CN104203305B - Treatment solution conveying in extracorporeal blood treatment equipment - Google Patents

Abstract

This article describes a blood therapy device and its method of use, which includes two or more intermediate containers located between a source of therapeutic solution and a port through which the therapeutic solution is delivered using the blood therapy device. The weight of these intermediate containers is measured and used to control the refilling and emptying of the therapeutic solution in the intermediate containers.

Description

Therapeutic Solution Delivery in Extracorporeal Blood Therapy Devices

technical field

Devices and methods for delivering therapeutic solutions in extracorporeal blood therapy devices and related methods are described herein.

Background technique

Extracorporeal blood therapy means taking blood from a patient, treating the blood outside the patient's body, and returning the treated blood to the patient. Extracorporeal blood therapy is typically used to extract undesirable substances or molecules from a patient's blood and/or add beneficial substances or molecules to the blood. Extracorporeal blood therapy is used in patients who cannot effectively remove substances from their blood (eg, in the case of patients with temporary or permanent renal failure). These and other patients may undergo extracorporeal blood therapy to add or remove substances from their blood, for example, to maintain acid-base balance or to eliminate excess body fluid.

Extracorporeal blood therapy is usually performed by collecting blood from a patient in a continuous flow, introducing the blood into the main chamber of a filter at least partially defined by a semipermeable membrane. Depending on the type of treatment, the semipermeable membrane selectively enables harmful substances contained in the blood to pass through the membrane from the primary chamber to the secondary chamber, and optionally enables beneficial substances contained in the fluid entering the secondary chamber. Passes through the membrane to the blood entering the main chamber.

Multiple extracorporeal blood treatments can be performed by the same machine. In ultrafiltration (UF) therapy, harmful substances are removed from the blood by convection across the membrane in the secondary chamber.

In hemofiltration (HF) therapy, blood flows through a chamber at least partially defined by a semipermeable membrane as in UF, beneficial substances are added to the blood (usually by Introduce fluid into blood prior to return to patient).

In hemodialysis (HD) treatment, a secondary fluid containing beneficial substances is introduced into the secondary chamber of the filter. Harmful substances of the blood pass through the semipermeable membrane by diffusion and penetrate into the secondary fluid, and beneficial substances of the secondary fluid can pass through the membrane and penetrate into the blood.

In hemodiafiltration (HDF) treatment, the blood and secondary fluid exchange their substances as in HD, additionally substances are added to the blood as in HF (usually by introducing fluid into the treatment before the blood is returned to the patient blood); removal of harmful substances from the blood by convection and diffusion.

In those treatments using a secondary fluid, the secondary fluid passes through the secondary chamber of the filter and receives noxious substances of the blood by diffusion and/or convection across the membrane. This liquid is then extracted from the filter: this liquid is usually called waste and is sent to a drain or container (which is then intended to be drained into the drain).

In extracorporeal therapy using a secondary fluid, as shown in Figure 1, the secondary fluid may be supplied in a sterile disposable bag. For this purpose, the secondary fluid can be the dialysate contained in the dialysate bag 11 . The dialysate bag 11 delivers the dialysate to the secondary chamber 4 through the outlet line 9 . This bag 11 is combined with a gravimetric scale 21 linked to a control unit 41 . Thus, the weight signal is sent to the control unit 41, which is able to monitor the change in the weight of the bag 11 and control the pump 31 acting on the outlet line 9 (i.e. the line that transports the dialysate from the bag 11 to the secondary chamber 4) .

However, in some embodiments, the treatment session lasts for multiple days, and the disposable dialysate bag 11 is depleted before the treatment session is complete. This phenomenon will be more pronounced during intensive treatment. Of course, one wishes both to exchange large volumes of fluid in HF or HDF therapy, and to perform long-term therapy.

As soon as the bag 11 reaches a set level (or at another time selected by the user), the pump acting on the outlet line 9 (or other pumps as required) can be temporarily stopped, while blood continues to flow outside the main chamber 3 of the filter. cycle. Once the pump 31 is stopped, the user must disconnect and remove the empty dialysate bag 11 . The user then attaches and connects a new full disposable bag 11 to the treatment device and restarts the pump to return to extracorporeal treatment with fluid circulation through the two chambers (3, 4) of the filter 2.

There are a number of potential disadvantages to this bag changing operation. Performed by healthcare personnel who must monitor multiple patients at the same time (waiting time before personnel action often increases treatment time and may require additional treatment time or result in reduced treatment efficiency), periodic replacement of dialysate bags during treatment sessions increases treatment economy cost, and the bag is a heavy and relatively fragile object that is difficult to handle and could potentially be punctured while handling.

Although described herein in connection with the delivery of dialysate, it should be understood that similar problems may also be encountered in blood therapy devices that deliver fluid to the blood (whether before or after a filter or before a blood pump). For purposes of this discussion, any of these fluids will be referred to as a "therapeutic solution," which may include, for example, dialysate; replacement fluid in convective replacement therapy for renal function; plasma, which may be used in therapeutic plasma exchange (TPE), albumin or colloid solution; or any other known type of medical fluid used in replacement therapy.

Contents of the invention

The blood treatment devices described herein include two or more intermediate containers located between a source of treatment solution and a port through which the treatment solution is delivered by the blood treatment device. The weight of these intermediate containers is measured and used to control the refilling and emptying of the therapeutic solution in the intermediate containers. Using two or more intermediate containers at a location between the source of therapeutic solution and the rest of the blood treatment apparatus as described herein reduces or eliminates stopping delivery of therapeutic solution for replacement when the intermediate container is emptied and/or refilled The need for an intermediate container. As a result, the duration of uninterrupted therapy can be significantly increased.

The amount of therapeutic solution delivered to the selected portion of the blood treatment device is typically controlled based on the weight of the therapeutic solution delivered to the output controller (determined by a weight meter as described herein). In some embodiments, the flow rate of the therapeutic solution through the output controller can also be controlled based at least in part on the change in weight of the intermediate container.

In one aspect, some embodiments of the blood treatment apparatus described herein comprise: a blood circuit comprising an arterial line intended to draw blood from a patient and a venous line intended to return blood to said patient; and a treatment solution A delivery system configured to deliver a therapeutic solution through a therapeutic solution port within the blood treatment device. The therapeutic solution delivery system may include: a first weight meter configured to weigh the first intermediate container; a second weight meter configured to weigh the second intermediate container; a source flow controller configured to weigh the second intermediate container; configured to deliver therapeutic solution from a source of therapeutic solution to said first intermediate container weighed by said first weight scale and said second intermediate container weighed by said second weight scale; an output controller, which is configured to control the flow of therapeutic solution from the first intermediate reservoir and the second intermediate reservoir to the therapeutic solution port; a reservoir selection controller positioned between the source flow controller and the output controller in the therapeutic solution path; a control unit operatively attached to said first weight meter, said second weight meter, said source flow controller, said container selection controller and said output controller. The control unit is configured to: receive weight signals from the first weight scale and the second weight scale; control the source flow controller, the container selection controller and the output controller in a first mode, wherein therapeutic solution is delivered to the output controller, therapeutic solution exits the first intermediate container, and the second intermediate container is filled with therapeutic solution; in a second mode controlling the source flow controller, the A container selection controller and the output controller, wherein the second intermediate container delivers therapeutic solution to the output controller and the first intermediate container is filled with therapeutic solution from the therapeutic solution source.

In some embodiments of the blood treatment apparatus described herein, the control unit is configured to control the source flow controller, the container selection controller and the output controller such that when in the first mode A continuous flow of therapeutic solution is provided to the therapeutic solution port when switching between and between the second mode.

In some embodiments of the blood treatment device described herein, the blood treatment device comprises a filter having a primary chamber and a secondary chamber separated by a semipermeable membrane, wherein the blood circuit is configured to Blood passes through the primary chamber, and wherein the therapeutic solution port is configured to deliver therapeutic solution to the secondary chamber.

In some embodiments of the blood treatment apparatus described herein, the treatment solution port is configured to deliver a treatment solution to blood in the blood circuit.

In some embodiments of the blood treatment apparatus described herein, the apparatus includes an air detector positioned between the source of therapeutic solution and the first and second intermediate containers such that The therapeutic solution source is delivered to the first intermediate container and the therapeutic solution in the second intermediate container passes through the air detector.

In some embodiments of the blood treatment apparatus described herein, the apparatus includes a sterile filter positioned between the source of therapeutic solution and the port for therapeutic solution such that the source of therapeutic solution is delivered to Therapeutic solution from the therapeutic solution port passes through the sterile filter. In some embodiments, the sterile filter is located between the source of therapeutic solution and the first and second intermediate containers such that the The therapeutic solution of the container passes through the sterile filter.

In some embodiments of the blood treatment apparatus described herein, the apparatus includes a source flow controller positioned between the source of therapeutic solution and the first and second intermediate containers such that Therapeutic solution delivered from the source of therapeutic solution to the first intermediate vessel and the second intermediate vessel passes through the source flow controller. A sterile filter may be positioned between the source flow controller and the first and second intermediate containers such that therapeutic solution delivered from the source of therapeutic solution to the first and second intermediate containers passes through the sterile filter. The sterilizing filter, if included, may have passive pores comprising a hydrophobic membrane.

In some embodiments of the blood treatment apparatus described herein, the source of treatment solution comprises a plurality of supply reservoirs.

In some embodiments of the blood treatment apparatus described herein, the therapeutic solution source comprises a liquid source, a therapeutic solution precursor, and a mixing device configured to combine liquid from the liquid source with the therapeutic solution precursor to A therapeutic solution is formed.

In some embodiments of the blood treatment apparatus described herein, the container selection controller includes a valve configured to have an open state and a closed state, in the open state allowing flow through the The line, in the closed state, prevents flow through the line to which the valve acts.

In some embodiments of the blood treatment apparatus described herein, the container selection controller includes a pump configured to deliver a treatment solution through a pipeline in which the pump is located when the pump is in operation, and when the pump is A therapeutic solution is prevented from flowing through the tubing in which the pump is located when the pump is not in operation.

In some embodiments of the blood treatment apparatus described herein, the reservoir selection controller includes a multi-way valve, wherein, in a first configuration, the multi-way valve allows therapeutic solution from the therapeutic solution source to flow to the first intermediate vessel and prevents the therapeutic solution from flowing into the second intermediate vessel, and wherein, in the second configuration, the multi-way valve allows therapeutic solution from the therapeutic solution source to flow to the into the second intermediate container and prevent the therapeutic solution from flowing into the first intermediate container.

In some embodiments of the blood treatment apparatus described herein, the first intermediate container outlet flow controller and the second intermediate container outlet flow controller comprise a multi-way valve, wherein, in a first configuration, the multi-way valve allows therapeutic solution from the first intermediate tank flows to the output controller and prevents therapeutic solution from the second intermediate tank from flowing to the output controller, and wherein, in a second configuration, the multi-way valve allows Treatment solution from the second intermediate vessel flows to the output controller and prevents flow of treatment solution from the first intermediate vessel to the output controller.

In some embodiments of the blood treatment apparatus described herein, the control unit is configured to calculate from the received weight signal Controller the amount of treatment solution.

In another aspect, some embodiments of a method of controlling flow of a therapeutic solution in a blood treatment facility may include the step of filling a first intermediate container with a therapeutic solution by transferring the therapeutic solution from a source of therapeutic solution to the first intermediate container, weighing the first intermediate container to determine when the amount of therapeutic solution in the first intermediate container rises to a selected fill level, and when the amount of therapeutic solution in the first intermediate container rises to ceasing delivery of therapeutic solution to said first intermediate container at said selected fill level; and delivering therapeutic solution from a second intermediate container to an output controller while filling said first intermediate container from said source of therapeutic solution, weighing the second intermediate container to determine when the amount of therapeutic solution in the second intermediate container has dropped to a selected refill level, and when the amount of therapeutic solution in the second intermediate container has dropped to the selected refill level The delivery of therapeutic solution to the output controller is stopped at the selected refill level.

The blood treatment device used to practice some embodiments of the methods described herein may be any of the various embodiments of the blood treatment device described herein.

In some embodiments, the method may include the step of filling the second intermediate container with a therapeutic solution by transferring the therapeutic solution from the source of therapeutic solution to the second intermediate container, the second intermediate container weighing to determine when the amount of therapeutic solution in the second intermediate container rises to a selected fill level, and when the amount of therapeutic solution in the second intermediate container rises to the selected fill level ceasing delivery of therapeutic solution to the second intermediate tank; and delivering therapeutic solution from the first intermediate tank to the output controller while filling the second intermediate tank from the source of therapeutic solution, for the The first intermediate container is weighed to determine when the amount of therapeutic solution in the first intermediate container has dropped to a selected refill level, and when the amount of therapeutic solution in the first intermediate container has dropped to the selected refill level Delivery of therapeutic solution to the output controller is stopped at the refill level.

In some embodiments, the methods described herein may include the step of exchanging a plurality of supply reservoirs in the source of therapeutic solution while delivering therapeutic solution to the first intermediate container or the second intermediate container One or more supply reservoirs in .

In some embodiments, the methods described herein may include the step of constituting a therapeutic solution from a therapeutic solution precursor and a liquid source in a therapeutic solution source while delivering the therapeutic solution to the first intermediate vessel or the second intermediate vessel.

In some embodiments of the methods described herein, the therapeutic solution is delivered to the output controller substantially continuously.

In some embodiments, the methods described herein can include the step of passing the therapeutic solution from the therapeutic solution source through an air detector while delivering the therapeutic solution from the therapeutic solution source to the first intermediate vessel or the second intermediate vessel.

In some embodiments, the methods described herein can include the step of passing the therapeutic solution from the source of therapeutic solution through a sterile filter when transferring the therapeutic solution from the source of therapeutic solution to the first intermediate container or the second intermediate container.

In some embodiments of the methods described herein, the step of filling the first intermediate container or the second intermediate container includes the step of pumping the therapeutic solution from the therapeutic solution source to the first intermediate container or the second intermediate container via a source flow controller. intermediate container.

In some embodiments of the methods described herein, the amount of therapeutic solution delivered to the output controller from both the first intermediate container and the second intermediate container is calculated based on the weight of the first intermediate container and the second intermediate container.

As used herein and in the appended claims, the singular forms "a," "an" and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, "a" or "the" component may include one or more of components known to those skilled in the art and equivalents thereof. Additionally, the term "and/or" means one or all of the listed elements or any combination of two or more of the listed elements.

It should be noted that the term "comprising" and variations thereof do not have a restrictive meaning where these terms appear in the following description. In addition, "a", "the", "at least one" and "one or more" are used interchangeably herein.

The above summary is not intended to describe each embodiment or every implementation of the blood therapy apparatus described herein. Rather, a more complete understanding of the invention will be apparent and appreciated by referring to the following detailed description and claims with reference to the accompanying drawings.

Description of drawings

Figure 1 shows a known extracorporeal blood treatment device.

Figure 2 shows one embodiment of an extracorporeal blood treatment device as described herein.

Figure 3 shows a first mode of operation of the extracorporeal blood treatment apparatus of Figure 2, wherein the first intermediate container is filled from a source of therapeutic solution while the second intermediate container is delivering therapeutic solution to the output controller.

Figure 4 shows a second mode of operation of the extracorporeal blood treatment apparatus of Figure 2, wherein the second intermediate container is filled from a source of therapeutic solution while the first intermediate container is delivering therapeutic solution to the output controller.

Figure 5 shows another embodiment of an extracorporeal blood treatment device as described herein.

Figure 6 shows a first mode of operation of the extracorporeal blood treatment apparatus of Figure 5, wherein the first intermediate container is filled from a source of therapeutic solution while the second intermediate container is delivering therapeutic solution to the output controller.

Figure 7 shows a second mode of operation of the extracorporeal blood treatment apparatus of Figure 5, wherein the second intermediate container is filled from a source of therapeutic solution while the first intermediate container is delivering therapeutic solution to the output controller.

Figure 8 shows another embodiment of an extracorporeal blood treatment device as described herein.

Figure 9 shows a first mode of operation of the extracorporeal blood treatment apparatus of Figure 8, wherein the first intermediate container is filled from a source of therapeutic solution while the second intermediate container is delivering therapeutic solution to the output controller.

Fig. 10 shows a second mode of operation of the extracorporeal blood treatment apparatus of Fig. 8, wherein the second intermediate container is filled while the first intermediate container is delivering treatment solution to the output controller.

Figure 11 shows the change in weight of the intermediate container in the embodiment of Figure 8 during operation of the blood treatment apparatus.

detailed description

In the following description of illustrative embodiments, reference is made to the accompanying drawings which form a part hereof, and which show by way of illustration certain embodiments. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention.

In various exemplary embodiments of Fig. 2, Fig. 5 and Fig. 8, a blood treatment device 1 is shown. The illustrated hemotherapy device 1 has an operational configuration enabling it to perform hemodialysis treatments. Of course, the other treatment configurations (ultrafiltration, hemofiltration, and hemodiafiltration) previously mentioned are possible within other embodiments, and the principles, systems and methods described herein are applicable to those embodiments as well.

The blood treatment device 1 shown in FIGS. 2 , 5 and 8 includes a filter 2 having a primary chamber 3 and a secondary chamber 4 separated by a semipermeable membrane 5 . The blood circuit in the blood treatment device 1 comprises an arterial line 7 intended to draw blood from the patient, a main chamber 3 of the filter and a venous line 6 intended to return blood from the main chamber 3 to the patient.

In various embodiments, a treatment solution (eg, dialysate, etc.) is delivered to the blood treatment apparatus 1 . Since the treatment solution in the various embodiments shown is dialysate, the treatment solution is delivered to the secondary chamber 4 of the filter 2 through the treatment solution port 10 connected to the inlet line 9 using the output controller 31 . Liquid is removed from the secondary chamber 4 of the filter 2 through the drainage line 8 .

Although in the embodiments of FIGS. 2 , 5 and 8 the output controller 31 is shown in the form of a peristaltic pump, the output controller 31 may be provided in various alternative forms that can be used to control the flow of therapeutic solution. , including, for example, other pumps (eg, piston pumps, diaphragm pumps, etc.), other flow control mechanisms (eg, valves, clamps, etc.), and the like.

Although the various embodiments of the blood treatment apparatus shown in FIGS. chamber 4, but in other embodiments other therapeutic solutions may also be delivered directly to the blood in the arterial line 7 and/or venous line 6 (or even in some embodiments, to the blood residing in the main chamber 3 in the blood).

In other embodiments, a blood treatment device as described herein may include delivery of two or more different therapeutic solutions to the same or different locations within the blood treatment device. For example, a treatment solution in the form of dialysate may be delivered to the secondary chamber 4 of the filter as shown in the embodiments of FIGS. Blood in chamber 3, arterial line 7 and/or venous line 6.

The therapeutic solution delivered by the therapeutic solution delivery system within the blood treatment apparatus described herein is supplied using two or more intermediate containers. The weight of the intermediate container can be measured and used to control refilling and emptying of the therapeutic solution in the intermediate container. In some embodiments, the amount of treatment solution delivered to selected portions of the blood treatment apparatus may also be controlled based at least in part on the weight and/or weight change of the intermediate container. The therapeutic solution in two or more intermediate containers is provided to the intermediate container from a therapeutic solution source, which can potentially reduce or eliminate the need to stop delivery of therapeutic solution to replace the intermediate container when the intermediate container is emptied and/or refilled. need.

In the blood treatment apparatus described herein, an "intermediate container" may take any suitable form capable of storing a liquid, such as a bag, bottle, reservoir, or the like.

In the embodiment of the blood treatment apparatus 1 shown in FIGS. 2 , 5 and 8 , the first intermediate container 11 and the second intermediate container 12 are used to supply the therapeutic solution to the output controller 31 which in turn The therapeutic solution is supplied to the therapeutic solution port 10 (connected to the inlet line 9 in the embodiment shown). The first weight scale 21 is configured to weigh the first intermediate container 11 , the weight indicating the amount of the treatment solution contained in the first intermediate container 11 . The second weight scale 22 is configured to weigh the second intermediate container 12 , the weight indicating the amount of therapeutic solution contained in the second intermediate container 12 .

Another feature common to the exemplary embodiments of the blood treatment apparatus shown in FIGS. 2 , 5 and 8 is that the control unit 41 is linked to the first and second weight scales 21 , 22 and to the output controller 31 . Regardless of the additional fluid flow control components that may or may not be present in the blood treatment apparatus described herein, the control unit 41 may be linked to (other than the first weight scale 21, the second weight scale 22, and the output controller 31) Various fluid flow control assemblies such that one of the intermediate containers (11, 12) is filled with therapeutic solution while the therapeutic solution flows from the other of the intermediate containers (12, 11), and vice versa.

The control unit 41 may be provided in any suitable form and may, for example, include a memory and a controller. The controller may be in the form of, for example, one or more microprocessors, application specific integrated circuit (ASIC) state machines, or the like. Control unit 41 may include any suitable input device configured to allow a user to operate the device (e.g., a keyboard, touch screen, mouse, trackball, etc.) and a display device (e.g., a monitor ( may or may not be a touch screen), indicator light, etc.).

More specifically, the blood treatment apparatus described herein comprises an output controller 31 acting downstream of the first intermediate container 11 and the second intermediate container 12 . The control unit 41 may be configured to control the output controller 31 to provide a substantially continuous flow of therapeutic solution to the therapeutic solution port 10 during therapy delivered with the blood therapy device. Various fluid flow control components and reservoirs in the device are controlled to provide a substantially continuous flow of therapeutic solution through therapeutic solution port 10 (at a constant flow rate and/or at a variable flow rate according to a selected flow rate profile).

The weight information supplied to the control unit 41 by the first weight scale 21 is used to monitor the weight of the first intermediate container 11 to know the amount of therapeutic solution flowing out of the first intermediate container 11 and using two preselected thresholds (for example, 11.1 and 11.2) (can be set based on the volume of each intermediate container) Control the filling and discharging phases of the first intermediate container 11 and the second intermediate container 12 .

The second weight scale 22 provides weight information to the control unit 41 so that the weight of the second intermediate container 12 can be monitored. This weight information can be used to determine the amount of therapeutic solution flowing out of the second intermediate container 12 . This weight information can also be used to control the cyclic filling and draining process using one or two thresholds (eg, 12.1 and 12.2) for the second weight gauge and one or two thresholds (11.1 and 11.2) for the first weight gauge. If using two thresholds is sufficient for controlling therapeutic solution flow control, in some embodiments, four thresholds for two weights can be used for other functions, such as preventative alarm use related to abnormal state of the bag, etc.

In some embodiments, the control unit 41 is configured to calculate the amount of therapeutic solution delivered from the therapeutic solution source 60 to the blood treatment device based on a weight signal received from a weight gauge configured to control Each intermediate container weighing (in the embodiment shown, including the first and second weighing scales (21 and 22)) of the fluid delivered by the controller 31, but if more than two intermediate containers are used to feed the output controller 31 , more weights can be included).

The various exemplary embodiments of the blood treatment apparatus shown in FIGS. 2 , 5 and 8 include a source of treatment solution 60 that provides treatment solution to an intermediate container, which in turn is used to supply treatment to the output controller 31. solution. The therapeutic solution source 60 is in fluid communication with a container selection controller 32 which can be used to direct therapeutic solution from the therapeutic solution source 60 to the first intermediate container 11 or the second intermediate container depending on which intermediate container requires refilling. Therapeutic solution source 60 supplies therapeutic solution to container selection controller 32 through source flow controller 33 .

Although source flow controller 33 is shown in the embodiments of FIGS. 2 , 5 and 8 as being in the form of a peristaltic pump, source flow controller 33 can be in various alternative forms that can be used to control the flow of therapeutic solution. to provide, including, for example, other pumps (eg, piston pumps, diaphragm pumps, etc.), other flow control mechanisms (eg, valves, clamps, etc.), and the like.

In the embodiment shown in FIG. 2, the therapeutic solution in the therapeutic solution source 60 may include multiple reservoirs 61, 62, 63 that may be replaced independently to ensure that the therapeutic solution source 60 continues to selectively control the reservoir. Container 32 provides a therapeutic solution. The reservoirs 61, 62, 63 may take any form suitable for containing the liquid to be delivered, such as bags, bottles or the like. The reservoirs 61, 62, 63 may be suitable for one-time use (they will then be disposed of), but the reservoirs 61, 62, 63 may also be capable of being refilled when not connected within the therapeutic solution source 60 to deliver the therapeutic solution .

In some embodiments, all reservoirs 61, 62, 63 may be in fluid communication with source flow controller 33 simultaneously, but in other embodiments, one or more of reservoirs 61, 62, 63 may be selectively One is provided in fluid communication with the source flow controller 33, while one or more of the reservoirs 61, 62, 63 are not in fluid communication with the source flow controller 33 (they may be disconnected, for example, or the fluid lines pass through valves, clamp or other flow control).

Although the therapeutic solution source 60 shown in FIG. 2 includes three reservoirs 61, 62, 63, other embodiments may operate with as few as one or two reservoirs, and other embodiments of the therapeutic solution source may be provided with Four or more reservoirs containing therapeutic solutions. Additionally, in some embodiments, the reservoirs may all hold the same volume of liquid, or they may hold different volumes of therapeutic solution.

In some embodiments, therapeutic solution source 60 includes a reservoir fill monitor 66 configured to monitor the fill status of reservoirs 61, 62, 63 (individually or together). Fill monitor 66 may monitor fluid volume using any suitable technique or combination of techniques (e.g., using weight, using capacitive, optical or other sensors, using fluid pressure (e.g., in line 44), etc.) . Fill monitor 66 may potentially be operatively linked to control unit 41 such that blood treatment device 1 may provide an alert or indication (e.g. visual, audible, etc.) so that appropriate action can be taken. If the filling status of the reservoirs 61, 62, 63 are monitored together, then when the total amount of therapeutic solution in the reservoirs 61, 62, 63 reaches a selected lower limit (e.g., the maximum amount of therapeutic solution that will be contained in the three reservoirs) 1/3) of the time (meaning that at least one of the reservoirs 61, 62, 63 may need to be replaced, refilled, etc.), any warning or indication may be activated.

Another optional feature in the embodiment of blood treatment apparatus 1 shown in FIGS. 44 in. An air detector 70 may be used to detect air in line 44 before it reaches source flow controller 33 . At this point, the operator may take appropriate action to replace any empty reservoirs in therapeutic solution source 60 , or take any other appropriate action required to find the cause of the air in line 44 .

If air is detected by the air detector 70, in some embodiments the control unit 41 (operably connected to the air detector 70 and the source flow controller 33) may be configured to operate the source flow controller 33 in reverse, The therapeutic solution in line 44 is allowed to refill the fluid circuit back to therapeutic solution source 60 . In a system configured for such reverse operation, the intermediate tanks downstream of the tank selection controller 32 (e.g., the first intermediate tank 11 and the second intermediate tank 12) should be filled from the bottom of the intermediate tanks such that at source flow During the reverse operation of the controller 33, the treatment solution in the intermediate container can be withdrawn from the intermediate container through the same line used to fill the intermediate container, and the extracted treatment solution is used in part to help refill the intermediate container (11 or 12) and treat Fluid lines between solution sources 60 .

Another optional feature in the embodiment of the blood treatment apparatus 1 shown in FIGS. 2 , 5 and 8 is a sterile filter 80 . Sterile filter 80 may be located in the fluid delivery path upstream of container selection controller 32 . In some embodiments, sterile filter 80 may be located downstream of source flow controller 33 (i.e., between flow controller 33 and vessel selection controller 32), although other locations are possible (e.g., flow control upstream of device 33). A sterile filter 80 is provided to reduce the likelihood of delivery of contaminated therapeutic solution to the container selection controller 32 and hence to an intermediate container used to supply the output controller 31 .

In some embodiments, sterile filter 80 may include a vent (eg, a passive vent in the form of a hydrophobic membrane) to help remove air that may be entrained within the treatment solution.

In some embodiments, a sterile filter 80 may be located downstream of the source flow controller 33 . Placing the filter 80 downstream of the flow controller 33 avoids the generation of negative pressure within the line 44 feeding the flow controller 33 and any associated out-gassing of the fluid that may result therefrom.

In operation, the control unit 41 in the exemplary embodiment of the blood treatment apparatus shown in FIGS. 2, 5 and 8 may be capable of receiving weight information from the first weight scale 21 and/or the second weight scale 22, calculating The actual flow rate of the therapeutic solution delivered to the therapeutic solution port 10, the actual flow rate is compared to a selected constant flow rate or to a selected flow rate profile and determined using the fluid flow output controller 31, source flow controller 33 and/or Any other fluid flow control mechanism (eg, pumps, valves, clamps, etc.) that may be provided in the blood treatment devices described herein controls the actual flow rate of the treatment solution.

The control unit 41 may also be configured to receive weight information from the first weight scale 21 and/or from the second weight scale 22 during delivery of the treatment solution to the treatment solution port 10, determine the filling state of each intermediate container, based on the The fill status controls the alternate and continuous intermediate container filling and discharge processes. For example, the control unit 41 may be configured to receive weight information from the first weight scale 21 and/or from the second weight scale 22, detect upper and lower thresholds (e.g., 11.2, 11.1, 12.2, 12.1) for each intermediate container, and Threshold based intermediate container filling and draining procedures are controlled according to the following process: the first intermediate container 11 is filled to an upper threshold (e.g. 11.1), while the second intermediate container 12 is discharged until a lower threshold of the second intermediate container 12 is detected (e.g. , 12.2), then the first intermediate container 11 is discharged until its lower threshold (eg, 11.2) is detected, while the second intermediate container 12 is filled to its upper threshold (eg, 12.1).

In order to continuously deliver therapeutic solution to port 10, the fluid flow rate from source flow controller 33 should be greater than the rate at which first intermediate container 11 and second intermediate container 12 discharge (corresponding to the rate of therapeutic solution delivered through port 10 by output controller 31). flow rate). Maintaining this flow rate relationship should generally ensure that the intermediate container being filled reaches its upper threshold before the intermediate container being discharged reaches its lower threshold. In some embodiments, if the flow rate of therapeutic solution being delivered through source flow controller 33 is lower than the flow rate from output controller 31 to port 10, it will typically be necessary to occasionally stop flow through port 10 to allow the intermediate reservoir to refill. .

Referring to the schematic embodiments of the blood treatment device shown in Figures 2-4, the device 1 comprises components related to the delivery of therapeutic solutions in the blood treatment device 1 that are common to the different embodiments described herein. These common components include first intermediate container 11, second intermediate container 12, first weight scale 21, second weight scale 22, output controller 31, container selection controller 32, source flow controller 33, control unit 41, treatment Solution source 60 , air detector 70 and sterile filter 80 .

In this embodiment, container selection controller 32 includes an outlet 51 and an inlet 52 . Therapeutic solution flows from therapeutic solution source 60 (through source flow controller 33 ) into reservoir selection controller 32 through inlet 52 . The therapeutic solution flows out of the container selection controller 32 through the outlet 51 and into the output controller 31 . Various components within container selection controller 32 allow selective filling and draining of first intermediate container 11 and second intermediate container 12 while also providing the ability to maintain a substantially continuous flow of therapeutic solution through outlet 51 to output controller 31 .

Within the vessel selection controller 32, a first line 57 connects the outlet 51 to each of the two outlets (53 and 55) of the first and second intermediate vessels (11 and 12). Flow controllers ( 122 and 124 ) are arranged to act on the first line 57 between the output ports ( 53 and 55 ) and the outlet 51 to allow or prevent flow through the first line 57 to the outlet 51 . Although shown schematically as clamps, flow controllers (122 and 124) may be in the form of, for example, valves, clamps, pumps, and the like.

The vessel selection controller 32 shown in FIG. 2 also includes a second tube that puts the inlet 52 in fluid communication with each of the two input ports (54 and 56) of the first and second intermediate vessels (11 and 12) Road 58. Flow controllers (121 and 123) are arranged to act on the second line 58 between the inlet 52 and the input ports (54 and 56) to allow or prevent flow of the therapeutic solution through the second line 58 to the input port (54 and 56). Although shown schematically as clamps, flow controllers (121 and 123) may be in the form of, for example, valves, clamps, pumps, and the like.

In the operation of the blood treatment apparatus 1, the first intermediate container 11 and the second intermediate container 12 are alternately filled and discharged by controlling various flow controllers (121, 122, 123, 124) in the container selection controller 32, Such that a substantially continuous flow of therapeutic solution may be provided to the outlet 51 feeding the output controller 31 . Figures 3 and 4 show the operation of the blood treatment device 1 such that the intermediate containers (11 and 12) can be alternately filled and discharged via the first and second lines (57 and 58).

In FIG. 3, the flow controller 121 is open and the flow controller 123 is closed. As a result, therapeutic solution can flow from the source flow controller 33 through the second line 58 into the first intermediate container 11 , but is prevented from flowing into the second intermediate container 12 due to the closed flow controller 123 . In the configuration shown in Figure 3, the flow controller 122 on the first line 57 is closed and the flow controller 124 is open. As a result, therapeutic solution can flow from the second intermediate container 12 through the first line 57 to the output controller 31 , but is prevented from flowing out of the first intermediate container 11 due to the closed flow controller 122 . Thus, the configuration shown in FIG. 3 can be described as a configuration in which the first intermediate container 11 is filled or charged via the second line 58 , while the second intermediate container 12 is being emptied or drained via the first line 57 .

FIG. 4 shows a different configuration of the blood treatment device 1 of FIG. 2 , in which the first intermediate container 11 is being emptied or drained, while the second intermediate container 12 is being filled or primed. Specifically, in the configuration of Figure 4, flow controller 123 is open and flow controller 121 is closed. As a result, therapeutic solution can flow from the source flow controller 33 through the second line 58 into the second intermediate container 12 , but is prevented from flowing into the first intermediate container 11 due to the closed flow controller 121 . In the configuration shown in Figure 4, flow controller 124 is also closed and flow controller 122 is open. As a result, therapeutic solution can flow from the first intermediate container 11 through the first line 57 to the output controller 31 , but is prevented from flowing out of the second intermediate container 12 due to the closed flow controller 124 .

In some embodiments, the control unit 41 can be configured to control the container selection controller 32 such that the flow shown in FIGS. Conversion between configurations. For example, when switching between the configurations shown in Figures 3 and 4, both flow controllers 122 and 124 on the first line 57 are open simultaneously before one of the flow controllers is closed.

In some embodiments of the blood treatment apparatus described herein, short interruptions (eg, 60 seconds or less) of treatment solution flow to output controller 31 may be tolerated and may be considered to fall within within the definition of "substantially continuous" therapeutic solution delivery.

The control unit 41 can be configured to control the output controller 31 in different configurations. In one configuration, when only one of the first intermediate container 11 or the second intermediate container 12 is draining (while, for example, the other intermediate container is being filled), the control unit 41 based on the output from the first weighing scale 21 or the second intermediate container 12 Weight information from weight scale 22 controls output controller 31 , container selection controller 32 and source flow controller 33 to achieve a selected flow rate profile of therapeutic solution through therapeutic solution port 10 . In other words, the flow rate of the therapeutic solution through the output controller 31 is a function of the rate of change of the amount of therapeutic solution in the first intermediate container 11 or the second intermediate container 12 . The choice of weight (21 or 22) is based on which intermediate container (11 or 12) is being discharged at the moment.

In another configuration, the control unit 41 controls the output controller 31, the container selection controller 32, and the source flow controller 33 based on weight information from both the first and second weight gauges (21, 22) to achieve through Selected flow rate profile of therapeutic solution to therapeutic solution port 10 . This configuration may be used, for example, when flow controllers 122 and 124 are both open so that therapeutic solution can be delivered from both first intermediate container 11 and second intermediate container 12 to first conduit 57 .

Referring to the exemplary embodiments of the blood treatment apparatus shown in Figures 5-7, the apparatus 1 comprises components related to the delivery of the therapeutic solution in the blood treatment apparatus 1 that are common to the different exemplary embodiments described herein. These common components include first intermediate container 11, second intermediate container 12, first weight scale 21, second weight scale 22, output controller 31, container selection controller 32, source flow controller 33, control unit 41, treatment Solution source 60 , air detector 70 and sterile filter 80 .

In this embodiment, the container selection controller 32 also includes an outlet 51 and an inlet 52 . Therapeutic solution flows from therapeutic solution source 60 (through source flow controller 33 ) through inlet 52 into reservoir selection controller 32 . The therapeutic solution flows out of the container selection controller 32 through the outlet 51 and into the output controller 31 . Various components within container selection controller 32 allow selective filling and draining of first intermediate container 11 and second intermediate container 12 while also providing the ability to maintain a substantially continuous flow of therapeutic solution through outlet 51 to output controller 31 .

Within the vessel selection controller 32, a first line 57 connects the outlet 51 to each of the two outlets (53 and 55) of the first and second intermediate vessels (11 and 12). The flow controller 125 is arranged to act on the first conduit 57 between the outlet ports (53 and 55) on the first and second intermediate containers (11 and 12) and the outlet 51 to allow or prevent passage The first conduit 57 flows to the outlet 51 . The flow controller 125 may be, for example, a multi-port flow controller capable of being configured between at least two alternate configurations, wherein flow is allowed from one of the output ports (53 and 55) through the first line 57, and It is prevented from flowing out from the other output port through the first pipeline 57 . In some embodiments, the multi-port flow controller 125 may have a third configuration in which flow from both output ports ( 53 and 55 ) is allowed through the first conduit 57 . The multi-port flow controller 125 may be provided in the form of a multi-way valve, clamp assembly, or the like. In some embodiments, multiport flow controller 125 may be operatively linked to control unit 41 as shown in FIG. 5 such that control unit 41 may be used to switch multiport flow controller 125 between its various configurations.

The vessel selection controller 32 shown in FIG. 5 also includes a second tube that puts the inlet 52 in fluid communication with each of the two input ports (54 and 56) of the first and second intermediate vessels (11 and 12) Road 58. Flow controller 126 is provided to allow or prevent flow of therapeutic solution through second conduit 58 . The flow controller 126 may be, for example, in the form of a multi-port flow controller capable of being configured between at least two alternate configurations, wherein flow is permitted through the second conduit 58 to one of the inlet ports (54 and 56), And stop flowing to another other input port by the second pipeline 58. In some embodiments, the multi-port flow controller 126 may have a third configuration in which flow is permitted through the second line 58 to both input ports (54 and 56). The multi-port flow controller 126 may be provided in the form of a multi-way valve, clamp assembly, or the like. In some embodiments, multiport flow controller 126 may be operatively linked to control unit 41 as shown in FIG. 5 such that control unit 41 may be used to switch multiport flow controller 126 between its various configurations.

In the operation of the blood treatment apparatus 1, the first intermediate container 11 and the second intermediate container 12 are alternately filled and discharged by controlling the flow controllers (125 and 126) in the container selection controller 32, so that the output can be Outlet 51 fed by controller 31 provides a substantially continuous flow of therapeutic solution. Figures 6 and 7 show the operation of the blood treatment device 1 such that the intermediate containers (11 and 12) can be alternately filled and discharged via the first and second lines (57 and 58).

In FIG. 6 , flow controller 126 is configured to allow therapeutic solution to flow from source flow controller 33 through second conduit 58 into first intermediate vessel 11 , while preventing therapeutic solution from flowing into second intermediate vessel 12 . In the embodiment shown in FIG. 6 , the flow controller 125 is configured to allow the therapeutic solution to flow from the second intermediate container 12 through the first conduit 57 to the output controller 31 , while preventing the therapeutic solution from flowing out of the first intermediate container 11 . Therefore, the configuration shown in FIG. 6 can be described as a configuration in which the first intermediate container 11 is filled or filled through the second line 58 , while the second intermediate container 12 is being emptied or drained through the first line 57 .

FIG. 7 shows a different configuration of the blood treatment device 1 of FIG. 5 , in which the first intermediate container 11 is being emptied or drained, while the second intermediate container 12 is being filled or primed. Specifically, in the configuration of FIG. 7, the flow controller 126 is configured so that the therapeutic solution can flow from the source flow controller 33 through the second conduit 58 to the second intermediate container 12, while preventing the therapeutic solution from flowing to the first intermediate container 12. In an intermediate container 11. In the embodiment shown in FIG. 7, the flow controller 125 is configured to allow the therapeutic solution to flow from the first intermediate container 11 to the output controller 31 through the first line 57, while preventing the therapeutic solution from flowing out of the first line 57 through the first line 57. Two intermediate containers 12 . Thus, the configuration shown in FIG. 7 can be described as a configuration in which the first intermediate container 11 is being emptied or discharged via the first line 57 and the second intermediate container 12 is being filled or filled via the second line 58 .

In some embodiments, the control unit 41 may be configured to control the container selection controller 32 such that switching between the configurations shown in FIGS. 6 and 7 is effected in a manner that does not interrupt the flow of therapeutic solution to the output controller 31 . For example, in some embodiments, when switching between the configurations shown in FIGS. The path 57 flows to the treatment solution output flow controller 31.

The control unit 41 can be configured to control the output controller 31 in different configurations. In one configuration, when only one of the first intermediate container 11 or the second intermediate container 12 is draining (while, for example, the other intermediate container is being filled), the control unit 41 based on the output from the first weighing scale 21 or the second intermediate container 12 Weight information from weight scale 22 controls output controller 31 , container selection controller 32 and source flow controller 33 to achieve a selected flow rate profile of therapeutic solution through therapeutic solution port 10 . In other words, the flow rate of the therapeutic solution through the output controller 31 is a function of the rate of change of the amount of therapeutic solution in the first intermediate container 11 or the second intermediate container 12 . The choice of weight (21 or 22) is based on which intermediate container (11 or 12) is being discharged at the moment.

In another configuration, the control unit 41 controls the output controller 31, the container selection controller 32, and the source flow controller 33 based on weight information from both the first and second weight gauges (21, 22) to achieve through Selected flow rate profile of therapeutic solution to therapeutic solution port 10 . This configuration may be used, for example, if the flow controller 125 allows therapeutic solution to flow through the first conduit 57 from both the first intermediate container 11 and the second intermediate container 12 .

In general, the output controller 31 is configured to deliver the treatment solution at the flow rate of the dialysis fluid through the treatment solution port; to this end, the control unit 41 is configured to receive a set point for the flow rate of the dialysis fluid (e.g., from a user interface which is set for receiving the dialysis fluid flow rate from the operator), and then controlling the output controller 31 so that the treatment solution flows at the dialysis fluid flow rate corresponding to the treatment solution port 10 .

In other words, the dialysis fluid flow rate is set by the physician at the beginning of treatment, and the machine is controlled such that the output controller (ie, the pump) is driven to tend to deliver the set fluid.

In more detail, the control unit 41 is configured to control the output controller 31 based on the weight signals from the first weight scale 21 and the second weight scale 22 so that the treatment solution flows according to the flow rate of the dialysis fluid.

In a first mode in which the first intermediate container 11 supplies fluid to the filter and/or directly to the blood, the control unit 41 is configured to control the output controller 31 based on the weight signal from the first weight scale 21 so that the treatment solution follows the dialysis Fluid velocity flow. In the first mode, the weight signal from the other weight scale 22 is used to monitor the supply of new treatment fluid through the source flow controller; thus, in the first mode, the control unit 41 is configured to In the event of a weight signal from the weight scale 22, the output controller 31 is controlled.

In a second mode in which the second intermediate container 12 supplies fluid to the filter and/or directly to the blood, the control unit 41 is configured to control the output controller 31 based on the weight signal from the second weight scale 22 so that the treatment solution follows the dialysis Fluid velocity flow.

In the second mode, the weight signal from the other weight scale 21 is used to monitor the supply of new treatment fluid through the source flow controller 33; thus, in the second mode, the control unit 41 is configured to The output controller 31 is controlled in case of a weight signal from the weight scale 21 .

To implement the treatment prescription, the control unit 41 is configured to alternately switch between the first mode and the second mode a plurality of times during the treatment session.

Furthermore, typically, the control unit 41 is configured to control the source flow controller 33 to provide a fluid flow rate higher than (or at most equal to) the dialysis fluid flow rate provided by the output controller 31 during therapy.

Another feature shown in connection with the embodiment of the blood treatment apparatus 1 of FIG. A fluid source 67, a therapeutic solution precursor 68, and a mixing device 69 configured to combine a fluid (e.g., water, a suitable aqueous solution, etc.) from the fluid source 67 and a therapeutic solution precursor 68 (e.g., concentrated solutions, etc.) are combined to form a therapeutic solution. Unlike the therapeutic solution source 60 of FIG. 2 , the therapeutic solution delivered using the therapeutic solution source 60 of FIG. 5 is not provided in a reservoir, but rather, is composed within the therapeutic solution source 60 .

Referring to the exemplary embodiments of the blood treatment apparatus shown in Figures 8-10, the apparatus 1 comprises components related to the delivery of therapeutic solutions in the blood treatment apparatus 1 that are common to the different exemplary embodiments described herein. These common components include first intermediate container 11, second intermediate container 12, first weight scale 21, second weight scale 22, output controller 31, container selection controller 32, source flow controller 33, control unit 41, treatment Solution source 60 , air detector 70 and sterile filter 80 .

In the embodiment shown in Figures 8-10, gravity is used in part to control the filling and discharge of the first intermediate container 11 and the second intermediate container 12 . Specifically, the control unit uses the vertical position of the first intermediate container 11 relative to the second intermediate container 12 in combination with the container selection controller 32, the output controller 31 and the source flow controller 33 to selectively fill and discharge the second intermediate container. An intermediate container 11 and a second intermediate container 12.

Source flow controller 33 is connected to output controller 31 by fluid line 157 . The first intermediate container 11 is in fluid communication with a fluid line 157 via a fluid line 152 which is connected to the fluid line 157 at a connection 153 . The second intermediate container 12 is in fluid communication with a fluid line 157 via a fluid line 154 , which is connected to the fluid line 157 at a connection 155 . In the illustrated embodiment, container selection controller 32 is positioned along fluid line 157 between connections 153 and 155 .

Gravity is used in the blood treatment apparatus shown in FIG. 8 by positioning the first intermediate container 11 at a higher vertical position than the second intermediate container 12 . In some embodiments, the upper limit (eg, 12.1) of the second intermediate vessel 12 is lower than the lower limit (eg, 11.2) of the first intermediate vessel 11 or they are at the same level. In the operation of the blood treatment apparatus 1, the first intermediate container 11 and the second intermediate container 12 are alternately filled and discharged by controlling the container selection controller 32 together with the source flow controller 33 so that the output controller 31 can be supplied with Substantially continuous flow of therapeutic solution.

9 and 10 illustrate the operation of the blood treatment apparatus 1 shown in FIG. 8 such that the intermediate containers ( 11 and 12 ) can be alternately filled and drained via the fluid lines 152 , 154 and 157 . In FIG. 9, the container selection controller 32 is turned off. As a result, therapeutic solution flows from source flow controller 33 through fluid lines 152 and 157 into first intermediate container 11 , while therapeutic solution is prevented from flowing through container selection controller 32 to second intermediate container 12 or output controller 31 . As a result, in the configuration shown in FIG. 9 , the treatment solution from the source flow controller 33 fills or fills the first intermediate container 11 . Since the container selection controller 32 is closed in FIG. 9 , the therapeutic solution in the second intermediate container 12 flows out of the second intermediate container 12 to the output controller 31 . Thus, the configuration shown in FIG. 9 can be described as a configuration in which the first intermediate container 11 is filled or filled, while the second intermediate container 12 is emptied or discharged.

FIG. 10 shows a different configuration of the blood therapy device 1 of FIG. 8 , in which the first intermediate container 11 is being emptied or drained, while the second intermediate container 12 is filled or filled with a therapeutic solution. Specifically, in the configuration of FIG. 10 , source flow controller 33 is disabled or closed such that no therapeutic solution is delivered through flow controller 33 into fluid line 157 and container selection controller 32 is open. Since the first intermediate container 11 is higher than the second intermediate container 12 , the therapeutic solution will flow from the first intermediate container 11 into the fluid line 157 to deliver the therapeutic solution to both the output controller 31 and the second intermediate container 12 . Treatment solution introduced into the fluid line 157 from the first intermediate container 11 will flow into the second intermediate container 12 beyond the solution removed from the fluid line 157 by the output controller 31 . Thus, the configuration shown in FIG. 10 can be described as a configuration in which the first intermediate container 11 is being emptied or drained via the fluid line 157 and the second intermediate container 12 is being filled or filled.

In order to ensure that the therapeutic solution flows continuously through the output controller 31, some flow rate conditions must be met for the following three flow rates: the flow rate from the source flow controller 33 (Q33), the flow rate through the output controller 31 (Q31), and the flow rate at the refill cycle time. The mean value (Q2g) of the gravity-driven flow rate (Q2g) of the treatment solution from the first intermediate container 11 to the second intermediate container 12 (this flow through the line 154 into the second intermediate container 12 only exists in the operating configuration shown in Figure 10 middle).

Two conditions that should be met for continuous flow through the output controller 31 are: 1) the source flow should be greater than the output flow, i.e., Q33>Q31; and 2) the gravity-driven flow rate Q2g is large enough to fill the second intermediate vessel 12 in time, while still flowing to The output controller 31 feeds, ie, Q2g>(Q31/(Q33/(Q31-1)).

If the flow rate from the source flow controller 33 is higher than three times the flow rate through the output controller 31 (i.e., Q33>(3×Q31)), then the flow rate of the treatment solution from the first intermediate container 11 to the second intermediate container 12 The gravity-driven flow rate (Q2g) should be at least half of the desired flow rate through the output controller 31 (ie, Q2g>(Q31/2)).

If the flow rate from the source flow controller 33 is higher than 1.5 times the flow rate through the output controller 31 (i.e., Q33>(1.5×Q31)), the treatment solution from the first intermediate container 11 to the second intermediate container 12 The gravity-driven flow rate (Q2g) should be at least twice the desired flow rate through the output controller 31 (ie, Q2g>(2*Q31)).

Figure 11 shows the change in weight of the first intermediate container and the second intermediate container as a function of treatment time for the embodiment of the blood treatment apparatus shown in Figures 8-10, where time (seconds) is represented along the X or horizontal axis, and weight ( grams) are represented along the Y or vertical axis.

Starting with the specific example of Fig. 11, two consecutive phases or steps during the drainage cycle will now be described, preceding the system preparation phase. At the beginning of the treatment session, recording that the two intermediate containers were nearly empty (eg, approximately 80 grams (g) in weight), a preparatory phase was performed.

The control unit arms source flow controller 33 , opens container selection controller 32 , and does not operate output controller 31 so that no therapeutic solution is removed from fluid line 157 through fluid output controller 31 .

Source flow controller 33 controls the flow of therapeutic solution from therapeutic solution source 60 into fluid line 157 .

The second intermediate container 12 is downstream of the source flow controller 33 relative to the first intermediate container 11 , but at a lower position than the first intermediate container 11 . Since the second intermediate container 12 is lower than the first intermediate container 11 , the second intermediate container 12 is filled with the treatment solution before the first intermediate container 11 . Thus, it can be seen that the weight of the second intermediate container 12 (PE2 on FIG. 11 ) increases preferentially and regularly with respect to the weight of the first intermediate container 11 (PE1 on FIG. 11 ), which remains constant.

As the second intermediate container 12 reaches a selected weight (e.g., about 280 g in the illustrated embodiment), the blood treatment device 1 will operate according to the first phase as shown in FIG. 9: the source flow controller 33 continues to deliver therapy Solution, container selection control 32 is closed and output control 31 is operable to deliver therapeutic solution to port 10 .

As can be seen from Figure 9, the second intermediate container 12 will discharge into fluid line 157 where the treatment solution will be delivered to output controller 31 to, for example, initiate a treatment session. It can be seen that the weight of the second intermediate container 12 decreases regularly (eg, from about 280 g to about 120 g).

It can also be seen from FIG. 9 that the first intermediate container 11 is filled with the treatment solution from the source flow controller 33 . It can be seen that the weight of the first intermediate container 11 increases (for example, from 80 g to about 680 g).

This first stage is performed until a minimum weight threshold for the second intermediate container 12 is reached (e.g., about 120 g in the illustrated embodiment), or a maximum weight threshold for the first intermediate container is reached (e.g., in the illustrated embodiment , 680g), or the first of the above two thresholds is reached.

When such a threshold is detected, the control unit enters the second stage shown in FIG. 10 .

In the second phase, the therapeutic solution flows out of the first intermediate container 11 (as indicated by the decrease in the weight of the first intermediate container 11), while the therapeutic solution flows into the second intermediate container 12 (as indicated by the increase in the weight of the second intermediate container 12). indicated). During this phase, control unit 41 opens reservoir selection controller 32 and stops flow of therapeutic solution from source flow controller 33 (in some embodiments, source flow controller 33 is stopped before reservoir selection controller 32 is opened). As a result, the treatment solution from the first intermediate container 11 flows into the second intermediate container 12 and to the output controller 31 .

This second stage continues until the first intermediate container 11 reaches a selected minimum weight (e.g., about 100 g in the illustrated embodiment) or the second intermediate container 12 reaches a selected maximum weight (e.g., in the illustrated embodiment). In an embodiment, about 590 g).

At the end of the second phase, the system switches back to the first phase, where the source flow controller 33 delivers therapeutic solution and the container selection controller 32 is closed, while the output controller 31 delivers therapeutic solution to port 10 .

With the container selection controller 32 closed, the second intermediate container 12 drains the therapeutic solution delivered to the output controller 31 to continue the therapy session. It can be seen that the weight of the second intermediate container 12 decreases regularly (eg, from about 590 g to about 120 g).

On the other hand, the first intermediate container 11 is filled with the treatment solution from the source flow controller 33 . It can be seen that the weight of the first intermediate container 11 increases (for example, from 80 g to about 680 g).

It should be noted that the first intermediate container 11 reaches its selected maximum threshold (eg, approximately 680 g) before the second container 12 reaches its selected minimum threshold. As a result, delivery of the therapeutic solution into the first intermediate container 11 stops, as shown by the steady (constant) weight of the first intermediate container in FIG. 11 . Alternatively, it may occur after the first intermediate container 11 reaches its selected maximum threshold (which would occur after the second intermediate container reaches its selected minimum threshold (e.g., in the embodiment shown in FIG. 11 , about 400 g or Smaller) any time before) triggers a switch back to the second-stage operation.

When the minimum weight threshold for the second container is reached, the system can then enter a second stage of operation as described herein, wherein based on the minimum and maximum thresholds of the first intermediate container 11 and the second intermediate container 12, the Switch between phases until the end of the treatment session.

Illustrative embodiments of blood therapy apparatus and methods of use thereof are discussed and reference is made to possible variations. These and other changes and modifications of the invention will be apparent to those skilled in the art without departing from the scope of the invention, and it should be understood that this invention is not limited to the illustrative embodiments set forth herein. Accordingly, the invention is to be limited only by the claims provided below and their equivalents.

Claims (25)

1. A blood treatment device (1), the blood treatment device (1) comprising: a blood circuit comprising an arterial line (7) intended to draw blood from a patient and a venous line (6) intended to return blood to said patient; A filter (2) having a primary chamber (3) and a secondary chamber (4) separated by a semipermeable membrane, wherein the blood circuit is configured to pass blood through the primary chamber (3), and wherein, The blood treatment apparatus (1) comprises a drainage line (8) exiting the secondary chamber (4) to remove spent dialysate from the secondary chamber; and A therapeutic solution delivery system having a therapeutic solution port (10) configured to deliver to the secondary chamber (4) and/or the secondary chamber (4) and/or the A blood circuit delivers a therapeutic solution, wherein the therapeutic solution delivery system includes: a first intermediate container (11); a first weight (21) configured to weigh said first intermediate container (11); a second intermediate container (12); a second weight scale (22) configured to weigh said second intermediate container (12); source of therapeutic solution (60); a source flow controller (33) configured to flow from the therapeutic solution source (60) to the first intermediate container (11) weighed by the first weight scale (21) and from the second Said second intermediate container (12) weighed by a gravimeter (22) delivers the treatment solution; a sterile filter (80) positioned between the therapeutic solution source (60) and the therapeutic solution port (10) such that delivery from the therapeutic solution source (60) to the The treatment solution at the treatment solution port (10) passes through the sterilizing filter (80), wherein the sterilizing filter (80) is located downstream of the source flow controller (33); an output controller (31) configured to control flow of therapeutic solution from said first intermediate container (11) and said second intermediate container (12) to said therapeutic solution port (10); a container selection controller (32) located in the therapeutic solution path between said source flow controller (33) and said output controller (31); a control unit (41) operatively attached to said first weight meter (21), said second weight meter (22), said source flow controller (33), said vessel selection controller ( 32) and the output controller (31), wherein the control unit (41) is configured to: receiving weight signals from said first weight scale (21) and said second weight scale (22); The source flow controller (33), the vessel selection controller (32) and the output controller (31) are controlled in a first mode in which therapeutic solution is delivered to the output controller (31), while the therapeutic solution leaves the first intermediate container (11), and the second intermediate container (12) is filled with the therapeutic solution; and The source flow controller (33), the container selection controller (32) and the output controller (31) are controlled in a second mode, in which the second intermediate container (12 ) delivers therapeutic solution to the output controller (31), while the first intermediate container (11) is filled with therapeutic solution from the therapeutic solution source. 2. The device according to claim 1, comprising a user interface for receiving a set value for a dialysis fluid flow rate, wherein said output controller (31) is configured to pass said dialysis fluid flow rate through said The treatment solution port delivers treatment solution, the control unit (41) is configured to: - receiving a setpoint for said dialysis fluid flow rate; - controlling said output controller (31) such that said treatment solution flows at said dialysis fluid flow rate corresponding to said treatment solution port (10). 3. The apparatus according to claim 2, wherein the control unit (41) is configured to control the The output controller (31) is configured to cause the therapeutic solution to flow in accordance with the dialysis fluid flow rate. 4. Apparatus according to any one of claims 2 to 3, wherein the control unit (41) is configured in the first mode based on the The weight signal controls the output controller (31) such that the treatment solution flows at the dialysis fluid flow rate without using the weight signal from the second weight scale (22). 5. Apparatus according to any one of claims 2 to 3, wherein the control unit (41) is configured to, in the second mode, be based on the The weight signal controls the output controller (31) such that the treatment solution flows at the dialysis fluid flow rate without using the weight signal from the first weight scale (21). 6. The device according to any one of claims 1 to 3, wherein the control unit (41) is configured to switch between the first mode and the second mode multiple times during a treatment session. Second-rate. 7. The apparatus according to any one of claims 1 to 3, wherein said control unit (41) is configured to control said source flow controller (33) to provide The fluid flow rate of the dialysis fluid flow rate provided by the controller (31) is output. 8. The apparatus according to any one of claims 1 to 3, wherein the control unit (41) is configured to control the source flow controller (33), the container selection controller (32) and said output controller (31) such that a continuous flow of therapeutic solution is provided to said therapeutic solution port when switching between said first mode and said second mode. 9. Apparatus according to any one of claims 1 to 3, wherein the secondary chamber (4) comprises an inlet line (9) to receive a treatment fluid, the treatment solution port (10) being configured to A therapeutic solution is delivered to the inlet line (8) of the secondary chamber (4) and/or to the blood circuit. 10. Apparatus according to any one of claims 1 to 3, wherein, with respect to the therapeutic fluid flow direction, said first intermediate container (11) and said second intermediate container (12) and said container A selection controller (32) is arranged upstream of said filter (2). 11. Apparatus according to any one of claims 1 to 3, wherein said apparatus further comprises a source (60) of therapeutic solution which is connected to said first intermediate container (11) and The second intermediate container (12) is in fluid communication for delivering therapeutic fluid to the first intermediate container or the second intermediate container. 12. Apparatus according to any one of claims 1 to 3, wherein, In said first mode, therapeutic solution can flow from said source flow controller (33) into said second intermediate container (12) while preventing therapeutic solution from flowing into said first intermediate container (11), and therapeutic solution is able to flow from said first intermediate container (11) to said output controller (31) while preventing therapeutic solution from flowing out of said second intermediate container (12), and/or In said second mode, therapeutic solution can flow from said source flow controller (33) into said first intermediate container (11) while preventing therapeutic solution from flowing into said second intermediate container (12), and Treatment solution is able to flow from the second intermediate vessel (12) to the output controller (31) while preventing treatment solution from flowing out of the first intermediate vessel (11). 13. The device according to any one of claims 1 to 3, wherein the device further comprises a sterilizing filter (80) located at the source flow controller (33 ) and the first intermediate container (11) and/or the second intermediate container (12). 14. The apparatus according to any one of claims 1 to 3, wherein said source flow controller (33) is located between said therapeutic solution source (60) and said first intermediate container (11) and said between the second intermediate container (12), so that the therapeutic solution delivered from the therapeutic solution source (60) to the first intermediate container (11) and the second intermediate container (12) passes through the source flow Controller (33). 15. Apparatus according to any one of claims 1 to 3, wherein the vessel selection controller (32) comprises a valve configured to have an open state and a closed state, in the open state allowing Flow through the line to which the valve acts, in the closed state, prevents flow through the line to which the valve acts. 16. Apparatus according to any one of claims 1 to 3, wherein the container selection controller (32) comprises a pump configured to pass through the A tubing carries a therapeutic solution that prevents flow of therapeutic solution through the tubing in which the pump is located when the pump is not operating. 17. Apparatus according to any one of claims 1 to 3, wherein the vessel selection controller (32) comprises a multi-way valve, wherein, in a first configuration, the multi-way valve allows therapeutic solution from the therapeutic solution source flows into the first intermediate container and prevents the therapeutic solution from flowing into the second intermediate container, and wherein, in a second configuration, the multi-way valve allows A therapeutic solution from a therapeutic solution source flows into the second intermediate container and prevents the therapeutic solution from flowing into the first intermediate container. 18. The apparatus according to any one of claims 1 to 3, wherein the first intermediate container outlet flow controller and the second intermediate container outlet flow controller comprise a multi-way valve, wherein, at In one configuration, the multi-way valve allows therapeutic solution from the first intermediate vessel to flow to the output controller and prevents therapeutic solution from the second intermediate vessel to flow to the output controller, and wherein, at In a second configuration, the multi-way valve allows therapeutic solution from the second intermediate reservoir to flow to the output controller and prevents therapeutic solution from the first intermediate reservoir to flow to the output controller. 19. Apparatus according to any one of claims 1 to 3, wherein the control unit (41) is configured to calculate from the received weight signal the weight from the first intermediate container (11) and the The amount of therapeutic solution delivered to the output controller (31) by both the second intermediate container (12). 20. The device according to any one of claims 1 to 3, wherein the device further comprises an air detector (70) located between the therapeutic solution source (60) and the between the therapeutic solution ports (10), such that the therapeutic solution delivered from the therapeutic solution source to the therapeutic solution port passes through the air detector (70). 21. Apparatus according to any one of claims 1 to 3, wherein said apparatus further comprises an air detector located between said therapeutic solution source (60) and said source flow controller (33) (70). 22. Apparatus according to any one of claims 1 to 3, wherein, in the first mode, the control unit (41) is configured to The weight signal controls the source flow controller (33) such that the second intermediate container (12) is filled with therapeutic solution without using the weight signal from the first weight scale (21) . 23. Apparatus according to any one of claims 1 to 3, wherein, in the second mode, the control unit (41) is configured to The weight signal controls the source flow controller (33) such that the first intermediate container (11) is filled with therapeutic solution without using the weight signal from the second weight scale (22) . 24. The apparatus according to any one of claims 1 to 3, wherein the sterilizing filter (80) includes an air vent configured to remove air entrained within the treatment solution. 25. The apparatus of claim 24, the vent comprising a hydrophobic membrane.