LAA Occluder Delivery Hub Alignment for Secure Catheter Coupling
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Solution Overview
Problem
Existing medical devices, such as LAA occluders, face challenges in precise alignment and secure attachment during delivery through catheters, leading to potential detachment and misalignment during transseptal puncture and deployment.
Innovation Solution
A catheter sheath system with a sheath hub and dilator hub featuring proximal aligning features and rotation indicators for precise alignment and secure coupling, ensuring the dilator hub aligns correctly with the sheath hub, preventing accidental detachment and providing tactile feedback during procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a catheter system is used to deliver LAA occluder devices, then non-invasive delivery is achieved, but precise alignment and secure attachment during transseptal puncture and deployment become difficult
Solution Approach 1:
The patent introduces a dilator as an intermediary component between the catheter and the occluder device. The dilator features a hub with aligning features that interface with the catheter hub, providing a stable platform for precise alignment during transseptal puncture. This intermediary structure enables accurate positioning while maintaining the non-invasive catheter-based delivery approach.
Solution Approach 2:
The dilator is advanced through the catheter before the occluder device, preparing the delivery path and establishing proper positioning. The aligning features on the dilator hub are engaged with the catheter hub in advance, ensuring that the system is pre-aligned before the actual puncture and device deployment occur, thereby improving alignment precision.
2Ease of operation
If the dilator hub is made detachable for device delivery, then device deployment is enabled, but accidental detachment during procedure may occur
Solution Approach 1:
The aligning features between the dilator hub and catheter hub are designed with asymmetric geometries that allow insertion in only one correct orientation. This asymmetric coupling mechanism prevents accidental detachment while enabling controlled deployment, as the features must be precisely aligned and engaged to maintain the connection throughout the procedure.
3Measurement precision
If alignment features are added to the sheath hub and dilator hub, then alignment precision is improved, but device complexity increases
Solution Approach 1:
The alignment system is segmented into distinct features: aligning features on the catheter hub and corresponding aligning features on the dilator hub. This segmentation allows each component to be independently designed and manufactured with specific alignment geometries, simplifying the overall design while achieving precise alignment. The features are modular and can be integrated into existing hub structures without requiring complete redesign.
Data Source
Figure 1A
Figure 1B
Figure 2A
AI summary
A delivery device includes a catheter sheath extending distally from the handle, a sheath hub coupled to the catheter sheath, the sheath hub having a body including at least one proximal aligning feature, a dilator insertable within the catheter sheath, and a dilator hub coupled to the dilator, the dilator hub having a hub aligning feature configured to couple to the at least one proximal aligning feature of the sheath hub.