Biphasic Neurostimulation Waveforms for Vascular Denervation
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Solution Overview
Problem
Existing methods for denervating nerves, such as those in vascular tissue, are inefficient in identifying suitable neural tissue for therapy and require excessive time due to the lack of effective neural stimulation techniques.
Innovation Solution
A therapeutic device is configured to apply multiphasic-pulsed neurostimulation, specifically biphasic waveforms, to vascular tissues, alternating the leading phase of each pulse to enhance neural response and facilitate accurate identification and denervation of nerves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional neural stimulation techniques are used for identifying neural tissue during denervation procedures, then the procedure can be performed, but the time required for identifying suitable neural tissue is excessive and the efficiency is low
Solution Approach 1:
The patent applies periodic pulsed waveforms with alternating polarities (anodal and cathodal phases) to stimulate neural tissue. By delivering sequences of pulses with varying phases rather than continuous stimulation, the method efficiently elicits neural responses for identification while reducing total procedure time compared to traditional techniques
Solution Approach 2:
The patent changes stimulation parameters by using multiphasic waveforms with alternating anodal and cathodal phases, and by adjusting pulse duration, amplitude, and frequency. These parameter variations optimize neural tissue identification efficiency and reduce the time required to identify suitable targets for denervation
2Reliability
If single-phase or simple biphasic waveforms are used for neural stimulation, then the stimulation can be applied, but the likelihood of stimulating neural tissue across vessel walls is reduced
Solution Approach 1:
The patent employs periodic pulsed waveforms with multiple phases (anodal and cathodal phases) delivered in sequence. This periodic multiphasic approach increases the probability of stimulating neural tissue across vessel walls by repeatedly applying stimulation with alternating polarities, thereby improving reliability without excessive complexity
Solution Approach 2:
The stimulation waveform is segmented into distinct phases (anodal phase and cathodal phase) rather than using a single continuous waveform. This segmentation allows each phase to target different aspects of neural excitability, increasing the overall likelihood of successful neural tissue stimulation
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
The multiphasic neurostimulation increases the likelihood of stimulating neural tissue, reduces the time required for identifying suitable neural tissue, and enhances the accuracy of denervation therapy by promoting a greater neural response.
Implementation Method 1
applying pulses of neurostimulation energy having at least two phases to the target tissue via the plurality of electrodes
Implementation Method 2
each pulse of the neurostimulation energy includes an anodal phase and a cathodal phase
Data Source
AI summary
A method of performing and assessing a therapeutic procedure includes navigating a therapeutic device to target tissue, transitioning the therapeutic device from a first, linear configuration to a second, deployed configuration such that a plurality of electrodes on the therapeutic device are in engagement with the target tissue, applying pulses of neurostimulation energy having at least two phases to target tissue via the plurality of electrodes, the neurostimulation energy including an anodal phase and a cathodal phase, wherein a phase of the neurostimulation is switched from anodal to cathodal or cathodal to anodal for each successive pulse, observing a physiological response to the neurostimulation energy indicative of a neural response, denervating the nerves of the target tissue, and applying the neurostimulation energy to the target tissue, wherein a physiological response less than a threshold is indicative of a successful denervation of the nerves of the target tissue.