Generator Assemblies for Renal Neuromodulation Therapy

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Solution Overview

Problem

Current pharmacologic strategies for managing chronic activation of the sympathetic nervous system, particularly in conditions like hypertension and heart failure, have limited efficacy, compliance issues, and significant side effects, necessitating alternative treatment approaches.

Innovation Solution

The development of generator assemblies and systems for renal neuromodulation therapy, which involve the use of RF energy to inhibit or disrupt renal sympathetic nerves through intravascular access, providing thermal heating effects to achieve neuromodulation and reduce sympathetic tone.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If pharmacologic strategies are used to manage chronic sympathetic nervous system activation, then sympathetic tone can be reduced, but compliance issues and significant side effects occur

Engineering Contradiction:
Improveefficacy of sympathetic tone reductionVSAvoidside effects and compliance issues
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces pharmacologic (chemical) intervention with RF energy delivery (physical/thermal) to achieve sympathetic nerve modulation. The RF generator delivers energy through catheter electrodes that heat renal sympathetic nerves to approximately 60°C, creating lesions that reduce sympathetic outflow without requiring ongoing medication compliance or exposing patients to drug side effects

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

Solution Approach 2:

The patent extracts the harmful effects associated with pharmacologic management by removing the need for continuous drug administration. The one-time RF energy delivery procedure eliminates ongoing compliance issues and many drug-related side effects while maintaining the therapeutic benefit of reduced sympathetic tone

Inventive Principle:
Principle #2Taking out (Extraction)

2Object-affected harmful factors

If RF energy is delivered to renal sympathetic nerves through intravascular access, then neuromodulation can be achieved with reduced side effects, but thermal heating must be precisely controlled to avoid tissue damage

Engineering Contradiction:
Improveside effectsVSAvoidthermal heating control precision
Core Design Contradiction:
Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The system incorporates real-time temperature monitoring through thermocouples or other temperature sensors positioned near the RF electrodes. The generator continuously monitors temperature feedback and automatically adjusts RF energy delivery to maintain temperatures within the therapeutic range (approximately 50-70°C), preventing both insufficient heating and excessive tissue damage

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system dynamically changes RF delivery parameters (power level, pulse duration, duty cycle) based on real-time temperature measurements and tissue impedance changes. This allows precise control of the thermal heating process to achieve effective neuromodulation while avoiding collateral tissue damage

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If generator assemblies are designed for portable use with removable battery packs, then ease of operation and charging convenience are improved, but device complexity increases

Engineering Contradiction:
Improvecharging convenience and portabilityVSAvoidgenerator assembly structure
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The generator assembly is divided into modular components: a main generator body and a removable battery pack. The battery pack can be easily detached and reattached to the generator body through a standardized interface, allowing users to replace depleted batteries without servicing the entire device. This segmentation provides portability and charging convenience while keeping the interface simple and user-friendly

Inventive Principle:
Principle #1Segmentation

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, potentially treating conditions associated with excessive sympathetic tone, such as hypertension and heart failure, with improved efficacy and reduced side effects compared to traditional pharmacologic methods.

Implementation Method 1

The generator assembly can include a RF generator configured to deliver RF energy to a renal artery

Methodology Applied
Scientific EffectRF energy thermal heating: Joule Heating

Data Source

PatentEP4094701A1Generator assemblies for neuromodulation therapy
Publication Date: 2022.11.30 MEDTRONIC IRELAND MFG UNLIMITED CO
  • EP4094701A1 patent drawingFigure 1
  • EP4094701A1 patent drawingFigure 2
  • EP4094701A1 patent drawingFigure 3A~3B

AI summary

Generator assemblies and systems for neuromodulation therapies are disclosed herein. A generator system configured in accordance with a particular embodiment of the present technology can include, for example, a generator console and a stand assembly configured to releasably carry the generator console. The generator console can include a plurality of radiofrequency (RF) channels configured to deliver energy to a plurality of electrodes of a neuromodulation device. The generator console can also include a display configured to indicate operating conditions of the RF channels during energy delivery. The stand assembly can include a recessed portion having a plurality of spring-loaded locking members and a release mechanism operably coupled to the locking members. The release mechanism can be configured to move the locking members from a locked arrangement to an unlocked arrangement to disengage the generator console from the stand assembly.