3D Atraumatic Guidewire Tip for Cardiac Perforation Prevention
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Solution Overview
Problem
Current guidewires used in transcatheter procedures, such as TAVR and TMVR, often lead to left ventricular perforation due to inadequate distribution of stress and force, resulting in cardiac damage and high mortality rates during emergency cardiac surgery.
Innovation Solution
A 3-dimensional guidewire design that distributes stress and force more evenly by adopting a shape that extends beyond a plane, such as a spherical or oblong structure, to reduce the risk of cardiac damage during intravascular and endoscopic procedures, utilizing materials like Nitinol for shape memory and superelasticity, and incorporating features like a three-dimensional atraumatic tip and a delivery sheath to minimize cardiac perforation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional guidewire with spiral end is used, then the guidewire can be advanced into the left ventricle, but the spiral end does not distribute stress and force enough, leading to left ventricular perforation
Solution Approach 1:
The guidewire tip is transformed from a two-dimensional spiral shape into a three-dimensional structure (such as a spherical or oblong shape with radial extensions). This dimensional change allows the tip to distribute force across a larger surface area in three-dimensional space, reducing stress concentration on the left ventricular wall and preventing perforation while maintaining navigability
2Object-affected harmful factors
If the guidewire tip is made larger to distribute force, then cardiac damage is reduced, but the ability to navigate through narrow vessels and align with the valve may be compromised
Solution Approach 1:
The guidewire is divided into distinct functional segments: a long, thin shaft for navigation through vessels, and a separate three-dimensional protective tip structure at the distal end. This segmentation allows the shaft to maintain small dimensions for easy navigation while the tip provides large surface area for force distribution, resolving the contradiction between navigability and safety
Solution Approach 2:
The tip structure extends in radial dimensions perpendicular to the longitudinal axis of the guidewire, creating a three-dimensional shape that increases surface area without significantly increasing the longitudinal profile. This allows the tip to be large enough for force distribution while remaining compact enough to navigate through vessels and align with the valve
3Reliability
If a three-dimensional atraumatic tip is added to the guidewire, then force distribution and safety are improved, but the device complexity increases
Solution Approach 1:
The guidewire tip utilizes material parameter changes, specifically employing Nitinol (a nickel-titanium alloy) with shape memory and superelastic properties. This allows the complex three-dimensional tip structure to be formed through controlled thermal or mechanical treatment of the material itself, rather than requiring assembly of multiple separate components, thereby reducing manufacturing complexity while maintaining the protective function
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
The 3D guidewire effectively reduces the risk of cardiac damage by spreading force over a greater surface area, allowing for safer delivery and alignment of cardiac devices, thereby decreasing the likelihood of perforation and improving procedural safety and accuracy.
Implementation Method 1
The 3D guidewire proposed may better distribute stress and force from the wire to reduce the risk of damage to cardiac structures
Implementation Method 2
utilizing materials like Nitinol for shape memory and superelasticity
Implementation Method 3
utilizing materials like Nitinol for shape memory and superelasticity
Data Source
AI summary
Disclosed are example embodiments of a guidewire. The guidewire includes an elongated core with a proximal end, a distal end, and a length extending along a longitudinal axis therebetween, and a three-dimensional atraumatic tip disposed at the distal end of the elongated core. The three-dimensional atraumatic tip may include a spherical shaped coil of wire. The three-dimensional atraumatic tip may include an oblong shaped coil of wire. The three-dimensional atraumatic tip may include an umbrella shaped coil of wire.