Blood Treatment Device For Carrying Out An Extracorporeal Blood Treatment, Blood-Guiding Device, Blood Treatment System

Abstract

The invention relates to a blood treatment device for carrying out an extracorporeal blood treatment in which blood is guided in a blood guidance device having a main blood line and at least one secondary line, the latter being fluidically connected to the main blood line and the main blood line having a dialyzer and, downstream from the dialyzer, a blood treatment element, wherein the blood treatment device has a control device; and a pump configuration, which is equipped for generating blood flows in the main blood line and also in the at least one secondary line, wherein the control device is designed to operate the pump configuration in such a way that a first blood flow rate in the dialyzer is decoupled from a second blood flow rate in the blood treatment element. Furthermore, the invention relates to a blood guidance device for cooperation with the blood treatment device as well as for a blood treatment system.

Claims

1. A blood treatment device for carrying out an extracorporeal blood treatment in which blood is guided in a blood guidance device having a main blood line and at least one secondary line, the latter being fluidically connected to the main blood line, and wherein the main blood line has a dialyzer and, downstream from the dialyzer has a blood treatment element, wherein the blood treatment device has: a control device; and a pump configuration, which is equipped for generating blood flows in the main blood line and also in the at least one secondary line, wherein the control device is configured to operate the pump configuration in such a way that a first blood flow rate in the dialyzer is decoupled from a second blood flow rate in the blood treatment element.

2. The blood treatment device according to claim 1, wherein the pump configuration is designed to generate independent blood flow rates in the main blood line and in the at least one secondary line.

3. The blood treatment device according to claim 1, wherein the extracorporeal blood guidance device also has a second secondary line which is fluidically connected to the main blood line, wherein the pump configuration is also equipped for generating a blood flow in the second secondary line, and wherein the control device is configured to operate the pump configuration in such a way that the blood flow rate in at least one section of the main blood line is independent at least of one of the blood flow rates in the secondary lines.

4. The blood treatment device according to claim 1, wherein the blood treatment device has: an infusion pump for supplying medical fluid to the main blood line, or two infusion pumps for supplying medical fluid into the main blood line, or three infusion pumps for supplying medical fluid into the main blood line, or four or more infusion pumps for supplying medical fluid into the main blood line.

5. The blood treatment device according to claim 4, wherein the control device is configured to regulate the delivery rate of at least one of the infusion pumps as a function of the blood rate in the dialyzer.

6. The blood treatment device according to claim 1, wherein the blood treatment device has a pressure sensor for determining the pressure in the main blood line downstream from the dialyzer and upstream from the blood treatment element.

7. The blood guidance device for cooperating with a blood treatment device according to claim 1, comprising: a main blood line for fluidic connection to a dialyzer and for fluidic connection to a blood treatment element downstream from the dialyzer, wherein the main blood line has at one end a blood withdrawal port for connection to a blood withdrawal access of a patient and at the other end has a blood return port for connection to a blood return access of the patient; at least one secondary line, which branches off from the main blood line at a first branch and recombines with the main blood line at a second branch; and one or more pump configuration sections, designed for action of the pump configuration on the blood treatment device.

8. The blood guidance device according to claim 7, wherein the first branch is disposed upstream from the connection point for the dialyzer, and wherein the second branch is disposed downstream from the connection point for the dialyzer and upstream from the connection point for the blood treatment element.

9. The blood guidance device according to claim 7, wherein the first branch is disposed downstream from the connection point for the blood treatment element, and wherein the second branch is disposed upstream from the connection point for the blood treatment element and downstream from the connection point for the dialyzer.

10. The blood guidance device according to claim 7, comprising a second secondary line, which branches off from the main blood line at a recirculation branch and opens into a recirculation return port, wherein the first branch is disposed upstream from the connection point for the dialyzer, and wherein the second branch is disposed downstream from the connection point for the dialyzer and upstream from the connection point for the blood treatment element, and wherein the recirculation branch is disposed downstream from the connection point for the blood treatment element, and wherein the recirculation return port is disposed in the main blood line upstream from the connection point for the blood treatment element and downstream from the connection point for the dialyzer, or wherein the recirculation return port is disposed in the first secondary line upstream from the second branch.

11. The blood guidance device according to claim 7, wherein the main blood line comprises: an injection port for a first medical fluid for anticoagulation upstream from the connection point for the dialyzer; and/or an injection port for a second medical fluid for anticoagulation downstream from the connection point for the treatment element.

12. The blood guidance device according to claim 8, wherein the main blood line comprises: an injection port for a first medical fluid for anticoagulation downstream from the first branch and upstream from the connection point for the dialyzer; and/or an injection port for a second medical fluid for anticoagulation downstream from the connection point for the treatment element; and/or an injection port for a third medical fluid for anticoagulation upstream from the first branch.

13. The blood guidance device according to claim 7, wherein the main blood line has a pressure measurement section for determining the pressure in the main blood line downstream from the connection point for the dialyzer and upstream from the connection point for the blood treatment element.

14. The blood guidance device according to claim 7, wherein the main blood line comprises: an injection port for a dilution fluid upstream from the connection point for the dialyzer; and/or an injection port for a dilution fluid downstream from the connection point for the dialyzer and upstream from the connection point for the blood treatment element; and/or an injection port for a dilution fluid downstream from the connection point for the blood treatment element.

15. Blood guidance device according to claim 7, wherein the blood guidance device comprises the dialyzer and the blood treatment element.

16. Blood treatment system, comprising: a blood treatment device according to claim 1 and a blood guidance device comprising: a main blood line for fluidic connection to a dialyzer and for fluidic connection to a blood treatment element downstream from the dialyzer, wherein the main blood line has at one end a blood withdrawal port for connection to a blood withdrawal access of a patient and at the other end has a blood return port for connection to a blood return access of the patient; at least one secondary line, which branches off from the main blood line at a first branch and recombines with the main blood line at a second branch; and one or more pump configuration sections, designed for action of the pump configuration on the blood treatment device.

17. The blood treatment device according to claim 5, wherein the control device is configured to regulate the delivery rates of at least two of the infusion pumps each as a function of the blood flow rate in the dialyzer.

18. The blood treatment element of claim 15, wherein the blood treatment element is a gas exchanger.

Description

[0053] In these drawings:

[0054] FIG. 1: shows a schematic diagram of one embodiment of a blood treatment system according to the invention.

[0055] FIG. 2: shows a schematic diagram of one embodiment of a blood guidance device according to the invention, comprising a connected dialyzer and a connected blood treatment element.

[0056] FIG. 3a: shows in a schematic diagram the flow plan of a blood guidance device according to the invention.

[0057] FIG. 3b: shows in a schematic diagram the flow plan of the blood guidance device illustrated in FIG. 3a with additional optional components.

[0058] FIG. 4a: shows in a schematic diagram of the flow plan an alternative embodiment variant of the pump configuration as an example, represented by the pump configuration segments.

[0059] FIG. 4b: shows in a schematic diagram of the flow plan another alternative embodiment variant of the pump configuration as an example, represented by the pump configuration sections.

[0060] FIG. 4c: shows in a schematic diagram of the flow plan another alternative embodiment variant of the pump configuration as an example, represented by the pump configuration sections.

[0061] FIG. 4d: shows in the schematic diagram of the flow plan an additional alternative embodiment variant of the pump configuration represented by the pump configuration sections.

[0062] FIG. 5a: shows in a schematic diagram the flow plan a blood guidance device according to the invention in an alternative embodiment.

[0063] FIG. 5b: shows in a schematic diagram the flow plan of the blood guidance device shown in FIG. 5a with additional optional components.

[0064] FIG. 6a: shows in a schematic diagram the flow plan of an additional alternative embodiment of a blood guidance device according to the invention.

[0065] FIG. 6b: shows in a schematic diagram the flow plan of the blood guidance device shown in FIG. 6a with an alternative arrangement of the recirculation return port there.

[0066] FIG. 7: shows in a schematic diagram the flow plan of the blood guidance device shown in FIG. 6a with additional optional components.

[0067] As shown in FIG. 1, the blood treatment system 1000 has a blood treatment device 10 and a blood guidance device 100. FIG. 1 shows the blood treatment device 10 in the form of a dialysis machine for acute dialysis, equipped with a blood guidance device 100 designed as a cassette. The blood treatment device has a control device 30 and a pump configuration 7. In addition, FIG. 1 shows the main blood line 101 of the blood guidance device 100, to which a dialyzer 102 and a blood treatment element 103 in the form of a gas exchanger are connected. The main blood line 101 may also have one or more pressure measurement segments at which the pressure can be determined by means of the pressure sensors 17 that are optionally present in the blood treatment device 10.

[0068] According to the invention, the blood guidance device 100 may be designed as a medical disposable item in the form of a blood cassette (FIG. 2). The blood guidance device 100 may have one or more pump configuration segments 107 on which the pump configuration 7 of the blood treatment device 10 can act to deliver the fluid in the corresponding line segment of the blood treatment device 100. FIG. 2 shows the main blood line 101, which branches off from the cassette body of the blood guidance device 100, comprising the dialyzer 102 and the blood treatment element 103, namely here in the form of a gas exchanger, in series and then recycling it back to the cassette body, where the pump configuration segments 107 may be disposed. The first branch 104 from which the first secondary line 106 branches off may be disposed upstream from the dialyzer 102. The second branch 105, where the first secondary line 106 again combines with the main blood line 101 may be disposed downstream from the dialyzer 102 and upstream from the blood treatment element 103. Furthermore, an injection port 108 for a first medical fluid for anticoagulation such as citrate may be disposed upstream from the dialyzer 102. Downstream from the blood treatment element 103 a recirculation branch 119 may be disposed, from which the second secondary line 120 branches off. The second secondary line 120 opens into a recirculation return port 121 which may be disposed in the main blood line 101 upstream from the blood treatment element 103 and downstream from the dialyzer 102.

[0069] The blood guidance device 100 has a main blood line 101, wherein the main blood line 101 has a blood withdrawal port 127 at one end for connection to a blood withdrawal access of a patient and at the other end a blood return port 128 for connection to a blood return access of the patient. In the main blood line 101, the blood withdrawn from the patient can be sent in the extracorporeal circulation to the dialyzer 102 and to the blood treatment element 103 for further extracorporeal blood treatment therapy as well as being infused back into the patient, as indicated schematically by the flow plan in FIG. 3a.

[0070] A dialyzer 102 is disposed in the main blood line. It usually has a blood chamber and a dialysate chamber (not shown here), wherein the two chambers are separated by a semipermeable membrane through which the blood can interact osmotically with the dialysis solution flowing in the dialysate circulation. According to the invention, the dialyzer may also be used for other renal support and/or renal replacement therapies that are customary in dialysis, such as, for example, hemodiafiltration, hemodialysis, hemoperfusion, hemofiltration, ISO-UF, etc., in particular also for therapy methods in which no dialysis solution is delivered on the dialysate side.

[0071] Downstream from the dialyzer 102, the main blood line 101 carries blood through a blood treatment element 103, designed here as a gas exchanger. The latter has a blood chamber and a gas chamber (not shown here), wherein the two chambers are separated by a semipermeable membrane through which the blood can interact osmotically with the gas flowing in the gas line.

[0072] Dialyzer 102 as well as gas exchanger 103 may have a plurality of individual membranes in the form of hollow fibers. Individual chambers for blood, dialysate or gas in the sense of the present invention may also consist of a plurality of individual volumes, which are situated inside the hollow fibers and are connected fluidically to one another at the ends of the fibers.

[0073] Upstream from the dialyzer 102, the main blood line 101 has a first branch 104. A first secondary line 106 leads from this first branch 104 to a second branch 105 of the main blood line 101.

[0074] Furthermore, the blood guidance device has pump configuration sections 107, to which the blood can be delivered by means of the pump configuration 7 of the blood treatment device 10 through the main blood line 101 and also through the first secondary line 106. In the exemplary embodiment shown in FIG. 3a, the first pump configuration 7 is shown in the form of two occlusive blood pumps, one blood pump being situated upstream from the first branch 104 in the main blood line 101 and the second blood pump being situated in the main blood line 101 downstream from the first branch 104 and upstream from the dialyzer 102. In this exemplary embodiment, the first pump delivers the fluid at the rate of 500 mL/min, for example, while the second pump delivers the fluid at only 200 mL/min. Thus, a flow rate of 300 mL/min is established in the secondary line 106. A blood flow rate of 200 mL/min is established on the dialyzer 102, and the gas exchanger 103 has 500 mL/min flowing through it because the two partial flows of 200 mL/min and 300 mL/min are combined at the second branch 105.

[0075] As shown schematically in FIG. 3b, the blood guidance device may optionally have injection ports for medical fluid for anticoagulation. Thus, an injection port 108 for citrate solution may be disposed downstream from the first branch 104 and upstream from the dialyzer 102. The injection port may also be designed as a citrate line 108, which is connected to a citrate reservoir 109. Furthermore, the blood treatment device 10 may have an infusion pump 110, which is designed to deliver citrate out of the reservoir 112 and through the injection port 108 into the main blood line 101. An injection port 111 for calcium solution may also be provided downstream from the blood treatment element 103. The injection port may also be designed as a calcium line 111, which is connected to a calcium reservoir 112. Furthermore, the blood treatment device 10 may have another infusion pump 113 which is designed to deliver calcium out of the reservoir 112 via the access port 111 and into the main blood line 101.

[0076] FIG. 3b also shows another optional citrate addition possibility. Therefore, a third injection port 114 for the medical fluid for anticoagulation is disposed upstream from the first branch 104 in the main blood line. The injection port 114 may also be designed as a delivery line, which may be connected to a citrate reservoir 115. Furthermore, the blood treatment device 10 may have another infusion pump 116, which is designed to deliver citrate out of the reservoir 115 and into the main blood line 101 by way of the injection port 114. Alternatively, the third feed line 114 can also be supplied from the first reservoir 109 (not shown here). In addition, also as an alternative, the third infusion pump 116 may be omitted if the pressure created by the first infusion pump 110 is used in a third feed line branching off from that downstream. To do so, the third delivery line may have a valve or a throttle, which adjusts the pressure accordingly.

[0077] FIGS. 4a to 4d each show schematically a detail of the main blood line 101 of the blood guidance device 100 in the region around the first branch 104 and the second branch 105, which in this embodiment contains the two flow paths through the secondary line 106 and through the section of the main blood line 101 through the dialyzer 102. FIGS. 4a to 4d show examples of various possible embodiments of the pump configuration, represented by the pump configuration sections 207, 307, 407, 507 for the action of the pump configuration 7 of the blood treatment device 10.

[0078] Whereas the pump configuration of the embodiment illustrated in FIG. 3a, represented by the pump configuration sections 107, has an occlusive blood pump in the main blood line 101 upstream from the first branch 104 and another occlusive blood pump in the main blood line 101 between the dialyzer 102 and the first branch 104, FIG. 4a shows a variant of the pump configuration represented by the pump configuration sections 207, which also has a first blood pump in the main blood line 101 upstream from the first branch 104 but with an alternative arrangement of the additional occlusive blood pump in the secondary line 106.

[0079] In the examples of pump configurations shown in FIGS. 4b and 4c, represented by the pump configuration sections 307, 407, the additional blood pumps in the secondary line 106 and/or in the main blood line 101 between the dialyzer 102 and the first branch 104 have each been replaced by throttle elements.

[0080] FIG. 4d shows another exemplary embodiment of a first pump configuration, represented by the pump configuration sections 507, comprising two occlusive blood pumps, one of which is disposed in the secondary line 106 and the other of which is situated between the dialyzer 102 and the first branch 104 in the main blood line 101.

[0081] All the pump configurations according to the invention can both generate a blood flow in the main blood line 101 and also carry a partial flow at a defined flow rate through the secondary line 106, so that the ratio between the total flow in the main blood line 101 upstream from the first branch 104 and/or downstream from the second branch 105 and in the area of the dialyzer 102 is adjustable. The invention is not limited to the embodiments of the pump configuration 7 shown in FIGS. 4a to 4d. As those skilled in the art will recognize, there are numerous other possibilities in the prior art for controlling the ratio of the flow rates in the two line sections. In many embodiments, the pump configuration 7 can control the flow rates of the two line sections independently of one another. The pump configuration 7 may have various fluidic components including occlusive pumps, non-occlusive pumps, clamps, valves, throttles, etc. The components of the pump configuration 7 may also be disposed at other locations in the extracorporeal blood circulation or may act at those locations.

[0082] As shown schematically in FIG. 5a on the basis of the flow plan, the blood guidance device 100 may also have an alternative flow guidance. In this example, the first branch 104, at which the secondary line 106 branches off from the main blood line 101, is disposed downstream from the blood treatment element 103. Furthermore, in this example, the second branch 105, at which the secondary line 106 combines with the main blood line 101 again, is disposed upstream from the blood treatment element 103 and downstream from the dialyzer 102.

[0083] As shown schematically in FIG. 5b, the blood guidance device may optionally have injection ports for medical fluid for anticoagulation. Thus, an injection port 108 for a citrate solution may be disposed upstream from the dialyzer 102. This injection port may also be embodied as a citrate line 108, which is connected to a citrate reservoir 109. Furthermore, the blood treatment device 10 may also have an infusion pump 110, designed to deliver citrate from the reservoir 112 into the main blood line 101 through the injection port 108. An injection port 111 for calcium solution may be disposed downstream from the blood treatment element 103. It may also be designed as a calcium line 111 connected to a calcium reservoir 112. Furthermore, the blood treatment device 10 may have an additional infusion pump 113, designed to deliver calcium out of the reservoir 112 into the main blood line 101 through the injection port 111.

[0084] FIG. 6a shows schematically on the basis of the flow plan another alternative embodiment of a blood guidance device according to the invention, wherein a second secondary line 120 for repeated recirculation of the blood through the blood treatment element 103 designed as a gas exchanger here is also present in addition to the features of FIG. 3a. The second secondary line 120 leads from a recirculation branch 119 from the main blood line 101 and opens into a recirculation return port 121. In the example of FIG. 6a, the recirculation return port 121 is disposed in the first secondary line 106 upstream from the second branch 105. The example in FIG. 6b shows an alternative line guidance in this regard and differs from the embodiment illustrated in FIG. 6a in that the recirculation return port 121 is disposed directly in the main blood line 101 downstream from the dialyzer 102 and upstream from the blood treatment element 103. In the embodiments in FIGS. 6a and 6b, the pump configuration 7 of the blood treatment device 10 may also be equipped for generating a blood flow in the second secondary line 120. To do so, the pump configuration 7 of the blood treatment device 10 in FIGS. 6a and 6brepresented here by the pump configuration sections 107comprises an additional occlusive pump in the second secondary line 120. In addition, the control device 30 of the blood treatment device 10 may be designed to operate the pump configuration 7 in such a way that the blood flow rate in at least one section of the main blood line 101 is independent of at least one of the blood flow rates in the secondary lines 106, 120.

[0085] FIG. 7 shows schematically an embodiment of the blood guidance device from FIG. 6a with additional optional components. The injection ports 108, 111, 114 already described for the exemplary embodiment in FIG. 3b as well as the corresponding infusion pumps 110, 113, 116 and reservoirs 109, 112, 115 may also be provided in the embodiment with two secondary lines 106, 120.

[0086] FIG. 7 also shows two optional pressure measurements 117, 118 in the main blood line 101 downstream and upstream from the dialyzer 102. First, the pressure downstream from the dialyzer and optionally also upstream from the dialyzer is helpful in determining the transmembrane pressure. This is an important variable which provides information about an imminent filter blockage in the course of dialysis therapy, for example. The transmembrane pressure can also be taken into account in determining the calcium delivery rate via the second injection port 111. Secondly, the pressures in the respective flow sections are also helpful for monitoring the treatment by means of pressure limit value windows.

[0087] Furthermore, FIG. 7 shows optional components which allow hemofiltration and/or hemodiafiltration to also take place on the side of renal substitute therapy. To do so the extracorporeal blood circulation may have one or more injection ports 124, 125, 126 for dilution fluid, optionally also designed as a substitute line through which substitution fluid from a reservoir 122 can be fed into the main blood line 101 by means of another infusion pump 123. The substitute line may also be connected in predilution 124, then open upstream from the dialyzer 102 into the main blood line 101. The substitute line may also be connected during post-dilution. In post-dilution, the blood circulation device according to the invention offers two possible connection positions. In a first option, the post-dilution line 125 between the dialyzer 102 and the blood treatment element 103 may open into the main blood line 101. In a second option, the post-dilution line 126 may also open into the main blood line 101 downstream from the gas exchanger. The last variant 126 offers the advantage that the substitution solution which usually contains calcium reduces the anticoagulant effect of the citrate only in the rear portion of the extracorporeal blood circulation.

[0088] Alternatively the substitute line may also be intentionally connected by the user to one or more of the aforementioned positions. In a combination of pre- and post-dilution, two infusion pumps that pump the fluid independently of one another are optionally also possible for the dilution fluid (not shown).

[0089] The blood treatment device 10 comprises a control device 30. The control device 30 may be configured for controlling and regulating a treatment process. According to one method covered by the invention, in all the embodiments, a blood flow rate between 0 and 300 mL/min can be created in the main blood line 101 in the area of the dialyzer 102 by means of the pump configuration 7. In addition, a blood flow rate of more than 500 mL/min can be created in the area of the blood treatment element 103. In the example in FIGS. 3a and 3b, the flow rate in the main blood line 101 upstream from the first branch 104 corresponds to the flow rate in the blood treatment element 103. The desired dialysate flow rate can be adjusted by means of the pump configuration 7. This yields the flow rate in the secondary line 106 as the difference between the flow rate in the blood treatment element 103 and in the dialysate flow rate.

[0090] The flow rate in the blood treatment element 103 may also be great than 800 mL/min, greater than 1 mL/min or greater than 2 L/min in all embodiments of the invention. ECMO methods are generally used with blood rates of up to 8 L/min. All these flow rates and even higher flow rates are possible according to the invention in the area of a blood treatment element 103 which is designed as a gas exchanger, for example.

[0091] The dialyzer flow rate may also be in the range between 100 and 250 mL/min in all embodiments. It may also be in the range of 175 to 225 mL/min or may be exactly 200 mL/min.

[0092] The flow rate of the first medical fluid for anticoagulation, for example, citrate, which is pumped by means of the first infusion pump 110 into the main blood line 101, may be regulated by the control device 30 as a function of the dialyzer flow rate.

[0093] The flow rate of the second medical fluid for anticoagulation, for example, calcium, which is pumped by means of the second infusion pump 113 into the main blood line 101, can be regulated by the control device 30 as a function of the dialyzer flow rate. The regulation may additionally take into account other dependencies such as, for example, the flow rate of the first medical fluid for anticoagulation, the flow rate of the third medical fluid for anticoagulation, the transmembrane pressure (TMP), the type of dialyzer and/or other parameters, optionally also those to be selected or entered by the user.

[0094] The flow rate of the third medical fluid for anticoagulation, for example, citrate, can be controlled by means of direct selection by the user. It may also be regulated as a function of the flow rate in the blood treatment element 103 or it may be regulated as a function of the difference between the flow rate in the blood treatment element 103 and the dialyzer flow rate.