Torque-Anchored Heart Valve Delivery for Secure Mitral Implantation
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Solution Overview
Problem
Existing heart valve prostheses face challenges in secure anchoring during transcatheter implantation, particularly at sites like the native mitral valve, leading to issues such as unwanted migration and paravalvular leakage.
Innovation Solution
A delivery device with a torque anchoring mechanism, featuring a balloon and tether shaft, is used to rotate and embed torque anchoring mechanisms of the heart valve prosthesis into tissue at the implantation site, ensuring secure anchoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional open surgery is used for heart valve replacement, then the valve can be properly implanted, but the patient experiences significant trauma, discomfort, and requires extensive recuperation time
Solution Approach 1:
The patent replaces the mechanical open surgical system with a percutaneous transcatheter delivery system. The heart valve prosthesis is delivered through a catheter inserted via a peripheral blood vessel, eliminating the need for thoracotomy and direct cardiac manipulation. This substitution of the delivery mechanism reduces patient trauma while maintaining implantation reliability.
Solution Approach 2:
The patent employs a flexible delivery catheter with a collapsible balloon that can be inserted through small percutaneous access points. The catheter's flexible structure allows navigation through the vascular system to reach the heart, enabling minimally invasive valve replacement without traditional surgical incisions.
2Object-affected harmful factors
If percutaneous transcatheter delivery is used for heart valve replacement, then patient trauma is reduced, but the heart valve prosthesis may experience unwanted migration and paravalvular leakage due to inadequate anchoring
Solution Approach 1:
The patent incorporates anchoring mechanisms (such as hooks, barbs, or flares) that are pre-integrated into the heart valve prosthesis frame. These anchoring features are prepared in advance during device fabrication and are activated when the valve is deployed at the implantation site, ensuring immediate secure attachment to the annulus tissue before the patient leaves the procedure.
Solution Approach 2:
The patent introduces an intermediary anchoring structure that mediates between the delivered heart valve prosthesis and the native annulus tissue. This intermediary component (such as an anchoring ring or tissue-engaging elements) provides a mechanical interface that secures the valve in place, preventing migration and paravalvular leakage while allowing percutaneous delivery.
3Length of moving object
If the heart valve prosthesis is delivered in a compressed configuration, then it can be introduced percutaneously, but the anchoring mechanisms require additional rotation and embedding steps to ensure secure fixation
Solution Approach 1:
The patent employs dynamic anchoring mechanisms that transition from a compressed, low-profile delivery configuration to an expanded, anchored implanted configuration. The anchoring elements (such as self-expanding frames or balloon-expandable structures) automatically or manually transform after deployment, rotating or embedding into the tissue to secure the valve without requiring complex external manipulation tools.
Solution Approach 2:
The patent incorporates self-anchoring features where the heart valve prosthesis automatically secures itself to the annulus tissue upon deployment. The anchoring mechanisms (such as self-expanding nitinol frames or tissue-penetrating elements) activate autonomously when the valve is released from the delivery catheter, eliminating the need for separate rotation or embedding steps and reducing procedural complexity.
Data Source
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AI summary
A delivery device for delivery and deployment of a heart valve prosthesis with a torque anchoring mechanism includes a balloon having a shaped surface configured to engage a corresponding shaped surface of the heart valve prosthesis. The balloon is configured to rotate about a central longitudinal axis of the delivery device to rotate the heart valve prosthesis.