Housing for Medical Device Disinfection

Abstract

A disinfection enclosure for medical devices is disclosed, comprising: a plurality of modules configured to define an enclosure having a base and at least one upright wall extending from the base; and a lid member configured to be mounted on the at least one upright wall to enclose the enclosure, each module including an inner surface having a plurality of UVC LEDs disposed thereon, each of the plurality of UVC LEDs operable to emit UVC light to irradiate all surfaces of a medical device disposed within the enclosure.

Description

Related Applications

[0001] This application claims priority based on Australian Provisional Patent Application No. 2019901886, filed on May 31, 2019, the entire content of which is incorporated herein by reference.

Technical Field

[0002] The present invention generally relates to a disinfection device for medical devices, and more particularly to a disinfection enclosure that employs ultraviolet type C (UVC) light irradiation to remove microorganisms present on the surface of medical devices such as ultrasonic transducers.

Background Art

[0003] In the medical industry, various types of sterilization and disinfection systems have been proposed for use in various devices and equipment. The degree of sterilization or disinfection required for a particular device or part of the equipment is highly dependent on the way the device or equipment is used and the potential for secondary contamination among the users of the device or equipment.

[0004] In the field of ultrasonic diagnostic machines, ultrasonic transducers used for contacting the human body are employed to generate appropriate images for analysis by medical professionals. Such transducers are used in various applications depending on the area of the body that requires imaging. In this regard, the transducers can be used in contact with individuals with healthy and intact skin, as well as through other conditions where the transducers may come into direct contact with mucous membranes, blood, and other body secretions of individuals with skin lacerations. Since the range of use of such transducers for individuals with various different conditions is wide, the likelihood of the surface of the transducer coming into contact with various microorganisms carried on the surface of the transducer is increasing. Therefore, it is extremely important to subject such transducers to a high-level disinfection or sterilization process after use to remove organisms that may be present on their surfaces.

[0005] To perform such high-level disinfection, there are currently four processes that can meet this requirement. These processes include chemical soaking, chemical aerosol, surface wiping, and UVC irradiation. Chemical soaking is a process that requires placing the ultrasonic transducer to be immersed in a chemical reagent. One example of such a system is the GUS disinfection soaking station made by CIVCO Medical Solutions. Such a process generally requires an immersion time to keep the transducer immersed in the reagent for about 8 to 45 minutes. Although an appropriate level of disinfection can be achieved, the drawback of this process is that the reagent is dangerous, exposure to the reagent can harm the operator and patients, and the disposal of chemical waste can harm the environment. Furthermore, because careful handling of chemicals is required, this method is manually operated and time-consuming.

[0006] Chemical aerosol is a process of placing the ultrasonic transducer in a chamber filled with nebulised hydrogen peroxide. An example of such a commercially available system is the system developed by Nanosonics Ltd., under the brand name Trophon. Typically, the transducer is placed in the chamber for 7 to 12 minutes depending on specific conditions. Again, the drawback of this method is that due to the use of the reagent, the residual reagent remaining on the transducer can harm the operator and patients.

[0007] The desired level of disinfection can be achieved by using surface wipes. Such processes use different combinations of chemical wipes to manually wipe the transducer surface. This process requires pre-cleaning, disinfection, and rinsing steps. One example of a commercially available method using such surface wipes is the Tristel chlorine dioxide formulation. However, the drawbacks of this method are that it requires manual labor, is prone to human error, is costly, and is time-consuming.

[0008] The remaining process for achieving such high levels of disinfection involves the use of UVC irradiation, typically through mercury vapor tubes. This process requires placing an ultrasonic transducer in a chamber containing multiple mercury vapor tubes as the disinfection light source. Several commercially available systems utilize UVC irradiation to disinfect ultrasonic transducers. However, all of these systems use mercury vapor tubes as the UVC light source. These tubes pose a potential risk to operators, who may be exposed to mercury vapor leaking from the tubes. Additionally, disposal of these mercury vapor tubes is environmentally hazardous and requires additional cost and complexity to be accomplished safely. This disposal issue is significant and was addressed by the 2013 United Nations Minamata Convention on Mercury, an international treaty to protect human health and the environment from anthropogenic emissions and releases of mercury and mercury compounds. This treaty establishes regulatory measures for various mercury-containing products, with their manufacture, import, and export to be completely banned by 2020.

[0009] In addition to the problems associated with continuing to use mercury tubes, such tubes are only capable of emitting UVC at a wavelength of 254 nm, which is inefficient for germicidal effects and requires longer exposure times to achieve the desired level of disinfection.

[0010] Therefore, there is a need to provide a highly efficient, safe and environmentally friendly alternative process for performing high-level disinfection such as ultrasonic transducers.

[0011] The above references and prior proposals or product descriptions are not intended to be construed as stating or admitting general knowledge in the art, nor should they be so construed. In particular, the discussion of the prior art above is not related to what is generally or well known to those skilled in the art, but rather is helpful in understanding that the inventiveness of the present invention, here the identification of relevant prior art proposals is only a part of it.

SUMMARY OF THE INVENTION

[0012] The invention according to one or more aspects is as defined in the independent claims. Some optional and / or preferred features of the invention are defined in the dependent claims.

[0013] Thus, in one aspect of the invention, there is provided a disinfection enclosure for a medical device including the following. A plurality of modules configured to define an enclosure having a base and at least one upright wall extending from the base; and a lid member configured to be placed on at least one upright wall to surround the enclosure, each of the modules including an inner surface having a plurality of UVC LEDs provided thereon, and each of the plurality of UVC LEDs being operable to emit UVC light for irradiating the entire surface of a medical device disposed within the enclosure.

[0014] In one aspect of the invention, each module further includes a heat dissipation member for dissipating heat generated by the UVC LEDs from its inner surface.

[0015] The plurality of modules may include a plurality of side wall modules for forming at least one upright wall of the enclosure and at least one base module for forming the base of the enclosure.

[0016] In one embodiment, the frame member can be provided to form a module, and the frame member can have a plurality of open spaces into which a plurality of modules can be inserted to form a housing. The housing can be in the form of a polyhedron, and the module can form the base and side walls of the polyhedron. The polyhedron can be an octahedron.

[0017] In another embodiment, the modules can be directly configured together without including the frame member. In this embodiment, the modules are assembled to form a housing in a desired shape including the base and side walls of the housing. In one embodiment, the distance (denoted as "L") between adjacent UVC LEDs on the inner surface of the base module may be less than 12136 in TIFF0007716991000001.tif: Here, D is the distance between the UVC LED and the medical device, and Φ is the illumination angle of the UVC LED.

[0018] In another embodiment, the distance (denoted as "L") between adjacent UVC LEDs on the inner surface of the side wall module is less than 12136 in TIFF0007716991000002.tif: Here, D is the distance between the UVC LED and the medical device, and Φ is the illumination angle of the UVC LED.

[0019] The heat dissipation member may include a heat sink placed on the outer surface of each module to conduct heat from the UVC LED away from the housing.

[0020] The distance between the UVC LED and the closest surface of the medical device can be greater than 1 cm and less than 20 cm. The lid member may include a suspension or clamp mechanism for suspending or holding the medical device inside the housing. The medical device can be an ultrasonic transducer.

[0021] In another aspect, it includes a plurality of chamber walls configured to form a closed space, each chamber wall having a plurality of windows formed therein, each window being configured to be transparent to UVC light so that UVC light can pass through, one or more UVC LED chips being placed on a light board attached to the outside of the chamber wall, and the one or more UVC LED chips placed thereon transmitting UVC light into the closed space through the windows, a disinfection chamber disposed adjacent to the windows, and one or more heat sinks being placed on the back surface of the light board to transfer and dissipate the heat transfer generated by the one or more UVC LED chips, and a disinfection chamber is provided.

Brief Description of the Drawings

[0022] The present invention can be better understood from the following non-limiting description of the preferred embodiments.

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DETAILED DESCRIPTION OF THE INVENTION

[0023] Preferred features of the present invention will be described with particular reference to the accompanying drawings. However, it will be understood that the features described with reference to the drawings should not be construed as limiting the scope of the present invention.

[0024] The present invention will be described below for use in disinfecting transducers for medical ultrasonic devices. However, it will be understood that the present invention can be used in a variety of different applications, both medical and non-medical, where disinfection of elements is required.

[0025] Referring first to FIG. 1, according to a preferred embodiment of the present invention, an isolated UVC disinfection housing 10 consisting of a plurality of modules 11 is depicted. The modules 11 are arranged to form the housing and a transducer device is arranged for disinfecting the surface, as will be discussed in more detail below.

[0026] The housing 10 is configured to define a closed space that forms the housing 10, and is depicted as having a polyhedral shape (e.g., octagonal) in which each module 11 is joined to an adjacent module 11. In this regard, a base module 12 and a lid member 13 are provided to completely enclose the space or housing, and the modules support UVC LEDs, that is, the inner surfaces of modules 11 and 12 have UVC LEDs formed thereon, and are adapted to emit UVC light to irradiate all surfaces of the ultrasonic transducers suspended within the housing 10.

[0027] Referring to FIG. 2, an exploded schematic view of an embodiment of the light source module 11 is depicted. The light source module includes a cover member 15 configured to engage with a frame member 18 by one or more screws, or buckles, etc. The UVC LED board 16 is placed between the cover member 15 and the heat sink 19. The light board 16 includes a plurality of UVC LEDs 17 disposed on its surface and sending its light into the internal space of the housing 10. The heat sink 19 faces away from the housing 10 and contacts the light board 16 to dissipate the heat generated by the UVC LEDs 17 from the housing 10. In the embodiment shown in FIG. 2, the frame member 18, although such a frame member is optional, is employed to hold the light board 16 and the heat sink 19 together.

[0028] Modules 11 and 12 are of different shapes and sizes from each other, but the base module 12 is constructed in the manner shown in FIG. 2. Once the modules are assembled, the modules 11, 12 and the lid member 13 (which may also include those without UVC LEDs) are placed within the frame structure 20 of the disinfection housing as shown in FIG. 3.

[0029] As shown in FIG. 4, the frame structure 20 of the disinfection housing includes a base member 21, a top member 22, and a plurality of side members 23 that are assembled to form the assembled disinfection housing frame 20. In a preferred embodiment, since the frame 20 is in the shape of an octagonal polyhedron, as shown in FIG. 3, there are four side members 23 each consisting of the cross-section of two upright walls angled with respect to each other. The fourth side wall member 23 is hinged to an adjacent side wall member along one connection end to form a door for opening, closing, and accessing the housing of the assembled disinfection housing device. In that state, three of the side members 23 are fixed in place with respect to the base member 21 and the top member 22.

[0030] Referring to FIG. 5, the manner in which the light source module 11 is mounted within the side member 23 of the disinfection housing frame 20 is shown. In a preferred embodiment, the light source module 11 is fixed in place at a predetermined position within recesses 25 pre-formed in the side member 23 by mechanical fastening means such as screws, rivets, etc. As will be understood, the base module 12 and the lid member 13 are placed within recesses pre-formed in the base member 21 and the top member 22, respectively.

[0031] Once the light source modules 11, 12, and 13 are fully assembled within the frame 20, the resulting disinfection housing will have UVC LEDs evenly distributed around the surface or space of the resulting housing. Optionally, the modules 11 and 12 can be easily and efficiently removed from the frame 20 and replaced as needed.

[0032] In a preferred embodiment, for each of the modules 11 and 12, the chips of the UVC LEDs 17 are placed directly on a light board 16 in contact with a heat sink 19 to facilitate heat dissipation from the UVC LEDs 17. This arrangement can increase the irradiation intensity within the unit area of the disinfection housing to a desired level.

[0033] Referring again to FIG. 1 , the layout of modules 11 and 12 to form housing 10 depicts a lid member 13 having an ultrasound transducer cable clamping structure 9 for supporting ultrasound transducer 30 within the housing. Cable clamping structure 9 functions to suspend and / or hold ultrasound transducer 30 located inside the housing. The ultrasound transducer cable may be clamped by clamping structure 9 so that ultrasound transducer 30 can be inverted within the housing for disinfection. In one embodiment, as ultrasound transducer 30 naturally descends due to gravity, the entire bottom end surface of the transducer can be fully illuminated by UVC LED light.

[0034] FIG. 6 shows different types of ultrasonic transducers 30 that can be used in the disinfection enclosure of the present invention.

[0035] 7 shows how different ultrasonic transducers 30 are arranged inside the disinfection enclosure 10. In this embodiment, three types of ultrasonic transducers 30 are processed, with reference number 34 representing the bottom end of the upper ultrasonic transducer 30 and reference number 35 representing the bottom end of the lower ultrasonic transducer 30.

[0036] 11 illustrates an embodiment of how positional memory markers may be employed within the housing 10 to assist the operator in properly positioning the transducer 30 within the housing to ensure optimal irradiation of its surface. In this regard, markers are provided to identify a preferred positional range for the bottom end 34 of the transducer 30 located within the housing 10. In this manner, when the ultrasound transducer 30 is placed within the housing 10, the transducer 30 is positioned at the bottom end of the housing 10 as close to the bottom of the housing as possible, within limits, to allow the bottom end of the transducer to be fully disinfected by the UVC LEDs located on the base module 12. As illustrated, the range indicators may be in the form of a label affixed or otherwise attached within the sidewall of the housing.

[0037] FIG. 12 shows another embodiment for providing a level indicator for positioning the bottom end of the transducer relative to the bottom of the housing 10. In this embodiment, the range indicator is in the form of a label attached or otherwise mounted on the inner wall of the housing 10.

[0038] In the embodiment of the housing frame assembly 20 of FIGS. 3 to 5, the recess 25 is provided in the side member 23 and / or the base member 21. The side walls and the base modules 11, 12 are engaged with the recesses 25 of the side member 23 and the base member 21, so that the heat sink 19 is connected to the optical boards of the modules 11, 12 and is arranged outside the housing 10. The heat generated by the UVC LED is dissipated through the heat sink 19, providing heat dissipation to the UVC LED module.

[0039] The heat sink 19 may further include a heat dissipation fan (not shown) disposed on the back surface of the side wall module 11 and / or a base module 12 for heat dissipation. In another arrangement, a heat dissipation pipe such as a condensation pipe may be disposed on the back surface of the side wall module 11 of the housing to dissipate heat from the side wall module or the base module.

[0040] As already described, to provide a high level of disinfection, the UVC LED light source modules 11, 12 are respectively disposed on the side wall and the bottom of the housing 10. Each optical board 16 of each module 11, 12 is disposed on the surface of the module facing inward with respect to the housing, and the UVC light emitted by the UVC LEDs 17 mounted on the optical board 16 irradiates the entire surface of the ultrasonic transducer 30 placed in the housing. Thereby, the entire surface of the ultrasonic transducer 30 is disinfected by the UVC light, effectively avoiding the attenuation of the light intensity due to reflection and overheating, and it is guaranteed that the purpose of complete and thorough high-level disinfection can be achieved.

[0041] As can be understood, the disinfection housing provided by the present invention provides an arrangement in which the UVC LED 17 irradiates the entire surface of the ultrasonic transducer 30 placed inside the housing. At the same time, heat dissipation modules are provided for each module, so that the heat generated from the UVC LEDs of the side wall module 11 and the base module 12 is dissipated from the housing 10, and the disinfection result inside the housing is guaranteed.

[0042] As can be more clearly seen in FIGS. 1 and 7, the base module 12 includes a plurality of base module pieces that cover the base of the housing 10, but the base module 12 can also be configured as a single piece having a flat surface. Alternatively, the base module 12 may include a plurality of flat and / or curved pieces. Regarding the base module 12, the light board 16 may have one or more UVC LEDs 17 placed thereon for irradiating the ultrasonic transducer 30 located above.

[0043] As shown in each of the illustrated embodiments of the present invention, in a preferred embodiment, the side module 11 is all configured to be substantially flat or planar. However, in an alternative embodiment, the side wall module 11 includes a plurality of flat or curved surfaces, each having one or more UVC LEDs 17 disposed thereon.

[0044] Referring to FIG. 13, a schematic diagram is drawn showing how the distance (denoted as L) between adjacent UVC LEDs 17 on the inner surface of the base module is controlled. In this configuration, the distance between the UVC LED 17 to be disinfected and the medical device 30 is denoted as "D", and the illumination angle of the UVC LED is Φ.

[0045] The way of arranging the UVC LEDs 17 on the surfaces of the light boards 16 of the side wall module 11 and the base module 12 can be calculated to determine the optimal surface irradiation of the transducer 30. The distance between the UVC LEDs of the base module is typically TIFF0007716991000003.tif is less than 12136. Here, D is the distance between the UVC LED 17 and the ultrasonic transducer 30, and Φ is the illumination angle with respect to the UVC LED 17.

[0046] The distance between the UVC LEDs of the sidewall light source module is typically TIFF0007716991000004.tif is less than 12136. Here, D is the distance between the UVC LED 17 and the ultrasonic transducer 30, and Φ is the illumination angle with respect to the UVC LED 17.

[0047] Referring to FIG. 8, a schematic diagram depicting how the illumination angle of the UVC LED 17 is obtained is provided. In this embodiment, 31 is the light emitting surface of the UVC LED 17, 32 is the normal direction of the light emitting surface, and 33 is the UVC LED emission angle. A schematic diagram of the UVC LED spectrum is shown in FIG. 9.

[0048] FIG. 10 is a schematic diagram providing the UVC LED lighting distribution curve, where the illumination angle refers to the angle at which the illumination intensity of the UVC LED illumination decays to 50%.

[0049] In one embodiment of the present invention, the illumination angle of the UVC LED 17 is 120°, and the distance between the surface of the transducer and the UVC LED 17 is 3 cm. In this situation, according to the present invention, the distance between adjacent UVC LEDs 17 on the surface of the light board 16 of the module 11 is 10.4 cm or less.

[0050] In another embodiment, if the UVC LED dispersion angle is 90° and the distance between the light source and the transducer surface is 3 cm, the distance between adjacent UVC LEDs 17 on the surface of the light board 16 of the module 11 is 6 cm or less.

[0051] Generally, the disinfection housing is configured such that the distance between the UVC LED 17 and the surface of the ultrasonic transducer 30 is greater than 1 cm and less than 20 cm. If the distance to be described is too close, when the transducer 30 is placed in the housing, the transducer 30 may contact the inner side wall surface of the module 11. Conversely, if the distance is too far, the irradiation of the surface of the transducer is too weak to remove microorganisms, and the disinfection time will become too long.

[0052] An embodiment showing how the light source is configured is shown in FIG. 14. The disinfection chamber is surrounded by one or more chamber walls 35, and the chamber walls 35 include a plurality of windows 36 made of a material transparent to UVC light so that UVC light can pass through. The UVC LED chip 36 is adhered to the light board 37. This light board 37 is attached to the outside of the chamber wall so that the UVC LED chip 36 can face the window 36 and UVC light can be transmitted into the chamber through the window 36. The heat sink 39 may be placed on the back surface of the light board 37 as needed to transfer and dissipate heat transfer.

[0053] In one embodiment of the present invention, a plurality of removable modules may be arranged around the frame of the disinfection housing. In another embodiment, the light source module may be located on a removable module, and the UVC LEDs are evenly distributed on the removable module.

[0054] As already discussed, none of the four high-level disinfection methods for existing ultrasonic transducers can perform efficient, safe, and environmentally friendly high-level disinfection. Comparing existing disinfection methods that use UVC LEDs to form a disinfection box, mainly because such devices cannot cope with the heat generated, only a small number of UVC LEDs are installed inside the disinfection box. As a result, such devices are unable to uniformly irradiate all surfaces of the ultrasonic transducer to achieve the required high level of disinfection. The present invention overcomes this problem and performs high-level disinfection by arranging modules on the side walls and base of a sealed housing. Such modules employ UVC LEDs on their inner surfaces to irradiate light on the entire surface of the ultrasonic transducer. Since the housing is sealed, irradiation that completely covers the whole can be achieved while substantially removing UVC light leakage. Such a system ensures that the disinfection process is efficient, safe, and environmentally friendly.

[0055] It will be understood that by providing a heat sink on the outer surface of each module, the heat accumulation inside the disinfection housing is significantly reduced, and the lifespan of the UVC LEDs is extended. At the same time, it ensures that the temperature of the disinfection housing is within a safe level that does not damage the transducer during the disinfection process.

[0056] The above are only preferred embodiments of the present invention and do not limit the present invention. All changes, equivalent substitutions, and improvements made within the essence and principle of the present invention should be included within the protection scope of the present invention.

[0057] Throughout this specification and claims, the word "comprises" and its derivatives have an inclusive rather than exclusive meaning unless expressly stated to the contrary or unless the context otherwise requires. That is, the word "comprises" and its derivatives are used to indicate the inclusion of not only the directly referenced element, step, or function, but also other elements, steps, or functions not specifically recited. Orientational terms used in the specification and claims (vertical, horizontal, top, bottom, upper, lower) should be interpreted relative to the extent that the element, item, article, tool, device, or equipment is normally considered in a particular orientation, typically relative to the top of a housing.

[0058] It will be apparent to those skilled in the art that many changes and modifications can be made to the methods of the invention described herein without departing from the spirit and scope of the invention.

Claims

1. A plurality of modules arranged in a detachable configuration in contact with each other so as to define a housing having a base and at least one upright wall extending from the base; and A lid member configured to be placed on at least one upright wall to surround the housing, Each of the above modules includes a board having a plurality of UVC LEDs placed on its surface, and each of the plurality of UVC LEDs is controlled by a UVC LED chip placed on the board so as to emit UVC light for irradiating the surface of a medical device arranged inside the housing, and the board has a heat dissipation member attached to its back surface so as to be in direct contact with the board and dissipate the heat generated by each UVC LED from the housing. A disinfection housing for medical devices.

2. The disinfection housing according to claim 1, wherein each module further includes a frame member configured to hold the board in direct contact with the heat dissipation member.

3. The distance between adjacent UVC LEDs placed on the surface of the board of the module arranged to form the base of the housing is Less than, where D is the distance between the UVC LED and the medical device, and Φ is the illumination angle of the UVC LED. The disinfection housing according to claim 1.

4. The distance between adjacent UVC LEDs placed on the surface of the board of the module arranged to form at least one upright wall of the housing is Less than, where D is the distance between the UVC LED and the medical device, and Φ is the illumination angle of the UVC LED. The disinfection housing according to claim 1.

5. The plurality of modules include a plurality of side wall modules arranged in a detachable configuration in contact with each other to form at least one upright wall of the housing, and at least one base module for forming the base of the housing. The disinfection housing according to claim 1.

6. The disinfection housing according to claim 5, wherein the plurality of base modules are arranged in a detachable configuration in contact with each other to form the base of the housing.

7. The disinfection housing according to claim 6, wherein the plurality of base modules have a flat and / or curved configuration so as to form the base of the housing.

8. The disinfection housing according to claim 5, wherein at least one base module includes a single module having a flat surface.

9. The disinfection enclosure according to any one of claims 5 to 8, wherein at least one base module is mounted on a board having one or more UVC LEDs for irradiating a medical device disposed within the enclosure.

10. The disinfection enclosure according to claim 5, wherein the side wall module is configured to be substantially flat or planar.

11. The disinfection enclosure according to claim 1, further comprising a frame having a plurality of open spaces for inserting a plurality of modules to form the enclosure.

12. The disinfection enclosure according to claim 11, wherein the enclosure is in the form of a polyhedron and the modules are arranged in a detachable configuration in contact with each other to form the base and side walls of the polyhedron.

13. The disinfection enclosure according to claim 12, wherein the polyhedron is an octahedron.

14. The disinfection enclosure according to claim 1, wherein the heat dissipation member includes a heat sink mounted on the outer surface of each module for conducting heat from the UVC LEDs outside the enclosure.

15. The distance between the UVC LEDs and the medical device when the medical device is disposed within the enclosure is greater than 1 cm and less than 20 cm, for the disinfection enclosure according to claim 1.

16. The disinfection enclosure according to claim 1, wherein the lid member includes a suspension or clamping mechanism for suspending or holding the medical device inside the enclosure.

17. The disinfection enclosure according to claim 1, wherein the inner surface of the enclosure has one or more indicators for assisting in positioning the base of the housing of the medical device.

18. The disinfection enclosure according to claim 1, wherein the medical device is an ultrasonic transducer.

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