Variable-Stiffness Guidewire for Radiation-Free Cardiac Placement
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Solution Overview
Problem
Existing guidewires for medical devices face challenges in precise placement within the heart due to the need for fluoroscopy, which exposes patients and physicians to radiation, and require skilled intervention to avoid vessel perforation, especially in emergency situations.
Innovation Solution
A guidewire with varying stiffness along its length, featuring a flexible tip to prevent vessel perforation and a stiffer section for device advancement, equipped with sensors for tracking and markers for ultrasound guidance, allowing for precise placement without radiation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopy is used to ensure correct positioning of guidewire, then placement accuracy is improved, but patient and physician are exposed to high radiation
Solution Approach 1:
The patent replaces the fluoroscopy-based mechanical imaging system with an electromagnetic tracking system that uses magnetic fields and sensors to monitor guidewire position, eliminating the need for continuous X-ray exposure while maintaining positioning accuracy
Solution Approach 2:
The patent introduces electromagnetic fields as an intermediary medium between the guidewire and the monitoring system, allowing position tracking through the body without direct radiation exposure to patients or physicians
2Ease of operation
If guidewire is made stiff for device advancement, then delivery capability is improved, but risk of vessel perforation increases
Solution Approach 1:
The guidewire is segmented into multiple sections with different stiffness characteristics - a softer distal tip section for safe navigation and a stiffer proximal section for effective device advancement, allowing both functions to be performed safely
Solution Approach 2:
The guidewire exhibits local quality variations along its length, with the distal tip having different mechanical properties (softer) compared to the proximal section (stiffer), optimizing both safety and functionality at different locations of the same component
3Reliability
If guidewire is made flexible to prevent vessel perforation, then safety is improved, but ability to advance device and guidewire within body deteriorates
Solution Approach 1:
The guidewire is divided into functional segments with differentiated stiffness - a flexible distal portion for safe vessel navigation and a stiffer proximal portion for effective device pushability, resolving the contradiction between safety and deliverability
Solution Approach 2:
Different sections of the guidewire are assigned different local mechanical qualities, with the tip being more flexible for safety and the shaft being stiffer for推进 capability, allowing both requirements to be met simultaneously
4Measurement precision
If correct placement is achieved by skilled intervention, then placement accuracy is improved, but procedural complexity increases
Solution Approach 1:
The electromagnetic tracking system provides real-time feedback on guidewire and medical device position, allowing physicians to monitor placement accuracy continuously without requiring extensive experience or complex fluoroscopy interpretation skills
Data Source
AI summary
The present invention relates to a guidewire (10) for placing a medical device into a patient's body, the guidewire (10) comprising: an elongated main body (12) having a distal axial end (14) and a proximal axial end (16). The elongated main body (12) comprises a first portion (18) having a first stiffness and a second portion (20) having a second stiffness. The first stiffness of the first portion (18) is different from the second stiffness of the second portion (20).