Dural repair material

• US 8,932,619 B2
• Filed: 06/27/2007
• Issued: 01/13/2015
• Est. Priority Date: 06/27/2007
• Status: Active Grant

• Current Assignee: Sofradim Production SAS (Medtronic Plc)
• Original Assignee: Sofradim Production
• Inventors: Ladet, Sebastien, Gravagna, Philippe, Bayon, Yves
• Primary Examiner(s): Sasan, Aradhana
• Assistant Examiner(s): AL-AWADI, DANAH J
• Application Number:
  US11/823,275
• Publication Number:
  US 20090004239A1
• Time in Patent Office: 2,757 Days
• Field of Search: None
• US Class Current: 424/423
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body

Abstract

Multilayer structures including a porous layer and a non-porous layer having a reinforcement member are useful as dural repair materials.

Claims

1. A dural repair material comprising a foam layer comprising a mixture of oxidized collagen and glutaraldehyde crosslinked collagen joined to a non-porous film comprising crosslinked, oxidized collagen, and a mesh reinforcement member embedded within the non-porous film, wherein the mixture comprises a ratio of concentration of the oxidized collagen and glutaraldehyde crosslinked collagen between 1:

1 and 1;

5.

4. The dural repair material of any of claims 1, 2 or 3 further comprising a bioactive agent.

5. The dural repair material of claim 1, wherein the mesh reinforcement member is produced from a bioabsorbable material.

6. The dural repair material of claim 1, wherein the non-porous layer comprises 0.1% to 1% (w/w) of non-heated oxidized collagen.

7. The dural repair material of claim 1, wherein the non-porous layer comprises 0.1% to 6% (w/w) of heated oxidized collagen.

15. The dural repair material of claim 1, wherein the foam layer is calendared.

2. A dural repair material comprising a porous layer comprising a mixture of oxidized collagen and glutaraldehyde crosslinked collagen joined to a non-porous layer comprising crosslinked, oxidized collagen and containing at least one mesh reinforcement member embedded within the non-porous layer, wherein the mixture comprises a ratio of concentration of the oxidized collagen and glutaraldehyde crosslinked collagen between 1:

1 and 1;

5.

8. The dural repair material of claim 2, wherein the mesh reinforcement member is produced from a bioabsorbable material.

9. The dural repair material of claim 2, wherein the non-porous layer comprises 0.1% to 1% (w/w) of non-heated oxidized collagen.

10. The dural repair material of claim 2, wherein the non-porous layer comprises 0.1% to 6% (w/w) of heated oxidized collagen.

16. The dural repair material of claim 2, wherein the porous layer is calendered.

3. A dural repair material comprising a porous layer comprising a mixture of oxidized collagen and glutaraldehyde crosslinked collagen sandwiched between a mesh reinforced non-porous layer comprising crosslinked, oxidized collagen and a second non-porous layer comprising a collagenic constituent, wherein the mixture comprises a ratio of concentration of the oxidized collagen and glutaraldehyde crosslinked collagen between 1:

1 and 1;

5.

11. The dural repair material of claim 3, wherein the mesh reinforcement member is produced from a bioabsorbable material.

12. The dural repair material of claim 3, wherein the mesh reinforced non-porous layer comprises 0.1% to 1% (w/w) of non-heated oxidized collagen.

13. The dural repair material of claim 3, wherein the mesh reinforced non-porous layer comprises 0.1% to 6% (w/w) of heated oxidized collagen.

14. The dural repair material of claim 3, wherein the second non-porous layer is formed from a mixture of oxidized collagen and glutaraldehyde crosslinked collagen.

17. The dural repair material of claim 3, wherein the porous layer is calendered.