Device and method of creating a fluid containment field for administering therapeutics to a nerve
Inventors
Jackson, David M. • Trevino, Richard • Hoffman, Jordan A.
Assignees
Publication Number
US-11633188-B2
Publication Date
2023-04-25
Expiration Date
2038-07-24
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Abstract
A severed nerve may be surgically rejoined and severed axons fused via sequential administrations of solutions. The solutions may include a priming solution comprising methylene blue in a Ca2+-free saline solution, a fusion solution comprising about 50% (w/w) PEG, and a sealing solution comprising Ca2+-containing saline. The PEG fusion solution may be applied in a nerve treatment device configured to isolate the injured segment of the nerve. The device may include a containment chamber for creating a fluid containment field around the anastomosis. The device may have slits, slots, and/or apertures in opposing endwalls of the device designed to receive the nerve. The device may have an open bath configuration or may include separable lower and upper bodies to create a closed bath configuration. The device may include one or more fluid ports in fluid communication with the containment chamber for introducing and/or removing fluid.
Core Innovation
The invention provides a nerve treatment device and corresponding method designed to create a fluid containment field around an isolated segment of a nerve during therapeutic procedures, specifically for nerve repair involving polyethylene glycol (PEG)-mediated axonal fusion. The device comprises an elongate body with a containment chamber extending between two endwalls, equipped with features such as apertures, slits, or flanges to receive and seal around the nerve segment. The device can exist in open or closed bath configurations, utilizes flexible materials for atraumatic handling, and incorporates fluid ports to introduce or remove therapeutic solutions in a controlled manner.
The core problem addressed by the invention, as identified in the background, is the lack of devices capable of: (1) creating an isolated fluid containment field that enables focal delivery of pharmaceutical solutions to specific regions of a nerve, (2) protecting non-target tissues from exposure to potentially damaging agents like high-concentration PEG during nerve repair, and (3) providing a design permitting placement and removal without harming the fragile, recently repaired nerve anastomosis. Existing methods and devices fail to offer these protective and handling capabilities during PEG-fusion nerve repair procedures.
Through sequential administration of priming, fusion, and sealing solutions (including methylene blue, 50% PEG, and Ca2+-containing saline, respectively), the device facilitates the precise fusion of severed axons within the nerve bundle. The design ensures consistent and sustained exposure of the nerve repair site to therapeutic agents while minimizing exposure to adjacent tissues and enabling efficient removal of residual solutions. The method and device may also support quantitative or qualitative evaluation of nerve recovery, such as measuring compound action potentials across the repaired segment.
Claims Coverage
There are two main independent inventive features covered by the patent claims, focusing on the structure and function of a nerve treatment device for creating a fluid containment field around a nerve.
Nerve treatment device with flexible endwalls, slits, apertures, and a containment chamber for isolating a segment of a nerve
A nerve treatment device is comprised of: - An elongate body extending from a first endwall to a second endwall, each with a top surface and a longitudinal axis. - A laterally extending handle. - A containment chamber inside the elongate body, with a void volume intersecting the top surface to provide an access area for insertion of an isolated nerve segment. - The first and second endwalls each have an aperture opening into the containment chamber, configured to retain and form fluid seals around the ends of the nerve segment. - The apertures are horizontally disposed more towards a front end of the elongate body. - Each endwall contains a slit extending from the top surface to its respective aperture. The slits intersect the front edges of the apertures. - At least a portion of each endwall, or a front wall, is flexible and can be biased to increase the width between the edges of the slit, allowing nerve insertion through the slit into the aperture. Notably, this structure enables atraumatic placement of the nerve and formation of a temporary, isolated fluid containment field for administering therapeutics directly to the nerve segment.
Front wall configuration allowing concurrent biasing for slit widening in nerve access
The front wall of the elongate body, located between the first and second slits, is designed to be flexible and configured so that it can be biased in a frontward direction. This increases both slit widths simultaneously, facilitating easy insertion of the nerve segment through both slits into corresponding apertures. This configuration enables the device to be manipulated such that both entry points for the nerve are widened together, improving efficiency and minimizing risk of mechanical disturbance to the treated nerve.
In summary, the patent claims protect nerve treatment devices uniquely configured with flexible endwalls and slits to enable atraumatic nerve placement and efficient creation of a fluid containment field for direct, localized delivery of therapeutic agents during nerve repair.
Stated Advantages
Provides an isolated fluid containment field around a sutured nerve for topical delivery of therapeutic solutions to a focal region.
Prevents unnecessary exposure of uninjured nerve segments and adjacent tissues to pharmaceutical solutions such as high-concentration PEG.
Allows device placement and removal without disturbing or damaging the recently sutured or fused nerve anastomosis.
Facilitates sustained and consistent exposure of the injured nerve segment to PEG and enables convenient and efficient removal of PEG solution after administration.
Supports qualitative and/or quantitative evaluation of restored nerve electrophysiology, such as measurement of compound action potentials using the containment field.
Documented Applications
Acute surgical repair of injured peripheral nerves, including sutured or engrafted nerve segments.
Repair of injured spinal column nerves.
Engraftment of segments of peripheral nerves into regions ablated by trauma, including allografts, autografts, and xenografts.
Pharmacological and electrophysiological in situ studies or experiments involving isolated nerve segments.
Application in electrofusion (e-fusion) protocols or fusion protocols using agents other than PEG.
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