CONFORMABLE TISSUE REPAIR IMPLANT CAPABLE OF INJECTION DELIVERY

• US 20110097381A1
• Filed: 12/29/2010
• Published: 04/28/2011
• Est. Priority Date: 11/26/2003
• Status: Active Grant

• Current Assignee: DePuy Mitek Incorporated (Johnson & Johnson)
• Original Assignee: DePuy Mitek Incorporated (Johnson & Johnson)
• Inventors: Binette, Francois, Mukhopadhyay, Krish, Rosenblatt, Joel, Hammer, Joseph J.
• Granted Patent: US 8,137,702 B2
• Time in Patent Office: Days
• US Class Current: 424/426
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/38 containing added animal cells organs or tissue containing native cells A61L27/36
• CPC Class Codes: A61L 27/3852 Cartilage, e.g. meniscus
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/04 for non-specific disorders of the connective tissue
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 39/06 Free radical scavengers or antioxidants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

Abstract

A conformable tissue implant is provided for use in repairing or augmenting a tissue defect or injury site. The tissue implant contains a tissue carrier matrix comprising a plurality of biocompatible, bioresorbable granules and at least one tissue fragment in association with the granules. The tissue fragment contains one or more viable cells that can migrate from the tissue and populate the tissue carrier matrix. Also provided is a method for injectably delivering the tissue implant.

Claims

1-43. -43. (canceled)

44. A tissue repair implant comprising:

a tissue carrier matrix in the form of an injectable suspension, the tissue carrier matrix comprising a plurality of biocompatible, bioresorbable granules and at least one tissue fragment in association with the tissue carrier matrix, the at least one tissue fragment having an effective amount of viable cells that can migrate out of the tissue fragment and populate the tissue carrier matrix, and the granules having an average outer diameter in a range of about 150 to about 300 μ

m.

45. The implant of claim 44, wherein the granules comprise at least one of aliphatic polyesters, copoly(ether-esters), solid copolymers of fatty acid esters of glycerol and succinic acid, polyoxaesters, collagen, gelatin, albumin, hyaluronate, glycosaminoglycans, polyanhydrides, polysaccharides, polyphosphazines, subintestinal mucosa, and acellular tissues.

46. The implant of claim 44, wherein the at least one tissue fragment has a particle size in the range of about 0.1 to about 2 mm³.

47. The implant of claim 44, wherein the at least one tissue fragment is obtained from a connective tissue type selected from the group consisting of cartilage, meniscus, tendon, ligament, dermis, bone, fat, synovial tissue, muscle tissue, and combinations thereof.

48. The implant of claim 44, wherein the tissue carrier matrix comprises at least one of a proteoglycan, heparan sulfate, heparin, chondroitin sulfate, dermatan sulfate, keratan sulfate, and hyaluronan.

49. The implant of claim 44, wherein the at least one tissue fragment comprises a tissue selected from the group consisting of autogeneic tissue, allogeneic tissue, xenogeneic tissue, and combinations thereof.

50. The implant of claim 44, wherein the granules comprise an aliphatic polyester selected from the group consisting of homopolymers or copolymers of lactides, glycolides, ε

-caprolactone, p-dioxanone (1,4-dioxan-2-one), trimethylene carbonate (1,3-dioxan-2-one), and combinations thereof.

51. The implant of claim 44, wherein the at least one tissue fragment is not contained within the granules.

52. The implant of claim 44, wherein the tissue carrier matrix further comprises at least one biological component selected from the group consisting of antibiotics, antimicrobial agents, anti-inflammatory agents, growth factors, growth factor fragments, small-molecule wound healing stimulants, hormones, cytokines, proteins, peptides, antibodies, enzymes, isolated cells, glycosaminoglycans, immunosuppressants, nucleic acids, analgesics, platelets an activator of platelets, viruses, virus particles, and combinations thereof.

53. The implant of claim 52, wherein the at least one biological component is an isolated cell selected from the group consisting of osteocytes, fibroblasts, stem cells, pluripotent cells, chondrocyte progenitors, chondrocytes, osteoclasts, osteoblasts, endothelial cells, macrophages, adipocytes, monocytes, plasma cells, mast cells, umbilical cord cells, leukocytes, stromal cells, mesenchymal stem cells, epithelial cells, myoblasts, tenocytes, ligament fibroblasts, and bone marrow cells.

54. A tissue repair implant comprising:

a tissue carrier matrix in the form of an injectable suspension, the tissue carrier matrix comprising a plurality of biocompatible, bioresorbable granules and at least one tissue fragment in association with the tissue carrier matrix, the at least one tissue fragment having an effective amount of viable cells that can migrate out of the tissue fragment and populate the tissue carrier matrix, the at least one tissue fragment having a particle size in the range of about 0.1 to about 2 mm³.

55. The implant of claim 54, wherein the granules comprise at least one of aliphatic polyesters, copoly(ether-esters), solid copolymers of fatty acid esters of glycerol and succinic acid, polyoxaesters, collagen, gelatin, albumin, hyaluronate, glycosaminoglycans, polyanhydrides, polysaccharides, polyphosphazines, subintestinal mucosa, and acellular tissues.

56. The implant of claim 54, wherein each of the plurality of granules have an average outer diameter in a range of about 150 to about 300 μ

m.

57. The implant of claim 54, wherein the at least one tissue fragment is obtained from a connective tissue type selected from the group consisting of cartilage, meniscus, tendon, ligament, dermis, bone, fat, synovial tissue, muscle tissue, and combinations thereof.

58. The implant of claim 54, wherein the tissue carrier matrix comprises at least one of a proteoglycan, heparan sulfate, heparin, chondroitin sulfate, dermatan sulfate, keratan sulfate, and hyaluronan.

59. The implant of claim 54, wherein the at least one tissue fragment comprises a tissue selected from the group consisting of autogeneic tissue, allogeneic tissue, xenogeneic tissue, and combinations thereof.

60. The implant of claim 54, wherein the granules comprise an aliphatic polyester selected from the group consisting of homopolymers or copolymers of lactides, glycolides, ε

-caprolactone, p-dioxanone (1,4-dioxan-2-one), trimethylene carbonate (1,3-dioxan-2-one), and combinations thereof.

61. The implant of claim 54, wherein the at least one tissue fragment is not contained within the granules.

62. The implant of claim 54, wherein the tissue carrier matrix further comprises at least one biological component selected from the group consisting of antibiotics, antimicrobial agents, anti-inflammatory agents, growth factors, growth factor fragments, small-molecule wound healing stimulants, hormones, cytokines, proteins, peptides, antibodies, enzymes, isolated cells, glycosaminoglycans, immunosuppressants, nucleic acids, analgesics, platelets an activator of platelets, viruses, virus particles, and combinations thereof.

63. The implant of claim 62, wherein the at least one biological component is an isolated cell selected from the group consisting of osteocytes, fibroblasts, stem cells, pluripotent cells, chondrocyte progenitors, chondrocytes, osteoclasts, osteoblasts, endothelial cells, macrophages, adipocytes, monocytes, plasma cells, mast cells, umbilical cord cells, leukocytes, stromal cells, mesenchymal stem cells, epithelial cells, myoblasts, tenocytes, ligament fibroblasts, and bone marrow cells.