Implantable barrier device

• US 9,801,982 B2
• Filed: 03/10/2008
• 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: Herweck, Steve A., Ferraro, Joseph, Martakos, Paul, Karwoski, Theodore, Horton, Anthony Richard
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): HELM, CARALYNNE E
• Application Number:
  US12/075,223
• Publication Number:
  US 20080206305A1
• Time in Patent Office: 3,522 Days
• Field of Search: None
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• 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: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids

Abstract

A barrier device is formed of a barrier component that can exhibit anti-inflammatory properties, non-inflammatory properties, and/or adhesion-limiting properties, as well as generate a modulated healing effect on injured tissue. The barrier component can be a non-polymeric cross-linked gel derived at least in part from a fatty acid compound, and may include a therapeutic agent. The barrier device can have anchoring locations to provide an area on the barrier device to interface with an anchoring mechanism. The anchoring locations can include openings and/or anchor elements. The barrier device can also include truss structures that provide additional strength to the barrier component. The barrier device is implantable in a patient for short term or long term applications, and can include controlled release of the therapeutic agent.

Claims

1. An implantable medical barrier device, comprising:

a barrier component having a perimeter defined by at least one pair of opposing edges, and a surface extending between the opposing edges, the barrier component comprising 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 fatty acids are reversibly cross-linked to each other in a substantially random configuration to form a three dimensional hydrolytically degradable network, and wherein the barrier component is bio-absorbable and breaks down in vivo into non-inflammatory substances consumable by tissue cells; and

an anchoring location formed at least one of on, in, or about the surface of the barrier component and comprising a biocompatible mesh, the at least one anchoring location occupying a first area that is less than an area of the barrier component.

2. The device of claim 1, wherein the biocompatible mesh facilitates an anchoring of the barrier device to an anatomical area.

3. The device of claim 1, wherein the biocompatible mesh is disposed along a perimeter of the barrier component.

4. The device of claim 3, wherein the biocompatible mesh forms a continuous frame along the perimeter of the barrier component.

5. The device of claim 1, wherein the barrier component has a non-circular shape.

6. The device of claim 1, wherein the cured fish oil is a partially cured fish oil.

7. The device of claim 1, wherein the barrier component comprises at least one therapeutic agent component.

8. The device of claim 7, 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.

9. The device of claim 1, wherein the barrier component comprises a plurality of tiers.

10. The device of claim 9, wherein the barrier component comprises a first tier and a second tier configured on the first tier, wherein the first tier is cured to a greater extent than the second tier.

11. The device of claim 1, wherein the barrier component comprises an oil composition that includes fish oil in combination with at least one component selected from the group consisting of an additional oil component, a therapeutic agent component, a solvent, and a preservative.

12. The device of claim 1, wherein the barrier component further comprises alpha tocopherol or a derivative or analog thereof.

13. The device of claim 1, wherein the device is configured for implantation in a bowel region.

14. The device of claim 1, wherein the barrier component has a circular shape.

15. The device of claim 1, wherein the barrier component is a standalone film that is completely absorbed into surrounding tissue.

16. An implantable medical barrier layer device, comprising:

a barrier component having a perimeter defined by at least one pair of opposing edges, and a surface extending between the opposing edges, the barrier component comprising 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 fatty acids are cross-linked to each other in a substantially random configuration to provide a three-dimensional hydrolytically degradable network of a bio-absorbable and anti-adhesive film, and wherein the barrier component breaks down in vivo into non-inflammatory substances consumable by tissue cells;

at least one anchor element coupled to the barrier component, the at least one anchor element comprising a biocompatible material and having an area that is less than the area of the barrier component to provide an anchoring location on the barrier device for anchoring the barrier layer to an anatomical area; and

a truss structure that extends across a non-perimeter portion of the surface between the opposing edges of the barrier component and toward the perimeter of the barrier component to provide additional support to the barrier component;

wherein the truss structure contacts the perimeter.

17. The device of claim 16, wherein the truss structure comprises a biocompatible material.

18. The device of claim 16, wherein the barrier component is a standalone film that is completely absorbed into surrounding tissue.

19. An implantable medical barrier device, comprising:

a standalone film having a perimeter defined by at least one pair of opposing edges, and a gliding surface extending between the opposing edges, wherein the standalone film comprises a cured fish oil having cross-linked fatty acids, wherein the standalone film is bio-absorbable and breaks down in vivo into non-inflammatory substances consumable by tissue cells so that the standalone film is completely absorbed; and

an anchoring location formed on the gliding surface of the standalone film, or in the gliding surface of the standalone film, or on and in the gliding surface of the standalone film, wherein the at least one anchoring location occupies a first area that is less than a total area of the standalone film.

20. The device of claim 19, wherein the cured fish oil forming the standalone film modulates healing so that substantially no fibrous capsule forms on the standalone film during healing.

21. The device of claim 19, wherein the anchoring location comprises a biocompatible mesh at least partially encapsulated by the standalone film.

22. The device of claim 21, further comprising:

a truss structure that extends across a non-perimeter portion of the surface between the opposing edges of the standalone film and toward the perimeter of the standalone film to provide additional support to the standalone film, wherein the truss structure contacts the perimeter.

23. The device of claim 19, wherein the anchoring location comprises an opening formed through the standalone film.