Axially Lengthening Thrombus Capture for Limited Vessel Space
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Solution Overview
Problem
Current methods for removing blood clots from blood vessels are inefficient, time-consuming, and pose risks such as hemolysis and distal embolization, particularly in large vessels with limited distal space, and existing devices lack flexibility for varied clinical situations.
Innovation Solution
A capture system with a shape memory body that can expand and lengthen axially to capture blood clots, using a mesh material connected to a capture guide and shafts, allowing for variable configurations to accommodate different vessel sizes and conditions, and includes a suction element for removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If thrombolytic agents are used to dissolve blood clots, then the blood clots can be dissolved, but the procedure takes a long time and patients may experience serious bleeding complications
Solution Approach 1:
The patent replaces chemical thrombolytic agents with a mechanical thrombectomy device that physically removes clots through a catheter-based aspiration system, eliminating the need for prolonged chemical infusion and associated bleeding risks while achieving faster clot removal
Solution Approach 2:
The device extracts and removes blood clots directly from the vascular system using mechanical aspiration forces, separating the clot removal function from the chemical dissolution process and enabling immediate physical elimination of the obstruction
2Productivity
If mechanical debulking and aspiration devices are used to remove blood clots, then the obstruction is removed directly, but there is minimal to no flow during the procedure causing hemodynamic instability
Solution Approach 1:
The device maintains continuous blood flow through the vessel during the thrombectomy procedure by using a balloon that can be inflated to seal around the clot and deflated to allow blood flow, enabling uninterrupted circulation while still removing clots efficiently
Solution Approach 2:
The balloon inflation/deflation creates localized changes in flow dynamics at the treatment site, allowing clot capture in specific segments while maintaining overall vascular flow, thus improving both removal efficiency and hemodynamic stability
3Ease of operation
If small catheters are used to remove large amounts of blood clot, then the procedure can be performed percutaneously, but the process is time-consuming and inefficient with limited suction capability
Solution Approach 1:
The device uses a dynamically adjustable balloon system that can be inflated to various sizes depending on the clot volume and vessel characteristics, allowing the catheter to adapt to different treatment scenarios and maintain optimal suction capability throughout the procedure
Solution Approach 2:
The thrombectomy process is divided into sequential stages using the balloon mechanism: positioning, inflation to seal, aspiration, and deflation, allowing systematic removal of large clots in manageable segments rather than attempting to suction everything at once
4Reliability
If conventional devices are used that require full axial and radial deployment, then they can be functional, but they lack flexibility for use in limited distal space
Solution Approach 1:
The device features a dynamic balloon that can be inflated and deflated, allowing it to adapt its size and shape to match the available distal space in the vessel while maintaining sufficient functionality for clot removal, thus achieving both reliability and adaptability
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 efficient, safe, and immediate removal of large blood clots with reduced risk of complications, maintaining blood flow and minimizing debris migration, suitable for both vascular and non-vascular applications.
Implementation Method 1
a shape memory body (8) that is transformable from a first configuration to a second configuration... the capture assembly can be configured to expand the capture guide (11) and the distal opening end when the shape memory body proximal end is compressed in the delivery system
Data Source
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AI summary
Disclosed herein are systems and methods to remove material of interest, including blood clots, from a body region, including but not limited to the circulatory system for the treatment of pulmonary embolism (PE), deep vein thrombosis (DVT), cerebrovascular embolism, and other vascular occlusions.