Patent Application
20250009948
This invention pertains in general to the field of providing solutions, particularly medical solutions. More particularly the invention relates to mixing at least one powder with a solvent to provide a medical solution, such as a dialysate solution.
U.S. Pat. No. 6,149,294 discloses an apparatus for preparation of fluids intended for medical use from powder. The apparatus comprises a container such that the water and powder can be mixed and a concentrate provided in the container, and a recirculation circuit for recirculation of the water or concentrate solution into the container for further mixing of the water and powder to prepare a concentrate having a predetermined concentration.
This apparatus is able to prepare a ready mixed dialysis solution or replacement solution to be delivered to a dialysis machine performing hemodialysis (HD), hemodiafiltration (HDF) or hemofiltration (HD). The prepared solution may as well be used for other purposes, such as peritoneal dialysis, or as nutritional solution for infusion into the blood of a patient. However, this apparatus comprises several valves and other devices requiring control by a computer. Thus, there is a need for a simpler device for preparing a medical solution.
EP2035059 discloses a container comprising a plurality of compartments separated by compartment dividers, and an inlet connector for receiving a liquid via a connection tube. The compartment dividers rupture when a sufficient pressure is applied by a liquid or gas introduced into the container through the inlet connector. Some of the compartments comprise powder, which dissolves at the introduction of liquid into the container. The document further discloses a mixing system to be used with the described containers. However, there may exist a substantial time delay when preparing a new container with a ready to use solution after start of mixing the container contents with a liquid. This process can be time consuming as clean water facilities have a limited delivery amount of such water. Furthermore circulation in the bag needs to be done while a patient needs to wait for a supply of ready mixed dialysate solution.
Thus, there is a need for an improved device, system and method for mixing and providing a medical solution. It is also desired to improve the precision and quality of the final medical solution for providing to a patient. The improvement should also provide for time savings by decreasing the dissolving time and thus the effectiveness of the mixing. The device should also minimize the effect on a clinic's RO-water system. The invention may also be seen as an alternative to what is hitherto available, preferably more cost-effective.
Hence, an improved mixing system for mixing at least one powder with a solvent to provide a medical solution would be advantageous and in particular for improving the quality of a medical solution and allowing for increased flexibility and effectiveness would be advantageous.
Accordingly, examples of the present invention preferably seek to mitigate, alleviate or eliminate one or more deficiencies, disadvantages or issues in the art, such as the above-identified, singly or in any combination by providing devices and methods according to the appended patent claims.
In a first aspect of the disclosure, a device for providing a medical solution is described. The device comprising a tank. The tank has a height. The tank comprises a first chamber. The tank may comprise a second chamber. The second chamber may be adapted to have a larger volume than the first chamber. The first chamber is adapted to have a defined volume. The first chamber is configured to be connected to a liquid providing system to fill the first chamber with the defined volume of liquid. The device may further include a connector for connecting a container comprising a content such as at least one powder; the connector has an inlet and an outlet. A channel may be connecting the first chamber with the inlet of the connector. The device may further include an outlet for distributing the medical solution. The second chamber may further comprise a perforated structure arranged along the height and inside the tank. The device may further include a movable wall separating the first and second chamber. A portion of the perforated structure may have a volume.
In some examples, the tank may have a cylindrical shape. Alternatively, or in addition, the perforated structure may have at least a portion having a cylindrical shape.
In some examples the first volume may be defined by the space between the perforated structure and an inner wall of the tank. The second volume is defined by the whole volume of the tank.
In another aspect of the disclosure, a device for providing a medical solution is described. The device includes a first chamber adapted to have a defined volume, the first chamber is configured to be connected to a liquid providing system to fill the first chamber with the defined volume of liquid. The device may further include a connector for connecting a container including at least one powder; the connector has an inlet and an outlet. A channel may be connecting the first chamber with the inlet of the connector. The device may further include an outlet for distributing the medical solution. The device may be configured to mix the at least one powder with the defined volume of liquid for a period of time. The device may further be configured to fill the first chamber with the liquid from the liquid providing system while mixing the medical solution and/or distributing the mixed medical solution through the outlet.
In some examples, the device may include a re-circulation pump for mixing the powder and liquid by recirculation.
In some example, the device may include a second chamber adapted to have a volume larger than the first chamber, wherein the second chamber comprises an inlet and an outlet. The inlet of the second chamber is connected to the outlet of the connector for transferring a mixture including the at least one powder and the volume of liquid from the container to the second chamber. The outlet of the second chamber may further be connected to the outlet for distributing the medical solution. The second chamber may be configured for mixing the mixture for the period of time by recirculation through the inlet and the outlet of the second chamber.
In some example, the device may include a second chamber, wherein the second chamber comprises an inlet and an outlet; the inlet of the second chamber may be connected to the outlet of the connector for transferring a mixture including the at least one powder and the volume of liquid from the container to the second chamber. The outlet of the second chamber may be connected to the outlet for distributing the medical solution. The first chamber and the second chamber may be separated by a flexible or movable wall. The second chamber may further be configured for mixing the mixture for the period of time by recirculation rough the inlet and the outlet of the second chamber.
In some examples of the device, the second chamber may include two parts, a first part and a second part, the first part has the same volume as the first chamber and may be defined by the flexible or movable wall and a fixed wall being perforated. The second part may be connected to the perforated wall to provide a larger volume to the second chamber compared to the first chamber.
In a further aspect of the disclosure, a dialysis machine which comprises a mixing device as described herein id disclosed for providing an A-concentrate.
Also, in a further aspect of the disclosure, a method of providing a medical solution is disclosed. The method includes, filling a first chamber having a defined volume with a liquid to obtain a defined volume of liquid. The method may further include connecting a container including at least one powder to a connector having and inlet and an outlet and introducing the liquid from the first chamber to the container through the inlet of the connector. Th method may further include mixing the at least one powder with the defined volume of liquid for a period of time by recirculation, and distributing the medical solution through a distribution outlet. The first chamber may be filled with liquid while mixing the medical solution and/or distributing the mixed medical solution through the distribution outlet.
In one example, the method may include pumping a mixture which includes the at least one powder and the defined volume of liquid from the container to a second chamber, through the outlet of the connector to an inlet of the second chamber. Then mixing the mixture for the period of time by recirculation the mixture through the inlet and the outlet of the second chamber. The example may further include connecting the outlet of the second chamber to the distribution outlet.
In one example of the method, the medical solution may be an A-concentrate. The distribution outlet may be connected to a dialysis machine.
In another aspect of the disclosure, a method of rinsing a system for providing a medical solution is described. The method may include by-passing a connector for connecting a container, filling a first chamber having a defined volume with a liquid, and emptying the first chamber by pumping the liquid from the first chamber through the by-passed connector and through an inlet to a second chamber. The method may further include recirculating the liquid through an outlet and the inlet of the second chamber, when the first chamber is empty, for a period of time. The method may also include emptying the liquid through an outlet to a drain.
In yet another aspect of the invention, a dialysis machine having a first chamber being a buffer chamber for liquid is described. The buffer chamber having a volume, and the buffer chamber may be arranged to fill with the defined volume of the liquid up to maximum of the buffer chamber volume, such as from a liquid providing system. The machine may be controlled to distribute a mixed medical solution from the machine from a delivery chamber different than the buffer chamber, which delivery chamber previously has been in fluid communication with the buffer chamber for mixing the medical solution with liquid from the buffer chamber.
In another aspect of the disclosure, a method of mixing a medical solution in a dialysis machine is described. The method including filling a first chamber of the machine, the first chamber being a buffer chamber, with a defined volume of liquid, while the machine may distributing a mixed medical solution from the machine from a delivery chamber different than the buffer chamber, and wherein the method may include previously mixing the medical solution in the delivery chamber with liquid from the buffer chamber. Further embodiments of the invention are defined in the dependent claims, wherein features for the second and subsequent aspects of the invention are as for the first aspect mutatis mutandis.
It should be emphasized that the term “comprises/comprising” when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.
These and other aspects, features and advantages of which examples of the disclosure are capable of will be apparent and elucidated from the following description of examples of the present disclosure, reference being made to the accompanying drawings, in which
Specific examples of the disclosure will now be described with reference to the accompanying drawings. This disclosure may, however, be embodied in many different forms and should not be construed as limited to the examples set forth herein; rather, these examples are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.
The following description focuses on examples of the present disclosure applicable to be used with a dialysis system and in particular to the preparation of a dialysis liquid or dialysate concentrates of different concentrations using powder concentrates. However, it will be appreciated that the disclosure is not limited to this application but may be applied to many other examples of systems where it may be an advantage to provide powders to be mixed with a solvent, such as a liquid to be used with, for example, a solution providing system. Thus, medical solutions prepared by the exemplary embodiments described below may be used in dialysis treatments, as concentrate solutions or ready-made solutions for dialysis, as infusion solutions, such as Ringer's lactate, as nutrition solutions, as replacement solutions, as plasma expander solutions, etc.
In its most general form, the device may be used for providing a medical solution by mixing at least one powder with a solvent. The medical solution may in some examples be an A-concentrate to be used in dialysis. The A-concentration may be made from a salt concentrate which together with bicarbonate is mixed with RO-water (reversed osmosis). The A-concentrate is the dialysate solution which is consumed during a renal treatment.
The system includes a disposable container, such as a bag or cartridge. The container includes at least one powder. In the example given here for dialysis, the container includes a salt, such as sodium chloride, and electrolytes, such as calcium, potassium, and magnesium. The container may also include an acid, such as acetic acid or citric acid, and glucose. The acid is commonly a solution but there are acids that are available as powders on the marked today that may be used, such as citric acid. Commonly, the container includes three separated chambers, one for the salt and the electrolytes, one for the acid and one for the glucose. The container may also be configured to have two chambers, or only one chamber, in the case the acid is provided as a powder and does not react with the other compounds or substances.
The device, which can be considered as a mixer, is positioned close to a solvent source, for example a Reverse osmosis water supply (RO-water system) used of provided a concentrate for dialysis. If the device is used with a dialysis machine, the device is arranged either close to or on the dialysis machine, for example as a stand-alone unit. Alternatively, the device may be built into a dialysis machine. In a further alternative, the device is sized to be used for central delivery at a clinic.
The device is measuring up an exact volume of solvent, for example water, this may be done for example by pumping the water into a first chamber of the system having a defined volume.
The first chamber may be fluidly connected to the inlet of a connector for connecting a container, for example by tubes. The measured solvent is then pumped to a connected container.
The solvent will mix with the powder and may be either pumped out through an outlet of the connector or may flow out by itself. The container may for example be hanged on a stand with the interface of the container to be connected to the connector of the mixing device arranged at the bottom of the container. In this arrangement, the solvent may be pumped into the container but the initial mixture between the content of the container and the solvent may flow out through an outlet of the connector without the need of a pump, alternatively a pump may be used. Alternatively, the connection interface is arranged at the top of the container, then the solvent will be pumped into the container, but the initial mix needs to be pumped out from the container, this may be done by pressurizing the container or by suction using, for example, a tube arranged as a straw inside the container.
The outlet of the connector may be connected to the device for mixing the content of the container with the solvent through recirculation using a pump, such as a circulation pump. The recirculation may be done using flow channels inside the mixing device, such as tubes, and the container. Optionally, the outlet of the connector may be connected to an inlet of a second chamber of the device, where the second chamber may be used for mixing the medical solution. The mixing may be conducted by using a pump, such as a circulation pump, for recirculating the mixture of the content of the container and the solvent, for example by recirculating the mixture out from the second chamber through an outlet thereof and back in through the inlet of the second chamber.
The recirculation of the mixture may be done for a pre-defined period of time known to achieve a complete saturation between the solvent and the content of the container. For a normal batch of A-concentrate used for a dialysis patient, the recirculation may be carried out for about 3 min. The predefined time may for example be between 1 to 10 min, 2 to 10 min, 3 to 10 min, 4 to 10 min, 5 to 10 min, 6 to 10 min, 5 to 9 min, 4 to 9 min, 3 to 9 min, 2 to 9 min, 1 to 9 min, 5 to 8 min, 4 to 8 min, 3 to 8 min, 2 to 8 min, 1 to 8 min, 5 to 7 min, 4 to 7 min, 3 to 7 min, 2 to 7 min, 1 to 7 min, 4 to 6 min, 3 to 6 min, 2 to 6 min, 1 to 6 min, 3 to 5 min, 2 to 5 min, 1 to 5 min, 2 to 4 min, 1 to 4 min, 1 to 5 min. Depending on the size of the final volume, the re-circulation has to be run for longer, such as about 15 min, such as about 20 min, such as about 30 min or longer. The recirculation may also be run until a completely saturated solution between the solvent and the content of the container has been achieved.
When the mixing has been finalized the medical solution is distributed through and outlet of the mixing device. The medical solution may either be pumped out from the mixing device or suction from an external device may be used. The outlet may for example be connected to a dialysis machine, for example by connecting the device to the connection for “central delivery system”.
Depending on how the mixing device is arranged, the first chamber, such as the measuring chamber, may start to fill up with a solvent either during the recirculation or when the distribution of the medical solution starts. A new container may be connected to the device after the first one has been emptied, for example when the recirculation starts or during distribution of the finished medical solution. Alternatively, the container may also be attached to the device as soon at the distribution of the previous batch of medical solution has been distributed.
Since the solvent, such as water from the RO-water system, has been measured during the recirculation or distribution of the previous batch, the mixing may start direct when the distribution has finished. This allows for a new batch of medical solution to be prepared and started to be distributed within the time for the re-circulation, i.e. for a dialysis patient around 3 min.
An advantage is that the volume of solvent will always be the exactly the same, while the content of the container may be varied, for example, when preparing an A-concentrate, with respect to the amount of salt, electrolytes, acid or glucose to provide a specific recipe or formula being prescribed.
Another advantage is that each container may include ingredients that has been weighted up separately with high accuracy, each container may therefore be a batch with a specific recipe or formula.
A further advantage of this arrangement, is that the system allows a longer filling time of solvent. Demanding all the solvent, such as RO-water, needed for the preparation immediately under a short period of time, may cause a high load on a supply system, for example a RO-water supply system. Even about 2 lite of RO-water, which is the normal volume required for a single batch, may cause a too high load if the mixing device must be filled under a short period of time. In a standard RO system, only about 500 ml/min is what maximum can be supplied to II outlets. A high load on a supply system, such as a RO-water supply system, may cause disturbances or in worse case break down the system, so that all units in a clinic may not receive the amount of water they require, which may cause problems for other departments or patents not receiving any water when needed. This may further prolong the preparation of a batch. With the system described herein, the withdrawal of RO-water may be around 15 ml/min if the system is filled up with the same rate as final medicament is being delivered to the patient. In some examples of the system, even lower amount of RO-water may be withdrawn if a first chamber used for measuring the volume may be filled during both mixing and delivery of a different batch.
The second chamber 12 may comprise a wall which is perforated, like a strainer. The second chamber, further comprises an inlet for receiving unsolved solution from the container, and an outlet used for recirculating the solution during mixing. The outlet of the second chamber 2 is also used during distribution of the finished solution and when draining the system during cleaning.
The second chamber 12 may also include an extension 14, such as a housing, connected to and covering the perforated wall. The extension 14 provides extra volume to the second chamber 12 needed since the solution has a larger volume than the measured volume of solvent introduced to the first chamber 11 due to the volume of the content of the solution should be mixed with.
The device may further include some valves, for example, 2A, 2B, 2C, 2D, and 3. The device may also include a valve 4 to prevent back flow.
Valve 2A is configured for allowing solvent to flow into the first chamber 11 from the supply, such as a RO-water supply system. The flexible or movable wall 13 is pushed into the second chamber 12. The air in the first chamber may exit through the vent 15. When filling the first chamber 11 with a solvent, the flexible or movable wall 13 may reach an inside of the perforated wall, due to the pressure of the solvent. When the first chamber 11 is filled with solvent, the pressure will increase inside the first chamber 11 whereby the sensor 8 may send a signal to close the valve 2A which stops the filling of the first chamber 11. In this way, the volume of solvent, such as water, will be the same each time when starting the mixture.
A valve, such as valve 2A may be configured to open to allow the solvent to flow out from the first chamber 11 and to the inlet of a connector 9. Emptying the first chamber 11 may be aided by using pump 5. The solvent will be mixed with the content of a container connected to the connector 9. The container includes at least one powder which will be dissolved in the solvent. The mixed flows out from an outlet of the connector 9 via valve 2B to an inlet of the second chamber 12 and the extension 14.
After the first chamber 11 and the container has been emptied, valve 2B closes the connection to the outlet of the connector 9 and the mixing device is adjusted to facilitate the recirculation of the at least partially unsolved mixture of the at least one powder and the solvent, for example by opening valves 3, 2C and 2D. Pump 6 is then starting to re-circulate the mixture from an outlet of the second chamber 12 and through a tube system back to an inlet of the second chamber 12. The recirculation is carried out until a completely saturated solution is obtained from the mixture of solvent and the at least one powder. The finished medical solvent is then distributed through outlet 7, for example via valve 2C. When the finished solution is an A-concentrate for dialysis, the outlet 7 may be connected to an inlet for “Central Delivery System” on the dialysis machine.
The device may also be connectable to a drain when draining and cleaning the mixing system, for example via valve 2D.
The mixing device may include, apart from the chambers, pumps, valves tubes and connectors, also the electronics used for regulating the process and the different sequences of the mixing process. When the mixing device is configured as a stand-alone machine, the mixing device may also include a display for displaying, for example, start, stop, and the present sequence being carried out. The device may also have an input unit, such as a keyboard or a touch screen.
Some of the Different Modes that the Device May be Perform are:
The disclosure is not limited to a specific type of connector or container. In this application, an example of a connector and container is disclosed, but other connectors and containers known in the art would work, for example, connectors and containers described in EP2723417, EP2035059, and U.S. Pat. No. 6,149,294. Neither is the disclosure limited to a single container. The system may be adapted so that, for example, two, or three separate containers are connected to the mixing device. For example, where the powders are in a first container, and the acid in a second container; or where the salt and electrolyte is arranged in a first container, the acid in a second container, and the glycose in a third container.
When filing the first chamber 11 with a solvent, the flexible or movable wall 13 is pushed into the second chamber 12. The air in the first chamber may exit through the vent 15. When filling the first chamber 11, the flexible or movable wall 13 reaches an inside of the perforated wall, due to the pressure of the solvent. When the first chamber 11 is filled with solvent, the pressure will increase inside the first chamber 11 whereby the sensor 8 may send a signal to close the valve 2A which stops the filling of the first chamber 11. In this way, the volume of solvent, such as water, will be the same each time when starting the mixture.
For RO-water, the first time the start-up mode is run, it may be possible to utilize up to the full rate of RO-water delivery. The reason is that the start-up mode may be done at a time of the day when there is not much demand for RO-water. For the consecutive fill-ups of water during a day a restriction to the delivery rate of mixed medicament to a patient, such as about 15 ml/min, may apply.
After the first chamber 11 has been filled, mode for filling the container may be initiated.
The advantages of this is that the machine will be ready to start to mix the solution through recirculation without first filling up the device with water. This allows for a new batch of medical solution to be prepared and started to be distributed within the time for the re-circulation, i.e. for a dialysis patient around 3 min. Another advantage of this arrangement, is that the system allows a longer filling time of solvent. Demanding all the solvent, such as RO-water, needed for the preparation immediately under a short period of time, may cause a high load on a supply system, for example a RO-water supply system. Even about 2 liters of RO-water, which is the normal volume required for a single batch, may cause a too high load if the mixing device must be filled under a short period of time. A high load on a supply system, such as a RO-water supply system, may cause disturbances or in worse case break down the system, so that all units in a clinic may not receive the amount of water they require, which may cause problems for other departments or patents not receiving any water when needed. This may further prolong the preparation of a batch.
In the example of the finished solution being an A-concentrate, the outlet of the device may be connected to a dialysis machine and the concentrate may pass through an exchangeable particle filter. The filter may be arranged in a tube connecting the mixing device with the dialysis machine. The tube may be connected to dialysis machine at the inlet for “central delivery system”. There are three main ways a dialysis machine may receive the finished A-concentrate: the dialysis machine uses suction to receive the concentrate from the mixing device; the recirculation pump 6 is used to pump out the solution to the dialysis machine; and the filling of the first chamber 11 with a solvent may push out the finished solution in the second chamber 12.
The solvent, such as RO-water, in the first chamber 11, is pumped, for example by pump 5, through the bypassed connector and into the second chamber 12. When the first chamber 11 is empty, the recirculation pump 6 starts to recirculate the solvent through the inlet and the outlet of the second chamber 12 and the tubes connecting them. This will rinse the part of the mixing device that has been in contact with the solution and will flush out any residuals of the solvent.
A-concentrate is considered to be sterile and it is therefore not required during normal use to rinse the system with more than RO-water. Sometimes disinfection may be needed, for example if the system may have been exposed to any risk for contamination. For example, if the device has been serviced or repaired; or if not used for a long time. Disinfection may also be needed if the disclosed technology is used for mixing a solution that is not sterile. The device may be disinfected by connecting a container with a disinfecting solution or powder and then mix it and recirculating the solution in the device before being drained. Alternatively, the inlet may be connected to source of disinfecting solution which is pumped in and recirculated in the device before being drained.
After the device has been disinfected a rinse mode may be run to remove any residuals of the disinfection solution.
The rinse mode and drain mode may be repeated should so be needed. A special rinsing liquid may also be used for this process.
The device may further include some valves, for example, 20A, 20B, 20C, and 20D. Valve 20A is configured for allowing solvent to flow into the first chamber 21 from the supply source, such as a RO-water supply system. When filling the first chamber 21 with a solvent, the air in the first chamber 21 may exit through the vent 26. When the first chamber 21 is filled with solvent, the pressure will increase inside the first chamber 21 whereby the sensor 28 may send a signal to close the valve 20A which stops the filling of the first chamber 21. In this way, the volume of solvent, such as RO-water, will be the same each time when starting the mixture.
Valves, such as valve 20A and 20B may be configured to open to allow the solvent to flow out from the first chamber 21 and to the inlet of a connector 29. Emptying the first chamber 21 may be aided by using pump 25. The solvent will be mixed with the content of a container connected to the connector 29. The container includes at least one powder which will be dissolved in the solvent.
After the first chamber 21 has been emptied into the container, valve 20B closes the connection between the first chamber 21 and the inlet of the connector 29. The mixture flows out from an outlet of the connector 29 via valve 20C and into a tubing system of the mixing device, the at least partially unsolved mixture of the at least one powder and the solvent is recirculated by pump 25 through the container and the tubing system of the device, for example by opening valves 20B and 20C. The recirculation is carried out until a completely saturated solution is obtained from the mixture of solvent and the at least one powder.
The finished medical solvent is then distributed through outlet 27, for example via valve 20D. When the finished solution is an A-concentrate for dialysis, the outlet 27 may be connected to an inlet for “Central Delivery System” on the dialysis machine.
The device may also be connectable to a drain 20 when draining and cleaning the mixing device, for example via valve 20C.
The mixing device may include, apart from the chambers, pumps, valves tubes and connectors, also the electronics used for regulating the process and the different sequences of the mixing process. When the mixing device is configured as a stand-alone machine, the mixing device may also include a display for displaying, for example, start, stop, and the present sequence being carried out. The device may also have an input unit, such as a keyboard or a touch screen.
Some of the different modes that the device may be perform are:
In the mode for connecting a container, the container, such as a bag or cartridge, is connected to the connector 29. When connecting the container to the device, the container may for example be hanged on a stand with the interface of the container to be connected to the connector of the mixing device located at the bottom of the container. Alternatively, the connection interface is arranged at the top of the container, then the solvent may be pumped into the container, but the initial mix of partially unsolved mixture of the at least one powder and the solvent needs to be pumped out from the container, this may be done by pressurizing the container or by suction using, for example, a tube arranged as a straw inside the container.
The disclosure is not limited to a specific type of connector or container. In this application, an example of a connector and container is disclosed, but other connectors and containers known in the art would work, for example, connectors and containers described in EP2723417, EP2035059, and U.S. Pat. No. 6,149,294. Neither is the disclosure limited to a single container. The system may be adapted so that, for example, two, or three separate containers are connected to the mixing device. For example, where the powders are in a first container, and the acid in a second container; or where the salt and electrolyte is arranged in a first container, the acid in a second container, and the glycose in a third container.
In the start-up mode, the first chamber 21 is getting filled up with a solvent, such as RO-water, by opening valve 20A. The start-up mode may be initiated by a confirmation, for example, by pushing a button or touching an area on the display. The first chamber 21 is filled until sensor 28 indicates that the first chamber 21 is completely filled with solvent, and whereby valve 20A closes. In this way, the volume of solvent, such as water, will be the same each time when starting the mixture
For RO-water, the first time the start-up mode is run, it may be possible to utilize up to the full rate of RO-water delivery. The reason is that the start-up mode may be done at a time of the day when there is not much demand for RO-water. For the consecutive fill-ups of water during a day a restriction to the delivery rate of mixed medicament to a patient, such as about 15 ml/min or lower, may apply.
If the first chamber 21 may start to get filled during the mixing of a preparation of a solution, the time it may take to fill up the first chamber 21 may be allowed to be longer than when only filing the first chamber 21 during delivery of a preparation. A longer filling time may allow a lower flow rate from a supply system, such as a lower rate than 15 ml/min which is the delivery rate of an A-concentrate to a patient. A lower flow rate decreases the risk of a too large total demand from a source of liquid, such as RO-water.
If the first chamber 21 may start to get filled during the distribution of a prepared solution, the filling time of the first chamber 21 may be the same as the distribution time. For example, the distribution of A-concentrate is about 15 ml/min, since the volume of a prepared solution is larger than the first chamber 21, the filling rate may be 15 ml/min or a little lower. A lower flow rate decreases the risk of a too large total demand from a source of liquid, such as RO-water
In the example of the finished solution being an A-concentrate, the outlet of the device may be connected to a dialysis machine and the concentrate may pass through an exchangeable particle filter. The filter may be arranged in a tube connecting the mixing device with the dialysis machine. The tube may be connected to dialysis machine at the inlet for “central delivery system”. There are two main ways a dialysis machine may receive the finished A-concentrate: the dialysis machine uses suction to receive the concentrate from the mixing device; and the pump 25 may be used to pump out the solution to the dialysis machine.
The solvent, such as RO-water, in the first chamber 21, is pumped, for example by pump 25, through the bypassed connector and through the tubes of the device. Since the first chamber 21 holds a larger volume than the tubes and the bypassed connector. The valves 20B, and 20C may be switched so that 20B is first open, allowing the tube system to fill-up with clean solvent. 20B is closed and the solution is re-circulated by pump 25. Valve 20C is then switched to connect the tubes to the drain 20 and the tubes are emptied, by running the pump 25. This may be repeated until the first chamber 21 is empty. This will rinse the part of the mixing device that has been in contact with the solution and will flush out any residuals of the solvent.
A-concentrate is considered to be sterile and it is therefore not required during normal use to rinse the system with more than RO-water. Sometimes disinfection may be needed, for example if the system may have been exposed to any risk for contamination. For example, if the device has been serviced or repaired; or if not used for a long time. Disinfection may also be needed if the disclosed technology is used for mixing a solution that is not sterile.
The device may be disinfected by connecting a container with a disinfecting solution or powder and then mix it and recirculating the solution in the device before being drained. Alternatively, the inlet may be connected to source of disinfecting solution which is pumped in and recirculated in the device before being drained.
After the device has been disinfected a rinse mode may be run to remove any residuals of the disinfection solution.
The first chamber 31 is connectable through an inlet to a liquid supply, such as a solvent supply, such as a RO-water supply system. The first chamber 31 may include sensor 38, such as a pressure transmitter or pressure sensor. The first chamber 31 may also include a vent 36, such as a breather.
The second chamber 32, comprises an inlet for receiving unsolved solution from the container, and an outlet used for recirculating the solution during mixing. The outlet of the second chamber 32 is also used during distribution of the finished solution and when draining the system during cleaning.
The device may further include some valves, for example, 30A to 30F. Valve 30A is configured for allowing solvent to flow into the first chamber 31 from the supply, such as a RO-water supply system. When the first chamber 31 is filled with solvent, the pressure will increase inside the first chamber 31 whereby the sensor 38 may send a signal to close the valve 30A which stops the filling of the first chamber 31. In this way, the volume of solvent, such as water, will be the same each time when starting the mixture.
Valves, such as valves 30A, 30B and 30C, may be configured to open to allow the solvent to flow out from the first chamber 31 and to the inlet of a connector 39. Emptying the first chamber 31 may be aided by using pump 35. The solvent will be mixed with the content of a container connected to the connector 39. The container includes at least one powder which will be dissolved in the solvent. The mixture flows out from an outlet of the connector 39 via valve 30D to an inlet of the second chamber 32.
After the first chamber 31 and the container has been emptied, valve 30C and 3D close the connection to the outlet and the inlet of the connector 39 and the mixing device is adjusted to facilitate the recirculation of the at least partially unsolved mixture of the at least one powder and the solvent, for example by positioning valves 30B, to 30F so that the pump 35 may re-circulate the mixture from an outlet of the second chamber 32 and through a tube system back to an inlet of the second chamber 32 without the solvent passes through the connector 39.
The recirculation is carried out until a completely saturated solution is obtained from the mixture of solvent and the at least one powder. The finished medical solvent is then distributed through outlet 37, for example via valve 30F. When the finished solution is an A-concentrate for dialysis, the outlet 37 may be connected to an inlet for “Central Delivery System” on the dialysis machine.
The device may also be connectable to a drain 30 when draining and cleaning the mixing system, for example via valve 30E.
The mixing device may include, apart from the chambers, pumps, valves tubes and connectors, also the electronics used for regulating the process and the different sequences of the mixing process. When the mixing device is configured as a stand-alone machine, the mixing device may also include a display for displaying, for example, start, stop, and the present sequence being carried out. The device may also have an input unit, such as a keyboard or a touch screen.
Some of the Different Modes that the Device May be Perform are:
When the first chamber 31 is filled with solvent, the pressure will increase inside the first chamber 31 whereby the sensor 38 may send a signal to close the valve 30A which stops the filling of the first chamber 31. In this way, the volume of solvent, such as water, will be the same each time when starting the mixture
During start-up mode, a mode of connecting a container may also be performed. The container, such as a bag or cartridge, is connected to the connector 39. When connecting the container to the device, the container may for example be hanged on a stand with the interface of the container to be connected to the connector of the mixing device located at the bottom of the container. Alternatively, the connection interface is arranged at the top of the container, then the solvent may be pumped into the container, but the initial mix of partially unsolved mixture of the at least one powder and the solvent needs to be pumped out from the container, this may be done by pressurizing the container or by suction using, for example, a tube arranged as a straw inside the container.
The disclosure is not limited to a specific type of connector or container. In this application, an example of a connector and container is disclosed, but other connectors and containers known in the art would work, for example, connectors and containers described in EP2723417, EP2035059, and U.S. Pat. No. 6,149,294.
Neither is the disclosure limited to a single container. The system may be adapted so that, for example, two, or three separate containers are connected to the mixing device. For example, where the powders are in a first container, and the acid in a second container; or where the salt and electrolyte is arranged in a first container, the acid in a second container, and the glycose in a third container.
For RO-water, the first time the start-up mode is run, it may be possible to utilize up to the full rate of RO-water delivery. The reason is that the start-up mode may be done at a time of the day when there is not much demand for RO-water. For the consecutive fill-ups of water during a day a restriction to the delivery rate of mixed medicament to a patient, such as about 15 ml/min or lower, may apply.
The advantages of this is that the machine will be ready to start to mix the solution through recirculation without first filling up the device with water. This allows for a new batch of medical solution to be prepared and started to be distributed within the time for the re-circulation, i.e. for a dialysis patient around 3 min. Another advantage of this arrangement, is that the system allows a longer filling time of solvent. Demanding all the solvent, such as RO-water, needed for the preparation immediately under a short period of time, may cause a high load on a supply system, for example a RO-water supply system. Even about 2 liters of RO-water, which is the normal volume required for a single batch, may cause a too high load if the mixing device must be filled under a short period of time. A high load on a supply system, such as a RO-water supply system, may cause disturbances or in worse case break down the system, so that all units in a clinic may not receive the amount of water they require, which may cause problems for other departments or patents not receiving any water when needed. This may further prolong the preparation of a batch.
If the first chamber 31 may start to get filled during the mixing of a preparation of a solution, the time it may take to fill up the first chamber 31 may be allowed to be longer than when only filing the first chamber 31 during delivery of a preparation. A longer filling time may allow a lower flow rate from a supply system, such as a lower rate than 15 ml/min which is the delivery rate of an A-concentrate to a patient. A lower flow rate decreases the risk of a too large total demand from a source of liquid, such as RO-water.
If the first chamber 31 may start to get filled during the distribution of a prepared solution, the filling time of the first chamber 31 may be the same as the distribution time. For example, the distribution of A-concentrate is about 15 ml/min, since the volume of a prepared solution is larger than the first chamber 31, the filling rate may be 15 ml/min or a little lower. A lower flow rate decreases the risk of a too large total demand from a source of liquid, such as RO-water
In the example of the finished solution being an A-concentrate, the outlet of the device may be connected to a dialysis machine and the concentrate may pass through an exchangeable particle filter. The filter may be arranged in a tube connecting the mixing device with the dialysis machine. The tube may be connected to dialysis machine at the inlet for “central delivery system”. For this example of a mixing device, there are two main ways a dialysis machine may receive the finished A-concentrate: the dialysis machine uses suction to receive the concentrate from the mixing device; and the recirculation pump 35 is used to pump out the solution to the dialysis machine.
The rinsing may be done by the solvent, such as RO-water, in the first chamber 31, being pumped, for example by pump 35, through the bypassed connector and into the second chamber 32. When the first chamber 31 is empty, the recirculation pump 35 starts to recirculate the solvent through the inlet and the outlet of the second chamber 32 and the tubes connecting them. This will rinse the part of the mixing device that has been in contact with the solution and will flush out any residuals of the solvent.
Alternatively, and/or additionally, the solvent for rinsing the system may be received directly from the supply source, such as the RO-water supply (as illustrated).
A-concentrate is considered to be sterile and it is therefore not required during normal use to rinse the system with more than RO-water. Sometimes disinfection may be needed, for example if the system may have been exposed to any risk for contamination. For example, if the device has been serviced or repaired; or if not used for a long time. Disinfection may also be needed if the disclosed technology is used for mixing a solution that is not sterile.
The device may be disinfected by connecting a container with a disinfecting solution or powder and then mix it and recirculating the solution in the device before being drained. Alternatively, the inlet may be connected to source of disinfecting solution which is pumped in and recirculated in the device before being drained.
After the device has been disinfected a rinse mode may be run to remove any residuals of the disinfection solution.
The rinse mode and drain mode may be repeated should so be needed. A special rinsing liquid may also be used for this process.
In this mode, the pump 35 may be used to pump out the solvent used for the rinse. Alternatively, the solvent used for the rinse may be drained without the use of pump 35, for example by gravity or by suction from the drain 30.
The perforated volume extension structure 14 may have a top and/or bottom portion having a conical shape. The conical shape may be a truncated conical shape. When the first chamber 11 is filled, the movable wall 13 is pressed against an outer surface of the perforated volume extension structure 14. Thus, the perforated volume extension structure 14 separates the second chamber 12 into a first and a second part. The first part being the volume between an outer surface of the perforated volume extension structure 14 and an inner surface of the external wall 16 of the tank 20. The second part being inside the perforated volume extension structure 14.
The perforated volume extension structure 14 may comprise a plurality of holes, slits or perforations in a wall thereof for allowing a fluid to flow between the inside of the perforated volume extension structure 14 and an outside of the fixed wall.
The inlet of the second chamber 12 may be located on the tank 20 so that it is connected to an inside of the perforated volume extension structure 14. The outlet of the second chamber 12 may be located within the fixed wall of the perforated volume extension structure 14.
In an embodiment the inlet of the second chamber 12 is located at a top side of the tank 20. In a further example, the outlet of the second chamber 12 is located at a bottom of said tank 20. In some examples, the bottom of the tank 20 is shaped so that the outlet is located at the lowest point, for example, the bottom of the tank may be convex or slightly conical
In the schematic view of the device in
When the movable wall 13 moves towards the perforated volume extension structure 14, the movable wall 13 folds inwards.
The volume between the external surface of the perforated volume extension structure 14 and the inside surface of the external wall 16 of the tank 20 defines the volume of the first chamber 11. The first chamber 11 may encircle the perforated volume extension structure 14.
When the second chamber 12 is filled, the content of the container and the fluid from the first chamber 11 fill the volume inside of the perforated volume extended structure 14 and the volume between the external surface of the perforated volume extended structure 14 and an internal surface of the movable wall 13 which is arranged against an internal surface of the outer wall 16 of the tank 20.
When the second chamber 12 is filled up by the initial mixture of the content and liquid from the container and the first chamber 11, the mixture will flow in through the inlet of the second chamber and flow out of the perforations of the perforated volume extension structure 14. The movable wall 13 will then move away from the outer surface of the perforated volume extension structure 14 and towards an inner surface of the eternal wall 16 of the tank 20. When the movable wall 13 moves from the perforated volume extension structure 14 towards the outer wall 16 of the tank 20, the movable wall 13 unfolds to its original shape. As such, the second volume, i.e. the volume of the second chamber 12, encompasses the volume of the first chamber 11, and that of the inside of the perforated volume extension structure 14. Hence, the second chamber 12 has a larger volume than the first chamber 11.
To prevent a vacuum from forming between the movable wall 13, which may be a membrane of silicon, and the inner surface of the external wall 16 of the tank 20, such as an inner surface of a cylindrical wall, the device may comprise a layer of a material between the movable wall/membrane 13 and the inner surface of the outer wall 16 of the tank 20. Any vacuum formed may prevent the first chamber from filling which may prevent the function of the device.
Such material may provide the device with a small space between the movable wall/membrane 13 and the inner surface of the outer wall 16. The material may be a mesh material, a grid material, or any other material providing an air space between the membrane and the cylinder wall. The material may be arranged at the inner surface of the outer wall 16 of the tank 20.
In some examples the space between the movable wall/membrane 13 and the inner surface of the external wall 16 of the tank 20 may be formed by a feature of the inner surface of the external wall 16. The inner surface of the external wall 16 may comprise a plurality of protrusions in the direction of the movable wall/membrane 13. In other examples, the inner surface of the external wall 16 may comprise a grid of protrusions forming a mesh-like structure, a grid-like structure, a plurality or ridges arranged horizontally and/or vertically, or the like. In some embodiments, inner surface of the external wall 16 may comprise a plurality of indentations or groves. The plurality of indentations or groves may be arranged horizontally and/or vertically on the inner surface of the outer wall 16. In other embodiments, the inner wall of the cylinder may comprise a grid of indentations.
In some examples, a combination of protrusions and indentations may be arranged on the inner surface of the outer wall 16.
Alternatively, and/or in addition, an external surface of the movable wall/membrane 13 may be configured to provide a space between the movable wall/membrane 13 and the inner surface of the outer wall 16 of the tank 16. In some examples the external surface of the movable wall/membrane 13 may be provided with protrusions to provide a space between the movable wall/membrane 13 and the inner surface of the outer wall 16. The protrusions may be similar to the protrusions described for the inner surface of the outer wall 16. In some examples, the outside of the movable wall/membrane 13 may be provided with a plurality of indentations. The indentations may be similar to the protrusions described for the inner surface of the outer wall 16.
In the illustrated configuration, the volume extension structure 14 is rotational around a rotational axis of the volume extension structure 14. In some examples, the rotational axis of the volume extension structure 14, such as the hyperboloid or the spool-like shape, is the same rotational axis as the rotational axis of the tank. Such a configuration of the volume extension structure 14 in relation to the tank may provide the device with improved mixing capabilities.
In some examples, the tank 20 may have an inclination at the bottom. The tank 20 may have a lowest position in the second chamber. In some examples, the outlet 17 of the second chamber is located at the lowest position. Having the outlet 17 of the second chamber at a lowest position of the tank 20, may improve emptying of the second chamber. The gravity may assist any emptying of the second chamber.
Preferably, the movable wall/membrane 13 is a thin layer of material, to ensure flexibility of the movable wall/membrane 13. The movable wall/membrane 13 may be made of a silicone material. However, this is only an example of a suitable material for the movable wall/membrane 13.
In
The movable wall/membrane 13 folds towards the central axis of the tank when the first chamber 11 is filled with a liquid. This is illustrated in
A spool shaped, conical, or inclined portions of the volume extension structure 14 facilitates the inwards movement and folding of the movable wall/membrane 13. The movable wall/membrane 13 folds along the inclined portions of the volume extension structure 14. The fold or folds are created, to allow the first chamber 11 to fill, and to prevent the movable wall/membrane 13 to move without forming tension in the material of the movable wall/membrane 13. tensions in the material may stretch the material and creating a back pressure that may affect the filling of the first chamber 11.
The movable wall 13 may be a membrane. The membrane may be made of a silicone material.
With the membrane being configured to move towards an outer surface of the volume extension structure 14 and fold itself to form the first chamber 11, differences in properties of the membrane or movable wall 13 does not affect the volume capacity of the chambers. The sensor 8 determines when the chamber is completely filled, and is not affected by tolerances of the movable wall material.
The movable wall 13 and/or perforation of the volume extension structure 14 may allow the size of the two chambers to be determined. The device, and movable wall 13 may be arranged to prevent any tension from forming in the movable wall 13. Such configuration may also prevent the movable wall 13 to provide any pressure onto the liquid causing a pressure inside the tank preventing the first chamber to be filled to its predetermined volume.
Upon the filling of the second chamber, the movable wall 13 expands and revert to its natural shape, as is presented in
The present invention has been described above with reference to specific embodiments. However, other embodiments than the above described are equally possible within the scope of the invention. Different method steps than those described above, performing the method by hardware or software, may be provided within the scope of the invention. The different features and steps of the invention may be combined in other combinations than those described. The scope of the invention is only limited by the appended patent claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2151371-8 | Nov 2021 | SE | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/SE2022/051043 | 9/11/2022 | WO |
