Medicament container and infusion system having such medicament container

Abstract

A medicament container and an infusion system having such a medicament container are disclosed. Drug containers (10), in particular for use in infusion therapy, are known. They are often flexible drug pouches. The medicament container (10) has a wall (20) that encloses an interior (12). A liquid to be applied is contained in the interior. The medicament container (10) further comprises at least one fluid coupling (30) for connecting a fluid line (100) for the purpose of extracting liquid from the medicament container. It is proposed that the medicament container (10) comprises a first transmission device (40), the first transmission device (40) being adapted to perform data communication with an information carrier (70) applied on an outer side of a wall (20) of the medicament container (10).

Description

Technical Field

[0001] This invention relates to a drug container and an infusion system having such a drug container. A general-purpose drug container is used to contain medical fluids before administration to a patient. In particular, such a drug container can be formed as a drug bag, although a form with rigid walls is also possible. Background Technology

[0002] In the context of this invention, medical fluid can refer to any fluid used in the context of medical therapy, including, for example, nutrient solutions and blood products.

[0003] For example, intelligent medical fluid conduction and transfer systems and components thereof are described in US 2022 / 0273930 A1 and WO 2021 / 023639 A1, which are from the same patent family.

[0004] Many treatments, such as cancer treatments, use personalized medical fluids tailored to the individual patient's needs. These are administered from standard-type medication containers. The containers for these customized medical fluids are routinely labeled to prevent misdispensing.

[0005] To ensure that no dispensing errors occur during treatment (i.e., the use of a drug container not intended for the patient in question), it has been proposed to provide a drug container with a memory such that the information in the memory can be read by the control device of the infusion system.

[0006] US 2007 / 0145150 A1 describes an apparatus for applying an RFID tag carrier to an object. The proposed arrangement involves a retaining portion for the tag carrier that is pivotally connected to an adhesive portion. Therefore, the tag can be protruded and pivoted or moved by the user toward a reader for easier reading in different locations. Summary of the Invention

[0007] An aspect of the present invention is to provide a drug container that further reduces the risk of improper dispensing and / or facilitates processing.

[0008] The independent claim defines the subject matter to be protected. The dependent claims provide additional improvements.

[0009] According to aspects of the invention, it is proposed to provide a drug container, particularly a drug container for use in infusion therapy, configured as described below. Drug containers of the type according to the invention are generally not technically complex and are designed as single-use or disposable products.

[0010] Drug containers typically have walls that enclose the interior, within which the liquid to be administered can be contained. The liquid can be, for example, a sterile liquid, a pharmaceutical preparation, or a nutrient solution. This includes any liquid administered to a patient in the context of treatment. For example, this also includes water, solutions, blood components, and blood itself.

[0011] The walls are typically made primarily of biocompatible and chemically stable plastics to ensure the sterility and integrity of the liquid. Specifically, PVC, polyolefins, EVA, or polyethylene are often considered. The walls can also be configured as metal or glass walls. UV protection can be additionally provided.

[0012] In particular, the drug container can be configured as a drug bag with (geometrically) flexible bag walls. Such bags are often used in infusion therapy. However, the present invention also includes drug containers with rigid walls.

[0013] The drug container has at least one fluid connection for attaching a fluid line to obtain liquid from the drug container, and particularly for administering the liquid to a patient via an intravenous route.

[0014] The fluid connection of the drug container can be configured, for example, as a Luer connector.

[0015] According to the invention, a drug container is provided with a first transmission device for data communication with an information carrier applied to the outer side of a wall. In other words, the drug container includes a first transmission device adapted to communicate with an information carrier attached to the outside of the wall (which encloses the interior) of the drug container. The information carrier need not be part of the drug container. The drug container is configured such that the information carrier can be attached to the wall, and when the information carrier is attached to the outside of the wall enclosing the interior of the drug container, the first transmission device is adapted to communicate with the information carrier. The information carrier may optionally be part of the drug container. The first transmission device is preferably provided on the front wall (front portion wall) of the drug container, particularly preferably approximately in the middle of the front wall.

[0016] During the intended use of the drug container, this information carrier is applied to the outer side of the wall, specifically adhesively bonded there. The information carrier has an electronic memory, which is coupled to a second transmission device that is part of the information carrier.

[0017] In this way, first and second transmission devices can be used to enable the electronic storage of the information carrier to be read from the drug container.

[0018] The first and second transmission devices can be configured in various ways to allow data communication between the drug container and the information carrier attached thereto. A simple possibility is to configure the first transmission device as conductive contact areas, which are optionally exposed on the outer side of the wall after the protective film is removed. Correspondingly, electrical contact areas are also provided on the rear side of the information carrier, which are supported on the contact area of ​​the drug bag after the information carrier has been applied.

[0019] Alternatively, the transmission device can also be configured as a capacitive or inductive transmission device.

[0020] The capacitive transmission device introduced into the wall comprises thin conductive capacitor plates, which are preferably sealed inwards and outwards by a film and thus electrically insulated from the outside. The conductive capacitor plates act as electrodes capable of generating and receiving electric fields. Accordingly, the capacitor plates are also provided in the information carrier.

[0021] The inductive transmission device has a transmission coil integrated into a wall. It is preferably a planar, and particularly preferably flexible, transmission coil, which is enclosed both externally and internally by a membrane layer of the wall. The transmission coil consists of one or more turns of a conductive material, typically copper or aluminum. The membrane layer can be laminated onto the wall, for example, or applied there using injection-molded inserts (in-mold labeling) or by ultrasonic or laser welding.

[0022] The transmission coil can be configured, in particular, as a layer applied by printing or coating techniques, or it may have been cut from a flat material (especially by means of laser cutting) and then integrated into a wall. It can also be manufactured by means of coating or printing. The transmission coil can be formed from a metallic material, which is preferably presented in the form of a transmission coil by printing and coating or by laser cutting.

[0023] The transmission coil may be part of an NFC tag (including an NFC chip) that is applied to or introduced into the wall of the drug container.

[0024] Preferably, a support membrane is provided, which is applied to the wall of the drug container, and a transmission coil or capacitor plate of the first transmission device is applied to the support membrane. The support membrane, together with the transmission coil or capacitor plate, is applied to the front wall of the drug container. The information carrier is externally applied (particularly adhesively bonded) to the membrane.

[0025] In the case of a drug pouch, the size of the aforementioned support film can correspond to the size of the front wall on which the support film is applied, so that it forms a film covering the entire front wall.

[0026] Preferably, the first transmission device is connected to the data connector via a signal line, allowing the first transmission device to be connected to an external control device via the data connector. The data connector on the drug container allows the drug container to be connected to a data line leading to an external control device, enabling the control device to connect to and read the memory of the information carrier via the data connector and via the first and second transmission devices.

[0027] Data connectors can be integrated into fluid couplings in a manner that will be described in more detail below.

[0028] The aforementioned support membrane supporting at least the first transmission device can form a pre-assembled unit together with a fluid coupling having an integrated data connector. This pre-assembled unit is already a modular sub-unit before the support membrane is applied to the wall. This facilitates assembly because all wires between the first transmission device and the data connector are already part of the aforementioned pre-assembled unit, which eliminates the need for electrical connections between the data connector and the first transmission device when the support membrane is applied.

[0029] In principle, it is possible that the drug container itself includes a control device in the form of an integrated circuit, which controls data communication via the first transmission device and / or via a data connector. Nevertheless, a preferred configuration is one in which the control device for controlling data communication via the first transmission device is not part of the drug container but is provided externally, for example, integrated into or coupled to the pump of the infusion system. This external control device is connected to the drug container via a data connector and thus to the first transmission device.

[0030] The signal line of the drug container is preferably integrally formed with the transmission coil, contact area, or capacitor plate, i.e., formed in one piece. In particular, the signal line may be made of the same metal foil as the first transmission device formed as the transmission coil or capacitor plate. At least one signal line may be integrally formed with the transmission device configured as the transmission coil, particularly in the form of a composite consisting of transmission coil turns and a signal line made of metal foil.

[0031] The data connector is preferably fixed in place relative to the at least one fluid coupling, such that by attaching the fluid line connector to the fluid coupling, the second data connector provided on the coupling can be simultaneously connected to the data connector of the drug bag.

[0032] Specifically, the data connector can be integrated into the fluid coupling. In this configuration, attaching the connector to the fluid coupling also establishes a data connection. Regarding the configuration of the fluid coupling, reference WO 2021 / 023639 A1 and its parallel publications, whose disclosure regarding the configuration of the connector as a fluid coupling is included in the disclosure of this invention by express reference.

[0033] Data connectors may be provided, specifically, as electrical contact areas at fluid couplings. In the case of a data transmission coil at the fluid coupling, the transmission coil is preferably formed around the fluid line of the fluid coupling.

[0034] As described above, the drug container may optionally include an information carrier. The information carrier may be attached to the wall of the drug container in the region of the first transmission device. The information carrier may include an electronic memory and a second transmission device, the second transmission device preferably having a transmission coil for inductive data transmission, such that the contents of the electronic memory can be read via the first and second transmission devices.

[0035] The information carrier (which is specifically configured as an adhesive sticker and equipped with a second transmission device) preferably contains not only the information in the aforementioned electronic memory, but also provides a visually readable label, which is preferably provided here by printing.

[0036] In particular, we then envision a use in which the visually readable labels and the data in the memory at least partially match.

[0037] This configuration (where the digital data of the information carrier and its tag are matched) offers a significant advantage, ensuring that no discrepancies occur when the information carrier is tagged and its memory is written to in the same process. This guarantees that the information in the tag and memory will not differ from each other due to negligence.

[0038] The information carrier preferably has a multi-layered structure, specifically including an inward-facing support film, a transmission coil serving as a second transmission device, and an outward-facing printed surface that receives the label. In a ready state, the drug container is provided with the information carrier, which is printed on it, and its electronic memory contains information corresponding to the printed information.

[0039] Additionally, the information carrier may have further electronic components. In particular, a sensor is conceivable that records temperature and makes it available for external reading via first and second transmission devices. The information carrier may, for example, include at least one sensor. The sensor can be read via the first and second transmission devices.

[0040] A drug container (e.g., a drug bag) having a first transmission device can be configured as an electronic reader for an information carrier to be attached to the outer wall of the drug container.

[0041] The first transmission device may be adapted to communicate data with an information carrier applied to the exterior of the wall of the drug container (i.e., to be applied to the exterior of the wall of the drug container or to be attached to the exterior of the wall of the drug container), wherein the information carrier may be an RFID sticker. The first transmission device of the drug container may include a reading antenna for the RFID sticker.

[0042] In addition to the drug container itself, the present invention relates to an infusion system in which a drug container of the type described above is used. Regarding the structure of such an infusion system, reference is made to WO 2021 / 023639 A1 and its parallel publications, the disclosure of which regarding the configuration of the infusion system is included in the disclosure of this invention by express reference.

[0043] The infusion system according to the invention includes: a control device, particularly a control device integrated into a pump device or a control device connected to the pump device via a data cable; and at least one drug container connected via a fluid line.

[0044] The drug container is configured as described above.

[0045] The aforementioned control device can be connected to the drug container via a data cable, which preferably terminates in a data connector that can be connected to a corresponding data connector on the drug container. The data cable is preferably integrated into the fluid line. The data connectors belonging to the drug container and the fluid line are preferably each integrated into a fluid coupling, particularly into a mating Luer connector.

[0046] The control device is configured to read data applied to the information carrier of the drug container via a first transmission device of the drug container and a second transmission device of the information carrier.

[0047] This data can then be used to validate existing drug protocols. The drug protocols themselves may also be stored in the memory of the information carrier and read by the control device. Attached Figure Description

[0048] Further advantages and features of the invention will become apparent from the claims and the following description of preferred exemplary embodiments of the invention, which are explained below with reference to the accompanying drawings.

[0049] Figure 1 An infusion system according to the invention is shown, which has a drug container according to the invention.

[0050] Figure 2 A pharmaceutical container according to the invention is shown before the application of the information carrier.

[0051] Figure 3 The information carrier is shown.

[0052] Figure 4 A drug container with an information carrier is shown.

[0053] Figure 5 A fluid connection for a drug container is shown, and data transmission from the drug container to an external control device is illustrated. Detailed Implementation

[0054] Figure 1 A schematic representation of an infusion system 200 according to the present invention is shown. The infusion system 200 has a plurality of drug containers 10 in the form of (geometrically) flexible bags. The drug containers 10 are connected to an infusion pump 210 via fluid lines 100.

[0055] The infusion pump 210 is configured to deliver fluid from the drug container 10 to the central venous catheter 230 of the patient 240 according to the medication plan.

[0056] Each infusion pump 210 has a control device 220 for controlling the infusion pump. This control of the infusion pump 210 in the infusion system 200 according to the invention also includes data from the drug container 10.

[0057] For this purpose, each of the drug containers 10 is provided with a memory, as will be explained in more detail below.

[0058] Data transmission between the control device 220 and the drug container 10 occurs via data lines 102 integrated into the fluid line 100. These data lines 102 are connected to the infusion pump 210 via data lines and, in turn, to the control device 220 via the latter.

[0059] At the drug container 10, the data cable 102 is connected to the drug container 10 via connectors 30 and 110, which will be explained in more detail below.

[0060] Figure 2 and Figure 4 A drug container 10 in the form of a flexible drug bag is shown, and Figure 3 The information carrier 70 applied thereon is shown.

[0061] Figure 2 The drug container 10 shown does not yet include this information carrier 70. (As from...) Figure 2As can be seen, the drug container 10 has walls 20, specifically, a front wall 22 and a rear (rear) wall, which enclose an interior 12 containing a medical liquid. At its lower end, the drug container 10 has a fluid coupling 30 for attaching a fluid line 100.

[0062] Furthermore, the drug container 10 has a first transmission device 40 in the form of a transmission coil on its front wall 22. This transmission coil is connected to a data connector 52 via a signal line 50, which also has a transmission coil 54 and is integrated into the fluid coupling 30 in this exemplary embodiment. This will be explained below with the aid of... Figure 5 To provide a more detailed explanation.

[0063] Figure 3 The information carrier 70 shown is intended to be applied to the front wall 22 of the drug container 10. The information carrier 70 has an electronic memory 72 coupled to a transmission coil 76 of a second transmission device 74. The memory 72 and transmission coil 76 can be elements of a commercially available NFC tag. In addition to the electronic memory 72, the information carrier also has a printed surface 82 designed to receive a tag, or in this example, a tag 78 has already been provided. In this example, the tag consists of the patient's name and a date indicating the expiration date of the contents of the drug container 10. Other data that can be stored in the memory is an ID, which is assigned to data in an external central memory. The memory may also contain evidence of the authenticity of the medication and / or the digital signature of the creator.

[0064] The unique feature of the information carrier 70 is that it contains the same information, such as the expiration date in this example, both electronically in memory 72 and printed in the form of a tag 78. This information is preferably applied in an integrated process. For example, a printer with an integrated NFC transmission device can be provided, which applies the tag in an integrated process and stores the same data in memory 72.

[0065] The information carrier 70 may have additional electronic components. In particular, it may also include sensors (e.g., temperature sensors) for monitoring whether the liquid is always maintained at a target temperature. If it is also intended that data can be acquired by means of these sensors when the drug container 10 is not connected to the data line 102 and is not supplied with power, this can be achieved by providing a battery and / or evaluation electronics on the information carrier or as part of the drug container.

[0066] Figure 4A drug container 10 with an information carrier 70 applied is shown. For application of the information carrier, the information carrier 70 has a support membrane 80 on the rear side of which an adhesive surface is provided. The information carrier 70 has been applied to the front wall 22 of the drug container 10 by means of this adhesive surface. The first transmission device 40 and its transmission coil 42 on the front wall 22 of the drug container 10 are covered by the information carrier 70, and in particular by its second transmission device 74 and its transmission coil 76.

[0067] By applying the information carrier in this manner, the memory 72 can be read from the data connector 52. Sensor data can also optionally be read via the data connector 52.

[0068] Figure 5 The illustration shows the manner in which data transmission occurs from the fluid line 100 to the drug container 10. A connector 110, such as a female Luer connector, is provided at the end of the fluid line 100. Similarly, a connector 30, forming a fluid coupling 30, is provided on the drug container 10 and can be configured, for example, as a male Luer connector.

[0069] Both connectors 30 and 110 are equipped with integrated data connectors 52 and 112. Each of these data connectors 52 and 112 is equipped with a transmission coil 54 and 114, enabling inductive data transmission. At the drug container 10, the transmission coil 54 is connected to signal lines 50, which, as already described, are connected to transmission coil 42 at their opposite ends. At the fluid line 100, the transmission coil 114 is connected to data line 102, and thus indirectly connected to the associated control device 220.

[0070] In this way, control device 220 can access memory 72 and electronically read the information it contains via transmission coils 54, 114 and via transmission coils 42, 76. Control device 220 can thus determine, for example, whether drug container 10 is actually intended for use by patient 240 connected to intravenous catheter 230. If not, the delivery of fluid by means of pump device 210 can be stopped.

[0071] At the same time, the tag 78 and its creation, as described above, in the integrated process of storing data in memory 72, also ensure that the data on information carrier 70 is consistent. This eliminates the possibility that tag 78 gives the impression that the drug container is intended for patient 240, but the data in memory 72 contradicts this.

Claims

1. A drug container (10), particularly a drug container for use in infusion therapy, said drug container having the following characteristics: a. The drug container (10) has a wall (20) that encloses the interior (12), and b. The drug container (10) has at least one fluid connection (30) for attaching a fluid line (100) to obtain liquid from the drug container. It is characterized by the following additional features: c. The drug container (10) has a first transfer device (40), wherein, The first transmission device (40) is adapted to communicate data with an information carrier (70) applied to the outside of the wall (20) of the drug container (10).

2. The drug container (10) according to claim 1, wherein the drug container has the following additional features: a. The drug container (10) is configured as a drug bag, and b. The wall (20) is configured as a flexible bag wall.

3. The drug container (10) according to claim 1 or 2, wherein the drug container has the following additional features: a. The first transmission device (40) includes a conductive contact area on the outer side of the wall, or b. The first transmission device (40) is configured as a capacitive transmission device with embedded capacitor plates.

4. The drug container according to claim 1 or 2, wherein the drug container has the following additional features: a. The first transmission device (40) has a transmission coil (42). The drug container preferably has the following additional features: b. The transmission coil (42) is configured as a planar transmission coil, which is located in the plane of the wall of the drug container, and / or c. The transmission coil (42) is formed of a metallic material, which is preferably presented in the form of the transmission coil by printing and coating or by laser cutting.

5. The drug container according to claim 3 or 4, wherein the drug container has the following additional features: a. A support membrane is provided, which is applied to the wall of the drug container, and the transmission coil or the capacitor plate is applied to the support membrane. The drug container preferably has any of the following additional features: b. The size of the support membrane corresponds to the size of the wall on which the support membrane is applied, and / or c. The support membrane, together with the fluid connector, forms a pre-assembled unit, which is a combined sub-unit before the support membrane is applied to the wall.

6. The drug container (10) according to any one of the preceding claims, wherein the drug container has the following additional features: a. The first transmission device (40) is connected to the data connector (52) via a signal line (50), and the first transmission device (40) can be connected to the control device (210) via the data connector. The drug container preferably has the following additional features: b. The control device (220) is not part of the drug container (10), and / or c. At least one signal line (50) is integrally formed with the transmission device (40) configured as a transmission coil (42), particularly in the form of a composite consisting of a transmission coil turn and a signal line (50) made of metal foil.

7. The drug container (10) according to claim 6, wherein the drug container has the following additional features: a. The data connector (52) is fixed in place relative to the at least one fluid connector (30) such that by attaching the connector (110) of the fluid line (100) to the fluid connector (30), a second data connector (112) provided on the connector (110) can be simultaneously connected to the data connector (52) of the drug bag (10).

8. The drug container (10) according to claim 7, wherein the drug container has the following additional features: a. The data connector (52) is integrated into the fluid coupling (30). The drug container preferably has the following additional features: b. The data connector (52) includes an electrical contact area and / or a transmission coil (54).

9. The drug container (10) according to any one of the preceding claims, wherein the drug container has the following additional features: a. The drug container (10) includes the information carrier (70), wherein, The information carrier (70) is applied to the wall (20) of the drug container (10) in the region of the first transmission device (40), and b. The information carrier (70) includes an electronic memory (72) and a second transmission device (74), the second transmission device preferably including a transmission coil (76) for inductive data transmission, so that the contents of the electronic memory (72) can be read via the first and second transmission devices (40, 74).

10. The drug container (10) according to any one of the preceding claims, wherein the drug container has the following additional features: a. The information carrier (70) has a visually readable label (78). The drug container preferably has at least one of the following additional features: b. The visually readable label (78) and the data in the memory (72) at least partially match, and / or c. The information carrier (70) is formed as an adhesive sticker, and / or d. The information carrier (70) has a multi-layer structure, specifically including an inward-facing support film (80), the transmission coil (76), and an outward-facing printed surface (82).

11. The drug container (10) according to claim 9 or 10, wherein the drug container has the following additional features: a. The information carrier (70) includes at least one sensor, and b. The sensor can be read via the first and second transmission devices (40, 74).

12. The drug container (10) according to any one of the preceding claims, wherein the drug container has the following additional features: a. The first transfer device (40) is provided on the front wall (22) of the drug container (10), preferably in the middle of the front wall (22).

13. The drug container (10) according to any one of the preceding claims, wherein, The drug container (10) having the first transmission device (40) is configured as an electronic reader for attaching to the outer wall (20) of the drug container (10) as an information carrier (70).

14. The drug container (10) according to any one of the preceding claims, wherein the drug container has the following additional features: a. The first transmission device (40) is adapted to communicate data with an information carrier (70) attached to the outside of the wall (20) of the drug container (10), wherein, The information carrier (70) is an RFID sticker; b. The first transmission device (40) of the drug container (10) includes a reading antenna for the RFID sticker.

15. An infusion system (200) having the following characteristics: a. The infusion system (200) includes a control device (220), particularly a control device (220) integrated into the pump unit (210) or a control device (220) connected to the pump unit (210) via a data line, and b. The infusion system (200) includes at least one drug container (10) connected via a fluid line (100). The infusion system is characterized by the following additional features: c. The drug container (10) is configured according to any one of the preceding claims, and d. The control device (210) is connected to the drug container (10) via a data cable, and e. The control device (210) is configured to read data applied to the information carrier (70) of the drug bag (10) via a first transmission device (40) of the drug container (10).

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