MXPA98008360A - Equipment to register the state of health of a patie - Google Patents

Abstract

It is not easy to measure and record the health status of a patient, despite reliable statements or records concerning how the patient's health varies over time, particularly when the patient is receiving medication is desirable for doctors and for research purposes. A mobile unit is proposed to determine and record the health status of the patient, the patient who records the variation in the effect of the medication with time to press the unit's buttons, thus storing this data in a recording medium. The unit (1) has buttons (2, 3, 4) by means of which the patient can record the time at which he took the medication and the time and degree of any positive or negative effect. The variation of the effect with time is recorded and can be emitted by means of a microcircuit (8) and therefore reproduced. The unit is suitable for use in therapy and pharmaceutical research

Description

EQUIPMENT TO REGISTER THE STATE OF HEALTH OF A PATIENT The invention relates to a portable device for registering, displaying and storing subjective values concerning the state of health of a patient according to the preamble of patent claim 1. It is known as recording certain physiological values of a patient by means of measuring equipment or sensors that can be carried in the body, and storing these values in a recording medium or recording equipment. Thus, for example, changes in a patient's blood pressure can be measured and recorded over time. The measurement is carried out by means of convenient measuring equipment, this is automatically without any action on the part of the patient. It is also known to use special measuring equipment to detect and record the movements of a patient's hand in terms of its amplitude in order to obtain a reliable image of the movement pattern over time. Finally, oxygen meters to continuously measure the oxygen content of a patient's blood in respiratory problems and apnea syndrome are also known. These devices fail in cases where it is a matter of recording physiological values that can not be measured physically easily. In these cases, the doctor has to rely on questioning the patient about his / her state of health and about the effect of the medication. Since the answers given by the patient are based on memory, the experiences are often distorted and often wrong assessments are made and inaccurate data are given, which therefore are only of limited use if they have it, for the doctor. In German Patent DE-A-37 03 404 a pocket computer has already been described for recording patient data. In this, the patient introduces subjective parameters with reference to their health status in the team at certain times that are fixed by a program, and the team stores the data with the time and date. Using control buttons, the patient can set the cursor on a scale so that the degree of their subjective symptoms is marked and then stored. This equipment and the data recorded with it do not refer at all to the time in which the medication was taken by the patient. German Patent DE-A 40 25 830 has disclosed a computer running miniaturalizada batteries to collect data from outpatient, in which the patient, after a complicated cycle of questions, assess their health subjectively and introduces this assessment by means of buttons on the equipment and stores it. This data interrogation and data entry also only has an indirect reference to the time at which the medication is taken. In addition, the input values have no reference to the previous value, that is to say "absolute". The patient can not see the value he introduced to the last one, and therefore he must carry out an absolutely new assessment at the moment in question. Therefore, there is no coherent and significant picture of changes in health status over time. Patent WO 94/06088 describes a process which, by means of a portable computer, gives the patient notice about when and how to take medication. The patient himself enters different data, which are requested by the computer, in the equipment and these data are processed and used to give instructions on the administration of medicines in terms of dose and schedule, and in addition to this an expert system is consult that finally emits the recommendation forcing the patient. Up to this point this process represents a "closed loop" between the patient and the computer, in which the computer obviously assumes the role of the doctor. This process, and the equipment necessary to carry out this process, are very elaborate and complicated and therefore not always convenient for patients whose faculty of perception and mobility is impaired. further, the recommendations given by a "computer doctor" should therefore be qualified since this team can not take the place of a real doctor. The object of the invention is to make available equipment for recording physiological values that can not be measured objectively, or the state of health of a patient, with respect to the medication that the patient is taking, in particular a patient whose faculty or perception and / or motor mobility are limited. According to the invention, this objective is achieved by means of the features in the claims. Using the equipment according to the invention, it is possible to record the subjective health status of the patient, in particular after taking the medication, and doing this the same patient. In this way, the variation in effect, that is to say the change in the effect of the medication during the course of time, is recorded in a recording medium and can be observed by the attending physician. By means of this reproducible graduation, it is possible to optimize the medication, especially in the case of medication with only a short duration of action. The goal here is to achieve a more uniform effect of the medication for the patient, to avoid side effects caused by overdose, and to help the patient by ensuring that the medication is being taken at the correct time, for example, in Parkinson's disease. In addition, the same patient has the advantage that by recording the intensity of the possible side effect after taking the medication, he can better evaluate the effect. Moreover, this equipment increases the willingness of the patient to cooperate constructively with the doctor (the so-called obedience). Finally, this equipment can also be used with advantage to carry out tests and tests on new active substances, drugs and treatment procedures (for example clinical trials of drugs, natural healing processes, radiation and the like) in order to determine the variations indeed with much more precision. By means of the equipment according to the invention, that is to say by means of the apparatus of the size of a pack of cigarettes or of a wristwatch, which can be operated by the patient and is very comfortable to be used, it is possible to simply record and store the subjective health status of a patient after taking the medication, ie the subjective effect of the medication which, for example, is in the form of an instruction to take a drug at certain times, or also in different compositions of the drug (with respect to the amount of active substance equipment), and to introduce into the equipment, by means of buttons, the changes in effect during the course of time. At the end of this record, which can be repeated as often as you want and by simple button pressing, the recorded values are stored with a recording medium function that can be removed from the equipment as a chip or can be transferred directly the analysis equipment (for example a personal computer) through an adapter. This chip, or the visual display of data on the screen, is used by the treating physician or therapist as a means of verifying the effect of a medication and at the same time instructing the patient about when to take the medication. The invention is described in detail below on the basis of several illustrative modalities and is also represented as equipment in the drawing, in which: Figure 1 shows a simplified design of a portable recording equipment. Figure 2 shows a diagram of the function showing the change in effect over time, in the equipment according to Figure 1. Figure 3 shows an extended design of the recording equipment in the form of a wristwatch with deployment functions optical. Figure 4 shows a diagram of the step effect function of the equipment according to Figure 3. Figure 5 shows another design of the recording equipment with extended input functions, and Figure 6 shows another design of the recording equipment with an external key switch and an external sensor.

Figure 1 shows the recording equipment 1 which can be used on the patient's body and which is approximately the size of a wristwatch or a pocket calculator. This equipment has, on its front side as shown in the drawing, three buttons 2, 3 and 4 which are given the letters M, N and P. A visual display 5 is also provided which indicates the time from the which drug was taken and / or the time of day which can be selected via a button 7. Finally, a removable chip 8 is shown which, as a means of registration, contains the registered values. The equipment is operated as follows. The patient who is using the equipment in his body, or who takes it with him, first takes the medication prescribed by the doctor and at the same time presses the M button. This starts a chronometer, that is, the time starts to run at zero and optionally it can be shown in visual display 5. If, after taking the medication, the patient now experiences a positive effect, he presses the P3 button. The equipment recognizes that the button has been pressed by emitting an acoustic signal (buzzing) or an optical signal from light 6, so that the patient receives confirmation of the input he has made. If after a certain time the patient feels that the effect is decreasing, press the N4 button. Then take your medication a second time as instructed by your doctor, and again press the M2 button, as a result of which the time is stored. The procedure described above is then repeated, ie by pressing the P button when it experiences a positive effect and pressing the N button when it feels that the effect is decreasing. This is certainly done in each case based on the subjective feelings of the patient. The result of a single entry cycle of this kind made by the patient is shown in the diagram according to Figure 2. There, the positive effect of the drug is plotted on the ordinate on the time axis t, and only as a positive value of the order 1. The start of each measurement cycle after drug administration is marked by the point Mx, on the abscissa, that is, the time axis. Here, therefore, the effect of the drug is equal to 0. After some time, the period known as latent L, the patient first experiences a positive effect and presses the P button, as a result of which the value f is recorded ( l) = l in time ti. After another time interval, at time t2, the patient feels that the effect decreases or disappears completely and presses the N button, as a result of which the value f (2) = 0 is recorded. The next time on the time axis is M2, that is, the time t3, in which the medication is taken a second time. M2 is registered by pressing the M button; As you can see, the effect of the medication is still at 0 at this time t3, so that the time called vacuum F is presented, that is, a time interval t = t3 - t2 in which there are no effects of the medication. After the second administration of drug M2, again there is a latent period L ', ie the time difference with time t4, in which the patient again experiences a positive effect and presses the P3 button. This second latent period L 'can be different than the first period L. The measurement cycle started in this way can be continued as frequently as desired by repeating the administration of medication in consecutive times M3, M ..., Mi, with the corresponding record of the effect. The result is stored as a function according to the pattern in Figure 2 and can be removed as a recording medium, for example on the chip. It would also be possible to analyze the function stored directly on a personal computer by means of a personal computer adapter, for example by comparing the effect profiles on different days, or by printing the stored function. These data, ie the effect function, help the doctor to adopt the optimal or corrected medication program for the patient, and this with the goal of eliminating the empty times F mentioned above and the subsequent latent periods repeated L ', ie the time intervals in which there is no effect of the medication.

Figure 3 shows another illustrative embodiment of the invention namely the recording equipment 10 in the form of a wristwatch with securing fasteners 11 and 12 for a strap (not shown). The equipment 10, which is thus essentially of circular design in its plan view, has first the button M13 and other buttons 14 and 15 to introduce a positive and a negative effect, the button 14 showing a smiling face and the button 15 It shows a sad face. Moreover, a visual display 16 is provided to optionally display a running time (of a stopwatch) and the clock time, with the appropriate mode being possible to be selected using the button 17. The equipment 10 also has five optical devices 19 (diodes). light emitters) which represent a respective registered value. Five optical devices 21 (light emitting diodes) are provided correspondingly to the left side of the circular equipment 10 to display the recorded negative effect. Between these two groups of five, 19 and 21, a configuration of lights 18 is provided for fixing at 0, ie without effect. The equipment 10 also has a larger light configuration 20 which is intended to indicate an optimum for the health status of the patient. Finally, three other light configurations 22 are provided for the so-called medication excess effect. The aforementioned groups of light configurations are of different geometric designs and are lit in different colors, for example group 19 and 20 in green, group 21 in blue and group 22 in yellow. Finally, an optical or acoustic signal configuration 23 is provided in the area of the "clock face" of the equipment 10, whose configuration 23 emits acoustic or optical signals at the time previously programmed to take the medication (MI, M2, M3, etc.). .) in order to remind the patient to take the medication. The signal can also be generated by vibration. Finally, the equipment has a connection point 24 but an adapter (not shown) by which the stored data can be transferred to a personal computer and displayed on its screen. The function recorded and stored using the equipment 10 according to Figure 3 is shown in the diagram in Figure 4. Both the positive effect and the negative effect after taking the drug are plotted on the time axis t, with five values from Pl to P5 provided for the positive effect and five values from NI to N5 for the negative effect. Above the value P5 there is an OPT value, which represents the optimum, that is, the best that the patient feels, and on top of this there are three additional values for an excessive effect of the drug Ül, 02, and Ü3. The diagram shown represents the variation in effect between the times in which drug Mi and M2 were taken and recorded by pressing buttons 13 (M), 14 for a positive effect and 15 for a negative effect. The measurement cycle begins at the time at which the patient presses the M or 13 button on the first dose of medication. After the latent period L has elapsed, it experiences a first positive effect and presses the button 14 once in time ti, as a result of which the value f (l), corresponding to the value Pl, is recorded in the positive ordinate . At time t2 the patient experiences an increased positive effect which he values subjectively with the value P4, and for this he has to press button 14 three times in succession, which results in a jump from Pl to P4 at the value f (2) . When the Pl value is registered, the first light configuration 19 (green) is turned on, and when the P4 value is registered, three other light configurations 19 are switched on, ie four light configurations 19 are turned on 19. At time t3 the patient experiences an optimal effect and presses the button 14 again, as a result of which it reaches the value P5, and pressing the button 14 once more the value OPT, that is, the optimum, corresponding to f (3) if it reaches, and at the same time a larger lighting configuration 20 (green) is turned on. The patient sees that the optimal effect of the medication has now been registered. At time t he experiences a surplus effect of medication and therefore presses the button 14 again, and as a result of which the value f (4) corresponding to Ül is recorded on the ordinate. When the value Ül is reached, that is to say recording a surplus effect, another light configuration 22 (yellow) is turned on, thereby optically signaling the range of the successive effect. If the patient feels that this excess effect decreases, he can press the button 15, as a result of which, if the latter is pressed once, the OPT (optimum) value is reached again. If the effect decreases more, the patient can again press the button 15- one unit is subtracted for each simple activation in the case shown, pressing the button 15 four times, reaches the value P3 in time ts, corresponding to f (5) , and pressing it again reaches the value P2 at time te, corresponding to af (6). At time t the patient experiences a very diminished effect, going down to the negative range. Therefore, press button 15 four times and reach the negative value f (7) corresponding to N2. At the same time, two light settings 21 are now turned on (blue); five light-emitting diodes 21 (blue) corresponding to the negative scale of the values of NI to N5 are provided. The next time corresponds to the planned time M2 to take the second dose of the medication. In this case, therefore, there is still a negative effect of the medication that takes until time tg; only then does the patient experience a positive effect again, and press the button 14 with the smiling face three times and reach the value f (9) that corresponds to the value Pl in the ordinate. The time interval between t8 and t.7 corresponds to the empty time F in which there is no positive effect for the drug, and the time interval between tg and t8 is the second latent period L 'after taking the second dose of the drug . After this, the measurement cycle continues as described above. Each of the groups of light emitting diodes 19 to 22 may have different colors (as indicated above) or they may be ignited in the same color but with different brightness or with different contour (if the patient is colorblind). This diagram, which can be stored on a recording medium or can be transferred to a personal computer by means of an adapter, is used by the doctor as a basis to adapt the medication more precisely, that is, on the one hand in terms of the choice of times MI, M2, M3, etc., and also in terms of the dose of the medication. The latter can be adapted, for example, if there is an excess effect in this case up to the value Ül over time you - since in this case the dose of the drug was too strong. Finally Figure 5 shows another design of the invention, namely in the form of the equipment 30 having an enlarged visual display or a small screen 31, a keyboard 33, 34 and the buttons already described with the letters M, P and N corresponding to the reference numbers 35, 36, 37. In addition, a time switch 32 with T is provided that it is possible to alternately switch between the chronometer and the normal time. The buttons 34 with the numbers 1, 2, 3, to 0 correspond to the side effects, for example headache, nausea, fever or tachycardia. Thus, using the keyboard, the patient is able to represent on the screen the lateral effect that occurs after taking the medication and record the moment in which it occurs. In addition to introducing the side effects, it is also possible to select specific symptoms on the device that pretend to be influenced by the medication, for example, tremors (tremor of body parts) muscle mobility, anxiety or agitation, to assess these and record the moment in which were presented. In this way, different effect profiles can be stored in parallel. Finally, the program of this equipment 30 makes it possible to record the effect or combinations in medicine, that is to say several medicines that are taken at the same time. Figure 6 shows another embodiment of the equipment according to the invention with a more extensive way of superimposed recording of additional events and symptoms of a disease and its assessment. The equipment 40, like the equipment 1 and 10, has three buttons corresponding to the buttons M, N and P or 13, 14 and 15, that is to say the button 41 with the letter M is intended to introduce the time in which took the medication, the button 42 with the smiley face is intended to introduce a positive effect or assessment and the button 43 with the sad face is intended to introduce a negative effect or assessment. A button 44 with the letter W is also provided by means of which certain effects and symptoms of certain diseases can be represented in a visual display of two lines 45 and is displayed. For example, several main terms such as tremor, mobility, headache, nausea or anxiety can be represented and displayed on the upper line 46 of the screen display 45 by activating the button 44 (W). A possible evaluation of the corresponding event then appears on the bottom line 47. By activating the buttons 42 and 43, an assessment can be made in different stages, for example for headaches: No headache (0) Very slight headache (1) Light headache (2) Moderate headache (3) Severe headache (4) Very severe headache (5) This assessment is not made in response to your request, but when the patient feels that ' be necessary.

The event and its evaluation are then superimposed on the record of the aforementioned effect of the medication according to Figure 2 and Figure 4. The physician thus has additional information that allows him to make an accurate assessment of the effect of the medication. For the visual confirmation of the individual inputs by using the buttons 41, 42, 43 and 44, they are assigned the colored lights 48, 49 and 51 that light up when an entry is made, namely in yellow (48). ), green (49), red (50), and blue (51). The equipment 40 also has a small horn 52 by means of which certain inputs receive an audible spoken confirmation, for example via the high voice of the equipment 40"says" the following words or phrases: "Administration or registered drug" or "Effect of the medication now: slight improvement ", a switch that is pressed 53 is also configured in the equipment 40 and is used to switch the loud voice 52 on and off. A plug switch 55 that can be operated by the patient can be connected to the equipment 40 via the cable 54 and the connection plug 56, and inputs can be made using this plug switch 55 in addition to the buttons 42 and 43. The plug switch represents, as it were, a remote control for the equipment 40 in some cases: for example, by pressing the pin switch 55, it is possible to record additional and sudden events together with the time of day, without the patient having to Take out the equipment 40, which you carry with you, out of your pocket. This is particularly advantageous for patients with Parkinson's disease in the so-called disconnected phase, because the patient at that time is very restricted. Also in the case of anxiety attacks or other sudden and critical changes in the state of health, for example, absences in epileptics, the immediate activation of the plug switch 55 allows this event to be recorded immediately. The pin switch 55, however, can also be used as an alternative for the input buttons 42 and 43, in other words to introduce a positive or negative effect of the medication. For this purpose, a code which is easily understood for the patient can be used: for example a short oppression of the pin switch 55 would mean that there is no effect of the medicament, and a long oppression in the pin switch 55 would mean that there is a positive effect This remote input via the plug switch 55 can be acoustically confirmed by the loud voice 52 of the equipment 40, so that the patient knows that it has been registered. Alternatively, confirmation by means of vibration is also possible. Finally, the equipment 40 also has an accessory 57 for various sensors or measuring equipment by which physically measurable patient data are recorded. Here, by way of example, a measurement sensor 59 is connected, shown diagrammatically, by a cable 58 and used to measure the patient's heart rate. Alternatively, or in addition to this, other measuring sensors may be connected, for example to measure blood pressure, oxygen in the blood, or blood sugar levels, tremor, muscle tone (muscle tension) and temperature of the blood. Skin or moisture of the skin. These objectively measurable values can be measured and recorded automatically, without the help of the patient, and can be achieved in the aforementioned recording medium and output. With regard to this it is possible, with this combination of equipment 40, for the subjective state of health after the medication and the objectively determined physiological values that are recorded and stored in parallel. This represents a considerable therapeutic aid for the doctor and an improvement in the patient's medication. The drawing does not show a combination of the aforementioned equipment with a medicament dispenser containing the medicament in writing in a convenient amount for a defined period. In the times previously set My, M2, M, etc., which are stored in the equipment, the medication dispenser opens and supplies the prescribed dose of the medication, ie the patient can then remove the medication. At the same time, the configured signal or alarm described above can be activated and thus remind the patient to take their medication. The medication that is going to be taken at that moment can be displayed, for example: "1/2 tablet of Madopar 125 T". As noted above, the equipment according to the invention is not only intended for use when a patient is being treated with medication by a physician, but can also be used, for example, in pharmaceutical research when new active substances are being evaluated. , remedies, drugs or similar and are being tested to see their effects on the human body.

Claims (14)

1. Portable equipment (in the form of a pocket computer) for recording, displaying and storing values concerning the subjective health status of a patient, the values being introduced by the patient itself through operation configurations, characterized in that the operation configurations consist of: a) a first button (M, 2, 13, 35, 41) to record the time (to) in which the medication was taken (MI, M2, M3, etc.), b) a second button (P, 3, 14, 36, 42) to record a positive effect and time (ti), and c) a third button (N, 4, 15 , 37, 43) to record a negative effect and time (t2). and that the input values according to (a), (b) and (c) as a function of the effect of the drug over time are recorded in a recording medium (8) and can be reproduced.

The equipment according to claim 1, characterized in that the recording medium (8) can be removed.

The equipment according to claim 1, characterized in that the equipment (10) has an interface (24) for a personal computer adapter by means of which the stored data can be transferred to a personal computer.

The equipment according to claim 1, 2 or 3, characterized in that the equipment (1, 10, 30, 40) has a display (5, 16, 31, 45) to display information, for example the elapsed time (chronometer ) from the time the medication was taken and / or the time of day and the state of health.

The device according to one of the claims 1 to 4, characterized in that the device (1, 10, 40) has an acoustic, tactile (vibration) and / or confirmatory visual configuration (6; 17; 18, 19, 20, 21, 22, 23, 48, 49, 50, 51, 52) for each entry.

The equipment according to claim 5, characterized in that the acoustic confirmation configuration includes a speaker module with a high voice (52) that provides a spoken audible confirmation of the respective input.

The equipment according to one of the preceding claims, characterized in that the equipment (40), in addition to the buttons (42, 43), has a plug switch (55) which can be connected via a cable (54) and by means of which information signals can be input to the equipment (40) by hand.

8. The equipment according to one of the preceding claims, characterized in that the equipment (10, 30, 40) has a signal confirmation (23, 31, 45, 52) in which it points to the patient, either acoustically or visually, or by vibration, in the times set in advance (Mi, M, M3, etc.) in which the medication must be taken.

The equipment according to one of the preceding claims, characterized in that the equipment (10) has optical display devices (18, 19, 20, 21, 22) to show the respectively registered positive values (19) negative (21). ) or of excess (22) or the optimum (20).

10. The equipment according to one of the preceding claims, characterized in that the equipment (10) It has approximately the shape and size of a wristwatch and can be worn around - from the patient's wrist.

The equipment according to one of the claims from 4 to 10, characterized in that they can be displayed in additional events and their evaluation on the visual display (45) in which case the events can be displayed by means of an additional button W ( 44) and their ratings can be entered via the input buttons P (42) and N (43).

12. The equipment according to one of claims 1 to 10, characterized in that the equipment (30) has other buttons labeled (keyboards 0, 1, 2, 3; M, P, N, etc.) to register the input of collateral effects to the team or specific feelings of the patient's experiences. The equipment according to one of claims 1 to 12, characterized in that the equipment (40) has, in addition to the recording configuration operated by the patient, a measurement or sensor configuration (59) for detecting and record physiologically measurable physiological values of the patient. The equipment according to one of the preceding claims, characterized in that a medicament dispenser connected to the equipment (1, 10, 30, 40) contains the medicament and doses it at previously established times (Mi, M2, M3, etc.). ) and the appropriate dose.