Asymmetric Dual-Directional Steerable Catheter Sheath
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Solution Overview
Problem
Current steerable guide sheaths are inadequate for navigating catheters into both left and right pulmonary veins due to their simple curves, which complicates the precise placement and ablation procedures for treating atrial fibrillation, requiring complex maneuvers and invasive open heart surgery.
Innovation Solution
A steerable catheter sheath with a distal end that can be bent in two distinct configurations, allowing precise targeting of both left and right pulmonary veins, facilitated by a handle with a steering mechanism and first and second steering wires, enabling the catheter to be positioned near target sites before deployment and retracting easily after procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional steerable guide sheaths with simple curves are used, then the device structure remains simple, but the ability to navigate catheters into both left and right pulmonary veins is inadequate
Solution Approach 1:
The guide sheath incorporates a dynamic steering mechanism with two independent steering wires that allow the distal end to be deflected into different bending configurations. This enables the sheath to adapt its shape dynamically to navigate to different pulmonary veins (left or right) based on procedural needs, transforming a static simple-curve design into a dynamically adjustable multi-configuration system.
Solution Approach 2:
The steering mechanism is segmented into two independent steering wires (first and second steering wires) that can be controlled separately. Each steering wire independently controls deflection in a specific direction, allowing the operator to segment the navigation task into discrete directional adjustments to reach different target veins.
2Adaptability or versatility
If complex maneuvers are performed to place catheters in pulmonary veins, then access to both left and right pulmonary veins becomes possible, but the procedure becomes more complex and time-consuming
Solution Approach 1:
The guide sheath is pre-configured with two distinct bending configurations that are prepared in advance. The first bending configuration pre-positions the distal end for accessing one pulmonary vein, while the second bending configuration pre-positions it for accessing the other pulmonary vein. This preliminary preparation of directional configurations eliminates the need for complex real-time maneuvers during catheter placement.
Solution Approach 2:
The ability to dynamically switch between two bending configurations simplifies the operator's task. Instead of performing complex continuous maneuvers, the operator can simply activate the appropriate steering wire to switch between pre-designed configurations, making catheter placement to either pulmonary vein more straightforward and less time-consuming.
3Adaptability or versatility
If the catheter travels a long distance to reach target sites, then the catheter can access distant pulmonary veins, but the procedure becomes more difficult and less effective
Solution Approach 1:
The guide sheath's dynamic bending configurations position the distal end in optimized locations for each pulmonary vein approach. By deflecting into the first or second bending configuration, the sheath brings the catheter entry point closer to the target pulmonary veins, effectively reducing the travel distance the catheter must traverse to reach ablation sites.
Solution Approach 2:
The sheath design provides localized positioning optimization at the distal end through asymmetric bending configurations. Each configuration is specifically shaped to position the distal end near a particular pulmonary vein, creating a locally optimized entry point that reduces catheter travel distance to that specific target region.
Data Source
AI summary
A steerable catheter sheath for use in directing a catheter into a desired position is provided. The sheath includes an elongated member configured to receive the catheter therein. The distal end of the elongated member is steerable in two directions, each direction having a different bent configuration, e.g., a sharp curve in one direction and an open arching curve in the other direction. A resilient structure having different bending properties in each of its lateral sides is carried in the distal portion of the elongated member and causes the asymmetric bending. In one embodiment, the resilient structure includes a hypotube with a plurality of notches and slits in the sides. In another embodiment, the resilient structure is covered in an outer coating having different durometer portions. The sheath is particularly useful for accessing left and right pulmonary veins when a transeptal entry approach is used into the left atrium.