Heart Valve Delivery Shaft Control for Stable Valve Positioning
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Solution Overview
Problem
Existing prosthetic heart valve delivery systems face challenges in achieving precise positioning and stabilization during implantation, leading to issues such as paravalvular leakage and inadequate sealing between the prosthetic valve and the native valve.
Innovation Solution
A delivery system with three independently actuatable shafts, including a delivery shaft, a sleeve shaft, and a pusher shaft, is used to stabilize and position a docking device, allowing for a variable encircling turn that better encircles the chordae tendineae, thereby improving the positioning of the prosthetic heart valve and reducing paravalvular leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a traditional delivery system with limited shafts is used, then the device complexity is lower, but the positioning precision and stabilization capability during implantation deteriorate
Solution Approach 1:
The delivery system is divided into three independently actuatable shafts (first shaft, second shaft, third shaft), each capable of independent movement and control. This segmentation allows precise positioning of the docking device through coordinated action of multiple shafts, resolving the contradiction between positioning precision and device complexity by breaking down the complex positioning task into manageable independent movements.
Solution Approach 2:
The shafts are designed to be independently actuatable, allowing dynamic adjustment of the delivery system configuration during implantation. The ability to move shafts independently enables real-time stabilization and positioning adjustments, transforming a static delivery system into a dynamic one that can adapt to anatomical variations and achieve precise docking device placement.
2Stability of the object's composition
If a delivery system without stabilizer assembly is used, then the device complexity is lower, but the stabilization capability during implantation deteriorates
Solution Approach 1:
The stabilizer assembly integrates multiple support structures including a hub assembly support with a hub assembly cradle, a sleeve handle cradle, and a linear actuator into a unified stabilization system. This merging of components creates a coordinated stabilization mechanism that secures the docking device during implantation, achieving enhanced stability while managing complexity through integrated design.
Solution Approach 2:
The hub assembly cradle and sleeve handle cradle act as intermediary structures between the shafts and the docking device, providing stable support and control. These intermediary elements facilitate precise positioning and stabilization by mediating the interaction between the actuatable shafts and the implantation target, reducing direct stress and improving control accuracy.
3Measurement precision
If the shafts are not independently actuatable, then the ease of operation is higher, but the positioning precision of the docking device deteriorates
Solution Approach 1:
Each shaft (first, second, and third shafts) is equipped with independent actuation mechanisms, allowing individual control of each shaft's movement. This segmentation of control enables precise positioning of the docking device by independently adjusting each shaft's position and orientation, resolving the contradiction between operational simplicity and positioning precision through divided control authority.
Solution Approach 2:
The independent actuation of shafts allows for dynamic parameter changes in the delivery system configuration during implantation. By independently adjusting the position, orientation, and movement parameters of each shaft, the system achieves precise docking device positioning while maintaining operational flexibility through programmable or manual control of individual shaft parameters.
Data Source
AI summary
A delivery system can comprise a delivery apparatus and a stabilizer assembly. The delivery apparatus can comprise a delivery shaft, a sleeve shaft, a pusher shaft, a hub assembly coupled to the pusher shaft, and a sleeve handle coupled to the sleeve shaft. The delivery shaft, sleeve shaft, and pusher shaft can be independently actuatable. The stabilizer assembly can include a hub assembly cradle configured to receive the hub assembly, a sleeve handle cradle configured to receive the sleeve handle, and a linear actuator configured to move the hub assembly cradle in an axial direction relative to the sleeve handle cradle. The stabilizer assembly can be configured to actuate the hub assembly relative to the sleeve handle while keeping the sleeve handle stationary, thereby stabilizing the delivery apparatus in such a way that allows for independent actuation of the delivery shaft, the sleeve shaft, and the pusher shaft.