Kits and materials for implantable collagen devices

• US 10,689,621 B2
• Filed: 12/15/2017
• Issued: 06/23/2020
• Est. Priority Date: 11/02/2011
• Status: Active Grant

• Current Assignee: Mimedx Group Incorporated
• Original Assignee: Mimedx Group Incorporated
• Inventors: Koob, Thomas J.
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US15/843,695
• Publication Number:
  US 20180127711A1
• Time in Patent Office: 921 Days
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61L 2430/10 for reconstruction of tendons or ligaments
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/386 Ligaments, tendons
• CPC Class Codes: C12N 2506/1307 from adult fibroblasts
• CPC Class Codes: C12N 2506/1346 from mesenchymal stem cells
• CPC Class Codes: C12N 2527/00 Culture process characterised by the use of mechanical forces, e.g. strain, vibration
• CPC Class Codes: C12N 2533/54 Collagen; Gelatin
• CPC Class Codes: C12N 5/066 Tenocytes; Tendons, Ligaments

Abstract

The invention relates to implantable collagen devices made by seeding at least one elongate collagen construct, e.g., comprising at least one elongate synthetic collagen fiber with a plurality of cells and applying a strain and/or stress to the at least one elongate collagen fiber to induce the cells to differentiate into target phenotypes, e.g., tendon or ligament phenotype cells (and/or fibroblasts), typically with an extracellular matrix of collagen to organize into a tissue on the at least one collagen fiber.

Claims

1. A medical kit, comprising:

a single-use flexible package holding a collagen construct comprising a plurality of synthetic elongate collagen fibers, wherein the plurality of synthetic elongate collagen fibers comprise ligament or tendon phenotype cells, and wherein the tendon or ligament phenotype cells extend over at least 50% of a length of the collagen fibers.

2. The medical kit claim 1, wherein the plurality of synthetic elongate collagen fibers are cross-linked with NDGA, and wherein the tendon or ligament phenotype cells cover at least a major portion of a surface area of each of the synthetic elongate collagen fibers for at least 50% of the length of the plurality of synthetic elongate collagen fibers.

3. The medical kit of claim 1, wherein the plurality of synthetic elongate collagen fibers are wound, braided, twisted and/or woven together.

4. The medical kit of claim 1, wherein the collagen construct is a tendon or ligament prosthesis and has a tensile strength, stiffness, and dynamic flexibility that meets or exceeds that of a natural tissue the collagen construct is designed to mimic.

5. The medical kit of claim 1, wherein the cells are differentiated cells derived from cells selected from the group consisting of embryonic, neonatal or adult cells, pluripotent stem cells, mesenchymal stem cells, tendon and/or ligament fibroblasts, or combinations thereof.

6. The medical kit of claim 1, wherein the plurality of elongate collagen fibers include the tendon phenotype cells and at least 20% extracellular matrix of collagen by volume, dry.

7. The medical kit of claim 1, wherein the plurality of synthetic elongate collagen fibers are derived from soluble collagen and define a construct body with a shape as the collagen construct, and wherein the construct body includes the tendon or the ligament phenotype cells and an extracellular matrix of collagen, in an amount between about 20% to 200% by volume of the construct body, dry.

8. A medical kit, comprising:

a single-use flexible package holding a collagen construct comprising a plurality of elongate collagen fibers, wherein the elongate collagen fibers comprise ligament or tendon phenotype cells, and wherein the tendon or ligament phenotype cells extend over at least 50% of a length of the collagen fibers,

wherein the elongate collagen fibers of the construct further comprise an extracellular matrix comprising collagen, and wherein collagen is present in the extracellular matrix in an amount greater than other extracellular matrix proteins.

9. The medical kit of claim 8, wherein the plurality of elongate collagen fibers is between 2-1000.

10. The medical kit of claim 8, wherein the plurality of elongate collagen fibers are arranged as a construct body providing the collagen construct, and wherein the attached tendon or ligament phenotype cells and extracellular matrix comprising collagen are organized into tendon-like or ligament-like tissue that increases a volume of the construct body, measured dry, by between about 20-200%, or that increases a thickness of the construct body by between 10%-200%.

11. A medical kit, comprising:

a single-use flexible package holding a collagen construct comprising a plurality of elongate collagen fibers, wherein the elongate collagen fibers comprise ligament or tendon phenotype cells, and wherein the tendon or ligament phenotype cells extend over at least 50% of a length of the collagen fibers,

wherein the flexible package is or comprises a polymeric pouch, the kit further comprising an auto-tensioner releasably attached to the pouch to apply a maintenance strain and/or stress to the collagen construct.