United States Patent
`
`[19]
`
`[11] Patent Number:
`
`5,772,586
`
`Heinonen et al.
`
`[45] Date of Patent:
`
`Jun. 30, 1998
`
`US005772586A
`
`[54 METHOD FOR MONITORING THE HEALTH
`OF A PATIENT
`
`0 680 727 A1
`7-307803
`WO 90/08361
`
`11/1995 European Pat. Off.
`11/1995
`Japan .
`7/1990 WIPO .
`
`.
`
`[75
`
`Inventors: Pekka Heinonen; Harri Okkonen,
`both of Espoo, Finland
`
`[73
`
`Assigneez Nokia Mobile Phones, Ltd” Finland
`
`[21 Appl' No’: 795’389
`[22
`Filed;
`Feb, 4, 1997
`
`Foreign Application Priority Data
`[30
`Feb. 12, 1996
`[F1]
`Finland .................................. .. 960636
`
`Int. Cl.5 ...................................................... .. A61B 5/00
`[51
`[52 U.S. Cl.
`......................... .. 600/300; 128/904; 600/365
`[58
`Field of Search ................................... .. 128/903, 904;
`600/309’ 365’ 301’ 300
`References Cited
`
`[56
`
`U.S. PATENT DOCUMENTS
`5/1995 Wilk ................................... .. 128/653.1
`5,415,167
`10/1995 Oka et al.
`.
`5,462,051
`.......................... 128/633
`4/1996 Backer et al.
`5,507,288
`.......................... .. 128/904
`8/1996 Davis et al.
`5,544,661
`FOREIGN PATENT DOCUMENTS
`
`OTHER PUBLICATIONS
`
`“A Telernedicine Distributed Decision—Support System for
`Diabetes Management”, proceedings of the Annual Interna-
`tional Conference of the IEEE Engineering in Medicine and
`Biology Society, vol. 14, Nov. 1992, (Paris, France), pp.
`1238-1239, E.J. Gomez et al.
`
`Primary Exammer_Jennifer Bahr
`Assistant Examiner—Eric F. Winaker
`Attorney, Agent, or Firm—Finnegan, Henderson, Farabow,
`Garrett’ & Dunner, LLB
`
`ABSTRACT
`[57]
`The present invention relates to a method for monitoring the
`health of a patient by utilizing measurements. In order to
`improve the contact between the patient and the person
`treating him, the results of the measurements are supplied
`V” a C.°H.1m“I.“Ca“°“S devlce (1). unhzmg a Wlrekss data
`transmission link to a data processing system (9) available to
`the Per_S°“ moflltonng the Patlem 5 health» and the Patlent 5
`health 15 Ihehltered by means Of the data Stored 1h the data
`processing system
`
`0 417 944 B1
`
`3/1991
`
`European Pat. Off.
`
`.
`
`7 Claims, 1 Drawing Sheet
`
`SIERRA WIRELESS 1010
`SIERRA WIRELESS 101 O
`
`

`
`U.S. Patent
`
`Jun. 30, 1998
`
`5,772,586
`
`
`
`FIG. 4
`
`

`
`5,772,586
`
`1
`METHOD FOR MONITORING THE HEALTH
`OF A PATIENT
`
`FIELD OF THE INVENTION
`
`The present invention relates to a method for monitoring
`the health of a patient by utilizing measurements. The
`invention further relates to a system for monitoring the
`health of a patient, the system comprising a portable mea-
`suring device for carrying out a measurement in order to
`evaluate the patient’s health, and a data processing system
`that is available to a person treating the patient and that
`maintains data about the results of the performed measure-
`ments. The invention also relates to a portable measuring
`device for carrying out a measurement in order to evaluate
`the health of a patient.
`The invention relates specifically to the self-care and
`monitoring of the health of a patient with diabetes, but the
`method, system and measuring device according to the
`invention can also be utilized in other connections.
`However, in the following the invention will be described by
`way of an example specifically in connection with treating
`diabetes.
`
`DESCRIPTION OF THE PRIOR ART
`
`As is well known, monitoring the health of a patient with
`diabetes is primarily based on the measurement of the
`patient’s blood glucose level at regular intervals. Treating
`diabetes requires regular measurements and regular moni-
`toring of the measurement results in order to ensure that the
`patient’s blood glucose level definitely remains within the
`allowable area and that the patient’s medication is optimal.
`However,
`in the present health care system it
`is not
`possible for financial and practical reasons for a person
`specialized in treating diabetes to personally monitor con-
`tinuously the health of a patient, but the monitoring of the
`patient’s health is largely dependent on the patient himself.
`Therefore the patient himself must perform measurements at
`regular intervals. In order to carry out measurements, the
`patient has to use several
`instruments which include at
`present for example a lancet for pricking the skin, a strip for
`taking a blood sample, and a measuring device to which the
`strip containing the blood sample is supplied in order to
`measure the blood glucose level. The prior measuring
`devices usually measure the blood glucose level either
`electrically or optically. For the purpose of obtaining data
`about the development of a patient’s health, for example the
`blood glucose level, over a longer period, the patient must
`also keep a record of the results of blood samples, for
`instance.
`
`The fact that a relatively large number of patients with
`diabetes also contract a secondary disease (e.g. cardiovas-
`cular diseases, neuropathy or blindness), which in turn
`causes considerable costs for the society, clearly indicates
`that at the moment doctors cannot treat patients with dia-
`betes sufficiently effectively or cannot help the patient to
`care for himself. One reason for this is that each doctor often
`
`treats a high number of patients, whereupon the contact
`between each individual patient and the doctor is insufficient
`due to for example too few appointments and the doctor
`cannot therefore monitor the development of the health of
`individual patients sufficiently effectively. Also,
`the data
`submitted to the doctor is dependent on the patient’s own
`recording, and there is always the possibility that a mea-
`surement result is erroneously recorded or it is not recorded
`at all.
`
`SUMMARY OF THE INVENTION
`
`invention is to solve the
`The purpose of the present
`above-described problem and to provide a method by means
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`of which a doctor treating a patient is able to monitor the
`health of the patient under his care more accurately and
`effectively than previously. This object is achieved with a
`method according to the invention in which a patient inde-
`pendently performs measurements and which is character-
`ized by supplying the results of the measurements via a
`communications device utilizing a wireless data transmis-
`sion link to a data processing system available to a person
`monitoring the patient’s health, and monitoring the patient’s
`health by means of the data stored in the data processing
`system.
`The expression “a person monitoring the patient’s health”
`refers in this connection to anyone who participates in the
`treatment of the patient and who needs to monitor the
`development of the patient’s health. Therefore this person
`does not necessarily have to be a doctor, but for example in
`connection with treating a child the parents may monitor the
`patient’s health.
`The invention also relates to a system wherein the method
`according to the invention can be utilized. The system
`according to the invention is characterized in that
`the
`measuring device consists of a measuring unit and a com-
`munications device that utilizes a wireless data transmission
`
`link and that is connected to said unit, the measuring device
`comprising means for supplying the result of the measure-
`ment carried out by the measuring unit via said data trans-
`mission link to said data processing system. The aforemen-
`tioned data processing system may be a data processing
`system of a hospital, for example, or some other correspond-
`ing support unit.
`The invention further relates to a portable measuring
`device with which the method according to the invention can
`be applied. The measuring device according to the invention
`is characterized in that the measuring device consists of a
`measuring unit and a communications device that utilizes a
`wireless data transmission link and that is connected to said
`
`unit, the measuring unit comprising means for supplying the
`result of the measurement via the communications device to
`
`a data processing system available to a person treating the
`patient.
`The term “communications device” refers in this connec-
`
`tion to any device which is suitable for wireless communi-
`cations and by means of which the patient can transmit his
`measurement results to the data processing system available
`to his doctor, regardless of where the patient
`is at
`the
`moment. Such a communications device may be for
`example any radio transmitter, such as a mobile phone
`operating via base stations or possibly via a satellite, or for
`example a two-way pager.
`The invention is based on the idea that when the results of
`
`the measurements carried out by the patient himself are
`transmitted automatically via a wireless data transmission
`link directly to the person or persons treating him, the doctor
`is able to monitor the development of the patient’s health
`better than before and to help the patient in his self-care, so
`that the treatment of the patient is considerably improved.
`Wireless data transmission enables the doctor to obtain the
`
`measurement results concerning the patient’s health in real
`time, if required, regardless of the patient’s current location.
`Therefore it is not necessary for the patient and the doctor to
`meet personally in order for the doctor to be informed about
`the latest developments in the patient’s health, but
`the
`patient can transmit the latest measurement results to the
`doctor for example from a summer cottage situated in a
`remote area, whereafter the patient and the doctor may
`discuss further treatment for example by phone, if necessary.
`
`

`
`5,772,586
`
`3
`Also, for example when examining the recent measurement
`results of the patient,
`the doctor may discover that
`the
`patient’s medication should be changed and he can thus ask
`the patient to make an appointment for more detailed tests.
`The primary advantages of the arrangement according to the
`invention therefore include the accurate and rapid transmis-
`sion of measurement results from the patient to the doctor,
`the gathering of measurement results in the patient’s normal
`environment so that for example the patient’s actual exercise
`level and/or diet are more apparent in the measurement
`results and hospital surroundings do not distort the results,
`and the possibility for the doctor to monitor the recent
`development of the patient’s health without
`the patient
`having to make an appointment with the doctor, in which
`case the patient can visit the doctor/the hospital only when
`he really needs and not according to a predetermined sched-
`ule.
`
`In a preferred embodiment of the measuring device
`according to the invention, the measuring device consists of
`a mobile phone and of a combination of a measuring unit
`and a battery placed in the battery space of the mobile phone.
`This embodiment of the invention is highly advantageous
`since it can be implemented utilizing prior components, i.e.
`for example a mobile phone of the GSM system and an
`existing mobile communication system, and therefore the
`application of the arrangement according to the invention is
`very economical. Also, when the measuring unit is designed
`in such a way that it can be placed in the battery space of the
`mobile phone, the number of the articles the patient has to
`carry with him is minimized. Therefore the patient can easily
`carry the measuring device with him without attracting the
`attention of other people in the same way as when carrying
`a separate measuring device. Another advantage of the
`mobile phone is that the doctor can contact the patient any
`time with the phone for example in a situation where the
`doctor has noticed a need for a personal contact on the basis
`of the patient’s recent measurement results, for example
`when the risk of hypoglycaemia has increased.
`The preferred embodiments of the method, system and
`measuring device according to the invention are disclosed in
`the appended dependent claims 2, 4 and 6 to 11.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`In the following, the invention will be described in greater
`detail by way of an example by means of a preferred
`embodiment
`illustrated in the accompanying figures,
`in
`which
`
`FIG. 1 illustrates the first preferred embodiment of the
`system according to the invention,
`FIGS. 2 and 3 illustrate the first preferred embodiment of
`the measuring device according to the invention, and
`FIG. 4 illustrates the strip shown in FIG. 3.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`FIG. 1 is a block diagram of the first preferred embodi-
`ment of the system according to the invention. The measur-
`ing device 1 shown in FIG. 1 consists of a mobile phone and
`a measuring unit. The invention will be described below by
`way of an example, assuming that
`the measuring unit
`comprises means for measuring the blood glucose level,
`even though the measuring unit may also comprise means
`for performing some other measurement, such as for mea-
`suring blood pressure, fever or pulse.
`When a patient has carried out a measurement utilizing
`the measuring unit comprised by the measuring device 1, the
`measuring device 1 transmits the measurement result to the
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`4
`data processing system 9 of the hospital 2. This takes place
`in such a way that the mobile phone that forms a part of the
`measuring device 1 and that is assumed to be, by way of an
`example, a mobile phone of the GSM mobile communica-
`tion system (Groupe Spécial Mobile) transmits the measure-
`ment result supplied by the measuring unit in the form of a
`short message 3 to a base station 4. The base station 4
`forwards the message via a base station controller 5, a
`mobile services switching centre (MSC) 6 and a gateway
`centre 7 to a short message service centre (SMSC) 8 in the
`mobile system. The GSM system and the short message
`service thereof are described in greater detail for example in
`The GSM System for Mobile Communications by M. Mouly
`and M.-B. Pautet, Palaiseau, France, 1992,
`ISBN:
`2-9507190-0-7, and therefore they will not be described in
`greater detail in this connection.
`The short message service centre 8 may be programmed
`specifically in each case to transmit
`the short message
`received from the patient’s measuring device 1 directly to
`the data processing system 9 of the hospital 2, where it is
`stored in the patient database of the hospital, or alternatively
`the message can be temporarily buffered to the short mes-
`sage service centre 8, until the doctor treating the patient
`reads it via the data processing system 9 of the hospital 2 or
`alternatively for example via his mobile phone 10. Therefore
`the doctor treating the patient has at all times access to the
`patient’s measurement results regardless of the current loca-
`tion of the doctor and/or the patient.
`The hospital data processing system 9 preferably contains
`for each patient the results of the measurements, carried out
`with the patient’s own measuring device 1 or alternatively
`performed at the hospital, for a period of several years.
`Therefore the doctor treating the patient can monitor the
`development of the patient’s health via the data processing
`system 9 for example by utilizing a trend analysis also when
`the doctor and the patient have not been in direct commu-
`nication with each other.
`
`the patient may also transmit information
`If required,
`other than the measurement result and the time of measure-
`ment from his measuring device 1. Thus, for example a
`patient with diabetes can supply data concerning for
`example his diet, dosage of insulin, exercise or the like via
`the keyboard of the measuring device, and also this infor-
`mation will be forwarded by means of a short message to the
`data processing system 9 used by the doctor treating the
`patient.
`The hospital data processing system 9 preferably also
`provides other reports concerning individual patients and/or
`for example all patients with a certain disease. Therefore,
`also users other than the patient’s own doctor can utilize the
`data gathered in the data processing system for example for
`the purpose of drafting different types of statistics or instruc-
`tions for treatment. Possible other users include for example
`authorities, insurance companies, research centres and the
`like.
`
`FIGS. 2 and 3 illustrate the first preferred embodiment of
`the measuring device according to the invention. In FIG. 2,
`the measuring device is shown in a diagonal front view and
`in FIG. 3 in a rear view. The measuring device 1 consists of
`a mobile phone MS and a measuring unit 11 placed in the
`battery space of the mobile phone. The measuring unit and
`the mobile phone may naturally also be entirely separate
`components that are connected for example by means of a
`cable, in which case the patient must carry with him two
`separate parts instead of one, however.
`The mobile phone MS shown in FIGS. 2 and 3 may be for
`example a phone of the GSM system known per se, provided
`with connectors by means of which the measuring unit 11
`placed in the battery space can be connected to a commu-
`nication bus of the phone. The phone may also have been
`
`

`
`5,772,586
`
`5
`subjected to changes concerning its software, so that the
`measuring unit 11 is able to utilize the display 12 and the
`keyboard 13 of the phone.
`The measuring unit 11 is designed in such a way that it fits
`in the battery space of the mobile phone MS when the
`normal battery of the phone has been removed therefrom. In
`addition to the measuring means, the measuring unit there-
`fore also comprises a battery 14 that supplies an operating
`voltage to the mobile phone MS and to the measuring unit
`11 itself. The measuring unit preferably further comprises a
`back-up battery that makes it possible to also perform
`measurements with the measuring unit when the battery 14
`has run down and no calls can be made from the mobile
`phone.
`FIG. 3 illustrates the measuring means provided in the
`measuring unit of the measuring device 1. The measuring
`device shown in FIG. 3 comprises means for measuring the
`blood glucose level in an electric manner known per se, even
`though the measuring device could also be provided with
`means for carrying out the measurement optically or even
`without a need to penetrate the skin.
`The measuring unit 11 comprises an integrated lancet 19
`that may be operated for example with a spring so that the
`patient can easily prick the skin with it. The patient there-
`after pulls out a strip 16 that is known per se and that is
`placed for example on a reel 15 in the measuring unit 11, the
`strip being impregnated with the drop of blood (the structure
`of the strip is illustrated in greater detail in FIG. 4). One reel
`provided in the measuring unit 11 may comprise for example
`strips needed for one week. Electrodes which are provided
`in the strip and between which the drop of blood is absorbed
`are connected to an electronic section provided in the
`measuring unit 11, the section comprising means for mea-
`suring the blood glucose level. For this purpose, the elec-
`tronic section 20 comprises for example an A/D converter
`and a memory, for example a ROM table, where the glucose
`levels corresponding to different electric measurement val-
`ues are stored. If the measuring unit employs optical mea-
`surement instead of resistance measurement, the ROM table
`correspondingly stores glucose levels corresponding to dif-
`ferent optical measurement values.
`The electronic section 20 also preferably comprises a
`memory where the measurement result can be stored.
`Therefore, carrying out a measurement does not require the
`mobile phone MS to be connected to the measuring unit 11
`at the moment of measurement, but the measuring unit can
`operate independently so that
`the measurement result is
`stored in the memory provided therein. Next time when the
`measuring unit 11 is connected to the mobile phone MS (or
`when the measurement is complete, if the measuring unit has
`been continuously connected to the mobile phone),
`the
`electronic section of the measuring unit 11 activates the
`short message transmission described in connection with
`FIG. 1 in order to forward the measurement result to the data
`processing system of the doctor treating the patient.
`The electronic section 20 preferably comprises means for
`storing in memory several earlier measurement results and
`for compiling statistics on them, so that the patient can
`browse through previous measurement results and monitor
`their development by means of the keyboard 13 and the
`display 12 of the mobile phone MS. The electronic section
`may also store a special program related to the act of
`measurement, the program guiding the patient in carrying
`out the measurement for example by providing advice via
`the display 12. The program may for example provide the
`patient with a prompt urging him to immediately contact the
`doctor if the measurement results exceed or fall below a
`predetermined threshold value.
`FIG. 4 illustrates the strip 16 shown in FIG. 3. The strip
`16 known per se, having for example the outer dimensions
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`of 2 mm><7 mm, comprises two integrated electrodes 17 and
`18. Between the electrodes there is a capillary which is
`impregnated with a blood sample. The blood sample can
`thereafter be subjected to electrical measurement by con-
`necting the ends of the electrodes 17 and 18 projecting from
`the strip to the measuring unit.
`It should be understood that the above description and the
`related figures are only intended to illustrate the present
`invention. Different variations and modifications of the
`invention will be evident for those skilled in the art without
`departing from the scope and spirit of the invention dis-
`closed in the appended claims.
`We claim:
`1. Asystem for use in monitoring the health of a patient,
`the system comprising:
`a portable measuring device for carrying out a measure-
`ment to provide measurement results suitable for evalu-
`ating the patient’s health;
`data processing system that maintains data corresponding
`to the measurement results;
`said measuring device comprising a measuring unit and a
`mobile phone having a battery space and using a
`wireless data transmission link, the mobile phone being
`connected to said measuring unit, wherein the measur-
`ing unit is located in the battery space of the mobile
`phone and is connected to a communication bus of the
`mobile phone, the measuring unit comprising means
`for supplying the measurement results to the mobile
`phone via the communication bus and further via a
`mobile communication network to the data processing
`system.
`2. A system according to claim 1, wherein the measuring
`unit comprises means for measuring the patient’s blood
`glucose level to provide the measurement results.
`3. Aportable measuring device comprising:
`to
`a measuring unit for carrying out a measurement
`provide measurement results suitable for evaluating a
`patient’s health, and
`a mobile phone having a battery space and using a
`wireless data transmission links,
`the mobile phone
`being connected to said measuring unit,
`wherein the measuring unit is located in the battery space
`of the mobile phone and is connected to a communi-
`cation bus of the mobile phone,
`the measuring unit
`comprising means for supplying the measurement
`results to the mobile phone via the communication bus
`and further via a mobile communication network to a
`
`data processing system.
`4. A portable measuring device according to claim 3,
`wherein the measuring unit comprises means for measuring
`the patient’s blood glucose level to provide the measurement
`results.
`5. A portable measuring device according to claim 3,
`wherein the measuring device comprises means for measur-
`ing the patient’s blood glucose level including measuring
`strips maintained on a reel inside the measuring device.
`6. A portable measuring device according to claim 3,
`wherein the measuring unit comprises memory means for
`storing the measurement results when the measuring unit is
`separate from the mobile phone and means for supplying the
`stored measurement results via the mobile phone to the data
`processing system when the measuring unit is connected to
`the mobile phone.
`7. A portable measuring device according to claim 3,
`wherein the mobile phone utilizes a GSM mobile system and
`comprises means for transmitting the measurement results in
`the form of a short message of the GSM system.
`*
`*
`*
`*
`*
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`CERTIFICATE OF CORRECTION
`
`PATENTNO.
`
`: 5,772,586
`
`DATED
`: June 30, 1998
`|NvEN'roR(s) ; HEINONEN ET AL.
`
`It is certified that error appears in the above-indentified patent and that said Letters Patent is hereby
`corrected as shown below:
`
`Claim 1, col. 6, line 17, after "health;" insert --and--.
`
`Claim 1, col. 6, line 18, before "data processing" insert —-a--.
`
`Claim 3, col. 6, line 39, delete "links" and insert --link--.
`
`Ar1e.s-t.-
`
`Signed and Sealed this
`
`Twenty-t‘1fth Day of August, 1998
`
` & Miéi
`
`BRUCE LEHMAN
`
`Al!P.Vl/fig 0_fi7(‘(’I'
`
`(‘nnmIi.s,\r'mrrr nf Pulrnh um! 'I'rmIr'murL\'