This application claims the benefit of U.S. Provisional Application No.

62/437,834, entitled "System and Method for Alerting a Sleeping User of a Medical Device Problem" and filed on December 22, 2016. The complete disclosure of said provisional application is hereby incorporated by reference. BACKGROUND ART

In the medical field, a wide variety of life-saving medical devices are used by patients and their caregivers. Many of these medical devices are equipped with visual, audial, or a combination of visual and audial alarms to indicate when the patient's health might be compromised. The devices may also be equipped with output ports, sometimes referred to as "nurse-call ports," which allow the device to be connected to a centralized monitoring station found in many hospitals and other clinical settings. These ports connect the device to a monitoring station such that when an alarm on the device sounds an alarm is also triggered at the monitoring station. In clinical settings, nurses or caregivers can respond to these monitoring station alarms to care for their patients.

Similar devices may also be used for in-home patient care, with an at-home health care professional ideally monitoring the device alarms. However, with health insurance limitations, the responsibility of at-home care often falls on parents or guardians of the patients (particularly when the patient is young) or on the patients themselves. While in hospital settings a healthcare professional is typically available 24 hours a day to monitor for device alarms, the parents or guardians of at-home patients and the patients themselves require sleep and cannot be expected to monitor the alarms throughout the night. The inventors recognize that failure to adequately alert a sleeping care provider or patient may lead to severe, and even fatal, health consequences. Examples of medical conditions in which an alarming device is vital include a rare autonomic condition called Congenital Central Hypoventilation Syndrome (CCHS) and diabetes. Although CCHS causes a variety of symptoms, one particular symptom of CCHS is that it causes the patient to cease breathing when sleeping. During sleep, a mechanical ventilator is used to keep the patient alive and monitors are used to track blood saturation and exhaled CO2 levels to maintain proper respiratory rates and pressures. Alerts on the ventilator and monitors are designed to alert the caregiver when attention is required. For example, an alert may notify the caregiver that the ventilator tube has disconnected from the patient or the blood saturation level has dropped below a safe level. A failure to be alerted by these alarms could cause the caregiver to miss a life critical event. In other situations, typically when the patient becomes older, the patient may be responsible for her own at-home care. In order to respond to life threatening events, the CCHS patient must be sufficiently alerted by the alarm to cause the patient to wake up and respond to the event. A failure to waken could cause the patient to miss a life critical event.

Diabetes, like CCHS, may have a severe impact on the lives of sleeping patients. It is estimated that up to 5% of deaths in Type 1 Diabetes cases are caused by "dead in bed" syndrome, where the patient dies from complications from their diabetes while sleeping. Monitors exist to alert the caregiver or patient when glucose levels fall below a critical level, but the monitors only work if the caregiver or patient is waken by the audio alarm. A common symptom of hypoglycemia in diabetes patients is sleepiness which could exacerbate the difficulty in responding to the audio alarm. CCHS and diabetes are only two examples of situations in which the failure to wake up could result in dire consequences, and these examples illustrate the need for an approach to patient health that generates a variety of output alarms and alerts to wake the caregiver or patient when a critical event exists.

Although several inventions exist that alert caregivers and patients when a critical event needs to be managed, the shortcomings of these inventions could result in fatal consequences, particularly for at-home patients who are responsible for their own care. For example, many medical devices have built in audio alarms and lights, some even designed to monitor nearby implantable medical devices, but these alarms and devices are not designed to wake individuals, particularly those desensitized to audio and visual alerts. Several remote monitoring systems have been developed for patient management; however, none of these inventions are designed for safe patient independence from caregivers for patients who rely on life saving medical devices and can manage care without the help from others. In addition, although many at-home patients currently rely on service animals to wake the patient when a critical event needs to be managed, these service animals are difficult to train, can ignore alarms, are expensive, and have a limited service life.

Furthermore, although some existing inventions are capable of connecting to a plurality of input sources (e.g. medical devices), several shortcomings exist for the current devices. These devices typically connect to the data output port of the medical devices, allowing them to determine not only that an alarm has occurred, but also the type of alarm and other diagnostic data. These existing devices require output connections that are specific to the medical device connected and thus these devices must be uniquely configured to process each of the medical devices connected. Due to the massive number of medical devices available, existing devices are only capable of being configured for a subset of available medical devices. Further, when upgrades or changes to the configuration of the medical devices occur, the monitoring device must be modified or it will fail. It is an aim of the present invention to provide a universal system that can be used with any medical device with a nurse call output port, while still providing the functionality of alerting the patient (even when sleeping) that a life threatening situation has arisen that needs attention. It is believed that the present invention overcomes the

shortcomings of existing technology and has the potential to save a number of lives.

DISCLOSURE OF THE INVENTION

The present invention is directed to a system and method of alerting a patient of a medical device problem. The system includes a medical device having a triggerable alarm, a processing device in communication with the medical device, and an output device in communication with the processing device. The processing device detects when the alarm of the medical device is triggered and then activates the output device. The output device generates a stimulus when activated, and the stimulus is sufficient to wake the patient while sleeping.

These and other features, objects and advantages of the present invention will become better understood from a consideration of the following detailed description of the preferred embodiments and appended claims in conjunction with drawings as described following:

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is a schematic of the input devices, processing device, and output devices of the present invention.

Fig. 2 is a schematic of the input devices, processing device, and output devices of the present invention.

Fig. 3 shows a logical flowchart of the present invention. BEST MODE FOR CARRYING OUT THE INVENTION

With reference to Figs. 1 -3, the preferred embodiments of the system and method of the present invention may be described. The present invention is directed toward a system and method that inputs an alert signal from one or more

heterogeneous medical devices and outputs one or more signals that can waken caregivers or patients, particularly in situations when that person is desensitized by audial or visual alerts integrated into medical devices. The present invention allows medical devices with output signals to provide the patient with several combinations of output stimuli adequate to waken caregivers or the patient. Failure to waken caregivers or the patient could be dangerous and even deadly; thus, system failure could be catastrophic. For this reason, the system is designed to provide

redundancy in operation. That is, the system is designed such that if one module fails, the redundant component will still alert the user. Redundancy in the signal processing and power module is high priority. The system may also incorporate other features, including but not limited to, digital or analog control methods, signal components and power system features that establish or improve fail-safe functioning of the system. Turning to Fig. 1 , the components of the present invention may be described. Generally, the invention includes a system 10 that consists of one or more input devices 12, a processing device 14, and one or more output signaling devices 16. In one embodiment, the present invention inputs an alert signal from one or more heterogeneous medical devices 12 and outputs one or more signals that can awake caregivers or the patient. This is particularly important in situations when the person is desensitized by alarms built into the medical devices. Generally speaking, the processing device 14 reads the input device 12 to determine whether the input device 12 is normal or indicating an alarm. If the input signal indicates an alarm, the processing device 14 activates an output device 16 to generate a stimuli on the patient or caregiver.

In one embodiment, the processing device 14 is housed in a container with a variety of external connectors, LED indicator lights, and a power switch. A series of bare wire electrical connectors connects one or more input medical devices. The electrical connectors, in one embodiment, are connected to the output port of the medical devices. For example, the processing device 14 may be attached to the output ports of both a mechanical ventilator and to a combination pulse oximeter and end tidal CO2 monitor. This example will be used throughout this application, but it is understood that the processing device may be used with any number of medical devices. The processing device 14 may be powered by a battery 18 or another secondary power source that would be well-known to those skilled in the art. The battery 18 is charged using a standard 1 10 AC to 15 volt DC plug combined with an internal, uninterrupted power supply (UPS). This connection is a typical DC power connector. During normal operation, the battery is charged and the system is powered by a standard outlet 20. In the event of a power loss, the battery powers the system 10. In the event the battery reaches a low threshold, the patient is signaled with the attached output device(s) and an indication of low power is provided. In one embodiment, the waking or output device(s) 16 (for example, a shaking device) is connected to the processing device container 62 with an additional DC power connector.

As noted above, the processing device 14 is connected to any number of medical devices 12. The processing device 14 is operable to read the input devices 12 to determine whether the input device 12 is reading as "normal" or is indicating an "alarm." In the above example, the processing device 14 may read the input device as signaling an "alarm," for example, when the ventilation tube has become disconnected. The input medical devices 12 may have a normally open circuit, that when closed, indicates an alarm, or the devices may have a normally closed circuit, that when open, indicates an alarm. In one embodiment, two independent relays 22, 24 act as switches to the connected output devices 16 and, when the input device 12 indicates an alarm, the first relay 22 is triggered and the connected output device(s) 16 turn on. The alarm functions the same when the input medical devices 12 have a normally closed circuit. When the circuit opens indicating an alarm, the output device(s) 16 are triggered. Because each relay acts independently to power the output device(s) 16, if either one of the relays 22 or 24 fails, the other relay 22 or 24 will still alert the user of any alarms. In Fig. 1 , the first relay is a hardwired relay and the second relay is a logical relay.

In one embodiment, a microcomputer 26 is connected to both the input device(s) 12 and the second relay 24. In other embodiments, other logic devices that would be well-known to those skilled in the art may be used instead of a

microcomputer 26. The microcomputer 26 is designed to sense a change in the normally open (or normally closed) circuit indicating an alarm. If the alarm of the input device 12 has been triggered, a signal is sent and received by the

microcomputer 26 and the first relay 22. The microcomputer 26 sends a signal to the second relay 24 powering the output device(s) 16. Each relay 22, 24 acts

independently to power the output devices; therefore, if one relay 22 or 24 fails, the patient is still alerted by the other relay 22 or 24. Alternatively, the microcomputer 26 may be connected to both the second relay 24 and the first relay 22. If the first relay 22 fails and does not signal the microcomputer 26, the microcomputer 26 will signal the user through a second relay 24 that will still signal an alert when the medical device 12 alarms. This failure is reported and recorded by the microcomputer 26 and stored on the data storage device 28. If the microcomputer 26 or second relay 24 fails, the first relay 22 will still power the output device 16, however, the system 10 will indicate to the user the problem with the second relay 24 or microcomputer 26. At start up, the microcomputer 26 will run through a diagnostic phase, testing for failure in the first redundancy. In the event the microcomputer 26 receives a low battery signal, the logical relay is preferably signaled to activate the attached output device(s) and an indication of the low power reading is provided to the user. The low battery reading is also preferably recorded and stored on the data storage device 28.

If the processing device 14 reads the input signal from the input medical devices 12 as indicating an "alarm," the processing device 14 activates an output device 16. The output device 16 generates one or more output stimuli adequate to wake the patient or caregiver. The output device 16 may generate any number of output stimuli, including vigorous vibrations, lights, sounds, physical movement, or any other energetic stimuli or combination thereof. The output stimuli is designed to wake the sleeping caregiver or patient when the medical device 12 alarms. Any number of output stimuli may be generated. For example, in one embodiment, an output device 16 that vibrates vigorously may be strapped to the patient's thigh. If the medical device 12 attached to the processing device 14 alerts to a critical event, the vibrating device 16 will be activated such that it shakes the patient awake. For example, if the patient requires a ventilator while sleeping, the device 16 may begin to vigorously vibrate if the ventilator's tubing becomes disconnected. It is understood that any combination of medical devices can be used with any combination of output stimuli devices 16.

While other inventions may create unique connections for various medical devices, the present invention creates a single ground and open/closed line paired connection system that allows the processing device 14 to be used with any medical device 12. Thus, in contrast with these other inventions, the present invention is a universal system. In one embodiment of the present invention, the processing device 14 has a bank of connections for open ended nurse call accessories. The

processing device 14 has two wire connections and a single toggle switch

corresponding to each connected device 12. The toggle switch is preferably a binary switch of the type well-known to those skilled in the art. One wire is attached to the ground connection and the normally open (or normally closed) wire is connected to the other. The toggle switch is set to determine which mode, normally open or normally closed, is used by the medical device and the wiring configuration. This determination is important, as a change from open to close (or vice versa) indicates an alarm triggered by the medical device 12. The processing device 14 will ignore any connections without wires attached, and the bank of connections can easily be modified to change the number of connections.

As noted above, the present invention is capable of implementing a wide variety of output stimuli to wake the caregiver or patient. Preferably, the output stimuli implemented from the system 10 of the present invention is in addition to the alarm of the medical device 12 being operated. The type of output stimuli used is determined by the patient's preference, with the stimuli most likely to wake the patient or caregiver being used. For example, a patient sensitive to light could be awakened by a light activated by the processing device 14. A patient desensitized to specific alarm sounds programmed into the medical device 12 could use a sound device that outputs a stimuli louder than the alarms on the medical device 12, or one that generates a sound different than the sounds to which the patient has been desensitized. An output device 16 with a long cord may be implemented such that the output device 16 can generate stimuli in the guardian or caregiver's separate room. In one embodiment, the bed itself may be the output stimuli, where the bed raises the sleeping patient into a sitting position when the alarms are activated.

Alternatively, the output device 16 could be a cellular or satellite device programmed to connect to a caregiver when an alert is not properly managed. The output device 16 may be a shaking device, light emitting device, sound emitting device, electric stimulation and devices that move the patient. Any output device 16 that is activated with incoming voltage may be used with the processing device 14. It is understood that the present invention may implement any of these devices separately or in combination, and that any other devices generating stimuli may also be used.

As noted above, it is also understood that the present invention may be used with any number of medical devices or input devices 12. Input devices 12 could be, but are not limited to, mechanical ventilators, pulse oximeters, end tidal C0 ₂ monitors, continuous glucose monitors, IV or PICC line pumps, insulin pumps, continuous positive airway pressure machines (CPAP), or oxygen concentrators. It is understood that any devices, including these mentioned, that have an output port may be implemented. Further, it is understood that the present invention could also implement an accessory well known in the art that is capable of connecting medical devices to a nurse call port or output port. These accessories typically end in either two or three open ended wires, one of which is generally a ground and the others are either a normally open connection, normally closed connection, or both. The present invention enables easy connections for these accessory connectors.

In one embodiment, the system utilizes a microprocessor or other data collection and storage device 28 to log or record system function data, including but not limited to, operating conditions, input device signals, and system alarms, including number and duration. The microprocessor or other data collection and storage device 28 is in communication with microcomputer 26. This data collection may be important and valuable to a long term management of certain medical conditions.

The inventors have tested a prototype in a variety of settings and

configurations. The inventors tested a first prototype to evaluate preferable locations to attach a shaker output device 16. When the shaker output device was placed on the test patient's upper thigh, the present system consistently woke the test patient up from sleep when either the test patient's ventilator or combination pulse oximeter and end tidal CO2 monitor alarmed during sleep. A second prototype was

constructed with battery backup and was also tested with redundant monitoring. Again, the test patient awoke immediately when either the ventilator or monitor alarmed. A more complete description of various testing scenarios is provided below.

The first testing scenario was aimed at testing the ability of the present invention to wake the test subject from sleep when activated. During this testing, the alarms were initially manually activated during a variety of sleep times to determine the effectiveness of the present invention in waking a sleeping patient. The alarms were manually activated during both light and heavy sleeps to assist in determining the effectiveness of the waking system 10. Manual activation of the alarms lasted approximately two weeks, and as the testing progressed the manual activation of the alarms was terminated. From this point forward the test subject only responded to actual alarms, typically one or two per night. This testing phase lasted approximately two months. During both testing phases (manual activation of alarms and actual alarm scenarios), there was never an instance that the test subject was not awakened by the present invention. For the first testing scenario, the waking system did not implement battery backup or use multiple input sensing modules. In other words, the redundancy feature was not implemented during this testing phase and, if the module failed, the system would not have had a backup module to activate the output device.

For the second testing scenario, the waking system 10 was constructed with an internal uninterrupted power supply. The redundancy feature was implemented during this testing phase, with the device using redundant sensing and alert modules. This redundancy feature is a fail-safe protection feature that operates to alert the user even in a scenario when one part of the control module fails.

Throughout this second round of testing, which took place over a three month period, the waking system relied only on alarms actually caused by the connected medical devices (no manual activation of alarms occurred). In order to test the device's ability to withstand various problems, however, various "problem situations" were manually created. For example, the waking system was unplugged from its power source in order to test the device's ability to operate on back-up battery power. The system performed properly on battery power for approximately 20 hours before alerting the test subject that a low battery threshold had been reached. The test subject plugged the device back into the power source, upon which the system returned to normal operation and began to recharge the back-up battery. The different sensing modules were tested by disabling each other sensing module. For each of these tests, the non-disabled modules activated the output device upon input alarms. During the entirety of this three month testing scenario, the waking system awoke the test subject within a few seconds of each and every alarm.

The components of the processing device 14 may be described with reference to Fig. 2. First, an input block 30 receives an input signal from one of a number of connected medical devices 12 (also referred to as input devices). The input block 30 sends a signal to a microcomputer device 26 for data storage and to relay block 32. The relay block 32 includes hardwired relay 22 and logical relay 24. Both components of relay block 32 send a signal to an output distribution block 34 such that, if either fails to send a signal, the signal sent by the other will still be received by output distribution block 34. Output distribution block 34 is responsible for the signaling of the waking devices 16 (also referred to as output devices), which may be a sound device 36, vibration device 38, digital based notification system 40, or any other device that wakes the user. The device may be powered by an external power source 20 and may also implement a battery powered power distribution block 42 with uninterrupted power source as a backup power source.

The general operation of the system 10 may be further described with reference to Fig. 3. The processing device 14 generally stays in standby mode until one of a number of connected medical devices 12 signals an alarm at step 44. Once the alarm is signaled by the medical device(s) 12 and received by the processing device 14 at step 46, the processing device 14 simultaneously triggers the attached waking device 16 (also referred to as output device) and any external

communication devices 60 at step 48. Data corresponding to the alarm event is also stored by data storage device 28 at step 50 for future inspection. Once the waking device 16 and communication devices 60 are triggered, the processing device 14 requires manual alarm dismissal at step 52. If no manual alarm dismissal is detected, the alarm 32 remains activated at step 54 and the waking device 16 and external communication devices 60 will again be triggered at step 48. If a manual alarm dismissal is detected at step 56, the alarm is stopped and the processing device 14 is returned to standby mode at step 58 until a new alarm event is detected at step 44.

The present invention has been described with reference to certain preferred and alternative embodiments that are intended to be exemplary only and not limiting to the full scope of the present invention.