Reverse-Curve Guidewire for Stable Heart Valve Delivery Withdrawal
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Solution Overview
Problem
Existing guidewires for delivering replacement heart valves often result in undesirable contact between the delivery device and the implant during withdrawal, leading to potential damage, mispositioning, or dislodgment of the implant due to their tendency to straighten, which is invasive and poses risks to the patient.
Innovation Solution
A guidewire with a coiled portion curved in a first direction and a reverse curve portion in an opposite direction, combined with varying stiffness and coating configurations, designed to navigate and stabilize the implant during deployment and withdrawal, minimizing contact with the delivery device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the guidewire is designed to be straight and stiff for stable implant delivery, then the delivery device can be positioned accurately, but the guidewire contacts the implant during withdrawal causing damage or dislodgment
Solution Approach 1:
The guidewire incorporates a reverse curve portion that curves in the opposite direction of the coiled portion, creating a balanced curved configuration. This curvature allows the guidewire to navigate vascular paths while maintaining stability, and the reverse curve specifically prevents contact between the delivery device and implant during withdrawal by creating a buffer zone that absorbs mechanical stresses.
2Object-affected harmful factors
If the guidewire is made flexible to navigate vascular paths, then the procedure is less invasive, but the guidewire cannot maintain stable positioning of the implant
Solution Approach 1:
The guidewire is divided into distinct sections with different mechanical properties: a distal section with a coiled portion for flexibility and navigation, a reverse curve portion for stability and contact prevention, and varying stiffness along the length. This segmentation allows each section to perform its specific function - the flexible distal section navigates vessels while the stiffer proximal sections maintain positioning accuracy.
Solution Approach 2:
Different portions of the guidewire have different stiffness characteristics, with the distal section being more flexible for navigation and the proximal section being stiffer for stable implant positioning. The reverse curve portion is strategically located to provide local structural support where needed while maintaining overall flexibility for minimally invasive delivery.
3Ease of operation
If the guidewire maintains a straight configuration, then the delivery device withdraws easily, but the implant may become dislodged or damaged due to guidewire straightening
Solution Approach 1:
The reverse curve portion is pre-formed in the guidewire to counteract the straightening tendency during withdrawal. This preliminary anti-action configuration creates a mechanical buffer that absorbs the forces generated when the delivery device is withdrawn, preventing these forces from being transmitted to the implant and causing dislodgment or damage.
Data Source
AI summary
An improved guidewire may include an elongate shaft including a distal section and a proximal section extending proximally from the distal section. The elongate shaft includes a coiled portion disposed within the distal section. The coiled portion is curved in a first direction in a first plane. The elongate shaft includes a reverse curve portion curved in a second direction opposite the first direction. The reverse curve portion is disposed proximal of the coiled portion. A kit for forming the improved guidewire may include a guidewire having a coiled portion and a forming tool configured to form a reverse curve portion in the guidewire proximal of the coiled portion.