Additively manufactured porous polymer medical implants
Inventors
Reith, Todd • Erbe, Erik • Linder, Eric • Heskett, Ryan
Assignees
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Publication Number
US-12263278-B2
Publication Date
2025-04-01
Expiration Date
Abstract
An article includes multiple layers of polyaryletherketone (PAEK), in which each layer is composed of a continuous length of PAEK, in which the continuous length of PAEK in at least one of the layers includes an interior portion, and an exterior surface including crystalline regions, in which a crystallinity of the exterior surface is higher than a crystallinity of the interior portion. The cross-sectional area of the continuous length of PAEK is non-uniform within each layer. Each layer defines a plane, and a portion of the continuous length of PAEK in each layer extends out of the plane defined by the layer. The multiple layers of PAEK define a network of interconnected pores.
Core Innovation
The invention relates to an article comprising multiple layers of polyaryletherketone (PAEK), where each layer is composed of a continuous strand of PAEK. At least one layer includes a continuous strand with an interior portion and an exterior surface that includes crystalline regions, and the crystallinity of the exterior surface is higher than the crystallinity of the interior portion.
The article further defines material and geometry features that produce a porous architecture. The cross-sectional area of the continuous strand of PAEK is non-uniform within each layer, and the multiple layers of PAEK define a network of interconnected pores.
The disclosed porous PAEK architecture is positioned for medical-implant use. The document describes additively manufactured porous medical implants made from multilayer PAEK/PEEK in which the strand interior and exterior exhibit different amorphous and crystalline characteristics, and the exterior provides surface roughness.
Claims Coverage
The document contains two independent claims: an article claim defining a multilayer PAEK porous structure, and a method claim focused on implanting that article. Across both independent claims, the coverage centers on three inventive features, with the method claim additionally requiring implantation in a patient.
Multiple layers of PAEK with interior/exterior crystallinity contrast
Multiple layers of polyaryletherketone (PAEK), in which each layer is composed of a continuous strand of PAEK, in which the continuous strand of PAEK in at least one of the layers comprises an interior portion and an exterior surface including crystalline regions, in which a crystallinity of the exterior surface is higher than a crystallinity of the interior portion.
Non-uniform continuous strand cross-sectional area
In which the cross-sectional area of the continuous strand of PAEK is non-uniform within each layer.
Network of interconnected pores defined by the layers
In which the multiple layers of PAEK define a network of interconnected pores.
Implanting the PAEK article in a patient
Implanting, in a patient, an article comprising multiple layers of polyaryletherketone (PAEK) with continuous strands having an interior portion and an exterior surface including crystalline regions, wherein the crystallinity of the exterior surface is higher than the crystallinity of the interior portion; wherein the cross-sectional area of the continuous strand of PAEK is non-uniform within each layer; and wherein the multiple layers of PAEK define a network of interconnected pores.
Overall claim coverage is grounded in multilayer PAEK articles having a continuous-strand interior/exterior crystallinity gradient, non-uniform strand cross-sectional area within each layer, and a porous network of interconnected pores; the second independent claim limits the use to implanting the article in a patient.
Stated Advantages
Supports bone ingrowth and osseointegration as characterized in the document.
Provides osteoconductive/osseointegrative/osteogenic and immunomodulatory/osteoinduction positioning as stated in the document.
Documented Applications
Implantation of the disclosed porous multilayer PAEK/PEEK article in a patient for medical implantation, including evaluation via in vivo sheep implantation with histology and micro-CT, with/without hydroxyapatite coating.
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