Sterilizing device and method for sterilizing medical device

Abstract

A sterilization apparatus for sterilizing a medical device, the sterilization apparatus comprising: a housing comprising a sterilization chamber adapted to at least partially enclose a section of the medical device; at least one ultraviolet light emitting diode (UV-LED) configured to emit UV light directly into the disinfection chamber; a control unit configured to control the UV-LED (light emitting diode); and an integrated power source, the integrated power source being connected to the UV-LED; wherein the control unit is further configured to operate a plurality of sterilization cycles, each sterilization cycle comprising an ON period in which UV light is emitted from the UV-LED and an OFF period in which UV light is not emitted from the UV-LED.

Description

Technical Field

[0001] The present invention relates to a sterilization apparatus and method for sterilizing medical equipment. More particularly, the present invention relates to an apparatus and method for sterilizing medical equipment by using germicidal ultraviolet (UV) light. Background Art

[0002] Sterilizing medical devices to minimize the risk of infection to patients during medical treatment is a well-established procedure in healthcare settings. However, the use of sterile medical devices is not always sufficient to ensure patient safety. In treatments that employ invasive catheters, tubing, and the like, infection may be caused by the migration of microorganisms along the catheter or tubing, necessitating continued sterilization or replacement. There are different types of instant UV light disinfection devices, one example being described in WO 2020200389, and while such devices can provide good disinfection, further optimization is desired when it comes to time of use, risk of overheating, and minimization of UV light exposure to patients, individuals, and / or medical devices, as excessive doses of exposure may result in health risks or material degradation. Summary of the invention

[0003] It is an object of the present invention to provide an improved sterilization apparatus and method for sterilizing medical equipment which overcome at least some of these problems. It is particularly desirable to provide a sterilization apparatus and method which allows the safety and quality of sterilization to be maintained or improved even after prolonged use.

[0004] According to a first aspect of the present invention, this object and other objects are achieved by providing a disinfection device for disinfecting medical equipment, the disinfection device comprising: a housing having a disinfection chamber suitable for at least partially enclosing a section of the medical equipment; at least one ultraviolet light emitting diode (UV-LED), the at least one ultraviolet light emitting diode being configured to emit ultraviolet (UV) light directly into the disinfection chamber; a control unit configured to control the UV-LED; and an integrated power supply connected to the UV-LED; wherein the control unit is further configured to run a plurality of disinfection cycles, each disinfection cycle comprising an on period during which UV light is emitted from the UV-LED and an off period during which UV light is not emitted from the UV-LED.

[0005] By this device configuration, the use time of the device is increased compared to the devices of the prior art, because the disinfection occurs in multiple disinfection cycles and there will be no or very limited power consumption during the off-periods, and therefore the power consumption of the device will be reduced. In addition, the off-periods will result in reduced heat generation, which may help to increase patient safety because the risk of overheating of the disinfection device is reduced. Thirdly, since the UV light emission only occurs during the on-periods, the total UV dose emitted will be reduced compared to continuous light emission, which improves the safety of patients and individuals in the surrounding environment and reduces the risk of degradation of the medical device itself.

[0006] The goal of running multiple disinfection cycles is to achieve disinfection of at least a section of the medical device. Disinfection refers to exposing the medical device to a sufficiently high UV dose for a period of time to achieve at least a 1-log reduction in harmful microorganisms (also known as germs) residing on the medical device. This reduction in harmful microorganisms should be achieved while limiting the emission of UV light, so the device will consume less power, reduce heat generation, and limit the amount of UV light potentially reaching the surrounding environment.

[0007] The housing may include a through hole, which extends through the entire housing and is suitable for enclosing at least one section of an elongated medical device (such as a catheter, a pipe, a cable or a wire), and a disinfection chamber may form a part of the through hole. This allows the disinfection device to be mounted on the elongated medical device and is used to prevent harmful microorganisms (such as bacteria, etc.) from traveling along the elongated medical device into the patient's body. Additionally or alternatively, the housing may include a proximal end, a distal end, an attachment portion, and a through hole extending through both the attachment portion and the disinfection chamber, the through hole having a distal opening, the distal opening being positioned at the distal end of the housing and leading to the disinfection chamber, and the attachment portion being configured to retain a part of the medical device (such as a catheter pipe) in the through hole. The central axis may extend from the proximal end of the housing to the distal end of the housing. The through hole may extend parallel to the central axis. The proximal end of the housing is intended to be oriented toward the patient, and the distal end of the housing is intended to be oriented away from the patient. This will ensure that the germs moving toward the patient along the medical device are eliminated or at least reduced before entering the patient's body.

[0008] The diameter of the through hole of the attachment portion may substantially correspond to the outer diameter of the medical device designed to be retained. The medical device may be, for example, a catheter tube or a medical guidewire. The attachment portion may include at least one rib configured to retain the section of the medical device located in the through hole. The attachment portion may be configured to retain the section of the medical device located in the through hole axially and / or radially.

[0009] The through hole may have a substantially circular cross-section perpendicular to the central axis substantially from the distal end of the through hole to the proximal end of the through hole. The through hole may have a changing cross-section perpendicular to the central axis substantially from the distal end of the through hole to the proximal end of the through hole. The central axis of the housing may form the centerline of the through hole.

[0010] The distal opening may be positioned at one end of the through hole. The distal opening may be positioned adjacent to the sterilization chamber. The distal opening may lead directly to the sterilization chamber. The distal opening may be generally circular so as to provide a substantially uniform radial extent of air gap around the typically cylindrical catheter tubing. The distal opening may have a shape substantially the same as the medical device, such as circular to accommodate a segment of a catheter tubing or a medical guidewire.

[0011] The distal opening may have a diameter large enough to prevent pathogens from passing from the outer surface of the medical device through the air gap to the housing.

[0012] The housing may alternatively be configured to completely enclose the sterilization chamber without the through-hole extending throughout the device.

[0013] In some embodiments, a UV reflecting area is provided in the disinfection chamber. By reflecting UV light, it will increase UV exposure, thereby potentially improving disinfection efficiency.

[0014] The housing may include, or consist essentially of, a material such as a polymer material, which is configured to absorb UV light of at least the same wavelength as the light emitted by the at least one UV-LED. The housing may include a material that reflects the UV light emitted by the UV-LED. The housing may include, or consist essentially of, a combination of materials that absorb and reflect UV light, respectively. The use of such materials may help to realize a disinfection device in which the UV light emitted by the UV-LED is optimally used for disinfection of medical devices while preventing or reducing the emission of UV light from the disinfection device to the surrounding environment. Currently, it is particularly contemplated to use a material that is configured to absorb UV light at the edge of the disinfection chamber, such as at the proximal opening of the through hole at the proximal end (i.e., the opening facing the patient during use).

[0015] The housing may extend circumferentially around the central axis.The sterilization chamber and / or the attachment portion of the housing may extend circumferentially around the central axis.

[0016] The sterilization chamber may have a cavity that is filled with air, even when a medical device is positioned therein, thereby ensuring an air gap between the sterilization chamber and the medical device.

[0017] The disinfection device may include more than one UV-LED, for example at least two, three, four, five, or even more UV-LEDs. The UV-LEDs may emit different wavelengths, have different light intensities, or otherwise differ from each other.

[0018] The at least one UV-LED is configured to emit UV light into the disinfection chamber of the housing to disinfect the exterior surface and possibly even one or more interior surfaces of a medical device positioned in the disinfection chamber.

[0019] The disinfection device may include a circuit system that connects the integrated power supply to other electronic components, such as the control unit and the UV-LED. A power source, such as a battery, powers the at least one UV-LED.

[0020] The control unit may include any circuit and / or device suitable for performing the function of running multiple disinfection cycles. The control unit may include a general or special programmable microprocessor, such as a digital signal processor (DSP), an application specific integrated circuit (ASIC), a programmable logic array (PLA), a field programmable gate array (FPGA), a central processing unit (CPU), a microcontroller unit (MCU), a dedicated electronic circuit, etc., or a combination thereof. The control unit may be equipped with a receiver, a transmitter and / or a transceiver for receiving and transmitting signals via a wired or wireless connection.

[0021] The control unit may include volatile and / or non-volatile memory, such as random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), flash memory, etc. The control unit may include a data storage device. The data storage device may store one or more instructions to run a disinfection cycle consisting of different modes of on-period to off-period. The data storage device may store instructions for a calibration process. The data storage device may store patient information, such as a specific treatment program for a disinfection cycle. Storing instructions for running a disinfection cycle consisting of different modes of on-period to off-period can allow one disinfection device to be used for several different purposes, such as targeting different types of bacteria. It can also allow the disinfection process to vary over time, for example starting with a relatively long on-period to achieve initial disinfection, and then changing to a relatively short on-period to maintain disinfection over time.

[0022] The control unit may be configured to control the UV-LED by controlling the light emission, radiation intensity or wavelength range of the UV-LED. Additionally or alternatively, the control unit may be configured to control the UV-LED by running a plurality of disinfection cycles and by controlling, for example, the duration, periodic function or intensity of each on period during which UV light is emitted and each off period during which no UV light is emitted.

[0023] The plurality of sterilization cycles may follow a pattern where in each of the plurality of sterilization cycles the on period and the off period have the same duration, for example 10 seconds on and 10 seconds off.

[0024] The plurality of sterilization cycles may follow a pattern where in each of the plurality of sterilization cycles the on period and the off period have different durations, such as 30 seconds on and 300 seconds off, or 30 seconds on and 10 seconds off.

[0025] Multiple sterilization cycles may follow more complex patterns where the on and off periods change duration depending on the sterilization cycle, for example, sterilization cycle 1; on for 30 seconds and off for 300 seconds, sterilization cycle 2; on for 0.5 seconds and off for 10 seconds, sterilization cycle 3; on for 10 seconds and off for 10 seconds, etc.

[0026] The plurality of sterilization cycles may include at least 2, 3, 4, 5, 10, 20, 50 or 100 consecutive sterilization cycles, each sterilization cycle including an on period and an off period.

[0027] In some embodiments, each of the plurality of disinfection cycles includes an on period of at least 0.5 seconds in duration. Experiments have shown that a good degree of disinfection is achieved when the on period is at least 0.5 seconds in duration. However, since microorganisms require different UV doses to be eliminated, the exact duration required depends on the target microorganisms and the desired degree of disinfection.

[0028] In some embodiments, for each of the plurality of disinfection cycles, the duration of the off period is at least twice the duration of the on period. The duration of the off period being at least twice the duration of the on period provides low power consumption for the device and potentially also provides low UV exposure to the environment. As with selecting the correct on period duration, the duration of the off period can be subject to calibration and / or testing in order to establish an optimal duration for a particular microorganism or degree of disinfection.

[0029] In some embodiments, the UV-LED is configured to emit UV light in the wavelength range of 100 nm to 400 nm, preferably 200 nm to 315 nm, and more preferably 260 nm to 300 nm. These specific wavelengths have been proven to be germicidal, but can be calibrated and / or tested to establish the optimal wavelength for a specific microorganism, degree of disinfection, or power consumption and material degradation of a medical device.

[0030] In some embodiments, the total UV dose emitted by the UV-LEDs is at least 20.833 mJ / cm2 measured over 30 minutes. 2 , or 41.66 mJ / cm measured in 1 hour 2 , 500mJ / cm measured over 12 hours 2 , or 1000mJ / cm measured over 24 hours 2A device is thereby provided that can achieve at least a 1 log reduction in harmful microorganisms within any of the above time frames. UV dose refers to the UV intensity / irradiance delivered by the UV-LED multiplied by the duration of UV light exposure.

[0031] UV irradiance x time = UV dose, where intensity / irradiance will be measured by a calibrated optical probe no more than 1 cm away from the UV-LED.

[0032] As mentioned above, microorganisms require different UV doses to be eliminated. The UV dose dependence and the intensity (irradiance) from the UV-LED over time, as well as the efficacy against different microorganisms, also depends on the wavelength of the emitted UV light. A person skilled in the art can set up a small series of simple experiments without undue effort to establish a specific calibration of the duration of the switch-on period to meet a specific desired need, for example the UV dose required for a 3-log reduction of E. coli is described as 5.5 mJ / cm 2 , while for Staphylococcus aureus it is described as 7.8 mJ / cm 2 , described as 16.8 mJ / cm for Pseudomonas aeruginosa 2 .

[0033] The examples given above all involve bacteria, which are the most common cause of infection associated with the use of medical devices, but the disinfection devices and methods according to the present invention can also be used to prevent other types of infections caused by other types of harmful microorganisms (also known as pathogens, including but not limited to viruses and fungi).

[0034] While reference is primarily made to the elimination of microorganisms, it is understood that the weakening of microorganisms or a reduction in their number may be sufficient to prevent infection because the number of harmful microorganisms that reach the patient's body is reduced to a level that can be handled by the immune system.

[0035] In some embodiments, the integrated power source is a primary battery. Primary batteries provide a compact solution with high energy density and longer storage life. The primary battery can be a zinc-air battery or a lithium manganese dioxide battery, or any other suitable primary battery.

[0036] In some embodiments, the disinfection device is a single-use device, and the primary battery is designed for short-term use, with sufficient power capacity for 1 day, preferably 3 days, and more preferably 7 days of continuous use. Alternatively, the primary battery is designed for medium-term use, with sufficient power capacity for 7 days, preferably 14 days, and more preferably 30 days of continuous use. Alternatively, the primary battery is designed for long-term use, with sufficient power capacity for 30 days, preferably 45 days, and more preferably 60 days of continuous use. The need for device replacement is thereby minimized, thereby limiting the burden of use on patients and personnel.

[0037] In some embodiments, the device further comprises an antimicrobial or bacteria-repellent coating. This will further reduce the risk of infection in the patient by limiting the migration of microorganisms and / or by increasing the elimination of microorganisms.

[0038] In some embodiments, the disinfection device has a length, a width and a height, wherein the length is a maximum of 0.15 m measured along the longest axial length of the device, and the width and the height are both a maximum of 0.1 m measured in a direction perpendicular to the axial length. Thus, a compact and streamlined device is provided. The compact size improves the user experience of the patient, as the device will weigh less and the device takes up less space. Additionally, it makes the device an ideal point-of-care device.

[0039] In one embodiment which presently appears to be advantageous, the disinfection device has a length, a width and a height, wherein the length is a maximum of 0.05 m measured along the longest axial length of the device, and the width and height are both a maximum of 0.03 m measured perpendicular to the axial length.

[0040] Additionally or alternatively, the disinfection device has a maximum of 0.0015m 3 total volume.

[0041] In one embodiment which is currently considered advantageous, the disinfection device has a maximum 3 total volume.

[0042] In some embodiments, the disinfection device has an open configuration and a closed configuration, wherein the disinfection device is in the closed configuration during use.

[0043] The open configuration may enable a section of a medical device or a section of a medical device to be placed into the sterilization chamber, and the closed configuration encloses the UV-LED so that no UV light or only a very limited amount is emitted directly outside the sterilization chamber. In the open configuration, radial access may be provided to the sterilization chamber so that a medical device may be radially inserted into the sterilization chamber. This may allow the sterilization device to be attached to an extracorporeal section of a medical device (where a section is already positioned in a patient) and thus increase the usability of the device.

[0044] Additionally or alternatively, the housing comprises or consists of two parts interconnected by a hinge, the hinge being configurable into an open configuration and a closed configuration, wherein in the open configuration a radial passage is provided such that a segment of the medical device can be radially inserted into the sterilization chamber, and / or wherein the two parts of the housing surround the sterilization chamber in the closed configuration such that a segment of the medical device already present in an attachment portion of the housing can be at least radially retained.

[0045] This may offer the advantage of a particularly mechanically simple arrangement.

[0046] In the open configuration, the two parts may be positioned at a distance from each other.

[0047] The hinge may be a living hinge, which may be particularly suitable for this purpose as it is easier to clean the hinge. The hinge may alternatively be a pin-joint hinge or a floating hinge.

[0048] The hinge may include an internal cavity through which a portion of the device's integrated electronics or circuitry may extend.

[0049] Additionally or alternatively, the two parts of the housing may be in the form of halves of the housing and may be movable about a hinge axis of the hinge, which may be parallel to the centre axis of the through hole.

[0050] In some embodiments, when the disinfection device is in the open configuration, the activation of a switch or sensor connected to the control unit prohibits the emission of UV light. The advantages of stopping the emission of light in the open configuration may include preventing UV light leakage, which may irritate the skin, damage the eyes, or even have carcinogenic effects, and saving energy. The switch or sensor can work with the enabling device, wherein the switch or sensor is configured to cause at least one UV-LED to start emitting UV light when the sensor detects a signal from the enabling device (for example, to indicate that the housing is in the closed configuration). The signal from the enabling device can be caused by a magnetic field, an electric current, or a mechanical arrangement. The advantages of starting to emit light in the closed configuration may include improving the disinfection ability of the device because the device does not have to be actively turned on after being installed on the medical device.

[0051] Additionally or alternatively, the switch or sensor may be configured to stop at least one UV-LED from emitting UV light when the detector device detects that the housing is in an open configuration. The switch or sensor may be connected to the control unit, or alternatively, the switch may simply close or interrupt the circuitry of the device to connect or disconnect power from the integrated power supply to the UV-LED.

[0052] According to a second aspect of the invention, the object is achieved by providing a method for disinfecting at least one section of a medical device, the method comprising: placing a disinfection device in contact with at least one section of the medical device, such that the disinfection device at least partially encloses the section of the medical device; and causing a control unit comprised by the disinfection device to run a plurality of disinfection cycles, each disinfection cycle comprising an on period during which UV light is emitted from a UV-LED and an off period during which no UV light is emitted, wherein the UV light emitted during the on period is emitted directly onto the section of the medical device intended to be disinfected. A disinfection method is thereby provided, which provides good disinfection, with low power consumption, low heat generation, and limited emission of UV light to the surrounding environment.

[0053] In some embodiments, the on period has a duration of at least 0.5 seconds.Longer periods of continuous light emission may also increase the rate of disinfection, as microbial DNA and / or RNA repair mechanisms cannot keep up with the damage provided by continuous UV light emission.

[0054] In some embodiments, the duration of the off period is at least twice the duration of the on period in each disinfection cycle. Longer off periods between on periods provide a method of consuming less power and having lower UV exposure to the environment.

[0055] Some embodiments further include running the plurality of disinfection cycles for at least 1 hour, thereby allowing the continued UV emission to accumulate into a total UV dose over a period of 1 hour or longer.

[0056] Some embodiments further include running multiple disinfection cycles for up to 60 days. Current investigations have shown good results for continuous disinfection of urinary catheters using the device. These catheters are often used for long periods of time, so enabling continuous disinfection will be beneficial in keeping patients free of infection. Similar good results are expected for all kinds of medical catheters and other elongated medical devices.

[0057] Some embodiments further include: causing the control unit to stop the plurality of disinfection cycles; removing the disinfection device from the medical device; and / or disposing of the disinfection device. The disinfection device is primarily intended as a single-use device to mitigate the risk of transferring infection between users. Therefore, proper disposal is important.

[0058] In some embodiments, when the disinfection device is in the open configuration, the UV-LED is automatically turned off, thereby stopping any emission of UV light. As described in relation to the first aspect, stopping any UV light emission when the disinfection device is in the open configuration acts as a safety feature to ensure minimal UV exposure from the disinfection device to the surrounding environment.

[0059] Additionally or alternatively, the purpose of the second aspect of the present invention can be achieved by providing a method for disinfecting at least a section of a medical device, the method comprising: a. at least partially enclosing at least a section of the medical device in a disinfection device; b. exposing the section of the medical device to UV light emitted by a UV-LED included in the disinfection device for a duration of at least 0.5 seconds, c. turning off the emission of UV light, the duration being at least twice the duration of the previous step b.; d. repeating steps b. and c., with a total duration of at least one hour.

[0060] Some embodiments further comprise shutting off the emission of UV light if at least one of the following occurs: the medical device is removed from contact with the disinfection apparatus; and the disinfection apparatus is turned on.

[0061] Unless otherwise stated, embodiments and advantages described with reference to the first aspect also apply to the second aspect, and vice versa. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] Figure 1 showing a perspective view of a disinfection device attached to a section of catheter tubing,

[0063] Figure 2a Shows Figure 1 Side view of the sterilization device and catheter fittings,

[0064] Figure 2b Shows the disinfection device and catheter tubing along Figure 2a A side cross-sectional view of section line BB,

[0065] Figure 3 shows a perspective view of the disinfection device in an open configuration without the catheter tubing,

[0066] Figure 4a Shows Figure 3 A side view of a disinfection device,

[0067] Figure 4b Shows the disinfection device along Figure 4a A cross-sectional view of section line CC,

[0068] Figure 4c Shows the disinfection device along Figure 4a A cross-sectional view of the section line DD,

[0069] Figure 5 Corresponds to Figure 1 However, different embodiments of the disinfection device are shown.

[0070] Figure 6 Corresponds to Figure 3 But it shows Figure 5The embodiments in

[0071] Figure 7 Shows Figure 5 and Figure 6 a disinfection device when used on a urinary catheter, and

[0072] Figure 8a -e shows different embodiments of the sterilization cycle. DETAILED DESCRIPTION

[0073] First reference Figure 1 and Figure 2a , the disinfection device 1 is shown with a medical device 9 (in the form of a catheter tubing 9) extending therethrough. Although reference will be made primarily to the catheter tubing 9, it will be appreciated that this is merely an example and that the disinfection device may also be used for wires or other elongated items protruding into a patient's body.

[0074] The disinfection device 1 comprises a housing 2 having a proximal end 2a, a distal end 2b and an outer surface 28. The proximal end 2a of the housing 2 is intended to be oriented toward the patient in the use state of the disinfection device, and the distal end 2b of the housing 2 is intended to be oriented away from the patient. The outer surface 28 of the housing 2 faces the outside of the disinfection device 1 and has a streamlined curved shape from the proximal end 2a to the distal end 2b without sharp edges or corners, so as to prevent pressure sores from being caused if the disinfection device 1 ends under the patient. The housing 2 comprises a through hole 24 having a circular proximal opening 24a located at the proximal end 2a of the housing 2 and a circular distal opening 24b located at the distal end 2b of the housing 2.

[0075] Steering Figure 2b , the central axis 26 extends from the proximal end 2a of the housing 2 to the distal end 2b of the housing 2. The central axis 26 of the housing 2 forms the center line of the through hole 24. The through hole 24 has a circular cross section perpendicular to the central axis 26 from the distal opening 24b at the distal end 2b of the housing 2 to the proximal opening 24a at the proximal end 2a of the through hole 24.

[0076] The housing 2 comprises an attachment portion 21, a sterilization chamber 22, and a through hole 24 extending through both the attachment portion 21 and the sterilization chamber 22. The through hole 24 leads directly into the sterilization chamber 22 from a distal opening 24b. A section of the catheter tube 9 is retained in the through hole 24 by the attachment portion and the centering member 27.

[0077] The disinfection chamber 22 includes a wall surface 23 extending between the UV-LED 6 and the distal opening 24b. The wall surface 23 forms an inner surface of the through hole 24 extending in the circumferential direction and the axial direction. The distal opening 24b forms a boundary of the wall surface 23.

[0078] Reference now Figure 3, which shows the disinfection device 1 in an open configuration. The housing 2 comprises a floating hinge 5 connecting a first half 41 and a second half 42 of the housing 2 to each other. The halves 41, 42 of the housing 2 are movable about a hinge axis 51 of the hinge 5, which is parallel to the central axis 26. The hinge 5 allows the disinfection device 1 to be arranged in a position such as Figure 3 and Figures 4a to 4c The open configuration shown, and Figure 1 and Figure 2a to Figure 2b The open configuration provides radial access to the through hole 24 so that a section of a catheter tube or other elongated medical device can be radially inserted into the through hole 24 and attached to the housing 2 via the attachment portion 21 of the housing 2. In the open configuration, the two halves 41, 42 radially surround the catheter tube 9 in the through hole 24 to radially retain the catheter tube 9 in the through hole 24.

[0079] In this embodiment, the disinfection device 1 comprises a centering member 27 in the form of a tube holder, such as Figure 3 In the closed position, the centering member 27 is attached to the catheter tube 9 by elastic deformation and snapping onto the outer surface 92 of the catheter tube 9. The centering member 27 biases the catheter tube 9 toward the center line of the sterilization chamber 22, i.e., the center axis 26, as shown. Figure 2b The centering member 27 is essentially made of UV translucent or UV transparent material.

[0080] The attachment portion 21 of this embodiment includes three ribs 210, which are configured to retain the section of the catheter tube 9 located in the through hole 24. The diameter of the through hole 24 in the sterilization chamber portion of the housing is larger than the diameter of the through hole 24 at the ribs 210 of the attachment portion 21 of the housing 2, so that when the catheter tube 9 is retained in the through hole 24 by the attachment portion 21 of the housing 2, an air gap 3 is formed between the sterilization chamber 22 and the catheter tube 9, as shown in FIG. Figure 2b It can be seen between the centering member 27 and the wall surface 23 of the disinfection chamber 22.

[0081] The UV-LED 6 is in the form of a light emitting diode configured to emit germicidal UV light having a wavelength in the range of 100 nm to 400 nm, preferably 200 nm to 315 nm, and more preferably 260 nm to 300 nm into the disinfection chamber 22 of the housing 2. The UV-LED 6 is located in the disinfection chamber 22 and emits light thereto to disinfect the portion of the catheter tubing 9 located in the disinfection chamber.

[0082] The control unit 83 is configured to control the UV-LED 6 to emit UV light in a plurality of sterilization cycles, the sterilization cycles comprising an on period during which light is emitted and an off period during which no light is emitted. Figure 8a -e Describe the disinfection cycle in more detail.

[0083] The wall surface 23 of the disinfection chamber 22 consists essentially of a polymer material that is configured to at least partially absorb UV light.

[0084] The UV-LED 6 is positioned in the light well 63, as in Figure 3 and Figure 4c This ensures that the light emitted from the UV-LED 6 essentially leaves the light well 63 as a light column 61 centered around the optical axis 62 of the UV-LED 6, as best seen in FIG. Figure 4c As shown by the dotted line in Figure 4c As can be seen, the optical axis 62 of the UV-LED 6 is substantially perpendicular to the central axis, so that the light emitted directly by the UV-LED 6 is received and at least partially absorbed by the opposite side of the wall surface of the disinfection chamber 22, the centering member 27 or the outer surface 92 of the catheter tube 9. This has the advantage that the intensity / irradiance of the UV light reaching the distal opening 24b of the through hole 24 is kept to a minimum.

[0085] As in Figures 4a to 4c As best seen in FIG. 1 , the disinfection device 1 further comprises an activation device 81 in the form of a protruding pin, a switch 82, a control unit 83, and a power source 7 in the form of a primary battery. The circuit system interconnects the control unit 83, the switch 82, the UV-LED 6, and the power source 7. The power source is configured to provide power to the circuit system, thereby providing power to the control unit 83 and the UV-LED 6. The activation device 81 is positioned on the second half 42 of the housing 2, and the switch 82 is positioned on the first half 41 of the housing 2.

[0086] In the open configuration, Figure 3 As shown, the enabling device 81 is positioned at a distance from the switch 82, thereby disconnecting the power source 7 from the UV-LED 6, causing the UV-LED 6 to stop emitting UV light.

[0087] In the closed configuration, Figure 1 and Figure 2a to Figure 2b As shown, the enabling device 81 contacts the switch 82, thereby connecting the power supply 7 to the UV-LED 6, causing the UV-LED 6 to begin emitting UV light in a pre-programmed disinfection cycle.

[0088] Alternatively, instead of disconnecting the power source 7 from the UV-LED 6, the switch 82 may cause the control unit 83 to switch the UV-LED 6 on and off. In this case, the device 1 will preferably have two or more switches 82 of the same or multiple types, thereby ensuring a redundant and safe mechanism to switch off the UV-LED 6 emitting UV light when the device 1 is in the open configuration, thereby making the device 1 single-fail safe. Examples of suitable switches for such applications are Hall effect sensors and reed switches.

[0089] Figures 5 to 7 In the figures and in the description relating thereto, different embodiments of the disinfection device 1' are shown. In these figures and in the description relating thereto, the same reference is used for features having the same function even if they are not necessarily identical. Figure 1 To avoid excessive repetition, only the following will be described in detail. Figures 5 to 7 Examples and references Figure 1 The difference to the embodiment described in FIG. 4 .

[0090] Figure 5 The disinfection device 1' is shown mounted on a catheter tube 9 and Figure 6 1 shows a disinfection device in an open configuration. As can be seen, this disinfection device 1 ' has a Figure 1 The disinfection device 1 in FIG. 4 has a more rounded outer shape, and the cross section of the through hole 24 through the device 1 is not completely circular.

[0091] In order to be able to attach the disinfection device 1 ′ to the catheter tube 9 as close as possible to the opening 101 in the patient's body 100 (see Figure 7 ), thereby minimizing the area on the catheter tubing through which microorganisms can bypass the device, a soft, resilient foam / silicone material in the form of a proximal portion 29 is added to the proximal end 2a of the device 1'. When a catheter or another elongated medical device is inserted through an opening 101 in a patient's body 100, the proximal portion 29 is positioned proximal to the opening 101 in the patient's body 100, such as Figure 5 and Figure 7 As shown. Figure 7 In the embodiment, the catheter tube 9 is a urinary catheter inserted into the urethra of a male patient, but it can also be used for female patients or for different types of elongated medical devices, such as abdominal catheters or wires for temporary pacemakers.

[0092] The provision of the proximal portion 29 reduces the risk of the disinfection device 1' exerting pressure on the patient's body. Figure 7 This pressure can be particularly unpleasant when used on the genitals as indicated and can also lead to skin damage and therefore increased risk of infection.

[0093] Another advantage of the soft and flexible proximal portion 29 is that it reduces the risk of the catheter tubing 9 being pulled or pushed when the patient moves. Figure 7 In the example of , the catheter tubing 9 is held in place in the patient's bladder 102 by a balloon 93 arranged on the section of the catheter tubing extending into the bladder. The balloon prevents the catheter tubing 9 from being pulled out, but does not prevent it from being pushed further in. The provision of the proximal portion 29 allows the disinfection device 1 ' to be positioned very close to the opening in the patient's body, in this case as little as about 1 mm from the opening, which in itself reduces the risk of the catheter tubing 9 being pushed inwards. Furthermore, the elasticity of the material of the proximal portion 29 means that it can compensate for some movement.

[0094] As mentioned above Figure 3 As stated, Figures 5 to 7 The disinfection device 1 ' is also composed of two halves 41, 42, which are connected to each other at a hinge 5, such as Figure 6 The proximal portion 29 is also composed of two halves 29a, 29b, each associated with a respective half 41, 42 of the device.

[0095] To ensure that the disinfection device 1' is tightly closed around the catheter tube 9, a convex locking portion 43 is provided in the first half 41 and a concave locking portion 44 is provided on the second half 42. Figure 6 The open configuration in moves to Figure 5 Furthermore, one half 29b of the proximal portion 29 is provided with an adhesive (not visible), which is covered by the cover sheet 292. Before closing the disinfection device 1 ' around the catheter tubing 9, the cover sheet will be removed so that the two halves 29a, 29b of the proximal portion 29 adhere to each other in the open configuration.

[0096] Other means for locking the two halves 41, 42 to each other and / or for connecting the two halves 29a, 29b of the proximal portion are also possible, including the use of tape and hook-and-loop fasteners, such as Velcro. Figure 6 As can be seen in the figure, this embodiment of the disinfection device 1 ' comprises a series of centering members 27 protruding from the inner wall surface 23 at the distal end. Each of these centering members 27 contacts the catheter tubing 9 and helps to keep it centered with the disinfection device. The advantage of using these centering members is that the contact area with the catheter tubing is small.

[0097] Figures 5 to 7The embodiment in FIG. 1 comprises a UV-reflecting area 25 on the inner wall surface 23, which extends from the rib marked 210' of the attachment part 21 to the centering member 27. The surface of the UV-reflecting area is made of a material that reflects UV radiation. Due to the reflection of the UV light emitted by the UV-LED 6, the UV-reflecting area is different from that if a UV-reflecting area without UV-reflecting area or with a centering member as in reference 1 is used. Figure 3 The conduit tubing 9 extending through the sterilization chamber 22 will be subject to increased UV exposure compared to a corresponding sterilization device described in FIG. 4 that is configured to absorb UV light from a wall surface.

[0098] Figures 5 to 7 The embodiment in the embodiment further comprises a control unit 83, which is configured to control the UV-LED 6 to emit UV light in a plurality of disinfection cycles, the disinfection cycle comprising as described in reference Figure 4c The device 1' further comprises an enabling device 81' and a switch unit 82', the enabling device and the switch unit are configured to when the disinfection device 1' is as described in reference Figure 4a -c When turned on as described above, the UV-LED 6 stops emitting UV light. Figure 6 The switch unit 82' shown comprises two switches, both of which work in conjunction with the enabling device, so that if one of the switches fails, the device 1' still has an active safety mechanism, i.e., shutting off the emission of UV light by the UV-LED 6 when the device 1' is in the open configuration. In the embodiment shown, the switches are reed switches and Hall effect sensors, and the enabling device 81' is a magnet. However, other choices of the type of enabling device and switch are also conceivable within the scope of the invention.

[0099] Although the activation device 81' and the switch unit 82' described with respect to this embodiment are placed separately from the male locking portion 43 and the female locking portion 44, it is conceivable that the device 1' is designed to integrate the activation device 81' and the switch unit 82' into the male locking portion 43 and the female locking portion 44. Likewise, the activation device 81' and the switch unit 82' may be integrated into either the first half 41 or the second half 42 of the device 1'.

[0100] Finally go to Figure 8a -e, which shows some examples of sterilization cycles that can be programmed into the control unit 83 and run by the control unit.

[0101] The purpose of running multiple disinfection cycles is to expose a section of a medical device (such as the catheter 9 described above) to a sufficiently high UV dose for a period of time to eliminate most harmful microorganisms present on and moving along it, while limiting the amount of UV light emitted. By limiting the emission of UV light, the device 1 will consume less power, generate less heat, and the UV exposure caused to the surrounding environment is limited.

[0102] The disinfection cycle is composed of an on period during which light is emitted from the UV-LED 6 and an off period during which light is not emitted from the UV-LED 6. Figure 8a -e, the horizontal axis represents time and the vertical axis represents light intensity. Figure 8a -e shows multiple disinfection cycles in each. When light is emitted, the graph shows a certain light intensity. During each off period, the light intensity is zero. Over a certain period of time, the individual light intensities from the on periods will accumulate and reach the desired UV dose defined by the area under the graph. There are several ways to obtain the desired UV dose. Figure 8a shows the case where the duration of the on-period and the off-period are equal. Figure 8b In the embodiment, the duration of the off period is twice the duration of the on period. Figure 8c The situation is shown where the duration of the off-period is many times the duration of the on-period, here approximately ten times the duration of the on-period. Figure 8a -c shows some possible arrangements for multiple sterilization cycles, however other relationships between the duration of the on period and the duration of the off period are also conceivable, including relationships in which the duration of the off period is shorter than the duration of the on period in each sterilization cycle. It is also important to note that successive sterilization cycles need not be identical, but rather multiple sterilization cycles may be complex, such as Figure 8d The duration of the on-time and off-time periods may vary from sterilization cycle to sterilization cycle and also vary within each sterilization cycle. Figure 8e As shown, the maximum intensity reached in each on-period can be accumulated and gradually eliminated over a portion of the duration of the on-period, and the light intensity can also be gradually increased and decreased, which will produce a curve graph. Likewise, the accumulation and gradual elimination sequences can have different durations, resulting in different on-periods for multiple disinfection cycles. Multiple disinfection cycles can include disinfection cycle types with intensities from 0 to 100% and disinfection cycle types with intensity accumulation, which are arranged in any desired combination, including on-periods with lower intensities than other on-periods.

[0103] In order to achieve a sufficiently high disinfection quality, different configurations of the device can be applied. A person skilled in the art understands that there are many ways to configure the device and design a disinfection cycle in order to achieve this goal. Taking into account the wavelength and intensity of the UV light emitted by the UV-LED, and the on-period and off-period of the disinfection cycle, some examples of complete device configurations are provided below.

[0104] Example 1: 275-280nm, 30 seconds on, 300 seconds off, 1mJ / s / cm 2 .

[0105] Example 2: 275-280nm, 3 seconds on, 30 seconds off, 1mJ / s / cm 2 .

[0106] Example 3: 275-280nm, 1 second on, 5 seconds off, 2mJ / s / cm 2 .

[0107] Example 4: 275-280 nm, on for 60 seconds, off for 600 seconds, 0.5 mJ / s / cm 2 .

[0108] The following is a list of reference numerals used throughout this specification. If in doubt, please use the reference numerals in the following list.

[0109] 1 Disinfection device

[0110] 2 Housing

[0111] 2a Proximal

[0112] 2b Far End

[0113] 21 Attachment

[0114] 210 Ribs

[0115] 22 Disinfection Room

[0116] 23 Wall surface

[0117] 24 Through Holes

[0118] 24a Proximal opening

[0119] 24b Distal opening

[0120] 25 Reflection Zone

[0121] 26 Central axis

[0122] 27 Centering member

[0123] 28 External surface

[0124] 29 Proximal part

[0125] 29a First half of the proximal part

[0126] 29b Second half of the proximal portion

[0127] 292 Covering sheet on proximal portion

[0128] 3 Air Gap

[0129] 41 First Half

[0130] 42 The Second Half

[0131] 43 Locking part on the first half

[0132] 44 Locking part on the second half

[0133] 5. Hinge

[0134] 51 Hinge axis

[0135] 6 UV-LED

[0136] 61 Light Column

[0137] 62 Optical axis

[0138] 63 light well

[0139] 7 Power Supply

[0140] 81 Enabling device

[0141] 82 Switch

[0142] 82' Switch Unit

[0143] 83 Control Unit

[0144] 9. Catheter fittings

[0145] 92 External surface

[0146] 93 Balloon

[0147] 100 Patient Body

[0148] 101 Openings in the patient's body

[0149] 102 Bladder

Claims

1. A disinfection device for disinfecting medical equipment, the disinfection device comprising: a housing including a sterilization chamber adapted to at least partially enclose a section of the medical device; at least one ultraviolet light emitting diode (UV-LED) configured to emit UV light directly into the disinfection chamber; a control unit configured to control the UV-LED; as well as an integrated power supply connected to the UV-LED; in The control unit is further configured to run a plurality of disinfection cycles, each disinfection cycle including an on-period during which UV light is emitted from the UV-LED and an off-period during which UV light is not emitted from the UV-LED.

2. The disinfection device according to claim 1, wherein: At least one sterilization cycle of the plurality of sterilization cycles includes an on period having a duration of at least 0.5 seconds.

3. The disinfection device according to claim 1 or 2, wherein: For each sterilization cycle of the plurality of sterilization cycles, the duration of the off period is at least twice the duration of the on period.

4. The disinfection device according to any one of claims 1 to 3, wherein: The UV-LED is configured to emit germicidal UV light in the wavelength range of 100 nm to 400 nm, preferably 200 nm to 315 nm, more preferably 260 nm to 300 nm.

5. The disinfection device according to any one of claims 1 to 4, wherein: The total UV dose emitted by the UV-LED is at least 20.833 mJ / cm2 measured over 30 minutes. 2 , or 41.66 mJ / cm measured in 1 hour 2 , or 1000mJ / cm measured over 24 hours 2 .

6. A disinfection device according to any one of the preceding claims, wherein: The housing comprises a through hole extending throughout the housing and adapted to enclose at least a section of an elongate medical device, such as a catheter, a tube, a cable or a wire, and wherein the sterilization chamber forms part of the through hole.

7. A disinfection device according to any one of the preceding claims, wherein: The integrated power source is a primary battery.

8. The disinfection device according to claim 7, wherein: The disinfection device is a single-use device and the primary battery has sufficient power capacity for at least 1 day, or 3 days, or 7 days, or 14 days, or 30 days, or 45 days or 60 days of continuous use.

9. A disinfection device according to any one of the preceding claims, wherein: The disinfection device has a maximum 3 total volume.

10. A disinfection device according to any one of the preceding claims, wherein: The disinfection device has an open configuration and a closed configuration, wherein the disinfection device is in the closed configuration during use.

11. A method for sterilizing at least a section of a medical device, the method comprising: placing a disinfection device in contact with at least a section of the medical device such that the disinfection device at least partially encloses the section of the medical device; as well as A control unit included in the disinfection device is caused to run a plurality of disinfection cycles, each disinfection cycle comprising an on-period during which UV light is emitted from the UV-LED and an off-period during which no UV light is emitted, wherein the UV light emitted during the on-period is directly emitted onto a section of the medical device intended to be disinfected.

12. The method according to claim 11, wherein: The on-period has a duration of at least 0.5 seconds.

13. The method according to claim 11 or 12, wherein: In each sterilization cycle, the duration of the off period is at least twice the duration of the on period.

14. The method according to any one of claims 11 to 13, further comprising running the plurality of sterilization cycles for at least 1 hour.

15. The method of any one of claims 11 to 14, further comprising running the plurality of sterilization cycles for up to 60 days.

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