Bioresorbable implant

• US 20090036997A1
• Filed: 07/30/2007
• Published: 02/05/2009
• Est. Priority Date: 07/30/2007
• Status: Active Grant

• Current Assignee: Sofradim Production SAS (Medtronic Plc)
• Original Assignee: Sofradim Production SAS (Medtronic Plc)
• Inventors: Bayon, Yves, Gravagna, Philippe, Meneghin, Alfredo, Therin, Michel
• Granted Patent: US 8,834,578 B2
• Time in Patent Office: Days
• US Class Current: 623/23.750
• CPC Class Codes: A61L 27/38 containing added animal cells organs or tissue containing native cells A61L27/36
• 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 31/005 Ingredients of undetermined constitution or reaction products thereof
• 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
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin
• CPC Class Codes: D04B 21/12 characterised by thread material
• CPC Class Codes: D10B 2403/0112 One smooth surface, e.g. laminated or coated
• CPC Class Codes: D10B 2403/0213 with apertures, e.g. with one or more mesh fabric plies
• CPC Class Codes: D10B 2509/08 Hernia repair mesh

Abstract

Bioresorbable wall reinforcement implants include a bioresorbable porous matrix based on a collagen sponge which defines first pores, a bioresorbable porous three-dimensional knit which defines second pores, with the matrix filling the knit and all the first and second pores being at least partially interconnected with one another. Tissue engineering supports including such an implant and uses thereof are also described.

Claims

1. A bioresorbable wall reinforcement implant comprising:

a bioresorbable porous matrix based on a collagen sponge which defines first pores,

a bioresorbable porous three-dimensional knit which defines second pores,

said porous matrix filling said three-dimensional knit and all the first and second pores being at least partially interconnected with one another.

2. An implant according to claim 1, wherein said collagen is a mixture of at least one collagen which undergoes slow bioresorption in vivo and at least one collagen which undergoes rapid bioresorption in vivo.

3. An implant according to claim 2, wherein the collagen which undergoes slow bioresorption in vivo is selected from the group consisting of glutaraldehyde-crosslinked collagen, bifunctional or trifunctional glycidyl ethers, carbodiimides, acyl azides and mixtures thereof.

4. An implant according to claim 2, wherein the collagen which undergoes rapid bioresorption in vivo is selected from the group consisting of oxidized collagen, glutaraldehyde-crosslinked collagen, bifunctional or trifunctional glycidyl ethers, carbodiimides, acyl azides, collagen crosslinked by UV irradiation or by heat treatment, and mixtures thereof.

5. An implant according to claim 1 wherein the collagen forming said sponge is a mixture of oxidized collagen and glutaraldehyde-crosslinked collagen.

6. An implant claim 1 wherein said three-dimensional knit consists of monofilament and/or multifilament yarns made of bioresorbable material which has an in vivo degradation time ranging from approximately 3 months to 2 years.

7. An implant according to claim 1 wherein said bioresorbable material is selected from the group consisting of poly(lactic acid) (PLA), poly(glycolic acid) (PGA), oxidized cellulose, polycaprolactone (PCL), polydiaxanone (PDO), trimethylene carbonate (TMC), polyvinyl alcohol (PVA), polyhydroxyalkanoates (PHAs), polyamides, polyethers, copolymers thereof and mixtures thereof.

8. An implant according to claim 1 wherein said second pores have an average diameter ranging from 1 to 5 mm.

9. An implant according to claim 1 wherein said knit has a two-dimensional porosity of less than or equal to 20%.

10. An implant according to claim 1 wherein said knit has a three-dimensional porosity of greater than or equal to 90%.

11. An implant according to claim 1 wherein said three-dimensional knit has a thickness ranging from approximately 2 mm to 6 mm.

12. An implant according to claim 1 wherein said three-dimensional knit comprises a first face and a second face, said first face and said second face being opposite and separated from one another by the thickness of said knit, said first face and said second face being connected to one another by a spacer made of monofilament yarns, multifilament yarns or a combination of monofilament yarns and multifilament yarns.

13. An implant according to claim 12 wherein said spacer is made of monofilament yarns.

14. An implant according to claim 12 or 13 wherein said first and second faces of the knit are made of monofilament yarns, multifilament yarns or a combination of monofilament and multifilament yarns.

15. An implant according to claim 12 wherein the monofilament or multifilament yarns used to prepare the first and second faces and the spacer of the three-dimensional knit are selected from the group consisting of yarns made of material which undergoes slow bioresorption, yarns made of material which undergoes rapid bioresorption, and mixtures thereof.

16. An implant according to claim 15 wherein the yarns made of material which undergoes slow bioresorption are made of poly(lactic acid).

17. An implant according to claim 15, wherein the yarns made of material which undergoes rapid bioresorption are selected from the group consisting of poly(glycolic acid) yarns, oxidized cellulose yarns, poly(lactic acid) yarns partially degraded by a treatment such as repeat cycles of gamma-irradiation at doses of greater than or equal to 25 kGy, and mixtures thereof.

18. An implant according to claim 13, wherein said monofilament yarns which make up said spacer consist of yarns made of material which undergoes slow bioresorption.

19. An implant according to claim 18 wherein said monofilament yarns which make up said spacer are made of poly(lactic acid).

20. An implant according to claim 15, wherein said first and second faces are made of a mixture of multifilament yarns made of material which undergoes slow bioresorption and of multifilament yarns made of material which undergoes rapid bioresorption.

21. An implant according to claim 12 wherein said first and second faces are made of poly(lactic acid) multifilament yarns.

22. An implant according to claim 1 wherein said knit is isoelastic.

23. An implant according to claim 1 wherein said knit has mechanical strength in the longitudinal direction, measured according to ISO standard 13934-1, ranging from 50 to 300 N.

24. An implant according to claim 1 wherein said knit has a mechanical strength in the transverse direction, measured according to ISO standard 13934-1, ranging from 50 to 300 N.

25. An implant according to claim 23, wherein said knit has a mechanical strength in the longitudinal direction, measured according to ISO standard 13934-1, ranging from 100 to 250 N.

26. An implant according to claim 24, wherein said knit has a mechanical strength in the transverse direction, measured according to ISO standard 13934-1, ranging from 75 to 200 N.

27. An implant according to claim 1 wherein said knit has an elongation at 50 N in the longitudinal direction, measured according to ISO standard 13934-1, ranging from 10% to 50%.

28. An implant according to claim 1 wherein said knit has an elongation at 50 N in the transverse direction, measured according to ISO standard 13934-1, ranging from 10% to 50%.

29. An implant according to claim 6 wherein at least a part of the yarns constituting said three-dimensional knit are coated with a bioresorbable coating.

30. An implant according to claim 29 wherein said coating comprises a material selected from the group consisting of collagen, chitosan, polysaccharides and mixtures thereof.

31. An implant according to claim 1 further comprising one or more active compounds selected from the group consisting of antiseptics, anti-inflammatories, growth factors, polysaccharides, extracellular matrix proteins, and mixtures thereof.

32. An implant according to claim 1 further comprising a bioresorbable film on at least one of its faces.

33. An implant according to claim 32 wherein said film comprises at least one collagen.

34. An implant according to claim 33 wherein said film comprises oxidized collagen, polyethylene glycol and glycerol.

35. An implant claim 1 that is seeded with live cells.

36. An implant according to claim 35 wherein the cells are selected from the group consisting of striated muscle cells, smooth muscle cells, endothelial cells, epithelial cells, mesothelial cells, fibroblasts, myofibroblasts, stem cells of striated muscle cells, stem cells of smooth muscle cells, stem cells of endothelial cells, stem cells of epithelial cells, stem cells of mesothelial cells, stem cells of fibroblasts, stem cells of myofibroblasts, and combinations thereof.

37. A tissue engineering support comprising at least one implant according to claim 1.

38. A support according to claim 37 that it is seeded with live cells.

39. A support according to claim 38 wherein the cells are selected from the group consisting of striated muscle cells, smooth muscle cells, endothelial cells, epithelial cells, mesothelial cells, fibroblasts, myofibroblasts, stem cells of striated muscle cells, stem cells of smooth muscle cells, stem cells of endothelial cells, stem cells of epithelial cells, stem cells of mesothelial cells, stem cells of fibroblasts, stem cells of myofibroblasts, and combinations thereof.

40. Use of an implant according to claim 1 for culturing live cells.