Aneurysm occlusion device containing bioactive and biocompatible copolymer shell and biocompatible metallic frame member

• US 8,425,542 B2
• Filed: 04/25/2008
• Issued: 04/23/2013
• 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: Moftakhar, Roham, Masters, Kristyn S., Crone, Wendy C., Xu, Fangmin
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US12/110,094
• Publication Number:
  US 20090062834A1
• Time in Patent Office: 1,824 Days
• Field of Search: 606/151, 606/157, 606/158, 606/200, 424/423, 527/300
• US Class Current: 606/158
• 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 biocompatible metallic frame member. The copolymer is sufficiently flexible and strong for endovascular delivery into a vascular aneurysm and for use as a polymeric shell for receiving the biocompatible metallic frame member. The biometallic frame member may include one or more components constructed from a NiTi alloy.

Claims

1. An endovascular medical device comprising:

a polymeric member defining an interior chamber, wherein the polymeric member is constructed from a copolymer comprising a biocompatible polyurethane and a bioactive polysaccharide, wherein the bioactive polysaccharide is incorporated into the biocompatible polyurethane backbone of the copolymer; and

a biocompatible metallic frame member comprising one or more components constructed from a NiTi alloy having a transformation temperature below a patient'"'"'s body temperature, disposed within the interior chamber, and adapted to structurally support the polymeric member.

2. The medical device of claim 1, wherein the bioactive polysaccharide is a bioactive glycosaminoglycan.

3. The medical device of claim 2, 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.

4. The medical device of claim 3, 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.

5. The medical device of claims 4, wherein the salt of hyaluronic acid has 5 to 10,000 repeating units, and wherein the dimethyldioctadecylammonium salt of heparin has 5 to 65 repeating units.

6. The medical device of claim 1, wherein the weight content of the bioactive polysaccharide is in the range of about 0.05% to about 30%.

7. The medical device of claim 6, wherein the high and low range endpoints of the weight content of the bioactive polysaccharide are any combination of members selected from the group consisting of 0.05%, 0.1%, 0.33%, 0.66%, 1.3%, 2.0%, 5.4%, 10% and 30%.

8. The medical device of claim 7, comprising the cetylpyridinium salt of hyaluronic acid.

9. The medical device of claim 1, 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 1, 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.

11. The medical device of claim 1, 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.

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

13. The medical device of claim 12, wherein the polymeric member is adapted to substantially conform to a vascular aneurysm.

14. The medical device of claim 1, wherein the NiTi alloy comprises in the range of about 49 to about 51 wt. % Ni and in the range of about 51 to about 49 wt. % Ti.

15. The medical device of claim 14, wherein the metallic frame member comprises a single component.

16. The medical device of claim 14, wherein the metallic frame member is in the shape of a coil.

17. An endovascular medical device comprising:

a polymeric member defining an interior chamber and constructed from an elastic, hemocompatible polymer, wherein the elastic, hemocompatible polymer is modified with an anti-thrombotic agent and wherein the elastic, hemocompatible polymer is a member selected from the group consisting of poly(ethylene glycol), poly(vinyl alcohol), polytetrafluoroethylene, polyethylene terephthalate, poly(hydroxyethyl methacrylate), poly(hydroxyethyl acrylate), and a copolymer thereof, and,

a biocompatible metallic frame member comprising one or more components constructed from a NiTi alloy having a transformation temperature below a patient'"'"'s body temperature, disposed within the interior chamber, and adapted to structurally support the polymeric member.

18. The medical device of claim 17, wherein the copolymer is a member selected from the group consisting of poly(ethylene glycol) diacrylate, poly(ethylene glycol) dimethacrylate and acrylated poly(vinyl alcohol).

19. The medical device of claim 17, wherein the anti-thrombotic modified derivative includes the hemocompatible polymer modified by an anti-thrombotic agent selected from the group consisting of heparin, chitosan and a nitric oxide donor molecule.

20. The medical device of claim 17, wherein the anti-thrombotic modified derivative is a member selected from the group consisting of heparin-releasing polyvinylpyrrolidone, heparin-releasing methacrylate, heparin-releasing polyester, nitric oxide-releasing polyester, and nitric oxide-releasing polyvinyl chloride.

21. The medical device of claim 17, wherein the polymeric member has a wall thickness in the range of 0.05 to 0.4 mm.

22. The medical device of claim 17, wherein the polymeric member is adapted to substantially conform to a vascular aneurysm.

23. The medical device of claim 17, wherein the alloy comprises in the range of about 49 to about 51 wt. % Ni and in the range of about 51 to about 49 wt. % Ti.

24. The medical device of claim 23, wherein the metallic frame member comprises a single component.

25. The medical device of claim 24, wherein the metallic frame member is in the shape of a coil.