Self-Inflating Balloon Thrombectomy Catheter Design
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Solution Overview
Problem
Existing thrombectomy catheters face challenges in effectively stopping blood flow and minimizing vessel damage while removing thrombi, often requiring larger sheaths and increasing procedure costs, and struggle with centering and uniform drug delivery.
Innovation Solution
A rheolytic thrombectomy catheter with a self-inflating distal balloon formed from the catheter tube, inflated by high-velocity fluid jet streams, which centers the device and creates a stagnant region for effective thrombus removal and drug delivery, minimizing hemolysis and vessel damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a balloon on a guide catheter or guidewire is used for occlusion, then flow cessation is achieved, but the occlusive balloon is not directly placed on the catheter requiring upsizing of the interventional sheath or substantial increase in procedure cost
Solution Approach 1:
The patent merges the occlusive balloon function directly into the catheter structure by forming an inflatable balloon from the catheter tube material itself. This integration eliminates the need for separate guide catheters or guidewires with balloons, and allows the same-sized introducer sheath to accommodate the catheter with built-in occlusion capability, thereby reducing device complexity and procedure cost while maintaining flow cessation functionality.
Solution Approach 2:
The catheter performs its own occlusion function through the self-inflating balloon formed from its tube structure. The high-velocity fluid jet streams automatically inflate the balloon to achieve flow cessation, eliminating the need for external occlusion devices or complex sheath configurations. This self-service approach reduces the need for upsizing the sheath and lowers procedure costs.
2Productivity
If inflow orifices are positioned close to the vessel wall for effective thrombus engagement, then thrombus removal efficacy is improved, but vessel damage increases due to negative pressure suction and high velocity jet stream impact
Solution Approach 1:
The self-inflating balloon acts as an intermediary element positioned between the high-velocity fluid jet orifices and the vessel wall. By inflating the balloon, the catheter creates a protective barrier that centers the orifices away from the vessel wall, reducing direct contact between the high-velocity jet streams and the vessel wall while maintaining effective thrombus engagement. This intermediary structure decreases vessel damage from suction and jet impact.
Solution Approach 2:
The invention introduces a radial dimension to the catheter-vessel interaction by inflating the balloon in the radial direction. This creates a three-dimensional configuration where the balloon expands outward from the catheter shaft, pushing the inflow orifices away from the vessel wall in the radial direction. This dimensional change allows the orifices to be positioned optimally for thrombus engagement while maintaining safe distance from the vessel wall to minimize damage.
3Productivity
If the catheter is moved while inflow orifices are sucked onto the vessel wall, then thrombus engagement is enhanced, but vessel damage occurs through the mechanism of moving the catheter with attached orifices
Solution Approach 1:
The self-inflating balloon is inflated before the catheter is moved through the vessel. This preliminary inflation action centers the orifices and creates a protective barrier that prevents the orifices from suctioning onto the vessel wall during subsequent catheter movement. The balloon maintains the orifices in a fixed, centered position, eliminating the harmful effect of movement-induced vessel damage while preserving effective thrombus engagement.
4Manufacturing precision
If a self-inflating balloon is used to center the device and create stagnant region, then uniform drug delivery and thrombus removal is improved, but device complexity increases
Solution Approach 1:
The patent combines the centering function and thrombus engagement function into a single integrated structure. The self-inflating balloon is formed from the same material as the catheter tube, creating a unified structure where the balloon's inflation simultaneously centers the device in the vessel and creates the necessary stagnant region for thrombus removal. This merging of functions achieves precise centering and uniform drug delivery while minimizing the increase in device complexity through a single integrated component.
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 self-inflating balloon allows for efficient thrombus removal, reduced vessel damage, and uniform drug delivery, maintaining the same sheath size with minimal cost increase, enhancing the efficacy of thrombectomies and embolization procedures.
Implementation Method 1
The self-inflating balloon is inflated and expanded by the utilization of internal operating forces consisting of forwardly directed high velocity fluid jet streams
Implementation Method 2
forwardly directed high velocity fluid jet streams and entrained thrombus particulate therein
Implementation Method 3
The self-inflating balloon is aligned within the walls of the blood vessel to isolate sections of the blood vessel distal and proximal to the inflated balloon in order to prevent flow of thrombus particulate, fluids and the like, distal to the self-inflating balloon and to provide a stagnant nonflow region proximal to the self-inflating balloon
Implementation Method 4
rheolytic thrombectomy catheter for purposes of removing or removing attempts to remove thrombus or clots or other obstructive material from a blood vessel or other conduit
Data Source
AI summary
The devices of the present disclosure are rheolytic thrombectomy catheters with a self-inflating distal balloon. A self-inflating balloon is located distal to an inflow gap or orifice and distal to a fluid jet emanator, which self-inflating balloon is inflated and expanded by the utilization of internal operating forces consisting of forwardly directed high velocity fluid jet streams and/or entrained thrombus particulate therein. The self-inflating balloon, when inflated, impinges on the wall of the blood vessel to isolate sections of the blood vessel distal and proximal to the inflated balloon in order to prevent flow of thrombus particulate, fluids and the like distal to the self-inflating balloon and to provide a stagnant nonflow region proximal to the self-inflating balloon. The devices of the present disclosure also provide for a uniform spacing of the catheter tube with respect to the thrombus and/or wall of the blood vessel.