A MEDICAL INSTRUMENT DISINFECTING ENCLOSURE

There is disclosed a disinfecting enclosure for a medical instrument 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 so as to enclose the enclosure; wherein each said module comprises an inner surface having a plurality of UVC LEDs provided thereon, each of the plurality of UVC LEDs being actuable to emit UVC light to irradiate all surfaces of a medical instrument located within the enclosure.

RELATED APPLICATIONS

The present application claims priority from Australian Provisional Patent Application No. 2019901886, filed 31 May 2019, the entire contents of which are incorporated herein by reference

FIELD OF INVENTION

The present invention relates generally to a disinfecting device for medical instruments, and in particular, to a disinfecting enclosure that employs Ultraviolet Type C (UVC) light irradiation to eliminating the presence of microorganisms on the surface of medical instruments, such as ultrasound transducers.

BACKGROUND OF THE INVENTION

Within the medical industry, a variety of different types of sterilisation and disinfecting systems have been proposed for use on a variety of different devices and equipment. The degree of sterilisation or disinfection required for a specific device or piece of equipment will largely depend upon the manner in which the device or equipment is used and the likelihood of cross-contamination between users of the device or equipment.

In the field of diagnostic ultrasound machines, ultrasound transducers are employed which are used to contact the human body in order to generate appropriate images for analysis by healthcare professionals. Such transducers are used in a variety of different applications depending upon the area of the body requiring imaging. In this regard, the transducers may be used in contact with individuals having healthy and intact skin, through to individuals with skin lacerations and other conditions where the transducer may be in direct contact with mucous membranes and blood and other bodily secretions. Due to the large range of use of such transducers on individuals with a variety of different conditions, there is an increased likelihood that the surface of the transducer may be in contact with various microorganisms which are carried on the surface of the transducer. Thus, it is critically important that after use, such transducers undergo a high level disinfecting or sterilisation process, to eliminate any organisms that may be present on the surface thereof.

To achieve such a high-level degree of disinfection, there exist currently four processes capable of fulfilling this requirement. These processes include: chemical soaking, chemical aerosol, surface wiping, and UVC irradiation:

Chemical soaking is a process that requires placing the ultrasound transducer such that it is immersed into a chemical reagent. One example of such system is the GUS Disinfection Soak Station made by CIVCO Medical Solutions. Such processes generally require a soaking time for the transducer to be left immersed in the chemical reagent of between around 8 minutes to 45 minutes. Whilst the appropriate level of disinfection may be achievable, the disadvantage of this process is that the chemical reagent is hazardous and any exposure to the chemical reagent may harm the operator and patient and disposal of the chemical waste may harm the environment. Further, as care is required in handling the chemicals, this method is manually operated and time-consuming.

Chemical aerosol is a process whereby the ultrasound transducer is placed within a chamber that is flooded with a nebulised hydrogen peroxide. One example of such a commercially available system that employs this process is the system developed by Nanosonics Ltd., under the brand Trophon. Typically, the transducer is placed within the chamber for between 7 to 12 minutes, depending on the specific conditions. Once again, due to the use of the chemical reagent, the disadvantage of this method is that the residual of chemical reagent left on transducers may harm the operators and patients.

It is possible to achieve the desired level of disinfection through the use of surface wipes. Such a process uses different chemical wipe combinations to manually wipe the surface of the transducer. The procedure requires steps of pre-cleaning, disinfection and rinsing. One example of such a commercially available method of using surface wipes is using chlorine dioxide formulation made by Tristel. However, a drawback with such a method is that it requires manual application and is prone to human error, costly and is time intensive.

The remaining process for achieving such a high-level degree of disinfection is through the use of UVC irradiation, typically by way of lighting through mercury vapour tubes. Such a process requires the ultrasound transducer to be positioned within a chamber having multiple mercury vapor tubes as light sources for disinfection. There are several commercial systems available which utilise UVC irradiation to disinfect ultrasound transducers. However, all of these systems use mercury vapour tubes as their UVC light source. Such tubes pose a potential risk to operators who may be exposed to mercury vapour leakage from the tubes. In addition, the disposal of these mercury vapour tubes is harmful to the environment and requires additional cost and complexity to do so in a safe way. Such disposal problems are significant and have been raised by the UN Minamata Convention on Mercury in 2013, where an international treaty was enacted to protect human health and the environment from anthropogenic emissions and releases of mercury and mercury compounds. This treaty sets down controlling measures over a variety of products containing mercury, the manufacture, import and export of which will be altogether prohibited by 2020.

In addition to the problems associated with continuing to use mercury vapour tubes, such tubes can only emit UVC with wavelength at 254 nm, which is inefficient for germicidal efficacy, requiring longer exposure times to achieve the desired level of disinfection.

Thus, there is a need to provide an alternative process for achieving high-level disinfection of ultrasound transducers and the like, that is highly-efficient, safe and environmentally friendly.

The above references to and descriptions of prior proposals or products are not intended to be, and are not to be construed as, statements or admissions of common general knowledge in the art. In particular, the above prior art discussion does not relate to what is commonly or well known by the person skilled in the art, but assists in the understanding of the inventive step of the present invention of which the identification of pertinent prior art proposals is but one part.

STATEMENT OF INVENTION

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.

Accordingly, in one aspect of the invention there is provided a disinfecting enclosure for a medical instrument 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 so as to enclose the enclosure; wherein each said module comprises an inner surface having a plurality of UVC LEDs provided thereon, each of the plurality of UVC LEDs being actuable to emit UVC light to irradiate all surfaces of a medical instrument located within the enclosure.

In one aspect of the invention, each module further comprises a heat dissipation member for dissipating heat generated by the UVC LEDs away from the inner surface thereof.

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

In one embodiment, a frame member may be provided for configuring the modules, the frame member may have a plurality of open spaces into which the plurality of modules may be inserted to form the enclosure. The enclosure may be in the form of a polyhedron and the modules may form a base and sidewalls of the polyhedron. The polyhedron may be an octagonal polyhedron.

In another embodiment, the modules may be directly configured together, without a frame member. In this embodiment, the modules are assembled to form the enclosure in the desired shape, including the base and sidewalls of enclosure.

In one embodiment, the distance between adjacent UVC LEDs on the inner surface of the base module (denoted as “L”) may be less than:

2⁢D*tan⁢ϕ2⁢⁢or⁢⁢15⁢⁢cm;where, D is the distance between the UVC LEDs and the medical instrument and ϕ is an illumination angle of the UVC LEDs.

In another embodiment, the distance between adjacent UVC LEDs on the inner surface of the side wall module (denoted as “L”) is less than:

2⁢D*tan⁢ϕ2⁢⁢or⁢⁢15⁢⁢cm;where D is the distance between the UVC LEDs and the medical instrument and ϕ is an illumination angle of the UVC LEDs.

The heat dissipation member may comprise a heat sink mounted on an external surface of each of the modules that conducts heat from the UVC LEDs away from the enclosure.

The distance between the UVC LEDs and the closest surface of medical instrument may be greater than 1 cm and less than 20 cm.

The lid member may comprise a suspension mechanism or clamping mechanism for hanging or holding the medical instrument inside of the enclosure.

The medical instrument may be an ultrasound transducer.

In another aspect, there is provided a disinfecting chamber comprising a plurality of chamber walls configured to form an enclosed space, each chamber wall having a plurality of windows formed therein, each window being configured to be transparent to UVC light so as to allow the UVC light to transmit therethrough, one or more UVC LED chips are mounted onto a light board that is attached to an outer side of the chamber walls such that the one or more UVC LED chips mounted thereto are positioned adjacent a window to transmit the UVC light through the window and into the enclosed space, wherein one or more heat sinks are mounted to a rear surface the light board for transmitting and dissipating heat transmission generated by the one or more UVC LED chips.

DETAILED DESCRIPTION OF THE DRAWINGS

Preferred features of the present invention will now be described with particular reference to the accompanying drawings. However, it is to be understood that the features illustrated in and described with reference to the drawings are not to be construed as limiting on the scope of the invention.

The present invention will be described below in relation to its application for use in disinfecting a transducer for a medical ultrasound device. However, it will be appreciated that the present invention could be used in a variety of different applications, both medical and non-medical, where disinfection of an element is required.

Referring initially toFIG. 1, there is depicted an isolated UVC disinfecting enclosure10, made up of a plurality of modules11, in accordance with a preferred embodiment of the present invention. The modules11are arranged to form an enclosure, into which a transducer device is to be placed for disinfecting the surface thereof, as will be discussed in further detail below.

The enclosure10is depicted as having a multi-sided (for example, octagonal) polyhedron shape with each of the modules11being configured to abut an adjacent module11to define an enclosed space that forms the enclosure10. In this regard, a base module12and a lid member13are provided to fully enclose the space or enclosure and the modules support UVC LEDs such that the internal surfaces of the modules11and12have UVC LEDs formed thereon to emit UVC light to irradiate all surfaces of an ultrasound transducer that is suspended within the enclosure10.

Referring toFIG. 2, a schematic diagram of an exploded view of an embodiment of a light source module11is depicted. The light source module comprises a cover member15which is configured to engage with a frame member18by way of one or more screws, or buckles, or the like. A UVC LEDs board16is mounted between the cover member15and the heat sink19. The light board16comprises a plurality of UVC LED17positioned over the surface thereof for delivering the light into the internal space of the enclosure10. The heatsink19faces away from the enclosure10and is in contact with the light board16to dissipate heat generated by the UVC LED17away from the enclosure10. In the embodiment as depicted inFIG. 2, a frame member18is employed to hold the light board16and the heat sink19together, although such a frame member is optional.

Whilst the modules11and12are of a different shape and size to each other, the base module12is constructed in the manner shown inFIG. 2. Once the modules have been assembled, the modules11,12and the lid member13(which could comprise no UVC LEDs) are mounted within a disinfecting enclosure frame construction20as depicted inFIG. 3.

The disinfecting enclosure frame construction20comprises a base member21, a top member22and a plurality of side members23which are assembled together to form the assembled disinfecting enclosure frame20, as depicted inFIG. 4. Due to the octagonal polyhedron shape of the frame20, in a preferred embodiment, there are four side members23, each consisting of two upright wall sections angled with respect to each other, as depicted inFIG. 3. Three of the side wall members23are fixed in position with respect the base member21and top member22, with the fourth side wall member23being hingedly mounted to a neighbouring side wall member along one connecting edge, to form a door for opening and accessing the enclosure of the assembled disinfecting enclosure device.

Referring toFIG. 5, the manner in which the light source modules11are mounted within the side members23of the disinfecting enclosure frame20is shown. In a preferred embodiment, the light source modules11are secured in position within the pre-formed recesses25formed in the side members23by way of mechanical fastening means, such as screws, rivets and the like. As will be appreciated, the base module12and lid member13will also be mounted within the pre-formed recess formed in the base member21and top member22respectively.

Once the light source modules11,12and13have been fully assembled within the frame20, the resultant disinfecting enclosure will have the UVC LEDs evenly distributed around the surfaces of the resultant enclosure or space. As desired, the modules11and12can be simply and effectively detached from the frame20and replaced as required.

In a preferred embodiment, for each of the modules11and12, the chips of the UVC LED17are directly mounted on the light board16which is on contact with the heatsink19to facilitate heat dissipation from the UVC LED17. This arrangement enables the irradiation intensity in the unit area of the disinfecting enclosure to be increased to a level as desired.

Referring again toFIG. 1, the layout of the modules11,12to form the enclosure10depicts the lid member13having an ultrasound transducer cable clamping structure9for supporting the ultrasound transducer30within the enclosure. The cable clamping structure9functions to suspend and/or hold the ultrasound transducer30when it is positioned inside of the enclosure. The ultrasound transducer cable may be clamped by the clamping structure9such that the ultrasound transducer30is inverted inside the enclosure for disinfection. In one embodiment, as the ultrasound transducer30falls downwards naturally due to the effects of gravity, the whole bottom end surface of the transducer can be irradiated by the UVC LED light sufficiently.

FIG. 6depicts different types of ultrasound transducers30that can be used in the disinfecting enclosure of the present invention

FIG. 7shows how different ultrasound transducers30can be positioned inside the disinfecting enclosure10. In this embodiment, three different types of ultrasound transducers30are to undergo treatment, with reference numeral34representing the bottom end of the upper ultrasound transducer30and reference numeral35representing the bottom end of the lower ultrasound transducer30.

FIG. 11shows an embodiment of how a position scale marker may be employed within the enclosure10to aid an operator in positioning the transducer30correctly within the enclosure10to ensure optimal irradiation of the surface thereof. In this regard, the marker is provided to identify a preferred range of positions for the bottom end34of the transducer30to be positioned within the enclosure. Thus, when the ultrasound transducer30is placed within the enclosure10, the transducer30is positioned in the bottom end of the enclosure10to be as close to the bottom of the enclosure within the limits, so that the bottom end of the transducer can be fully disinfected by the UVC LEDs positioned on the base module12. As depicted, the range indicators may be in the form of labels adhered or otherwise applied within the side walls of the enclosure.

FIG. 12shows another embodiment for providing a level indicator for positioning the bottom end of the transducer with respect to the bottom of the enclosure10.

In this embodiment, the range indicators are in the form of labels adhered or otherwise applied to the inside walls of the enclosure10.

In the embodiment of the enclosure frame assembly20ofFIG. 3-5, recesses25are provided on the side members23and/or on the base member21. The sidewall and the base modules11,12are engaged with the recesses25of the side members23and the base member21such that the heatsinks19are connected to the light board of the modules11,12so as to be disposed outside the enclosure10. As the heat generated by the UVC LEDs is dissipated out through the heat heatsinks19to provide heat dissipating for the UVC LED modules.

The heatsinks19may further comprise heat dissipation fans (not shown) that are disposed on the rear of the sidewall modules11and/or the base modules12for heat dissipation. In an alternative arrangement, heat dissipation pipes such as condensation pipes may be disposed on the rear of the sidewall modules11of the enclosure for dissipating heat from the sidewall modules or base modules.

As previously discussed, in order to provide high-level disinfection, the UVC LED light source modules11,12are disposed on sidewalls and bottom of the enclosure10respectively. The light boards16of each of the modules11,12are disposed on the surface of the modules facing inwardly with respect to the enclosure, so that the UVC light emitted by the UVC LED17mounted on the light boards16irradiate the whole surface of the ultrasound transducer30mounted within the enclosure. This ensures that the whole surface of the ultrasound transducer30is disinfected by the UVC light, effectively avoiding any light intensity attenuation due to reflection and overheating and achieving the purpose of full and thorough high-level disinfection.

As will be appreciated, the disinfecting enclosure provided by the present invention provides an arrangement whereby the UVC LED17are irradiated onto the whole surface of the ultrasound transducer30mounted inside the enclosure. Meanwhile, heat dissipation modules are provided with each module, such that the heat generated from the UVC LEDs on the sidewall modules11and the base module12can be dissipated out of the enclosure10to ensure the disinfecting result inside the enclosure.

As is seen more clearly inFIG. 1andFIG. 7, the base module12includes a plurality of base module pieces to cover the base of the enclosure10, however the base module12may be configured such that it is a single piece comprising a flat surface. Alternatively, the base module12may comprise a plurality of flat and/or curved pieces. With regard to the base module12, the light board16may have one or a plurality of UVC LED17mounted thereon to perform irradiation of the ultrasound transducer30located above.

As is shown in each of the depicted embodiments of the invention, in a preferred embodiment the side modules11are all configured to be substantially flat or planar surfaces. However, in an alternative embodiment, the sidewall modules11may comprise a plurality of flat or curved surfaces, each of which has one or more UVC LED17disposed thereon.

Referring toFIG. 13, there is depicted a schematic diagram showing how the distance between adjacent UVC LEDs17on the inner surface of the base module (denoted as “L”) is controlled. In this arrangement, the distance between the UVC LEDs17and the medical instrument30that is to undergo disinfection is denoted as “D”, and the illumination angle of the UVC LEDs is ϕ.

The manner in which the UVC LED17are arranged upon the surfaces of the light boards16of the side wall modules11and base modules12can be calculated to determine optimum surface irradiation of the transducers30. The distance between the UVC LEDs on the base modules is typically less than

or 15 cm

Where, D is the distance between the UVC LED17and the ultrasound transducer30, and ϕ is the angle of illumination for the UVC LED17.

The distance between the UVC LEDs of the sidewall light source module is typically less than:

Where D is the distance between the UVC LED17and the ultrasound transducer30, and ϕ is the angle of illumination for the UVC LED17.

Referring toFIG. 8, a schematic diagram is provided depicting the manner in which the illumination angle of a UVC LED17is obtained. In this embodiment,31is a light emitting surface of the UVC LED17,32is a normal direction of the emitting light surface, and33is the UVC LED emitting angle. A UVC LED spectrum schematic diagram is depicted inFIG. 9.

FIG. 10is a schematic diagram providing a UVC LED lighting distribution curve, wherein the illumination angle refers to the angle when the illumination intensity of the UVC LED lighting is attenuated to 50%.

In one embodiment of the present invention, the illumination angle of the UVC LED17is 120°, and the distance between the UVC LED17and the surface of the transducer is 3 cm. In this situation, according to the present invention, the distance between adjacent UVC LED17on a surface of the light boards16of the modules11, will be no more than 10.4 cm.

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 LED17on a surface of the light boards16of the modules11, will be no more than 6 cm.

In general practice, the disinfecting enclosure will be configured such that the distance between the UVC LED17and the surface of the ultrasound transducer30is greater than 1 cm and less than 20 cm. If the distance described is too close, the transducer30may come into contact with the inner sidewall surfaces of the modules11when the transducer30is placed into the enclosure. Conversely, if the distance is too far, the irradiation on the surfaces of the transducer will be too weak to eliminate the microorganisms, resulting in disinfection times that will become too long.

An embodiment depicting how the light source is configured, is illustrated inFIG. 14. The disinfection chamber is enclosed by one or more chamber walls35, the chamber wall35comprises multiple windows36, which are made from a material that is transparent to UVC light so as to allow the UVC light to transmit therethrough. The UVC LED chips36are bonded onto the light boards37. The light boards37are attached to an outer side of the chamber walls, which allows the UVC LED chips36to face the windows36, to transmit the UVC light through the windows36and into the chamber. Heat sinks39may be attached on the back of the light boards37, for transmitting and dissipating heat transmission as required.

In an embodiment if the present invention, a plurality of detachable modules may be disposed about the frame of the disinfection enclosure. In another embodiment, a light source module maybe located on the detachable module, and the UVC LEDs are evenly distributed on the detachable module.

As previously discussed, each of the existing four high-level disinfecting methods for ultrasound transducers cannot achieve efficient, safe and environmentally friendly high-level disinfection. In comparing existing disinfecting methods that use UVC LEDs to form disinfecting boxes, only a small number of UVC LEDs are installed inside the disinfecting boxes, due largely to the inability of such devices to cope with the heat that is generated. As a result, such devices find it is impossible to uniformly irradiate all surfaces of the ultrasound transducer to achieve a necessary high-level disinfection. The present invention overcomes this problem and achieves a high-level disinfection by locating modules onto the sidewalls and base of a sealed enclosure. Such modules employ UVC LEDs on an inside surface thereof to achieve light irradiation on the entire surface of the ultrasound transducer. Since the enclosure is sealed, full coverage irradiation is possible, whilst substantially eliminating any UVC light leakage. Such a system ensures that the disinfecting process is efficient, safe and environmentally friendly.

It will be appreciated that with the provision of heat sinks on an outer surface of each of the modules, heat accumulation within the disinfection enclosure is significantly reduced, thereby extending the lifespan of the UVC LEDs. At the same time, it is ensured that the temperature of the disinfection enclosure is within the safe level which will not damage the transducers during the disinfecting procedure.

The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included in the range of protection of the present invention.

Throughout the specification and claims the word “comprise” and its derivatives are intended to have an inclusive rather than exclusive meaning unless the contrary is expressly stated or the context requires otherwise. That is, the word “comprise” and its derivatives will be taken to indicate the inclusion of not only the listed components, steps or features that it directly references, but also other components, steps or features not specifically listed, unless the contrary is expressly stated or the context requires otherwise.

Orientational terms used in the specification and claims such as vertical, horizontal, top, bottom, upper and lower are to be interpreted as relational and are based on the premise that the component, item, article, apparatus, device or instrument will usually be considered in a particular orientation, typically with the enclosure uppermost.

It will be appreciated by those skilled in the art that many modifications and variations may be made to the methods of the invention described herein without departing from the spirit and scope of the invention.