Prosthetic Valve Delivery with Expandable Tabs for Mitral Anchoring
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Solution Overview
Problem
Current prosthetic valves for treating mitral regurgitation face challenges in accurate positioning and secure anchoring, particularly due to anatomical variations and the risk of improper engagement with the native valve leaflets, leading to potential dislodgement and functional inefficiency.
Innovation Solution
A prosthetic valve delivery system that includes a self-expanding frame with adjustable tabs and a rapid pacing mechanism to facilitate precise positioning and anchoring, where the valve is expanded and anchored using tabs that engage the native valve leaflets and annulus, with the option of an anti-pivoting mechanism to prevent rotation and ensure proper alignment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical implantation methods are used for prosthetic valve replacement, then the valve can be securely anchored, but the procedure requires open-heart surgery with high invasiveness and long recovery time
Solution Approach 1:
The patent employs a flexible delivery catheter that can be inserted through blood vessels to reach the heart valve, replacing the need for open-heart surgery. The catheter delivers the prosthetic valve in a compressed state and then allows it to expand to its functional configuration, achieving secure anchoring through the natural cardiac anatomy while minimizing patient trauma and recovery time
Solution Approach 2:
The prosthetic valve is delivered in a nested configuration where the valve is compressed within a delivery catheter, which itself is inserted through a larger access vessel. This nested delivery system allows the valve to be transported in a low-profile state and then deployed in situ, transforming the implantation procedure from highly invasive to minimally invasive
2Ease of operation
If less invasive percutaneous catheter techniques are used for prosthetic valve delivery, then patient trauma is reduced, but the valve may not be successfully anchored due to anatomical variations and positioning difficulties
Solution Approach 1:
The prosthetic valve is designed with dynamic expansion capabilities, transitioning from a compressed delivery state to an expanded functional state. The valve includes expandable frames and adjustable anchoring elements that can be deployed after reaching the target position, allowing adaptation to various anatomical configurations and ensuring reliable anchoring despite patient-specific variations
Solution Approach 2:
The valve anchoring system is divided into multiple independent anchoring elements distributed around the valve circumference. These segmented anchoring mechanisms can engage with different portions of the native valve anatomy, providing redundancy and flexibility to achieve successful anchoring even when some anchoring points are suboptimal due to anatomical variations
3Length of moving object
If the prosthetic valve is delivered in a compressed state on a catheter, then the delivery profile is reduced for easier navigation, but the valve requires complex expansion mechanisms and precise positioning control
Solution Approach 1:
The prosthetic valve incorporates self-expanding features where the valve frame automatically expands to its functional configuration upon release from the delivery catheter, utilizing the elastic memory of the frame material. This self-service expansion mechanism eliminates the need for complex external expansion devices, reducing overall system complexity while maintaining the low delivery profile advantage
Solution Approach 2:
The valve delivery system utilizes phase transitions or elastic deformation of the frame material to transform the valve from a compressed low-profile state during delivery to an expanded functional state at the implantation site. This parameter change approach allows the valve to navigate through narrow vessels in a compressed state and then automatically assume its functional geometry upon deployment, simplifying the expansion mechanism
4Strength
If anchors are used to secure the prosthetic valve to the native valve leaflets, then anchoring strength is improved, but the valve may be pushed upward toward the atrium during ventricular contraction if anchors do not successfully engage, resulting in improper positioning
Solution Approach 1:
The prosthetic valve employs different anchoring mechanisms at different locations: anchors engage with the native valve leaflets or annulus to provide strong anchoring, while a flanged region is positioned upstream to prevent upward displacement during ventricular contraction. This localized differentiation of anchoring strategies ensures both strong attachment and precise positioning control
Solution Approach 2:
The flanged region is positioned upstream of the valve leaflets before ventricular contraction occurs, creating a preliminary counteracting force that prevents the valve from being pushed upward during systole. This preliminary anti-action mechanism proactively counteracts the harmful displacement force before it can cause improper positioning
Data Source
AI summary
A method for delivering a prosthetic valve to a patient's heart having a native valve with a plurality of valve leaflets includes providing a delivery device with a prosthetic valve, advancing the delivery device toward the native valve, and expanding a portion of the prosthetic valve to form a flanged region that is upstream of the valve leaflets. One or more tabs on the prosthetic valve are released so that they expand outward to a position that is transverse to the longitudinal axis of the prosthetic valve. The position of the prosthetic valve is adjusted relative to the valve leaflets and rapid pacing is applied to the patient's heart so that the valve leaflets move inward toward the prosthetic valve or the delivery device. The tabs are further released to allow the tabs to move into their final positions.