Reinforced foam implants with enhanced integrity for soft tissue repair and regeneration

• US 20060067967A1
• Filed: 11/16/2005
• Published: 03/30/2006
• Est. Priority Date: 12/21/2000
• Status: Active Grant

• Current Assignee: DePuy Mitek Incorporated (Johnson & Johnson)
• Original Assignee: DePuy Mitek Incorporated (Johnson & Johnson)
• Inventors: Binette, Francois, Hwang, Julia, Rezania, Alireza, Bowman, Steven M., Melican, Mora Calolynne, Bruker, Izi
• Granted Patent: US 8,691,259 B2
• Time in Patent Office: Days
• US Class Current: 424/422
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/3872 Meniscus for implantation between the natural bone surfaces
• 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 2002/30004 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30766 Scaffolds for cartilage ingrowth and regeneration
• CPC Class Codes: A61F 2002/3092 having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2240/004 Using a positive or negative model, e.g. moulds
• 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 2250/0023 differing in porosity
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 27/44 having a macromolecular matrix
• CPC Class Codes: A61L 27/446 : with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46
• CPC Class Codes: A61L 27/46 : with phosphorus-containing inorganic fillers
• CPC Class Codes: A61L 27/48 : with macromolecular fillers
• 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 31/127 : containing fillers of phosphorus-containing inorganic materials
• CPC Class Codes: A61L 31/128 : containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
• CPC Class Codes: A61L 31/129 : containing macromolecular fillers
• CPC Class Codes: A61L 31/146 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 : Materials at least partially resorbable by the body

Abstract

A biocompatible tissue repair stimulating implant or “scaffold” device is used to repair tissue injuries, particularly injuries to ligaments, tendons, and nerves. Such implants are especially useful in methods that involve surgical procedures to repair injuries to ligament, tendon, and nerve tissue in the hand and foot. The repair procedures may be conducted with implants that contain a biological component that assists in healing or tissue repair.

Claims

1. A method for making a reinforced foam, biocompatible tissue implant, comprising:

providing a solution of a foam forming polymeric material in a suitable solvent;

providing a mesh containing reinforcing material;

pressing flat the reinforcing material;

placing the reinforcing material in a mold in a desired position and at a desired orientation;

adding the solution to the mold in a controlled manner; and

lyophilizing the solution to obtain a tissue implant having a mesh reinforced foam component.

2. The method of claim 1, wherein the polymeric material includes a copolymer.

3. The method of claim 1, wherein the polymeric solution includes a blend of polymers or copolymers.

4. The method of claim 3, wherein the polymeric solution is a blend of ε

-caprolactone-co-glycolide and ε

-caprolactone-co-lactide at about a molar ratio in the range of about 50;

50.

5. The method of claim 3, wherein the polymeric solution is a 35:

65 copolymer of polyglycolic acid and polycaprolactone.

6. The method of claim 3, wherein the polyglycolic solution is a 50:

50 blend of a 35;

65 copolymer of polyglycolic acid and polycaprolactone and 40;

60 ε

-caprolactone-co-lactide.

7. The method of claim 1, wherein the solution further comprises biocompatible solid particles having an average diameter in the range of 50 microns to 1 mm, the solid particles being present at 1 to 50 percent by volume of the solution.

8. The method of claim 7, wherein the solid particles are selected from the group consisting of barium sulfate, demineralized bone, calcium phosphate particles, bioglass particles, calcium sulfate, calcium carbonate, leachable solids, particles of bioabsorbable polymers not soluble in the solvent system, biocompatible metals, bioinert ceramics, non-bioabsorbable polymers, and combinations thereof.

9. The method of claim 8, wherein the leachable solids are selected from the group consisting of non-toxic salts, monosaccharides, disaccharides, polysaccharides, and water soluble proteins.

10. The method of claim 8, wherein the biocompatible metals are selected from the group consisting of stainless steel, coblat chrome, titanium, and titanium alloys.

11. The method of claim 8, wherein the bioinert ceramics are selected from the group consisting of alumina, zirconia, and calcium sulfate.

12. The method of claim 8, wherein the non-bioabsorbable polymers are selected from the group consisting of polyvinylacetate, polymethylmethacrylate, silicone, polyethyleneoxide, polyethylene glycol, polyurethane, polyvinyl alcohol, fluorinated polymers, flurinated copolymers, cellulose, chitin, keratin, silk, and collagen.

13. The method of claim 1, wherein the reinforcing material is placed in the mold so as to be in a substantially flat position.

14. The method of claim 13, wherein the reinforcing material is, at least in part, suspended above a bottom portion of the mold.

15. The method of claim 13, wherein the solution is added to the mold in a manner in which air bubbles are not permitted to form.

16. The method of claim 15, wherein the mold is tilted while the solution is added.

17. The method of claim 1, wherein the polymeric material is a 35:

65 copolymer of polyglycolic acid and polycaprolactone and the reinforcing material is a polydioxanone mesh.

18. The method of claim 17, wherein the solvent is dioxane.

19. The method of claim 1, wherein one or more indicators is embedded within the implant in a direction indicative of a dimension of the implant having a desirable property.

20. The method of claim 1, wherein the reinforcing material is pressed flat using a heated press prior to its placement within the mold.