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WO2015172246A1 - Système de surveillance multifonctionnel comprenant des capteurs fixés à un article absorbant - Google Patents

Système de surveillance multifonctionnel comprenant des capteurs fixés à un article absorbant Download PDF

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Publication number
WO2015172246A1
WO2015172246A1 PCT/CA2015/050426 CA2015050426W WO2015172246A1 WO 2015172246 A1 WO2015172246 A1 WO 2015172246A1 CA 2015050426 W CA2015050426 W CA 2015050426W WO 2015172246 A1 WO2015172246 A1 WO 2015172246A1
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WO
WIPO (PCT)
Prior art keywords
patient
temperature
alarm
processor
garment
Prior art date
Application number
PCT/CA2015/050426
Other languages
English (en)
Inventor
Eugen Cretu-Petra
Original Assignee
EM Medical LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US14/278,261 external-priority patent/US9545342B2/en
Application filed by EM Medical LLC filed Critical EM Medical LLC
Publication of WO2015172246A1 publication Critical patent/WO2015172246A1/fr

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Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/002—Monitoring the patient using a local or closed circuit, e.g. in a room or building
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/202—Assessing bladder functions, e.g. incontinence assessment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/6808—Diapers
    • A—HUMAN NECESSITIES
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    • A61B5/7282—Event detection, e.g. detecting unique waveforms indicative of a medical condition
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    • A61B5/746—Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
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    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
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    • A61B5/024—Measuring pulse rate or heart rate
    • A61B5/02438—Measuring pulse rate or heart rate with portable devices, e.g. worn by the patient
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    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/1113—Local tracking of patients, e.g. in a hospital or private home
    • A61B5/1115—Monitoring leaving of a patient support, e.g. a bed or a wheelchair
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/1116—Determining posture transitions
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    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/113—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb occurring during breathing
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/44—Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441—Skin evaluation, e.g. for skin disorder diagnosis
    • A61B5/445—Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/6804—Garments; Clothes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271—Specific aspects of physiological measurement analysis
    • A61B5/7275—Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
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    • A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
    • A61B5/7435—Displaying user selection data, e.g. icons in a graphical user interface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/42—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators with wetness indicator or alarm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/84—Accessories, not otherwise provided for, for absorbent pads

Definitions

  • Multifunctional Monitoring System Comprising Sensors Attached to an Absorbent Article
  • the invention relates to monitoring systems for monitoring various functions of patients in nursing homes, hospitals or home care.
  • a problem with previous systems is that their useful life is limited to detecting only one urination or defecation event. Since typically such monitors use sensors that are inside the diaper, once the diaper is wet or soiled, for example, subsequent events cannot be detected. There is therefore a need for a monitoring system in which the diaper is useful for more than one incontinence event. There is also a need for a monitoring system which can detect, monitor and report multiple events of urination or defecation without the diaper or other garment having been changed. There is a further need for a system in which the attendant can determine how many incontinence events have occurred in the diaper, the volume of such events, how long since the last event and how frequent the events are. There is a further need for systems for monitoring incontinence which can be used in wound management.
  • a monitoring system which can detect, monitor and report multiple events of urination or defecation without the diaper or other garment having been changed. More particularly the need for a transducer or sensor which must stay inside diaper which, once it becomes wet or soiled cannot detect a second soil-ness/wetness is avoided. Temperature variations are measured on the diaper surface. Sensor variations are interpreted by an intelligent processor suitably programmed with software to detect and measure more than one urination or defecation event in the same diaper. [0010] Further an embodiment may also provide an accelerometer and related software working with the same processor to make possible more accurate detection of incontinence events and also possibly patient turn-check as part of wound management, fall, position or orientation and motion.
  • Embodiments may measure body temperature, air temperature, oxygen concentration in the blood and blood pressure or other variables or characteristics.
  • the system links sensors, interfaces and care-giver pagers or smartphones by Wi-Fi through a central computer to co-ordinate processing and recordal of data from multiple patients.
  • Embodiments therefore provide a system for monitoring multiple patients to an individually determined standard of institutional or home care, for incontinence, wound management, patient location for wandering or falls.
  • the system may include a portable and reusable multi-sensory device, wherein all sensors are on the external surface of the diaper or the patient's skin and thus are reusable.
  • the device may be attached on each patient with wireless connection to a nurse pager by RF signal or to a server through a Wi-Fi, GPS and GPRS interface.
  • This server may allow monitoring on terminals or caregivers' portable devices such as mobile phone or tablet to receive and record alarms for immediate attention, and other data for future analysis for one or multiple patients.
  • the system increases the quality of care for one patient in home care or multiple patients while allowing the caregiver to reduce costs.
  • FIG. 1 is a schematic diagram and circuit diagram illustrating a monitoring system according to a first embodiment of the invention
  • Fig. 2 is a cross-sectional view illustrating the multi-sensory device installed on a diaper
  • FIG. 3 illustrates the construction of a temperature sensor according to the invention
  • FIG. 4 and 5 illustrate two variants of the sensor connections shown in Fig. 2;
  • FIG. 6-8 are schematic diagrams illustrating the circuitry of alternative embodiments of the multisensory device.
  • FIG. 9 is a schematic diagram illustrating an embodiment of the communication system used in the invention.
  • FIG. 10 is a schematic diagram illustrating an embodiment of the patient interface used in the invention.
  • Fig. 11 and 12 are screen shots of a caregiver smartphone used in the invention.
  • Fig. 13 is a schematic diagram illustrating the circuitry of the multisensory device and patient interface
  • Fig. 14 is a graph illustrating detection of events by a temperature sensor
  • Fig. 15 is a schematic diagram illustrating the functioning of the invention in a multi-room healthcare facility
  • Fig. 16 - 18 are schematic diagrams illustrating further embodiments of the communication system used in the invention.
  • Fig. 19 - 33 are screen shots of the monitoring application (MA) which controls the functions of the system, on the Doctor's and Nurse's systems respectively. Description
  • a first embodiment comprises a system for monitoring patients in nursing homes, hospitals or home care where a patient has a multi-sensory device Dl which wirelessly communicates with one nurse pager PI such as by radio frequency signals.
  • the devices Dl Preferably have a long RF range of a minimum 100 yards, transmitting for example at 900 MHz.
  • multi-sensory device Dl incorporates urination sensors SI, S2, defecation sensor S3, body temperature sensor Sb, air temperature sensor Sa, reflective pulse oximeter O, blood pressure meter and pulse detector Bp, accelerometer ACC, micro controller C, and RF transmitter or transceiver T.
  • Micro controller C may be for example a PIC micro controller from Microchip.
  • Accelerometer ACC may be for example a Freestyle Semiconductor's micro- machined (MMA) series accelerometer. Accelerometer ACC outputs are wired to microcontroller C analog to digital inputs. A nurse call button B may be provided on Dl.
  • MMA Freestyle Semiconductor's micro- machined
  • Nurse pager PI may have a display SCR such as an LCD color display, cell phone vibrator V, buzzer or beeper Bz, micro controller C, and RF transmitter or transceiver T.
  • Button B on PI may be provided to be pressed after an alarm is resolved, which will cancel the alarm on PI and the alarm display on SCR.
  • a first embodiment of multisensory device Dl designated as 10, is illustrated attached by adhesive tape to a diaper 24 worn on patient 26, shown in cross-section.
  • Urination sensors SI and S2, designated as 28 and 30 and defecation sensor S3, shown as 32 are attached to the outer surface of diaper 24.
  • Body temperature sensor Sb, shown as 36 is attached to the skin of patient 26.
  • Air temperature sensor Sa shown at 34 is provided on the exterior of device 10.
  • Oximeter O and pulse and blood pressure sensors Bp can be together in the same sensor body with Sb and connected through the same jack connector to detector body 11 or can be separately connected to detector body 11 through a cable as other sensors.
  • Oximeter O and pulse and blood pressure sensors Bp can be applied directly to the patient body, for example on a finger, stomach or on a leg.
  • urination sensors 28 and 30 and defecation sensor 32 are preferably temperature sensors which may each comprise thermistors 37 of the type used in electronic medical thermometers, stainless steel covered, which are each fixed in and extend from a plastic disc as shown in Fig. 3.
  • Urination sensors 28 and 30 and defecation sensor 32 may for example be secured to the diaper 24 exterior surface by a removable adhesive surface attached to the sensor.
  • Preferably two sensors are used for sensing a urine event and one for defecation.
  • a single urine sensor may be sufficient.
  • one urine sensor 28 is on the detector body 11 which is a plastic shell in tight contact with the diaper 24 and the second sensor 30 is on the cable 13 as described.
  • Sensors 37 have a stainless steel cover and are soldered/assembled on a thin elastic printed circuit board (PCB) film.
  • both urine sensor 30 and defecation sensor 32 may be connected to the device through a single cable 13 and jack 31.
  • Jack 33 and cable 15 as shown in Fig. 5 connect a single sensor and can be used to connect body temperature sensor 36 when connected to the upper side of detector body 11 or the defecation sensor 32, when it is connected to lower side of detector body 11.
  • Either jack 33 with one sensor or jack 31 with two sensors can be connected to the lower female connector depending on the size of the patient, smaller for jack 33 and bigger for jack 31, and the software on microcontroller C distinguishes which sensors are connected to each female connector.
  • Jacks 31 and 33 can be of the audio plug type and cables 13, 15 are preferably flexible cables less than 1.5 mm in diameter.
  • Device 10 measures outputs from the accelerometer ACC and all other sensors, preferably very frequently, for example, at least 10 times per second.
  • Accelerometer ACC measures co-ordinate acceleration and also orientation and can measure position by reference to a fixed position, whether pre-defined or taken from a GPS, through measurement of the change in co-ordinate motion.
  • the ACC integrated circuit is positioned on device 10's printed circuit board (PCB) in such way that its sides, the PCB sides and detector body 11 plastic shell's sides are aligned.
  • ACC position or orientation is the same as patient position or orientation and thus patient position or orientation is determined by measuring and interpreting the ACC three axis outputs. This also applies when the ACC measures acceleration. Acceleration and position or orientation is given by those three axes' amplitude. Adding those three outputs provides patient motion intensity.
  • the patient walking/running direction, steps cadence and speed can be calculated.
  • Such measuring at high frequency such as at least 10 times per second, is necessary to determine when the patient leaves his/her bed or when the patient urinates or defecates.
  • the difference between urination and defecation is detected by the position of the temperature sensor where the temperature increase occurred. For example if in a certain period of time there is measured at one of the sensors 28, 30 or 32 a temperature rise of a certain minimal value such as 0.2 degrees, this rise is interpreted by controller C as a urination or defecation detection, depending on which sensor was detected.
  • the specific temperature rise will depend on the specific type of diaper, whether paper or cloth, size and thickness of the absorbent material, diaper starting temperature, and urine or defecation quantity and rate of flow.
  • the temperature rise will also depend on the frequency of incontinence events. A greater frequency of events will mean less time between each event and less temperature rise at each event, but no matter how high the frequency is there will always be a minimal rise, for example of at least 0.2 degrees detected within a certain time period.
  • the increase in temperature at the diaper outer surface can also be influenced by the patient's position or orientation in bed.
  • the multi- sensory device 10 comes between the patient and the bed which further insulates the diaper and temperature measured at the diaper surface can increase a few tenths of a degree.
  • the microcontroller C will take the position or orientation measured by the accelerometer ACC into the calculation in determining whether an incontinence event has occurred.
  • the temperature at the diaper surface can also be affected by the patient uncovering herself and by a change in the ambient air temperature, which the microcontroller C will take into account from measurements at
  • Microcontroller C takes into account the starting temperature, rate of increase, time to the maximum temperature, and total temperature rise, as well as the patient position or orientation and temperature at sensor Sa, 34, to estimate volume and rate of flow of each event. Microcontroller C calculates and records the measurements and determines when an alarm condition is fulfilled. When the maximum number of urinations or defecations is reached, an alarm can be signaled and sent to pager PI, or whether these detections occurred too often or they were too rare. These may be symptoms of patient problems such as diarrhea, constipation, cystitis, prostate problems, etc. When a urination or bowel movement occurs the pager PI receives the detection signal and displays that there is a urination or a bowel movement. The pager also counts how many times these events occurred.
  • One of the advantages of this method is that the system can detect more than one urination or defecation in the same diaper with reusable sensors, which work outside on the diaper surface. That is of benefit for the patient as well as for nurse and health care facility by savings on diapers and nurse time.
  • a Multi-Sensory OFF alarm is given when the multisensory device 10 falls off of the patient diaper or skin. This detection is done with heat sensor SI (28) located on detector body 11 and in direct contact with diaper 24.
  • controller C measures a decrease in temperature at this sensor 28 and gives the alarm.
  • Sensor S2 (30) OFF and/or sensor S3(32) OFF alarm is achieved in the same way. When C measures a decrease in temperature at one or both of these sensors this alarm is given. In a situation where only one sensor 32 is connected to multisensory device 10, an alarm is given correspondingly. These alarms may be given by sound and visually whether on computer and nurse pager PI and are recorded in the computer. When at least one of the above alarms are given, multisensory device 10 may not transmit any data until the nurse reattaches the parts and pushes the reset button.
  • Another embodiment of multisensory device 10, shown as Dl.a in Fig. 6 contains all or some of the sensors as shown in the embodiment in Fig. 1 plus an extra
  • Device Dl.a communicates with pager PI as shown in Fig. 1 by 900MHz radio-frequency signal.
  • microcontroller C turns off transmitter or transceiver T and turns on the GPS module
  • a multisensory device 10 having the features of Dl .a can be used in the other two embodiments D2.a and D3.a described below.
  • FIG. 7 illustrates another embodiment of multisensory device 10 designated Dl.b similar to Dl.a but without a transmitter or transceiver T.
  • Alarms and data are transmitted by GPRS as coded SMS messages to a nurse/caregiver pager PI or smart phone.
  • a custom application in the smart phone decodes alarms and data and displays it by sound and on screen. All data is recorded in smart phone memory to be downloaded later.
  • a smart phone may send all data received to a server by Wi-Fi.
  • Alarms can be received at any distance between patient and nurse.
  • a nurse smart phone can receive alarms and data from more than one patient each having a device 10 as in Dl.b.
  • the caregiver/attendant activates from his/her smart phone the GPS module in Dl.b, patient position can be detected with nurse smart phone as in Dl.a.
  • Figure 8 illustrates another embodiment of multi-sensory device 10 designated Dl.c and contains all or some sensors as in the embodiment shown in Fig.
  • Dl.c can communicate data with the patient's smart phone or issued pager (not shown), which transmits data further to a server.
  • Device Dl .c sleeps when there is no alarm to be transmitted and wakes up just to transmit the alarm.
  • Dl .c communicates directly with a smart phone which displays and records data in it. It can be any smart phone having installed the required application. The advantage is that the attendant's own smart phone can be used for this purpose. Alarms can be received anywhere a Wi-Fi service is available in the facility.
  • Dl.c can also be used in the embodiments shown In Fig. 1, 6 and 7.
  • ACC outputs and by them calculates patient position or orientation.
  • Device 10 is affixed upside up on the patient's front, on the diaper as in Fig. 2 or on the patient's body front, with adhesive tape.
  • the position of the accelerometer ACC and its three outputs depends on device 10's position. Being affixed on the diaper 24, the accelerometer ACC output thus depends on the diaper wearer position or orientation.
  • Microcontroller C in device 10 measures ACC outputs and calculates patient position or orientation by its software. All position or orientations such as Stand Up, Lay Down, Left Side, Right Side, Face Down, Face Up are transmitted to nurse pager PI or server and monitoring application MA through interface 12, 14 and Wi-Fi as described below in the second and third embodiments. MA analyzes these position or orientations and their timing and sends alarms and data by Wi-Fi to pager PI.
  • OFF SEAT alarm is used in situations where it is important to get an alarm when a patient just rises from a seated position. In that case device 10 is affixed on the patient's thigh front so that device 10 is upside up when the patient is standing.
  • the alarm may be off when patient half rises and an alarm, which may include a local beeper or vibrator included in Detector 10 to alert when the patient rises out of a chair.
  • ACC outputs for patient movement and acceleration are measured by C in multisensory device 10. In this way patient movement and steps can be detected. Knowing the timing between steps, number of steps and the acceleration of each step, C can calculate the speed, distance walked or run by the patient, motion intensity and total motion in a certain time, like a nurse's shift or a day.
  • a patient agitation alarm may be given when a prescribed motion acceleration value stored in the MA table is reached or exceeded. Values of motion as a result of ACC output values are determined based on empirical data. In order to determine patient motion intensity per unit of time, C receives accumulated measurements from all three outputs of the ACC over a short period of time, on the order of a few seconds.
  • a Patient Fall is detected when the patient changes his/her position from Stand Up to Lay Down in less than a certain time and a certain minimum motion has been detected.
  • the parameters for analyzing this data are determined empirically.
  • Up and Go alarm is detected when patient changes position from Lay Down to Stand Up in less than certain time and immediately thereafter walks a few steps. Walking is calculated from motion intensity and variation of acceleration on a certain axis which shows when the patient made each step. If this alarm is associated with distance between D2 and 12 (defined below) it shows with certainty when patient left his/her bed.
  • the ACC can identify patient lying face up, face down, left or right side, and stand up, and alerts the nurse when patient is agitated, and moves too quickly. It further alerts nurse when patient has left bed and taken steps.
  • the MA can program patient's maximum range of travel, in association with the GPS can locate the patient inside or outside the facility radius, and the nurse sees patient location on her pager screen.
  • UP alarm is given when patient position or orientation has changed from Lay Down to Stand up in less than a certain time limit.
  • Position alarm is given when patient is in one of the selected positions listed in Fig. 19.
  • the Wound Management or Turn-Check alarm uses the same ACC whose outputs are analyzed by C and transmits patient position or orientation to MA through 12 or 13, Wi-Fi and server S2 or S3. In this case only position or orientations in bed are needed, such as Left Side, Right Side, Face Down and Face Up.
  • MA analyzes the time patient was in one of these position or orientations and if the patient did not turn to another position or orientation within a prescribed time tries first to wake the patient by waking sounds by MP3 module.
  • a minimum time and a maximum time can be set in the MA table (see Fig. 19). Both are as set, for example by a doctor.
  • the minimum time also called Oxygenation time, is the minimum for a certain position or orientation to be considered as enough for oxygenation of a wound. If patient stays less than this time in a position or orientation, the system does not consider that the time was enough for re-oxygenation of body wound. Usually this time is around 15 minutes. If the patient stays in one position or orientation longer than the maximum time prescribed and entered in the MA table, at first wake-up sounds are played to the patient, then the alarm of Turn- Check is sent to nurse pager P2 or P3.
  • the three axis accelerometer ACC sends its data on three lines to its amplifier and its microcontroller C. Each line corresponds to variation in accelerations on one of the three axes.
  • the position of the accelerometer ACC is given by the Detector Dl's printed circuit board contained inside of the Detector Dl. Slight breathing motion may also be detected with the accelerometer ACC. Different position or orientations of diaper wearer are detected with accelerometer ACC. If no motion has been detected a no motion alarm is sent to pager PI , P2 or P3.
  • the table in the MA in Fig. 19 can be set to send an alarm when the patient comes out from a coma or from a very long period of no motion.
  • Breath detection is obtained with the same accelerometer ACC by adding an amplifier to the 3 outputs of the accelerometer and programming it accordingly in Controller C. Controller C measures and calculates all outputs from accelerometer ACC. Breath count and its frequency is done by measuring and interpreting ACC outputs oscillations in time, their maximums and minimums and counting them. If in a certain time period these outputs are under a certain value determined by preliminary tests, absence of breath or motion has been detected and an alarm is sent to pager PI. If a patient stops moving and breathing an alarm is signaled and a Nurse can intervene.
  • monitoring table MA is setup to alarm when patient starts moving.
  • FIG. 15 is a schematic of a section of an institution in which each patient 100 has his/her own multisensory device 10/Dl on his/her body on a diaper or secured to the patient's body with adhesive tape.
  • Patient position in a room 102 can be in bed or out of bed.
  • a patient interface 14 is provided in each room 102 .
  • Such interfaces are at fixed locations with power supplied through wall outlets.
  • In the hallway 104 is a patient 100 who may be walking. All interfaces in the vicinity receive the
  • Door detectors associated with described location detection method can give a better idea about patient location, the door he/she is at and the direction patient has passed door.
  • Such door detectors can be installed at all doors or only at main doors such as entrance or back doors which go outside.
  • These repeaters Rn are wall plugged for power with voltage adapters and are on all the time.
  • a door Detector DD comprises one repeater R connected to an optical motion sensor OMS installed on top of each side of the door. Optical sensors are oriented in such a way to detect patient only when is very close to the door. When patient approaches the door on one side, optical motion sensor detects patient and wakes R up. Repeater R "interrogates" patient Device 10 and finds out its identity.
  • Video camera VCn is located over the patient bed or in any other places of interest. It is wired to a repeater R which is an interface 12 or 13 without MP3 module. Repeater transmits video or still images to server S2. VCn are wall plugged for power with voltage adapters and are on all the time. Images are seen on the computer PC and nurse pager or tablet.
  • Transmission frequency varies as function of patient position, mobility and location. When a patient is in bed, transmission frequency is low, perhaps once in 10-
  • Nurse Call is produced when button B is pressed on device 10 and if this alarm is checked in the monitoring application MA table 200 in server S2 or S3. Nurse Reminder is an alarm to remind nurse when she has to do something. It produces an alarm if alarm is checked in MA table 200. The reminder allows the nurse to enter the specified time of reminder and what the nurse has to be reminded about.
  • a Distance alarm is given when a certain value in MA table 200 or location is reached and only if this alarm is checked in the table. Values are chosen conventionally and are approximately proportional to the distance between device 10 and interface 12 or 13. They are obtained by measuring the amplitude of signal received by transmitter, transceiver T in 12 or 13. The location is determined as the closest interface.
  • Too Hot and Too Cold alarms are generated as a function of the values written in MA table 200 at Air Temp cold and hot temperature limits. If the measured temperature by sensor 34 (Sa) is equal to or less than the limit prescribed at Cold column in the table 200, a Too Cold Alarm is generated. If the measured temperature is equal to or higher than the value recorded at Hot column in MA table 200 a Too Cold Alarm is generated. If the measured temperature is equal to or higher than the value recorded at Hot column in MA table 200 a Too
  • Hot alarm is generated at pager PI or 118 (P2 or P3). Ambient air temperature is always displayed at pager PI or 118 (P2). A Fever alarm is generated if temperature measured at Sb is equal or bigger than value recorded in table under Body Temp (see Fig. 19). Thus Sensor 34 sends to microcontroller C data about temperature at the detector 10 exterior surface. If the diaper wearer is uncovered or it is too cold or too hot, the pager 118 alarms the attendant. Alarms are also given if measured pulse, oxygen concentration in blood and blood pressure are out of setup limits. Air temperature and body temperature are measured at all times for all patient locations to protect the patient's life.
  • Data transmission from Dl device 10 occurs at equal intervals of time and is organized in bits of data which are transmitted sequentially as binary strings.
  • this binary string contains in sequential order: a code of identification of device 10 followed by 0 or 1 if device 10 works in normal mode with occasional (10 minutes) sync transmissions or in search mode (once or twice per second), urination detection (0 or 1), defecation detection (0 or 1), urination event quantity in a certain # of bits, defecation event quantity, urine maximum flow, 6 bits showing six position or orientations of up, right side, left side, face up, face down, lay down, nurse call (0 or 1), a certain number of bits expressing body temperature, a certain number of bits expressing the air temperature, a certain number of bits expressing motion intensity, low battery alarm, alarm off chair, Stand Up alarm, Fall alarm, Agitation alarm, UP & Go alarm, Lay Down alarm, oxygen concentration,
  • a second embodiment illustrated in Fig. 9 has one or a multitude n of multi-sensory devices D2.n each having the features of device 10 as described above. There are one or a multitude of interfaces I2.n. Server S2 may be one or a multitude of local computers and individual computers PC communicate over the internet by Wi-Fi with interfaces I2.n and pagers P2.n. One or a multitude of Nurse Pagers
  • Devices 10 shown as D2.1, D2.2 etc. have the same construction and functions as device 10 in the previous embodiment. Incontinence, Fall and wandering alarms and Wound management detection and/or measure can be provided in all the described embodiments.
  • interface 12, shown as 12, 14 is located always next to patient bed. It comprises a receiver or a transceiver T and microcontroller C.
  • CV module is a converter. It converts signals from microcontroller C into Wi-Fi and sends them to server S2.
  • MP3 is an MP3 module controllable by microcontroller C.
  • SP is a speaker.
  • B" is a button on 12. A nurse presses this button after she resolves an alarm.
  • the monitoring application (MA) understands that the alarm has been resolved and stops flashing red the alarm on computer PC screen and on pager P2.
  • interface 12, 14 (12) may contain an extra phone module GPRS which sends data to pagers P2 which are smart phones or to computers PC.
  • GPRS GPRS module receives data from D and serves as safety backup in case Wi-Fi does not work.
  • the module GPRS may replace the Wi-Fi module. In this situation in which there is only GPRS module and no Wi-Fi module the system can be used in places where is no Wi-Fi.
  • transmissions from Dl to PI are synchronized with crystals of high accuracy. These crystals are electronic components used to sync two devices.
  • PI turns its reception on exactly when a transmission from dl is expected. This is necessary to save battery life in PI and because frequency of transmission varies as a function of patient position and motion. Transmissions are rare when a patient is in bed or in a room and are more frequent when the patient stands up and/or is moving. This is detected when Stand Up, Up & Go and distance alarms are triggered. Resynchronization is necessary for the first embodiment shown in Fig. 1 and is done when device 10 and pagerPl are restarting or when
  • Pager PI reception is on each second and it turns on for a period of time 5% longer than the time of a whole transmission, to cover time error from device 10. For purposes of a perfect synchronization, each time pager PI receives it readjusts its reception timing after the last reception. If device 10 and pager PI both have transceivers instead of Transmitter and Receiver it is advantageous for an easier synchronization and safer data reception, but power consumption at device 10 and pager PI is increased.
  • the advantage with using a transceiver is that pager or interface transceiver respond to device 10 transceiver to repeat transmission if data reception is not accurately received. This is important especially for alarms transmission accuracy and for patient identification.
  • interfaces 12 and 13 do not need synchronization with device 10 because they are on continuously, being supplied with power from a wall plug.
  • Microcontroller C in pager PI or interface 12, 14 receives data from device 10 through receiver or transceiver T and compares number of bits and binary string structure to the model it has in its memory. If they do not correspond that transmission is not considered as good and it is not considered at all. If they correspond microcontroller C further reads the identification code from its memory. If it finds it to be correct, microcontroller C considers the transmission as good and reads the detections in the data string. If the ID code is not the one pager PI has it in its memory the reception is canceled. In the case of homecare where usually there is only one device 10 and pager PI this does not occur. If there are multiple patient devices then this identification is useful.
  • Minimizing power consumption of device 10 is necessary. All companies making RF components try to minimize their products' power consumption. This is important for device 10 and its battery to be as small as possible and to last as long as possible. This can be achieved by optimizing the frequency, power and duration of transmissions.
  • device 10 transmissions are made only when an alarm is detected or when patient location detection is needed.
  • device 10 in addition to alarms or data transmissions there are also transmissions for synchronization. Synchronization transmissions are rare (e.g. every 10 minutes). When a patient has left the bed, communication turns from normal mode to search mode and as a result transmission interval is much decreased.
  • T As a transceiver in device 10 and pager PI and it works as follows: when a signal received by the pager/interface is greater than a certain minimum amplitude prescribed in its software, the transceiver in the pager/interface 'tells' the transceiver T in device 10 to reduce correspondingly its transmission power. With these optimizations in transmission frequency and power it becomes possible that D can work with a coin battery such as CR2032 for a long period of time. In the case of device 10, a GPS and GPRS module's power consumption is significantly higher and they can be used only a short time and only in case of emergency. In case of the embodiments in Fig. 6 and 7, the GPS, Wi-Fi and GPRS modules need a bigger battery. [0059] Being worn on patient body, device 10 needs to be as small as possible.
  • the patient can be an infant, a pet or a senior.
  • This device size minimization is done by choosing a non-rechargeable small lithium battery which lasts a minimum one week or a built in lithium rechargeable battery. Optimization of battery consumption applies in the same way as above for the second and third embodiments.
  • pager/smartphone PI may contain any or all of the main features: incontinence, Fall and wandering, Turn-Check, Oxygen concentration detection, Blood pressure and Pulse meter. When an alarm comes up it is displayed on pager PI screen and/or by sound or vibration. Prescribed values or settings of all alarm limits are recorded in pager PI menu in a similar but simpler manner as they are recorded in the embodiments 2 and 3 described below which have a monitoring application MA table (see Fig. 19) in the system computer. PI may contain all features but only the feature that has been paid for is activated.
  • Nurse Pager P2, P3 may be an Android, or other operating system, smart phone 118 connected to Wi-Fi working with a custom smart phone application which converts it into a Nurse pager. Nurse receives alarms and data about her patients from server S2 or S3 and displays them on its screen 120.
  • smart phone 118 is configured as shown in the screenshot 120 in Fig. 11.
  • a list of patients 124 is displayed (Fig. 12).
  • pager 118 rings an alarm and the Nurse turns on her smart phone Pager 118, the patient with the alarm 126 flashes red. If the Nurse touches the alarm all data of that patient appears on screen 128. After the alarm is viewed and resolved by pressing Interface 12, 14 button B, the patient color returns to yellow. All data 130 about any patient is seen in real time on the screen by touching patient name.
  • the first stage and color is when an alarm was first received in server S2 from 12 and sent to P2.
  • the second stage and next color is when an alarm is acknowledged by a nurse by touching the flashing patient name on her pager 118 (P2) screen. After that alarm is displayed on P2 the just received alarm refers to that patient.
  • a flashing color occurs when a certain time passes without the alarm being resolved.
  • the final color comes after the nurse resolves the alarm and presses the 12 button B". Then the alarm disappears from P2's screen.
  • P3 is the same as P2.
  • the detector transmits temperature measurements from sensors to computer S2.
  • monitoring application table 200 the temperature rise limit and time, in which it occurs, are settable. Also all volumes and flows are calculated and recorded.
  • Server S2 or S3 receives data from all interfaces and, by its monitoring application (MA - see Fig. 19), compares data with its settings. If data values received from the interfaces are equal to settings values prescribed in that table it sends alarms to nurse pagers 18.
  • Server S2 may be only one computer with server software and monitoring application (MA) installed on it or it can be one computer working as server and a multitude of secondary computers PC, one in each facility section. Each computer PC has its own monitoring application MA installed.
  • the system for one patient containing one D2, one 12 and a nurse pager P2 and a computer is preferred for homecare and has the advantage of recording all data about the patient with the possibility of medical staff to access these records online. Settings are prescribed by an operator in the monitoring application MA as the doctor
  • Each assistant accesses a "Patient Options" page, from the assistant's home page, for each patient the assistant is responsible for, as shown in Fig. 19, in which the assistant can set the parameters for each variable which will trigger an alarm.
  • the assistant maintains a list of his/her patients as in Fig. 20, with a record of each patient's location and monitor identification. Monitors can be added (Fig. 23).
  • the level of difficulty which is assigned for that patient for the assistant to respond to each type of alarm event which the assistant may need to deal with for that patient can be viewed or set as in Fig. 21. Doctors and assistants with access to the system are added, removed or viewed from the Administrator's home page (Fig. 24, 25) as can monitors 9FDog. 23. The Administrator is provided a report on all alarms generated by patients (Fig. 22).
  • Fig. 31 An Alarm Delays Report showing the delay which occurred from the time of the alarm to the time of response by the assistant, selected by assistant, patient or time period.
  • Fig. 26 illustrates a work repartition report which provides to the Administrator by assistant and time period the amount of work required for that assistant to respond to patient alarms.
  • Alarm frequency reports are provided as a graph, selected by patient (Fig. 27), alarm type per patient (Fig. 28), by assistant (Fig.
  • a third embodiment 3 contains i) a multitude of units Un; ii) a multitude of access points AP connected to a multitude of PC's USB, connected to Wi-Fi; and iii) a server S3 similar to S2 and connected to Wi-Fi.
  • a unit U contains: I) multitude of multi-sensory devices D3.n attached to the patient front on diaper or body, ii) a multitude of Interfaces 13. n located next to patient bed wall plugged in power; iii) an access point AP connected to a computer USB; iv) a computer PC connected to Wi-Fi; v) a multitude of Nurse Pagers P3 identical to P2.
  • D3's controller CT communicates with 13 's controller CT by RF communication.
  • Controller CT includes a
  • D3 communicates with 13 by Zigbee protocol compliant to regulation
  • a unit U communicates to a central server S3 through PC and Wi-Fi.
  • PC works as a local server and has installed a Monitoring application MA as in the second embodiment.
  • PC communicates to Wi-Fi and from there to pagers 118 (P3n) and institution server S3 or other computers.
  • a unit U may serve a healthcare facility section comprising multiple e.g. 1 to 20 pairs of devices 10 (D3) and interfaces 13 and one to 10 pagers 118 (P3). If a patient comes out of the reception range of interfaces 13 repeaters R are necessary.
  • An R is an interface 13 without MP3 capability, SP and button B.
  • Repeater R reports D3's location to the closest 13 or D3. If a patient's device 10 (D3) goes beyond the last 13, and 13 receives a weaker RF signal from D3, 13 orders D3 to increase its transmission strength. If reception is lost the last 13 or R generates an alarm. Always D3 transmission strength is optimized in order to save battery power, as currently applied for in cell phones. While D3 stays close to an 13 transmission strength is optimized as small as possible. By Zigbee protocol a patient location is thus always known by the closest Interface 13 or Repeater R. Therefore in this embodiment communication is assured no matter how many patients are in facility. Patient location is given by the closest 13 and it is displayed on MA and on P3.
  • the advantages of the second and third embodiments in Fig. 9 and Fig. 16- 18 over the first embodiment are that one nurse takes care of more than 1 patient. Communication range is everywhere in a facility using its Wi-Fi. A Nurse sees continuously on her pager 118 all data about her patients. MA entries make possible the following. A dispatcher can supervise on computer S2 or S3 all alarms resolving. All data from devices 10 is processed safer and faster. Server S3 records and processes all data. A manager can see and optimize each nurse's activities, which nurse work is harder or easier, which patient is easier or harder to care of. A Doctor can see each patient data and conclude about their health problems.
  • interfaces 13 can be dispensed with.
  • Turn-Check function does not have the ability (MP3 module) to wake up the patient.
  • D3 can incorporate a vibrator or sound maker which can fulfill this function of waking up the patient.
  • Embodiment 3 shown in Fig. 16 if D3 contains an extra GPS module and a GPRS module they start to transmit to P3 data about patient and patient global position when patient is out of the RF Zigbee range as in Dl.a. Communication by Zigbee protocol then stops. As a further variant, if D3 contains an extra Wi-Fi module it starts communicating with S3 and P3 through Wi-Fi when it is out of RF Zigbee range as in Dl.c. Then communication by Zigbee protocol stops and D3 starts to communicate directly with Wi-Fi in locations not covered by 13 or repeaters. Then when the patient comes out the area covered by Wi-
  • the controller CT stops transmissions to Wi-Fi and starts GPS and GPRS modules. Since communication between D and P or I can be done through GPRS in Embodiments 2 and 3, data can be transmitted to a nurse smart phone. A smart phone can play the role of server for all nurses and patients, with the smart phone communicating by Wi-Fi to the facility server. Data can be recorded in the smart phone and/or in facility server. This way there is no limit to the communication range. If GPS is in D and location coordinates are transmitted through GPRS to nurse smart phone 118, the patient can be located wherever he is outside the facility.
  • the present invention allows one nurse to handle more than one patient with one nurse receiving alarms from multiple patients, or it permits one detector/sensor to be exclusive to one nurse pager only.
  • the system detects more than one urination or defecation in the same diaper, the system detects each urination and defecation separately in same diaper with reusable sensors since the sensors do not contact urine or feces inside diaper.
  • the system measures urine and defecation quantity and flow. Frequency and number of incidents per patient and other patient data are recorded on administrative charts for later reference.
  • a nurse is alerted as necessary, by sound and pager message, per the settings individually programmed for each patient. An alert sounds or is displayed on a nurse's pager if incidents are too frequent or too rare. This can show hidden patient problems like diarrhea, constipation, infection, prostate problems, diabetes, or cystitis.
  • the system can be used with less than all functions activated. It is suitable for a nursing home or a hospital, but also for homecare and for infants or pets. The system is useful for child monitoring, newborns, and youngsters, mentally challenged children and/or adults with propensity to wander. A simpler and less expensive system for home care use would include only a Multi-sensory device 10 and a Pager PI.
  • Customers can purchase the complete package or a single feature, e.g. Turn Check. Additional features can be purchased online, one at a time, by end user, and activated immediately when approval is granted by provider. Patient needs are programmed individually and activated /deactivated as health needs change.
  • Body temperature alert which measures patient body temperature and alerts nurse if fever, can be provided; Diaper wearer body temperature and fever; setup, alarm and display of said body temperature and fever; ii) Ambient temperature alert, which measures air temperature around patient and alerts if is cold or hot; Diaper wearer surrounding air temperature; setup, alarm and display of the air temperature; iii) Nurse Reminder of Patient appointments can be set in nurse's pager; v) The Nurse Call button on device Dl for patient use is provided; vi) Diaper wearer breath motion and non-motion; alarm and display of said breath non-motion; Breath count;
  • Diaper wearer position when he or she lies in bed; setup, alarm and display of said position or orientation; Stand up position of diaper wearer and when it occurs; setup, alarm and display of said stand up position; Diaper wearer sit down position; display of said sit down position; viii) alarm if patient is in the process of rising from a seated position; Fall of diaper wearer; alarm and display of the fall; ix) Detect and display of stepping; stepping count, cadence and diaper wearer speed display; Diaper wearer run detection; alarm and setup; Distance walked or run; setup, alarm and display of said distance; Diaper wearer speed; display of said speed.; Direction walked or run; Setup, alarm and display of said direction; Diaper wearer movement intensity; display of said intensity; setup and alarm if said intensity and timing when it occurs; x) Diaper wearer presence in a certain perimeter with a settable alarm radius; Setup, alarm and display of said perimeter; Diaper wearer passing through certain doors and

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Abstract

L'invention concerne un système de surveillance pour surveiller diverses fonctions corporelles, telles que la température, l'incontinence, l'incontinence légère, un mouvement corporel, etc., de patients. Un problème rencontré avec les systèmes précédents réside dans le fait que leur durée de vie utile est limitée à la détection d'un seul événement de défécation ou de miction. Le système de surveillance de la présente invention comprend : i) une pluralité de capteurs de température (34, 36) à fixer à la surface extérieure d'un article absorbant (24) utilisé par le patient et générant un signal ; ii) un accéléromètre (ACC) pour fournir un signal indiquant un changement de mouvement, de position ou d'orientation dudit article ; iii) un émetteur (T) pour communiquer lesdits signaux à un processeur ou à un ordinateur central (S2) qui est pourvu d'un code informatique pouvant déterminer si un événement de défécation ou de miction a eu lieu dans ledit article absorbant, ou si la position du patient a changé ; iv) un moyen d'affichage pour afficher ledit événement ou une variation de position à une personne soignante.
PCT/CA2015/050426 2014-05-15 2015-05-12 Système de surveillance multifonctionnel comprenant des capteurs fixés à un article absorbant WO2015172246A1 (fr)

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