Devices for delivering neuroregenerative therapy
Inventors
Willand, Michael Patrick • Aguirre, Sergio David
Assignees
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Publication Number
US-11247044-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 relates to neuroregenerative electrical stimulation systems that stimulate an injured peripheral nerve by delivering stimulation energy via a lead and at least one electrode electrically coupled to the lead. The device is configured to deliver stimulation energy in different operating phases, including a verification phase and a therapeutic phase.
During the verification phase, stimulation energy having a first frequency is delivered to the target nerve to confirm at least one condition based on measurement of at least one electrical parameter upstream to an injury site of the target nerve. In some configurations, delivery of stimulation energy during confirmation activates an indicator confirming confirmation of the at least one condition.
After confirmation, the device delivers stimulation energy having a second frequency to the target nerve for a predetermined time period during a therapeutic phase. The delivery of stimulation energy during the therapeutic phase is configured to create a regenerative effect to the target nerve, and the second frequency is equal to or greater than the first frequency, with one configuration specifying 10 Hz to 100 Hz.
The lead is advanced to or near the target nerve through a skin surface via a para-incisional pathway that is percutaneous and separate of an opening of the skin surface related to the injury site. The disclosed arrangements include confirming an upstream electrical condition, activating an indicator upon confirmation, and providing regenerative-effect stimulation while the lead is routed through a separate percutaneous para-incisional pathway.
Claims Coverage
The partial content provides three independent device claims. Across these independent claims, the inventive features focus on phase-based verification and therapy using upstream electrical parameter measurement, regenerative-effect stimulation using a second frequency, indicator activation upon confirmation, and a para-incisional percutaneous lead pathway separate from the injury-site skin opening.
Verification-phase upstream condition confirmation with first frequency stimulation
During a verification phase, deliver stimulation energy having a first frequency to the target nerve via at least one electrode, wherein delivery is configured to confirm at least one condition comprising measurement of at least one electrical parameter upstream to an injury site of the target nerve, where the electrical parameter is associated with the target nerve.
Therapeutic-phase regenerative-effect stimulation with second frequency for a predetermined time
During a therapeutic phase, deliver stimulation energy having a second frequency to the target nerve for a predetermined time period via at least one electrode, wherein delivery is configured to create a regenerative effect to the target nerve, wherein the second frequency is equal to or greater than the first frequency.
Percutaneous para-incisional lead pathway separate from injury-site opening
Advance the lead to or near the target nerve through a skin surface via a para-incisional pathway, wherein the para-incisional pathway is percutaneous and is separate of an opening of the skin surface related to the injury site of the target nerve.
Upstream condition confirmation with regenerative-effect stimulation and indicator activation at a specified frequency range
Deliver stimulation energy to confirm at least one condition, wherein the condition comprises measurement of at least one electrical parameter at a location upstream to an injury site and associated with the target nerve; deliver stimulation energy at a frequency for a predetermined time period configured to create a regenerative effect; specify the frequency as 10 Hz to 100 Hz; and activate an indicator when there is confirmation of the at least one condition.
Across the independent claims, the device structure is coupled to an operational concept in which stimulation is used to confirm at least one upstream electrical condition associated with the target nerve, optionally activating an indicator upon confirmation, followed by delivering stimulation at a second frequency for a predetermined time configured to create a regenerative effect. The independent claims further require a percutaneous para-incisional pathway for advancing the lead to or near the target nerve that is separate from the injury-site opening of the skin surface, and one independent claim specifies a frequency range of 10 Hz to 100 Hz.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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