Porous composite biomaterials and related methods
Inventors
Roeder, Ryan K. • Converse, Gabriel L. • Smith, Stephen M.
Assignees
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Publication Number
US-12048633-B2
Publication Date
2024-07-30
Expiration Date
Abstract
A composite material for use, for example, as an orthopedic implant, that includes a porous reinforced composite scaffold that includes a polymer, reinforcement particles distributed throughout the polymer, and a substantially continuously interconnected plurality of pores that are distributed throughout the polymer, each of the pores in the plurality of pores defined by voids interconnected by struts, each pore void having a size within a range from about 10 to 500 nm. The porous reinforced composite scaffold has a scaffold volume that includes a material volume defined by the polymer and the reinforcement particles, and a pore volume defined by the plurality of pores. The reinforcement particles are both embedded within the polymer and exposed on the struts within the pore voids. The polymer may be a polyaryletherketone polymer and the reinforcement particles may be anisometric calcium phosphate particles.
Core Innovation
The invention relates to a porous reinforced composite scaffold for orthopedic implants that includes a thermoplastic polymer matrix defining a material volume and a plurality of reinforcement particles distributed in the matrix. The scaffold further includes a substantially continuously interconnected plurality of pores distributed throughout the thermoplastic polymer matrix, where each pore is defined by voids interconnected by struts.
At least a portion of the plurality of reinforcement particles is exposed on the struts within the pore voids. The scaffold structure is designed to provide bioactivity/bioresorption by exposing calcium-phosphate reinforcement particles on the struts within the pore voids, and the pore architecture can be tailored through reinforcement volume fraction, reinforcement particle morphology/orientation, and graded architecture, including microporosity.
The described scaffold includes embodiments using polymer matrix materials such as PEEK and PEKK, and calcium phosphate reinforcement particles such as hydroxyapatite. The disclosure further describes optional incorporation of a growth factor, including BMP, in pores/voids, and documented mechanical testing includes unconfined compression results for HA-whisker reinforced PEKK scaffolds.
Claims Coverage
The disclosed independent claims are clm-00001 and clm-00010. Across these independent claims, the core inventive coverage centers on a porous reinforced composite scaffold with a thermoplastic polymer matrix, substantially continuously interconnected pores defined by voids and struts, and exposed reinforcement particles on the struts within the pore voids, with clm-00010 further limiting non-equiaxed reinforcement and a specified pore size range.
Substantially continuously interconnected pores with voids interconnected by struts
A porous reinforced composite scaffold comprising a thermoplastic polymer matrix and a substantially continuously interconnected plurality of pores distributed throughout the thermoplastic polymer matrix, where each pore is defined by voids interconnected by struts.
Exposed reinforcement particles on struts within pore voids
A porous reinforced composite scaffold wherein at least a portion of the plurality of reinforcement particles is exposed on the struts within the pore voids.
Thermoplastic polymer matrix defining material volume and pore volume
A porous reinforced composite scaffold where the thermoplastic polymer matrix and the plurality of reinforcement particles define a material volume of the scaffold and the plurality of pores define a pore volume of the scaffold.
Non-equiaxed reinforcement present in specified material volume and pore size range
A porous reinforced composite scaffold wherein the plurality of reinforcement particles are non-equiaxed and present in the thermoplastic polymer matrix from about 1% to about 60% of the material volume, and each of the pores is defined by voids interconnected by struts and has a size within a range from about 10 μm to about 500 μm.
Independent claim coverage is directed to a porous reinforced composite scaffold combining a thermoplastic polymer matrix with a substantially continuously interconnected pore network defined by voids interconnected by struts and exposed reinforcement particles on the struts within pore voids. The second independent claim additionally requires non-equiaxed reinforcement in a specified material-volume range and pores having a specified 10–500 μm size range.
Stated Advantages
Bioactivity/bioresorption by exposing calcium-phosphate reinforcement particles on the struts within the pore voids.
Porosity tailored to match trabecular bone mechanical properties while reducing stress shielding.
Increasing porosity decreases compressive modulus and yield strength while adding HA increases modulus.
Documented Applications
Orthopedic implant use, including interbody spinal fusion cages.
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