Intravascular Thermal Neuromodulation for Renal Denervation
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Solution Overview
Problem
Current therapies for hypertension, chronic heart failure, and chronic renal failure are unsatisfactory due to limited efficacy, compliance issues, and side effects, particularly in addressing the complex electrical, mechanical, and hormonal forces regulating blood pressure, where overactive sympathetic stimulation of the kidneys exacerbates these conditions.
Innovation Solution
An apparatus and method for intravascular thermal neuromodulation, specifically targeting the renal sympathetic nerve plexus using an expandable structure with electrodes and sensors, delivering thermal energy to modulate renal sympathetic activity through renal denervation, thereby reducing efferent and afferent sympathetic nerve fiber activity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current pharmacological and surgical therapies are used for hypertension and cardiovascular diseases, then some blood pressure control is achieved, but efficacy is limited and side effects occur
Solution Approach 1:
The patent replaces pharmacological chemical action with thermal energy delivery through RF electrodes. The expandable structure with multiple electrodes delivers controlled thermal energy to the renal nerve plexus, substituting drug-based therapy with a physical energy-based approach that avoids pharmacological side effects while achieving reliable blood pressure control through renal denervation
Solution Approach 2:
The patent introduces thermal energy as an intermediary between the delivery catheter and the renal nerves. The expandable structure with RF electrodes serves as a mediator that converts electrical energy to thermal energy, which then selectively affects the renal nerve plexus through controlled heating, providing a controlled intermediate step that improves therapeutic reliability while minimizing harmful effects
2Reliability
If renal sympathetic activity is reduced through denervation, then blood pressure control improves, but the complexity of the intravascular apparatus increases
Solution Approach 1:
The patent divides the renal nerve plexus treatment into multiple segments by using an expandable structure with multiple RF electrodes distributed around the renal artery. This segmentation allows selective treatment of different portions of the nerve plexus while using a single catheter delivery system, achieving reliable blood pressure control without requiring multiple separate devices
Solution Approach 2:
The patent employs a nested structure where the expandable RF electrode array is contained within a delivery catheter. The complex multi-electrode structure is collapsed into a compact form for intravascular delivery, then expanded at the target site to achieve the full therapeutic configuration, reducing delivery complexity while maintaining treatment effectiveness
3Reliability
If thermal energy is delivered to modulate renal sympathetic nerves, then nerve activity is effectively reduced, but the precision of thermal delivery to specific nerve fibers must be maintained
Solution Approach 1:
The patent applies local quality by concentrating thermal energy delivery at the specific interface between the expandable electrode structure and the renal nerve plexus. The RF electrodes are positioned to create localized thermal fields that selectively affect the nerves in direct contact with the expanded structure, achieving effective neuromodulation while limiting thermal spread to surrounding tissues through controlled local heating zones
Solution Approach 2:
The patent incorporates temperature sensors that provide real-time feedback on tissue temperature during RF energy delivery. This feedback mechanism allows dynamic adjustment of the RF power to maintain precise thermal delivery, ensuring the temperature remains within the therapeutic window for renal nerve denervation while preventing overheating or inadequate treatment
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 effectively decreases renal sympathetic activity, alleviating hypertension and related cardiovascular diseases by reversing fluid and salt retention, reducing inappropriate renin release, and halting the deleterious RAAS cascade, thus lowering blood pressure and improving cardiovascular and renal function.
Implementation Method 1
delivering thermal energy to modulate renal sympathetic activity through renal denervation
Data Source
AI summary
A thermal neuromodulation apparatus, system, and methods for the ablative and non-ablative application of thermal energy to the renal nerves of a patient are disclosed. The thermal neuromodulation apparatus includes an elongated, hollow body configured to traverse the tortuous intravascular pathways of the renal vasculature and includes an expandable structure bearing electrodes and configured to selectively apply thermal energy via electric fields to the renal nerves through a vessel wall. The thermal neuromodulation apparatus may also include sensors and an imaging apparatus to obtain data from the treatment area before, during, and after neuromodulation to monitor and/or control the neuromodulation process.