Self-Expanding Heart Valve Leaflet Clipping for Secure Positioning
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Solution Overview
Problem
Conventional heart valve replacement surgeries are invasive and require lengthy recovery periods, and there are challenges in accurately positioning prosthetic valves due to imaging system limitations and heart movement, leading to issues like valve migration and tilted landings.
Innovation Solution
A sutureless cardiac valve prosthesis with a radially expandable support frame and movable valve claspers, such as u-shaped members, is deployed using a delivery device with independent control of sheaths and wires to anchor the claspers in the heart's sinus, ensuring precise positioning and expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional open heart surgery is used to replace heart valves, then the prosthetic valve can be securely implanted, but the surgical invasiveness increases and recovery time lengthens
Solution Approach 1:
The implantation procedure is divided into two independent stages: first delivering the support frame through a minimally invasive catheter, then separately deploying the valve leaflets. This segmentation allows the frame to be positioned securely first, followed by the valve components, achieving reliable implantation without requiring open heart surgery
Solution Approach 2:
The support frame is delivered and positioned at the target site before the valve leaflets are deployed. This preliminary action ensures the frame is securely in place first, providing a stable foundation for subsequent valve implantation, thereby achieving secure implantation through minimally invasive means
2Ease of manufacture
If standard imaging systems are used to guide valve positioning, then the procedure can be performed with conventional equipment, but the positioning accuracy decreases due to 2mm standard error and heart movement
Solution Approach 1:
A radiopaque marker is introduced as an intermediary element that is easily visible on standard fluoroscopic imaging. This marker is attached to the support frame and provides a clear visual reference point, enabling precise positioning of the valve even with conventional imaging systems that have 2mm standard error
Solution Approach 2:
The radiopaque marker changes the visual appearance on imaging systems by being highly visible under fluoroscopy. This allows the support frame position to be accurately tracked and adjusted, compensating for the limited precision of standard imaging systems and heart movement
3Ease of operation
If sutureless valve design is used to simplify implantation, then the ease of operation improves, but the risk of valve migration increases due to lack of sutures for securing
Solution Approach 1:
The support frame is designed with a curved, arc-shaped configuration that matches the natural curvature of the aortic root. This curved geometry allows the frame to conform to and engage with the aortic wall, providing mechanical anchoring that prevents migration while maintaining the sutureless design for ease of operation
Solution Approach 2:
The support frame with its self-expanding structure is deployed first to engage with the aortic wall and provide anchoring. This preliminary action creates the secure attachment necessary to prevent migration, while the subsequent valve leaflet deployment maintains the simplicity of the sutureless approach
4Ease of operation
If the prosthetic valve is made expandable for minimally invasive delivery, then the ease of operation improves, but the device complexity increases due to expandable frame and movable claspers
Solution Approach 1:
The delivery catheter, support frame, and valve leaflets are merged into a single integrated assembly. The support frame is crimped onto the delivery catheter, and the valve leaflets are attached to the frame, creating a unified device that can be delivered through a minimally invasive catheter while maintaining controlled complexity through integration
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 solution enables accurate and secure implantation of prosthetic valves with minimal invasiveness, reducing recovery time and preventing migration by anchoring the valve securely in the heart's sinus.
Implementation Method 1
a radially expandable support frame
Implementation Method 2
at least one valve clasper movable along the axis between a nesting position with the outer surface of the support frame and an engagement position
Implementation Method 3
anchor the claspers in the heart's sinus, ensuring precise positioning and preventing migration
Data Source
AI summary
A delivery device can deploy a heart valve prosthesis within a patient's native aortic valve. The valve prosthesis includes a self-expanding lattice frame coupled to a sinus locator. The delivery device includes a sheath configured to maintain the sinus locator in a collapsed position during advancement toward the native aortic valve sinus. The sheath can be proximally retracted relative to the sinus locator to permit partial radial expansion of a distal portion thereof to permit engagement of the sinus locator with the native aortic valve sinus. Thereafter, a tubular member, positioned distal to the sheath and holding the lattice frame in a collapsed position, can be distally advanced relative to the lattice frame to expose and permit expansion of the lattice frame. The expansion of the lattice frame within the sinus locator can thereby sandwich the native valve leaflets between the expanded lattice frame and the sinus locator.