IN SITU FORMING HEMOSTATIC FOAM IMPLANTS

• US 20150224235A1
• Filed: 09/22/2014
• Published: 08/13/2015
• Est. Priority Date: 08/24/2009
• Status: Active Grant

• Current Assignee: Arsenal Medical, Inc
• Original Assignee: Arsenal Medical, Inc
• Inventors: Sharma, Upma, Gitlin, Irina, Zugates, Gregory T., Rago, Adam, Zamiri, Parisa, Busold, Rany, Freyman, Toby, Caulkins, Robert J., Pham, Quynh P., Carbeck, Jeffrey D., You, Changchen
• Granted Patent: US 9,700,656 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61L 24/001 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 24/0036 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 24/0042 Materials resorbable by the body
• 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 2400/04 Materials for stopping bleeding
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• 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 31/141 Plasticizers
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• 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 63/00 : Compositions of epoxy resins; Compositions of derivatives of epoxy resins
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Systems and methods related to polymer foams are generally described. Some embodiments relate to compositions and methods for the preparation of polymer foams, and methods for using the polymer foams. The polymer foams can be applied to a body cavity and placed in contact with, for example, tissue, injured tissue, internal organs, etc. In some embodiments, the polymer foams can be formed within a body cavity (i.e., in situ foam formation). In addition, the foamed polymers may be capable of exerting a pressure on an internal surface of a body cavity and preventing or limiting movement of a bodily fluid (e.g., blood, etc.).

Claims

22. A method of treating a patient by forming a polymer foam within a body cavity to control the flow of a bodily fluid, the method comprising:

combining a first component comprising a first polymer and a second component comprising a second polymer to form a polymer formulation;

introducing said polymer formulation into a body cavity;

foaming said polymer formulation; and

crosslinking at least a portion of said first and second polymers of said polymer formulation to form a polymer foam.

23. The method of claim 15, wherein said polymer foam exerts pressure on an internal surface of said body cavity to at least partially limit the movement of a bodily fluid.

24. The method of claim 1, wherein said polymer formulation is flowable.

25. The method of claim 1, wherein said foaming and said crosslinking occur at substantially the same time.

26. The method of claim 1, wherein said foaming occurs prior to the occurrence of substantial crosslinking.

27. The method of claim 1, wherein said foaming comprises introducing a gas under conditions such that a plurality of bubbles are formed within said polymer formulation.

28. The method of claim 6, wherein said gas is introduced into said polymer formulation from an external source.

29. The method of claim 6, wherein said gas is a reaction product of the crosslinking of said first and second polymers.

30. The method of claim 6, wherein forming said plurality of bubbles causes the polymer formulation to expand.

31. The method of claim 6, wherein said first and second polymers of said polymer formulation crosslink around said bubbles thereby creating a plurality of pores.

32. The method of claim 1, wherein said crosslinking is initiated by the contact of said first and second polymers with an aqueous solution.

33. The method of claim 11, wherein said aqueous solution is blood.

34. The method of claim 1, wherein said crosslinking is catalyzed by an initiator.

35. The method of claim 1, wherein said first component is a polyol selected from the group consisting of polypropylene glycol, polyethylene glycol, polycarbonate, polybutadiene and polyester.

36. The method of claim 1, wherein said second component is a multi-functional isocyanate selected from the group consisting of hexamethylene diisocyanate (HDI), toluene diisocyanate (TDI), methylene diphenyl diisocyanate (MDI) and polymeric methylene diisocyanate.

37. The method of claim 1, wherein said polymer foam is biodegradable.

38. The method of claim 1, wherein said polymer foam is hydrophobic.

39. The method of claim 1, wherein said polymer foam has a rise time of up to 240 seconds.

40. The method of claim 1, wherein said polymer foam has a cream time of up to 25 seconds.

41. The method of claim 1, wherein at least one of said first or second component further comprises a surfactant.

42. The method of claim 1, wherein at least one of said first or second component further comprises a chain extender.

43. The method of claim 1, wherein at least one of said first or second component further comprises a plasticizer.

44. The method of claim 1, wherein at least one of said first or second component further comprises a filler.

45. The method of claim 1, wherein at least one of said first or second component further comprises a pore opener.