Apparatus for surface disinfection, in particular apparatus for surface disinfection of medical instruments or medical implements

The disinfection apparatus with adjustable UV radiation sources and a Lambertian reflector system provides rapid and reliable disinfection of complex medical instruments by optimizing radiation distribution and intensity, addressing inefficiencies in existing manual and semi-automated methods.

JP2025535603APending Publication Date: 2025-10-24FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV +1
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Patent Information

Application Number
JP2025526753
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-11-10
Filing Date
2023-11-07
Publication Date
2025-10-24

AI Technical Summary

Technical Problem

Existing disinfection methods for complex medical instruments, such as endoscopes and ultrasound probes, are inefficient and difficult to automate due to their complex geometries and inaccessibility, requiring prolonged exposure to UV radiation and manual chemical processes, which are hard to validate.

Method used

A disinfection apparatus with a cylindrical chamber and independently controllable UV radiation sources at different heights, combined with a Lambertian reflector and rotation mechanism, ensures uniform illumination and adjustable intensity, allowing rapid and reliable disinfection of complex medical instruments by varying radiation doses based on object geometry.

Benefits of technology

Enables rapid, reliable, and automatable disinfection of complex medical instruments, ensuring uniform coverage and reduced exposure time without compromising disinfection efficacy, suitable for diverse instrument geometries.

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Abstract

The apparatus for surface disinfection of objects, particularly medical instruments or medical implements, comprises a disinfection chamber 1 with a cylindrical interior space. A hanger or holder 4 is arranged in the upper region of the interior space, on which an object 2 to be disinfected can be suspended. At least two groups of radiation sources 3A, 3B emitting disinfecting UV radiation are arranged at different heights on the interior walls defining the sides of the interior space. The at least two groups of radiation sources 3A, 3B can be controlled independently of each other to generate radiation of different intensities. The interior walls of the disinfection chamber 1 are provided with a coating that diffusely reflects UV radiation in the wavelength range of the radiation sources used. The proposed apparatus enables fast and reliable automatic disinfection of medical instruments.
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Description

[Technical Field]

[0001] The present invention relates to an apparatus for surface disinfection of objects, in particular medical instruments or implements, comprising a disinfection chamber, the disinfection chamber having, in the upper region of its interior, a hanger or holder on which the object to be disinfected can be suspended, and a radiation source emitting UV radiation in a wavelength range in which the UV radiation has a disinfecting effect.

[0002] Surface disinfection of objects plays an important role, especially in the medical field. Semi-critical medical devices must be disinfected before use on patients. This is particularly problematic for complex instruments and instruments that cannot be thermally disinfected due to their heat instability or cannot be processed mechanically and chemically in a RDG (Reinigung-Desinfektion-Geraet) due to structural constraints. In recent years, the number of such instruments has increased in the medical field. These instruments can usually only be disinfected using chemical disinfectants in manual processes. The problem here is that each treatment process for semi-critical medical devices must be validated, which is difficult to do with manual processes. [Background technology]

[0003] The above problems are partially avoided by replacing medical devices that cannot be thermally or mechanically sterilized with disposable instruments. Where this is not possible, for example in the case of highly complex devices such as echocardiographic probes, these devices are currently chemically cleaned and disinfected using manual processes. Semi-automated chemical methods are also used.

[0004] Furthermore, automated disinfection systems for medical ultrasound and TEE probes are known, in which the probes are suspended in a disinfection chamber and exposed to UVC radiation for disinfection. However, complex medical instruments have both easily accessible and less accessible areas. Therefore, the exposure must be prolonged to ensure sufficient radiation dose is delivered to the less accessible areas. Summary of the Invention [Problem to be solved by the invention]

[0005] The object of the present invention is to provide an apparatus for surface disinfection of objects, which allows reliable, rapid and automatable disinfection of even complex medical instruments or medical devices, in particular medical endoscopes or ultrasound probes. [Means for solving the problem]

[0006] The above problem is solved by a device according to patent claim 1. Advantageous configurations of the device are the subject of the dependent claims or can be derived from the following description and exemplary embodiments.

[0007] The proposed device comprises a sterilization chamber having a cylindrical interior space that can be opened to introduce objects to be sterilized and closed to perform sterilization. A hanging or holding device is arranged in the upper region of the cylindrical interior space, which is formed in the form of a straight (upright) cylinder, on which the objects to be sterilized can be suspended. The hanging or holding device can be a hook or other mechanism, such as a clamping mechanism. At least two groups of radiation sources are arranged on the inner wall that defines the sides of the interior space and forms the side of the cylinder, at different heights of the interior space. The arrangement of the at least two groups of radiation sources is such that the objects to be sterilized are directly irradiated along their entire length, starting from the hanging portion. In the proposed device, the at least two groups of radiation sources can be controlled independently of each other, thereby allowing the areas of the objects to be sterilized that are irradiated by the radiation sources to be sterilized to be irradiated with different light intensities. Preferably, the radiation sources in the topmost group of radiation sources have a smaller emission angle than the radiation sources in the other groups of radiation sources. The interior walls of the disinfection chamber are provided with a coating that diffusely reflects UV radiation in the wavelength range of the radiation source used in the proposed device, thus forming or at least approximating a Lambertian reflector. This coating is preferably made of optical PTFE (polytetrafluoroethylene) or barium sulfate. The coating preferably has a reflectivity R>0.9 for the UV radiation emitted by the radiation source and irradiated into the interior space.

[0008] The proposed device therefore uses suitable UV radiation in a disinfection chamber to irradiate and disinfect objects to be disinfected, in particular medical instruments or medical devices, where disinfection means reducing the number of viable microorganisms per unit of material to be disinfected to 10 -5This is understood as a case where the radiation intensity is reduced by a factor of 1. For disinfection, the objects to be disinfected are suspended in a suspender or holder in the disinfection chamber and irradiated by a radiation source. Due to diffuse reflection on the inner walls of the disinfection chamber, uniform illumination of the objects to be disinfected in each height region is achieved with only one reflection, and shadows on the objects are avoided.

[0009] In a preferred form, the device also includes a rotation device that allows the hanger or holder to rotate about the cylindrical axis of the cylindrical interior space, thereby further assisting in uniform illumination of the object.

[0010] The radiation sources preferably comprise LEDs, which form a group of individual radiation sources, for example in the form of one or more LED arrays. LEDs have the advantage that they do not emit thermal radiation into the interior space of the disinfection chamber and therefore do not heat this interior space. This is particularly important when disinfecting thermally unstable objects. It is also possible to introduce radiation from one or more central radiation emitters (radiation sources) into the disinfection chamber via optical fibers, the output openings of which then form the different radiation sources according to the invention.

[0011] The at least two groups of radiation sources are arranged to achieve as uniform illumination as possible of the object to be disinfected in each height region of the interior space where the groups of radiation sources are arranged. Due to the difference in controllability and the difference in the heights at which the two groups of radiation sources are arranged, two regions of the object can be irradiated with different radiation intensities. This allows for irradiating the hard-to-reach region with a higher intensity than the more accessible region in the case of corresponding medical instruments or medical devices where the radiation accessibility of these regions differs (e.g., an endoscope having a control section and a distal end). Therefore, the total irradiation time for disinfecting the object can be reduced without compromising the reliability of disinfection. The proposed device preferably includes more than two groups of radiation sources arranged at different heights, so that more than two regions of the object to be disinfected can be irradiated with different intensities as needed, for example, three groups of radiation sources at three different heights of the interior space. Using the proposed device, for example, a medical endoscope can be disinfected in a shorter time by irradiating the grip region of the endoscope with a higher irradiation intensity than the rest of the endoscope. Just in the grip area, the angle means that the radiation is not equally accessible everywhere, and therefore a higher intensity of radiation is required to achieve the required radiation dose in the same exposure time as in more accessible areas.

[0012] In a preferred embodiment of the proposed device, one or more of the groups of radiation sources further comprise optical elements that influence the radiation characteristics of the individual radiation sources. This is typically an optical lens or lens system suitable for modifying or determining the radiation angle of the individual radiation sources. The top group of radiation sources preferably comprises a corresponding optical device that limits the radiation angle, thereby increasing the radiation intensity at the object compared to the other groups of radiation sources (for the same control). For example, the top group of radiation sources can achieve (smaller) radiation angles, especially in the range of up to 60 degrees, while the other group(s) of radiation sources can achieve larger radiation angles of the individual radiation sources, especially above 120 degrees.

[0013] Preferably, the radiation source is configured to emit radiation of a wavelength or combination of wavelengths in the UVC range. Wavelengths in the UVC range, i.e., the wavelength range from 200 nm to 290 nm, have a germicidal effect. If a radiation source emitting in the wavelength range below 240 nm is used, ozone may be generated. In this case, the device preferably comprises a corresponding device for neutralizing the ozone.

[0014] In a further advantageous embodiment, one or more sensors are arranged on the inner wall of the interior space, capable of continuously measuring the radiation intensity. The sensors are correspondingly calibrated so that, based on measurements at the sensor locations, the radiation intensity (I) present at each of one or more locations on the object to be disinfected can be determined, thereby determining the applied dose (I*t). Using the one or more sensors, the entire disinfection process is monitored and controlled by the device's control unit. The duration of the disinfection process is determined based on the measured values ​​and a predefined target dose. This ensures that the predefined target dose is applied even in the event of aging or failure of individual radiation sources. The number of sensors corresponds at least to the number of groups of radiation sources, and preferably, a separate sensor is assigned to each group of radiation sources. Furthermore, the sensors are arranged in the height region of each group, continuously measure the radiation intensity of each group during the disinfection process, and transmit the detected measurement values ​​to the control unit. It is also possible to provide multiple sensors per group. The control unit again determines the exposure dose already applied by each group of radiation sources based on the measurements and controls the duration of exposure by those groups by comparing the exposure dose already applied with the target dose.

[0015] The corresponding data regarding the disinfection process can be entered by the operator into the device's operating unit or stored on a label attached to each object to be disinfected. The proposed device preferably includes a device for short-range wireless communication, which reads the data from the label and transmits it to the control unit. In addition to the target dose, further data regarding the object to be disinfected, in particular the medical instrument or medical device, can also be stored on the label and read from it. These data include, for example, data regarding the type of object, the user, and the time of disinfection. The device's control unit preferably includes a memory having a database (databank) in which different types of objects to be disinfected and their corresponding radiation profiles (which can be generated by groups of radiation sources), and optionally also the target doses for disinfecting these objects, are stored. Based on the data regarding the type of object stored on the label, a specific radiation profile precisely tailored to the object to be disinfected can be set on the basis of the database stored in the control unit's memory. This relates, inter alia, to the control of the irradiation intensity and / or irradiation time in different areas of the object, and thus the different groups of radiation sources. The individual groups of radiation sources are controlled according to the patterns stored in the database. This allows the proposed device to automatically disinfect instruments and equipment of a wide variety of geometries and properties without operator input. Of course, in an alternative form, the operator can also input the above data regarding the object to be disinfected.

[0016] The disinfection process proceeds as follows, for example: the operator first cleans the object to be disinfected of any gross dirt. Next, the operator scans the label to transmit all relevant information about the object, including the target dose, to the device's control unit. The object is then hung on a holder in the disinfection chamber provided for this purpose and the disinfection chamber is closed. The disinfection process is initiated via the device's control panel. After a few minutes, the process is complete, and the device preferably notifies the operator of this by a visual and / or audible signal. The object can then be removed, disinfected, and ready for use again.

[0017] The proposed device allows for the rapid and reliable disinfection of semi-critical medical devices, especially those of the semi-critical A category, in an easily verifiable process. Here, object- or instrument-specific irradiation is carried out, so that instruments and instruments of different geometries and properties can be subjected to the same high-quality disinfection process in the proposed device, which is a universally applicable device. Naturally, the device is also suitable for disinfecting instruments and instruments in clean rooms in medical production, or even non-medical objects.

[0018] The proposed device will now be briefly explained again on the basis of an exemplary embodiment in conjunction with the drawings. [Brief explanation of the drawings]

[0019] [Figure 1] 1 is a schematic diagram of an exemplary configuration of the proposed device; [Figure 2] 2 is a schematic diagram of exemplary radiation characteristics of a group of different radiation sources; DETAILED DESCRIPTION OF THE INVENTION

[0020] The proposed device comprises a disinfection chamber 1, which is shown in a highly schematic example in FIG. 1. In this example, the disinfection chamber 1 is formed in the shape of an upright, straight cylinder and has a cylindrical interior space. Of course, the outer shape of the disinfection chamber 1 does not have to be cylindrical, as long as the interior space is cylindrical. In this example, the disinfection chamber 1 has a closable flap through which the medical instruments 2 to be disinfected can be introduced into the interior space of the chamber 1. It is also possible for the disinfection chamber 1 to be composed of two half-shells that open accordingly. The medical instruments 2 are then suspended on a hanger 4 within the interior space of the disinfection chamber 1. Two groups of radiation sources 3A and 3B are arranged on the inner walls that laterally define the interior space of the disinfection chamber 1, in this example at different heights of the interior space. As shown schematically, in this example, both groups 3A and 3B are formed from stripe-shaped LED arrays. Here, the upper group of radiation sources 3A illuminates the upper area of ​​the instrument 2 to be disinfected, while the lower group 3B illuminates the remaining lower area. The LED arrays of each group 3A, 3B are evenly distributed around the periphery of the interior space. The inner walls of the disinfection chamber are provided with a coating that diffusely reflects the UV radiation emitted by the radiation sources, although this coating is not visible in this example. During disinfection, the hanging device 4 rotates around the cylindrical axis of the disinfection chamber 1 via a rotation device (not shown). The disinfection process is initiated via an operation panel 5 located on the outer surface of the disinfection chamber 1. Both groups of radiation sources 3A, 3B can be controlled independently from each other via a control unit (not shown) so that the upper area of ​​the instrument 2 can be irradiated with a different intensity than the lower area.

[0021] In this regard, Figure 2 exemplarily shows in longitudinal section the radiation characteristics of both groups of radiation sources 3A, 3B illuminating the entire length of the fixture 2. In this example, the radiation angle of the upper group of radiation sources 3A is only 60 degrees, while the radiation angle of the lower group is approximately 150 degrees. This is achieved by placing different auxiliary lenses in front of the radiation sources of the different groups 3A, 3B. [Explanation of symbols]

[0022] 1 disinfection chamber 2. Medical equipment 3A, 3B Radiation source group 4 Hanging device 5 Operation panel

Claims

1. An apparatus for surface disinfection of objects, in particular medical instruments or medical implements, comprising a disinfection chamber (1) having a cylindrical interior space, The sterilization chamber (1) comprises, in the upper region of the interior space, a hanger or holder (4) on which the object (2) to be sterilized can be suspended; At least two groups of radiation sources (3A, 3B) arranged at different heights on the inner walls of the sterilization chamber (1) that define the sides of the interior space, emitting UV radiation in a wavelength range in which the UV radiation has a disinfecting effect; Equipped with the inner walls of the sterilization chamber (1) are provided with a coating that diffusely reflects the UV radiation, the at least two groups of radiation sources (3A, 3B) are controllable separately from one another to emit UV radiation of different intensities; The radiation sources of the top group of radiation sources (3A, 3B) have smaller emission angles than the radiation sources of the other groups of radiation sources (3A, 3B).

2. 2. The apparatus of claim 1, wherein the coating has a reflectivity R>0.9 for the UV radiation emitted by the radiation source.

3. 3. Apparatus according to claim 1 or 2, characterized in that the apparatus comprises a rotation device capable of rotating the suspending or holding device (4).

4. The device according to any one of claims 1 to 3, characterized in that the radiation source is an LED or an LED array.

5. 5. Device according to any one of claims 1 to 4, characterized in that the group of radiation sources (3A, 3B) emit the UV radiation at one wavelength or at different wavelengths in the wavelength range from 200 nm to 290 nm.

6. 6. The device according to claim 1, wherein the coating is made of optical polytetrafluoroethylene or barium sulfate.

7. 7. Apparatus according to any one of claims 1 to 6, characterized in that one or more of the radiation sources of the group of radiation sources (3A, 3B) are provided with auxiliary optics that influence the radiation characteristics of the radiation source.

8. 8. The apparatus according to claim 7, characterized in that the radiation sources of the top group of radiation sources (3A, 3B) are provided with auxiliary optics that make them have smaller emission angles than the radiation sources of the other groups of radiation sources (3A, 3B).

9. 9. The device according to any one of claims 1 to 8, characterized in that the device comprises a control unit, which controls the group of at least two radiation sources (3A, 3B) to emit the UV radiation.

10. One or more sensors are arranged on the inner wall of the sterilization chamber (1), which continuously measure the radiation intensity during the sterilization process and transmit the detected measurements to the control unit; 10. The apparatus of claim 9, wherein the controller is configured to determine an already applied dose of radiation based on the measurements and to control a duration of radiation by comparing the already applied dose of radiation with a target dose.

11. 10. The device according to claim 9, characterized in that a plurality of sensors are arranged on the inner wall of the disinfection chamber (1), at least one sensor of which is assigned to each group of radiation sources (3A, 3B), which continuously measure the radiation intensity of each group during the disinfection process and transmit the detected measured values ​​to the control unit, which is configured to determine the irradiation dose already applied by each group of radiation sources (3A, 3B) based on the measured values ​​and to control the duration of irradiation by these groups by comparing the already applied irradiation dose with a target dose.

12. 12. The device according to claim 10 or 11, characterized in that it comprises a device for short-range wireless communication, via which data relating to the disinfection process, which may also include a target dose, can be read from a label attached to the object to be disinfected (2) and transmitted to the control unit.

13. 13. The device according to any one of claims 9 to 12, characterized in that the control unit comprises a database in which various types of objects to be disinfected and their assigned radiation profiles, and optionally also target doses for disinfecting these objects, are stored, and the control unit is configured to read out the radiation profile assigned to the object (2) from the database based on information about the type of the object (2) to be disinfected input by an operator via an operation panel, and to control the different groups of radiation sources (3A, 3B) to emit radiation having this radiation profile during the disinfection process.

14. 13. The device according to claim 12, characterized in that the control unit comprises a database in which various types of objects to be disinfected and their assigned radiation profiles, and optionally also target doses for disinfecting these objects, are stored, and the control unit is configured to read the radiation profile assigned to the object (2) from the database based on information about the type of the object (2) to be disinfected, which information is read from the label on the object (2) via the device for short-range wireless communication, and to control the different groups of radiation sources (3A, 3B) to emit radiation having this radiation profile during a disinfection process.