Devices and methods for repairing damage to a nerve
Inventors
Clements, Isaac Perry • Willsie, Andrew • Ross, James David • Weidenbach, Alex • Isaacs, Jonathan
Assignees
Virginia Commonwealth University • Biocircuit Technologies Inc
Publication Number
US-10994130-B2
Publication Date
2021-05-04
Expiration Date
2037-09-06
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Abstract
An example device for repairing a nerve is described herein. The device can include a flexible carrier layer made of a biologic material, and a metallic support member including a plurality of micro-protrusions extending therefrom. The metallic 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 nerve, and the micro-protrusions can be configured to attach to a superficial tissue of the nerve.
Core Innovation
The invention describes a device for repairing nerves that includes a flexible carrier layer made from a biologic material and a metallic support member featuring a plurality of micro-protrusions. The metallic support member is at least partially integrated with the flexible carrier layer. The flexible carrier layer is configured to cover at least a portion of the nerve, and the micro-protrusions are designed to attach to the superficial tissue of the nerve, specifically targeting the outer epineurium while avoiding critical internal nerve structures such as the fascicles.
The core problem addressed by this invention is the significant challenge in surgical nerve repair due to limitations of conventional microsuturing, including inconsistency, risk of scar tissue inhibiting axonal regeneration, lengthy operation times, high technical demand, and the inadequacies of alternative biomaterial adhesives and conduits. Existing approaches suffer from either insufficient mechanical strength, neurotoxicity, technical complexity, or can impede nerve regeneration.
The core innovation combines the mechanical advantages of entubulation (repair-site encapsulation) with a means for mechanical attachment superior to microsutures. The device uses microfabricated arrays of barbed or otherwise appropriately shaped micro-protrusions embedded in or attached to a biologic carrier, such as small intestine submucosa (SIS), to ensure atraumatic and effective mechanical engagement with the nerve surface. This construction allows for fast, technically accessible application and can avoid the need for microsuturing, potentially simplifying and expediting surgical repairs.
Claims Coverage
The patent claims cover one independent inventive feature related to a device for repairing a nerve utilizing specific physical structures and materials.
Device for repairing a nerve using a flexible carrier layer and metallic support member with micro-protrusions
The device comprises: - At least one flexible carrier layer made of a biologic material. - A metallic support member that includes a plurality of elongate strips and a plurality of micro-protrusions extending from the elongate strips. - The metallic support member is at least partially integrated with the flexible carrier layer. - The flexible carrier layer is configured to cover at least a portion of the nerve. - The micro-protrusions are configured to attach to a superficial tissue of the nerve. - The elongate strips of the metallic support member are not interconnected with one another within the flexible carrier layer. - For each elongate strip, its length along a longitudinal axis of the nerve is longer than its length along an axis perpendicular to that longitudinal axis. These features together define the structural relationship and configuration intended to facilitate nerve repair by mechanical attachment to the nerve surface with a biologically compatible carrier.
Overall, the claims focus on a nerve repair device structure that integrates a biologic flexible carrier and a specialized metallic support member, designed for mechanical engagement with nerve tissue without the need for interconnection among elongate strips, thereby enabling effective, atraumatic nerve repair.
Stated Advantages
Enables rapid and technically accurate alignment of nerves without requiring microsurgical skill or a surgical microscope.
Decreases technical challenges, operating room time, and resource requirements for nerve repair surgery.
Reduces trauma and scar tissue formation at the repair site by avoiding sutures and distributing tension over a broader area of superficial nerve tissue.
Creates a more biologically favorable microenvironment for nerve regeneration by isolating and protecting the repair site and containing neurotrophic and growth factors.
Offers mechanical attachment strength comparable to microsutures while minimizing penetration depth to avoid damage to vital nerve elements.
Improves patient access by making surgery less dependent on specialized training and equipment.
Facilitates repairs in smaller, tighter spaces, potentially resulting in less surgical dissection and smaller scars.
Allows for the use of pro-regenerative biological materials, such as small intestine submucosa (SIS), in the flexible carrier layer.
Provides the potential to deliver drugs, cells, or electrical stimulation directly to the nerve through the device design.
Documented Applications
Repairing transected nerves, including coaptation and nerve gap repairs using conduits.
Repair of other types of nerve damage, such as allograft, autograft, and xenograft procedures.
Repair of other tissues, including muscle, tendon, vasculature, skin, fascia, solid organs (such as liver), hernia repair, and patching defects such as tendon defects in rotator cuff repairs.
Repair of tissues comprised of two different types, such as tendon-to-bone repair in rotator cuff surgeries.
Delivery of drugs, cell transplantation, or electrical stimulation/recording through the nerve repair device.
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