Patent Description:
The disclosed subject matter relates generally to devices, methods, systems, improvements, and components for preparing medicaments and making medicament available for use by a consumer, for example, a dialysis cycler.

Peritoneal dialysis is a mature technology that has been in use for many years. It is one of two common forms of dialysis, the other being hemodialysis, which uses an artificial membrane to directly cleanse the blood of a renal patient. Peritoneal dialysis employs the natural membrane of the peritoneum to permit the removal of excess water and toxins from the blood.

In peritoneal dialysis, sterile peritoneal dialysis fluid is infused into a patient's peritoneal cavity using a catheter that has been inserted through the abdominal wall. The fluid remains in the peritoneal cavity for a dwell period. Osmotic exchange with the patient's blood occurs across the peritoneal membrane, removing urea and other toxins and excess water from the blood. Ions that need to be regulated are also exchanged across the membrane. The removal of excess water results in a higher volume of fluid being removed from the patient than is infused. The net excess is called ultrafiltrate, and the process of removal is called ultrafiltration. After the dwell time, the dialysis fluid is removed from the body cavity through the catheter.

It is referred to <CIT>, <CIT> and <CIT> as prior art.

Methods, device, and systems for preparing medicaments such as, but not limited to, dialysis fluid are disclosed. In embodiments, medicament is prepared at a point of care (POC) automatically using a daily sterile disposable fluid circuit, one or more concentrates to make batches of medicament at the POC.

Embodiments of medicament preparation, devices, systems, and methods are described herein. The features, in some cases, relate to automated dialysis such as peritoneal dialysis, hemodialysis and others, and in particular to systems, methods, and devices that prepare peritoneal dialysis fluid in a safe and automated way at a point of care. The disclosed features may be applied to any kind of medicament system and are not limited to dialysis fluid.

Objects and advantages of embodiments of the disclosed subject matter will become apparent from the following description when considered in conjunction with the accompanying drawings.

Embodiments will hereinafter be described in detail below with reference to the accompanying drawings, wherein like reference numerals represent like elements. The accompanying drawings have not necessarily been drawn to scale. Where applicable, some features may not be illustrated to assist in the description of underlying features.

Referring to <FIG>, a purified water source <NUM> with a water pump <NUM> supplies highly purified water through a connector <NUM> and then through a water line <NUM>. The water line <NUM> has a non-reopenable clamp <NUM>, another connector <NUM>, a manual tube clamp <NUM>, and a pair of redundant <NUM> micron sterilizing filters <NUM>. A water inlet clamp <NUM>, batch release clamp <NUM>, and a conductivity sensor clamp <NUM> are controlled by a controller <NUM>. Also, each of a first concentrate clamp <NUM> and a second concentrate clamp <NUM> control the flow of two concentrates, respectively. A mixing container line clamp <NUM> controls flow to and from a mixing container <NUM>. The controller <NUM> controls the pinch clamps and a peristaltic pump <NUM> to make a batch of diluted concentrate in the mixing container <NUM>. The mixing container <NUM> may be a vessel of any type, for example a bag. As a bag is held by a tub <NUM>. The tub <NUM> is useful when the mixing container <NUM> may constitute a bag in order to provide support. A tub leak sensor <NUM> detects leaks into the tub <NUM> and a temperature sensor <NUM> detects the temperature of the fluid in the mixing container <NUM>. A warmer <NUM> may be used if one does not exist in the medicament user <NUM>. The medicament user <NUM> may be any type of a consuming device for example, a medical treatment device, for example, a peritoneal dialysis cycler or a hemodialysis cycler.

The peristaltic pump <NUM> moves fluid in a line <NUM> connected to the mixing container <NUM>. The peristaltic pump <NUM> also moves fluid, at selected times, through the line <NUM> which may return the fluid to the mixing container <NUM> to stir its contents. Initially the purified water from the purified water source <NUM> is pumped by the water pump <NUM> with water inlet clamp <NUM> open and other clamps closed. The peristaltic pump <NUM> runs in a rightward direction to provide water to the mixing container <NUM>. The water pump <NUM> and the peristaltic pump <NUM> may work in tandem with the controller controlling the speed of the water pump <NUM> and/or the peristaltic pump <NUM> to maintain a predefined pressure in a manifold line <NUM> responsively to the pressure indicated by a pressure sensor <NUM>. The reason for pressure control is that the peristaltic pump <NUM> output is sensitive to inlet pressure changes. To mix the contents of the mixing container <NUM> the peristaltic pump <NUM> pumps fluid in a circular path through lines <NUM> and <NUM> with the all the clamps closed except for mixing container line clamp <NUM>. The direction of the flow for mixing may be reversed such that the mixing may work in either way. Thus, the contents of the mixing container <NUM> are mixed by the flow circulating through the mixing container <NUM>. A sample of the fluid in the mixing container <NUM> may be pumped through a drain conductivity line <NUM> which contains conductivity/ temperature sensors 159c and <NUM> to determine a temperature-compensated conductivity of the diluted medicament. At this time, the batch release clamp <NUM> is open and the other clamps are closed. A pump, not shown, in a medicament user <NUM>, may then draw fluid. The peristaltic pump <NUM> is feedback controlled, based on input from a pressure sensor <NUM>, to maintain a predefined pressure at the pressure sensor <NUM>. The medicament user <NUM> may be any type of treatment device or container that receives the mixed medicament from the mixing container <NUM>.

Note that as used herein, the temperature-compensated conductivity (or simply conductivity) may be a value that is generated by the controller <NUM> by multiplying the measured conductivity with a value that represents the rate of change of concentration with temperature. In other embodiments, the controller <NUM> may calculate a concentration directly using a look-up table or formula.

Included in a disposable unit <NUM> are a medicament supply line <NUM>, manifold line <NUM>, water source line <NUM>, drain conductivity line <NUM> and the mixing container <NUM>. The disposable fluid circuit has permanent connection up to and including the connectors <NUM>. A check valve <NUM> prevents back flow in the drain conductivity line <NUM>. A pair of conductivity temperature sensors 159c and <NUM>. An attachment to drain or waste container is provided by a connector <NUM>.

Mixed fluid is pumped through conductivity/ temperature sensors 159c (control) and <NUM> (safety) and is determined to be mixed when two consecutive measurements are close within a range of each other. That is, consecutive samples at different points along the flowing stream of the contents of the mixing container <NUM> may agree or not. If not the contents of the mixing container may be mixed again in mixing container <NUM> one or more times. If they differ, the mixing container <NUM> may be mixed again but if a failure will be output if the specified number of times does not result in an agreement.

The reason for the redundant conductivity/ temperature sensors 159c and <NUM> is that it provides a check on each conductivity/ temperature sensors 159c and <NUM>. If they disagree, the mixing can be halted until the problem is worked out. The mixing container <NUM> may be perform another mixing of mixing container <NUM> and see if the measurement of the mixing container <NUM> is uniform.

A door lock <NUM> is provided adjacent the user interface door <NUM> to lock the user interface door. A door sensor <NUM> detects whether the door lock <NUM> is in an open or a locked position. The door sensor <NUM> ensures the actuators such as pinch clamps and peristaltic pump actuator fully engage the disposable circuit. The pure water flows into the disposable circuit <NUM> where a pair of <NUM> micron sterilizing filters <NUM> are located to ensure that any touch contamination making the connections for <NUM> are prevented from flowing into the disposable circuit <NUM>.

A two-concentrate component system is illustrated. There are two concentrate containers - dextrose container <NUM> and electrolyte container <NUM> connectable to the rest of the fluid circuit by respective connectors <NUM>. Note the concentrates are not limited to two - the two concentrates are shown for illustration.

In the present example in the concentrates are dextrose and electrolytes that may be used to create a ready-to-use peritoneal dialysis fluid. The dextrose concentrate may contain part of the electrolyte required to make the concentration of dextrose measurable by means of a conductivity sensor. The ratio of electrolyte to osmotic agent (e.g., dextrose) may be the lowest ratio of osmotic agent to electrolyte so that only the contents of the osmotic agent the need to be mixed if the lowest dose is required. That is, the amount of electrolyte in the dextrose container may be the amount of a predefined minimum prescribed dose of dextrose, in which case, the separate dextrose is not used. Note the number and type of the medicament concentrate may be different and within the scope of the present so the example described is not limiting of the disclosed subject matter.

<FIG> shows a procedure for reliably measuring the conductivity of a fluid. In this procedure two consecutive measurements are made. The fluid first passes through conductivity/ temperature sensors 159c and <NUM> giving a first temperature compensated conductivity. Then the peristaltic pump <NUM> moves more of the fluid from the mixing container <NUM> and the resulting fluid is measured again. Thus, consecutive measurements cover different portions of a stream of fluid. The measurements are compared by the controller <NUM> and if the temperature-compensated conductivities are within a predefined range of each other then the measurement is output as a reliable measurement at S13. If the measurements show a difference in concentration beyond a predefined range, then the mixing container <NUM> is mixed again, and the acquisition of consecutive measurement is repeated the remix is N times and the consecutive measurements still disagree the batch may be failed. The rationale for remixing is that a difference in magnitude of the consecutive measurements is caused by inadequate mixing. Again, after mixing again and repeating the making of two consecutive measurements, the magnitudes are still outside of the predefined range of each other, then the controller outputs a measurement failure or data indicating "bad measurement. " Also, after the initial measurement the controller determines if there is a predefined difference between the measurement and a predefined or calculated estimate then the algorithm will immediately output an indication and stops the process.

Note that the consecutive measurements may be done sequentially in time using one temperature-compensated conductivity measurement indicated by conductivity/ temperature sensor 159c, only. The fluid then is conveyed and a temperature-compensated conductivity measurement is measured again by the same sensor. In alternative embodiments, separate pairs or single temperature-compensating may be separated along a line and the measurement generated by them may be compared instead.

Referring to <FIG>, at S1, the fluid whose concentration is to be measured is pumped through a conductivity/ temperature sensor. The system is placed in the configuration of <FIG>. At S3, the temperature compensated conductivity, which is proportional to the concentration, is measured a first time by flowing fluid through or past a temperature and conductivity sensors and storing a magnitude. If the disparity between an estimate and the measured compensated conductivity is beyond a threshold, then the process stops and an output indicates the type of failure (or may output a non-specific failure) S5. If there is no indication of a predefined disagreement between estimate and actual measurements, then after a time (S7) when a different volume of fluid (but part of the same stream) is in or passing the conductivity/temperature sensors, then a second measurement is made and either determined to be within a predefined range of each other or outside the range (S11). If the difference is within the range, then control proceeds to S13 and the measurement can be output to the calling routine. But if not within the range, control proceeds to S15 (the system is placed in the configuration of <FIG>) where the contents of the mixing container are mixed again. At S17, the system is placed in the configuration of <FIG>. A third measurement of the fluid from the mixing container is taken, the fluid moved again S <NUM> and a fourth measurement taken S21. The controller determines if the third and fourth measurements agree at S23. If they agree (are within a defined range) then the measurement is output at S13. If not, at S25, a failure is indicated by the controller. Note that when conductivity is measure, the temperature is also measured so that a quantity representing temperature-compensated conductivity is generated. This applies to the operation of <FIG> and others. Another embodiment can use just a conductivity sensor rather that both a conductivity/ temperature sensor if temperatures are consistently close to a predefined temperature. Note that in the specification, "bad measurement" means a measurement of the temperature-compensated conductivity could not be generated by the procedure of <FIG>.

<FIG> and <FIG> show a flow chart describing a procedure that may be executed by the controller <NUM> using the hardware embodiment of <FIG> or <FIG>. The procedure of <FIG> incorporates the procedure of <FIG> by the description reference to a "conductivity test. " When the conductivity test is referenced it means the procedure of <FIG> is entered and upon exiting proceeds to the next procedure element in <FIG>.

At S30, water is added by pumping it into the mixing container <NUM>. This is done by the controller <NUM> to place the system in the configuration of <FIG>. The water pump <NUM> and the peristaltic pump <NUM> are run for a predefined number of cycles or a predefined time interval. The pumps are controlled to hold the pressure at the pressure sensor <NUM> at a steady pressure to provide a consistent upstream pressure for the peristaltic pump <NUM>. The amount conveyed at S30 may be a fraction of the total estimate required for a sufficient level of dilution.

Next, at S32, all of the osmotic agent (dextrose in this example) is added to the mixing container after placing the system in the configuration of <FIG>. In a different embodiment, the concentrate may be added until the concentrate container is empty where by a known about of the electrolyte can be stored in a memory. This works without the need for metering the concentrate by the peristaltic pump. The mass of electrolyte may be stored by the controller <NUM> and the conductivity test is performed. At S36 it is determined whether there was bad measurement or a gross error after the conductivity test was performed. If the signal indicates yes, then control proceeds to S60 where the batch is indicated as failed. If the determination is negative, then control proceeds to S38 where additional water is added but still insufficient to prepare a ready-to-use medicament (Configuration is that of <FIG>). Then at S40, the conductivity test is performed again.

At S42 it is determined whether there was bad measurement or a gross error, the gross error meaning a large difference between the measurement and a predefined range representing the presumed (or possible) range magnitudes. If procedure of <FIG> outputs either signal, for example to indicate gross error or bad measurement, then control proceeds to S60 where the batch is indicated as failed. If the determination is negative, then control proceeds to S44 where a dose of electrolyte concentrate is conveyed to the mixing container after placing the system in the configuration of <FIG>. At S46, electrolyte is added to the mixing container <NUM> after placing the system into configuration of <FIG>. At S48, the conductivity test is performed. If a valid measurement is received at S50, then, at S52, a final fraction of the remaining water is added after placing the system in the configuration of <FIG>. The conductivity test is performed at S54 and if a no gross error or bad measurement is indicated by the procedure of <FIG> (i.e., a valid measurement), then the medicament is made available for use at S58 (Configuration = <FIG>). If the procedure of <FIG> indicates a gross error or bad measurement at S56, the batch is failed at S60.

The medicament may be made available for use by closing the clamps except for batch release clamp <NUM> and feedback controlling the peristaltic pump <NUM> to maintain a target pressure indicated by pressure sensor <NUM>. The medicament user <NUM> may draw the fluid through the clamp <NUM> on-demand.

Referring now to <FIG>, the process of <FIG> is modified with respect to the order in which water, electrolyte, and osmotic agent are added. Although <FIG> generally describes the process of preparing the final dialysate in terms of adding water in step S30, then adding osmotic agent (e.g., dextrose) in step S32, then adding more water in step S38, then adding electrolyte in step S46, and adding yet more water in step S52, the order of these steps could be changed as shown in <FIG>.

In another example, the electrolyte and osmotic agent may be provided in a single concentrated mixture. Here, the concentrated mixture can be flowed into the mixing container, conductivity is measured to determine the appropriate amount of water, water is added and mixed with the concentrate. Then, another conductivity measurement may be made and a final amount of water is added and mixed. Alternatively, water may be added into the mixing container <NUM> first, then the electrolyte and osmotic agent concentrate, and the contents mixed. Subsequently, conductivity is measured to determine the final amount of water needed, the final amount of water is added, and mixed, to create the final medicament.

Referring now to <FIG>, another example system for preparing a ready to use medicament from multiple media including concentrate and water, similar to 1A, is shown. Elements having the same numbers have the same function and are not described again. The system of 1E differs from that of 1A with regard to locations of valves (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) relative to the pump <NUM>.

In <FIG>, disposable unit <NUM> has different flow paths than the disposable unit <NUM> of <FIG>, and in particular includes a pressure sensor <NUM> as shown in the figure. The pressure sensor <NUM> measure fluid pressure at the output side of the pump <NUM>, while pressure sensor <NUM> measure the pressure at the input of the pump <NUM>. Further, a valve <NUM> and a pressure sensor <NUM> are provided between connector <NUM> and sensor <NUM> on the drain conductivity line <NUM>. Pressure sensors Pci (<NUM>) and Pco (<NUM>) are disposed on opposite sides of pump <NUM>, and may be of a type that includes a connection to a vacuum pump <NUM>. A pressure sensor Pv (<NUM>) may be provided on the vacuum line between sensors <NUM> and <NUM>. Unless otherwise described, the operation of the system of <FIG> proceeds as described above with respect to <FIG>.

<FIG> shows a water treatment plant <NUM> that may constitute an embodiment the purified water source <NUM>. The water treatment plant <NUM> has an initial pretreatment stage that includes a connector <NUM> to connect to an unfiltered water source <NUM>, for example a water tap. The water flows through a check valve <NUM>, through a pressure regulator <NUM>, and then through a sediment filter <NUM>. The check valve <NUM> prevents backflow of the water. The water then flows through an air vent <NUM> that removes air from the water. The water then flows through a connector <NUM> that connects to a water shutoff clamp <NUM>, a snubber <NUM>, and a water inlet pressure sensor <NUM>. Water is pumped by water pump <NUM> which has an encoder <NUM> for precise tracking of the water pump <NUM> speed. The snubber <NUM> reduces pressure fluctuations. The water then flows through a water output pressure sensor <NUM>, through an ultraviolet light lamp <NUM> and into a filter plant <NUM> that performs deionization, carbon filtration, and sterilizing filtration. A combined control unit and leak sensor are indicated at <NUM>. In the sterilizing filter plant <NUM>, the water flows through a carbon filter <NUM> and three separated bed deionization filters <NUM> which may be resin separated bed filters. A mixed bed deionization follows the separated bed filters A resin mixed bed filter <NUM> is followed by first and second ultrafilters <NUM> and into the consumer of pure water <NUM>. The embodiment of <FIG> is an example of a consumer of pure water <NUM>.

Between a last separated bed deionization filter <NUM> and a mixed bed deionization filter <NUM> is a resistivity sensor <NUM> which indicates when the deionization resin separated bed filters <NUM> are nearing exhaustion, or at exhaustion. The deionization resin mixed bed filter <NUM> is still able to hold a predefined minimum magnitude of resistivity but the deionization resin separated bed filters <NUM> and the deionization resin mixed bed filter <NUM> may be replaced at the same time. In embodiments, along with the deionization resin separated bed filters <NUM> and the deionization resin mixed bed filter <NUM>, the carbon filter <NUM> and ultrafilters <NUM> along with the interconnecting lines and other components may also be replaced as a single package. A current treatment can be completed in reliance on the deionization resin mixed bed filter <NUM> before the exhausted filters are replaced. A further resistivity sensor <NUM> detects unexpected problems with the deionization separated bed filter <NUM> upstream deionization filters which may require shutdown of the treatment and immediate replacement of the filters. Note that each of the ultrafilters <NUM> has an air vent <NUM>. A check valve <NUM> is located downstream of the ultrafilters <NUM>. The consumer of pure water <NUM> may be unit such as that of <FIG> which mixes a batch of medicament for use by a medicament user <NUM> such as a peritoneal dialysis cycler or any other type of medicament consuming device.

<FIG> shows the configuration for transferring water from the purified water source <NUM> to the mixing container <NUM>. Note the amount of water to be transferred is a fraction, e.g., <NUM>% of the amount of water needed to make a ready-for-use medicament. It will be observed that the clamp <NUM> is open and the other clamps closed and that the peristaltic pump <NUM> draws water. The water pump <NUM> and the peristaltic pump <NUM> operate in tandem. The speed of the water pump <NUM> and/or the peristaltic pump <NUM> may be regulated to maintain a predefined operating pressure indicated by pressure sensor <NUM>. The pressure regulation is implemented because the peristaltic pump <NUM> volumetric efficiency is sensitive to its inlet pressure. In a different embodiment the peristaltic pump <NUM> clamp <NUM> is opened and the water pump <NUM> is used to transfer water to the mixing container <NUM>.

<FIG> shows the configuration where dextrose concentrate (which may be any component of a <NUM>-part medicament) is pumped by the peristaltic pump <NUM> into the mixing container <NUM>. It will be observed by inspection of the arrows, that the clamp <NUM> is open and the other clamps closed. The peristaltic pump <NUM> is run in the right hand direction as indicated by the arrow.

<FIG> shows the configuration in which the contents of the mixing container <NUM> are mixed by pumping fluid from the mixing container <NUM> back the mixing container <NUM> by the peristaltic pump <NUM> to mix its contents. All the clamps are closed except for mixing container line clamp <NUM>. The peristaltic pump <NUM> is run in the right-hand direction.

<FIG> shows the configuration that provides for temperature-compensating conductivity measurement. Fluid from the mixing container <NUM> is pumped by peristaltic pump <NUM> from the mixing container <NUM> through conductivity sensor clamp <NUM> through the drain conductivity line <NUM> and through the control conductivity/ temperature sensor 159c and the safety conductivity/ temperature sensor <NUM>. This allows a temperature-compensated conductivity to be measured. The fluid ultimately is conducted to a drain through a drain connector.

<FIG> shows the configuration where electrolyte is transferred through second concentrate clamp <NUM>, pumped by peristaltic pump <NUM> into the mixing container <NUM>. Note that either concentrate may be pumped first with the other concentrate being pumped second. Note also that multiple different concentrates may be provided in alternative embodiments.

<FIG> shows the configuration for providing ready-to-use medicament to the medicament user <NUM>. The ready-to-use medicament flows through the batch release clamp <NUM> and through the medicament line <NUM> pumped by the peristaltic pump <NUM>.

However, it is also possible to utilize one or more pumps that are a part of the medicament user <NUM> (internal to medicament user <NUM>) to convey the ready-to-use medicament from the mixing container <NUM> without the use of peristaltic pump <NUM>. In the system of <FIG>, valves <NUM> and <NUM> are opened, and the medicament user <NUM> draws the medicament through line <NUM>, without the use of peristaltic pump <NUM>. For example, the medicament user <NUM> may be a dialysis cycler that includes a pump that is configured to draw in dialysate, such as from a bag of pre-mixed dialysate. By using this existing functionality of the cycler, the system can provide dialysate from mixing container <NUM> to the cycler.

Note that in alternative embodiments, there may be a single conductivity/ temperature sensor instead of the pair 159c and <NUM> as shown. A pair of conductivity sensors may provide a check against poor accuracy or failure of one of the sensors. A method may be implemented by the controller <NUM> in which one of the conductivity/ temperature sensors 159c or <NUM> may be used for the temperature-compensated conductivity signal for preparing medicament. For example, the conductivity/ temperature sensor 159c. The other conductivity/ temperature sensor <NUM> may be compared to the signal of the conductivity/ temperature sensor 159c, at some point during a treatment or treatment cycle or other frequency, to determine if there is agreement between the output of the conductivity/ temperature sensor 159c and conductivity/ temperature sensor <NUM>. For example, this comparison may be done by the controller <NUM> at the end of the preparation of a batch to detect the reliance on erroneous output. The controller to indicate a failed batch in response to a disagreement between the two outputs. To do this, a sample of the completed batch may be conveyed through conductivity/ temperature sensor 159c and conductivity/ temperature sensor <NUM> to detect disagreement between the indications of outputs of the two sensors <NUM> and 159c. The controller <NUM> may store a predefined range within which the conductivity/ temperature sensor 159c and conductivity/ temperature sensor <NUM> indications and used for sufficiency detect a low or high reading. Note that the agreement between the foregoing outputs may be checked at a variety of different frequencies and the allowed tolerance range my differ. For example, there may be fluctuations in the temperature of fluid drawn from the mixing container <NUM> which may cause the.

In alternative embodiments where the purified water source <NUM> has a final stage including one or more ultrafilters, the ultrafilters can be located in medicament line <NUM> instead of the final stage of the purified water source <NUM>. For example, in the <FIG> embodiment of a purified water source <NUM>, ultrafilters <NUM> can be positioned to sterile-filter the final product medicament as it is supplied to the medicament user <NUM>. In this case, the ultrafilters <NUM> can be positioned in medicament line <NUM> instead of in the water purification plant. In other alternative embodiments, a sterilizing filter stage may be added to the medicament line <NUM>, for example, a filter or filters such as the <NUM> micron sterilizing filters <NUM> or one of them. Note that in all embodiments where two or multiple sterilizing filters are provided, in further embodiments, a testable filter may alternatively to be used to form further embodiments. Testable filters are ones where the integrity of the filter membrane is tested after providing a medicament. The test may be done automatically by the controller <NUM>, for example, by providing an air pump to perform a pressure decay test. The test may a trans-membrane pressure to test for a bubble point test. Testing may be done in a variety different ways. And the embodiments are not limited to the choice of test.

A water pump as shown at <NUM> in <FIG> or <NUM> in <FIG>, may or may not be present. This is because the peristaltic pump may pull fluid from the consumer. Also, there may be separate pumps but it may be that they are not linked in series as in the system of <FIG> with the <FIG> embodiment of a purified water source <NUM>. Embodiments include ones where there are two separate pumps and that flow in tandem i.e., are located at points along the same flow path in a push-pull fashion. In embodiments, the water pump (<NUM> in <FIG> or <NUM> in <FIG>) may be operated at a fixed rate and the peristaltic pump <NUM> may be controlled to mitigate variations in the pressure linking the two. This may be implemented as a negative feedback control such as a proportional, derivative, and integral (PID) control. In other embodiments the peristaltic pump <NUM> may be operated at a fixed rate and the water pump may be controlled. The compliance of the channel connecting the two may be adjusted by providing an accumulator or tubing of a material that adds compliance or another method to alter the compliance in a manner that makes the pressure between the pumps stable and at a predefined range of pressures.

Note that in variations of most of the embodiments, the purified water source <NUM> may include a container or containers of purified water such as one or more polymer bags. In such embodiments, there may be a water pump arranged in a "pull" configuration. In any of the embodiments, the medicament user <NUM> may include a pump. For example, the medicament user <NUM> may include a dialysis cycler that is configured to draw from a container of dialysis fluid.

To permit the medicament user <NUM> to draw medicament on-demand, the controller may be programmed to maintain a constant pressure that is compatible with a pump in the medicament user <NUM>. For example, the pressure-based control using the pressure sensor <NUM> may maintain a pressure that mimics a simple container that allows the medicament user <NUM> to draw from a container of dialysis fluid.

In embodiments, the medicament user <NUM> can use its own pump to move fluid from the mixing container <NUM> without the use of pump <NUM>. In this example, valves <NUM> and <NUM> will be opened, and the medicament user <NUM> will operate its pump to draw fluid form the mixing container <NUM>.

An alternative to metering with the pump <NUM> is to allow the concentrates to empty entirely into the mixing container <NUM> by gravity. The mass or volume of the concentrates in each of the concentrate containers may be stored by the controller allowing the controller to calculate the amount of water required to complete a batch of water to provide a ready-use medicament.

According to embodiments, the disclosed subject matter includes an admixing device, comprising. A mixing machine has a controller. The mixing machine is configured to engage with a fluid circuit, the fluid circuit has a connector configured for connection to a source of pure water and a connector configured for connecting respectively to at least one source of medicament concentrate. The fluid circuit has a mixing container. The mixing machine further has a pressure sensor configured to engage with the fluid circuit to indicate a pressure of a medicament manifold line of the fluid circuit with a connector configured to connect to a selected one of several different medicament user devices. The controller is configured to, by feedback control, maintain a respective pressure applied to said machine controller pump actuator being applied at an inlet to said selected one of several different medicament user devices or storage containers. The selected one of said plurality of pressures corresponding respectively to a selected one of multiple different medicament user devices.

In a variation of the embodiments, the medicament user device includes a peritoneal dialysis cycler.

In a variation of the embodiments, the controller is configured to actively control said predefined pressure using feedback control. In a variation of the embodiments, the mixing machine has a pump actuator and said fluid circuit has a pumping portion configured to engage said pump actuator. In variations of embodiment the embodiments the flow switch the pump actuator is a peristaltic pump actuator.

In a variation thereof, the disclosed embodiments includes ones in which the mixing machine and the pumping portion are connected between said mixing container and said manifold line.

In a variation thereof, the disclosed embodiments includes ones in which said pump actuator runs in a first direction to transfer medicament and to said manifold to the medicament user, and an opposite direction to proportion concentrate and water in said mixing container.

In a variation thereof, the disclosed embodiments includes ones in which said manifold and said pressure sensor are directly connected to said pumping portion.

In a variation thereof, the disclosed embodiments includes ones in which the pump actuator is configured to pump fluid into and out of said mixing container to mix the contents of said mixing container.

In a variation thereof, the disclosed embodiments includes ones in which said manifold line is connected to valve portions of said fluid circuit and said mixing machine having valve actuators that engage with the valve portions, the fluid circuit having a valve portion engageable with a respective valve actuator for each of said medicament concentrates, one for said medicament user device, one for said one for said source of pure water, one for a drain, and one for said mixing container, wherein a line with said pumping portion that connects the manifold line to said mixing container has no valve portion.

In a variation thereof, the disclosed embodiments includes ones in which said mixing container has two lines, both of which connect the mixing container with the manifold line, one connecting to the manifold line through the pumping portion.

In a variation thereof, the disclosed embodiments includes ones in which said manifold line is connectable to a drain.

In a variation thereof, the disclosed embodiments includes ones in which said pressure sensor is positioned to detect pressure in said manifold line.

<FIG> shows a block diagram of an example computer system according to non-claimed embodiments of the disclosed subject matter. In various embodiments, all or parts of system <NUM> may be included in a medical treatment device/system such as a renal replacement therapy system. In these embodiments, all or parts of system <NUM> may provide the functionality of a controller of the medical treatment device/systems. In some embodiments, all or parts of system <NUM> may be implemented as a distributed system, for example, as a cloud-based system.

System <NUM> includes a computer <NUM> such as a personal computer or workstation or other such computing system that includes a processor <NUM>. However, alternative embodiments may implement more than one processor and/or one or more microprocessors, microcontroller devices, or control logic including integrated circuits such as ASIC.

Computer <NUM> further includes a bus <NUM> that provides communication functionality among various modules of computer <NUM>. For example, bus <NUM> may allow for communicating information/data between processor <NUM> and a memory <NUM> of computer <NUM> so that processor <NUM> may retrieve stored data from memory <NUM> and/or execute instructions stored on memory <NUM>. In one embodiment, such instructions may be compiled from source code/objects provided in accordance with a programming language such as Java, C++, C#,. net, Visual Basic™ language, LabVIEW, or another structured or object-oriented programming language. In one embodiment, the instructions include software modules that, when executed by processor <NUM>, provide renal replacement therapy functionality according to any of the embodiments disclosed herein.

Memory <NUM> may include any volatile or non-volatile computer-readable memory that can be read by computer <NUM>. For example, memory <NUM> may include a non-transitory computer-readable medium such as ROM, PROM, EEPROM, RAM, flash memory, disk drive, etc. Memory <NUM> may be a removable or non-removable medium.

Bus <NUM> may further allow for communication between computer <NUM> and a display <NUM>, a keyboard <NUM>, a mouse <NUM>, and a speaker <NUM>, each providing respective functionality in accordance with various embodiments disclosed herein, for example, for configuring a treatment for a patient and monitoring a patient during a treatment.

Computer <NUM> may also implement a communication interface <NUM> to communicate with a network <NUM> to provide any functionality disclosed herein, for example, for alerting a healthcare professional and/or receiving instructions from a healthcare professional, reporting patient/device conditions in a distributed system for training a machine learning algorithm, logging data to a remote repository, etc. Communication interface <NUM> may be any such interface known in the art to provide wireless and/or wired communication, such as a network card or a modem.

Bus <NUM> may further allow for communication with one or more sensors <NUM> and one or more actuators <NUM>, each providing respective functionality in accordance with various embodiments disclosed herein, for example, for measuring signals.

It will be appreciated that the modules, processes, systems, and sections described above can be implemented in hardware, hardware programmed by software, software instruction stored on a non-transitory computer readable medium or a combination of the above. For example, a method for providing a medicament to a medicament user can be implemented, for example, using a processor configured to execute a sequence of programmed instructions stored on a non-transitory computer readable medium. For example, the processor can include, but not be limited to, a personal computer or workstation or other such computing system that includes a processor, microprocessor, microcontroller device, or is comprised of control logic including integrated circuits such as, for example, an Application Specific Integrated Circuit (ASIC). The instructions can be compiled from source code instructions provided in accordance with a programming language such as Java, C++, C#. net or the like. The instructions can also comprise code and data objects provided in accordance with, for example, the Visual Basic™ language, LabVIEW, or another structured or object-oriented programming language. The sequence of programmed instructions and data associated therewith can be stored in a non-transitory computer-readable medium such as a computer memory or storage device which may be any suitable memory apparatus, such as, but not limited to read-only memory (ROM), programmable read-only memory (PROM), electrically erasable programmable read-only memory (EEPROM), random-access memory (RAM), flash memory, disk drive and the like.

Furthermore, the modules, processes, systems, and sections can be implemented as a single processor or as a distributed processor. Further, it should be appreciated that the steps mentioned above may be performed on a single or distributed processor (single and/or multi-core). Also, the processes, modules, and sub-modules described in the various figures of and for embodiments above may be distributed across multiple computers or systems or may be co-located in a single processor or system. Exemplary structural embodiment alternatives suitable for implementing the modules, sections, systems, means, or processes described herein are provided below.

The modules, processors or systems described above can be implemented as a programmed general purpose computer, an electronic device programmed with microcode, a hardwired analog logic circuit, software stored on a computer-readable medium or signal, an optical computing device, a networked system of electronic and/or optical devices, a special purpose computing device, an integrated circuit device, a semiconductor chip, and a software module or object stored on a computer-readable medium or signal, for example.

Embodiments of the method and system (or their sub-components or modules), may be implemented on a general-purpose computer, a special-purpose computer, a programmed microprocessor or microcontroller and peripheral integrated circuit element, an ASIC or other integrated circuit, a digital signal processor, a hardwired electronic or logic circuit such as a discrete element circuit, a programmed logic circuit such as a programmable logic device (PLD), programmable logic array (PLA), field-programmable gate array (FPGA), programmable array logic (PAL) device, or the like. In general, any process capable of implementing the functions or steps described herein can be used to implement embodiments of the method, system, or a computer program product (software program stored on a non-transitory computer readable medium).

Furthermore, embodiments of the disclosed method, system, and computer program product may be readily implemented, fully or partially, in software using, for example, object or object-oriented software development environments that provide portable source code that can be used on a variety of computer platforms. Alternatively, embodiments of the disclosed method, system, and computer program product can be implemented partially or fully in hardware using, for example, standard logic circuits or a very-large-scale integration (VLSI) design. Other hardware or software can be used to implement embodiments depending on the speed and/or efficiency requirements of the systems, the particular function, and/or particular software or hardware system, microprocessor, or microcomputer being utilized. Embodiments of the method, system, and computer program product can be implemented in hardware and/or software using any known or later developed systems or structures, devices and/or software by those of ordinary skill in the applicable art from the function description provided herein and with a general basic knowledge of control systems of medical devices and/or computer programming arts.

Claim 1:
An admixing device, comprising:
a mixing machine with a controller (<NUM>);
the mixing machine being configured to engage with a fluid circuit (<NUM>);
the fluid circuit (<NUM>) having a connector (<NUM>) configured for connection to a source of pure water (<NUM>) and a connector (<NUM>) configured for connecting respectively to at least one source of medicament concentrate (<NUM>, <NUM>);
the fluid circuit having a mixing container (<NUM>) and a manifold line (<NUM>);
the mixing machine further having a pressure sensor (<NUM>) configured to engage with the fluid circuit (<NUM>) to indicate a pressure of fluid in the manifold line (<NUM>) of the fluid circuit, the manifold line (<NUM>) having a connector (<NUM>) configured to connect to a selected one of several different medicament user devices (<NUM>);
the controller (<NUM>) being configured to, by feedback control, control a pump actuator (<NUM>) to maintain a respective target fluid pressure at an inlet to said selected one of several different medicament user devices (<NUM>); and
the respective target fluid pressure corresponding respectively to a selected one of multiple different medicament user devices (<NUM>),
wherein the mixing machine has the pump actuator (<NUM>) and said fluid circuit has a pumping portion (<NUM>) configured to engage said pump actuator (<NUM>),
the mixing machine and the pumping portion (<NUM>) are connected between said mixing container (<NUM>) and said manifold line (<NUM>), and
the pump actuator (<NUM>) is configured to pump fluid into and out of said mixing container (<NUM>) in a circular path to mix contents of said mixing container (<NUM>).