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

• US 7,241,316 B2
• Filed: 07/31/2003
• Issued: 07/10/2007
• Est. Priority Date: 06/13/2002
• Status: Expired due to Term

• Current Assignee: DSM IP Assets BV (DSM-Firmenich AG)
• Original Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Inventors: Evans, Douglas G, Kronengold, Russell T., Goldman, Scott M.
• Primary Examiner(s): McDermott; Corrine
• Assistant Examiner(s): Blanco; Javier G.
• Application Number:
  US10/631,431
• Publication Number:
  US 20040064193A1
• Time in Patent Office: 1,440 Days
• Field of Search: 623/23.5, 623/23.51, 623/23.55, 623/23.58, 623/23.61, 623/23.63
• 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 implant for deployment in select locations or select tissue for regeneration of tissue is disclosed. The implant comprising collagen and or other bio-resorbable materials, 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 bone tissue of a living being, said implant comprising a porous osteoconductive matrix and a depot of material, at least a portion of said matrix comprising soluble collagen and native insoluble collagen, wherein said native insoluble collagen comprises native collagen fibers, and wherein said at least a portion of said matrix defines pores of a diameter of greater than about 100 microns, and still further wherein said implant is arranged to be implanted within a body of a living being.

2. The implant of claim 1, wherein said depot of material further comprises at least one therapy.

3. The implant of claim 2, wherein said therapy comprises at least one of blood cells, drugs and biologically active agents.

4. The implant of claim 1, wherein said matrix further comprises at least one therapy.

5. The implant of claim 4, wherein said therapy comprises at least one of drugs and biologically active agents.

6. The implant of claim 1, wherein said matrix comprises at least one polymer in addition to said soluble collagen and native insoluble collagen.

7. The implant of claim 6, wherein said additional polymer is at least partially bio-resorbable.

8. The implant of claim 7, wherein said additional polymer comprises at least one of chitin, PGA/PLLA copolymers, hydrogel, Lactide/ε

-caprolactone copolymers, PGA, PLA, and PCL.

9. The implant of claim 6, wherein said additional polymer is not cross-linked.

10. The implant of claim 1, wherein said matrix is capable of functioning as a carrier for material lacking structural competence.

11. The implant of claim 10, wherein said material lacking structural competence comprises at least one ceramic.

12. The implant of claim 11, wherein said ceramic comprises calcium salt.

13. The implant of claim 12, wherein said calcium salt comprises at least one of calcium phosphate and calcium sulfate.

14. The implant of claim 13, wherein said calcium phosphate comprises hydroxyapatite.

15. The implant of claim 1, wherein said depot of material comprises at least one ceramic.

16. The implant of claim 15, wherein said ceramic comprises at least one of calcium phosphate, calcium sulfate, and hydroxyapatite.

17. The implant of claim 1, wherein said matrix further comprises reconstituted collagen.

18. The implant of claim 1 wherein said matrix and said material are resorbable, with said matrix resorbing at a different rate than said material.

19. The implant of claim 1, wherein said depot of material acts as a carrier for at least one other constituent selected from the group consisting of a biologically active agent, a cellular material, a filler material, a polymer plasticizer, nanoparticles, and a coating material.

20. The implant of claim 1, said implant further being in a bio-matched condition.

21. An implant for the repair or regeneration of tissue within the body of a living being, said implant comprising a matrix and a depot, said implant further being in a bio-matched condition, and further wherein at least a portion of said matrix further comprising soluble collagen and native insoluble collagen, wherein said native insoluble collagen comprises native collagen fibers, and wherein said at least a portion of said matrix defines pores of a diameter of greater than about 100 microns, and still further wherein said implant is arranged to be delivered to a site of a bone defect in a body of a living being.

22. The implant of claim 21, wherein said bio-matched condition comprises integrity matched, porosity matched, compliance matched or weight matched.

23. The implant of claim 22, wherein said integrity matched condition comprises a cross-linked condition.

24. The implant of claim 21, wherein said depot comprises at least one ceramic.

25. The implant of claim 24, wherein said ceramic comprises at least one of calcium phosphate, calcium sulfate, and hydroxyapatite.

26. The implant of claim 21, wherein said bio-matched condition comprises a plurality of integrity matched, porosity matched, compliance matched, or weight matched conditions.

27. The implant of claim 21, wherein said depot is in the form of a drug or biologic that acts as a depot for nutrients for proliferating and growing cells.

28. An implant for the repair or regeneration of bone tissue of a living being, said implant comprising a porous osteoconductive matrix and a depot of material, at least a portion of said matrix comprising soluble collagen and native insoluble collagen, wherein said native insoluble collagen comprises native collagen fibers, and wherein said at least a portion of said matrix defines pores of a diameter of greater than about 100 microns, wherein said implant comprises a form selected from the group consisting of loose fibrous material, a sponge, a paste/flowable material, a folded membrane, a woven or non-woven sheet, and pellets, and still further wherein said implant is arranged to be implanted within a body of a living being.