Producing and dosing a substituate during blood treatment

Abstract

The present disclosure relates to methods for dosing a substituate produced by a blood treatment apparatus. Dosing for the present disclosure is via a hydraulic system of the blood treatment apparatus, the hydraulic system having at least one dialysis liquid supply line which leads into a dialyzer and at least one substituate line. Regulating or controlling the size of the share which passes through the second filtration stage is performed by affecting at least one conveying apparatus and/or at least one flow limitation device and/or a flow divider valve, which are each located or which each operate in the dialysis liquid supply line and/or the substituate line and/or in the branch line which connects the dialysis liquid Supply line with the substituate line. The present disclosure further relates to a control device, a blood treatment apparatus, and a medical functional apparatus.

Claims

1. A medical system comprising: a blood treatment apparatus; and a medical functional apparatus, configured to operate with the blood treatment apparatus, wherein the medical functional apparatus is a blood cassette, an extracorporeal blood tube or a blood tube set, the medical functional apparatus comprising: a first substituate line; and a substituate port for receiving a substituate produced by the blood treatment apparatus, wherein the medical functional apparatus is free of any apparatus arranged or provided for dosing the substituate from the substituate line into a blood-conducting line; wherein the blood treatment apparatus comprises: a first filter, a second filter, a dialysis liquid supply line in fluid communication with the first filter, a second substituate line in fluid communication with the second filter, wherein the second substituate line emerges from the second filter and is arranged downstream of the second filter, and wherein the second substituate line is in fluid communication with the first substituate line of the medical functional apparatus when the first substituate line and the second substituate line are coupled to the substituate port, a flow sensor situated along the second substituate line, at least one conveying apparatus that is arranged downstream of the first filter along the dialysis liquid supply line and upstream of the second filter, at least one flow limitation device located along at least one of the dialysis liquid supply line and the second substituate line, wherein the at least one flow limitation device is a proportional valve or a throttle, and a control device programmed to control the blood treatment apparatus to: convey a fluid through the first filter of the blood treatment apparatus and into the dialysis liquid supply line, thereby generating a dialysis liquid which is suitable for use in a dialyzer connected to the dialysis liquid supply line; guide a portion of the dialysis liquid into the second substituate line that is in fluid communication with the second filter of the blood treatment apparatus, thereby generating substituate which is suitable for use in an extracorporeal blood circuit via the substituate port of the medical functional apparatus after the dialysis liquid passes through the second filter; monitor substituate flow in the second substituate line with the flow sensor situated along the second substituate line; operate the at least one conveying apparatus and the at least one flow limitation device to generate the substituate; based on the substituate flow in the second substituate line monitored by the flow sensor situated along the second substituate line, regulate the flow of the substituate by controlling the at least one conveying apparatus and the at least one flow limitation device to regulate a volume of a portion of the dialysis liquid which passes through the second filter to generate the substituate.

2. The system according to claim 1, wherein the blood treatment apparatus is or comprises a hemodialysis apparatus, a hemofiltration apparatus, or a hemodiafiltration apparatus.

3. The system according to claim 1, further comprising: a proportional valve or a throttle disposed in at least one of the dialysis liquid supply line or in the second substituate line downstream of the second filter, wherein the second filter is integrated in the dialysis liquid supply line.

4. The system according to claim 1, further comprising: a pressure pump disposed in the second substituate line downstream of the second filter, wherein the second filter is integrated in the dialysis liquid supply line.

5. The system according to claim 4, further comprising: at least one of a temperature sensor in the second substituate line downstream of the pressure pump, a particle filter in the second substituate line downstream of the pressure pump, or a bypass line branching off the second substituate line.

6. The system according to claim 1, further comprising: a volume pump in the second substituate line downstream of the second filter, wherein the second filter is integrated in the dialysis liquid supply line.

7. The system according to claim 6, further comprising: at least one of a substituate pressure sensor in the second substituate line upstream of the volume pump, a particle filter downstream of the volume pump, or a pressure sensor downstream of the volume pump.

8. The system according to claim 1, further comprising: at least one flow sensor disposed in the dialysis liquid supply line.

9. The system according to claim 1, further comprising: a branch line which branches off from the dialysis liquid supply line at a branch point, wherein the branch line, downstream from the branch point, leads into the second filter; and a flow divider valve in the branch point upstream of the second filter.

10. The system according to claim 1, further comprising: a branch line which branches off from the dialysis liquid supply line at a branch point; and at least one proportional valve or throttle, wherein the branch line leads into the second filter downstream, and wherein the at least one proportional valve is located in the dialysis liquid supply line downstream of the branch point, or the at least one proportional valve or throttle is located in the branch line upstream of the second filter.

11. The system according to claim 1, further comprising: a branch line which branches off from the dialysis liquid supply line at a branch point; and a pre-pressure pump, wherein the branch line leads into the second filter downstream, and wherein the pre-pressure pump is arranged in the branch line downstream of the branch point.

12. The system according to claim 11, further comprising: a temperature sensor located in the branch line downstream of the pre-pressure pump.

13. The system according to claim 1, further comprising: a branch line which branches off from the dialysis liquid supply line at a branch point; a volume pump located in the branch line downstream of the branch point; and a branch line pressure sensor, wherein the branch line leads into the second filter downstream, wherein the branch line is located downstream of the branch point, and wherein the branch line pressure sensor is located downstream of the volume pump but upstream of the second filter.

14. The system according to claim 1, further comprising: a branch line which branches off from the dialysis liquid supply line at a branch point, a pre-pressure pump, and a flush line, wherein the branch line leads into the second filter downstream, wherein the pre-pressure pump is located upstream of the branch point, and wherein the flush line branches off the second filter.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The present invention is hereafter exemplarily explained with reference to the appended figures in which identical reference numerals refer to same or similar components. In the partially highly simplified figures it applies that:

(2) FIG. 1 shows in a schematically simplified way and in extracts the hydraulic system of the blood treatment apparatus according to a first exemplary embodiment according to the present invention;

(3) FIG. 2 shows in a schematically simplified way and in extracts the hydraulic system of the blood treatment apparatus according to a second exemplary embodiment according to the present invention;

(4) FIG. 3 shows in a schematically simplified way and in extracts the hydraulic system of the blood treatment apparatus according to a third exemplary embodiment according to the present invention;

(5) FIG. 4 shows in a schematically simplified way and in extracts the hydraulic system of the blood treatment apparatus according to a fourth exemplary embodiment according to the present invention;

(6) FIG. 5 shows in a schematically simplified way and in extracts the hydraulic system of the blood treatment apparatus according to a fifth exemplary embodiment according to the present invention;

(7) FIG. 6 shows in a schematically simplified way and in extracts the hydraulic system of the blood treatment apparatus according to a sixth exemplary embodiment according to the present invention;

(8) FIG. 7 shows in a schematically simplified way and in extracts the hydraulic system of the blood treatment apparatus according to a seventh exemplary embodiment according to the present invention; and

(9) FIG. 8 shows in a schematically simplified way and in extracts the hydraulic system of the blood treatment apparatus according to an eighth exemplary embodiment according to the present invention.

DETAILED DESCRIPTION

(10) FIG. 1 shows in a schematically simplified way a hydraulic system 1 according to the present invention of a treatment apparatus 100 according to the present invention by which the method according to the present invention can be executed, and a blood circuit 200 which is only indicated schematically as an example of a medical functional apparatus.

(11) The hydraulic system 1 comprises a dialysis liquid supply line 3, also denoted as dialysate line, which leads dialysis liquid which was produced online, i.e. by the treatment apparatus 100, to a blood filter or dialyzer 5. As dialysis liquid supply line 3 the whole line is understood herein through which dialysis liquid flows, which extends from a junction 3a downstream from a first filter F04 which is also denoted as first filtration stage up to the entry of the dialysis liquid supply line 3 at an entry site 3b into the dialyzer 5.

(12) A dialysate drain line 7 attaches to the dialyzer 5 which discharges the dialysis liquid from the dialyzer 5. The dialysis liquid which is supplied to the dialyzer 5 by the dialysis liquid supply line 3 passes not only through the first filter F04 but also trough a second filter F05, which is also denoted as second filtration stage, before it enters the dialyzer 5. The second filter F05 is integrated in the dialysis liquid supply line 3 and dialysis liquid flows through it. Dialysate can flow through the second filter F05 along the dialysis liquid supply line 3 without being filtered.

(13) In the second filter F05 thus a filtrate is produced which hereafter is also denoted as “substituate” which, being a share or portion of the dialysis liquid, is filtrated, lead through or pressed through the membrane or sterile membrane of the second filter F05 and lead into a second substituate line 9b. From the second substituate line 9b, the substituate which is produced this way may for example be supplied via a substituate port to an extracorporeal blood circuit 200, which may partially run on a blood cassette which is not illustrated. This may optionally take place in predilution and/or postdilution. The extracorporeal blood circuit 200, which is only schematically indicated in the appended figures, comprises at least one blood drain line 200a which is connected to the dialyzer 5, a blood supply line 200b which is also connected to the dialyzer 5, and a section 200c, which is in direct fluid connection with a first substituate line 9a.

(14) A clamp or a valve V24 is optionally integrated in the dialysis liquid supply line 3. A clamp or a valve V25 is optionally integrated in the dialysate drain line 7. A clamp or a valve V31 is optionally integrated in the second substituate line 9b between the second filter F05 and the substituate port H32.

(15) A connection line 10 attaches to the substituate port H32. It connects the first substituate line 9a and the second substituate line 9b with the dialysate drain line 7. Further valves V32 and V33, which are also only optionally provided, are shown in the connection line 10 in FIG. 1. A retention valve V22, a bypass valve V26 and a flush port H33 are also optionally provided.

(16) Between the first filter F04 and the second filter F05, a pre-pressure pump 11 and a dialysate pre-pressure sensor 13 may be, each optionally, provided. Equally, a substituate pressure sensor 15 and a blood detector 17 may be, each optionally, provided in the second substituate line 9b.

(17) According to the present invention, if there is mention of a “pre-pressure,” the respective element—such as the pre-pressure pump 11 or the dialysate pre-pressure sensor 13—is arranged or acts upstream of the second filter F05.

(18) For dosing the substituate flow or substituate volume, a first proportional valve Vdia, which is integrated in the dialysis liquid supply line 3, and a second proportional valve Vsub, which is integrated in the second substituate line 9b are provided in the first exemplary embodiment illustrated in FIG. 1. It has to be noted that the elements Vdia and Vsub are only exemplarily proportional valves. They can also be embodied as other suitable flow or stream limitation devices which are known to the person skilled in the art. The valve position or valve positions are controlled or regulated in the exemplary embodiment shown in FIG. 1 such that the desired flow separation between the dialysis liquid flow in the dialysis liquid supply line 3 and substituate flow in the second substituate line 9b is achieved.

(19) In case it has to be ensured that the dialysate pre-pressure which for example can be measured with the dialysate pre-pressure sensor 13 does not fall below a defined or predetermined pressure value, the valve position of one of the two proportional valves Vdia and Vsub or the valve positions of both proportional valves Vdia and Vsub can be accordingly set or regulated. This predetermined pressure value may be determined such that both in the dialysis liquid supply line 3 and in the second substituate line 9b defined flows can be ensured. An optionally provided upper pressure limitation may take place by the hydraulic system. When falling below a minimum pressure, closing the second substituate line 9b, for example by the valve V31, can optionally take place as a safety measure.

(20) Alternatively or additionally, a desired pre-pressure can be generated or ensured by a pump, for example by the optionally provided pre-pressure pump 11.

(21) Optionally, a flow sensor 19b in the dialysis liquid supply line 3 and/or a flow sensor 19a in the second substituate line 9b are further provided for monitoring the achieved or the desired flow separation. Thereby, the flow sensor 19a is located downstream of the valve Vsub, the flow sensor 19b is located downstream of the valve Vdia. It is noted that according to the present invention, contrary to the exemplary embodiment as described herein, one, some or all of the flow sensors may alternatively be also located upstream of the proportional valves, regardless of the location of the remaining flow sensors, as long as they are located downstream of the branch point of dialysate and substituate or the branch point of the branch line.

(22) The desired flow separation may optionally be monitored and ensured by corresponding pressure measurements and the pressure measurement apparatuses which are optionally provided herefor. In this case, it may be advantageously possible to do without the optionally provided flow sensors 19a and 19b.

(23) If the valve Vsub is embodied as a tube squeeze valve, as is provided in further exemplary embodiments according to the present invention, the additional provision of a valve V31 in the second substituate line 9b may be waived. In such case, a flow sensor can be advantageously used. With it, a desired conveying rate precision of for example 10% can be easily checked and optionally readjusted accordingly.

(24) The explanations made with respect to FIG. 1 also apply to the following figures, where seen as useful by the person skilled in the art. This applies in particular to the elements shown in FIG. 1, their designations, and their functions.

(25) For controlling or regulating the above-named components of the hydraulic system 1 in order to execute the method according to the present invention the blood treatment apparatus 100 comprises a regulating or control apparatus 300 according to the present invention, or it is connected herewith in signal or operative connection.

(26) FIG. 2 shows again in a schematically simplified way and only in extracts the hydraulic system 1 of the blood treatment apparatus 100 in a second exemplary embodiment according to the present invention. In the setup or arrangement shown in FIG. 2, a throttle 21 is again merely optionally provided at the site at which the valve Vsub is shown in FIG. 1 instead of the valve Vsub which is optionally embodied as proportional valve. Apart from that, the setup of FIG. 2 may be the one of FIG. 1.

(27) The exemplary embodiment according to the present invention which is disclosed with regard to FIG. 2, in which only one proportional valve, that is the valve Vdia, is provided may be appropriate especially if it can be ensured that the pressure drop across the second substituate line 9b or the whole substituate branch is always higher than across the dialysis liquid supply line 3 or the whole dialysate branch. If this is the case, which always has to be assumed in a hemodiafiltration treatment as otherwise no dialysate would flow anymore and the treatment would become a hemofiltration treatment, one proportional valve can be saved as shown in FIG. 2.

(28) It is assumed that the pressure drop across the substituate branch should usually be higher than across the dialysate branch as the dialysis liquid which remains in the dialysis liquid supply line passes through the second filter F05 in a longitudinal direction and the share of the dialysis liquid which is discharged into the substituate branch however has to be pressed through the membrane of the second filter F05.

(29) Furthermore, usually a non-return valve which is present on a disposable such as a blood cassette or the extracorporeal blood circuit and which is not shown here is located in the substituate branch for preventing a return flow. This non-return valve comprises a cracking pressure or opening pressure to ensure the blocking function of the non-return valve. Thus, the pressure drop across the substituate branch is higher. The opening pressure may exemplarily be more than 100 mbar.

(30) If it has to be ensured that the pressure drop across the substituate branch is higher than the pressure drop across the dialysis liquid branch, the substituate branch may be furnished with a throttle 21 as shown in FIG. 2. In its setup, the maximum admissible substituate flow as well as the maximum or maximum admissible dialysate pre-pressure can be considered.

(31) FIG. 3 shows a third exemplary embodiment according to the present invention. The explanations to it substantially correspond to those made with regards to FIGS. 1 and 2. Compared to the illustrations of FIGS. 1 and 2, however, a pump 12 which is located downstream of the second filter F05 is arranged in the second substituate line 9b instead of the pre-pressure pump 11 located upstream from the second filter F05. Furthermore, a temperature sensor 23 and/or a particle filter 25 may optionally be provided downstream from the pump 12, which may for example be embodied as a pressure pump. Based on the temperature values provided by the temperature sensor 23 it can be ensured that the substituate supplied to the blood circuit 200 has not been heated up to an inadmissible extend, which could have taken place by the pump 12 upstream from it. Should an inadmissible heating be detected, the heated substituate may completely or partly be discharged via an optionally provided bypass line 27 by opening an arranged bypass valve Vbp.

(32) FIG. 4 shows again in a schematically simplified way and only in extracts the hydraulic system 1 of the blood treatment apparatus 100 in a fourth exemplary embodiment according to the present invention.

(33) In the exemplary embodiment of FIG. 4, a substituate pre-pressure sensor 29 is optionally provided in the second substituate line 9b downstream of the second filter F05. Instead of a pre-pressure pump 11 which is provided in the dialysis liquid supply line 3, in the exemplary embodiment of FIG. 4 a volume pump 31 is provided in the second substituate line 9b. There, it is located downstream of the second filter F05 and—if available—downstream of the substituate pre-pressure sensor 29.

(34) Also in the exemplary embodiment shown in FIG. 4 a particle filter 25 may be optionally provided. It can be arranged downstream of the volume pump 31.

(35) In addition, the second substituate line 9b comprises a substituate sensor 15. It is located downstream of the volume pump.

(36) FIGS. 5 to 8, which are discussed hereafter, show further exemplary embodiments according to the present invention which differ from the ones of FIGS. 1 to 4 in that the second filter F05 is not a part of the dialysis liquid supply line 3. In fact, different to what has been discussed regarding FIGS. 1 to 4, the dialysis liquid which enters the dialyzer 5 does not also flow through the second filter F05. In the arrangements of FIGS. 5 to 8, only the share of dialysis liquid which is produced online by the first filter F04 flows through the second filter F05, which is used for the production of filtrate or substituate.

(37) In the arrangements of FIGS. 5 to 8, this takes place in that a branch line 35 which starts at a branch point 35a is provided between the dialysis liquid supply line 3 and the second filter F05.

(38) FIG. 5 shows again in a schematically simplified way and only in extracts the hydraulic system 1 of the blood treatment apparatus 100 in a fifth exemplary embodiment according to the present invention.

(39) In contrast to what is illustrated in the preceding figures, a flow divider valve 37 which is provided at a branch point 35a ensures that the volume flow which flows through the first filter F04 and which optionally is conveyed through a pre-pressure pump 11 is separated in the desired ratio into a dialysate flow and a branch or substituate flow. By integrated pressure compensators, this flow ratio can be maintained independently from the respective counter-pressure. For ensuring the function, the pre-pressure pump 11 which is optionally provided upstream of the flow divider valve 37 can supply the pre-pressure required to operate the flow divider valve 37. The arrangement of FIG. 5 comprises a flush line 28 which contains a flush valve VF1.

(40) Other than the preceding figures, FIG. 5 comprises a third flow sensor 19c which is only optionally provided, which is arranged in the branch line 35. The third flow sensor 19c may optionally be provided together with the first flow sensor 19a or the second flow sensor 19b or both flow sensors 19a and 19b. According to the present invention, it also suffices to provide only one of the flow sensors 19a, 19b and 19c or arbitrary combinations hereof, for example at the sites of the hydraulic system 1 shown in FIG. 5.

(41) FIG. 6 just as FIG. 5 again shows in a schematically simplified way the hydraulic system 1 in a sixth exemplary embodiment according to the present invention.

(42) The flow separation is achieved in FIG. 6 again with two proportional valves Vdia and Vsub as illustrated. The advantages associated herewith encompass reduced mechanical complexity and an improved cleaning possibility by staff and/or machine.

(43) FIG. 7 shows a seventh exemplary embodiment according to the present invention. In this exemplary embodiment, a pre-pressure pump 11 is provided, preferably in the branch line 35, which with the support of one or several flow sensors 19a, 19b and 19c can be regulated to achieve the desired substituate flow. The pressure pump or pre-pressure pump 11 may for example be a geared pump having a bypass or a centrifugal pump.

(44) As for example a centrifugal pump can significantly heat up the substituate, a temperature sensor 23 may optionally be provided downstream of the pre-pressure pump 11 for monitoring the temperature of the substituate. According to the present invention, it can be provided that when an excess temperature is detected or when a predetermined temperature limit value is exceeded, substituate that has been heated too much can be discharged via the flush valve VF1 and the flush line 28. The valve V31 can be completely or partially closed for this purpose.

(45) FIG. 8 shows the hydraulic system 1 according to the present invention of a treatment apparatus 200 according to the present invention according to an eighth exemplary embodiment according to the present invention.

(46) In this exemplary embodiment, a volume pump 31 is provided, preferably in the branch line 35. It can generate a predefined substituate flow. The volume pump or flow pump 31 may for example be designed as a gear pump without bypass, a membrane pump, a tube roller pump or also as a rotary vane pump.

(47) In this or similar exemplary embodiments according to the present invention, the pressure may be monitored by a suitable pressure measurement apparatus such as for example the branch line pressure sensor 16 for limiting the pressure in the branch line 35 depending on the utilized pump type.

(48) Some of the features of the exemplary embodiments according to the present invention which are illustrated in the figures can be taken from the following Table 1:

(49) TABLE-US-00001 TABLE 1 feature FIG. 1 FIG. 2 FIG. 3 FIG. 4 FIG. 5 FIG. 6 FIG. 7 FIG. 8 conventional yes yes yes yes no no no no switching of the second filtration stage in dialysis liquid supply line second filtration no no no no yes yes yes yes stage in branch line of the dialysis liquid supply line flush line at the outlet no no no no yes yes yes yes of the dialysate chamber of the second filtration stage bypass line branching no no yes no no no no no off the filtrate line to the flush flow divider valve in no no no no yes no no no dialysis liquid supply line downstream of first filtration stage proportional valve in yes yes no no no yes no no dialysis liquid supply (opt.) (opt.) line downstream of second filtration stage proportional valve in yes no no no no no no no substituate line (opt.) downstream of second filtration stage flow measurement in yes yes yes no yes yes yes no dialysis liquid supply (opt.) (opt.) (opt.) (opt.) (opt.) (opt.) line flow measurement in no no no no yes yes yes no branch line upstream (opt.) (opt.) (opt.) of the second filtration stage flow measurement in yes yes yes no yes yes yes no substituate line (opt.) (opt.) (opt.) (opt.) (opt.) downstream of the second filtration stage pre-pressure pump in yes yes no no yes yes no no dialysis liquid supply line downstream of the first filtration stage pre-pressure yes yes no no no no no no measurement in dialysis liquid supply line downstream of the first filtration stage pre-pressure pump in no no no no no no yes no branch line upstream of the second filtration stage pressure pump in no no yes no no no no no substituate line downstream of the second filtration stage volume pump in no no no no no no no yes branch line upstream of the second filtration stage volume pump in no no no yes no no no no branch line downstream of the second filtration stage temperature sensor no no yes no no no yes no downstream of pressure pump pressure monitoring no no no yes no no no yes downstream of volume pump pre-pressure no no no yes no no no no measurement upstream of volume pump particle filter in no no no yes no no no no substituate line downstream of volume pump blood detector in yes yes yes yes yes yes yes yes substituate line (generally optional)

REFERENCE NUMERAL LIST

(50) 1 hydraulic system of the treatment apparatus 100 3 dialysis liquid supply line 3a junction 3b entry site 5 dialyzer or filter 7 dialysate drain line 9a first substituate line 9b second substituate line 10 connection line 11 pre-pressure pump 12 pump 13 dialysate pre-pressure sensor 15 substituate pressure sensor 16 branch line pressure sensor 17 blood sensor 19a first flow sensor 19b second flow sensor 19c third flow sensor 21 throttle 23 temperature sensor 25 particle filter 27 bypass line 28 flush line 29 substituate pre-pressure sensor 31 volume pump 35 branch line 35a branch point 37 flow divider valve 100 treatment apparatus 200 extracorporeal blood circuit 200a blood drain line 200b blood supply line 200c section of the extracorporeal blood circuit 200 with direct fluid connection to the first substituate line 9a 300 control device or regulating device V22 retention valve V24 clamp or valve V25 clamp or valve V26 bypass valve V31 valve in the substituate line VF1 flush valve Vbp bypass valve Vdia valve in the dialysis liquid supply line Vsub valve in the substituate line F04 first filter F05 second filter H32 substituate port H33 flush port