Two-Stage Prosthetic Heart Valve System for Rapid Implantation
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Solution Overview
Problem
Conventional open-heart surgery for prosthetic heart valve implantation is lengthy and risky, particularly for frail patients, leading to high morbidity and mortality rates, and existing minimally invasive techniques face resistance from surgeons and regulatory bodies due to unfamiliarity and complexity.
Innovation Solution
A two-stage prosthetic heart valve system featuring an expandable base stent and a valve component with a non-expandable, non-collapsible orifice, where the base stent is radially expanded and anchored to the heart valve annulus, and the valve component is quickly and efficiently coupled to the stent using a balloon-expandable coupling stent, reducing the need for suturing and shortening the surgical procedure time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional open-heart surgery is used for prosthetic heart valve implantation, then the valve can be reliably implanted, but the surgical procedure time is lengthy and the risk to frail patients is high
Solution Approach 1:
The prosthetic valve is divided into separate components: a base stent and a valve component. The base stent is implanted first and serves as an anchor, then the valve component is coupled to it. This segmentation allows for faster implantation compared to conventional single-unit valves requiring extensive suturing, while maintaining reliable anchoring and valve function.
Solution Approach 2:
The base stent is implanted and anchored to the heart valve annulus before the valve component is coupled to it. This preliminary action establishes a stable foundation that simplifies the subsequent valve coupling process, reducing overall surgical time while ensuring reliable implantation.
2Reliability
If conventional suturing methods are used to attach the valve, then secure attachment is achieved, but the surgical procedure becomes more time-consuming and complex
Solution Approach 1:
The traditional mechanical suturing process is replaced with a balloon-expandable coupling mechanism. The coupling stent is expanded using a balloon to create a secure mechanical interlock with the base stent, eliminating the need for complex suturing operations while maintaining secure attachment.
Solution Approach 2:
The coupling mechanism utilizes changes in the balloon's volume and pressure parameters during expansion to create a secure mechanical interlock between the coupling stent and base stent. This parameter-based mechanism simplifies the surgical procedure compared to manual suturing while ensuring reliable attachment.
3Object-affected harmful factors
If minimally invasive techniques are used for valve implantation, then patient risk is reduced, but the techniques face resistance from surgeons and regulatory bodies due to unfamiliarity and complexity
Solution Approach 1:
By segmenting the valve into a base stent and valve component, the system maintains compatibility with conventional surgical tools and techniques while enabling minimally invasive delivery. The modular design allows surgeons familiar with traditional methods to adopt the new technique more easily.
Solution Approach 2:
The base stent acts as an intermediary that bridges conventional surgical knowledge and the new minimally invasive technique. It provides a familiar anchor structure that can be implanted using conventional methods, while the subsequent valve coupling uses the balloon-expandable mechanism to achieve minimally invasive implantation.
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 significantly reduces the time required for surgical implantation, minimizes the duration of extracorporeal circulation, and allows for the use of larger prosthetic valves, thereby reducing patient risk and enhancing surgical efficiency while being more acceptable to surgeons and regulatory bodies.
Implementation Method 1
the base stent being radially expanded and anchored to the heart valve annulus
Implementation Method 2
the valve component is quickly and efficiently coupled to the stent using a balloon-expandable coupling stent
Data Source
AI summary
A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve has a base stent that is deployed at a treatment site, and a valve component configured to quickly connect to the base stent. The base stent may take the form of a self- or balloon-expandable stent that expands outward against the native valve with or without leaflet excision. The valve component has a non-expandable prosthetic valve and a self- or balloon-expandable coupling stent for attachment to the base stent, thereby fixing the position of the valve component relative to the base stent. The prosthetic valve may be a commercially available to valve with a sewing ring and the coupling stent attaches to the sewing ring. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment. A catheter-based system and method for deployment is provided.