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

• US 10,140,837 B2
• Filed: 11/17/2014
• Issued: 11/27/2018
• Est. Priority Date: 04/22/2010
• Status: Active Grant

• Current Assignee: Leaf Healthcare, Inc. (Smith & Nephew PLC)
• Original Assignee: Leaf Healthcare, Inc. (Smith & Nephew PLC)
• Inventors: Shen, Daniel Z., Larson, Barrett J., Weckwerth, Mark V
• Primary Examiner(s): Zimmerman, Brian
• Assistant Examiner(s): Dorsey, Renee
• Application Number:
  US15/036,782
• Publication Number:
  US 20160275776A1
• Time in Patent Office: 1,471 Days
• Field of Search: None
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• 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 2562/043 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 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/1113 Local tracking of patients, e.g. in a hospital or private home
• CPC Class Codes: A61B 5/113 occurring during breathing
• 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 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/6891 Furniture
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• CPC Class Codes: A61G 2203/42 for inclination
• CPC Class Codes: A61G 2203/46 for temperature
• 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: G08B 21/043 detecting an emergency event, e.g. a fall
• CPC Class Codes: G08B 21/0461 integrated or attached to an item closely associated with the person but not worn by the person, e.g. chair, walking stick, bed sensor
• CPC Class Codes: G08B 21/22 : responsive to presence or absence of persons
• CPC Class Codes: G16H 20/10 : relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/30 : relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

Methods, systems and devices for monitoring patient orientation, direction, altitude and location to determine the need for turns as well as to detect impending or actual bed exits or falls. A patient-worn sensor communicates with at least one host server through a mesh network of relay antennae to provide data representative of various patient characteristics. The sensor comprises one or more of an accelerometer, a magnetometer and an altimeter, along with optional other sensors. Various user interfaces are provided for managing patient care using the information developed by algorithms processed at the server based on data received from the patient sensors.

Claims

1. A mesh network for patient monitoring comprising:

a plurality of wireless nodes including;

a patient-worn sensor;

a server; and

a plurality of relay antennas for receiving signals from the patient-worn sensor and from other relay antennas, one or more of the relay antennas in communication with the server for receiving and processing data from the patient-worn sensor;

wherein the patient-worn sensor comprises at least one sensor configured to detect patient orientation data;

wherein in response to activation of the patient-worn sensor, the patient-worn sensor is configured to;

automatically join the mesh network by communicating with a relay antenna proximate the patient-worn sensor; and

automatically output a human perceptible notification indicating that the patient-worn sensor has joined the mesh network; and

wherein the plurality of relay antennas are configured to automatically define communication pathways from the patient-worn sensor to the server via the mesh network by a process wherein;

each respective wireless node in the mesh network has at least one neighboring wireless node defined based on a signal strength of communications between the respective wireless node and one or more other wireless nodes;

each pair of neighboring wireless nodes are separated by a logical communication distance of one hop;

each respective wireless node is configured to communicate with its respective neighboring wireless node or nodes to determine a total logical distance, based on a number of hops, between the respective wireless node and the server along at least one potential communication pathway, wherein a total logical distance of one hop is defined between the server and each wireless node that neighbors the server, a total logical distance of two hops is defined between the server and each wireless node that neighbors a wireless node that neighbors the server, and so on; and

the plurality of wireless node are configured to collectively select, from the potential communication pathways, at least one communication pathway between each respective wireless node and the server based at least on the total logical distance of each respective potential communication pathway.

2. A method for evaluating a bed exit by a person using a wearable sensor device comprising at least one magnetometer and an at least one accelerometer, the method comprising the steps of:

affixing to the person the wearable sensor device comprising the at least one magnetometer and the at least one accelerometer;

collecting, by the at least one magnetometer of the wearable sensor device, direction data indicating a direction of the person;

collecting, by the at least one accelerometer of the wearable sensor device, acceleration data indicating at least an orientation of the person;

receiving, at a processor, from the at least one magnetometer and the at least one accelerometer of the wearable sensor device, the direction data and the acceleration data indicating the direction and orientation of the person;

comparing, by the processor, the direction and orientation of the person indicated by the direction data and the acceleration data with predefined bed-exit parameters corresponding with a bed exit state;

wherein the predefined bed-exit parameters corresponding with a bed exit state include an upright orientation of the person'"'"'s torso, and the comparison step includes determining whether the acceleration data indicates an upright orientation of the person'"'"'s torso; and

determining, by the processor, based at least on the comparison, a bed exit state of the person.

4. The method of claim 2, further comprising analyzing signal strength data or time-of-flight data of wireless signals communicated to or from the wearable sensor device to determine a directional orientation of the person'"'"'s body.

5. The method of claim 4, comprising:

receiving a wireless signal from the wearable sensor device at a plurality of wireless antennas spaced apart from the wearable sensor device;

determining signal strength data or time-of-flight data for the wireless signal received at each of the wireless antennas; and

determining the directional orientation of the person'"'"'s body based on the determined signal strength data or time-of-flight data.

6. The method of claim 2, comprising generating a bed exit alarm in response to determining the bed exit state of the person.

7. The method of claim 6, comprising automatically deactivating the bed exit alarm in response to detecting a caregiver or other operator proximate the wearable sensor device.

8. The method of claim 2, wherein the bed exit state of the person indicates a pending bed exit.

9. The method of claim 2, wherein the bed exit state of the person indicates an executed bed exit.

11. The method of claim 2, wherein the acceleration data collected by the at least one accelerometer of the wearable sensor device comprises static acceleration data indicating the orientation of the person.

3. A method for evaluating a bed exit by a person using a wearable sensor device comprising at least one magnetometer and an at least one accelerometer, the method comprising the steps of:

affixing to the person the wearable sensor device comprising the at least one magnetometer and the at least one accelerometer;

collecting, by the at least one magnetometer of the wearable sensor device, direction data indicating a direction of the person;

collecting, by the at least one accelerometer of the wearable sensor device, acceleration data indicating at least an orientation of the person;

receiving, at a processor, from the at least one magnetometer and the at least one accelerometer of the wearable sensor device, the direction data and the acceleration data indicating the direction and orientation of the person;

comparing, by the processor, the direction and orientation of the person indicated by the direction data and the acceleration data with predefined bed-exit parameters corresponding with a bed exit state;

wherein the predefined bed-exit parameters corresponding with a bed exit state specify a direction orthogonal to a support surface on which the person is supported; and

wherein the comparison step includes determining that the direction data collected by the at least one magnetometer of the wearable sensor device indicates a direction of the person orthogonal to the support surface; and

determining, by the processor, based at least on the comparison, a bed exit state of the person.

10. A method for evaluating a bed exit by a person using a wearable sensor device, the method comprising:

affixing to the person the wearable sensor device comprising at least one sensor;

collecting, by the at least one sensor, sensor data indicating a direction and an orientation of the person;

comparing, by the processor, the direction and orientation of the person indicated by the collected sensor data with predefined bed-exit parameters corresponding with a bed exit state; and

determining a bed exit probability based at least on the comparison of the direction and orientation of the person indicated by the collected sensor data with the predefined bed-exit parameters corresponding with a bed exit state;

comparing the determined bed exit probability with a bed exit probability threshold; and

determining a bed exit state based on the comparison of the determined bed exit probability with the bed exit probability threshold.

12. A method for evaluating a bed exit by a person using a wearable sensor device comprising at least one magnetometer and an at least one accelerometer, the method comprising the steps of:

affixing to the person the wearable sensor device comprising the at least one magnetometer and the at least one accelerometer;

collecting, by the at least one magnetometer of the wearable sensor device, direction data indicating a direction of the person;

collecting, by the at least one accelerometer of the wearable sensor device, acceleration data including static acceleration data indicating the orientation of the person and dynamic acceleration data indicating a movement of the person relative to a support surface;

receiving, at a processor, from the at least one magnetometer and the at least one accelerometer of the wearable sensor device, the direction data and the acceleration data indicating the direction and orientation of the person;

comparing, by the processor, the direction, orientation, and movement of the person indicated by the direction data, the static acceleration data, and the dynamic acceleration data with predefined bed-exit parameters corresponding with a bed exit state; and

determining, by the processor, based at least on the comparison, a bed exit state of the person.

13. A system for evaluating a bed exit by a person, comprising:

a wearable sensor device configured to be worn by the person or secured to an article worn by the person, the wearable sensor device comprising;

at least one magnetometer configured to generate magnetometer data indicating a direction of the person;

at least one accelerometer configured to generate accelerometer data indicating an orientation of the person; and

a processor configured to;

receive the magnetometer data indicating the direction of the person from the at least one magnetometer;

receive the accelerometer data indicating the orientation of the person from the at least one accelerometer;

compare the direction and orientation of the person indicated by the magnetometer data and orientation data with predefined bed-exit parameters corresponding with a bed exit state;

wherein the predefined bed-exit parameters corresponding with a bed exit state include an upright orientation of the person'"'"'s torso, and the comparison step includes determining whether the acceleration data indicates an upright orientation of the person'"'"'s torso; and

identify, based at least on the comparison, a bed exit state of the person.