In-situ forming foams with outer layer

• US 9,044,580 B2
• Filed: 03/15/2013
• Issued: 06/02/2015
• Est. Priority Date: 08/24/2009
• Status: Active Grant

• Current Assignee: Arsenal Medical, Inc
• Original Assignee: Arsenal Medical, Inc
• Inventors: Freyman, Toby, Lomakin, Joseph, Marini, John, Mortensen, Jennifer, Rago, Adam, Busold, Rany, Sharma, Upma, Zugates, Gregory T.
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US13/815,910
• Publication Number:
  US 20130317418A1
• Time in Patent Office: 809 Days
• Field of Search: 623/1.35, 623/23.72, 424/426
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61L 2300/60 characterised by a special physical form
• CPC Class Codes: A61L 24/0036 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 24/0089 containing inorganic fillers not covered by groups A61L24/0078 or A61L24/0084
• CPC Class Codes: A61L 24/046 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043 takes precedence
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• 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 31/128 containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 83/04 : Polysiloxanes

Abstract

Systems, methods and kits relating to in-situ forming polymer foams for the treatment of aneurysms or fluid filled spaces are disclosed. The systems include an insertable medical device and an in-situ forming foam of lava like materials with a fast forming outer skin and a slower hardening interior that is formed from a one-, two- or multi-part formulation. 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

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 within the aneurysm in the presence of an aqueous environment to generate a gas and form a foam structure comprising a first portion comprising a skin and a second portion within said first portion.

2. The method of claim 1, wherein said in-situ forming foam comprises a multi-functional silane.

3. The system of claim 1, wherein said multi-functional silane is formulated with tin.

4. The system of claim 1, wherein said multi-functional silane is formulated with titans.

5. The method of claim 1, wherein said in-situ forming foam is formed by the reaction of a multifunctional silane and hydroxyl containing siloxanes.

6. The method of claim 5, wherein said multifunctional silane comprises at least one of actoxy, oxime, alkoxy, isopropenoxy, amide, amine, aminoxy, or other functional groups containing silane with the hydrolytically susceptible Si—

O—

C bond.

7. The method of claim 1, wherein said in-situ forming foam is formed from a multi-functional isocyanate polymer.

8. The method of claim 1, wherein said in-situ forming foam is formed by the reaction of hydride functional (Si—

H) siloxanes and silanol elastomer formulations.

9. The method of claim 1, wherein said in-situ forming foam is formed by the reaction of isocyanate functionalized carbinols and silanol elastomer formulations.

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

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

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

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

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

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

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

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

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

19. The method of claim 18, 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.

20. The method of claim 19, wherein said catheter comprises a one-way valve.

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 within the aneurysm in the presence of an aqueous environment to generate a gas and form a foam structure comprising a first portion comprising a skin and a second portion within said first portion.

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

23. The method of claim 21, wherein said foam structure is a coil configuration.