Adjustable Distal Loop Guidewire for TAVR Safety
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Solution Overview
Problem
Current TAVR valve replacement procedures require multiple guidewires, increasing the risk of perforation and injury due to the use of bare metal wires, which complicates the procedure and poses safety concerns.
Innovation Solution
A guidewire and guidetube combination where a microcatheter guidetube made of plastic surrounds a flexible guidewire with an adjustable distal loop, reducing the number of wires needed and minimizing the risk of perforation, by using a kink-resistant, semi-rigid plastic tube and a flexible steel or alloy core wire with a tapered tip.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple bare metal guidewires are used sequentially, then the valve delivery function is achieved, but the risk of perforation and injury increases
Solution Approach 1:
A plastic coating is applied to the guidewire to serve as an intermediary layer between the metal core and the biological tissue. This coating reduces the harmful interaction between the bare metal wire and the vessel wall, significantly lowering the risk of perforation and injury while maintaining the wire's structural integrity and delivery function.
Solution Approach 2:
The guidewire is constructed as a composite structure with a metal core providing strength and a plastic coating providing safety. This composite design combines the advantages of both materials: the metal core maintains guidewire stiffness and pushability, while the plastic coating reduces friction and perforation risk during advancement through the aortic valve and vessels.
2Manufacturing precision
If multiple guidewires are used sequentially, then proper valve positioning is achieved, but the procedural complexity increases
Solution Approach 1:
The coated guidewire is designed to perform multiple functions that previously required separate wires. It can serve as both the crossing wire for navigating the aortic valve and the delivery wire for transporting the replacement valve, eliminating the need for sequential wire exchanges and reducing procedural complexity while maintaining positioning precision.
Solution Approach 2:
The invention merges the functions of multiple guidewires into a single integrated device. By combining the crossing and delivery functions in one wire, the procedure is simplified, reducing the number of steps and potential complications associated with multiple wire insertions and exchanges.
3Strength
If a stronger wire is used for valve delivery, then the delivery function is improved, but the perforation risk increases
Solution Approach 1:
The guidewire uses a composite construction where a strong metal core provides the necessary strength for valve delivery, while an outer plastic coating reduces the harmful interaction with tissue. This allows the wire to be strong enough for delivery without the perforation risks associated with bare metal wires.
Solution Approach 2:
Different parts of the guidewire have different properties optimized for their specific functions. The core maintains high strength throughout, while the coating provides localized protection at the wire-vessel interface. The distal tip may have specific properties for crossing the valve, while the proximal portion maintains strength for delivery.
Data Source
AI summary
A microcatheter device for crossing a patient's aortic valve has a guidetube combined with a free-floating and removable guidewire. The guidetube is generally hollow with a main shaft and a distal ring, the main shaft and the distal ring formed from flexible plastic. The distal ring is larger in diameter than the main shaft, and is configured to conform to an internal guidewire for insertion into the aorta, and then to deploy to form a downwardly-extending loop when in place in the left ventricle. A guidewire is received by the guidetube and is configured to advance into the distal ring to cause a diameter of the distal ring to expand, retract, or completely straighten. The distal ring diameter is thus adjustable to fit the size of the patient's left ventricle.