Apparatus containing a dialysis solution

The present invention relates to an apparatus for transporting a dialysis solution, wherein the apparatus has a flexible inner bag for receiving the dialysis solution that is arranged in a rigid outer packaging that is preferably parallelepiped-shaped.

The invention relates to an apparatus for transporting a dialysis solution contained therein.

It is in particular customary in the field of peritoneal dialysis to provide the patient with solution bags that are filled with a dialysis solution suitable for the patient. The patient then connects these solution bags to an inflow hose, i.e. to the patient catheter, independently or with the aid of trained medical personnel to fill the peritoneum with the solution. The dialysis solution typically has to be transported to the patient's home in the fully prepared state.

It is the object of the invention to provide an apparatus for transporting a dialysis solution with which a safe transport can be ensured with costs and waste production that are as small as possible.

Against this background, the invention relates to an apparatus containing a dialysis solution and to a medical connector for connecting the apparatus to a line that leads to a patient and that has a flexible inner bag for receiving the dialysis solution that is arranged in a rigid outer packaging. On the use of the apparatus, a dialysis solution is received within the inner bag. The outer packaging is preferably a parallelepiped-shaped box.

Such a bag-in-box packaging has the advantage that the inner bag, that is typically formed as a disposable element, is protected from mechanical influences by the outer packaging. The mechanical robustness of the solution bag, here an inner bag, has reduced importance with respect to previously known solutions, whereby a material-saving and less expensive design is made possible. The cost saving and the saving of waste are in particular considerable due to the fact that the solution bags are typically disposable products. The outer packaging can be designed as more complex and optionally also with additional functions such as reservoirs or patient-specific labels. The manufacturing costs and the material effort play a lesser role here due to the possibility of multiple use. On the other hand, the outer packaging can, for example, be manufactured from cardboard in a cost-saving and environmentally friendly manner. The outer packaging can be designed such that a stacking of the apparatus can be optimized.

The inner bag is typically produced from plastic films that are connected to one another along weld seams. Since dialysis solutions often contain a bicarbonate buffer, multi-layer films having low gas permeability are preferably used.

The preferably parallelepiped-shaped outer packaging can be produced from a rigid plastic material, from metal, or from cardboard.

Provision is made in an embodiment that the inner bag is fastened to at least one, and preferably to a plurality of inner walls of the outer packaging, with provision preferably being made that fastening elements that can be reversibly connected to one another are provided at the inner wall or walls and at the bag. The position of the bag in the outer packaging can be defined and stabilized by such a fastening. Examples include mechanical connections such as latch connections, plug-in elements having projections at the bag, and corresponding apertures or guides at the outer packaging as well as corresponding hooks and receivers. In addition to the reversibly releasable fastenings, fastenings can be considered that cannot be released in a nondestructive manner such as an adhesive bonding or welding.

Provision is made in an embodiment that the inner bag has at least one extraction port for the extraction of dialysis solution that comprises the medical connector, with provision preferably being made that the outer packaging has an extraction opening or an extraction perforation, with the extraction port and the extraction opening or extraction perforation being arranged relative to one another such that access can be made to the extraction port through the extraction opening or extraction perforation. The inner bag can, for example, be arranged in and fastened to the outer packaging such that the extraction port is arranged directly behind or in the extraction opening or extraction perforation. The inner bag and the outer packaging can also be connected to one another in the region of the extraction port or extraction perforation to fix the position of the extraction port relative to the extraction opening or extraction perforation. The extraction opening itself can, for example, be closed by a removable film or flip-cover to keep the extraction port sterile. Alternatively or additionally, the port can be closed, preferably in a sterile manner, by a removable cap or by a removable covering.

Provision is made in an embodiment that the inner bag is arranged in the outer packaging such that the extraction port is arranged in at least one possible standing position of the outer packaging at the lowest point of the bag. It can thus be ensured that liquid can flow off completely from the inner bag. For example, a ramp that extends obliquely to the respective side surface can be arranged at at least one side surface in the parallelepiped-shaped outer packaging. The bag can thus lie at a slant on the ramp. The extraction port can be arranged at the end of the ramp close to the side surface. Alternatively, the bag can be shaped such that one side of the bag, that is disposed opposite a side of the bag fastened to the inner side of the outer packaging, is sloped. The extraction port can be arranged at the end of the slope.

Provision is made in an embodiment that the outer packaging has a suspension apparatus at a corner or side edge and that the inner bag is arranged in the outer packaging such that the extraction port contacts the oppositely disposed corner or side edge of the outer packaging. If the outer packaging is suspended at a suitable stand using the suspension apparatus, the extraction port is then at the lowest point so that liquid can flow off completely out of the inner bag.

Provision is made in an embodiment that the inner bag has at least one filling port for its filling with dialysis solution, with provision preferably being made that the outer packaging has a filling opening, with the filling port and the filling opening being arranged relative to one another such that access can be made to the filling port through the filling opening. A filling of the bag already located in the outer packaging is thus made possible. The inner bag can, for example, be arranged in and fastened to the outer packaging such that the filling port is arranged directly behind or in the filling opening or extraction perforation. The inner bag and the outer packaging can also be connected to one another in the region of the filling port and the filling opening to fix the position of the filling port relative to the filling opening. Such a fixing is preferably realized by a latch connection, a weld connection, or an adhesive connection.

In an embodiment, the inner bag has at least two ports, a filling port for its fitting with dialysis solution and an extraction port for extracting dialysis solution. The filling port can be arranged at a side of the apparatus disposed opposite the extraction port.

Provision is made in an embodiment that the outer packaging comprises at least two compartments, with the inner bag being arranged in one of the two compartments. The other compartment is free and can be used for accommodating tube sets or other accessory parts such as gloves or the like. The bag compartment is preferably dimensioned such that it is substantially filled by the filled bag.

Provision can be made in an alternative variant that the inner bag completely fills up the outer packaging. Tube sets and accessory parts can, for example, be arranged in a film packaging at the outside of the outer packaging.

Provision is made in an embodiment that the outer packaging has a cover that releases an opening in the inner space of the outer packaging. The cover can, for example, be arranged such that access can be made to a compartment of the inner space in which the bag is not arranged, but in which a tube set and/or accessory parts is/are arranged. The cover can, for example, be formed by a section of the outer packaging separated by perforation lines. The outer packaging can be designed such that the inner space is terminated in a sterile manner with respect to the environment before an opening of the cover.

Provision is made in an embodiment that the apparatus has a gripping element for carrying the apparatus, with provision preferably being made that the gripping element is fastened to the inner bag and passes to the outside through a gripping opening in the outer packaging. The force is directly introduced into the inner bag by such an arrangement, with the inner bag typically being heavier than the outer packaging due to its filling with dialysis solution.

Provision is made in an embodiment that the outer packaging is designed such that it can be collapsed in a defined manner by folding along predefined axes. The box can, for example, have defined fold lines or side surfaces having a plurality of surfaces foldable with respect to one another. Pressure can be exerted onto the inner bag by a collapsing from outside the outer packaging to facilitate the former's complete emptying. A collapsed container is furthermore easier to transport and has a smaller waste volume in the event of disposal.

Provision is made in an embodiment that the outer packaging has an inspection window to be able to monitor the filling level of the inner bag. This can be of advantage, for example, when the apparatus is used as a drain bag for consumed dialysis solution after the emptying of the inner bag. The inspection window can, for example, be provided with filling level marks.

Provision is made in an embodiment that the outer packaging is designed as gas-tight. An additional gas barrier can thereby be provided, which increases the service life of the bicarbonate-buffered dialysis solutions, on the one hand, and enables a design of the inner bag that has thinner walls and is thus more cost-saving and material-saving.

Provision is made in an embodiment that the container is produced from sterilizable materials. The materials are preferably of such a nature that they are of stable shape at temperatures that are customary within the framework of a heat sterilization of a dialysis solution, that is, for example, at approximately 120° C., and do not decompose or emit pollutants.

Provision is made in an embodiment that all the inner spaces of the container that are closed with respect to the environment and that contain medical liquids or ports are sterile. This in particular applies to the inner volume of the inner bag and to the medical connector.

An embodiment of a transport box in accordance with the invention is shown inFIG.1. The transport box1represents a double packaging in the manner of a bag-in-box packaging for dialysis solutions. It comprises an inner bag10that is mechanically supported and protected by a rigid outer packaging20. The box1is intended to be filled with ready-to-use dialysis solution in a treatment center or in an automatic output machine, that is optionally mobile, and then to be transported home by the patient.

The box1is shown in the state in which it is handed over to the patient in the top left image. The box1will now first be described in this state.

Both the parallelepiped-shaped outer packaging20and the inner bag10are designed as disposable products, with the outer packaging comprising cardboard and being able to be recycled in an environmentally friendly manner and being able to be manufactured very inexpensively. The inner bag10is produced from multi-layer plastic films that are connected to one another along weld seams. The mechanical robustness of the inner bag10, however, loses importance with respect to already known solutions, whereby a material-saving and less expensive design of the inner bag10is made possible.

The outer packaging20comprises two compartments21and22that are separated by an intermediate wall23, with the inner bag10being arranged in a large bag compartment21. A tube set30is accommodated in the small tube compartment22and is combined with further accessory parts31such s gloves and the like to form a bundle. The bag compartment21and the inner bag10are dimensioned such that the inner bag10substantially completely fills up the bag compartment21, i.e. except for a ramp-like cut-out25. The ramp-like cut-out25in the bag compartment21is a consequence of a special shape of the inner bag10and of a fastening of the inner bag10to the inner walls of the bag compartment21in the embodiment shown. As an alternative, the arrangement of a ramp belonging to the outer packaging20within the bag compartment is also conceivable. The function of the ramp-like cut-out25will be described further below.

The inner bag10has an extraction port11for the extraction of dialysis solution. The extraction port11of the inner bag10reaches through an extraction opening24in the intermediate wall23into the tube compartment22and is preconnected to the tube set30so that the patient no longer has to connect the tube set30to the extraction port11on a following use. Although this cannot be recognized in any more detail inFIG.1, the inner bag10and the outer packaging20are connected to one another in the region of the extraction port11and of the extraction opening24to fix the position of the extraction port11in the extraction opening24.

The inner bag10is also fastened to a plurality of points at the wall of the bag compartment21disposed opposite the intermediate wall23. The corresponding fastening points are marked by reference numeral40.

The fastenings can, for example, be configured as adhesive dots or as welds. A releasable embodiment is furthermore conceivable in which the solution bag10is provided with barbs41and the wall of the outer packaging20is provided with reception holes42such as is shown inFIG.2a.

The inner bag can also be fastened to the walls of the outer packaging20at the side inFIG.1in an embodiment to stabilize its position within the outer packaging. A fastening by means of adhesive spots or welds or a releasable fastening is in turn conceivable, for example in the manner as shown inFIG.2b, with corresponding holding projections43and44at the solution bag10and the outer packaging20.

The outer packaging20has a cover26that bounds the tube compartment22at its side disposed opposite the intermediate wall23. The cover26extends over the entire corresponding side of the outer packaging20and comprises, like the remaining parts of the outer packaging20, cardboard, with it being separated from the remaining parts of the outer packaging20by a perforation line.

The course of the use of the box1at the patient's is schematically explained in the further images ofFIG.1.

The standing box1of the top left image is first opened by tearing the cover26along the perforation line and by a subsequent folding open of the cover26so that the patient can access the upwardly disposed tube compartment22. The tube set30connected to the extraction port11and the accessories31are then removed from the tube compartment22. The box is then rotated by 180° so that the extraction port11is at the bottom. In this position, the box can, for example, be placed at an elevated position or can be fastened to a stand such that is in an elevated position with respect to the patient. A slipping of the inner bag10out of the outer packaging20is prevented in this position by the fastening to the fastening points40. The extraction port is at the lowest point due to the special shape of the inner bag10that leaves the ramp-like cut-out25free and due to its fixing to the now upwardly disposed side of the bag compartment21so that the inner bag10can be completely emptied by gravity during the treatment.

FIG.3again shows the box1already described while looking atFIG.1, with a further detail of the box being recognizable here, namely a filling port12at the side of the inner bag10disposed opposite the extraction port11, i.e. at that side of the inner bag10that is fixed at the fastening points40to the inner wall of the bag compartment21of the outer packaging20. The outer packaging20has a filling opening27at a point corresponding to the filling port12and the filling port12can be accessed through it from the outside so that a filling of the inner bag10already located in the outer packaging20is made possible.

The inner bag10therefore has exactly two ports, namely the filling port11for its filling with dialysis solution and the extraction port12for the extraction of dialysis solution. The filling port11is arranged at the side of the inner bag10—or also of the outer packaging20and the box1as a whole—disposed opposite the extraction port12.

An alternative variant of the box in accordance with the invention is shown inFIG.4in which the outer packaging20only has one compartment that is substantially completely filled by the inner bag10. A tube compartment is missing in this variant. The tube set30and the accessories31are instead received in a film packaging50at the outside of the outer packaging20. The extraction opening24of the outer packaging20is arranged below the film packaging and is covered by it in an air-tight manner. The extraction port11of the inner bag10reaches through this extraction opening24into the inner space of the film packaging50and is preconnected to the tube set30so that the patient now only has to open the film packaging on a subsequent use and no longer has to connect the tube set30to the extraction port11.

A further variant of a box1in accordance with the invention is shown inFIG.5, with a gripping element13for carrying the box1being fastened to the inner bag10and passing to the outside through a gripping opening28in the outer packaging20. The force is directly introduced into the inner bag10by such an arrangement when carried, with the inner bag typically being heavier than the outer packaging20due to its filling with dialysis solution. The extraction port11is configured as inFIG.4, with the film packaging50no longer being shown separately.

In the variant of a box1in accordance with the invention shown inFIG.4, the wedge-shaped recess25in the inner space of the outer packaging25is missing in comparison with the variant shown inFIG.1so that when the box1is placed flat on its bottom, the inner bag10does not run toward its extraction port11. The extraction port11and the corresponding extraction opening24are, however, arranged in the region of a side edge of the outer packaging20so that the inner bag is arranged at the lowest point of the inner bag on a slanted positioning of the box1.

The box12can therefore, as is shown inFIG.6a, have suspension tab29at the side edge of the outer packaging20disposed opposite the extraction port11and the extraction opening24and the box1can be suspended by said suspension tab, as shown inFIG.6b, at an infusion stand60, for example. In the suspended state, the extraction opening11is then, as can be recognized inFIG.6b, automatically at the lowest point of the box, whereby a complete gravimetric emptying of the inner bag10is made possible.

A variant of the transport box1in accordance with the invention is shown inFIG.7in which the outer packaging20is designed such that it can be collapsed by a folding of the side walls along horizontal axes if pressure is exerted on the upper side of the box in the direction of the arrow A. A complete emptying of the inner bag10can be promoted by the exertion of pressure even if the inner bag10does not run toward the extraction opening11.