Balancing Unit Being Independent of Temperature Disturbance and Balancing Method

Abstract

The disclosure relates to a functional device, in particular a medical functional device, having at least one fluid circuit. The fluid circuit comprises at least one heat exchange device being arranged and/or embodied between a first section of the fluid circuit and a second section of the fluid circuit. The disclosure relates further to a balancing unit, a treatment apparatus, and a balancing method.

Claims

1.-16. (canceled)

17. A medical device, comprising a fluid circuit or one section thereof, wherein the medical device or the fluid circuit comprises a heat exchange device or is connected thereto, wherein the heat exchange device is arranged between a first section of the fluid circuit and a second section of the fluid circuit.

18. The medical device according to claim 17, wherein the heat exchange device is configured to balance a temperature of fluid in the first section and a temperature of fluid in the second section, or the heat exchange device is configured such that a temperature difference of the fluids in the first and second sections is at least reduced before and after exiting the heat exchange device.

19. The medical device according to claim 17, wherein the heat exchange device comprises a heat conducting body, and wherein a section of the fluid circuit extends along or is arranged in the heat conducting body.

20. The medical device according to claim 17, wherein the heat exchange device is a separate, substitutable, or interchangeable device which is releasable from the medical device as a disposable item.

21. The medical device according to claim 17, wherein the medical device is configured to be connected or connectable to a flow sensor or comprises a flow sensor, wherein the flow sensor is arranged to measure a volume flow in either the first section or the second section, or in both of the first section and the second section of the fluid circuit.

22. The medical device according to claim 21, wherein the flow sensor is a magneto-inductive flow sensor, or is a section thereof.

23. The medical device according to claim 21, wherein the flow sensor is a two-channel flow sensor.

24. The medical device according to claim 21, wherein the flow sensor is arranged in the heat exchange device or is part thereof.

25. The medical device according to claim 17, wherein the medical device comprises a tubing system, or a cassette, or both.

26. The medical device, according to claim 17, wherein the medical device is a single-use item or is disposable.

27. A balancing unit for determining a fluid balance between a first volume flow in a first section of a fluid circuit and a second volume flow in a second section of the fluid circuit, wherein the balancing unit comprises a medical device or is at least in data communication with a medical device or with parts thereof, wherein the medical device comprises a fluid circuit or one section thereof, wherein the medical device or the fluid circuit comprises a heat exchange device or is connected thereto, wherein the heat exchange device is arranged between a first section of the fluid circuit and a second section of the fluid circuit.

28. The balancing unit according to claim 27, wherein the balancing unit is configured to be connected or connectable with a flow sensor or comprises a flow sensor, wherein the flow sensor is arranged to measure a volume flow in either the first or the second section, or in both of the first section and the second section of the fluid circuit.

29. The balancing unit according to claim 28, wherein the balancing unit: (i) further comprises an evaluation unit for generating a fluid balance between a first volumetric flow in the first section of the fluid circuit and a second volumetric flow in the second section of the fluid circuit, or (ii) further comprises a control device for controlling at least one further volume flow of the fluid circuit, or (iii) further comprises both the evaluation unit of (i) and the control device of (ii).

30. The balancing unit of claim 29, wherein the evaluation unit or the control device is part of a treatment apparatus, or is arranged at or in a treatment apparatus.

31. A medical treatment apparatus for treating a medical fluid, the medical treatment apparatus having a balancing unit, or having a medical device, or having both a balancing unit and a medical device, wherein the balancing unit is configured for determining a fluid balance between a first volume flow in a first section of a fluid circuit and a second volume flow in a second section of the fluid circuit, wherein the medical device comprises a fluid circuit or one section thereof, wherein the medical device or the fluid circuit comprises a heat exchange device or is connected thereto, wherein the heat exchange device is arranged between the first section of the fluid circuit and the second section of the fluid circuit.

32. A method for controlling a volume flow in a section of a fluid circuit, the method comprising: providing: (i) a medical device comprising the fluid circuit or one section thereof, wherein the medical device or the fluid circuit comprises a heat exchange device or is connected thereto, wherein the heat exchange device is arranged between a first section of the fluid circuit and a second section of the fluid circuit, or (ii) a treatment apparatus comprising a balancing unit configured for determining a fluid balance between a first volume flow in a first section of the fluid circuit and a second volume flow in a second section of the fluid circuit, or (iii) both the medical device of (i) and the treatment apparatus of (ii); determining or setting the first volume flow in the first section of the fluid circuit; determining the second volume flow in the second section of the fluid circuit; determining the fluid balance between the first volume flow and the second volume flow; and using the determined fluid balance for controlling a volume flow of the fluid circuit, a pumping rate of a pump of the fluid circuit, or a cross-section of a section of the fluid circuit.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0114] FIG. 1 shows, in a simplified illustration, a fluid circuit of a treatment apparatus according to some embodiments described herein;

[0115] FIG. 2 shows, in a highly simplified illustration, a first exemplary functional device according to some embodiments described herein having two flow sensors;

[0116] FIG. 3 shows, in a highly simplified illustration, an exemplary arrangement of a treatment apparatus having a further functional device according to some embodiments described herein;

[0117] FIG. 4 shows, in a highly simplified illustration, a further functional device according to some embodiments described herein;

[0118] FIG. 5 shows, in a highly simplified illustration, a further functional device according to some embodiments described herein; and

[0119] FIG. 6 shows, in a highly simplified illustration, yet a further functional device according to some embodiments described herein.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0120] FIG. 1 shows, in a highly simplified illustration, a section of a fluid circuit 1 which is connected in fluid communication with, or which is a part of, a treatment apparatus 3 according to some embodiments described herein. The treatment apparatus 3 is connected to a balancing unit 4, or the treatment apparatus 3 comprises the balancing unit 4. The treatment apparatus 3 or the balancing unit 4 is/are in addition connected to or comprise(s) a control or regulating device 5 for controlling or regulating pumps, valves, etc. for performing the treatment of the patient. The balancing unit 4 is further connected to two flow sensors Q1, Q2 or is connected to at least one two-channel flow sensor, or comprises the latter. In the example shown, the flow sensors are not illustrated as part of the treatment apparatus 3. Alternatively, both or at least one flow sensor Q1 and/or Q2 may be designed as part of the treatment apparatus 3 or may be arranged in it or attached to it.

[0121] The balancing unit 4 may optionally comprise the control or regulating device 5, or may be in signal communication with it, as exemplarily shown in FIG. 1.

[0122] The treatment device 3 illustrated in FIG. 1, and in all the following figures, is purely exemplarily designed as an ultrafiltration device; the fluid circuit 1 as a circuit for the extracorporeal blood treatment. Both of these assumptions serve solely for the better understanding of the inventive concepts described herein with respect to concrete examples, and should in no way limit the inventive concepts.

[0123] The fluid circuit 1 comprises an extracorporeal blood circuit 6 and a dialysate circuit 7, which, purely exemplarily, are in both substance exchange and fluid exchange by means of a filter or filtering device 9. The arrows denote a flow direction of different fluids during a treatment of a patient (not illustrated) by the treatment apparatus 3.

[0124] Blood of the patient flows into the extracorporeal blood circuit 6 through an arterial blood line 6a to the filter device 9 to be cleaned. The cleaned blood is returned to the patient through a venous blood line 6b. The blood lines 6a, 6b may comprise corresponding hose clamps.

[0125] In some embodiments, the dialysate circuit 7 (which may be a substituate or dialysate circuit, and which comprises a dialysis fluid line 7a and a dialysate line 7b, a first pump 15, and a second pump 16) may for simplification be disposed or arranged for generating a particular volume flow within the dialysate circuit 7. The pumps 15, 16 are, as suggested by the dashed line, optionally each in signal communication with the control or regulating device 5.

[0126] The dialysate circuit 7 comprises further a heat exchange device 19 arranged between a first section A1 and a second section A2 of the fluid circuit 1, and which allows and causes a heat balance or compensation between both sections A1 and A2.

[0127] Additionally, the blood circuit 6 may optionally comprise at least one pump (not illustrated in the figures) for conveying blood. Such a pump may also be in signal communication with the control or regulating device 5.

[0128] In FIG. 1, an arrow indicates an ultrafiltration, occurring optionally, in which fluid from the blood circuit 6 enters with a flow or volume flow UF (ultrafiltration) through the filter 9 into the dialysate circuit 7. The ultrafiltration rate UF may be set, adjusted, or controlled and/or regulated by means of the control or regulating device 5 and respective pumps (e.g., the first pump 15, the second pump 16, and/or a blood pump, not illustrated).

[0129] The arrangement of FIG. 1 is suitable to execute the methods described herein due to the programmed balancing unit 4 and/or to the programmed control or regulating device 5.

[0130] The pumps 15, 16, illustrated in FIG. 1 and at least the non-illustrated blood pump will not be repeatedly illustrated in the following figures, for the sake of simplicity. They may however be optionally provided unchanged in the following described embodiments.

[0131] FIG. 2 shows, in a highly simplified illustration, a functional device 17, which comprises parts of the dialysate circuit 7 and, purely optionally, also parts of the blood circuit 6. While the functional device 17 does not usually comprise the filter 9, it may however be connected in fluid communication therewith.

[0132] A first section A1 of the dialysate circuit 7 comprises or is connected to a first flow sensor Q1. A second section A2 of the dialysate circuit 7 comprises or is connected to a second flow sensor Q2. The first and/or the second flow sensor Q1, Q2 is/are optionally part of the functional device 17.

[0133] The first section A1 is exemplarily part of the dialysis fluid line 7a, and the second section A2 is exemplarily part of the dialysate line 7b.

[0134] The temperature of the fluid flowing out from the first section A1 (the first section A1 being disposed upstream of the filter device 9 in the depicted embodiment) shall be denoted as T1.

[0135] The temperature of the fluid entering or flowing into the first section A1 shall be denoted as T1.

[0136] The temperature of the fluid which flows out from the second section A2 shall be denoted as T2. The second section A2 is disposed downstream of the filter device 9 in the depicted embodiment.

[0137] The temperature of the fluid that enters or flows into the second section A2 shall be denoted as T2.

[0138] The temperature T1 may be determined by an optional temperature sensor S1. The temperature sensor S1 is however not required, in particular when the temperature T1 is known or can be estimated. For example, in some treatment scenarios, it can be assumed in sufficiently good approximation, that T1 (the temperature with which the fluid flows into the first section A1) corresponds to the temperature the fluid has in a fluid source.

[0139] The temperature T2 may be determined by an also optional temperature sensor S2. This temperature sensor S2 is however not required, in particular when the temperature T2 is known or can be estimated. In fact, used dialysate generally exhibits a low temperature variation when flowing out of the filter device 9. Generally, the temperature of the fluid being discharged from the filter device 9 varies within the range of the body temperature (ca. 37 C.). It may therefore be assumed, in some treatment scenarios, in sufficiently good approximation, that T2 corresponds to the body temperature of the patient.

[0140] As suggested in FIG. 2 by a dashed line, the sensors Q1, Q2 and, if applicable S1 and/or S2, are in signal communication with the control or regulating device 5, the evaluation device, and/or the balancing unit 4.

[0141] FIG. 3 shows, in a highly simplified illustration, a functional device 17 in a further exemplary embodiment in accordance with some embodiments described herein. The functional device 17 corresponds substantially to that of FIG. 2.

[0142] FIG. 3 also shows that the first flow sensor Q1 may be unnecessary in some embodiments. This can be the case, for example, when the first flow F1 is known or can be estimated, or the second volume flow F2 is adjustable and/or set by a device suitable for this purpose (e.g. a pump and/or a control or regulating device and/or an input device).

[0143] The particular feature of the embodiment of FIG. 3, according to which there is no necessity of a flow sensor Q, and/or of a temperature sensor S1 for the first section, and/or a temperature sensor S2 for the second section A2, is combinable, where useful, with any other embodiment described herein.

[0144] FIG. 4 shows in a highly simplified illustration a further embodiment of the functional device 17.

[0145] The functional device 17 comprises, optionally, a first and second flow sensor Q1 and Q2. The functional device 17 comprises or is connected to at least one heat exchange device 19.

[0146] The optionally provided first sensor Q1 is arranged in a first section A1 of the substituate or dialysate circuit 7 of the fluid circuit 1, preferably in the dialysis fluid line 7a. The optionally provided second flow sensor Q2 is arranged in a second section A2 of the substituate or dialysate circuit 7 of the fluid circuit 1, preferably in the dialysate line 7b.

[0147] The first section A1 is optionally positioned upstream of a filter device 9 (for example a blood filter), the second section A2 is optionally positioned downstream of the filter device 9. In this example, the first and the second sections A1, A2 are optionally each in fluid communication with the filter device 9.

[0148] The heat exchange device 19 is arranged with regard to the flow direction of the fluid during a blood treatment (said direction being indicated by arrows) for an exchange of heat or thermal energy between the fluid flowing through the first section Al and the fluid flowing through the second section A2.

[0149] In particular, the heat exchange device 19 is optionally arranged upstream of the first flow sensor Q1, which is itself arranged upstream of the filter device 9. The heat exchange device 19 is at the same time optionally arranged upstream of the second flow sensor Q2, which is itself arranged downstream of the filter device 9.

[0150] The heat exchange device 19 may optionally be part of the first section A1 and/or of the second section A2 (e.g., an integral part thereof), and/or it may optionally only be connected (e.g., thermally) with the first section A1 and/or with the second section A2.

[0151] The heat exchange device 19 is provided, suitable, and/or designed to effect a heat exchange between the fluid flowing through the first section A1 and the fluid flowing through the second section A2.

[0152] A heat balance as used herein may mean that the difference between: (i) a temperature T1 of the fluid after leaving the heat exchange device 19 but before or at the first flow sensor Q1, and in particular before the filter device 9, and (ii) a temperature T2 of the fluid flowing out after passing the heat exchange device 19 but before or at the second flow sensor Q2, is zero or substantially zero. It may also be understood, that the above-mentioned difference is in any case less than the difference between the temperature T1 and T2, which the fluid or fluids respectively had before entering in the heat exchange device 19.

[0153] In some embodiments, one or more devices are included to detect the temperature T1 and/or the temperature T2 (e.g., by at least one temperature sensor, not illustrated), and/or to set or adjust the temperature T1 and/or the temperature T2 (e.g., by a suitable device such as a heater).

[0154] FIG. 5 shows, in a highly simplified illustration, yet another further exemplary embodiment of the functional device.

[0155] The arrangement of the heat exchange device 19 and the flow sensors Q1 and Q2 corresponds basically to that of the FIG. 4. The flow sensors Q1 and Q2 of the heat exchange device 19 are each arranged downstream with respect to a flow direction of the fluid (of a medical fluid).

[0156] Likewise, the heat exchange device 19 is provided and/or arranged to effect a heat balance between the sections that are each arranged downstream, in particular directly, after the heat exchange device 19.

[0157] The section denoted with the reference numeral 19 may be designed as a removable or detachable section, or as a sector or insert, which may be removed from or out of the functional device 17. This removable section 19 comprises at least the heat exchange device 19. In addition, this removable section 19 may optionally comprise one or both flow sensors Q1, Q2, or at least sections thereof, as exemplarily illustrated.

[0158] The removable section 19 may optionally be designed as a single-use item or as a disposable. The same may apply to the functional device 17 in some embodiments.

[0159] The removable section 19 may optionally comprise at least one solid body, in particular a highly thermal or heat conductive body, for example a metallic hard part, in which the respective sections A1, A2 of the fluid circuit 7 extend.

[0160] Both respective sections A1, A2 of the fluid circuit 7 may exemplarily be separated from each other within the heat exchange device 19 through a thin, in particular fluid-tight, film and/or plate.

[0161] Additionally, in this case, it may optionally be intended to use only one flow sensor Q1 or Q2, in particular when at least one of the two flows F1 and/or F2, with which the fluid flows through the sections A1, A2, respectively, is already set and/or is adjustable.

[0162] FIG. 6 shows in a highly simplified illustration the functional device 17 in a yet further embodiment. Thereby, the arrangement and/or the design of the removable section 19 of FIG. 5 or another section of the functional device 17 may additionally comprise at least one heater Hi (i=1, 2).

[0163] The heater Hi may be arranged particularly in the first section A1 of the fluid circuit 1.

[0164] There are two heaters H1 and H2 illustrated in FIG. 6. Both are exemplarily arranged and/or designed in the first section A1. The first heater H1 is arranged upstream or before the removable section 19, while the second heater H2 is arranged downstream or after the removable section 19. Both heaters H1, H2 are, not part of the functional device 17. In some embodiments, they may however be part of the functional device 17. Both flow sensors Q1, Q2 are not part of the functional device 17. They may be part of the balancing unit 4 and/or of the treatment apparatus 3.

[0165] In some embodiments, only a single heater H1 or H2 is included in or along the fluid circuit 1.

[0166] In some embodiments, at least one heater Hi (e.g., in the first section A1 of the fluid circuit 1) is arranged upstream of the heat exchange device 19 and/or downstream of a flow sensor (not illustrated) which is arranged downstream of the heat exchange device 19.

[0167] In a further, not illustrated embodiment of the functional device 17, a heater Hi may optionally be designed and/or arranged at, in, and/or at least in connection with the heat exchange device 19, the removable section 19, or at least sections thereof, respectively.

[0168] The heater Hi may be designed to guarantee or ensure a predetermined minimum temperature of the fluid. Thus, a measurement of temperature may be unnecessary in certain embodiments.

[0169] Heaters Hi, as shown in FIG. 6, may be included in the arrangements of any of the embodiments shown in the preceding figures.

[0170] By using the arrangements of the figures and the particular configuration of the balancing unit 4, a correct fluid balance can be generated. Alternatively or additionally, an ultrafiltration rate may be adapted or adjusted by the control and/or regulating device 5.

LIST OF REFERENCE NUMERALS

[0171] 1 fluid circuit [0172] 3 blood treatment apparatus [0173] 4 balancing unit [0174] 5 control or regulating device [0175] 6 blood circuit [0176] 6a arterial blood line [0177] 6b venous blood line [0178] 7 dialysate and/or substituate circuit [0179] 7a dialysis fluid line [0180] 7b dialysate line [0181] 9 filter or filtering device [0182] 15 first pump [0183] 16 second pump [0184] 17 functional device [0185] 19 heat exchange device [0186] 19 removable section of the functional device [0187] A1 first section of the dialysate and/or substituate circuit [0188] A2 second section of the dialysate and/or substituate circuit [0189] Q1 first flow sensor [0190] Q2 second flow sensor [0191] S1 temperature sensor [0192] S2 temperature sensor [0193] F1 first volumetric flow in the first section of the fluid circuit [0194] F2 second volumetric flow into the second section of the fluid circuit [0195] Hi (i=1, 2, . . . ) heater