Many people have died in their homes in their sleep while suffering from COVID-19 infection, and some of these people were in the prime of their lives, ranging from ages 30 to 45 years of age. Some of these people had their significant others and other family members sleeping in different rooms of the same house, or sometimes in the same room. These patients' family members had no way of knowing that the patients' breathing status was declining in the middle of the night during sleep, because there was no alert system designed, implemented or activated to notify them or other healthcare system entities that said patient breathing status was declining.
This method and system of alert, as presented in this nonprovisional patent application, may prevent a COVID-19 related death that may have been preventable, if only family members or other system partners had been alerted in a timely fashion as to the breathing status of the patient, in the middle of the night when the patient and family members are all sleeping. The author of this nonprovisional patent application spent many nights in a hospital cardiac unit as a nurse watching over sleeping patients' heart and breathing rates. Also, she spent many nights on a children's hospital unit watching over sleeping babies and children's heart and breathing rates. When the nurse is alerted to the decline in patient breathing status, the nurse role is to inspect such patients and often times wake them up, perform further assessment and call for additional help.
Also, within the hospital environment, these patients were often connected to monitors watched over by external off-nursing floor central watch stations, manned by live human being personnel who would also serve as “back-up watchers” of heart and breathing rates, in the event that none of the nurses or doctors on the floor could attend to the alert event when it suddenly occurred. These off-nursing floor external central watch stations often were composed of groups of people sitting in a room filled with monitors, simply watching for heart and breathing anomalies, all night long. In the event that any of the monitors demonstrated any heart rate or breathing rate anomalies, the central watch station employees would call the relevant nurse's station to understand what was happening with the patient and also to take additional actions as defined by preestablished hospital protocols. These preestablished protocols are often refined and updated based on clinical effectiveness measures, real-world outcome studies and all manner of other kinds of scientific studies.
The author of this patent application also watched over her four children every time they became sick with respiratory disease, all night long without sleeping herself, because of a mother's worry about her children's breathing during sleep when they were ill with respiratory conditions. In the event that such a portable, mobile, fully functional alert system becomes widely available, patients and caregivers may be able to sleep with less anxiety overall during pandemic related respiratory illnesses. Such systems may prevent COVID-19 related or other future pandemic related deaths of patients who died while sleeping in their own homes.
Introduction: This nonprovisional patent application via omnibus specification (since no one compartmentalized specification makes any sense as a “standalone invention”) is being submitted only a few days after the USPTO announced the COVID-19 patent accelerated review process, in the hopes that manufacturers, healthcare systems, computer technology companies, government regulators, health insurance companies and many other stakeholders, can work together to quickly develop such an alert system or a similar alert system to allow family members to be alerted to their loved ones' decline in breathing status during sleep. There are 5 distinct parts of this nonprovisional utility patent application and therefore 5 claims. The following is a brief overview of each of the 5 Parts of this patent application.
Part 1: For the patient, a fingernail-based pulse oximeter is attached to a bracelet that the patient wears. This portable pulse-oximeter bracelet device will contain a digital wireless component to be able to deliver signals to other connected devices such as their personal mobile phone and the caregiver's alert reception bracelets.
Part 2: The caregiver will also wear a bracelet that is connected digitally to the patient's bracelet, and when the patient's heart rate or pulse oximetry oxygen reading dips below the thresholds as established by prescribing physicians when the device is prescribed, the caregiver will receive an alert vibration and noise from their own bracelet to notify them of a potential anomaly in the patient's breathing.
Part 3: In addition to the caregiver alert, the digital alert will also be delivered to the Central Breathing Status Watch Station, which will be a center established with human beings who are on call 24 hours a day, 365 days a week, to watch breathing status measurements and heart rate measurements for each bracelet that is prescribed. In the event that the breathing or heart rate status presents an anomaly, not only will family members be alerted through their bracelet alerts, but this Central Breathing Status Watch Station will also receive an alert to take measures in notifying first responders as appropriate.
Part 4: Due to the imperfections of digital wireless remote access technology, especially for those who live in rural areas or are otherwise lacking the necessary resources for Internet connection, the patient and caregiver alert bracelet system will also contain a robust alert mechanism using two-way radio transmission technology, that can serve as a back-up in the potential failure of the digital wireless system and also can serve as an initial alert system for those who lack connection to high speed Internet.
Part 5: Lastly, a probable reason why such a system has not already been invented and implemented widely for home use for patients, caregivers and central watch stations is perhaps because of the potential patient death liability issue. Even if such a system were designed, launched and implemented in wide home use to mitigate for pandemic COVID-19 related deaths at home during sleep, manufacturers and service providers may be very wary of the liability implications of actually working together to develop solutions. Therefore, there is a very sad possibility that this institutional fear of liability prevents very large well-capitalized companies all across the planet from developing such systems and launching them to market. To properly structure corporate and organizational incentives for the benefit of our nation's public health, the author of this patent also recommends that governmental authorities, including officials from the FDA, who must approve such product and system for use as “Digital Health Software” (“Software as a Medical Device” aka “SaMD”), take additional legislative initiatives regarding managing product and device liability in collaboration with manufacturers, health service providers, information technology product and service providers as well as with health insurance companies. The legislative precedent that could be followed is that of vaccine related product liability, for which the US government assumes a special form of liability funding responsibility through the National Childhood Vaccine Injury Act.
PART 1 DETAILED DESCRIPTION: This patent application involves a method and system by which a fingernail-based pulse oximeter is attached to a bracelet that the patient wears and this portable pulse-oximeter bracelet device will contain a digital wireless component to be able to deliver signals to other connected devices such as their personal mobile phone and the caregiver's alert reception bracelets, based on triggers defined by thresholds of expected normal breathing status parameters and normal heart rate parameters, as defined by the patient's physician (
PART 2 DETAILED DESCRIPTION: The caregiver will also wear a bracelet that is connected digitally or via radio frequency to the patient's pulse oximetry and heart rate bracelet, and when the patient's heart rate or pulse oximetry oxygen reading and breathing rate dips below the thresholds as established by prescribing physicians when the device is prescribed, the caregiver will receive an alert vibration and noise from their own bracelet to notify them of a potential anomaly in the patient's breathing (
PART 3 DETAILED DESCRIPTION: In addition to the caregiver alert, the digital alert will also be delivered to the Central Breathing Status Watch Station, which will be a center established with human beings who are on call 24 hours a day, 365 days a week, to watch breathing status measurements and heart rate measurements for each bracelet that is prescribed. In the event that the breathing or heart rate status presents an anomaly, not only will family members be alerted through their bracelet alerts, but this Central Breathing Status Watch Station will also receive an alert to take measures in notifying first responders as appropriate. This claim involves the actual physical development of a real life “Central Breathing Status Watch Station” that is manned by live, trained human beings at all times over the 24-hours, 365 days, during the entire year. Such “Central Breathing Status Watch Stations” may have to be manned by people who are licensed for various roles, depending on state laws, since some state laws may indicate that those technicians who are responsible for watching telemetry monitoring equipment must be licensed and trained in a particular way. Regardless, these “Central Breathing Status Watch Stations” should be housed in centralized facilities with their human being employees showing up to work at the actual physical facility in question, without the possibility of “remote work-from-home” since the entire point of the “Watch Station” is to make sure there are human beings who are truly awake in the middle of the night to serve as back up watchers for family members of sick patients. For those employees of the “Central Breathing Status Watch” stations, during their “Non-Watch Shift” days, they can be free to “work from home” and perform other work duties, such as training, development, etc. Similar to “911 Operators” these employees must be trained and prepared to handle the life and death implications of how they perform their duties during their active “Watch Shifts.”
PART 4 DETAILED DESCRIPTION: Due to the imperfections of digital wireless remote access technology, especially for those who live in rural areas or are otherwise lacking the necessary resources for Internet connection, the patient and caregiver alert bracelet system will also contain a robust alert mechanism using two-way radio transmission technology, that can serve as a back-up in the potential failure of the digital wireless system and also can serve as an initial alert system for those who lack connection to high speed Internet (
PART 5 DETAILED DESCRIPTION: Lastly, a probable reason why such a home-based caregiver alert system has not already been invented and implemented widely for home use for patients, caregivers and remote backup central watch stations is perhaps because of the potential patient death liability involved. Even if such a system were designed, launched and implemented in wide home use to mitigate for pandemic COVID-19 related deaths at home during sleep, manufacturers and service providers may be wary of the liability implications of actually working together to develop solutions. Even in the case of 1 patient death liability suit, stakeholder entities could quickly become bankrupt and potentially have to forfeit their continuing existence and an ongoing business operation. Therefore, there is a very sad possibility that this institutional and organizational fear of liability prevents very large and very well-capitalized companies all across the planet from developing such home-based alert systems and launching them to market. Therefore, to properly structure corporate incentives to innovate for the benefit of our nation's public health, and to mitigate for the possibility of more loved ones dying of COVID-19 related illness during sleep while caregivers are also sleeping under the same roof, this author of this patent also recommends that governmental authorities, including officials from the FDA, who must approve such product and system for use as “Digital Health Software” (“Software as a Medical Device” aka “SaMD”), take additional legislative initiatives regarding managing product and device liability in collaboration with manufacturers, health service providers, information technology product and service providers as well as with health insurance companies. The legislative precedent that could be followed is that of vaccine related product liability, for which the US government assumes a special form of liability funding responsibility through the National Childhood Vaccine Injury Act. Perhaps the related legislation could be titled the “National Home Breathing Monitoring System Injury Act” or some similar nomenclature. Such an Act would prevent the full liability tort related suits from bankrupting healthcare service companies, health information technology vendors, medical device manufacturers, pulse-oximetry component manufacturers, home health caregiver companies, group home caregiver entities, mobile communications carriers, radio frequency technology service providers, and a long list of other stakeholders involved to make such a caregiver alert system a reality for our country. If any of the key stakeholders are afraid that their respective organizational entities would not financially survive the potential product or service liability tort actions, due to patient deaths (that are occurring now anyway, without any such home caregiver alert systems whatsoever) then those stakeholders, despite being large, powerful and well-capitalized, may actively seek to avoid developing requisite solutions or otherwise come up with politically palatable reasons why developing such solutions is not feasible.