Why is it done this way? Who started it and why?
An extremely new product making its impact on the health and wellness marketplace is the Airing. It is a small, hoseless, cordless, CPAP machine, which looks and (purportedly) feels completely different than its predecessors.
CPAP stands for Constant Positive Airway Pressure and is a therapy device used to treat those with sleep apnea. The new device, called Airing, was developed by inventor Steven Marsh, from a project that was focused on very different technology. He refers to its development as an “incredibly happy accident (Medcalf 1).” He was working on a technology focused research assignment on mico-fluid pumps in micro electro mechanical systems when he rated the high-pressure micro blower. It was this technology that naturally translated into the altered CPAP space.
More specifically, after seeing a photograph of his brother using a traditional CPAP machine her realized not only the nightly discomfort of wearing such a bulky piece of equipment, but also the inherent risk in sleeping with cords and hoses, demanded that something better be created. He said: “As someone with a family member who suffers from sleep apneaI understand the potential serious health impacts of this condition. As a result of recent research, I realized that current pumps possess several deficiencies which severely limit their effectiveness and saw an opportunity to apply a new design to these pumps that could be used in a variety of ways ( Sleep Review 1).”
He noted that while the treatment for apnea, the use of air forced continuously in through the nasal passages during sleep, is extremely successful when used consistently, the reality is that few who need the treatment can tolerate its use long term (Timpano 1).
As a result, Marsh developed what is being called the “micro-CPAP,” and shared his concept with medical professionals and experts in the fields of both medicine and technology, all of whom endorsed his concept and the significant solution it proposed for the issue of CPAP compliance. They then assisted him in improving and finalizing his design, in order to prepare it for both patenting and FDA approval (Sleep Review 1).
The small device that uses micro-blowers, or small internal pumps to provide the same amount of air pressure as a traditional CPAP, in a wireless, hoseless device that weights no more than an ounce, and which causes less disruption to both the wearer and their bedmates than traditional devices. The device is designed with limited us batteries, and is to be disposed after a series of uses, and replaced. The cost per device is an estimated $3.
Marsh said of the inspiration for his device “The picture of my brother scared me, but I didn’t actually realize how bad [the condition] is and what the health effects are. I think that if we can get something out there that could treat this in a way that people would use, it would change so many lives for the better ().”More specifically the patent for the device states that it is designed to “address pervasive concerns about obstructive sleep apnea patients’ CPAP non-compliance ().”
What alternatives did they consider, and what idea did their new idea replace?
CPAP machines are the most common method for treating obstructive sleep apnea, however despite their effectiveness overall they may not be the best option for most patience. The CPAP machine works by forcing a continuous pressurized flow of air in through the nose while a person is sleeping. This prevents the tissue based obstruction of the breathing passages that typically causes those suffering from obstructive sleep apnea to stop breathing during the night, it also significantly lower the overnight blood pressure, and is often better in terms of outcomes and other non-surgical methods for treating the same conditions.
Unfortunately, use of a CPAP machine, ongoingly, also result in some serious health risks. These risks include disrupted sleeping and dreaming patterns, dry nose and throat, increased nasal congestion, runny nose, and excessive sneezing, irritation of the eye scan in space or chasing, abdominal bloat, and general discomfort as a result of poor fit, leaks around the mask, irritation around the harness (MayoClinic 1).
The side effects and discomforts, have a significant effect on the continued use of CPAP machine among those who have been diagnosed with Obstructive sleep apnea and who have been prescribed a CPAP machine with a specific set of airflow settings as treatment for their condition. In fact, medical studies show that up to 83% of patients with obstructive sleep apnea self-reported they are not here until their treatment program (Weaver & Grunstien 173). Evidence suggests that says who use a CPAP consistently for more than 6 hours a night have decreased sleepiness, improves functioning during the day, and greater memory function, however, in spite of these benefits most patients cease use of the CPAP machine within the first year (McArdle et al. 1108). This indicates strongly that alternatives are needed to increase compliance, rather than efficiency.
There are other treatments available, however, like the Airing, many of them are still in the experimental stages, and many doctors are still hesitant to shy away from CPAP treatment model, which has proven, thus far, the most effective of the available treatment
One alternative, is oral devices. There are more than 100 oral devices which have been FDA approved from the treatment of snoring and Obstructive Sleep Apnea. These appliances are worn like a mouth guard, and are designed to hold the lower jaw forward to prevent obstruction or collapse of the upper airway(AOSAA 1). These devices are highly recommended by the American Academy of Sleep Medicine, and can be used alone or in combination with other treatments (Phillips, 1). Similarly, devices can be worn that adjust the position of the mandible, in order to prevent obstruction.
Less traditional, or newer therapies approved by the FDA include a small internal device, called the inspire, which monitors breathing patterns, and delivers mild electronic stimulation to the airway muscles in order to keep them open during sleep. The only device of this kind, currently, is called the Inspire, and is actually surgically implanted inside your body and controlled by remote control, so that it is only active during your sleeping hours (O’Connor 1).
Finally, there are several surgical options, which involve invasive procedures to remove tissue in order to prevent obstruction. The most common of these, the uvlopalatropharyngoplasty, removes tissue from the soft palate and paharnyx, and is significantly less successful in providing a cure, or effective ongoing treatment of obstructive sleep apnea than the less invasive devise, such as oral devices and CPAP machines (Gharibeh & Mehra 233).
How is this done in other towns, countries, cultures, or eras of time?
Sleep apnea has been a recognized and readily treated issue for between three and four decades, however this is not always been the case. The medical community first started trying to describe and diagnose obstructive sleep apnea in the late half of the 19th century. At the time a linkage had been made specifically between obesity and noisy snoring, nighttime insomnia, and excessive daytime sleepiness, but a true understanding of the disease was yet to be captured.
The earliest doctors to diagnose the disease, in 1889 in 1990, referred to it as "pickwickian" or respiratory failure during sleep because of a failure of the chest and diaphragmatic movements. As such, it was officially defined as a specific sleeping disorder by Silas Mitchell in 1890 (Lavie, 2025).
Perhaps the first to write an accurate clinical picture adult obstructive sleep apnea was Charles Dickens, who wrote about Joe the Fat Boy in The Pickwick Papers, creating the first and most complete clinical description of the condition in his time. This understanding of sleep apnea led to the medical opinion that treatment of obesity was actually the best and only treatment for sleep apnea.
For those with severe sleep apnea in the early 20th century, before the introduction of the CPAP machine in 1980, the only known treatment was the creation of a tracheotomy(Sulivan 1). In less severe cases sleeping on one side and wearing a bite plate to keep the mouth open were recommended. However, none of these treatments were as effective as the devices available today.
Eastern medicine relies much more on what they see as natural treatment of sleep apnea than Western medicine, which relies on surgical techniques, devices, and pharmaceutical prescriptions to treat most conditions.
Eastern medicine and braces the idea the acupuncture can be effective it easy obstructive sleep apnea. From a scientific standpoint, repetitive accupuncture treatments lead to significant strengthening of the tongue muscles, reducing the occurrence of the tongue dropping back and obstructing the airway (Freire et al. 43). Acupuncture sure also reduce inflammation in the tissues of the airway reducing apneic related episodes.
Similarly, a study of traditional Chinese medicine, studied the effectiveness of using single herbs or simple herb combinations to treat sleeping disorders including obstructive sleep apnea in the over a period of 4 weeks. Through the study’s conclusion it was determined that Emily 118 subjects enrolled, through before and after scores, it could be said that excessive snoring, daytime sleepiness, and sleep destruction were all improved through the use of oral herbal compounds. Subjects also self reported significant gains and quality of life, with no significant side effects ( Wu et al. 11). Unfortunately, these types of treatments, in spite of their apparent effectiveness are commonly disregarded in Western civilization in favor of more clinical approaches to the issue.
What different assumptions did they make or constraints did they have?
There are several significant constraints of barriers to consider with regard to Marsh's design for a completely cordless CPAP system. Some of these are related to the device is designed specifically, while others are related to the nature of the medical community, and the government regulation regarding medical treatment.
Perhaps the most easily visible constraint on the project was signs. In creating a device that is inserted into the nasal passages, but which must contain the necessary power to apply constant air pressure at a specific rate, and to contain enough power to run for a minimum of one six- hours sleep cycle in order to be effective, there is clearly a lot of technology which must be packed into a device that is touted to weigh less than one- ounce.
One of the workaround of this system is that most design his micro CPAP to be disposable, this limits the amount of battery capacity which must be contained inside the device, and there was no need to take up space with a charging mechanism. In essence when the button battery contained inside the device dies it is simply replaced by a whole new device, rather than trying to replace the battery power inside the small device.
Another major constraint of the project is related to funding and FDA approval. Because it is a medical device, which will not be intended for over-the-counter availability, it must undergo certain medical testing for safety and efficacy before it can be used by the public. Until the product is approved for human use by the FDA it remains only a concept, or prototype, and not a radially available option for those suffering from obstructive sleep apnea disorders.
Perhaps the greatest assumption made by Marsh in creating the Airing is related to why C PAP users do not use their devices. It's assumes that by making a smaller, cordless version of the CPAP device compliance to CPAP use will increase. However, this is yet to be demonstrated. There is a good chance that this assumption is incorrect, in that the discomfort related to wearing the device will be equal to or supersede the discomfort of wearing a traditional mask, that patients will still object to the sensation of the continuous pressurized air in their nostrils, and then there are other compliance factors like simply forgetting to wear the device, because remembering to do so is inconvenient, which affect the overall use of the C PAP and equally affect the overall use of the Airing.
There is also an assumption the people will be willing to buy the device repeatedly. The traditional CPAP as purchased one time and then used for years to come. While certain elements, like the mask may need replaced overtime, the machine itself is constant. The frequent replacement of the Airing may actually discourage its use.
How can I apply any of the above to what I do?
I think there are two or three major takeaways from Marsh's product design, especially as it relates to the history of the condition he hopes to treat, and the assumptions that he has made about the viability of his product.
First, he has applied a "see a need, fill in need" to his work. He was inspired by something he saw in his immediate world, and was inspired by the flaw he saw in its workings. In a sense he saw a problem, and then looks for a way to solve that problem. This is an effective way for anyone to invent, or launch and entrepreneurial pursuit, because there is a known and ready market waiting for a solution to the problem (Warnock 79).
I also think it is interesting to consider that this product was born out of research intended for another project. Marsh did not allow himself to be pigeonholed by his research, rather he allowed his own sense of innovation to guide the application of the research that he was performing. He took the time to think outside the box, and to apply an unconventional rationale to the problem at hand. This too can be ready at readily applied to my work.
He also refuse to see good as good enough, it is interesting that he tackle the problem with sleep apnea because there's been a standard of treatment related to that condition since the 1980s. The C PAP is extremely effective, I'm trying to move the medical community away from its application and toward alternative treatment plans can be a challenge. He did not allow the tradition of treating the condition to affect the innovation of its potential treatments.
Finally, with regard to assumptions, a warning can be taken away from the assumption that he made. Assuming that your product will be superior and solve the problems related to a certain situation or treatment is, perhaps, arrogant. Trials need to be done in order to determine whether or not compliance to CPAP treatment can be improved through the use of the device, and whether or not the device is actually more comfortable than is larger scale alternative.
Works Cited:
American Obstructive Sleep Apnea Association. “OSA Treatment Options.” Treatment. Web. 23 June 2015.
Freire, AO. Et al. “Treatment of moderate obstructive sleep apnea syndrome with acupuncture: a randomised, placebo-controlled pilot trial.” Sleep Medicine.8.1 (2007): 43-50.
Gharibeh, Tarek & Reena Mehra. “Obstructive sleep apnea syndrome: natural history, diagnosis, and emerging treatment options.” National Science of Sleep. 2 (2010): 233-255.
Lavie, P. “Nothing new under the moon. Historical accounts of sleep apnea syndrome.” Archive of Internal Medicine. 144.10 (1984): 2025-2028.
McArdle, Nigel, et al. “Long-term Use of CPAP Therapy for Sleep Apnea/Hypopnea Syndrome.” American Journal of Respiratory and Critical Care Medicine.159.4 (1999):1108-1114.
Medcalf, Laura. “Introducing Airing” Eastern Seals Tech. Medical Devices. 26 May 2015. Web. 23 June 2015.
O’Connor, Anahad. “Treating Sleep Apnea Without the Mask.” The New York Times.” 12 April 2012. Web. 23 June 2015.
Phillips, Kevin. “9 Alternative Treatments to CPAP Therapy.” Alaska Sleep Clinic. 29 July 2014. Web. 21 June 2015.
Sleep Review. “Disposable Micro-CPAP That Weighs Less Than One Ounce?” The Journal of Sleep Specialists. 19 May 2015. Web. 21 June 2015.
Sullivan, Colin. “Past, Present, and Future of CPAP.” The Sleep Foundation. 2009. Web. 21 June 2015.
Timpano, Andrea. “A Local Inventor is Devleoping A New Device to Treat Sleep Apnea” Boston Magazine. 29 May 2015. Web. 21 June 2015.
Warnock, Brent. Fill a Need: 13 Critical Tips for Success in Business and Life. N.p.: Cedar Fort, 2014. Print.
Weaver, Terri & Ronald Grunstein. “Adherence to Continuous Positive Airway Presure Therapy.” Proceedings of the American Thoracic Society. 5.2 (2008):173-178.
Wu, YH. Et al. “Clinical outcomes of traditional Chinese medicine compound formula in treating sleep-disordered breathing patients.” American Journal of Chinese Medicine. 40.1 (2012): 11-24.
