In situ forming hemostatic foam implants

• US 9,173,817 B2
• Filed: 08/12/2011
• Issued: 11/03/2015
• 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., You, Changcheng, Carbeck, Jeffrey D.
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US13/209,020
• Publication Number:
  US 20120107439A1
• Time in Patent Office: 1,544 Days
• Field of Search: 623/1.35, 623/23.72, 424/426
• 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

1. A system for forming a medical implant to limit movement of a bodily fluid, comprising:

a first chamber containing a first composition, the first composition including a polyol comprising up to 50 weight percent polyethylene oxide, up to 10 pphp of an amine catalyst, and up to 20 pphp water;

a second chamber containing a second composition, the second composition including a multifunctional isocyanate;

a mechanism that places the first composition into contact with the second composition thereby forming a polyurethane foam; and

a nozzle insertable into a body of a patient, the nozzle configured to permit the flow of a mixture of the first and second compositions into a body cavity of the patient;

wherein said foam is configured to control movement of bodily fluids when formed while in contact with bodily tissue;

wherein the foam is characterized by a rise time of up to 150 seconds.

2. The system of claim 1, wherein the first composition comprises up to 15 weight percent polyethylene oxide.

3. The system of claim 1, wherein said first composition comprises up to 20 pphp water.

4. The system of claim 1, wherein the polyol is selected from the group consisting of polypropylene glycol, polyethylene glycol, polycarbonate, polybutadiene, polyester, and copolymers and blends thereof.

5. The system of claim 1, wherein the isocyanate is one of hexamethylene diisocyanate (HDI), toluene diisocyanate (TDI), methylene diphenyl diisocyanate (MDI), polymeric MDI, and a mixture of MDI isomers.

6. The system of claim 1, wherein the isocyanate is selected from the group consisting of a quasi pre-polymer and a true pre-polymer.

7. The system of claim 1, wherein the first and second compositions have viscosities of between 1 and 3,000 centipoise.

8. A system for forming a medical implant to limit movement of a bodily fluid, comprising:

a first chamber containing a first composition, the first composition including a polyol;

a second chamber containing a second composition, the second composition including a multifunctional isocyanate;

a mechanism that places the first composition into contact with the second composition, thereby forming a polyurethane foam;

a nozzle insertable into a body of a patient, the nozzle configured to permit the flow of a mixture of the first and second compositions into a body cavity of the patient; and

instructions for controlling the movement of bodily fluids with the foam;

wherein the foam is characterized by a rise time of up to 150 seconds.