Expandable Flow Restoration Member for Clot Extraction
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Solution Overview
Problem
Current treatments for thromboembolism, particularly pulmonary embolism, are inadequate as they take too long to be effective, can cause hemorrhage, and involve complex mechanical devices that are costly and prone to trauma, with a focus on overall clot reduction rather than urgent restoration of blood flow.
Innovation Solution
An occlusion management system comprising a catheter, a pusher, and a radially expandable flow restoration member that engages and removes occlusive materials, along with an extraction member to rapidly restore blood flow and remove clots from blood vessels.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If anticoagulants and thrombolytics are used to reduce or remove pulmonary embolism, then clot reduction is achieved, but treatment takes a prolonged period of time (hours to days) and can cause hemorrhage
Solution Approach 1:
The patent replaces chemical mechanisms (anticoagulants and thrombolytics) with a mechanical extraction system. The device uses a catheter with a retrieval member that mechanically grasps and extracts clots from the pulmonary artery, eliminating the need for prolonged chemical treatment and associated hemorrhage risks.
Solution Approach 2:
The invention directly extracts clots from the pulmonary circulation using a retrieval member that can be advanced through the pulmonary artery and positioned within clots. This extraction approach immediately removes the obstruction rather than relying on chemical processes to gradually dissolve or prevent clot formation.
2Productivity
If known mechanical devices are used to remove embolism, then clot removal is achieved, but the devices are highly complex, prone to cause undue trauma to the vessel, and difficult and expensive to manufacture
Solution Approach 1:
The device is divided into distinct functional segments: a catheter for delivery, a retrieval member for clot engagement, and a pusher for positioning. This segmentation allows each component to be optimized independently and simplifies manufacturing compared to monolithic complex devices.
Solution Approach 2:
The invention employs a disposable catheter-assembled-with-retrieval-member configuration that can be manufactured cost-effectively and discarded after single use. This eliminates the need for complex, expensive, and difficult-to-manufacture reusable mechanical devices.
3Productivity
If known treatment methods focus on overall clot reduction and removal, then clot management is achieved, but urgent restoration of blood flow is not prioritized
Solution Approach 1:
The device performs preliminary action by first engaging and extracting the bulk of the clot material to restore blood flow, then addressing remaining clot fragments. This reverses the conventional approach of treating overall clot reduction first and blood flow restoration second.
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 enables rapid restoration of blood flow and effective removal of occlusive materials, addressing the limitations of existing treatments by providing a more efficient and less invasive method for managing thromboembolism.
Implementation Method 1
a radially expandable flow restoration member that engages and removes occlusive materials
Data Source
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AI summary
A system and method for managing an occlusion, such as a blood clot, within a lumen or passageway of a patient. More particularly, a system and method for rapidly restoring blood flow through an occlusion including a self-expanding, tubular member through which blood may flow when in an expanded state. The tubular member has a structure configured to engage the occlusive material, thereby allowing for extraction of at least a portion of the occlusive material. The system may further employ a material extraction member that is deployed distally of the tubular member.