Distal Rapid Exchange Vascular Closure Device
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Solution Overview
Problem
Current vascular closure devices require a time-consuming sheath exchange and add complexity to the closure procedure, particularly due to the need for a procedural sheath compatible with treatment devices and closure devices.
Innovation Solution
A vascular closure device featuring a catheter with a balloon and guidewire lumen, where the guidewire lumen extends distally from a proximal port to a rapid exchange port positioned distal of the balloon, allowing the device to be advanced through the vessel puncture without a sheath, and the balloon inflates to temporarily seal the puncture internally.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a procedural sheath is used to provide an unobstructed path for treatment devices, then device delivery is facilitated, but the closure procedure becomes more complex and time-consuming due to required sheath exchange
Solution Approach 1:
The patent combines the guidewire delivery function and the closure device function into a single integrated system. The introducer assembly includes both the guidewire lumen for delivering the guidewire and the catheter for delivering the closure device, eliminating the need for separate procedural sheaths and reducing procedural steps.
Solution Approach 2:
The introducer assembly serves multiple functions: it acts as a delivery sheath for the guidewire, provides structural support during catheter advancement, and facilitates the deployment of the closure device. This multi-functional design replaces the need for multiple separate components including the procedural sheath.
2Adaptability or versatility
If a procedural sheath is used for instrument access, then intravascular access is achieved, but additional sheath exchange steps are required which increase procedure time
Solution Approach 1:
The introducer assembly is pre-configured with the guidewire lumen and rapid exchange port before patient insertion. The guidewire can be quickly exchanged through the pre-positioned rapid exchange port without requiring removal and re-insertion of the entire introducer assembly, significantly reducing procedure time.
Solution Approach 2:
The rapid exchange port acts as an intermediary mechanism that allows quick guidewire exchange while the introducer remains in place. This mediator component enables rapid transition between guidewires without disrupting the established intravascular access pathway.
3Ease of manufacture
If the guidewire lumen terminates proximal of the balloon, then guidewire delivery is simplified, but the device profile increases and complicates the closure procedure
Solution Approach 1:
The guidewire lumen is extended into the distal direction, past the balloon, to terminate at the rapid exchange port. This spatial reconfiguration in the distal dimension allows the guidewire to exit beyond the balloon, enabling simpler guidewire delivery while maintaining a compact overall device profile.
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
This solution reduces the need for a sheath exchange, simplifies the closure procedure, and allows for a lower profile device construction, enabling efficient and straightforward sealing of vessel punctures without the need for additional lumens or complex assembly steps.
Implementation Method 1
The balloon, when inflated, may be configured to abut against an internal wall of the vessel to temporarily seal the vessel puncture
Implementation Method 2
The introducer, catheter and a distal waist of the balloon may be heat bonded together
Data Source
AI summary
A vascular closure device includes a catheter, a balloon, an introducer, and a guidewire lumen. The catheter includes an inflation lumen. The balloon is positioned at a distal end portion of the catheter. The introducer is positioned distal of the balloon. The guidewire lumen extends along at least a portion of the introducer and terminates at a rapid exchange port positioned distal of the balloon. The guidewire lumen is receptive of a guidewire to guide the catheter through a vessel puncture in a vessel to position the balloon within the vessel.