Guidewire Spatial Geometry Prevents Tissue Damage
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Solution Overview
Problem
Existing medical guidewire assemblies face challenges in preventing unintended tissue damage during transseptal access procedures due to unpredictable deployment of sharp distal tips, which can lead to inadvertent puncture and increased procedural complexity.
Innovation Solution
A medical guidewire assembly with a flexible distal shaft section configured to form a predetermined spatial geometry upon exiting the guidewire introducer, featuring a piercing stylet device that punctures the biological wall and then forms a spatial geometry to prevent further contact with adjacent tissue, ensuring safety by maintaining the stylet and tissue in a non-contact relationship.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a sharp distal tip is used for puncturing the septum, then puncturing capability is improved, but the risk of inadvertent tissue damage increases
Solution Approach 1:
A curved section is introduced as an intermediary element between the sharp distal tip and the tissue. This curved section acts as a mediator that allows the sharp tip to perform its puncturing function while simultaneously preventing direct contact between the tip and adjacent tissue structures, thus resolving the contradiction between puncturing capability and tissue safety
Solution Approach 2:
The guidewire incorporates a curved section with a specific radius of curvature that redirects the orientation of the sharp distal tip. This curvature transforms the linear path into a controlled arc, enabling the tip to penetrate the septum at the intended location while the curved geometry prevents the tip from contacting adjacent tissue during deployment and manipulation
2Ease of operation
If the distal tip is exposed after puncturing, then access to the left atrium is achieved, but unpredictable deployment direction increases procedural complexity
Solution Approach 1:
The curved section is pre-formed into the guidewire structure before deployment. This preliminary configuration ensures that when the guidewire is advanced through the catheter and deployed, the curved section automatically orients the distal tip in a predictable direction toward the left atrium, eliminating the need for complex manual manipulation and reducing procedural complexity
3Object-affected harmful factors
If a curved geometry is used to protect the distal tip, then tissue contact is prevented, but deployment predictability decreases
Solution Approach 1:
The guidewire design applies different geometric properties to different sections: the curved section has a specific radius and orientation optimized for tissue protection, while the distal tip maintains its sharp puncturing capability. This localized differentiation allows the curved section to prevent tissue contact while the overall wire geometry and tip orientation ensure predictable deployment direction
Data Source
AI summary
Medical guidewire assembly is movable through guidewire introducer positionable proximate to a biological wall located within the body of a patient. Medical guidewire assembly has flexible distal shaft section configured to extend along the guidewire introducer. Medical guidewire assembly has a predetermined spatial geometry once the flexible distal shaft section is removed from guidewire introducer. Medical guidewire assembly also has a piercing stylet device configured to puncture the biological wall in response to placement of guidewire introducer (in use) proximate to the biological wall, and movement of the flexible distal shaft section through the guidewire introducer. The predetermined spatial geometry is configured to prevent physical contact between the piercing stylet device and adjacently positioned tissue of the patient in response to formation of the predetermined spatial geometry.