Split Anchoring Stent for Precise Transcatheter Aortic Valve Fixation
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Solution Overview
Problem
Existing transcatheter aortic valve (TAVR) systems struggle to effectively anchor in patients with severe calcification, ascending aortic dilatation, coronary artery occlusion risk, and aortic regurgitation, often leading to complications such as valve regurgitation, displacement, or detachment due to valve deformation, coronary obstruction, and perivalvular leakage.
Innovation Solution
A split type precisely-anchorable transcatheter aortic valve system with a transcatheter aortic valve anchoring stent and artificial biological aortic valve, designed based on personalized three-dimensional reconstruction of patient image data, allowing for precise anchoring through a two-part stent design that clamps onto the aortic valve leaflets and subvalvular tissue, with the stent transitioning from a first to a second anchoring state via balloon expansion to ensure secure integration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a self-expanding nitinol frame is used to provide radial force for valve anchoring, then valve anchoring and sealing are improved, but the risk of embolization and device migration increases due to limited adjustability
Solution Approach 1:
The frame transitions from a static self-expanding structure to a dynamic system with adjustable radial force. The shape memory alloy properties enable the frame to be deployed in a compressed low-profile state and then expanded to a larger diameter, with the ability to adjust radial force after deployment by applying heat to activate shape memory recovery, thereby maintaining anchoring reliability while enabling post-deployment adjustment.
Solution Approach 2:
The radial force parameters of the frame are made changeable through shape memory alloy phase transitions. By controlling temperature, the frame can transition between different radial force states (compressed, expanded, and intermediate positions), allowing optimization of anchoring force and prevention of embolization or migration after valve deployment.
2Length of moving object
If the valve is deployed in a compressed low-profile state and then expanded, then the profile for delivery is reduced, but the time required for deployment and expansion increases
Solution Approach 1:
The frame is pre-formed with the final expanded geometry encoded in its shape memory alloy structure. During delivery, it is temporarily compressed into a low-profile state without altering its inherent shape. Upon deployment, applying heat triggers rapid shape memory recovery to the pre-programmed expanded configuration, achieving both low delivery profile and quick deployment without requiring time-consuming manual expansion or assembly.
Solution Approach 2:
The shape memory alloy undergoes a phase transition from austenite (high-temperature, expanded shape) to martensite (low-temperature, compressed shape) during delivery and storage, then reverses back to austenite when heated during deployment. This phase transition enables reversible shape change, allowing the frame to maintain a compressed low-profile state for delivery and then rapidly expand to its functional configuration when thermal energy is applied.
3Ease of operation
If a mechanical delivery system is used to deploy the valve, then deployment control is improved, but the system complexity and procedure time increase
Solution Approach 1:
The complex mechanical deployment mechanism is extracted and replaced with a simpler system. The frame is delivered in a compressed state within a delivery catheter, and deployment is achieved by applying heat (e.g., via resistive heating or external heating element) to trigger shape memory recovery. This eliminates the need for complex mechanical expansion mechanisms while maintaining controlled deployment through thermal activation.
Solution Approach 2:
The mechanical system for frame expansion is replaced with a thermal system. Instead of using mechanical forces to expand the frame from a compressed state, thermal energy is applied to induce shape memory alloy phase transition and automatic shape recovery. This substitution simplifies the delivery system by eliminating complex mechanical expansion components while maintaining precise deployment control through thermal management.
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 system achieves accurate and stable anchoring, reducing complications and ensuring the transcatheter aortic valve remains securely in place, minimizing displacement and regurgitation, while allowing for personalized and efficient treatment through intelligent, large-scale implementation.
Implementation Method 1
The frame is constructed of a shape memory alloy and is deployed in a compressed low-profile state. Upon deployment, the frame is heated to transform from a martensitic phase to an austenitic phase.
Implementation Method 2
Upon deployment, the frame is heated to transform from a martensitic phase to an austenitic phase. In this way, the frame can be deployed in a compressed low-profile state and then expanded to a larger diameter after implantation.
Data Source
Figure 1~3A
Figure 3B~4C
Figure 5A~6B
AI summary
A split type precisely-anchorable transcatheter aortic valve system comprises a split transcatheter aortic valve anchoring stent (10) and a transcatheter artificial biological aortic valve (20), wherein the shape and structure of the transcatheter aortic valve anchoring stent (10) are matched with the real structure of the aortic valve after the patient's image data is subjected to three-dimensional reconstruction, the transcatheter aortic valve anchoring stent (10) is delivered to the aortic valve position of the patient to be released, deformed and combined with the aortic valve leaflet tissue and the subvalvular tissue of the patient; the transcatheter artificial biological aortic valve (20) is delivered into the transcatheter aortic valve anchoring stent (10) to be released, the valve stent is deformed to expand the valve to the functional state, the transcatheter aortic valve anchoring stent (10) is deformed again and combined with the expanded transcatheter artificial biological aortic valve (20), and meanwhile, the transcatheter aortic valve anchoring stent (10) is deformed and anchored again. A system designed based on three-dimensional reconstruction can realize accurate anchoring of transcatheter aortic valve personalization.