Telescoping Valve Capsule for Precise Mitral Repositioning
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Solution Overview
Problem
Current prosthetic heart valve delivery systems face challenges in percutaneously replacing mitral valves due to their non-circular, D-shaped and non-planar anatomy, which is difficult to conform to, and the lack of radial support from surrounding tissue, leading to potential distortion and malfunction of the prosthetic leaflets.
Innovation Solution
A telescoping delivery capsule system with a first and second housing that allows for partial deployment and resheathing of the prosthetic heart valve, enabling precise positioning and repositioning of the device through trans-septal, trans-apical, or retrograde approaches, using hydraulic or mechanical means for deployment and resheathing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a traditional delivery system is used for prosthetic heart valve, then the device can be delivered percutaneously, but the prosthetic valve cannot be precisely positioned or repositioned due to lack of partial deployment capability
Solution Approach 1:
The delivery capsule is divided into two telescoping housings (first housing and second housing) that can move independently relative to each other. This segmentation allows the system to perform multiple functions: the first housing controls initial partial deployment while the second housing manages final deployment and resheathing. This division enables precise positioning capability without requiring an overly complex single-unit delivery system.
Solution Approach 2:
The delivery system incorporates dynamic, movable components including the telescoping housings that can extend and retract, and the prosthetic valve that can transition between compressed and expanded states. This dynamic design allows the system to adapt during the procedure, enabling partial deployment for positioning adjustments and full deployment when optimally positioned, thereby improving positioning precision.
2Reliability
If the prosthetic valve is deployed in the complex mitral valve anatomy, then it can treat the valve condition, but the prosthetic leaflets may become distorted due to lack of radial support
Solution Approach 1:
The system enables preliminary partial deployment of the prosthetic valve before final implantation. This preliminary action allows the operator to assess the fit and positioning of the prosthetic leaflets within the mitral valve anatomy before full deployment. By checking alignment and leaflet function during this intermediate stage, potential distortion issues can be identified and corrected before the valve is fully deployed, thereby ensuring reliability and reducing distortion risk.
Solution Approach 2:
The telescoping delivery capsule provides visual and tactile feedback during the deployment process. As the first housing moves relative to the second housing during partial deployment, the operator can observe the positioning of the prosthetic valve and make real-time adjustments. This feedback mechanism allows for optimization of valve placement to ensure proper alignment with the mitral annulus, reducing the risk of leaflet distortion and improving overall functionality.
3Adaptability or versatility
If the delivery system allows partial deployment and resheathing, then the prosthetic valve can be repositioned, but the delivery system becomes more complex with multiple housings
Solution Approach 1:
The delivery system employs a nested structure where the second housing is positioned within the first housing, and both can telescope relative to each other. This nesting arrangement allows the system to maintain a compact profile during delivery while providing the mechanical complexity needed for partial deployment and resheathing. The telescoping action of nested housings enables repositioning capability without requiring entirely separate delivery mechanisms, thus balancing adaptability with structural efficiency.
4Volume of moving object
If the delivery capsule is compact for percutaneous delivery, then it can traverse tight vascular paths, but there is limited space for complex deployment mechanisms
Solution Approach 1:
The delivery capsule utilizes longitudinal dimensionality through telescoping housings that extend and retract along the length of the capsule. Instead of adding radial complexity that would increase the capsule's cross-sectional volume, the design employs axial movement of nested housings to achieve partial deployment and resheathing functions. This dimensional approach allows complex deployment mechanisms to be accommodated within a compact capsule volume suitable for percutaneous delivery through tight vascular paths.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Facilitates precise deployment and repositioning of prosthetic heart valves within the complex mitral valve anatomy, reducing the risk of distortion and improving the fit of the prosthetic leaflets, while allowing for compact delivery through tight vascular paths.
Implementation Method 1
The first housing can be moved relative to the second housing during deployment by a mechanism such as, but not limited to, a fluid chamber
Implementation Method 2
A biasing device can be positioned within the second housing and operably coupled to the first housing such that the biasing device stores energy and releases the energy to move the first housing relative to the second housing
Data Source
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AI summary
Delivery systems with telescoping capsules for delivering prosthetic heart valve devices and associated methods are disclosed herein. A delivery system configured in accordance with embodiments of the present technology can include, for example, a delivery capsule having a first housing, a second housing slidably disposed within a portion of the first housing, and a prosthetic device constrained within the first and second housings. The delivery capsule can further include first and second chamber defined in part by the first and second housings. During deployment, fluid is delivered to the first chamber to move the first housing distally over the second housing, thereby releasing a portion of the prosthetic device. Subsequently, fluid is delivered to the second chamber such that the first and second housings move together in the distal direction to release a second portion of the prosthetic device.