Vibrating Guidewire for Occlusion Drilling and Tissue Sensing
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Solution Overview
Problem
Current medical devices for opening and navigating through occluded body internal passages, such as coronary arteries, lack flexibility and maneuverability, often causing damage to the artery walls during procedures like PTCA for CTOs, and fail to accurately characterize tissues and substances in real-time.
Innovation Solution
A guidewire with embedded miniature magnetic elements that induces axial vibrations through an alternating magnetic field, allowing for efficient drilling through occlusions while minimizing damage to soft tissues and providing real-time tissue characterization using magnetic and acoustic impedance sensing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a guidewire is pushed through a totally occluded vessel with hard plaque, then the guidewire may penetrate through the artery wall layers creating a neo-lumen or dissection, but this causes damage to the artery wall and increases risk of perforation
Solution Approach 1:
The guidewire incorporates a distal tip that generates high-frequency mechanical vibrations (e.g., ultrasonic vibrations) to drill through the occlusive plaque. The vibrations enable the guidewire to penetrate hard calcified plaque without exerting excessive lateral force on the artery wall, thus avoiding dissection and perforation while maintaining reliable passage through the occlusion.
Solution Approach 2:
The guidewire utilizes changes in mechanical parameters (vibration frequency, amplitude, and direction) to adapt to different plaque characteristics. By modulating these parameters, the guidewire can effectively drill through varying densities of occlusive material while minimizing damage to the surrounding artery wall structure.
2Reliability
If a catheter device with operative means for occlusion opening is used, then the occlusion can be opened, but the device lacks flexibility and maneuverability due to its bulky structure
Solution Approach 1:
The invention extracts the occlusion-opening function from a bulky catheter device and concentrates it in a small, flexible guidewire tip. The guidewire itself carries the vibrational drilling mechanism at its distal end, eliminating the need for a large catheter structure and thereby maintaining both occlusion-opening capability and device flexibility.
Solution Approach 2:
The guidewire with active vibrational tip is nested within a standard catheter structure, allowing the compact drilling mechanism to be delivered through conventional catheterization pathways. The nested configuration enables the small guidewire to pass through the catheter while the catheter provides support and access to the target vessel.
3Productivity
If conventional catheterization procedures are used for CTO, then the procedure workflow is well-established, but the practitioner cannot determine in real-time whether the device is navigating through the true lumen or perforating the artery wall
Solution Approach 1:
The guidewire incorporates sensors at its distal tip that provide real-time feedback on tissue characteristics during navigation. The sensors detect mechanical properties (e.g., stiffness, density) of the tissue being contacted, allowing the practitioner to distinguish between soft plaque, hard calcified plaque, and artery wall tissue, thereby preventing perforation while maintaining efficient workflow.
Solution Approach 2:
The invention replaces subjective mechanical sensing (practitioner feel) with objective sensor-based detection of tissue properties. The sensors convert mechanical tissue characteristics into electrical signals that can be processed and displayed, providing accurate real-time information about the guidewire's position relative to the true lumen and occlusion.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables safe and effective navigation through occlusions with reduced risk of perforation or dissection, allowing for conventional treatments like balloon catheters and stents, while accurately distinguishing between plaque and vessel walls.
Implementation Method 1
A guidewire with embedded miniature magnetic elements that induces axial vibrations through an alternating magnetic field
Implementation Method 2
guidewire with embedded miniature magnetic elements that induces axial vibrations through an alternating magnetic field
Data Source
AI summary
The present invention is directed to a device and method for opening obstructed body internal passages and for sensing and characterizing tissues and substances in contact with the device. In general, the device comprises a catheter tube capable of inducing vibrations in a guidewire contained therein, wherein said vibrations of the guidewire are utilized for opening a passage through an occlusion. The in-vivo vibrations may be induced by means of a magnetic field actuating means and a guidewire comprising magnetic coupling means, or by means of transducers, which may be also used for the sensing. The invention also relates to the field of minimal invasive catheterization, particularly an apparatus for opening and/or removing obstructions occluding body internal passages by means of an active guidewire comprising a coil to which an alternating voltage can be applied. In that way the guidewire can vibrate if an external magnetic field is applied.