Systems and methods for delivering neuroregenerative therapy
Inventors
Willand, Michael Patrick • Aguirre, Sergio David
Assignees
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Publication Number
US-10589089-B2
Publication Date
2020-03-17
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 invention provides systems and methods for electrically stimulating injured peripheral nerves of a subject to accelerate neuroregeneration by creating a regenerative effect in a target nerve. A stimulation protocol includes a verification phase and a therapeutic phase that both deliver stimulation energy to the target nerve via at least one electrode assembly, and the electrode assembly includes at least one electrode and a lead electrically coupled to the electrode.
During the verification phase, stimulation energy having a first frequency is delivered to confirm at least one condition. The condition comprises measurement of at least one electrical parameter at a location upstream to an injury site of the target nerve, where the electrical parameter is associated with the target nerve, and in related configurations confirmatory stimulation energy is used to validate that a regenerative effect to the target nerve is being accomplished when delivering therapeutic stimulation energy.
During the therapeutic phase, stimulation energy having a second frequency is delivered for a predetermined time period via the same electrode assembly, wherein the therapeutic stimulation creates a regenerative effect to the target nerve. The second frequency is equal to or greater than the first frequency, and in some embodiments the therapeutic frequency is 10 Hz to 100 Hz. The lead is configured to be advanced to or near the target nerve through a skin surface via a para-incisional percutaneous pathway separate from an opening related to the injury site.
Claims Coverage
The patent document includes three independent methods. Across these independent claims, the core inventive coverage is the combination of a verification or confirmatory phase using upstream electrical-parameter measurement and a therapeutic phase delivering regenerative neurostimulation with defined frequency relationships and a para-incisional percutaneous lead pathway, optionally including validation of regenerative effect during therapy.
Upstream verification via confirmatory stimulation energy and electrical parameter measurement
Delivering stimulation energy during a verification phase to confirm at least one condition, where the condition comprises measurement of at least one electrical parameter at a location upstream to an injury site of the target nerve, and where the electrical parameter is associated with the target nerve.
Therapeutic regenerative stimulation at a second frequency for a predetermined time period
During a therapeutic phase, delivering stimulation energy having a second frequency to the target nerve for a predetermined time period via the at least one electrode assembly, wherein delivering stimulation energy to the subject during the therapeutic phase creates a regenerative effect to the target nerve.
Frequency relationship between verification and therapy
The second frequency is equal to or greater than the first frequency.
Para-incisional percutaneous lead advancement to or near the target nerve
Configuring the lead of the at least one electrode assembly to be advanced to or near the target nerve through a skin surface of the subject via a para-incisional pathway, wherein the para-incisional pathway is percutaneous and is separate from an opening of the skin surface related to the injury site of the target nerve.
Therapeutic frequency range of 10 Hz to 100 Hz
The frequency of the therapeutic stimulation energy is 10 Hz to 100 Hz.
Validation that regenerative effect is being accomplished during therapeutic stimulation
The at least one condition comprises validation that a regenerative effect to the target nerve is being accomplished when delivering therapeutic stimulation energy.
Confirmatory and therapeutic stimulation as separate events
Delivering confirmatory stimulation energy to the subject via at least one electrode assembly to confirm at least one condition is performed separately from delivering therapeutic stimulation energy having a frequency to the subject via the at least one electrode assembly.
Collectively, the independent claims cover neuroregenerative stimulation of an injured target nerve using an electrode assembly with a lead advanced through a para-incisional percutaneous pathway, where upstream electrical-parameter measurements occur during a verification or confirmatory phase, followed by therapeutic stimulation delivered for a predetermined time to create a regenerative effect, with the therapeutic frequency optionally constrained to 10 Hz to 100 Hz and with an option to validate that the regenerative effect is being accomplished during therapeutic stimulation.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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