Renal Nerve Neuromodulation System for Reversible Hypertension Treatment
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Solution Overview
Problem
Current treatments for hypertension, such as renal nerve ablation, are irreversible and can lead to undesirable side effects like neuroma formation and neuropathic pain, failing to dynamically manage blood pressure without permanent physiological alterations.
Innovation Solution
A neuromodulation system comprising a cylindrical support structure with electrodes and sensors deployed in a blood vessel, using electrical therapeutic energy to modulate renal nerve branches based on sensed blood pressure, evoking or blocking compound action potentials to treat hypertension without permanent damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If renal nerve ablation is performed to treat hypertension, then blood pressure is reduced, but permanent physiological alterations occur leading to neuroma formation and neuropathic pain
Solution Approach 1:
The patent applies dynamics by transitioning from static, irreversible nerve ablation to dynamic, reversible neuromodulation. The system delivers adjustable electrical stimulation pulses that can be tuned in real-time to achieve blood pressure control while allowing the nervous system to remain functional and adaptable, thereby avoiding permanent damage and associated complications.
Solution Approach 2:
The patent utilizes parameter changes by varying electrical stimulation parameters (amplitude, pulse width, frequency, duty cycle) to achieve therapeutic effects without causing tissue destruction. By precisely controlling these parameters, the system modulates renal nerve activity to lower blood pressure while staying below the thresholds that would cause neuroma formation or neuropathic pain.
2Reliability
If renal nerve ablation is performed to treat hypertension, then blood pressure is reduced, but the treatment is irreversible making re-adjustment difficult
Solution Approach 1:
The system provides dynamic control through programmable stimulation parameters and adjustable delivery protocols. Clinicians can modify stimulation intensity, timing, and patterns in response to changing patient needs, such as acute blood loss or varying blood pressure targets, enabling flexible re-adjustment that irreversible ablation cannot provide.
Solution Approach 2:
The system incorporates feedback mechanisms where blood pressure monitoring informs stimulation delivery adjustments. This closed-loop approach allows the system to respond to physiological changes and automatically or manually adjust treatment parameters to maintain optimal blood pressure control while adapting to new clinical conditions.
3Reliability
If electrical energy is delivered to ablate renal nerves, then hypertension is treated, but permanent damage to the renal nervous system occurs
Solution Approach 1:
The patent applies parameter changes by delivering electrical energy at intensities and durations below the ablation threshold. By controlling voltage, current, pulse width, and frequency within specific ranges, the system achieves neuromodulation effects that treat hypertension while preserving neural tissue integrity and avoiding the permanent damage associated with high-energy ablation.
Solution Approach 2:
The system uses periodic electrical stimulation pulses rather than continuous high-energy delivery. By applying brief, intermittent stimulation bursts with appropriate inter-pulse intervals, the system accumulates therapeutic effects over time while allowing tissue recovery between pulses, thereby preventing the thermal or electrochemical damage that leads to nerve destruction.
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
This approach allows for dynamic management of hypertension, reducing blood pressure effectively while avoiding permanent renal nervous system alterations and associated side effects, providing a reversible treatment option.
Implementation Method 1
The sensor may be a piezoresistive strain gage, in which case, the neuromodulation system may further comprises an intraluminal catheter configured for being filled with a liquid in communication with the piezoresistive strain gage
Implementation Method 2
the support structure comprises an electrically insulative material for preventing electrical energy from being radially conveyed inward from the cylindrical support structure
Implementation Method 3
delivering electrical therapeutic energy in accordance with a set of neuromodulation parameters to a nerve branch of a renal artery of the patient, thereby treating the chronic hypertension
Data Source
AI summary
A system and method for treating a patient suffering from chronic hypertension. Electrical therapeutic energy is delivered to a nerve branch of a renal artery of the patient, thereby treating the chronic hypertension. Another system and method for treating a medical condition of a patient. Electrical stimulation energy is delivered to a stimulation site on the wall of a blood vessel, thereby evoking a compound action potential in a nerve branch associated with the blood vessel, sensing the evoked compound action potential at a sensing site on the wall of the blood vessel, identifying a circumferential location of the nerve branch as being adjacent the stimulation site or sensing site based on the sensed compound action potential(s), and delivering therapeutic energy to a therapeutic site on the wall of the blood vessel adjacent the circumferential location of the nerve branch, thereby modulating the nerve branch and treating the medical condition.