Bioprinted meniscus implant and methods of using same

Inventors

WADSWORTH, SamBEYER, SimonMohamed, TamerWALUS, KonradKAMAL KHAN, Mohammad MostofaKAPYLA, ElliHwang, JuliaAULT, Joe

Assignees

Aspect Biosystems LtdDePuy Synthes Products Inc

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Publication Number

US-12029834-B2

Patent

Publication Date

2024-07-09

Expiration Date


Abstract

Provided herein are meniscus implant compositions, as well as method for making and using the same. The subject meniscus implants find use in repairing and/or replacing damaged or diseased meniscal tissue in a mammalian subject.

Core Innovation

The invention relates to synthetic, bioprinted meniscus implants comprising a plurality of layers deposited by a bioprinter, where each layer comprises synthetic tissue fiber(s) including a solidified biocompatible matrix. At least one layer includes a reinforced composite hydrogel, and the reinforced composite hydrogel includes a hydrogel material selected from alginate and/or chitosan.

The hydrogel material is cross-linked with printing and is used as the basis for forming a double network hydrogel with added reinforcement materials. The reinforced composite hydrogel further includes at least one reinforcement material selected from PEGDA and/or PVA, where the reinforcement material is blended with the hydrogel material and cross-linked either simultaneously or sequentially with printing to form a double network hydrogel.

In additional embodiments, the reinforced composite hydrogel includes a first reinforcement material blended with the hydrogel material and cross-linked during or with printing, and a second reinforcement material that is added and cross-linked post-printing. The first and second reinforcement material can be the same and comprise PVA, or the first can comprise PVA and the second can comprise PEGDA, while forming the double network hydrogel.

The described bioprinted meniscus implants are presented as having multi-layer, multi-zone architectures based on the deposited synthetic tissue fiber(s) and solidified biocompatible matrix. The document characterizes reinforced composite hydrogel strategies using double-network hydrogel concepts, including cross-linking during printing and post-printing reinforcement incorporation.

Claims Coverage

The partial content provides two independent claims (clm-00001 and clm-00028). Across these independent claims, the coverage centers on a bioprinted, multi-layer meniscal implant where at least one layer uses a reinforced composite double network hydrogel based on an alginate/chitosan matrix with reinforcement material(s) (PEGDA and/or PVA) cross-linked during/with printing and optionally added and cross-linked post-printing.

Bioprinted multi-layer meniscal implant with synthetic tissue fibers and solidified matrix

A meniscal implant comprising a plurality of layers deposited by a bioprinter, each layer comprising synthetic tissue fiber(s) comprising a solidified biocompatible matrix, wherein the solidified biocompatible matrix in at least one layer comprises a reinforced composite hydrogel.

Alginate or chitosan hydrogel matrix cross-linked with printing and double network formation

A reinforced composite hydrogel comprising a hydrogel material selected from alginate and chitosan, where cross-linking of the hydrogel material occurs with printing, and a double network hydrogel formed by blending and cross-linking reinforcement material(s) with the hydrogel material either simultaneously or sequentially with printing.

Reinforcement strategy with first reinforcement blended and cross-linked with printing and second reinforcement added post-printing

A reinforced composite hydrogel comprising a hydrogel material selected from alginate and chitosan, a first reinforcement material blended with the hydrogel material and cross-linked simultaneously or sequentially with printing, and a second reinforcement material added and cross-linked post-printing, where the first and second reinforcement material are the same and comprise PVA or where the first comprises PVA and the second comprises PEGDA, and wherein a double network hydrogel is formed.

The independent claim set covers meniscal implants formed by bioprinting multiple layers of synthetic tissue fibers with a solidified alginate/chitosan matrix, where a reinforced composite hydrogel is implemented as a double network using PEGDA and/or PVA reinforcement. The claims distinguish reinforcement incorporation carried out during/with printing versus additional reinforcement added and cross-linked post-printing, including embodiments where the first and second reinforcement materials are both PVA or where the first is PVA and the second is PEGDA.

Stated Advantages

Improved mechanical properties are reported, including tensile/compressive/indentation strengths and suture pull-out performance targets, with comparisons among printed-only, cast, and composite tissues.

Secondary matrices (PEGDA or PVA) are described as improving stability and shear/indentation while maintaining suture retention, including addressing delamination issues noted in the partial content.

Documented Applications

The partial content describes cadaveric evaluation involving knee testing and assessments of delamination and related mechanical outcomes for the bioprinted meniscus implants.

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