ANEURYSM OCCLUSION DEVICE CONTAINING BIOACTIVE AND BIOCOMPATIBLE COPOLYMER SHELL AND A LIQUID EMBOLIC AGENT

• US 20090118761A1
• Filed: 04/25/2008
• Published: 05/07/2009
• Est. Priority Date: 04/27/2007
• Status: Active Grant

• Current Assignee: Wisconsin Alumni Research Foundation (University of Wisconsin System)
• Original Assignee: Wisconsin Alumni Research Foundation (University of Wisconsin System)
• Inventors: Kienitz, Beverly Aagaard, Xu, Fangmin, Crone, Wendy C., Masters, Kristyn S., Moftakhar, Roham
• Granted Patent: US 8,425,541 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61K 31/75 of ethene
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 33/0035 using a polymer with positively charged atoms in the polymeric backbone, e.g. ionenes
• CPC Class Codes: C08B 37/0063 Glycosaminoglycans or mucopolysaccharides, e.g. keratan sulfate; Derivatives thereof, e.g. fucoidan
• CPC Class Codes: C08B 37/0069 Chondroitin-4-sulfate, i.e. chondroitin sulfate A; Dermatan sulfate, i.e. chondroitin sulfate B or beta-heparin; Chondroitin-6-sulfate, i.e. chondroitin sulfate C; Derivatives thereof
• CPC Class Codes: C08B 37/0072 Hyaluronic acid, i.e. HA or hyaluronan; Derivatives thereof, e.g. crosslinked hyaluronic acid (hylan) or hyaluronates
• CPC Class Codes: C08B 37/0075 Heparin; Heparan sulfate; Derivatives thereof, e.g. heparosan; Purification or extraction methods thereof
• CPC Class Codes: C08G 18/10 Prepolymer processes involving reaction of isocyanates or isothiocyanates with compounds having active hydrogen in a first reaction step
• CPC Class Codes: C08G 18/3206 aliphatic
• CPC Class Codes: C08G 18/4854 Polyethers containing oxyalkylene groups having four carbon atoms in the alkylene group
• CPC Class Codes: C08G 18/64 Macromolecular compounds not provided for by groups C08G18/42 - C08G18/63
• CPC Class Codes: C08G 18/6484 Polysaccharides and derivatives thereof
• CPC Class Codes: C08G 18/7657 containing two or more aromatic rings
• CPC Class Codes: C08G 18/7671 containing only one alkylene bisphenyl group
• CPC Class Codes: C08L 75/04 Polyurethanes

Abstract

An endovascular device for occluding a vascular aneurysm is disclosed. The device includes a polymeric shell member that, in one embodiment, may be constructed from a bioactive and biocompatible polyurethane-diol-glycosaminoglycan copolymer, and a liquid embolic agent. The copolymer is sufficiently flexible and strong for endovascular delivery into a vascular aneurysm and for use as a polymeric shell for receiving the liquid embolic agent. Upon activation inside of the polymeric shell within the aneurysm, the liquid embolic agent solidifies enabling biological isolation of the aneurysm and improved patient outcomes.

Claims

1. An endovascular medical device comprising:

a polymeric member defining an interior chamber; and

a liquid embolic agent, the liquid embolic agent being capable of solidifying upon activation.

2. The medical device of claim 1, wherein the polymeric member is constructed from a copolymer comprising the reaction product of a biocompatible urethane and a bioactive polysaccharide.

3. The medical device of claim 1, wherein the polymeric member is constructed of a material selected from the group consisting of polyester materials, silicone-based materials and derivatives thereof, polyethylene materials, polytetrafluoroethylene, biocompatible urethanes and derivatives thereof, and combinations thereof.

4. The medical device of claim 1, wherein the liquid embolic agent is selected from the group consisting of a calcium solution and an alginate solution, a sodium solution and an alginate solution, cyanoacrylate solutions, polyvinyl alcohol solutions, ethylene vinyl copolymer solutions, cellulose acetate solutions, polymethylmethacrylate solutions, polyvinyl acetate solutions, hydrogel solutions, polyurethane solutions, poly(ethylene glycol) solutions, polyester solutions, polyhydroxyethyl methacrylate solutions, polyanhydride solutions, silicone solutions, polysilane solutions and combinations and copolymers thereof.

5. The medical device of claim 1, wherein the device additionally comprises a first chamber for containing a first component of a liquid embolic agent and a second chamber for containing a second component of a liquid embolic agent, said first chamber and said second chamber being configured to allow for mixing of the first component and the second component upon ejection from the medical device.

6. The medical device of claim 2, wherein the bioactive polysaccharide is a bioactive glycosaminoglycan.

7. The medical device of claim 6, wherein the bioactive glycosaminoglycan is a member selected from the group consisting of a suitable salt of hyaluronic acid and a suitable salt of heparin.

8. The medical device of claim 7, wherein the salt of hyaluronic acid is a member selected from the group consisting of a cetylpyridinium salt and a tetrabutylammonium salt, and wherein the salt of heparin is a dimethyldioctadecylammonium salt.

9. The medical device of claim 8, wherein the biocompatible urethane is the reaction product of 4,4′

-methylene-di-(p-phenyl isocyanate) and poly(tetramethylene oxide)_n and further reacted with 1,4-butanediol, and wherein n=10 to 40.

10. The medical device of claim 8, wherein the biocompatible urethane is the reaction product of a suitable isocyanate-containing molecule and a suitable poly(C_2-10 alkylene oxide)_n and further reacted with a suitable C_4-50 diol-containing molecule, wherein n=10 to 40, wherein the C_2-10 alkylene is linear or branched, substituted or un-substituted, and wherein the C_4-50 is linear or branched, substituted or un-substituted.

11. The medical device of claim 1, wherein the polymeric member has a wall thickness in the range of 0.05 to 0.4 mm.

12. The medical device of claim 1, further comprising a contrast agent.

13. The medical device of claim 12, wherein the contrast agent is present on an inside surface of the polymeric member wall.

14. An endovascular method of occluding a vascular aneurysm comprising:

endovascularly disposing into a vascular aneurysm an elastic hemocompatible polymeric member defining an interior chamber;

endovascularly disposing a liquid embolic agent within the interior chamber; and

activating the liquid embolic agent to solidify the liquid embolic agent in the interior chamber.

15. The method of claim 14, wherein the liquid embolic agent is selected from the group consisting of a calcium solution and an alginate solution, a sodium solution and an alginate solution, cyanoacrylate solutions, polyvinyl alcohol solutions, ethylene vinyl copolymer solutions, cellulose acetate solutions, polymethylmethacrylate solutions, polyvinyl acetate solutions, hydrogel solutions, polyurethane solutions, poly(ethylene glycol) solutions, polyester solutions, polyhydroxyethyl methacrylate solutions, polyanhydride solutions, silicone solutions, polysilane solutions and combinations and copolymers thereof.

16. The method of claim 14, wherein the polymeric member is constructed from a member of the group consisting of the reaction product of a biocompatible urethane and a bioactive polysaccharide, polyester materials, silicone-based materials and derivatives thereof, polyethylene materials, polytetrafluoroethylene, biocompatible urethanes and derivatives thereof, and combinations thereof.

17. The method of claim 14, wherein the activation of the liquid embolic agent is done using ultraviolet radiation, ultrasonic energy, mixing, agitation, heating, and combinations thereof.

18. The method of claim 16, wherein the bioactive polysaccharide is a bioactive glycosaminoglycan.

19. The method of claim 18, wherein the bioactive glycosaminoglycan is a member selected from the group consisting of a suitable salt of hyaluronic acid and a suitable salt of heparin.

20. The method of claim 19, wherein the salt of hyaluronic acid is a member selected from the group consisting of a cetylpyridinium salt and a tetrabutylammonium salt, and wherein the salt of heparin is a dimethyldioctadecylammonium salt.

21. The method of claim 20, wherein the biocompatible urethane is the reaction product of 4,4′

-methylene-di-(p-phenyl isocyanate) and poly(tetramethylene oxide)_n and further reacted with 1,4-butanediol, and wherein n=10 to 40.

22. The method of claim 16, wherein the biocompatible urethane is the reaction product of a suitable isocyanate-containing molecule and a suitable poly(C_2-10 alkylene oxide)_n and further reacted with a suitable C_4-50 diol-containing molecule, wherein n=10 to 40, wherein the C_2-10 alkylene is linear or branched, substituted or un-substituted, and wherein the C_4-50 is linear or branched, substituted or un-substituted.

23. The method of claim 14, wherein the polymeric member has a wall thickness in the range of 0.05 to 0.4 mm.

24. The method of claim 15 wherein the polymeric member comprises a contrast agent.

25. An endovascular method of occluding a vascular aneurysm comprising:

endovascularly disposing into a vascular aneurysm an elastic hemocompatible polymeric member defining an interior chamber;

endovascularly disposing a liquid embolic agent comprising a first component and a second component within the interior chamber and allowing the first component and second component to mix with each other and solidify.

26. The method of claim 25, wherein the first component is selected from the group consisting of a calcium solution and a sodium solution and the second component is an alginate solution.

27. The method of claim 25 wherein the polymeric member is constructed from a member of the group consisting of the reaction product of a biocompatible urethane and a bioactive polysaccharide, polyester materials, silicone-based materials and derivatives thereof, polyethylene materials, polytetrafluoroethylene, biocompatible urethanes and derivatives thereof, and combinations thereof.

28. The method of claim 27, wherein the bioactive polysaccharide is a bioactive glycosaminoglycan.

29. The method of claim 28, wherein the bioactive glycosaminoglycan is a member selected from the group consisting of a suitable salt of hyaluronic acid and a suitable salt of heparin.

30. The method of claim 29, wherein the salt of hyaluronic acid is a member selected from the group consisting of a cetylpyridinium salt and a tetrabutylammonium salt, and wherein the salt of heparin is a dimethyldioctadecylammonium salt.

31. The method of claim 27, wherein the biocompatible urethane is the reaction product of 4,4′

-methylene-di-(p-phenyl isocyanate) and poly(tetramethylene oxide)_n and further reacted with 1,4-butanediol, and wherein n=10 to 40.

32. The method of claim 27, wherein the biocompatible urethane is the reaction product of a suitable isocyanate-containing molecule and a suitable poly(C_2-10 alkylene oxide)_n and further reacted with a suitable C_4-50 diol-containing molecule, wherein n=10 to 40, wherein the C_2-10 alkylene is linear or branched, substituted or un-substituted, and wherein the C_4-50 is linear or branched, substituted or un-substituted.

33. The method of claim 25, wherein the polymeric member has a wall thickness in the range of 0.05 to 0.4 mm.

34. An endovascular method of occluding a vascular aneurysm comprising:

endovascularly disposing into a vascular aneurysm an elastic hemocompatible polymeric member defining an interior chamber;

activating a liquid embolic agent; and

endovascularly disposing the activated liquid embolic agent within the interior chamber.