Two-Part Stent System for Heart Valve Positioning Accuracy
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Solution Overview
Problem
Existing devices for transvascular implantation and fixation of prosthetic heart valves often lack the necessary positioning accuracy, making it difficult to precisely place the valve in the ventricle, and correcting improperly positioned valves is cumbersome and risky.
Innovation Solution
A two-part stent system comprising a self-expanding positioning stent and a heart valve stent, where the positioning stent is used to accurately position and anchor the heart valve stent, allowing for precise alignment and fixation of the prosthetic heart valve, with the positioning stent being reversibly expandable and collapsible for easy maneuverability and removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If a self-expanding prosthetic heart valve is implanted through a catheter system, then the surgical procedure time is reduced and patient risk is lowered, but positioning accuracy of the valve in the ventricle is insufficient
Solution Approach 1:
The device is divided into two independent parts: a positioning stent and a heart valve stent. The positioning stent is implanted first to establish accurate positioning, then the heart valve stent is attached to it. This segmentation allows the positioning function to be optimized separately from the valve function, resolving the contradiction between quick implantation and precise positioning.
Solution Approach 2:
The positioning stent acts as an intermediary element between the catheter system and the heart valve stent. It provides a stable reference structure that enables precise positioning of the valve while maintaining the minimally invasive catheter-based approach, thus bridging the gap between quick implantation and accurate placement.
2Measurement precision
If traditional surgical procedures are used to implant prosthetic heart valves, then positioning accuracy is improved, but patient risk and procedure time increase
Solution Approach 1:
By separating the positioning stent from the heart valve stent, the device enables precise positioning (traditionally requiring open surgery) to be achieved through minimally invasive catheter-based implantation. The positioning stent provides the accuracy of surgical procedures while the catheter approach maintains low patient risk.
Solution Approach 2:
The positioning stent is designed to self-expand and self-position within the ventricle using the body's natural blood flow and pressure. This self-service mechanism eliminates the need for complex surgical manipulation while maintaining high positioning accuracy, thereby reducing patient risk associated with prolonged surgery.
3Device complexity
If a single integrated stent structure is used, then device complexity is reduced, but the ability to correct improperly positioned valves is limited
Solution Approach 1:
The two-part structure with separable positioning stent and heart valve stent allows the positioning component to be independently adjusted or removed if positioning is incorrect. This segmentation provides correction capability while keeping each individual component relatively simple in design.
Solution Approach 2:
If positioning is improper, the positioning stent can be removed or adjusted independently from the heart valve stent. This allows for correction of positioning errors without requiring removal of the entire device, facilitating easier repair and repositioning while maintaining overall structural simplicity.
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
This solution enhances the positioning accuracy and simplifies the implantation process, reducing the risk of incorrect deployment and enabling easier correction or removal of improperly positioned prosthetic heart valves, while ensuring secure anchorage and precise angular positioning.
Implementation Method 1
a self-expanding positioning stent and a heart valve stent, where the positioning stent is used to accurately position and anchor the heart valve stent
Data Source
AI summary
A device for the transvascular implantation and fixation of prosthetic heart valves having a self-expanding heart valve stent (10) with a prosthetic heart valve (11) at its proximal end is introducible into a patient's main artery. With the objective of optimizing such a device to the extent that the prosthetic heart valve (11) can be implanted into a patient in a minimally-invasive procedure, to ensure optimal positioning accuracy of the prosthesis (11) in the patient's ventricle, the device includes a self-expanding positioning stent (20) introducible into an aortic valve positioned within a patient. The positioning stent is configured separately from the heart valve stent (10) so that the two stents respectively interact in their expanded states such that the heart valve stent (10) is held by the positioning stent (20) in a position in the patient's aorta relative the heart valve predefinable by the positioning stent (20).