Device and method for transferring at least one sensor system from a sterile environment into a medium to be examined

Abstract

Device for transferring at least one mobile, fully integrated sensor system (4) from a sterile environment into a medium to be examined, with a control module (1) and a sterile module (2) that can be connected to the control module (1), wherein the sterile module (2) comprises a magazine (3) for receiving the at least one sensor system (4), a singulation unit (5) with an activation unit (6) arranged thereon for forwarding and activating the at least one sensor system (4), and a sealing cap (7) for transferring the at least one sensor system (4) into the medium to be examined and the control module (1) comprises an identification unit (8) for non-contact identification of the medium to be examined, a holding unit (9) for receiving the sterilization module (2), a power supply unit, an actuating unit (13, 14) for the closure cap (7) and a control unit for controlling the identification unit (8), the singulation unit (5) and the closure cap (7), wherein the sterilization module (2) and the control module (1) are mechanically and electrically contacted by a connecting unit (10).

Description

[0001] The present invention relates to a device and a method for transferring at least one sensor system from a sterile environment into a medium to be examined.

[0002] Mobile, fully integrated sensors, such as those described in patent application DE 10 2014 217 342 A1, are increasingly being used in metrological applications. In contrast to previously fixed measuring devices, where a rod-shaped probe is inserted into a process volume via a standardized port before a sterilization step and connected to a transmitter and subsequently to a process control system via cable, this sensor concept involves manually inserting at least one miniaturized sensor sphere, e.g., using tweezers, into the process volume, typically a liquid.

[0003] Such sensors have an integrated energy source, such as a battery. If these mobile, fully integrated sensors are applied before sterilization and sterilized along with a culture vessel, increased leakage currents can occur due to heat exposure, leading to a loss of operating time. Therefore, separate sterilization is generally preferable, although this requires the sensors to be recharged without breaching a sterile barrier. Manual insertion and positioning within an electromagnetic activation and parameterization field is also laborious and prone to errors, as complete sterility cannot be guaranteed. Furthermore, it can sometimes be difficult to ensure a clear assignment of the sensor to the respective culture vessel. A connector for stable connection with a complementary connector is known from German patent application DE 10 2006 005 533 A1.German patent application DE 10 2010 063 031 A1 discloses a potentiometric sensor with a housing, wherein the potentiometric sensor has means for establishing an electrolytic contact through a through-hole between a reference electrolyte and the medium surrounding the housing. A device for introducing sensors into a sterile environment with a connector is known from German patent application DE 10 2004 015 703 A1. German patent application DE 10 2011 112 953 A1 relates to a tablet dispenser designed for singulating tablets of different dimensions. A similar device for singulating tablets or dragees is known from German patent application DE 75 29 321 U. German patent application DE 10 2006 024 072 A1 discloses a device for feeding spherical objects into a container.

[0004] The present invention therefore aims to develop a device and a method that avoid the aforementioned disadvantages, and with which a miniaturized sensor system can be introduced into a measurement environment in a simple and reliable sterilized manner.

[0005] This problem is solved according to the invention by a device according to claim 1 and a method according to claim 10. Advantageous embodiments and further developments are described in the dependent claims.

[0006] A device for transferring at least one sensor system from a sterile environment into a medium to be tested comprises a control module and a sterile module connectable to the control module. The sterile module has a magazine for receiving the at least one sensor system, a singulation unit with an attached activation unit for advancing and activating the at least one sensor system, and a sealing cap for transferring the at least one sensor system into the medium to be tested. The control module comprises an identification unit for non-contact identification of the medium to be tested, a holding unit for receiving the sterile module, a power supply unit, an actuating unit for the sealing cap, and a control unit for controlling the identification unit, the singulation unit, and the sealing cap.The control module and the sterilization module are mechanically and electrically connected to each other via a connecting unit.

[0007] By designing the control module and the sterile module to be attachable and detachable, the sensor systems housed in the sterile module, or at least the one sensor system housed within it, can be sterilized without requiring any special precautions for the control module. Furthermore, since the sensor system can only be removed from the sterile module via the cap when the sterile module and the control module are connected, sterility is ensured until the sensor system is introduced into the medium under investigation, typically a liquid or, more generally, a fluid.

[0008] Since the activation of the at least one sensor system only occurs through the activation unit arranged on the singulation unit, the sensor system is only brought from a resting phase to an active phase shortly before being released into the medium under investigation. For this purpose, the sensor system is typically provided with a fluid-tight, preferably spherical housing containing at least one sensor or transducer, for example, a temperature sensor, a pH sensor, a sensor for determining glucose concentration and / or oxygen content, a unit for wirelessly transmitting a measurement signal, and an energy storage device for supplying the sensor and the wireless transmission unit, as well as a corresponding electronic circuit. The dimensions of the housing of such a sensor system can be less than 8 mm, i.e., the radius of the spherical housing is preferably a maximum of 4 mm.

[0009] The identification unit allows the medium to be identified, for example by means of a marker, and the information thus obtained is forwarded via the control unit to the activation unit, which then stores it in the sensor system. Since the activation unit is typically manually operated, the sensor system is only released from the device when actuated by a user.

[0010] The connecting unit typically comprises one or more pins or compression springs made of an electrically conductive material on the control module and the sterilization module, or pins on one of the two modules and corresponding contact surfaces on the other module to establish a reliable electrical contact.

[0011] It may be provided that the locking cap has a basic position in which the at least one sensor system remains in the sterile module, i.e., is held within it, and that the locking cap can only change this basic position after the actuating unit is activated, if the sterile module is arranged on the control module. Only in the latter case does the actuating unit trigger a corresponding reaction in the sterile module, thus ensuring reliable storage of the at least one sensor system in the typically sealed interior of the sterile module, and that this sterile interior remains sterile.

[0012] Typically, the magazine is tubular. It can also be closed at one end by a locking device located on the singulation unit. This device, by actuating a compression spring, allows exactly one single sensor system to enter the singulation unit from the magazine and then, via the compression spring, forwards this single sensor system into the activation unit. Efficient insertion is achieved by allowing the compression spring to move the sensor to two different positions, in which the magazine is either closed or open, and by selecting dimensions of the singulation unit such that only one sensor system can be located in this unit at any given time. Preferably, one direction of travel of the compression spring is oriented orthogonally to a longitudinal axis of the magazine.

[0013] The activation unit can comprise a tubular container for housing the at least one sensor system. This container is sealed by a cap. Preferably, at least one activation antenna of the activation unit is arranged on the tubular container to activate the at least one sensor system by means of an electromagnetic signal. Typically, the activation unit, or at least the activation antenna, encloses the tubular container so that the at least one, now isolated, sensor system is activated and / or parameterized as reliably as possible, i.e., switched from its standby state to an active state by the electromagnetic signal, in which measured values ​​are acquired and transmitted, and parameterized by storing additional information.

[0014] It may be provided that a longitudinal axis of the container is arranged parallel to, but spatially spaced apart from, a longitudinal axis of the magazine, so that the at least one isolated sensor system can only move from the magazine into the container after the compression spring has been tensioned and released.

[0015] The cap can be moved with a torsion spring, so that the cap can be easily folded away to release the at least one sensor system into the medium to be examined.

[0016] The control module can have a display on which information is shown. Alternatively or additionally, the actuating element can also be designed as a switch to allow targeted selection of information on the display and to control the control unit. Preferably, at least two pushbuttons or buttons are provided.

[0017] The identification unit can be designed as an optical identification unit that can read a marker attached to a culture vessel containing the medium to be examined, such as a barcode or a QR code (Quick Response code), and preferably store the information contained therein in the sensor system via the activation unit. Alternatively, another wireless transmission system, such as an RFID (Radio Frequency Identification) transponder and a corresponding receiver, or an NFC (Near Field Communication) tag, can be used for this purpose. Preferably, when using the optical identification unit, an illumination unit is arranged on the identification unit to illuminate the marker for reading.

[0018] The holding unit typically includes a spring-loaded pressure piece for securing the sterile module. When the sterile module is attached to the control module, the pressure piece can be pushed back and then fit into a recess in the sterile module, thus securely holding the sterile module. Preferably, the spring-loaded pressure piece is movable by the control unit; at least it should be retractable far enough into the control module to allow the sterile module to be removed from the holding unit of the control module.

[0019] To ensure reliable attachment of the magazine to the singulation unit, a bayonet fitting may be provided.

[0020] A method for transferring at least one sensor system from a sterile environment to an environment to be examined using the described device comprises a step in which the sterile module, typically already pre-sterilized, is filled and sealed in a sterile environment with at least one sensor system, typically also pre-sterilized, or is sterilized together with the sensor system after filling, and is subsequently inserted into the control module in any environment and the at least one sensor system is transferred from the device into the medium to be examined.

[0021] By dividing the system into the sterilization module and the control module, "intelligent sterilization" can be performed, as only selected parts need to be sterilized and are easy to keep sterile.

[0022] Exemplary embodiments of the invention are shown in the drawings and are described below with reference to theFig. 1, Fig. 2 to Fig. 3 explained.

[0023] They show: Fig. 1. A perspective view of a device for transferring at least one sensor system from a sterile environment into a medium to be examined; Fig. 2 one Fig. 1. Corresponding representation of the device with separate control module and sterilization module and Fig. 3 A schematic side view of a singulation of a sensor system in the sterile module.

[0024] In Fig. Figure 1 shows a perspective view of a device for transferring at least one sensor system from a sterile environment into a medium to be examined. The control module 1 is mounted on a sterile module 2; the two components are shown assembled, i.e., ready for operation, forming a handheld device.

[0025] The Sterile Module 2 is used for storing, sterilizing and precisely positioning sensor systems; when inserted into the Control Module 1, it allows for singulation and precise positioning of the sensor systems.

[0026] A display 12 for showing various information is arranged on the top side of the control module 1. The information displayed can be controlled via two pushbuttons 13 and 14, also located on the top side of the control module 1. The control module 1 has a closed housing 12 with a recess into which a magazine 3 of the sterile module 2 can be inserted. The sterile module 2 is held securely to the control module 1. The housing 12 itself is splash-proof, and a material of the housing 12 is solvent-resistant, thus enabling spray disinfection.

[0027] A camera 8, serving as an optical recording unit, and a lamp 19 are arranged on the front of the control module 1 to illuminate and detect markers on a container holding the medium to be examined, in this case a liquid. A handle 11 is positioned below the camera 8, protecting it from contact or other contamination and allowing the entire device to be held by a user. The handle 11 rests on the index finger, while the thumb operates the pushbuttons 13 and 14. The dimensions of the device are 180 mm x 50 mm x 45 mm.

[0028] In its lower part, the control module 1 has a holding unit 9 for receiving and holding the sterile module 2. Inside the housing 12, a control unit in the form of an electronic circuit and a power supply unit, for example a battery, are arranged.

[0029] Sterile module 2 instructs in Fig. The visible components next to the magazine 3, which is arranged on a singulation unit 5 by means of a bayonet fitting, include the singulation unit 5, which is closed by a cap 7. Several spherical sensor systems can be stacked on top of each other in the magazine 3, and one of these sensor systems can be dispensed into the liquid to be analyzed via the singulation unit 5 and the cap 7.

[0030] Magazine 3 can be made of a material transparent to electromagnetic radiation in the visible wavelength range, i.e., wavelengths between 400 nm and 800 nm, such that at least 80 percent of the incident electromagnetic radiation in the visible range is transmitted by this material. This allows the filling of magazine 3 to be monitored.

[0031] The cap 7 is in Fig. 1 is shown in its basic position on an underside of the sterile module 2, in which no sensor system can leave the device shown. Only when the user uses the device in its assembled state and presses one of the push buttons 13 or 14 provided as an actuating unit in the respective embodiment, does the locking cap 7 open and release a sensor system contained in the singulation unit 5, which falls downwards due to gravity.

[0032] In further embodiments, the sterile module 2 can also have a housing that is flush with the housing 12 of the control module 1 and is preferably made of the same material as the material of the housing 12.

[0033] Fig. 2 shows in a Fig. Figure 1 shows the sterile module 2, which is separate from the control module 1. Recurring features in this and the following figure are designated with identical reference numerals. In addition to the recess, the control module 1 has a spring-loaded pressure piece 15 for receiving and holding the sterile module 2. When the sterile module 2 is inserted into the recess, the pressure piece 15 is pushed back against the spring force. When the sterile module 2 reaches its end position, the spring force engages the pressure piece 15 in a corresponding receptacle on the sterile module 2, thus mechanically holding the sterile module 2 on the control module 1. To separate the modules, a corresponding instruction can be selected via one of the two pushbuttons 13 and 14 and the display 12 in the illustrated embodiment. The pressure piece 15 is then retracted into the housing 12 by means of the control unit and an electric motor attached to the pressure piece 15.In further embodiments, however, a manual movement of the pressure piece 15 by means of a push button can also be provided.

[0034] A connection unit 10 consisting of several pins on the control module 1 and corresponding contact surfaces on the sterile module 2 or mechanical pushbuttons allows electrical and mechanical contact between the two modules 1 and 2. Alternatively or additionally, contact can also be made via spring contact pins.

[0035] Fig. Figure 3 shows a schematic side view of the singulation process of one of the sensor systems 4. Fig. 3A is the tubular magazine 3 filled with several stacked sensor systems 4. The inner diameter of the magazine 3 is selected such that the sensor systems 4 can be stacked individually with a loose clearance. The singulation unit 5 has a sliding closing device 16 in the form of a singulation slide, which initially closes one outlet of the magazine 3 and is held in this position by a compression spring 17. The sealing cap 7 is held in its closed home position by a torsion spring 18 and seals the singulation unit 5 pressure-tight and liquid-tight.

[0036] As in Fig. As shown in Figure 3B, the pressure spring 17, along with the locking device 16, can be retracted by a command from the control unit, so that exactly one of the sensor systems 4 falls by gravity into the singulation unit 5, more precisely into a receiving cavity or bore of the locking device 16, which has dimensions that allow for the precise reception of one sensor system 4. For this purpose, the receiving cavity is mounted flush with the magazine 3. In the illustrated embodiment, a direction of movement of the locking device 16 and a longitudinal axis of the magazine 3 are perpendicular to each other. The closing cap 7 remains closed.

[0037] After the compression spring 17 has returned the closing device 16 to its original position, and thus the receiving cavity with the sensor system 4 contained therein is aligned with a tubular container of the singulation unit 5, the sensor system 4 falls into this container due to gravity and is optimally positioned with respect to an activation unit 6 by the mandrel-shaped closing cap 7. This state is in Fig. Figure 3C shows that the direction of movement of the closing device 16 and a longitudinal axis of the container are arranged orthogonally, or perpendicularly, to each other. The longitudinal axis of the magazine 3 and the longitudinal axis of the container are therefore parallel to each other, but the magazine 3 and the container are spatially offset from each other. The closing cap 7 is still closed, so the sensor system 4 is now stored in the container.

[0038] The container is enclosed by a coil that is part of the activation unit 6. Upon a corresponding command from the control unit, this coil is energized by an electric current and can inductively charge the sensor system 4, preferably by means of a charging pulse, or switch the sensor system 4 from a standby mode to an active mode. The status of the respective sensor system 4 can also be checked during this process. The user is informed of the result of this status query on the display 12, and the next steps are instructed. If a sensor system 4 is defective, an instruction appears on the display 12 to discard the currently isolated sensor system 4.

[0039] Furthermore, after the coil has confirmed a proper status, additional information can be transmitted contactlessly to the sensor system 4 and stored there, for example, information about the medium under investigation obtained via the camera 8. The sensor systems 4 can also be charged by inserting the entire sterilization module 2 into a charging module and inductively charging it via charging antennas. Subsequent sterilization typically takes place in an autoclave.

[0040] Typically, to enable a unique assignment of the measurement data to the respective reactor vessel, the user is prompted on the display 12 to scan a machine-readable and / or two-dimensional code attached to the vessel using the camera 8. This identification code can then be transmitted to the base station via the communication interface and assigned to the respective sensor system 4.

[0041] After the sensor system 4 has been prepared or parameterized in this manner, the control unit actuates the torsion spring 18, which opens the closure cap 7 downwards and releases the sensor system 4 from the container, as shown in Fig. shown in 3D. The one in the Fig. The process described in 3A to 3D can be carried out automatically after being triggered by the user.

[0042] The energy storage unit of the control module 1 is designed such that it supplies all electrical energy consumers. Likewise, all moving parts of the device can be moved by means of an electromechanical actuator, e.g., a servo motor with a boom. The control unit preferably comprises a main board with one or more sub-boards, for example, an antenna driver board. Furthermore, a communication interface to a base station, which may be designed as an electromagnetic radio unit, can also be provided on the control module 1. In further embodiments, the activation unit 6 can also be configured for communication, in particular for reading data from the sensor system 4 or systems 4.

[0043] The described device enables mobile, fully integrated, spherical sensor systems 4, only a few millimeters in diameter, to be used for data acquisition, for example, in cultivation vessels for biological cultures. These systems are first sterilized, for example, by steam sterilization, then singulated, activated, and parameterized, and subsequently automatically applied to the cultivation vessel. The sensor system 4 can move independently within the process volume, e.g., in bioreactors, and wirelessly transmits the recorded process measurements to a process control system. For storage, the sensor systems 4 are kept in a deep sleep mode outside of a reaction volume. Before use, they must be sterilized and, if necessary, recharged, activated, parameterized, assigned to the respective process or vessel, and then sterilely applied to the vessel.

[0044] Only features of the various embodiments disclosed in the exemplary embodiments can be combined and claimed individually.

Images