Double-sided Encapsulated Planar Catheter for Cardiac Mapping
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Solution Overview
Problem
Current cardiac mapping catheters face challenges in achieving high mapping resolution, conforming to irregular tissue surfaces, and maintaining atraumatic advancement due to their stiffness, which limits electrode contact and data collection efficiency during cardiac arrhythmia treatments.
Innovation Solution
A multilayered end effector design for catheters, featuring flexible circuits, a framework, and non-conductive layers, along with a location sensing coil layer, allows for improved flexibility and contact with various tissue surfaces while maintaining structural integrity, enabling better mapping and ablation procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If stiff internal structural members are used to maintain predetermined configuration, then structural integrity is improved, but ease of operation deteriorates as electrodes cannot contact tissue
Solution Approach 1:
The catheter is divided into multiple segments including a collapsible body, expandable distal portion, and framework with multiple struts. This segmentation allows the catheter to collapse for navigation and expand for stable electrode contact, resolving the contradiction between structural integrity and ease of operation.
Solution Approach 2:
The catheter transitions from a collapsed state during navigation to an expanded state during mapping/ablation. The expandable distal portion and adjustable framework enable dynamic adaptation, providing structural support when needed while allowing flexibility for tissue contact.
2Ease of operation
If a catheter is made flexible to contact irregular tissue surfaces, then ease of operation is improved, but structural integrity deteriorates
Solution Approach 1:
The catheter employs a collapsible body with flexible walls and an expandable distal portion that can conform to irregular tissue surfaces. These flexible structures maintain sufficient structural integrity through their design, allowing the catheter to adapt to various anatomical geometries while retaining shape stability.
Solution Approach 2:
The catheter combines different materials with complementary properties: flexible polymers for the collapsible body, shape memory alloys or nitinol for the framework struts, and conductive materials for electrodes. This composite construction provides both flexibility for tissue contact and structural integrity for maintaining configuration.
3Ease of operation
If the catheter is collapsed for advancement through vasculature, then ease of operation is improved, but mapping resolution deteriorates due to reduced electrode contact
Solution Approach 1:
The catheter dynamically changes its configuration state: collapsed during advancement through vasculature for atraumatic navigation, then expanded at the target site to maximize electrode contact with tissue surfaces, thereby achieving high mapping resolution without compromising either phase of the procedure.
Solution Approach 2:
The separation between the collapsible body and the expandable distal portion with framework allows independent optimization: the collapsible body enables easy advancement while the expandable distal portion with its rigid framework and positioned electrodes provides stable, high-resolution tissue contact for accurate mapping.
4Measurement precision
If multiple electrodes are positioned to contact different tissue surfaces, then mapping resolution is improved, but device complexity increases
Solution Approach 1:
The expandable distal portion with framework serves multiple functions simultaneously: it provides structural support, positions multiple electrodes on different surfaces, enables stable tissue contact, and maintains catheter configuration. This multi-functionality achieves high mapping resolution without proportionally increasing device complexity.
Data Source
AI summary
A multilayered end effector for a mapping catheter including a first flexible circuit, a framework generally parallel to the first flexible circuit and separated therefrom by a first orthogonal gap orthogonal to the longitudinal axis, a second flexible circuit, and a location sensing coil layer having a plurality of coils suitably oriented and preferably disposed generally parallel to the framework and separated from the framework by a second orthogonal gap. The second flexible circuit can be separated from the location sensing coil layer by a third orthogonal gap. The first orthogonal gap, the second orthogonal gap, and the third orthogonal gap can be filled with a flexible non-conductive material, and the first face of the first flexible circuit and the first face of the second flexible circuit being coated with the flexible non-conductive material.