Granules of porous biocompatible materials

Inventors

Maginness, MaxMarshall, AndrewGlaister, Christine L.Alvarez, Michel

Assignees

Healionics Corp

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Publication Number

US-8927022-B2

Patent

Publication Date

2015-01-06

Expiration Date


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.

Core Innovation

The invention provides a composition comprising a plurality of granules suspended in a biocompatible fluid. The granules consist of a porous synthetic polymer having a plurality of substantially connected pores, and each granule is capable of being recoverably compressed. The pores within the granules range from about 20 μm to about 90 μm in diameter, and 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.

The porous synthetic polymer is selected from poly(2-hydroxyethyl methacrylate) (HEMA), medical-grade silicone, poly(ε-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. The defined pore size and granule volume provide a recoverably compressible particulate structure made of porous synthetic polymer with substantially connected pores.

In the disclosed context, the granules are arranged to create interstitial spaces between granules, enabling larger vessel formation between granules and extending tissue ingrowth beyond prior limits. The compositions are delivered as wet slurries or dry forms and are optionally injectable.

Claims Coverage

The independent claim provides a composition definition for recoverably compressible porous-polymer granules in a biocompatible fluid, with size and pore constraints and porous polymer material identity. The inventive features supported across the input are eight.

Recoverably compressible porous synthetic polymer granules in biocompatible fluid

A composition comprising a plurality of granules suspended in a biocompatible fluid, where the plurality of granules consist of a porous synthetic polymer having a plurality of substantially connected pores, and the granules are capable of being recoverably compressed.

Granule porous structure with defined pore and granule-volume ranges

Pores within the granules range from about 20 μm to about 90 μm in diameter, and 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.

Porous synthetic polymer selection

The porous synthetic polymer is selected from the group consisting of poly(2-hydroxyethyl methacrylate) (HEMA), medical-grade silicone, poly(ε-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.

Needle-lumen injectability constraint tied to granule diameter equivalent

The granules are injectable through a needle whose lumen is smaller than the smallest diameter equivalent of the granules.

Internal porosity range of the granules

Each granule has internal porosity of about 60% to about 75%.

Inter-pore throat geometry constraint relative to connecting pore diameter

The granule composition has two connecting pores within a granule that define a throat diameter about 15% to 40% of the diameter of each connecting pore.

Bioactive or bioactive-ingredient biocompatible fluid

The biocompatible liquid is either bioactive or contains a bioactive ingredient.

Tissue ingrowth in soft tissue context

The composition is suitable for effecting tissue ingrowth when introduced into soft tissue.

Across the independent claim and refinements, the core coverage is a recoverably compressible composition of granules made from a porous synthetic polymer with substantially connected pores, with specified pore diameter and granule volume equivalence ranges, selected from enumerated polymer families. Dependent coverage further adds microstructural geometry constraints, injectability through needle-lumen constraints, specification of a bioactive biocompatible fluid, and suitability for tissue ingrowth in soft tissue.

Stated Advantages

Enables larger vessel formation between granules.

Extends tissue ingrowth beyond prior limits.

Provides early ingrowth/angiogenesis and later complete tissue ingrowth with larger vessels between granules.

Documented Applications

In vivo mice subcutaneous implantation with histology reporting early ingrowth/angiogenesis and later complete tissue ingrowth with larger vessels between granules.

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