Deflectable Sheath Alignment for Variable Left Atrial Appendage Ostia
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Solution Overview
Problem
Current implantable devices for occluding left atrial appendages face challenges due to variability in ostium size and volume, leading to inadequate fit and orientation, which can compromise their effectiveness in modifying the appendage anatomy.
Innovation Solution
A medical device system featuring a deflectable sheath with adjustable pivot locations and deflectable portions, allowing for precise alignment and orientation of the device within the left atrial appendage, facilitated by a slidable tubular member, control wires, and actuators like a rack and pinion system or hydraulic system for controlled deflection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixed-configuration implantable device is used for occluding the left atrial appendage, then the device structure is simple and easy to manufacture, but the device cannot accommodate the wide variability in ostium size and volume, resulting in inadequate fit and orientation
Solution Approach 1:
The sheath is designed with deflectable portions that can be dynamically adjusted during delivery to orient the device appropriately relative to the ostium. The pivot locations can be moved along the longitudinal length of the distal portion, allowing the radius of curvature to be changed to match different anatomical configurations of the left atrial appendage.
Solution Approach 2:
The sheath structure integrates multiple functions: it provides a delivery pathway for the device, enables orientation adjustment through deflectable portions, and allows pivot location adjustment to accommodate different ostium geometries. This multi-functional design allows a single device to address the wide variability in patient anatomy.
2Manufacturing precision
If the sheath has multiple deflectable portions with adjustable pivot locations to achieve precise orientation, then the positioning accuracy is improved, but the device complexity and difficulty of operation increase
Solution Approach 1:
The sheath is divided into multiple deflectable portions with distinct pivot locations along its length. This segmentation allows independent control of different sections, enabling precise orientation adjustment while maintaining a manageable overall structure that can be controlled through a sheath handle.
3Adaptability or versatility
If the pivot locations are made adjustable along the longitudinal length of the sheath to change the radius of deflectable portions, then the adaptability to different appendage geometries is improved, but the ease of operation deteriorates due to additional adjustment mechanisms
Solution Approach 1:
A sheath handle serves as an intermediary device that simplifies the manipulation of the complex sheath structure. The handle provides control mechanisms for deflecting the deflectable portions and adjusting the pivot locations, translating complex internal adjustments into simple external operations for the operator.
Data Source
AI summary
Medical devices, systems and methods for occluding a left atrial appendage of a heart with an implant are provided. In one embodiment, a medical device system includes a sheath for delivering the implant. The sheath includes, at a distal portion of the sheath, first and second deflectable portions that are each independently deflectable relative to first and second pivot locations, respectively. With this arrangement, at least one of the first and second pivot locations are adjustable along a longitudinal length of the distal portion of the sheath.