Devices and methods for delivering neuroregenerative therapy
Inventors
Willand, Michael Patrick • Aguirre, Sergio David
Assignees
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Publication Number
US-12318608-B2
Publication Date
2025-06-03
Expiration Date
Abstract
Systems, devices and methods are disclosed for the treatment of injured peripheral nerves or other tissue using electrical stimulation. The systems can be used either in intraoperative or peri-operative settings and incorporate the use of either a plurality of monopolar electrodes with a patch used as return or a plurality of bipolar electrodes such as a cuff. The systems can provide hands-free delivery of electrical stimulation therapy over a predetermined set of time.
Core Innovation
The disclosure provides electrical neuroregenerative therapy systems and methods for treating an injured target nerve of a subject. The treatment uses a stimulation device having a lead with an electrode assembly positioned adjacent the injury of the target nerve to create a neuroregenerative effect. The approach includes creating an opening along a skin surface separate from a main procedural incision located along the surface near the injury of the target nerve.
The method includes percutaneously advancing the lead through the opening via a para-incisional pathway to position the electrode assembly adjacent the injury of the target nerve. After positioning, the electrode assembly is activated to deliver energy to create a neuroregenerative effect on the target nerve. The lead is then removed from the subject via the para-incisional pathway.
The disclosure also describes coordinating therapy with locating and verification activity prior to activating therapy mode, including delivering a first frequency stimulation during a verification or locating phase and delivering a second frequency stimulation during a therapeutic phase for a predetermined time. It further describes monitoring and safety-related functionality such as verification of electrode integrity and/or nerve contact using measurable responses including action potentials, motor, sensory, or evoked responses, and monitoring current flow and impedance while providing charge balancing for stimulation delivered in a controlled biphasic or charge-balanced manner.
Claims Coverage
The claim set centers on a stimulation-device method for treating an injured target nerve using a separate skin opening and a para-incisional pathway to position and activate an electrode assembly, followed by lead removal. The excerpted independent and dependent claims present six inventive features.
Separate skin opening and para-incisional lead positioning
Creating an opening along a skin surface separate from a main procedural incision located along the surface near the injury of the target nerve, and percutaneously advancing a lead through the opening via a para-incisional pathway to position an electrode assembly adjacent the injury of the target nerve.
Activate electrode assembly to create neuroregenerative effect and remove lead via para-incisional pathway
Activating the electrode assembly to deliver energy to create a neuroregenerative effect on the target nerve, and removing the lead from the subject via the para-incisional pathway.
Intraoperative activation and postoperative lead removal
Activating the electrode assembly during surgery and removing the lead postoperatively.
Insertion tool for creating the opening and advancing the lead
Using an insertion tool to create the opening along a subject’s skin surface and/or to percutaneously advance the stimulation device lead through the opening.
Temporarily securing the lead to maintain electrode assembly position
Temporarily securing the lead to surrounding tissue of the subject to maintain the electrode assembly’s position relative to the target nerve.
Association with specified nerve procedures
Using the method in connection with one or more specified nerve procedures including transection, decompression, transfer, grafting or allograft, neurolysis, and decompressions/releases for the thoracic outlet, carpal tunnel, cubital tunnel, and tarsal tunnel.
The core inventive concept is positioning an electrode assembly adjacent an injured target nerve via a percutaneous lead advanced through a separate skin opening using a para-incisional pathway, activating the electrode assembly to create a neuroregenerative effect, and removing the lead via the same para-incisional pathway. Dependent claims add intraoperative activation, postoperative lead removal, use of an insertion tool, temporary lead securing, and application to specified nerve procedures.
Stated Advantages
Documented Applications
Nerve procedures including transection, decompression, transfer, grafting or allograft, neurolysis, and decompressions/releases for the thoracic outlet, carpal tunnel, cubital tunnel, and tarsal tunnel.
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