Methods of tissue repair and compositions therefor

• US 20060228391A1
• Filed: 06/07/2006
• Published: 10/12/2006
• Est. Priority Date: 07/12/2004
• Status: Active Grant

• Current Assignee: Isto Technologies Ii LLC
• Original Assignee: ISTO Technologies, Inc. (Isto Biologics, Inc.)
• Inventors: Seyedin, Mitchell S., Gage, Gary
• Granted Patent: US 8,512,730 B2
• Time in Patent Office: Days
• US Class Current: 424/422
• CPC Class Codes: A61K 31/727 Heparin; Heparan
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 31/737 Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate A61K31/727 takes precedence
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/04 for non-specific disorders of the connective tissue
• CPC Class Codes: C08L 5/00 Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

The present application discloses matrix compositions to support the repair of tissue defects such as an injury to tendon tissue, ligament tissue, vascular tissue, dermal tissue, or muscle tissue. A matrix described herein comprises a polyester polymer entangled with a polysaccharide polymer. Also disclosed are methods of preparing a matrix, and methods of using a matrix in the repair of tissue. In certain configurations, a matrix can comprise a polyester cross-linked with a polysaccharide, which can be an oxidized polysaccharide. In some configurations, a matrix can further comprise one or more additional components, such as a growth factor or an anti-infective agent. In some configurations, a matrix can be a viscous fluid or a paste, while in other configurations a matrix can be comprised by a solid such as a plug, a granule or a membrane.

Claims

1. A method for promoting tissue growth in a mammal in need thereof, the method comprising administering to the mammal, at a site in need of tissue growth, a matrix comprising a polyester entangled with a polysaccharide, wherein the site of tissue growth comprises tendon tissue, ligament tissue, vascular tissue, dermal tissue, periodontal tissue, intervertebral disc tissue, hyaline cartilage, fibrous cartilage, elastic cartilage, a nerve tunnel or a combination thereof.

2. A method for promoting tissue growth in accordance with claim 1, wherein the administering the matrix comprises injecting the matrix.

3. A method for promoting tissue growth in accordance with claim 1, wherein the administering the matrix comprises implanting the matrix.

4. A method for promoting tissue growth in accordance with claim 1, wherein the mammal is a human in need of treatment.

5. A method for promoting tissue growth in accordance with claim 1, wherein the site in need of tissue growth comprises dermis.

6. A method for promoting tissue growth in accordance with claim 1, wherein the site in need of tissue growth comprises a rotator cuff tendon.

7. A method for promoting tissue growth in accordance with claim 1, wherein the site in need of tissue growth comprises an Achilles tendon.

8. A method for promoting tissue growth in accordance with claim 1, wherein the site in need of tissue growth comprises a ligament selected from the group consisting of an anterior cruciate ligament (ACL), a posterior cruciate ligament, (PCL), a medial collateral ligament, a lateral collateral ligament and a periodontal ligment.

9. A method for promoting tissue growth in accordance with claim 1, wherein the site in need of tissue growth comprises a sphincter.

10. A method for promoting tissue growth in accordance with claim 9, wherein the sphincter is selected from the group consisting of an anal sphincter, a urethral sphincter, an esophageal sphincter and an antral sphincter.

11. A method for promoting tissue growth in accordance with claim 1, wherein the site in need of tissue growth comprises herniated tissue.

12. A method for promoting tissue growth in accordance with claim 11, wherein the herniated tissue is selected from the group consisting of an abdominal hernia, a Cooper'"'"'s hernia, a diaphragmatic hernia, an epigastric hernia, a femoral hernia, an incisional hernia, an inguinal hernia, an intervertebral disc hernia, a Littre'"'"'s hernia, an obturator hernia, a pantaloon hernia, a perineal hernia, a properitoneal hemia, a Richter'"'"'s hernia, a sciatic hernia, a sliding hernia, a Spigelian hernia and an umbilical hernia.

13. A method for promoting tissue growth in accordance with claim 1, wherein the site in need of tissue growth comprises an intervertebral disc nucleus.

14. A method for promoting tissue growth in accordance with claim 1, wherein the site in need of tissue growth comprises an intervertebral disc annulus.

15. A method for promoting tissue growth in accordance with claim 1, wherein the site in need of tissue growth comprises periosteal tissue.

16. A method for promoting tissue growth in accordance with claim 1, wherein the site in need of tissue growth comprises neural tissue.

17. A method for promoting tissue growth in accordance with claim 16, wherein the neural tissue comprises central nervous system tissue.

18. A method for promoting tissue growth in accordance with claim 17, wherein the central nervous system tissue is spinal cord tissue.

19. A method for promoting tissue growth in accordance with claim 16, wherein the neural tissue comprises demyelinated neural tissue.

20. A method for promoting tissue growth in accordance with claim 1, wherein the vascular tissue comprises cardiovascular tissue.

21. A method for promoting tissue growth in accordance with claim 20, wherein the cardiovascular tissue is selected from the group consisting of a mitral valve, a tricuspid valve, an aortic heart valve and a pulmonary heart valve.

22. A method for promoting tissue growth in accordance with claim 20, wherein the cardiovascular tissue comprises a vascular tissue graft.

23. A method for promoting tissue growth in accordance with claim 20, wherein the tissue comprises a stent.

24. A method for promoting tissue growth in accordance with claim 20, wherein the cardiovascular tissue comprises stenotic cardiovascular tissue.

25. A method for promoting tissue growth in accordance with claim 1, wherein the hyaline cartilage is costal cartilage.

26. A method for promoting tissue growth in accordance with claim 1, wherein the fibrous cartilage is meniscus cartilage.

27. A method for promoting tissue growth in accordance with claim 1, wherein the elastic cartilage is selected from the group consisting of epiglottic cartilage, laryngeal cartilage, external ear cartilage and auditory tube cartilage.

28. A method for promoting tissue growth in accordance with claim 27, wherein the laryngeal cartilage is selected from the group consisting of arytenoid cartilage, cricoid cartilage, cuneiform cartilage and corniculate cartilage.

29. A method for promoting tissue growth in accordance with claim 1, wherein the tissue growth comprises facial contour augmentation.

30. A method for promoting tissue growth in accordance with claim 1, wherein the tissue growth comprises repair of scar tissue.

31. A method for promoting tissue growth in accordance with claim 1, wherein the matrix further comprises at least one therapeutic agent.

32. A method for promoting tissue growth in accordance with claim 31, wherein the at least one therapeutic agent is selected from the group consisting of an anti-infective agent, a pain medication, an analgesic, an anti-inflammatory agent, and an immunosuppressive agent.

33. A method for promoting tissue growth in accordance with claim 1, further comprising securing the matrix with a fastener.

34. A method for promoting tissue growth in accordance with claim 1, wherein the tissue is a periodontal ligament.

35. An implant for promoting repair of a tissue, the implant comprising a matrix comprising a polyester entangled with a polysaccharide, wherein the implant is a fastener or a prosthesis.

36. An implant in accordance with claim 35, wherein the fastener is selected from the group consisting of a staple, a dart, a pin, a screw, a suture, a glue and a tack.

37. An implant in accordance with claim 35, wherein the prosthesis is a prosthetic plate.

44. An implant in accordance with claim 35, wherein the implant further comprises at least one therapeutic agent.

45. An implant in accordance with claim 44, wherein the at least one therapeutic agent is selected from the group consisting of an anti-infective agent, a pain medication, an analgesic, an anti-inflammatory agent, and an immunosuppressive agent.

46. An implant in accordance with claim 45, wherein the anti-infective agent is an antibiotic selected from the group consisting of gentamicin, dibekacin, kanendomycin, lividomycin, tobramycin, amikacin, fradiomycin, sisomicin, tetracycline, hydrochloride, oxytetracycline, hydrochloride, rolitetracycline, doxycycline hydrochloride, ampicillin, piperacillin, ticarcillin, cephalothin, cephaloridine, cefotiam, cefsulodin, cefinenoxime, cefinetazole, cefazolin, cefotaxime, cefoperazone, ceftizoxime, moxolactam, latamoxef, thienamycin, sulfazecin, azthreonam and a combination thereof.

38. An implant for promoting repair of a tissue, the implant comprising a matrix comprising a polyester entangled with a polysaccharide, wherein the implant comprises a substantially anatomical shape or a substantially geometric shape.

39. An implant in accordance with claim 38, wherein the substantially geometrical shape is selected from the group consisting of a substantially cylindrical shape, a substantially pyramidal shape and a substantially frustoconical shape.

40. An implant in accordance with claim 38, wherein the substantially anatomical shape is selected from the group consisting of a condyle, a hemi-condyle, an acetabular cup, a tibial plateau and a femoral head.

41. An implant in accordance with claim 38, wherein the substantially anatomical shape is a substantially skeletal anatomical shape.

42. An implant in accordance with claim 41, wherein the substantially skeletal anatomical shape is selected from the group consisting of a maxilla, a mandible, a temporal bone, a sphenoid bone, a frontal bone and a zygoma.

43. An implant in accordance with claim 38, wherein the substantially anatomical shape is a substantially dental shape.

47. A matrix for supporting repair of a tissue, the matrix comprising a polyester entangled with a polysaccharide, wherein the matrix has a viscosity from about 200,000 centipoise to about 3×

10¹⁰ centipoise at 20°

C.

48. A matrix in accordance with claim 47, wherein the matrix has a viscosity from about 10⁶ centipoise to about 10⁹ centipoise at 20°

C.

49. An matrix in accordance with claim 47, wherein the matrix further comprises at least one therapeutic agent.

50. An implant in accordance with claim 47, wherein the at least one therapeutic agent is selected from the group consisting of an anti-infective agent, a pain medication, an analgesic, an anti-inflammatory agent, and an immunosuppressive agent.

51. An implant in accordance with claim 50, wherein the anti-infective agent is an antibiotic selected from the group consisting of gentamicin, dibekacin, kanendomycin, lividomycin, tobramycin, amikacin, fradiomycin, sisomicin, tetracycline, hydrochloride, oxytetracycline, hydrochloride, rolitetracycline, doxycycline hydrochloride, ampicillin, piperacillin, ticarcillin, cephalothin, cephaloridine, cefotiam, cefsulodin, cefinenoxime, cefinetazole, cefazolin, cefotaxime, cefoperazone, ceftizoxime, moxolactam, latamoxef, thienamycin, sulfazecin, azthreonam and a combination thereof.

52. A matrix for supporting repair of a tissue, the matrix comprising a polyester entangled with a polysaccharide, wherein the matrix is comprised by a solid selected from the group consisting of a plug, a granule, and a membrane.

53. A plug comprising the matrix of claim 52.

54. A granule comprising the matrix in of claim 52.

55. A membrane comprising the matrix of claim 52.

56. A matrix in accordance with claim 52, wherein the matrix is an injectable matrix.

57. A paste comprising a matrix, wherein the matrix comprises a polyester entangled with a polysaccharide, and wherein the paste supports repair of a tissue when implanted in a mammal subject.

58. A paste in accordance with claim 57, wherein the mammal subject is a human in need of treatment.

59. A method of repairing an anatomical defect, the method comprising administering a therapeutically effective amount of the paste of claim 57 at the site of an anatomical defect in a patient in need thereof.

60. A method of performing an interbody fusion, the method comprising inserting an interbody cage in the spine of a patient in need of treatment, and filling the cage with a therapeutically effective amount of the paste of claim 57.

61. A method of performing an interbody fusion in accordance in accordance with claim 60, wherein the interbody fusion is selected from the group consisting of an anterior lumbar interbody fusion, a posterior lumbar interbody fusion and a cervical interbody fusion.