# US 10,869,902 B2 · Cured gel and method of making

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- Number: US 10,869,902 B2
- Document ID: US10869902B2
- Status: Granted
- Kind: B2
- Application number: 15/841,993
- Filed: 2017-12-14
- Published: 2018-07-19
- Granted: 2020-12-22
- Earliest claimed: 2004-09-28
- Assignees: Atrium Medical Corporation
- Applicants: Atrium Medical Corporation
- Inventors: Roger Labrecque; Philip McNamara; Joseph Ferraro; Lisa Rogers; Paul Martakos; Theodore Karwoski; Steve A. Herweck; Keith M. Faucher; Thomas M. Swanick
- Web page: https://patentgrep.com/patent/US10869902B2

## CPC

- A61K 35/60: Fish, e.g. seahorses; Fish eggs
- A61F 13/02: Adhesive bandages or dressings
- A61F 13/023: {wound covering film layers without a fluid retention layer}
- A61K 9/0024: {Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue (compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L)}
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 31/225: Polycarboxylic acids
- A61K 31/355: Tocopherols, e.g. vitamin E
- A61K 38/13: Cyclosporins
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61L 2/07: Steam
- A61L 2/081: Gamma radiation
- A61L 2/087: Particle radiation, e.g. electron-beam, alpha or beta radiation
- A61L 2/206: Ethylene oxide
- A61L 2/208: Hydrogen peroxide
- A61L 27/36: containing ingredients of undetermined constitution or reaction products thereof {, e.g. transplant tissue, natural bone, extracellular matrix (isolated natural compounds, e.g. collagen A61L27/24)}
- A61L 27/3604: {characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel}
- A61L 27/52: Hydrogels or hydrocolloids
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 31/005: {Ingredients of undetermined constitution or reaction products thereof}
- A61L 31/10: Macromolecular materials
- A61L 31/145: {Hydrogels or hydrocolloids}
- A61F 2/06: Blood vessels
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps
- A61L 2300/22: Lipids, fatty acids, e.g. prostaglandins, oils, fats, waxes
- A61L 2300/252: Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
- A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents
- A61L 2300/41: Anti-inflammatory agents, e.g. NSAIDs
- A61L 2300/414: Growth factors
- A61L 2300/42: Anti-thrombotic agents, anticoagulants, anti-platelet agents
- A61L 2300/602: Type of release, e.g. controlled, sustained, slow
- B05D 3/067: {Curing or cross-linking the coating}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- 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)
- B05D: PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL (conveying articles or workpieces through baths of liquid B65G, e.g. B65G49/02)

## Abstract

A cured non-polymeric gel including a plurality of non-polymeric cross-links. The non-polymeric cross-links result from curing an oil or oil composition at selected curing conditions to achieve a desired amount of cross-linking to form the non-polymeric gel. The desired amount of cross-linking is selected based on a desired rate of degradation of the gel after the gel is implanted. The oil or oil composition comprises one or more of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or alpha-linolenic acid (ALA).

## Claims

### Claim 1

A method of forming a cured non-polymeric gel, comprising:
determining a desired amount of non-polymeric cross-linking desired within an oil or oil composition, the oil or oil composition comprising one or more of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or alpha-linolenic acid (ALA); and
curing the oil or oil composition with selected curing conditions to achieve a sufficient amount of non-polymeric cross-linking within the oil or oil composition, so as to form the non-polymeric gel, wherein the cured non-polymeric gel comprises a plurality of non-polymeric cross-links resulting from curing the oil or oil composition at the selected curing conditions to achieve the sufficient amount of cross-linking to form the cured non-polymeric gel, wherein the amount of cross-linking is selected based on a desired rate of degradation of the gel after the gel is implanted within a patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein the gel further comprises at least one therapeutic agent and the method further comprises releasing the therapeutic agent from the gel at a predetermined rate determined by the curing at the selected curing conditions.

### Claim 3 (depends on 1)

The method of claim 1, wherein the oil or oil composition comprises at least one component selected from a group of components consisting of fatty acids, monoglycerides, diglycerides, triglycerides, free fatty acids, and esters of fatty acids.

### Claim 4 (depends on 1)

The method of claim 1, wherein the determining comprises selecting the amount of cross-linking based on a desired rate of degradation of the gel following implantation.

### Claim 5 (depends on 1)

The method of claim 1, further comprising applying heat: at a selected temperature, for a selected time duration, until a desired viscosity is obtained.

### Claim 6 (depends on 5)

The method of claim 5, wherein applying heat includes applying heat at the selected temperature, and the selected temperature is relatively higher if more cross-linking is desired and relatively lower if less cross-linking is desired.

### Claim 7 (depends on 5)

The method of claim 5, wherein applying heat includes applying heat at the selected time duration, and the selected time duration is relatively longer if more cross-linking is desired and relatively shorter if less cross-linking is desired.

### Claim 8 (depends on 5)

The method of claim 5, wherein the oil or oil composition is configured such that curing at a relatively greater temperature for a relatively lesser amount of time results in a greater amount of cross-linking within the oil or oil composition than curing at a relatively lesser temperature for a relatively greater amount of time.

### Claim 9 (depends on 1)

The method of claim 1, wherein a relatively lesser amount of cross-links provides a relatively faster rate of degradation of the gel, while a relatively greater amount of cross-links provides a relatively slower rate of degradation of the gel.

### Claim 10 (depends on 1)

The method of claim 1, wherein curing the gel is achieved by applying heat, UV, or a combination of applying heat and UV.

### Claim 11 (depends on 1)

The method of claim 1, wherein degradation of the gel is via hydrolysis.