In-situ forming foams for treatment of aneurysms

• US 10,420,862 B2
• Filed: 06/25/2012
• Issued: 09/24/2019
• Est. Priority Date: 08/24/2009
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Aresenal AAA LLC
• Inventors: Sharma, Upma, Zugates, Gregory, Busold, Rany, Freyman, Toby
• Primary Examiner(s): Schall, Matthew W
• Application Number:
  US13/532,013
• Publication Number:
  US 20120265287A1
• Time in Patent Office: 2,647 Days
• Field of Search: 623 115, 623 135
• 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
• 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 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;

delivering, with a catheter, a material between the exterior surface of said medical device and the surface of the aneurysm; and

forming a foam from said material upon delivery between the exterior surface of said medical device and the surface of the aneurysm;

wherein (a) said foam is formed by the reaction of said material with blood in situ and (b) the reaction includes the generation of a gas, said gas expanding a portion of the material into an interstitial area.

2. The method of claim 1, wherein said foam comprises polyurethane.

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

4. The method of claim 1, wherein said 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 delivered between the exterior surface of said medical device and the surface of the aneurysm as separate components to form said foam.

8. The method of claim 4, wherein said multifunctional isocyanate and said polyol are delivered between the exterior surface of said medical device and the surface of the aneurysm as a mixture to form said foam.

9. The method of claim 1, wherein said foam comprises a visualization material.

10. The method of claim 1, wherein said 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 said foam contacts said 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 delivering step comprises the steps of:

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

introducing said material through said catheter.

16. The method of claim 15, wherein said catheter comprises a one-way valve.

17. The method of claim 1, wherein the material is a fluid comprising a prepolymer.

18. The method of claim 1, wherein the material is a fluid prepolymer.

19. The method of claim 1, wherein the material comprises a polysiloxane.

20. The method of claim 19, wherein the material comprises a multifunctional isocyanate and the gas is carbon dioxide.