Vascular Puncture Locating Sheath Markers Without Blood Flashback
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Solution Overview
Problem
Existing vascular closure systems face challenges in accurately locating puncture sites, particularly with catheters similar in size to vessel internal diameter, as traditional 'blood flashback' methods are not feasible.
Innovation Solution
A method involving a guide wire and dilator system with radiopaque markers or depth markings to locate puncture sites, using blood flow feedback and imaging to position the dilator or sheath, and external markers for visual indication.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional 'blood flashback' method is used to position vascular device, then puncture site location can be determined, but this technique is not feasible with catheters whose size is similar to the vessel internal diameter due to limited flow
Solution Approach 1:
The patent introduces an intermediary indicator system consisting of a proximal marker and distal marker on the catheter, along with reference marks on the skin, to transfer and visualize the position information. This intermediary system allows precise location determination without relying on blood flashback, making it applicable to catheters of various sizes including those with limited flow capability.
2Manufacturing precision
If catheter size is reduced to match vessel internal diameter, then vascular access precision is improved, but blood flow capability is reduced limiting flashback visibility
Solution Approach 1:
The patent replaces the mechanical/biological indicator system (blood flashback) with a visual marker system consisting of proximal and distal markers on the catheter and corresponding reference marks on the skin. This substitution allows precise position indication independent of blood flow volume, enabling accurate puncture site location even with minimal flow through small-diameter catheters.
3Reliability
If vascular sheath is inserted to close puncture site, then vessel sealing is achieved, but precise positioning of sheath relative to puncture site becomes critical
Solution Approach 1:
The patent implements a feedback system where the operator observes the relative positions of the proximal marker, distal marker, and skin reference marks to determine when the catheter and sheath are correctly positioned. This visual feedback loop allows precise positioning and verification of the sheath relative to the puncture site, ensuring reliable vessel sealing.
Solution Approach 2:
The patent employs preliminary positioning actions where reference marks are placed on the skin before catheter insertion, and the catheter markers are positioned during insertion to align with these references. This preliminary setup establishes a reference framework that guides subsequent sheath positioning, ensuring accurate placement relative to the puncture site before the sealing action occurs.
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
Accurately locates puncture sites for precise vascular access and closure, enabling controlled dilation and sealing procedures.
Implementation Method 1
a radiopaque marker proximate to the inlet hole... determining a position of the radiopaque marker of the dilator on an imaging device
Data Source
AI summary
Disclosed are puncture sealing systems and methods of locating a puncture site within a vessel. The systems can include puncture locating dilators and access sheaths that are configured to locate the puncture site within a vessel so that the position of the puncture site relative to a distal end of the access sheath is known during a puncture sealing procedure.