Systems, devices and methods for the prevention and treatment of pressure ulcers, bed exits, falls, and other conditions

• US 10,258,258 B2
• Filed: 06/17/2016
• Issued: 04/16/2019
• Est. Priority Date: 03/07/2010
• Status: Active Grant

• Current Assignee: Leaf Healthcare, Inc. (Smith & Nephew PLC)
• Original Assignee: Leaf Healthcare, Inc. (Smith & Nephew PLC)
• Inventors: Larson, Barrett J., Shen, Daniel Z.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Xie, Dacheng
• Application Number:
  US15/186,344
• Publication Number:
  US 20160367170A1
• Time in Patent Office: 1,033 Days
• Field of Search: 600300-301
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 2562/0214 Capacitive electrodes
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/0223 Magnetic field sensors
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 2562/029 Humidity sensors
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• 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 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1113 Local tracking of patients, e.g. in a hospital or private home
• CPC Class Codes: A61B 5/1114 Tracking parts of the body
• CPC Class Codes: A61B 5/1115 Monitoring leaving of a patient support, e.g. a bed or a wheelchair
• CPC Class Codes: A61B 5/1117 Fall detection
• CPC Class Codes: A61B 5/1118 : Determining activity level
• CPC Class Codes: A61B 5/113 : occurring during breathing
• CPC Class Codes: A61B 5/14542 : for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14551 : for measuring blood gases
• CPC Class Codes: A61B 5/447 : specially adapted for aiding the prevention of ulcer or pressure sore development, i.e. before the ulcer or sore has developed
• CPC Class Codes: A61B 5/4866 : Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/4884 : inducing physiological or psychological stress, e.g. applications for stress testing
• CPC Class Codes: A61B 5/6801 : specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/683 : Means for maintaining contact with the body A61B5/6802 takes precedence
• CPC Class Codes: A61B 5/6843 : Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/6891 : Furniture
• CPC Class Codes: A61B 5/6892 : Mats
• CPC Class Codes: A61B 5/7246 : using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7275 : Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7282 : Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 7/00 : Instruments for auscultation
• CPC Class Codes: A61G 2203/32 : for force
• CPC Class Codes: A61G 2203/34 : for pressure
• CPC Class Codes: A61G 2203/42 : for inclination
• CPC Class Codes: A61G 2203/46 : for temperature
• CPC Class Codes: A61G 2205/60 : using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61G 7/057 : Arrangements for preventing bed-sores or for supporting patients with burns, e.g. mattresses specially adapted therefor ventilation openings in mattresses A47C21/042; pneumatic or hydraulic mattresses A47C27/08
• CPC Class Codes: G16H 20/00 : ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
• CPC Class Codes: G16H 20/10 : relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

A system for monitoring medical conditions including pressure ulcers, pressure-induced ischemia and related medical conditions comprises at least one sensor adapted to detect one or more patient characteristic including at least position, orientation, temperature, acceleration, moisture, resistance, stress, heart rate, respiration rate, and blood oxygenation, a host for processing the data received from the sensors together with historical patient data to develop an assessment of patient condition and suggested course of treatment. In some embodiments, the system can further include a support surface having one or more sensors incorporated therein either in addition to sensors affixed to the patient or as an alternative thereof. The support surface is, in some embodiments, capable of responding to commands from the host for assisting in implementing a course of action for patient treatment. The sensor can include bi-axial or tri-axial accelerometers, as well as resistive, inductive, capacitive, magnetic and other sensing devices, depending on whether the sensor is located on the patient or the support surface, and for what purpose.

Claims

1. A method for automatically determining the status of a wearable sensor device, the method comprising:

affixing the sensor device to a user, the sensor including at least one accelerometer,

generating, by the at least one accelerometer of the sensor device, acceleration data indicating an acceleration of the sensor device in at least one axis,

determining, by a processor, acceleration-based biometric data regarding the user based at least on the acceleration data generated by the at least one accelerometer, the acceleration-based biometric data including at least one of acceleration-based respiratory data, acceleration-based cardiac data, or acceleration-based body movement data,

comparing, by the processor, (a) the acceleration-based biometric data of the user to (b) reference biometric data stored in a data storage device associated with the processor,

identifying, by the processor, based on the comparison of the acceleration-based biometric data of the user with the reference biometric data, a sensor device attachment condition associated with the sensor device being not properly affixed to the user, and

in response to identifying the sensor device attachment condition, automatically outputting a human-perceptible alert notification via a display or other output device.

2. The method of claim 1 wherein the acceleration-based biometric data includes at least one of a respiratory rate, a heart rate, or a pulse rate.

3. The method of claim 1, comprising determining an angular orientation of the sensor device with respect to the user based on the acceleration data generated by the at least one accelerometer.

4. The method of claim 1, comprising determining a location on the user'"'"'s body at which the sensor device is affixed based on the acceleration data generated by the at least one accelerometer.

5. The method of claim 1, wherein comparing the acceleration-based biometric data of the user with reference biometric data comprises comparing the acceleration-based biometric data of the user with a predetermined range of biometric data values.

6. The method of claim 1, wherein the wearable sensor device includes visible indicia indicating an orientation direction for aligning the sensor device with respect to the user.

7. The method of claim 1, wherein:

comparing (a) the acceleration-based biometric data of the user to (b) reference biometric data stored in a data storage device associated with the processor comprises comparing (a) the acceleration-based biometric data of the user to (b) at least one reference biometric data threshold value, and

identifying a sensor device attachment condition based on the comparison of the acceleration-based biometric data of the user with the reference biometric data comprises determining that acceleration-based biometric data exceeds the at least one reference biometric data threshold value.

8. The method of claim 1, wherein:

comparing (a) the acceleration-based biometric data of the user to (b) reference biometric data stored in a data storage device associated with the processor comprises comparing (a) the acceleration-based biometric data of the user to (b) a reference biometric data range of limit values, and

identifying a sensor device attachment condition based on the comparison of the acceleration-based biometric data of the user with the reference biometric data comprises determining that acceleration-based biometric data falls outside the reference biometric data range of limit values.

9. The method of claim 1, further comprising:

monitoring, by the processor, based on the acceleration data generated by the at least one accelerometer, an orientation of the user over time;

identifying, by the processor, an orientation alert condition based on the monitored orientation of the user; and

in response to identifying the orientation alert condition, automatically generating and communicating a human-perceptible alert notification regarding the orientation of the user.

10. The method of claim 9, wherein:

monitoring an orientation of the user over time comprises monitoring the orientation of the user with respect to a turn protocol for the user; and

automatically generating and communicating turn notifications based on the monitored orientation of the user with respect to the turn protocol.

11. The method of claim 1, wherein comparing the acceleration-based biometric data of the user with reference biometric data comprises comparing the acceleration-based biometric data of the user with previously generated and stored acceleration-based biometric data of the user.

12. The method of claim 11, wherein identifying a sensor device attachment condition based on the comparison of the acceleration-based biometric data of the user with the reference biometric data comprises determining that a difference between the acceleration-based biometric data and the previously generated and stored acceleration-based biometric data of the user exceeds a defined threshold.

13. A system, comprising:

a wearable sensor device configured to be affixed to a person or to an article worn by the person;

at least one accelerometer provided in the wearable sensor device and configured to generate acceleration data indicating accelerations of the sensor device in at least one direction;

a processor communicatively coupled to the at least one accelerometer; and

a data storage device associated with the processor and storing reference biometric data;

wherein the processor is configured to;

determine acceleration-based biometric data regarding the user based at least on acceleration data received from the at least one accelerometer, the acceleration-based biometric data including at least one of acceleration-based respiratory data, acceleration-based cardiac data, or acceleration-based body movement data;

compare the acceleration-based biometric data of the user to the reference biometric data stored in the data storage device;

identify, based on the comparison of the acceleration-based biometric data of the user with the reference biometric data, a sensor device attachment condition associated with the sensor device being not properly affixed to the user, and

in response to identifying the sensor device attachment condition, automatically cause a human-perceptible alert notification to be output via a display or other output device.

14. The system of claim 13, wherein the acceleration-based biometric data includes at least one of a respiratory rate, a heart rate, or a pulse rate.

15. The system of claim 13, wherein the processor is configured to determine a location on the user'"'"'s body at which the sensor device is affixed, or an angular orientation of the sensor device with respect to the user, based on the acceleration data generated by the at least one accelerometer.

16. The system of claim 13, wherein comparing the acceleration-based biometric data of the user with reference biometric data comprises comparing the acceleration-based biometric data of the user with a predetermined range of biometric data values.

17. The system of claim 13, wherein the processor and the date storage device are provided in the wearable sensor device.

18. The system of claim 13, wherein comparing the acceleration-based biometric data of the user with reference biometric data comprises comparing the acceleration-based biometric data of the user with previously generated and stored acceleration-based biometric data of the user.

19. The system of claim 18, wherein identifying a sensor device attachment condition based on the comparison of the acceleration-based biometric data of the user with the reference biometric data comprises determining that a difference between the acceleration-based biometric data and the previously generated and stored acceleration-based biometric data of the user exceeds a defined threshold.