System and method for attaching soft tissue to an implant

• US 20060105015A1
• Filed: 12/22/2004
• Published: 05/18/2006
• Est. Priority Date: 11/12/2004
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson), Purdue Research Foundation (The Trustees of Purdue University (d/b/a Purdue University))
• Original Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Inventors: Malaviya, Prasanna, Webster, Thomas J., Perla, Venu
• Granted Patent: US 8,329,202 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61F 2/30 Joints
• CPC Class Codes: A61F 2/30771 applied in original prostheses, e.g. holes or grooves
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30064 Coating or prosthesis-covering structure made of biodegradable material
• CPC Class Codes: A61F 2002/3084 Nanostructures
• CPC Class Codes: A61F 2002/3092 having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/30929 having at least two superposed coatings
• CPC Class Codes: A61F 2002/3093 for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61F 2310/00982 Coating made of collagen
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 2300/624 Nanocapsules
• CPC Class Codes: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 2400/18 : Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2430/02 : for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/04 : Metals or alloys
• CPC Class Codes: A61L 27/32 : Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: A61L 27/34 : Macromolecular materials
• CPC Class Codes: A61L 27/50 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• 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 31/022 : Metals or alloys
• 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 19/04 : for non-specific disorders of the connective tissue
• CPC Class Codes: C25D 11/02 : Anodisation
• CPC Class Codes: C25D 5/34 : Pretreatment of metallic surfaces to be electroplated
• CPC Class Codes: Y10T 428/24355 : Continuous and nonuniform or irregular surface on layer or component [e.g., roofing, etc.]

Abstract

One embodiment of the present invention is directed to compositions and methods for enhancing attachment of soft tissues to a metal prosthetic device. In one embodiment a construct is provided comprising a metal implant having a porous metal region, wherein said porous region exhibits a nano-textured surface, and a biocompatible polymer matrix coating the nano-textured surface. The polymer matrix coating comprises a naturally occurring extracellular matrix with biocompatible inorganic materials distributed within the matrix, or a biocompatible polymer and an osteo-inductive agent.

Claims

1. A construct for enhancing attachment of a soft tissue to a metal implant, said construct comprising

a metal implant comprising a porous region, wherein said porous region exhibits a nano-textured surface;

and

a calcified material layer coating the nano-textured surface.

2. The construct of claim 1 wherein the average maximum height of the protrusions comprising the nano-textured surface is selected from the range of about 50 nm to about 200 nm.

3. The construct of claim 1 wherein the calcified material layer consists essentially of nano-scale hydroxyapatite particles.

4. The construct of claim 1 wherein the calcified material layer consists essentially of nano-scale hydroxyapatite particles and one or more bioactive agents.

5. The construct of claim 1 wherein the calcified material layer further comprises a biocompatible polymer matrix.

6. The construct of claim 5 wherein the biocompatible polymer matrix comprises collagen fibers.

7. The construct of claim 4 wherein the calcified material layer further comprises a bioactive agent.

8. The construct of claim 4 wherein the calcified material layer further comprises exogenously added biocompatible inorganic material selected from the group consisting of hydroxyapatite, calcium phosphate, alpha-tricalcium phosphate, beta-tricalcium phosphate, calcium carbonate, barium carbonate, calcium sulfate, barium sulfate, polymorphs of calcium phosphate, sintered and non-sintered ceramic particles.

9. The construct of claim 1 wherein the calcified material layer comprises a collagen-based matrix and nano-scale hydroxyapatite crystals, wherein said crystals are located within the collagen-based matrix.

10. The construct of claim 2 wherein the calcified material layer comprises a naturally occurring extracellular matrix and an exogenously added biocompatible inorganic material.

11. The construct of claim 10 wherein the naturally occurring extracellular matrix comprises intestinal submucosa, and the exogenous biocompatible inorganic material comprises hydroxyapatite.

12. The construct of claim 11 wherein the intestinal submucosa is in a fluidized or gel form and the biocompatible inorganic material is dispersed within the intestinal submucosa.

13. A construct for enhancing attachment of soft tissue to a metal implant, said construct comprising

a metal implant comprising a porous region, wherein said porous region exhibits a nano-textured surface;

and

a biocompatible polymer matrix coating the nano-textured surface, wherein the biocompatible polymer matrix comprises a naturally occurring extracellular matrix and an exogenous biocompatible inorganic material.

14. The construct of claim 13 wherein the naturally occurring extracellular matrix comprises intestinal submucosa in gel form, wherein the biocompatible inorganic material is dispersed within the intestinal submucosa.

15. The construct of claim 14 wherein the exogenous biocompatible inorganic material comprises hydroxyapatite and the gelled intestinal submucosa is coated onto the nano-textured surface and dried.

16. The construct of claim 15 further comprising an extender layer coupled to said metal implant and in contact with said biocompatible polymer matrix, wherein said extender layer comprises a submucosal matrix, and a synthetic portion coupled to the submucosal matrix.

17. The construct of claim 16 wherein said synthetic portion comprises a mesh member wherein said mesh member is coated with a comminuted naturally occurring extracellular matrix.

18. A composite bioprosthetic comprising

a metal implant that comprises a porous region, wherein said porous region exhibits a nano-textured surface;

a calcified material layer coating the nano-textured surface; and

a scaffold layer comprising a biocompatible polymer matrix and growth factors, wherein at least a portion of said scaffold layer is in contact with said calcified material layer.

19. The composite bioprosthetic of claim 18 wherein the calcified material layer consists essentially of nano-scale hydroxyapatite particles.

20. The composite bioprosthetic of claim 18 wherein the calcified material layer comprises hydroxyapatite and a biocompatible polymer matrix.

21. The composite bioprosthetic of claim 20 wherein the calcified material layer further comprises an exogenously added bioactive agent.

22. The composite bioprosthetic of claim 18 wherein the calcified material layer comprises a naturally occurring extracellular matrix and exogenously added biocompatible inorganic material selected from the group consisting of hydroxyapatite, calcium phosphate, alpha-tricalcium phosphate, beta-tricalcium phosphate, calcium carbonate, barium carbonate, calcium sulfate, barium sulfate, polymorphs of calcium phosphate, sintered and non-sintered ceramic particles.

23. The composite bioprosthetic of claim 18 wherein the scaffold layer comprises a submucosal matrix.

24. The composite bioprosthetic of claim 23 further comprising an extender layer coupled to said scaffold layer, said extender layer comprising a submucosal matrix, and a synthetic mesh member coupled to the submucosal matrix.

25. The composite bioprosthetic of claim 24 wherein the submucosal matrix comprises intestinal submucosa.

26. The composite bioprosthetic of claim 25 wherein the submucosal matrix of the scaffold layer further comprises a compound selected from the group consisting of copper (II) sulfate pentahydrate (CUSO₄.5H₂O), copper (II) chloride hydrate (CuCl₂.2H₂O), iron-dextran, iron (II) sulfate heptahydrate (FeSO₄.7H₂O), manganese (II) sulfate monohydrate (MnSO₄, H₂O), magnesium sulfate heptahydrate (MgSO₄.7H₂O), magnesium phosphate dibasic trihydrate (MgHPO₄.3H₂O), glycine, proteoglycans, Vit A, Vit B, Vit C, Vit D and eicosapentaenoic acid.

27. A kit for repairing a diarthrodial joint, said kit comprising

a metal implant construct, said construct comprising

a metal implant comprising a porous region, wherein said porous region exhibits a nano-textured surface;

and

a calcified material layer coating the nano-textured surface; and

an extender graft comprising a naturally occurring extracellular matrix, and a mesh member coupled to the naturally occurring extracellular matrix.

28. The kit of claim 27 further comprising a scaffold element, wherein said scaffold element comprises a biocompatible polymer matrix and a bioactive agent.

29. The kit of claim 27 wherein the scaffold element comprises a submucosal matrix.

30. The kit of claim 27 wherein the calcified material layer consists essentially of nano-scale hydroxyapatite particles.

31. The kit of claim 27 wherein the calcified material layer comprises a naturally occurring extracellular matrix and exogenously added biocompatible inorganic material.

32. The kit of claim 31 wherein the intestinal submucosa of the naturally occurring extracellular matrix is prepared as a gel, with the biocompatible inorganic material dispersed within the naturally occurring extracellular matrix.

33. The kit of claim 32 wherein the biocompatible inorganic material comprises nano-scale hydroxyapatite crystals.

34. A method of attaching soft tissue to a metal implant, said method comprising the steps of

providing a metal implant construct, said construct comprising

a metal implant comprising a porous region, wherein said porous region exhibits a nano-textured surface;

and

a biocompatible polymer matrix coating the nano-textured surface, wherein the biocompatible polymer matrix comprises a naturally occurring extracellular matrix and an exogenously added biocompatible inorganic material;

coupling at least a portion of a scaffold layer to the metal implant and in contact with the biocompatible polymer matrix, wherein said scaffold layer comprises a biocompatible polymer matrix and a growth factor;

attaching the proximal end of an extender portion to the scaffold layer, wherein said extender portion comprises a submucosal matrix, and a synthetic portion coupled to the submucosal matrix, said synthetic portion including a mesh member wherein said mesh member is coated with a naturally occurring extracellular matrix; and

attaching the distal end of the extender portion to a patient'"'"'s soft tissue.