Temporary Nitinol Stent for Vasospasm Treatment

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Solution Overview

Problem

Current treatments for vasospasm, such as medication with calcium channel blockers, are costly, time-consuming, and have significant side effects, necessitating an alternative approach for effectively managing this condition.

Innovation Solution

A stent structure with a self-expanding design, composed of interconnected struts or wires, is introduced into blood vessels to exert a constant radial force, temporarily treating vasospasm by expanding against the vessel wall and then being retracted, utilizing materials like Nitinol alloys and an insertion aid to minimize blood flow obstruction and facilitate easy removal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a stent structure is permanently implanted to treat vasospasm, then the treatment effectiveness is improved, but the complexity of the device and potential long-term complications increase

Engineering Contradiction:
Improvetreatment effectivenessVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The stent structure is designed to be temporarily implantable rather than permanent, allowing it to be inserted, expanded to treat vasospasm, and then removed after serving its purpose. This dynamic approach eliminates the need for permanent fixation mechanisms and reduces long-term complications while maintaining treatment effectiveness during the critical period.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The stent structure can be extracted from the blood vessel after treatment, unlike permanent implants. This extraction capability simplifies the device design by eliminating the need for permanent anchoring features and reduces potential long-term complications associated with foreign body presence.

Inventive Principle:
Principle #2Taking out (Extraction)

2Reliability

If the stent structure is expanded to exert radial force on the vessel wall, then the treatment of vasospasm is improved, but the obstruction of blood flow during insertion and removal increases

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidblood flow obstruction
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The stent structure is nested within a delivery catheter in a compressed state during insertion, minimizing blood flow obstruction. Once positioned at the target site, the stent is expanded to exert radial force for treatment. After treatment, the stent is compressed back into the catheter for removal, thus limiting the time of blood flow obstruction to only during insertion and removal procedures.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The stent dynamically transitions between compressed and expanded states. During insertion and removal, it remains compressed to minimize obstruction. During treatment, it expands to provide therapeutic radial force. This dynamic state change optimizes both treatment effectiveness and minimizes harmful blood flow obstruction periods.

Inventive Principle:
Principle #15Dynamics

3Object-affected harmful factors

If the stent structure is designed for temporary insertion and removal, then the side effects are minimized, but the ease of operation becomes more difficult due to the need for precise positioning and retrieval

Engineering Contradiction:
Improveside effectsVSAvoidease of operation
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The stent structure is designed with self-expanding properties using shape memory materials that automatically expand to the correct configuration upon deployment, eliminating the need for complex expansion mechanisms. This self-service capability simplifies the operator's task while maintaining precise positioning and enables easy retrieval by simply compressing the structure back into the delivery catheter.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The stent utilizes shape memory materials that change their physical parameters (shape, size) in response to temperature or other environmental conditions. This parameter change enables automatic expansion to the correct therapeutic configuration without complex mechanical systems, simplifying operation while ensuring precise positioning and facilitating easy retrieval.

Inventive Principle:
Principle #35Parameter changes

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 stent structure effectively treats vasospasm by exerting a consistent radial force, reducing the need for permanent implantation and minimizing side effects, allowing for repeated treatments with minimal disruption to blood flow and tissue supply.

Implementation Method 1

the expanded stent structure exerts a substantially constant radial force outside the proximal end over the effective length

Methodology Applied
Scientific EffectRadial force: Mechanical Force

Implementation Method 2

A stent structure made of a material with shape memory properties is advantageous for this purpose; in particular, the use of nickel-titanium alloys known as Nitinol has proven to be effective

Methodology Applied
Scientific EffectShape memory: Shape Memory Alloy

Data Source

PatentEP3463206B1Vasospasm treatment
Publication Date: 2024.10.09 FEMTOS GMBH
  • EP3463206B1 patent drawingFigure 1a~1b
  • EP3463206B1 patent drawingFigure 2
  • EP3463206B1 patent drawingFigure 3~4

AI summary

The invention relates to a device (1) with a stent structure (2), which is provided for introduction into the blood vessels of the human or animal body, wherein the stent structure (2) has an expanded state, in which it bears against the interior wall of the blood vessel, and a contracted state in which it is movable within a micro-catheter through the blood vessel, wherein the stent structure (2) is connected, preferably at its proximal end, to an insertion aid (3) and wherein the device (1) can be used for the treatment of a vasospasm. The invention also relates to a corresponding method for vasospasm treatment.