Composite scaffold for the repair, reconstruction, and regeneration of soft tissues

Inventors

Rocco, Kevin A.Mohanraj, BhavanaOtt, JeffreyBendigo, JustinKomenda, Jacob EdwardAronson, Mark TheodoreCarter, Andrew James

Assignees

Conmed CorpBiorez Inc

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Publication Number

US-11957565-B2

Patent

Publication Date

2024-04-16

Expiration Date


Abstract

A composite scaffold having a highly porous interior with increased surface area and void volume is surrounded by a flexible support structure that substantially maintains its three-dimensional shape under tension and provides mechanical reinforcement during repair or reconstruction of soft tissue while simultaneously facilitating regeneration of functional tissue.

Core Innovation

The invention relates to a composite scaffold for soft-tissue repair and reconstruction that includes a microporous matrix with a multitude of interconnected pores opening to an exterior surface. A support structure defines an interior space volume between first and second outer layers that are spaced apart, and the microporous matrix is disposed within the interior space while maintaining a three-dimensional textile support architecture.

Spacer elements extend through the interior space volume between the first and second layers and are attached therebetween to maintain separation of the first and second layers. The scaffold is configured so that its cross-sectional area changes less than approximately 5% upon elongation of the length dimension by approximately 13%, and this dimensional stability under tension is used to resist compression and dimensional distortion while supporting mechanobiological load sharing and oriented tissue ingrowth.

The microporous matrix provides high surface area and interconnected pore/void volume for cell infiltration and ECM deposition, with bioresorbable components intended to minimize adverse responses during tissue regeneration. Quantitative architectural characteristics are emphasized, including void space volume, porosity, permeability, tortuosity, and pore size distributions, as well as dimensional changes and swelling/absorbance behavior, and the microporous matrix degrades faster than the textile support structure.

Claims Coverage

The document provides one independent claim and multiple dependent claims. The inventive coverage centers on combining a microporous matrix within an interior space defined by two outer layers of a support structure separated by spacer elements, together with a quantitative constraint that limits cross-sectional area change during elongation; additional dependent claims further specify dimensional stability metrics, modulus range and calculation basis, microporous matrix forms, and scaffold composition categories.

Microporous matrix in a separated, spacer-held textile support with elongation stability

A composite scaffold comprising a microporous matrix having a multitude of interconnected pores opening to an exterior surface; a support structure with a length dimension between first and second ends and a cross-sectional area normal to the length dimension, the support structure comprising first and second outer layers spaced apart to define an interior space volume therebetween, the microporous matrix disposed within the interior space; and a plurality of spacer elements extending through the interior space volume between the first and second layers and attached therebetween to maintain separation of the first and second layers, wherein the cross-sectional area changes less than approximately 5% upon elongation of the length dimension by approximately 13%.

Overall claim coverage requires a spacer-maintained separation between first and second outer layers of a support structure that contains a microporous matrix with interconnected pores, and it further requires minimal cross-sectional area change upon elongation; dependent claims additionally refine dimensional stability thresholds, specify a modulus range and its calculation basis, enumerate microporous matrix forms, and define composition categories.

Stated Advantages

Resists compression and dimensional distortion while maintaining scaffold 3D shape under tension.

Provides high surface area and interconnected pore/void volume for cell infiltration and ECM deposition.

Supports oriented tissue ingrowth and mechanobiological load sharing.

Uses bioresorbable components intended to minimize adverse responses.

Documented Applications

Ligament or tendon repair/augmentation and reconstruction, including ACL/rotator cuff and other listed soft tissues (MPFL, ATFL, CFL, UCL, and flexor tendon).

Tensile testing contexts showing scaffold augmentation effects, including increased strength when augmented.

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