Expandable Vascular Treatment Device With Perfusion Lumen
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Solution Overview
Problem
Existing balloon catheters struggle to maintain adequate perfusion in larger vessels like the aorta during procedures such as balloon valvuloplasty or TAVR, as they either block blood flow entirely or require multiple smaller balloons that increase device bulk and complicate delivery.
Innovation Solution
A device with an expandable element and a reinforcing element, where the expandable element's expansion applies a longitudinally oriented force to the reinforcing element, creating a perfusion lumen, allowing blood flow while maintaining balloon pressure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Area of stationary object
If a conventional balloon catheter is used in larger vessels like the aorta, then the balloon can be inflated to maintain vessel occlusion, but the perfusion lumen becomes insufficient causing high pressure gradients and blocking blood flow
Solution Approach 1:
The device divides the balloon structure into an outer expandable element and an inner reinforcing element with a separate perfusion lumen. This segmentation allows the outer element to provide occlusion while the inner element maintains a dedicated large-diameter perfusion pathway, resolving the contradiction between maintaining occlusion and preserving adequate blood flow.
Solution Approach 2:
The reinforcing element with its perfusion lumen is nested within the expandable element. When the outer expandable element is inflated to occlude the vessel, the inner reinforcing element simultaneously provides a large-diameter perfusion lumen, allowing both occlusion and adequate blood flow to coexist without compromising either function.
2Area of stationary object
If multiple smaller balloons are used to maintain perfusion in larger vessels, then adequate perfusion can be achieved, but device bulk increases and delivery becomes more complex
Solution Approach 1:
The device merges the functions of multiple smaller balloons into a single integrated structure. The outer expandable element provides the occlusion function while the inner reinforcing element provides the perfusion function, consolidating what would otherwise require multiple separate devices into one unified catheter assembly.
Solution Approach 2:
The single device performs multiple functions simultaneously: the outer expandable element provides vessel occlusion while the inner reinforcing element provides blood flow maintenance. This multi-functionality eliminates the need for separate perfusion balloons, reducing device bulk and complexity.
3Stress or pressure
If the balloon is inflated to high pressure to maintain occlusion, then adequate occlusion is achieved, but the ventricle expands acutely and requires rapid pacing which causes ischemia and arrhythmias
Solution Approach 1:
The reinforcing element with its large-diameter perfusion lumen acts as an intermediary blood flow pathway. It allows blood to continue flowing through the catheter during balloon inflation, preventing the acute ventricular expansion and ischemia that would otherwise occur from complete occlusion, while still maintaining the necessary occlusion pressure.
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 provides a large perfusion lumen in larger vessels, minimizing pressure gradients and reducing the risk of myocardial ischemia and arrhythmias, while enhancing delivery and maneuverability through tortuous anatomy.
Implementation Method 1
expansion of the expandable element applies a longitudinally oriented force to the reinforcing element that causes the reinforcing element to radially expand
Data Source
Figure 1
Figure 2A~2C
Figure 2D~2E
AI summary
Devices, systems, and methods for treating a blood flow passage are discloses herein. In one example, a treatment device includes an expandable element configured to be positioned within the passage and a reinforcing element. The expandable element may have an expanded configuration in which the expandable element defines a lumen therethrough. The reinforcing element may be positioned within the lumen of the expandable element. The reinforcing element may be coupled to the expandable element such that expansion of the expandable element causes the reinforcing element to radially expand, thereby creating a perfusion lumen through the device.