Mapping Balloon with Predefined Folds for Electrode Positioning
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Solution Overview
Problem
Existing catheters for cardiac arrhythmia diagnosis and treatment face challenges in navigating and accurately mapping electrophysiological signals within the body, particularly due to unpredictable balloon configurations that affect electrode positioning and signal measurement accuracy.
Innovation Solution
A catheter device with a mapping balloon featuring predefined fold locations and a system that includes a catheter shaft, electrodes, and an electronic control unit (ECU) for navigating and mapping electrophysiological signals, allowing the balloon to adjust between collapsed and expanded configurations predictably, ensuring consistent electrode spacing and contact with tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the mapping balloon is made expandable to adjust size for navigation and measurement, then the ease of operation is improved, but the electrode positioning accuracy deteriorates due to unpredictable balloon configurations
Solution Approach 1:
The balloon is divided into multiple segments or sections, each containing electrodes at predetermined positions. This segmentation allows the balloon to be collapsed into a compact configuration for navigation while maintaining the relative positions of electrodes within each segment, thereby preserving positioning accuracy despite the overall size change.
Solution Approach 2:
Electrodes are pre-positioned and fixed to the balloon surface at predetermined locations before the balloon is inserted into the body. This preliminary action ensures that when the balloon expands or contracts, the electrodes maintain their predetermined spacing and geometric relationships, enabling accurate electrophysiological mapping regardless of the balloon's current size.
2Ease of operation
If the mapping balloon is collapsed to small size for navigation, then the ease of operation is improved, but the measurement precision deteriorates due to insufficient electrode contact with tissue
Solution Approach 1:
The balloon is designed to dynamically change size between a collapsed state for navigation and an expanded state for measurement. This dynamic capability allows the system to optimize for ease of operation during navigation and for measurement precision during the diagnostic procedure, with the balloon automatically transitioning between states as needed.
Solution Approach 2:
The mapping balloon can be nested within a delivery catheter or sheath during navigation, allowing it to be transported in a compact, collapsed state. Once positioned at the target site, the balloon is deployed from the delivery system and expanded to its functional size, enabling electrode contact with the tissue for accurate signal detection.
3Adaptability or versatility
If the balloon configuration changes unpredictably during expansion, then the adaptability is improved, but the manufacturing precision of electrode spacing deteriorates
Solution Approach 1:
Different regions of the balloon are designed with different properties: certain areas have reinforced structures or predefined fold lines that maintain electrode spacing, while other areas have greater flexibility to adapt to the anatomical geometry. This local differentiation allows the balloon to be adaptable to various tissue shapes while preserving electrode positioning accuracy in critical measurement zones.
Solution Approach 2:
The balloon is constructed using composite materials that combine regions of high structural integrity (to maintain electrode spacing) with regions of high flexibility (to adapt to tissue geometry). This composite construction allows the balloon to simultaneously achieve configuration flexibility for adaptability and precise electrode spacing for manufacturing accuracy.
Data Source
AI summary
A catheter including a catheter shaft and a mapping balloon configured for navigation within a body. The mapping balloon can be coupled to the catheter shaft, such as at a distal end of the catheter shaft. The mapping balloon can have an exterior surface including a plurality of predefined fold locations configured to allow the mapping balloon to be adjusted between a collapsed configuration and an expanded configuration. In the collapsed configuration, the mapping balloon can include a first dimension, and in the expanded configuration the mapping balloon can have a second dimension. The second dimension can be greater than the first dimension. A plurality of electrodes can be located along the exterior surface of the mapping balloon to communicate electrical signals with an electronic control unit.