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

• US 7,235,107 B2
• Filed: 11/14/2003
• Issued: 06/26/2007
• 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: Kronengold, Russell T., Goldman, Scott M., Evans, Douglas G.
• Primary Examiner(s): McDermott; Corrine
• Assistant Examiner(s): Blanco; Javier G.
• Application Number:
  US10/713,438
• Publication Number:
  US 20040127987A1
• Time in Patent Office: 1,320 Days
• Field of Search: 623 2356- 2358, 623/23.61, 623/23.63, 623/23.5, 623/23.51, 623/23.55
• 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 conformable, multi-phasic bone implant for the repair and regeneration of bone tissue, said implant consisting of a plastically deformable, tissue conductive matrix for tissue regeneration, said matrix consisting of two phases, wherein a first phase of said matrix consists of native insoluble collagen fibers and a second phase consists of soluble collagen, said implant having a consistency of a putty just prior to implantation, and remaining at least somewhat compliant after implantation.

2. A conformable, multi-phasic bone implant for the repair and regeneration of bone tissue, said implant comprising components that resorb in stages wherein:

a. At least a first of said components is a non-soluble ceramic granule;

b. At least a second of said components is native insoluble collagen fibers and

c. At least a third component is a flowable collagen gel;

wherein the ceramic granules are blended into the native insoluble collagen fibers as an admixture, and wherein the collagen gel holds the admixture of ceramic granules and native insoluble collagen fibers together, providing a level of structural integrity to the implant, and further wherein said porous implant is arranged for placement within a body of a living being, and still further wherein said implant is plastically deformable, tissue conductive, has a consistency of a putty just prior to implantation and retains at least some compliance following implantation.

3. The implant of claim 2, wherein said native insoluble collagen fibers do not consist of collagen fibrils at the highest level of structural organization.

4. A conformable, multi-phasic bone implant for the repair and regeneration of a defect in a bone of a living being, said implant comprising a plurality of components that resorb in stages wherein:

a. At least a first component of said components is native insoluble collagen fibers; and

b. At least a second component of said components is a flowable soluble collagen gel;

wherein said porous implant is arranged for placement in a body of said living being, further wherein the implant is plastically deformable, tissue conductive, has a consistency of a putty just prior to implantation and retains at least some compliance following implantation, and further wherein the flowable soluble collagen gel is mixed with the native insoluble collagen fibers and holds the native insoluble collagen fibers together, providing a level of structural integrity to the implant.

5. The bone implant of claim 4, wherein the implant initially comprises non-soluble collagen which is in the form of a depot surrounded by lyophilized soluble collagen prior to implantation, wherein the lyophilized soluble collagen collapses into said flowable gel upon hydration.

6. The bone implant of claim 5, wherein said hydration occurs prior to implantation.

7. The bone implant of claim 4, wherein said native insoluble collagen fibers do not consist of the fibrillar form of collagen at the highest level of structural organization.

8. A conformable, multi-phasic bone implant for the repair and regeneration of a defect in a bone of a living being, said implant comprising a plastically deformable, tissue conductive matrix for tissue regeneration, said matrix comprising at least two phases, wherein at least a first phase of said matrix comprises native insoluble collagen fibers and at least a second phase comprises a flowable biocompatible polymer comprising soluble collagen, further wherein said porous implant is suitable for placement within a body of said living being, said implant having a consistency of a putty just prior to implantation, and remaining at least somewhat compliant after implantation.

9. The implant of claim 8, wherein the second phase is initially dry, and non-flowable, and said dry second phase becomes flowable following hydration.

10. The implant of claim 8, wherein the second phase degrades faster than the first phase.

11. The implant of claim 10, wherein the second phase acts as a delayed porosifying agent.

12. The implant of claim 8, wherein the implant additionally comprises non-soluble chips or granules blended within said first phase as an admixture.

13. The implant of claim 12, wherein the granules or chips are in the form of spheres.

14. The implant of claim 13, wherein the granules or chips are in the form of micro spheres.

15. The implant of claim 12, wherein the granules or chips are composed of ceramic.

16. The implant of claim 15, wherein the ceramic is a tricalcium phosphate.

17. The implant of claim 16, wherein the tricalcium phosphate is porous.

18. The implant of claim 12, wherein the granules or chips comprise bone.

19. The implant of claim 18, wherein the bone has been demineralized.

20. The implant of claim 12, wherein the granules or chips improve the mechanical, biological or resorption characteristics of said implant.

21. The implant of claim 8, wherein the matrix further comprises biologically active or pharmaceutical agent.

22. The implant of claim 21, wherein the agent is added to the implant at, or immediately prior to placement of said implant into said tissue.

23. The implant of claim 22, wherein the agent comprises at least one of a biologically active agent, a pharmaceutical, and an active agent.

24. The implant of claim 23, wherein the biologically active agent comprises cells.

25. The implant of claim 24, wherein the cells are supplied as a constituent of blood or bone marrow.

26. In combination with the implant of claim 8, a syringe, wherein the conformable, multi-phasic implant is arranged to be stored and delivered with said syringe.

27. In combination with the implant of claim 8, a syringe-like cylindrical housing, wherein the conformable, multi-phasic implant is arranged to be stored and delivered with said syringe-like cylindrical housing.

28. In combination with the implant of claim 27, a laproscopic cannula or incision comprising a channel, wherein the cylindrical housing comprises a cross-sectional configuration which is arranged to permit sliding passage through the channel.