Expandable Ablation Mechanisms for Controlled Atrial Shunt Creation

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Solution Overview

Problem

Existing interatrial shunt devices (IASDs) face risks of right-to-left shunting and systemic embolization, and there is a need for improved devices that can safely create shunts between the left and right atria to manage elevated atrial pressures in heart failure patients.

Innovation Solution

A shunting catheter system with an expandable ablation mechanism, including a catheter shaft, an ablation shaft, and expandable struts, which delivers ablation energy to create a shunt by expanding and stabilizing against the atrial septum or coronary sinus walls, using energy sources like RF energy to ensure precise and safe tissue ablation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing interatrial shunt devices are used to create shunts between atria, then atrial pressure management is achieved, but risks of right-to-left shunting and systemic embolization occur

Engineering Contradiction:

Improveprocedural safetyVSAvoidright-to-left shunting and embolization risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The shunt device is divided into multiple expandable struts that can be independently positioned and expanded. This segmentation allows precise control over the shunt location and size, enabling the device to create a controlled shunt while preserving surrounding tissue and reducing embolization risk.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The device includes positioning elements that are deployed before expansion to establish the desired location and orientation. This preliminary positioning ensures accurate placement against the atrial septum or coronary sinus walls, preventing unintended shunting paths and reducing procedural risks.

Inventive Principle:

Principle #10Preliminary action

2Object-affected harmful factors

If an expandable ablation mechanism is deployed to create a controlled shunt, then tissue damage is minimized, but device complexity increases

Engineering Contradiction:

Improvetissue damageVSAvoidablation mechanism complexity

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The device combines multiple functions into a single integrated system: positioning elements, expandable struts, and ablation mechanisms are merged into one catheter assembly. This integration allows the device to achieve precise positioning and controlled tissue ablation through a unified structure, reducing overall complexity despite the multiple functional components.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The ablation mechanism replaces traditional mechanical cutting or drilling methods with energy-based tissue removal. By using RF energy or other forms of energy delivery, the device achieves precise tissue ablation with minimal mechanical trauma, reducing tissue damage while maintaining a relatively simple mechanical structure.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Manufacturing precision

If positioning elements are used to stabilize the ablation mechanism against atrial walls, then shunt control precision is improved, but the risk of embolization increases

Engineering Contradiction:

Improveshunt control precisionVSAvoidembolization risk

Core Design Contradiction:

Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The positioning elements are designed with specific local properties to interact with the atrial walls. They feature controlled geometry and material characteristics that allow them to engage with the tissue in a localized manner, achieving precise shunt positioning while minimizing the disruption to surrounding structures and reducing embolization risk.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The device allows for adjustable parameters in positioning element design, such as size, shape, and expansion force. By optimizing these parameters, the positioning elements can achieve sufficient precision for shunt control while maintaining a safe profile that reduces the risk of embolization and tissue damage.

Inventive Principle:

Principle #35Parameter changes

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 creates a controlled shunt, minimizing tissue damage and reducing the risk of embolization, thereby improving procedural safety and efficacy in managing atrial pressures.

Implementation Method 1

delivering ablation energy to a target location of a patient

Methodology Applied

Scientific EffectAblation: Ablation

Data Source

PatentUS20250302526A1Expandable ablation mechanisms for shunting catheters

Publication Date: 2025.10.02 THERAHEART INC

AI summary

Some embodiments of the present disclosure are directed to systems, apparatus, and methods for creating a shunt in a patient. In some embodiments, a shunting catheter includes an expandable ablation mechanism having a plurality of expandable struts and a plurality of positioning elements coupled to the plurality of expandable struts. The positioning elements are configured to be disposed radially outwardly from the expandable struts. The ablation mechanism is configured to receive energy from an energy source and deliver ablation energy to a target location of a patient.