Oh, patents! Helmet respirators

Copyright © Francoise Herrmann

In part due to the shortage of ventilators, both Italy and the United States have resorted to the use of less-invasive helmet respirators to support critically ill COVID19 patients, under specific conditions. Prior to the pandemic, such devices were demonstrated more effective than face masks respirators, relative to their effectiveness in delivering higher PEEP (positive end-expiratory pressure) levels within the lungs, and potentially preventing endo-tracheal ventilation. The results of this research are found in two clinical trials studies, carried out by pneumology researchers at the University of Chicago Medicine (Patel et al, 2016, 2018). Currently, within the COVID 19 pandemic, the helmets are also suspected far safer than mask respirators, since they incidentally appear to effectively prevent viral particles from escaping into the air, thus reducing ambient risks of contamination for healthcare providers.

The story of the American helmet respirators is enchanting as they are manufactured in what has been described as a small “mom and pop” company in Texas, called Sea-Long Medical Systems, LLC  (Cavazuti, McFadden & Schapiro, April 1, 2020). A company that was fulfilling just a few dozen orders per week, prior to the pandemic, which now produces 50,000 helmet respirators per week, thanks to donation of staff, equipment and supplies. In collaboration with the original University of Chicago researchers on helmet respirators, the company’s ramped-up production of helmet respirators has also been tailored to the COVID 19 pandemic conditions. Indeed, the Sea-Long helmet respirators are now equipped with viral filters, and direct oxygen hookups to the hospital supply lines, instead of hookup to ventilators, which are currently in such high demand. Sea-Long Medical Systems also appears as a proud company that has stood fast on their pricing at $166 per helmet, prior to the pandemic, refusing to gouge prices during the pandemic, while reserving quotas for Italy, with a generous sense of purpose.

The story of the Italian helmet respirators is far more dramatic, since it was under the horrendous conditions of peak pandemic, in Bergamo, the epicenter of the outbreak in Northern Italy,  that the use of helmet respirators was reported to the rest of the world (Bostok & Secon, March 22, 2020). Reporting that showed, via live footage, the use of helmet respirators on rows of patients, together with commentary on the daily thousand-fold increases in caseloads, and spiraling hundred-fold death rates. International communication, arising amidst the uncontained spread of the virus in Northern Italy, which included warnings to the rest of the world, to heed the severity of the situation. In fact, the understanding, mid-March 2020, was that Italy was experiencing everyone’s potential future. 

The Italian helmet respirator is a patented invention recited in the US utility patent US7677245B2, titled Helmet for artificial respiration, awarded on March 16 2010. For the purposes of resolving the risks of infection related to invasive artificial ventilation via tracheal tubes or tracheotomy cannulas, this invention offers means of non-invasive ventilation (NIV). The inventive NIV means comprise a transparent helmet with comfortable means of securing airtightness, via a flexible membrane. Compared to existing respirator helmets, this invention also offers means of interfacing with other diagnostic and therapeutic machines of the ICU.  The NIV helmet invention is also designed as a cost-effective device that is easy to use.

 The patent Figure 1 included here shows an embodiment of the artificial ventilation helmet 10 worn by a patient. The helmet 10 comprises a flexible plastic container 12 with a transparent front portion 14, allowing the patient to see through. The lower part of the container 12 is connected to a collar with a rigid ring 15. 

A large horizontal opening 31, secured with coupling elements 32  such as a zipper, welded to the container 12, enables quick access to the patient from the lower front part of the container 12. An internal membrane (unrepresented in Fig 1) presses against the zipper from the inside, to maintain an airtight cavity inside the helmet 10, when the opening is closed. When the opening 31 is unzipped, the helmet 10 can also be pulled back like a hood. 

The rigid ring 15, on the front of the collar, is equipped with a number of ISO-Standardized accessory fittings 17, and airtight cavity inlets 18. The rigid ring 15 thus provides an interface with a number of outside machines for ventilation, therapy and/or diagnostics, under operating conditions. The airtight inlets 18, equipped with caps 19 and internal airtight membranes, are used for access to the patient inside the helmet 10, for example for insertion of feeding tubes. When not in use the fittings 17 are equipped with a cap 21.  Specifically, one of the fittings 17 might be equipped with an extension element 23 for a central venous catheter (CVC) already in place for a patient. Figure 1 depicts the extension element 23 as a number of tubes 24, branching out from a CVC inserted in the patient, each tube 24, in turn, equipped with male and female connection tips 25 of the “Luer-lock” type, so that the same number of tubes branching from the CVC can be extended externally. Finally braces 28, attached to the collar ring 15 with a hook 27,  are used to secure the helmet 10 in place on the patient head, preventing pressure inside the container cavity 12, to lift the helmet 10.

The abstract of the respirator helmet invention is included below, together with a picture of a marketed helmet, in a demonstration.

A helmet for artificial respiration without the aid of tracheal tubes comprises a container body (12), having at least a transparent portion (14) and in which a patient’s head can be housed, and a collar for air-tight application to the patient’s neck, which consists of at least a rigid ring (15, 15"), equipped with a series of gas administration connection and accessory holder fittings (17), said rigid ring (15,15') being the only part of the helmet (10) connected to the outside when operating, wherein an opening (31) is present on the container body (12) for rapid access to the patient, which is substantially hermetically closed by rapid coupling elements (32). [Abstract US7677245B2]

References

Bostok, B and H. Secon (March 22, 2020) - Critical coronavirus patients in Italy are being treated with bubble-shaped containers over their heads. Here's what they do. Business Insider

https://www.businessinsider.com/coronavirus-italy-bergamo-icu-patients-bubble-helmets-explainer-2020-3

Easton, J. and M. Wood (March 25, 2020) Helmet-based ventilation is superior to face mask for patients with respiratory distress. University of Chicago Medicine.

https://www.uchicagomedicine.org/forefront/patient-care-articles/helmet-based-ventilation-is-superior-to-face-mask-for-patients-with-respiratory-distress

 Cavazuti, L., McFadden, C. and R. Schapiro (April 1, 2020) Texas 'mom and pop' business flooded with orders for helmet-style ventilation device. CNBC News
https://www.nbcnews.com/news/us-news/texas-mom-pop-business-flooded-orders-helmet-ventilators-amid-coronavirus-n1173466

Patel MD, B.K., Wolfe MD, K.S., Pohlman MSN, A.S., J.B. Hall MD and J.P. Kress MD (2016)
Effect of noninvasive ventilation delivered by helmet vs. face mask on the rate of endotracheal intubation in patients with acute respiratory distress syndrome: A randomized clinical trial.
JAMA. 2016; 315(22):2435-2441. doi:10.1001/jama.2016.6338
https://jamanetwork.com/journals/jama/fullarticle/2522693
Patel MD, K.D., Wolfe MD, K. S., Pohlman MSN, A.S., Hall MD, J. B., and J. P. Kress, MD (2018)
Effect of noninvasive ventilation delivered by helmet vs. face mask on the rate of endotracheal intubation in patients with acute respiratory distress syndrome: A randomized clinical trial.
Crit Care Med. 2018 Jul; 46(7): 1078–1084. doi: 10.1097/CCM.0000000000003124
Sea-Long Medical Systems, LLC
https://www.sea-long.com/