Implantable tissue repair device and method

• US 20040143344A1
• Filed: 12/29/2003
• Published: 07/22/2004
• Est. Priority Date: 07/16/2001
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Products Incorporated (Johnson & Johnson)
• Inventors: Schwartz, Herbert E., Malaviya, Prasanna, Whalen, Terrence David, Zannis, Anthony D., Jenks, Philip Joseph
• Granted Patent: US 7,819,918 B2
• Time in Patent Office: Days
• US Class Current: 623/23.72
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/3872 Meniscus for implantation between the natural bone surfaces
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30156 triangular
• CPC Class Codes: A61F 2002/30266 wedge-shaped parallelepipeds
• CPC Class Codes: A61F 2002/30281 wedge-shaped
• CPC Class Codes: A61F 2002/30324 differing in thickness
• CPC Class Codes: A61F 2002/30576 with extending fixation tabs
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30733 Inserts placed into an endoprosthetic cavity, e.g. for modifying a material property
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2230/0023 : triangular
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• CPC Class Codes: A61F 2230/0086 : Pyramidal, tetrahedral, or wedge-shaped
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2430/06 : for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 27/18 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/3629 : Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3633 : Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3654 : Cartilage, e.g. meniscus
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/005 : Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

An implantable tissue repair device has a cover and tissue regeneration material. The cover includes a top panel and a bottom panel joined together along a leading edge. The tissue regeneration material is positioned between the top and bottom panels. The cover includes a continuous sheet of biocompatible material extending across the edge and into the top panel and bottom panel. The cover is thicker along the leading edge than at least a portion of the top panel and thicker than at least a portion of the bottom panel. At least a portion of one of the panels covering the tissue regeneration material is thicker than a portion of the other panel covering the tissue regeneration material. A method of making the device is also disclosed.

Claims

1. An implantable tissue repair device comprising:

a cover including a top panel and a bottom panel joined together along a leading edge;

tissue regeneration material between the top and bottom panels;

wherein;

the cover includes a continuous sheet of biocompatible material extending across the edge and into the top panel and bottom panel;

the cover along the leading edge is thicker than at least a portion of the top panel and thicker than at least a portion of the bottom panel; and

at least a portion of one of the panels covering the tissue regeneration material is thicker than a portion of the other panel.

2. The implantable tissue repair device of claim 1 wherein at least part of the top panel is parallel to at least part of the bottom panel along at least part of the leading edge.

3. The implantable tissue repair device of claim 1 wherein the top panel and bottom panel are joined together along a trailing edge

4. The implantable tissue repair device of claim 1 wherein at least one of the cover and the tissue regeneration material includes a naturally occurring extracellular matrix material.

5. The implantable tissue repair device of claim 4 wherein the cover includes sheets of small intestine submucosa.

6. The implantable tissue repair device of claim 5 wherein the tissue regeneration material includes comminuted small intestine submucosa.

7. The implantable tissue repair device of claim 1 wherein the leading edge comprises a fold line.

8. The implantable tissue repair device of claim 1 wherein the device is sized and shaped to be used as a mensical implant.

9. An implantable tissue repair device comprising:

a cover including a top panel and a bottom panel joined together along a leading edge;

tissue regeneration material between the top and bottom panels;

wherein;

the cover includes a plurality of laminae of biocompatible material some of the laminae of the cover extend across the leading edge and into the top panel and bottom panel;

the cover has more laminae along the leading edge than at least a portion of the top panel and has more laminae along the leading edge than at least a portion of the bottom panel; and

at least a portion of one of the panels covering the tissue regeneration material has more laminae than a portion of the other panel.

10. The implantable tissue repair device of claim 9 wherein at least part of the top panel is parallel to at least part of the bottom panel along at least part of the leading edge.

11. The implantable tissue repair device of claim 9 wherein the top panel and bottom panel are joined together along a trailing edge

12. The implantable tissue repair device of claim 9 wherein at least one of the cover and the tissue regeneration material includes a naturally occurring extracellular matrix material.

13. The implantable tissue repair device of claim 12 wherein the laminae comprise sheets of small intestine submucosa.

14. The implantable tissue repair device of claim 13 wherein the tissue regeneration material includes small intestine submucosa.

15. The implantable tissue repair device of claim 9 wherein the leading edge comprises a fold line.

16. The implantable tissue repair device of claim 9 wherein the device is sized and shaped to be used as a mensical implant.

23. The implantable tissue repair device of claim 13 wherein the tissue regeneration material includes small intestine submucosa.

17. An implantable tissue repair device comprising:

a cover including a top panel and a bottom panel joined together along a leading edge;

tissue regeneration material between the top and bottom panels, the tissue regeneration material having a first side and a second side;

wherein;

the cover includes an outer group of laminae of biocompatible material and an inner group of laminae of biocompatible material;

the laminae of the inner group extend over the first side of the tissue regeneration material;

the laminae of the outer group extend across the leading edge, over the laminae of the inner group and over the second side of the tissue regeneration material.

18. The implantable tissue repair device of claim 17 wherein at least part of the top panel is parallel to at least part of the bottom panel along at least part of the leading edge.

19. The implantable tissue repair device of claim 17 wherein the top panel and bottom panel are joined together along a trailing edge

20. The implantable tissue repair device of claim 17 wherein at least one of the cover and the tissue regeneration material includes a naturally occurring extracellular matrix material.

21. The implantable tissue repair device of claim 20 wherein the laminae of the outer group comprise sheets of small intestine submucosa.

22. The implantable tissue repair device of claim 20 wherein the laminae of the inner group comprise sheets of small intestine submucosa.

24. The implantable tissue repair device of claim 17 wherein the leading edge comprises a fold line.

25. The implantable tissue repair device of claim 17 wherein the device is sized and shaped to be used as a mensical implant.

26. A method of making an implantable tissue repair device comprising:

providing a mold having a cavity, a surface surrounding the cavity and a groove spaced from the cavity;

placing a first sheet of biocompatible material on the surface of the mold with part of the sheet received in the cavity and part of the sheet received in the groove;

placing tissue regeneration material on the portion of the first sheet in the cavity; and

folding the first sheet along the portion in the groove to cover the tissue regeneration material with the sheet.

27. The method of claim 26 further comprising placing a second sheet of biocompatible material on top of the tissue regeneration material before folding the first sheet.

28. The method of claim 26 further comprising placing a second sheet of biocompatible material on top of the tissue regeneration material and extending over the first sheet of biocompatible material and into the groove, and wherein the folding step includes folding both the first and second sheets along the portions in the groove to cover the tissue regeneration material with both the first and second sheets so that two layers of the second sheet cover the tissue regeneration material.

29. The method of claim 26 wherein the first sheet of biocompatible material comprises a laminate.

30. The method of claim 28 wherein the second sheet of biocompatible material comprises a laminate.

31. A method of making an implantable tissue repair device comprising:

providing a mold having a cavity and a surface surrounding the cavity;

placing a first sheet of biocompatible material on the surface of the mold with part of the sheet received in the cavity;

placing tissue regeneration material on the portion of the first sheet in the cavity;

placing a second sheet of biocompatible material over the tissue regeneration material; and

folding the first sheet over the second sheet.

32. The method of claim 31 wherein:

the step of placing the second sheet of biocompatible material over the tissue regeneration material includes placing a part of the second sheet of biocompatible material over the first sheet of biocompatible material; and

the step of folding the first sheet over the second sheet includes folding a portion of the first sheet over itself.

33. The method of claim 31 wherein the first sheet comprises a laminate and the second sheet comprises a laminate.