Devices and methods for repairing damage to a tissue

Inventors

Isaacs, JonathanClements, Isaac PerryWillsie, AndrewRoss, James DavidWeidenbach, Alex

Assignees

Virginia Commonwealth UniversityBiocircuit Technologies Inc

Publication Number

US-11167131-B2

Publication Date

2021-11-09

Expiration Date

2037-09-06

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Abstract

An example device for repairing a tissue is described herein. The device can include a flexible carrier layer, and a support member including a plurality of micro-protrusions extending therefrom. The support member can be at least partially integrated with the flexible carrier layer. Additionally, the flexible carrier layer can be configured to cover at least a portion of the tissue, and the micro-protrusions can be configured to mechanically interface with the tissue.

Core Innovation

The invention provides a device for repairing tissue, particularly nerves, comprising a flexible carrier layer and a support member with a plurality of micro-protrusions (such as micro-hooks or micro-needles) extending from elongate strips. The support member is at least partially integrated with the flexible carrier layer, which is designed to cover at least a portion of the tissue. The micro-protrusions are configured to mechanically interface with the tissue, such as attaching to the superficial aspect of a nerve, specifically the outer epineurium, without causing significant trauma to the deeper fascicles.

The device addresses the problem inherent in conventional nerve repair, where standard microsuturing techniques are technically demanding, time-consuming, require specialized equipment, and often lead to inconsistent repair quality, misalignment, and scarring that impedes nerve regeneration. Existing alternatives such as tissue adhesives or conduits have significant limitations, including inadequate mechanical strength, poor alignment control, or persistent requirements for microsuturing.

Through innovations in microfabrication, the disclosed device enables mechanical coaptation and entubulation of a repair site without the need for microsutures. The flexible carrier layer may be a biologic or biodegradable material such as small intestine submucosa (SIS), and the metallic support member (potentially a superelastic alloy like Nitinol) increases device flexibility and conformability, reduces trauma at the repair interface, and allows for easy, efficient, and accurate nerve end alignment. The micro-protrusions can be optimized in shape, length, and configuration to ensure robust attachment to the tissue while minimizing invasiveness and tissue damage.

Claims Coverage

The patent contains one independent claim covering a device for tissue repair, with a focus on a unique integration of a flexible carrier layer, a support member comprising multiple non-interconnected elongate strips, and stabilized micro-protrusions.

Device with flexible carrier layer integrated with support member having non-interconnected elongate strips and stabilizing projecting members

The device comprises: - A flexible carrier layer configured to cover at least a portion of a tissue. - A support member that includes a plurality of elongate strips, each strip having one or more micro-protrusions extending from it and one or more projecting members extending laterally from the elongate strips to stabilize the micro-protrusions within the flexible carrier layer. - The support member is at least partially integrated with the flexible carrier layer. - The elongate strips are not interconnected with one another within the flexible carrier layer. - For each elongate strip, the length along the longitudinal axis of the tissue is longer than the length along the axis perpendicular to the longitudinal axis. - The micro-protrusions are configured to mechanically interface with the tissue.

In summary, the inventive coverage is centered on a mechanically interfacing tissue repair device where stabilized micro-protrusions extend from multiple non-interconnected elongate strips integrated with a flexible carrier layer.

Stated Advantages

Enables quick, easy, and technically accurate alignment of nerve or tissue ends without the need for microsurgical techniques or a microscope.

Distributes mechanical tension broadly across superficial tissue, minimizing trauma and scar formation at the nerve repair site.

Reduces surgical time and resources required for tissue repair compared to conventional microsuturing methods.

Improves biological environment at the repair site by isolating the area and containing neurotrophic and growth factors, which can enhance regeneration.

Minimizes invasiveness by allowing micro-protrusions to penetrate only superficial layers, reducing the risk of damaging vital nerve elements.

Device can be applied in tight surgical spaces, reducing the need for extensive exposure and associated scarring.

Allows for broader access to nerve repair procedures by decreasing the need for highly specialized microsurgical skills.

Avoids the negative effects of conduit lumen—nerve stump diameter mismatch by allowing direct, flexible application and sealing of the repair site.

Flexible, biocompatible, and potentially biodegradable materials improve device handling and integration with tissue.

Documented Applications

Repair of transected nerves, including coaptation and nerve gap repair (such as allograft, autograft, and xenograft nerve repairs).

Repair of other tissues such as muscle, tendon, vasculature, skin, fascia, bladder, uterus, and solid organs like the liver.

Use in hernia repairs or patching defects in tissues, including tendon defects in rotator cuff repairs.

Specialized repair of tissues of two different types, such as tendon-to-bone repairs in rotator cuff surgeries.

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