Adapter Stent Anchoring for Prosthetic Heart Valve Replacement
Solution Overview
Problem
Current methods for replacing surgically implanted prosthetic heart valves are invasive and risky, involving open heart surgery, and existing prosthetic valves vary widely in size and shape, making it difficult to develop a percutaneously delivered replacement valve that can adequately anchor and form an effective seal with the existing valve.
Innovation Solution
A percutaneously delivered adapter stent is deployed within the previously implanted prosthetic valve, serving as an anchor and platform for a replacement valve, which can be any known percutaneous valve, to increase frictional forces and ensure securement, and is delivered via the patient's vasculature using a catheter system that allows for expansion and anchoring within the existing valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a percutaneous replacement valve is delivered directly to replace an existing prosthetic valve, then the procedure avoids open heart surgery and reduces patient risk, but the replacement valve cannot adequately anchor or form an effective seal because existing valves vary widely in size and shape
Solution Approach 1:
An adapter stent is introduced as an intermediary component between the percutaneous replacement valve and the existing prosthetic valve. The adapter stent is deployed within the existing valve and provides a standardized anchoring structure that the replacement valve can reliably engage, regardless of the existing valve's size or shape variations. This mediator resolves the incompatibility between diverse existing valves and the standardized replacement valve design.
Solution Approach 2:
The replacement system is divided into three separate components: the existing prosthetic valve (to be retained), the adapter stent (new component), and the percutaneous replacement valve (new component). This segmentation allows each component to be optimized independently - the adapter stent can be designed specifically for anchoring within various existing valve types, while the replacement valve focuses on percutaneous delivery and sealing functionality.
2Reliability
If open heart surgery is used to replace the prosthetic valve, then the replacement valve can be securely implanted, but the procedure is traumatic and high risk with substantial morbidity and mortality
Solution Approach 1:
The invasive mechanical surgical approach (open heart surgery with direct manipulation and suturing) is replaced with a less invasive percutaneous delivery system. The replacement valve and adapter stent are delivered through the patient's vasculature using catheter-based techniques, eliminating the need for chest opening, cardiopulmonary bypass, and direct surgical manipulation, thereby dramatically reducing procedural risk.
Solution Approach 2:
The adapter stent and replacement valve are delivered nested within each other on a delivery catheter system. The adapter stent is positioned and deployed within the existing valve first, then the replacement valve is positioned within the deployed adapter stent. This nested delivery approach allows both components to be introduced through a single percutaneous access point.
3Adaptability or versatility
If the adapter stent is designed to fit within the existing prosthetic valve, then it can provide a mounting platform for the replacement valve, but the adapter stent must accommodate wide variations in existing valve geometry
Solution Approach 1:
The adapter stent is designed as a universal component that can be deployed within multiple types of existing prosthetic valves despite their size and shape variations. The adapter stent incorporates adjustable or compliant features that allow it to conform to different valve geometries while maintaining its primary function of providing a standardized anchoring platform for the replacement valve.
Solution Approach 2:
The adapter stent design incorporates parameters that can be adjusted or that naturally adapt to different valve dimensions, such as adjustable radial strength, compliant materials, or variable expansion characteristics. These parameter changes allow the same adapter stent design to effectively accommodate a range of existing valve sizes and shapes without requiring custom-designed adapters for each valve type.
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 method allows for the secure and predictable replacement of prosthetic heart valves without open heart surgery, accommodating various valve sizes and shapes, and provides a seal between the old and new valves to prevent blood flow, reducing morbidity and mortality risks.
Implementation Method 1
the adapter stent increases the frictional forces between the percutaneous replacement valve and the failing surgical valve, thereby providing a more predictable orientation and securement
Implementation Method 2
The adapter stent can then be deployed to cause the adapter stent to expand and become anchored to the inner surface of the previously implanted valve
Implementation Method 3
The sealing member provides a seal between the previously implanted valve and the replacement valve to prevent or at least minimize blood flow between the original and replacement valves
Data Source
Figure 1~3
Figure 2
Figure 4A~4D
AI summary
An assembly, comprising; an adapter stent comprising an outer frame and a flexible annular sealing member, wherein the sealing member is mounted on the inside of the outer frame; a plurality of barbs disposed along the outside of the outer frame; and a valve member comprising an inner frame and a flexible valve member having a leafed-valve configuration, the valve member sized to be positioned within the adapter stent.