The first nose-only oxygen mask made of extremely soft medical TPE material

A small innovative company relies on ultra-soft thermoplastic elastomers (TPE ), creating the first nose-only mask that replaces the standard full-face oxygen and ventilation masks that medical practitioners have used for decades, solving a long-standing problem in medical procedures related to drug sedation.

Unlike full-face masks, the patent-pending SuperNO2VA mask developed by Revolutionary Medical Devices, Inc. (RMD) is very easy to operate on the mouth. In addition, it is designed to deliver greater oxygen flow to the patient's airways under positive pressure. This single-use mask consists of a clear rigid polypropylene (PP) component with multiple access ports for anesthesia tubing or inflation bags. Additionally, a TPE bumper is included, overmolded on the PP structure. From Teknor

Apex's Medalist? MD-10105 medical elastomer molded TPE cushion plays a key role in providing a strong yet comfortable seal on the patient's face.

Medalist TPE is a gel-like compound with a Shore A hardness of 5 that is sufficiently "bondable" to be used to form a tight seal on the patient's face. RMD Chief Operating Officer Tom Reilly said: "In the product prototype stage, we turned to Teknor Apex for TPE because they can provide a medical compound that is very soft and meets all biocompatibility requirements. Although we found both ultra-soft and compatible with PP Compounds that would bond the parts well were a challenge, but Teknor Apex still went out of their way to develop a product that performed very well both in molding and in end use.”

According to Michael Pedro, MD, chief medical officer and co-founder of RMD, the use of medical sedation in medical procedures is increasing due to the increasing sophistication of surgical techniques, aging population, and increasing incidence of obesity. more. "The SuperNO2 VA™ mask is a highly effective, versatile alternative to full-face masks and nasal cannulae, and is particularly convenient for intraoral procedures such as upper gastrointestinal endoscopy and bronchial endoscopy," said Dr. Pedro. To optimize For oral operations, we would like to have a cushion that has a smaller profile than traditional inflatable "balloons" and provides a stronger seal. Teknor Apex's ability to provide very low durometer compounds is one of their major strengths advantage.”

Working together to solve the challenges of overmolding TPEs onto complex parts

RMD produces injection molded components for SuperNO2VA® masks through a US company's contracted injection molding subsidiary in China. Cushion pad parts are produced in blue, green, pink or yellow for color coding purposes. Teknor Apex currently supplies Medalist MD-10105 pre-dyed compound through its US facility, and will supply the same grade of compound through its Singapore facility once it achieves ISO-13485 certification, which is expected to occur in December this year.

Chris Morehouse, Regulatory Products Marketing Manager, Teknor Apex TPE Division, said: "Overmolding Medalist TPEs to PP substrates is a challenge for two reasons. First, the lower the hardness of the TPE, the more difficult it is to mold it. It bonds to PP. Second, TPE parts are complex, with thick and thin walled sections and recessed areas, or release chamfers, that must retain their shape during part ejection from the mold."

Ryan Redford, director of product development at RMD, noted that the large release chamfer located in the nose portion of the TPE cushion required a compound with high strength and high elongation. “Typically, mold release chamfers made with soft materials would tear, but this cushion has absolutely no problem coming out of the mold,” he said. “To this day, our Medalist compounds are well received by contract moldmakers.”