Dialysis fluid bag

Abstract

Dialysis fluid bags, as well as systems and methods involving dialysate bags, are disclosed herein. The dialysate bag comprises a first inlet / outlet port, a second inlet / outlet port, and an inner chamber containing peritoneal dialysate concentrate, the inner chamber being fluidically connected to the first inlet / outlet port and the second inlet / outlet port. The first inlet / outlet port and the second inlet / outlet port have an open state and a closed state, when open, each of the first inlet / outlet port and the second inlet / outlet port fluidically connects the inner chamber to the outside of the dialysate bag, and when closed, each of the first inlet / outlet port and the second inlet / outlet port fluidically separates the inner chamber from the outside of the dialysate bag.

Description

Technical Field

[0001] The present invention relates to the field of dialysis fluid bags useful for dialysis treatment, as well as systems and methods involving dialysis fluid bags.

Background Art

[0002] Dialysis fluid (also known as dialysate) is an aqueous solution used in both hemodialysis and peritoneal dialysis. Dialysis fluid is used in dialysis treatment and can remove toxins and other species from a patient's body by diffusing through a semipermeable membrane. This process can be performed in the peritoneum within the patient's body (peritoneal dialysis) or in a dialyzer outside the patient's body (hemodialysis). In either case, the dialysis fluid can be provided as a pre-made sterile solution.

[0003] Typically, dialysis fluid is provided as a ready-to-use solution packaged in bags. However, the main disadvantage associated with this is that ready-to-use solutions containing large amounts of water are very heavy and bulky. For example, a typical patient undergoing automated peritoneal dialysis (APD) needs to use 60L to 120L of dialysis fluid per week. This results in a very large amount of dialysis fluid being required, which takes up a lot of space and causes logistics problems due to the weight of the fluid. Furthermore, bags filled with dialysis fluid can be prone to rupture or breakage during transportation or storage.

[0004] When the dialysis fluid is provided as a powder or liquid concentrate for reconstitution immediately before dialysis treatment, it is essential to ensure that the solution is completely dissolved / reconstituted and thoroughly mixed before the start of treatment. This can be difficult when patients receive home dialysis without the supervision of a medical professional, as it is not possible to ensure that the dialysis fluid is completely dissolved and mixed, relying on the patient.

[0005] Furthermore, when the dialysis fluid is provided as a single liquid concentrate, the dialysis fluid can suffer from long-term storage stability problems. Therefore, there is a need for an improved dialysis bag that overcomes some or all of the problems associated with the prior art. [Prior art documents] [Patent Documents]

[0006] [Patent Document 1] (See international survey report) [Overview of the Initiative]

[0007] The inventors have surprisingly found that the dialysate bag disclosed herein overcomes the problems discussed above. In particular, the dialysate bag disclosed herein contains a dialysate concentrate that is stable for storage under home conditions and can be quickly and easily reconstituted by the patient at home, ensuring sufficient reconstitution and thorough mixing.

[0008] Therefore, the present invention provides the following numbered clauses (1 to 36). 1. Peritoneal dialysis fluid bag, The first entrance / exit port, The second entrance / exit port, An inner chamber containing a peritoneal dialysate concentrate, comprising an inner chamber fluidly connected to a first inlet / outlet port and a second inlet / outlet port, The first inlet / outlet port and the second inlet / outlet port have an open state and a closed state. When in the open state, the first inlet / outlet port and the second inlet / outlet port each fluidly connect the inner chamber to the outside of the dialysate bag. A peritoneal dialysate bag in which, when closed, the first inlet / outlet port and the second inlet / outlet port each fluidly isolate (separate) the inner chamber from the outside of the dialysate bag. 2. The inner chamber is A first region comprising a first peritoneal dialysis fluid concentrate, wherein the first region is fluidly connected to a first inlet / outlet port, A second region, which is fluidically separated from the first region and contains a second peritoneal dialysate concentrate, the second region being fluidically connected to a second inlet / outlet port, A destructible barrier separating a first region from a second region, The dialysate bag is configured such that the first region is fluidly connected to the second region by the rupture of a destructible barrier. A peritoneal dialysis fluid bag as described in Clause 1, wherein the maximum volume of the first region is less than the maximum volume of the second region. 3. The dialysate bag described in Clause 2, wherein the first region includes less than 40 volume percent (e.g., less than 35 volume percent or less than 30 volume percent) of the total maximum volume of the dialysate bag. 4. The dialysate bag according to Clause 2 or 3, wherein a destructible barrier is configured to break when the first region expands. 5. The destructible barrier is configured to break substantially along its entire length (for example, at least 60% of its length, at least 70% of its length, at least 80% of its length, such as at least 90% of its length), Optionally, a dialysis fluid bag according to any one of Clauses 2 to 4, wherein the destructible barrier comprises a peelable seal and / or a fragile seal. 6. A dialysate bag according to any one of clauses 2 to 5, wherein the dialysate bag has edges, and a destructible barrier extends from a first edge to an opposing edge. 7. A dialysate bag according to any one of Clauses 2 to 6, wherein the first peritoneal dialysate concentrate and the second peritoneal dialysate concentrate are suitable for mixing together with an appropriate volume of a physiologically acceptable aqueous liquid (e.g., water for infusion) to form a dialysate suitable for direct administration to a patient. 8. (a) The first peritoneal dialysate concentrate accounts for 10 to 90% (e.g., 10 to 50%) of the maximum volume of the first region, and / or (b) A dialysate bag according to any one of clauses 2 to 7, wherein the second peritoneal dialysate concentrate occupies 10 to 90 volume percent (e.g., 10 to 50 volume percent) of the maximum volume of the second region. 9. The first region and the second region together comprise a suitable amount of the first peritoneal dialysate concentrate and the second peritoneal dialysate concentrate to prepare n liters of dialysate, n is between 2 and 15 (for example, 5 to 13, 7 to 12, etc., such as 8 to 11). A dialysate bag according to any one of Clauses 2 to 8, wherein the maximum volume of the dialysate bag is suitable for administering n liters of dialysate to a patient. 10. The dialysate bag has a tapered region, and the first inlet / outlet port is located on top of the tapered region (e.g., at the top). A dialysate bag according to any one of clauses 2 to 9, wherein, optionally, a tapered region forms part of the first region. 11. The dialysate bag comprises one or more (e.g., one) spray tubes configured to increase the distribution of the fluid flowing through the dialysate bag, optionally, (a) One of the spray tubes is attached to the first inlet / outlet port, or (b) One of the spray tubes is attached to a destructible barrier, and / or A dialysate bag as described in any one of Clauses 2 to 10, wherein a destructible barrier is configured to prevent the passage of fluid through the spray tube when it is not destructible. 12. The dialysis fluid bag, A third region, which is fluidically separated from the first and second regions and contains a third peritoneal dialysis fluid concentrate, A dialysate bag according to any one of the clauses 2 to 11, comprising: a second destructible barrier separating a second region from a third region, wherein optionally, the maximum volume of the third region is greater than the maximum volumes of the first and second regions, respectively. 13. The dialysate bag is equipped with a third inlet / outlet port fluidically connected to a third region, and optionally the third inlet / outlet port has both an open and a closed state. When in the open state, the third inlet / outlet port fluidly connects the third region to the outside of the dialysate bag. The dialysate bag according to Clause 12, wherein, when in a closed state, the third region is fluidically isolated (separated) from the outside of the dialysate bag. 14. The dialysate bag is equipped with a third inlet / outlet port fluidically connected to the first region, and optionally the third inlet / outlet port has an open state and a closed state. When in the open state, the third inlet / outlet port fluidly connects the first region to the outside of the dialysate bag. A dialysate bag according to any one of clauses 2 to 11, wherein, when in a closed state, the first region is fluidically isolated (separated) from the outside of the dialysate bag. 15. A dialysate bag according to any one of clauses 2 to 14, which is suitable for forming dialysate while the dialysate bag is in a horizontal configuration. 16. A dialysate bag according to any one of clauses 2 to 15, which is suitable for forming dialysate while the dialysate bag is in a vertical configuration. 17. The first inlet / outlet port comprises two or more (e.g., three or more, four or more, or five or more) branching channels configured to distribute the fluid flowing through the first inlet / outlet port in two or more (e.g., three or more, four or more, or five or more) directions. A dialysate bag according to any one of clauses 2 to 16, comprising two or more (e.g., three or more, four or more, or five or more) branching channels, each optionally configured to distribute the fluid flowing through the second inlet / outlet port and / or third inlet / outlet port in two or more directions (e.g., three or more, four or more, or five or more). 18. A dialysate bag according to any one of clauses 1 to 17, wherein the first inlet / outlet port and the second inlet / outlet port are each sealed by a destructible seal that isolates each port from the inside of the bag. 19. A peritoneal dialysis fluid reconstitution system, A peritoneal dialysis fluid bag as described in any one of clauses 1 to 18, A peritoneal dialysis fluid reconstitution system comprising a physiologically acceptable aqueous liquid source in fluid communication with the dialysis fluid back. 20. The dialysis fluid back is as described in any one of clauses 1 to 18, The second inlet / outlet port is fluidly connected to the first inlet / outlet via an external connection to form a circulating fluid flow path through the first inlet / outlet port, the first region, the second region, the second inlet / outlet port, and the external connection. The dialysis fluid reconstitution system according to clause 19. 21. The dialysis fluid back is as described in clause 13 or any one of clauses 14 to 18 as a dependency of clause 13, The first, second, and, if present, third inlet / outlet ports are fluidly connected to each other via an external connection to form a plurality of circulating fluid flow paths through two or more of the first region, the second region, and the third region. The dialysis fluid reconstitution system according to clause 19 or 20. 22. The dialysis fluid back is as described in clause 14 or any one of clauses 15 to 18 as a dependency of clause 14, The first, second, and, if present, third inlet / outlet ports are fluidly connected to each other via an external connection to form a plurality of circulating fluid flow paths through the first region or the first and second regions. The dialysis fluid reconstitution system according to clause 19 or 20. 23. A method of preparing peritoneal dialysis fluid in a dialysis fluid back according to any one of clauses 1 to 17, (i) providing a dialysis fluid back according to any one of clauses 1 to 17; (ii) providing a physiologically acceptable aqueous liquid through the inlet / outlet port of the dialysis fluid back to form a dialysis fluid. 24. The dialysis fluid back is as described in any one of clauses 1 to 18, and step (ii) is (iia) Providing a physiologically acceptable aqueous liquid to a first region of the dialysate bag through a first inlet / outlet port to form a first intermediate dialysate from a first peritoneal dialysate concentrate and a physiologically acceptable aqueous liquid, Providing a physiologically acceptable aqueous liquid to the first region causes the first region to expand, break down the destructible barrier, and thereby enable fluid communication with the second region, forming... (iib) Providing an additional physiologically acceptable aqueous liquid through the first inlet / outlet port to form a second intermediate dialysate from the first intermediate dialysate, the additional physiologically acceptable aqueous liquid, and the second peritoneal dialysate concentrate, The method according to Clause 23, comprising (iic) mixing a second intermediate dialysis fluid to form a dialysis fluid suitable for direct administration to a patient. 25. The dialysate bag is one of those described in Clause 12, or any one of Clauses 13-18 as a subordinate of Clause 12, and step (ii) is (iia2) Providing a physiologically acceptable aqueous liquid to a first region of the dialysate bag through a first inlet / outlet port to form a first intermediate dialysate from a first dialysate concentrate and a physiologically acceptable aqueous liquid, Providing a physiologically acceptable aqueous liquid to the first region causes the first region to expand, break down the destructible barrier, and thereby enable fluid communication with the second region, forming... (iib2) Providing an additional physiologically acceptable aqueous liquid to a second region through a first inlet / outlet port to form a second intermediate dialysate from a first intermediate dialysate, the additional physiologically acceptable aqueous liquid, and a second dialysate concentrate, Providing a physiologically acceptable aqueous liquid to the second region causes the second region to expand, break down the second destructible barrier, and thereby enable fluid communication with the third region, forming... (iic2) Providing a further physiologically acceptable aqueous liquid through the first inlet / outlet port to form a third intermediate dialysate from the second intermediate dialysate, the further physiologically acceptable aqueous liquid, and the third dialysate concentrate, (iid2) The method according to Clause 23, comprising mixing a third intermediate dialysis fluid to form a dialysis fluid suitable for direct administration to a patient. 26. The method according to Clause 24 or 25, wherein step (iic) or (iid2) includes manual mixing of a second intermediate dialysis fluid. 27. (i) The method according to Clause 24, wherein the dialysate bag comprises a second inlet / outlet port, and step (iic) includes recirculating a second intermediate dialysate through the first inlet / outlet port and the second inlet / outlet port, or (ii) The method according to Clause 25, wherein the dialysate bag is provided with a third inlet / outlet port, and step (Iid2) includes recirculating a third intermediate dialysate through two or more of the first, second, and third inlet / outlet ports. 28. A method for treating patients who require peritoneal dialysis, wherein the method is (A) Preparing peritoneal dialysis fluid in a peritoneal dialysis fluid bag as described in any one of clauses 23 to 27, (B) A method comprising administering dialysis treatment to the patient using the dialysis fluid prepared in step (A). 29. A system for preparing peritoneal dialysis fluid, (i) A physiologically acceptable aqueous liquid source (e.g., water for injection), (ii) A peritoneal dialysis fluid bag containing one or more peritoneal dialysis fluid concentrates as described in any one of paragraphs 1 to 18, (iii) A fluid connection between a physiologically acceptable aqueous liquid source and a dialysate bag, A physiologically acceptable aqueous liquid source, a dialysate bag, and a fluid connector together form a fluid channel consisting of a physiologically acceptable aqueous liquid source, a dialysate bag, and a fluid connector. The fluid connector is connected to the first inlet / outlet port of the dialysate bag. A system in which a dialysate bag has a second inlet / outlet port that is fluidly connected to a fluid connector via an external connector, thereby forming a circulating fluid path through the first inlet / outlet port, the dialysate bag, the second inlet / outlet port, the external connector, and the fluid connector. 30. The system according to Clause 29, wherein the dialysate bag comprises one or more (e.g., one) spray tubes configured to increase the distribution of fluid flowing through the dialysate bag, and optionally, one of the one or more spray tubes is attached to a first inlet / outlet port of the dialysate bag. 31. A method for preparing peritoneal dialysis fluid, (a) a system, (i) A physiologically acceptable aqueous liquid source (e.g., water for injection), (ii) A peritoneal dialysis fluid bag containing one or more peritoneal dialysis fluid concentrates as described in any one of paragraphs 1 to 18, (iii) A fluid connection between a physiologically acceptable aqueous liquid source and a dialysate bag, The step of providing a system in which a physiologically acceptable aqueous liquid source, a dialysate bag, and a fluid connector together form a fluid channel consisting of a physiologically acceptable aqueous liquid source, a dialysate bag, and a fluid connector. (b) A step of supplying a physiologically acceptable aqueous liquid from a physiologically acceptable aqueous liquid source to a dialysate bag, and mixing the physiologically acceptable aqueous liquid with a peritoneal dialysate concentrate to form a dialysate, (1) A fluid connector is connected to a first inlet / outlet port of a dialysate bag, and the dialysate bag has a second inlet / outlet port which is fluidically connected to the fluid connector via an external connector, thereby forming a circulating fluid channel through the first inlet / outlet port, the dialysate bag, the second inlet / outlet port, the external connector, and the fluid connector, and step (b) includes recirculating physiologically acceptable aqueous liquid and dialysate concentrate into the circulating fluid channel to form a dialysate, or (2) A method comprising step (b) manually mixing a physiologically acceptable aqueous liquid with a peritoneal dialysis fluid concentrate using an orbital shaker or vibrating table or using a robotic arm. 32. The method according to clause 31, wherein option (1) is applied and recirculation is performed while the dialysate bag is in a vertical configuration. 33. The method according to clause 31 or 32, wherein the dialysate bag comprises one or more (e.g., one) spray tubes configured to increase the distribution of fluid flowing through the dialysate bag, and optionally, one of the one or more spray tubes is attached to a first inlet / outlet port of the dialysate bag. 34. Step (b) includes manually mixing a physiologically acceptable aqueous fluid with the peritoneal dialysate concentrate, The method according to clause 31, wherein, optionally, manual mixing is performed while the dialysate bag is in a horizontal configuration (e.g., while the dialysate bag is on a horizontal surface). 35. The method according to Clause 31, wherein step (b) includes mixing a physiologically acceptable aqueous liquid with the dialysate concentrate using an orbital shaker, vibrating table, or rocking platform mixer. 36. The method according to Clause 31, wherein step (b) includes using a robotic arm to mix a physiologically acceptable aqueous fluid with the peritoneal dialysis fluid concentrate. [Brief explanation of the drawing]

[0009] [Figure 1] The first dialysis fluid reconstitution system according to the present invention, comprising a first dialysis fluid bag according to the present invention, is shown. [Figure 2] The second dialysis fluid reconstitution system according to the present invention is shown, comprising a second dialysis fluid bag according to the present invention. [Figure 3] The third dialysis fluid reconstitution system according to the present invention is shown, comprising a third dialysis fluid bag according to the present invention. [Figure 4] The fourth dialysis fluid reconstitution system according to the present invention is shown, comprising a fourth dialysis fluid bag according to the present invention. [Figure 5] The fifth dialysis fluid reconstitution system according to the present invention is shown, comprising a fifth dialysis fluid bag according to the present invention. [Figure 6] This specification shows a dialysis fluid reconstitution system according to the present invention, comprising a dialysis fluid bag as described herein. [Figure 7] This specification shows a dialysis fluid reconstitution system comprising a dialysis fluid bag as described herein. [Figure 8] This specification shows a dialysis fluid reconstitution system comprising a dialysis fluid bag as described herein. [Figure 9] This shows a peritoneal dialysis fluid reconstitution system according to the present invention, which includes a peritoneal dialysis fluid bag according to the present invention. [Figure 10] Figure 1 shows the results of the dialysis fluid reconstitution test for the peritoneal dialysis fluid reconstitution system (graph). [Figure 11] Figure 2 shows the results of the dialysis fluid reconstitution test for the peritoneal dialysis fluid reconstitution system (graph). [Figure 12] Figure 3 shows the results of the dialysis fluid reconstitution test for the peritoneal dialysis fluid reconstitution system (graph). [Figure 13] Figure 5 shows the results of the dialysis fluid reconstitution test for the peritoneal dialysis fluid reconstitution system (graph). [Figure 14] Figure 6 shows the results of the dialysis fluid reconstitution test for the dialysis fluid reconstitution system (graph). [Figure 15] Figure 7 shows the results of the dialysis fluid reconstitution test for the dialysis fluid reconstitution system (graph). [Figure 16] Figure 8 shows the results of the dialysis fluid reconstitution test for the dialysis fluid reconstitution system (graph). [Figure 17] Figure 9 shows the results of the peritoneal dialysis fluid reconstitution test for the dialysis fluid reconstitution system (graph). [Figure 18] This shows a peritoneal dialysis fluid reconstitution system according to the present invention, which includes a peritoneal dialysis fluid bag according to the present invention. [Modes for carrying out the invention]

[0010] When used herein, the word “comprising” can be interpreted as requiring the features mentioned but not limiting the presence of other features. Alternatively, the word “comprising” can also relate to a situation where only the enumerated components / features are intended to exist (for example, the word “comprising” can be replaced with the phrases “consists of” or “consists essentially of”). It is expressly intended that both the broader and narrower interpretations may apply to all aspects and embodiments of the present invention. In other words, the word “comprising” and its synonyms can be replaced with the phrases “consisting of” or “consists essentially of”, and vice versa.

[0011] The phrase "consists essentially of" and its pseudoonyms may be interpreted herein as referring to a material that may contain small amounts of impurities. For example, a material may have a purity of 90% or more, e.g., more than 95%, e.g., more than 97%, e.g., more than 99%, e.g., more than 99.9%, e.g., more than 99.99%, e.g., more than 99.999%, e.g., 100%.

[0012] As used herein, the singular forms "a," "an," and "the" refer to multiple objects unless otherwise clearly indicated by the context. Thus, for example, a reference to "a composition" includes a mixture of two or more such compositions, a reference to "oxygen carrier" includes a mixture of two or more such oxygen carriers, a reference to "catalyst" includes a mixture of two or more such catalysts, and so on.

[0013] In a first aspect of the present invention, a peritoneal dialysis fluid bag, The first entrance / exit port, The second entrance / exit port, An inner chamber containing a peritoneal dialysate concentrate, comprising an inner chamber fluidly connected to a first inlet / outlet port and a second inlet / outlet port, wherein the first inlet / outlet port and the second inlet / outlet port have an open state and a closed state, When in the open state, the first inlet / outlet port and the second inlet / outlet port each fluidly connect the inner chamber to the outside of the dialysate bag. A peritoneal dialysate bag is provided, in which, when closed, the first inlet / outlet port and the second inlet / outlet port each fluidly isolate (separate) the inner chamber from the outside of the dialysate bag.

[0014] In a more specific embodiment of the configuration, the inner chamber of the peritoneal dialysis fluid bag is A first region comprising a first peritoneal dialysis fluid concentrate, wherein the first region is fluidly connected to a first inlet / outlet port, A second region, which is fluidically separated from the first region and contains a second peritoneal dialysate concentrate, the second region being fluidically connected to a second inlet / outlet port, It may include a destructible barrier separating the first region from the second region, The dialysate bag is configured such that the first region is fluidly connected to the second region by the rupture of a destructible barrier. The maximum volume of the first region is smaller than the maximum volume of the second region.

[0015] As used herein, “peritoneal dialysate bag” refers to a bag containing one or more (e.g., 1, 2, 3, or 4) peritoneal dialysate concentrates. Such peritoneal dialysate concentrates can be reconstituted and combined within the bag to form a ready-to-use dialysate fluid. Thus, the dialysate fluid can be reconstituted and then used directly from the dialysate bag for dialysis treatment.

[0016] In a particular embodiment, the peritoneal dialysis bag comprises a first region and a second region. The first and second regions are fluidically separated from each other by a breakable barrier. The breakable barrier may be breakable by expansion of the first region of the dialysis bag, such as by expansion caused by supplying a liquid (e.g., water or saline) to the first region of the dialysis bag. When the breakable barrier is broken, the first and second regions become fluidically connected. In other words, when the breakable barrier is broken, the first and second regions are combined. For example, if the internal volume of the dialysis bag is formed from the first and second regions, and the breakable barrier is broken, the internal volume forms a single region that replaces the previously existing first and second regions.

[0017] As can be understood, it may be advantageous for the breakable barrier to be configured to break substantially along its entire length. This allows for improved mixing of the fluid between the first and second regions. As used herein, substantially the entire length of the breakable barrier means at least 60% of its length, at least 70% of its length, at least 80% of its length, for example, at least 90% of its length. Thus, in some embodiments of the invention as referred herein, the breakable barrier may comprise a peelable seal and / or a fragile seal.

[0018] The peritoneal dialysis fluid bag is defined by an edge. In certain embodiments, a breakable barrier extends from a first edge to an opposing edge. When such a breakable barrier breaks, it allows for efficient and complete mixing of the fluid between the first and second regions.

[0019] The first region of the dialysate bag may contain a first peritoneal dialysate concentrate, and the second region may contain a second peritoneal dialysate concentrate. This arrangement allows the first and second concentrates to contain different components, which can be separated and maintained until reconstitution for immediate use. For example, this may be useful when long-term storage of certain components in the same concentrate may reduce the stability and shelf life of the concentrate; therefore, by separating and maintaining the relevant components, the shelf life of the peritoneal dialysate concentrate can be improved compared to a single combined peritoneal dialysate concentrate.

[0020] The first region is equipped with a first inlet / outlet port that can connect the first region to the outside of the peritoneal dialysate bag and can be used to allow fluid to enter or exit the dialysate bag. Thus, water can be supplied to the dialysate bag to reconstitute the dialysate from the peritoneal dialysate concentrate, and the resulting dialysate can be removed from the bag and used for dialysis treatment.

[0021] In the peritoneal dialysis fluid bag according to embodiments of the present invention, the maximum volume of the first region may be smaller than the maximum volume of the second region. This arrangement allows for improved (e.g., more certain and complete) rupture of the destructible barrier separating the first region from the second region when the first region expands. For example, the first region may contain less than 40% of the maximum volume of the dialysis fluid bag, such as less than 35% or less than 30%.

[0022] In a particular preferred embodiment, the peritoneal dialysate bag comprises a second inlet / outlet port fluidically connected to a second region. This further facilitates efficient mixing of the peritoneal dialysate concentrate with a diluent (e.g., water) during dilution, as the diluent is supplied to the first region, causing it to expand and break down the destructible barrier. This results in mixing of the peritoneal dialysate concentrate with the diluent and dilution of the peritoneal dialysate concentrate, forming a dialysate. To ensure thorough mixing and dilution of the peritoneal dialysate concentrate, the mixture may be circulated through a fluid channel comprising a first inlet / outlet port, the interior of the dialysate bag (i.e., the space formed from the first and second regions once the destructible barrier is broken), a second inlet / outlet port, and an external tube connecting the first and second inlet / outlet ports. This recirculation of the fluid can quickly, easily, and reliably provide a well-mixed and reconstituted dialysate, thus eliminating user error.

[0023] The first and second inlet / outlet ports may be positioned along opposing edges of the dialysate bag relative to each other. This arrangement allows the fluid to circulate throughout the entire volume of the bag, as it enters through one port on one edge of the bag and exits through the other port on the opposing edge of the bag. This arrangement can further facilitate the mixing of the dialysate fluid within the bag. The distance between the first and second inlet / outlet ports may be the maximum distance possible depending on the dimensions of the dialysate bag. The inlet / outlet ports are preferably positioned such that when the bag is held in a vertical configuration (e.g., the dialysate bag is suspended from a stand), one of the first or second inlet / outlet ports faces downwards and the other faces upwards.

[0024] The inlet / outlet ports (i.e., the first inlet / outlet port and / or second inlet / outlet port, and, if present, the third inlet / outlet port, as discussed below) have both open and closed states. When open, the inlet / outlet ports fluidly connect the inside and outside of the peritoneal dialysate bag, while when closed, the inside and outside of the dialysate bag are fluidly isolated (separated). The closed state may be useful, for example, during storage of the dialysate bag, while the open state may be useful during the reconstitution of the dialysate fluid.

[0025] The inlet / outlet ports (for example, a first inlet / outlet port and / or a second inlet / outlet port, and a third inlet / outlet port, if present, as discussed below) may comprise two or more (e.g., three or more, four or more, or five or more) branching channels configured to distribute the fluid flowing through each inlet / outlet port in two or more (e.g., three or more, four or more, or five or more) directions. The inlet / outlet ports may also be sealed by a breakable seal that isolates the ports from the inside of the bag before use, for example, when the bag is being stored. The seal may be hemispherical in shape to cover the opening formed in the bag by the port. Preferably, the seal seals and isolates the port from the inside of the bag until the fluid flows through the port and enters the bag. When the fluid flows through the port into the bag, the seal is broken, thereby allowing the fluid to enter the bag. Thus, when the bag is being stored, the seal maintains a sterile environment inside the bag.

[0026] During use of the peritoneal dialysis fluid bag, water (or a suitable aqueous solution, e.g., saline) may be supplied to the dialysis fluid bag (e.g., the first region). This reconstitutes the first peritoneal dialysis fluid concentrate, causing the first region to expand and break down any destructible barriers (if any), and thus reconstitutes the second peritoneal dialysis fluid concentrate as well. When the first and second peritoneal dialysis fluid concentrates are mixed together with an appropriate volume of a physiologically acceptable aqueous liquid (e.g., water for infusion), they can form a peritoneal dialysis fluid suitable for direct administration to the patient. In other words, the dialysis fluid can be prepared quickly and reliably by simply supplying a suitable aqueous liquid to the dialysis fluid bag.

[0027] The peritoneal dialysate concentrate may occupy any preferred proportion of the first and second regions. Preferably, this proportion is less than 90% by volume of the region to minimize the risk of rupture or destruction during storage or transport of the dialysate bag. Therefore, in some embodiments of the present invention, (a) The first peritoneal dialysate concentrate may occupy 10 to 90% by volume (e.g., 10 to 50% by volume) of the maximum volume of the first region, and / or (b) The second peritoneal dialysate concentrate may occupy 10–90% (e.g., 10–50%) of the maximum volume of the second region. It should be understood that the spatial proportions referred to herein may also apply to a first embodiment of the invention which may have a single region (i.e., an inner chamber).

[0028] The peritoneal dialysis bag of the present invention can be used to prepare any suitable amount of dialysis fluid, for example, 2 to 15 liters. In other words, in some embodiments of the present invention, The first region and the second region together may contain a suitable amount of the first dialysate concentrate and the second dialysate concentrate to prepare n liters of dialysate. n is between 2 and 15 (for example, 5 to 13, 7 to 12, etc., such as 8 to 11). The maximum volume of the dialysate bag is suitable for administering n liters of peritoneal dialysis fluid to the patient.

[0029] A peritoneal dialysate bag may have a tapered region (which may form part of a first region), and the first inlet / outlet port may be located on top of the tapered region (e.g., at the top). This can facilitate the dispersion of the fluid throughout the first region during the bag's inflation. More specifically, the dialysate bag is in a “vertical” configuration when the dialysate fluid is reconstituted in a dialysate bag suspended from a stand. The components of the dialysate concentrate may form a density gradient over time, such that differences in density and component concentration are formed within the dialysate concentrate in the bag if not mixed. For example, the components of the dialysate concentrate may accumulate at the bottom of the bag when suspended vertically. During reconstitution, water may be supplied from the bottom of the bag into the dialysate bag, preferably at the top located in the tapered region at the bottom of the bag. This ensures that the water mixes with the entire concentrate, improving mixing and reconstitution. In addition, since both ports into the bag are inlet / outlet ports, the fluid can enter the bag through the port at the bottom of the bag and exit through the same port. For example, this allows a diluent (e.g., water) to enter the bag through a port at the bottom of the bag during the dilution of the dialysate concentrate, forming the dialysate fluid, which can then circulate through a fluid path comprising a first inlet / outlet port, the interior of the dialysate bag, and a second inlet / outlet port, in the direction of exiting the bag through the port at the bottom of the bag and in the direction of entering the bag through the port at the top of the bag. Thus, in certain embodiments, the port located at the bottom of the bag when the bag is in a vertical configuration may need to function as an inlet / outlet port, while the port located at the top of the bag when the bag is in a vertical configuration may need to function only as an inlet port.

[0030] The distribution of fluid in the first and / or second region can also be improved by the use of one or more spray tubes. Accordingly, in some embodiments of the present invention, the peritoneal dialysis fluid bag comprises one or more (e.g., one) spray tubes configured to increase the distribution of fluid flowing through the dialysis fluid bag. The spray tubes may be attached to a first inlet / outlet port to distribute fluid to the first region, or to a destructible barrier to distribute fluid to the second region when the destructible barrier is breached. In the latter case, the destructible barrier may be configured to prevent the passage of fluid through the spray tubes when it is not breached.

[0031] A peritoneal dialysate bag may comprise a third region, which is fluidically separated from the first and second regions and contains a third dialysate concentrate, and a second destructible barrier separating the second region from the third region. This may be advantageous if it is desirable to include a third dialysate concentrate separated from the first and second dialysate concentrates. In some embodiments, the maximum volume of the third region may be greater than the maximum volumes of the first and second regions, respectively.

[0032] The dialysate bag may include a second inlet / outlet port fluidically connected to a second region and a third inlet / outlet port fluidically connected to a third region, such that all regions are connected to inlet / outlet ports that can each have both open and closed states. Alternatively, the third inlet / outlet port may be connected to a first region. Together with the first inlet / outlet port, this may be advantageous as it allows for the recirculation of the fluid through the first region without breaking the destructible barrier, and allows for sufficient reconstruction of the first dialysate concentrate before the destructible barrier is broken.

[0033] The dialysis fluid bag of the present invention can be used in any suitable arrangement, such as horizontally or vertically.

[0034] In certain exemplary embodiments, the dialysate bag of the present invention comprises a first inlet / outlet port, a second inlet / outlet port, a first region containing a first peritoneal dialysate concentrate, and a second region fluidly separated from the first region. The first region is fluidly connected to the first inlet / outlet port, and the second region is fluidly connected to the second inlet / outlet port and contains a second peritoneal dialysate concentrate. The bag also comprises an external tube fluidly connecting the first inlet / outlet port and the second inlet / outlet port. A breakable barrier is present separating the first region from the second region, and the breakable barrier is configured to break substantially along its entire length. The dialysate bag is configured such that the breakage of the breakable barrier results in the first region being fluidly connected to the second region. The first inlet / outlet port and the second inlet / outlet port each have an open state and a closed state. When open, each of the first inlet / outlet port and the second inlet / outlet port fluidically connects the inner chamber to the outside of the dialysate bag. When closed, each of the first inlet / outlet port and the second inlet / outlet port fluidically isolates (separates) the inner chamber from the outside of the dialysate bag. The first inlet / outlet port and the second inlet / outlet port may be positioned along opposing edges of the dialysate bag so that fluid entering the bag through one of the ports circulates throughout the entire volume of the bag before exiting the bag through the other port.

[0035] The dialysate bags disclosed herein, including a destructible barrier and a destructible seal, may be formed from any suitable flexible and fluid-impermeable polymer. For example, a dialysate bag including a destructible barrier and a destructible seal may be formed from polyvinyl chloride (PVC), polyethylene, polypropylene, or a blend thereof. The port and outer tube may be formed from any suitable polymer; for example, the port and outer tube may be formed from polypropylene.

[0036] As discussed herein, a peritoneal dialysate bag contains one or more dialysate concentrates. The dialysate concentrates may have any suitable composition to form a dialysate fluid / dialysate when reconstituted together. Examples of dialysates that can be prepared using the present invention are listed in Table 1 below. As will be understood by those skilled in the art, different patients may require different concentrations of electrolytes, and the present invention may be carried out using a dialysate bag suitable for preparing dialysates having compositions different from those listed in Table 1. [Table 1]

[0037] A suitable peritoneal dialysis fluid composition can be prepared from the concentrates described below. [Table 2]

[0038] While not bound by theory, providing peritoneal dialysate concentrates (such as the dialysate concentrates listed above) in the form of two or three separate concentrates may favorably improve the stability, shelf life, and lifespan of the concentrates.

[0039] In some embodiments of the present invention, the dialysate concentrate is provided as two separate concentrates, the first concentrate being present in a first region of the dialysate bag and the second concentrate being present in a second region. In such embodiments, the concentrate may contain the components shown in Tables 3A and 3B below. [Table 3]

[0040] In a particular embodiment, the peritoneal dialysate concentrate is provided as three separate concentrates, the first concentrate being present in a first region of the dialysate bag, the second concentrate in a second region, and the third concentrate in a third region. These concentrates can be formed from any preferred components, for example, by splitting the above two-component concentrate into three separate concentrates (for example, by providing sugar as a separate concentrate).

[0041] The present invention relates to a peritoneal dialysis fluid reconstitution system, The peritoneal dialysis fluid bag described herein, A physiologically acceptable aqueous liquid source in fluid communication with the dialysate bag, Furthermore, we provide a peritoneal dialysis fluid reconstitution system equipped with the following features.

[0042] Such a peritoneal dialysis fluid reconstitution system may be used to reconstitute peritoneal dialysis fluid within a peritoneal dialysis bag. The second inlet / outlet port of the dialysis bag may be fluidically connected to the first inlet / outlet via an external connector to form a circulating fluid path through the first inlet / outlet port, a first region, a second region, the second inlet / outlet port, and the external connector. This allows for the recirculation of the fluid through the first and second regions, which may be advantageous in ensuring sufficient reconstitution of the first and second dialysate concentrates to guarantee effective mixing. As will be understood by those skilled in the art, a similar configuration may be used when the dialysate bag has three fluid inlet / outlet ports. In such a case, the first, second, and / or third inlet / outlet ports may be fluidically connected to one or more circulating fluid paths through the first, second, and / or third regions. For example, if the dialysate bag has three regions, each is fluidically connected to an inlet / outlet port, and these inlet / outlet ports can be fluidically connected via an external connection to form fluid pathways through the first and second, first and third, second and third, and first, second, and third inlet / outlet ports. This allows for selective recirculation through different regions of the dialysate bag during the reconfiguration of the dialysate fluid. As described herein, the dialysate bag may also have two fluid inlet / outlet ports fluidically connected to the same region (e.g., the first region), which can be connected via an external connection to recirculate the fluid within a single region during reconfiguration.

[0043] The present invention also relates to a method for preparing peritoneal dialysis fluid in a peritoneal dialysis fluid bag as described herein, wherein the method is (i) To provide the peritoneal dialysis fluid bag described herein, (ii) A method is provided comprising providing a physiologically acceptable aqueous liquid through a first inlet / outlet port of a dialysate bag to form a dialysate.

[0044] In this method, if the dialysate bag has two regions, each containing a dialysate concentrate, step (ii) is: (iia) Providing a physiologically acceptable aqueous liquid to a first region of the dialysate bag through a first inlet / outlet port to form a first intermediate dialysate from a first dialysate concentrate and a physiologically acceptable aqueous liquid, Providing a physiologically acceptable aqueous liquid to the first region causes the first region to expand, break down the destructible barrier, and thereby enable fluid communication with the second region, forming... (iib) Providing an additional physiologically acceptable aqueous liquid through the first inlet / outlet port to form a second intermediate dialysate from the first intermediate dialysate, the additional physiologically acceptable aqueous liquid, and the second dialysate concentrate, (iic) This may include mixing a second intermediate dialysis fluid to form a dialysis fluid suitable for direct administration to the patient.

[0045] In such cases, the dialysate bag may be equipped with a second inlet / outlet port, and step (iic) may include recirculating a second intermediate dialysate through the first inlet / outlet port and the second inlet / outlet port.

[0046] If the dialysate bag comprises three regions as disclosed herein, each of the three regions contains a dialysate concentrate, and step (ii) is: (iia2) Providing a physiologically acceptable aqueous liquid to a first region of the dialysate bag through a first inlet / outlet port to form a first intermediate dialysate from a first dialysate concentrate and a physiologically acceptable aqueous liquid, Providing a physiologically acceptable aqueous liquid to the first region causes the first region to expand, break down the destructible barrier, and thereby enable fluid communication with the second region, forming... (iib2) Providing an additional physiologically acceptable aqueous liquid to a second region through a first inlet / outlet port to form a second intermediate dialysate from a first intermediate dialysate, the additional physiologically acceptable aqueous liquid, and a second dialysate concentrate, Providing a physiologically acceptable aqueous liquid to the second region causes the second region to expand, break down the second destructible barrier, and thereby enable fluid communication with the third region, forming... (iic2) Providing a further physiologically acceptable aqueous liquid through the first inlet / outlet port to form a third intermediate dialysate from the second intermediate dialysate, the further physiologically acceptable aqueous liquid, and the third dialysate concentrate, (iid2) This may include mixing a third intermediate dialysis fluid to form a dialysis fluid suitable for direct administration to the patient.

[0047] In such cases, step (iid2) may include recirculating a third intermediate dialysis fluid through two or more of the first, second, and third inlet / outlet ports.

[0048] Additionally, or alternatively, the above mixing steps (e.g., step (iic) or (iid2)) may include manual mixing (e.g., by hand). This may be done by gently pressing the dialysate bag by hand to mix the liquids until the concentrate is sufficiently dissolved and the liquids are thoroughly mixed. Such manual mixing may be performed when the dialysate bag is placed in a horizontal position, such as on a horizontal surface.

[0049] Additionally, or alternatively, the mixing step can be automated. For example, the bag may be placed in a mechanical mixer such as an orbital shaker, vibrating table, or rocking platform mixer. The mechanical mixer may be equipped with a heater to heat the dialysate fluid to a temperature that facilitates the dissolution of the dialysate concentrate in a physiologically acceptable aqueous liquid. Additionally, or alternatively, the mixing step can be automated by the use of a robotic arm, which is configured to mix the liquid in the bag in a manner similar to manual mixing.

[0050] The present invention also relates to a method for treating patients who require peritoneal dialysis, wherein the method is (A) Preparing peritoneal dialysate in a peritoneal dialysate bag disclosed herein, The present invention provides a method comprising (B) administering peritoneal dialysis treatment to the patient using the dialysis fluid prepared in step (A).

[0051] The present invention also relates to a system for preparing peritoneal dialysis fluid, (i) A physiologically acceptable aqueous liquid source (e.g., water for injection), (ii) A peritoneal dialysis fluid bag containing one or more dialysis fluid concentrates, (iii) A fluid connection between a physiologically acceptable aqueous liquid source and a dialysate bag, A physiologically acceptable aqueous liquid source, a dialysate bag, and a fluid connector together form a fluid channel consisting of a physiologically acceptable aqueous liquid source, a dialysate bag, and a fluid connector. The fluid connector is connected to the first inlet / outlet port of the dialysate bag. The system provides a circulating fluid path through the first inlet / outlet port, the dialysis fluid bag, the second inlet / outlet port, the external connector, and the fluid connector, with the dialysis fluid bag having a second inlet / outlet port that is fluidly connected to the fluid connector via an external connector.

[0052] In some embodiments of the above system, the dialysate bag comprises one or more (e.g., one) spray tubes configured to increase the distribution of fluid flowing through the dialysate bag. One of the one or more spray tubes may be attached to a first inlet / outlet port of the dialysate bag.

[0053] The present invention also relates to a method for preparing peritoneal dialysis fluid, (a) a system, (i) A physiologically acceptable aqueous liquid source (e.g., water for injection), (ii) A peritoneal dialysis fluid bag containing one or more dialysis fluid concentrates, (iii) A fluid connection between a physiologically acceptable aqueous liquid source and a dialysate bag, The step of providing a system in which a physiologically acceptable aqueous liquid source, a dialysate bag, and a fluid connector together form a fluid channel consisting of a physiologically acceptable aqueous liquid source, a dialysate bag, and a fluid connector. (b) A step of supplying a physiologically acceptable aqueous liquid from a physiologically acceptable aqueous liquid source to a dialysate bag, and mixing the physiologically acceptable aqueous liquid with the dialysate concentrate to form a dialysate, (1) A fluid connector is connected to a first inlet / outlet port of a dialysate bag, and a second inlet / outlet port is fluidically connected to the fluid connector via an external connector, thereby forming a circulating fluid channel through the first inlet / outlet port, the dialysate bag, the second inlet / outlet port, the external connector, and the fluid connector, and step (b) includes recirculating physiologically acceptable aqueous liquid and dialysate concentrate into the circulating fluid channel to form a dialysate, or (2) A method comprising step (b) manually mixing a physiologically acceptable aqueous liquid with a dialysate concentrate using an orbital shaker, a vibrating table, a rocking platform mixer and / or a robotic arm.

[0054] In certain embodiments, option (1) may be applied, and recirculation may be performed while the dialysate bag is in a vertical configuration.

[0055] A peritoneal dialysis fluid bag may comprise one or more (e.g., one) spray tubes configured to increase the distribution of fluid flowing through the dialysis fluid bag, one of which may be attached to a first inlet / outlet port of the dialysis fluid bag.

[0056] Step (b) can be performed in several ways. For example, step (b) can be: • Manually mixing a physiologically acceptable aqueous liquid with the dialysate concentrate, or • Mixing a physiologically acceptable aqueous liquid with the dialysate concentrate using an orbital shaker, vibrating table, or rocking platform mixer, or This may include mixing a physiologically acceptable aqueous liquid with the dialysate concentrate using a robotic arm.

[0057] The present invention is described in more detail below with reference to the drawings.

[0058] Figure 1 shows a dialysis system comprising a peritoneal dialysate bag 100 having a first region 101 containing a first peritoneal dialysate concentrate and a second region 102 containing a second peritoneal dialysate concentrate. The first and second regions are fluidically separated by a breakable barrier 103. During use, water can be supplied to the peritoneal dialysate bag by a water source 104 to a first fluid inlet / outlet port 105 along a coupling 1001. The expansion of the first region 101 results in the breakdown of the breakable barrier 103 and mixing of the water and peritoneal dialysate concentrate. Sufficient mixing can be achieved by recirculating the water using coupling 1002, the second inlet / outlet port 106, the peritoneal dialysate bag, and coupling 1001. The direction of the water flow can be controlled by unit 1003. Although shown operating in this mode, the dialysis system can also operate in reverse.

[0059] Modified versions of the design in Figure 1 are shown in Figures 2-4.

[0060] Figure 2 shows a modified design in which the peritoneal dialysis fluid bag has a tapered region 107, and the first fluid inlet / outlet port 105 is located at the top of the tapered region.

[0061] Figure 3 shows a modified design comprising spray tubes 109 and 108, each of which is configured to increase the distribution of fluid flowing through the dialysate bag, in a first region 101 and a second region 102, respectively.

[0062] Figure 4 shows a modified design with a third inlet / outlet port 110. This may allow for selective recirculation of the fluid in the first region 101 before the breakable barrier 103 is breached. This may also allow for improved mixing of the peritoneal dialysate concentrate with water through recirculation through all three inlet / outlet ports 105, 106, and 110.

[0063] Figure 5 shows a peritoneal dialysis system comprising a dialysate bag 500 having a first region 501 containing a first peritoneal dialysate concentrate and a second region 502 containing a second peritoneal dialysate concentrate. The first and second regions are fluidically separated by a breakable barrier 503. During use, water can be supplied to the dialysate bag by a water source 504 to a first fluid inlet / outlet port 505 along a coupling 5001. The expansion of the first region 501 results in the breakdown of the breakable barrier 503 and mixing of the water and dialysate concentrate. Sufficient mixing can be achieved by manually operating the bag, for example, by gently pressing the edges or corners of the bag. The water flow can be controlled by unit 5003.

[0064] Figure 6 shows a dialysis system comprising a dialysis bag 600 having a first region 601 and a second region 602, each containing a dialysis concentrate. The first region 601 and the second region 602 are separated by a fixed barrier, which includes a fluid port 603 that allows fluid to flow from the first region 601 to the second region 602. Water is supplied to the bag 600 from a water source 604 through a fluid inlet / outlet port 605 along a coupling 6001 and can be recirculated through a fluid inlet / outlet port 606 and coupling 6002. The water flow can be controlled by unit 6003.

[0065] Figure 7 shows a dialysis system comprising a first dialysis bag 701 and a second dialysis bag 702 arranged in series. The first bag 701 contains a first dialysate concentrate, and the second bag 702 contains a second dialysate concentrate. The second bag 702 includes a spray tube 707 configured to increase the distribution of fluid flowing through the second bag 702. Water can be supplied to the first bag 701 and mixed with the first dialysate concentrate, and then it flows to the second bag 702 and mixed with the second dialysate concentrate. Water can be supplied from a water source 704 along connections 7001a and 7001b. Water can be recirculated via connection 7002. The water flow can be controlled by unit 7003.

[0066] Figure 8 shows a modification of the design in Figure 7, which includes only one dialysis bag 801 containing a single dialysate concentrate. The dialysis bag 801 includes a spray tube 807 configured to increase the distribution of fluid flowing through the dialysis bag 801. Water can be supplied to the dialysis bag 801 and mixed with the dialysate concentrate. Water can be supplied from a water source 804 along a connector 8001. Water can be recirculated via a connector 8002. The water flow can be controlled by a unit 8003.

[0067] Figure 9 shows a peritoneal dialysis system comprising a peritoneal dialysis bag 901 containing a peritoneal dialysis fluid concentrate. Water can be supplied to the peritoneal dialysis bag 901 and mixed with the dialysis fluid concentrate. Water can be supplied from a water source 904 along a connector 9001. Water can be recirculated via a connector 9002. The water flow can be controlled by a unit 9003.

[0068] Figure 18 shows a peritoneal dialysis system comprising a peritoneal dialysis bag (1801) containing first, second, and third peritoneal dialysis fluid concentrates in first (18011), second (18012), and third (18013) regions. Water can be supplied to the peritoneal dialysis bag 1801 and mixed with the dialysis fluid concentrate. Water can be supplied from a water source 1804 along a connector 18020 to one of the inlet / outlet ports 18021, 18022, or 18023, the selection of which can be controlled by the use of a valve. Thus, water can be directed to any of the first to third regions which region is to be filled first (the selection of the region to be filled can be controlled by any suitable control system, e.g., the use of a valve). For example, a third region 18013 (e.g., containing a concentrate with 4.25% glucose) may be filled first, and once this region is filled, a breakable seal 1831 may break to allow the second region 18012 (e.g., containing a concentrate with 2.5% glucose) to be filled, and a breakable seal 1832 may break to allow the first region 18011 (e.g., containing a concentrate with 1.5% glucose) to be filled. As described, the third region 18013 may have the same volume as the second region 18012, or be smaller, and both may be smaller in volume than the first region 18011. As understood, the user may select any preferred filling method according to the user's preference or instructions provided to the user by the manufacturer.

[0069] Specific aspects and embodiments of the present invention are described in the following non-limiting examples. [Examples]

[0070] [Example 1] Peritoneal dialysis fluid reconfiguration was tested for the peritoneal dialysis fluid bag designs described herein and depicted in Figures 1-3 and 5-9.

[0071] The dialysate was reconstituted by initially filling a dialysate bag with a maximum volume of 15 L with water to a specified level of 10 L at a specified flow rate, and then recirculated at a specified flow rate. The conditions for each are listed in Table 6 below. The level / completeness of mixing of the reconstituted dialysate was evaluated by measuring the conductivity of the recirculated dialysate over time using an IBP conductivity meter (HDU-CDTP (high-precision conductivity / temperature sensor)) in the recirculation line. The reconstituted dialysate was considered well mixed when the conductivity reading leveled off.

[0072] For dialysate bags containing different concentrates present in the first and second regions, 300 ml of each concentrate was used (Figures 1, 2, 3, 4, 5, and 6). The concentrates had the following compositions (Tables 4A and 4B below). When used together, concentrates 1 and 2 are suitable for preparing 13 liters of dialysate. [Table 4]

[0073] For bags containing only a single dialysate concentrate, 600 mL of the following concentrates (Table 5) were used (Figures 7, 8, and 9). The concentrates were suitable for preparing 13 liters of dialysate. [Table 5]

[0074] [Table 6]

[0075] The results demonstrate that when the dialysate is reconstituted in the dialysate bag, recirculation and / or manual mixing of the fluid are necessary to ensure adequate mixing. Generally, recirculation is appropriate when the bag is positioned vertically, such as when suspended from a stand. Manual mixing may be appropriate when the bag is positioned horizontally, such as when resting on a flat surface.

[0076] The results demonstrate that fluid mixing can be improved by various means, including recirculation, manual mixing, dispensing tubes, and supplying fluid from the top of the bottom of a tapered suspended bag. [Explanation of Symbols]

[0077] 100 peritoneal dialysis fluid bags 101 First Domain 102 Second Domain 103 Destructible Barriers 104 Water source 105 First fluid inlet / outlet port 106 Second fluid inlet / outlet port 107 Tapered region 108,109 Spray tubes 110 Third fluid inlet / outlet port 500,600 dialysis fluid bags 501,601 First region 502,602 Second region 503 Destructible Barriers 504,604 Water source 505 First fluid inlet / outlet port 701, 702, 801, 901 Dialysis bags 704,804,904 Water source 707,807 Spray tubes 1801 Peritoneal dialysis bag 18011, 18012, 18013: The 1st, 2nd, and 3rd regions 18021, 18022, 18023 Entrance / Exit Ports 1804 Water source 1831, 1832 Destructible seal 1831

Claims

1. It is a peritoneal dialysis fluid bag. The first entrance / exit port, The second entrance / exit port, An inner chamber containing a peritoneal dialysis fluid concentrate, wherein the inner chamber is fluidly connected to a first inlet / outlet port and a second inlet / outlet port, and the first inlet / outlet port and the second inlet / outlet port have an open state and a closed state. When in the open state, the first inlet / outlet port and the second inlet / outlet port each fluidly connect the inner chamber to the outside of the dialysate bag. A peritoneal dialysis bag in which, when in the closed state, each of the first inlet / outlet port and the second inlet / outlet port fluidically separates the inner chamber from the outside of the dialysis bag.

2. The inner chamber, A first region comprising a first peritoneal dialysis fluid concentrate, wherein the first region is fluidly connected to the first inlet / outlet port, A second region, which is fluidically separated from the first region and contains a second peritoneal dialysate concentrate, wherein the second region is fluidically connected to the second inlet / outlet port, The invention comprises a destructible barrier separating the first region from the second region, The dialysate bag is configured such that the destruction of the destructible barrier causes the first region to be fluidly connected to the second region. The peritoneal dialysis fluid bag according to claim 1, wherein the maximum volume of the first region is smaller than the maximum volume of the second region.

3. The dialysate bag according to claim 1 or 2, wherein the first region includes less than 40 volume percent (for example, less than 35 volume percent or less than 30 volume percent) of the total maximum volume of the dialysate bag.

4. (a) The breakable barrier is configured to break when the first region expands, and / or (b) The breakable barrier is configured to break substantially along its entire length (for example, at least 60% of its length, at least 70% of its length, at least 80% of its length, such as at least 90% of its length), The dialysate bag according to claim 2 or 3, optionally comprising a destructible barrier, a peelable seal and / or a fragile seal.

5. The dialysate bag according to any one of claims 2 to 5, wherein the dialysate bag has an edge, and the destructible barrier extends from a first edge to an opposing edge.

6. The dialysate bag according to any one of claims 2 to 5, wherein the first peritoneal dialysate concentrate and the second peritoneal dialysate concentrate are suitable for mixing together with an appropriate volume of physiologically acceptable aqueous liquid (e.g., water for infusion) to form a dialysate suitable for direct administration to a patient.

7. (a) The first peritoneal dialysis fluid concentrate occupies 10 to 90% by volume (e.g., 10 to 50% by volume) of the maximum volume of the first region, and / or (b) The dialysate bag according to any one of claims 2 to 6, wherein the second peritoneal dialysate concentrate occupies 10 to 90 volume percent (e.g., 10 to 50 volume percent) of the maximum volume of the second region.

8. The first region and the second region together contain a suitable amount of a first dialysate concentrate and a second dialysate concentrate to prepare n liters of dialysate, n is between 2 and 15 (for example, 5 to 13, 7 to 12, etc., 8 to 11). The dialysate bag according to any one of claims 3 to 10, wherein the maximum volume of the dialysate bag is suitable for administering the n liters of dialysate to a patient.

9. The dialysate bag has a tapered region, and the first inlet / outlet port is located on the tapered region (for example, at the top). The dialysate bag according to any one of claims 2 to 7, wherein the tapered region optionally forms a part of the first region.

10. The dialysate bag according to any one of claims 2 to 9, wherein the dialysate bag comprises one or more (e.g., one) spray tubes configured to increase the distribution of fluid flowing through the dialysate bag.

11. (a) One of the one or more spray tubes is attached to the first inlet / outlet port, or (b) The dialysate bag according to claim 10, wherein one of the one or more spray tubes is attached to the destructible barrier.

12. The dialysate bag according to claim 10 or 11, wherein the destructible barrier is configured to prevent the passage of fluid through the spray tube when it is not destructible.

13. The aforementioned dialysate bag A third region, which is fluidically separated from the first and second regions and contains a third peritoneal dialysis fluid concentrate, A dialysate bag according to any one of claims 2 to 12, comprising: a second destructible barrier separating the second region from the third region, wherein optionally, the maximum volume of the third region is greater than the maximum volumes of the first region and the second region, respectively.

14. The first inlet / outlet port comprises two or more (e.g., three or more, four or more, or five or more) branching channels configured to distribute the fluid flowing through the first inlet / outlet port in two or more (e.g., three or more, four or more, or five or more) directions, A dialysate bag according to any one of claims 2 to 13, comprising two or more (e.g., three or more, four or more, or five or more) branching channels, each optionally configured to distribute the fluid flowing through the second inlet / outlet port and / or the third inlet / outlet port in two or more (e.g., three or more, four or more, or five or more) directions.

15. The dialysate bag according to any one of claims 1 to 14, wherein the first inlet / outlet port and the second inlet / outlet port are each sealed by a destructible seal that separates each port from the inside of the bag.

16. A peritoneal dialysis fluid reconstitution system, A peritoneal dialysis fluid bag according to any one of claims 1 to 15, A peritoneal dialysis fluid reconstitution system comprising a physiologically acceptable aqueous liquid source in fluid communication with the dialysate bag.

17. A method for preparing peritoneal dialysis fluid in a dialysate bag according to any one of claims 1 to 15, (i) To provide a peritoneal dialysis fluid bag according to any one of claims 1 to 15, (ii) A method comprising providing a physiologically acceptable aqueous liquid through the inlet / outlet port of the dialysate bag to form a dialysate.

18. The dialysate bag is one of the claims described in claim 2 and any one of claims 3 to 15 as dependent of claim 2, and step (ii) is (iiia) Providing the physiologically acceptable aqueous liquid to the first region of the dialysate bag through the first inlet / outlet port to form a first intermediate dialysate from the first dialysate concentrate and the physiologically acceptable aqueous liquid, Providing the physiologically acceptable aqueous liquid to the first region causes the first region to expand, break down the destructible barrier, and thereby enable fluid communication with the second region, (iib) Providing an additional physiologically acceptable aqueous liquid through the first inlet / outlet port to form a second intermediate dialysate from the first intermediate dialysate, the additional physiologically acceptable aqueous liquid, and the second dialysate concentrate, (iic) The method according to claim 17, comprising mixing the second intermediate dialysis fluid to form a dialysis fluid suitable for direct administration to a patient.

19. The dialysate bag is one described in claim 13, or claim 14 or 15 as a dependency of claim 13, and step (ii) is (iiia2) Providing the physiologically acceptable aqueous liquid to the first region of the dialysate bag through the first inlet / outlet port to form a first intermediate dialysate from the first dialysate concentrate and the physiologically acceptable aqueous liquid, Providing the physiologically acceptable aqueous liquid to the first region causes the first region to expand, break down the destructible barrier, and thereby enable fluid communication with the second region, (iib2) Providing an additional physiologically acceptable aqueous liquid to the second region through the first inlet / outlet port to form a second intermediate dialysate from the first intermediate dialysate, the additional physiologically acceptable aqueous liquid, and the second dialysate concentrate, Providing the physiologically acceptable aqueous liquid to the second region causes the second region to expand, break down the second destructible barrier, and thereby enable fluid communication with the third region, (iiC2) Providing a further physiologically acceptable aqueous liquid through the first inlet / outlet port to form a third intermediate dialysis fluid from the second intermediate dialysis fluid, the further physiologically acceptable aqueous liquid, and the third dialysate concentrate, (iid2) The method according to claim 17, comprising mixing the third intermediate dialysis fluid to form a dialysis fluid suitable for direct administration to a patient.

20. A system for preparing peritoneal dialysis fluid, (i) A physiologically acceptable aqueous liquid source (e.g., water for injection), (ii) A dialysate bag comprising one or more dialysate peritoneal concentrates according to any one of claims 1 to 15, (iii) comprising a fluid connection between the physiologically acceptable aqueous liquid source and the dialysate bag, The physiologically acceptable aqueous liquid source, the dialysate bag, and the fluid connector together form a fluid channel consisting of the physiologically acceptable aqueous liquid source, the dialysate bag, and the fluid connector. The fluid connector is connected to the first inlet / outlet port of the dialysate bag. A system in which a second inlet / outlet port is fluidically connected to the fluid connection via an external connection, forming a circulating fluid flow path through the first inlet / outlet port, the dialysate bag, the second inlet / outlet port, the external connection, and the fluid connection.

21. A method for preparing peritoneal dialysis fluid, (a) A system, (i) A physiologically acceptable aqueous liquid source (e.g., water for injection), (ii) A dialysate bag comprising one or more peritoneal dialysate concentrates according to any one of claims 1 to 15, (iii) comprising a fluid connection between the physiologically acceptable aqueous liquid source and the dialysate bag, The step of providing a system in which the physiologically acceptable aqueous liquid source, the dialysate bag, and the fluid connector together form a fluid channel consisting of the physiologically acceptable aqueous liquid source, the dialysate bag, and the fluid connector. (b) Providing a physiologically acceptable aqueous liquid from the physiologically acceptable aqueous liquid source to the dialysate bag, and mixing the physiologically acceptable aqueous liquid with the dialysate concentrate to form a dialysate, (1) The fluid connector is connected to a first inlet / outlet port of the dialysate bag, and a second inlet / outlet port is fluidically connected to the fluid connector via an external connector, thereby forming a circulating fluid channel through the first inlet / outlet port, the dialysate bag, the second inlet / outlet port, the external connector, and the fluid connector, and step (b) includes recirculating the physiologically acceptable aqueous liquid and the dialysate concentrate into the circulating fluid channel to form a dialysate, or (2) A method comprising step (b) manually mixing the physiologically acceptable aqueous liquid and the dialysate concentrate using an orbital shaker, a vibrating table, or a rocking platform mixer, or a robotic arm.

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