Method and apparatus for resurfacing an articular surface

• US 10,583,220 B2
• Filed: 08/11/2003
• Issued: 03/10/2020
• Est. Priority Date: 08/11/2003
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Inventors: Binette, Francois, Lu, Ed Yiling
• Primary Examiner(s): Pellegrino, Brian E
• Application Number:
  US10/638,562
• Publication Number:
  US 20050038520A1
• Time in Patent Office: 6,056 Days
• Field of Search: 623 1412, 623 2372- 2376
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30225 Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30751 for attaching cartilage scaffolds to underlying bone
• CPC Class Codes: A61F 2002/30764 Cartilage harvest sites
• CPC Class Codes: A61F 2002/30766 Scaffolds for cartilage ingrowth and regeneration
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61L 2430/06 for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 27/3654 Cartilage, e.g. meniscus
• CPC Class Codes: A61L 27/38 containing added animal cells organs or tissue containing native cells A61L27/36

Abstract

A biocompatible, bioresorbable tissue repair implant or scaffold device is provided for use in repairing a variety of cartilage tissue injuries, and particularly for resurfacing and/or repairing damaged or diseased cartilage. The repair procedures may be conducted with tissue repair implants that contain a biological component that assists in delaying or arresting the progression of degenerative joint diseases and in enhancing tissue healing or repair. The biocompatible, bioresorbable tissue repair implants include a scaffold and particles of viable tissue derived from cartilage tissue, such that the tissue and the scaffold become associated. The particles of living tissue contain one or more viable cells that can migrate from the tissue and populate the scaffold.

Claims

1. A method for resurfacing a diseased or damaged articular surface in a patient, comprising the steps of:

providing a biocompatible, bioresorbable scaffold, the scaffold comprising a flexible sheet;

collecting and mincing living tissue comprising viable cells to form a plurality of minced tissue fragments having an effective amount of said viable cells such that said viable cells can migrate out of the minced tissue fragments and populate the scaffold, the plurality of minced tissue fragments comprising particles in the range from at least about 0.1 mm³ to at least about 3 mm³;

immediately following the mincing step, associating the scaffold with at least one of the plurality of minced tissue fragments, wherein the at least one of the plurality of minced tissue fragments is distributed on a surface of the scaffold, thus forming a tissue repair implant;

following the associating, placing at least one layer of a retaining element over at least a portion of the scaffold;

preparing the articular surface to receive the tissue repair implant, wherein the surface area of the prepared articular surface is in the range of about 10 cm² to about 20 cm²;

after the placing and immediately after preparing the articular surface, implanting the tissue repair implant onto the prepared articular surface, wherein the scaffold is configured to (i) substantially conform to the prepared articular surface and (ii) substantially cover an entire surface area of the prepared articular surface; and

securing the tissue repair implant in place using at least one mechanical biocompatible, fastening agent;

wherein the tissue repair implant includes at least one biological component in association with the scaffold;

wherein the biocompatible scaffold further comprises at least one additional biological component applied thereto; and

wherein the at least one additional biological component comprises platelets, and further wherein the platelets are delivered in a biological or synthetic hydrogel selected from the group consisting of alginate, cross-linked alginate, hyaluronic acid, collagen gel, fibrin glue, fibrin clot, poly(N-isopropylacrylamide), agarose, chitin, chitosan, cellulose, polysaccharides, poly(oxyalkylene), a copolymer of poly(ethylene oxide)-poly(propylene oxide), poly(vinyl alcohol), polyacrylate, platelet poor plasma (PPP) clot, laminin, solubilized basement membrane, and combinations thereof.

2. The method of claim 1, wherein the biological component further includes an activator of platelets.

3. The method of claim 2, wherein the activator of platelets is selected from the group consisting of thrombin, adenosine di-phosphate (ADP), collagen, epinephrine, arachidonic acid, ristocetin, and combinations thereof.

4. A method for resurfacing a diseased or damaged articular surface in a patient, comprising the steps of:

providing a biocompatible, bioresorbable scaffold, the scaffold comprising a flexible sheet;

collecting and mincing living tissue comprising viable cells to form a plurality of minced tissue fragments having an effective amount of said viable cells such that said viable cells can migrate out of the minced tissue fragments and populate the scaffold, the plurality of minced tissue fragments comprising particles in the range from at least about 0.1 mm³ to at least about 3 mm³;

immediately following the mincing step, associating the scaffold with at least one of the plurality of minced tissue fragments, wherein the at least one of the plurality of minced tissue fragments is distributed on a surface of the scaffold, thus forming a tissue repair implant;

following the associating, placing at least one layer of a retaining element over at least a portion of the scaffold;

preparing the articular surface to receive the tissue repair implant, wherein the surface area of the prepared articular surface is in the range of about 10 cm² to about 20 cm²;

after the placing and immediately after preparing the articular surface, implanting the tissue repair implant onto the prepared articular surface, wherein the scaffold is configured to (i) substantially conform to the prepared articular surface and (ii) substantially cover an entire surface area of the prepared articular surface; and

securing the tissue repair implant in place using at least one mechanical biocompatible, fastening agent;

wherein the tissue repair implant includes at least one biological component in association with the scaffold; and

wherein the biocompatible scaffold further comprises an adhesion agent for anchoring a suspension of tissue fragment to the biocompatible scaffold.

5. The method of claim 4, wherein the adhesion agent comprises an anchoring agent selected from the group consisting of hyaluronic acid, fibrin glue, fibrin clot, collagen gel, gelatin-resorcin-formalin adhesive, mussel-based adhesive, dihydroxyphenylalanine (DOPA) based adhesive, chitosan, transglutaminase, poly(amino acid)-based adhesive, cellulose-based adhesive, synthetic acrylate-based adhesives, platelet rich plasma (PRP), Matrigel, Monostearoyl Glycerol co-Succinate (MGSA), Monostearoyl Glycerol co-Succinate/polyethylene glycol (MGSA/PEG) copolymers, laminin, elastin, proteoglycans and combinations thereof.

6. The method of claim 4, wherein the adhesion agent comprises a chemical cross-linking agent selected from the group consisting of divinyl sulfone (DVS), polyethylene glycon divinyl sulfone (VS-PEG-VS), hydroxyethyl methacrylate divinyl sulfone (HEMA-DIS-HEMA), formaldehyde, glutaraldehyde, aldehydes, isocyanates, alkyl and aryl halides, imidoesters, N-substituted maleimides, acylating compounds, carbodiimide, hydroxychloride, N-hydroxysuccinimide, light, pH, temperature, and combinations thereof.

7. A method for resurfacing a diseased or damaged articular surface in a patient, comprising the steps of:

providing a biocompatible, bioresorbable scaffold, the scaffold comprising a flexible sheet;

collecting and mincing living tissue comprising viable cells to form a plurality of minced tissue fragments having an effective amount of said viable cells such that said viable cells can migrate out of the minced tissue fragments and populate the scaffold, the plurality of minced tissue fragments comprising particles in the range from at least about 0.1 mm³ to at least about 3 mm³;

immediately following the mincing step, associating the scaffold with at least one of the plurality of minced tissue fragments, wherein the at least one of the plurality of minced tissue fragments is distributed on a surface of the scaffold, thus forming a tissue repair implant;

following the associating, placing at least one layer of a retaining element over at least a portion of the scaffold;

preparing the articular surface to receive the tissue repair implant, wherein the surface area of the prepared articular surface is in the range of about 10 cm² to about 20 cm²;

alter the placing and immediately after preparing the articular surface, implanting the tissue repair implant onto the prepared articular surface, wherein the scaffold is configured to (i) substantially conform to the prepared articular surface and (ii) substantially cover an entire surface area of the prepared articular surface; and

securing the tissue repair implant in place using at least one mechanical biocompatible, fastening agent.