Infusion Flow Guidewire for Thrombectomy in Tortuous Vessels

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Solution Overview

Problem

Existing neurological thrombectomy catheters face challenges in delivering effective thrombectomy due to their large size and interaction with guidewires, which complicates access to small, tortuous vessels and is underpowered for tough thrombi, posing risks to fragile vessel walls.

Innovation Solution

A 0.356 mm infusion flow guidewire system with a flexible nitinol hypotube, a reinforcement collar, and rearwardly directed jet orifices, designed for use with an external pressurized fluid supply, allowing for increased flexibility and high-pressure fluid jet streams to effectively navigate and treat thrombi without the need for a guidewire, thus minimizing vessel damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Power

If a two-part catheter system with jet body is used, then thrombectomy power is improved, but device complexity and difficulty of delivery are worsened

Engineering Contradiction:
Improvethrombectomy powerVSAvoiddevice complexity
Core Design Contradiction:
PowerVSDevice complexity

Solution Approach 1:

The patent combines the guidewire and catheter functions into a single integrated device. The jet body is permanently attached to the catheter tip, eliminating the need for separate jet body delivery and guidewire exchange. This integration maintains thrombectomy power while significantly reducing device complexity and procedural steps.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The single catheter device performs multiple functions: it serves as both the delivery vehicle and the thrombectomy tool. The catheter maintains guidewire-like deliverability while incorporating jet body functionality for thrombus disruption, achieving multi-functionality without requiring multiple separate devices.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Ease of operation

If catheter size is reduced for better deliverability, then ease of delivery is improved, but thrombectomy power is worsened

Engineering Contradiction:
Improveease of deliveryVSAvoidthrombectomy power
Core Design Contradiction:
Ease of operationVSPower

Solution Approach 1:

The catheter features a tapered design with a smaller distal tip for navigate tortuous vessels and a larger proximal section that houses the jet body. This local variation in dimensions allows the device to achieve both good deliverability through small vessels and sufficient thrombectomy power at the treatment site.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The jet body is nested within or integrated with the catheter structure, allowing the powerful thrombectomy mechanism to be contained within a compact delivery profile. This nesting enables high power output without requiring a large external catheter diameter.

Inventive Principle:
Principle #7Nested doll (Nesting)

3Volume of moving object

If guidewire is removed for jet body delivery, then catheter size is reduced, but reliability of vessel access is worsened

Engineering Contradiction:
Improvecatheter sizeVSAvoidreliability of vessel access
Core Design Contradiction:
Volume of moving objectVSReliability

Solution Approach 1:

The catheter is pre-formed with a shapeable tip that can be configured to follow the guidewire path through tortuous vessels before deployment. This preliminary shaping ensures reliable vessel access is achieved during the delivery phase, eliminating the need for a separate guidewire while maintaining access reliability.

Inventive Principle:
Principle #10Preliminary action

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 enhances deliverability and thrombectomy/fibrinolytic infusion effectiveness, allowing for safer and more efficient removal of thrombi in small, tortuous vessels by maintaining a smaller profile and reducing drag, while providing sufficient power to handle organized thrombi without prolonged fibrinolytic drips.

Implementation Method 1

The drawn-down distal end of the flexible hypotube, herein referred to as the drawn hypotube section, extends through a reinforcement collar and is secured therein by laser welds, soldering, welding or other suitable method

Methodology Applied
Scientific EffectHigh-pressure fluid jet: Jet

Implementation Method 2

A major portion of the infusion flow guidewire is a hypotube of flexible nitinol material which is drawn down to a reduced diameter section near the distal end thereof providing one portion thereof with increased flexibility

Methodology Applied
Scientific EffectFlexibility gradient:

Data Source

PatentEP2155301B1Infusion flow guidewire system
Publication Date: 2021.04.14 BOSTON SCI LTD
  • EP2155301B1 patent drawingFigure 1
  • EP2155301B1 patent drawingFigure 2
  • EP2155301B1 patent drawingFigure 3

AI summary

An infusion flow guidewire system including a delivery sheath and an infusion flow guidewire. The minimal cross section flexible infusion flow guidewire includes a nitinol hypotube, a flexible tip and distally located rearwardly directed orifices for infusion of fibrinolytics and for introduction of high pressure fluids for maceration and rearwardly directed flow of thrombus debris located in tortuous small sized vessels. Apparatus, some of which is removably attachable, is provided for grasping members of the invention for rotational torqueing and for longitudinal actuation along and within the vasculature.