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-11918801-B2
Publication Date
2024-03-05
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 relates to a device and methods for repairing tissue, particularly nerves, by utilizing a flexible carrier layer integrated with a support member that has a plurality of micro-protrusions extending from it. The device is designed so that the flexible carrier layer wraps around or covers at least a portion of the damaged tissue, while the micro-protrusions mechanically interface with (attach to) the superficial aspects of the tissue. These micro-protrusions can be various forms such as micro-hooks or micro-needles, and are configured to engage specifically with the outer layers of a nerve such as the epineurium, without damaging internal nerve fascicles.
The core problem addressed is the technical shortcomings of current nerve repair methods, notably the complexities and limitations of microsuturing such as the need for specialized skills, time, resources, and equipment, as well as inconsistencies in repair quality and biological complications like scar tissue that impedes axonal regeneration. Conventional alternatives (such as tissue adhesives, conduits, or entubulation) either require technical expertise, expensive or cumbersome equipment, may introduce toxicity, suffer inadequate holding strength, or lead to other complications such as misalignment or scar formation.
By integrating mechanically robust micro-protrusions into a flexible, potentially bioactive or biodegradable carrier, the device provides secure mechanical attachment, alignment, and entubulation of nerve ends or other tissues without the need for sutures, minimizing trauma and improving efficiency and consistency. The solution also features various design optimizations, such as the direction and penetration depth of micro-protrusions, choice of biocompatible materials (like Nitinol or SIS), and self-closure wrapping configurations. This approach addresses both mechanical and biological aspects of tissue repair, aiming to improve outcomes, reduce operational complexity, and expand accessibility to less-specialized practitioners.
Claims Coverage
There is one independent claim in this patent, which defines a device with several inventive features relating to tissue repair using a flexible carrier layer and integrated support member with micro-protrusions.
Device comprising a flexible carrier layer and integrated support member with micro-protrusions
The device has: - A flexible carrier layer configured to cover at least a portion of a tissue. - A support member at least partially integrated with the flexible carrier layer and comprising a plurality of micro-protrusions extending therefrom. - The micro-protrusions are configured to mechanically interface with the tissue. - The flexible carrier layer includes a wrapping portion configured as a self-closure mechanism for the device, where the wrapping portion is a flap without a separate mechanical element or separate adhesive material and the flexible carrier layer and wrapping portion are a single sheet of material.
The claims provide protection for a device using a single-sheet flexible carrier layer and an integrated support member with micro-protrusions, designed for mechanically interfacing with tissue and featuring a self-closure mechanism in the form of a wrapping flap without additional closure elements.
Stated Advantages
Allows easy and efficient application with rapid and technically accurate alignment that does not require microsurgical technique or a microscope.
Improves technical accuracy of repairs by decreasing over-approximation and improving fascicular alignment at the nerve repair site.
Creates an enhanced biological environment by entubulation, which prevents axonal escape and scar tissue invasion, and contains neurotropic and growth factors.
Minimizes damage to vital nerve elements by enabling more superficial penetration distributed away from crucial nerve ends, reducing trauma compared to sutures.
Provides improved mechanical fastening through micro-protrusions that securely attach the device to tissue, with optional tissue adhesive for additional fastening.
Enables nerve repair without the need for specialized equipment or extensive training, expanding the pool of surgeons capable of performing repairs and reducing resource requirements.
Supports smaller surgical exposures and less tissue dissection, potentially reducing scarring and operative morbidity.
Isolates and protects the repair (coaptation) site, shifts tension away from nerve ends, and reduces suture-induced trauma and subsequent scar tissue formation.
Can be economical, stable for transport, and have a reasonable shelf life.
Documented Applications
Repair of damaged or transected nerves, including primary repair, nerve gap repair (with conduit), allograft, autograft, and xenograft.
Repair of other tissues such as muscle, tendons, vasculature, skin, fascia, and solid organs (like the liver).
Hernia repairs and repair or patching of tendon defects, such as those in rotator cuff repairs.
Specialized repair for tissues of two different types (e.g., tendon-to-bone repairs as in rotator cuff surgeries).
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