Expandable Ablation Catheter Balloon for Cardiac Tissue Lesions
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Solution Overview
Problem
Conventional cardiac ablation catheters have narrow electrodes that require multiple ablations to create sufficient lesions, risking tissue damage and limiting lesion size due to their small surface area and rigid design, which can lead to unintentional perforation of cardiac tissue.
Innovation Solution
An ablation catheter with a collapsible and expandable balloon having a large conductive outer surface, allowing for increased contact area with cardiac tissue, reducing the risk of damage and enabling the formation of larger, shallower lesions through controlled delivery of high-energy ablation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a narrow ablation electrode is used to pass through a narrow sheath, then the catheter can be delivered to the heart, but the lesion size is limited and multiple ablations are required
Solution Approach 1:
The ablation electrode is designed to be dynamically changeable in size. It starts as a narrow electrode for delivery through the sheath, then expands to a larger surface area during ablation procedures. This dynamic transformation allows the electrode to adapt between delivery and ablation modes, resolving the contradiction between narrow delivery requirements and large ablation area needs.
Solution Approach 2:
The expandable ablation electrode is nested within the catheter shaft during delivery. The electrode can be collapsed or compressed into a narrow configuration for passage through the sheath, then expanded to a larger configuration for ablation. This nesting approach allows the electrode to occupy different volume states, enabling both narrow delivery and large ablation surface area.
2Ease of operation
If a narrow ablation electrode is used, then the catheter can pass through a narrow sheath, but the risk of tissue perforation increases due to concentrated force
Solution Approach 1:
The electrode dynamically changes from a narrow configuration during delivery to a wider configuration during ablation. This dynamic adjustment distributes the applied force over a larger area during ablation, reducing stress concentration and the risk of tissue perforation while maintaining ease of delivery through the narrow sheath.
Solution Approach 2:
The physical parameters of the electrode, specifically its diameter or cross-sectional area, are changed from a narrow state during delivery to a wider state during ablation. This parameter change allows the electrode to pass through narrow sheaths while providing sufficient contact area to distribute force and reduce perforation risk during tissue ablation.
3Reliability
If multiple ablations are performed with a narrow electrode, then sufficient lesion pattern can be achieved, but the procedure time increases
Solution Approach 1:
The electrode dynamically expands to a larger surface area during ablation procedures. This dynamic expansion allows a single ablation event to create a larger lesion pattern, reducing the number of repeated ablation steps needed and thereby decreasing overall procedure time while maintaining reliable lesion pattern formation.
Solution Approach 2:
The electrode is pre-configured in a narrow state for delivery, then rapidly expanded to a larger ablation surface area before energy delivery begins. This preliminary configuration allows the electrode to achieve sufficient lesion pattern in fewer steps by maximizing its ablation surface area from the start of the ablation phase.
4Productivity
If force is applied to push the narrow ablation catheter against tissue, then ablation can be performed, but the risk of unintentional damage increases
Solution Approach 1:
The electrode dynamically expands to a wider configuration during ablation, which distributes the applied force over a larger contact area. This dynamic expansion reduces the stress concentration at any single point, thereby reducing the risk of unintentional tissue damage while maintaining adequate ablation capability through the expanded surface area.
Solution Approach 2:
The electrode's physical dimensions, specifically its cross-sectional area, are changed from narrow to wide during the ablation process. This parameter change allows force application for ablation while distributing the load across a larger area, reducing the likelihood of stress-induced tissue perforation or damage.
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 solution allows for the creation of larger lesions with reduced risk of cardiac tissue damage, enabling more efficient ablation procedures with improved control and safety by expanding the contact area and distributing energy effectively.
Implementation Method 1
Radio frequency ('RF') catheter ablation can be used to form lesions that interrupt the mechanism of abnormal conduction
Data Source
AI summary
An ablation catheter having an expandable tip is disclosed herein. In some implementations, the ablation catheter includes a catheter shaft, an irrigation lumen, and an expandable tip secured to the catheter shaft. In some implementations, the expandable tip includes a balloon defining a volume in communication with the irrigation lumen. In these and other implementations, the balloon defines a plurality of irrigation orifices in fluid communication with the volume. In these and other implementations, the expandable tip comprises an ablation electrode and a plurality of sensing electrodes disposed along a distal section of the balloon. In these and still other implementations, the sensing electrodes disposed along the distal section of the balloon can be electrically isolated from and bounded by the ablation electrode.