HOLDING DEVICE FOR A STERILE PRODUCT, STERILE PRODUCT, AND METHOD FOR MONITORING A STERILE PRODUCT CYCLE

Abstract

A holding device for a sterile product, in particular for a sterile product container or a soft packaging, which device is provided to hold, during a preparation process, a medical product to be sterilised, and comprises communication means, and a part of the communication means is designed for a frequency range such that the part, when the sterile product is closed, supplies data in relation to the medical product to an environment of the sterile product. Also provided are a sterile product and a method for monitoring a sterile product cycle.

Claims

1. A holding device for medical products mounted on the holding device during a sterile product cycle, the holding device comprising: a plurality of sensors which are provided and configured to acquire parameters of preparation process steps, wherein each individual sensor is configured to acquire a different respective data parameter, and wherein respective data parameter is representative of a respective individual process step of the sterile product cycle differing from each other respective individual process step; and an evaluation unit configured to analyse the respective data parameters, on the basis of which an identification of a one of the respective individual process steps just performed takes place.

2. The holding device according to claim 1, wherein the plurality of sensors are configured to acquire in their entirety parameter data with respect to a use of the medical products in an operating room, and/or an ultrasonic cleaning, and/or a cleaning in a cleaning and disinfecting device, and/or a maintenance by lubricating, and/or a sterilisation.

3. The holding device according to claim 1, wherein the sensors are configured to detect in their entirety temperature, air moisture, pH value, pressure, sound waves, electric voltages, and/or vibrations.

4. The holding device according to claim 3, wherein at least one sensor of the plurality of sensors is a piezo element.

5. The holding device according to claim 3, wherein at least one sensor of the plurality of sensors is a radiometer.

6. The holding device according to claim 3, wherein at least one sensor of the plurality of sensors is a microphone.

7. The holding device according to claim 1, wherein the evaluation unit is configured to infer a lifetime and/or a condition of the medical products from the parameter data.

8. The holding device according to claim 1, wherein the plurality of sensors comprise at least two redundant sensors.

9. The holding device according to claim 1, wherein the holding device comprises a plurality of antennas and a read and write unit, wherein the antennas are connected to the read and write unit via an electronic distribution system (multiplexer).

10. The holding device according to claim 1, wherein the holding device comprises a modular structure configured to enable a removing of individual elements of the holding device.

11. The holding device according to claim 7, wherein the evaluation unit is configured to compare the respective data parameters representative of respective individual process steps with predetermined parameters, and to increment a respective counter when the evaluation unit determines that an individual process step was performed successfully.

12. The holding device according to claim 1, wherein the holding device comprises a signal transmitter configured to indicate information about one or more of the individual process steps to a user by an optical, acoustic, and/or haptic signal.

13. The holding device according to claim 1, wherein the holding device comprises a signal transmitter configured to indicate a position of the medical product to a user by an optical, acoustic, and/or haptic signal.

14. A holding device system comprising: a medical device holder; a plurality of sensors provided on the medical device holder; and a processor provided on the medical device holder and in communication with the plurality of sensors, wherein the processor is configured to: a) receive a respective signal from each of the plurality of sensors, each respective signal representing a respective measured parameter of at least one of a plurality of process steps performed on the holding device system, wherein at least two of the respective measured parameters are different from each other, and b) analyse the measured parameters to determine an identity of at least one of the plurality of process steps.

15. The holding device system of claim 14, wherein the plurality of process steps comprise one or more of: use of a medical product in an operating room; an ultrasonic cleaning; a cleaning in a cleaning and disinfecting device; a maintenance by lubricating; and a sterilisation.

16. The holding device system of claim 14, wherein the plurality of sensors are configured to detect one or more of: temperature; air moisture; pH value; pressure; sound waves; electric voltages; and vibrations.

17. The holding device system of claim 16, wherein the plurality of sensors comprise at least one of: a piezo element; a radiometer; and a microphone.

18. The holding device system of claim 14, further comprising one or more antennas and a read and write unit, wherein the one or more antennas are connected to the read and write unit via an electronic distribution system.

19. The holding device system of claim 14, further comprising a signal transmitter configured to indicate information about one or more of the process steps to a user by an optical, acoustic and/or haptic signal.

20. The holding device system of claim 14, further comprising a signal transmitter configured to indicate a position of a medical device to a user by an optical, acoustic and/or haptic signal.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0113] The disclosure will be explained in the following by means of drawings. There show:

[0114] FIG. 1 a schematic illustration of a holding system with its elements; and

[0115] FIG. 2 a schematic illustration of a system process.

[0116] The Figures are merely of schematic nature and serve exclusively for the understanding of the invention. The same elements are provided with the same reference numbers. The features of the individual embodiments may be exchanged mutually.

[0117] Moreover, spatially relative terms such as “positioned below”, “under”, “lower”, “positioned above”, “upper”, “left”, “right”, and the like may be used for the simple description of the relation of one element or one structure to one or a plurality of other elements or structures illustrated in the Figures. The spatially relative terms shall, in addition to the orientation illustrated in the Figures, comprise other orientations of the component in use or in operation. The component may be oriented differently (turned by 90 degrees or in another orientation), and the spatially relative descriptors used here may also be interpreted correspondingly.

DESCRIPTION OF THE FIGURES

[0118] The holding device, the method, and the sterile product, i.e., the sterile product container or sterile product screen, will now be described by means of embodiments.

[0119] FIG. 1 shows a schematic illustration of a holding system 1 with its elements. Specifically, the holding system 1 comprises a communication module 2 provided for the external communication of data. For this purpose, the data are provided by a microcontroller 3 which is in direct communication with the communication module 2. The microcontroller 3 controls an energy supply provided by an energy supply unit 4. For this purpose, the microcontroller 3 can influence the energy supply such that the energy supply is phased down and/or placed in an energy saving mode between process steps.

[0120] Furthermore, the microcontroller 3 is in direct communication with sensors 6. The sensors may be of different kind and be one or a plurality of the kind mentioned here. Likewise, the microcontroller 3 may be in contact with a signal transmitter 5. For this purpose, the sensors 6 may be in direct or indirect contact with the signal transmitter 5 via the microcontroller 3. The signal transmitter 5, for instance, an LED, a loudspeaker, or a radio module, informs the user, for instance, about where a medical product is just being and/or at which process step the system 1 is at the moment. The system 1 further comprises an NFC read and (possibly) write device 8 which is in connection and/or communicates in operation with one or a plurality of NFC antennas 9 of different products 7. This may take place by directly placing the products 7 on the NFC read and write device 8 and/or a plurality thereof.

[0121] Further details and aspects are mentioned in connection with the embodiments described before or in the following. The embodiment shown in FIG. 1 may comprise one or a plurality of optional additional features which correspond to one or a plurality of aspects mentioned in connection with the proposed concept or the embodiment described in the following with reference to FIG. 2.

[0122] FIG. 2 shows a schematic illustration of a possible system process 10. The system process 10 may, for instance, start with Step S1 in which the product is used during an operation. The user may then activate a search function for this product in Step X1. The signal transmitter 5 indicates the position of the product e.g. in the closed container to the user, see X2. The data about the use are written by the control device/microcontroller 3 onto the transponder, see M1. Then, the system 1 enters the energy saving mode Sx.

[0123] After termination of the energy saving mode Sx the pre-cleaning by means of ultrasound starts, see S2. The ultrasonic waves are detected by sensors 6 and analysed in the evaluation unit, for instance, after communication via the communication module 2 to outside of the holder (i.e., the container or the soft packaging), see M2. Then, the system 1 again enters the energy saving mode Sx.

[0124] After termination of the energy saving mode Sx the cleaning in the cleaning and disinfecting device starts, see S3. In this process the temperature sensor 6 detects the ambient temperature (and/or inner temperature of the holder) which is analysed in the evaluation unit 3, see M3. Then, maintenance by means of an oil spray is performed, see S4. The signal transmitter 5 indicates the sufficient duration of the spray, see X3. The temperature sensors 6 detect the spray and the evaluation unit detects the duration, see M4. After that, sterilisation takes place in the autoclave (not illustrated), see S5. The temperature sensors detect the ambient temperature (and/or the inner temperature of the holder and/or container) which is analysed in the evaluation unit, see M5. Then, the system 1 enters the energy saving mode again, see Sx.

[0125] In the case of successful steps M1, M2, M3, or M4 the respective counter is incremented, see X4, and/or the signal transmitter 5 indicates the failure/success of the process step, see X5.

[0126] Further details and aspects are mentioned in connection with the embodiments described before or in the following. The embodiment shown in FIG. 2 may comprise one or a plurality of optional additional features which correspond to one or a plurality of aspects mentioned in connection with the proposed concept or one or a plurality of embodiments described before (e.g. FIG. 1).

LIST OF REFERENCE SIGNS

[0127] 1 holding system
2 communication module
3 microcontroller
4 energy supply
5 signal transmitter
6 sensors
7 products
8 NFC read and write device
9 NFC antenna
10 method
S1 . . . S5, Sx operations
X1 . . . X5 events
M1 . . . M5 sensor events