PPE for ear, nose and throat
Ear, nose and throat (ENT) surgeons performing nasendoscopies are at risk of contracting the coronavirus because the procedure can make patients cough and sneeze. Until now, patients have had to remove their own face masks for the endoscope to be inserted, leaving surgeons reliant only on their own PPE gear. As a result, many hospitals have had to dramatically scale back the number of nasendoscopies they can perform.
The SNAP device—comprising a two-part valve and speculum—clips onto either side of a standard surgical face mask, creating a hole for an endoscope to be inserted and for patients to keep their nose and mouth completely covered. On withdrawal of the endoscope, a one-way valve closes the hole. Any coughs, splutters or sneezes during the procedure are caught within the mask, which is disposed of at the end.
The device is rolling out free to NHS clinics across the UK. The SNAP device—the brainchild of two Midlands surgeons, Ajith George and Chris Coulson—was developed in a matter of months thanks to a collaboration with engineers at Aston University and specialist UK-based manufacturing firms.
In tests, the SNAP device has been shown to dramatically reduce the spread of particles when a patient coughs, compared to either no mask or a mask with a hole cut in it. This reduction in particulate spread will reduce the likelihood of COVID-19 being transferred to clinicians.
Coulson, who works at the Queen Elizabeth Hospital in Birmingham, said: "As surgeons ourselves, we were concerned about the safety of doctors but also about the risk of missed diagnoses and opportunities for treatment of patients. So our aim has been to produce an easy-to-use, cheap device that would allow clinicians to return to their routine practice, while minimising the risk to themselves and other staff."
Reduce demand for invasive ventilators
Led by Lawson Health Research Institute, London Health Sciences Centre (LHSC), University Health Network (UHN) and General Dynamics Land Systems-Canada (GDLS-Canada), researchers have designed a non-invasive ventilation mask that could significantly reduce aerosolization—the production of airborne respiratory droplets that may contain viruses or bacteria—when treating patients with COVID-19. The device aims to reduce infection risks associated with non-invasive ventilation and lessen the demand for invasive ventilators. It is currently being tested through a clinical trial with patients at LHSC.
Unlike invasive ventilators, which require intubation, non-invasive ventilators help patients breathe through a mask that provides positive pressure to keep the lungs open and functioning. While non-invasive ventilators may be effective for some COVID-19 patients, their use comes with a much higher risk of spreading infection through aerosolization of respiratory droplets. "Non-invasive ventilators like CPAP (continuous positive airway pressure) and BiPAP (bi-level positive airway pressure) machines are associated with an increased risk of COVID-19 transmission and so many hospitals have moved directly to invasive ventilation," said Dr. Tarek Loubani, Lawson Associate Scientist and Emergency Department Physician at LHSC.
The team's non-invasive ventilation mask aims to eliminate this risk. The novel device is customized from a standard firefighter's mask using 3D printing and can be attached to any CPAP or BiPAP machine. Unlike traditional masks, it creates two tight seals—one around the patient's nose and mouth and another around the face. Patients breathe in and out of a filter that captures any viral particles before they are released to the air.
Python, the 3D-printed swab
Nasal swabs used for COVID-19 testing have a carefully designed tip section that serves to collect and retain sufficient nasopharyngeal fluids which are channeled into a holder for further testing. These are critical design factors as they could affect the accuracy of the test result when screening for SARS-CoV-2. Researchers at the National University of Singapore (NUS) have developed a total of three swab designs that are comparable to the current 'gold standard' swabs.
The first swab they developed is called 'Python'. The scientists used a double helix structure was used for the swab tip, as it had excellent fluid adsorption and caused minimal discomfort to the patient. In a case-controlled study of 40 patients diagnosed with COVID-19, and 10 control patients with acute respiratory illness who had tested negative for SARS-CoV-2, ‘Python’ demonstrated comparable accuracy and performance, with no significant difference against the standard swab. As such, it was deemed safe and acceptable for patient use, and could help mitigate strained resources in the escalating COVID-19 pandemic.
The researchers also introduced a new design that could be injection molded, named IM2. It was tested for its mechanical strength after sterilization, and for its efficacy in picking up viral loads. The results showed that its performance was comparable to the current commercially used swabs.
In addition, the team also redesigned the Python swab to enable it to be injection molded by increasing the circumferential strength, and working with the manufacturer to design a mold that enables the molding of the central hollow cavity. This design was coined IM3. Similar tests were performed to show that the design was comparable to the current commercially used swabs.
Physicists at the New Jersey Institute of Technology Additive Manufacturing Lab (AddLab) have developed a test swab that can be 3D printed using inexpensive, widely available materials and speedily assembled in a range of fabrication settings.
The design has novel features that simplify fabrication and storage and reduce contamination risk. The swab consists of two interlocking arms that work together, like forceps, to grip the swabbing material. By sliding the two arms against each other, the device can eject the sample, depositing it into a vial with no need to handle it. "Our swab is designed around geometries that eliminate the need for a support structure. This shaves off time and material. Over a 1000-unit run, a savings of 10 seconds and 0.1 grams per unit translates to over 2.5 hours and $2.00 of filament. On the scale that is needed globally, which is millions, the savings becomes even more significant," noted Nicholas Warholak, a technician and designer for the team.
FDA update on 3D printed swabs
The Food and Drug Administration (FDA) has recently updated its information regarding diagnostic devices for COVID-19, including 3D printed swabs. Within in its Frequently Asked Questions (FAQs), the FDA has listed the specimen types that can be swab tested which include nasopharyngeal, oropharyngeal, mid-turbinate and anterior nares specimens.
The FDA states that sterile swabs that do not require premarket notification will not need an emergency use authorization (EUA) for distribution to occur. However, all facilities that manufacture these sterile swabs must register and list their additively manufactured products. In addition, the swabs must meet any applicable medical device regulatory requirements. “As a general matter, 3D printing can introduce certain challenges not seen with conventional manufacturing. FDA is aware that some users have reported concerns of brittle 3D printed swabs that have broken into multiple sharp pieces, and non-traditional capture geometries that may not capture the sample sufficiently. While FDA and the clinical community have vast experience with traditional swabs, there is limited prior experience with the use of 3D printed swabs for specimen collection for diagnostic testing,” the FDA states.
Accelerating vaccine production
The development of an effective vaccine requires a lot of time, effort and the highest safety standards that also involve high costs. Supported by the EU-funded M-ERA.NET 2 project, a team of researchers is addressing these challenges and contributing to the development of new techniques to speed up the process of vaccine production and reduce the costs involved. They have developed a novel method for purifying viruses to enable fast, safe and cheaper production of vaccines.
The researchers use high-resolution ceramic 3D printing to produce chromatographic columns that purify adenoviruses. "Vaccine candidates are typically produced in multi-component environments consisting of numerous impurities and co-produced contaminants that require purification. This currently requires a multi-step process called chromatography. The procedure involves separating a mixture by passing it through a medium (in this case a column), in which the mixture's components move at different rates, and impurities are removed."
Deployed during the early stages of vaccine creation, the columns “could act to reduce the number of purification steps required, and therefore the associated production costs.”
Many designs are freely shared online through platforms such as the NIH 3D Print Exchange. This US-based 3D printing community recently partnered with the Food and Drug Administration (FDA) and the Department of Veterans Affairs, to assist with validating designs uploaded by the community.