AMS Spring 2023

Spanish Leitat1 Field Respirator Performs Initial Tests in ICU

Inkbit

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Previously mentioned in our coverage of emergency medical supplies was the Leitat1 bag valve mask (BVM). The emergency respirator, which features 3D printed components and was developed by a consortium of Spanish companies, is an auxiliary device for use when long-term respirator systems are unavailable. When we last wrote about the Leitat1, it was still undergoing design validation; however, the device has since been used in the field with patients in intensive care units (ICUs) in Hospital Parc Taulí in Catalonia, Spain.

According to the private technical institute that designed the device, Leitat Technological Center, the Leitat1 field respirator functioned appropriately during preliminary tests with patients in the hospital’s ICU. The device has garnered approval from the Spanish Agency for Medicine and Health Products (Agencia Española de Medicamentos y Productos Sanitarios or AEMPS) and will now be deployed to several other hospitals in Catalonia.

The Leitat1 emergency respirator. Image courtesy of 3D Printing Media Network.

The Leitat1 was developed and medically validated in the course of a week by the Free Zone Consortium (CZFB), HP, Leitat, CatSalut, via the Terrassa Sanitary Consortium (CST) and with the Hospital Parc Taulí in Sabadell. The design itself was developed by Leitat senior engineer Magí Galindo, made using parts 3D printed with HP’s Multi Jet Fusion technology with industrial scalability in mind. The Leitat1 was tested and optimized to guarantee its safety and achieve certifications from the AEMPS, with medical validation performed by mechanical ventilation expert Dr. Lluís Blanch from Parc Taulí de Sabadell. Since its initial prototype, the team has incorporated volumetric sensors, pressure sensors, and oxygen alarms, all necessary for the safety of patients and for longer periods of use.

Doctors with an intubated patient with the new field respirator, Leitat1. Image courtesy of Leitat.

Now that the device has functioned successfully, the clinical trial of the device will be expanded throughout the region, beginning with several hospitals—Parc Taulí de Sabadell, Vall d’Hebrón, Hospital del Mar, Consorci Sanitari de Terrassa and Hospital General de Granollers—and coordinated by the director of the ICU unit at Vall d’Hebrón, Dr. Ricard Ferrer.

Once production officially begins on the device, after clinical testing is achieved, production of the device is estimated to be 50 units daily at a cost of 10 times less than conventional respirator devices. The plan is to have parts printed using CZFB infrastructure and HP production teams, supported by the 3D Factory Incubator and IAM3DHUB, and assembled at the facilities of la Fundación Cares. Other businesses that plan to support the effort are BSH Electrodomésticos España and Airbus, who will help in the development of the Leitat2.0, the next generation of the device.

In the meantime, Leitat and its partners are participating in other projects for the medical resupply effort, including the production of a 3D printable ventilation splitter. This part allows multiple patients to use a single respirator. HP is hosting files for other devices, such as hands-free door openers, face shields, face masks and more on its website, as well. Requests and suggestions can also be made directly to HP.

Please note that field, emergency and AMBAG based respirators have a high incidence of delivering too much air to the patient which could lead to them aspirating vomit into their airways or lungs and dying.

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