RF Atrial Shunt Device for Stable Septal Puncture

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Solution Overview

Problem

Current treatments for heart failure with preserved ejection fraction, such as creating a hole in the atrial septum to drain blood pressure from the left atrium to the right atrium, face challenges in maintaining the hole open, leading to potential reclosure and inadequate pressure reduction.

Innovation Solution

A reaming type non-implanted atrial shunt device utilizing a catheter with a radio frequency component and ablation instrument to create a stable hole in the atrial septum, preventing reclosure by using radio frequency energy to ablate the tissue and a balloon to ensure accurate and convenient hole creation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a traditional puncture method is used to create a hole in the atrial septum, then the procedure is simple, but the hole is prone to reclosure and cannot maintain open state

Engineering Contradiction:
Improvehole stabilityVSAvoiddevice structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces traditional mechanical puncture methods with radio frequency energy-based ablation. The radio frequency component delivers electromagnetic energy to the atrial septum tissue, causing thermal ablation and forming a stable hole that resists reclosure, thereby improving hole stability without requiring complex mechanical retention structures

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

Solution Approach 2:

The patent utilizes radio frequency energy parameters to control the ablation process. By adjusting radio frequency power, duration, and delivery characteristics, the system creates a stable hole with specific tissue characteristics that prevent reclosure, transforming the physical state of the tissue through controlled thermal energy application

Inventive Principle:
Principle #35Parameter changes

2Reliability

If radio frequency ablation is used to create the hole, then the hole is difficult to reclose and stable, but the process requires precise energy delivery and tissue heating

Engineering Contradiction:
Improvehole stabilityVSAvoidtissue heating control
Core Design Contradiction:
ReliabilityVSTemperature

Solution Approach 1:

The patent incorporates temperature sensing capabilities within the radio frequency component to monitor tissue temperature during ablation. This feedback mechanism allows real-time detection of thermal conditions, enabling the system to adjust energy delivery to maintain optimal heating for hole formation while preventing excessive temperature that could cause tissue damage

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The radio frequency ablation process utilizes periodic energy delivery cycles. The system applies radio frequency energy in controlled pulses or cycles, allowing heat to build up to the necessary level for tissue ablation while providing intervals for thermal dissipation, thereby achieving stable hole formation with controlled temperature management

Inventive Principle:
Principle #19Periodic action

3Manufacturing precision

If a catheter with radio frequency component is used, then the hole can be created with fixed size and stable structure, but the device becomes more complex with multiple components

Engineering Contradiction:
Improvehole size controlVSAvoidcatheter structure
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The catheter component is designed as a multi-functional device that integrates guidance, radio frequency energy delivery, and temperature monitoring capabilities. This universal design allows a single catheter system to perform multiple functions including positioning, ablation, and thermal management, thereby achieving precise hole size control while minimizing the need for separate specialized components

Inventive Principle:
Principle #6Universality (Multi-functionality)

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

Effectively maintains an open hole to drain blood pressure from the left atrium to the right atrium, reducing left atrial pressure and improving treatment outcomes for heart failure with preserved ejection fraction.

Implementation Method 1

the radio frequency ablation instrument releases a radio frequency energy, and the radio frequency component ablates a wall of the puncture hole

Methodology Applied
Scientific EffectRadio frequency heating: Dielectric Heating

Implementation Method 2

the radio frequency component causes the hole wall tissue to generate heat

Methodology Applied
Scientific EffectJoule heating: Joule Heating

Implementation Method 3

the setting of a balloon enable the electrode to effectively ablate a wall of the puncture hole

Methodology Applied
Scientific EffectElastic expansion: Elasticity

Data Source

PatentEP3871626B1Expanding non-implanted atrial shunt device
Publication Date: 2024.04.17 SHANGHAI SHAPE MEMORY ALLOY
  • EP3871626B1 patent drawingFigure 1~2
  • EP3871626B1 patent drawingFigure 3~4
  • EP3871626B1 patent drawingFigure 5~6

AI summary

The application relates to a reaming type non-implanted atrial shunt device comprising a catheter component (2), a radio frequency component (1) disposed on an end of the catheter component (2) extending into a human body, and a radio frequency ablation instrument (4) disposed on the other end of the catheter component (2) and connected with the radio frequency component (1), wherein after the radio frequency component (1) extends into a puncture hole, the radio frequency ablation instrument (4) releases a radio frequency energy, and the radio frequency component (1) ablates a wall of the puncture hole. The radio frequency component (1) is delivered to the position of the puncture hole. When the radio frequency ablation instrument (4) releases energy, the radio frequency component (1) causes the hole wall tissue to generate heat and ablate the atrial septum at a target position to form a hole with fixed size, thereby achieving the purpose of creating a hole. Using radio frequency components (1) to create a hole through radio frequency make the hole not easy to reclose. The hole can effectively drain the left atrium blood into the right atrium, reduce pressure of the left atrium, thereby achieving the purpose of treatment.