METHODS, SYSTEMS, AND DEVICES FOR OPTIMAL POSITIONING OF SENSORS

• US 20160317088A1
• Filed: 12/23/2014
• Published: 11/03/2016
• Est. Priority Date: 12/31/2013
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: FOUGERE, Richard, LEE, Curtis, WALSH, Ryan
• Granted Patent: US 10,105,101 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/0533 Measuring galvanic skin response
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/684 Indicating the position of the sensor on the body
• CPC Class Codes: A61B 5/6844 Monitoring or controlling distance between sensor and tissue
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence

Abstract

A biomedical sensor has conducting elements disposed at least partly over a skin-facing surface. A sensing element detects a signal representative of a physiological parameter of a body using the conducting elements. A storage device stores a physiological model. A processor determines sensor placement quality by comparing the signal to the model and operates an indicator to indicate the determined quality. A method of measuring using the sensor includes computing a measurement acceptance criterion using numerous measurements, determining whether a subsequent test measurement corresponds to the measurement acceptance criterion obtained from the computing step, and indicating the results via the indicator. A system for measuring a physiological property of the body includes the sensor, a user interface device to receive measurements from the sensor, and a processor associated with the user interface device and configured to provide feedback if the measurement does not meet a selected acceptance criterion.

Claims

1. A biomedical sensor, comprising:

a) a sensor body having a skin-facing surface and an opposed surface;

b) a plurality of conducting elements disposed at least partly over the skin-facing surface;

c) a sensing element connected to the conducting elements, so that the sensing element detects a signal representative of a physiological parameter of a body facing the skin-facing surface using the conducting elements;

d) an indicator spaced apart from the skin-facing surface;

e) a storage device storing a physiological model; and

f) a processor coupled to the sensing element, the indicator, and the storage device, so that the processor determines a quality of sensor placement by comparing the signal to the stored physiological model and operates the indicator to provide a human-perceptible indication of the determined quality.

2. The sensor according to claim 1, in which the indicator includes plural separately-activatable visual indicators, in which the processor is configured to activate a selected number of the visual indicators to provide the human-perceptible indication, the selected number correlated with the determined quality.

3. The sensor according to claim 2, wherein the processor is configured to activate none of the visual indicators if the signal corresponds to an absence or failed detection of the physiological parameter;

to activate a selected first positive number of the visual indicators if the signal is not consistent with the physiological model; and

to activate a selected second positive number of the visual indicators if the signal is consistent with the physiological model, the selected second positive number being greater than the selected first positive number.

4. The sensor according to claim 1, wherein the physiological parameter is selected from the group consisting of blood pressure, pulse rate, pulse wave, skin conductance, galvanic skin response, temperature, electrocardiogram signal, blood glucose concentration, electroencephalogram signal, electromyogram signal, heart rate variability or combinations hereof.

5. The sensor according to claim 1, further including a motion sensor and a storage device storing a motion model corresponding to a selected location on the body, in which the processor is further configured to record motion data from the motion sensor, compare the recorded motion data to the stored motion model, and provide a human-perceptible indication of a result of the comparison.

6. The sensor according to claim 5, in which the processor is configured to provide a human-perceptible indication of the selected location if the recorded motion data do not correspond to the stored motion model.

7. The sensor according to claim 1, in which the processor is further configured to update the stored physiological model using the signal if the comparison indicates the detected physiological parameter corresponds to the stored physiological model.

8. A method of determining optimal placement of a sensor for measuring a physiological parameter of a user, the method comprising:

a calibration step of measuring the physiological parameter of the body using a sensor a plurality of times to provide respective measurements;

using a processor, automatically computing a measurement acceptance criterion using the respective measurements;

a testing step of measuring the physiological parameter of the body using the sensor to provide a test measurement;

automatically determining whether the test measurement corresponds to the measurement acceptance criterion obtained from the computing step; and

automatically operating an indicator of the sensor to provide a human-perceptible indication of the results of the determining step.

9. The method according to claim 8, in which the calibration step comprises presenting an indication via a user interface that the user should perform a specific action, and measuring the physiological parameter while the user performs the action.

10. The method according to claim 8, in which the operating step comprises deactivating the sensor for a selected period of time if the test measurement does not correspond to the measurement acceptance criterion obtained from the computing step.

11. The method according to claim 8, in which the indicator comprises plural separately-activatable visual indicators, in which the operating step comprises activating a selected number of the visual indicators to provide the human-perceptible indication, the selected number correlated with the results of the determining step.

12. The method according to claim 8, further including:

presenting an indication of a sensor site on the body via a user interface;

retrieving from a storage device a physiological model corresponding to the indicated sensor site;

measuring the physiological parameter of the body using the sensor;

automatically comparing the measured physiological parameter to the retrieved physiological model; and

a second operating step of automatically operating the indicator to provide a human-perceptible indication of the result of the comparing step.

13. The method according to claim 12, further including, if the measured physiological parameter does not correspond to the retrieved physiological model:

performing a recommending step of automatically determining a second sensor site on the body; and

repeating the presenting-indication, retrieving, measuring, and comparing steps, and the second operating step, using the second sensor site.

14. The method according to claim 13, further including receiving via the user interface one or more user indication(s) of respective rating(s) of sensor placement(s) in respective region(s) of the body and storing the received user indication(s) in the storage device, the recommending step including determining the second sensor site using the stored user indication(s).

15. The method according to claim 13, further including receiving via the user interface an indication of a medical condition of the user and storing the indication in the storage device, the recommending step including determining the second sensor site using the stored indication.

16. A system to determine optimal placement of a sensor for measuring a physiological parameter of a user, the system comprising:

a) a sensor having a sensing element configured to measure the physiological parameter, and having a first transceiver configured to communicate the measurement;

b) a user interface device including a second transceiver configure to receive the measurement from the first transceiver; and

c) a processor associated with the user interface device and configured to automatically determine, using the received measurement, whether a sensor position over the body at a time corresponding to the received measurement meets a selected acceptance criterion, and, if not, to present sensor-position feedback to the user via the user interface device.

17. The system according to claim 16, in which the user interface device comprises a device separate from the sensor, and the first and second transceivers including radio-frequency communications transceivers.

18. The system according to claim 17, the user interface device including a touchscreen configured to present the sensor-position feedback.

19. The system according to claim 16, in which the processor is configured to receive a plurality of measurements from the sensor via the first and second transceivers and to concurrently present respective sensor-position feedback for each of the plurality of measurements via the user interface device.

20. The system according to claim 16, further including a storage device configured to store data representing the selected acceptance criterion.