Valve Prosthesis Centering Devices for Transcatheter Delivery
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Solution Overview
Problem
Current transcatheter valve delivery systems face challenges such as vessel trauma, inaccurate placement, conduction disturbances, and paravalvular leakage due to improper centering of valve prostheses relative to the native annulus, which can lead to complications like dislodgement and regurgitation.
Innovation Solution
The use of circumferential and longitudinal centering devices integrated with valve delivery systems to ensure precise positioning of valve prostheses within the native anatomy, utilizing self-expanding structures and inflatable balloons to maintain the prosthesis in a centered and anchored position, thereby preventing abutment against vessel walls and ensuring proper apposition with the native valve annulus.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If percutaneous delivery method is used for valve replacement, then invasiveness is reduced and patient safety is improved, but accurate positioning of the valve prosthesis relative to the native annulus becomes difficult
Solution Approach 1:
A centering device is introduced as an intermediary component between the delivery system and the native annulus. This device includes a first component with a first diameter and a second component with a second diameter, creating a tapered structure that facilitates accurate positioning. The centering device engages with the native annulus to provide a reference point for deploying the valve prosthesis, thereby enabling precise positioning while maintaining the benefits of percutaneous access.
Solution Approach 2:
The centering device utilizes diameter variation between its first and second components to achieve positioning. The tapered geometry (different diameters at different locations) allows the device to engage the native annulus at a specific depth, converting the dimensional parameter difference into positional accuracy. This parameter change approach enables the delivery system to self-center relative to the annulus without requiring complex active control mechanisms.
2Ease of operation
If the valve prosthesis is not accurately centered relative to the native annulus, then deployment is simplified, but complications such as dislodgement and paravalvular leakage occur
Solution Approach 1:
The centering device is deployed before the valve prosthesis to establish the correct positioning reference. By pre-positioning the tapered centering components against the native annulus, the system creates a stable framework that guides subsequent prosthesis deployment. This preliminary action ensures that when the prosthesis is released, it is already positioned accurately, preventing dislodgement and leakage while maintaining deployment simplicity.
Solution Approach 2:
The invention replaces complex active positioning mechanisms (such as adjustable arms, motors, or sensors) with a passive mechanical centering structure. The tapered geometry of the centering device naturally guides the delivery system into the correct position through geometric constraints alone, eliminating the need for complex mechanical positioning systems while ensuring reliable centering and implant stability.
3Adaptability or versatility
If a large delivery profile is used to deliver the prosthesis, then the prosthesis can be delivered through highly curved anatomy, but vessel trauma increases
Solution Approach 1:
The delivery system is segmented into multiple components: a collapsible delivery catheter for navigation, a centering device for positioning, and the valve prosthesis for implantation. The delivery catheter can be collapsed to a small profile for navigating curved anatomy, then the centering device is deployed to establish positioning. This segmentation allows the system to have both a small navigation profile and a larger deployment profile at different stages, reducing vessel trauma while maintaining anatomical adaptability.
Solution Approach 2:
The delivery system transitions dynamically between different profiles during the procedure. The delivery catheter collapses to a small profile for insertion and navigation through curved vessels, then expands to accommodate the centering device and prosthesis for deployment. This dynamic profile change allows the system to adapt to anatomical constraints during navigation while providing the necessary structure for accurate implantation, thereby reducing vessel trauma.
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
The centering devices effectively prevent dislodgement and leakage by ensuring the valve prosthesis is circumferentially and longitudinally centered, reducing complications and enhancing the success of valve deployment and function.
Implementation Method 1
utilizing self-expanding structures and inflatable balloons to maintain the prosthesis in a centered and anchored position
Implementation Method 2
utilizing self-expanding structures and inflatable balloons to maintain the prosthesis in a centered and anchored position
Data Source
AI summary
Embodiments hereof relate to centering devices for use with a valve delivery system and methods of delivering a valve prosthesis within a vasculature. A valve centering catheter is configured for use with a valve delivery system. The valve centering catheter includes a circumferential centering device at a distal portion thereof, and the circumferential centering device defines a central opening there-through when in an expanded configuration. The circumferential centering device is annular or has a C-shaped cross-section. The valve delivery system is tracked through the vasculature until the valve prosthesis is positioned through the central opening of the expanded circumferential centering device. The valve centering catheter may alternatively include a longitudinal centering device which acts as a marker for depth control during delivery of a valve delivery system, which may include an integral circumferential centering device.