WO2022006513A1

WO2022006513A1 - Blood pressure digital health devices, systems, and methods of use

Info

Publication number: WO2022006513A1
Application number: PCT/US2021/040280
Authority: WO
Inventors: Eric S. KIRKENDALL; Timothy Charles ORR
Original assignee: Wake Forest University Health Sciences
Priority date: 2020-07-02
Filing date: 2021-07-02
Publication date: 2022-01-06

Abstract

Provided herein are devices, methods, and systems for improving home, clinic, and hospital facility-based blood pressure measurements; for improving the quality of research and clinical blood pressure data; and for improving work flow efficiencies, wherein the device comprises: an activity sensing component in communication with a processor, wherein the processor receives data from the activity sensing component regarding the subject's activity and wherein a desired minimal activity level is pre-determined; and a blood pressure-measuring component in communication with the processor, wherein the processor activates the blood pressure-measuring component when the desired minimal activity level is maintained for a pre-determined duration, wherein the processor continues to receive data from the activity sensing component while the blood pressure measuring component is activated.

Description

BLOOD PRESSURE DIGITAL HEALTH DEVICES, SYSTEMS, AND METHODS OF

USE

BACKGROUND

Despite there being guidelines and best practices for obtaining blood pressure measurements that are clinically accurate, blood pressure measurements are notoriously difficult to perform correctly. Violation of this criteria, which happens frequently in busy clinics and other settings using current devices, can lead to blood pressure values that are not reflective of a patient’s true physiologic status. Often this is because it is time consuming for providers to get accurate measurements because, in an ideal situation, a measurement should not be taken until a patient has stopped moving for multiple (e.g., five) minutes. Additionally, the way that the data is currently recorded and stored by devices and electronic health records does not include any information about the quality and the conditions under which the measurements were taken.

Provided herein are devices, methods, and systems for improving home, clinic, and hospital facility-based blood pressure measurements; for improving the quality of research data; and for improving work flow efficiencies.

SUMMARY

The present disclosure relates to devices, methods, and systems for obtaining blood pressure readings.

An embodiment of the disclosure comprises a device for taking a subject’s blood pressure. In one embodiment, the device comprises: an activity sensing component in communication with a processor, wherein the processor receives data from the activity sensing component regarding the subject’s activity and wherein a desired minimal activity level is pre determined; and a blood pressure-measuring component in communication with the processor, wherein the processor activates the blood pressure-measuring component when the desired minimal activity level is maintained for a pre-determined duration, wherein the processor continues to receive data from the activity sensing component while the blood pressure measuring component is activated.

Another embodiment of the disclosure comprises methods for taking a subject’s blood pressure. In one embodiment, the method comprises: collecting data from a activity sensing component of a device regarding the subject’s activity; activating a blood pressure-measuring component of the device when the subject has a pre-determined minimal activity over a pre determined period of time; collecting data from the activity-sensing component and the blood pressure-measuring component while the blood pressure-measuring component is activated; and reporting the subject’s blood pressure..

Another embodiment of the disclosure comprises a system for carrying out any of the methods described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate certain embodiments of the technology and are not limiting. For clarity and ease of illustration, the drawings are not made to scale and, in some instances, various aspects may be shown exaggerated or enlarged to facilitate an understanding of particular embodiments.

Figure 1 depicts a wrist-based blood pressure measuring device with an accelerometer, a gyrometer, and a magnometer in accordance with an embodiment of this disclosure.

Figure 2 depicts a finger-based blood pressure measuring device with an accelerometer, a gyrometer, and a magnometer in accordance with an embodiment of this disclosure.

Figure 3 depicts an arm-based blood pressure measuring device with an accelerometer, a gyrometer, and a magnometer in accordance with an embodiment of this disclosure.

Figure 4 depicts data collected from a subject by a blood pressure measuring device with an accelerometer, a gyrometer, an altimeter over a period of time in accordance with an embodiment of this disclosure.

DETAILED DESCRIPTION

The following description recites various aspects and embodiments of the present compositions and methods. No particular embodiment is intended to define the scope of the compositions and methods. Rather, the embodiments merely provide non-limiting examples of various methods and systems that are at least included within the scope of the compositions and methods. The description is to be read from the perspective of one of ordinary skill in the art; therefore, information well known to the skilled artisan is not necessarily included. Definitions

The present disclosure now will be described more fully hereinafter. The disclosure may be embodied in many different forms and should not be construed as limited to the aspects set forth herein; rather, these aspects are provided so that this disclosure will satisfy applicable legal requirements. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art to which this disclosure belongs. All patents, applications, published applications and other publications referred to herein are incorporated by reference in their entireties. If a definition set forth in this section is contrary to or otherwise inconsistent with a definition set forth in the patents, applications, published applications and other publications that are herein incorporated by reference, the definition set forth in this section prevails over the definition that is incorporated herein by reference.

When introducing elements of the present disclosure or the embodiment(s) thereof, the articles “a”, “an”, “the” and “said” are intended to mean that there are one or more of the elements. The terms “comprising”, “including” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. It is understood that aspects and embodiments of the disclosure described herein include “consisting” and/or “consisting essentially of’ aspects and embodiments.

The term “and/or” when used in a list of two or more items, means that any one of the listed items can be employed by itself or in combination with any one or more of the listed items. For example, the expression “A and/or B” is intended to mean either or both of A and B, i.e. A alone, B alone or A and B in combination. The expression “A, B and/or C” is intended to mean A alone, B alone, C alone, A and B in combination, A and C in combination, B and C in combination or A, B, and C in combination.

Various aspects of this disclosure are presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

Devices

An embodiment of the disclosure comprises a device for taking a subject’s blood pressure. In one embodiment, the device may comprise: an activity sensing component in communication with a processor, wherein the processor receives data from the activity sensing component regarding the subject’s activity and wherein a desired minimal activity level is pre determined; and a blood pressure-measuring component in communication with the processor, wherein the processor activates the blood pressure-measuring component when the desired minimal activity level is maintained for a pre-determined duration, wherein the processor continues to receive data from the activity sensing component while the blood pressure measuring component is activated.

In some embodiments, the activity sensing component may be a motion sensing component. In some embodiments, the motion sensing component may be an accelerometer. In some embodiments, the motion sensing component may be a gyrometer. In some embodiments, the motion sensing component may be a magnometer. In some embodiments, the motion sensing component may be a barometer. In some embodiments, the motion sensing component may be a altimeter. In some embodiments, the motion sensing component may comprise one or more of an accelerometer and a gyrometer, a magnometer, a barometer, and/or an altimeter.

The pre-determined conditions include adjustable parameters that the user may set, including activity level thresholds, position, and the duration of time at which the patient has to meet the conditions for the BP measurement to be taken.

Default settings for the device may include requiring the patient be in a seated position with the lowest amount of activity on a numerical scale (e.g., 1 on a scale of 1-5) of motion for a duration of 5 minutes. These parameters can be changed by the user to include or exclude any condition or combination of conditions, as well as adjust the parameters of particular conditions. The amount of activity may be categorized into the ordinal scale by the device (e.g., 1 being the lowest amount of activity and 5 being the highest). This activity will be measured by the device and classified into this scale based on machine learning models embedded in the software acting on the sensor data. Users may adjust the predetermined conditions to allow for alternative activity levels minimums. For example, a user may set the pre-determined minimal activity at 2 or less instead of 1 or less. Users may also set pre-determined minimums for other factors such as ambient noise and ambient light.

In some embodiments, the pre-determined duration of the minimal activity level may not be less than 5 minutes. In some embodiments, the pre-determined duration of minimal activity level may not be less than about 1, 2, 3, or 4 minutes. In some embodiments, the pre-determined duration of minimal activity level may not be less than about 6, 7, 8, 9, or 10 minutes. In some embodiments, the pre-determined duration of minimal activity level may not be less than about 15 minutes.

In some embodiments, the device may also comprises a position sensing component, wherein the processor receives data from the position sensing component regarding the subject’s position. In some embodiments, the position sensing component may comprise a magnometer.

In some embodiments, the position sensing component may comprise a barometer. In some embodiments, the position sensing component may comprise an altimeter. In some embodiments, the position sensing component may comprise one or more of a magnometer, barometer and/or an altimeter.

In some embodiments, the processor may activate the blood pressure-measuring component when the position sensing component indicates the subject is in a pre-determined position. In some embodiments, the processor continues to receive data from the position sensing component while the blood pressure-measuring component is activated.

In some embodiments, the device may also comprise a temperature sensing component.

In some embodiments, the device may also comprise a noise sensing component. In some embodiments, the device may also comprise a light sensing component. In some embodiments, the device may also comprise a humidity sensing component.

In some embodiments, the processor may calculate a measurement quality score based on data received from at least the activity sensing component and the blood pressure-measuring component. In some embodiments, the measurement quality score may be calculated based on data received from the position sensing component, the activity sensing component, and the blood pressure-measuring component. In some embodiments, the measurement quality score may be calculated based on data received from the blood pressure-measuring component and one or more of the activity sensing component, a position sensing component, a temperature sensing component, a sound sensing component, a light sensing component, and/or a humidity sensing component.

In some embodiments, the devise further comprises a memory component in communication with the processor. In some embodiments, the memory component stores data from the processor for the subject. In some embodiments, the stored data is used to set the desired minimums for the subject’s subsequent measurements.

Methods

Another embodiment of the disclosure comprises methods for taking a subject’s blood pressure. In one embodiment, the method may comprise: collecting data from a activity sensing component of a device regarding the subject’s activity; activating a blood pressure-measuring component of the device when the subject has a pre-determined minimal activity over a pre determined period of time; collecting data from the activity-sensing component and the blood pressure-measuring component while the blood pressure-measuring component is activated; and reporting the subject’s blood pressure..

In some embodiments, the method additionally comprises collecting data from a position sensing component of the device. In some embodiments, the activating step takes place when the subject is in a pre-determined desired position. In some embodiments, the position sensing component may comprise a magnometer. In some embodiments, the position sensing component may comprise a barometer. In some embodiments, the position sensing component may comprise an altimeter. In some embodiments, the position sensing component may comprise one or more of a magnometer, barometer and/or an altimeter.

In some embodiments, the method also comprises calculating a measurement quality score based on data received from at least the motion sensing component and the blood pressure measuring component and reporting the measurement quality score. In some embodiments, the method further comprises calculating the measurement quality score based on data received from the position sensing component. In some embodiments, the method further comprises calculating the measurement quality score based on data received from at least one sensor in addition to the activity sensing component and the motion sensing component. In some embodiments, the at least one sensor is chosen from a light sensor, a sound sensor, and/or a humidity sensor.

Systems

Another embodiment of the disclosure comprises a system for carrying out any of the methods described in the above embodiments. Various embodiments of the disclosure have been described herein. It should be recognized that these embodiments are merely illustrative of the present disclosure. Variations of those preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. It is expected that skilled artisans can employ such variations as appropriate, and the disclosure is intended to be practiced otherwise than as specifically described herein. Accordingly, this disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the disclosure unless otherwise indicated or otherwise clearly contradicted by context.

EXAMPLES

Example 1 Device Use in a Clinical Setting

A patient presents to a clinic for an ambulatory visit. After check-in, the patient is guided into an exam room. The next generation blood pressure (BP) device is placed on the patient and the office staff start the device by interacting with the device interface/buttons. The device is activated and begins using its sensors to gather data about the patient and the environment. Figure 1 shows an example wrist based device comprising sensors including an accelerometer, a gyrometer, and a magnometer. Figure 2 shows a similar finger-based device. Figure 3 shows a similar arm-based device.

This data is compiled and processed by the software associated with the device to determine when the actual BP measurement should be taken according to pre-determined, user- defined conditions. Figure 4 depicts an example diagram showing how data inputs from the device’s sensors are used to determine optimal conditions for the accurate measurement of blood pressure (BP). Sensors obtain data about the person’s position (labeled ‘altitude’ in the figure), orientation and angular velocity in space (‘GyroX’, ‘GyroY’, ‘GyroZ’), and acceleration (‘AccX’, ‘AccY’, ‘AccZ’). As the person moves throughout space, the data from the sensors is used to determine if thresholds are met, i.e., if a BP measurement is taken, it will be reasonably accurate. Once the thresholds are met (may include if thresholds are met for a defined interval of time), the BP measuring device can be automatically signaled to take a measurement. The device and associated software will take the BP measurement once the pre determined conditions are met and record both the conditions before and during the BP measurement, as well as the BP measurement itself. This activation of the BP device is automatic and does not require the presence of staff to initiate the measurement. The device and software will record this data for further review so clinicians and researchers will be able to make clinical and research judgements about the quality of the data and its utility. The device will have the capability to repeat the measurements at defined intervals as well, calculating the maximum, mean, and average values of the components of the blood pressure measurement (systolic and diastolic). If a patient moves or repositions themselves in a way that violates the pre-determined condition thresholds, the device can restart the duration counter so as not to take a measurement outside of optimal conditions. Users can, however, opt to manually override the condition limitations and perform a BP measurement on demand as some patients may have some medical conditions that do not lend themselves to remaining motionless and seated, for example. The system will obtain the BP measurement, but also record the conditions under which the measurement was obtained. The device can also be programmed to repeat measurements in one sitting, at specified amounts of time between the measurements (e.g., 1, 2 minutes, etc.).

Example 2 Device Use Outside of Clinical Settings

The device is used for ambulatory home-based measurements, outside of the clinical office setting, and used by patients themselves. In this use case, the device can be applied and, when the data from the device is reviewed by a clinician or researcher, the conditions under which the blood pressure was obtained can be reliably known. This automation of measurement under ideal conditions removes the need for clinical or study staff to be present to obtain reliable measurements.

Example 3 Examples of Certain Embodiments

Listed hereafter are non-limiting examples of certain embodiments of the technology.

Al. A device configured to take a subject’s blood pressure comprising: an activity sensing component in communication with a processor, wherein the processor receives data from the activity sensing component regarding the subject’s activity and wherein a desired minimal activity level is pre-determined; and a blood pressure-measuring component in communication with the processor, wherein the processor activates the blood pressure-measuring component when the desired minimal activity level is maintained for a pre-determined duration, wherein the processor continues to receive data from the activity sensing component while the blood pressure-measuring component is activated.

A2. The device of embodiment Al, wherein the activity sensing component is a motion sensing component.

A3. The device of embodiment A2, wherein the motion sensing component comprises an accelerometer, gyrometer, a magnometer, and/or a barometer.

A4. The device of any of the preceding embodiments, wherein the pre-determined duration of the minimal activity level is not less than five minutes.

A5. The device of any of the preceding embodiments, wherein the device also comprises a position sensing component, wherein the processor receives data from the position sensing component regarding the subject’s position.

A6. The device of embodiment A5, wherein the position sensing component comprises a magnometer, a barometer and/or an altimeter.

A7. The device of embodiment A5, wherein the processor activates the blood pressure measuring component when the position sensing component indicates the subject is in a pre determined position. A8. The device of any one of the preceding embodiments, wherein the processor continues to receive data from the position sensing component while the blood pressure-measuring component is activated.

A9. The device of any one of preceding embodiments, wherein the processor calculates a measurement quality score based on data received from at least the activity sensing component and the blood pressure-measuring component.

A10. The device of embodiment A9, wherein the measurement quality score is calculated based on data received from the position sensing component, the motion sensing component, and the blood pressure-measuring component.

A11. The device of any of the preceding embodiments, further comprising a memory component in communication with the processor.

A12. The device of embodiment All, wherein the memory component stores data from the processor for the subject.

A13. The device of embodiment A12, wherein the stored data is used to set the desired minimums for the subject’s subsequent measurements.

A14. The device of any of the preceding embodiments, additionally comprising at least one of a temperature sensing component, a sound sensing component, a light sensing component, and/or a humidity sensing component.

B 1. A method of taking a subj ect’ s blood pressure comprising: collecting data from a activity sensing component of a device regarding the subject’s activity; activating a blood pressure-measuring component of the device when the subject has a pre-determined minimal activity over a pre-determined period of time; collecting data from the activity-sensing component and the blood pressure-measuring component while the blood pressure-measuring component is activated; and reporting the subject’s blood pressure.

B2. The method of Bl, wherein the activity sensing component is a motion sensing component.

B3. The method of embodiments Bl or B2, additionally comprising collecting data from a position sensing component of a device.

B4. The method of B3, wherein the activating step takes place when the subject is in a desired position.

B5. The method of any of embodiments B1-B4, comprising calculating a measurement quality score based on data received from at least the motion sensing component and the blood pressure-measuring component; and reporting the measurement quality score.

B6. The method of embodiment B5 further comprising calculating the measurement quality score based on data received from the position sensing component.

B7. The method of any of embodiments B1-B5, further comprising calculating the measurement quality score based on data received from a temperature, light, and/or humidity sensing component.

Cl. A system for carrying out any of the methods described in embodiments B1-B6.

Claims

THAT WHICH IS CLAIMED IS:

1. A device configured to take a subj ecf s blood pressure comprising: an activity sensing component in communication with a processor, wherein the processor receives data from the activity sensing component regarding the subject’s activity and wherein a desired minimal activity level is pre-determined; and a blood pressure-measuring component in communication with the processor, wherein the processor activates the blood pressure-measuring component when the desired minimal activity level is maintained for a pre-determined duration, wherein the processor continues to receive data from the activity sensing component while the blood pressure-measuring component is activated.

2. The device of claim 1, wherein the activity sensing component is a motion sensing component.

3. The device of claim 2, wherein the motion sensing component comprises an accelerometer, gyrometer, a magnometer, and/or a barometer.

4. The device of any of the preceding claims, wherein the pre-determined duration of the minimal activity level is not less than five minutes.

5. The device of any of the preceding claims, wherein the device also comprises a position sensing component, wherein the processor receives data from the position sensing component regarding the subject’s position.

6. The device of claim 5, wherein the position sensing component comprises a magnometer, a barometer and/or an altimeter.

7. The device of claim 5, wherein the processor activates the blood pressure-measuring component when the position sensing component indicates the subject is in a pre-determined position.

8. The device of any one of the preceding claims, wherein the processor continues to receive data from the position sensing component while the blood pressure-measuring component is activated.

9. The device of any one of preceding claims, wherein the processor calculates a measurement quality score based on data received from at least the activity sensing component and the blood pressure-measuring component.

10. The device of claim 9, wherein the measurement quality score is calculated based on data received from the position sensing component, the motion sensing component, and the blood pressure-measuring component.

11. The device of any of the preceding claims, further comprising a memory component in communication with the processor.

12. The device of claim 11, wherein the memory component stores data from the processor for the subject.

13. The device of claim 12, wherein the stored data is used to set the desired minimums for the subject’s subsequent measurements.

14. The device of any of the preceding claims, additionally comprising at least one of a temperature sensing component, a sound sensing component, a light sensing component, and/or a humidity sensing component.

15. A method of taking a subj ect’ s blood pressure comprising: collecting data from a activity sensing component of a device regarding the subject’s activity; activating a blood pressure-measuring component of the device when the subject has a pre-determined minimal activity over a pre-determined period of time; collecting data from the activity-sensing component and the blood pressure-measuring component while the blood pressure-measuring component is activated; and reporting the subject’s blood pressure.

16. The method of claim 15, wherein the activity sensing component is a motion sensing component.

17. The method of claim 15 or 16, additionally comprising collecting data from a position sensing component of a device.

18. The method of claim 17, wherein the activating step takes place when the subject is in a desired position.

19. The method of any of claims 15-18, comprising calculating a measurement quality score based on data received from at least the motion sensing component and the blood pressure-measuring component; and reporting the measurement quality score.

20. The method of claim 19 further comprising calculating the measurement quality score based on data received from the position sensing component.

21. The method of any of claims 15-20, further comprising calculating the measurement quality score based on data received from a temperature, light, and/or humidity sensing component.

22. A system for carrying out any of the methods described in claims 15-21.