the therapeutic agent is capable of being released by degradation of the host polymer.

12. The graft of claim 1 wherein the graft body section comprises biocompatible material capable of inhibiting transport of a bulk of the host polymer.

13. The graft of claim 1 wherein the host polymer is capable of being introduced into the inflatable channel before, during, or after graft deployment or implantation.

14. The graft of claim 1 wherein the inflation medium has a cure time ranging from about three minutes to about twenty minutes and a post-cure elastic modulus ranging from about 50 psi to about 400 psi.

15. The graft of claim 1 wherein the channel comprises one or more features selected from the group consisting of helical spirals, longitudinal channels, and circumferential rings.

16. The graft of claim 1 wherein the at least one inflatable porous cuff is disposed at the proximal end of the graft body section and further comprising at least one second inflatable porous cuff disposed at the distal end of the graft body section in fluid communication with the at least one channel, wherein the at least one second inflatable porous cuff is disposed in an axisymmetric cylindrical manner around the distal end of the graft body section.

17. A graft comprising:

a graft body section having a proximal end, a distal end, and defining at least one inflatable porous channel therebetween;

a connector member affixed to the proximal or distal end of the graft body section, the connector member comprising one or more connector elements;

a stent comprising one or more proximal stent connector elements coupled to the one or more connector member connector elements wherein the stent comprises a multi-crown configuration; and

a curable inflation medium including at least one therapeutic agent configured to be introduced into the inflatable channel.

18. The graft of claim 17, wherein the curable inflation medium comprises a curable liquid.

19. The graft of claim 17 wherein the connector member comprises a multi-apex configuration.

20. The graft of claim 19 wherein the connector member comprises a twelve-apex configuration.

21. The graft of claim 17 wherein the stent comprises a three-crown portion.

22. The graft of claim 17 wherein the stent comprises a six-crown portion.

23. The graft of claim 17 wherein the stent comprises a three-crown portion and a six-crown portion.

24. The graft of claim 17 wherein the connector member affixed to the proximal end of the graft body section;

and further comprising

a second connector member affixed to the distal end of the graft body section, the second connector member comprising one or more second connector elements; and

a second stent comprising one or more proximal second stent connector elements coupled to the one or more second connector member connector elements, wherein the second stent comprises a multi-crown configuration.

25. The graft of claim 17 wherein the at least one therapeutic agent comprises one or more agents selected from the group consisting of an endothelialization promoting agent, an angiogenesis promoting agent, an anti-thrombotic agent, an anti-aneurysmal agent, an anti-infection agent, an anti-inflammatory agent, an anti-restenosis agent, a chemotherapeutic agent, and an anti-cancer agent.

26. A graft comprising:

a graft body section having a proximal end, a distal end, and defining at least one inflatable porous channel;

at least one inflatable porous cuff disposed at the proximal or distal end of the graft body section and in fluid communication with the at least one channel, wherein the at least one inflatable porous cuff is disposed in an axisymmetric cylindrical manner around the proximal end of the graft body section;

a connector member affixed to the proximal or distal end of the graft body section, the connector member comprising one or more connector elements;

a stent comprising one or more proximal stent connector elements coupled to the one or more connector member connector elements wherein the stent comprises a multi-crown configuration; and

an inflation medium including at least one therapeutic agent configured to be introduced into the inflatable channel;

wherein the inflation medium comprises a curable liquid.

27. The graft of claim 26 wherein the at least one inflatable porous cuff is disposed at the proximal end of the graft body section and further comprising at least one second inflatable porous cuff disposed at the distal end of the graft body section in fluid communication with the at least one channel, wherein the at least one second inflatable porous cuff is disposed in an axisymmetric cylindrical manner around the distal end of the graft body section.

28. The graft of claim 26 wherein the connector member comprises a multi-apex configuration.

29. The graft of claim 28 wherein the connector member comprises a twelve-apex configuration.

30. The graft of claim 26 wherein the stent comprises a three-crown portion.

31. The graft of claim 26 wherein the stent comprises a six-crown portion.

32. The graft of claim 26 wherein the stent comprises a three-crown portion and a six-crown portion.

33. The graft of claim 26 wherein the connector member affixed to the proximal end of the graft body section;

and further comprising

a second connector member affixed to the distal end of the graft body section, the second connector member comprising one or more second connector elements; and

a second stent comprising one or more proximal second stent connector elements coupled to the one or more second connector member connector elements, wherein the second stent comprises a multi-crown configuration.

34. The graft of claim 26 wherein the at least one therapeutic agent comprises one or more agents selected from the group consisting of an endothelialization promoting agent, an angiogenesis promoting agent, an anti-thrombotic agent, an anti-aneurysmal agent, an anti-infection agent, an anti-inflammatory agent, an anti-restenosis agent, a chemotherapeutic agent, and an anti-cancer agent.