“Systems And Methods Of Integrating Ambulatory Medical Devices” in Patent Application Approval Process (USPTO 20200253477)

2020 AUG 31 (NewsRx) -- By a News Reporter-Staff News Editor at Hospital & Nursing Home Daily -- A patent application by the inventors Freeman, Gary A. (Waltham, MA); Crowell, Suzanne (Beverly, MA); Volpe, Shane S. (Saltsburg, PA), filed on April 30, 2020, was made available online on August 13, 2020, according to news reporting originating from Washington, D.C., by NewsRx correspondents.

This patent application is assigned to ZOLL Medical Corporation (Chelmsford, Massachusetts, United States).

The following quote was obtained by the news editors from the background information supplied by the inventors: “This disclosure relates generally to external medical devices, and more specifically, to apparatus and processes that integrate ambulatory medical devices with hospital medical devices.

“There are a wide variety of electronic and mechanical medical devices for monitoring and treating patients’ medical conditions. The one or more particular medical devices used to monitor and/or treat a patient depend on the underlying medical condition with which the patient is afflicted. For example, where a patient has a medical condition that affects the patient’s cardiac function (e.g., a cardiac arrhythmia), medical devices such as cardiac pacemakers or defibrillators may be used to treat the patient. In some cases, these medical devices may be surgically implanted or externally connected to the patient. Such medical devices may be used alone, or in combination with drug therapies, to treat medical conditions such as cardiac arrhythmias.

“One of the most deadly cardiac arrhythmias is ventricular fibrillation, which occurs when normal, regular electrical impulses are replaced by irregular and rapid impulses, causing the heart muscle to stop normal contractions and to begin to quiver. Normal blood flow ceases, and organ damage or death can result in minutes if normal heart contractions are not restored. Because the victim has no perceptible warning of the impending fibrillation, death often occurs before the necessary medical assistance can be administered. Other cardiac arrhythmias include excessively slow heart rates known as bradycardia.

“Implantable or external pacemakers and defibrillators (such as automated external defibrillators or AEDs) have significantly improved the ability to treat these otherwise life-threatening conditions. Such devices operate by applying corrective electrical pulses directly to the patient’s heart. For example, bradycardia can be corrected through the use of an implanted or external pacemaker device. Ventricular fibrillation can be treated by an implanted or external defibrillator.

“Some medical devices operate by continuously or substantially continuously monitoring the patient’s heart for treatable arrhythmias via one or more sensing electrodes and, when such is detected, applying corrective electrical pulses directly to the heart through one or more therapy electrodes. Patients use these devices while ambulatory and visiting various locations, such as their home or place of work.”

In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors’ summary information for this patent application: “An ambulatory medical device stores a wealth of data regarding a patient that is potentially useful to a hospital practitioner when caring for the patient. Examples of this patient data include data descriptive of patient activity, compliance, body position, electrocardiogram (ECG) readings, heart sounds, respiration, blood oxygen level, and other patient parameters. Patient data may also include patient demographic data (e.g., name, address, insurance provider, etc.), data descriptive of healthcare provider observations of the patient, and images of the patient. Both the hospital practitioner and patient may further benefit from granting control of the ambulatory medical device upon the patient’s entry into the hospital. This is especially true where the ambulatory medical device is configured to provide treatment to the patient that may be manually initiated by the hospital practitioner in an emergency. Further, publication of the data, along with data generated by other medical devices located in the hospital, can be used to construct a patient dashboard summarizing the patient’s condition over time and illustrating a chronology of care provided to the patient via the ambulatory medical device and the other medical devices located in the hospital. This chronology may both inform a caregiver’s treatment of the patient in an emergency and be studied to prescribe an extended course of treatment to the patient.

“In one example, an ambulatory medical device is provided. The ambulatory medical device includes at least one sensor configured to acquire physiological data of a patient, at least one network interface and at least one processor coupled to the at least one sensor and the at least one network interface. The at least one processor is configured to detect, via the at least one network interface, a medical device, to establish a secure communication session with the medical device via the at least one network interface, to detect a data capacity of the secure communication session, to identify a category of patient data associated with the data capacity, and to transmit patient data of the category to the medical device via the secure communication session.

“In the ambulatory medical device, the at least one processor may be configured to detect the medical device in response to the ambulatory medical device entering a predefined range of the medical device. The at least one processor may be configured to determine whether the medical device is trusted prior to establishing the secure communication session.

“In the ambulatory medical device, the patient data may include a summary based on electrocardiogram data. The summary may describe a heart rate of the patient. The at least one processor may be configured to monitor the data capacity and to include electrocardiogram data within the patient data where the data capacity exceeds a predetermined threshold.

“The ambulatory medical device may further include at least one electrode configured to shock the patient. The ambulatory medical device may further include a garment housing the at least one electrode. In the ambulatory medical device, the at least one processor may be configured to determine whether the medical device is within the predefined range based on at least one of a Wi-Fi signal strength, a BLUETOOTH signal strength, and a near field communication signal strength. The at least one processor may be configured to determine that the medical device is within the predefined range based on physical contact between the medical device and at least one of the ambulatory medical device and the patient.

“In the ambulatory medical device, the at least one processor may be configured to receive instructions to treat the patient from the medical device and to execute the instructions to treat the patient. The at least one processor may be configured to implement a web server to receive the instructions within the secure communication session. The at least one processor may be configured to receive instructions to execute a diagnostic protocol from the medical device and to execute the diagnostic protocol. The ambulatory medical may further include a user interface coupled to the at least one processor, the diagnostic protocol may include a six-minute walk test and the at least one processor may be configured to prompt the user, via the user interface, to perform the six-minute walk test.

“In the ambulatory medical device, the at least one processor may be configured to implement a web server to transmit the patient data to a programmable device distinct from the medical device and the ambulatory medical device. The programmable device may include at least one of a mobile computing device, a remote server, and a hospital data system. The patient data may include compliance data. The at least one processor may be configured to detect a predefined patient condition and to transmit instructions for the medical device to issue an alert via a user interface regarding the patient condition.

“In another example, a hospital medical device is provided. The hospital medical device includes at least one network interface and at least one processor coupled to the at least one network interface. The at least one processor is configured to detect, via the at least one network interface, an external ambulatory medical device; to establish a secure communication session with the external ambulatory medical device via the at least one network interface; to receive patient summary data via the secure communication session; and to process the patient summary data.

“In the hospital medical device, the at least one processor may be configured to request, in response to processing the patient summary data, detailed data upon which the summary data is based from the external ambulatory medical device via the secure communication session. The at least one processor may be configured to transmit patient data to the external ambulatory medical device via the secure communication session. The hospital medical device may include at least one of a defibrillator, a temperature management system, a ventilator, a resuscitation system, and a telemetry system.

“In the hospital medical device, the patient summary data may be based on electrocardiogram data. The patient summary data may describe a heart rate of the patient. The at least one processor may be configured to determine whether the external ambulatory medical device is within a predefined range of the hospital medical device based on at least one of a Wi-Fi signal strength, a BLUETOOTH signal strength, and a near field communication signal strength. The at least one processor may be configured to determine the external ambulatory medical device is within a predefined range based on physical contact between the hospital medical device and at least one of the external ambulatory medical device and the patient.

“The hospital medical device may further include a user interface coupled to the at least one processor. The at least one processor may be configured to receive input via the user interface, to generate instructions to treat the patient based on the input, and to transmit the instructions to the external ambulatory medical device. The at least one processor may be configured to implement a web server to transmit the instructions within the secure communication session. The at least one processor may be configured to receive input via the user interface, to generate instructions to execute a diagnostic protocol based on the input, and to transmit the instructions to the external ambulatory medical device. The diagnostic protocol may include a six-minute walk test. The at least one processor may be configured to receive instructions from the external ambulatory medical device to issue an alert via the user interface regarding a patient condition. The at least one processor may be configured to display patient data on the user interface.

“In the hospital medical device, wherein the at least one processor may be configured to implement a web server to transmit patient data to a programmable device distinct from the hospital medical device and the external ambulatory medical device. The programmable device may include at least one of a mobile computing device, a remote server, and a hospital information system. The patient data may include compliance data.

“In another example, a system of medical devices is provided. The system includes an external ambulatory medical device and a hospital medical device. The external ambulatory medical device includes one or more network interfaces and at least one sensor configured to acquire physiological data of a patient. The hospital medical device includes at least one network interface and at least one processor coupled to the at least one network interface. The at least one processor is configured to detect, via the at least one network interface, the external ambulatory medical device; to establish a secure communication session with the external ambulatory medical device via the at least one network interface; to receive patient summary data via the secure communication session; to process the patient summary data.

“In the system of medical devices, the at least one processor of the hospital medical device may be configured to request, in response to processing the patient summary data, detailed data upon which the patient summary data is based from the external ambulatory medical device via the secure communication session. The external ambulatory medical device may include one or more processors configured to limit transmission of patient data at least in part by calculating the patient summary data, transmitting the patient summary data to the hospital medical device, receiving a request for detailed data, and transmitting, in response to receiving the request, the detailed data to the hospital medical device.

“In the system, the hospital medical device may include a resuscitation system, the external ambulatory medical device may include an accelerometer, and the at least one processor of the hospital medical device may be configured to receive location tracking data measured by the accelerometer and to detect whether chest compressions are of a correct depth using the location tracking data.

“In the system, the hospital medical device may include a temperature management system, the external ambulatory medical device may include a temperature sensor configured to measure a body temperature of the patient, and the at least one processor may be configured to receive body temperature data measured by the temperature sensor and to detect whether the body temperature transgresses a threshold.

“In the system, the at least one processor may be configured to receive electrocardiogram data and to process the electrocardiogram data to generate the patient summary data. The hospital medical device may further include a user interface coupled to the at least one processor. The at least one processor may be configured to display, on a screen of the user interface, data originated by the hospital medical device and display, on the screen of the user interface, data originated by the external ambulatory medical device.

“In another example, a method of integrating an ambulatory medical device with a hospital medical device is provided. The method includes acts of acquiring, by the ambulatory medical device, physiological data of a patient; detecting, by the ambulatory medical device, the hospital medical device; establishing a secure communication session between the ambulatory medical device and the hospital medical device; detecting, by the ambulatory medical device, a data capacity of the secure communication session; identifying, by the ambulatory medical device, a category of patient data associated with the data capacity; and transmitting, by the ambulatory medical device, patient data of the category to the hospital medical device via the secure communication session.

“In the method, the act of detecting the hospital medical device may include an act of detecting the hospital medical device in response to the ambulatory medical device entering a predefined range of the hospital medical device. The method may further include an act of determining whether the hospital medical device is trusted prior to establishing the secure communication session. In the method, the act of transmitting the patient data may include an act of transmitting a summary based on electrocardiogram data.

“Still other aspects, examples and advantages of these aspects and examples, are discussed in detail below. Moreover, it is to be understood that both the foregoing information and the following detailed description are merely illustrative examples of various aspects and features, and are intended to provide an overview or framework for understanding the nature and character of the claimed aspects and examples. Any example or feature disclosed herein may be combined with any other example or feature. References to different examples are not necessarily mutually exclusive and are intended to indicate that a particular feature, structure, or characteristic described in connection with the example may be included in at least one example. The appearances of such terms herein are not necessarily all referring to the same example.”

The claims supplied by the inventors are:

“1. A system of medical devices comprising: an external ambulatory medical device comprising one or more network interfaces and at least one sensor configured to acquire electrocardiogram (ECG) data of a patient; and a hospital medical device comprising at least one network interface and at least one processor coupled to the at least one network interface, the at least one processor being configured to detect, via the at least one network interface, the external ambulatory medical device in response to the external ambulatory medical device entering a predefined range of the hospital medical device, determine whether the external ambulatory medical device is a trusted medical device, establish a secure communication session with the external ambulatory medical device via the at least one network interface upon determining that the external ambulatory medical device is a trusted medical device, receive patient summary data via the secure communication session, and process the patient summary data.

“2. The system of medical devices of claim 1, the at least one processor being configured to request, in response to processing the patient summary data, detailed data upon which the patient summary data is based from the external ambulatory medical device via the secure communication session.

“3. The system of medical devices of claim 1, the external ambulatory medical device comprising one or more processors configured to limit transmission of patient data at least in part by calculating the patient summary data, transmitting the patient summary data to the hospital medical device, receiving a request for detailed data, and transmitting, in response to receiving the request, the detailed data to the hospital medical device.

“4. The system of medical devices of claim 1, the at least one processor being configured to receive the electrocardiogram data and to process the electrocardiogram data to generate the patient summary data.

“5. The system of medical devices of claim 1, the hospital medical device comprising a user interface coupled to the at least one processor and the at least one processor being configured to: display, on a screen of the user interface, data originated by the hospital medical device; and display, on the screen of the user interface, data originated by the external ambulatory medical device.

“6. The system of medical devices of claim 1, the hospital medical device comprising at least one of a defibrillator, a temperature management system, a ventilator, a resuscitation system, and a telemetry system.

“7. The system of medical devices of claim 1, the hospital medical device further comprising a user interface coupled to the at least one processor, the at least one processor being configured to: receive input via the user interface; generate instructions to execute a diagnostic protocol based on the input; and transmit the instructions to the external ambulatory medical device.

“8. The system of medical devices of claim 7, the instructions to execute the diagnostic protocol comprising one or more of instructions to prompt the patient to perform a physical test, instructions to treat the patient, and instructions to issue an alert.

“9. The system of medical devices of claim 1, the at least one processor being configured to determine whether the external ambulatory medical device is within a predefined range of the hospital medical device based on at least one of a Wi-Fi signal strength, a BLUETOOTH signal strength, and a near field communication signal strength.

“10. The system of medical devices of claim 1, the at least one sensor comprising one or more of an ECG sensor, a motion sensor, an audio sensor, a respiratory sensor, and a temperature sensor.

“11. An ambulatory medical device configured to acquire physiological data for a patient wearing the ambulatory medical device, the device comprising: at least one sensor configured to couple to the patient and to acquire physiological signals from the patient; at least one network interface; and at least one processor coupled to the at least one sensor and the at least one network interface and configured to determine physiological data for the patient from the acquired physiological signals, detect, via the at least one network interface, an external medical device in response to the ambulatory medical device entering a predefined range of the external medical device, determine whether the external medical device is a trusted medical device, establish a secure communication session with the external medical device via the at least one network interface upon determining that the external medical device is a trusted medical device, generate patient data comprising at least a portion of the patient physiological data, and transmit the generated patient data to the external medical device via the secure communication session.

“12. The ambulatory medical device of claim 11, the patient data comprising data descriptive of one or more of activity of the patient, compliance of the patient, body position of the patient, at least one electrocardiogram (ECG) reading of the patient, at least one heart sound of the patient, respiration of the patient, blood oxygen level of the patient, demographics of the patient, and medical history of the patient.

“13. The ambulatory medical device of claim 11, the at least one sensor comprising one or more of an ECG sensor, a motion sensor, an audio sensor, a respiratory sensor, and a temperature sensor.

“14. The ambulatory medical device of claim 11, the at least one processor being configured to: detect a data capacity of the secure communication session; and determine a category of information to transmit to the external medical device based upon the detected capacity.

“15. The ambulatory medical device of claim 14, the determined category of information to transmit comprising summary information, and the patient data comprising a summary based on the physiological data, the summary comprising one or more of a heart rate of the patient, a heartbeat of the patient, an arrhythmia determination regarding the patient, and an arrhythmia detection alert regarding the patient.

“16. The ambulatory medical device of claim 11, the at least one processor being configured to determine whether the medical device is within the predefined range of the external medical device based on at least one of a Wi-Fi signal strength, a BLUETOOTH signal strength, and a near field communication signal strength.

“17. The ambulatory medical device of claim 11, the at least one processor being configured to receive instructions to execute a diagnostic protocol from the external medical device and to execute the diagnostic protocol.

“18. The ambulatory medical device of claim 17, the instructions to execute the diagnostic protocol comprising one or more of instructions to prompt the patient to perform a physical test, instructions to treat the patient, and instructions to issue an alert.

“19. The ambulatory medical device of claim 11, the at least one processor being configured to receive instructions within the secure communication session to transmit the patient data to a programmable device distinct from the medical device and the ambulatory medical device.

“20. The ambulatory medical device of claim 19, the programmable device comprising at least one of a mobile computing device, a remote server, and a hospital data system.”

URL and more information on this patent application, see: Freeman, Gary A.; Crowell, Suzanne; Volpe, Shane S. Systems And Methods Of Integrating Ambulatory Medical Devices. Filed April 30, 2020 and posted August 13, 2020. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220200253477%22.PGNR.&OS=DN/20200253477&RS=DN/20200253477

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