Patient Monitor System for Collecting Data of a Patient, Display Device, Medical Treatment Apparatus and Method
20230395252 · 2023-12-07
Inventors
Cpc classification
A61M1/28
HUMAN NECESSITIES
G16H50/70
PHYSICS
G16H20/40
PHYSICS
G16H10/60
PHYSICS
International classification
G16H10/60
PHYSICS
G16H50/70
PHYSICS
G16H50/30
PHYSICS
G16H20/40
PHYSICS
A61M1/34
HUMAN NECESSITIES
A61M1/28
HUMAN NECESSITIES
Abstract
The present disclosure relates to a patient monitor system with at least one collecting device which is programmed to collect behavior-related data and/or vital parameters of a patient. The patient monitor system further includes an output device and a calculation unit. The calculation unit is programmed to prompt or trigger the collecting device in order to collect the data and vital parameters. It is further programmed to generate instructions for controlling or regulating a medical treatment apparatus, and for outputting the instructions by the output device. The calculation unit is hereby further programmed to generate instructions and/or to have them output by the output device when the behavior-related data of the patient, or part of this data, and/or the vital parameters of the patient, or part these vital parameters do not lie in a value range respectively predetermined for them and/or lie beyond a limit value respectively predetermined for them.
Claims
1-15. (canceled)
16. A patient monitor system, comprising: at least one collecting device configured and/or programmed to collect: behavior-related data of a patient; and/or vital parameters of the patient; an output device; and a calculation unit, programmed to: receive the behavior-related data and/or the vital parameters collected by the at least one collecting device; generate instructions in order to control or regulate a medical treatment apparatus; and output the instructions using the output device, wherein the calculation unit is further programmed to generate the instructions and/or to have the instructions output by the output device when the behavior-related data of the patient, or part of the behavior-related data, do not lie in a predetermined behavior-related data value range and/or lie beyond a predetermined behavior-related data limit value, and/or the vital parameters of the patient, or part of the vital parameters do not lie in a predetermined vital parameter value range and/or lie beyond a predetermined vital parameter limit value.
17. The patient monitor system according to claim 16, wherein the calculation unit is programmed to initiate or trigger the collecting device in order to collect the behavior-related data and/or vital parameters using the collecting device at a point in time at which the patient is not being treated by the medical treatment apparatus in a treatment session, or between two successive treatment sessions by the medical treatment apparatus.
18. The patient monitor system according to claim 16, wherein the calculation unit is programmed to detect or evaluate the vital parameters, or a part thereof, only in the event that the calculation unit has recognized that the detected behavior-related data, or a part thereof, do not lie in the predetermined behavior-related data value range and/or lie beyond the predetermined behavior-related data limit value, and/or wherein the calculation unit is programmed to collect or evaluate the behavior-related data, or a part thereof only in the event that the calculation unit has recognized that the collected vital parameters, or a part thereof, do not lie in the predetermined vital parameter value range and/or lie beyond the predetermined vital parameter limit value.
19. The patient monitor system according to claim 16, wherein the collecting device is designed as a portable device.
20. The patient monitor system according to claim 19, wherein the collecting device is designed as a wristband, wristwatch, mobile phone, wearable, accessory, as a garment, or part thereof or combinations thereof.
21. The patient monitor system according to claim 16, wherein the behavior-related data are or encompass sleep data, movement data, activity data, a parameter of a medication intake, and/or data on food and/or fluid intake; and wherein the vital parameters are or encompass cardiovascular data, heart rate, heart rate variability, QT wave, blood pulse wave, oxygen saturation, respiratory rate, respiratory amplitude, galvanic skin response, weight, body temperature and/or blood pressure.
22. The patient monitor system according to claim 21, wherein the activity data comprises a number of steps taken per day.
23. The patient monitor system according to claim 21, wherein the parameter of the medication intake comprises a regularity of the medication intake.
24. The patient monitor system according to claim 16, further comprising a storage device for storing: the behavior-related data and/or vital parameters of the patient collected by the collecting device, behavior-related data and/or vital parameters of the patient collected in the past, behavior-related data and/or vital parameters obtained from patient collectives, limit values, and value ranges.
25. The patient monitor system according to claim 16, wherein the calculation unit is configured to compare the behavior-related data and/or the vital parameters of a current or most recently viewed period with the behavior-related data and/or vital parameters of past time periods of the patient, and wherein the result of the comparison is evaluated based on the behavior-related data value range, the behavior-related data limit value, the vital parameter value range, and/or the vital parameter limit value.
26. The patient monitor system according to claim 16, wherein the calculation unit is configured to compare the behavior-related data and/or the vital parameters of a current or most recently viewed period with the behavior-related data or the vital parameters of a patient collective, and wherein the result of the comparison is evaluated based on the behavior-related data value range, the behavior-related data limit value, the vital parameter value range, and/or the vital parameter limit value
27. The patient monitor system according to claim 16, wherein the calculation unit is programmed to calculate a patient's probability of an occurrence of diseases or secondary diseases based on the behavior-related data and/or the vital parameters, and is further programmed in order to output an instruction if the patient's probability of the occurrence of diseases or secondary diseases exceeds a predetermined disease limit value.
28. A display device for displaying at least one instruction for controlling or regulating a medical treatment apparatus, wherein the display device is part of a patient monitor system according to claim 16 and/or is in signal communication with the output device of a patient monitor system according to claim 16.
29. A medical treatment apparatus with the display device according to claim 28 and/or in signal communication with the display device according to claim 28.
30. A medical treatment apparatus having a patient monitor system according to claim 16 and/or in signal communication with the patient monitor system according to claim 16.
31. The medical treatment apparatus according to claim 29, embodied as a blood treatment apparatus.
32. The medical treatment apparatus according to claim 30, embodied as a dialysis apparatus, hemodialysis apparatus, hemofiltration apparatus, hemodiafiltration apparatus or as an apparatus for chronic renal replacement therapy, for apheresis, or for whole blood adsorption treatment or as a treatment apparatus for peritoneal dialysis.
33. The medical treatment apparatus according to claim 31, embodied for plasmapheresis treatment.
34. The medical treatment apparatus according to claim 29, comprising a control device or closed-loop control device which is programmed to adjust or set at least one treatment parameter based on the instructions outputted by the calculation unit.
35. A method for preparing a treatment or treatment session of a patient to be performed by a medical treatment apparatus, the method comprising: detecting behavior-related data at least one point in time at which the patient is not being treated by the medical treatment apparatus in a treatment session, or between two successive treatments or treatment sessions by the medical treatment apparatus. collecting vital parameters at at least one point in time at which the patient is not being treated by the medical treatment apparatus in the treatment session, or between two successive treatments or treatment sessions by the medical treatment apparatus. outputting instructions if or when the behavior-related data of the patient do not lie in a predetermined behavior-related data value range and/or lie beyond a predetermined behavior-related data limit value, and/or the vital parameters of the patient do not lie in a predetermined vital parameter value range and/or lie beyond a vital parameter limit value.
36. The method according to claim 34, wherein the method is carried out using a patient monitor system comprising: at least one collecting device configured and/or programmed to collect: the behavior-related data of the patient; and/or the vital parameters of the patient; an output device; and a calculation unit, programmed to: receive the behavioral data and/or the vital parameters collected by the at least one collecting device; generate the instructions in order to control or regulate the medical treatment apparatus; and output the instructions using the output device; wherein the calculation unit is further programmed to generate the instructions and/or to have the instructions output by the output device when the behavior-related data of the patient, or part of the behavior-related data, do not lie in the predetermined behavior-related data value range and/or lie beyond the predetermined behavior-related data limit value, and/or the vital parameters of the patient, or part of the vital parameters do not lie in the predetermined vital parameter value range and/or lie beyond the predetermined vital parameter limit value.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0082] In the following, the present systems, devices, and methods are described based on embodiments thereof with reference to the accompanying drawing. In the figures, the following applies:
[0083]
[0084]
[0085]
[0086]
DETAILED DESCRIPTION
[0087]
[0088] Pumps, actuators and/or valves in the area of the blood circuit 300 are connected to the treatment apparatus 100 or to a control device or closed-loop control device 150 encompassed by it. This control device or closed-loop control device 150 may be provided in order to be connected to a patient monitor system 1 (see
[0089] The blood circuit 300 includes (or is connected to) an arterial patient tube clamp 302 and an arterial connection needle of an arterial section or of an arterial patient line, blood withdrawal line or first line 301. The blood circuit 300 also includes (or is connected to) a venous patient tube clamp 306 and a venous connection needle of a venous section, a venous patient line, a blood return line or a second line 305.
[0090] A blood pump 101 is provided in or at the first line 301, a substituate pump 111 is connected to a dialysis liquid inlet line 104 for conveying fresh dialysis liquid, which is filtered in a filter (F2) (substituate). A substituate line 105 may be fluidically connected to the inlet line 104. Using the substituate pump 111, substituate may be introduced by predilution, via a predilution valve 107, or by postdilution, via a postdilution valve 109, via associated lines 107a or 109a into line sections, for example into the arterial line section 301 or into the venous line section 305 (here between a blood chamber 303b of a blood filter 303 and a venous air separation chamber or venous blood chamber 329 of the blood circuit 300.
[0091] The blood filter 303 includes the blood chamber 303b connected to the arterial line section 301 and to the venous line section 305. A dialysis liquid chamber 303a of the blood filter 303 is connected to the dialysis liquid inlet line 104 leading to the dialysis liquid chamber 303a and to a dialysate outlet line 102, which guides dialysate, i.e., spent dialysis liquid, leading away from the dialysis liquid chamber 303a. Dialysis liquid chamber 303a and blood chamber 303b are separated from each other by a mostly semipermeable membrane 303c. It represents the partition between the blood side with the extracorporeal blood circuit 300 and the machine side with the dialysis liquid or dialysate circuit, which is shown in
[0092] The arrangement in
[0093] An optional single-needle chamber 317 is used in
[0094] The arrangement of
[0095] An optional addition site 325 for Heparin or for other anticoagulation medication may be provided.
[0096] On the left in
[0097] A pump 171, which can be referred to as concentrate pump or sodium pump, is fluidly connected to the mixing device 163 and a source of sodium, for example the container B, and/or coveys out of it.
[0098] Furthermore,
[0099] A further pressure sensor may be provided as PS4 downstream of the blood filter 303 on the water side, but preferably upstream of an optional ultrafiltration pump 131 in the dialysate outlet line 102 for measuring the filtrate pressure or membrane pressure of the blood filter 303. Additional, optional pressure measuring points P may also be provided.
[0100] Blood leaving the blood filter 303 flows through an optional venous blood chamber 329, which may include a deaeration device 318 and may be in fluid communication with the pressure sensor PS3.
[0101] The exemplary arrangement shown in
[0102] By using the device for on-line mixing of the dialysis liquid, a variation of its sodium content, controlled by the control device or closed-loop control device 150, is possible within certain limits. For this purpose, in particular the measured values determined by the conductivity sensors 163a, 163b may be taken into account. Should an adjustment of the sodium content of the dialysis liquid (sodium concentration) or of the substituate turn out to be necessary or desired, this can be done by adjusting the conveyance rate of the sodium pump 171.
[0103] In addition, the treatment apparatus 100 includes means for conveying fresh dialysis liquid and dialysate. For this purpose, upstream of the blood filter 303, the first flow pump 159 is provided which conveys free dialysis liquid towards the blood filter 303. A first valve may be provided between the first flow pump 159 and the blood filter 303, which first valve opens or closes the inflow towards the blood filter 303 at the inlet side. A second, optional pump or flow pump 169 which conveys dialysate through the drainage line 153 is provided, e.g., downstream of the blood filter 303. A second valve may be provided between the blood filter 303 and the second flow pump 169, which second valve opens or closes the outflow at the outlet side.
[0104] Furthermore, the treatment apparatus 100 optionally includes a device 161 for balancing the flow flowing into and out of the dialyzer 303 on the machine side. The device 161 for balancing is preferably arranged in a line section between the first flow pump 159 and the second flow pump 169.
[0105] The treatment apparatus 100 further includes means, such as the ultrafiltration pump 131, for the precise removal of a volume of liquid from the balanced circuit, as predetermined by the user and/or by the control device or closed-loop control device 150.
[0106] Sensors such as the optional conductivity sensors 163a, 163b serve to determine the conductivity, which in some embodiments is temperature-compensated, as well as the fluid flow upstream and downstream of the dialyzer 303.
[0107] Temperature sensors 165a, 165b may be provided as one or a plurality thereof. Temperature values supplied by them may be used to determine a temperature-compensated conductivity.
[0108] A leakage sensor 167 is optionally provided.
[0109] Further flow pumps in addition or alternatively to, e.g., the one with the reference numeral 169 may also be provided.
[0110] A number of optional valves are each denoted with V in
[0111] The control device or closed-loop control device 150 may determine for example the electrolyte balance and/or liquid balance based on the measured values from the aforementioned optional sensors.
[0112] Filters F1 and F2 can be connected in series.
[0113] Even when using non-pure water, the filter F1 exemplarily serves herein to generate sufficiently pure dialysis liquid by the mixing device 163, which then flows through the blood filter 303, e.g., using the countercurrent principle.
[0114] The filter F2 exemplarily serves herein to generate sterile or sufficiently filtered substituate from the sufficiently pure dialysis liquid leaving the first filter F1, by filtering, e.g., pyrogenic substances. This substituate may then be safely added to the extracorporeally flowing blood of the patient and thus ultimately to the patient's body.
[0115] The treatment apparatus 100 is optionally shown in
[0116] A port 113 inside the treatment apparatus 100 may be provided, for example to enable rinsing or priming the extracorporeal blood circuit 300.
[0117] The present disclosure is not limited to the embodiment described above; this only serves for illustration.
[0118] The arrows shown in
[0119]
[0120] The patient monitor system 1 includes a collecting device 3, which in turn includes a number of sensors S.sub.1 to S.sub.n and/or an optional input device 5.
[0121] The herein exemplary n sensors may in particular be provided to automatically, for example continuously or at certain time intervals, or initiated by the calculation unit 9, which is also encompassed by the patient monitor system 1, to take measurements, in particular of vital parameters (e.g., cardiovascular data, HR, HRV, QT wave, temperature, etc.) and/or collect behavior-related data of the patient (e.g., regarding exercise, sleep, etc.).
[0122] The input device 5 may in particular be provided in order to collect data entered manually by the patient, for example because they cannot be collected automatically with the sensors. Manually entered data may include some vital parameters (e.g. weight, etc.) as well as behavior-related data (e.g., liquid and/or food intake, medication intake, etc.). The input device 5 may optionally be provided in a common device with the collecting device 3, for example as push buttons or touchscreen of a wearable device, for example a wristwatch. The input device 5 may, however, also be implemented or realized via a further device. For example, the input device 5 may be provided on or in a smartphone, tablet or keyboard of the home computer of the patient or of the attending person. A wireless connection may thus take place between the collecting device 3 and the device on which the input device 5 is optionally implemented. This may be done via a home network, a radio link or a Bluetooth connection. The data collected by the collecting device 3 may thus be changed or supplemented via the input device 5.
[0123] By the calculation unit 9 or by another device, the above-mentioned data may be stored in or on an optionally available storage device 11, or the storage may be initiated by it. The calculation unit 9 may also be part of the collecting device 3, or it may be designed decentral to it. Thus, the calculation unit 9 may be arranged on a further mobile terminal, a server, which is arranged in a monitoring station for the attending persons, or designed in a decentralized manner. The calculation unit 9 may also be constructed in a cloud-based manner.
[0124] The storage device 11 is or includes a, in particular non-volatile, storage medium, in particular in the form of a machine-readable carrier, in particular in the form of a flash-based memory chip, a memory card, EEPROM, FRAM (Ferroelectric RAM) or SSD (Solid-State-Drive), or a combination thereof, in particular with electronically readable control signals. Likewise, the storage device 11 may also be located in the collecting device 3, a further mobile terminal of the patient or of the attending person, a decentralized server or designed as a cloud-based memory.
[0125] Limit or threshold values and/or (permissible) value ranges for the behavior-related data and/or vital parameters may be stored in the storage device 11.
[0126] Corresponding data of the patient (behavior-related data and/or vital parameters) already collected in the past by the collecting device 3 may also be stored in the storage device 11. Alternatively or in addition, behavior-related data and/or vital parameters obtained from at least one patient collective may be stored in the storage device 11.
[0127] In several embodiments, the calculation unit 9 is further configured to generate instructions by comparing the current data (behavior-related data and/or vital parameters) of the patient detected by the collecting device 3 with comparison values (behavior-related data and/or vital parameters) stored in the storage device 11. The instructions, for example, be used by a control device or closed-loop control device 150 of a medical treatment apparatus 100 (see
[0128] The instructions may for this purpose be output by the output device 7, for example to the control device or closed-loop control device 150 of the medical treatment apparatus 100.
[0129] In several embodiments, the instructions are then or only then generated and/or output by the output device 7 if at least the behavior-related data of the patient, or a part of these data, on the one hand, and the vital parameters of the patient, or a part of these vital parameters, on the other hand, do not lie in a value range (W) predetermined for them and/or lie beyond a limit value (L) predetermined for them (see
[0130]
[0131] The sensors S.sub.1, . . . , S.sub.n (see
[0132] Corresponding communication devices, suitably programmed and/or configured for this purpose, are also encompassed.
[0133] In the example of
[0134] In another example, if the behavior-related data, which could herein also be referred to as non-specific data, show that the patient sleeps comparatively little and possibly restlessly between two treatment sessions, and if the specific data show that the blood pressure is higher than the patient's comparison values, the physician is shown the treatment proposal as instructions to increase the amount of water to be removed during treatment sessions in the course of the following dialysis treatment.
[0135] If, in yet another example, the behavior-related data show that the patient's sleep and/or movement behavior on the day after dialysis treatment differs significantly from that on the day before treatment, it can be concluded that the patient is excessively stressed by the treatment parameters selected last. Before the next treatment, this course in comparison to average values is for example displayed or shown to the physician. Depending on specific treatment parameters, the physician will be given a recommendation to readjust the medication or to check and adjust the composition of the dialysis liquid.
[0136] If, on the other hand, the behavior-related data show in another example that the patient changes their behavior (amount of movement, proportion of time spent in motion, standing, sitting) towards calmer behavior and if the specific data such as temperature and heart rate show an increase, this is communicated and visualized to the physician before treatment. The change must deviate from the characteristic daily course by a certain amount. This may provide the doctor with information about an emerging infection process in the patient and a recommendation for further measures (depending on the severity, such as blood tests) is given.
[0137]
[0138] In the example of
[0139] In the example of
[0140] In both step S1 and step S2 it is provided to initiate or perform the detection at at least one point in time when the patient is not being treated by the medical treatment apparatus (100) in a treatment session, i.e., for example between two successive treatments or treatment sessions by using the medical treatment apparatus (100).
[0141] Step S3 represents the outputting of instructions if both the behavior-related data of the patient on the one hand and the vital parameters of the patient on the other hand do not lie within a value range (W) predetermined for them and/or lie beyond a limit value (L) predetermined for them.
[0142] In certain embodiments, it may be provided that the outputting of instructions is or encompasses transmitting these instructions to the treatment apparatus 100, in particular to the control device or closed-loop control device thereof. Alternatively or in addition, it may be provided to output the instructions on a display device 13 in order to request confirmation from the attending person. The display device 13 may be or include a display device, e.g., a display of the patient monitor system 1 or a display device, e.g., a screen or display of the treatment apparatus 100 (see
LIST OF REFERENCE NUMERALS
[0143] 1 patient monitor or monitoring system [0144] 3 collecting device [0145] 5 input device [0146] 7 output device [0147] 9 calculation unit [0148] 11 storage device [0149] 13 display device [0150] 100 medical treatment apparatus [0151] 101 blood pump [0152] 102 dialysis outlet line [0153] 104 dialysis liquid inlet line [0154] 105 substituate line [0155] 107 predilution valve [0156] 107a line corresponding or assigned to the predilution valve [0157] 109 postdilution valve [0158] 109a line corresponding or assigned to the postdilution valve [0159] 111 substitute pump [0160] 113 port [0161] 131 ultrafiltration pump [0162] 150 control device or closed-loop control device [0163] 153 drainage line or discharge line [0164] 155 water source [0165] 157 heat exchanger [0166] 159 first flow pump [0167] 161 device for balancing [0168] 163 mixing device [0169] 163a conductivity sensor [0170] 163b conductivity sensor [0171] 165a temperature sensor [0172] 165b temperature sensor [0173] 166 concentrate supply [0174] 167 leakage sensor [0175] 168 concentrate supply [0176] 169 second flow pump [0177] 171 natrium pump [0178] 300 extracorporeal blood circuit [0179] 301 first line (arterial line section) [0180] 302 (first) tube clamp, [0181] arterial patient tube clamp [0182] 303 blood filter or dialyzer [0183] 303a dialysis liquid chamber [0184] 303b blood chamber [0185] 303c semipermeable membrane [0186] 305 second line (venous line section) [0187] 306 (second) tube clamp, [0188] venous patient tube clamp [0189] 315 detector [0190] 317 single-needle chamber [0191] 318 deaeration device [0192] 319 detector [0193] 325 addition site for Heparin [0194] 329 venous blood chamber (optional) [0195] A container [0196] B container [0197] F1 filter [0198] F2 filter [0199] L limit value; limit [0200] W value range [0201] P pressure measuring points [0202] PS1 arterial pressure sensor (optional) [0203] PS2 arterial pressure sensor (optional) [0204] PS3 pressure sensor (optional) [0205] PS4 pressure sensor for measuring the filtrate pressure (optional) [0206] S.sub.1, . . . , S.sub.n sensors [0207] V valve(s) [0208] VB bypass valves [0209] Y Y connector