Expandable Catheter for Subclavian Vein Stabilization
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Solution Overview
Problem
Accessing and stabilizing the subclavian vein for the insertion of pacemaker or ICD leads is challenging due to the inability to visualize the target vessel from outside the body and its tendency to collapse, leading to difficulties in delivering leads safely and efficiently.
Innovation Solution
A catheter device with an expandable element, such as inflatable balloons or compressible coils, is used to provide support and visualization of the blood vessel by releasing a contrast medium, allowing for easier navigation and insertion of leads through the subclavian vein.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the subclavian vein is accessed without visualization support, then the procedure is simpler, but the puncture site cannot be properly located and the vessel cannot be stabilized
Solution Approach 1:
The patent introduces a catheter device as an intermediary tool that delivers contrast medium into the subclavian vein, enabling fluoroscopic visualization of the vessel lumen and puncture site. This mediator allows the physician to see the target area without directly visualizing it, thereby improving localization accuracy while maintaining procedural feasibility
Solution Approach 2:
The catheter is advanced into the subclavian vein and contrast medium is injected before needle puncture to pre-visualize the vessel course and puncture site. This preliminary visualization action allows proper site selection and prevents blind puncture, resolving the contradiction between simplicity and accuracy
2Ease of operation
If the subclavian vein is accessed without support, then the device is simpler, but the vessel collapses and lead delivery becomes difficult
Solution Approach 1:
An expandable balloon mounted on the catheter serves as a mechanical intermediary that physically supports the subclavian vein from within. The balloon prevents vessel collapse during lead delivery, making the procedure easier to perform while the catheter-balloon assembly manages the added complexity
Solution Approach 2:
The catheter device with expandable balloon is positioned in the subclavian vein before lead insertion. The balloon can be inflated to stabilize the vessel in advance, creating favorable conditions for subsequent lead delivery and preventing vessel collapse during the critical insertion phase
3Loss of information
If contrast medium is released to visualize the blood vessel, then the vessel can be seen, but the device complexity increases
Solution Approach 1:
The catheter device merges multiple functions into a single integrated system: the catheter body, contrast medium injection capability, and expandable balloon support are combined. This unified device delivers contrast medium for visualization while simultaneously providing mechanical support, managing complexity through functional integration rather than separate components
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 device stabilizes the blood vessel, facilitates visualization, and reduces the complexity of lead insertion, making the procedure safer and more efficient by preventing vessel collapse and ensuring accurate placement of leads.
Implementation Method 1
an expandable element near the distal end of the longitudinal member for providing support to the blood vessel
Implementation Method 2
The expandable element may comprise an inflatable balloon
Implementation Method 3
a contrast release port near the distal end of the longitudinal member for releasing a contrast medium into the blood vessel to visualize the blood vessel
Data Source
AI summary
Medical devices, systems and methods for providing visualization as well as support and/or stability for blood vessels during procedures for inserting electrical leads are disclosed. One aspect of the device may include a longitudinal member having a distal end and a proximal end, an expandable element near the distal end of the longitudinal member for providing support to the blood vessel, and a contrast release port near the distal end of the longitudinal member for releasing a contrast medium into the blood vessel to visualize the blood vessel.