WO2025201671A1

WO2025201671A1 - Dosing device and method for dosing a chemical substance for cleaning and/or disinfecting a medical device, system for cleaning and/or disinfecting a medical device

Info

Publication number: WO2025201671A1
Application number: PCT/EP2024/084701
Authority: WO
Inventors: Oliver HOPF
Original assignee: Olympus Winter and Ibe GmbH
Current assignee: Olympus Winter and Ibe GmbH
Priority date: 2024-03-27
Filing date: 2024-12-04
Publication date: 2025-10-02
Anticipated expiration: 2026-09-27
Also published as: DE102024108837A1

Abstract

The invention relates to a dosing device (2) and a method for dosing a chemical substance (12) for cleaning and/or disinfecting a medical device (22) as well as a system (1) for cleaning and/or disinfecting the medical device (22). The dosing device (2) comprises a reception unit (4) and an opening device (6). The reception unit (4) is formed to receive and hold a sealed container (10) prefilled with a predetermined quantity of the substance (12). The opening device (6) comprises a sharp tip (7, 8) configured to penetrate an outer hull (16) of the sealed container (10), while the sealed container (10) is arranged in the reception unit (4). The opening device (6) is further configured to flush the sealed container (10) with the fluid (32) from the tip (7, 8) in order to extract a mixture (42) of the fluid (32) and the substance (12) from the sealed container (10).

Description

Dosing device and method for dosing a chemical substance for cleaning and/or disinfecting a medical device, system for cleaning and/or disinfecting a medical device

The present disclosure relates to a dosing device for dosing a chemical substance for cleaning and/or disinfecting a medical device. The present disclosure further relates to a system for cleaning and/or disinfecting a medical device and a method for dosing a chemical substance for cleaning or disinfecting a medical device.

Medical devices, for example surgical instruments like endoscopes, have to be cleaned and disinfected after use in order to prevent contamination of patients. This is often done in specialized systems and devices, for example reprocessing devices. The medical devices to be cleaned are placed in the reprocessing devices, which then start a cleaning program in order to remove any contamination from the medial device. As part of the cleaning and disinfecting, the medical device is usually treated with a cleaning fluid. Such a cleaning fluid usually comprises water and may additionally comprise a chemical substance in order to disinfect all surfaces and inner areas of the medical device. These chemical substances are usually dosed via a system that pumps the substance from an intermediate tank and at the same time measures the flow of the substance. This pumping process continues for a predefined period of time. At the end of the process the flow is compared with a predefined flow value in order to determine, if the dosing was successful or not.

However, such a system is both complex and prone to errors. The filling level of the tank has to be checked regularly and both the flow sensors and the evaluation electronics are expensive and prone to failures.

It is an object of the present invention to simplify a dosing process for a chemical substance for cleaning and/or disinfecting a medical device, and making the dosing process less prone to failure.

This object is achieved by a dosing device for dosing a chemical substance for cleaning and/or disinfecting a medical device, the dosing device comprising a reception unit and an opening device, wherein the reception unit is formed to receive and hold a sealed container prefilled with a predetermined quantity of the substance, wherein the opening device comprises a sharp tip configured to penetrate an outer hull of the sealed container, while the sealed container is arranged in the reception unit, and flush the sealed container with a fluid from the tip in order to extract a mixture of the fluid and the substance from the sealed container.

Advantageously, by providing a sealed container prefilled with a predetermined quantity of the substance, a measurement of a flow rate is no longer required. Once the outer hull of the sealed container is penetrated, the entire substance will be extracted and mixed with the fluid in order to form a cleaning fluid, which is then applied to the medical device. In this way, a very high dosing accuracy is achieved. The dosing device is also less complex and thus less prone to technical failures, because there is no need for a flow sensor or a similar device for measuring the quantity of the substance.

The predetermined quantity of the substance in particular equals the quantity necessary to perform a specific cleaning or disinfecting step. Thus, for this step, the dosing device provides the exact quantity of the substance required to perform the step.

The reception unit and the opening device may be arranged in close proximity to one another. In this way, when the reception unit receives the sealed container, the sharp tip of the opening device can easily penetrate the outer hull. For example, in a resting state of the tip, the tip may be arranged in close proximity to the outer hull of the sealed container, when the sealed container is arranged in the reception unit. By moving the tip in a linear direction towards the reception unit and/or the sealed container, the tip will pierce through the outer hull of the sealed container.

The fluid may be water or a similar cleaning fluid. The mixture of the fluid and the substance is in particular a cleaning fluid and/or a disinfecting fluid. Thus, by mixing the fluid with the substance, the mixture may acquire the desired cleaning and/or disinfecting properties.

After the cleaning and disinfecting is finished, the empty container may be removed from the reception unit. As the chemical substance has been extracted from the container at this point, it does no longer pose any health risk to the person handling the container.

Preferably, the opening device comprises a first tip and a second tip, wherein each tip comprises a central opening extending along a longitudinal direction of the tip, wherein the first tip is connected to a supply tube and the second tip is connected to an extraction tube. By providing a first tip and a second tip, each connected to a different tube, the fluid may be pumped into the container through the first tip and the mixture may be flushed out of the container through the second tip. The first tip is connected to a supply tube. The supply tube may be connected to the first tip at a first end and/or to a fluid source at a second end. In particular, the supply tube comprises a valve. The valve may regulate the supply of the fluid to the dosing device. In particular, the dosing device or a control device is configured to open the valve in order to flush the fluid from the supply tube through the sealed container into the extraction tube. The second tip may be connected to a first end of an extraction tube. A second end of the extraction tube may be connected to a cleaning device.

Preferably, the opening device is configured to push the first tip and the second tip through opposite ends of the outer hull of the sealed container. In particular, the first tip and the second tip are arranged in opposition to each other. The sealed container may be arranged in between the first tip and the second tip. This allows for an easy piercing of the outer hull be simply moving the tips towards each other and towards the sealed container. In addition, this arrangement of the tips facilitates the process of flushing the sealed container and extracting the mixture.

Preferably, the reception unit is designed to hold the sealed container in a form-fit connection. By providing a form-fit connection for the sealed container, the sealed container may be easily received and extracted from the reception unit. The reception unit may be a reception recess. A reception recess is advantageous as it allows a user to insert the sealed container into the reception unit and holding it within the reception unit without the need for additional holding means. In particular, the tip or tips of the opening device are arranged in an opening in a wall of the reception unit, in particular the reception recess.

According to an embodiment, the dosing device comprises one or more of the sealed container prefilled with a predetermined quantity of the substance. In other words, the prefilled container may be part of the dosing device. The sealed container may comprise or consist of a plastic or a metal. The container is, in particular, rounded. In particular, the container is capsule-shaped or egg-shaped. A capsule shape consists of two half-spherical ends and a cylindrical body in the middle. Such a form of the sealed container is advantageous, as it allows the fluid to flow through the container without obstructions. In particular, the sealed container does not comprise any openings. Instead, the sealed container is completely sealed after it is prefilled with the substance. The sealing of the container is broken only when the tip is punched through the outer hull. The dosing device may comprise multiple containers. In particular, at least two of the multiple sealed containers are filled with a different chemical substance and/or a different quantity of the substance.

Preferably, the sealed container comprises a RFID transmitter and the dosing device comprises a RFID receiver, wherein the RFID receiver is configured to read the RFID transmitter of the sealed container in order to identify the sealed container. By reading the RFID transmitter of the sealed container, the dosing device may identify the sealed container and learn if the sealed container comprises the correct chemical substance and the correct quantity of the substance. In this way, insertion of an incorrect sealed container into the reception unit is prevented. Preferably, the outer hull of the sealed container comprises a coding specifying the substance and the quantity of the substance within the sealed container. Through the coding, a user may identify a sealed container. This allows the user to insert the correct sealed container into the reception unit. For example, the coding may comprise one or more rings on the outer hull.

Preferably, the coding protrudes from the outer hull. By providing a coding that protrudes from the outer hull, the coding gives the user a haptic feedback. In addition, the reception unit may be formed to receive only sealed containers with a specific coding protruding from its outer hull. The reception units may comprise indentations corresponding to the coding of a specific type of sealed container. Thus, only this type of sealed container may be placed into any given reception unit. Alternatively, the coding may be designed, at least partly, as indentations and the reception units may comprise protrusions matching the indentations. There may also be a mixture of indentations and matching protrusions on both the sealed container and the reception unit. By providing multiple reception units, each formed to receive containers with differently formed coding on its outer hull, the containers will be automatically placed in the correct reception units, because they will not fit into an incorrect reception unit.

The dosing device may also be used for dosing a chemical substance for cleaning and/or disinfecting during a surgery. In this way, the correct dosage of the chemical substance is provided even in time critical and stressful situations, as they may occur during surgeries.

The object is further achieved by a system for cleaning and/or disinfecting a medical device, wherein the system comprises a dosing device according to one of the previously described embodiments and a cleaning device, wherein the opening device of the dosing device is connected to the cleaning device in order to supply the cleaning device with the mixture of the fluid and the substance, wherein the cleaning device is configured to receive the medical device and clean and/or disinfect the medical device with the mixture.

The system for cleaning and/or disinfecting a medical device embodies the same advantages and characteristics as the dosing device described above.

The system for cleaning and/or disinfecting a medical device may comprise or consist of a reprocessing device. The system may comprise a fluid source. The fluid source may be connected to the opening device via the supply tube. The reception unit may be arranged inside a door or drawer of the system. In this way, the reception unit is easily accessible when opening the system.

Advantageously, by providing a system for cleaning and disinfecting medical devices with a dosing device according to the invention, the tubes of the system will experience less erosion, because the substance will travel through the tubes only in diluted form. In addition, the security of the system is increased during maintenance, as the tubes will be free of substance when the system is not running.

Preferably, the system comprises a control device, wherein the control device is configured to control the dosing system and the cleaning device, wherein the control device is configured to execute a program for washing and/or cleaning the medical device and control the opening device as part of the program to penetrate the outer hull of the container at a point in time, when the mixture is required for the washing and/or cleaning of the medical device. The control device will control the opening device in such a way, that the sealed container is penetrated exactly when the program requires a dosing of the chemical substance. Thus, the substance is provided exactly when required.

The object is additionally achieved by a method for dosing a chemical substance for cleaning and/or disinfecting a medical device, the method comprising the following steps:

Inserting a sealed container into a reception unit of a dosing device, wherein the sealed container is prefilled with a predetermined quantity of the substance,

Penetrating an outer hull of the container with a sharp tip of an opening device,

Flushing the container with a fluid from the tip in order to extract a mixture of the fluid and the substance from the container.

The method for dosing a chemical substance for cleaning and/or disinfecting a medical device embodies the same advantages and characteristics as the dosing device and the system described above. The method may also be used for dosing a chemical substance for cleaning and/or disinfecting during a surgery.

Further characteristics of the invention will become apparent from the description of the embodiments according to the invention together with the claims and the included drawings. Embodiments according to the invention can fulfil individual characteristics or a combination of several characteristics.

The invention is described below, without restricting the general intent of the invention, based on exemplary embodiments, wherein reference is made expressly to the drawings with regard to the disclosure of all details according to the invention that are not explained in greater detail in the text. The drawings show in:

Fig. 1 schematic simplified representation of a system for cleaning and/or disinfecting a medical device,

Fig. 2a - 2c schematic simplified representation of three different sealed containers comprising different chemical substances,

Fig. 3 schematic simplified representation of a system for cleaning and/or disinfecting a medical device configured as a reprocessing device, and

Fig. 4 schematic simplified representation of an opening device for extracting the substance from a sealed container.

In the drawings, the same or similar types of elements or respectively corresponding parts are provided with the same reference numbers in order to prevent the item from needing to be reintroduced.

Fig. 1 shows a schematic simplified representation of a system 1 for cleaning and/or disinfecting a medical device 22. The system 1 may be or comprise a reprocessing device. The system 1 comprises a cleaning device 20, which may comprise a main chamber for receiving the medial device 22. In addition, the cleaning device 20 will comprise several instruments, which may clean and disinfect the medical device 22, for example with the cleaning fluid.

In order to supply this cleaning fluid, the system 1 comprises a fluid source 30, which supplies a fluid 32, for example water. The fluid source 30 is connected via a supply tube 50 with a dosing device 2. The dosing device 2 receives a sealed container 10, which is prefilled with a chemical substance 12. This substance 12 is mixed with the fluid 32 inside the dosing device 2 and the mixture is guided through an extraction tube 60 to the cleaning device 20 to act as a cleaning fluid. The valve 52 regulates the flow of the fluid 32 from the fluid source 30 through the supply tube 50 to the dosing device 2. The extraction tube may also comprise one or more valves not shown in Fig. 1. A control device 40 is connected to the dosing device 2, the cleaning device 20 and the fluid source 30 as well as the valve 52. The control device 40 may execute a washing program to clean and disinfect the medical device 22 by controlling the different cleaning instruments in the cleaning device 20, e.g. spray nozzles, and controlling the supply of the cleaning fluid by controlling the dosing device 2 and regulating the flow of the fluid 32 to the dosing device 2.

Fig. 2a, 2b and 2c show different embodiments of the sealed container 10. In the first embodiment shown in Fig. 2a, the sealed container 10 is filled with a first substance 12, which is indicated by dashed lines. A coding 14, in this embodiment a protruding ring on the center of the sealed container 10, helps the user to identify the sealed container 10. In this way, the user may know which substance 12 and what quantity of the substance 12 is prefilled in the sealed container 10.

In Fig. 2b, the sealed container 10 is filled with a different substance 12 indicated by a different dashed line. In order to indicate this to the user, the coding 14 comprises two wing-shaped protrusions instead of a single one. In Fig. 2c, the sealed container 10 is filled with a third substance 12. In addition, the sealed container 10 is not filled completely, but only a part of the sealed container 10 is filled with the substance 12. The coding 14 consists of two wing-shaped protrusions, which are, however, placed at a different position compared to the sealed container 10 in Fig. 2b. This allows the user to distinguish all three sealed containers 10.

Fig. 3 shows a schematic perspective representation of a system 1 in the form of a reprocessing device. A door 70 of the system 1 is opened to reveal a main chamber of the cleaning device 20. The door 70 comprises multiple reception units 4, which are formed as recessions in the door 70. These reception units 4 are form-fitted for the sealed containers 10 shown in Figs. 2a to 2c. Thus, each reception unit 4 is designed to receive a specific type of sealed container 10. In order to do this, each reception unit 4 may comprise indentions corresponding to the coding 14 of the sealed containers 10. When the sealed containers 10 have been inserted into the reception units 4, a RFID receiver 72 of each reception unit 4 may identify the sealed container 10 inserted into the respective reception unit 4. This allows the system 1 to read a RFID transmitter 74 of each sealed container 10, shown in Fig. 4, in order to separately identify each sealed container 10 and check if each sealed container 10 is placed in the correct reception unit 4. When each sealed container 10 has been inserted correctly, the door 70 is closed.

Each of the sealed containers 10 and their respective substance 12 may correspond to a specific cleaning and/or disinfecting step performed by the system 1. Thus, when the system 1 starts the respective step, the corresponding sealed container 10 is opened and the substance 12 is released and mixed with the fluid 32. This mixture 42 is then used as cleaning fluid for the step.

Fig. 4 shows a schematic simplified representation of an opening device 6 of the dosing device 2. This opening device 6 is used to extract the substance 12 from the sealed container 10. In order to do so, the opening device 6 comprises a sharp first tip 7 and a sharp second tip 8, which are arranged at opposite sides of the sealed container 10, while the sealed container 10 is resting inside the reception unit 4. To open the sealed container 10, both tips 7, 8 penetrate an outer hull 16 of the sealed container 10. Through the supply tube 50, which is connected to the first tip 7, the fluid 32 is flushed inside the sealed container 10. For this purpose, both the first tip 7 and the second tip 8 comprise a central opening 9, which extends along the longitudinal direction of the tips 7, 8. Inside the sealed container 10, the fluid 32 mixes with the substance 12. Through the pressure of the entering fluid 32, the mixture 42 is pressed out of the sealed container 10 through the second tip 8, which is connected to the extraction tube 60. From there, the mixture 42 is guided towards the cleaning device 20.

All named characteristics, including those taken from the drawings alone, and individual characteristics, which are disclosed in combination with other characteristics, are considered alone and in combination as important to the invention. Embodiments according to the invention can be fulfilled through individual characteristics or a combination of several characteristics. Features which are combined with the wording “in particular” or “especially” are to be treated as preferred embodiments.

List of References

1 system

2 dosing device

4 reception unit

6 opening device

7 first tip

8 second tip

9 central opening

10 sealed container

12 substance

14 coding

16 outer hull

20 cleaning device

22 medical device

30 fluid source

32 fluid

40 control device

42 mixture

50 supply tube

52 valve

60 extraction tube

70 door

72 RFID receiver

74 RFID transmitter

Claims

Dosing device and method for dosing a chemical substance for cleaning and/or disinfecting a medical device, system for cleaning and/or disinfecting a medical device Claims

1. Dosing device (2) for dosing a chemical substance (12) for cleaning and/or disinfecting a medical device (22), the dosing device (2) comprising a reception unit (4) and an opening device (6), wherein the reception unit (4) is formed to receive and hold a sealed container (10) prefilled with a predetermined quantity of the substance (12), wherein the opening device (6) comprises a sharp tip (7, 8) configured to penetrate an outer hull (16) of the sealed container (10), while the sealed container (10) is arranged in the reception unit (4), and flush the sealed container (10) with a fluid (32) from the tip (7, 8) in order to extract a mixture (42) of the fluid (32) and the substance (12) from the sealed container (10).

2. Dosing device (2) according to claim 1 , wherein the opening device (6) comprises a first tip (7) and a second tip (8), wherein each tip (7, 8) comprises a central opening (9) extending along a longitudinal direction of the tip (7, 8), wherein the first tip (7) is connected to a supply tube (50) and the second tip (8) is connected to an extraction tube (60).

3. Dosing device (2) according to claim 2, wherein the opening device (6) is configured to push the first tip (7) and the second tip (8) through opposite ends of the outer hull (16) of the sealed container (10).

4. Dosing device (2) according to one of claims 1 to 3, wherein the reception unit (4) is designed to hold the sealed container (10) in a form-fit connection.

5. Dosing device (2) according to claim 4 comprising multiple reception units (4), wherein each reception unit (4) is formed to receive differently formed sealed containers (10).

6. Dosing device (2) according to one of claims 1 to 5 comprising one or more of the sealed container (10) prefilled with a predetermined quantity of the substance (12).

7. Dosing device (2) according to claim 6, wherein the sealed container (10) comprises a RFID transmitter (74) and the dosing device (2) comprises a RFID receiver (72), wherein the RFID receiver (72) is configured to read the RFID transmitter (74) of the sealed container (10) in order to identify the sealed container (10).

8. Dosing device (2) according to claim 6 or 7, wherein the outer hull (16) of the sealed container (10) comprises a coding (14) specifying the substance (12) and the quantity of the substance (12) within the sealed container (10).

9. Dosing device (2) according to claim 8, wherein the coding (14) protrudes from the outer hull (16).

10. System (1 ) for cleaning and/or disinfecting a medical device (22), wherein the system (1 ) comprises a dosing device (2) according to one of claims 1 to 9 and a cleaning device (20), wherein the opening device (6) of the dosing device (2) is connected to the cleaning device (20) in order to supply the cleaning device (20) with the mixture (42) of the fluid (32) and the substance (12), wherein the cleaning device (20) is configured to receive the medical device (22) and clean and/or disinfect the medical device (22) with the mixture (12).

1 1. System (1 ) according to claim 10 comprising a control device (40), wherein the control device (40) is configured to control the dosing system (2) and the cleaning device (20), wherein the control device (40) is configured to execute a program for washing and/or cleaning the medical device (22) and control the opening device (6) as part of the program to penetrate the outer hull (16) of the container at a point in time, when the mixture (42) is required for the washing and/or cleaning of the medical device (22).

12. Method for dosing a chemical substance (12) for cleaning and/or disinfecting a medical device (22), the method comprising the following steps:

Inserting a sealed container (10) into a reception unit (4) of a dosing device (2), wherein the sealed container (10) is prefilled with a predetermined quantity of the substance (12), Penetrating an outer hull (16) of the container with a sharp tip (7, 8) of an opening device (6), Flushing the container with a fluid (32) from the tip (7, 8) in order to extract a mixture (42) of the fluid (32) and the substance (12) from the container.