In-Situ Forming Foams for Treatment of Aneurysms

• US 20120265287A1
• Filed: 06/25/2012
• Published: 10/18/2012
• Est. Priority Date: 08/24/2009
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Arsenal Medical, Inc
• Inventors: Sharma, Upma, Zugates, Gregory, Busold, Rany, Freyman, Toby
• Granted Patent: US 10,420,862 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices artificial blood vessels A61L27/507
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/141 Plasticizers
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: C08L 75/04 Polyurethanes

Abstract

Systems, methods and kits relating to in-situ forming polymer foams for the treatment of aneurysms are disclosed. The systems include an insertable medical device and an in-situ forming foam that is formed from a polymer that reacts in an aqueous environment. When used to treat an aneurysm, the foam is placed into contact with at least a portion of an exterior surface of the medical device and/or the tissue surface of the aneurysm.

Claims

1. A method for treating an aneurysm within a patient, the aneurysm characterized by a first end, a second end, and a tissue surface between the first and second ends, said method comprising the steps of:

placing a medical device within said aneurysm, said medical device comprising a structure having a first end, a second end, and an exterior surface between said first and second ends; and

forming an in-situ forming foam between the exterior surface of said medical device and the tissue surface of the aneurysm;

wherein said in-situ forming foam comprises a polymer that reacts in the presence of an aqueous environment to generate a gas.

2. The method of claim 1, wherein said in-situ forming foam comprises polyurethane.

3. The system of claim 2, wherein said polyurethane is a poly(urethane urea).

4. The method of claim 1, wherein said in-situ forming foam is formed by the reaction of a multifunctional isocyanate and a polyol.

5. The method of claim 4, wherein said isocyanate is at least one of hexamethylene diisocyanate, toluene diisocyanate, methylene diphenyl diisocyanate, lysine isocyanate, isophorone diisocyanate, and mixtures thereof.

6. The method of claim 4, wherein said polyol is selected from the group consisting of polyethers and polybutadienes.

7. The method of claim 4, wherein said multifunctional isocyanate and said polyol are inserted during said inserting step as separate components to form said in-situ forming foam.

8. The method of claim 4, wherein said multifunctional isocyanate and said polyol are inserted as a mixture during said inserting step to form said in-situ forming foam.

9. The method of claim 1, wherein said in-situ forming foam comprises a visualization material selected from the group consisting of contrast media and/or radiopaque agents.

10. The method of claim 1, wherein said in-situ forming foam further comprises at least one of a surfactant, a chain extender, a pore opener, a filler, a catalyst, a diluent, and a plasticizer.

11. The method of claim 1, wherein the in-situ forming foam contacts said tissue surface of said aneurysm.

12. The method of claim 1, wherein said medical device comprises a graft.

13. The method of claim 1, wherein said medical device comprises a stent-graft.

14. The method of claim 1, wherein said medical device comprises a balloon.

15. The method of claim 1, wherein said aqueous environment comprises blood.

16. The method of claim 15, wherein said forming step comprises the steps of:

placing a catheter between said first and second ends of said aneurysm; and

introducing said in-situ forming foam through said catheter.

17. The method of claim 16, wherein said catheter comprises a one-way valve.

18. A method for treating an aneurysm within a patient, the aneurysm characterized by a first end, a second end, and a tissue surface between the first and second ends, said method comprising the steps of:

placing a medical device within said aneurysm, said medical device comprising a structure having a first end, a second end, and an exterior surface between said first and second ends; and

delivering an in-situ forming foam between the exterior surface of said medical device and the tissue surface of the aneurysm; and

exposing said in-situ forming foam to a fluid;

wherein said in-situ forming foam comprises a polymer that reacts in the presence of said fluid to generate a gas.

19. The method of claim 18, wherein said step of exposing said in-situ forming foam to a fluid comprises the step of exposing said polymer to blood.

20. The method of claim 18, wherein said step of exposing said in-situ forming foam to a fluid comprises the step of delivering said fluid between the exterior surface of said medical device and the tissue surface of the aneurysm.

21. A method for treating an aneurysm within a patient, the aneurysm characterized by a first end, a second end, and a tissue surface between the first and second ends, wherein said aneurysm has been pre-treated by the placement of a medical device within said aneurysm, said medical device comprising a structure having a first end, a second end, and an exterior surface between said first and second ends, said method comprising the step of delivering an in-situ forming foam between the exterior surface of said medical device and the tissue surface of the aneurysm, wherein said in-situ forming foam comprises a polymer that reacts in the presence of an aqueous environment to generate a gas.

22. The method of claim 21, wherein said medical device is a stent-graft.

23. The method of claim 21, wherein said in-situ forming foam comprises polyurethane.

24. The system of claim 23, wherein said polyurethane is a poly(urethane urea).

25. The method of claim 21, wherein said in-situ forming foam is formed by the reaction of a multifunctional isocyanate and a polyol.