Cured gel and method of making

• US 10,016,465 B2
• Filed: 10/10/2014
• Issued: 07/10/2018
• Est. Priority Date: 09/28/2004
• Status: Active Grant

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Labrecque, Roger, McNamara, Philip, Ferraro, Joseph, Rogers, Lisa, Martakos, Paul, Karwoski, Theodore, Herweck, Steve A., Faucher, Keith M., Swanick, Thomas M.
• Primary Examiner(s): Hartley, Michael G
• Assistant Examiner(s): EBRAHIM, NABILA G
• Application Number:
  US14/511,765
• Publication Number:
  US 20150079191A1
• Time in Patent Office: 1,369 Days
• Field of Search: 424523, 514 205
• CPC Class Codes: A61F 13/02 Adhesive bandages or dressings
• CPC Class Codes: A61F 13/023 wound covering film layers without a fluid retention layer
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 31/225 Polycarboxylic acids
• CPC Class Codes: A61K 31/355 Tocopherols, e.g. vitamin E
• CPC Class Codes: A61K 35/60 Fish, e.g. seahorses; Fish eggs
• CPC Class Codes: A61K 38/13 Cyclosporins
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/14 Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• CPC Class Codes: 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
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2/206 Ethylene oxide
• CPC Class Codes: A61L 2/208 Hydrogen peroxide
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: A61L 2300/22 Lipids, fatty acids, e.g. prostaglandins, oils, fats, waxes
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/404 : Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/41 : Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/414 : Growth factors
• CPC Class Codes: A61L 2300/42 : Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/602 : Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: 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
• CPC Class Codes: 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
• CPC Class Codes: A61L 27/52 : Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/005 : Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/145 : Hydrogels or hydrocolloids
• CPC Class Codes: B05D 3/067 : Curing or cross-linking the coating

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 get. 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 alphalinolenic acid (ALA).

Claims

1. A cured non-polymeric gel, comprising:

a plurality of non-polymeric cross-links, wherein the non-polymeric cross-links result from curing an oil or oil composition at selected curing conditions to achieve a 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, and wherein the oil or oil composition comprises one or more of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or alpha-linolenic acid (ALA),

wherein the gel is configured as a coating on a medical device or as a stand-alone film.

2. The gel of claim 1, wherein curing the gel is achieved by application of heat, UV, chemicals, or a combination including at least one of the foregoing.

3. The gel of claim 1, wherein the selected curing conditions include temperature, time, or a combination including at least one of the foregoing.

4. The gel of claim 3, wherein the selected curing conditions include a selected time duration of within a range between 24 hours and 3 days.

5. The gel of claim 3, wherein the selected curing conditions include a selected temperature of between about 150°

F. to 200°

F.

6. The gel of claim 1 further comprising a therapeutic agent, wherein the cured non-polymeric gel is configured to provide controlled release of the therapeutic agent.

7. The gel of claim 1, wherein the cross-linked gel is bio-absorbable.

8. The gel of claim 1, wherein the cross-linked gel maintains at least one property selected from a group of properties comprised of anti-inflammatory properties, non-inflammatory properties, and wound healing properties.

9. The gel of claim 1, further comprising vitamin E, or an equivalent thereof, in the oil or oil composition to be cured to decrease a degradation rate of the cured gel.

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

11. The gel of claim 1, wherein the oil or oil composition is a fish oil.