Abstract:
An arrangement of equipment for the remote monitoring of bodily functions of a mammal under medical care, comprises: a function-measurement device to measure a physiological quantity relevant to bodily function; a first display unit disposed remotely from the function-measurement device and monitored by a responsible medical person, to display the measured values of the measured physiological quantity and a function characterization derived therefrom; an input unit disposed remotely from the function-measurement device, for the input of control commands for the function-measurement device, and to input warning signals; and a bi-directional public telecommunication-network connection with an outward channel between the function-measurement device and the first display unit and a return channel between the input unit and the function-measurement device, where, for each connected device, there is provided an interface adapted to a transmission protocol of the telecommunication network.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     The present application claims the benefit of European Priority Application No. 02 008 958.7 filed in Europe on Apr. 22, 2002, the disclosure of which is incorporated herein by reference.  
       BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     The present invention relates to monitoring physiologic data in real time, and more specifically to monitoring such data remotely.  
         [0004]     2. Related Art  
         [0005]     Advances in medical technology have made it possible to treat a large number of diseases and disorders in such a way that although the affected people are not ultimately cured, they can have a good quality of life despite the disease. However, such illnesses (e.g., diabetes, various heart diseases, asthma, diseases of the rheumatic type, cancers, Alzheimer&#39;s disease, allergies) demand continuous medical care of the patients, because medications must be taken regularly, and long-term diagnostic monitoring by appropriate measurement devices is required. Furthermore, the diagnostic data obtained from the patient must regularly be checked by a specialist, and the patient must remain under the care of a physician so that the progress of the disorder can be made as nearly optimal for the patient as possible.  
         [0006]     Further, advances in medical technology for the treatment of the chronically ill (e.g., installations to allow asthmatics to breathe oxygen) and for the collection of diagnostic data (e.g., glucose measurement in diabetes) have become so well developed that the patient can manage them autonomously while ambulant.  
         [0007]     The generally known state of the art in cardiac and circulatory diseases includes heart clinics in which infarct patients spend weeks and months under observation. The care system is supplemented by clinic-based physicians who can prepare ECGs and provide the patients with 24-hour recording devices, so that a daily visit by the doctor can be eliminated. Systems are also known in which a patient can hold an instrument similar to a mobile phone against his chest whenever he thinks it necessary, so as to transmit data about his heart condition to a physician&#39;s practice by way of a wireless network.  
         [0008]     For asthmatics, there are devices to measure pulmonary function that the patient can operate independently. However, even in combination with visits to a doctor, this is not sufficient for successful therapy, because the latter requires a regular intake of medicines (particularly during symptom-free periods, when many patients tend to neglect their medication) as well as adjustment of the therapy schedule by the doctor to suit particular situations. In many cases patients with chronic lung disorders also need special breathing aids (to increase oxygen content and filter out dust and pollen), the maintenance of which must also be carried out by specially trained workers.  
         [0009]     From the areas of space travel and sports medicine it is also known that the bodily functions of individual people (astronauts in a spaceship, high-performance athletes during running or training) can be monitored by measurement devices carried on the subject&#39;s body or in any case disposed near the subject of the investigation, the results of the measurement being transmitted over a specially established wireless route to a central unit, such as a ground station, an accompanying vehicle or a training centre, for evaluation and observation. There the data can be evaluated nearly in real time. In some cases means are also provided for wireless transmission of instructions to the investigated person, for instance regarding how to adjust the level of physical activity, or that certain manipulations should be carried out.  
         [0010]     These last solutions to the problem of remote monitoring are unsuitable for a large health-monitoring system from which a large number of patients, especially the chronically ill, can benefit and which in its medical components can be operated by a widely branching network of clinics, physicians&#39; practices and other medical-care sites, because the means of information transmission are very elaborate and because of specific technical properties of the transmission routes employed.  
       SUMMARY OF THE INVENTION  
       [0011]     The invention includes function-measurement devices situated near or on the subject, i.e. the patient, of the investigation, which are connected by way of a public telecommunication network to display units and/or automatic monitoring and control apparatus situated in the clinical or ambulant region. The use of a public network ensures not only considerable advantages of economy in comparison to specially established wireless routes, but also a practically unlimited system capacity and extraordinarily great availability of the communication link and hence convincing reliability of monitoring. When a mobile wireless network is employed, which is preferable from the present viewpoint, there is the additional advantage that the patient can be reached practically everywhere within range, without any gaps, at least in the industrialized countries.  
         [0012]     The invention implements, within the framework of the above-mentioned connection by a telecommunication network, both an outgoing and an incoming channel. The data obtained from the patient by measurement or evaluation are sent to the display unit or monitoring and control apparatus. Instructions for activities can be sent to the patient, or control commands to a measurement or detection device associated with the patient or also to a device provided for remote-controlled therapy.  
         [0013]     In a first implementation, the invention incorporates the active participation of medical personnel in the remote monitoring and optional remote-controlled therapy of the patient. In a second implementation of the invention, a substantially automatic evaluation of the measurements obtained from the patient is provided for the automatic generation of control commands or instructions to the patient. Either of the two implementations can be preferred, depending on the specific state of development of a national health system within which the invention is being employed, and in particular on the specific nature of the patient&#39;s illness and the therapeutic measures being undertaken.  
         [0014]     In larger systems of the kind in accordance with the invention it may well be advantageous to combine the two variants in such a way that, depending on the illness, primacy will be given to treatment either initiated by medical personnel or performed automatically. It should be understood that normally at least every automated patient-care treatment will be documented and subjected to evaluation by a physician together with the data and/or event that initiated the treatment, whether temporally in parallel or subsequently.  
         [0015]     In view of the above explanations, it should further be apparent that an established system of the kind in accordance with the invention will comprise many function-measurement devices associated with a large group of patients, and a whole network of display units and monitoring and control apparatus disposed at the medical end, so that a correspondingly large number of interfaces with a telecommunication network or even several telecommunication networks are provided. The incorporation of several independent telecommunication networks into the system may be necessary in particular for system solutions that extend across national boundaries, but for reasons of competition and economy it can also play a role in national systems. The devices connected to the communication network on both sides can of course be quite different from one another—all that is required is to establish a transmission standard (or several compatible standards) for their communication and interaction.  
         [0016]     In an embodiment preferred for its practical usefulness, the proposed system comprises in addition to the fundamental components, i.e. the function-measurement devices, display units or monitoring and control apparatus, and telecom network with outward and return channels, therapeutic devices and/or additional display units at the patient&#39;s end, so that in response to a monitoring result that demands a medical reaction instructions as to what should be done can immediately be displayed to the patient, or the therapeutic device can be directly controlled so that it automatically initiates suitable therapy.  
         [0017]     By application of the invention patients at home or travelling can receive treatment of approximately the same quality as they would under stationary conditions in a clinic. Over the spatial distance it is possible, first, for the medical data specific to the individual to be transmitted and evaluated by a specialist physician. Second, monitoring ensures that medication is being taken as prescribed. Third, there can be a direct, video-supported contact between the patient or the patient&#39;s caregivers and the doctor. Fourth, medical devices can be operated and maintained by remote control. Fifth, the patient can use an Internet portal at all times to access personal data, advice from the doctor, servicing dates for the devices being used, and so on.  
         [0018]     In carrying out medical studies, but also when particular routines are to be followed, the compliance of the subjects, i.e. the degree of precision with which they conform to the prescriptions for taking medicines and using equipment, is of crucial significance. Here the invention contributes to recording the data reliably, managing the data and testing the data for correctness. The invention also enables devices to be employed in a simple manner for objective measurement of patient compliance.  
         [0019]     In an exemplary embodiment, the present invention can be a arrangement of equipment for the remote monitoring of bodily functions of a mammal under medical care, comprising: a function-measurement device to measure a physiological quantity relevant to bodily function; a first display unit disposed remotely from the function-measurement device and monitored by a responsible medical person, to display the measured values of the measured physiological quantity or a function characterization derived therefrom; an input unit disposed remotely from the function-measurement device, for the input of control commands for the function-measurement device, and to input warning signals; and a bi-directional public telecommunication-network connection with an outward channel between the function-measurement device and the first display unit and a return channel between the input unit and the function-measurement device, wherein for each connected device there is provided an interface adapted to a transmission protocol of the telecommunication network.  
         [0020]     In another exemplary embodiment, the present invention can be a arrangement of equipment for the remote monitoring of bodily functions of a mammal under medical care comprising: a function-measurement device to measure a physiological quantity relevant to bodily function; an automatic monitoring and control unit disposed remotely from the function-measurement device, to evaluate the measured values of the physiological quantity or a function characterization derived therefrom, and to generate control commands in response to the result of the evaluation for the function-measurement device; and a bi-directional public telecommunication-network connection with an outward channel between the function-measurement device and the automatic monitoring and control unit and a return channel between the automatic monitoring and control unit and the function-measurement device, wherein for the connected device there is provided an interface adapted to a transmission protocol of the telecommunication network.  
         [0021]     Further features and advantages of the invention, as well as the structure and operation of various embodiments of the invention, are described in detail below with reference to the accompanying drawings. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0022]     Further advantages and useful features of the invention will be apparent from the subordinate claims and from the following description of preferred exemplary embodiments with reference to the figures, wherein  
         [0023]      FIG. 1  is a sketch showing the principles of an arrangement according to a first embodiment of the invention;  
         [0024]      FIG. 2  is a sketch showing the principles of an arrangement according to a second embodiment of the invention;  
         [0025]      FIG. 3  is a sketch showing the principles of an arrangement according to a third embodiment of the invention; and  
         [0026]      FIG. 4  is a sketch showing the principles of an arrangement according to a fourth embodiment of the invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0027]     A preferred embodiment of the invention is discussed in detail below wherein like reference numbers generally indicate identical, functionally similar, and/or structurally similar elements. While specific exemplary embodiments are discussed, it should be understood that this is done for illustration purposes only. A person skilled in the relevant art will recognize that other components and configurations can be used without departing from the spirit and scope of the invention.  
         [0028]     The invention relates to an arrangement of equipment for the remote monitoring of bodily functions of a human under medical care, or a mammal under the care of a veterinarian. The functions that can be served by equipment thus arranged include monitoring an athlete in the context of sports medicine, or a patient with a chronic disorder, and, where appropriate, monitoring of the bodily functions of highly valuable animals in high-performance animal husbandry.  
         [0029]      FIG. 1  shows as a first embodiment of the invention an arrangement  10  of equipment for the care of an asthmatic patient P who is some distance away from a centre specializing in pulmonary disorders. The patient P has at his disposal a simply constructed device  11  for the diagnosis of pulmonary function, which he carries on his body and can operate with no problems. The device  11  incorporates a Bluetooth card and is in permanent connection, by way of a short-range wireless connection a according to the Bluetooth standard, with a similarly equipped mobile wireless terminal  12 .  
         [0030]     The mobile wireless terminal  12  can, for example, be a GSM mobile telephone with a data input as an interface to a mobile wireless network GSM (here shown only schematically), which in case of need can establish a long-range wireless connection b to another mobile wireless terminal  14  near a physician A in the specialized pulmonary centre. The diagnosis device  11  and the mobile wireless terminal  12  on the patient&#39;s side together can also be termed the patient-condition monitoring unit  13 .  
         [0031]     The pulmonary-function diagnosis device  11  stores at least one threshold value for a quantity characterizing the pulmonary function or breathing activity, for instance the respiratory rate and/or the respired volume. The device  11  is designed to detect the corresponding measured values and compare these with the threshold value. If the measured values pass significantly below the threshold value or values, the comparator unit automatically sends an alarm signal over the Bluetooth connection a to the mobile telephone  12 , which then likewise automatically initiates the transmission of an alarm announcement over the mobile wireless connection b to the mobile telephone  14  on the pulmonary centre side, causing an alarm announcement to appear on a display unit  15 , for example, a PC screen, attached thereto.  
         [0032]     Using the associated PC  16  as input unit, the physician A can then give a remote-control command to activate a therapeutic device  17 , for example, an aerosol applicator, that is continually in the vicinity of the patient or carried by the patient. The command is transmitted by way of the return channel comprising the physician&#39;s mobile telephone  14  and the mobile telephone  12  on the patient&#39;s side, plus a second Bluetooth connection between the mobile telephone  12  and the aerosol applicator  17 , with the result that a pre-specified therapy consisting of supplying the patient with aerosol is automatically initiated. That is, the therapy is given regardless of the patient&#39;s condition and whether or not he is capable of taking action himself, and hence is reliable even in case of a severe, acute asthma attack.  
         [0033]     When an irregularity in the patient&#39;s breathing is detected, the pulmonary-function data measured and the alarm signal identifying an irregularity are sent, and provided with a time stamp, to the display unit  15  and to a central patient-data memory  18  in the specialized centre, where the information is stored with reference to the individual patient. The data management is achieved by an associated data-management unit  19 , with which is associated an authorization testing stage  20  to determine whether external attempts to gain access are authorized. By way of a data-net interface  21   a  the patient-data memory  18  can be connected to the Internet, and on the patient&#39;s side, by way of the mobile telephone  12  or a PC  22  and a data-net interface  21   b , the patient can view his own data from the past by entering an appropriate authorization code.  
         [0034]     The aerosol applicator  17 , by way of its Bluetooth connection c to the patient&#39;s mobile telephone  12 , receives the appropriate control signals from the medical centre in case therapy is needed, and, at regular servicing intervals, receives function-monitoring signals from a remote service technician ST, who enters them into his PC  23  from which they are transmitted by a mobile wireless terminal  24  on the technician&#39;s side and a separate connection e in the mobile wireless network GSM. The PC  23  of the service technician ST thus has the function of a remote monitoring and maintenance device, and the wireless connection in this case likewise ensures that the necessary activities can be carried out regardless of the current location of the patient.  
         [0035]     Servicing and repair visits by the service technician ST to the patient P are not rendered fundamentally superfluous by these means of remote-controlled maintenance, but their frequency can be reduced and efficiency increased. Furthermore, it becomes possible for the service technician to contact the patient directly by way of the mobile wireless connection or, alternatively, over the Internet, in order to make an appointment for servicing that must be done on site; however, to preserve the clarity of the illustration these possibilities are not indicated in the figure.  
         [0036]     In  FIG. 2  another example of a system in accordance with the invention is sketched, in this case an arrangement  30  of equipment with which a patient P′ with high blood pressure can be treated by remote control by a physician A′ in a medical practice. Components having substantially the same function as components in the arrangement according to  FIG. 1  are identified by the same reference numerals, plus twenty, as in the  FIG. 1 , and—insofar as there are no special features to be noted in the present arrangement—are not explained again.  
         [0037]     The arrangement  30  comprises a blood-pressure measurement device  31 , which is carried and operated by the patient and is connected to the patient&#39;s mobile telephone  32  by a data cable  31   a . The blood-pressure measurement device  31  and the mobile telephone  32  again (as in the first example) form a patient-monitoring unit  33 .  
         [0038]     The physician A′ has at his disposal the same system components that were available in the specialized pulmonary centre in the first example, and the transmission to him of signals indicating blood-pressure values that should be considered irregular is the same as in the first example. A difference is that here the patient has no therapeutic device available, but rather when his blood pressure becomes unacceptably high or low, receives from the physician specific advice as to medication by way of the return channel e of the long-range mobile wireless connection between the mobile telephone  34  on the physician&#39;s side and the mobile telephone  32  on the patient&#39;s side. With this kind of signal transmission, the patient&#39;s mobile telephone  32  serves simultaneously as a display unit, by way of which the patient receives instructions about taking medications to adjust blood pressure, in the form of spoken output or a display.  
         [0039]     Regarding the availability of a patient data bank, this embodiment is also the same as the first example, in  FIG. 1 ; but the means of remote-controlled maintenance can be eliminated in the diagnosis device employed here, which is produced in large numbers, operates reliably over long periods and does not include a therapeutic device.  
         [0040]      FIG. 3  shows—likewise schematically—a third arrangement  50  of equipment for remote diagnosis and therapy, in this case for a patient suffering from chronic diabetes. It includes a central therapy-control unit C supervised by a diabetes physician A′ in a diabetes centre. The basic construction of this arrangement corresponds to that of the first example, shown in  FIG. 1 , so that here again components with substantially the same action are identified by the same reference numerals as in  FIG. 1 , plus forty, and are not described again.  
         [0041]     The diagnosis device concerned here is an implanted glucometer  51 , and the therapeutic device is a likewise implanted insulin pump  57  under remote control. The outward and return channels of a mobile wireless connection between these devices on the patient&#39;s side and the diabetes centre are basically configured as in  FIG. 1 —except that now in addition to the connection to a PC  56  of the diabetes physician, a direct connection to the therapy-control unit C is also made as soon as the glucometer detects questionable blood-sugar levels.  
         [0042]     In response to an evaluation of the transmitted blood-sugar values the therapy-control device C, with no need for intervention by the physician, sends out a control command for the insulin pump. The control command is transmitted through the return channel of the mobile wireless connection to the insulin pump and activates the latter in the pre-specified manner, or alters the amount of insulin injected.  
         [0043]     Particular testing and maintenance functions for the glucometer and the insulin pump are implemented as remote-controlled maintenance, analogous to the system according to  FIG. 1 , and the patient-data storage in a data bank and the data management are also correspondingly organized.  
         [0044]      FIG. 4  shows, using the same reference numerals as those used in  FIG. 3  for the third embodiment, a fourth embodiment, distinguished from the third with respect to the network structure for the relevant information-transfer events. The arrangement as a whole is identified by the reference numeral  50 ′ and differs from the third embodiment in that the Internet is used for transmission of all the information.  
         [0045]     The long-range information transfer between the patient-condition monitoring unit  53  and the mobile wireless terminal  54  on the clinic&#39;s or physician&#39;s side as well as in the opposite direction, between the latter and the patient-condition monitoring unit, is in each case subdivided into three sections, b 1 ′ to b 3 ′ and c 1 ′ to c 3 ′, respectively. The first and last sections in each case are formed by a mobile wireless connection between the associated terminal and a gateway  62   a  or  62   b  to the internet, whereas the middle section is established by sending an e-mail or a file transfer within the data network. The gateways  62   a ,  62   b  carry out an SMS/e-mail or e-mail/SMS conversion in a manner known per se and made available as a service by providers.  
         [0046]     In this embodiment the data transfer between the mobile wireless terminal  64  of the service technician ST and the insulin pump  57  (by way of the mobile wireless element  52 ) is organized in the same way. For the data transfer concerned here it is also possible to provide another combination of generally used transmission formats with corresponding conversion, such as a combination of SMS and fax transmission, or of e-mail and fax transmission.  
         [0047]     Specifically for patients with cardiac disorders, the function-measurement device provided is a pulse-rate or heart-rhythm detector, both of which are known in the art. Alternatively or in addition, patients with chronic circulatory diseases can have as function-measurement devices a blood-pressure meter and/or an oximeter to measure the oxygen content of the blood. Additional measurement devices can also be employed within the framework of the proposed system, such as are used in patients with implanted cardiac pacemakers to supplement the data provided by the heart-rate detector with other reliable data—for instance, a sensor to detect body position (standing/reclining) or an accelerometer to detect strenuous body activities.  
         [0048]     In an exemplary embodiment of the present invention, diabetics are advantageously given a means for the periodic, automatic measurement of blood sugar (glucose) content. In another exemplary embodiment of the present invention, patients with severe airway diseases have a device to detect pulmonary performance or respiratory rhythm, which is known in the art. In another exemplary embodiment of the present invention, patients with, in some cases potentially lethal, nerve diseases can carry a portable EEG recorder to detect the brain currents. This list is not exhaustive and is meant merely to illustrate important applications of the proposed system and the data-collection devices that can be used therewith.  
         [0049]     For the above-mentioned cardiac patients, the therapeutic device preferably takes the form of a cardiac pacemaker, known in the art. In the case of high-frequency disturbances of cardiac rhythm that might lead to fibrillation, the therapeutic device can be a defibrillator. These devices for correcting cardiac rhythm have long been available in designs suitable for implantation and remote control by way of short-range telemetry, and they can and should also be employed in the system proposed here.  
         [0050]     Likewise for cardiac patients, but also for the treatment of other diseases that can develop into acute risk conditions requiring urgent medication, medicine-dosing devices can also be employed as therapeutic devices. These too are preferably controllable by remote means and of course are particularly advantageous (in the form of the known implantable insulin pumps) primarily for patients with severe diabetes. A simple and more economical way to implement the dispensing of medicine in conformity with this system consists in instructing patients to take a medicine in the form of pills or drops, or to give themselves an injection. For a permanently reliable treatment with medication, however, since the results are independent of the patients&#39; following such instructions, the more expensive medicine-dosing devices have considerable advantages in terms of security.  
         [0051]     For patients with severe airway diseases, again especially if the disease might rapidly become acutely dangerous (as in the case of asthmatics suddenly exposed to allergens), remote-controlled breathing aids can be used in conformity with the system. These can in particular comprise an oxygen or aerosol generator. Here, again, the less costly variant specifically in the case of asthmatics consists of instructing the patients to make use of a device that they operate themselves—but devices that can be centrally controlled by way of the return channel of the telecom connection have security advantages in some of these cases as well.  
         [0052]     In addition to the above-mentioned devices, which can be considered diagnostic or therapeutic devices in the narrow sense, in an advantageous embodiment the system additionally comprises a picture-recording device on the patient&#39;s side, as well as “centrally” (i.e., at a distance from the picture-recording device) a video reception and display device, so that the pictures taken by the patient can be displayed to the medical personnel to facilitate their evaluation of the patient&#39;s condition. In cases of severe chronic dermatological diseases this picture-recording device (video camera) can also replace the function-measurement device, and the picture it delivers is evaluated in analogy to the measured data in the case of other diseases.  
         [0053]     The interfaces associated with individual system components to connect them to the telecom network take the form, in a preferred embodiment, of mobile wireless terminals with inputs and outputs suitable for data. The term “mobile wireless terminal” in the context of the invention should be understood to include not only normal mobile telephones but also transmitter/receiver elements with reduced functionality (e.g., with no means for speech transmission), as well as hand-held PCs or personal digital assistants (PDA) with a mobile wireless component.  
         [0054]     Outward and return channels for data transmission in SMS or EMS format or based on the wireless application protocol (WAP) standard (specifically per WAP push) can be designed in the same way as is known for other applications. In the outward channel the transmission is preferably activated automatically by way of the function-measurement device or the picture-recording device, whereas in the return channel it is initiated either manually by the medical personnel who are evaluating the results, or automatically by the monitoring and control unit in the patient-care centre. The outward and return channels can also be permanent, packet-oriented exclusive connections according to the GPRS standard within a GSM network or according to the future UMTS standard.  
         [0055]     In a preferred embodiment, to preserve the data, on the physician&#39;s side there is provided a central data bank to store the relevant transmitted measured data or information identifiers, and associated therewith is in particular a central data-bank management system for the management of these data for the medical care devices. The data-preservation system is preferred because it is accessible on the basis of appropriate authorization. With graded authorization tests and access controls, both the authorized medical personnel (e.g., the house doctor) and also the patient can be granted simple access to the stored data from any desired terminal devices.  
         [0056]     The above-mentioned function-measurement devices or therapeutic device can be connected to the system by way of an outward and/or return channel that comprises a wireless short-range connection to an associated interface of the telecom network. The above-mentioned picture-recording device on the patient&#39;s side (e.g. a video camera or web-cam) can likewise have a similar wireless connection, for example, a wireless LAN, a Bluetooth or a DECT connection. With respect to cost, the Bluetooth and the DECT connections appear advantageous, and, according to preliminary information, the Bluetooth standard additionally offers advantages in reliability.  
         [0057]     The embodiment of the invention is not limited to the aspects emphasized above or to the preferred exemplary embodiments, but is equally possible in a large number of modifications that are within the competence of a person skilled in the art.  
         [0058]     While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should instead be defined only in accordance with the following claims and their equivalents.