Variable Loop Cardiac Ablation Catheter for Anatomical Adaptation
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Solution Overview
Problem
Current cardiac ablation technologies, particularly pulsed field ablation (PFA) catheters, face limitations in adapting to varying cardiac anatomies and creating effective lesions in pulmonary veins and the posterior wall of the left atrium, with risks of thermal complications and inefficiencies in lesion formation.
Innovation Solution
A steerable cardiac ablation catheter with a variable loop design that allows for different lesion shapes and sizes, equipped with a shape-imparting mechanism and non-metallic braid reinforcement, enabling flexible interfacing with cardiac anatomy and minimizing thermal risks through low-flow, low-pressure fluid delivery and simultaneous use of interventional tools.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional radiofrequency ablation or cryo-therapeutic devices are used, then ablation therapy can be delivered, but thermal complications and life-threatening risks occur due to thermal unselectivity
Solution Approach 1:
The patent transitions from thermal-based ablation (radiofrequency or cryotherapy) to non-thermal pulsed field ablation by changing the physical parameter of energy delivery. PFA uses high-voltage electrical pulses to create irreversible electroporation in cardiac tissue, eliminating thermal effects and associated thermal complications while maintaining effective ablation capability.
2Adaptability or versatility
If fixed-loop catheter designs are used, then device structure is simple, but the catheter cannot adapt to varying cardiac anatomies and create effective lesions in pulmonary veins and posterior wall
Solution Approach 1:
The patent employs a dynamic loop structure that can change its configuration from a compressed state during delivery to an expanded working configuration inside the heart. The loop is capable of dynamic adjustment to adapt to different anatomical structures including pulmonary veins and posterior wall, providing versatility without requiring multiple fixed-size catheters.
Solution Approach 2:
The catheter design nests the loop structure within the catheter body during delivery, allowing the loop to be compressed and contained within the catheter shaft. Once positioned, the loop can be deployed outward to its working configuration. This nesting principle enables a complex adaptive structure to be delivered through a relatively simple and small delivery catheter.
3Adaptability or versatility
If multiple catheter sizes and shapes are used to interface with various cardiac anatomies, then treatment coverage is improved, but device complexity and procedural cost increase
Solution Approach 1:
The patent creates a universal catheter design that can perform multiple functions and adapt to various cardiac anatomies through a single device. The dynamic loop structure can be configured to treat different regions including pulmonary veins and posterior wall, eliminating the need for multiple specialized catheters and reducing procedural complexity and cost.
4Temperature
If high-flow fluid delivery is used during ablation, then cooling effect is improved, but costly pumps are required and procedural complexity increases
Solution Approach 1:
The catheter design eliminates the need for external pumps by using passive fluid delivery mechanisms. The system utilizes natural pressure gradients and the catheter's own structure to achieve adequate fluid flow for cooling and irrigation during the ablation procedure, reducing device complexity and procedural cost while maintaining effective temperature control.
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 catheter achieves flexible lesion formation without electrode overlap, reducing thermal risks and procedural complications, enhancing efficacy and safety by adapting to various cardiac structures and eliminating the need for costly pumps.
Implementation Method 1
a shape imparting element having a proximal end and a distal end; the proximal end is adapted to be coupled to the steering mechanism and the distal end of the element is adapted to be coupled to the steerable loop
Implementation Method 2
pulsed field ablation (PFA), also known as irreversible electroporation, is a highly effective catheter-based cardiac ablation therapy
Implementation Method 3
non-metallic braid reinforcement, enabling flexible interfacing with cardiac anatomy and minimizing thermal risks
Data Source
AI summary
A pulsed field ablation catheter for use in atrial fibrillation treatment having a distal steerable variable loop with multiple electrodes coupled to the distal end of a multilumen shaft and a handle coupled to the proximal end of the multilumen shaft. A shape imparting mechanism coupled to the handle is configured to change the shape of steerable loop by manipulating a steering mechanism to steer the steerable loop to the treatment site and a rotational actuator to change the diameter of the variable loop to better interface with varying human anatomy.