Use of reinforced foam implants with enhanced integrity for soft tissue repair and regeneration

• US 6,884,428 B2
• Filed: 12/16/2002
• Issued: 04/26/2005
• Est. Priority Date: 12/21/2000
• Status: Expired due to Term

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: DePuy Mitek Incorporated (Johnson & Johnson)
• Inventors: Binette, Francois, Hwang, Julia, Rezania, Alireza, Melican, Mora Carolynne, Bowman, Steven M., Bruker, Izi
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): HOWARD, SHARON LEE
• Application Number:
  US10/320,751
• Publication Number:
  US 20030147935A1
• Time in Patent Office: 862 Days
• Field of Search: 424/422, 424/423, 424/424, 424/484, 424/485
• 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 biocompatible tissue repair stimulating implant, comprising:

a bioabsorbable polymeric foam component having pores with an open cell pore structure;

a reinforcing component formed of a biocompatible, mesh-containing material, wherein the foam component is integrated with the reinforcing component such that the pores of the foam component penetrate the mesh of the reinforcing component and interlock with the reinforcing component; and

at least one biological component in association with the implant, wherein the biological component is a growth factor or a source of growth factors.

2. The implant of claim 1, wherein the biological component is contained within pores of the foam component.

3. The implant of claim 1, wherein the source of growth factors includes platelets.

4. The implant of claim 1, wherein the biological component further includes an activator of platelets.

5. The implant of claim 4, 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.

6. The implant of claim 1, wherein the growth factor is selected from the group consisting of a transforming growth factor-β

, bone morphogenic protein, cartilage derived morphogenic protein, growth differentiation factor, fibroblast growth factor, platelet-derived growth factor, vascular endothelial cell-derived growth factor, epidermal growth factor, insulin-like growth factor, hepatocyte growth factor, and fragments and combinations thereof.

7. The implant of claim 1, wherein the growth factor is autologous.

8. The implant of claim 3, wherein the platelets are delivered to the implant with a material selected from the group consisting of plasma and fibrinogen.

9. The implant of claim 3, wherein the platelets are delivered in the form of a platelet rich plasma clot.

10. The implant of claim 3 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.

11. The implant of claim 1, wherein the foam component is present in one or more layers.

12. The implant of claim 11, wherein adjacent foam layers are integrated with one another by at least a partial interlocking of pores.

13. The implant of claim 1, wherein the reinforcing component is present in one or more layers.

14. The implant of claim 11, wherein separate foam layers are constructed of different polymers.

15. The implant of claim 14, wherein the properties of the foam component vary throughout a thickness dimension of the implant.

16. The implant of claim 15, wherein outer layers of the implant have a greater overall pore volume than does an inner region thereof.

17. The implant of claim 15, wherein an inner region of the implant has a greater overall pore volume than do outer layers of the implant.

18. The implant of claim 16, wherein the concentration of the biological component is greater in the outer layers than in the inner region.

19. The implant of claim 17, wherein the concentration of the biological component is greater in the inner region than in the outer layers.