Wireless patient monitoring systems and methods

• US 10,383,527 B2
• Filed: 08/31/2016
• Issued: 08/20/2019
• Est. Priority Date: 08/31/2015
• Status: Active Grant

• Current Assignee: Masimo Corporation
• Original Assignee: Masimo Corporation
• Inventors: Al-Ali, Ammar
• Primary Examiner(s): Towa, Rene T
• Assistant Examiner(s): Melhus, Benjamin S
• Application Number:
  US15/253,567
• Publication Number:
  US 20170055887A1
• Time in Patent Office: 1,084 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 2562/0204 Acoustic sensors
• 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 2562/0271 Thermal or temperature sensors
• CPC Class Codes: A61B 2562/029 Humidity sensors
• CPC Class Codes: A61B 2562/166 the sensor is mounted on a specially adapted printed circuit board
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/0015 characterised by features of the telemetry system
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/004 adapted for image acquisition of a particular organ or body part A61B5/0082 takes precedence; arrangements for optical scanning A61B5/0062
• 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 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• 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 5/1116 : Determining posture transitions
• CPC Class Codes: A61B 5/1117 : Fall detection
• CPC Class Codes: A61B 5/1118 : Determining activity level
• CPC Class Codes: A61B 5/1121 : Determining geometric values, e.g. centre of rotation or angular range of movement
• CPC Class Codes: A61B 5/1126 : using a particular sensing technique
• CPC Class Codes: A61B 5/113 : occurring during breathing
• CPC Class Codes: A61B 5/14551 : for measuring blood gases
• CPC Class Codes: A61B 5/14552 : Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/25 : Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/318 : Heart-related electrical modalities, e.g. electrocardiography [ECG]
• 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 5/6801 : specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6823 : Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/68335 : including release sheets or liners
• CPC Class Codes: A61B 5/7264 : Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• 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 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/743 : Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/746 : Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61G 2203/32 : for force
• CPC Class Codes: A61G 2203/36 : for motion
• 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: G01K 1/16 : Special arrangements for conducting heat from the object to the sensitive element
• CPC Class Codes: G01K 13/20 : Clinical contact thermometers for use with humans or animals
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment

Abstract

A patient monitoring system to help manage a patient that is at risk of forming one or more pressure ulcers is disclosed. The system includes a patient-worn wireless sensor that senses the patient'"'"'s orientation and wirelessly transmits information indicative of the sensed orientation to a patient monitor. The patient monitor receives, stores, and processes the transmitted information. It also displays and transmits information indicative of the patient'"'"'s orientation to help caregivers manage the patient'"'"'s risk of formation of one or more pressure ulcers. The system can identify the present orientation of the patient and determine how long the patient has been in the present orientation. If the patient remains in an orientation beyond a predefined duration, the system can notify the patient and/or caretakers that the patient is due to be repositioned.

Claims

1. A method to reduce a risk that a monitored patient will develop one or more pressure ulcers by pairing a wireless physiological sensor with a patient monitoring device in a caregiver environment where other wireless sensors may be paired with and communicating with other patient monitoring devices,

the physiological sensor including a movement sensor, a first processor, and a first wireless transceiver, the physiological sensor configured to eventually be positioned with respect to a surface of said monitored patient to transmit information responsive to one or more of a movement of the patient, a lack of movement of the patient, or both, said physiological sensor being disposable and configured for power activation from an inactive powered-down state,

the patient monitoring device including a second processor, a memory device, a storage device, a display, and a second wireless transceiver, the patient monitoring device responsive to the transmitted information from the physiological sensor to present to a caregiver patient information indicative of said risk of said pressure ulcers,

the method comprising:

upon activation of initial power in said physiological sensor, automatically electronically entering a default mode of operation in said physiological sensor, wherein the default mode of operation initiates a pairing mode of operation in said physiological sensor, wherein the default mode is a low-power mode;

wirelessly transmitting from said physiological sensor a low-power pairing signal based on a first transmission protocol comprising a frequency of transmission configured to be effective for a limited pairing signal transmission range, thereby preventing unintended or incidental association of said physiological sensor with said other patient monitoring devices that may be nearby but which are not intended to be paired with said physiological sensor, said low-power pairing signal including information identifying said physiological sensor;

in said physiological sensor, electronically receiving a confirmation signal from said patient monitoring device confirming that said physiological sensor has been paired with said patient monitoring device responsive to a user physically moving the physiological sensor in proximity with the patient monitoring device that is stationary during the default mode of operation;

upon said receipt of said confirmation signal in said physiological sensor, automatically electronically exiting said pairing mode of operation with said physiological sensor and subsequently initiating a patient parameter sensing mode of operation using said physiological sensor; and

wirelessly transmitting to said patient monitoring device from said physiological sensor, a patient parameter sensing signal based on said first transmission protocol and said frequency of transmission, said patient parameter sensing signal configured to be effective for a patient parameter sensing signal transmission range, and using said physiological sensor, increasing power to said patient parameter sensing signal transmission range, said patient parameter sensing signal including information indicative of said risk of said pressure ulcers,

wherein said pairing signal transmission range is predetermined to be effective up to one (1) foot and said patient parameter sensing transmission range is predetermined to be effective up to thirty (30) feet.

2. The method of claim 1, wherein said wirelessly transmitting said low-power pairing signal comprises wirelessly transmitting said low-power pairing signal configured to be effective within zero (0) to eleven (11) inches.

3. The method of claim 1, wherein said wirelessly transmitting said low-power pairing signal comprises wirelessly transmitting said low-power pairing signal configured to be effective within zero (0) to nine (9) inches.

4. The method of claim 3, wherein said wirelessly transmitting said low-power pairing signal comprises wirelessly transmitting said low-power pairing signal configured to be effective within zero (0) to six (6) inches.

5. The method of claim 4, wherein said wirelessly transmitting said low-power pairing signal comprises wirelessly transmitting said low-power pairing signal configured to be effective within zero (0) to three (3) inches.

6. The method of claim 1, wherein said wirelessly transmitting said patient parameter sensing signal comprises wirelessly transmitting said patient parameter sensing signal configured to be effective up to ten (10) feet.

7. The method of claim 1, wherein said wirelessly transmitting said patient parameter sensing signal comprises wirelessly transmitting said patient parameter sensing signal configured to be effective up to three (3) meters.

8. The method of claim 1, wherein said wirelessly transmitting said low-power pairing signal and said patient parameter sensing signal comprises wirelessly transmitting said patient parameter sensing signal configured to be effective over a first transmission range which is an order of magnitude greater than a second transmission range of said low-power pairing signal.

9. The method of claim 1,

wherein said transmitting said low-power pairing signal and said patient parameter sensing signal further comprises transmitting to an extender/repeater, and

wherein said receiving said confirmation signal further comprises receiving from said extender/repeater.

10. The method of claim 1, comprising:

sensing acceleration using an accelerometer of said patient movement sensor and angular velocity using a gyroscope of said patient movement sensor;

with said first processor, processing signals responsive to said sensed acceleration and angular velocity; and

with said first wireless transceiver, transmitting said patient parameter sensing signal responsive to said processing.

11. The method of claim 1, wherein said transmitting said low-power pairing signal further comprises transmitting a message indicating that said wireless physiological sensor has been previously activated.

12. The method of claim 1, wherein said transmitting said low-power pairing signal further comprises transmitting a notification indicating that a quality standard associated with said physiological sensor is compromised.

13. The method of claim 1, wherein said transmitting said patient parameter sensing signal further comprises transmitting a message indicating that said physiological sensor is nearing an end of service life.

14. The method of claim 1, wherein activation of initial power in said wireless physiological sensor comprises removing a battery isolator from said wireless physiological sensor.

15. A method to reduce a risk that a monitored patient will develop one or more pressure ulcers by pairing a wireless physiological sensor with a patient monitoring device in a caregiver environment where other wireless sensors may be paired with and communicating with other patient monitoring devices,

the physiological sensor including a movement sensor, a first processor, and a first wireless transceiver, the physiological sensor configured to eventually be positioned with respect to a surface of said monitored patient to transmit information responsive to one or more of a movement of the patient, a lack of movement of the patient, or both, said physiological sensor being disposable and configured for power activation from an inactive powered-down state and further configured to enter a default mode of operation which initiates a pairing mode of operation in said physiological sensor, wherein the default mode is a low-power mode,

the patient monitoring device including a second processor, a memory device, a storage device, a display, and a second wireless transceiver, the patient monitoring device responsive to the transmitted information from the physiological sensor to present to a caregiver patient information indicative of said risk of said pressure ulcers,

the method comprising:

in said patient monitoring device, automatically electronically receiving a low-power pairing signal transmitted from said wireless physiological sensor upon activation of initial power in said physiological sensor, wherein said transmitted low-power pairing signal is based on a first transmission protocol comprising a frequency of transmission and is configured to be effective for a limited pairing signal transmission range, thereby preventing unintended or incidental association of said physiological sensor with said other patient monitoring devices that may be nearby but which are not intended to be paired with said physiological sensor, said low-power pairing signal including information identifying said physiological sensor;

in said patient monitoring device, automatically electronically associating said wireless physiological sensor with said patient monitoring device, said patient monitoring device responsive to a user physically moving the wireless physiological sensor in proximity to the patient monitoring device that is stationary during the default mode of operation;

wirelessly transmitting to said wireless physiological sensor, a confirmation signal confirming that said wireless physiological sensor is associated with said patient monitoring device; and

upon receipt of the confirmation signal in said physiological sensor, in said patient monitoring device, receiving a patient parameter sensing signal transmitted from said physiological sensor, wherein said transmitted patient parameter sensing signal is based on said first transmission protocol and said frequency of transmission and is configured to be effective for a patient parameter sensing signal transmission range, and using said physiological sensor, increasing power to the patient parameter sensing signal transmission range, said patient parameter sensing signal including information indicative of said risk of said pressure ulcers,

wherein said pairing signal transmission range is predetermined to be effective up to one (1) foot and said patient parameter sensing transmission range is predetermined to be effective up to thirty (30) feet.

16. The method of claim 15, wherein said patient parameter sensing signal is responsive to an orientation of said patient at a first time period and at a second time period;

the method comprising processing said patient parameter sensing signal to determine whether there is a difference in said patient parameter sensing signal between said first time period and said second time period that indicates a patient turn.

17. The method of claim 15, wherein said patient parameter sensing signal is responsive to a sensor data vector comprising data elements;

the method comprising electronically;

processing said data elements to determine a plurality of features indicative of a patient fall to form a feature vector;

applying a weight vector to said feature vector to derive an activation value;

analyzing said activation value to determine whether the patient has fallen; and

reporting a patient fall in response to a determination that a patient fall has occurred.

18. A system for reducing a risk that a monitored patient will develop one or more pressure ulcers by pairing a wireless sensor with a portable computing device in a caregiver environment where other wireless sensors may be paired with and communicating with other computing devices, the system comprising:

a wireless sensor comprising an accelerometer, a gyroscope, a first processor, and a first wireless transceiver, said wireless sensor being disposable and configured for power activation from an inactive powered-down state, said wireless sensor configured to, upon activation of initial power in said wireless sensor, automatically electronically enter a default mode of operation, the default mode of operation being a low-power mode, wherein the default mode of operation initiates an association mode to transmit a low-power association signal a limited desired association transmission range, thereby preventing unintended or incidental association of said wireless sensor with said other computing devices that may be nearby but which are not intended to be paired with said wireless sensor, said low-power association signal based on a first transmission protocol comprising a frequency of transmission, the wireless sensor also configured to operate in a patient parameter measurement mode to transmit a measurement signal a desired measurement signal transmission range, said measurement signal based on said first transmission protocol and said frequency of transmission, wherein said association transmission range is predetermined to be effective up to one (1) foot and said measurement signal transmission range is predetermined to be effective up to thirty (30) feet; and

a portable computing device comprising a second processor, a memory device, a storage device, a display, and a second wireless transceiver, said computing device configured to automatically electronically receive said association signal, said computing device also configured to transmit an association confirmation signal, and said computing device also configured to receive said measurement signal;

wherein said computing device, in response to receiving said association signal, automatically electronically associates said wireless sensor with said computing device and automatically electronically transmits said association confirmation signal, said portable computing device responsive to a user physically moving the wireless sensor in proximity to the portable computing device that is configured to be stationary during the default mode of operation; and

wherein said wireless sensor, upon receipt of said association confirmation signal, discontinues operating in said association mode, begins to operate in said patient parameter measurement mode and to transmit said measurement signal, and increases power to said measurement signal transmission range.