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Australia’s Lab22 3D prints first customizable stent from nitinol

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Lab22, Australia’s center for innovation in metal additive manufacturing, has assisted in the development of the world’s first customized 3D printed self-expanding stent. The medical device was developed in collaboration with the Medical Innovation Hub (MIH) and is made from nitinol, a shape memory alloy that becomes super elastic when under stress.

The 3D printed nitinol stent, which can be customized to the patient, has been clinically certified and could help treat peripheral arterial disease (PAD). PAD is a progressive condition caused by plaque buildup in the arterial system; today, roughly 10% of the world’s population has PAD. One of the most common treatments for the disease is endovascular stenting, which is a minimally invasive procedure with a relatively quick recovery time.

Presently, there are two types of metallic stents used to treat PAD: balloon-expandable stents made from stainless steel or cobalt-chromium alloys, and self-expanding stents made from nitinol, a nickel-titanium alloy. Both of these options come in standard sizes, so there has still been the need for an improved product which could be customized to the patient.

3D printed nitinol stent Lab22

MIH and CSIRO’s Lab22 have therefore been working to develop a self-expanding stent made from nitinol that can be tailored to the patient. The resulting product is a clinically certified, 3D printed nitinol stent that can be customized and manufactured on-site. According to the Lab22 team, the mesh stent can be tailored to fit the diameter of a patient’s proximal and distal vessels.

The partners did face some challenges in the development of the medical stent, particularly related to working with nitinol. Because of the material’s changing crystal structure when stressed or heated, Lab22 had to find the optimal printing parameters. As the team explained: “The alloy’s two distinct phases (martensite and austenite) are determined by temperature, and the phase transformation temperatures are extremely sensitive to the stent manufacturing conditions. For the stent to display self-expansion, the transformation temperature needs to be below the body temperature, 37°C.”

The parameters of the selective laser melting (SLM) technology used had to take these properties into account, so that the desired phase transformation temperature could be achieved. The SLM parameters also had to meet the requirements to fabricate the fine mesh geometry of the stent, which has features as fine as 80-200 µm.

Ultimately, the customizable 3D printed nitinol stents can improve patient care by conforming to the patient’s blood vessels, and enhance resource efficiencies by being produced on-site and on-demand. Lab22 is also behind a number of other groundbreaking medical innovations, including the first 3D printed titanium heel and the first 3D printed titanium sternum and partial ribcage.

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Tess Boissonneault

Tess Boissonneault is a Montreal-based content writer and editor with five years of experience covering the additive manufacturing world. She has a particular interest in amplifying the voices of women working within the industry and is an avid follower of the ever-evolving AM sector. Tess holds a master's degree in Media Studies from the University of Amsterdam.

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