Transformable Catheter Electrode Alignment for Renal Neuromodulation
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Solution Overview
Problem
Current pharmacologic strategies for managing chronic activation of the sympathetic nervous system, particularly renal sympathetic stimulation, have limitations such as limited efficacy, compliance issues, and side effects, and do not effectively address conditions like hypertension and renal dysfunction.
Innovation Solution
Low-profile neuromodulation catheters with energy delivery elements configured to deliver energy to nerves within a body lumen, featuring a treatment assembly that transforms from a low-profile delivery configuration to an expanded deployed configuration, allowing electrodes to be aligned orthogonally and positioned for effective ablation of target tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pharmacologic strategies are used to manage renal sympathetic stimulation, then treatment is provided, but efficacy is limited and side effects occur
Solution Approach 1:
The patent replaces pharmacologic strategies with a mechanical/electrical intervention system. A catheter with electrodes is inserted into the renal artery to deliver electrical energy directly to the renal sympathetic nerves, substituting the chemical mechanism of drugs with an physical electrical stimulation mechanism to achieve more reliable and targeted treatment with fewer side effects.
Solution Approach 2:
The catheter and electrodes serve as intermediaries between the external control system and the renal sympathetic nerves. This intermediary device allows precise delivery of electrical energy to the target nerves, enabling controlled neuromodulation that bypasses the non-specific action of pharmacologic strategies and reduces harmful side effects.
2Reliability
If a treatment assembly is expanded to deploy electrodes for nerve ablation, then treatment effectiveness is improved, but device profile increases
Solution Approach 1:
The treatment assembly is designed to nest within the catheter shaft during delivery. The electrodes and expansion members are contained within the catheter's internal lumen, allowing the catheter to maintain a small profile for easy insertion through blood vessels while enabling effective treatment when deployed at the target location.
Solution Approach 2:
The treatment assembly transitions from a compressed, low-profile state during delivery to an expanded state at the treatment site. This dynamic transformation allows the device to adapt its configuration based on operational requirements - small profile for delivery, expanded for effective electrode contact with renal nerves.
3Measurement precision
If electrodes are positioned orthogonally for ablation, then precision of nerve targeting is improved, but device complexity increases
Solution Approach 1:
The treatment assembly is segmented into multiple independent electrodes that can be individually positioned and controlled. This segmentation allows each electrode to be optimally oriented for contacting specific nerve fibers, achieving precise nerve targeting through distributed contact points rather than requiring complex single-unit configurations.
Solution Approach 2:
The electrodes are arranged in multiple dimensions - radially around the catheter shaft and at different longitudinal positions. This multi-dimensional arrangement enables orthogonal positioning relative to the renal arteries, providing precise three-dimensional coverage of the target nerves while distributing the complexity across multiple simpler electrode elements.
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 catheter system enables precise and effective neuromodulation, reducing renal sympathetic activity, which can help treat hypertension, heart failure, and other conditions associated with systemic sympathetic overactivity, offering a more targeted approach than existing pharmacologic methods.
Implementation Method 1
energy delivery elements configured to deliver energy to nerves at or near a treatment location within a body lumen
Data Source
Figure 1
Figure 2A~2B
Figure 2C
AI summary
Catheters including elements configured to deliver energy to nerves at or near a treatment location within a body lumen. A treatment assembly is transformable between a low-profile delivery configuration wherein a pair of electrodes are in a staggered arrangement relative to each other along the longitudinal axis, and an expanded deployed configuration wherein the pair of electrodes is aligned along an electrode axis that is orthogonal relative to the longitudinal axis.