# US 10,765,781 B2 · In situ forming hemostatic foam implants

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- Number: US 10,765,781 B2
- Document ID: US10765781B2
- Status: Granted
- Kind: B2
- Application number: 15/642,968
- Filed: 2017-07-06
- Published: 2018-03-08
- Granted: 2020-09-08
- 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; Toby Freyman; Robert J. Caulkins; Quynh P Pham; Changcheng You; Jeffrey D. Carbeck
- Web page: https://patentgrep.com/patent/US10765781B2

## 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 method of treating a patient by forming a polymer foam within a body cavity of the patient to control movement of a bodily fluid, comprising:
placing a synthetic hydrophobic material into a body cavity of a living subject;
foaming the hydrophobic polymer material while within the body cavity to form a foam; and
limiting movement of a bodily fluid with the foam relative to an amount of movement of bodily fluid that would occur in the absence of the foam;
wherein the step of foaming the hydrophobic polymer material comprises reaction of the hydrophobic polymer material with the water of a water-containing environment within the body cavity, wherein the reaction includes the generation of CO2 gas, said CO2 gas expanding the hydrophobic polymer material more than 12-fold and forcing the hydrophobic polymer material into an interstitial area of the body cavity.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the hydrophobic polymer material is cross-linked by a reagent that comprises CO2 groups or a reagent that comprises isocyanate groups.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the hydrophobic polymer material contains CO2 producing groups or isocyanate groups.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the molecular weight of the foam is between about 1000 and 10,000 g/mol.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the foam has a modulus of between about 0.05 MPa and about 500 MPa.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the foam limits movement of a bodily fluid for at least 3 hours.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the foam is biodegradable.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the foam comprises a polyester.

### Claim 9 (depends on 8)

The method according to claim 8, wherein the polymer material comprises an isocyanate-functionalized poly(glycerol-sebacate).

### Claim 10 (depends on 8)

The method according to claim 8, further comprising incorporating a drug into the foam.

### Claim 11 (depends on 8)

The method of claim 8, wherein the hydrophobic polymer material comprises a contrast agent.

### Claim 12 (depends on 1)

The method according to claim 1, wherein the foam comprises a poly alpha-hydroxy acid.

### Claim 13 (depends on 1)

The method of claim 1, wherein the hydrophobic polymer material comprises a contrast agent.

### Claim 14 (depends on 1)

The method of claim 1, wherein the synthetic hydrophobic polymer material is injected into a wound cavity.