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-11672646-B2
Publication Date
2023-06-13
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 an implantable composite scaffold for soft-tissue repair/regeneration that includes a microporous matrix with a multitude of interconnected pores opening to an exterior surface of the microporous matrix. The microporous matrix is disposed within an interior space of a supporting structure, and the supporting structure comprises first and second outer layers separated by an interior space, and a plurality of spacer elements extending through the interior space and connecting the first and second outer layers.
The composite scaffold is configured to maintain a three-dimensional scaffold shape under tension and to resist compression. The disclosed arrangement of the microporous matrix within the interior space and the textile support structure enables cell infiltration and contiguous axial ingrowth while sharing mechanical load. The scaffold is further characterized by measurable dimensional stability in substantially dry state and defined dimensional change behavior upon fluid absorption.
The scaffold includes measurable properties that define its structural and transport characteristics, including surface area per unit weight, total pore volume, porosity, permeability, and pore-size distribution. The disclosed pore and dimensional characterization is supported by measurement approaches including Mercury Intrusion Porosimetry and other adsorption methods.
The invention further describes manufacturing approaches that form the microporous matrix and support structure, including use of a warp knitting 3D spacer textile with two outer layers and spacer elements, and formation of collagen microporosity via mold/lyophilization, along with optional crosslinking and hydrophilicity coatings.
Claims Coverage
The partial claim set provided includes three independent claims (clm-00001, clm-00006, and clm-00011). Each independent claim focuses on the same composite scaffold architecture with three inventive features, combined with quantified dimensional-stability relationships after fluid absorption.
Interconnected-pore microporous matrix supported within a three-dimensional textile interior space
A composite scaffold comprising a microporous matrix having a multitude of interconnected pores opening to an exterior surface of the microporous matrix, and a structure supporting the microporous matrix comprising first and second outer layers separated by an interior space and a plurality of spacer elements extending through the interior space and connecting the first and second outer layers, with the microporous matrix disposed within the interior space.
Dry weight to dry volume dimensional-stability range under fluid absorption
The composite scaffold has a measurable dry weight value and a measurable dry volume value in a substantially dry state, wherein an increase of between approximately 200% and 600% of the dry weight value from fluid absorption changes the dry volume value between approximately 0% and 10%.
Dry weight to dry length dimensional-stability threshold under fluid absorption
The composite scaffold has a measurable dry weight value and a measurable dry length value in a substantially dry state, wherein an increase of between approximately 200% and 600% of the dry weight value from fluid absorption changes the dry length value by less than between approximately 0% and 3%.
Dry weight to cross sectional profile dimensional-stability range under fluid absorption
The composite scaffold has a measurable dry weight value and a measurable cross sectional profile value in a substantially dry state, wherein an increase of between approximately 300% and 600% of the dry weight value from fluid absorption changes the cross sectional profile value between approximately 0% and 3%.
Across the independent claims, the inventive concept is the composite scaffold architecture with interconnected pores supported within an interior space between first and second outer layers connected by spacer elements, together with quantified dimensional stability metrics after fluid absorption.
Stated Advantages
Provides measurable dimensional stability in response to fluid absorption, limiting dry volume change between approximately 0% and 10%.
Provides measurable dimensional stability in response to fluid absorption, with dry length change less than between approximately 0% and 3%.
Provides measurable dimensional stability in response to fluid absorption, with cross sectional profile change between approximately 0% and 3%.
Enables cell infiltration and contiguous axial ingrowth while sharing mechanical load.
Documented Applications
ACL augmentation/repair.
Rotator cuff augmentation/repair.
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