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-11622847-B2
Publication Date
2023-04-11
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
A composite scaffold is provided for soft-tissue repair in which a three-dimensional support structure is defined by first and second outer layers separated by an interior space. Spacer elements extend through the interior space and connect the first and second outer layers, maintaining a separated outer-layer structure while providing mechanical reinforcement through the scaffold thickness.
A microporous matrix is disposed in the interior space and includes a multitude of interconnected pores collectively defining void space between the first and second outer layers. The interior void space is described as contiguous void space, and the pores and void space are associated with facilitating cell infiltration and extracellular matrix deposition and supporting oriented neo-tissue formation.
Mechanical reinforcement is emphasized alongside resistance to compression under tension while maintaining the contiguous void space for neotissue regeneration. The scaffold includes synthetic or natural polymers for scaffold components and microporous matrix options such as collagen microporous matrix and freeze-dried sponge, open-cell foam, or particulate leached sponge, with 3D spacer textiles, warp knitting patterns, pores formed by design, optional crosslinking, and staggered component resorption to support tissue integration and mechanical function over time.
Claims Coverage
The document includes one independent claim defining a composite scaffold, with dependent claims adding specific structural, material, porosity, and mechanical or geometry constraints. The inventive coverage is centered on a separated first and second outer-layer 3D support structure with through-interconnecting spacer elements and a microporous matrix defining interconnected pores within the interior void space.
Three-dimensional support with separated outer layers and spacer elements
A three-dimensional support structure defined by 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.
Microporous matrix with interconnected pores defining void space
A microporous matrix disposed in the interior space and having a multitude of interconnected pores collectively defining void space between first and second outer layers of the support structure.
Void space portion with pore size threshold
The microporous matrix is characterized such that at least approximately 70% of its void space consists of pores with a size dimension of 10 μm or greater.
Microporous matrix selected from sponge/foam/fiber types
The microporous matrix is selected from a freeze-dried sponge, an open cell extrusion foam, a particulate leached sponge, or any combination of these.
Microporous matrix configured with specified materials and fabrication formation options
The microporous matrix includes specified materials and is formed within the scaffold by one or more listed fabrication methods, potentially together with cross-linking.
Quantitative stiffness range
The composite scaffold has a stiffness approximately within the range of 2.5 N/mm to 25 N/mm.
Cross-sectional area and limited change under strain
The scaffold has a cross-sectional area between 3 mm^2 and 250 mm^2 that changes by less than about 17% at a strain percentage of 13%.
Overall claim coverage focuses on the combined architecture of a 3D support structure with first and second outer layers separated by an interior space and connected by spacer elements, together with a microporous matrix disposed in that interior space where interconnected pores define void space. Dependent claims further specify pore-size and void-space proportions, microporous matrix material types, formation methods and optional cross-linking, and quantitative mechanical and geometric performance constraints.
Stated Advantages
Mechanical reinforcement while resisting compression under tension.
Maintaining contiguous void space for cell infiltration and oriented neotissue formation.
Supporting extracellular matrix deposition and neotissue regeneration.
Documented Applications
Soft-tissue repair, including ligament/tendon repair and reconstruction, and tendon augmentation versus tendon alone.
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