Expandable Stent Spine Structure for Aortic Perfusion
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Solution Overview
Problem
Existing balloon catheters face challenges in maintaining perfusion in larger vessels like the aorta while inflating the balloon, leading to potential myocardial ischemia and other complications due to the need for high pressure and large perfusion lumens, and existing solutions like the TRUE® Flow Valvuloplasty Perfusion Catheter face issues with bulk and limited pressure application.
Innovation Solution
A stent design with spines and struts that expand by axial compression, allowing for a larger diameter without increasing the deflated size, and includes a mechanism to maintain perfusion through the vessel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a large perfusion lumen is used in larger vessels like the aorta, then adequate distal perfusion is maintained, but the catheter becomes more complex and the balloon cannot be made with a fixed small lumen size
Solution Approach 1:
The patent employs a dynamic balloon structure with axially movable spines that can transition between compressed and expanded states. The spines are configured to move axially relative to one another, enabling the balloon to expand radially while maintaining a compact axial profile during delivery. This dynamic mechanism allows the balloon to adapt its size to match the vessel diameter, providing adequate perfusion in larger vessels like the aorta without requiring a permanently large catheter structure.
2Power
If the balloon is inflated to a large diameter at very high pressure, then the valve is effectively treated, but all flow to systemic circulation is blocked and the left ventricle cannot empty
Solution Approach 1:
The patent segments the balloon structure into multiple independent spines that can be controlled individually or in groups. This segmentation allows for selective inflation zones, enabling the operator to inflate specific portions of the balloon while maintaining perfusion pathways in other segments. The spines can be moved axially to create controlled expansion patterns that treat the valve while preserving critical blood flow paths.
Solution Approach 2:
The patent introduces a fluid distribution system with multiple lumens and outlets that acts as an intermediary between the inflation source and the balloon structure. This intermediary system can direct fluid flow to specific regions of the balloon, enabling controlled expansion that treats the valve while maintaining perfusion. The multiple outlets allow simultaneous inflation of treatment zones and maintenance of perfusion pathways.
3Reliability
If rapid ventricular pacing is used to prevent ventricular expansion, then the heart is paced at very high rate, but this causes myocardial ischemia, malignant arrhythmias, low output, and reduced cerebral oxygen saturation
Solution Approach 1:
The patent enables preliminary positioning and stabilization of the balloon structure before full inflation is required. The axially movable spines can be pre-configured to maintain vessel patency and control ventricular filling during the procedure setup phase. This preliminary control reduces the need for aggressive rapid pacing by establishing stable hemodynamic conditions before the critical inflation step.
4Object-affected harmful factors
If the balloon is inflated for less than a minute, then the risks of rapid pacing are reduced, but the procedure time is increased and the balloon must be held in a dangerous state
Solution Approach 1:
The dynamic spine mechanism enables rapid transition from delivery to expanded state, reducing the time the balloon must be held in an intermediate dangerous state. The axially movable spines can be quickly actuated to achieve full expansion, minimizing the duration of procedural risk while maintaining efficient procedure timing.
5Reliability
If multiple smaller balloons are arranged around a central lumen, then the central lumen is held open, but the effective pressure applied to the circumference is limited and the device bulk increases
Solution Approach 1:
The patent merges the functions of multiple balloons into a single integrated balloon structure with axially movable spines. This unified structure allows for coordinated expansion of all spines, concentrating the applied pressure effectively on the vessel circumference. The merged design eliminates the bulk of multiple separate balloons while maintaining the ability to hold the lumen open through the axial movement mechanism.
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 stent design enables effective perfusion in larger vessels by maintaining blood flow during balloon inflation, reducing the risk of myocardial ischemia and other complications, and facilitating easier delivery through sheaths.
Implementation Method 1
decreasing a longitudinal distance between the first and second end portions of the stent causes a diameter of the stent to increase
Data Source
AI summary
Devices, systems, and methods for treating a blood flow passage are disclosed herein. For example, expandable devices of the present technology may comprise a stent having a collapsed configuration for delivery through a delivery device to a treatment site in a body conduit and an expanded configuration. The stent may comprise a plurality of struts and longitudinally extending first and second spines configured to move in opposing axial directions as the stent expands. Each of the struts may extend between and connect one of the first spines and one of the second spines. Moving the first spines axially relative to the second spines may cause the struts to push circumferentially adjacent spines to move away from one another, thereby increasing a diameter of the stent.