Patent ID: 12239770

The embodiment shown inFIG.1of an apparatus in accordance with the invention comprises a supply connector1for solvent having a supply line3in which a supply valve2is arranged. The supply line3opens into a main circuit5in which inter alia a pump7, a first regulation valve22, and a product container27are arranged.

In a first preliminary step for preparing a dialysis concentrate solution, RO water is filled as a solvent through the supply line3into the product container27by the charging pressure applied at the supply connector1with an open valve2. The quantity of the liquid that has run into the product container27or its filling level can be determined with reference to the flowmeter4or with reference to the filling level sensors30and35. A gravimetric sensor, not shown in the Figure, can furthermore be provided to determine the filling level in the product container27. After completion of this preliminary step, the supply valve3can be closed.

The apparatus further comprises a branch section10that is in communication with the main circuit5. The branch section10branches off from the main circuit5at a branch point8at the pressure side of the pump7and comprises a flushing line11, a second regulation valve23, and a suction line16that comprises a further regulation valve38_1. The suction line16and the flushing line11are connectable to a raw material container18.

The suction line16opens into the main circuit5at a suction unit15configured as a Venturi nozzle. The raw material container18in the embodiment in accordance withFIG.1is a rigid container that can be reused multiple times and that has a connector19for the flushing line11, a connector14for the suction line16, and a filling connector17for filling and, optionally, emptying the raw material container18. A filling level sensor56is furthermore provided for determining the filling level in the raw material container18, in particular for avoiding an overflow of the raw material container18.

In a second preliminary step for preparing a dialysis concentrate solution, the raw material container18is connected to the apparatus. If the raw material container is not already filled with raw material, it can be filled with a specific quantity of a raw material through the filling connector17. It can here be a solid raw material, for example a powder or a granulate, or a high viscosity concentrate, for example a slurry or low viscosity concentrate. The (re)filling can take place in the connected state or in the disconnected state of the raw material container.

On a use of solid materials or high viscosity concentrates, provision can be made in a third preliminary step to pump some of the solvent from the product container27using the pump7on opening the valve38_1and with a closed regulation valve22through the suction line16against the suction direction into the raw material container18that is for this purpose vented to the environment by a venting means, not shown. This portion of the solvent serves as a transport medium for, for example, the solid raw material that is at least dispersed therein, albeit still hardly dissolved in this step, and is thus made line-capable.

The order of the preliminary steps can substantially be as desired with the only limitation that the product container27has to be filled with solvent before a portion of the solvent located therein is pumped into the raw material container18. Provision can, for example, be made only to fill raw material into the raw material container18after a partial filling with solvent. The filling of the raw material container18with the raw material can also take place before the filling of the product container27with solvent.

At the start of the mixing process, solvent is circulated out of the product container27in the main circuit5using the pump7with an open first regulation valve22. Liquid raw material or raw material dispersed and not dissolved in liquid is here sucked into the solvent circulating in the main circuit5from the connected raw material container18through the section line16at the suction unit15through injection and is taken along. In the direction of flow downstream of the suction unit15, fine mixing chambers48_1and48_2arranged in series are provided in series in the main circuit5. The not yet dissolved raw material is dissolved in solvent in the fine mixing chambers48_1and48_2. The fine mixing chambers48_1and48_2each comprise a retention element provided for the undissolved components of the raw material. The presence of two fine mixing chambers48_1and48_2serves the optimization of the apparatus in accordance with the invention. The principle of the invention only requires the presence of at least one fine mixing chamber48_1.

FIG.2shows an embodiment for such a fine mixing chamber48_1and48_2in which the retention element is configured as a filter element. The liquid having the at least partially undissolved raw concentrate material is flowed into the fine mixing chamber housing104laterally downwardly and preferably with a lateral offset through the inflow101of the fine mixing chamber and moves into a swirl chamber107that extends around the filter element106. Alternatively, the fine mixing chamber can also be positioned at the bottom (102) instead of laterally at the fine mixing chamber housing104.

A swirl arises in the swirl chamber107in the fine mixing chamber housing104by the flowing in of the suspension from laterally below or from below. To arrive at the filter element106, the liquid having the not yet dissolved raw material has to flow through the swirl chamber107upwardly against gravity. Undissolved components are here preferably held in the swirl chamber107by the swirl and by gravity where their dissolution is accelerated by the swirl. Undissolved components nevertheless arriving at the filter element are retained at the filter element106and are dissolved by the overflowing of the liquid. The liquid or solution flowing through the filter element106is collected in the manifold105and is led via the outflow103of the fine mixing chamber48_1further into the mixing line of the mixing system either to a further fine mixing chamber48_2(as shown inFIG.1) or directly back into the product container27.

The filter element of the second fine mixing chamber48_2can have a finer particle permeability than the filter element of the first fine mixing chamber48_1, i.e. the retention capability of the first fine mixing chamber can be less than that of the second fine mixing chamber48_2to promote a step-wise dissolution of the raw material.

The liquid exiting the fine mixing chambers48_1and48_2arrives back in the product container27. The filters of the fine mixing chambers48_1and48_2allow liquid to pass in accordance with their retention capability and hold back any undissolved raw material particles to the required degree. It can thus be avoided that raw material particles arrive in the product container27.

The solvent can be heated before and during the dissolution process to accelerate and optimize the dissolving process. For this purpose, a continuous-flow heater9and a temperature sensor29are arranged in the main circuit5upstream of the suction unit15and the fine mixing chambers48_1and48_2in the direction of flow.

A regulation valve38_1and a sensor39, that can be configured as a pressure sensor, are arranged just before the opening into the suction unit15in the suction line16. The sensor39serves the monitoring of the mixing process and the filling level recognition of a connected raw material container18. The suction line16can be interrupted as required by the regulation valve38_1, e.g. when the raw material container18is empty and a suction of air should be prevented.

The solvent or the produced dialysis concentrate solution is circulated for so long in the main circuit5until the total raw material is dissolved that is contained in the connected raw material container18. It can be necessary in this process to carry out an interposed step a plurality of times in the course of the dissolution process, said step corresponding to the third preliminary step described above, that is to pump a portion of the solvent from the product container27through the suction line16of the branch section10into the connected raw material container18using the pump7with a suitable position of the regulation valves22and38_1to make further portions of the raw material, that is solid for example, line-capable. The complete consumption of the raw material can be monitored using a time control and/or using the sensor39. A gravimetric sensor or an otherwise suitable sensor can furthermore be arranged at the raw material container18.

Once the total raw material located in the raw material container18is consumed and the raw material container18has been sucked empty by the suction unit15, the dissolution process and the circulation of the now ready dialysis concentrate solution in the main circuit5can be ended or circulation can be continued for a certain time beforehand so that residues of undissolved raw material remaining in the fine mixing chambers are also dissolved. The apparatus can optionally have sensors for the automatic quality control of the dialysis concentrate solution such as density sensors, conductivity measurement cells or refractometers.

The retention of undissolved raw material particles in a fine mixing chamber48_1and48_2respectively is a substantial advantage of the solution in accordance with the invention. In static mixers such as are frequently used in the prior art, the raw material is dissolved by swirling with the solvent and the mixture is then pumped into a product container. Undissolved raw material likewise enters into the product container. In the course of the preparation method in accordance with the invention or as part of the apparatus in accordance with the invention, no dissolution of raw material takes place in the product container27since the undissolved raw material does not enter into the product container27at all due to the fine mixing chamber.

If the retention element in the fine mixing chamber48_1and48_2is configured as a filter element, the system can operate in a self-regulating manner while including the suction unit15without any further auxiliary means. If undissolved raw material reduces the throughflow through the filter element, the flow through the suction unit that is configured as a Venturi nozzle in this embodiment is reduced. Less undissolved raw material is thereby sucked in and introduced into the fine mixing chamber until the clogging raw material portions release due to the overflowing liquid and reduce or even end the clogging again, whereby the throughflow increases again. This self-regulation promotes the dissolving of the raw material and simultaneously prevents a significant clogging of the retention element and thus of the liquid flow with the raw material.

The completed dialysis concentrate solution can be pumped to different consumer stations T1a-T3bsuch as dialysis machines or solution containers, e.g. for storage, through a product line having a filter12and a transfer valve13using the pump7.

On completion of the process, the system and all the flow paths can be flushed and optionally disinfected. For this purpose, cleansing liquid, for example RO water or RO water admixed with peroxides (that was e.g. metered into the container27from the supply connector1or admixed with peroxides) can be pumped through the lines of the system using the pump7. The cleansing can include a connected raw material container18before it should again be filled with raw material at the same position or at a separate position or should be cleansed or disposed of. The apparatus can also be configured such that it prepares the liquid required for the cleaning itself as in the case of the medical solution with the aid of a raw material container18filled with a disinfecting agent or disinfecting solution.

A spray head51connected to the flushing line11is provided in the raw material container18for the purpose of the cleaning. A spray head26is also provided in the product container27and is connected to a cleansing line25with a cleansing valve24. The cleansing line25branches off from the flushing line11of the branch section10. A flushing of the raw material container18and of the product container27can therefore be carried out in that cleansing liquid arrives in the flushing line11and from there, depending on the position of the second regulation valve23and of the cleansing valve24, into the spray head51of the raw material container18and/or into the spray head26of the product container27and is sprayed into the respective container by the pump7with an open supply valve2and a closed first regulation valve22. It is also possible that the cleansing liquid is first metered into the container27via the supply connector1before the circulation by the pump7. The main mixing paths can also be cleansed by opening the first regulation valve22and closing the regulation valves23and24. If the flow relationships allow, the regulation valves22,23, and24can also simultaneously be open during the cleansing process. Consumed cleansing solution can be discarded through the outflow6.

FIG.3shows a flow chart of a further embodiment of an apparatus in accordance with the invention for preparing a dialysis concentrate solution. The flow chart is generally similar to that ofFIG.1and only differences will be discussed in the following.

In contrast to the apparatus ofFIG.1, no rigid container that is usable multiple times is used as the raw material container in the apparatus ofFIG.3, but a flexible disposable bag18is rather used.

The disposable bag18has an optional connector19for the line11that here optionally serves the venting and has a connector14for the suction line16of the branch section10. The connection between the optional connector19and the line11, on the one hand, and the connector14and the suction line16, on the other hand, is releasable. The corresponding connectors can, for example, be equipped with fast-closing couplings. A coupling point21is located close to the connector point of the disposable bag18at the machine side and both the end of the line11connectable to the optional connector19and the end of the section line16connectable to the connector14can be connected thereto. The coupling point21has a line portion having two connectors, for example fast-closing couplings.

The end of the line11is connected to the coupling point21or, in the case of an optional connector19, selectively to the connector19. The end of the suction line16can selectively be connected to the connector14or to the coupling point21. If both ends are connected to the coupling point, a closed circuit is formed while omitting the bag18. This configuration should be present during the cleansing of the system and generally always when no bag is connected. A connection of the end of the suction line16to the connector14replaces the second preliminary step described in connection withFIG.1. This configuration is shown inFIG.3.

A connection of the end of the line11to the connector19can be carried out in connection with the third preliminary step described with respect toFIG.1when a venting of the bag during a possible filling via the suction line16is desired. It can, however, also be the case, particularly with disposable bags, that the bag18is already sufficiently filled with liquid for flushing the undissolved raw materials at the manufacturer's side so that a filling process with liquid is dispensable or partially dispensable.

The medical solution and preferably the dialysis concentrate solution is subsequently mixed and prepared as already explained.

In the case of this embodiment, the dissolution process can be ended once the total liquid containing raw material located in the bag18has been sucked empty and residual raw material quantities remaining in the fine mixing chambers have been dissolved.

The bag18is separated and the suction line16and the line11are—if not already connected—short-circuited via the coupling point21for the subsequent cleansing. To cleanse the suction line16and the lines11and25, the regulation valves38_1and24have to be open.

An apparatus in accordance with the invention can naturally be designed such that both a rigid raw material container usable multiple times as inFIG.1and a flexible disposable bag as inFIG.3can be connected. Alternative connectors and/or slots can be provided for this purpose.

FIG.4shows a flow chart of yet another embodiment of an apparatus in accordance with the invention. The flow chart substantially corresponds to a combination of the embodiments shown inFIGS.1and3.

In the apparatus ofFIG.4, a second suction line20having a second regulation valve38_2is provided that extends in parallel with the first suction line16and opens into the first suction line16at the measurement point of the sensor39between the regulation valve38_1and the suction unit15, that is just before the suction unit15. This second suction line20serves the connection of a second raw material container52in the form of a disposable bag filled with a liquid. A liquid concentrate or an active ingredient solution can be present in this bag52and should be introduced into the dialysis concentrate solution in addition to the raw material of the raw material container18. For this purpose, the end of the second suction line20is connectable to the connector22of the second raw material container52. On a circulation of the solvent or of the produced dialysis concentrate solution in the main circuit5and on a flowing through of the suction unit15, not only liquid containing raw material is sucked into the solvent circulating in the main circuit5and is taken along by Venturi injection through the suction line16, but also an additional raw material through the second suction line20(for example alternately or simultaneously).

In the case of this embodiment, the dissolving process can be ended once the total liquid containing raw material located in the container18and the total additional content located in the bag52have been sucked empty and the residual raw material quantities remaining in the fine mixing chambers have been dissolved.

If no additional raw material container52is connected, for example on a non-use or on a flushing of the circuit, the end of the second suction line20can be connected to a coupling point21departing from the flushing line11and having a check valve, said coupling point comprising a suitable connector, for example a fast-closing coupling. In the case of the embodiment ofFIG.4, a venting option of the container52can furthermore be provided via a connection as in the case of the embodiment ofFIG.3, which is not shown in any more detail inFIG.4.