Devices and methods for treating defects in the tissue of a living being

• US 20040138758A1
• Filed: 11/05/2003
• Published: 07/15/2004
• Est. Priority Date: 06/13/2002
• Status: Abandoned Application

• Current Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Original Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Inventors: Kronengold, Russell T., Goldman, Scott M., Evans, Douglas G.
• Application Number:
  US10/702,622
• Publication Number:
  US 20040138758A1
• Time in Patent Office: Days
• US Class Current: 623/23.51
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4618 of cartilage
• 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 2002/2825 Femur
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30004 the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• 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 2002/30075 : swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/3021 : frustoconical
• CPC Class Codes: A61F 2002/30224 : cylindrical
• CPC Class Codes: A61F 2002/30233 : Stepped cylinders, i.e. having discrete diameter changes
• CPC Class Codes: A61F 2002/30235 : tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30293 : Cylindrical body made by spirally rolling up a sheet or a strip around itself
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30822 : Circumferential grooves
• CPC Class Codes: A61F 2002/30827 : Plurality of grooves
• CPC Class Codes: A61F 2002/30881 : Circumferential ribs, flanges or fins
• CPC Class Codes: A61F 2002/30891 : Plurality of protrusions
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4662 : for measuring penetration depth
• CPC Class Codes: A61F 2002/4677 : using a guide wire
• CPC Class Codes: A61F 2002/4681 : by applying mechanical shocks, e.g. by hammering
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0061 : swellable
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0014 : having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0023 : differing in porosity
• CPC Class Codes: A61F 2250/003 : differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• 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: A61F 2310/00383 : Gelatin
• CPC Class Codes: A61K 33/06 : Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61K 33/42 : Phosphorus; Compounds thereof
• CPC Class Codes: A61K 38/39 : Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• CPC Class Codes: A61L 2300/406 : Antibiotics
• CPC Class Codes: A61L 2300/414 : Growth factors
• CPC Class Codes: A61L 27/12 : Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: A61L 27/24 : Collagen
• CPC Class Codes: A61L 27/38 : containing added animal cells organs or tissue containing native cells A61L27/36
• CPC Class Codes: A61L 27/44 : having a macromolecular matrix
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• 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 31/042 : Polysaccharides
• CPC Class Codes: A61L 31/044 : Collagen
• CPC Class Codes: A61L 31/146 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 19/02 : for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/08 : for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

An implantable material for deployment in select locations or select tissue for tissue regeneration is disclosed. The implant comprises collagen, ceramics, and or other bio-resorbable materials or additives, where the implant may also be used for therapy delivery. Additionally, the implant may be “matched” to provide the implant with similar physical and/or chemical properties as the host tissue.

Claims

1. A flowable implant for the repair or regeneration of tissue, said implant comprising an osteoconductive matrix, wherein at least a first portion of said matrix comprises a ceramic granule and at least a second portion comprises a non-porous material.

2. The implant of claim 1, wherein said ceramic granule is a porous ceramic.

3. The implant of claim 2, wherein said porous ceramic is at least one of calcium phosphate and calcium sulfate.

4. The implant of claim 3, wherein said porous ceramic is at least one of tricalcium phosphate and hydroxyapatite.

5. The implant of claim 3, wherein said porous ceramic comprises from about ten to about ninety percent of the weight of the implant.

6. The implant of claim 1, wherein said non-porous material comprises a gel.

7. The implant of claim 6, wherein said gel comprises soluble collagen.

8. The implant of claim 1, wherein said non-porous material comprises collagen.

9. The implant of claim 8, wherein said collagen comprises soluble collagen.

10. The implant of claim 1, wherein said matrix additionally comprises additives.

11. The implant of claim 10, wherein said additives comprise at least one of ceramics, biologically active agents, drugs, and therapies.

12. The implant of claim 11, wherein said additives are dispersed throughout the implant.

13. The implant of claim 11, wherein said biologically active agent comprises at least one of bone marrow, autologous blood, and bone morphogenic protein.

14. The implant of claim 10, wherein said additive is added to the implant at, or immediately prior to, placement of said implant into said tissue.

15. The implant of claim 14, wherein said osteoconductive matrix is dry and said additive is liquid, such that said additive hydrates said matrix upon the addition thereof.

16. The implant of claim 3, wherein said matrix is arranged to be compressed.

17. The implant of claim 16, wherein said compression occurs during the implant procedure.

18. The implant of claim 17, wherein said compression causes said implant to conform to the shape of the defect being treated.

19. The implant of claim 16, wherein said compression occurs prior to the implant procedure.

20. The implant of claim 19, wherein elastic recovery from said compression occurs following release into defect site.

21. The implant of claim 20, wherein said elastic recovery causes said implant to conform to the shape of the defect being treated.

22. A multi-stage composite implant for the repair or regeneration of tissue, with said implant comprising at least a first and a second material, wherein at least said first material is comprised of soluble collagen and is resorbable, with said second material comprising porous ceramic, and wherein at least a first material resorbs at a faster rate than said second material.

23. The implant of claim 22, wherein said soluble collagen serves to provide structural integrity to the implant.

24. The implant of claim 22, wherein at least one of said materials is osteoconductive.

25. The implant of claim 22, wherein said resorption of said first material causes said first material to act as a delayed porosifying agent.

26. The implant of claim 22, wherein said ceramic comprises calcium salt.

27. The implant of claim 26, wherein said calcium salt comprises at least one of calcium phosphate and calcium sulfate.

28. The implant of claim 27, wherein said calcium phosphate comprises at least one of tricalcium phosphate and hydroxyapatite.

29. The implant of claim 28, wherein said calcium phosphate comprises from about ten to about ninety percent of the weight of the implant.

30. The implant of claim 22, wherein said implant additionally comprises an additive comprising at least one of biologically active agents, drugs, and therapies.

31. The implant of claim 30, wherein said additive is dispersed throughout the implant.

32. The implant of claim 30, wherein said biologically active agent comprises at least one of bone marrow, autologus blood, and bone morphogenic protein.

33. The implant of claim 30, wherein said biologically active agent is added to the implant at the time of the procedure.

34. A flowable multi-phasic implant for the repair and regeneration of tissue, said implant comprising an osteoconductive matrix wherein at least a first phase of said matrix comprises an insoluble material and at least a second phase comprises a non-porous material.

35. The implant of claim 34, wherein the second non-porous phase is a hydrated flowable material.

36. The implant of claim 35, wherein the hydrated flowable material comprises at least one of soluble collagen paste and gel.

37. The implant of claim 34, wherein the second non-porous phase degrades faster than the first porous phase.

38. The implant of claim 37, wherein the second non-porous phase serves as a delayed porosifying agent.

39. The implant of claim 34, wherein the first phase comprises insoluble fibers.

40. The implant of claim 39, wherein the insoluble fibers are collagen fibers.

41. The implant of claim 40, wherein the collagen fibers are composed of natural insoluble collagen.

42. The implant of claim 34, wherein the first phase comprises insoluble granules.

43. The implant of claim 42, wherein the granules are in the form of spheres.

44. The implant of claim 43, wherein the granules are in the form of micro spheres.

45. The implant of claim 42, wherein the granules are composed of ceramic.

46. The implant of claim 45, wherein the ceramic is a tricalcium phosphate.

47. The implant of claim 46, wherein the tricalcium phosphate is porous.

48. The implant of claim 34, wherein the matrix further comprises a biologically active or pharmaceutical agent.

49. The implant of claim 48, wherein the agent is added to the implant at, or immediately prior to placement of said implant into said tissue.

50. The implant of claim 49, wherein the agent comprises one or more of the biologically active agents, pharmaceuticals, or active ingredients.

51. The implant of claim 49, wherein said biologically active agent comprises cells.

52. The implant of claim 51, wherein the cells are in blood or bone marrow.

53. The implant of claim 34, wherein the first phase is in the form of a depot surrounded by the second phase.

54. The implant of claim 53, wherein the first phase is homogeneous within the second phase.

55. The implant of claim 34, wherein the first phase in the form of a granule, chip or fiber.

56. The implant of claim 55, wherein the first phase is composed of a synthetic polymer material.

57. The implant of claim 55, wherein the second phase provides some level of structural integrity to the first phase.

58. The implant of claim 55, wherein the chip comprises bone.

59. The implant of claim 58, wherein the bone has been demineralized.

60. The implant of claim 34, wherein the first phase is between 10 percent and 90 percent of the construct by weight.

61. The implant of claim 34, wherein the first phase is between 70 percent and 90 percent of the construct by weight.

62. The implant of claim 34, wherein the first phase is between 75 percent and 85 percent of the construct by weight.

63. The implant of claim 34, wherein the flowable implant is arranged for storage and delivery in a tube.

64. The implant of claim 34 wherein the flowable implant is arranged for storage and delivery in a syringe.

65. The implant of claim 34, wherein the flowable implant is arranged for storage and delivery in a syringe-like cylindrical housing.

66. A flowable multi-phasic implant for the repair and regeneration of tissue, said implant composed of components that resorb in stages wherein:

a. At least a first component is an insoluble ceramic granule; and

b. At least a second component is a non-porous collagen gel;

wherein the non-porous collagen gel suspends the granules, providing a level of structural integrity to the implant.

67. The implant of claim 66, wherein the implant initially comprises ceramic granules which are in the form of a depot surrounded by lyophilized soluble collagen prior to implantation, wherein the lyophilized soluble collagen collapses into said non-porous gel upon hydration.

68. The implant of claim 67, wherein said hydration occurs following implantation.

69. The implant of claim 67, wherein said hydration occurs prior to implantation.

70. A flowable multi-phasic implant for the repair and regeneration of tissue, said implant comprising a plurality of components that resorb in stages wherein:

a. At least a first component is an insoluble ceramic granule;

b. At least a second component is an insoluble collagen fiber; and

c. At least a third component is a non-porous collagen gel;

wherein the non-porous collagen gel suspends the Granules and fiber, providing a level of structural integrity to the implant.