Intraluminal Device Stiffness Modulator for Tortuous Vasculature

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Solution Overview

Problem

Conventional intravascular devices have fixed flexibility/stiffness characteristics, making it challenging to traverse diverse anatomical features within the human body during medical procedures, particularly in navigating occlusions and tortuous vasculature, which limits the accuracy of diagnostic and therapeutic interventions for heart disease.

Innovation Solution

An intraluminal device with an adjustable stiffness modulator, allowing physicians to change the flexibility/stiffness of the catheter during procedures, equipped with a sensing element for data acquisition such as IVUS images, pressure measurements, and flow measurements, using a tensioning mechanism and resilient components to adapt to different anatomical features.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the intraluminal device uses fixed stiffness characteristics, then the device structure is simple and easy to manufacture, but the device cannot adapt to different anatomical features requiring different flexibility levels

Engineering Contradiction:

Improveadaptability to different anatomical featuresVSAvoiddevice structure complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The catheter incorporates a stiffness modulator that allows dynamic adjustment of the catheter body's flexibility during the medical procedure. The modulator includes a resilient mechanism with a biasing member that can be actuated to change the catheter from a flexible state to a rigid state, enabling adaptation to different anatomical features such as tortuous vasculature or occlusions.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The device changes its mechanical parameter (stiffness/flexibility) on demand through the stiffness modulator. By adjusting the stiffness parameter of the catheter body, the device can traverse tight turns requiring flexibility while also crossing occlusions requiring stiffness, using the same device throughout the procedure.

Inventive Principle:

Principle #35Parameter changes

2Adaptability or versatility

If the catheter is made stiff to cross occlusions, then the device can traverse occlusions effectively, but the device cannot navigate tight turns and tortuous vasculature

Engineering Contradiction:

Improveability to traverse occlusionsVSAvoidability to navigate tortuous vasculature

Core Design Contradiction:

Adaptability or versatilityVSEase of operation

Solution Approach 1:

The stiffness modulator enables the catheter to dynamically switch between rigid and flexible states. When navigating tortuous vasculature, the modulator is set to allow flexibility for easy navigation. When encountering an occlusion, the modulator is actuated to provide rigidity for effective crossing, thus resolving the contradiction between navigating turns and crossing occlusions.

Inventive Principle:

Principle #15Dynamics

3Ease of operation

If the catheter is made flexible to navigate tight turns, then the device can traverse tortuous vasculature easily, but the device cannot cross occlusions effectively

Engineering Contradiction:

Improveability to navigate tortuous vasculatureVSAvoidability to cross occlusions

Core Design Contradiction:

Ease of operationVSAdaptability or versatility

Solution Approach 1:

The dynamic stiffness adjustment capability allows the catheter to be flexible during navigation of tortuous vasculature for ease of operation. Upon encountering an occlusion, the operator activates the stiffness modulator to increase rigidity, enabling the catheter to cross the occlusion effectively. This dynamic adaptation resolves the contradiction between ease of navigation and occlusion crossing capability.

Inventive Principle:

Principle #15Dynamics

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

Enables the intraluminal device to effectively traverse various anatomical features by adjusting stiffness, improving the accuracy and effectiveness of data acquisition and therapeutic interventions, particularly in navigating occlusions and tortuous vasculature.

Implementation Method 1

the biasing member is operable to translate axially and rotate within the stiffness modulator

Methodology Applied

Scientific EffectElasticity: Elasticity

Data Source

PatentUS11786214B2Adjustable flexibility stiffness intraluminal device and associated devices systems and methods

Publication Date: 2023.10.17 PHILIPS IMAGE GUIDED THERAPY CORP

AI summary

An interventional device includes an elongate member configured to be inserted into a body of a patient, the elongate member comprising a proximal portion and a distal portion, a sensing element disposed at the distal portion of the elongate member and configured to obtain measurement data associated with a body lumen; a stiffening mechanism coupled to the elongate member and configured to change the stiffness of the elongate member during a medical procedure. Associated devices, systems and methods are also provided.