Granules of porous biocompatible materials

• US 8,927,022 B2
• Filed: 03/03/2010
• Issued: 01/06/2015
• Est. Priority Date: 11/25/2009
• Status: Active Grant

• Current Assignee: Healionics Corporation
• Original Assignee: Healionics Corporation
• Inventors: Maginness, Max, Marshall, Andrew, Glaister, Christine L., Alvarez, Michel
• Primary Examiner(s): Bredefeld, Rachael E
• Assistant Examiner(s): Lazaro, Dominic
• Application Number:
  US13/511,971
• Publication Number:
  US 20130022648A1
• Time in Patent Office: 1,770 Days
• Field of Search: None
• US Class Current: 424/489
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2400/10 Materials for lubricating medical devices
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• 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

Abstract

The disclosure provides granular forms of porous biomaterials and methods for forming and applying these biomaterials, including uses to promote vascularization and tissue ingrowth.

Claims

1. A composition comprising a plurality of granules suspended in a biocompatible fluid the plurality of granules consisting of a porous synthetic polymer, the porous synthetic polymer having a plurality of substantially connected pores, wherein pores within the granules range from about 20 μ

m to about 90 μ

m in diameter and wherein each granule has a volume that is at least the volume of a sphere of at least about 0.1 mm diameter equivalent and not more than the volume of a sphere of about 2 mm diameter equivalent, wherein the granules are capable of being recoverably compressed, and wherein the porous synthetic polymer is selected from the group consisting of poly (2-hydroxyethyl methacrylate) (HEMA), medical-grade silicone, poly (epsilon-caprolactone) dimethylacrylate, polysulfone, (poly)methyl methacrylate (PMMA), soluble copolymers of tetrafluoroethylene and perfluoro-2,2-dimethyl- 1,3-dioxole, polyethylene teraphthalate (PET), nylon, polyvinyl alcohol, polyurethane, and mixtures thereof.

2. The composition of claim 1, wherein the volume of an individual granule is not more than the volume of a sphere of about 1 mm diameter equivalent.

3. The composition of claim 1, wherein the volume of an individual granule is at least the volume of a sphere of about 0.1 mm diameter equivalent and not more than the volume of a sphere of about 0.4 mm diameter equivalent.

4. The composition of claim 1, wherein each granule has an internal porosity of about 60% to about 75%.

5. The composition of claim 1 wherein each granule has an aspect ratio of not more than 5.

6. The composition of claim 1 wherein the pores within each granule have a mean diameter of between about 20 μ

m and 40 μ

m.

7. The composition of claim 1 wherein two connecting pores within a granule define a throat diameter that is about 15% to 40% of the diameter of each of the two connecting pores.

8. The composition of claim 1, wherein the biocompatible fluid is bioresorbable.

9. The composition of claim 1, wherein the biocompatible fluid comprises sodium hyaluronate or saline.

10. The composition of claim 1, wherein the composition is injectable through a needle having a lumen smaller than the smallest diameter equivalent of the granules.

11. The composition of claim 1, wherein the biocompatible liquid is bioactive or comprises a bioactive ingredient.

12. The composition of claim 11, wherein the bioactive ingredient is an antibiotic, a drug, or a growth factor.

13. the composition of claim 1, wherein the porous synthetic polymer is medical grade silicone.

14. The composition of claim 1, wherein the porous synthetic polymer is poly (2-hydroxethyl methacrylate).

15. The composition of claim 1, wherein the composition further comprises a drug or a sensor of a body condition.

16. The composition of claim 1, wherein the composition is suitable for effecting tissue ingrowth when introduced into soft tissue.