Composite scaffold for the repair, reconstruction, and regeneration of soft tissues
Inventors
Rocco, Kevin A. • Mohanraj, Bhavana • Ott, Jeffrey • Bendigo, Justin • Komenda, Jacob Edward • Aronson, Mark Theodore • Carter, Andrew James
Assignees
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Publication Number
US-11523895-B2
Publication Date
2022-12-13
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 scaffold structure for soft-tissue repair/reconstruction/regeneration in which a support structure includes first and second outer layers separated by an interior space. Spacer elements extend through the interior space and connect the outer layers, while a microporous matrix is disposed within the interior space between the outer layers. The scaffold is designed to maintain a three-dimensional configuration under tensile loading so that the support structure resists collapse or compression while providing interconnected void volume and high surface area.
The support structure is further characterized by a length dimension defined by first and second ends and a thickness dimension normal to the length dimension, with a performance requirement that the thickness dimension of the support structure changes less than approximately 10% upon elongation of the length dimension by approximately 5%. The scaffold includes interior void space containing microporous material so that pores provide interconnected pathways opening to an exterior surface for cell infiltration, ECM deposition, and oriented neo-tissue formation.
The composite scaffold incorporates material and structural options described as a flexible three-dimensional textile support combined with a highly porous secondary matrix, including collagen and polymer-based components such as PLLA fibers and PEG/PCL-derived hydrogels. The structure can include features such as spacer textile geometry with outer layers and spacer elements forming channels and interior pore matrix for transport and swelling/absorption/absorbance behavior. The disclosed scaffold performance is supported by quantitative ranges and tests, including increased tendon strength when augmented with the composite scaffold.
Claims Coverage
The claims include one independent claim defining the overall scaffold structure and thickness stability requirement, with dependent claim elements that further specify microporous connectivity and optional hydrophilic coating. The main inventive features are as follows.
Three-dimensional support with outer layers, interior space, and spacer elements
A support structure having a length dimension defined by first and second ends and a thickness dimension normal to the length dimension, further at least partially defined by first and second outer layers separated by an interior space therebetween, and a plurality of spacer elements extending through the interior space and connecting the first and second outer layers.
Microporous matrix disposed within the interior space
A microporous matrix disposed within the interior space between the first and second outer layers.
Thickness stability under elongation
Wherein the thickness dimension of the support structure changes less than approximately 10% upon elongation of the length dimension by approximately 5%.
Microporous matrix with interconnected pores open to exterior surface
The microporous matrix whose pores are interconnected and collectively open to an exterior surface.
Hydrophilic coating via hydrophilic solution
At least a portion coated with a hydrophilic solution.
Overall claim coverage centers on a composite scaffold structure with first and second outer layers separated by an interior space containing spacer elements and a microporous matrix, together with a thickness dimension stability requirement under specified elongation. Dependent aspects further narrow microporous matrix pore connectivity to interconnected pores opening to an exterior surface and optionally include coating at least a portion with a hydrophilic solution.
Stated Advantages
Maintains a scaffold thickness dimension by changing less than approximately 10% upon elongation of the length dimension by approximately 5%, supporting resistance to collapse/compression under tensile loading.
Provides interconnected void volume and high surface area to support cell infiltration and ECM deposition and oriented neo-tissue formation.
Increases tendon strength when augmented with the composite scaffold.
Documented Applications
Soft-tissue repair/reconstruction/regeneration, including ligament and tendon repair/reconstruction/regeneration.
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