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

• US 20040034434A1
• Filed: 08/14/2003
• Published: 02/19/2004
• Est. Priority Date: 06/13/2002
• Status: Active Grant

• Current Assignee: DSM IP Assets BV (DSM-Firmenich AG)
• Original Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Inventors: Kronengold, Russell T., Goldman, Scott M., Evans, Douglas G.
• Granted Patent: US 7,156,880 B2
• 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. An implant for the repair or regeneration of tissue, said implant comprising an osteoconductive matrix, wherein at least a portion of said matrix comprises native insoluble collagen, soluble collagen, and a calcium salt.

2. The implant of claim 1, wherein said calcium salt is at least one of calcium phosphate and calcium sulfate.

3. The implant of claim 2, wherein said calcium phosphate is at least one of tricalcium phosphate and hydroxyapatite.

4. The implant of claim 2, wherein said calcium phosphate comprises from about ten to about ninety percent of the weight of the implant.

5. The implant of claim 4, wherein the ratio of said native insoluble collagen to soluble collagen is from about 10:

1 to 1;

20.

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

7. The implant of claim 6, wherein said additives comprise at least one of ceramics, biologically active agents, drugs, and therapies.

8. The implant of claim 7, wherein said additives are dispersed throughout the implant.

9. The implant of claim 7, wherein said biologically active agent comprises at least one of bone marrow, autologous blood, and bone morphogenic protein.

10. The implant of claim 6, wherein said additive is added to the implant at, or immediately prior to, placement of said implant into said tissue.

11. The implant of claim 10, wherein said osteoconductive matrix is dry and said additive is liquid, such that said additive hydrates said matrix upon the addition thereof.

12. The implant of claim 2, wherein said matrix is arranged to be compressed.

13. The implant of claim 12, wherein said compression occurs during the implant procedure.

14. The implant of claim 13, wherein said compression causes said implant to conform to the shape of the defect being treated.

15. The implant of claim 12, wherein said compression occurs prior to the implant procedure.

16. The implant of claim 15, wherein elastic recovery from said compression occurs following release into defect site.

17. The implant of claim 16, wherein said elastic recovery causes said implant to conform to the shape of the defect being treated.

18. An implant for the repair or regeneration of tissue, said implant comprising an osteoconductive matrix, wherein at least a portion of said matrix comprises native insoluble collagen, and at least a first additive.

19. The implant of claim 18, wherein said first additive comprises soluble collagen.

20. The implant of claim 18, wherein said matrix additionally comprises soluble collagen and with said first additive comprising polyethylene glycol.

21. The implant of claim 18, wherein said first additive comprises polyethylene glycol.

22. The implant of claim 18, wherein said matrix additionally comprises soluble collagen and with said first additive comprising calcium salt.

23. The implant of claim 22, wherein said calcium salt comprises at least one of calcium phosphate and calcium sulfate.

24. The implant of claim 23, wherein said calcium phosphate comprises at least one of tricalcium phosphate and hydroxyapatite.

25. The implant of claim 22, wherein said calcium phosphate comprises from about ten to about ninety percent of the weight of the implant.

26. The implant of claim 25, wherein the ratio of said native insoluble collagen to soluble collagen is from about 10:

1 to 1;

20.

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

28. The implant of claim 27, wherein said additives are dispersed throughout the implant.

29. The implant of claim 28, wherein said biologically active agent comprises at least one of bone marrow, autologous blood, and bone morphogenic protein.

30. The implant of claim 29, wherein said additive is added to the implant at, or immediately prior to, placement of said implant into said tissue.

31. An implant for the repair or regeneration of tissue, said implant comprising an osteoconductive matrix, a macrostructure, and at least a first additive, wherein at least a portion of said matrix comprises native insoluble collagen.

32. The implant of claim 31, wherein said first additive comprises soluble collagen.

33. The implant of claim 31, wherein said matrix additionally comprises soluble collagen and with said first additive comprising polyethylene glycol.

34. The implant of claim 31, wherein said macrostructure comprises calcium salt.

35. The implant of claim 34, wherein said calcium salt is arranged in the form of spherical-like structures and is comprised of at least one of calcium phosphate and calcium sulfate.

36. The implant of claim 35, wherein said calcium phosphate comprises at least one of tricalcium phosphate and hydroxyapatite.

37. The implant of claim 34, wherein said calcium phosphate comprises from about ten to about ninety percent of the weight of the implant.

38. The implant of claim 37, wherein the ratio of said native insoluble collagen to soluble collagen is from about 10:

1 to 1;

20.

39. The implant of claim 31, wherein said additive comprises at least one of biologically active agents, drugs, and therapies.

40. The implant of claim 39, wherein said additives are dispersed throughout the implant.

41. The implant of claim 40, wherein said biologically active agent comprises at least one of bone marrow, autologous blood, and bone morphogenic protein.

42. The implant of claim 41, wherein said biologically active agent is added to the implant at the time of the procedure.

43. 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 native insoluble collagen and is resorbable, and wherein at least a first material resorbs at a faster rate than said second material.

44. The implant of claim 43, wherein said native insoluble collagen serves to provide some structural integrity to the implant.

45. The implant of claim 43, wherein at least one of said materials is osteoconductive.

46. The implant of claim 44, wherein said second material comprises at least one ceramic.

47. The implant of claim 46, wherein said ceramic comprises calcium salt.

48. The implant of claim 47, wherein said calcium salt comprises at least one of calcium phosphate and calcium sulfate.

49. The implant of claim 48, wherein said calcium phosphate comprises at least one of tricalcium phosphate and hydroxyapatite.

50. The implant of claim 49, wherein said calcium phosphate comprises from about ten to about ninety percent of the weight of the implant.

51. The implant of claim 50, wherein said first material additionally comprises soluble collagen wherein the ratio of said native insoluble collagen to soluble collagen is from about 10:

1 to 1;

20.

52. The implant of claim 46, wherein said implant additionally comprises an additive comprising at least one of biologically active agents, drugs, and therapies.

53. The implant of claim 52, wherein said additive is dispersed throughout the implant.

54. The implant of claim 52, wherein said wherein said biologically active agent comprises at least one of bone marrow, autologus blood, and bone morphogenic protein.

55. The implant of claim 52, wherein said biologically active agent is added to the implant at the time of the procedure.

56. An implant for the repair or regeneration of bone, said implant comprising at least a first portion and a second portion, said first portion comprising a sleeve material and said second portion comprising an inner core material, with at least a portion of said inner core material comprising native insoluble collagen.

57. The implant of claim 56, wherein at least a portion of said sleeve material comprises metal with said sleeve material serving as a scaffold.

58. The implant of claim 56, wherein at least a portion of said sleeve material comprises metal.

59. The implant of claim 58, wherein said inner core material additionally comprises soluble collagen.

60. The implant of claim 59, wherein said inner core material additionally comprises calcium salt.

61. The implant of claim 60, wherein said calcium salt comprises at least one of calcium phosphate and calcium sulfate.

62. The implant of claim 61, wherein said calcium phosphate comprises at least one of tricalcium phosphate and hydroxyapatite.

63. The implant of claim 62, wherein said inner core material additionally comprises soluble collagen wherein the ratio of said native insoluble collagen to soluble collagen is from about 10:

1 to 1;

20.

64. The implant of claim 59, wherein said implant additionally comprises an additive comprising at least one of biologically active agents, drugs, and therapies.

65. The implant of claim 64, wherein said additive is dispersed throughout the implant.

66. The implant of claim 64, wherein said wherein said biologically active agent comprises at least one of bone marrow, autologous blood, and bone morphogenic protein.

67. The implant of claim 66, wherein said additive is added to the implant at, or immediately prior to, placement of said implant into said tissue

68. The implant of claim 57 wherein said metal serves to provide structural integrity to the implant.

69. The implant of claim 68, wherein said inner core material does not have structural competence.