Vagal Nerve Stimulation Synchronization with Transient Physiological Effects
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Solution Overview
Problem
Current medical devices for nerve tissue stimulation, such as vagal nerve stimulation, face challenges in optimizing the delivery of electrical stimulation to achieve consistent therapeutic effects, particularly in managing heart rate and cardiovascular conditions, as existing methods do not effectively synchronize stimulation with transient physiological effects and recovery periods.
Innovation Solution
The approach involves delivering electrical stimulation proximate nerve tissue during transient physiological effect periods, separated by recovery periods, using implantable medical devices with leads placed intravascularly or transvascularly near the vagus nerve or other target tissues, and employing techniques to determine the efficacy of stimulation through sensed physiological signals to adjust therapy parameters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If electrical stimulation is delivered continuously to nerve tissue, then therapeutic effects may be maintained, but the efficacy decreases due to transient physiological effects and recovery periods not being accounted for
Solution Approach 1:
The patent applies periodic action by delivering electrical stimulation in discrete pulses synchronized with the physiological response cycle of the nerve tissue. The device detects transient physiological effects and schedules subsequent stimulation pulses to occur after recovery periods, creating a periodic stimulation pattern that matches the tissue's natural response-time characteristics. This ensures each stimulation pulse occurs when the tissue is most responsive, maintaining consistent therapeutic efficacy while avoiding continuous stimulation during refractory periods.
2Reliability
If electrical stimulation dosage is increased to enhance therapeutic effect, then heart rate management improves, but side effects increase and tolerance develops
Solution Approach 1:
The patent implements dynamics by making the stimulation dosage adaptive rather than fixed. The device continuously monitors physiological responses and dynamically adjusts the amplitude, pulse width, and frequency of stimulation pulses in real-time. When transient physiological effects are detected, the system modulates the dosage to maintain therapeutic effectiveness while preventing over-stimulation. This dynamic adjustment prevents the development of tolerance and minimizes side effects by delivering only the necessary dosage at each moment.
Solution Approach 2:
The patent employs feedback mechanisms where the device senses physiological parameters (such as heart rate, neural activity, or other biomarkers) and uses this information to regulate subsequent stimulation delivery. The sensed physiological signals provide real-time feedback about the tissue's response state, allowing the control system to adjust stimulation parameters accordingly. This closed-loop feedback ensures optimal therapeutic effect while preventing excessive stimulation that could cause side effects or tolerance.
3Productivity
If electrical stimulation is delivered without considering recovery periods, then therapy coverage is maximized, but therapeutic efficacy is reduced due to diminished response
Solution Approach 1:
The patent applies preliminary action by detecting and identifying transient physiological effects before delivering the next stimulation pulse. The system proactively monitors for signs of tissue response and uses this information to schedule subsequent stimulation at optimal times. By anticipating the tissue's recovery state through continuous monitoring, the device ensures each pulse is delivered when the tissue is primed for maximum response, thereby maintaining both high therapy coverage and consistent therapeutic efficacy.
Data Source
AI summary
The present disclosure is directed to a method of using an implantable medical device. One embodiment of the present disclosure comprises delivering electrical stimulation proximate nerve tissue of a patient during a transient physiological effect period separated by a recovery period. The transient physiological effect period is when electrical stimulation has an increased level of efficacy and the recovery period is when additional electrical stimulation does not provide a beneficial physiological effect to the patient.