Composite scaffold for the repair, reconstruction, and regeneration of soft tissues

Inventors

Rocco, Kevin A.Mohanraj, BhavanaOtt, JeffreyBendigo, JustinKomenda, Jacob EdwardAronson, Mark TheodoreCarter, Andrew James

Assignees

Biorez Inc

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Publication Number

US-11701217-B2

Patent

Publication Date

2023-07-18

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 composite scaffold for soft-tissue repair that includes a three-dimensional support structure constructed by knitting first and second layers spaced apart to define an interior space, where the layers are attached together by a plurality of spacer elements extending through the interior space. The support structure extends along a length dimension between first and second ends.

Within the interior space, a microporous matrix is formed having a multitude of interconnected pores in fluid communication with exterior surfaces of the support structure. The interconnected pores are oriented relative to a dimensional characteristics of the support structure.

The composite scaffold concept includes engineered interconnected pores and pore orientation, intended to provide mechanical reinforcement and resistance to compression under tension. The document describes manufacturing approaches for the three-dimensional support structure and for forming the microporous matrix, including knitted 3D spacer textiles and microporous matrix formation routes such as freeze-dried sponge and other porous matrix forms.

The described use cases include tendon/ligament repair, with examples including ACL and rotator cuff soft tissues, and the document further references graft augmentation concepts such as auto- or allo-grafts and fixation concepts.

Claims Coverage

The document provides one independent claim (clm-00001). It covers a method in which a knitted three-dimensional support structure is constructed and then a microporous matrix is formed in the interior space, with pore orientation relative to dimensional characteristics of the support structure.

Knitted three-dimensional support structure with spacer elements

Constructing a three-dimensional support structure by knitting a scaffold comprising first and second layers spaced apart to define an interior space therebetween but attached together by a plurality of spacer elements extending through the interior space, the support structure extending along a length dimension between first and second ends thereof.

Microporous matrix with interconnected pores in fluid communication

Forming a microporous matrix within the interior space, the microporous matrix having a multitude of interconnected pores in fluid communication with exterior surfaces of the support structure.

Interconnected pore orientation relative to dimensional characteristics

Wherein a plurality of the interconnected pores are oriented relative to a dimensional characteristics of the support structure.

Overall, the claim coverage centers on the combination of a knitted three-dimensional spacer-textile support structure defining an interior space, a microporous matrix formed within that interior space with interconnected pores in fluid communication with exterior surfaces, and an orientation of the interconnected pores relative to dimensional characteristics of the support structure.

Stated Advantages

Mechanical reinforcement and resistance to compression under tension.

Engineered pore structure and pore orientation with measurable performance metrics including porosity, permeability, surface area/void volume, swelling/absorbance behavior, and tensile mechanics.

Documented Applications

Tendon/ligament repair, including ACL and rotator cuff soft tissues.

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