Guidewire Identification Device for Imaging Visibility
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Solution Overview
Problem
Existing medical guidewire assemblies face challenges in visualizing the leading edge of piercing stylets during transseptal puncture procedures due to their low density and radiolucency, leading to potential errors and damage to unintended anatomical structures.
Innovation Solution
A medical guidewire assembly with an elongate body featuring a tapered section and an identification device positioned on the proximal portion, which can be either an echogenic or radiopaque element, enhancing visibility under medical imaging systems like fluoroscopy and echocardiography.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If nitinol material is used for the piercing stylet to achieve shape memory and kink resistance, then the device can be manipulated and returned to its relaxed configuration, but the leading edge becomes difficult to visualize under imaging modalities due to low radiopacity
Solution Approach 1:
The patent applies local quality by adding radiopaque material specifically to the distal portion and leading edge of the piercing stylet, while the proximal portion maintains nitinol material for shape memory properties. This localized differentiation allows the leading edge to be highly visible under imaging modalities without compromising the overall shape memory functionality of the device.
Solution Approach 2:
The patent employs composite materials by combining nitinol (for shape memory and elasticity) with radiopaque materials (such as tungsten, platinum, or gold) in a single piercing stylet structure. This composite construction enables both the mechanical properties needed for safe manipulation and the imaging visibility required for precise navigation and puncture.
2Object-affected harmful factors
If the cross-section of the piercing stylet is made smaller to reduce trauma to vasculature, then the device is less traumatic, but the leading edge becomes even more difficult to see via typical imaging modalities
Solution Approach 1:
The patent applies local quality by concentrating radiopaque material at the distal portion and leading edge of the piercing stylet. This allows the entire device to maintain a small cross-section for reduced vascular trauma, while the radiopaque leading edge provides enhanced visibility for precise navigation and puncture under imaging guidance.
3Force
If the piercing stylet is made of thin, ductile materials with a pointed bevel to lower the force required for puncture, then the input force is reduced, but the leading edge remains challenging to visualize
Solution Approach 1:
The patent employs composite materials by combining thin, ductile nitinol material (which requires low force for puncture) with radiopaque material at the distal portion and leading edge. This composite construction maintains the low-force puncture capability while simultaneously providing enhanced visibility of the sharp distal tip under imaging modalities.
4Difficulty of detecting and measuring
If radiopaque materials with higher density are used to enhance visibility, then the object becomes more visible under imaging modalities, but the device complexity and potential harm to tissue increase
Solution Approach 1:
The patent applies local quality by placing radiopaque material only at the distal portion and leading edge of the piercing stylet, rather than throughout the entire device. This localized approach enhances visibility of the critical puncture area while minimizing the amount of dense material that could cause tissue damage, thereby reducing overall device complexity and potential harm.
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 identification device improves the visibility of the guidewire assembly, allowing for more accurate navigation and reduced risk of unintended tissue damage by providing clear visualization of the guidewire's position and optimal positioning for device exchange in the left atrium.
Implementation Method 1
Fluoroscopy relies on directing an x-ray beam through the body where the signal is attenuated by tissues and used to create a series of real-time images
Implementation Method 2
Echocardiography relies on using ultrasound waves to reflect off mediums (such as tissue, catheters, etc.) to create an image of their surroundings
Data Source
AI summary
A medical guidewire configured for puncturing a tissue. The medical guidewire includes an elongate guidewire body having a proximal portion with a first outer diameter and a distal portion with a second outer diameter. The second outer diameter is smaller than the first outer diameter, forming a tapered section between the first outer diameter and second outer diameter. The medical guidewire further includes a piercing device extending from the distal portion, forming a puncturing distal tip. An identification device is positioned on the elongate guidewire body on the first outer diameter proximal the tapered section. The identification device is configured to enhance detectable visibility of the medical guidewire.