Barrier layer with underlying medical device and one or more reinforcing support structures

• US 9,492,596 B2
• Filed: 02/02/2007
• Issued: 11/15/2016
• Est. Priority Date: 11/06/2006
• 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): Tran, Susan
• Assistant Examiner(s): CRAIGO, WILLIAM A
• Application Number:
  US11/701,799
• Publication Number:
  US 20080109017A1
• Time in Patent Office: 3,574 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues of bone tissue onto implantable joints A61F2002/3093
• CPC Class Codes: A61F 2002/009 for hindering or preventing attachment of biological tissue of bone tissue onto implantable joints A61F2002/30932
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A barrier layer device is formed of an underlying biocompatible structure having a barrier layer coating 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. As implemented herein, the barrier layer is a non-polymeric cross-linked gel derived at least in part from a fatty acid compound, and may include a therapeutic agent. The underlying structure can be in the form of a surgical mesh. The barrier device is further provided with anchoring reinforcements to aid with the fastening of the barrier device for implantation purposes and reinforcing truss sections or portions that prohibit or substantially reduce the occurrence of excessive stretching and tearing. 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. A barrier layer device comprising:

a generally flexible base surgical mesh sheet structure having a perimeter;

at least one anchoring support element formed as a first additional layer of mesh material disposed on the base surgical mesh sheet structure at a location on the perimeter and configured to receive insertion of anchors therethrough when anchoring the device with anchors, wherein the at least one anchoring support element reinforces the location on the perimeter;

at least one reinforcing support truss structure formed as a second additional layer of mesh material disposed on the base surgical mesh sheet support structure at a location not on the perimeter, wherein the support truss structure extends over less area than the base surgical mesh sheet structure, and wherein the at least one reinforcing support truss structure reinforces the location that is not on the perimeter; and

a non-polymeric barrier layer comprising an at least partially cured and cross-linked gel, wherein the at least partially cured and cross-linked gel comprises an oil composition that includes components selected from one or more of fatty acids, glycerol and glycerides, wherein the at least partially cured and cross-linked gel includes one or more ester bonds between the components selected from fatty acids, glycerol and glycerides, and wherein the non-polymeric barrier layer is at least partially located between the base surgical mesh and each of the at least one anchoring support element and the at least one reinforcing support truss structure such that the at least one anchoring support element and the at least one reinforcing support truss structure are encapsulated in the non-polymeric barrier layer and the non-polymeric barrier layer forms a layer on a top side of the barrier layer device and a layer on a bottom side of the barrier layer device, wherein the layer on the top side is thinner than the layer on the bottom side and the layer on the top side has a rougher finish than the layer on the bottom side.

2. The device of claim 1, wherein the barrier layer is configured on two sides of the surgical mesh sheet structure.

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

4. A barrier layer device, comprising:

a generally flexible base surgical mesh sheet structure having a perimeter and a pair of opposing surfaces each defined by a surface area;

at least one anchoring support element formed as an additional layer of material disposed on either surface of the base surgical mesh sheet structure at at least one first location located near or following the perimeter and suitable for receiving insertion of anchors therethrough when anchoring the device with the anchors, the at least one anchoring support element adapted to reinforce the at least one first location, the at least one anchoring support element covering at most about sixty percent of the surface area of either surface of the base surgical mesh sheet structure;

at least one reinforcing support truss structure disposed on either surface of the base surgical mesh sheet structure at at least one second location that is located interior to the at least one first location and different than the at least one first location, wherein the support truss structure and the anchoring support element together occupy less area than the surface area of either surface of the base surgical mesh sheet structure; and

a non-polymeric barrier layer encapsulating at least a portion of the base surgical mesh sheet structure, the at least one anchoring support element, and the at least one reinforcing support truss structure, so as to provide a smoothing transition between the at least one anchoring support element and the portion of the base surgical mesh and a smoothing transition between the at least one reinforcing support truss structure and the portion of the base surgical mesh, wherein the smoothing transition between the at least one anchoring support element and the portion of the base surgical mesh fills in a step between the at least one anchoring support element and the portion of the base surgical mesh, and the smoothing transition between the at least one reinforcing support truss structure and the portion of the base surgical mesh fills in a step between the at least one reinforcing support truss structure and the portion of the base surgical mesh;

wherein the barrier layer is formed of a cured, or at least partially cured, oil composition that comprises fish oil having at least one fatty acid compound, wherein the cured oil composition forms a cross-linked gel comprising one or more ester bonds between the fatty acids, glycerol and glycerides.

5. The device of claim 4, wherein at least one end of the at least one reinforcing support truss structure contacts the perimeter.

6. The device of claim 4, wherein the at least one reinforcing support truss structure does not contact the perimeter.

7. The device of claim 4, wherein the at least one reinforcing support truss structure comprises a biocompatible mesh.

8. The device of claim 4, wherein the generally flexible base surgical mesh sheet structure is comprised of a first mesh and a second mesh sheet structure coupled together forming a seam.

9. The device of claim 8, wherein the at least one reinforcing support truss structure is coupled to the first and second base surgical mesh sheet structures straddling the seam.

10. The device of claim 4, wherein the base surgical mesh sheet structure comprises a first mesh sheet structure and a second mesh sheet structure, wherein the first and second mesh sheet structures are coupled to the at least one reinforcing support truss structure.

11. The device of claim 4, wherein the barrier layer generates a modulated healing effect on injured tissue contacting the barrier layer upon implantation.

12. The device of claim 4, wherein the barrier layer comprises a physical adhesion-limiting barrier.

13. The device of claim 4, wherein the barrier layer comprises at least one therapeutic agent component.

14. The device of claim 13, 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, adhesion-limiting agents, germicides, analgesics, prodrugs, and antiseptics.

15. The device of claim 4, wherein the barrier layer further comprises at least one component selected from a group of components consisting of an additional oil component, a therapeutic agent component, a solvent, and a preservative.

16. The device of claim 4, wherein the barrier layer is bio-absorbable.

17. The device of claim 4, wherein the barrier layer maintains anti-inflammatory properties.

18. The device of claim 4, further comprising at least a second reinforcing support truss structure disposed on the surface of the base surgical mesh sheet structure.

19. The device of claim 4, where the at least one reinforcing support truss structure maintains a structurally different mesh pattern from the base surgical mesh sheet structure.

20. The barrier layer device of claim 4, wherein the non-polymeric barrier layer forms a layer on a top side of the barrier layer device and a layer on a bottom side of the barrier layer device, wherein the layer on the top side is thinner than the layer on the bottom side.

21. The barrier layer device of claim 20, wherein the layer on the top side has a rougher finish than the layer on the bottom side.

22. The barrier layer device of claim 4, wherein the barrier layer further comprises a vitamin E compound.

23. The barrier layer device of claim 4, wherein the at least one anchoring support element and the at least one reinforcing support truss structure are formed of a different material from that of the base surgical mesh sheet structure.

24. The barrier device of claim 23, wherein the at least one anchoring support element and the at least one reinforcing support truss structure are offset from the base surgical mesh sheet structure.