Systems and methods for delivering neuroregenerative therapy
Inventors
Willand, Michael Patrick • Aguirre, Sergio David
Assignees
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Publication Number
US-11247045-B2
Publication Date
2022-02-15
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 a method of enhancing neuroregeneration in a subject by delivering stimulation energy to a target peripheral nerve using at least one electrode assembly. The method uses a first phase to deliver stimulation energy of a first frequency and a second phase to deliver stimulation energy of a second frequency for a predetermined period. The electrode assembly is configured for percutaneous positioning adjacent the target peripheral nerve during both phases, and is configured to be placed within the subject using a percutaneous pathway and removed using the same pathway following delivery of stimulation energy.
In the method, the second phase delivers stimulation energy that creates a regenerative effect to the target peripheral nerve. The first phase is configured to confirm at least one validation condition. The validation condition is confirmed during the delivery associated with the first phase, and in the independent claim variants, confirmation is described as occurring while positioning and/or delivering adjacent to the target peripheral nerve and while creating the regenerative effect.
The disclosed framework further encompasses confirmation approaches in dependent claim language, including confirming that the at least one electrode assembly is working via an activated indicator, detecting motor or sensory responses, and measuring an electrical parameter. The stimulation frequencies used for confirming the validation condition and for creating the regenerative effect are constrained in dependent claims, including relationships in which the second frequency is greater than the first. An electrode configuration refinement includes configuring the at least one electrode assembly to at least partially surround the target peripheral nerve.
Claims Coverage
The partial document contains two independent claims (methods) that cover enhancing neuroregeneration using percutaneously placed electrode assemblies adjacent a target peripheral nerve, with validation during delivery and regenerative-effect stimulation for a predetermined period. Across the two independent claims, the inventive structure comprises (i) percutaneous electrode placement and removal, (ii) a validation-associated stimulation portion, and (iii) a regenerative-effect stimulation portion, with optional dependent refinements to electrode configuration and validation confirmation modalities.
Percutaneously placed electrode assembly adjacent the target peripheral nerve
The at least one electrode assembly is configured to be percutaneously positioned adjacent the target peripheral nerve during both a first phase and a second phase, configured to be placed at a location within the subject using a percutaneous pathway, and configured to be removed from the subject using the percutaneous pathway following the delivery of stimulation energy.
First phase stimulation that confirms at least one validation condition
During the first phase, stimulation energy of a first frequency is delivered to the target peripheral nerve via at least one electrode assembly, wherein delivering stimulation energy during the first phase is configured to confirm at least one validation condition.
Second phase stimulation creates a regenerative effect for a predetermined period
During the second phase, stimulation energy of a second frequency is delivered for a predetermined period via the at least one electrode assembly, wherein delivering stimulation energy to the subject during the second phase creates a regenerative effect to the target peripheral nerve.
Validation during placement/delivery while creating regenerative effect
Stimulation energy is delivered to a target peripheral nerve via at least one electrode assembly to confirm at least one validation condition, and stimulation energy is delivered via the at least one electrode assembly to create a regenerative effect, wherein the at least one electrode assembly is configured to be percutaneously positioned adjacent the target peripheral nerve while confirming the at least one validation condition and while creating a regenerative effect, and wherein the at least one electrode assembly is configured to be removed from the subject using the percutaneous pathway following the delivery of stimulation energy.
Overall, the claim coverage centers on a two-part or two-step stimulation concept (validation-associated stimulation and regenerative-effect stimulation) implemented using percutaneously positioned electrode assemblies adjacent a target peripheral nerve, with dependent claim refinements describing how validation is confirmed and constraining frequencies and electrode placement/configuration.
Stated Advantages
Documented Applications
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