Barrier layer

• US 9,801,913 B2
• Filed: 09/28/2005
• Issued: 10/31/2017
• Est. Priority Date: 09/28/2004
• Status: Active Grant

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Ferraro, Joseph, Rogers, Lisa, Martakos, Paul, Karwoski, Theodore, Herweck, Steve A., Faucher, Keith, McNamara, Philip
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): HELM, CARALYNNE E
• Application Number:
  US11/237,420
• Publication Number:
  US 20060078586A1
• Time in Patent Office: 4,416 Days
• Field of Search: None
• 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 barrier layer and corresponding method of making provide anti-inflammatory, non-inflammatory, and anti-adhesion functionality for a medical device implantable in a patient. The barrier layer can be combined with a medical device structure to provide anti-adhesion characteristics, in addition to improved healing, non-inflammatory, and anti-inflammatory response. The barrier layer is generally formed of a naturally occurring oil, or an oil composition formed in part of a naturally occurring oil, that is at least partially cured forming a cross-linked gel. In addition, the oil composition can include a therapeutic agent component, such as a drug or other bioactive agent.

Claims

1. An implantable medical device, comprising:

a surgical mesh structure; and

an anti-adhesion barrier layer and a biological oil barrier layer formed on at least a portion of the surgical mesh structure, wherein the anti-adhesion barrier layer comprises a cured fish oil that is hydrolysable by lipase, wherein the fish oil comprises eicosapentaenoic acid and docosahexanoic acid, wherein the cured oil comprises fatty acids and glycerides, wherein two or more of the fatty acids are cross-linked to each other by ester bonds in a substantially random configuration, wherein the anti-adhesion barrier layer is solid but flexible and serves as a physical barrier, and wherein the anti-adhesion barrier layer is bio-absorbable and degrades into non-inflammatory substances, and

wherein the biological oil barrier layer comprises uncured fish oil.

2. The device of claim 1, wherein the anti-adhesion barrier layer and the biological barrier layer each comprises at least one therapeutic agent component.

3. The device of claim 2, wherein the therapeutic agent component comprises an agent selected from the group consisting of antioxidants, anti-inflammatory agents, anti-coagulant agents, drugs to alter lipid metabolism, anti-proliferatives, anti-neoplastics, tissue growth stimulants, functional protein/factor delivery agents, anti-infective agents, imaging agents, anesthetic agents, chemotherapeutic agents, tissue absorption enhancers, anti-adhesion agents, germicides, analgesics, prodrugs, and antiseptics.

4. The device of claim 1, wherein the anti-adhesion barrier layer comprises a plurality of tiers.

5. The device of claim 1, wherein the anti-adhesion barrier layer comprises a first tier configured on the mesh structure and a second tier configured on the first tier, wherein the first tier is cured to a greater extent than the second tier.

6. The device of claim 1, wherein the anti-adhesion barrier layer comprises a first tier configured on the mesh structure and a second tier configured on the first tier, wherein the second tier is cured to a greater extent than the first tier.

7. The device of claim 1, wherein the anti-adhesion barrier layer is configured to provide controlled release of a therapeutic agent component.

8. The device of claim 1, wherein the anti-adhesion barrier layer comprises the cured fish oil in combination with at least one component selected from a group of components consisting of uncured fish oil of the biological oil barrier layer, a therapeutic agent component, a solvent, and a preservative.

9. The device of claim 1, wherein the anti-adhesion barrier layer maintains anti-inflammatory properties.

10. The device of claim 1, wherein the anti-adhesion barrier layer comprises the uncured fish oil of the biological oil barrier layer interdispersed with the cured fish oil of the anti-adhesion barrier layer, such that the anti-adhesion barrier layer forms a cured cross-linked gel and together with the uncured fish oil forms a combined biological oil barrier and anti-adhesion barrier as a single layer on the medical device.

11. The device of claim 1, wherein the anti-adhesion barrier layer is configured on one side of the mesh structure.

12. The device of claim 1, wherein the anti-adhesion barrier layer is configured on a portion of one side of the mesh structure.

13. The device of claim 1, wherein the anti-adhesion barrier layer is configured on two sides of the mesh structure.

14. The device of claim 1, wherein the anti-adhesion barrier layer and the biological oil barrier layer each further comprises one or more of alpha tocopherol, beta-tocopherol, delta-tocopherol, gamma-tocopherol, alpha-tocotrienol, beta-tocotrienol, delta-tocotrienol, gamma-tocotrienol, alpha-tocopherol acetate, beta-tocopherol acetate, gamma-tocopherol acetate, delta-tocopherol acetate, alpha-tocotrienol acetate, betatocotrienol acetate, delta-tocotrienol acetate, gamma-tocotrienol acetate, alpha-tocopherol succinate, beta-tocopherol succinate, gamma-tocopherol succinate, delta-tocopherol succinate, alpha-tocotrienol succinate, beta-tocotrienol succinate, delta-tocotrienol succinate, gammatocotrienol succinate, mixed tocopherols, vitamin E TPGS, and pharmaceutically acceptable salts thereof.

15. The device of claim 1, wherein the biological oil barrier layer is disposed on the anti-adhesion barrier layer as a top coat.

16. An implantable barrier layer device, comprising:

a biocompatible mesh structure; and

an anti-adhesion barrier layer and a biological oil barrier layer formed on at least a portion of the mesh structure so that the anti-adhesion barrier layer covers a first side of the mesh but does not completely cover the other side of the mesh, wherein the anti-adhesion barrier layer comprises a heat-cured fish oil that is hydrolysable by lipase, wherein the fish oil comprises eicosapentaenoic acid and docosahexanoic acid, wherein the cured oil comprises fatty acids and glycerides, wherein two or more of the fatty acids are cross-linked to each other by ester bonds in a substantially random configuration, wherein the anti-adhesion barrier layer is in a solid state that is flexible, and wherein the anti-adhesion barrier layer is bio-absorbable and degrades into non-inflammatory substances, and

wherein the biological oil barrier layer comprises uncured fish oil.

17. The device of claim 16, wherein the anti-adhesion barrier layer comprises at least one therapeutic agent component.

18. The device of claim 17, wherein the therapeutic agent component comprises an agent selected from the group consisting of antioxidants, anti inflammatory agents, anti-coagulant agents, drugs to alter lipid metabolism, anti-proliferatives, anti-neoplastics, tissue growth stimulants, functional protein/factor delivery agents, anti-infective agents, imaging agents, anesthetic agents, chemotherapeutic agents, tissue absorption enhancers, anti-adhesion agents, germicides, analgesics, prodrugs, and antiseptics.

19. The device of claim 16, wherein the anti-adhesion barrier layer comprises a plurality of tiers.

20. The device of claim 16, wherein the anti-adhesion barrier layer comprises a first tier configured on the mesh structure and a second tier configured on the first tier, wherein the first tier is cured to a greater extent than the second tier.

21. The device of claim 16, wherein the anti-adhesion barrier layer comprises a first tier configured on the mesh structure and a second tier configured on the first tier, wherein the second tier is cured to a greater extent than the first tier.

22. The device of claim 16, wherein the anti-adhesion barrier layer is configured to provide controlled release of a therapeutic agent component.

23. The device of claim 16, wherein the anti-adhesion barrier layer comprises the cured fish oil in combination with at least one component selected from a group of components consisting of an uncured fish oil, a therapeutic agent component, a solvent, and a preservative.

24. The device of claim 16, wherein the heat-cured fish oil of the anti-adhesion barrier layer maintains anti-inflammatory properties.

25. A barrier layer device, comprising:

a biocompatible mesh structure; and

a barrier layer formed on at least a portion of the mesh structure;

wherein the barrier layer comprises cured fish oil and uncured fish oil, wherein the cured fish oil is hydrolysable by lipase and comprises fatty acids and glycerides, wherein two or more of the fatty acids are cross-linked to each other by ester bonds in a substantially random configuration so that the barrier layer provides a biological oil barrier and a physical anti-adhesion barrier, and wherein the barrier layer degrades into non-inflammatory substances.

26. An implantable medical device, comprising:

a surgical mesh structure;

a bioabsorbable anti-adhesion barrier layer formed on at least a portion of the surgical mesh structure, wherein the barrier layer comprises a cured fish oil, wherein the fish oil comprises eicosapentaenoic acid and docosahexanoic acid, wherein the cured fish oil comprises fatty acids and glycerides, wherein the cured fish oil is hydrolysable by lipase and contains cross-linking between two or more fatty acids of the fish oil, wherein cross-linking in the anti-adhesion barrier layer is provided by ester and peroxide bonds, and wherein the anti-adhesion barrier layer is solid but flexible and serves as a physical barrier, and wherein the anti-adhesion barrier layer degrades into non-inflammatory substances comprising free fatty acids; and

a biological oil barrier layer supported by the anti-adhesion barrier layer, wherein the biological oil barrier layer comprises uncured fish oil.