Method and Devices for Providing a Solution for the Treatment of Blood

Abstract

The present invention relates to a blood treatment apparatus: at least one first source for a saline solution, a fresh dialysate, or a substituate as a first fluid; at least one first conduit portion which connects to the first source; at least one second source of a second fluid in the form of a concentrate or a solution; at least one second conduit portion which connects to the second source; at least one third conduit portion, which is in fluid communication with a section of the extracorporeal blood circuit to which both the first conduit portion and the second conduit portion are fluidly connected such that both the first source and the second source are in fluid communication with the third conduit portion; a first fluid conveying device, arranged to convey a fluid present inside the third conduit portion. The invention further relates to a corresponding method.

Claims

1.-22. (canceled)

23. A method for providing a solution for a blood treatment of a patient, the method comprising: providing a blood treatment apparatus comprising: at least one first source of saline solution, fresh dialysate or substituate as a first fluid; at least one first conduit portion, which connects to the first source; at least one second source of a second fluid in the form of a concentrate or a solution; at least one second conduit portion, which connects to the second source; at least one third conduit portion, which is in fluid communication with a section of an extracorporeal blood circuit and to which both the first conduit portion and the second conduit portion are fluidly connected such that both the first source and the second source are in fluid communication with the third conduit portion; and a first fluid conveying device arranged to convey a fluid present inside the third conduit portion; wherein the method comprises: operating at least the first conveying device such that a combination of the first fluid and the second fluid is conveyed through the third conduit portion.

24. The method of claim 23 wherein the extracorporeal blood circuit comprises a blood cassette.

25. The method according to claim 23, wherein the blood treatment apparatus comprises a second conveying device, and wherein the method comprises: conveying, with the second conveying device, the second fluid out of the second source and into the second conduit portion.

26. The method according to claim 23, wherein the blood treatment apparatus comprises a second conveying device, and wherein the method comprises: conveying, with the second conveying device, the second fluid out of the second source and into the third conduit portion.

27. The method according to claim 23 further comprising: conveying the first fluid from the first source into the first conduit portion and conveying the second fluid from the second source into the second conduit portion in a volume relation or a flow relation determined by the user.

28. The method according to claim 23 comprising: monitoring, with at least one monitoring device, a volume conveyed into the third conduit portion or a respective feed rate into the third conduit portion of at least one of the first conveying device and the second conveying device.

29. The method according to claim 28 further comprising: detecting, with the at least one monitoring device, a distance, by which a section of the second conveying device is moved; and comparing, with a comparing device, the detected distance with reference data.

30. The method according to claim 28 further comprising: counting, with a drop counter, drops of at least one of the first and second fluids; and comparing, with a comparing device, the detected number of drops with reference data.

31. The method according to claim 23 further comprising: detecting, with at least one scale, a change of a weight of the first source; and monitoring a conveying rate of the first conveying device based on the detected change of the weight of the first source.

32. The method according to claim 23, further comprising: providing the second source as a source of a fluid selected from the group consisting of citrate, calcium solution, and heparin solution.

33. The method according to claim 23, wherein the blood treatment apparatus is a hemodialysis, hemofiltration, or hemodiafiltration apparatus.

34. A blood treatment apparatus comprising: at least one first source of saline solution, fresh dialysate, or substituate as a first fluid; at least one first conduit portion, which connects to the first source; at least one second source of a second fluid in the form of a concentrate or a solution; at least one second conduit portion, which connects to the second source; at least one third conduit portion, which is in fluid communication with a section of an extracorporeal blood circuit, and to which both the first conduit portion and the second conduit portion are fluidly connected such that both the first source and the second source are in fluid communication with the third conduit portion; and a first fluid conveying device arranged to convey a fluid present inside the third conduit portion.

35. The method of claim 34 wherein the extracorporeal blood circuit comprises a blood cassette.

36. The blood treatment apparatus according to claim 34, further comprising a second conveying device, which is arranged to convey the second fluid into the second conduit and/or into the joint or common conduit.

37. The blood treatment apparatus according to claim 34, further comprising a first monitoring device for monitoring the pumping function of the first conveying device.

38. The blood treatment apparatus of claim 37 wherein the first monitoring device is configured to monitor the function of the first conveying device by counting drops of the first fluid, and is further configured to compare, by a comparing device, the detected number of drops with reference data.

39. The blood treatment apparatus according to claim 34 comprising a second monitoring device for monitoring the pumping function of the second conveying device.

40. The blood treatment apparatus of claim 39 wherein the second monitoring device is configured to monitor the function of the second conveying device by counting drops of the second fluid, and is further configured to compare, by a comparing device, the detected number of drops with reference data.

41. The blood treatment apparatus according to claim 36, wherein the second conveying device comprises a syringe pump comprising a stamp, and wherein the second monitoring device is configured to detect the distance by which the stamp of the second conveying device is moved, and to compare, with a comparing device, the detected distance with reference data.

42. The blood treatment apparatus according to claim 34, wherein the second source is a source of a fluid selected from the group consisting of citrate, calcium solution, and heparin solution.

43. The blood treatment apparatus according claim 34, wherein the blood treatment apparatus is configured as a hemodialysis, a hemofiltration, or a hemodiafiltration apparatus.

44. The blood treatment apparatus of claim 34 further comprising a control unit configured to send a control signal to operate at least the first conveying device such that a combination of the first fluid and the second fluid is conveyed through the third conduit portion.

45. A control unit of a blood treatment apparatus, the blood treatment apparatus comprising: at least one first source of saline solution, fresh dialysate or substituate as a first fluid; at least one first conduit portion, which connects to the first source; at least one second source of a second fluid in the form of a concentrate or a solution; at least one second conduit portion, which connects to the second source; at least one third conduit portion, which is in fluid communication with a section of an extracorporeal blood circuit and to which both the first conduit portion and the second conduit portion are fluidly connected such that both the first source and the second source are in fluid communication with the third conduit portion; a first fluid conveying device arranged to convey a fluid present inside the third conduit portion, wherein the control unit comprises an interface for communicating with a computer program product and wherein the control unit is configured to operate at least the first conveying device such that a combination of the first fluid and the second fluid is conveyed through the third conduit portion.

46. The control unit of claim 44 wherein the computer program product comprises a machine readable medium.

47. The control unit of claim 45 wherein the machine readable medium comprises electrically readable control signals and is selected from the group consisting of a disk, a CD, a DVD, and an EPROM.

48. One or more computer readable media storing instructions that are executable by a processing device, and upon such execution cause the processing device to perform operations comprising: prompting the mechanical operation of at least a first conveying device of a blood treatment apparatus such that a combination of a first fluid and a second fluid is conveyed through a third conduit portion of the blood treatment apparatus.

49. The computer readable media storing instructions of claim 48 wherein the computer readable media storing instructions are electrically readable control signals and are stored on a device selected from the group consisting of a disk, a CD, a DVD, and an EPROM.

Description

[0075] Hereinafter, the present invention is purely exemplarily described with reference to the accompanying figures. In the figures, same reference numerals refer to the same or identical components or parts. The following applies:

[0076] FIG. 1 shows a simplified illustration of a blood treatment apparatus according to the present invention with an extracorporeal blood circuit in a first embodiment; and

[0077] FIG. 2 shows a simplified illustration of a blood treatment apparatus according to the present invention with an extracorporeal blood circuit in a second embodiment;

[0078] FIG. 3 shows a simplified illustration of a blood treatment apparatus according to the present invention with an extracorporeal blood circuit in a third embodiment;

[0079] FIG. 4 shows a simplified illustration of a blood treatment apparatus according to the present invention with an extracorporeal blood circuit in a fourth embodiment; and

[0080] FIG. 5 shows a simplified illustration of a blood treatment apparatus according to the present invention with an extracorporeal blood circuit in a fifth embodiment.

[0081] FIG. 1 shows a simplified illustration of a blood treatment apparatus 1000 according to the present invention with an extracorporeal blood circuit 2000.

[0082] The extracorporeal blood circuit 2000 comprises or is connected to a blood treatment device 3000, here exemplarily a blood filter or dialyzer. An arterial conduit section 1 of the extracorporeal blood circuit 2000 brings or carries blood from the vascular system of the patient (not shown), towards the blood filter 3000. A venous conduit section 3 of the extracorporeal blood circuit 2000 brings or carries blood from the blood filter 3000 towards the vascular system of the patient (not shown).

[0083] The blood treatment apparatus 1000, illustrated in FIG. 1 through only some of its devices, by means of which the method described here is executed, has a blood pump P1. The blood pump P1 conveys blood through portions of the extracorporeal blood circuit 2000 and towards the blood filter 3000, as shown by the small arrowheads generally indicating the flow direction in the figures.

[0084] In addition to the aforementioned pump P1, the arrangement shown in FIG. 1 comprises, also purely optional, a number of other pumps P2, P4, P5 and P6, which are provided as purely optional, except for the conveying device P6 which is to be understood in the present embodiment as the first conveying device.

[0085] The pump P4 is one of the optional pumps. It is provided to convey/bring fresh dialysate out of a corresponding source Q4, for example a bag, and through an optionally present bag heating with bag H2 using a fresh dialysate conduit 4.

[0086] The fresh dialysate supplied in this way exits out of the blood filter 3000 again through a spent dialysate conduit 2, supported by a pump P2, and can be discarded.

[0087] The pump P5 is also one of the optional pumps. It supplies or brings a solution of calcium (Ca-solution) out of a source Q5, e.g. a bag, and into the venous conduit section 3.

[0088] The pump P6 is not optional, based on the specific embodiment of FIG. 1, wherein pump P6 is to be understood in the example of FIG. 1 as the first conveying device. Pump P6 conveys a combined or mixed fluid along a conduit 6, to be understood here as a joint conduit, into the arterial conduit section 1.

[0089] The combined fluid is produced from or at a crossing point K or a connection of a first conduit 4 with a second conduit 6 forming the joint first conduit 6 and being a combination or mixture of a first fluid and a second fluid.

[0090] The first fluid comes from a first source Q4, here for example a bag of fresh dialysate (but could also be substituate, saline or another solution or liquid), and is conveyed at first until the crossing point K in the conduit 4.

[0091] The second fluid comes from a second source Q6, here a syringe containing citrate or citrate concentrate (Ci-concentrate), and is conveyed to the crossing point K in a second conduit 6. The syringe has its own conveying device, a syringe pump which is not shown here. It is evident for the person skilled in the art that such a syringe pump is however not required if the second source Q6 is not a syringe but, for example, a bag. In this case the conveying device is a pump and it is not optional.

[0092] The first conduit 4 and the second conduit 6 merge or flow from the crossing point or intersection point K into the joint conduit 6.

[0093] In the present example, the first source Q4 and the source Q4 are independent sources for one and the same fluid, namely fresh dialysate. The invention encompasses however also that Q4 and Q4 are one and the same source or are sources being in fluid communication with each other.

[0094] An optional arterial sensor PS1 is provided upstream of the blood pump P1; it measures arterial pressure P_art.

[0095] A further, optional pressure sensor PS2 is provided downstream of the blood pump P1, but upstream of the blood filter 3000, and, if provided, of an addition site 25 for heparin. It measures the pressure upstream of the blood filter 3000 (PHF stands for pre-hemofilter).

[0096] A still further pressure sensor PS4 downstream of the blood filter 3000, but upstream of the pump P2 in the spent dialysate conduit 2, may be provided for measuring a pressure filter of the blood filter 3000.

[0097] Blood exiting the blood filter 3000, flows through a venous blood chamber 29 which may comprise a de-aeration device 31.

[0098] In the example of FIG. 1, the sources Q4 and Q4 and the collected or discarded spent dialysate are optionally subject to a balancing. Three scales W1, W2 and W3 are provided for the purpose of the balancing.

[0099] The examples shown here corresponds to a gravimetric balancing. The present invention encompasses however also any other balancing, for example by means of balancing chambers.

[0100] For example, the crossing point K may be in fluid communication with a balancing unit. The volume proportion of the combined fluid, which does not originate from the second source Q6, i.e. the first fluid, may optionally be compensated for by the balancing unit.

[0101] The exemplary arrangement shown in FIG. 1 comprises a first monitoring device 41. It is designed for monitoring the correct function and/or for detecting a flow rate or a flow volume of the first conveying device, in this case the pump P6.

[0102] The exemplary arrangement shown in FIG. 1 further comprises a second monitoring device 43. It is designed for monitoring the correct function and/or for detecting a feed rate or a flow volume of the second conveying device, in this case of the syringe pump with the second source Q6. The second monitoring device 43 is, purely optionally, recognizably designed as a distance sensor. Both the first and the second monitoring devices 41, 43 can be designed as a drop counter. Both the first and the second monitoring devices 41, 43 may be connected to a comparing device, not shown in the figures.

[0103] Other monitoring devices can also be provided as shown in FIG. 1 in the example of the monitoring device 45.

[0104] A control or regulating unit 4000 according to the present invention is indicated in FIG. 1. It is in signal communication with all relevant devices, in any case or in particular with the pump P6.

[0105] FIG. 2 shows a simplified illustration of a blood treatment apparatus 1000 according to the present invention with an extracorporeal blood circuit in a second embodiment.

[0106] Pump P6 represents or is the second conveying device. Pump P6 is located downstream of the second source Q6 and upstream of the crossing point K.

[0107] A drip chamber 51 is provided between the second source Q6 and the pump P6. The drip chamber 51 can be used to monitor via a monitoring device. The embodiment of FIG. 2, comprises in the area of the first and second sources Q4 and Q6 as well as in the area of the conduit 6, purely exemplarily, only one monitoring device.

[0108] The second source Q6 contains merely exemplarily any concentrate.

[0109] FIG. 3 shows a simplified illustration of a blood treatment apparatus 1000 according to the present invention with an extracorporeal blood circuit in a third embodiment.

[0110] The embodiment of FIG. 3 differs from that of FIG. 1 by the fact that both the first monitoring device 41 and the second monitoring device 43 are in the conduit 6. The first conduit 6, however, does not have, purely optionally, any monitoring device anymore.

[0111] FIG. 4 shows a simplified illustration of a blood treatment apparatus 1000 according to the present invention with an extracorporeal blood circuit in a fourth embodiment.

[0112] The embodiment of FIG. 4 differs from that of FIG. 1 by the fact that the pump P6, as a first conveying device, introduces the combined fluid not in the arterial conduit section 1 but rather in the venous conduit section 3.

[0113] In addition, reference is made to the elaborations on FIG. 1.

[0114] FIG. 5 shows a simplified illustration of a blood treatment apparatus according to the present invention with an extracorporeal blood circuit 2000 in a fifth embodiment.

[0115] In the embodiment of FIG. 5, the first source Q4 comprises a substituate, while the source Q4 contains fresh dialysate. The source Q4 contains, purely exemplary, calcium concentrate.

[0116] The arrangement comprises in contrast to the embodiments of the preceding figures, a further bag heating H1 with a bag for substituate. In order to convey the substituate, a pump P3 is provided downstream of the source Q4 but upstream of an addition site (may be a valve or may have a valve) for the substituate in post-dilution.

[0117] The joint conduit 6 flows into the venous conduit section 3.

[0118] The following features, although not shown in the figures, may in each embodiment according to present invention be again purely optional and provided in any combination.

[0119] The arterial conduit section 1 may comprise an arterial clamp.

[0120] The arterial conduit section 1 may comprise an arterial septum, optionally as an addition device.

[0121] The venous conduit section 3 may comprise a venous air bubble detector/optical sensor.

[0122] The venous conduit section 3 may comprise a venous clamp.

[0123] The blood cassette may comprise a check valve

[0124] For the purpose of adding heparin into the interior of the conduit of the extracorporeal blood circuit 2000 or of the blood cassette during an extracorporeal blood treatment, the extracorporeal blood circuit 2000 or the blood cassette may get connected or be connected by means of a corresponding port with an addition site for heparin 25, such as a heparin solution or syringe.

[0125] The arterial conduit section 3 may have an arterial bubble detector/optical sensor.

TABLE-US-00001 Reference Numeral List 1000 blood treatment apparatus 2000 extracorporeal blood circuit 3000 blood treatment device, blood filter or dialyzer 4000 control or regulating unit 1 arterial conduit section 2 spent dialysate conduit 3 venous conduit section 4 fresh dialysate conduit 4 first conduit coming from first source 6 joint or common conduit 6 second conduit coming from second source H1 bag heater with bag H2 bag heater with bag P1 blood pump P2, P3, P4, P5 optional pumps P6 pump, first conveying device P6 pump, second conveying device PS1 arterial sensor, measures the arterial pressure P_art PS2 optional pressure sensor PS4 pressure sensor for measuring a filter pressure Q4 source with fresh dialysate Q4 first source Q5 source Q6 second source 25 heparin addition site 29 venous blood chamber 31 de-aeration device K crossing point or intersection point or connection point of the first conduit with the second conduit W1, W2, W3 scales 41 first monitoring device 43 second monitoring device 45 monitoring device 51 drip chamber