Vascular Containment Element for Thrombus Fragmentation Control

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Solution Overview

Problem

Existing devices for removing occlusive material from a patient's vasculature often result in partial or full exposure of the thrombus, leading to fragmentation and distal embolization risks, and require flow arrest techniques that are difficult to implement due to vessel collaterals and stiffness, limiting efficacy.

Innovation Solution

A device with a containing element that can be constricted and expanded to capture and contain material, featuring a suction source and control bodies to manage tension, allowing for controlled aspiration and containment of the material within a vascular location.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If existing devices extract clot by attaching and pulling through vascular lumen, then clot removal is achieved, but thrombus fragmentation and distal embolization risk increase due to partial or full exposure

Engineering Contradiction:

Improveclot removal efficiencyVSAvoidthrombus fragmentation and distal embolization risk

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The device combines multiple functions into a single integrated system: the containing element provides both flow arrest and clot containment, while the aspiration mechanism removes the clot. This multi-functional design eliminates the need for separate flow arrest devices and suction catheters, reducing the risk of fragmentation while maintaining efficient clot removal.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The containing element is delivered in a compressed state within a delivery catheter, then expanded at the target site to enclose the clot. This nested configuration allows the device to navigate through narrow vasculature while providing a large containment volume when deployed, preventing fragmentation during extraction.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Object-affected harmful factors

If flow arrest techniques such as balloon-assisted proximal vessel occlusion are used, then distal clot fragmentation is minimized, but device stiffness and size make delivery difficult and require large entry wounds

Engineering Contradiction:

Improvedistal clot fragmentationVSAvoiddevice deliverability and entry wound size

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The containing element is constructed from flexible, collapsible materials that allow the device to be compressed into a narrow profile for delivery through small catheters and entry wounds. Once deployed, the flexible material expands to provide effective flow arrest and clot containment without requiring excessive stiffness.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The device transitions from a static, rigid flow arrest balloon to a dynamic, collapsible containing element that can change its configuration between delivery and deployment states. This dynamic transformation enables easy deliverability while maintaining effective flow arrest capability when needed.

Inventive Principle:

Principle #15Dynamics

3Reliability

If complete flow arrest is attempted in neuro thrombectomy, then clot extraction safety improves, but extensive collaterals such as Circle of Willis limit efficacy and utility

Engineering Contradiction:

Improveclot extraction safetyVSAvoidefficacy in presence of collateral vessels

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The containing element provides partial flow arrest by enclosing the clot and restricting flow only at the site of clot location, rather than requiring complete flow arrest of the entire vessel. This partial action is sufficient to prevent fragmentation while allowing collateral circulation to maintain perfusion to dependent territories.

Inventive Principle:

Principle #16Partial or excessive action

Solution Approach 2:

The device extracts the clot from the vascular lumen by enclosing it within the containing element and aspirating it through the catheter. This extraction removes the hazard from the circulation without requiring complete flow arrest, as the clot is contained and removed locally rather than requiring global flow cessation.

Inventive Principle:

Principle #2Taking out (Extraction)

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 device effectively encases the occlusive material, reducing fragmentation risks and enabling complete extraction while providing controlled blood flow arrest, enhancing patient safety and procedural efficacy.

Implementation Method 1

A suction source is in fluid communication with the interior chamber to facilitate removal of the material from the vessel.

Methodology Applied

Scientific EffectSuction: Suction

Implementation Method 2

The containing element may be moved between constricted and expanded configurations by the application and removal of tension to the containing element through the first control body.

Methodology Applied

Scientific EffectElasticity: Elasticity

Data Source

PatentUS12440230B2Devices and methods for removing material from a patient

Publication Date: 2025.10.14 PENUMBRA INC

AI summary

A containing element is used to capture material in a blood vessel for removal. The containing element is advanced through the blood vessel or a catheter in a constricted configuration. A control body is coupled to the containing element which assists moving the containing element. In some embodiments, the containing element is used for restricting blood flow within a vessel.