CALCULATION DEVICE AND DIALYSIS APPARATUS

Abstract

The present disclosure relates to a calculation device for determining an interdialytic sodium intake of a patient and/or for determining a non-osmotically triggered interdialytic liquid intake, including a storage device and/or an input device configured for storing or for entering parameter values of the patient; a computing device, configured for calculating the interdialytic sodium intake of the patient and/or for calculating his non-osmotically triggered interdialytic liquid intake; and an output device for outputting a signal for controlling or closed-loop controlling a communication device and/or a medical blood treatment apparatus.

Claims

1-11. (canceled)

12. A calculation device for determining an interdialytic sodium intake of a patient and/or for determining an interdialytic liquid intake, the calculation device comprising: a storage device and/or an input device configured for storing or entering parameter values of said patient; a computing device, configured for calculating the interdialytic sodium intake of the patient and/or for calculating an interdialytic liquid intake of said patient; and an output device for outputting a signal to control or closed-loop control a communication device and/or a medical blood treatment apparatus.

13. The calculation device according to claim 12, wherein the computing device is configured for calculating the interdialytic sodium intake and/or the interdialytic liquid intake based on a plasma sodium concentration prevalent at a beginning of a dialysis session.

14. The calculation device according to claim 12, wherein the computing device is configured for calculating the interdialytic sodium intake and/or the interdialytic liquid intake based on a sodium concentration in urine.

15. The calculation device according to claim 12, wherein the computing device is configured to be in signal communication with the medical blood treatment apparatus such as to repeatedly query or receive from the medical blood treatment apparatus, during a dialysis session carried out by the medical blood treatment apparatus, values measured by the medical blood treatment apparatus, in order to, based thereon, repeat or specify the calculation of the interdialytic sodium intake and/or of the interdialytic liquid intake.

16. The calculation device according to claim 12, wherein the output device is configured to display, output, and/or store the interdialytic sodium intake and/or the interdialytic liquid intake on a display device.

17. The calculation device according to claim 16, wherein the display device is a communication device.

18. The calculation device according to claim 17, wherein the communication device comprises at least one of: a monitor, a display, a printer, a storage element, or a database.

19. The calculation device according to claim 17, wherein the output device is configured to output, store, and/or to display on the display device, calculated values, wherein the calculated values comprise the interdialytic sodium intake and/or the interdialytic liquid intake, while also stating a qualitative and/or quantitative accuracy of the displayed, outputted, and/or stored value.

20. The calculation device according to claim 19, wherein stating the qualitative and/or quantitative accuracy of the displayed value is or includes specifying a value range, a confidence interval, a representation in one of a plurality of predetermined colors, the size of an error, an uncertainty, a possible value range, a confidence interval, a standard deviation, a variance, a color coding, and/or a traffic light display.

21. The calculation device according to claim 20, wherein the color coding comprises multiple colors.

22. The calculation device according to claim 12, wherein the output device for outputting a signal for controlling of a communication device is configured for stating a prescription based on the interdialytic sodium intake and/or on the interdialytic liquid intake.

23. The calculation device according to claim 12, wherein the output device is configured for controlling the medical blood treatment apparatus, via the signals outputted by said output device to the medical blood treatment apparatus, such that a dialysis session ends when or once a determined interdialytic sodium intake and/or liquid intake has been withdrawn from treated blood.

24. The calculation device according to claim 12, configured for reading values of at least one or several of the following parameters: distribution volume of the patient; interdialytic liquid excess corresponding to interdialytic weight gain; plasma sodium concentration at the beginning of a dialysis session; plasma sodium concentration at an end of a previous dialysis session; accumulated residual urine excretion between dialysis sessions; sodium concentration in urine; and number of days between the end of the previous dialysis session and the current dialysis session, determined by a current date and a stored date of a previous dialysis session.

25. A medical blood treatment apparatus comprising: fluid lines which encompass at least one dialysis liquid inlet line and/or a dialysate outlet line; at least one conveying device for conveying a dialysis liquid within the dialysis liquid inlet line and/or within the dialysate outlet line; and at least one control device and/or closed-loop control device, wherein the medical blood treatment apparatus is configured to be connected to a dialysis liquid chamber of a blood filter respectively by the dialysis liquid inlet line and the dialysate outlet line, wherein the blood filter comprises a blood chamber, wherein dialysis liquid chamber and blood chamber are separated from each other by a semipermeable membrane, and wherein the control device and/or closed-loop control device is configured for prompting or effecting a blood treatment using the medical blood treatment apparatus by hemofiltration, hemodialysis, or hemodiafiltration, for the purpose of which the control device and/or the closed-loop control device is connected to in signal transmission or comprises a calculation device comprising: a storage device and/or an input device configured for storing or entering parameter values of said patient; a computing device, configured for calculating the interdialytic sodium intake of the patient and/or for calculating an interdialytic liquid intake of said patient; and an output device for outputting a signal to the control device and/or closed-loop control device.

26. The medical blood treatment apparatus according to claim 25, suitable and/or configured to execute a hemodialysis, a hemofiltration, a hemodiafiltration, or a separation method.

27. The medical blood treatment apparatus according to claim 25, wherein the computing device is configured for calculating the interdialytic sodium intake and/or the interdialytic liquid intake based on a plasma sodium concentration prevalent at a beginning of a dialysis session.

28. The medical blood treatment apparatus according to claim 25, wherein the computing device is configured for calculating the interdialytic sodium intake and/or the interdialytic liquid intake based on a sodium concentration in urine.

29. The medical blood treatment apparatus according to claim 25, wherein the computing device is configured to be in signal communication with the medical blood treatment apparatus such as to repeatedly query or receive from the medical blood treatment apparatus, during a dialysis session carried out by the medical blood treatment apparatus, values measured by the medical blood treatment apparatus, in order to, based thereon, repeat or specify the calculation of the interdialytic sodium intake and/or of the interdialytic liquid intake.

30. The medical blood treatment apparatus according to claim 25, wherein the output device is configured to display, output, and/or store the interdialytic sodium intake and/or the interdialytic liquid intake on a display device.

31. The medical blood treatment apparatus according to claim 25, wherein the calculating device is configured for reading values of at least one or several of the following parameters: distribution volume of the patient; interdialytic liquid excess corresponding to interdialytic weight gain; plasma sodium concentration at the beginning of a dialysis session; plasma sodium concentration at an end of a previous dialysis session; accumulated residual urine excretion between dialysis sessions; sodium concentration in urine; and number of days between the end of the previous dialysis session and the current dialysis session, determined by a current date and a stored date of a previous dialysis session.

32. The medical blood treatment apparatus according to claim 25, wherein the at least one dialysis liquid inlet line and the dialysate outlet line are connected in fluid communication with each other by a connector.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0136] In the following, the present disclosure is described based on embodiments thereof with reference to the accompanying drawings. The following applies in the figures:

[0137] FIG. 1 shows, in a schematically simplified manner, sections of a medical blood treatment apparatus in an exemplary embodiment, exemplarily connected to a blood cassette for executing a patient's treatment, controlled and/or closed-loop controlled by a control device which is connected in signal communication to a calculation device;

[0138] FIG. 2 shows a user interface as part of a calculation device; and

[0139] FIG. 3 shows an exemplary calculation device.

DETAILED DESCRIPTION

[0140] FIG. 1 shows an extracorporeal blood circuit 1, which would be connected for a treatment to the vascular system of the patient (not shown) via double-needle access or via single-needle access using, e.g., an additional Y-connector. The blood circuit 1 is provided optionally in sections thereof in or on a blood cassette 2. This blood cassette 2 is designed to be used also in other treatment types, e.g., a single-needle treatment.

[0141] Pumps, actuators, and/or valves in the area of the blood circuit 1 are connected to a blood treatment apparatus 4 or to a control device 29 included by it.

[0142] The blood circuit 1 includes an arterial patient hose clamp 6 and an arterial connection needle 5 (as an example for an access device) of an arterial section or of an arterial patient line or blood withdrawal line 9. The blood circuit 1 further includes a venous patient hose clamp 7 and a venous connection needle 27 (as an example for a further or second access device) of a venous section or of a venous patient line or blood return line 23.

[0143] A blood pump 11 is provided in the arterial section 9 and a substituate pump 17 is connected to a substituate line 17a. The substituate line 17a can be connected with a substituate source through an, e.g., automatic, substituate port 18. By the substituate pump 17, substituate may be introduced via pre-dilution or via post-dilution through associated lines 13 or 14 into line sections, e.g., into the arterial section 9 or into a venous section 23a (between a blood chamber 19a of a blood filter 19 and a venous air separation chamber 21), of the blood circuit 1.

[0144] The blood filter 19 includes the blood chamber 19a which is connected to the arterial section 9 and to the venous section 23. A dialysis liquid chamber 19b of the blood filter 19 is connected to a dialysis liquid inlet line 31a leading to the dialysis liquid chamber 19b and to a dialysate outlet line 31b leading away from the dialysis liquid chamber 19b.

[0145] The dialysis liquid inlet line 31a optionally includes a valve V24 by which the flow within the dialysis liquid inlet line 31a may be interrupted. The dialysate outlet line 31b optionally includes a valve V25 by which the flow within the dialysate outlet line 31b may be interrupted.

[0146] The dialysis liquid inlet line 31a is further optionally connected to a compressed air source 26 by another internal valve of the apparatus. The compressed air source 26 may be provided as a component of the blood treatment apparatus 4 or as a part separated thereof. A pressure sensor 37 may be provided downstream of the compressed air source 26.

[0147] A venous connection with, e.g., the venous section 23 or 23a may be achieved by a factory-provided optional connection section 24.

[0148] The control device 29 may be part of or embody a control device of the blood treatment apparatus 4.

[0149] The arrangement of FIG. 1 includes an optional detector 15 for detecting air and/or blood. The arrangement of FIG. 1 further includes one or two pressure sensors 33a, 33b at the illustrated points in FIG. 1. Further pressure sensors may be provided, e.g., the pressure sensor 37.

[0150] In FIG. 1, the single-needle chamber 36 is used as buffer and/or compensation tank during or after a single-needle method during which the patient is connected to the extracorporeal blood circuit 1 via only one of the two blood lines 9, 23.

[0151] The arrangement in FIG. 1 additionally includes an optional detector 25 for detecting substituate and/or blood.

[0152] In FIG. 1, the calculation device 100 is exemplarily shown in signal communication with the control device and/or closed-loop control device 29.

[0153] The present invention is not limited to the embodiments as described herein, this is considered only for illustrative purposes.

[0154] FIG. 2 shows an exemplary user interface as an example for an input device 103 and/or a display device 109 of a calculating device 100 for displaying and prescribing the salt and liquid balance.

[0155] Such a user interface may be positioned directly on the hemodialysis apparatus and/or on an external display and computing unit (computer, laptop, tablet device, etc.) connected to the dialysis apparatus. In this example, the display and input elements are arranged in series by function, although also other arrangements, labelings, etc. are possible. Also, not all elements must be present, or also further data may be represented respectively. These may either be additional dialysis parameters or the conversion of values of the represented parameters in other units.

[0156] Line 1 encompasses input elements for prescribing a hemodialysis treatment (includes HD and all types of HDF and HF): [0157] V(UF) in field F1 of FIG. 2: prescription of liquid removal by ultrafiltration. The volume set by the doctor will be withdrawn from the patient until the end of the treatment. [0158] Target plasma sodium change (field F2), target diffusive Na removal (field F3), target free water removal (field F4): These three input elements may be used alternatively, since the quantities contained herein are in a fixed relationship to each other: As described in the formulas, they can be converted into each other with the additional knowledge of V(urea) and plasma sodium (pre). It is also possible to select the displayed physical unit within the elements using internally stored conversion factors (e.g., conversion “mmol NaCl” into “g NaCl”). Negative values at the diffusive Na removal mean a sodium transfer into the patient, corresponding to a “free water removal”.

[0159] Line 2 encompasses input elements for the input of auxiliary quantities which are required to convert the prescription from line 1 into specific settings of dialysis parameters, for example the dialysis liquid sodium concentration, or to be able to determine the physiologically relevant quantities of lines 4 to 6 from measured quantities of the dialysis apparatus: [0160] V(urea) (field F5): distribution volume of the patient. For converting concentration changes in the patient to substance amounts. [0161] Daily residual diuresis (field F6), Na in the urine (field F7): For calculating the total salt intake.

[0162] Line 3 encompasses input elements, whose values may come from different sources: [0163] Plasma sodium (pre) (field F8): Patient's plasma sodium at the beginning of the dialysis. This value may be preallocated from electronic records, e.g., from current or historical laboratory data. Also, a manual input at the beginning of the treatment is possible. In the course of the treatment, this value is automatically determined by the apparatus and the initial value is replaced by the determined value.

[0164] Line 4 encompasses display elements, which characterize the progress of the treatment: [0165] V(UF) act (field F9): amount of liquid withdrawn by ultrafiltration up to the present point of time [0166] total Na removal (field F10): total amount of salt withdrawn by ultrafiltration and diffusion up to the present point of time (possible display in different units) [0167] Na removal diffusive (field F11): amount of salt withdrawn by diffusion up to the present point of time. This may be positive or negative. A negative value corresponds to salt transfer into the patient. [0168] Free water removal (field F12): Reached volume of “free water removal” up to the present point of time. Since the free water removal is included in the here displayed value plasma sodium (pre), which is initially only present as an estimated value, there may be carried out in addition to the numerical display of the value a marking whether this is a preliminary calculation based on estimated values or an updated or even final calculation based on intradialytic measurements.

[0169] Line 5 encompasses display elements for salt intake of the patient: [0170] “Interdialytic salt intake” (field F13): calculated from the residual diuresis and sodium in the urine, as well as the total sodium removal (ultrafiltration and diffusion) during dialysis. At the beginning of the treatment, the prescription values are used hereby and the displayed result, as in the indication of “free water removal”, is marked as an estimated value. Until the end of the treatment, the accuracy will then be gradually improved with measured values of the sodium balance obtained during the treatment, which may also be visually identified. In addition, because of the uncertainty of the sodium content in the urine, a range of values corresponding to a confidence interval may be displayed instead of a single value for the interdialytic salt intake. [0171] “Daily salt intake since the last dialysis” (field F14): As described, display modalities as supra. The number of days required for the calculation since the previous dialysis may be determined by accessing an internal or external storage medium, which receives the date of the previous dialyses of the patient, or may be entered using the input device 103. [0172] “Average daily salt intake” (field F15): as described, display modalities as supra. For this purpose, the values determined in the previous dialysis are used, e.g., by accessing an external or internal storage medium or after an input.

[0173] Line 6 encompasses display elements for the drinking amount of the patient: [0174] “Interdialytic excess drinking amount” (field F16): Drinking amount which has led to a change in plasma sodium concentration; positive when the plasma sodium concentration has decreased. The calculation may be carried out in accordance with Formula 10, based on the current prescription, or in accordance with Formula 11 based on the plasma sodium value at the end of the previous treatment read from an internal or external storage medium. As with the values in line 5, the temporary use of estimated values may be optically represented. [0175] “Daily excess drinking amount since the last dialysis” (field F17): Calculation analogously to “daily salt intake since the last dialysis” [0176] “Average daily excess drinking amount” (filed F18): Calculation analogously to “average daily salt intake” from field F15

[0177] FIG. 3 shows a calculation device 100 for determining an interdialytic sodium intake m.sub.inter of a patient and/or for determining a mostly non-osmotically triggered interdialytic liquid intake V.sub.excess drink.

[0178] The calculation device 100 includes a storage device 101 and/or an input device 103. They serve for storing or entering parameter values of the patient.

[0179] The calculation device 100 further includes a computing device 105. It is configured for calculating the interdialytic sodium intake m.sub.inter of the patient and/or for calculating his non-osmotically triggered interdialytic liquid intake V.sub.excess drink. Corresponding algorithms and formulas, such as disclosed herein, may for this purpose be stored in the computing device 105 or read by it from suitable sources such as the storage device 101.

[0180] Finally, the calculation device 100 includes an output device 107. It serves to output a signal for controlling or closed-loop controlling an optional communication device 109 and/or the medical blood treatment apparatus 4.

[0181] The communication device 109 may be configured for wired or wireless signal connection with a component of the medical blood treatment apparatus 4, e.g., its control or closed-loop control device 29.

[0182] The communication device 109 may additionally or alternatively be connected to an optionally provided display device or may be designed as such. The display device 109 may be, or may include, the user interface shown in FIG. 2.

[0183] The communication device 109 may, for example, be designed as a display device, be part of the calculation device 100 or of the medical blood treatment apparatus 4.

[0184] Where it is not technically impossible, several of the aforementioned apparatuses may be combined into a single unit.

LIST OF REFERENCE NUMERALS

[0185] 1 extracorporeal blood circuit [0186] 2 blood cassette [0187] 4 blood treatment apparatus [0188] 5 access device, for example arterial connection needle [0189] 6 arterial patient hose clamp [0190] 7 venous patient hose clamp [0191] 8 inlet line [0192] 9 arterial section or arterial blood withdrawal line or arterial patient line [0193] 11 blood pump [0194] 13 addition site for substituate (pre-dilution) [0195] 14 addition site for substituate (post-dilution) [0196] 15 arterial air-blood-detector [0197] 17 conveying device, for example a substituate pump [0198] 17a substituate line [0199] 18 automatic substituate port [0200] 19 blood filter [0201] 19a blood chamber [0202] 19b dialysis liquid chamber [0203] 21 venous air separation chamber [0204] 23 venous section or venous blood return line or venous patient line [0205] 23a venous section [0206] 24 connecting site, connecting section [0207] 25 venous substituate-blood-detector [0208] 26 compressed air source [0209] 27 access device, for example venous connection needle [0210] 29 control device and/or closed-loop control device [0211] 31a dialysis liquid inlet line [0212] 31b dialysate outlet line [0213] 33a pressure sensor [0214] 33b pressure sensor [0215] 35 single needle valve [0216] 36 single needle chamber [0217] 37 pressure sensor [0218] 41 connector [0219] 100 calculation device [0220] 101 storage device [0221] 103 input device [0222] 105 computing device [0223] 107 output device [0224] 109 communication device and/or display device [0225] F 1 bis F 16 display fields of the interface [0226] V24 valve [0227] V25 valve