Renal Nerve Ablation System with Predictive Action Potential Testing

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Solution Overview

Problem

Current methods for ablating renal nerve tissue to treat hypertension lack precision in predicting the effectiveness of energy application, leading to inconsistent blood pressure regulation.

Innovation Solution

A system comprising an ablation unit, electrode units, and a control unit that detects blood pressure values before and after applying non-ablative and ablative energies to the renal nerve, allowing for predictive and adaptive energy application to optimize tissue ablation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If ablative energy is applied to renal nerve tissue to treat hypertension, then blood pressure regulation is improved, but the precision in predicting treatment effectiveness is insufficient leading to inconsistent results

Engineering Contradiction:
Improvetreatment effectiveness consistencyVSAvoidprediction precision of energy application effectiveness
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The system performs preliminary testing by applying sub-ablative energy levels to the renal nerve tissue before committing to full ablative treatment. This preliminary action allows measurement of the tissue's electrophysiological response and prediction of treatment effectiveness, ensuring that only responsive patients proceed to full ablation, thereby improving consistency of treatment outcomes.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system continuously monitors electrophysiological parameters (action potentials, nerve firing rates) during energy application and uses this feedback to adjust energy delivery in real-time. The control unit compares measured responses against predicted outcomes and modifies subsequent energy applications to optimize treatment effectiveness, ensuring consistent blood pressure regulation results.

Inventive Principle:
Principle #23Feedback

2Reliability

If electrical currents are applied to initiate or block action potentials in renal nerve, then blood pressure control is improved, but the complexity of controlling energy application increases

Engineering Contradiction:
Improveblood pressure regulationVSAvoidcontrol system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The renal nerve tissue itself provides the feedback signal through its natural electrophysiological responses (action potentials, firing rates). The system leverages the tissue's own electrical activity as the sensing mechanism, eliminating the need for separate complex sensors. The nerve's intrinsic electrical signals directly inform the control unit about treatment effectiveness, simplifying the overall system architecture while maintaining reliable blood pressure control.

Inventive Principle:
Principle #25Self-service

3Measurement precision

If multiple electrode units are used to apply excitatory and blocking currents, then the precision of nerve modulation is improved, but the device complexity and procedural difficulty increase

Engineering Contradiction:
Improvenerve modulation precisionVSAvoidprocedural ease
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The system combines multiple electrode units (excitatory electrodes, blocking electrodes, sensing electrodes) into a single integrated catheter assembly that is delivered through a single transluminal access point. The control unit manages all electrodes simultaneously, coordinating excitatory and blocking current application as a unified treatment protocol. This merging approach maintains precise nerve modulation capability while simplifying the procedural steps and reducing operational complexity.

Inventive Principle:
Principle #5Merging (Combining)

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 system enables precise control of energy application to the renal nerve, effectively regulating blood pressure by blocking or initiating action potentials, thereby improving treatment efficacy for hypertension.

Implementation Method 1

at least one electrode unit, coupled to the ablation unit, and configured to be percutaneously advanced to a site adjacent to a second portion of the nerve tissue of the subject, and to initiate unidirectional action potentials in the nerve tissue

Methodology Applied
Scientific EffectAction potential initiation:

Implementation Method 2

the ablation unit includes a radio-frequency ablation unit, and the control unit is configured to drive the radio-frequency ablation unit to ablate the first portion of the nerve tissue by applying an ablative radio-frequency current to the first portion of the nerve tissue

Methodology Applied
Scientific EffectRadio-frequency heating: Dielectric Heating

Implementation Method 3

the ablation unit includes an ultrasound ablation unit, and the control unit is configured to drive the ultrasound ablation unit to ablate the first portion of the nerve tissue by applying ablative ultrasound energy to the first portion of the nerve tissue

Methodology Applied
Scientific EffectUltrasonic heating: Ultrasonic Vibration

Implementation Method 4

the electrode unit is configured to apply a non-ablative blocking current to the second portion of the nerve tissue of the subject, the non-ablative blocking current being configured to reversibly block endogenous action potentials from propagating through the second portion of the nerve tissue

Methodology Applied
Scientific EffectAction potential blocking:

Data Source

PatentUS9770593B2Patient selection using a transluminally-applied electric current
Publication Date: 2017.09.26 SYMAP MEDICAL (SUZHOU) LIMITED
  • US9770593B2 patent drawing
  • US9770593B2 patent drawing
  • US9770593B2 patent drawing

AI summary

Apparatus for facilitating ablation of nerve tissue of a subject is provided, comprising (1) an ablation unit, configured to be percutaneously advanced to a site adjacent to a first portion of the nerve tissue; (2) at least one electrode unit, coupled to the ablation unit, and configured to be percutaneously advanced to a site adjacent to a second portion of the nerve tissue, and to initiate unidirectional action potentials in the nerve tissue, such that the unidirectional action potentials propagate toward the first portion of the nerve tissue; and (3) a control unit, configured: (a) to drive the ablation unit to ablate, at least in part, the first portion of the nerve tissue of the subject, and (b) to drive the at least one electrode unit to initiate the unidirectional action potentials by applying an excitatory current to the second portion of the nerve tissue.