Percutaneous Transcatheter Heart Valve Removal Device
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Solution Overview
Problem
There is a clinical need for a percutaneous method to remove and replace transcatheter heart valves, as existing technologies do not provide a transcatheter approach for removing failed valves, which is necessary for younger surgical patients and those requiring multiple valve replacements due to growth or durability concerns.
Innovation Solution
A device featuring a control handle and flexible shaft with deployable engagement elements, such as jaws, loops, coils, or balloons, that position next to the transcatheter heart valve and retract it through the shaft for removal, utilizing various mechanisms to grip and reduce the valve's diameter for extraction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a transcatheter heart valve is implanted to replace a failed native valve, then the patient benefits from lower morbidity and shorter hospital stay compared to surgical replacement, but there is no device available to remove a failed transcatheter heart valve percutaneously
Solution Approach 1:
The removal device is divided into multiple functional components including engagement elements (jaws, loops, or hooks), a flexible shaft for navigation, and a control handle for operation. This segmentation allows each component to perform its specific function while working together to achieve valve removal through the catheter access route.
Solution Approach 2:
The flexible shaft with engagement elements acts as an intermediary tool that connects the operator's control to the implanted valve. The engagement elements (jaws, loops, or hooks) serve as intermediaries to grasp and secure the valve frame, enabling force transmission from the catheter to the valve for removal.
2Strength
If engagement elements are deployed to grip the transcatheter heart valve, then the valve can be securely held for removal, but the engagement elements must be small enough to pass through the catheter shaft
Solution Approach 1:
The engagement elements are designed to be nested within the flexible shaft during delivery. The jaws, loops, or hooks are contained within the catheter shaft in a compressed or folded state, allowing them to pass through the narrow access route while maintaining their functional structure for engagement.
Solution Approach 2:
The engagement elements transition from a compressed delivery configuration to an expanded functional configuration upon deployment. The jaws open to grip the valve, loops expand to encircle the frame, or hooks deploy to engage the structure, allowing small delivery profile but large engagement capability.
3Ease of operation
If the transcatheter heart valve is pulled through the flexible shaft for removal, then the valve can be extracted percutaneously, but the valve diameter must be reduced to fit through the shaft
Solution Approach 1:
The flexible shaft is designed with a curved or tapered geometry that facilitates the bending and compression of the valve during retrieval. The curved path allows the valve to be gradually manipulated into a compact configuration suitable for passing through the catheter shaft.
Solution Approach 2:
The flexible shaft acts as a flexible container that can deform and adapt to the shape of the valve during retrieval. The shaft's flexibility allows it to accommodate the valve in a compressed state and guide it through the catheter access route without rigid constraints.
Data Source
AI summary
The disclosure features a method for removing a transcatheter heart valve from a heart in a patient by providing a removal device that deploys one or more transcatheter engagement elements to engage the transcatheter heart valve.