Inverted Sleeve Clot Retrieval System

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Solution Overview

Problem

Current clot removal systems in the vascular system often face challenges in effectively capturing and removing clots with reduced risk, as they may result in incomplete retrieval or fragmentation, leading to potential serious damage or life-threatening conditions.

Innovation Solution

A clot retrieval system featuring an elongate shaft with an inverted sleeve having a closed end and an open end that is radially expanded distal to a clot and then proximally retracted using an expansion device, such as a balloon and expandable stent, to capture the clot, with a tether mechanism for secure retraction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional clot removal systems are used, then clot removal capability is provided, but complete capture and reduced fragmentation risk are not achieved

Engineering Contradiction:

Improveclot capture completenessVSAvoidsystem structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The device segments the clot capture function into distinct components: the inverted sleeve for engagement, the expansion device for securing, and the tether for retrieval. This segmentation allows each component to perform its specific function effectively, ensuring complete capture while managing complexity through modular design.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The inverted sleeve is nested within the delivery catheter in a collapsed configuration during insertion, and the expansion device is positioned within the sleeve. This nesting allows the complex multi-component system to be delivered through a relatively small access point while maintaining all necessary functional elements for reliable clot capture.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Reliability

If the open end of the inverted sleeve is radially expanded distal to the clot, then clot capture effectiveness is improved, but device profile and ease of delivery are worsened

Engineering Contradiction:

Improveclot capture effectivenessVSAvoiddevice profile

Core Design Contradiction:

ReliabilityVSLength of moving object

Solution Approach 1:

The inverted sleeve transitions from a collapsed low-profile state during delivery to an expanded high-capture-effectiveness state at the target site. This dynamic transformation allows the device to optimize its profile for delivery and then optimize its capture geometry when needed, resolving the contradiction between delivery ease and capture effectiveness.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The radial expansion of the inverted sleeve changes its geometric parameters from a compressed configuration to an expanded configuration. This parameter change enables the sleeve to engage the clot effectively while the system maintains a low profile during delivery through the collapsed state.

Inventive Principle:

Principle #35Parameter changes

3Reliability

If the open end is proximally retracted to capture the clot, then complete clot retrieval is achieved, but risk of fragmentation increases

Engineering Contradiction:

Improveclot retrieval completenessVSAvoidclot fragmentation risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The expansion device is positioned and expanded before the proximal retraction of the inverted sleeve begins. This preliminary expansion secures the clot within the sleeve, creating a containment environment that prevents fragmentation during the subsequent retraction and retrieval process.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The inverted sleeve provides a protective containment environment for the clot during retraction. By having the sleeve already in place and expanded before retraction begins, the system cushions and protects the clot from forces that would cause fragmentation, ensuring complete retrieval without harm.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

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 effective and complete capture of clots, reducing the risk of fragmentation and ensuring safe removal, providing a low-profile solution for percutaneous vascular procedures.

Implementation Method 1

an expansion device supported on the elongate shaft at an axial location proximally spaced from the closed end and aligned with or distally spaced from the open end, where the expansion device is configured for radially expanding the open end of the inverted sleeve

Methodology Applied

Scientific EffectRadial expansion:

Data Source

PatentEP2851016B1Clot retrieval system with inverted sleeve

Publication Date: 2020.01.01 COOK MEDICAL TECHNOLOGIES LLC

Figure 1~2
Figure 3~4

AI summary

A clot retrieval system includes a delivery catheter defining a lumen and having proximal and distal ends. An elongate shaft has proximal and distal ends and is configured for receipt within the delivery catheter. An inverted sleeve has a closed end attached to a distal segment of the elongate shaft and an open end. An outer section of the inverted sleeve that includes the open end is folded over onto an inner section of the inverted sleeve that includes the closed end at a rolling fold. An expansion device is supported on the elongate shaft at an axial location proximally spaced from the closed end and aligned with or distally spaced from the open end. The expansion device is configured for radially expanding the open end of the inverted sleeve.