Devices and methods for repairing damage to a tissue
Inventors
Isaacs, Jonathan • Clements, Isaac Perry • Willsie, Andrew • Ross, James David • Weidenbach, Alex
Assignees
Virginia Commonwealth University • Biocircuit Technologies Inc
Publication Number
US-12161862-B2
Publication Date
2024-12-10
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. The support member can be made from a metallic or superelastic alloy and includes elongated strips from which the micro-protrusions extend. The flexible carrier layer, formed from a different material such as biocompatible, biodegradable, or biologic materials (e.g., small intestine submucosa), is configured to cover at least a portion of the tissue and integrate with the support member.
This device addresses the significant technical challenges presented by current nerve repair techniques, such as microsutures and adhesives, which are associated with high technical complexity, lengthy operative times, risk of poor alignment, scar tissue formation, and suboptimal patient outcomes. Other alternatives like adhesives carry risks of toxicity, inadequate strength, and possible impediments to axonal regeneration.
The device's micro-protrusions are arranged in first and second groups oriented in opposite directions on elongate strips, which are not interconnected, allowing the strips to extend across a repair site and provide holding force by mechanically interfacing with superficial tissue structures (such as the nerve's epineurium), without puncturing deeper, critical nerve structures. The flexible carrier layer may be designed as a wrap or tape that can entubulate or sandwich the repair site, and the device may feature self-closure, drug delivery, cell transplantation, or electrical stimulation/recording capabilities.
Claims Coverage
The patent claims cover two independent inventive features focusing on a device for repairing tissue, especially nerves, utilizing a combination of flexible carrier layers and micro-protrusion-equipped support members.
Device with integrated flexible carrier layer and non-interconnected elongate strips with oppositely oriented micro-protrusions
A device comprises: - A flexible carrier layer formed of a first material (biocompatible, biodegradable, or biologic). - A support member formed of a second, different material (such as a metal or superelastic alloy), at least partially integrated with the carrier layer. - The support member includes a plurality of elongate strips (not interconnected within the carrier layer), each bearing micro-protrusions. - The micro-protrusions are divided into first and second groups, oriented in opposite directions to apply a holding force across a tissue repair site. - The flexible carrier layer is configured to cover at least a portion of the tissue, and the micro-protrusions mechanically interface with the tissue. Optional features include projecting members for micro-protrusion stabilization, regions without micro-protrusions near repair sites, drug delivery or cell transplantation capability, configurations to avoid piercing vital structures (e.g., fascicles), configurations for electrical stimulation/recording, self-closure with a wrapping portion, and selection of materials such as superelastic alloys containing nickel and titanium.
Device for repairing a nerve with flexible carrier layer and elongate strips bearing oppositely oriented micro-protrusions
A device for nerve repair comprises: - A flexible carrier layer formed of a first material. - A support member formed of a second, different material at least partially integrated with the carrier layer. - The support member includes elongate strips that are not interconnected and extend across the nerve repair site, each bearing micro-protrusions divided into first and second groups facing opposite directions to apply a holding force at the site. - The flexible carrier layer is configured to cover at least a portion of the nerve, and the micro-protrusions attach to superficial nerve tissue. Additional features may include configurations ensuring the micro-protrusions pierce only the outer epineurium (not fascicles), selection of specific materials, wrapping and sandwiching designs, capacity for drug/cell delivery, and accommodation for self-closure.
The inventive features broadly protect tissue and nerve repair devices comprising a flexible carrier layer and a support member with non-interconnected elongate strips bearing oppositely oriented micro-protrusions. The claims establish essential elements such as integration of dissimilar materials, interface with superficial tissue layers, adaptable closure or wrapping configurations, and optional therapeutic or diagnostic enhancements.
Stated Advantages
Provides rapid and technically accurate alignment of tissue or nerve without requiring microsurgical skills or microscopes.
Reduces technical complexity, operating time, and required resources in nerve and tissue repair.
Minimizes trauma to vital tissue structures by limiting penetration to superficial layers, distributing tension away from crucial nerve ends.
Enhances biological repair environment by isolating the repair site, preventing scar tissue invasion, and containing neurotrophic and growth factors.
Offers improved mechanical attachment strength distributed over a broad area, reducing the risk and effects of focal tension.
Facilitates repairs in tight surgical spaces, requiring less dissection and exposure.
Can serve as a platform for drug delivery, cell transplantation, and electrical stimulation or recording.
Reduces foreign body reaction and inflammation compared to conventional adhesives or sutures.
Provides self-closure capability, potentially eliminating the need for additional closure mechanisms or adhesives.
Documented Applications
Repairing transected nerves, including coaptation of nerve ends.
Repairing other types of nerve damage including nerve gap repairs, allograft, autograft, and xenograft.
Repairing tissues such as muscle, tendons, vasculature, skin, fascia, or solid organs including liver, kidneys, bladder, and uterus.
Use in hernia repairs.
Patching defects in tissues such as tendon defects in rotator cuff repairs.
Repair of tissues comprising two different types, such as tendon-to-bone repairs in rotator cuff surgeries.
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