Expandable Ablation Mechanism for Shunting Catheter Safety
Solution Overview
Problem
Existing interatrial shunt devices (IASDs) pose risks for right-to-left shunting and systemic embolization, and there is a need for improved devices that can safely and effectively create shunts in the cardiovascular system.
Innovation Solution
A shunting catheter system that includes a catheter shaft with a shaft lumen, an ablation shaft that can be extended, and an ablation mechanism with expandable struts. The ablation mechanism is configured to receive energy and deliver ablation energy to a target location, allowing for the creation of a shunt by expanding an opening and stabilizing the catheter during the procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing interatrial shunt devices are used, then shunt creation is achieved, but risk for right-to-left shunting and systemic embolization increases
Solution Approach 1:
The shunt device is divided into multiple expandable struts that can be independently deployed to create a controlled opening in the interatrial septum. This segmentation allows precise control over the shunt creation process, reducing unintended right-to-left shunting and embolization risks while maintaining effective shunt function.
Solution Approach 2:
The device includes a delivery catheter with a controlled expansion mechanism that prepares and deploys the expandable struts in a predetermined sequence. This preliminary action ensures proper positioning and controlled expansion of the shunt structure before full function is activated, minimizing harmful effects during deployment.
2Power
If an expandable ablation mechanism is deployed, then ablation energy delivery is improved, but device complexity increases
Solution Approach 1:
The ablation mechanism is integrated with the expandable strut structure, combining the ablation function with the structural support function. This merging reduces the need for separate complex ablation delivery systems while maintaining effective ablation energy delivery capability through the expandable cage structure.
Solution Approach 2:
The expandable strut structure serves multiple functions: providing structural support for the shunt, delivering ablation energy to the target tissue, and maintaining catheter stability during the procedure. This multi-functionality reduces overall device complexity by eliminating the need for separate dedicated components for each function.
3Ease of operation
If the ablation shaft is extended, then access to target location is improved, but catheter stability during procedure decreases
Solution Approach 1:
The ablation shaft is designed with dynamic extendability, allowing it to be extended only when needed for ablation delivery and retracted when stability is required. The expandable strut structure provides mechanical stability during the procedure while the shaft can be dynamically positioned to access target locations, balancing accessibility with stability.
Solution Approach 2:
The catheter is segmented into a stable delivery shaft and an extendable ablation shaft. This segmentation allows the main catheter body to remain stable for procedure support while the ablation shaft can be independently extended to reach target locations, resolving the conflict between stability and accessibility.
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 shunting catheter system effectively creates a shunt by expanding an opening at the target location, reducing the risk of right-to-left shunting and systemic embolization, while also providing stability during the procedure.
Implementation Method 1
an ablation mechanism disposed on the ablation shaft and expandable at the second state, the ablation mechanism configured to receive energy from an energy source and deliver ablation energy to a target location of the patient
Data Source
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 a puncture element and an expandable ablation mechanism for creating the shunt in the patient.