# US 2018/0008650 A1 · Barrier layer

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- Number: US 2018/0008650 A1
- Document ID: US20180008650A1
- Status: Published application
- Kind: A1
- Application number: 15/710,514
- Filed: 2017-09-20
- Published: 2018-01-11
- Earliest claimed: 2004-09-28
- Assignees: Atrium Medical Corporation
- Applicants: Atrium Medical Corporation
- Inventors: Joseph FERRARO; Lisa ROGERS; Paul MARTAKOS; Theodore KARWOSKI; Steve HERWECK; Keith FAUCHER; Phillip MCNAMARA
- Web page: https://patentgrep.com/patent/US20180008650A1

## 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 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

### Claim at position 1

1-45. (canceled)

### Claim 46

A method of making a barrier layer device, the method comprising the steps of:
providing a medical device structure; and
creating a barrier layer formed on at least a portion of the medical device structure; wherein the barrier layer is formed of a biological oil or oil composition comprising a cured fish oil, wherein the cured fish 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 barrier layer is solid but flexible and serves as a physical barrier, and wherein the barrier layer degrades into non-inflammatory substances.

### Claim 47 (depends on 46)

The method of claim 46, wherein creating the barrier layer comprises:
providing a biological oil or oil composition;
applying the oil or oil composition to the medical device structure; and
curing the oil or oil composition on the medical device structure to form the barrier layer.

### Claim 48 (depends on 47)

The method of claim 47, further comprising partially curing the biological oil or oil composition prior to applying the oil or oil composition to the medical device structure to thicken the oil or oil composition.

### Claim 49 (depends on 46)

The method of claim 46, further comprising applying the oil or oil composition using multiple tiers.

### Claim 50 (depends on 46)

The method of claim 46, further comprising applying an additional tier of oil or oil composition after curing the oil or oil composition on the medical device.

### Claim 51 (depends on 46)

The method of claim 46, wherein the cross-linked gel is derived from at least one fatty acid compound.

### Claim 52 (depends on 46)

The method of claim 46, wherein the barrier layer comprises at least one type of layer selected from a group of layers comprising a biological oil barrier and a physical anti-adhesion barrier.

### Claim 53 (depends on 46)

The method of claim 46, further comprising adding at least one therapeutic agent to the barrier layer.

### Claim 54 (depends on 46)

The method of claim 46, wherein the barrier layer comprises a first tier configured on the medical device structure and a second tier configured on the first tier, wherein the first tier is cured to a greater extent than the second tier.

### Claim 55 (depends on 46)

The method of claim 46, wherein the barrier layer comprises a first tier configured on the medical device structure and a second tier configured on the first tier, wherein the second tier is cured to a greater extent than the first tier.

### Claim 56 (depends on 46)

The method of claim 46, wherein the barrier layer is configured to provide controlled release of a therapeutic agent component.

### Claim 57 (depends on 46)

The method of claim 46, wherein the barrier layer is bio-absorbable.

### Claim 58 (depends on 46)

The method of claim 46, wherein the biological oil barrier layer maintains anti-inflammatory properties.

### Claim 59 (depends on 46)

The method of claim 46, wherein the barrier layer further comprises alpha tocopherol or a derivative or analog thereof.

### Claim 60 (depends on 46)

The method of claim 46, wherein the medical device comprises a biocompatible mesh.

### Claim 61 (depends on 46)

The method of claim 46, wherein curing comprises applying a curing mechanism selected from a group of curing mechanisms consisting of heat and UV light, chemical means, and reactive gases.

### Claim 62 (depends on 46)

The method of claim 46, further comprising sterilizing the barrier layer and medical device with a method of sterilization selected from a group of methods of sterilization consisting of ethylene oxide, gamma radiation, e-beam, steam, gas plasma, and vaporized hydrogen peroxide (VHP).