Cryoballoon Contact Sensing for Real-Time Tissue Assessment
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Solution Overview
Problem
Current methods for assessing contact between treatment elements and cardiac tissue during ablation procedures, such as cryoablation, are inadequate, often requiring auxiliary imaging systems, exposing patients to radiation and contrast media, and providing inconclusive results due to sensor placement issues and blood conductivity interference.
Innovation Solution
A medical system with resistive-type and capacitive-type contact sensing elements, including a treatment element with expandable balloons and sensing elements between them, which transmit electrical signals to a control unit for real-time contact assessment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopic imaging with contrast medium is used to assess pulmonary vein occlusion, then contact assessment can be performed, but the patient is exposed to large doses of contrast medium and radiation
Solution Approach 1:
The patent replaces fluoroscopic imaging (optical/radiological system) with electrical impedance sensing elements integrated into the treatment element. The sensing elements detect tissue contact through electrical impedance changes, eliminating the need for radiation-based imaging while providing continuous real-time contact assessment during the ablation procedure
Solution Approach 2:
The treatment element itself serves dual functions: delivering the ablation energy and simultaneously sensing tissue contact through integrated sensing elements. This self-monitoring capability eliminates the need for separate auxiliary imaging systems, allowing the device to assess its own contact status with tissue during the procedure
2Loss of information
If impedance, temperature, or pressure measurements are used for contact assessment, then contact information can be obtained, but the results are inconclusive due to difficulty in accurate measurement and insufficient sensor coverage
Solution Approach 1:
The sensing system is divided into multiple discrete sensing elements distributed across the surface of the treatment element. This segmentation allows contact assessment at multiple locations simultaneously, providing comprehensive coverage and enabling identification of specific contact gaps rather than providing a single aggregate measurement
Solution Approach 2:
The sensing elements are designed to measure multiple parameters (impedance, temperature, pressure) simultaneously using the same sensor infrastructure. This multi-functionality provides comprehensive contact assessment data without requiring separate sensor systems for each measurement type, improving both accuracy and completeness of contact information
3Measurement precision
If sensors are placed on balloons for intracardiac use, then contact sensing is possible, but the sensors may peel or dislodge during manipulation and blood conductivity affects measurements
Solution Approach 1:
The sensing elements are integrated directly into the structural material of the treatment element itself, merging the sensing function with the treatment element's mechanical structure. This integration eliminates the need for separate sensor attachments that could peel or dislodge, ensuring sensors remain securely positioned throughout device manipulation and the procedure
Solution Approach 2:
The patent introduces an insulating layer or coating between the sensing elements and the conductive blood environment. This intermediary protects the electrical measurements from being corrupted by blood conductivity while still allowing the sensing elements to detect tissue contact through impedance changes, maintaining measurement consistency in the conductive physiological environment
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
Provides accurate, real-time contact assessment between the treatment element and tissue, enabling precise positioning and complete circumferential contact without exposing patients to radiation or contrast media.
Implementation Method 1
The one or more contact sensing elements may be resistive-type and/or capacitive-type contact sensors
Implementation Method 2
The one or more contact sensing elements may be resistive-type and/or capacitive-type contact sensors
Data Source
AI summary
Devices, systems, and methods for assessing contact between a treatment element and an area of target tissue using resistive-type and/or capacitive-type contact sensing elements. In one embodiment, a medical system for determining tissue contact includes an elongate body including a distal portion and a proximal portion and a treatment element coupled to the elongate body distal portion. The treatment element may have a first expandable element, a second expandable element, the first expandable element being within the second expandable element, and at least one contact sensing element between the first and second expandable elements. In one example, the device may include a plurality of contact sensing elements arranged in a matrix or in a plurality of linear configurations. In another example, the device may include a layer of conductive microparticles or a contact-sensing film.