Bicarbonate cartridge

Abstract

The present disclosure relates to a medical bicarbonate cartridge (1) comprising a container body (7), an inlet connector (3), and an outlet connector (5) formed separately from the inlet connector (3), wherein the container body (7) is designed as a foil tube which forms a fluid-tight connection between the inlet connector (3) and the outlet connector (5). The present disclosure further relates to a system comprising the medical bicarbonate cartridge (1) and a holder (31).

Description

Technical area

[0001] The present disclosure relates to a medical bicarbonate cartridge for dialysis applications, in particular for hemodialysis applications, and a system comprising the medical bicarbonate cartridge and a holder.

[0002] Bicarbonate or bicarbonate solution is an indispensable part of modern hemodialysis procedures. Bicarbonate is used in hemodialysis as a buffer substance to balance the acid-base balance. Unlike other buffer substances, bicarbonate has little impact on a patient's cardiovascular system. Most hemodialysis machines today produce the required bicarbonate solution automatically. For this purpose, bicarbonate cartridges filled with powdered / granulated bicarbonate are used. Water is introduced into the bicarbonate cartridge, which is enriched with bicarbonate and then discharged as a bicarbonate solution.

[0003] The current state of the art uses injection-molded cartridge bodies filled with powdered bicarbonate. These injection-molded cartridge bodies have the disadvantage that manufacturing errors, such as friction welding or a body crack, can lead to cartridge leaks, which can compromise the dialysis process and thus patient safety. Furthermore, injection-molded cartridges are expensive to manufacture and, due to their rigid shape, generate a high volume of waste.

[0004] The object of the present disclosure is therefore to eliminate or at least reduce the disadvantages of the prior art. Specifically, the object of the present disclosure is to provide a bicarbonate cartridge that increases patient safety and reduces manufacturing costs and the resulting waste volume.

[0005] This problem is solved by a medical bicarbonate cartridge according to claim 1 and by a system according to the independent claim. Advantageous further developments are part of the dependent claims.

[0006] Specifically, the problem is solved by the medical bicarbonate cartridge having a container body, an inlet connector and an outlet connector formed separately from the inlet connector, wherein the container body is formed as a film tube / film body which forms an outwardly fluid-tight connection between the inlet connector and the outlet connector.

[0007] In other words, the medical bicarbonate cartridge includes the container body / cartridge body, which, as a film tube, has a preferably substantially tubular outer surface that is closed to the outside (fluid-tight). The film tube or the outer surface of the container body has a flexible structure. In other words, the film tube as a whole is flexible.

[0008] The film tube includes a first end opening and a second end opening, which are arranged / formed at longitudinally opposite ends of the film tube. The first end opening is closed by the inlet connector (initially in the design position). The second end opening is closed by the outlet connector (initially in the design position). The film tube, the inlet connector, and the outlet connector form a fluid-tight storage space.

[0009] The core of the invention is therefore that the medical bicarbonate cartridge is formed with a film tube which defines a flexible storage space which is fluid-tight to the outside and can be flowed through in the longitudinal direction.

[0010] Specifically, the invention consists in providing two (rigid) plates or closure sections forming the end faces of a hose container / hose cartridge, preferably with a substantially oval and more preferably pointed-oval cross-section, in each of which a through-hole is formed, in / on each of which a connection piece or connecting section for an inlet and an outlet is formed / formed / arranged (which extends substantially perpendicular to the respective plate). Furthermore, a film tube is provided with a reduced rigidity compared to the plates, which is fixed (glued, welded, etc.) to the opposite long sides of each plate (extending in the longitudinal direction of the oval) in a fluid-tight manner (i.e., is connected to each plate in a fluid-tight manner over its entire circumference), thus defining a fluid-tight container / cartridge interior (with the exception of the connections).In addition, a film strip can be arranged / formed in the area of ​​the (tapered) plate ends seen in the oval or plate longitudinal direction, which protrudes over the plates in the plate longitudinal direction and extends between the two plates in the container longitudinal direction.

[0011] Alternatively, two film strips are provided that are flexible relative to the plates and are fixed (glued, welded, etc.) to the opposite long sides of each plate in a fluid-tight manner. These strips extend beyond the two free ends of the plates in the longitudinal direction, thus forming a kind of strip-shaped edge (film strip) at both long sides of each plate. These strips are essentially an extension of the long sides of the plates and are connected to each other in a fluid-tight manner (glued, welded, etc.). This creates a receiving space for the hose container / hose cartridge that can only be connected to the outside via the connections, but is otherwise closed.

[0012] Furthermore, the invention specifically consists of the plate-shaped inlet connector and the plate-shaped outlet connector, wherein the geometry of the inlet connector can correspond to the geometry of the outlet connector, and the film tube, which connects the inlet connector and the outlet connector to the outside in a fluid-tight manner with a constant diameter and is materially connected to the inlet connector and the outlet connector.

[0013] A bicarbonate cartridge designed in this way is more fracture-resistant than a completely rigid cartridge body manufactured by injection molding. In addition, the disclosed bicarbonate cartridge can reduce waste volume by approximately 70%, since the disclosed cartridge body collapses or is collapsible after use. Furthermore, by designing the cartridge body as a film tube, manufacturing and material costs can be reduced compared to designing the cartridge body as an injection-molded part.

[0014] In a first aspect, the inlet connector and the outlet connector can each be designed as a connector boat with a connecting portion and a closure portion and close the container body in a materially bonded manner, preferably by welding.

[0015] In other words, the inlet connector and the outlet connector can each include a preferably substantially plate-shaped closure portion, which closes the first end-face opening and the second end-face opening, respectively, in a planar manner. The closure portion can be fixed in or on the first or second end-face opening in a material-to-material manner. In addition to welding, other material-to-material connection types, such as gluing, are conceivable. A connecting portion can be formed on the inlet connector and the outlet connector, which extends substantially perpendicular to the closure portion. The inlet connector and the outlet connector can each be designed as a connector, which is provided and designed to connect the storage space of the bicarbonate cartridge to a line, a hose, or the like.The connecting portion of the inlet connector can be provided and configured to be connected to a water supply line. The connecting portion of the outlet connector can be provided and configured to be connected to a bicarbonate solution line.

[0016] By designing the inlet connector and the outlet connector in this way, water can be introduced into the storage chamber via the inlet connector, a uniform flow through the bicarbonate cartridge, and the bicarbonate solution can be discharged via the outlet connector. The integral connection of the inlet connector and the outlet connector to the film hose ensures the tightness of the bicarbonate cartridge.

[0017] In a further aspect, the closure portion may have a pointed oval geometry.

[0018] In other words, the closure portion of the inlet connector and / or the outlet connector may have a lens shape or an oval shape which tapers to a point at two diametrically opposite end points.

[0019] By shaping the closure section in this way, the transport and storage capacity of the bicarbonate cartridge according to the disclosure can be improved, since rolling away of the bicarbonate cartridge can be prevented without creating dead zones within the bicarbonate cartridge.

[0020] In a further aspect, a sieve section with a sieve may be formed between the connecting section and the closure section.

[0021] In other words, both the inlet connector and the outlet connector can be designed with a sieve that separates the storage space from the environment surrounding the bicarbonate cartridge.

[0022] The sieve section or sieve in the inlet connector and the outlet connector prevents the bicarbonate from leaving the bicarbonate cartridge in undissolved form (powder / granulate). In particular, it prevents clumped bicarbonate from entering the bicarbonate solution line and endangering patient safety.

[0023] In a further aspect, the container body may have at least one holding section, which may be formed, preferably as a film strip, in a longitudinal direction of the film tube.

[0024] In other words, at least one, preferably at least two, holding sections can be formed on the container body in the form of the film tube. The at least one holding section can preferably be formed as a film strip made of a material identical to a material of the film tube. Preferably, the at least one holding section can be formed as part of the film tube. In other words, the holding section can be formed integrally with the container body or the film tube. Preferably, the at least one holding section can extend over a complete length in the longitudinal direction or a complete longitudinal extent of the container body.

[0025] The at least one support section can have a thicker wall thickness than the container body in the form of the film tube. In particular, the at least one support section can have a wall thickness substantially twice as thick as the container body, whereby the support section fulfills a certain supporting function with respect to the container body.

[0026] In the preferred embodiment in which two holding sections are formed on the container body, the holding sections can particularly preferably be formed diametrically opposite each other on the container body.

[0027] Further preferably, the at least one holding section can be aligned / oriented in the longitudinal direction of one of the two diametrically opposite end points of the closure section. In the preferred embodiment in which two holding sections are formed on the container body, they can each be aligned / oriented in alignment with one of the two diametrically opposite end points of the closure section.

[0028] By designing the container body with at least one holding section, the bicarbonate cartridge can be securely fixed in a corresponding holding device. In other words, the holding sections can be provided and configured to be received by a holding device. This ensures that the bicarbonate cartridge retains its shape during operation despite the flexible container body and does not buckle or collapse uncontrollably, which could impair the flow through the bicarbonate cartridge.

[0029] In a further aspect, the container body can be formed from a polypropylene or polyethylene film. Alternatively, other plastics suitable for pharmaceutical use or approved for packaging medical products and pharmaceuticals are conceivable for forming the container body. Furthermore, the at least one holding section can be formed from the polypropylene or polyethylene film.

[0030] In a further aspect, the container body can be transparent at least in sections.

[0031] In other words, the container body can be designed with at least one translucent / transparent section. Alternatively, the entire container body can be transparent.

[0032] By designing the container body in this way, a content of the bicarbonate cartridge and / or a fill level of the bicarbonate cartridge and / or a manufacturing process of the bicarbonate solution can be optically checked / monitored by an operator or a corresponding optical sensor system.

[0033] In a further aspect, the connection section of the inlet connector and / or the outlet connector can be closed by a tamper-evident closure, preferably in the form of a cap. The tamper-evident closure can be formed, for example, by a seal, a tamper-evident ring, a tear-off / break-off geometry, or the like.

[0034] In a further aspect, the inlet connector and the outlet connector can be formed in one piece, preferably in one piece.

[0035] In a further aspect, the inlet connector and the outlet connector can be designed as a Luer-Lock connector.

[0036] In a further aspect, at least the inlet connector and / or the outlet connector can each be formed with a check valve to define a flow direction of the bicarbonate cartridge and to prevent desired backflow.

[0037] In a further aspect, a cross-sectional area of ​​the storage space parallel to the inlet connector and the outlet connector may correspond to a cross-sectional area of ​​the inlet connector and the outlet connector and may preferably be constant over an extension of the container body.

[0038] A specific bicarbonate cartridge can include the inlet connector, the outlet connector, and the container body, which is formed as a film tube and is in circumferentially connected to the inlet connector and the outlet connector in the front openings of the container body. The storage space enclosed by the inlet connector, the outlet connector, and the container body can have a cylindrical shape with a pointed oval, preferably constant, cross-sectional area. Both the outlet connector and the inlet connector can have the connecting section facing away from the storage space.

[0039] Furthermore, the object of the present disclosure is achieved by a system comprising the bicarbonate cartridge according to one of the above aspects and a holder / holding device, wherein the holder is provided and designed to fix the medical bicarbonate cartridge in or on a dialysis machine.

[0040] Furthermore, the function of the holder is to create a constant and fixed distance between the inlet and outlet connector in order to connect the flexible container body to the corresponding connection adapters of the dialysis machine.

[0041] In other words, the holder of the system is designed to (reversibly) fix the bicarbonate cartridge to the flexible container body in such a way that uncontrolled buckling or collapsing, which could impair the flow through the bicarbonate cartridge, is prevented. Preferably, the holder fixes the bicarbonate cartridge via the at least one holding section optionally formed on the bicarbonate cartridge. Particularly preferably, the bicarbonate cartridge is fixed in the holder with a force fit and / or a form fit. The holder has an external geometry that enables the bicarbonate cartridge to be fixed in the dialysis machine. In other words, the holder forms a fastening adapter to fix the disclosed bicarbonate cartridge in the dialysis machine and to ensure a defined and rigid distance between the inlet and outlet connectors.

[0042] In a first aspect, the holder can substantially completely surround the bicarbonate cartridge in a radial direction. In particular, the holder can completely surround the container body of the bicarbonate cartridge.

[0043] By designing the system consisting of the bicarbonate cartridge and holder in this way, the holder protects the bicarbonate cartridge from being punctured / cut by a pointed / sharp object.

[0044] In a further aspect, the holder of the system can also be designed as a one-piece structural element that encloses the bicarbonate cartridge in the form of a rigid bracket or a pair of pliers and holds it in a fixed position.

[0045] In a further aspect, the holder of the system can be designed in several parts.

[0046] In one aspect, the holder of the system can be designed to be foldable.

[0047] In other words, the holder can in particular contain two shells which are hingedly connected to one another via at least one hinge. A receiving space can be formed in the holder, which is intended and designed to receive the bicarbonate cartridge. The receiving space of the holder can be accessible by opening the holder or folding the two shells towards one another. The two shells can be designed essentially symmetrically to one another. The two shells forming the holder can form an essentially cuboid-shaped outer geometry in a closed / folded state. In the folded state, the bicarbonate cartridge can be fixed in the holder in a form-fitting and / or force-fitting manner.

[0048] In a further aspect, the holder of the system may include at least one quick release.

[0049] In other words, at least one quick-release fastener can be configured, preferably on a side of the holder facing away from the at least one hinge, to reversibly, in particular positively, secure the closed state of the holder. In still other words, the quick-release fastener can be configured to connect / clamp the two shells together in such a way that the bicarbonate cartridge is secured between the shells.

[0050] In a further aspect, the receiving space of the holder can have a substantially cylindrical shape with a pointed oval base. In other words, a geometry of the receiving space can correspond to an (external) geometry of the bicarbonate cartridge.

[0051] In a further aspect, the holder of the system can fix the bicarbonate cartridge in such a way that in the fixed state, a relative movement of the inlet and outlet connectors to the holder is prevented.

[0052] In a further aspect, the holder of the system can include openings that are provided and configured to receive the preferably substantially plate-shaped closure sections of the inlet and outlet connector in a form-fitting and / or force-fitting manner. In an alternative aspect, the holder of the system can include alternative openings that are provided and configured to receive the connecting sections.

[0053] In a further aspect, the preferably substantially plate-shaped closure sections of the inlet and outlet connector and / or the openings of the holder can be formed with a locking geometry that enables the closure sections to be locked in the openings of the holder.

[0054] In a further aspect, the holder may include at least one viewing window that allows an operator to visually check / monitor the contents of the bicarbonate cartridge and the bicarbonate solution preparation process.

[0055] In a further aspect, the holder can be transparent.

[0056] In a further aspect, the holder of the system can be made of plastic and / or a stainless steel sheet and / or a grid material and / or a cardboard box. Short description of the characters Fig. 1 is a perspective view of a bicarbonate cartridge according to the disclosure; Fig. 2 is a sectional view of the disclosed bicarbonate cartridge; and Fig. 3 is a perspective view of a holder and bicarbonate cartridge system according to the disclosure. Description of the embodiments

[0057] Hereinafter, embodiments of the present disclosure will be described based on the accompanying figures.

[0058] Specifically, Fig. 1 an embodiment of the disclosed bicarbonate cartridge 1 in a perspective view and Fig. 2 shows the disclosed bicarbonate cartridge 1 in a sectional view.

[0059] Below, the bicarbonate cartridge is described using Fig. 1 and Fig. 2 explained.

[0060] The bicarbonate cartridge 1 includes an inlet connector 3 and an outlet connector 5, each designed as a connector boat, as well as a container body in the form of a film tube 7. The film tube 7 represents a fluid-tight connection between the inlet connector 3 and the outlet connector 5 and extends in a longitudinal direction L of the bicarbonate cartridge 1. In other words, the inlet connector 3, the outlet connector 5, and the film tube 7 delimit a storage space 9 of the bicarbonate cartridge 1. The inlet connector 3 closes a first end-face opening 11 of the film tube 7. The outlet connector 5 closes a second end-face opening 13 of the film tube 7.

[0061] In the embodiment shown here, the inlet connector 3 and the outlet connector 5 are constructed identically.

[0062] The inlet connector 3 includes a closure section 15 and a connecting section 17. The closure section 15 has a substantially pointed oval, flat shape. The connecting section 17 extends centrally on the closure section 15, essentially perpendicular to the flat extent of the closure section, away from the closure section 15. The closure section 15 includes a circumferential connecting edge 19. The connecting edge 19 is integrally connected to the film tube 7. In other words, the film tube 7 is welded to the connecting edge 19 in a region of the first end-face opening 11, such that the first end-face opening 11 is closed by the closure section 15 of the inlet connector 3.

[0063] The drain connector 5 includes the closure section 15 and the connecting section 17. The closure section 15 has a substantially pointed oval, flat shape. The connecting section 17 extends centrally on the closure section 15, essentially perpendicular to the flat extent of the closure section, away from the closure section 15. The closure section 15 includes the circumferential connecting edge 19. The connecting edge 19 is integrally connected to the film tube 7. In other words, the film tube 7 is welded to the connecting edge 19 in a region of the second end-face opening 13, such that the second end-face opening 13 is closed by the closure section 15 of the drain connector 3.

[0064] The film tube 7 further includes two support sections in the form of film strips 21. The film strips 21 are formed integrally with the film tube 7 and extend over a length of the film tube in the longitudinal direction L. The film strips 21 are formed at diametrically opposite positions relative to the film tube 7. Specifically, the film strips 21 are formed in a plane defined by tips 22 of the closure sections 15, outside the storage space 9.

[0065] The inlet connector 3 and the outlet connector 5 each include a sieve 23, which is formed in an inlet opening 25 of the inlet connector 3 and in an outlet opening 27 of the outlet connector 5. In other words, the sieve 23 is a separating element between the storage space 9 and an environment 27 surrounding the bicarbonate cartridge 1. The inlet connector 3 and the outlet connector 5 are each closed with a tamper-evident closure in the form of a cap 29.

[0066] The following describes the functionality of the bicarbonate cartridge 1 using Fig. 1 and Fig. 2 briefly explained.

[0067] The storage chamber 9 of the bicarbonate cartridge 1 is filled with bicarbonate, preferably in powder or granular form. Before application / use, the tamper-evident seal in the form of the cap 29 is removed from the inlet connector 3 and the outlet connector 5. The inlet connector 3 is connected to a water line of a dialysis machine (not shown) in such a way that water can flow through the inlet opening 25 into the storage chamber 9. The water flows through the storage chamber 9 in the longitudinal direction L and is enriched with bicarbonate. In other words, a bicarbonate solution is formed from the water and bicarbonate along the longitudinal direction of the storage chamber. The bicarbonate solution leaves the bicarbonate cartridge 1 via the outlet opening 27 of the outlet connector 5 and flows into a bicarbonate solution line (not shown) of the dialysis machine.The sieves 23 retain the powdered bicarbonate in the storage chamber 9 and ensure that only bicarbonate solution leaves the bicarbonate cartridge 1.

[0068] Fig. 3 shows a system comprising the bicarbonate cartridge 1 and a holder 31. The holder 31 consists of a first shell 33 and a second shell 35. The holder 31 forms a bicarbonate cartridge receiving space 37 between the first shell 33 and the second shell 35, which is provided and designed to receive the bicarbonate cartridge 1. The bicarbonate cartridge 1 is in Fig. 3 is shown transparently. The bicarbonate cartridge receiving chamber 37 has an internal geometry adapted to an external geometry of the bicarbonate cartridge 1.

[0069] The first shell 33 and the second shell 36 each have a substantially rectangular half-shell geometry, each with a rectangular base 39 and a peripheral wall 41 extending perpendicularly from the rectangular base 39. Recesses / openings 43 are formed in the peripheral wall, which are provided and designed to receive the closure section 15 of the inlet connector 3 and the outlet connector 5, respectively.

[0070] For better illustration, the first shell 33 and the second shell 35 are in Fig.3 are shown separately from one another. The first shell 33 and the second shell 35 are hingedly connected to one another by means of hinges 45, which are formed on a long side of the first shell 33 or second shell 35. On a side of the first shell 33 or second shell 35 facing away from the hinges 45, quick-release fasteners 47 are formed to releasably connect the first shell 33 and the second shell 35 to one another or to reversibly close them to the holder 31.

[0071] In the closed state (not shown), the foil strips 21 of the bicarbonate cartridge 1 are non-positively secured in the holder 31. The foil strips 21 are clamped, for example, between the circumferential wall 41 of the first shell 33 and the circumferential wall 41 of the second shell 35. Embodiments are also conceivable in which the holder 31 has receptacles, for example in the form of hooks or the like, for receiving the holding sections of the bicarbonate cartridge 1.

[0072] The bicarbonate cartridge 1 is arranged in the holder 31 such that the connecting section 15 of the inlet connector 3 and the outlet connector 5, respectively, is arranged in an opening in the holder 31 formed by the recesses 43. In the closed state, the inlet connector 3 and the outlet connector 5 are fixed in position relative to the holder 31. Preferably, the inlet connector 3 and the outlet connector 5 are fixed in a force-fitting manner in the respective opening formed by the recesses 43. The force-fitting connection can be effected in particular via the connecting edge 19, thereby further improving the seal between the film tube 7 and the connecting section 15.

[0073] Embodiments are also conceivable in which the first shell 33 and the second shell 35 are connected to each other exclusively by means of quick-release fasteners 47. In such an embodiment, for example, the hinges 45 are replaced by additional quick-release fasteners 47.

[0074] In the rectangular base area 39 of the first shell 33 or second shell 35, viewing windows 49 are also formed, which allow a visual inspection of the bicarbonate cartridge 1 when the holder 31 is closed. List of reference symbols 1 bicarbonate cartridge 3 Inlet connector 5 Drain connector 7 Film tube / film web 9 Storage space 11 first front opening 13 second front opening 15 Closure section / front plate preferably in pointed-oval shape 17 connecting section 19 Connecting edge 21 foil strips 22 peaks 23 Sieve 25 Inlet opening 27 Drain opening 29 cap 31 holders 33 first bowl 35 second bowl 37 Bicarbonate cartridge chamber 39 floor space 41 surrounding wall 43 Recess 45 Hinge 47 quick release 49 viewing windows L longitudinal direction

Claims

[1] Medical bicarbonate cartridge (1) with a container body (7), an inlet connector (3) and an outlet connector (5) formed separately from the inlet connector (3), characterized by that the container body (7) is designed as a film tube which forms an outwardly fluid-tight connection between the inlet connector (3) and the outlet connector (5). [2] Medical bicarbonate cartridge (1) according to claim 1, characterized by that the inlet connector (3) and the outlet connector (5) are each designed as a connector boat with a nozzle-shaped connecting section (17) and a plate-shaped closure section (15) and close the container body (7) at the end in a material-to-material manner, preferably by means of welding. [3] Medical bicarbonate cartridge (1) according to claim 2, characterized by that the plate-shaped closure section (15) has a pointed oval geometry. [4] Medical bicarbonate cartridge (1) according to claim 2 or 3, characterized by that a sieve section with a sieve (23) is formed between the nozzle-shaped connecting section (17) and the plate-shaped closure section (15). [5] Medical bicarbonate cartridge (1) according to one of claims 1 to 4, characterized by that the container body (7) has at least one holding section (21) which is formed, preferably as a film strip, in a longitudinal direction (L) of the container body. [6] Medical bicarbonate cartridge (1) according to one of claims 1 to 5, characterized by that the container body (7) is made of a flexible film material. [7] Medical bicarbonate cartridge (1) according to one of claims 1 to 5, characterized by that the container body (7) is made of a thermoplastic material in film form. [8] Medical bicarbonate cartridge (1) according to one of claims 1 to 5, characterized by that the container body (7) is made of a polypropylene film. [9] Medical bicarbonate cartridge (1) according to one of claims 1 to 5, characterized by that the container body (7) is made of a polyethylene film. [10] Medical bicarbonate cartridge (1) according to one of claims 1 to 6, characterized by that the container body (7) is transparent at least in sections. [11] System comprising a medical bicarbonate cartridge (1) according to one of claims 1 to 7, preferably according to claim 5, and a holder (31), characterized by that the holder (31) is provided and designed to fix the medical bicarbonate cartridge (1) in or on a dialysis machine and to connect it thereto. [12] System according to claim 8, characterized bythat the holder (31) is foldable, preferably with at least two shells (33, 35) and at least one hinge (45). [13] System according to claim 8, characterized by that the holder (31) includes at least one quick-release fastener (47). [14] System according to claim 8, characterized by that the holder (31) is formed in one piece, preferably in the form of a rigid bracket or a partially open half-shell.

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