System and method for attaching soft tissue to an implant comprising a nanotextured surface

• US 9,498,218 B2
• Filed: 01/22/2015
• Issued: 11/22/2016
• 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 Incorporated (Johnson & Johnson), Purdue Research Foundation (The Trustees of Purdue University (d/b/a Purdue University))
• Inventors: Venu, Perla, Malaviya, Prasanna, Webster, Thomas J.
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US14/603,080
• Publication Number:
  US 20150142126A1
• Time in Patent Office: 670 Days
• US Class Current: 1/1
• 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 the 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 kit for repairing a diarthrodial joint, the kit comprising:

a metal implant construct, the construct comprising

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

a calcified material layer coating the nano-textured surface;

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

a scaffold element, wherein the scaffold element comprises a biocompatible polymer matrix and a bioactive agent.

2. The kit of claim 1 wherein the scaffold element comprises a submucosal matrix.

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

4. A kit for repairing a diarthrodial joint, the kit comprising:

a metal implant construct, the construct comprising

a metal implant comprising a porous region, wherein the 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, wherein the calcified material layer comprises a naturally occurring extracellular matrix and exogenously added biocompatible inorganic material.

5. The kit of claim 4 wherein the naturally occurring extracellular matrix includes intestinal submucosa that is prepared as a gel, with the biocompatible inorganic material dispersed within the naturally occurring extracellular matrix.

6. The kit of claim 5 wherein the biocompatible inorganic material comprises nano-scale hydroxyapatite crystals.

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

providing a metal implant construct, the construct comprising

a metal implant comprising a porous region, wherein the 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 the scaffold layer comprises a biocompatible polymer matrix and a growth factor;

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

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