Peripheral Nerve Electrode Assemblies for Verified Regenerative Stimulation
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Solution Overview
Problem
Current surgical methods for treating peripheral nerve injuries result in inadequate functional recovery due to slow nerve regeneration and misdirection, with a limited window of opportunity for nerve regeneration and declining regenerative capacity over time.
Innovation Solution
A method involving electrode assemblies that deliver stimulation energy at specific frequencies to confirm nerve conditions and create a regenerative effect, utilizing a verification phase and a therapeutic phase with distinct or combined frequency settings to stimulate and regenerate nerves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical repair or release procedures are performed to treat peripheral nerve injuries, then nerve continuity is re-established, but functional recovery remains inadequate due to slow regeneration and misdirection
Solution Approach 1:
The patent applies preliminary action by delivering neuroregenerative stimulation therapy before surgical repair to prime and accelerate nerve regeneration. The stimulation device is positioned on the nerve proximal to the injury site and activated prior to and during surgical procedures, creating a favorable environment for subsequent nerve regrowth and improving functional outcomes.
Solution Approach 2:
The patent employs parameter changes by delivering electrical stimulation at specific frequencies (e.g., 1-100 Hz) and pulse durations to modulate nerve regeneration. By adjusting stimulation parameters such as frequency, amplitude, and duty cycle, the device optimizes neuroregenerative effects while accounting for the declining regenerative capacity over time.
2Reliability
If surgical procedures are performed to repair transected nerves, then nerve continuity is restored, but the window of opportunity for regeneration is limited and regenerative capacity declines with time
Solution Approach 1:
The device is positioned and activated immediately upon nerve injury, before the window of opportunity closes. By initiating stimulation therapy at the time of injury and continuing through the acute phase, the system maintains regenerative capacity and extends the effective treatment window beyond what would be available with delayed surgical intervention alone.
Solution Approach 2:
The patent implements continuity of useful action by delivering uninterrupted neuroregenerative stimulation therapy from the time of injury through the regeneration phase. The device provides continuous or intermittent stimulation over extended periods, ensuring that the regenerative process is supported throughout the critical time window without interruption.
3Measurement precision
If electrical stimulation is delivered to confirm electrode functionality and nerve contact, then verification of proper placement is achieved, but additional time and complexity are introduced to the treatment protocol
Solution Approach 1:
The patent merges the verification function with the therapeutic stimulation device itself. The same electrode assembly used for neuroregenerative therapy also performs verification by detecting electrical parameters such as impedance or evoked responses, eliminating the need for separate verification equipment and simplifying the overall treatment protocol.
Solution Approach 2:
The device incorporates feedback mechanisms that automatically monitor electrical parameters during stimulation to confirm proper electrode-nerve contact. By providing real-time feedback on impedance changes or evoked muscle responses, the system verifies placement accuracy without requiring additional manual testing procedures.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Accelerates nerve regeneration by confirming electrode functionality and nerve contact, ensuring effective delivery of neuroregenerative therapy, suitable for various clinical workflows and nerve types, and allowing continuous monitoring of therapy efficacy.
Implementation Method 1
delivering stimulation energy having a first frequency to the subject via at least one electrode assembly... delivering stimulation energy having a second frequency to the subject for a predetermined time period via the at least one electrode assembly
Data Source
AI summary
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.