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

Biorez Inc

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 for soft-tissue repair, reconstruction, or regeneration that includes a three-dimensional textile support structure and a degradable microporous matrix disposed within an interior void space. The support structure includes first and second outer layers separated by an interior space, with spacer elements extending through the interior space and connecting the first and second outer layers. The support structure has an exterior profile and is configured to resist compression under tension while supporting load sharing.

A microporous matrix is disposed within the interior space and has a multitude of interconnected pores opening exteriorly of the support structure. The pores are oriented relative to dimensional characteristics of the support structure, thereby establishing an interconnected pore network for tissue ingrowth and cell infiltration. The scaffold design includes pore orientation, porosity, permeability, surface area to weight, and void volume, with reduced swelling to maintain scaffold geometry under fluid absorption and mechanical loading.

The composite scaffold is described with engineered pore characteristics including defined pore size distributions and specified permeability/porosity relationships. Degradation-rate staggering between the textile support structure and the porous matrix is described to support an intended tissue regeneration timeline. Manufacturing and characterization approaches are described for forming interconnected pores and for evaluating scaffold mechanical support and compression resistance.

Claims Coverage

The relevant independent claim defines inventive coverage for a composite scaffold having a spacer-connected two-layer support structure and a microporous matrix with interconnected, outwardly opening pores whose orientation is relative to the support structure’s dimensional characteristics. This independent claim includes four dependent refinements that further specify pore orientation and alternative exterior profile cross-sectional shapes.

Across the independent claim and its dependents, the main inventive elements are the spacer element connection between two outer layers to form an interior space, the placement of a microporous matrix within that interior space, and the requirement that interconnected pores open exteriorly and are oriented relative to the support structure’s dimensional characteristics; further refinements specify radially inward and length-dimension pore orientation and substantially rectangular or circular exterior profile cross-sections.

Stated Advantages

Documented Applications