Ablation Device with Multiple Modes and Conductive Balloon
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Solution Overview
Problem
Current ablation devices face challenges in efficiently isolating tissue during cardiac arrhythmia treatments, such as tedious procedures for isolating pulmonary veins and potential scarring, dehydration, and incomplete ablation lines due to discrete ablation points, which can lead to residual arrhythmias.
Innovation Solution
An ablation device featuring an ionically conductive balloon with a composite structure, including a hydrophobic proximal section and a hydrophilic distal section, that inflates to create a conical shape with a semi-permeable distal section, allowing for efficient RF energy transmission and fluid circulation, along with a spring-actuated plunger assembly and temperature sensing, to form controlled lesions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If discrete ablation points are used to treat tissue, then ablation lesions can be formed, but the procedure becomes tedious and time-consuming with potential gaps in the ablation line
Solution Approach 1:
Multiple ablation electrodes are integrated into a single catheter assembly with a common balloon structure, allowing simultaneous delivery of RF energy to multiple tissue sites. This merging of multiple ablation functions into one device enables continuous circumferential ablation without the need to reposition the catheter repeatedly, thereby improving procedural efficiency and reducing treatment time.
Solution Approach 2:
The invention transitions from discrete point-based ablation to a distributed multi-point ablation approach by arranging multiple electrodes along the balloon circumference. This spatial dimensionality change allows parallel ablation across multiple locations, converting a sequential process into a concurrent one, thus significantly reducing the time required to create complete ablation lines.
2Reliability
If direct contact ablation electrodes are used, then ablation points can be created, but dehydration and scarring occur as the lesion heals
Solution Approach 1:
A balloon interface is introduced as an intermediary between the RF energy source and the tissue. The balloon can be configured with semi-permeable or porous materials that allow controlled energy and fluid exchange. This intermediary structure enables RF energy transmission while maintaining fluid balance at the tissue interface, preventing excessive dehydration and reducing scarring while preserving ablation effectiveness.
Solution Approach 2:
The invention changes the physical parameters of the ablation interface by using a balloon with controllable permeability characteristics. By adjusting the balloon material properties and fluid saturation level, the system can modulate energy delivery and fluid exchange parameters, achieving effective tissue heating while minimizing harmful dehydration effects that lead to scarring.
3Reliability
If multiple discrete ablation points are created, then tissue can be treated, but gaps in the ablation line may remain that continue to initiate arrhythmias
Solution Approach 1:
Multiple ablation electrodes are combined into a single integrated catheter assembly that can deliver RF energy simultaneously to multiple circumferential locations. This merging enables continuous, gap-free ablation lines by creating overlapping lesions around the pulmonary veins in one procedure, ensuring complete electrical isolation without requiring multiple separate interventions.
Solution Approach 2:
The balloon is divided into multiple segments, each containing ablation electrodes at different circumferential positions. This segmentation allows independent control of each ablation site while maintaining overall system integration. By activating multiple segments simultaneously or sequentially with overlap, the system creates continuous ablation lines that eliminate gaps, ensuring complete electrical isolation of the pulmonary veins.
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 device effectively isolates tissue, reduces scarring, and ensures complete ablation lines by providing uniform and controlled RF energy distribution, minimizing residual arrhythmias and improving procedural efficiency.
Implementation Method 1
the distal balloon section is configured with a hydrophilic polymer that is ionically conductive when in contact with an aqueous solution... the first RF electrode... generates an RF electrical field within the balloon interior
Implementation Method 2
generates an RF electrical field within the balloon interior... forming at least one ablation lesion within the body tissue using the first RF electrical field
Implementation Method 3
the proximal balloon section... comprises a hydrophobic polymer... the hydrophobic polymer prevents conduction of the RF electrical field
Implementation Method 4
a spring mechanism configured to bias the balloon in the collapsed state
Implementation Method 5
an inflatable balloon... configured to transmit the RF electrical field... the distal balloon section is configured with a hydrophilic polymer that is ionically conductive when in contact with an aqueous solution
Data Source
AI summary
Devices, systems, and methods for performing ablation therapy on body tissue are disclosed. An example ablation device for treating body tissue includes an ionically conductive balloon and a radio-frequency electrode that delivers RF energy into a distal section of the balloon. The balloon is configured to transmit the RF energy in a direction distally towards a leading end of the ablation device. Multiple ablation electrodes on the device can be used for providing lesions of different size or shape.