Cryotherapy Balloon Catheter with Integrated Mapping Electrodes
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Solution Overview
Problem
Current medical procedures for treating atrial fibrillation, such as RF ablation and cryotherapy, often require separate catheters for mapping and ablation, which can be invasive and risk damaging healthy tissue, necessitating precise electrical mapping before treatment to avoid conduction blocks and ensure targeted ablation.
Innovation Solution
A cryotherapy balloon catheter with electrodes on its expandable surface allows for both electrical mapping and cryotherapy delivery at the same site, enabling characterization of tissue before and after treatment without moving the catheter, using a single device for both functions, and incorporating a safety chamber to protect tissue in case of balloon rupture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If separate catheters are used for mapping and ablation, then mapping precision can be improved, but device complexity and procedural invasiveness increase
Solution Approach 1:
The patent combines mapping electrodes and ablation elements into a single integrated catheter device. The catheter includes multiple electrodes positioned at its distal end for electrical mapping, and an expandable balloon with ablation capability at the same location, allowing both functions to be performed through one device rather than requiring separate mapping and treatment catheters
Solution Approach 2:
The catheter is designed to perform multiple functions: electrical mapping to identify target tissue, cryotherapy delivery for ablation, and post-ablation remapping to confirm treatment efficacy. This multi-functional design eliminates the need for multiple specialized catheters and reduces procedural complexity
2Measurement precision
If multiple catheters are used for mapping and treatment, then mapping accuracy improves, but risk of damaging healthy tissue increases
Solution Approach 1:
The catheter performs electrical mapping and cryomapping procedures before actual ablation to identify precise target sites and assess potential treatment effects. This preliminary characterization allows the physician to plan the ablation strategy in advance, ensuring that only confirmed target tissue is ablated and healthy tissue is preserved
Solution Approach 2:
The catheter enables real-time electrical mapping during and after the ablation procedure. By comparing pre-ablation and post-ablation electrical signals, the system provides feedback on treatment efficacy, allowing the physician to confirm that the intended tissue was ablated and that healthy tissue remains functional, thereby reducing the risk of inadvertent damage
3Ease of operation
If a single catheter performs both mapping and ablation, then procedural simplicity improves, but measurement precision may deteriorate
Solution Approach 1:
The catheter incorporates specialized electrode arrangements at its distal end specifically optimized for electrical mapping and tissue characterization. These electrodes are positioned to make direct contact with or closely approximate the target tissue, maintaining high measurement precision despite the integrated design. The mapping electrodes are distinct from and optimized for their measurement function, separate from the ablation balloon
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
This approach reduces procedural risks by allowing precise, targeted treatment with reduced need for multiple catheters, enabling accurate characterization and confirmation of treatment efficacy while minimizing damage to healthy tissue, and allows for both temporary and permanent tissue alteration phases.
Implementation Method 1
electrodes at those sites can provide signals to a processing system external to a patient that can process the signals and provide physicians with information
Implementation Method 2
Release of the cryotherapy agent into the chamber cools the chamber, the balloon's outer surface, and tissue that is in contact with the outer surface
Implementation Method 3
cooling tissue to near freezing (e.g., to 0° C.) but well above a temperature at which the tissue would be ablated (e.g., −20° C.)
Implementation Method 4
high frequency energy can be employed, for example, to cause ionic agitation and frictional heat in targeted tissue, causing permanent damage to the tissue
Data Source
AI summary
In some implementations, a method of ablating body tissue includes (a) locating an inflatable balloon portion of a cryotherapy balloon catheter at a treatment site internal to a patient's body, and inflating the inflatable balloon portion; (b) employing electrodes that are disposed on an expandable surface of the inflatable balloon portion to electrically characterize body tissue at the treatment site; (c) ablating the body tissue by supplying a cryotherapy agent to the inflatable balloon portion to cool the body tissue to a therapeutic temperature; (d) employing the electrodes to determine whether the ablating caused desired electrical changes in the body tissue; and (e) repeating (c) and (d) when it is determined that the ablating did not cause the desired electrical changes.