Multi-Electrode Catheter for Renal Neuromodulation

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Solution Overview

Problem

Current pharmacological strategies for managing excessive renal sympathetic nerve activity, which contributes to hypertension and renal disease, have limited efficacy, compliance issues, and significant side effects, necessitating alternative treatment approaches.

Innovation Solution

The development of a multi-electrode radio frequency (RF) ablation catheter apparatus for intravascular renal neuromodulation, which uses a catheter with a multi-electrode array that can be deployed in a helical shape within the renal artery to deliver energy for thermal or electrical neuromodulation of renal nerves, thereby reducing sympathetic nerve activity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If pharmacological strategies are used to manage renal sympathetic nerve activity, then treatment can be administered orally, but efficacy is limited and side effects are significant

Engineering Contradiction:
Improveoral administrationVSAvoidefficacy
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent replaces pharmacological (chemical) mechanisms with a mechanical/electrical intervention system. A catheter with electrodes is inserted into the renal artery to deliver electrical signals that directly modulate sympathetic nerve activity, eliminating the need for oral medications and their associated limited efficacy and side effects.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces an intermediary system (catheter with electrodes) that acts as a mediator between the external control system and the renal sympathetic nerves. This intermediary delivers targeted electrical stimulation to modulate nerve activity, providing more reliable and direct control compared to pharmacological agents.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If radio frequency ablation is used to create lesions in renal nerves, then sympathetic nerve activity can be reduced, but risk of overheating and occlusion increases

Engineering Contradiction:
Improveneuromodulation effectivenessVSAvoidoverheating and occlusion risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs periodic or pulsed electrical stimulation rather than continuous high-energy ablation. The electrodes deliver controlled electrical signals in a periodic manner that achieves neuromodulation while allowing heat dissipation, thereby reducing the risk of excessive overheating and vascular occlusion.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The patent changes the parameters of energy delivery by using electrical stimulation with controlled amplitude, frequency, and duration. This allows precise modulation of nerve activity while maintaining temperature within safe limits, avoiding the harmful effects of uncontrolled overheating associated with traditional RF ablation.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If multi-electrode arrays are deployed in helical shape within renal artery, then deeper and larger lesions can be created, but device complexity increases

Engineering Contradiction:
Improvelesion depth and sizeVSAvoidcatheter structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent divides the treatment function into multiple segments by using a multi-electrode array. Each electrode can independently deliver electrical stimulation to create discrete lesions along the renal artery, allowing cumulative effect to achieve deeper and larger overall lesion coverage while maintaining manageable complexity through modular design.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent transitions from a single-point treatment approach to a multi-dimensional approach by deploying electrodes in a helical configuration within the renal artery. This three-dimensional arrangement allows simultaneous treatment of nerves at multiple locations and depths, achieving more comprehensive neuromodulation without proportionally increasing device complexity.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

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 reduces renal sympathetic nerve activity, offering a potential treatment for hypertension, heart failure, and renal disease by creating deeper and larger lesions with reduced risk of overheating and occlusion, while allowing for longer activation times.

Implementation Method 1

multi-electrode radio frequency (RF) ablation catheter apparatus for intravascular renal neuromodulation

Methodology Applied
Scientific EffectRadio frequency heating: Dielectric Heating

Implementation Method 2

deliver energy for thermal or electrical neuromodulation of renal nerves

Methodology Applied
Scientific EffectJoule heating: Joule Heating

Data Source

PatentUS11116572B2Catheter apparatuses having multi-electrode arrays for renal neuromodulation and associated systems and methods
Publication Date: 2021.09.14 MEDTRONIC ARDIAN LUXEMBOURG SARL
  • US11116572B2 patent drawing
  • US11116572B2 patent drawing
  • US11116572B2 patent drawing

AI summary

Catheter apparatuses, systems, and methods for achieving renal neuromodulation by intravascular access are disclosed herein. One aspect of the present technology, for example, is directed to a treatment device having a multi-electrode array configured to be delivered to a renal blood vessel. The array is selectively transformable between a delivery or low-profile state (e.g., a generally straight shape) and a deployed state (e.g., a radially expanded, generally helical shape). The multi-electrode array is sized and shaped so that the electrodes or energy delivery elements contact an interior wall of the renal blood vessel when the array is in the deployed (e.g., helical) state. The electrodes or energy delivery elements are configured for direct and/or indirect application of thermal and/or electrical energy to heat or otherwise electrically modulate neural fibers that contribute to renal function or of vascular structures that feed or perfuse the neural fibers.