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Publication Number
US-11179243-B2
Publication Date
2021-11-23
Expiration Date
Abstract
Implantable devices for orthopedic, including spine and other uses are formed of porous reinforced polymer scaffolds. Scaffolds include a thermoplastic polymer forming a porous matrix that has continuously interconnected pores. The porosity and the size of the pores within the scaffold are selectively formed during synthesis of the composite material, and the composite material includes a plurality of reinforcement particles integrally formed within and embedded in the matrix and exposed on the pore surfaces. The reinforcement particles provide one or more of reinforcement, bioactivity, or bioresorption.
Core Innovation
The invention relates to implantable orthopedic porous reinforced polymer scaffolds comprising a thermoplastic polymer matrix and a substantially continuously interconnected pore network formed by voids interconnected by struts. Reinforcement particles are distributed throughout the thermoplastic polymer matrix and are both embedded within the thermoplastic polymer matrix and exposed on the struts within the pore voids.
The scaffold includes at least two regions, including a central region and an outer region surrounding a perimeter of the central region, where porosity is different between the central region and the outer region. The porosity and pore size are tailored to enable mechanical property matching to bone and to reduce stress shielding/subsidence, while supporting osteoconduction/vascularization.
The scaffold can be implemented in implantable spinal fusion/interbody spinal fusion cages, including functionally graded porosity that can vary radially from the central region to the outer region, where the outer region is relatively less porous and more dense than the central region prior to implantation and upon implantation. The thermoplastic polymer matrix can include polyaryletherketone, polyetheretherketone, polyetherketonekteone, or polyetherketone, and the reinforcement particles can include anisometric calcium phosphate, including hydroxyapatite whiskers.
Claims Coverage
The document includes two independent claims: clm-00001 and clm-00014. Across these claims, there are two principal inventive features: a porous reinforced composite scaffold with embedded reinforcement particles that are also exposed on pore struts within a substantially continuously interconnected pore network, and regionally differentiated porosity between a central region and an outer region, including radial variation where the outer region is relatively less porous and more dense.
Regionally differentiated porous reinforced scaffold with exposed embedded reinforcement
An implantable device comprising at least two regions including a central region and an outer region surrounding a perimeter of the central region, wherein at least one region comprises a porous reinforced composite scaffold material having a thermoplastic polymer matrix, a plurality of reinforcement particles distributed throughout the thermoplastic polymer matrix, and a substantially continuously interconnected plurality of pores distributed throughout the thermoplastic polymer matrix, each pore defined by voids interconnected by struts, and wherein the reinforcement particles are both embedded within the thermoplastic polymer matrix and exposed on the struts within the pore voids.
Porosity differs between central and outer regions
The implantable device wherein the porosity of the central region is different from the porosity of the outer region; wherein prior to implantation and upon implantation, the porosity of the two regions varies radially from the central region to the outer region and the outer region is relatively less porous and more dense than the central region.
Spinal fusion device with anisometric calcium phosphate reinforcement
An implantable spinal fusion device comprising a central region having a central void and comprising a porous reinforced composite scaffold material comprising a thermoplastic polymer matrix comprising one of polyaryletherketone, polyetheretherketone, polyetherketonekteone, and polyetherketone, and a plurality of anisometric reinforcement particles comprising calcium phosphate distributed throughout the thermoplastic polymer matrix, and a substantially continuously interconnected plurality of pores defined by voids interconnected by struts, wherein reinforcement particles are both embedded within the thermoplastic polymer matrix and exposed on the struts within the pore voids.
Overall, claim coverage centers on a porous reinforced composite scaffold in which reinforcement particles are embedded and also exposed on struts within a continuously interconnected pore network, combined with a device architecture having different porosity between a central region and an outer region, including radial variation where the outer region is relatively less porous and more dense than the central region. In the spinal fusion device claim, the scaffold specifies anisometric calcium phosphate reinforcement with the same embedded-and-exposed reinforcement structure.
Stated Advantages
Mechanical property matching to bone.
Reduction of stress shielding/subsidence.
Support of osteoconduction/vascularization.
Provision of reinforcement and bioactivity/bioresorption via reinforcement exposed on pore surfaces/struts.
Documented Applications
Spinal fusion cages/interbody spinal fusion.
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