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  3. a steerable guidewire of 0.33mm diameter.
Structural mechanics, product development

a steerable guidewire of 0.33mm diameter.

Memory Metal Holland BV (MMH) introduced a technological solution for creating medical steerable guidewires. The distal end of a guidewire can be shaped mechanically with an actuation mechanism at the other end of the guidewire. Such steerable guidewires will have a major benet for navigating guidewires through the human body during operation. By shaping the distal end inside the body, it can easier take turns when reaching complex junctions. This behavior has multiple advantages such as better steerability, reduction of the amount of used wires, decrease of operation time and thus saving lives.

The guidewire of, initially, several centimeters long and a diameter of 0.33 mm had limited shaping capabilities while the tip rotates and bends simultaneously. Moreover, there was insuffcient insight on specific behavior of the concept. Demcon multiphysics successfully supported with simulations and analyses to explain the unknown features of the design. This was the start of a fruitful collaboration between Demcon and MMH. We set our common goal to develop a steerable guidewire of more than 1.5 m length and capable of shaping its distal end by bending and rotating seperately with a suitable controller.

Figure 1 Physician looking at a real-time X-ray image to navigate a guidewire through a body.
Figure 1 Physician looking at a real-time X-ray image to navigate a guidewire through a body.

medical product development.

Different concepts were developed to realize a tip that only bends in-plane or purely revolves around its own axis. Other requirements like safety, costs, ergonomics and biocompatibility were also included in these designs.

The most promising concepts were virtually tested with the use of FEM simulations. Evaluation criteria were: bending shape, rotation behavior, tip load, support stiness, force actuation and maximum stresses. Production followed and the designs were experimentally validated. The validation showed promising results, validating our virtual prototyping approach, even for delicate and high accuracy structures such as guidewires.

A similar approach was used for developing the controller, increasing guidewire length and combining the bending and rotation tip in a fully integrated design.

Figure 2 The steerable guidewire with controller. The tip is able to bend and rotate, independently from each other.
Figure 2 The steerable guidewire with controller. The tip is able to bend and rotate, independently from each other.

result.

A 1.5 m long variant of the steerable guidewire including a controller was realized and patented. It is platform ready to engineer it further towards a specific medical application, like neurovascular surgery, cardiology, gastroenterology or radiology.

Curious about the patent? Have a look under: EP3344323B1, EP3578221A2, US 10,441,746, US 11,241,557, US 2022/0143362, Pending N2032588

“we have created a major medical innovation.”

It has been very special to develop a major innovation like the Redwire for a medical instrument that is of great use in potentially life-saving procedures. We talked to physicians about their needs and the new applications and added value they expected from a guidewire. Our new design, which was developed in a collaboration with Peter Besselink from Memory Metal Holland B.V., extends their range in operation. They can, for example, take an extra corner to reach the intended target in the circulatory system exactly or to guide the catheter of choice that cannot be handled by a conventional wire.

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Arnoud van der Stelt

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Demcon multiphysics.

Demcon multiphysics is an engineering agency with high-end expertise in the area of heat transfer, fluid dynamics, structural mechanics, acoustics, electromagnetism and nuclear physics. We support clients from a wide variety of market sectors and help them achieve their goals in research and development with deep physical insights.

We combine fundamental physical knowledge from an analytical approach with Computer Aided Engineering (CAE) simulations tools from ANSYS, MATHWORKS, COMSOL, STAR-CCM+ and FLUKA to setup, execute, analyze and evaluate numerical simulations. The use of Computational Fluid Dynamics (CFD), Finite Element Analysis (FEM / FEA), Lumped Element Modelling (LEM), Computational Electromagnetics (CEM) and Monte Carlo simulations enables us to make a virtual prototype of your design. With these techniques we can simulate the fluid and gas flows, energy exchange, heat and mass transfer, stresses, strains and vibrations in structures and the interaction of electromagnetic fields with other physical aspects like heat generation. Simulation-driven product development increases the development efficiency and reduces the product development time. Our services can therefore fully support you in the designing phase, from idea up to prototype, from prototype to final design.

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