Device for extracorporeal blood treatment, disposable assembly for the device

Abstract

An apparatus for extracorporeal blood processing is provided, comprising: a processing unit (10), a blood circuit coupled to the processing unit (10), a blood pump (22) configured to be coupled to a pump portion of the blood circuit, and at least two fluid lines (40, 60, 70, 70b, 70c) connected to respective containers (48, 68, 78, 88) and connected to the blood circuit and / or connected to the processing unit (10). The apparatus further includes a fluid dispenser (300) having a common area (310), wherein the at least two fluid lines (40, 60, 70, 70b, 70c) are connected to each other at the common area (310) upstream of the blood circuit for selectively allowing fluid flow between the at least two fluid lines (40, 60, 70, 70b, 70c) through the common area (310).

Description

Technical Field

[0001] The present invention relates to an apparatus for extracorporeal blood processing, a disposable component for the apparatus, and a control method for the apparatus for extracorporeal blood processing.

[0002] Extracorporeal blood processing involves removing blood from a patient, processing the blood outside the patient's body, and returning the processed blood to the patient. Extracorporeal blood processing is commonly used to remove unwanted substances or molecules from a patient's blood and to add desired substances or molecules back into the blood. It is used for patients who cannot effectively remove substances from their blood, such as when a patient has temporary or permanent kidney failure. For example, these and other patients may undergo extracorporeal blood processing to add or remove substances from their blood, such as to maintain acid / base balance or remove excess body fluids, or to perform extracorporeal gas exchange procedures.

[0003] In particular, the present invention relates to a continuous renal replacement therapy (CRRT) system. The CRRT system is configured to deliver treatment designed for patients suffering from acute-state illness who have temporarily and completely lost their renal function. In this respect, the CRRT system may differ structurally and / or operationally from extracorporeal blood processing systems designed for long-term patient care.

[0004] CRRT monitors should be able to deliver a variety of treatments (SCUF, CCVH, CWHDF, TPE). Delivery of these treatments requires specific arrangements of the loop channels and a variety of different solutions that can be provided in bag form. Background Technology

[0005] Document US2015 / 0292529 discloses a system for processing blood, which includes a single cassette allowing fluid dispensing to perform various CRRT treatments. The cassette includes a dispensing chamber and a connecting chamber. One of the dispensing chambers includes an inlet channel controlled by a controller and three outlet channels to allow fluid to be injected into a blood filtration device, before and / or after the blood filtration device.

[0006] US 4,610,781 discloses a fluid handling system including an integrated flow control and distribution manifold for establishing fluid communication between piping sections of the system. The manifold is housed in an actuator head of an associated processor device, wherein valve elements selectively coil valve passages in the manifold to execute a program.

[0007] Document WO 2015 / 177606 discloses a dialysis system that includes a filter, a pump, a reverse filtration system, and an adsorbent device for performing dialysis.

[0008] Document US2007 / 278155 discloses a renal failure treatment system comprising a dialysate supply, a valve actuator, a pump actuator, and a disposable unit. The disposable unit includes a first flexible sheet and a second flexible sheet, and a pumping section. The first and second flexible sheets are sealed together to form a flow channel configured to be in fluid communication with the dialysate supply and operable with the valve actuator. The pumping section is configured to operate with at least one pump actuator.

[0009] On the fresh fluid loop side, known problems, challenges, and limitations associated with known extracorporeal blood processing systems include one or more of the following.

[0010] FB1: It is not easy to reliably detect air from the infusion container and / or reliably prevent it from being injected into the blood circuit.

[0011] FB2: Typically, fluid is not supplied at a single site (simultaneously or alternately) from several connected fluid containers.

[0012] FB3: Typically, fluid is not provided for injection at different sites (e.g., once per injection) from a single fluid container.

[0013] FB4: Custom infusion fluids produced by ratio-metric mixing of fluids from two connected containers are not typically provided at sites in the blood circuit.

[0014] FB5: Typically, it does not provide analysis of the composition of fluids from connected fluid containers.

[0015] On the outflow fluid loop side, known problems, challenges, and limitations associated with known extracorporeal blood processing systems include:

[0016] EB1: Typically does not offer automatic recalibration of effluent sensors, such as blood leak detectors (BLDs), by filling the BLD chamber with fresh dialysate or replacement fluid.

[0017] The overall objective of this invention is to provide an apparatus for extracorporeal blood processing that alleviates or minimizes the aforementioned disadvantages.

[0018] Another object of the present invention is to provide a method for controlling an apparatus for extracorporeal blood processing, which alleviates or minimizes the aforementioned disadvantages.

[0019] The specific object of this invention is to provide an apparatus for the extracorporeal processing of blood, which can be configured in various ways to deliver various treatments (e.g., SCUF, CCVH, CVVHDF, TPE) and to achieve other operational requirements, such as:

[0020] - Empty the solution bag completely;

[0021] - Change the bag without interrupting the fluid exchange therapy;

[0022] - Control the proper mixing of the two compartment bags;

[0023] - Freely select one or more infusion sites for one or more solution bags. Summary of the Invention

[0024] The apparatus according to one or more of the appended claims achieves at least one of the above-described objectives, either alone or in any combination.

[0025] The following describes apparatus and methods according to various aspects of the present invention, which are capable of achieving one or more of the above objectives.

[0026] In a first independent aspect, an apparatus for extracorporeal blood processing is provided, comprising: a processing unit; a blood circuit coupled to the processing unit and including a blood removal line and a blood return line capable of being connected to a patient's vascular system; and a blood pump, a pump portion configured to be coupled to the blood circuit;

[0027] Multiple fluid lines, which are connected to or can be connected to their respective containers, and connected to blood circuits and / or to processing units;

[0028] A fluid dispenser having a common area, wherein at least two of the plurality of fluid lines are connected to each other at the common area upstream of the blood circuit, for selectively allowing fluid flow between the at least two fluid lines through the common area.

[0029] Optionally, an effluent line configured to discharge fluid from the processing unit is provided.

[0030] Optionally, the plurality of fluid lines includes: a plurality of infusion lines having a second end connected to a blood circuit; wherein at least two of the plurality of infusion lines are connected to each other in the common area.

[0031] Optionally, the plurality of fluid lines include: a plurality of infusion lines; a dialysate circuit including a dialysate line having a first end connected to or capable of being connected to a dialysate container and a second end connected to a processing unit; wherein the dialysate line and the effluent line are connected to each other in the common area.

[0032] Optionally, the plurality of fluid lines include:

[0033] A pre-infusion line having a first end connected to or capable of being connected to a pre-infusion pump container and a second end connected to a blood removal line; and / or a pre-infusion line having a first end connected to or capable of being connected to an infusion container and a second end connected to a blood removal line downstream of the blood pump; and / or at least one post-infusion line having a first end connected to or capable of being connected to an infusion container and a second end connected to a blood return line; and / or a dialysate circuit including a dialysate line having a first end connected to or capable of being connected to a dialysate container and a second end connected to a processing unit.

[0034] In the second aspect according to the preceding aspect 1, the device includes an air detector array configured to detect air or gas in each of the at least two fluid lines (optionally, in the pre-blood pump line, in the pre-infusion line and / or in the post-infusion line and / or in the dialysate line); optionally, the air detector array is arranged near the respective container and / or on the respective line directly downstream of the respective pump relative to the fluid from the container.

[0035] In a third aspect according to aspect 1 or 2, the apparatus includes a plurality of pumps operating on a fluid line, optionally some of the pumps operating on an infusion line, optionally a pre-blood pump operating on a pre-blood pump line, and / or an infusion pump operating on a pre-infusion line, and / or a dialysate pump operating on a dialysate line, and optionally, and / or an effluent pump operating on an effluent line, and / or an additional pump operating on a post-infusion line.

[0036] In the fourth aspect of aspect 3 when pursuant to aspect 2, the air detector array is placed upstream or downstream of the pump, optionally upstream or downstream of the pre-blood pump and / or infusion pump and / or dialysate pump and / or auxiliary pump.

[0037] In the fifth aspect according to any one of aspects 1 to 4, the fluid analyzer is located on the effluent line upstream of the effluent container or drain pipe and is configured to examine / analyze the composition of the fresh fluid or effluent, and / or an external fluid analyzer is connected to the effluent line via an interface port.

[0038] In a sixth aspect according to any one of aspects 1 to 5, the apparatus includes an ejector configured to connect a fluid line (optionally, a pre-blood pump line, a pre-infusion line, a post-infusion line, and a dialysate line) to an effluent line.

[0039] In the seventh aspect according to the preceding aspect 6, the discharger includes a discharger fluid line configured to connect the common area of ​​the fluid distributor to the effluent line, optionally connecting the common area of ​​the fluid distributor to the effluent line at a junction between the effluent pump and the effluent container or drain line.

[0040] In the eighth aspect according to the preceding aspect 6 or 7, the discharger includes a discharger flow controller configured to selectively allow fluid flow between the common area and the effluent line.

[0041] According to aspect 8 and aspect 9 above, the discharger flow controller includes: a shut-off pump, optionally a peristaltic pump, wherein an extension of the discharger fluid line is configured to be coupled to the shut-off pump; or a two-way valve configured to selectively allow or prevent fluid flow.

[0042] In accordance with aspect 7 or in accordance with aspect 8 or aspect 9 when pursuant to aspect 7, the discharger includes a discharger air detector disposed on the discharger fluid line and configured to detect air or gas in the fluid flow between the common area of ​​the fluid distributor and the effluent line.

[0043] In aspect 7 or in aspect 11 of any of aspects 8 to 10 when aspect 7 is applied, the discharger fluid line includes a check flow controller configured to allow fluid flow from the common area of ​​the fluid distributor toward the discharge line and to prevent fluid flow from the discharge line toward the common area. Optionally, the check flow controller includes a check valve.

[0044] In the 12th aspect according to aspect 11, a check flow controller is arranged on the discharge fluid line downstream of the discharger relative to the fluid flow from the public area toward the effluent line.

[0045] In the 13th aspect according to any one of aspects 1 to 12, the fluid dispenser includes a plurality of valves placed in a common area and configured to selectively allow fluid flow between the at least two fluid lines (optionally, between the pre-blood pump line, the pre-infusion line, the post-infusion line, and the dialysate line).

[0046] In the 14th aspect according to any one of aspects 1 to 13, each of the at least two fluid lines includes branches upstream or downstream of a respective pump relative to the fluid flow from the respective container. Optionally, the fluid distributor includes a pre-blood pump line branch departing from the pre-blood pump line and / or a pre-infusion line branch departing from the pre-infusion line and / or a dialysate line branch departing from the dialysate line and / or an additional post-infusion line branch departing from the additional post-infusion line, which are connected to each other in a common area.

[0047] In the 15th aspect according to any one of aspects 1 to 14, the at least two fluid lines (optionally, a pre-blood pump line and / or a pre-blood pump line and / or a dialysate line and / or an additional post-infusion line) pass through a common area.

[0048] In a 16th aspect according to any one of aspects 1 to 15, the fluid distributor includes a valve on each of the at least two fluid lines for selectively allowing fluid flow between the respective line and a common area; optionally, the fluid distributor includes:

[0049] - A first valve, configured to selectively allow fluid flow between the pre-blood pump line and a public area;

[0050] - A second valve configured to selectively allow fluid flow between the pre-infusion line and the common area; and

[0051] - A third valve, configured to selectively allow fluid flow between the dialysate line and the common area;

[0052] - Fourth valve, which is configured to selectively allow fluid flow between the additional post-infusion line and the common area.

[0053] In the 17th aspect of the preceding aspect 16 when pursuant to aspect 14, the branches are connected to respective valves of the fluid dispenser; optionally, a first valve is placed on the pre-infusion line branch and / or a second valve is placed on the pre-infusion line branch and / or a third valve is placed on the dialysate line branch and / or a fourth valve is placed on the additional post-infusion line branch.

[0054] In the 18th aspect of aspect 16 when pursuant to aspect 3, the pre-blood pump line includes, upstream of the pre-blood pump relative to the fluid flow from the pre-blood pump container, a pre-blood pump line branch connected to a first valve.

[0055] In accordance with aspect 18 or in aspect 16 when pursuant to aspect 3, the pre-infusion line includes, upstream of the infusion pump relative to the fluid flow from the pre-infusion container, a pre-infusion line branch connected to a second valve.

[0056] In aspect 18 or 19 or in aspect 16 when citing aspect 3, the dialysate line includes, upstream of the dialysate pump relative to the fluid flow from the dialysate container, a dialysate line branch connected to a third valve.

[0057] In a 21st aspect according to aspect 19 or 20 or according to aspect 16 when according to aspect 3, the fluid dispenser includes a flow controller; the pre-blood pump line includes a pre-blood pump line branch connected to a first valve downstream of the pre-blood pump relative to the fluid flow from the pre-blood pump container, and the flow controller is disposed on the pre-blood pump line downstream of the pre-blood pump line branch.

[0058] In aspect 18 or 20, or in aspect 16 when citing aspect 3, the fluid distributor includes a flow controller; the pre-injection line includes a branch of the pre-injection line connected to a second valve downstream of the injection pump relative to the fluid flow from the injection container, and the flow controller is disposed on the pre-injection line downstream of the branch of the pre-injection line.

[0059] In accordance with aspect 18 or 19 or in the 23rd aspect of aspect 16 of aspect 3, the fluid distributor includes a flow controller; the dialysate line includes, downstream of the dialysate pump relative to the fluid flow from the dialysate container, a dialysate line branch connected to a third valve, and the flow controller is disposed on the dialysate line downstream of the dialysate line branch.

[0060] In aspect 24 according to aspect 23 above, the flow controller includes a two-way valve configured to selectively allow or prevent fluid flow.

[0061] In the 25th aspect according to any one of aspects 1 to 24, the fluid dispenser is configured to allow bidirectional flow in at least a portion of the at least two fluid lines (optionally, in a pre-blood pump line and / or a pre-infusion line and / or a dialysate line).

[0062] In aspect 14 or in aspect 26 of any of aspects 17 to 23, the fluid dispenser is configured to allow bidirectional flow in the pre-blood pump line branch and / or in the pre-infusion line branch and / or in the dialysate line branch.

[0063] In aspect 2 or in aspect 27 of any of aspects 3 to 26 when pursuant to aspect 2, the air detector array includes: a pre-blood pump air detector disposed on the pre-blood pump line.

[0064] In aspect 28 according to aspect 27 above, the pre-blood pump air detector is arranged near the pre-blood pump container and / or on a respective line directly downstream of the pre-blood pump container relative to the fluid flow from the pre-blood pump container.

[0065] In aspect 2 or in aspect 29, which is any of aspects 3 to 28 when pursuant to aspect 2, the air detector array includes: a pre-infusion air detector disposed on the pre-infusion line.

[0066] In aspect 30 according to aspect 29 above, the pre-injection air detector is arranged near the pre-injection container and / or on the pre-injection line directly downstream of the pre-injection container relative to the fluid flow from the pre-injection container.

[0067] In aspect 2 or in aspect 31 of any of aspects 3 to 30 when pursuant to aspect 2, the air detector array includes: a dialysate air detector disposed on a dialysate line.

[0068] In aspect 32 according to aspect 31 above, the dialysate air detector is arranged near the dialysate container and / or on the dialysate line directly downstream of the dialysate container relative to the fluid flow from the dialysate container.

[0069] In aspect 33 according to any of the preceding aspects 1 to 32, a plurality of flow controllers are placed between the pump and infusion station on the fluid lines and the blood removal lines and / or blood return lines and / or processing units; optionally, a pre-infusion flow controller is arranged on the pre-infusion line; a dialysate flow controller is arranged on the dialysate line; the post-infusion line has a first end in fluid communication with the pre-infusion flow controller and the dialysate flow controller and a second end connected to the blood return line; optionally, each flow controller includes: a two-way valve configured to selectively allow or prevent fluid flow; optionally, at least one of the flow controllers is placed on two or more fluid lines and configured to selectively allow fluid flow into one or more of the two or more fluid lines.

[0070] In aspect 34 according to aspect 33 above, the pre-infusion flow controller is configured to selectively allow fluid flow to enter only the pre-infusion line, only the post-infusion line, or both the pre-infusion line and the post-infusion line.

[0071] In aspect 35 according to aspect 33 or 34 above, the dialysate flow controller is configured to selectively allow fluid flow to enter only the dialysate line, only the post-infusion line, or both the dialysate line and the post-infusion line.

[0072] In accordance with aspect 2 and / or aspect 3 and / or aspect 6 and / or aspect 36, the control unit is connected to the ejector, to the air detector array, to the pump (optionally, to the pre-blood pump, infusion pump, dialysate pump) and to the fluid dispenser.

[0073] In aspect 37 according to aspect 36 above, the control unit is configured to control at least one of the pumps (optionally, a pre-blood pump and / or an infusion pump and / or a dialysate pump) and to control a fluid dispenser such that fluid from one or more (optionally, from one) of the pre-blood pump container, the infusion container, and the dialysate container is delivered to the second end of one or more (optionally, all) of the fluid lines (optionally, the pre-blood pump line, the pre-infusion line, and the dialysate line).

[0074] In aspect 38 according to aspect 36 above, the control unit is configured to control at least two of the pumps (optionally, a pre-blood pump, an infusion pump, and a dialysate pump) and to control a fluid dispenser such that fluids from at least two (optionally, all) of the pre-blood pump container, the pre-infusion container, and the dialysate container are mixed and then delivered to the second end of one or more (optionally, one) of the fluid lines (optionally, a pre-blood pump line, a pre-infusion line, and a dialysate line).

[0075] In aspect 39 according to aspects 36, 37 or 38 above, the control unit is configured to execute commands for a task of removing air, the task comprising the following steps:

[0076] • Receive a signal from the air detector array indicating the presence of air detected upstream of at least one of the pumps (optionally, a pre-blood pump, an infusion pump, or a dialysate pump);

[0077] • If air is detected, stop at least one of the pumps (optionally, a blood booster pump, an infusion pump, or a dialysate pump);

[0078] • After the cause of the air presence (optionally, due to an empty container) is removed, the exhaust device is activated and the fluid distributor is controlled to remove the air.

[0079] In aspect 40, according to any of the preceding aspects 1 to 39, the effluent line includes an effluent sensor, optionally, a blood leak detector (BLD), optionally located near the effluent container or drain line.

[0080] In aspect 41 of the preceding aspects, as in any of aspects 36 to 39, the control unit is connected to the blood leak detector (BLD) and configured to execute commands for a task of calibrating the blood leak detector (BLD), the task comprising the following steps:

[0081] • Control the pre-blood pump, infusion pump, dialysate pump, effluent pump, fluid dispenser and drainer to supply fluid from the pre-blood pump container and / or infusion container and / or dialysate container to the fluid dispenser, and further to the effluent line via the drainer, and fill the blood leak detector (BLD) with fluid.

[0082] • Perform calibration of the blood leak detector.

[0083] In aspect 5 and / or aspect 42, which is based on one or more of the preceding aspects 1 to 42, the interface port is optionally located between the blood leak detector (BLD) and the effluent container or drain line, and optionally located between the integrated fluid analyzer and the effluent container or drain line.

[0084] In aspect 43, a method is provided for controlling an apparatus for extracorporeal blood processing according to one or more of the foregoing aspects.

[0085] In aspect 44 according to aspect 43 above, the method includes: delivering fluid from one or more containers (optionally, from one or more of the pre-blood pump container, infusion container and dialysate container) to a second end of one or more (optionally, all) fluid lines (optionally, the second end of one or more of the pre-blood pump line, pre-infusion line and dialysate line) by controlling a pump (optionally, by controlling a pre-blood pump and / or infusion pump and / or dialysate pump and fluid dispenser).

[0086] In aspect 45 according to aspect 43 above, the method includes: mixing fluids from at least two (optionally from all) containers (optionally, pre-blood pump container, pre-infusion container, and dialysate container), and then delivering the mixed fluids to a second end of one or more (optionally, one) fluid lines (optionally, pre-blood pump line, pre-infusion line, and dialysate line) by controlling a pump (optionally, pre-blood pump and / or infusion pump and / or dialysate pump) and a fluid dispenser.

[0087] In aspect 46 according to aspect 43 above, the method includes:

[0088] • Receive a signal from the air detector array indicating that air is detected upstream of at least one of the pumps (optionally, a pre-blood pump, an infusion pump, or a dialysate pump);

[0089] • If air is detected, stop at least one of the pumps (optionally, a pre-blood pump, an infusion pump, or a dialysate pump);

[0090] • After the cause of the air presence (optionally, due to an empty container) is removed, the exhaust device is activated and the fluid distributor is controlled to remove the air.

[0091] In aspect 47 of prior aspect 43, the method includes: controlling a pump (optionally, a pre-blood pump, an infusion pump, a dialysate pump, an effluent pump), a fluid dispenser, and an outlet to supply fluid from a container (optionally, a pre-blood pump container and / or an infusion container and / or a dialysate container) to the fluid dispenser, and further to the effluent line via the outlet.

[0092] In aspect 48 according to aspect 47 above, the method includes: filling a blood leak detector (BLD) with fluid from the effluent line and performing calibration of the blood leak detector; and / or examining / analyzing the composition of the fresh fluid or effluent from the effluent line using a fluid analyzer.

[0093] In a separate 49th aspect, a disposable component for an extracorporeal blood processing apparatus is provided, wherein the disposable component includes: a processing unit; a blood circuit coupled to the processing unit and including a blood removal line and a blood return line capable of being connected to a patient's vascular system; wherein the blood circuit has a pump portion configured to be coupled to a blood pump of the extracorporeal blood processing apparatus;

[0094] Multiple fluid lines are connected to or can be connected to their respective containers and connected to blood circuits and / or to processing units;

[0095] In this embodiment, at least two of the plurality of fluid lines are connected to each other at a common area and upstream of the blood circuit, for selectively allowing fluid flow between the at least two fluid lines through the common area.

[0096] In aspect 50 according to aspect 49, the processing unit, blood circuit and multiple fluid lines of the device of aspects 1 to 42 are part of a disposable component of aspect 49 and / or aspect 51 to 69 below.

[0097] In aspect 51, according to any of the preceding aspects 49 and 50, the disposable component includes an effluent line configured for discharging fluid from the processing unit.

[0098] In aspect 52, according to any of the preceding aspects 49 to 51, the plurality of fluid lines include:

[0099] A pre-infusion line having a first end connected to or capable of being connected to a pre-infusion container and a second end connected to a blood removal line; and / or a pre-infusion line having a first end connected to or capable of being connected to an infusion container and a second end connected to a blood removal line downstream of the blood pump; and / or at least one post-infusion line having a first end connected to or capable of being connected to an infusion container and a second end connected to a blood return line; and / or a dialysate circuit including a dialysate line having a first end connected to or capable of being connected to a dialysate container and a second end connected to a processing unit.

[0100] In aspect 53, according to any of the preceding aspects 49 to 52, each of the plurality of fluid lines has a pump portion configured to be coupled to a respective fluid pump.

[0101] In aspect 54, according to any of the preceding aspects 49 to 53, each of the plurality of fluid lines has an air detector portion configured to be coupled to an air detector array.

[0102] In aspect 55, according to any of the preceding aspects 49 to 54, the disposable component includes an ejector fluid line configured to couple to an ejector configured to connect the fluid line to an effluent line.

[0103] In aspect 56 according to aspect 55 above, the discharge fluid line is configured to connect the common area to the effluent line.

[0104] In aspect 57 according to aspect 55 or 56, the discharger fluid line includes a flow controller portion configured to be coupled to a discharger flow controller configured to selectively allow fluid flow between the common area and the discharge line.

[0105] In aspect 58, according to any of the preceding aspects 55 to 57, the discharge fluid line includes an air detector section configured to be coupled to a discharge air detector configured to detect air or gas in the fluid flow between the common area of ​​the fluid distributor and the discharge line.

[0106] In aspect 59, according to any of the preceding aspects 55 to 58, the discharger fluid line includes a check flow controller configured to allow fluid flow from the common area toward the discharge line and to prevent fluid flow from the discharge line toward the common area.

[0107] In aspect 60, according to any of the preceding aspects 49 to 59, each of the at least two fluid lines includes a branch that departs upstream or downstream of a respective pump section relative to the fluid flow from the respective container; wherein the branches are connected to each other at a common area.

[0108] In another subordinate aspect 60, according to any one of the preceding aspects 49 to 60, at least the pre-infusion line is connected in the common area and upstream of the blood circuit to the pre-infusion line and / or to the post-infusion line and / or to the dialysate line, for selectively allowing fluid flow between the fluid lines through the common area.

[0109] In another subordinate aspect 60 of the preceding aspects 49 to 60, the pre-blood pump line includes a branch that exits upstream or downstream of the pump portion relative to the fluid flow from the container; wherein the branch is connected to a public area.

[0110] In aspect 61, according to aspect 60 or 60 of the preceding aspects, each branch is connected to or is capable of being connected to its respective valve in the fluid distributor.

[0111] In aspect 62, which is according to any of aspects 60 to 61 when pursuant to aspect 52, the pre-blood pump line includes, upstream or downstream of the pre-blood pump portion relative to the fluid flow from the pre-blood pump container, a pre-blood pump line branch that is connected to or can be connected to the first valve.

[0112] In aspect 63, which is based on any of aspects 60 to 62 when pursuant to aspect 52, the pre-infusion line and / or post-infusion line includes, upstream or downstream of the infusion pump portion relative to the fluid flow from the pre-infusion container, a pre-infusion line branch that is connected to or can be connected to a second valve.

[0113] In aspect 64, which is based on any of aspects 60 to 64 when pursuant to aspect 52, the dialysate line includes, upstream or downstream of the dialysate pump portion relative to the fluid flow from the dialysate container, a dialysate line branch that is connected to or can be connected to a third valve.

[0114] In aspect 65, according to any of the preceding aspects 49 to 64, each of the plurality of fluid lines has a flow controller portion configured to be coupled to a flow controller placed between the pump and the infusion site.

[0115] In aspect 66 of aspect 51, the effluent line includes an effluent sensor or is configured to be coupled to an effluent sensor, optionally coupled to a blood leak detector (BLD), optionally located near an effluent container or drain line.

[0116] In aspect 67 according to aspect 66 above, the effluent line includes an interface port configured to connect to a fluid analyzer, wherein the interface port is optionally located between a blood leak detector (BLD) and an effluent container or drain line.

[0117] In aspect 68, according to any of the preceding aspects 49 to 66, the blood circuit and / or multiple fluid lines include a tube (optionally, a flexible tube), optionally, a tube made of plastic.

[0118] In aspect 69 according to aspect 68 above, the pipes of at least two of the plurality of fluid lines are connected to each other by bonding, welding or jointing (optionally, Y-joints or T-joints).

[0119] In a 70th aspect according to any of the preceding aspects, wherein the fluid line includes a pre-infusion line for infusing fluid into a blood circuit upstream of the processing unit, the pre-infusion line including a post-infusion branch into a blood circuit downstream of the processing unit, optionally the post-infusion branch being located downstream of a pump line of the pre-infusion line.

[0120] In aspect 71 according to any of the preceding aspects, wherein the fluid line includes a dialysate line for directing fluid to a second chamber of the treatment unit, the dialysate line including a post-dialysis infusion branch for infusing fluid into a blood circuit downstream of the treatment unit, optionally the post-dialysis infusion branch being located downstream of a pump line of the dialysate line.

[0121] In aspect 72, according to aspects 70 and 71 above, the post-infusion branch and the dialysate post-infusion branch share a common end length for direct infusion into the blood circuit downstream of the processing unit, and in particular, the common end length is directly infused into a bubble trap placed on the blood return line.

[0122] In aspect 73, the apparatus for extracorporeal blood processing according to aspects 1 to 42 includes a machine and a disposable component according to any of the preceding aspects 49 to 72; wherein the machine includes a body that includes at least a blood pump, a fluid pump, and a control unit; wherein the body is configured to retain the disposable component during processing.

[0123] In aspect 74, the machine includes a fluid distributor and / or an air detector array and / or a fluid discharger and / or a flow controller and / or a fluid analyzer.

[0124] Further features of the invention will become more apparent from the following detailed description of some embodiments of the invention, which are illustrated by way of non-limiting examples in the accompanying drawings of the Drawings section. Attached Figure Description

[0125] The description will now refer to the accompanying drawings, which are provided by way of non-limiting example, in which:

[0126] Figure 1 schematically illustrates an extracorporeal blood processing device according to an example of the prior art;

[0127] Figure 2 , Figure 2A and Figure 2B An extracorporeal blood processing apparatus according to a first embodiment of the present invention is schematically shown;

[0128] Figure 3 , Figure 3A , Figure 3B , Figure 3C An extracorporeal blood processing apparatus according to a second embodiment of the present invention is schematically shown;

[0129] Figure 4 The flushing and calibration of a BLD sensor according to an embodiment of the present invention are illustrated schematically;

[0130] Figure 5 The integration of a fluid analyzer and / or fluid sampler according to an embodiment of the present invention is illustrated schematically;

[0131] Figure 6 The integration of an external fluid analyzer according to an embodiment of the present invention is illustrated schematically;

[0132] Figure 7An extracorporeal blood processing apparatus according to a third embodiment of the present invention is schematically shown;

[0133] Figures 8 to 10 A flowchart illustrating an embodiment of a method for controlling an extracorporeal blood processing device according to the present invention is shown. Detailed Implementation

[0134] Figure 1 schematically illustrates an example of an extracorporeal blood processing device according to the prior art. The extracorporeal blood processing device 1 includes an extracorporeal blood circuit BC coupled to a processing unit 10, a fresh fluid flow path FFP, and an outflow fluid flow path EFP. The fresh fluid flow path FFP and the outflow fluid flow path EFP shown in Figure 1 are part of a prior art hydraulic circuit.

[0135] The processing unit 10 (e.g., dialyzer, plasma filter, blood filter or blood permeation filter) includes a first chamber and a second chamber, which are separated by a semipermeable membrane, such as a hollow fiber type or a plate type.

[0136] The device 1 includes a blood circuit BC (including a processing unit 10, a blood removal line 20, a blood return line 30, and optionally a blood warmer 33 and / or an air separator / bubble trap 35 equipped with a pressure sensor 31) and a dialysate circuit, which includes a processing unit 10, a dialysate line 40 and an effluent line 50.

[0137] It should be noted that the first chamber of processing unit 10 is understood as part of the blood circuit BC, which is connected to the blood removal line 20 and the blood return line 30, and the second chamber of processing unit 10 is understood as part of the dialysate circuit, which is connected to the dialysate line 40 and the effluent line 50. Therefore, processing unit 10 can be considered as a component of both the blood circuit BC and the dialysate circuit. In some embodiments, device 1 includes additional fluid lines, such as a pre-blood pump (PBP) line 60, a pre-infusion line 70, and a post-infusion line 70b.

[0138] Dialysis fluid line 40, pre-blood pump (PBP) line 60, pre-infusion line 70, and post-infusion line 70b are part of the fresh fluid pathway FFP. Effluent line 50 is part of the effluent fluid pathway EFP. In the example shown in Figure 1, the fresh fluid pathway FFP and effluent fluid pathway EFP are schematically shown as separate elements for clarity. It should be noted that the distinction between the FFP and EFP shown in Figure 1 (and some subsequent figures) does not require a corresponding structural, operational, or otherwise shape or form of the separate element shown in any of the figures.

[0139] The blood removal line 20 has a first end 20-1, which is designed to connect to a patient's vascular system. The specific manner in which the first end 20-1 of the blood removal line 20 is fluidly connected to the patient's vascular system can be achieved using known components and methods. The blood removal line 20 also includes a second end 20-2, which is configured to connect to the processing unit 10, specifically to the inlet port 12 of the first chamber of the processing unit 10. A blood pump 22 is coupled to a portion of the blood removal line 20.

[0140] The blood return line 30 has a first end 30-1 configured to connect to the processing unit 10, specifically to the outlet port 14 of the first chamber of the processing unit 10. The blood return line 30 also has a second end 30-2 designed to connect to the patient's vascular system. The specific manner in which the second end 30-2 of the blood return line 30 is fluidly connected to the patient's vascular system can be achieved using known components and methods.

[0141] A dialysate line 40 is configured to supply dialysate to the processing unit 10, and an effluent line 50 is configured to discharge used fluid from the processing unit 10 toward a drain line (not shown) or to a corresponding effluent container 58. The dialysate line 40 has a first end 40-1 and a second end 40-2, the first end 40-1 being configured to connect to the dialysate container 48, such as a dialysate bag or other source of dialysate fluid, and the second end 40-2 being configured to connect to the inlet port 16 of the second chamber of the processing unit 10. A dialysate pump 42 is coupled to a portion of the dialysate line 40.

[0142] The effluent line 50 has a first end 50-1 and a second end 50-2. The first end 50-1 is configured to connect to the outlet port 18 of the second chamber of the processing unit 10, and the second end 50-2 is configured to connect to an effluent container 58, which is configured to receive used fluid from the second chamber of the processing unit 10. In some embodiments, the second end 50-2 of the effluent line is directly connected to a drain pipe and is configured to directly discharge used fluid into the drain pipe. An effluent pump 52 is coupled to a portion of the effluent line 50. A blood leak detector (BLD) 53 is mounted on the effluent line 50 between the effluent pump 52 and the effluent container 58.

[0143] The pre-blood pump (PBP) line 60 has a first end 60-1 and a second end 60-2, the first end being connected to the pre-blood pump container 68 and the second end being configured to connect to the blood removal line 20. A pre-blood pump 62 is coupled to a portion of the pre-blood pump (PBP) line 60.

[0144] The pre-infusion line 70 has a first end 70-1 and a second end 70-2, the first end 70-1 being configured to connect to a displacement fluid container 78, and the second end 70-2 being configured to connect to a blood removal line 20. A displacement fluid pump 72 is coupled to a portion of the pre-infusion line 70.

[0145] The post-infusion line 70b branches off from the pre-infusion line 70 at a branch 73 located downstream of the displacement fluid pump 72. The post-infusion line 70b has a second end 70b-2 configured to connect to the blood return line 30. The branch typically includes a flow controller (e.g., one or more valves or clamping mechanisms) configured to selectively allow fluid flow through the pre-infusion line 70 or through the post-infusion line 70b.

[0146] Each of the dialysate container 48, outflow fluid container 58, pre-blood pump container 68, and replacement fluid container 78 is monitored by its respective sensors 49, 59, 69, and 79, which are configured to detect the amount of fluid in the container.

[0147] A displacement fluid pump 72, operating on the pre-infusion line 70 and located upstream of branch 73 (relative to the fluid flow from displacement fluid container 78 toward branch 73), is configured to supply displacement fluid from displacement fluid container 78 to blood circuits 20, 30. Branch 73 (including, for example, flow controllers, valves, and / or clamps; see above) is configured to selectively allow displacement fluid to be supplied from displacement fluid container 78 via pre-infusion line 70 or via post-infusion line 70b. In the case of pre-infusion, displacement fluid is introduced into blood removal line 20 at a first pre-infusion station 20-3b upstream of processing unit 10 (relative to the fluid flow from the first end 20-1 of blood removal line 20 to the second end 20-2 of blood removal line 20). In the case of post-infusion, displacement fluid is introduced into blood return line 30 downstream of processing unit 10 (relative to the fluid flow from the first end 30-1 of blood return line 30 to the second end 30-2 of blood return line 30). An anticoagulant injector 24 equipped with a check valve 24c can be connected to the blood removal line 20 at the first pre-infusion station 20-3b.

[0148] The hydraulic circuit may also include a second dialysate line 40b, which branches off from dialysate line 40 at branch 43. The branch typically includes a flow controller (e.g., one or more valves or clamping mechanisms) configured to selectively allow fluid flow (only) through dialysate line 40 (i.e., from its first end 40-1 to its second end 40-2), or alternatively, through a first portion of dialysate line 40 up to branch 43 and further through the second dialysate line 40b and the post-infusion line 70b (i.e., from the first end 40-1 of dialysate line 40 to branch 43, through the second dialysate line 40b and the post-infusion line 70b to the second end 70b-2 of the post-infusion line 70b). In detail, a dialysate pump 42, operating on dialysate line 40 and arranged upstream of branch 43 (relative to fluid flow from dialysate container 48 toward branch 43), is configured to supply dialysate from dialysate container 48 to processing unit 10. Branch 43 (including, for example, flow controllers, valves, and / or clamps; see above) is configured to selectively allow dialysate to be supplied from dialysate container 48 via dialysate line 40 or via a second dialysate line 40b and subsequently further via post-infusion line 70b.

[0149] Within the scope of this specification, the terms "upstream" and "downstream" refer to the general direction of fluid flow along fluid lines and / or through components of the device under processing conditions (e.g., from a first end of a line toward a second end of a line; and / or from an arterial access to a venous access for the patient). Typically (e.g., during processing), fluid flows from the first end 20-1 of the blood removal line 20 toward the second end 30-2 of the blood return line 30, through the blood removal line 20, the processing unit 10, and the blood return line 30. Additionally, fluid flows from containers 48, 68, and 78 toward the blood return circuit, while used fluid flows from the processing unit 10 toward and into container 58 (or, alternatively, toward and into the drain line). Unless otherwise stated, the terms upstream and downstream refer to the above general direction of fluid flow through lines and components during normal operation of the device (e.g., during processing).

[0150] The extracorporeal blood processing device 1 also includes a control unit 80, i.e., a programmable / programmable control unit, which is configured to control components of the device (e.g., pumps, valves, clamps) and receive signals from components (e.g., sensors). The control unit 80 may, for example, include one or more digital microprocessor units or one or more analog units or other combinations of analog and digital units. The extracorporeal blood processing device 1 may also include a user interface (e.g., a graphical user interface or GUI). The user interface is also connected to the control unit 80 and is configured to present information to the user or operator both through output units (e.g., screens, touchscreens, monitors, LED elements, etc.) and through input units (e.g., keyboards, hardware buttons, mice, touchscreens, voice recognition, optical recognition).

[0151] As shown in Figure 1, device 1 may include a clamp 37 configured to receive a portion of the blood return line 30 and configured to clamp (e.g., close) the fluid flow through the blood return line 30, particularly the fluid flow proximal to the second end 30-2 of the blood return line 30. Similarly, device 1 may also include a clamp 27 configured to receive a portion of the blood removal line 20 and configured to clamp (e.g., close) the fluid flow through the blood removal line 20, particularly the fluid flow proximal to the first end 20-1 of the blood removal line 20.

[0152] Each of the pumps 22, 42, 52, 62, and 72 included in the extracorporeal blood processing device 1 may include a positive displacement pump, such as a peristaltic pump. The peristaltic pumps typically operate on their respective pump lines (e.g., 22t, 42t, 52t, 62t, 72t), which are configured to be operatively connected to their respective pumps such that pump motion (e.g., rotation) is transmitted through the pump lines, causing fluid to move along their respective pump lines and thus through one or more of their respective lines (20, 40, 40b, 50, 60, 70b) and other components (e.g., processing unit 10, blood warmer 33, and / or air separator / bubble trap 35).

[0153] Figure 2 , Figure 2A and Figure 2B An extracorporeal blood processing apparatus according to a first embodiment of the present invention is illustrated schematically.

[0154] The blood circuit BC is shown only schematically, as the blood circuit BC may be the same as the blood circuit BC disclosed in the prior art example of Figure 1.

[0155] According to a first embodiment, the hydraulic circuit (fresh fluid flow path FFP and outflow flow path EFP) according to the invention is provided with an air detector array 200 consisting of air detectors 264, 274, 244 positioned downstream of fluid containers 68, 78, 48 (optionally, positive) and upstream of respective pumps 62, 72, and 42. The air detectors 264, 274, 244 are connected to a control unit 80 and configured to detect any gas or air in the flowing fluid. Each air detector 264, 274, 244 is configured to send a respective signal to the control unit 80 indicating the detected gas or air in the fluid flowing through its respective air detector 264, 274, 244.

[0156] According to a first embodiment, the hydraulic circuit (fresh fluid flow path FFP and outflow flow path EFP) is provided with a fluid distributor 300, which includes a plurality of valves 320 configured to control fluid flow between their respective fluid lines 60, 70, 40 and a common area 310 of the fresh fluid distributor. A control unit 80 is connected to the fluid distributor 300 (optionally, to each of the plurality of valves 326, 327, 324) and configured to control the fluid distributor 300, and optionally, to control (e.g., control the opening or closing) of each of the plurality of valves 326, 327, 324.

[0157] In this way, problem FB2 can be solved, wherein any one of the lines 60, 70, and 40 can be connected in fluid communication with any one of the pumps 62, 72, and 42, so that fluid from any one of the containers 68, 78, and 48 can be supplied to the blood circuit BC by any one of the pumps 62, 72, and 42 (each supplying to a different site, see above). In other words, any one of the pumps 62, 72, and 42 can pump fluid from one or more of the containers 68, 78, and 48.

[0158] The plurality of valves 320 includes a first valve 326 configured to selectively fluidly communicate a pre-blood pump (PBP) line 60 with a common area 310. The plurality of valves 320 also includes a second valve 327 configured to selectively fluidly communicate an infusion line 70 with the common area 310. The plurality of valves 320 further includes a third valve 324 configured to selectively fluidly communicate a dialysate line 40 with the common area 310. Each of the connections to lines 60, 70, and 40 optionally branches downstream of fluid containers 68, 78, and 48 (and downstream of array 200) and upstream of pumps 62, 72, and 42, such that a fresh fluid dispenser 300 is configured to receive fresh fluid from containers 68, 78, and / or 48, which have been checked for air or gas, and is configured to supply the received fluid to pumps 62, 72, and / or 42.

[0159] The hydraulic circuit also includes an air and fluid ejector 400, which includes a flow controller 452 (e.g., a pump, optionally a shut-off pump) and an ejector air detector 454. The air and fluid ejector 400 is fluidly connected to the common area 310 of the fluid distributor 300 and to the effluent line 50 of the outflow fluid passage. The ejector fluid line 450 is downstream of the effluent pump 52 and branches off upstream of the effluent line 50 from the drain line or effluent container 58.

[0160] This arrangement of the air and fluid discharger 400 allows for the delivery of any mixture of air and fluid previously detected upstream of pumps 62, 72, 42 by air detectors 264, 274 and / or 244 (any one or more of these air detectors) in order to resolve the aforementioned problem FB1.

[0161] Furthermore, this arrangement allows fresh fluid to be sent from containers 68, 78, 48 (any one or more of these containers) to the effluent line 50, and specifically to the blood leak detector (BLD) 53 within the effluent line 50. In this way, the blood leak detector 53 can be (re)calibrated when the effluent pump 52 is stopped, so that only fresh fluid is sent through the effluent line 50 from the air and fluid drainer 400. This resolves the aforementioned problem EB1.

[0162] In one example, to (re)calibrate the blood leak detector 53, any one or more of valves 326, 327, and / or 324 can be opened while pumps 62, 72, 42, and 52 remain stopped. When the flow controller / pump 452 is operated, fresh fluid is drawn from one or more containers 68, 78, 48 and directed toward the drain line or container 58 through the discharge fluid line 450 into the effluent line 50. The fresh fluid also passes through the blood leak detector 53, enabling (re)calibration to be performed. It should be noted that for this purpose, the control unit 80 is connected to the respective components (e.g., sensors, pumps, valves) and configured to operate these components as described above.

[0163] Figure 2A and Figure 7 An example configuration of an extracorporeal blood processing apparatus according to a first embodiment of the present invention is schematically shown. As described above, the fresh fluid dispenser 300 can be configured to alternately associate one or more connected containers 68, 78, 48 to a single fluid pump. In this example, the pre-blood pump 62 and the replacement fluid pump 72 are controlled to stop, while the dialysate pump 42 is controlled to supply fluid from the dialysate container 48 and via the fluid dispenser 300 from the pre-blood pump container 68 and the replacement fluid container 78 to the dialysate line 40. As shown, valves 173-70, 173-70b, and 143-70b are controlled to close, and valve 143-40 is controlled to open. Figure 2A The example illustrates a configuration where fluid from all containers 68, 78, and 48 is supplied to dialysate pump 42. This solves the aforementioned problem FB2 and also allows for the replacement of empty containers without interrupting blood circulation and / or treatment. During ongoing treatment, any of containers 68, 78, and 48 can be replaced (e.g., if empty) because fluid can be supplied from one or more of the remaining containers, as shown. Although fluid is supplied from several containers, the fluid flow is always controlled by the respective pump (dialysis pump 42 in the example shown).

[0164] Figure 2B and Figure 8Another example configuration of the extracorporeal blood processing apparatus according to a first embodiment of the invention is schematically shown. When air is detected upstream of the fluid pump (in the illustrated example, upstream of the pre-blood pump 62) (see above issue FB1), the pre-blood pump 62 is stopped to prevent air from being introduced into the blood circuit BC. If the associated fluid container (here, the pre-blood pump container 68) is empty, the operator can replace the container. The relevant valve (first valve 326) can then be opened in the fluid dispenser 300. Subsequently, the flow controller / pump 452 is controlled to remove air from the affected circuit segment (in the illustrated example, between the pre-blood pump 68 and the common area 310 of the fluid dispenser 300) and send it to the effluent circuit 50. The flow controller / pump 452 can be controlled to operate when air is detected by the respective upstream air detectors (here, air detector 264). When no more air is detected at the upstream air detector 264, the flow controller / pump 452 is further controlled to operate in order to fill the entire loop of the fluid distributor 300 and the discharger 400 with liquid up to the downstream discharger air detector 454, thereby ensuring that the common area 310 of the fluid distributor 300 is free of air. It should be noted that during this procedure, it may be necessary to deactivate / disable the blood leak detector 53 to prevent false alarms (e.g., because the blood leak detector 53 detected air).

[0165] In some embodiments, it may be necessary to employ a control loop to compensate for fluid removed from one of the containers 68, 78, 48 in a manner described, since such a fluid flow control loop, which controls the flow rates of one or more of the respective pumps 62, 72, 42, may be based on the weight or weight variation of the respective associated containers 68, 78, 48.

[0166] Figure 3 , Figure 3A , Figure 3B and Figure 3C An extracorporeal blood processing apparatus according to a second embodiment of the present invention is illustrated schematically. The blood circuit BC is shown only schematically, as the blood circuit BC may be the same as the blood circuit BC disclosed in the prior art example of FIG1.

[0167] The hydraulic circuit according to the second embodiment of the present invention also includes the air detector array 200 as described above with respect to the first embodiment. Furthermore, in addition to the description below, the hydraulic circuit according to the second embodiment of the present invention also includes a fresh fluid distributor 300 and an air and fluid discharger 400 as described above with respect to the first embodiment.

[0168] The fluid dispenser 300 according to the second embodiment includes four two-way valves 326, 327, 324, and 326'. Valve 326' (flow controller) is arranged on a pre-blood pump (PBP) line 60, which runs downstream of the pre-blood pump (PBP) 62 through the fluid dispenser 300. The pre-blood pump line 60 branches (pre-blood pump line branch 600) to valve 326, which connects the pre-blood pump line 60 to a common area 310. Valves 327 and 324 connect the infusion line 70 and the dialysate / infusion line 40 to the common area 310 via a pre-infusion line branch 700 and a dialysate line branch 800, respectively.

[0169] The air and fluid ejector 400 according to the second embodiment also includes a flow controller 452 (e.g., a two-way valve) that connects the common area 310 to the ejector fluid line 450 upstream of the blood leak detector (BLD) 53 and further to the effluent line 50. In the second embodiment, the flow controller 452 includes a two-way valve. Including a pump in the flow controller 452 is not necessary, as pumping action can be provided by one (or more) of the pumps 62, 72, and 42. A check flow controller 456 is provided in the ejector fluid line 450. The check flow controller 456 (e.g., a check valve) is configured to allow fluid flow from the ejector fluid line 450 toward and into the effluent line 50, while preventing fluid flow in the opposite direction.

[0170] The second embodiment also addresses problems FB1, FB2, and EB1 as described above with respect to the first embodiment. Furthermore, the second embodiment addresses problems FB3 and FB4 (see above). The fluid distributor 300 can be configured to allow fluid from any of the containers 68, 78, 48 to be directed to any infusion station (e.g., via any of the lines 60, 70, 70b, 40) via control valves 326, 327, 324, and 326'. Similarly, the fluid distributor 300 can be configured to allow customized fluid to be directed to any infusion station, the customized fluid being generated by mixing fluids from any two containers 68, 78, 48.

[0171] Figure 3A and Figure 8 An example configuration of an extracorporeal blood processing apparatus according to a second embodiment of the present invention is illustrated schematically. As described above, the fresh fluid dispenser 300 can be configured to alternately associate one or more connected containers 68, 78, 48 to a single injection site (here: supplying dialysate to the processing unit 10). Figure 3AThe example illustrates a configuration where fluid from all containers 68, 78, and 48 is supplied to dialysate line 40. This corresponds to the configuration based on the first embodiment (see...). Figure 2A Similar to the corresponding description above, valves 326, 327, and 324 are opened while valve 326' is closed. Conversely, pumps 62, 72, and 42 are controlled to supply (the same) fluid to dialysate line 40, and valve arrays 143 and 173 are correspondingly controlled (see [reference]). Figure 3A Valves 173-70, 173-70b, and 143-70b are closed, and valve 143-40 is opened. Specifically, pumps 62 and 72 are controlled to supply fluid from containers 68 and 78 via fluid distributor 300 to dialysate line 40, while pump 42 is controlled to supply fluid directly from container 48 to dialysate line 40. This solves the aforementioned problem FB2 and also allows for the replacement of empty containers without interrupting blood circulation and / or treatment. During ongoing treatment, any container 68, 78, or 48 can be replaced, as fluid can be supplied from one or more other containers as shown. Since each fluid pump 62, 72, or 42 is controlled to deliver fluid only from each associated container 68, 78, or 48, this configuration has no impact on the fluid balance system control loop, as the flow rate of each pump is related to the weight of its respective individual associated container.

[0172] Figure 3B and Figure 10 Another example configuration of the extracorporeal blood processing apparatus according to a second embodiment of the present invention is illustrated schematically. As described above, the fresh fluid dispenser 300 can be configured to allow the mixing of fluids from two separate containers 68, 78, 48 in a defined ratio and to infuse the mixture to a single station (or several stations) on the blood or dialysate side (e.g., lines 70, 70b and / or 40). Figure 3CThe example illustrates a configuration where fluids from displacement fluid container 78 and dialysate container 48 are mixed in a defined ratio and supplied to post-infusion line 70b, while fluid from pre-blood pump (PBP) container 68 is supplied to pre-blood pump (PBP) line 60 by pre-blood pump 62 and via fluid distributor 300. Valves 173-70b, 324, 327, and 326' are controlled to open, while valves 173-70, 143-70b, 143-40, and 326' are controlled to close. Displacement fluid pump 72 and dialysate pump 42 are each controlled to operate at a predetermined rate to achieve the desired mixing ratio, thereby supplying fluid from containers 78 and 48 to post-infusion line 70b respectively via fluid distributor 300. Pre-blood pump 62 is also controlled to supply fluid from pre-blood pump container 68 to pre-blood pump (PBP) line 60 via fluid distributor 300. Because the first valve 326 remains closed, mixing of the pre-blood pump (PBP) fluid with other fluids passing through the fluid dispenser 300 is prevented.

[0173] Figure 3C and Figure 9 Another example configuration of the extracorporeal blood processing apparatus according to a second embodiment of the invention is schematically shown. When air is detected upstream of the fluid pump (in the illustrated example, upstream of the pre-blood (PBP) pump 62) (see above issue FB1), the pump is stopped to prevent air from being introduced into the blood circuit BC. If the associated fluid container (here, the pre-blood pump container 68) is empty, the operator can replace the container. The relevant valve (here, the first valve 326) can then be opened in the fluid dispenser 300, and the flow controller 452 in the air and fluid ejector 400 can be controlled to open (other valves 327, 324, 326' remain closed or are controlled to close). Subsequently, the respective pumps (in this example, the pre-blood pump 62) are controlled to remove air from the affected circuit segment (in the illustrated example, between the pre-blood pump container 68 and the common area 310 of the fluid dispenser 300) and send it to the effluent line 50 via the ejector fluid line 450. When the respective upstream air detectors (here, air detector 264) detect air, the respective pumps (here, pre-blood pump 62) can be controlled to operate. When no more air is detected at the upstream air detectors, the respective pumps (here, pre-blood pump 62) are further controlled to operate, so as to fill the entire loop of fluid dispenser 300 and drainer 400 with liquid up to the downstream drainer air detector 454, so as to ensure that the common area 310 of fluid dispenser 300 is free of air. It should be noted that during this procedure, it may be necessary to deactivate / disable the blood leak detector (BLD) 53 to prevent false alarms (e.g., due to air detected by the blood leak detector 53). Figure 3C As shown, the displacement fluid pump 72 and dialysate pump 42 can be controlled to continue operating, and thus continue to supply infusion fluid from displacement fluid container 78 and dialysate or infusion fluid from dialysate / infusion container 48 to lines 70 / 70b and 40, respectively. Valve arrays 173 and 143 can be configured as needed, while valves 327 and 324 of the control fluid distributor 300 are kept closed. Figure 3C The configuration shown solves the problem FB1 mentioned above.

[0174] The hydraulic circuit and structure according to embodiments of the invention facilitate fluid management, air removal from the fluid, and large modularity in BLD flushing. Furthermore, the possibility of distributing any fluid in the supplied fluid to a single location or station within the hydraulic circuit pathways facilitates the potential integration of fluid analysis sensors at such locations or stations. Due to its position on the effluent circuit, this device can be used to measure effluent as well as fresh fluid from containers 68, 78, 48. Several sensing techniques (spectroscopy, electrochemistry, photoelectric) can be employed for analyzing electrolytes and solutes of clinical interest in the fluid. This circuit structure allows for comparison of two consecutive measurements of two fluid samples taken by the same sensor.

[0175] For fresh fluid, the composition of the newly connected fluid container can be checked before use to ensure it is identical to that of the previous fluid container (e.g., to verify that the multi-compartment bag is well mixed, or that the PBP container containing citric acid is set as a replacement container). This loop configuration allows for comparison of effluent composition with changes in fresh dialysate, which serves as a reference sample. This loop configuration also allows for the detection of the presence and concentration of citric acid in the PBP container.

[0176] Comparative measurements allow for simplification and improved accuracy of absorbance spectroscopy and electrochemical methods. The possibility of periodically rinsing the current / potential electrochemical sensor with fresh solution allows for time-dependent bias or polarization control.

[0177] Figure 4The flushing and calibration of a blood leak detector BLD 53 according to an embodiment of the present invention are schematically illustrated. As shown, to address the aforementioned problem EB1, fresh fluid (e.g., PBP fluid, replacement fluid, or dialysate fluid) from any one or more of containers 68, 78, 48 (not shown) can be supplied to the fresh fluid dispenser 300 and further supplied to the effluent line 50 via the air and fluid drainer 400. The blood leak detector BLD 53 can be (re)calibrated simultaneously with the delivery of fresh fluid and the control of the effluent pump 52 to stop. Specifically, the blood leak detector BLD 53 can be filled with fresh dialysate or replacement fluid in a manner described, allowing (re)calibration to be performed and / or controlled by the control unit 80 (not shown). Since the fresh fluid from any of containers 68, 78, 48 used for recalibrating the blood leak detector BLD 53 can be collected by the effluent container 58, the general principle of monitoring patient weight loss for managing the activity of the effluent pump 52 is not affected by this process. As for removing air from the fresh fluid, the patient's weight loss can always be calculated as the total weight of the effluent minus the weight of all the fresh fluid that has been used.

[0178] Figure 5 An integrated fluid analyzer and / or fluid sampler according to an embodiment of the invention is schematically illustrated (in order to address the aforementioned problem FB5). An integrated online fluid analyzer 56 can be arranged on the effluent line 50 to determine the properties of the fluid passing through the line 50, or an external fluid analyzer 500 can be connected to the effluent line 50 via interface ports 501 and 502. Additionally, a check valve 57 (e.g., a check valve, see...) Figure 6 It can be arranged on the effluent line 50 to prevent unknown fluids from flowing back from the effluent container 58 and / or the drain line (not shown).

[0179] If the sensor technology is incompatible with the CRRT-set sterilization process, an optional external fluid analyzer 500 may be required. Otherwise, some sensors may need to remain in a waiting state during their measurements without flow of fluid samples. In this case, the external fluid analyzer 500 may need to manage its own sampling pump (e.g., exhibiting a lower sampling flow rate than the fluid flow rate toward the effluent container 58; see [link to relevant documentation]). Figure 6 (and the corresponding description below). The effluent loop area, including check valve 57, allows fluid flow to be maintained. Syringe pump 24 can be connected to the piping that connects external fluid analyzer 500 to interface ports 501 and 502.

[0180] Figure 6 The integration of an external fluid analyzer 500 according to an embodiment of the present invention is illustrated schematically. Figure 5 The general configuration shown is consistent with that shown. Figure 6 Further details regarding the external fluid analyzer 500 are shown. If desired, the external fluid analyzer 500 includes an analyzer flushing and calibration solution container 558, and a valve array 533 configured to selectively allow fluid flow from the calibration container 558 and / or from the inlet line 510 toward the sampling pump 552 and toward an array of sensors 560 configured to determine the properties of the fluid passing through the external fluid analyzer 500. Additionally, a valve 534 is configured to selectively allow fluid to flow back from the array 560 through the outlet line 590 toward the effluent line 50 and into the effluent container 58 or a drain line (not shown). The fluid connection between the outlet line 590 and the effluent container 58 of the fluid analyzer 500 facilitates the use of the effluent container 58 for collecting waste fluid from the fluid analyzer 500. If the fluid analyzer 500 requires a large volume of calibration or flushing solution from the calibration container 558, this additional fluid volume can be accounted for in CRRT monitoring fluid balance.

[0181] Figure 7 A third embodiment of the invention, similar to the second embodiment, is shown. In this third embodiment, the replacement fluid from the respective containers 78 can be routed before or after the processing unit 10. A post-filter infusion line 70c is connected between the processing unit 10 and the blood warmer 33. The dialysate circuit does not have the capability to route to the post-infusion line 70b as in the first and second embodiments. An additional fluid circuit (additional fluid container 88, additional pump 82, fourth valve 328, air detector 284, additional post-infusion line 70d with flow control valve 328') is added to deliver the post-infusion directly to the air separator / bubble trap 35. Additional flow control valves 324' and 326' are placed on the dialysate line 40 and the pre-blood pump (PBP) line 60.

[0182] The blood circuit BC, dialysate line 40, pre-blood pump (PBP) line 60, pre-infusion line 70, post-infusion lines 70b, 70c, 70d, and effluent line 50 may be part of a disposable component according to an independent aspect of the invention.

[0183] The pipelines are made of flexible plastic tubing and have respective sections configured to couple with their respective fluid pumps, air detectors, or flow controllers. The fluid pipelines can be connected to each other in common areas by bonding, welding, or joints (optionally, Y-joints or T-joints).

[0184] The disclosed apparatus includes a machine comprising a body having a pump, a control unit, sensors, and a controller, as well as possible other elements configured to hold the various parts of a disposable component. The disposable component is coupled to the machine for performing a single treatment on only one patient and is discarded after use.

[0185] Although the invention has been described in conjunction with embodiments that are now considered to be the most practical and preferred, it should be understood that the invention is not limited to the disclosed embodiments, but rather is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims.

Claims

1. An apparatus for extracorporeal blood treatment, comprising: a treatment unit (10); a blood circuit coupled to the treatment unit (10) and comprising a blood removal line (20) and a blood return line (30) connectable to a vascular system of a patient (P); a blood pump (22) configured to be coupled to a pump portion of the blood circuit; a plurality of fluid lines (40, 60, 70, 70b, 70c, 70d) connected or connectable to a respective container (48, 68, 78, 88), wherein the fluid lines (40, 60, 70, 70b, 70c, 70d) are connected to the blood circuit and to the treatment unit (10); a plurality of pumps (42, 62, 72, 82) acting on the fluid lines (40, 60, 70, 70b, 70c, 70d), wherein the plurality of fluid lines (40, 60, 70, 70b, 70c, 70d) comprises: a plurality of infusion lines (60, 70, 70b, 70c, 70d) having a first end (60-1, 70-1) connected to the container (68, 78, 88) and a second end (60-2, 70-2, 70b-2) connected to the blood circuit, wherein some of the plurality of pumps (42, 62, 72, 82) (62, 72, 82) act on the infusion lines (60, 70, 70b, 70c, 70d); a dialysate circuit (40) comprising a dialysate line (40) having a first end (40-1) connected or connectable to a dialysate container (48) and a second end (40-2) connected to the treatment unit (10); an effluent line (50) configured for draining fluid from the treatment unit (10); wherein the plurality of pumps (42, 62, 72, 82) comprises a dialysate pump (42) acting on the dialysate line (40) and an effluent pump (52) acting on the effluent line (50); a fluid distributor (300) having a common area (310), wherein at least two of the plurality of fluid lines (40, 60, 70, 70b, 70c, 70d) are connected to each other at the common area (310) upstream of the blood circuit for selectively allowing fluid flow between the at least two fluid lines (40, 60, 70, 70b, 70c, 70d) through the common area (310), wherein at least two of the plurality of infusion lines (60, 70, 70b, 70c, 70d) are connected to each other at the common area (310). the dialysate line (40) and the effluent line (50) are connected to each other at the common area (310). the plurality of infusion lines (60, 70, 70b, 70c, 70d) comprises:

2. The apparatus of claim 1, wherein, ​ 3. The apparatus of claim 1 or 2, wherein, ​ a pre-blood pump line (60) having a first end (60-1) connected or connectable to a pre-blood pump container (68) and a second end (60-2) connected to the blood removal line (20); a pre-infusion line (70) having a first end (70-1) connected or connectable to an infusion container (78) and a second end (70-2) connected to the blood removal line (20) downstream of the blood pump (22), and / or at least one post-infusion line (70b, 70c, 70d) having a first end (70-1) connected or connectable to an infusion container (78, 88) and a second end (70b-2) connected to the blood return line (30); wherein the plurality of pumps (42, 62, 72, 82) comprises a pre-blood pump (62) acting on the pre-blood pump line (60) and / or an infusion pump (72) acting on the pre-infusion line (70).

4. The device of claim 1, comprising an ejector (400), wherein, The drain (400) comprises a drain fluid line (450) configured for connecting the common area (310) of the fluid dispenser (300) to the effluent line (50), and a drain flow controller (452) configured for selectively allowing fluid flow between the common area (310) and the effluent line (50).

5. The apparatus of claim 1, wherein, The fluid dispenser (300) comprises a plurality of valves (326, 327, 324, 328) placed at the common area (310) and configured for selectively allowing fluid flow between the at least two fluid lines (40, 60, 70, 70b, 70c, 70d).

6. The apparatus of claim 1, wherein, The fluid dispenser (300) is configured to allow bidirectional flow in at least a portion of the at least two fluid lines (40, 60, 70, 70b, 70c, 70d).

7. The apparatus of claim 1, wherein, The fluid dispenser (300) comprises a valve (326, 327, 324, 328) on each of the at least two fluid lines for selectively allowing fluid flow between the respective line and the common area (310).

8. The apparatus of claim 1, comprising a plurality of flow controllers (173, 143, 326', 324', 328') placed on the fluid lines (40, 60, 70, 70b, 70c, 70d) and between the pumps (42, 62, 72, 82) and the blood removal line (20) and / or blood return line (30) and / or an infusion site on the processing unit (10).

9. The apparatus of claim 7, wherein, Each of the at least two fluid lines, upstream from a respective pump relative to a flow of fluid from a respective container, comprises a branch connected to a respective valve (326, 327, 324, 328).

10. The apparatus of claim 4, wherein, The discharger flow controller (452) comprises a shut-off pump.

11. The device of claim 8, comprising an ejector (400), wherein, The discharger (400) comprises a discharger fluid line (450) configured for connecting the common area (310) of the fluid dispenser (300) to the effluent line (50) and a discharger flow controller (452) configured for selectively allowing fluid flow between the common area (310) and the effluent line (50), wherein each flow controller (173, 143, 326', 324', 328') comprises a two-way valve configured to selectively allow or prevent fluid flow; and The discharger flow controller (452) comprises a two-way valve configured to selectively allow or prevent fluid flow.

12. The apparatus of claim 4, wherein, The discharger (400) comprises a discharger air detector (454) arranged on the discharger fluid line (450) and configured for detecting air or gas in a fluid flow between the common area (310) of the fluid dispenser (300) and the effluent line (50).

13. The apparatus of claim 1, comprising an air detector array (200) configured to detect air or gas on each of the at least two fluid lines.

14. The apparatus of claim 13, wherein, The air detector array (200) comprises air detectors (264, 274, 244, 284) arranged on each of the at least two fluid lines, each air detector (264, 274, 244, 284) being arranged on a respective line proximate to a respective container (68, 78, 88, 48) and / or directly downstream from a respective pump (62, 72, 82, 42) relative to a flow of fluid from the container (68, 78, 88, 48).

15. The apparatus of claim 8, wherein, At least one of the flow controllers (173, 143, 326', 324', 328') is placed on two or more fluid lines (40, 60, 70, 70b, 70c, 70d) and is configured to selectively allow fluid flow into one or more of the two or more fluid lines.

16. The device of claim 1, comprising a control unit (80) connected to the pump (42, 62, 72, 82) and to the fluid dispenser (300); wherein, The control unit (80) is configured to control at least one of the pumps (42, 62, 72, 82) and is configured to control the fluid dispenser (300) such that fluid from one or more of the containers (48, 68, 78, 88) is delivered to the second end portion of one or more of the fluid lines (40, 60, 70, 70b, 70c, 70d); or wherein the control unit (80) is configured to control at least two pumps (42, 62, 72, 82) and to control the fluid distributor (300) so that fluid from the at least two pumps (42, 62, 72, 82) is mixed and then delivered to the second end portion of one or more of the fluid lines (40, 60, 70, 70b, 70c, 70d).

17. The device of claim 16, comprising an ejector (400), wherein, The discharger (400) comprises a discharger fluid line (450) configured for connecting the common area (310) of the fluid distributor (300) to the effluent line (50) and a discharger flow controller (452) configured for selectively allowing fluid flow between the common area (310) and the effluent line (50), wherein the apparatus further comprises an air detector array (200) placed upstream or downstream of the pumps (42, 62, 72, 82) and configured for detecting air or gas in at least one of the fluid lines (40, 60, 70, 70b, 70c, 70d); wherein the control unit (80) is connected to the discharger (400) and to the air detector array (200); wherein the control unit (80) is configured for command execution of a task of air removal, the task comprising the steps of: • receiving from the air detector array (200) a signal indicative of air detected upstream of at least one of the pumps (42, 62, 72, 82); • in case of air detection, stopping the at least one of the pumps (42, 62, 72, 82); • after air cause removal, activating the discharger (400) and controlling the fluid distributor (300) for air removal.

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