Partial Occlusion Catheter for Tumor Embolization
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Solution Overview
Problem
Current embolization therapies for tumors, such as transarterial chemoembolization and radioembolization, face challenges with inconsistent efficacy and non-target embolization due to retrograde reflux and anterograde bypass of embolic agents, leading to variable dosages and poor distribution within the tumor vasculature.
Innovation Solution
A catheter system with a partial occlusion structure that allows unidirectional bypass flow, featuring one or more channels with one-way valves to regulate flow and pressure, reducing retrograde reflux and enhancing embolic agent distribution within the tumor by controlling arterial flow and pressure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If embolic agents are injected directly into the tumor vasculature using standard microcatheters, then the tumor receives therapeutic agents, but retrograde reflux and anterograde bypass occur causing non-target embolization and inconsistent dosage delivery
Solution Approach 1:
The catheter is divided into multiple functional segments: a proximal balloon for occluding the parent artery, distal balloons for occluding tumor-feeding branches, and injection lumens positioned at specific locations. This segmentation allows selective control of embolic agent flow to specific tumor regions while preventing retrograde reflux and anterograde bypass to non-target areas.
Solution Approach 2:
Balloons are introduced as intermediary structures between the catheter and the vascular system. These balloons mediate the flow control by creating controlled occlusions that direct embolic agents through predetermined pathways, ensuring agents reach the tumor vasculature without causing non-target embolization through retrograde reflux or bypass.
2Quantity of substance
If injection pressure is increased to improve embolic agent delivery, then more agents reach the tumor, but retrograde reflux increases causing delivery of toxic agents to organs that can be damaged
Solution Approach 1:
The proximal balloon is inflated beforehand to create a controlled occlusion at the parent artery level. This preliminary action establishes a pressure barrier that prevents retrograde reflux even when injection pressure increases, thereby protecting non-target organs from toxic embolic agents while still allowing sufficient delivery to the tumor.
Solution Approach 2:
The system changes the pressure parameters dynamically through selective balloon inflation and deflation. By controlling the occlusion level and timing of balloon deployment, the system maintains injection pressures high enough for effective tumor delivery while preventing pressure reversals that would cause retrograde reflux and non-target organ damage.
3Device complexity
If standard microcatheters are used relying on normal blood flow, then the device is simple, but embolic agent distribution is poor and dosage is unknown
Solution Approach 1:
The system incorporates pressure monitoring capabilities that provide real-time feedback on embolic agent delivery. This feedback allows the operator to adjust injection parameters and balloon occlusion levels to achieve precise dosage control, ensuring accurate and reproducible delivery of therapeutic agents to the tumor vasculature.
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 system improves the consistency and efficacy of embolization by reducing non-target embolization, ensuring a controlled and quantitative delivery of therapeutic agents directly to the tumor, thereby enhancing treatment outcomes and reducing toxicity.
Implementation Method 1
The channels are configured to permit a controllable arterial or venous flow which is less than the un-occluded flow of the artery or vein, and the channel(s) may have one-way valve(s) that allow flow in only one direction
Implementation Method 2
In some embodiments, the device includes an occlusion structure adapted to the distal section of a two lumen catheter, whereby the occlusion structure has one or more channels disposed from its proximal surface to its distal surface allowing flow therethrough
Implementation Method 3
Trans-Arterial Embolization therapy is the transvascular injection of drug and/or embolic agents directly into the tumor vasculature using a microcatheter
Data Source
AI summary
A method of embolizing a tumor includes advancing a distal end of a device having a catheter body and an occlusion structure to a target tumor site within a blood vessel of a body. The occlusion structure is activated within the blood vessel, and a real time pressure measurement in the vascular space distal to the activated occlusion structure is monitored. The method further includes waiting for a pressure drop in the vascular space distal to the activated occlusion structure and for the pressure drop to cause a blood flow reversal in branch vessels antegrade to the occlusion. An embolic substance is injected from the distal end of the delivery device to permit the reversed blood flow to carry the embolic substance into the vasculature of the target tumor and the device is withdrawn from the body. Other catheter assemblies and methods of use are also disclosed.