本文摘譯自MASSDEVICE 2020年7月8日

以下為詳文

Brigham婦女醫院近日表示，醫院正在研發一種新型的可替代在COVID-19大流行期間的N95口罩。

meiyujiankang.com網站截圖

據新聞發布，由波士頓醫院和麻省理工學院（MIT）的生物工程師和臨床專家組成的團隊正在研究在冠狀病毒大流行期間能提供保護的“注射成型高壓滅菌、可伸縮、舒適型”iMASC系統。

新聞表示，iMASC系統由可消毒的材料制作而成，尚處于原型階段，但是，發表在英國醫學雜志《Open》上的早期研究結果表明，該系統能適合不同大小的臉形，而且，它是可以消毒再利用的。

研究人員選擇道康寧QP1-250液態硅橡膠（LSR）作為口罩材料，因為這種材料能承受熱度上升到572℉的高溫，然后使用注射成型方法制成面具，再加上彈性帶和兩個阻擋固體顆粒的可替換的過濾器。

pubmed.ncbi.nlm.nih.gov網站截圖

Traverso和研究團隊對口罩采取多種滅菌方法進行檢測，包括高壓滅菌、浸泡漂白溶液和浸泡異丙醇。他們觀察到，與滅菌前產品相比，滅菌后的口罩無明顯差異，10次高壓滅菌循環會使口罩稍硬一點。

團隊還利用3D建模來觀察面具如何才能貼合在各式不同大小的臉形上，接著招募Brigham醫護人員進行一項小型的擬合測試研究。所有20名參與者完成了這項測試過程，有60%的人說他們更愿意佩戴iMASC系統而不是外科口罩，20%的人說他們沒有偏好；此外，25%的人表示，他們喜歡iMac系統要超過N95，而60%的人則沒有偏好。

研究者們也承認這項研究具有局限性，即擬合測試的小樣本量，而規模化生產將需要對過濾器組件進行更嚴格的質量控制。

原文：

Boston researchers have created a potential N95 mask alternative

JULY 8, 2020 BY SEAN WHOOLEY LEAVE A COMMENT

Brigham & Women’s Hospital says it is developing a new, sustainable alternative to N95 respirator masks that are in demand during the COVID-19 pandemic.

A team of bioengineers and clinical experts at the Boston-based hospital and the Massachusetts Institute of Technology (MIT) are working on the “injection molded autoclavable, scalable, conformable” iMASC system for providing protection during the pandemic, according to a news release out today.

The iMASC, made from sterilizable materials, is still in its prototyping stage, but early results from studies published in the British Medical Journal Open suggest that it could fit faces of different sizes and shapes, plus it could be sterilized for reuse, according to a news release.

Researchers selected Dow Corning QP1-250 liquid silicone rubber (LSR) for the mask material, as it can withstand heat rising up to 572 degrees Fahrenheit, then created masks using injection molding, plus elastic straps and two replaceable filters to keep out solid particles.

“Like many of our colleagues, when we heard about shortages in personal protective equipment, we wanted to help,” Brigham gastroenterologist, MIT biomedical engineer & corresponding author Giovanni Traverso said in the news release. “We thought that an approach that could be helpful would be to develop a mask system that could be readily sterilized in many different ways and reused.”

Traverso and the research team tested a number of sterilization methods on the masks, including autoclaving, soaking in a bleach solution and soaking in isopropanol. They observed that 10 autoclave cycles made the masks slightly stiffer, there were no large differences in the sterilized masks compared to the products before sterilization.

They also used 3D modeling to see how the mask might fit on faces of all shapes and sizes, recruiting healthcare workers from Brigham for a small fit testing study. All 20 participants completed the process, with 60% saying they were willing to wear the iMASC system instead of a surgical mask and 20% saying they had no preference. Additionally, 25% said they preferred the iMASC system over an N95, while 60% had no preference.

Authors involved in the research acknowledged the limitations of the study, namely the small sample size of the fit testing, while large-scale production would require greater quality control of filter components.

“From the beginning, we were thinking about scalability,” Brigham department of radiation oncology resident & postdoctoral fellow in the Traverso lab Dr. James Byrne said. “We selected materials recognized to be sterilizable and comfortable and a manufacturing process designed to be scaled.”