Staged Balloon Delivery Catheter for Small Artery Access
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Solution Overview
Problem
Current percutaneous heart valve systems require large delivery/deployment apparatus, which can be difficult to insert through small femoral arteries, particularly in elderly female patients, leading to invasive surgical procedures and complications.
Innovation Solution
A method and apparatus for endoluminal delivery of intravascular devices using a staged balloon expansion system, where the stent-valve is divided into smaller parts for separate insertion and reassembly in a larger vessel, allowing for full expansion without the need for a large delivery balloon, utilizing a carrier balloon for initial expansion and a larger delivery balloon for final deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a large delivery balloon is used to fully expand the stent-valve, then the stent-valve can be deployed to full size, but the delivery apparatus becomes too large to pass through small femoral arteries
Solution Approach 1:
The delivery system is divided into two separate balloons: a smaller carrier balloon for initial delivery and a larger delivery balloon for final expansion. This segmentation allows the stent-valve to be delivered through a small catheter and then fully expanded using a larger balloon that is introduced separately through the stent-valve structure.
Solution Approach 2:
The smaller carrier balloon is nested within the larger delivery balloon during the delivery process. The carrier balloon is first positioned and inflated to deliver the stent-valve, then the delivery balloon is introduced through the stent-valve and inflated to achieve full expansion. This nested arrangement allows both balloons to coexist in the delivery system.
2Length of moving object
If the stent-valve is compressed to a small diameter for delivery, then it can be inserted through small arteries, but the stent-valve cannot be fully expanded without a large balloon
Solution Approach 1:
The expansion process is segmented into two stages: initial compression delivery using a small carrier balloon, followed by final expansion using a larger delivery balloon. This allows the stent-valve to be delivered in a compressed state and then fully expanded without requiring the entire delivery system to be large throughout the procedure.
Solution Approach 2:
The carrier balloon performs preliminary action by delivering the stent-valve to the target location in a compressed state. This preliminary delivery action prepares the stent-valve for its final expansion by the delivery balloon, separating the delivery function from the expansion function.
3Length of moving object
If surgical incision is performed to access a larger artery, then the stent-valve can be delivered, but the procedure becomes more invasive with increased complications
Solution Approach 1:
The delivery system is segmented into two balloons of different sizes, allowing the smaller carrier balloon to access small femoral arteries percutaneously, avoiding surgical incision. The larger delivery balloon is then introduced through the stent-valve structure itself, eliminating the need for surgical access to larger vessels.
Solution Approach 2:
The stent-valve structure serves as an intermediary pathway, allowing the larger delivery balloon to be introduced through the already-positioned stent-valve rather than requiring direct surgical access to large vessels. This mediator approach enables the use of a larger balloon without requiring larger access vessels.
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
Enables the delivery of stent-valves through smaller arteries, reducing the risk of complications and making percutaneous heart valve therapy more accessible to a wider patient population with a lower risk of access site and blood vessel issues.
Implementation Method 1
the first balloon is inflated so as to expand the stent-valve to an intermediate diameter configuration
Implementation Method 2
the second balloon is then inflated so as to expand the stent-valve to its full operational diameter
Data Source
Figure 1~2
Figure 3
Figure 4A~4C
AI summary
A dual-balloon delivery catheter system includes a carrier segment that is a lead/carrier balloon or mandrel at a distal portion of a catheter. The carrier segment is sequentially arrayed with a more proximally positioned delivery segment, wherein the delivery segment is a delivery balloon or mandrel. The first carrier segment expands the stent-valve a sufficient amount to receive the delivery segment after the carrier segment is moved away from the sent-valve. The delivery segment is then positioned at the target site and the stent-valve is then deployed.