Implantable bioabsorbable article

• US 6,031,148 A
• Filed: 04/02/1993
• Issued: 02/29/2000
• Est. Priority Date: 12/06/1990
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: White, Charles F., Hayes, Byron Kent, Hardwick, William R., Butler, Mark D.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): REICHLE, KARIN M
• Application Number:
  US08/042,293
• Time in Patent Office: 2,524 Days
• Field of Search: 606/152, 606/154, 623/1, 623/11, 623/12, 600/37
• US Class Current: 623/11.11
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2090/0816 for preventing adhesion
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61C 8/0006 Periodontal tissue or bone regeneration support means for endoprosthetic bone substitute or bone graft implants A61F2/2846
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/2846 Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2002/30032 differing in absorbability or resorbability, i.e. in absorption or resorption time
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/003 differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 6/50 : Preparations specially adapted for dental root treatment
• CPC Class Codes: A61L 27/18 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 : Macromolecular materials
• CPC Class Codes: A61L 27/58 : Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/06 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/148 : Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 69/00 : Compositions of polycarbonates; Compositions of derivatives of polycarbonates

Abstract

An implantable bioabsorbable article for the separation and regeneration of tissue at a tissue defect site in the form of a fibrous matrix laminarly affixed to both surfaces of a cell-barrier sheet material. When implanted it allows ingrowth of tissue into the fibrous matrix side of the material; simultaneously the tissue to be regenerated at the tissue defect site is separated from the ingrowing tissue by the cell-barrier sheet material. A method for making the implantable bioabsorbable article is also described.

Claims

1. A bioabsorbable article useful for the separation and regeneration of tissue comprising:

a) a bioabsorbable, pliable, not brittle, cell-barrier polymeric sheet material being defined by a length, a width, and a thickness wherein the thickness has the smallest dimension, and wherein surfaces bounded by the length and width define first and second opposing surfaces, said first and second opposing surfaces being separated by the thickness of the sheet material;

b) a bioabsorbable fibrous matrix laminarly affixed to the first opposing surface of said bioabsorbable cell-barrier sheet material to cover at least a portion of the first opposing surface; and

c) a bioabsorbable fibrous matrix laminarly affixed to the second opposing surface of said bioabsorbable cell-barrier sheet material to cover at least a portion of the second opposing surface.

2. The article of claim 1 wherein both the cell-barrier sheet material and the fibrous matrix are comprised of a synthetic bioabsorbable material selected from the group consisting of polylactic acid, polyglycolic acid, poly-P-dioxanone, trimethylene carbonate, polycaprolactone and copolymers thereof.

3. The article of claim 2 wherein both the cell-barrier sheet material and the fibrous matrix are comprised of a copolymer of polylactic acid and polyglycolic acid.

4. The article of claim 2 wherein the cell-barrier sheet material is comprised of a copolymer of polylactic acid and polyglycolic acid and the fibrous matrix is comprised of polyglycolic acid fibers.

5. The article of claim 4 wherein the cell-barrier sheet material is comprised of a copolymer of about 50% polylactic acid and 50% polyglycolic acid.

6. The article of claim 4 wherein the cell-barrier sheet material is comprised of a copolymer of about 65% polylactic acid and 35% polyglycolic acid.

7. The article of claim 4 wherein the cell-barrier sheet material is comprised of a copolymer of about 85% polylactic acid and 15% polyglycolic acid.

8. The article of claim 1 wherein the fibrous matrix comprises a mesh of fibers in a random, unorganized configuration.

9. The article of claim 1 wherein the bioabsorbable fibrous matrix comprises a mesh of fibers in an organized configuration selected from the group consisting of threads, yarns, nets, knits, weaves, laces and felts.

10. The article of claim 1 wherein the cell-barrier sheet material is porous having a pore size small enough to substantially preclude the passage and ingrowth of tissue.

11. The article of claim 1 incorporating a suture affixed to the bioabsorbable article.

12. The article of claim 1 wherein at least a portion of the article is impregnated with a substance selected from the group consisting of antibiotics, antimicrobials, growth factors, differentiation factors and cell attachment factors.

13. A bioabsorbable article for promoting tissue regeneration, comprising a length of pliable, not brittle, bioabsorbable material having a first outer surface adapted for supporting tissue ingrowth, a second outer surface opposed to the first outer surface and adapted for supporting tissue ingrowth, the first and second outer surfaces each extending substantially the length of the bioabsorbable material, and a polymeric barrier between the first and second surfaces and extending substantially the length of the bioabsorbable material, the barrier adapted to substantially prevent tissue migration between the first and second outer surfaces.

14. The article of claim 13, wherein the length of bioabsorbable material is substantially planar in shape.

15. The article of claim 13, further comprising a suture attached to the length of bioabsorbable material.

16. A multi-layered bioabsorbable article for promoting tissue regeneration, comprising a pliable, not brittle, substantially cell-impermeable polymeric inner layer defined by a length, a width, and a thickness wherein the thickness has the smallest dimension, and wherein surfaces bounded by the length and width define first and second opposing surfaces, a first cell-permeable outer layer superposed on a first surface of the inner layer, and a second cell-permeable outer layer superposed on a second surface of the inner layer opposite the first surface so that the inner layer is positioned between and separates the first and second outer layers.

17. The article of claim 16, wherein the article is substantially planar in shape.

18. The article of claim 16, further comprising a suture attached to the article.

19. A bioabsorbable article useful for the separation and regeneration of tissue comprising:

a) a bioabsorbable, pliable, not brittle, cell-barrier sheet material being defined by a length, a width, and a thickness wherein the thickness has the smallest dimension, and wherein surfaces bounded by the length and width define first and second opposing surfaces, said first opposing surface being in a first plane and said second opposing surface being in a second plane, said planes being separated by the thickness of the sheet material;

b) a bioabsorbable fibrous matrix laminarly affixed to the first opposing surface of said bioabsorbable cell-barrier sheet material to cover at least a portion of the first opposing surface; and

c) a bioabsorbable fibrous matrix laminarly affixed to the second opposing surface of said bioabsorbable cell-barrier sheet material to cover at least a portion of the second opposing surface.

20. A bioabsorbable article for promoting tissue regeneration, comprising a length of pliable, not brittle, bioabsorbable material having a first outer surface adapted for supporting tissue ingrowth, a second outer surface opposed to the first outer surface and adapted for supporting tissue ingrowth, the first and second outer surfaces each extending substantially the length of the bioabsorbable material, and a cell barrier between the first and second surfaces and extending substantially the length of the bioabsorbable material, the barrier adapted to substantially prevent tissue migration between the first and second outer surfaces.

21. A multi-layered bioabsorbable article for promoting tissue regeneration, comprising a pliable, not brittle, substantially cell-impermeable inner layer defined by a length, a width, and a thickness wherein the thickness has the smallest dimension, and wherein surfaces bounded by the length and width define first and second opposing surfaces, a first cell-permeable outer layer superposed on a first surface of the inner layer, and a second cell-permeable outer layer superposed on a second surface of the inner layer opposite the first surface so that the inner layer is positioned between and separates the first and second outer layers.