Ablation Catheter Pulse Rate Feedback Control

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Solution Overview

Problem

During renal ablation procedures, the varying patient pulse rate affects temperature measurements at the lesion site, leading to difficulties in maintaining a consistent temperature range due to the cooling effect of blood flow, which can result in potential damage to the artery wall and inconsistent ablation outcomes.

Innovation Solution

Incorporating a pulse rate detector and feedback mechanism in electrical connection with the generator to monitor and adjust the energy supplied to the ablation catheter, compensating for the patient's pulse rate to maintain the lesion temperature within a desired range.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the ablation electrode is used to create lesions along the artery wall, then the renal nerves can be effectively ablated, but the varying pulse rate causes temperature fluctuations that can lead to artery wall damage

Engineering Contradiction:
Improveablation effectivenessVSAvoidartery wall damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system incorporates a temperature sensor that continuously monitors the temperature at the lesion site and feeds this information back to the control system. The control system adjusts the RF energy delivery in real-time based on the temperature feedback, ensuring the temperature remains within the safe and effective range (50-90°C) while preventing artery wall damage from excessive heating

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The ablation system dynamically adjusts the RF energy delivery parameters (power, duration) based on real-time temperature measurements and pulse rate variations. The system transitions from static, pre-programmed ablation protocols to dynamic, adaptive control that responds to physiological changes during the procedure, maintaining optimal temperature despite varying blood flow conditions

Inventive Principle:
Principle #15Dynamics

2Device complexity

If the operator manually monitors and tracks ablated areas, then the procedure can be performed with simple equipment, but it is difficult to maintain consistent temperature and avoid over-treatment

Engineering Contradiction:
Improvesystem simplicityVSAvoidtemperature control precision
Core Design Contradiction:
Device complexityVSManufacturing precision

Solution Approach 1:

A temperature sensor positioned at or near the ablation electrode provides real-time temperature feedback to the control system. This closed-loop feedback enables automatic adjustment of RF energy delivery to maintain precise temperature control (±5°C) throughout the ablation process, eliminating the need for complex manual monitoring while achieving consistent thermal outcomes

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system replaces manual visual monitoring and tracking by the operator with automated electronic temperature sensing and control. The mechanical/manual process of observing and recording temperature is substituted with electronic thermocouples or thermistors that continuously measure and digitally report temperature, enabling more precise and reliable temperature management

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

3Reliability

If multiple ablation areas are created along the artery, then complete nerve ablation can be achieved, but the procedure time increases and temperature consistency becomes more difficult to maintain

Engineering Contradiction:
Improvenerve ablation completenessVSAvoidprocedure time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system enables rapid sequential ablation by dynamically adjusting energy delivery parameters between lesions. The control system quickly recalibrates for each new ablation site based on real-time temperature feedback, allowing the operator to efficiently create multiple lesions along the artery without prolonged procedure time or loss of temperature control accuracy across different locations

Inventive Principle:
Principle #15Dynamics

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 allows for more accurate temperature control of the lesion, reducing the risk of artery damage and improving procedural efficiency and consistency by standardizing lesion outcomes.

Implementation Method 1

a pulse rate detector and feedback mechanism in electrical connection with the generator to compensate for the pulse rate of a patient

Methodology Applied
Scientific EffectPulse rate detection:

Implementation Method 2

feedback mechanism in electrical connection with the generator to compensate for the pulse rate of a patient and to monitor and adjust the energy supplied to an ablation catheter to control the temperature at a lesion site

Methodology Applied
Scientific EffectTemperature control through feedback: Feedback

Implementation Method 3

adjust the energy supplied to the at least one ablation catheter electrode to create the lesion based on the pulse rate of the patient so as to control the temperature of the lesion

Methodology Applied
Scientific EffectJoule heating: Joule Heating

Data Source

PatentUS10398501B2Ablation systems including pulse rate detector and feedback mechanism and methods of use
Publication Date: 2019.09.03 ST JUDE MEDICAL CARDILOGY DIV INC
  • US10398501B2 patent drawing
  • US10398501B2 patent drawing

AI summary

Methods, systems, and apparatuses for performing a renal denervation procedure using an ablation catheter are described. An ablation catheter system may include an ablation catheter including at least one electrode, a generator, and a pulse rate detector and feedback mechanism in electrical connection with the generator. In one embodiment, a method for controlling the temperature of a lesion created inside of a patient includes determining the pulse rate of the patient prior to, and optionally during, a renal denervation procedure and adjusting the amount of energy distributed to an ablation catheter electrode based at least in part on the pulse rate of the patient so as to control the temperature of the lesion being created. By controlling the temperature of the lesion during the ablation process, more consistent patient outcomes may be provided.