Infundibular Reducer Delivery System for Right Ventricular Outflow Tract
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Solution Overview
Problem
Current pulmonary valve replacement methods using venous or pericardial valves are limited by their narrow size range, making them unsuitable for patients with right ventricular outflow tracts larger than 22 mm in diameter, as they cannot be securely implanted in these patients.
Innovation Solution
A delivery system and method for percutaneous transcatheter implantation of a prosthetic valve, including an infundibular reducer device, which allows for the delivery of a self-expandable medical device, such as a pericardial heart valve or a valved segment of bovine jugular vein, to the right ventricular outflow tract without the need for a balloon, enabling secure placement in larger tracts.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If venous or pericardial valves are used for pulmonary valve replacement, then the procedure can be performed percutaneously, but the available size range is limited to approximately 22 mm diameter
Solution Approach 1:
The patent applies parameter changes by transitioning from fixed-size venous/pericardial valves to a self-expanding metallic stent structure that can be adjusted to different diameters. The stent's expandable framework allows it to accommodate larger diameters (exceeding 22 mm) while maintaining the percutaneous delivery approach through compression during catheter delivery and self-expansion at the implantation site.
2Ease of operation
If traditional balloon-expandable prosthetic valves are used, then the valve can be delivered percutaneously, but the device complexity increases due to the balloon catheter system
Solution Approach 1:
The patent applies the extraction principle by removing the balloon catheter component from the delivery system. Instead of using a balloon to expand the valve, the invention employs a self-expanding metallic stent structure that automatically expands to its functional configuration after being deployed from the delivery catheter, thereby simplifying the overall device architecture while maintaining percutaneous delivery capability.
Solution Approach 2:
The self-expanding metallic stent structure performs self-service by automatically expanding to its functional configuration upon deployment from the delivery catheter without requiring external balloon inflation. The memory properties of the metallic structure enable it to self-actuate and achieve its expanded state, eliminating the need for the complex balloon catheter system.
3Adaptability or versatility
If self-expandable metallic stent structure is used, then larger diameter valves can be implanted, but the risk of blood flow occlusion during deployment increases
Solution Approach 1:
The patent applies preliminary action by designing the delivery catheter with a distal opening that enables blood flow to pass through during the deployment process. This preliminary configuration allows blood to continue flowing through the device before full expansion is achieved, reducing the risk of occlusion. The stent structure is prepared in a compressed state within the catheter, then gradually deployed to maintain patency throughout the procedure.
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 approach allows for the secure implantation of prosthetic valves in larger right ventricular outflow tracts, reducing the risk of blood flow occlusion during deployment and enabling easier insertion and removal of the device, with the option to reposition the valve if necessary during the procedure.
Implementation Method 1
a self-expandable medical device, such as a pericardial heart valve or a valved segment of bovine jugular vein
Data Source
AI summary
Described is a delivery system for minimally invasive delivery of a self-expandable stent to a body lumen, and particularly delivery of a prosthetic valve to the right ventricular outflow tract. Also described is a method of loading a stent onto such a delivery system, and a method of delivering a self-expandable stent to a desired anatomic site.