Implantable medical device with thermoplastic composite body and method for forming thermoplastic composite body
Inventors
Snell, Douglas • Ball, Robert • Roeder, Ryan K.
Assignees
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Publication Number
US-11911535-B2
Publication Date
2024-02-27
Expiration Date
Abstract
An implantable medical device is disclosed comprising a thermoplastic composite body having anterior, first lateral, second lateral, posterior, superior, and inferior surfaces, and at least one dense portion and at least one porous portion which are integrally formed. The at least one dense portion is formed of a first thermoplastic polymer matrix that is essentially non-porous, and which is continuous through a thickness dimension from the superior surface to the inferior surface. The at least one porous portion is formed of a porous thermoplastic polymer scaffold having a second thermoplastic polymer matrix which is continuous through the thickness dimension. A method for forming the thermoplastic composite body is disclosed comprising disposing a first powder mixture in a first portion of a mold, disposing a second powder mixture in a second portion of the mold, simultaneously molding the first powder mixture and the second powder mixture, and leaching porogen.
Core Innovation
An implantable medical device is provided that includes a thermoplastic composite body having an anterior surface, first and second lateral surfaces, a posterior surface, a superior surface, and an inferior surface. The thermoplastic composite body includes at least one dense portion formed of a first thermoplastic polymer matrix that is essentially non-porous and at least one porous portion formed of a porous thermoplastic polymer scaffold formed of a second thermoplastic polymer matrix.
The dense portion and the porous portion are integrally formed such that the thermoplastic composite body is a single continuous article. The structure is free of adhesive joints between the dense portion and the porous portion and free of mechanical joints between the dense portion and the porous portion. In certain configurations, the dense portion and the porous portion are continuous through a thickness dimension from the superior surface to the inferior surface.
The porous portion is characterized as a porous thermoplastic polymer scaffold having interconnected pores, and the dense portion is characterized as essentially non-porous with a thickness-continuous relationship. The document further describes dense and porous regions that are configured to provide mechanical support while reducing stress shielding and supporting osteointegration, including enhanced osteointegration using porous calcium-phosphate reinforced regions.
Claims Coverage
The patent includes two independent claims that cover an implantable thermoplastic composite device and a thermoplastic composite body with integrally formed dense and porous regions. Across the independent claims, there are two main inventive features: the integrally formed dense/porous thermoplastic composite article without adhesive or mechanical joints, and the continuous-through-thickness nature of both dense and porous portions.
Integrally formed dense and porous thermoplastic composite article without joints
An implantable medical device with a thermoplastic composite body having at least one dense portion formed of a first thermoplastic polymer matrix that is essentially non-porous and at least one porous portion formed of a porous thermoplastic polymer scaffold formed of a second thermoplastic polymer matrix, wherein the at least one dense portion and the at least one porous portion are integrally formed such that the thermoplastic composite body is a single continuous article free of adhesive joints between the at least one dense portion and the at least one porous portion and free of mechanical joints between the at least one dense portion and the at least one porous portion.
Continuous dense and porous portions through thickness dimension
A thermoplastic composite body having an anterior surface, first and second lateral surfaces, a posterior surface, a superior surface, and an inferior surface, wherein at least one dense portion formed of a first thermoplastic polymer matrix that is essentially non-porous is continuous through a thickness dimension from the superior surface to the inferior surface, and at least one porous portion formed of a porous thermoplastic polymer scaffold formed of a second thermoplastic polymer matrix is continuous through the thickness dimension from the superior surface to the inferior surface, and wherein the at least one dense portion and the at least one porous portion are integrally formed such that the thermoplastic composite body is a single continuous article free of adhesive joints between the at least one dense portion and the at least one porous portion and free of mechanical joints between the at least one dense portion and the at least one porous portion.
Across the independent claims, the core coverage is an integrally formed single continuous thermoplastic composite article with distinct essentially non-porous dense regions and porous scaffold regions without adhesive or mechanical joints. One independent claim further requires continuity of both regions through a thickness dimension from the superior surface to the inferior surface.
Stated Advantages
Provides mechanical support while reducing stress shielding/subsidence risk.
Enhances osteointegration via porous calcium-phosphate reinforced regions.
Improves imaging/radiolucency using PAEK/PEEK radiolucency.
Documented Applications
Spinal interbody fusion implant.
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