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

• US 8,425,619 B2
• Filed: 11/16/2010
• Issued: 04/23/2013
• 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:
  US12/947,822
• Publication Number:
  US 20120046758A1
• Time in Patent Office: 889 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.

Claims

1. An implant for the repair or regeneration of an internal tissue in a living being, said implant comprising a first tissue conductive matrix and a second tissue conductive matrix;

wherein said first tissue conductive matrix comprises a blend of soluble collagen and native collagen fibers, wherein at least a portion of said first tissue conductive matrix is porous with a pore size that is at least about 100 microns, and wherein said second tissue conductive matrix comprises a polymer material, wherein said polymer of said second tissue conductive matrix comprises a synthetic polymer, wherein at least a portion of said second tissue conductive matrix is porous, wherein said implant is arranged to be implanted in the body of said living being, and wherein said implant is adapted to be located at a site of a cartilage defect, wherein said first tissue conductive matrix serves as a cartilage tissue substitute, and said second tissue conductive matrix is an osteoconductive matrix that serves as a bone tissue substitute.

2. The implant of claim 1, wherein said synthetic polymer is resorbable.

3. The implant of claim 1, wherein said polymer material comprises chitin, chitosan, PGA/PLLA copolymers, hydrogel, Lactide/caprolactone copolymers, PGA, PLA, PCL, tyrosine based polymers, cellulose, polyamino acids, polyurethane, polyvinyl alcohol, trimethyl carbonate, alginate, collagen, or fibrin.

4. The implant of claim 3, wherein said second tissue conductive matrix is osteoconductive.

5. The implant of claim 1, wherein at least one of the tissue conductive matrices further comprise a filler material selected from the group consisting of:

calcium phosphate, calcium sulfate, hydroxyapatite, glass, monetite, brushite, metals, metal oxides, fibrin, silk, thrombin, gold, demineralized bone, and combinations thereof.

6. The implant of claim 1, wherein at least one of the tissue conductive matrices further comprise a filler material comprising a ceramic in the form of particles blended with one of said tissue conductive matrices.

7. The implant of claim 6, wherein said ceramic particles are in the second tissue conductive matrix.

8. The implant of claim 1, wherein at least one of said tissue conductive matrices is bio-matched.

9. The implant of claim 8, wherein said at least one bio-matched, tissue conductive matrices comprise a matrix that is at least one of integrity matched, porosity matched, compliance matched or weight matched.

10. The implant of claim 1, wherein at least a portion of said implant exhibits elastic recovery after being compressed.

11. The implant of claim 1, wherein said implant further comprises at least one of cells and cellular components.

12. The implant of claim 11, wherein said cells or cellular components comprise at least one of platelet rich plasma (PRP), blood cells, cartilage cells, fat cells, genetic material, lipo-proteins, stem cells, progenitor cells, bone marrow, and combinations thereof.

13. The implant of claim 11, wherein said cells or cellular components are one of synthetic, autologous or allograft in origin.

14. The implant of claim 11, wherein said cells or cellular components are seeded in said implant.

15. The implant of claim 14, wherein said cells or cellular components are cultured for a period of time.

16. The implant of claim 15, wherein said period of time ranges from days to weeks prior to implantation.

17. The implant of claim 1, wherein said pores of each of said first and second tissue conductive matrices each make up more than 50 percent by volume of said porous portion of each matrix.

18. The implant of claim 1, wherein said first and second tissue conductive matrices are joined in a manner selected from the group consisting of lyophilization, thermal weld, solvent weld, and mechanically connected.

19. The implant of claim 1, wherein one of said matrices further comprises at least one drug or biologically active agent.

20. The implant of claim 19, wherein said biologically active agent is selected from the group consisting of cytokines, growth factors, glycosaminoglycans, proteoglycans, hormones, anti-biotics, amino acids, glycoproteins, lipids, viruses, and combinations thereof.

21. The implant of claim 19, wherein said biologically active agent is one of Adenovirus, Anti-growth factors, Anti-inflammatory agents, fibroblast growth factor (FGF), Bone morphogenic proteins (BMP), platelet-derived growth factor (PDGF), transforming growth factors (TGF), Bone marrow cells, Blood cells, Stem Cells, Fat cells, Bone cells, Cartilage cells, Cytokines, Glycosaminoglycans, metals and combinations thereof.

22. A system for the repair or regeneration of an internal tissue in a living being, said system comprising a delivery device and an implant, wherein the implant is contained within the delivery device, and is arranged to be delivered from the delivery device to an internal tissue site and adapted to be implanted therein, wherein said implant comprises a first tissue conductive matrix and a second tissue conductive matrix;

wherein said first tissue conductive matrix comprises a blend of soluble collagen and native collagen fibers, wherein at least a portion of said first tissue conductive matrix is porous, and wherein said second tissue conductive matrix comprises a polymer material, wherein at least a portion of said second tissue conductive matrix is porous, wherein said second tissue conductive matrix comprises a ceramic, and further wherein said first tissue conductive matrix serves as a cartilage tissue substitute, and said second tissue conductive matrix is an osteoconductive matrix that serves as a bone tissue substitute.

23. The treatment system of claim 22, wherein said polymer material comprises synthetic polymer.

24. The treatment system of claim 23, wherein said synthetic polymer is resorbable.

25. The treatment system of claim 22, wherein said porous portion of said first tissue conductive matrix has a pore size that is at least about 100 microns.

26. The treatment system of claim 22, wherein said delivery device comprises a tubular housing and a plunger.

27. The treatment system of claim 22, wherein said delivery device allows visualization of the implant material being delivered.

28. The treatment system of claim 27, wherein said delivery device is transparent.

29. The treatment system of claim 22, wherein at least a portion of said implant exhibits elastic recovery after being compressed.

30. The treatment system of claim 29, wherein said elastic recovery is characterized by the implant expanding to fill the internal tissue site to which said implant is delivered.

31. The treatment system of claim 22, wherein said internal tissue site to be repaired or regenerated comprises a defect in an articulating surface of a living being, said defect extending through an articular cartilage layer and into the cancellous bone material.

32. The treatment system of claim 22, wherein said implant can be adjusted by size to fit said internal tissue site by trimming with a trimming tool to a desired length, or shape.

33. The treatment system of claim 32, wherein said delivery device further comprises indicator markings useful for determining the appropriate size for adjusting said implant, to fit said internal tissue site.

34. The treatment system of claim 22, wherein said implant is loaded with biologically active agents or additives while the implant is contained within the delivery device.