EP3582740A1

EP3582740A1 - Bag for providing patient-specific drugs

Info

Publication number: EP3582740A1
Application number: EP18714968.7A
Authority: EP
Inventors: Uwe-Bernd Rose
Original assignee: Eurozyto GmbH
Current assignee: Eurozyto GmbH
Priority date: 2017-02-16
Filing date: 2018-02-15
Publication date: 2019-12-25
Also published as: WO2018149460A1; US20200237619A1; DE102017202510A1; DE202018100845U1

Abstract

The invention relates to a bag (1) for providing patient-specific, in particular oncologic drugs, having an interior space subdivided into a plurality of, preferably four ,separate chambers (2a, 2a', 2a", 2b). An infusion can be provided in at least one, preferably three chambers (2a, 2a', 2a", 2b) and patient-specific active substances can be added.

Description

BAG FOR PROVISION PATIENT-SPECIFIC

DRUG

The present invention relates to a bag for providing patient-specific, in particular oncological drugs.

In practice, in medical, especially in oncological applications, several separate, filled with infusion solution bags, so-called prefill bags, are used. Before the delivery of a patient-specific active substance, such as, for example, cytostatics, first of all liquid is withdrawn from it, namely according to the volume of the active substance to be administered. After removal of the appropriate volume of infusion solution, the bags are refilled in a second step with the appropriate active ingredient. Both the removal of the infusion solution and the delivery of the active substance should be carried out in a GMP (good manufacturing practice) -regulated clean room due to the existing risk of contamination. The relevant country-specific laws and regulations contain stipulations for this. Each work step is carried out with utmost precision and is logged. Accordingly, therefore, several steps in the clean room are required. This is both time, space, and in the result costly.

A high risk of contamination not only arises when preparing the bags, ie when emptying and filling with active ingredient, but also when attaching and reconnecting the individual bags directly to the patient. This results in a fairly high risk of infection. In addition, the transfer of infusion solutions to patients further problems, such as blood leakage at the venous connection of the patient. A further disadvantage of the standard known from practice lies in the complicated disposal of the individual bags and the necessary protective equipment for handling. To the bags of active substance providing bags of an infusion, there are added further separate bags, namely to provide a rinsing solution or other medicaments for pre- or post-medication, which complicate the handling and further increase the disposal and the risk of contamination.

Furthermore, when using individual bags, there is a risk of likelihood of not being neglected between the bags and thus the patient-specific active substances, in particular in the order of administration.

The required technical measures must relate to the design of the bag used to provide the infusion solution.

The present invention is therefore based on the object to offer a way to provide patient-specific, especially oncological drugs safely and inexpensively with simple design and administer.

The above object is achieved by the features of claim 1. Thereafter, the bag, to provide patient-specific, in particular oncological drugs, a subdivided into a plurality, preferably four separate chambers interior, at least one, preferably three chambers provide an infusion solution and patient-specific drugs are zugebbar. In accordance with the invention, it has been recognized that it is not necessary to use a plurality of separate bags that are extremely expensive to empty in a sterile environment and partially filled with active ingredient and combined under the risk of confusion and contamination risk for administration. On the contrary, the invention goes a completely different way, namely, not just several separate bags are used, but rather the interior of a bag divided into separate chambers. Specifically, the bag has a divided into a plurality, preferably four separate chambers interior, wherein in at least one, preferably three chambers an infusion prepared or provided and patient-specific drugs are attributable. Also, more than 3 chambers with infusion solution for the addition of active ingredients is conceivable. This eliminates not only steps in the clean room, but the entire handling is simplified, the contamination and thus risk of infection during handling, waste, required work surface and reduces the production time. Also a likelihood of confusion is counteracted by the exclusive use of a single bag.

Consequently, with the bag according to the invention for the provision of patient-specific, in particular oncological medicaments, a possibility is indicated for a simple construction to provide and administer patient-specific, in particular oncological medicaments safely and inexpensively.

Advantageously, at least one, preferably exactly one of the chambers serves to provide a rinsing solution. This saves the user attaching a separate bag with the appropriate rinse solution and an additional connection with the other bags. Also, this rinse solution serves to avoid the mixing of residues of the infusion solutions, which in extreme cases could lead to undesirable interactions in the active ingredients. Conceivable are NaCl, Ringer or glucose solutions.

It is particularly advantageous if the interior of the bag has exactly four chambers, three of which serves to provide a solution and to add a patient-specific active substance and the fourth chamber to provide a rinsing solution.

Furthermore, the formation of the bag from a hose is suitable for simple and inexpensive production. Polymer-based wide hoses are preferred, in particular polyolefins (POF), in particular polyethylene (PE) and / or polypropylene (PP), polyvinyl chloride (PVC) and / or ethylene-vinyl acetate (EVA). Polypropylene (PP) and polyethylene (PE) are distinguished in particular by their high stability when used for the bags according to the invention. Other advantages include transparency, low density compared to other materials, low water absorption, excellent chemical resistance to chemicals and physiological safety. In addition, polypropylene (PP) is particularly corrosion resistant. Polyethylene (PE) has anti-adhesive properties and is also suitable for use at low temperatures. Particularly advantageous to polyvinyl chloride (PVC) is its high chemical resistance, ease of processing, good weather resistance, low moisture absorption and transparency. For example, the hoses can be welded together at the edge of the hose by induced heat. The chambers are advantageously formed by welds, in particular by means of induced heat and / or by gluing and / or by clamping means, in particular clamps. Clamping means the number of individual chambers is variable.

In a further advantageous manner, the chambers are multi-layered, wherein the individual layers may consist of the same or different materials. By a multi-layered design, the gas density of the bag or the system can be increased.

Furthermore, it is advantageous if the chambers are at least partially dimensioned differently in their volume, depending on the volume requirement of the corresponding application. Equally large chambers are also conceivable. Preferred volumes of the individual chambers are 500 ml, 250 ml and 100 ml.

For filling and / or emptying the chambers with infusion solution and / or with active ingredient, it is of particular advantage if each chamber is assigned at least one connection piece. This can be a hose inlet for filling a chamber and a hose outlet for emptying a chamber or a connecting piece which simultaneously serves as hose inlet and hose outlet. In particular at the hose outlet a Luer-Lock hose connector is suitable. It is particularly advantageous to attach a merging system to the bag. Specifically, the merging system may include a plurality of tubes connected at one end to a chamber or fitting of the chambers, respectively, and converging at the other end for administration to the patient in preferably a tube. A transposition the merging system on the patient and a multi-tap system are thereby eliminated. The contents of the individual chambers may be administered one by one or simultaneously to the patient, preferably with the fluids of the individual chambers being sequentially administered without mixing.

The merging system can be arranged in a further advantageous manner, one or more injection ports for the addition of other liquids and / or agents. These are particularly well suited for further injections during treatment.

It is particularly advantageous to control or regulate the inflow from the filled bag chambers via closing clips on the hoses of the merging system. This is particularly advantageous in order to avoid a mixing of the liquids or active ingredients and to administer them to the patient one after the other.

Advantageously, the entire bag, the fittings and / or the Zusammenführungssystem is made exclusively on polymer basis and has / have no metal parts. Polyolefins (POF), in particular polyethylene (PE) and / or polypropylene (PP), polyvinyl chloride (PVC) and / or ethylene-vinyl acetate (EVA), are particularly suitable for the pouch. The foregoing benefits of these materials apply accordingly. In order to realize a nearly complete emptying of the chambers, it is of particular advantage to design the chamber shape and / or the materials used and / or the surface structuring of the interior of the bag accordingly, so that the patient can be administered its complete, individual dose.

To protect the active ingredients from light, it is of particular advantage if the chambers and / or the at least one connecting piece and / or the merging system is made of colored plastic which has a photoprotective effect. Alternatively, it is conceivable the chambers and / or to produce the at least one connecting piece and / or the Zusammenführungs- system of a clear plastic without light protection and this / these additionally surrounded with a photoprotective envelope. The object mentioned above is also achieved by a set having the features of claim 14. For the set according to the invention for providing patient-specific, in particular oncological medicaments, it is of particular importance that the latter comprises a pouch according to the invention and a collapsing system which can be coupled to the pouch for administering the patient-specific, in particular oncological medicaments to a patient. The bag and the merging system can be accommodated together in a closed package. The set preferably consists of a bag and a joining system, which are each received individually, ie separately from each other, in a sealed package. This kit allows immediate application of the patient-specific, in particular oncological medicines, wherein the bag and the packaging system are contained in the packaging. It is advantageous if bag and Zusammenführungssystem are included sterile in the packaging / packaging. For this purpose, the packaging (s) may consist of a foil, which enables a sterilization of the bag and of the merging system. For an immediate applicability of the set, it is conceivable if at least the infusion solution and possibly the rinsing solution are already contained in the bag, so that only active ingredients must be added. Furthermore, it should be noted at this point that the bag according to the invention can provide different drugs, in particular cytostatics, which are based on different mechanisms of action. In this case, chemical substances can be provided individually or as a regimen in a bag. Conceivable cytostatics - substance groups are vinca-alkloids such as vinblastine, vincristine or vinorelbine, epipdophyllotoxins such as etoposide, teniposide, campotethenes such as topotecan or irinotecan, antibiotic substances such as anthracyclines, antimetabolites such as modified purine and pyrimidine bases eg flurouracil or gemcitabine, alkylating agents such as bisulfane or cyclophosphamide, platinum substances such as carboplatin or oxaliplas- enzymes, such as asparaginase, hormones such as corticosteroids, monoclonal antibodies, such as breathtzuzumab or rituximab, taxanes, such as paclitaxel, topoisomerase inhibitors, such as etoposide, irinotecan or topotecan, intercalants, for example anthracyclines, doxorubicin (Adriamycin), daunorubicin , Epirubicin, idarubicin, mitoxantrone or amsacrine, aromatase inhibitors such as nastrozole, exemestane or letrozole, amatoxins, mitotane, hydroxycarbamide, altretamine, mitotic inhibitors such as vinorelbine, vincristine (Oncovin), vinblastine or vindesine, intercalants, such as anthracyclines, doxorubicin (adriamycin), daunorubicin, epirubicin, idarubicin, mitoxantrone or amsacrine, enzyme inhibitors such as tyrosine kinase inhibitors. As a supplement antiemetics and / or analgesics can be provided in the bag.

Independent of oncological drugs, patient-specific drugs are also conceivable for enzyme replacement therapy. For example, for the treatment of patients with Fabry disease, the pouch may include agalsidase alpha and agalsidase beta, for the treatment of Morquio Elosulfase alfa, for the treatment of Pompe alglucosidase alfa, or for the treatment of paroxysmal nocturnal hemoglobinuria eculizumab administered as intravenous infusions be administered.

There are now various possibilities for designing and developing the teaching of the present invention in an advantageous manner. On the one hand, reference should be made to the claims subordinate to claim 1 and, on the other hand, to the following explanation of preferred exemplary embodiments of the invention with reference to the drawing. In conjunction with the explanation of the preferred embodiments of the invention with reference to the drawings, also generally preferred embodiments and developments of the teaching are explained. In the drawing shows

1 is a schematic view of a first embodiment of a bag 1 according to the invention for the provision of patient-specific, in particular oncological drugs, and 2 shows a schematic view of a second embodiment of a bag 1 according to the invention for providing patient-specific, in particular oncological medicaments.

Fig. 1 shows a bag 1 for providing patient-specific oncological drug having in its interior four separate chambers 2a, 2a ', 2a ", 2b, wherein three of the chambers 2a, 2a', 2a" of providing an infusion solution and the addition of a patient-specific active ingredient and the fourth chamber 2b serve to provide a rinsing solution. The bag 1 is made of a wide ethylene vinyl acetate (EVA) tube with a weld 3 forming the right bag wall. The inner walls 4 of the individual chambers 2a, 2a ', 2a ", 2b are welded together by induced heat.The chambers 2a, 2a', 2a", 2b have partly different volumes, in the concretes 500 ml, 100 ml and twice 250 ml. Furthermore, the chambers 2a, 2a ', 2a ", 2b are elongated and have on their upper side a hose inlet 5 for filling the chambers 2a, 2a', 2a", 2b and at its lower side a hose outlet 6 for Emptying the chamber 2a, 2a ', 2a ", 2b The active ingredients are added through the hose inlet 5 into the respective chamber 2a, 2a', 2a", 2b.

The hose outlet 6 is associated with a Luer-lock hose connector 7, by means of which the bag 1 is connected to a merging system 8. The merging system 8 comprises individual hoses, each connected to a hose outlet 6, which are brought together on the ends opposite the hose outlets 6. In the region of the Luer-Lock hose connector 7 closing brackets 9 are arranged plastic to regulate the flow. The leftmost outer tube of the assembly system 8 is assigned an injection port 10 for further injections during the treatment. An opening 11 or a port for administration of the medicament to the patient via an infusion line is provided on the end of the convergent system 8 opposite the bag 1. The inside surface of the bag 1 is designed in such a way that an almost complete emptying of the chambers 2a, 2a ', 2a ", 2b can be realized Both the bag 1 and the merging system 8 are made of a photoprotective plastic to protect the inserted ones Protect medicines from light, or use a clear plastic.

2 shows a second preferred exemplary embodiment of a bag 1 according to the invention for providing patient-specific oncological medicaments, having a bag 1 which has four separate chambers 2a, 2a ', 2a ", 2b in its interior, three of the chambers 2a, 2a' being 2a "of providing an infusion solution and the addition of a patient-specific agent and the fourth compartment 2b serve to provide a rinse solution. The bag 1 is made of a wide and clear polymer tube, specifically made of polyolefin (POF). A photoprotective protective sheath, not shown in FIG. 1, can be arranged around the bag 1. Both the left and right bag walls are formed by folding the tube. At the top and at the bottom of the tubular bag 1 is welded shut. The inner walls 4 of the individual chambers 2a, 2a ', 2a ", 2b are likewise formed by welding, The chambers 2a, 2a', 2a", 2b have partially different volumes. The shape of the bag 1 or the chambers 2a, 2a ', 2a ", 2b is designed such that an almost complete emptying of the chambers 2a, 2a', 2a", 2b can be realized. Furthermore, the chambers 2a, 2a ', 2a ", 2b are elongate and extend from the upper end to the lower end of the tubular bag 1. On its lower side, they each have a connecting piece 5, 6 through the welds which can serve both as a hose inlet 5 for filling the chambers 2a, 2a ', 2a ", 2b and as a hose outlet 2a, 2a', 2a", 2b for emptying the chamber 2a, 2a ', 2a ", 2b.

The connecting piece 5, 6 is associated with a Luer-lock hose connector 7, by means of which the bag 1 or the individual chambers are connected to a merge system 8. Other means of connection of the Zusammenführungssystems 8 are conceivable. The merging system 8 comprises individual tubes, which are connected at one end to a connecting piece 5, 6 of a chamber 2a, 2a ', 2a ", 2b and to which the connecting piece 5, 6 opposite end are merged into a single tube. In the region of the Luer-Lock hose connector 7 or in the area before the merging of the individual hoses, each tube is provided with plastic closure clips 9 for regulating or opening and closing the flow. The left-most tube of the merging system 8 is assigned an injection port 10 for further injections during a treatment. At the end of the merging system 8 opposite the bag 1, an opening 11 or a port for administration of the medicament via an infusion line to the patient is provided. In the opening 1 1 a silicone plug is provided.

Frequently, the tube system 8 is pre-filled with saline solution via the opening 11 before the administration of the liquids or active substances contained in the chambers 2a, 2a ', 2a ", so that the patient is supplied with sufficient liquid / saline solution of the individual chambers 2a, 2a ', 2a "are generally not allowed to mix, they are administered to the patient one after the other. For this purpose, the administration of the liquids of the individual chambers 2a, 2a ', 2a ", 2b is controlled by the closing clips 9 and between the administration of two liquids or active substances at least the last section of the merging system 8, in which the individual, with the chambers 2a, 2a ', 2a ", 2b connected hoses are combined in a hose, rinsed with rinse solution, in particular with saline.

With regard to further advantageous embodiments of the bag according to the invention, reference is made to avoid repetition to the general part of the description and to the appended claims.

Finally, it should be expressly understood that the above-described embodiments of the bag according to the invention are only for the purpose of discussion of the claimed teaching, but this does not limit to the embodiments. LIST OF REFERENCE NUMBERS

1 bag

2a, 2a ', 2a "chamber with infusion solution and active ingredient

2b chamber with rinsing solution

3 weld

4 walls of the chambers

5 fitting, hose inlet

6 fitting, hose outlet

7 Luer-Lock hose connectors

8 merge system

9 locking clips

10 injection port

11 Opening / port of the merging system

Claims

1. pouch (1) for providing patient-specific, in particular oncological, medicaments, with an interior divided into a plurality, preferably four, separate chambers (2a, 2a ', 2a', 2b), wherein at least one, preferably three, chambers (2a, 2a, 2a) 2a ', 2a ") an infusion solution can be provided and patient-specific active ingredients can be added.

2. bag (1) according to claim 1, characterized in that at least and preferably a chamber (2b) is used to provide a rinse solution.

3. bag (1) according to claim 2, characterized in that the interior of the bag (1) has four chambers (2a, 2a ', 2a ", 2b), of which three (2a, 2a', 2a") of providing an infusion solution and the addition of a patient-specific drug and (2b) the provision of a rinsing solution is used.

4. bag (1) according to one of claims 1 to 3, characterized in that the bag (1) of a hose, preferably from a polymer hose, in particular polyolefins (POF), in particular polyethylene (PE) and / or polypropylene (PP), polyvinyl chloride (PVC) and / or ethylene-vinyl acetate (EVA), and the chambers (2a, 2a ', 2a ", 2b) by welds (3) and / or gluing and / or clamping means are formed.

5. bag (1) according to one of claims 1 to 4, characterized in that the chambers (2a, 2a ', 2a ", 2b) are formed multi-layered, wherein the layers consist of the same or different materials.

6. Bag (1) according to any one of claims 1 to 5, characterized in that the chambers (2a, 2a ', 2a ", 2b) are equal in their volume and / or different dimensions, preferably the volume of 500ml and / or 250 ml and / or 100 ml.

7. bag (1) according to one of claims 1 to 6, characterized in that each chamber (2a, 2a ', 2a ", 2b) at least one connecting piece for filling and / or emptying the chamber (2a, 2a', 2a" , 2b), preferably a hose inlet (5) and / or a hose outlet (6), in particular a Luer-Lock hose connector (7), is assigned.

8. bag (1) according to one of claims 1 to 7, characterized in that the container, preferably at the at least two connecting pieces, in particular the at least two Schlauchauslässen (6), a Zusammenführungs- system (8) is mounted, which preferably several Includes hoses, which are connected at one end in each case with a chamber (2a, 2a ', 2a ", 2b) and converge at the other end.

9. bag (1) according to claim 8, characterized in that the merging system (8) an injection port (10) for the addition of other liquids, in particular of active ingredients, having.

10. bag (1) according to claim 8 or 9, characterized in that the merging and / or the administration of the solutions is preferably regulated via hose clamps / are.

1 1. Bag (1) according to one of claims 1 to 10, characterized in that the bag (1) and / or the connecting pieces (6, 7) and / or the merging management system (8) preferably exclusively on a polymer basis, in particular of polyolefins ( POF), in particular polyethylene (PE) and / or polypropylene (PP), polyvinyl chloride (PVC) and / or ethylene-vinyl acetate (EVA).

12. bag (1) according to one of claims 1 to 1 1, characterized in that the shape and / or the material and / or the surface structuring of the chambers (2a, 2a ', 2a ", 2b) and / or the connecting pieces ( 5, 6) and / or the merging system (8) is / are designed such that an at least almost complete administration of the solutions can be realized.

13. bag (1) according to one of claims 1 to 12, characterized in that the chambers (2a, 2a ', 2a ", 2b) and / or the at least one connecting piece (5, 6) and / or the Zusammenführungssystems (8 ) is made of preferably colored plastic / which has a photoprotective effect.

14. A kit for providing patient-specific, in particular oncological medicaments, comprising a bag (1) according to one of claims 1 to 13 and a coupling system (8) which can be coupled to the bag (1) for administering patient-specific, in particular oncological medicaments to a patient, wherein the Bag (1) and the merging system (8) are housed together or individually in a closed package.