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-11712332-B2
Publication Date
2023-08-01
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 provides a composite scaffold that includes a microporous matrix having a multitude of interconnected pores opening to an exterior surface and collectively defining void space having a measurable volume. The microporous matrix is disposed within an interior space of a structure that supports the microporous matrix, and the composite scaffold occupies a measurable volume and defines measurable void space parameters associated with the microporous matrix pores.
The structure supporting the microporous matrix includes first and second outer layers separated by an interior space, and a plurality of spacer yarns extending through the interior space and connecting the first and second outer layers. The plurality of spacer yarns comprises a second material different from the first material of the microporous matrix, and the microporous matrix is located within the interior space between the outer layers.
The invention emphasizes quantitative control of scaffold internal void space and related surface metrics. The volume of the microporous matrix void space per gram is limited to between approximately 3.0 cm3/gram and 9.0 cm3/gram, the measurable void space volume of the microporous matrix is between approximately 75% and 98% of a measurable volume of the composite scaffold, and the void space surface area to measurable volume ratio is between approximately 5,000 cm2/cm3 and 16,000 cm2/cm3.
Claims Coverage
The relevant independent claims define a composite scaffold architecture with a microporous matrix supported by a first/second outer-layer textile structure using spacer yarns, with different quantitative constraints applied to void volume and void-space surface metrics. Across these independent claims, there are three main inventive feature sets tied to void-space volume per gram, void-space volume fraction, and void-space surface area-to-volume ratio.
Microporous matrix supported within a first/second outer-layer interior space using spacer yarns of different material
A composite scaffold comprising a microporous matrix with interconnected pores defining void space, and a structure supporting the microporous matrix having first and second outer layers separated by an interior space with a plurality of spacer yarns extending through the interior space to connect the outer layers, wherein the spacer yarns comprise a second material different from the first material, and wherein the microporous matrix is disposed within the interior space.
Void space volume per gram constrained to a defined range
The composite scaffold wherein the volume of the microporous matrix void space per gram is between approximately 3.0 cm3/gram and 9.0 cm3/gram.
Void-space volume fraction constrained to a defined range of composite scaffold volume
A composite scaffold comprising a microporous matrix with interconnected pores defining void space volume and disposed within an interior space between first and second outer layers, supported by spacer yarns extending through the interior space to connect the outer layers, the spacer yarns comprising a second material different from the first material, wherein the measurable void space volume of the microporous matrix is between approximately 75% and 98% of a measurable volume of the composite scaffold.
Void space surface area to measurable volume ratio constrained to a defined range
A composite scaffold occupying a measurable volume and comprising a microporous matrix defining interconnected pores collectively defining void space having a void space surface area, and a structure supporting the microporous matrix with first and second outer layers separated by an interior space and spacer yarns extending through the interior space to connect the outer layers, the spacer yarns comprising a second material different from the first material, wherein the microporous matrix is disposed within the interior space, and wherein the void space surface area to measurable volume of the composite scaffold is between approximately 5,000 cm2/cm3 and 16,000 cm2/cm3.
Across the independent claims, the core scaffold concept is the combination of a microporous matrix with interconnected pores disposed within an interior space between first and second outer layers, where spacer yarns connect the outer layers and are formed from a different material than the microporous matrix. The claim coverage differentiates the scaffold by imposing quantitative constraints on void space volume per gram, microporous matrix void space volume fraction of the composite scaffold, and void space surface area-to-measurable volume ratio.
Stated Advantages
Documented Applications
Soft-tissue repair/regeneration for ligament repair and tendon repair/augmentation, including ligament/tendon reconstruction.
ACL augmentation/repair.
Rotator cuff repair.
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