Radiofrequency Treatment System with Temperature Feedback Control

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Solution Overview

Problem

Existing systems for treating gastrointestinal sphincter dysfunction using radiofrequency energy face challenges in avoiding tissue ablation while ensuring effective thermal treatment, as they struggle to balance between overheating and underheating, leading to inconsistent tissue treatment outcomes.

Innovation Solution

A system employing a flexible outer tube with an expandable basket and movable electrodes, along with a spacer to maintain electrode alignment and control tissue temperature, applies radiofrequency energy to create tissue lesions without ablating the tissue, ensuring consistent and reliable thermal treatment by maintaining tissue temperature within a therapeutic range.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If radiofrequency energy is applied to create tissue lesions, then tissue structure is altered and therapeutic effect is achieved, but tissue may be overheated causing ablation

Engineering Contradiction:
Improvetherapeutic effect consistencyVSAvoidtissue ablation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system continuously monitors tissue temperature during radiofrequency energy application and provides real-time feedback to the control system. When the tissue temperature approaches the ablation threshold, the system automatically adjusts or terminates energy delivery, creating a closed-loop control system that prevents tissue ablation while maintaining therapeutic heating effects.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system dynamically adjusts radiofrequency energy delivery parameters (power, duration, pulse pattern) based on real-time tissue temperature measurements. By changing these parameters in response to temperature feedback, the system maintains heating within the therapeutic window without reaching ablation temperatures, resolving the contradiction between achieving therapeutic effect and preventing harm.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If radiofrequency energy application is monitored to prevent ablation, then tissue safety is improved, but treatment consistency may deteriorate due to undertreatment

Engineering Contradiction:
Improvetissue safetyVSAvoidtreatment consistency
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The continuous temperature monitoring and feedback control system enables the physician to safely push the therapeutic boundary by providing real-time visibility of tissue temperature. This confidence from monitoring allows more aggressive or prolonged energy application to ensure complete treatment, while the feedback mechanism prevents crossing into unsafe territory, thereby maintaining both safety and treatment consistency.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system maintains continuous radiofrequency energy delivery with continuous temperature monitoring, allowing sustained therapeutic heating without interruption. This continuous action ensures complete treatment of the target tissue while the concurrent monitoring prevents overheating, resolving the contradiction between treatment completeness and safety.

Inventive Principle:
Principle #20Continuity of useful action

3Object-affected harmful factors

If tissue temperature is strictly controlled to avoid ablation, then harmful effects are reduced, but therapeutic effectiveness may be compromised

Engineering Contradiction:
Improvetissue damageVSAvoidtherapeutic effectiveness
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The system utilizes the full therapeutic temperature range by dynamically adjusting energy parameters. It allows tissue temperature to rise to effective therapeutic levels (e.g., 45-65°C) while preventing exceedance of the ablation threshold (e.g., 100°C). This precise parameter control enables maximum therapeutic effectiveness without causing tissue damage, resolving the contradiction between effectiveness and safety.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The system transitions from static temperature control to dynamic control, where energy delivery parameters are continuously adjusted based on real-time temperature feedback. This dynamic approach allows the system to adapt to varying tissue properties and treatment conditions, maintaining optimal therapeutic effectiveness while preventing tissue damage throughout the treatment process.

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

The system effectively treats gastrointestinal sphincter dysfunction by creating tissue lesions that alter tissue structure without causing ablation, improving muscle function and reducing symptoms like GERD and fecal incontinence, while preventing both overheating and undertreatment.

Implementation Method 1

applying radiofrequency energy to tissue to create tissue lesions without ablating tissue

Methodology Applied
Scientific EffectResistive heating: Joule Heating

Data Source

PatentUS11471214B2Systems and methods for treating tissue with radiofrequency energy
Publication Date: 2022.10.18 MEDERI RF LLC
  • US11471214B2 patent drawing
  • US11471214B2 patent drawing
  • US11471214B2 patent drawing

AI summary

A system for controlling operation of a radiofrequency treatment device to apply radiofrequency energy to tissue to treat tissue to create lesions without ablating the tissue. The system includes a first treatment device having a plurality of electrodes. The electrodes are maintained in axial alignment and fixed radial spacing in retracted and extended positions. The device includes a basket having a plurality of arms. The arms are maintained in a fixed radial spacing in the collapsed position of the basket.