WO2022133784A1

WO2022133784A1 - Container for dialysis, corresponding assembly, corresponding kit, corresponding device and method for preparing solution

Info

Publication number: WO2022133784A1
Application number: PCT/CN2020/138567
Authority: WO
Inventors: Misha ZOU; Yufeng Wang
Original assignee: Fresenius Medical Care Deutschland Gmbh; Fresenius Medical Care R&D (Shanghai) Co., Ltd.
Priority date: 2020-12-23
Filing date: 2020-12-23
Publication date: 2022-06-30

Abstract

A container (1) for dialysis comprises an enclosure (11) configured to accommodate dry concentrate; a first connector (12) configured to allow a fluid to flow in and/or out of the enclosure (11); and a vent interface (13) disposed on the enclosure (11) to ventilate the enclosure (11); wherein the vent interface (13) is disposed above the first connector (12), and preferably at an upper portion (111) of the enclosure (11). A corresponding method for preparing a solution can be prepared effectively and efficiently, and can avoid a caking problem of the dry concentrate during a dissolving process.

Description

Container for Dialysis, Corresponding Assembly, Corresponding Kit, Corresponding Device and Method for Preparing Solution

Technical Field

The present disclosure relates to a container for dialysis, a corresponding assembly, a corresponding kit, a corresponding device and a method for preparing a solution.

Background Art

It is known that, in many fields, for example in the medical field, it is necessary to prepare solutions according to well-specified dosages in order to carry out specific treatments. Such is for example the case of dialysis solution for dialysis treatment.

Nowadays, the dialysis solution is often prepared just before dialysis sessions. As a typical manner, the dialysis solution may be prepared by mixing water with liquid concentrates which are stored in canisters, which are heavy and bulky. Some kind of liquid concentrate, for example bicarbonate solution, has a poor stability so that it is mostly provided as dry concentrate. In this case, the dry concentrate, for example in a form of powders, granules or tablets or mixtures thereof is placed in a container and can be dissolved by liquid, for example water to obtain a solution which may be the dialysis solution or an intermediate solution for preparing the dialysis solution.

An efficient way is to place the dry concentrate in a bag-like container and dissolve the dry concentrate directly in the container.

Further, the dissolution of the dry concentrate still faces many challenges. For example, there may exist a caking problem if the dry concentrate, particularly in a form of powders or granules, is dissolved improperly. The caking problem is a major problem in clinic use. When caking occurs, flowability of particles of the dry concentrate will become lower and thus a hollow cavity in the dry concentrate will be formed, leading to sudden decrease of concentration of the outflow solution. In this case, the outflow solution will be out of criteria, and the container cannot be used anymore even if there would be still a large amount of dry concentrate left.

Caking may occur in different ways from container to container.

For S-bags (Sodium Chlorite bag) , caking in salt is the formation of liquid and subsequently solid bridges between salt crystals caused by moisture movement within the salt bed. Some anticaking agents like potassium ferrocyanide can be added in a very small amount to crystals of the salt after the centrifugal separation and before a drying process. The addition of potassium ferrocyanide to the salt causes it to form a dendritic structure which is friable and only can form very weak intercrystallite bridging, thereby preventing caking in the salt. However, raw materials used in the dialysis treatment must be totally pure, which excludes use of the anticaking agents.

For bags containing sodium bicarbonate, caking of sodium bicarbonate is generally caused by a very small amount of anhydrous sodium carbonate on surfaces of sodium bicarbonate crystal particles, which results in bridge formation during the process of sodium carbonate and sodium bicarbonate changing into sodium carbonate monohydrate (Na ₂CO ₃·H ₂O) , sodium carbonate decahydrate (Na ₂CO ₃·10H ₂O) , sodium sesquicarbonate (Na ₂CO ₃ ·NaHCO ₃·2H ₂O) or Wegscheider’s salt (Na ₂CO ₃ ·3NaHCO ₃) , etc. Caking strengths depends strongly on particle size, humidity, temperature, and pressure, which is empirically known hard to change.

Thus, there is a need to improve the container to allow for effectively and efficiently dissolving the dry concentrate.

Summary of the Disclosure

In view of the problems existing in the prior art, an object of the disclosure is to provide a container for dialysis, a corresponding assembly, a corresponding kit, a corresponding device and a corresponding method for preparing a solution.

For achieving this object, according to a first aspect, provided is a container for dialysis, comprising: an enclosure configured to accommodate dry concentrate; a first connector configured to allow a fluid to flow in and/or out of the enclosure; and a vent interface disposed on the enclosure to ventilate the enclosure; wherein the vent interface is disposed above the first connector, and preferably at an upper portion of the enclosure.

According to an optional embodiment of the present disclosure, the vent interface is a flat interface with at least a hydrophobic membrane; and/or the vent interface is sealable to make the enclosure hermetically sealed.

According to an optional embodiment of the present disclosure, the container further comprises a second connector, which is disposed below the vent interface.

According to an optional embodiment of the present disclosure, the first connector and the second connector are disposed at a predetermined interval; or one of the first connector and the second connector is disposed so as to surround the other, preferably, the first and second connectors are coaxially disposed.

According to an optional embodiment of the present disclosure, the first connector is configured to allow the fluid to flow into the enclosure to dissolve the dry concentrate; and the second connector is configured to allow a dissolved solution to flow out of the enclosure; preferably, the first connector and the second connector are disposed at a lower portion of the enclosure and the vent interface is disposed at a top of the enclosure.

According to an optional embodiment of the present disclosure, the container comprises an inner tube, wherein the inner tube is enclosed within the enclosure and upwardly coupled with the first connector, and/or the inner tube is configured with the first connector as a one-piece component.

According to an optional embodiment of the present disclosure, the container further comprises a first filter, which is coupled to the second connector to prevent an undissolved concentrate from flowing out of the enclosure, and/or which is disposed at a top of the second connector; and/or the container further comprises a second filter, which is coupled to the first connector or the inner tube to prevent blocking of the first connector or the inner tube, and/or which is disposed at a top of the first connector or the inner tube.

According to an optional embodiment of the present disclosure, the enclosure is configured to allow for smoothly falling of the dry concentrate, preferably, the enclosure is configured as a truncated cone, preferably a cone angle of the truncated cone is in a range of from 25° to 45°.

According to an optional embodiment of the present disclosure, at least one hanging structure is provided at the upper portion of the enclosure for hanging the container.

According to a second aspect, provided is an assembly comprising the container described above and the dry concentrate accommodated within the container.

According to an optional embodiment of the present disclosure, the dry concentrate comprises hemodialysis concentrate, preferably sodium chlorite and/or sodium bicarbonate; and/or the dry concentrate is in a form of granule or powder.

According to a third aspect, provided is a kit comprising at least two assemblies described above.

According to a fourth aspect, provided is a device for dissolving dry concentrate by using the container described above, the assembly described above, or the kit described above.

According to an optional embodiment of the present disclosure, the device comprises a pumping device, preferably a balancing device and/or a dosing pump, preferably which is connected to the first connector through a transfer tube.

According to a fifth aspect, provided is a method for preparing a solution by using the container described above, the assembly described above, the kit described above, or the device described above, the method comprising: a fluid introducing step for introducing the fluid into the enclosure through the first connector; a dissolving step for dissolving the dry concentrate, optionally the vent interface is switched on for air penetration; and a solution delivering step for delivering the prepared solution out of the enclosure through the first connector or the second connector.

According to an optional embodiment of the present disclosure, the solution delivering step is carried out after the enclosure is filled to a predetermined extent or the dry concentrate is completely dissolved; and/or the first connector is switched off when the solution reaches a predetermined condition, for example a predetermined filling volume, a predetermined liquid level and/or an internal pressure.

According to an optional embodiment of the present disclosure, in the dissolving step, the first connector is switched on to introduce an additional fluid which is the same as or different from the fluid introduced in the fluid introducing step into the enclosure to accelerate dissolution of the dry concentrate; and/or the fluid introducing step is carried out by means of a pumping device.

According to an optional embodiment of the present disclosure, the additional fluid is introduced in a predetermined pattern, preferably in an impulse fluid flow generated by the pumping device; and/or the pumping device is a dosing pump and/or a balancing device.

According to an optional embodiment of the present disclosure, the fluid introduced in the fluid introducing step is RO water; and/or the solution prepared in at least one container is a saturated solution.

According to the disclosure, the solution can be prepared effectively and efficiently, and can avoid a caking problem of the dry concentrate during a dissolving process.

Brief Description of the Drawings

The disclosure and advantages thereof will be further understood by reading the following detailed description of some exemplary embodiments with reference to the drawings in which:

Fig. 1 shows a container for dialysis according to an exemplary embodiment of the present disclosure.

Fig. 2 shows the container according to another exemplary embodiment of the present disclosure.

Fig. 3 shows the container as shown in Fig. 2 in a different view compared with Fig. 2.

Fig. 4 shows a flow chart of a method for preparing a solution according to an exemplary embodiment of the present disclosure.

Detailed Description of Preferred Embodiments

Some exemplary embodiments of the present disclosure will be described hereinafter in more details with reference to the drawings to better understand the basic concept and advantages of the present disclosure.

According to the disclosure, herein firstly proposed is a container for dialysis, comprising: an enclosure configured to accommodate dry concentrate; a first connector configured to allow a fluid to flow in and/or out of the enclosure; and a vent interface disposed on the enclosure to ventilate the enclosure; wherein the vent interface is disposed above the first connector, and preferably at an upper portion of the enclosure.

The container may particularly be configured in a bag-like form. The container can be used to prepare a dialysis solution or an intermediate solution for preparing the dialysis solution.

Fig. 1 shows such a container 1 according to an exemplary embodiment of the present disclosure.

As shown in Fig. 1, the container 1 may comprise an enclosure 11 configured to accommodate dry concentrate; a first connector 12 configured to allow a fluid to flow in and/or out of the enclosure 11; and a vent interface 13 disposed on the enclosure 11 to ventilate the enclosure 11; wherein the vent interface 13 may be disposed above the first connector 12, and preferably at an upper portion 111 of the enclosure 11.

The skilled person in the art may understand that the container 1 is shown in Fig. 1 in the most common usage status and thus positional words, such as “above” , “below” , “top” , “bottom” and so on are used herein with respect to the most common usage status.

During use, the fluid, for example water, may be introduced into an interior space of the enclosure 11 through the first connector 12 to dissolve the dry concentrate. As an example, when the dry concentrate has been dissolved sufficiently after a period of time, the formed solution can be delivered out of the enclosure 11 through the first connector 12.

During introducing of the fluid into the enclosure 11, gas, such as air, within the enclosure 11 may need to be displaced by the fluid and thus the vent interface 13 may be in an opening status. The skilled person in the art may understand that the vent interface 13 also may need to be in the opening status at other usage phases. According to an exemplary embodiment of the present disclosure, the vent interface 13 can be switched on and off manually by a closure (not shown) .

According to an exemplary embodiment of the present disclosure, the vent interface 13 may be configured as a flat interface with at least a hydrophobic membrane. The use of the hydrophobic membrane may advantageously prevent outflow of the formed solution or the introduced fluid.

According to an exemplary embodiment of the present disclosure, the vent interface 13 may be configured to be sealable to make the enclosure 11 hermetically sealed.

Fig. 2 shows the container 1 according to another exemplary embodiment of the present disclosure. Fig. 3 shows the container 1 as shown in Fig. 2 in a different view compared with Fig. 2.

As shown in Fig. 2, the container 1 may further comprise a second connector 14, which is disposed below the vent interface 13.

According to an exemplary embodiment of the present disclosure, as shown in Fig. 2, the first connector 12 and the second connector 14 may be disposed at a predetermined interval, for example 2cm-3cm.

According to an exemplary embodiment of the present disclosure, one of the first connector 12 and the second connector 14 also may be disposed so as to surround the other. Preferably, the first and second connectors are coaxially disposed.

In the case of two connectors, the first connector 12 may be configured to allow the fluid to flow into the enclosure 11 to dissolve the dry concentrate, and the second connector 14 may be configured to allow a dissolved solution to flow out of the enclosure 11.

According to an exemplary embodiment of the present disclosure, the first connector 12 and the second connector 14 are disposed at a lower portion 112 of the enclosure 11, preferably a bottom of the enclosure 11.

Preferably, the vent interface 13 may be disposed at a top of the enclosure 11.

According to an exemplary embodiment of the present disclosure, the container 1 may comprise an inner tube 15 configured to guide the fluid. The inner tube 15 is enclosed within the enclosure 1. Preferably, the inner tube 15 may be upwardly coupled with the first connector 12, for example by a plug connection. Alternatively, the inner tube 15 may be configured with the first connector 12 as a one-piece component.

The inner tube 15 may have a length of 5cm-15cm, for example about 10cm.

According to an exemplary embodiment of the present disclosure, the container 1 may further comprise a first filter 16, which may be coupled to the second connector 14 to prevent an undissolved concentrate from flowing out of the enclosure 11. Preferably, the first filter 16 may be disposed at a top of the second connector 14.

According to an exemplary embodiment of the present disclosure, the container 1 may further comprise a second filter 17, which is coupled to the first connector 12 or the inner tube 15 to prevent blocking of the first connector 12 or the inner tube 15, and/or which is disposed at a top of the first connector 12 or the inner tube 15.

According to an exemplary embodiment of the present disclosure, the enclosure 11 may be configured to allow for smoothly falling of the dry concentrate in use. Preferably, the enclosure 11 may be configured as a truncated cone, as shown in Figs. 1 to 3. A cone angle of the truncated cone may be selected to be in a range of from 25° to 45°, preferred an angle of 42° as an example.

According to an exemplary embodiment of the present disclosure, at least one hanging structure 18 may be provided at the upper portion 111 of the enclosure 11 for hanging the container 1 during use.

As shown in Figs. 1 to 3, the hanging structure 18 may comprise at least one hanging hole, preferably two hanging holes disposed at two opposite sides of the enclosure 11 respectively.

According to the disclosure, herein further proposed is an assembly comprising the container 1 described above and the dry concentrate accommodated within the container 1.

According to an exemplary embodiment of the present disclosure, the dry concentrate may comprise hemodialysis concentrate, preferably sodium chlorite and/or sodium bicarbonate. The dry concentrate may be in a form of granule or powder.

According to the disclosure, herein further proposed is a kit comprising at least two assemblies described above. In this case, a first one of the at least two assemblies is used to prepare a first solution and a second one of the at least two assemblies is used to prepare a second solution different from the first solution, wherein the first solution and the second solution each may be constituents of the final dialysis solution and preferably can form the final dialysis solution for example by mixing with each other.

According to an exemplary embodiment of the present disclosure, herein further proposed is a device for dissolving dry concentrate by using the container 1 described above, the assembly described above, or the kit described above.

According to an exemplary embodiment of the present disclosure, the device may comprise a pumping device for example for pumping the fluid towards the container 1. Preferably, the pumping device may be a balancing device and/or a dosing pump. The pumping device may be connected to the first connector 12 through a transfer tube.

According to the disclosure, herein further proposed is a method for preparing a solution for medical use, by using the container 1 described above, the assembly described above, the kit described above, or the device described above.

Fig. 4 shows a flow chart of the method according to an exemplary embodiment of the present disclosure.

As shown in Fig. 4, the method may comprise: a fluid introducing step S1 for introducing the fluid into the enclosure 11 through the first connector 12; a dissolving step S2 for dissolving the dry concentrate, optionally the vent interface 13 is switched on for air penetration; and a solution delivering step S3 for delivering the prepared solution out of the enclosure 11 through the first connector 12 or the second connector 14.

The skilled person in the art may understand that these steps are not necessarily carried out in the above order and instead can be carried out in any suitable manner, for example, simultaneously or overlapping in time.

In the fluid introducing step S1, the vent interface 13 may be switched on for air penetration, thereby allowing for displacing the gas within the enclosure 11 to facilitate introducing of the fluid. In the solution delivering step S3, the vent interface 13 also may be switched on for air penetration, thereby allowing for balancing a pressure within the enclosure 11 to facilitate delivering of the solution.

According to an exemplary embodiment of the present disclosure, the solution delivering step S3 may be carried out after the enclosure 11 is filled to a predetermined extent or the dry concentrate is completely dissolved.

For example, for a certain concentrate particularly with good solubility, it can be dissolved sufficiently when the enclosure 11 is filled to the predetermined extent, such as a predetermined percent of a volume of the container 1. In this case, the formed solution can be delivered once the enclosure 11 is filled to the predetermined extent. Another possible case is to form a saturated solution, in which the dry concentrate is gradually dissolved to form the saturated solution continuously.

According to an exemplary embodiment of the present disclosure, the first connector 12 may be switched off when the solution reaches a predetermined condition, for example a predetermined filling volume, a predetermined liquid level and/or an internal pressure. This means that introducing of the fluid will be stopped when the solution reaches the predetermined condition. The skilled person in the art may understand that the predetermined condition is not limited thereto and can be selected differently for different applications.

According to an exemplary embodiment of the present disclosure, in the dissolving step S2, the first connector 12 may be switched on to introduce an additional fluid which may be the same as or different from the fluid introduced in the fluid introducing step S1 into the enclosure 11 to accelerate dissolution of the dry concentrate.

The additional fluid may even be gas, as long as it can accelerate dissolution of the dry concentrate to obtain the desired solution.

As an example, the additional fluid may be introduced in a predetermined pattern.

According to an exemplary embodiment of the present disclosure, the fluid introducing step S1 is carried out by means of the pumping device. In this case, the additional fluid may be introduced in an impulse fluid flow generated by the pumping device.

The impulse fluid flow can break intercrystalline bridging and take particles of the dry concentrate, thereby promoting flowing of the particles during the dissolving process.

While certain embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the disclosure. The attached claims and their equivalents are intended to cover all the modifications, substitutions and changes as would fall within the scope and spirit of the disclosure.

Claims

A container for dialysis, comprising:

an enclosure configured to accommodate dry concentrate;

a first connector configured to allow a fluid to flow in and/or out of the enclosure; and

a vent interface disposed on the enclosure to ventilate the enclosure;

wherein the vent interface is disposed above the first connector, and preferably at an upper portion of the enclosure.
The container according to claim 1, wherein

the vent interface is a flat interface with at least a hydrophobic membrane; and/or

the vent interface is sealable to make the enclosure hermetically sealed.
The container according to claim 1 or 2, wherein

the container further comprises a second connector, which is disposed below the vent interface.
The container according to any one of the preceding claims, wherein

the first connector and the second connector are disposed at a predetermined interval; or

one of the first connector and the second connector is disposed so as to surround the other, preferably, the first and second connectors are coaxially disposed.
The container according to any one of the preceding claims, wherein

the first connector is configured to allow the fluid to flow into the enclosure to dissolve the dry concentrate; and

the second connector is configured to allow a dissolved solution to flow out of the enclosure;

preferably, the first connector and the second connector are disposed at a lower portion of the enclosure and the vent interface is disposed at a top of the enclosure.
The container according to any one of the preceding claims, wherein

the container comprises an inner tube, wherein the inner tube is enclosed within the enclosure and upwardly coupled with the first connector, and/or the inner tube is configured with the first connector as a one-piece component.
The container according to any one of the preceding claims, wherein

the container further comprises a first filter, which is coupled to the second connector to prevent an undissolved concentrate from flowing out of the enclosure, and/or which is disposed at a top of the second connector; and/or

the container further comprises a second filter, which is coupled to the first connector or the inner tube to prevent blocking of the first connector or the inner tube, and/or which is disposed at a top of the first connector or the inner tube.
The container according to any one of the preceding claims, wherein

the enclosure is configured to allow for smoothly falling of the dry concentrate, preferably, the enclosure is configured as a truncated cone, preferably a cone angle of the truncated cone is in a range of from 25° to 45°.
The container according to any one of the preceding claims, wherein

at least one hanging structure is provided at the upper portion of the enclosure for hanging the container.
An assembly comprising the container according to any one of preceding claims and dry concentrate accommodated within the container.
The assembly according to claim 10, wherein

the dry concentrate comprises hemodialysis concentrate, preferably sodium chlorite and/or sodium bicarbonate; and/or

the dry concentrate is in a form of granule or powder.
A kit comprising at least two assemblies according to claim 10 or 11.
A device for dissolving dry concentrate by using the container according to any one of claims 1-9, the assembly according to claim 10 or 11, or the kit according to claim 12.
The device according to claim 13, wherein

the device comprises a pumping device, preferably a balancing device and/or a dosing pump, preferably which is connected to the first connector through a transfer tube.
A method for preparing a solution by using the container according to any one of claims 1-9, the assembly according to claim 10 or 11, the kit according to claim 12, or the device according to claim 13 or 14, the method comprising:

a fluid introducing step for introducing the fluid into the enclosure through the first connector;

a dissolving step for dissolving the dry concentrate, optionally the vent interface is switched on for air penetration; and

a solution delivering step for delivering the prepared solution out of the enclosure through the first connector or the second connector.
The method according to claim 15, wherein

the solution delivering step is carried out after the enclosure is filled to a predetermined extent or the dry concentrate is completely dissolved; and/or

the first connector is switched off when the solution reaches a predetermined condition, for example a predetermined filling volume, a predetermined liquid level and/or an internal pressure.
The method according to claim 15 or 16, wherein

in the dissolving step, the first connector is switched on to introduce an additional fluid which is the same as or different from the fluid introduced in the fluid introducing step into the enclosure to accelerate dissolution of the dry concentrate; and/or

the fluid introducing step is carried out by means of a pumping device.
The method according to any one of claims 15-17, wherein

the additional fluid is introduced in a predetermined pattern, preferably in an impulse fluid flow generated by the pumping device; and/or

the pumping device is a dosing pump and/or a balancing device.
The method according to any one of claims 15-18, wherein

the fluid introduced in the fluid introducing step is RO water; and/or

the solution prepared in at least one container is a saturated solution.