Implantable medical device with varied composition and porosity, and method for forming same

Inventors

Farris, Jeffery ABrown, Kevin LeeSnell, Douglas B.Roeder, Ryan K.MESSMAN, Mark G.

Assignees

Happe Spine LLC

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Publication Number

US-11426904-B2

Patent

Publication Date

2022-08-30

Expiration Date


Abstract

A method for forming a thermoplastic body having regions with varied material composition and/or porosity. Powder blends comprising a thermoplastic polymer, a sacrificial porogen and an inorganic reinforcement or filler are molded to form complementary parts with closely toleranced mating surfaces. The parts are formed discretely, assembled and compression molded to provide a unitary article that is free from discernible boundaries between the assembled parts. Each part in the assembly has differences in composition and/or porosity, and the assembly has accurate physical features throughout the sections of the formed article, without distortion and nonuniformities caused by variable compaction and densification rates in methods that involve compression molding powder blends in a single step.

Core Innovation

The invention relates to forming a unitary article by providing at least two powder blends that differ in content of polymer powder, porogen powder, and inorganic particle powder. The powder blends are dispensed into at least one mold and compacted into two or more preforms, where the preforms are then machined into two or more parts with complementary mating surfaces and assembled before compression molding.

In particular, at least two parts are discretely formed from powder blends by compression molding or cold pressing, followed by machining each part to provide interfitting machined parts with complementary mating surfaces. The interfitting machined parts are assembled and compression molded to provide the unitary article consisting of materials from the at least two powder blends, free from discernible boundaries between portions derived from the interfitting machined parts.

The method is directed to implantable articles and includes using different powder blends to create at least one porous preform and a porous region in the unitary article. Porogen can be leached from the unitary article to form porous structures, and compression molding is applied at a specified pressure to prevent volumetric expansion during heating while preserving accurate geometry.

Claims Coverage

The provided partial content contains three independent claims. The independent claims cover methods for forming a unitary article from at least two differing powder blends by discretely forming and machining parts or preforms with complementary mating surfaces, assembling them, and using compression molding to obtain a unitary article without discernible boundaries, including porogen leaching or porous-region preservation.

Unitary article from differing powder blends assembled from complementary mating parts

Provide at least two powder blends that differ in polymer powder, porogen powder, inorganic particle powder, or combinations; dispense each powder blend into a mold; compact each into two or more preforms; machine the preforms into two or more parts with complementary mating surfaces; assemble the parts; compression mold the assembly into a unitary article consisting of materials from the at least two powder blends; and leach porogen from the unitary article.

Unitary article free of discernible boundaries formed from discretely formed parts with interfitting mating surfaces

Discretely form at least two parts from powder blends by compression molding or cold pressing, where each part is formed from a different powder blend selected from polymer powder, polymer+porogen, polymer+inorganic particles, or polymer+porogen+inorganic particles; machine each part to provide interfitting machined parts with complementary mating surfaces; assemble the interfitting machined parts; and compression mold the assembly to provide a unitary article free from discernible boundaries between portions derived from the interfitting machined parts.

Implantable unitary article with porous region derived from porous preform while eliminating discernible boundaries

Discretely form at least two parts from powder blends by compression molding or cold pressing, wherein one powder blend includes polymer powder and inorganic particle powder but does not include porogen powder and another powder blend includes polymer powder, porogen powder, and inorganic particle powder; compact the powder blends to densify at a selected pressure to provide at least two preforms comprising at least one porous preform; machine each porous preform to provide interfitting machined parts with complementary mating surfaces; assemble the interfitting machined parts; and compression mold the assembly to provide a unitary article free from discernible boundaries between portions derived from the interfitting machined parts, where compression is applied at a specified pressure to prevent volumetric expansion during heating and the portion corresponding to the porous preform comprises a porous region of the unitary article.

Across the independent claims, the core coverage is the fabrication of a unitary article or implantable unitary article from multiple powder blends by discretely forming and machining components to create complementary or interfitting mating surfaces, assembling them, and compression molding to eliminate discernible boundaries while preserving or creating porous regions derived from porogen-containing powder blends.

Stated Advantages

Unitary article is free from discernible boundaries between portions derived from adjacent machined parts.

Porous region is formed or preserved in the unitary article corresponding to a porous preform.

Compression molding is applied at a specified pressure to prevent volumetric expansion during heating.

Preserves accurate geometry and avoids distortion or nonuniformities.

Documented Applications

Implantable biomedical devices, including an interbody spinal fusion implant.

Implantable articles with through-porosity for bone ingrowth/osteointegration.

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