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

• US 8,163,032 B2
• Filed: 02/22/2011
• Issued: 04/24/2012
• Est. Priority Date: 06/13/2002
• Status: Expired due to Term

• Current Assignee: DSM IP Assets BV (DSM-Firmenich AG)
• Original Assignee: Kensey Nash BVF Technology LLC (DSM-Firmenich AG)
• Inventors: Evans, Douglas G, Goldman, Scott M., Kronengold, Russell T.
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): BLANCO, JAVIER G
• Application Number:
  US13/032,193
• Publication Number:
  US 20110144767A1
• Time in Patent Office: 427 Days
• Field of Search: None
• 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 includes collagen and or other bio-resorbable materials, where the implant may also be used for therapy delivery. Additionally, the implant may include, or have blended in, an additive, such as an osteoinductive factor, for example biocompatible ceramics and glass.

Claims

1. A flowable implant for the repair or regeneration of bone tissue in a living being, said implant comprising an osteoconductive matrix, at least a portion of said osteoconductive matrix comprising a blend of soluble collagen and native insoluble collagen fibers and where at least a portion of said collagen is prepared from porcine tissue, wherein at least a portion of said implant is porous, and further wherein said porous implant has a pore size that is at least about 100 microns, wherein at least at a time of implantation said implant has a consistency of a substance selected from the group consisting of a putty and a paste, and further wherein said flowable implant comprises an implant that is capable of being delivered through a delivery system, and further wherein said implant is arranged to be implanted in the body of the living being, and still further wherein said delivery system comprises a syringe, tubular housing, or cannula.

2. The implant of claim 1, wherein said portion of said collagen derived from porcine tissue comprises native collagen fibers.

3. The implant of claim 2, wherein porcine tissue derived collagen comprises cellular materials.

4. The implant of claim 3, wherein said cellular materials comprise at least one of glycoproteins, growth factors, and sources of growth factors.

5. The implant of claim 2, wherein the native collagen fibers further comprise at least one of elastin, hyaluronic acid, polysaccharides, salts.

6. The implant of claim 2, wherein said porcine tissue derived collagen comprises biological constituents.

7. The implant of claim 6, wherein said biological constituents comprises at least one of angiogenic agents, anti-inflammatory agents, arteriogenesis agents, chondroitin, cytokines, prostaglandins, glycosaminoglycans, growth factors, heparin, hyaluronic acid, integrins, peptides, polypeptides, proteins, proteoglycans, or combinations thereof.

8. The implant of claim 1, wherein said matrix further comprises a therapy comprising at least one drug or biologically active agent.

9. The implant of claim 1, wherein said matrix further comprises at least one polymer other than collagen.

10. The implant of claim 9, wherein said polymer is synthetic.

11. The implant of claim 9, wherein said polymer is at least partially bio-resorbable.

12. The implant of claim 11, wherein said polymer comprises chitin, PGA/PLLA copolymers, hydrogel, Lactide/.mu.-caprolactone copolymers, PGA, PLA, or PCL.

13. The implant of claim 9, wherein said polymer is osteoinductive.

14. The implant of claim 1, wherein said tissue conductive matrix further comprises at least one ceramic.

15. The implant of claim 14, wherein said ceramic comprises calcium phosphate, calcium sulfate, or hydroxyapatite.

16. The implant of claim 14, wherein said at least one ceramic is in the form of particles, and further wherein said ceramic is blended with said tissue conductive matrix.

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

18. The implant of claim 1, wherein said tissue conductive matrix is bio-matched.

19. The implant of claim 18, wherein said bio-matched, tissue conductive matrix comprise a tissue conductive matrix that is at least one of integrity matched, porosity matched, compliance matched or weight matched.

20. The implant of claim 1, wherein said tissue conductive matrix exhibits elastic recovery after being compressed.

21. The implant of claim 1, wherein said pores make up more than 50 percent by volume of said porous portion.

22. The implant of claim 1, wherein said implant is located in said living being at a site of a bone defect.

23. The implant of claim 1 wherein said implant having a consistency of putty or paste further comprises thrombin glue, or growth factor gelatin.

24. A flowable implant for the repair or regeneration of bone tissue of a living being, said implant comprising an osteoconductive matrix, at least a portion of said osteoconductive matrix comprising a blend of soluble collagen and native insoluble collagen fibers, and where at least a portion of the collagen is prepared from porcine tissue, wherein at least a portion of said implant is porous, and further wherein said porous implant has a pore size that is at least about 100 microns, and further wherein said implant being in a form selected from the group consisting of sponges and loose, fibrous materials, and further wherein said flowable implant comprises an implant that is capable of being delivered through a delivery system, and further wherein said implant is arranged to be implanted in the body of said living being, and still further wherein said delivery system comprises a syringe, tubular housing, or cannula.

25. The implant of claim 24, wherein said portion of said collagen derived from porcine tissue comprises native collagen fibers.

26. The implant of claim 25, wherein said porcine tissue derived collagen comprises biological constituents.

27. The flowable implant of claim 24, wherein said delivery system comprises a syringe, tubular housing, or cannula.