Multi-phased, biodegradable and osteointegrative composite scaffold for biological fixation of musculoskeletal soft tissue of bone

• US 8,802,122 B2
• Filed: 12/22/2009
• Issued: 08/12/2014
• Est. Priority Date: 03/05/2004
• Status: Expired due to Fees

• Current Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Original Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Inventors: Lu, Helen H., Spalazzi, Jeffrey, Dionisio, Kathie
• Primary Examiner(s): DESAI, ANAND U
• Application Number:
  US12/655,193
• Publication Number:
  US 20100291178A1
• Time in Patent Office: 1,694 Days
• Field of Search: None
• US Class Current: 424/423
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues
• 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 2002/30028 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
• CPC Class Codes: A61F 2002/30059 differing in bone mineralization, e.g. made from both mineralized and demineralized adjacent parts
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30327 differing in diameter
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/3093 for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• 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 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0051 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61L 2430/30 : for muscle reconstruction
• CPC Class Codes: A61L 2430/34 : for soft tissue reconstruction
• CPC Class Codes: A61L 27/12 : Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: A61L 27/3839 : characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3891 : as distinct cell layers
• 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

Abstract

Methods and apparatuses are provided for musculoskeletal tissue engineering. For example, a scaffold apparatus is provided which comprises microspheres of selected sizes and/or composition. The microspheres are layered to have a gradient of microsphere sizes and/or compositions. The scaffold provides a functional interface between multiple tissue types.

Claims

1. A scaffold apparatus for musculoskeletal tissue engineering, said apparatus comprising three or more phases, a first end designed to promote growth and maintenance of bone tissue and a second end opposite the first end designed to promote growth and maintenance of a tissue which is other than bone tissue, wherein at least one of the three or more phases comprises a porous fiber mesh formed from degradable electrospun polymer fiber.

2. The scaffold apparatus of claim 1, wherein the scaffold apparatus promotes growth and maintenance of soft tissue and bone.

3. A scaffold apparatus for soft tissue-to-bone interface tissue engineering comprising:

a first region comprising composite microspheres of a first size and composition optimized to promote growth, proliferation, and differentiation of a first cell type for integration and growth of bone;

a second region joined to the first region, said second region comprising microspheres and/or a fibrous mesh, said microspheres and/or fibrous mesh having a second size and a second composition;

a third region joined to the second region, said third region comprising microspheres and/or a fibrous mesh, said microspheres and/or fibrous mesh having a third size and a third composition, and said second and third regions being optimized to promote growth, proliferation and differentiation of a second cell type for integration and formation of a first soft tissue and/or bone; and

a fourth region joined to the third region, said fourth region comprising microspheres and/or a fibrous mesh, said microspheres and/or fibrous mesh having a composition adapted to promote growth, proliferation, and differentiation of a third cell type for integration and growth of a second soft tissue and/or bone.

4. The scaffold apparatus of claim 3, wherein said first, second, third and fourth regions are joined together through one of a solid state sintering process and a solvent aggregation process, in which selected growth factors or bioactive agents are incorporated into each region to promote formation, growth and integration of bone and said first and second soft tissues.

5. The scaffold apparatus of claim 3, wherein said composite microspheres of said first region include a range of sizes.

6. The scaffold apparatus of claim 3, wherein said microspheres and/or fibrous mesh of said second region include a range of sizes.

7. The scaffold apparatus of claim 3, wherein said microspheres and/or fibrous mesh of said second region include a gradient of sizes.

8. The scaffold apparatus of claim 3, wherein said microspheres and/or fibrous mesh of said second region include a gradient of compositions.

9. The scaffold apparatus of claim 3, wherein said microspheres and/or fibrous mesh of said third region include a range of sizes.

10. The scaffold apparatus of claim 3, wherein said microspheres and/or fibrous mesh of said third region include a gradient of sizes.

11. The scaffold apparatus of claim 3, wherein said microspheres and/or fibrous mesh of said third region include a gradient of compositions.

12. The scaffold apparatus of claim 3, wherein said fibrous mesh is electrospun.

13. The scaffold apparatus of claim 3, wherein said scaffold apparatus is integrated in a graft collar.