System and methods for intelligent medical vigilance with bed exit detection

• US 7,629,890 B2
• Filed: 01/17/2007
• Issued: 12/08/2009
• Est. Priority Date: 12/04/2003
• Status: Expired due to Fees

• Current Assignee: Hoana Medical, Inc.
• Original Assignee: Hoana Medical, Inc.
• Inventors: Embree, Paul M., Epperson, Nicholas C., Hebsur, Shashidhar B., Glei, Matthew S., Sullivan, Patrick K.
• Primary Examiner(s): Nguyen; Tai T
• Application Number:
  US11/624,207
• Publication Number:
  US 20070156031A1
• Time in Patent Office: 1,056 Days
• Field of Search: 340/573.1, 340/573.4, 340/573.5, 340/575, 340/576, 340/511, 340/539.12, 600/300, 600/484, 600/537
• US Class Current: 340/573.1
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/046 in a matrix array
• 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 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/01 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 5/02455 provided with high/low alarm devices
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1115 Monitoring leaving of a patient support, e.g. a bed or a wheelchair
• CPC Class Codes: A61B 5/18 for vehicle drivers or machine operators
• CPC Class Codes: A61B 5/6892 Mats
• CPC Class Codes: A61B 5/6893 Cars
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts
• 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 5/743 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 12/00 Accommodation for nursing, e.g. in hospitals, not covered by groups A61G1/00 - A61G11/00, e.g. trolleys for transport of medicaments or food service or tea-tables, trolleys or wagons A47B31/00; Prescription lists
• CPC Class Codes: B60W 2040/0872 Driver physiology
• CPC Class Codes: G08B 21/02 Alarms for ensuring the safety of persons
• 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 40/20 : for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Abstract

An intelligent medical vigilance system that observes and analyzes, and, only in the event of a clinically significant negative condition, notifies and reports the event to the care staff utilizing the hospital'"'"'s existing nurse call system. The device includes a bedside unit connected to a pad or coverlet with a sensor array (placed under the patient) and also to an existing hospital nurse call system via an interface. Within the physical bedside unit are a signal processor and an alarm processor that measure data and evaluate whether a clinically significant event is occurring. The bedside unit is a wall-mounted unit with a display that becomes active when an alarm condition is enabled. The sensing pad or coverlet is a thin, piezoelectric film, or other similar sensing technology, with an array of sensors sheathed in soft padding and is not directly in contact with the skin of the patient. The nurse call feature is made up of hardware, software and cabling to connect to the nurse call system already installed in the hospital or care facility. The monitoring system can also be installed in vehicles to monitor operator physiological conditions. Vigilance alarms are suspended if a patient is detected out of bed. An unable-to-measure alert is provided if the system is unable to reliably monitor. Bed exit alarms can be placed into a pause mode for supervised bed exit of patients on bed restriction. An alert message is generated and maintained on the display screen to inform a responding caregiver of the time and reason for any alarm.

Claims

1. A method for improving reliability of a system for monitoring the physiology of a person, comprising:

placing a first plurality of sensors on a bed configured to detect physiological parameters of the person;

detecting one or more physiological parameters of the person with said first plurality of sensors;

converting the detected parameters to signals;

assigning one or more alarm conditions;

analyzing the signals to determine if they satisfy at least one of the alarm conditions;

activating an alarm when at least one of the signals satisfies an alarm condition;

placing a second plurality of sensors on the bed to detect the presence thereon or absence therefrom of the person;

detecting one or more signals from said second plurality of sensors;

analyzing the signals from said second plurality of sensors to determine whether the person is in bed, out of bed, or attempting to exit the bed; and

preventing any new alarm from being activated when the signals from the second plurality of sensors indicate that the person is out of bed or is attempting to exit the bed, but continuing any alarm which is active before the sensors detect that the person is out of bed or is attempting to exit the bed.

2. The method of claim 1, wherein the new alarms are prevented, alarm remains disabled until the signals from the second plurality of sensors indicate that the patient is in bed.

3. The method of claim 1, further comprising activating a bed exit alarm when the signals from said second plurality of sensors indicate that the person is out of bed or is attempting to exit the bed.

4. The method of claim 3, wherein the bed exit alarm is selectively enabled and disabled by a user.

5. The method of claim 3, wherein the bed exit alarm is a non-latching alarm.

6. The method of claim 1, further comprising:

activating a bed exit alarm when the signals from the second plurality of sensors indicate that the person is out of bed or is attempting to exit the bed;

disabling the bed exit alarm when the person is removed from the bed under supervision;

activating an alert when at least one of the signals from the first plurality of sensors satisfies an alert condition

providing a display;

generating a message on the display to provide an indication of the cause of the alert;

maintaining the message on the display until the display is cleared by a user;

assigning one or more unable-to-measure conditions which indicate that at least some of the signals may be unreliable;

analyzing the signals to determine if they satisfy at least one of the unable-to-measure conditions; and

providing an unable-to-measure alert when at least one of the unable-to-measure conditions is satisfied.

7. The method of claim 6, wherein the unable-to-measure conditions are selected from the group consisting of excessive motion by the person, low signal amplitude, sensor disconnection, sensor failure, and patient parameters outside operational limit.

8. The method of claim 6, further comprising:

placing a plurality of sensors on a bed to detect the presence thereon or absence therefrom of the person;

detecting one or more signals from said sensors on the bed;

analyzing from the second plurality of sensors the signals to determine whether the patient is in the bed; and

wherein the unable-to-measure conditions further comprise the presence of an in-bed determination with the absence of a signal from the sensors configured to detect physiological parameters.

9. The method of claim 6, wherein the unable-to-measure alert is provided only when the at least one unable-to-measure condition persists for a predetermined minimum period of time.

10. The method of claim 6, wherein the unable-to-measure alert comprises a sequence of dashes on the display.

11. The method of claim 6, wherein the display is placed in a room with a patient.

12. The method of claim 6, wherein the message provides an indication of the type of alert, the parameter values which trigged the alert, and the time of day the alert was activated.

13. The method of claim 12, wherein the message provides an indication of the first alert cause when multiple alerts of the same type occur.

14. The method of claim 12, wherein multiple messages are generated on the display when multiple alerts of the same type occur.

15. The method of claim 6, wherein a plurality of said messages are maintained simultaneously on the display in priority order.

16. The method of claim 6, further comprising automatically enabling the bed exit alarm upon expiration of a predetermined period of time.

17. The method of claim 6, wherein the bed exit alarm is disabled by pressing a button.

18. The method of claim 17, wherein the bed exit alarm is enabled if the button is pressed again prior to the expiration of a predetermined period of time.

19. Apparatus for monitoring the physiology of a person, comprising:

one or more physiological sensors adapted to be placed on a bed to detect physiological parameters of a person in the bed and generate corresponding electrical signals;

a processor configured to analyze the signals from the sensors to determine if the physiological parameters of the person satisfy at least one alarm condition;

an alarm system in communication with the processor for activating an alarm when at least one of the physiological parameters satisfies an alarm condition; and

one or more bed exit sensors adapted to be placed on the bed to detect whether the person is in bed or out of bed and generate corresponding electrical signals;

the processor being configured to analyze the signals from the bed exit sensors to determine whether the person is in bed and to prevent any new alarms from being activated when the processor determines that the person is out of bed, but to continue any alarm which is active before the processor determines that the person is out of bed.

20. The apparatus of claim 19, wherein the bed exit sensors are further adapted to detect when the person is attempting to exit the bed, and the processor is further configured to prevent any new alarms from being activated when the signals from the bed exist sensor indicate that the person is attempting to exit the bed.

21. The apparatus of claim 19, wherein the processor is further configured to continue analyzing the signals from the physiological sensors while preventing the new alarms from being activated.

22. The apparatus of claim 19, wherein the processor is further configured to enable the alarm only when the signals from the bed exit sensors indicate that the person is in the bed.

23. The apparatus of claim 20, further comprising a bed exit alarm system in communication with the processor for activating a bed exit alarm when the signals from the bed exit sensors indicate that the person is out of bed or is attempting to exit the bed.

24. The apparatus of claim 23, wherein the bed exit alarm system can be selectively enabled and disabled by a user, the processor being configured to prevent the new alarms from being activated even when the bed exit alarm is disabled.

25. The apparatus of claim 19, wherein the physiological sensor and the bed exit sensor are mounted in a common sensing array.