# US 10,307,515 B2 · In situ forming hemostatic foam implants

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- Number: US 10,307,515 B2
- Document ID: US10307515B2
- Status: Granted
- Kind: B2
- Application number: 14/928,857
- Filed: 2015-10-30
- Published: 2016-09-29
- Granted: 2019-06-04
- Earliest claimed: 2009-08-24
- Assignees: Arsenal Medical, Inc.
- Applicants: Arsenal Medical, Inc.
- Inventors: Upma Sharma; Irina Gitlin; Gregory T. Zugates; Adam Rago; Parisa Zamiri; Rany Busold; Robert J. Caulkins; Toby Freyman; Quynh Pham; Changcheng You; Jeffrey Carbeck
- Web page: https://patentgrep.com/patent/US10307515B2

## CPC

- A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)}
- A61B 17/12031: {complete occlusion}
- A61B 17/12163: {having a string of elements connected to each other}
- A61B 17/12186: {liquid materials adapted to be injected}
- A61J 1/2093: {Containers having several compartments for products to be mixed}
- A61L 24/001: {Use of materials characterised by their function or physical properties}
- A61L 24/0036: {Porous materials, e.g. foams or sponges}
- A61L 24/0042: {Materials resorbable by the body}
- A61L 24/046: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds (A61L24/043 takes precedence)}
- A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/56: Porous materials, {e.g. foams or sponges}
- A61L 27/58: Materials at least partially resorbable by the body
- A61L 31/141: {Plasticizers}
- A61L 31/146: {Porous materials, e.g. foams or sponges}
- A61L 31/148: {Materials at least partially resorbable by the body}
- 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)
- C08L 63/00: Compositions of epoxy resins; Compositions of derivatives of epoxy resins
- C08L 67/04: Polyesters derived from hydroxycarboxylic acids, e.g. lactones (C08L67/06 takes precedence)
- A61B 2017/12004: {for haemostasis, for prevention of bleeding}
- A61L 2400/04: Materials for stopping bleeding
- A61L 2400/06: Flowable or injectable implant compositions
- A61L 2400/18: Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)

## 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

### Claim 1

A system for forming a medical implant to limit movement of a bodily fluid, comprising:
a first composition comprising, a polyol;
a second composition comprising, a multifunctional isocyanate, the second composition being physically separated from the first composition;
a mechanism that places the first composition into contact with the second composition, thereby forming an elastomeric polyurethane foam; and
a device insertable into a body of a patient, the device configured to permit the flow of a mixture of the first and second compositions into a body cavity of the patient, wherein said elastomeric polyurethane foam undergoes greater than 12 times expansion.

### Claim 2 (depends on 1)

The system of claim 1, wherein the first composition comprises up to 50 weight percent polyethylene oxide.

### Claim 3 (depends on 2)

The system of claim 2, wherein the first composition comprises up to 25 weight percent polyethylene oxide.

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 1)

The system of claim 1, wherein the first composition includes an amine catalyst in an amount up to 10 pphp.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 1)

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.