3D-Printed CPAP Mask Designs – An Emerging Technology
Imagine a CPAP mask that is custom-fit and made-to-order. Among the many current innovations in PAP technology is the use of 3D scanning to do just that: create customized, perfect-fit CPAP masks. While these products are not yet commercially available, there are several prototypes undergoing clinical trials for FDA approval. Once this is achieved, the technology can move ahead with the proper infrastructure needed to serve the public. For those with persistent mask fitting issues and leakage problems, this technology may provide a solution. And these issues, as some studies have shown, are a leading cause of non-adherence among new patients as well as those with long-term difficulties. Other mask innovations, such as the development of nasal pillows, have helped to provide better comfort and effectiveness for a large number of patients, and it is the hope of those invested in 3D-printed mask designs that these products will provide a customizable alternative that further improves the PAP therapy experience.
How it Would Work
With 3D scanning and printing technologies becoming more advanced and affordable, it is now possible to develop tablet apps that capture accurate scans of facial profiles and features. With the help of computer aided design (CAD) algorithms, this information is used to generate a three-dimensional model of the patient’s face. Mobile device applications make the process very convenient and quick, taking just under two minutes to complete a scan.
Metamason, Inc, a leading innovator of CPAP automation and customization, has developed a complete mask fitting system using its own proprietary application to scan the patient’s face and send the data to a cloud-based platform for final printing and mold design. Data from any previous sleep studies is included as well, so that all related information is applied to the final configuration. This could include sleep habits, positions, or any other factor that may contribute to mask design preferences. The workflow arrangement, referred to as Scan, Fit, Print, includes an intuitive API that doctors or patients can access for process details.
At Metamason, the system of creating the design mold is automated, and once the mold is cast, the final product is sent to the patient within a week. Metamason uses a streamlined manufacturing process called investment molding, which combines the processes of molding and investment casting to create a casting mold that shapes the final product. Medical-grade soft silicone is poured into the mold and heated. During the heating process the silicone sets but the mold melts away, leaving only the mask in its final shape. This process can create detailed models that are not possible with standard production methods, making 3D-printed designs an effective option for those patients in need of a more customized therapy.
Metamason, consisting of several team members from ECR Labs in Los Angeles, is also planning to provide telemedicine support services to monitor for product effectiveness. The Metamason brand name, Respere (also called Miia), specializes in nasal mask designs, but also includes a full headgear for support and stability. Under the Respere brand name, they currently have two prototypes: the Respere Secure™ CPAP Mask, and the Respere Freedom™ CPAP Adapter, which directs airflow along the sides of the face to the crown of the head. As part of the FDA approval process, these prototypes will continue to be involved in hospital trials and studies before their final commercial release, likely to occur by the end of next year.
Another company, Inspirate Medical, is much smaller than Metamason, but is also gaining ground in the development of 3D-printed full-face and nasal-mask options. Like the Metamason product line, Inspirate masks are made of medical-grade soft silicone, and are attached to a polycarbonate frame and full-support headgear. The silicone is fully biocompatible, and designed to exceed FDA-compliance requirements. Also like Metamason, Inspirate uses a proprietary fitting algorithm to allow for on-demand services through mobile device applications. While Metamason, which was founded in the Los Angeles area, has focused mainly on the U.S. healthcare system to develop applicable services for American patients, Inspirate Medical was founded in Singapore and has focused on Asian countries such as Thailand, Malaysia, and the Philippines. Inspirate Medical is gaining ground quickly, and their models are extremely versatile, allowing for real-time feedback during scanning and processing.
Both of these companies are likely to make an impact on the CPAP market as the healthcare industry moves further into personalized medicine and point-of-care services. And these are just two examples of companies currently developing innovative new technologies to improve PAP therapy and healthcare in general. CPAP therapy, as a gold-standard treatment, will continue to benefit from these advancements in technology that are changing the relationship between patients, devices, and healthcare providers.
More Effective Masks for Children
One of the major benefits of customizable CPAP masks is improved fitting for children and especially neonate patients. Obstructive sleep apnea (OSA) is a common condition in the general pediatric population, cited by some studies as between 1 and 5 percent in total, and is dramatically more prevalent among children with craniofacial anomalies such as small or short jaws, facial hypoplasia, or large tongues. While tonsillectomy and adenoidectomy are used in some cases, further treatment is often needed for children with craniofacial anomalies, often including PAP therapy among other treatments in a long-term plan to alleviate the blockage. In this population, difficulty finding a functional and tolerable CPAP mask is common, and can be a barrier to proper treatment and recovery.
In some infants of low birth weight, CPAP therapy is delivered using soft, neonatal-sized nasal masks suitable for direct-skin and facial contact with newborns. These masks include prongs that are inserted into the nares to hold them in place. Available in four sizes, these small prongs are meant to fit children ranging from less than 400 grams in weight to those over 4 kilograms. In this population, poorly fitted nasal masks can cause difficulties and irritation over prolonged periods of time. It is the hope of some doctors and researchers that 3D scanning and printing technologies will help to improve the options for children, and especially for young infants. For companies like Metamason and Inspirate Medical, this poses an additional challenge, as the neonate prongs are not included in their current designs, but the potential for this development is high, as the scanning and printing processes would remain the same. This is yet another example of how the versatility of 3D printing technologies allows for a diversity of forms to suit the needs of a growing population of patients.
Comfort and Efficiency
While many patients using CPAP are comfortable with their mask choice, there are many who have difficulties finding a good fit. Using tailored-made mask designs may cost more than standard mask products on the market, but the comfort and convenience of simply scanning your features for a precise fit will be an attractive option for many. In fact, since these masks are 3D-modeled, they are likely to be much less expensive than an order for a customized mask today, using traditional means of production. By using emerging technologies such as 3D printed designs, these companies are hoping to provide an incentive for higher rates of compliance.
Canadian Respiratory Journal – https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2679572/
Clinicaltrials.gov – https://clinicaltrials.gov/ct2/show/NCT02896751
ECR Labs – https://www.ecrlabs.com/metamason-2/
Eossleep.com – https://www.eossleep.com/2014/08/15/cpap-goes-couture/
Journal of Otolaryngology – https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4992257/
HIT Consultancy – https://hitconsultant.net/2016/06/03/34257/#.Xbh9luhKjIU
Inspirate Medical – http://inspiratemedical.com/
Pneumologia – https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4301251/
Smartpatients.com – https://www.smartpatients.com/trials/NCT02261857