WO2010007589A1 - Dispositif médical et procédé de surveillance d'informations d'état - Google Patents

Dispositif médical et procédé de surveillance d'informations d'état Download PDF

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Publication number
WO2010007589A1
WO2010007589A1 PCT/IB2009/053102 IB2009053102W WO2010007589A1 WO 2010007589 A1 WO2010007589 A1 WO 2010007589A1 IB 2009053102 W IB2009053102 W IB 2009053102W WO 2010007589 A1 WO2010007589 A1 WO 2010007589A1
Authority
WO
WIPO (PCT)
Prior art keywords
sensor
light emitting
light
medical device
emitting element
Prior art date
Application number
PCT/IB2009/053102
Other languages
English (en)
Inventor
Giovanni Nisato
Roelf Kassies
Wilhelmus H. N. M. Van Mensvoort
Original Assignee
Koninklijke Philips Electronics N.V.
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
Application filed by Koninklijke Philips Electronics N.V. filed Critical Koninklijke Philips Electronics N.V.
Publication of WO2010007589A1 publication Critical patent/WO2010007589A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1101—Detecting tremor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1118—Determining activity level
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1124—Determining motor skills
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • 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
    • A61B5/681—Wristwatch-type devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0266—Operational features for monitoring or limiting apparatus function
    • A61B2560/0276—Determining malfunction
    • A—HUMAN NECESSITIES
    • 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

Definitions

  • the present invention relates to a method and a medical device comprising at least one sensor, and a fastening band.
  • the medical device can for instance be a monitoring device for monitoring one or more physiological parameters of a user and/or parameters relating to the device itself, and/or the device can be a drug delivery device.
  • the fastening band can be used to fasten the device around a body part of a patient or other type of user.
  • the user can be a human or animal subject.
  • Wearable electronic devices such as heart monitoring systems typically have a display showing the status of a measured parameter in alphanumerical signs.
  • An example of such a heart monitor is disclosed in US 5,980,060.
  • the disclosed device comprises a super thin lighting element, used for illumination. The problem encountered with such devices is that they require specific attention and that they need to be consulted actively on a regular base. A sudden status change may not directly be noticed.
  • the user or a caregiver can instantly check the status by looking at the medical device. It can directly alert a nearby caregiver, busy with some other activity or another patient. Especially for older patients, it is beneficial that the signaling is also observable by the partner, or the treating nurse. However, the signaling can be made suffiently discrete for the user to accept the medical device in his or her daily life and social settings.
  • Status information can for example be the status of a monitored physiological parameter, such as temperature or heart pulse, and / or it can be a parameter relating to the status of the device itself, such as battery level, quantity of still unused drug compound, medication flow or skin contact.
  • a monitored physiological parameter such as temperature or heart pulse
  • a parameter relating to the status of the device itself such as battery level, quantity of still unused drug compound, medication flow or skin contact.
  • light emitting element means that the element is able to emit light, but is not necessarily emitting light continuously.
  • the object of the invention is also achieved with a method for monitoring one or more parameters, e.g physiological parameters, wherein a patient is provided with a medical device comprising at least one sensor, a fastening band and at least one light emitting element configured to display light as a signal coding for status information.
  • a medical device comprising at least one sensor, a fastening band and at least one light emitting element configured to display light as a signal coding for status information.
  • the light emitting element can for example be configured to display a light signal of a variable colour, wherein the colour codes for the status information.
  • This information can for example be colour coded in a way compatible with conventional colour meanings.
  • the light emitting strip can for instance emit a red light in case immediate attention is required, or a green light in case the measured value for the monitored parameter is within a safe range.
  • the light emitting strip can be arranged to emit a blinking light, wherein the blinking pace codifies for the status information. For instance, fast blinking may code for a situation requiring immediate attention, while a situation not requiring attention may be coded by no blinking at all or by the complete absence of emitted light. Colour coding and coding by blinking may be combined to offer informational redundancy, which helps to draw the required attention and can help to reduce the risk of misinterpretation of signals.
  • the light emitting element can for example be positioned on the fastening band. Alternatively, it can also be positioned in any other part of the device, such as for instance a display on a watch case. Control circuitry can be used to link the sensor to the light emitting element in such way that the light emitting element is able to emit light in response to a signal from the sensor.
  • the fastening band can for example be a wrist band, an ankle band or a waist band, but if so desired it can also be designed to be worn on any other suitable body part.
  • the device can comprise an alphanumerical display showing information derived from the sensor. After the light emitting element has alerted the use or the caregiver, the display can be consulted for more precise information. Moreover, the display can also be used for other types of information, such as the battery status.
  • the display can for example be part of a user interface provided by an upper side of a watch case. Such a user interface can also be provided with one or more activation buttons, e.g., for scrolling or browsing through information on the display.
  • the device according to the invention can also comprise a drug reservoir and a dispenser nozzle operatively connected to the drug reservoir.
  • the drug dispenser can for example comprise one or more jet dispensers, for instance thermal droplet jet dispensers, which are particularly suitable for low speed jetting, or piezoelectric droplet dispensers, which can also be used for high speed jetting (above 30 m/s).
  • High speed jet dispensers are particularly suitable for intradermal or subcutaneous administration, requiring the medicament to be shot through the skin barrier.
  • Low speed injectors can be used for topical or transdermal administration, when the medicament passes the skin by diffusion.
  • a combination of high speed and low speed jet dispensers can be used. With jet dispensers, a wide range of drug molecules can be dispensed.
  • inkjet-related technology jet dispensers allows careful and accurate control of distribution of the medicament to the target. Exact dosing of the medicament can be achieved.
  • an activating pulse induces movement of a piezoelectric transducer changing the volume of a chamber containing liquid to be jetted.
  • the volume change of the chamber generates pressure for propelling a drop out of a nozzle.
  • the velocity of the jetted drops can be increased. Passing the nozzles, the medicament can be accelerated to a velocity which is sufficient to penetrate the patient skin. To this end, the velocity can be increased to more than 30 m/s, e.g., to a velocity of 50 - 150 m/s.
  • the jets can be generated by actuators located at each individual nozzle, e.g., by piezo actuators, or by a central pressure generating system in combination with electronically controlled valves.
  • the nozzles of the jet dispenser can have any suitably sized opening, e.g., having a diameter of 30 - 200 ⁇ m, for instance about 50 ⁇ m.
  • the light emitting element can for instance be a light emitting diode (LED).
  • a light guide such as a glass fiber light guide or a flexible optical polymer substrate operatively connected to a light source, e.g., via an optical coupling unit, can also be used.
  • the light source can for example comprise two or more LED's for generating light of different colours. The light from the LED's can gradually be mixed to obtain a range of colours.
  • a flexible, e.g., organic, light emitting diode can be used comprising an electro-luminescent stack deposited between two conducting layers on a flexible substrates encased in an airtight coating.
  • the stack can emit light via the coating or via the substrate made of a transparent material.
  • the light emitting element can be provided with two or more of such stacks forming elongated pixels generating different colors.
  • a color filter can be deposited on the transparent coating to enable the generation of at least two independent colors and possible mixing combinations.
  • the fastening band can comprise a light emitting strip, e.g. an LED strip, sandwhiched between two layers of a flexible band material, wherein one or both of these layers are provided with one or more windows or openings revealing the light emitting strip.
  • the fastening band can be provided with fastening means such as Velcro ® type fastening means or a conventional watch buckle fastening.
  • the sensor of the device can for example comprise a heart pulse sensor, a temperature sensor, or a sensor for measuring acceleration and gravity induced reaction forces, which is particularly useful if the device according to the present invention is used as a wearable accelerometer for the detection of the person's activity status or for the detection of motoric disease symptoms such as tremor motions of Parkinson's disease patients.
  • a wearable accelerometer for the detection of the person's activity status or for the detection of motoric disease symptoms such as tremor motions of Parkinson's disease patients.
  • Such a system can distinguish between "on medication”, “normal”, “dyskenetic” and “off or “under-medicated” statuses.
  • the colour coding corresponding to the status can also be used to signal the patient status to a nurse or partner helping with the treatment.
  • Other types of sensors can also be used.
  • the device can also comprise more than one sensor for combined monitoring of a number of physiological parameters.
  • the senor can comprise a sensor element for measuring a device status, such as battery level, level of left medication, medication flow, skin conact, etc.
  • the device can for instance display an alert signal when the medication flow sudddenly stops.
  • Fig. 1 shows a medical device according to the present invention
  • Figs. 2A - 2D show an alternative embodiment of a medical device according to the invention in four different situations of information display;
  • Fig. 2E shows the backside of the embodiment of Figures 2A - 2D;
  • Figs. 3 A - 3C show three stages of assembling a fastening band of a medical device according to the present invention;
  • Fig. 4 shows schematically in cross section a light emitting element of a medical device according to the present invention
  • Fig. 5 shows schematically in cross section and plan view another possible light emitting element of a medical device according to the present invention.
  • Figure 1 shows a medical device 1 worn by a user 2.
  • the medical device 1 comprises a watch case 3 with a sensor (not shown) and, on the upper side, a user interface 4 with activation buttons 5 and a display 6, showing detailed information generated by the sensor, e.g. in alphanumerical characters and/or symbolic icons. Besides sensor information, the display 6 can also show other types of information, such as time information and/or battery status information.
  • the user 2 can browse and select displayable information by using the activation buttons 5.
  • the medical device 1 also comprises a fastening band 7 which can be used to fasten the device 1 to a body part of a user 2, in this case a wrist. In other embodiments, the fastening band 7 can for example be an ankle or waist band.
  • the fastening band 7 is of a flexible material and comprises a back side contacting the user's skin when used, and a front side with two light emitting strips 8.
  • Control circuitry (not shown) links the sensor to the light emitting strips 8 in such way that the light emitting strips 8 emit light in response to a signal from the sensor.
  • the light emitting strips 8 generate a light signal coding for the status of the parameter measured by the sensor. This information can for example be colour coded in a way compatible with conventional colour meanings.
  • the light emitting strips 8 can for instance emit a red light in case immediate attention is required, or a green light in case the measured value for the monitored parameter is within a safe range.
  • the light emitting strips 8 can be arranged to emit a blinking light codifying the status information by the emitted blinking pace.
  • fast blinking may code for a situation requiring immediate attention, while a situation not requiring attention may be coded by no blinking at all or by not emitting light at all.
  • Colour coding and coding by blinking may be combined to offer informational redundancy, which helps in ensuring to draw the required attention and can help to reduce the risk of misinterpretation of signals.
  • Figures 2 A - 2E show another possible embodiment of a medical device 21 according to the present invention.
  • the medical device 21 of this embodiment is a drug delivery device 21 comprising a watch case 23 with a skin contact side comprising delivery nozzles 22 (see Figure 2E) for dosing a drug which is suitable for transdermal administration and which can be absorbed by a patients skin.
  • the front side of the drug delivery device 21 comprises a user interface 24 with two activation buttons 25 and a display 26.
  • the drug delivery device 21 further comprises a fastening band 27 with two lateral light emitting strips 28. In Figures 2B - 2D the light emitting strips 28 are shown with different hatchings, representing emitted light of different colours.
  • Monitored parameters can include, e.g., level of medication in the reservoir, drug delivery rate, degree of contact between the device and the patient's skin, etc..
  • FIG. 2E shows the backside of the drug delivery device 21.
  • the drug delivery device 21 comprises a removable medication cartridge 20 clicked within the watch case 23.
  • the medication cartridge 20 comprises dispensing nozzles 22 operatively connected to a drug reservoir encased in the medication cartridge 20.
  • the watch case 23 further comprises skin contact sensors 30. When the sensors 30 detect insufficient degree of contact between the drug delivery device 21 and the patient's skin, the light emitting strips 28 are activated to emit a predefined light signal.
  • FIGS 3A, 3B and 3C show a possible way of assembling a fastening band 37 for a device according to the present invention.
  • the fastening band 37 is made of an upper band 37a and a lower band 37b of equal dimensions, provided with longitudinal windows 39 extending in the longitudinal direction of the fastening band 37.
  • the windows 39 in the upper band 37a are in an alternating arrangement with the windows 39 in lower band 37b.
  • a light emitting strip 38 is sandwiched between the bands 37a, 37b in line with the windows 39.
  • the light emitting strip 38 has a width which is slightly larger than the width of the windows 39. As a result, the light emitting strip 38 completely covers all windows 39 and the light emitting strip 38 is visible from both sides of the band 37.
  • the bands 37a, 37b can be kept together by gluing.
  • the end of the band 37 is fixated with a transparent clip 40.
  • the end of the band 37 can be provided with a Velcro® strip 41 to attach it to a Velcro® counter part on the other end of the fastening band 37, or - if a band in two sections on either side of a watch case is used - on the outer end of the other band section.
  • Figure 4 shows schematically a light emitting element 48 comprising two light emitting diodes 48a each being able to generate light of a different colour.
  • the light from the light emitting diodes 48a is emitted into an optical coupling unit 48b and further into a light guide 48c of a flexible optical polymer provided with an array of light out coupling grooves 48d for lateral emission of light.
  • the light emitting element 50 comprises an electro-luminescent stack 51 sandwiched between two conductive electrode layers 52, 53 on a flexible substrate 54, coated with a transparent coating 55.
  • the light emitting element 50 is provided with at least two pixels 56 able to generate light of a different colour.
  • the light emitting element 50 comprises three parallel sets of electrodes 52, 53, each set forming an elongated pixel 56 of the light emitting element 50.
  • a colour filter can be deposited on the transparent coating to enable independent generation of at least two different colours and possible mixed combinations.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Physiology (AREA)
  • Dentistry (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention décrit un dispositif médical (21) et un procédé destinés à surveiller un ou plusieurs paramètres. Le dispositif médical (21) comporte au moins un détecteur, une bande de fixation (27) ainsi qu’au moins un élément émettant de la lumière (28) et conçu pour afficher de la lumière comme codage de signal pour des informations d'état liées au paramètre surveillé. Le patient peut porter dispositif médical (21) comme une montre, par exemple.
PCT/IB2009/053102 2008-07-18 2009-07-16 Dispositif médical et procédé de surveillance d'informations d'état WO2010007589A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP08160708 2008-07-18
EP08160708.7 2008-07-18

Publications (1)

Publication Number Publication Date
WO2010007589A1 true WO2010007589A1 (fr) 2010-01-21

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2009/053102 WO2010007589A1 (fr) 2008-07-18 2009-07-16 Dispositif médical et procédé de surveillance d'informations d'état

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WO (1) WO2010007589A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015001434A1 (fr) * 2013-07-01 2015-01-08 Seraphim Sense Ltd. Capteur de santé pouvant être porté
CN105828708A (zh) * 2013-12-18 2016-08-03 Lg电子株式会社 用于测量生物信息的设备及用于其误差补偿的方法
US9743890B2 (en) 2011-03-28 2017-08-29 Koninklijke Philips N.V. System and method for providing family mode for monitoring devices
US10449379B2 (en) 2014-03-27 2019-10-22 Koninklijke Philips N.V. Encoded status indicator for automated external defibrillators

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE20211621U1 (de) * 2002-07-16 2003-01-16 Muessli, Daniel, Rumisberg Tragbare Miniatur-Medikamentenpumpe
US20070208262A1 (en) * 2006-03-03 2007-09-06 Kovacs Gregory T Dual-mode physiologic monitoring systems and methods
US20080004510A1 (en) * 2006-03-13 2008-01-03 Citizen Watch Co., Ltd. Worn type electronic device and biological measuring apparatus provided with the same
WO2008038240A1 (fr) * 2006-09-29 2008-04-03 Koninklijke Philips Electronics, N.V. Système trans dermique de distribution de médicaments à buses multiples

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE20211621U1 (de) * 2002-07-16 2003-01-16 Muessli, Daniel, Rumisberg Tragbare Miniatur-Medikamentenpumpe
US20070208262A1 (en) * 2006-03-03 2007-09-06 Kovacs Gregory T Dual-mode physiologic monitoring systems and methods
US20080004510A1 (en) * 2006-03-13 2008-01-03 Citizen Watch Co., Ltd. Worn type electronic device and biological measuring apparatus provided with the same
WO2008038240A1 (fr) * 2006-09-29 2008-04-03 Koninklijke Philips Electronics, N.V. Système trans dermique de distribution de médicaments à buses multiples

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9743890B2 (en) 2011-03-28 2017-08-29 Koninklijke Philips N.V. System and method for providing family mode for monitoring devices
WO2015001434A1 (fr) * 2013-07-01 2015-01-08 Seraphim Sense Ltd. Capteur de santé pouvant être porté
CN105828708A (zh) * 2013-12-18 2016-08-03 Lg电子株式会社 用于测量生物信息的设备及用于其误差补偿的方法
EP3082584A4 (fr) * 2013-12-18 2017-08-09 LG Electronics Inc. Appareil de mesure de bio-informations et procédé de compensation d'erreur de celui-ci
US10449379B2 (en) 2014-03-27 2019-10-22 Koninklijke Philips N.V. Encoded status indicator for automated external defibrillators

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