Sterilization device and method for sterilizing medical equipment

Abstract

A sterilization device for sterilizing a medical device, comprising: a housing having a sterilization chamber adapted to at least partially surround an area of ​​the medical device; at least one ultraviolet light emitting diode (UV-LED) configured to directly irradiate ultraviolet light into the sterilization chamber; a control unit configured to control the UV-LED; and an internal power supply connected to the UV-LED, wherein the control unit is further configured to perform a plurality of sterilization cycles, each cycle comprising an on period during which ultraviolet light is emitted from the UV-LED and an off period during which ultraviolet light is not emitted from the UV-LED.

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present invention relates to a sterilization device and method for sterilizing medical instruments, and more particularly to a device and method for sterilizing medical instruments through the use of germicidal ultraviolet (UV) light. [Background technology]

[0002] Sterilization of medical devices is an established practice in healthcare settings to minimize the risk of infection for patients during medical procedures. However, the use of sterile medical devices does not always fully guarantee patient safety. In procedures involving invasive catheters or tubing, continuous sterilization or replacement is necessary because infection can occur due to the migration of microorganisms along the catheter or tubing. Various types of clinical UV sterilization devices exist, one example of which is described in WO2020200389. While such devices can provide good sterilization, further optimization is needed in terms of usage time, risk of overheating, and minimizing UV exposure of patients, staff, and / or medical devices. Excessive exposure can pose health risks and material degradation. Summary of the Invention

[0003] The object of the present invention is to provide a sterilization apparatus and method for sterilizing medical instruments that overcomes at least some of these problems. In particular, it is desirable to provide a sterilization apparatus and method that can maintain or improve the safety and quality of sterilization even after long-term use.

[0004] According to a first aspect of the present invention, this and other objects are achieved by providing a sterilization device for sterilizing a medical device, the sterilization device comprising: a housing having a sterilization chamber adapted to at least partially surround an area of ​​the medical device; at least one ultraviolet light emitting diode (UV-LED) configured to irradiate ultraviolet (UV) light directly into the sterilization chamber; a control unit configured to control the UV-LED; and an internal power supply connected to the UV-LED, wherein the control unit is further configured to perform a plurality of sterilization cycles, each cycle comprising an on period during which ultraviolet light is emitted from the UV-LED and an off period during which ultraviolet light is not emitted from the UV-LED.

[0005] This device configuration increases device usage time compared to prior art devices. This is because sterilization occurs in multiple sterilization cycles with no or very limited power consumption during off periods. Therefore, device power consumption is reduced. Furthermore, the off periods result in less heat generation, reducing the risk of overheating the sterilizer, which may result in greater patient safety. Third, because UV light is only emitted during the on periods, the overall total UV dose may be lower compared to continuous illumination. This increases the safety of patients and staff in the surrounding environment, while also reducing the risk of degradation of the medical device itself.

[0006] The purpose of performing multiple sterilization cycles is to achieve sterilization of at least one area of ​​a medical device. Sterilization means exposing the medical device to UV light for a period of time sufficient to achieve at least a one-log reduction in harmful microorganisms, also known as bacteria, present on the medical device. The reduction in harmful microorganisms should be achieved while limiting UV exposure, thereby reducing the device's power consumption, generating less heat, and limiting the amount of UV light that can reach the surrounding environment.

[0007] The housing may include a through-bore extending therethrough, the through-bore adapted to enclose at least a section of an elongated medical device, such as a catheter, tube, cable, or wire. The sterilization chamber may form a portion of the through-bore. This allows the sterilization device to be attached to the elongated medical device and used to prevent harmful microorganisms, such as bacteria, from entering a patient's body along the elongated medical device. Additionally or alternatively, the housing may include a proximal end, a distal end, a mounting portion, and a through-bore extending through both the mounting portion and the sterilization chamber, the through-bore having a distal opening located at the distal end of the housing that opens into the sterilization chamber, the mounting portion configured to hold a portion of the medical device, such as a catheter tube, within the through-bore. A central axis may extend from the proximal end of the housing to the distal end of the housing. The through-bore may extend parallel to the central axis. The proximal end of the housing is intended to face the patient, and the distal end of the housing is intended to face away from the patient. This ensures that bacteria traveling along the medical device towards the patient are eliminated, or at least reduced, before they enter the patient.

[0008] The diameter of the through hole of the mounting portion can substantially match the outer diameter of the medical device it is designed to hold. The medical device can be, for example, a catheter tube or a medical guidewire. The mounting portion can include at least one rib configured to hold a section of the medical device placed in the through hole. The mounting portion can be configured to axially and / or radially hold a section of the medical device placed in the through hole.

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

[0010] The distal opening may be located at the end of the through-hole. The distal opening may be located adjacent to the sterilization chamber. The distal opening may lead directly to the sterilization chamber. The distal opening may be substantially circular so as to provide an air gap having a substantially uniform radial extent around the typically cylindrical catheter tube. The distal opening may have substantially the same shape as the medical device, for example, a circular shape, to accommodate a section of the catheter tube or medical guidewire.

[0011] The distal opening may have a sufficiently large diameter so that bacteria cannot cross the air gap from the exterior surface of the medical device to the housing.

[0012] Alternatively, the housing may be configured to completely enclose the sterilization chamber without any through holes extending through the device.

[0013] In some embodiments, a UV reflection zone is provided within the sterilization chamber to reflect UV light, potentially improving the effectiveness of sterilization by increasing UV exposure.

[0014] The housing may consist essentially of, or may consist of, a material configured to absorb ultraviolet light at the wavelength of light emitted by at least one UV-LED, such as a polymeric material. The housing may consist of a material that reflects the ultraviolet light emitted by the UV-LED. The housing may consist essentially of, or may consist of, a combination of a material that absorbs and a material that reflects ultraviolet light, respectively. The use of such materials may facilitate a sterilization device in which the ultraviolet light emitted by the UV-LED is optimally used to sterilize medical devices, while at the same time preventing or reducing ultraviolet light radiation from the sterilization device to the surroundings. It is currently particularly contemplated to use a material configured to absorb ultraviolet light at the edge of the sterilization chamber, for example, at the proximal opening of the through-hole at the proximal end, i.e., the opening that faces the patient during use.

[0015] The housing may extend circumferentially about a central axis. The sterilization chamber and / or mounting portion of the housing may extend circumferentially about the central axis.

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

[0017] A disinfection device may include more than one UV LED, for example, at least 2, 3, 4, 5, or more UV LEDs, which may emit different wavelengths, have different light intensities, or be different from one another.

[0018] The at least one UV-LED is configured to irradiate ultraviolet light into the sterilization chamber of the housing to sterilize an exterior surface, and optionally one or more interior surfaces, of a medical device placed in the sterilization chamber.

[0019] The disinfection device may include circuitry connecting the built-in power supply to other electronic components such as a control unit and UV LEDs. A power source, such as a battery, provides power to at least one UV LED.

[0020] The control unit may comprise any circuitry and / or devices suitably adapted to perform the function of implementing multiple sterilization cycles. The control unit may comprise a general-purpose or special-purpose 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), special-purpose electronic circuitry, etc., or a combination thereof. The control unit may be provided with a receiver, transmitter, and / or transceiver for receiving and transmitting signals via wired or wireless connections.

[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 for implementing different patterns of sterilization cycles having on-period to off-period configurations. 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 having a sterilization cycle. Storing instructions for implementing different patterns of sterilization cycles having on-period to off-period configurations allows a single sterilization device to be used for multiple different purposes, for example, to target different types of bacteria. It may also be possible to vary the sterilization process over time, for example, starting with a relatively long on-period to achieve initial sterilization and then changing to a relatively short on-period to maintain sterilization over time.

[0022] The control unit may be configured to control the UV-LEDs by controlling their emission, radiation intensity, or wavelength range. Additionally or alternatively, the control unit may be configured to control the UV-LEDs by performing multiple disinfection cycles and, for example, by controlling the duration, cyclic function, or intensity of each on period of ultraviolet radiation and each off period of no ultraviolet radiation.

[0023] The multiple sterilization cycles may follow a pattern where the on and off periods are of the same duration in every sterilization cycle of the multiple sterilization cycles, for example 10 seconds on and 10 seconds off.

[0024] The multiple sterilization cycles may follow a pattern where the on and off periods are of different durations in every sterilization cycle of the multiple sterilization cycles, for example, 30 seconds on and 300 seconds off, or 30 seconds on and 10 seconds off.

[0025] The multiple sterilization cycles may follow a more complex pattern where the on and off periods vary in duration from one sterilization cycle to the next, e.g., sterilization cycle 1 is 30 seconds on and 300 seconds off, sterilization cycle 2 is 0.5 seconds temperature and 10 seconds off, sterilization cycle 3 is 10 seconds on and 10 seconds off, etc.

[0026] The multiple sterilization cycles may comprise at least 2, 3, 4, 5, 10, 20, 50, or 100 consecutive sterilization cycles, each comprising an on period and an off period.

[0027] In some embodiments, each sterilization cycle of the plurality of sterilization cycles comprises an on-period having a duration of at least 0.5 seconds. Experiments have shown that using on-periods of at least 0.5 seconds duration results in high levels of sterilization. However, because different amounts of UV light are required to eliminate microorganisms, the exact duration required will vary depending on the microorganisms targeted and the level of sterilization desired.

[0028] In some embodiments, for each sterilization cycle of the plurality of sterilization cycles, the off period has a duration at least twice the duration of the on period. Having an off period at least twice the duration of the on period may provide a device that consumes less power and, potentially, may also reduce UV exposure to the environment. Similar to selecting an appropriate duration for the on period, the duration of the off period may be subject to calibration and / or testing to establish an optimal duration for a particular microorganism or sterilization level.

[0029] In some embodiments, the UV-LEDs are configured to emit germicidal UV light in the wavelength range of 100-400 nm, preferably 200-315 nm, and more preferably 260-300 nm. These specific wavelengths have been shown to be germicidal, but may be subject to calibration and / or testing to establish optimal duration for specific microorganisms or germicidal levels, power consumption, and material degradation of medical devices.

[0030] In some embodiments, the total UV radiation emitted by the UV-LED is at least 20.833 mJ / cm when measured over a 30 minute period. 2 , or 41.66 mJ / cm when measured over one hour. 2 , or 1000mJ / cm when measured over a 24-hour period. 2 This provides a device that can achieve at least a 1 log reduction in harmful microorganisms over any of the above time frames. UV dose refers to the UV luminosity / illuminance provided by the UV-LED multiplied by the UV exposure time.

[0031] UV irradiance x time = UV dose, where luminous intensity / irradiance is measured with a calibrated optical probe less than 1 cm away from the UV-LED.

[0032] As mentioned above, various UV doses are required to eliminate microorganisms. The UV dose dependency, the light intensity (illuminance) over time from the UV-LED, and the effectiveness against various bacteria also vary depending on the wavelength of the UV light emitted. Those skilled in the art will be able to set up simple small-scale experiments to establish a specific configuration of on-period duration that meets specific desired needs without undue effort. For example, the UV dose required to reduce E. coli by 3 logs is 5.5 mJ / cm. 2 In addition, for Staphylococcus aureus, it is 7.8 mJ / cm 2 and 16.8 mJ / cm for Pseudomonas aeruginosa. 2 It is said that...

[0033] While all of the above examples relate to bacteria, which are the most common cause of infections associated with the use of medical devices, the sterilization device and method of the present invention can also be used to prevent infections caused by other types of harmful microorganisms, also known as bacteria, including but not limited to viruses and fungi.

[0034] Although reference has been made primarily to the elimination of microorganisms, it should be understood that infection can be prevented by weakening or reducing the number of harmful microorganisms that reach the patient's body to a level that can be handled by the immune system.

[0035] In some embodiments, the built-in power source is a primary cell battery. Primary cell batteries have high energy density and longer shelf life, providing a compact solution. The primary cell battery can be a zinc-air battery or a lithium manganese dioxide battery, or any other suitable primary cell battery.

[0036] In some embodiments, the sterilizer is a disposable device and the primary battery is designed for short-term use with a power capacity sufficient 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 a power capacity sufficient 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 a power capacity sufficient for 30 days, preferably 45 days, and more preferably 60 days of continuous use. This limits the burden on patients and staff while minimizing the need for device replacement.

[0037] In some embodiments, the device further comprises an antimicrobial or bacteria-repellent coating, which further reduces the patient's risk of infection by limiting the transfer of microorganisms and / or removing more microorganisms.

[0038] In some embodiments, the sterilization device has a length, a width, and a height. The length, when measured along the maximum axial length of the device, is at most 0.15 m. The width and height, when measured perpendicular to the axial length, are both at most 0.1 m. This provides a device with compact dimensions and a streamlined design. The compact dimensions improve ease of use for patients by reducing the weight and space consumption of the device. The compact dimensions also make the device an ideal point-of-care device.

[0039] In one presently preferred embodiment, the sterilization apparatus has a length, a width, and a height. The length, measured along the maximum axial length of the apparatus, is at most 0.05 m. The width and height, measured perpendicular to the axial length, are both at most 0.03 m.

[0040] Additionally or alternatively, the sterilizer may have a maximum diameter of 0.0015 m 3 has a total volume of

[0041] In one presently preferred embodiment, the sterilization device has a maximum diameter of 0.000045 m 3 has a total volume of

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

[0043] The open configuration allows the section or sections of the medical device to be placed within the sterilization chamber. In the closed configuration, the UV-LEDs are enclosed so that no or negligible UV light is directly irradiated outside the sterilization chamber. In the open configuration, a radial access path to the sterilization chamber may be provided, allowing the medical device to be inserted radially into the sterilization chamber. This allows the sterilization device to be attached to an ex vivo section of a medical device already placed within a patient's body, improving the ease of use of the device.

[0044] Additionally or alternatively, the housing may comprise or consist of two parts interconnected by a hinge that is configurable into an open and a closed configuration, wherein a radial access path is provided in the open configuration to allow a section of medical equipment to be radially inserted into the sterilization chamber, and / or the two parts of the housing may enclose the sterilization chamber in the closed configuration to at least radially retain a section of medical equipment already present in the mounting portion of the housing.

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

[0046] The two portions may be positioned at a distance from each other in the open configuration.

[0047] The hinge may be a biological hinge, which may be well suited for this purpose as it is easy to clean. Alternatively, the hinge may be a pin-and-knuckle hinge or a floating hinge.

[0048] The hinge may include an internal cavity through which a portion of the electronics or circuitry incorporated into the device 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 is optionally parallel to the central axis of the through-hole.

[0050] In some embodiments, when the sterilization device is in the open configuration, activation of a switch or sensor connected to the control unit inhibits UV radiation. Benefits of turning off UV radiation in the open configuration may include energy savings as well as preventing UV radiation leakage, which can cause skin irritation, eye damage, and even carcinogenesis. The switch or sensor may operate in conjunction with an actuator. When the sensor detects a signal from the actuator, such as a signal indicating that the housing is in the closed configuration, the switch or sensor causes the at least one UV-LED to begin emitting UV radiation. The signal from the actuator may be generated by a magnetic field, an electric current, or a mechanical structure. Benefits of turning on UV radiation in the closed configuration may include improved sterilization capabilities of the device, since the device does not need to be actively turned on after being attached to a medical device.

[0051] Additionally or alternatively, a switch or sensor may be configured to cause at least one UV-LED to cease emitting ultraviolet light when the detection device detects that the housing is in the open configuration. The switch or sensor may be connected to the control unit. Alternatively, the switch may simply close or interrupt a circuit in the device, thereby disconnecting or connecting the UV-LED to power from the built-in power source.

[0052] According to a second aspect of the present invention, this object is achieved by a method for sterilizing at least one area of ​​a medical device, comprising the steps of: placing a sterilization device in contact with at least one area of ​​the medical device so that the sterilization device at least partially surrounds the area of ​​the medical device; and causing a control unit of the sterilization device to execute a plurality of sterilization cycles, each cycle comprising an ON period during which ultraviolet light is emitted from a UV-LED and an OFF period during which ultraviolet light is not emitted, wherein the ultraviolet light emitted during the ON period is directly irradiated onto the area of ​​the medical device intended to be sterilized. This provides a sterilization method that consumes little power, generates little heat, and provides good sterilization with limited ultraviolet light exposure to the surrounding area.

[0053] In some embodiments, the on-period has a duration of at least 0.5 seconds. Longer periods of continuous light emission may also improve the kill rate because the DNA and / or RNA repair mechanisms of the microorganisms cannot keep up with the damage caused by continuous UV irradiation.

[0054] In some embodiments, in each sterilization cycle, the off periods have a duration at least twice the duration of the on periods. Longer off periods between on periods provide a method that consumes less power and exposes the environment to less UV light.

[0055] Some embodiments further comprise performing multiple disinfection cycles for at least one hour, whereby successive UV exposures can accumulate to provide a total UV dose over a period of one hour or more.

[0056] Some embodiments further comprise performing multiple sterilization cycles for up to 60 days. Recent studies have shown good results when the device is used for continuous sterilization of urinary catheters. Because urinary catheters are often used for extended periods of time, the ability to provide continuous sterilization is advantageous in protecting patients from infection. Similar good results are expected for all types of medical catheters and other elongated medical devices.

[0057] Some embodiments further comprise the steps of causing the control unit to stop the multiple sterilization cycles, detaching the sterilization device from the medical device, and / or disposing of the sterilization device. The sterilization device is primarily intended to be a single-use device to reduce the risk of infection transmission between users, in which case proper disposal is important.

[0058] In some embodiments, the UV-LEDs are automatically turned off and UV radiation is stopped when the sterilizer is in the open configuration. As described for the first aspect, stopping UV radiation when the sterilizer is in the open configuration provides a safety valve to minimize UV ​​radiation exposure from the sterilizer to the environment.

[0059] Additionally or alternatively, the object according to a second aspect of the present invention may be achieved by providing a method for sterilizing at least an area of ​​a medical device, said method comprising the steps of: a. at least partially enclosing at least an area of ​​said medical device in a sterilization device; b. exposing said area of ​​said medical device to a UV-LED provided in said sterilization device for a duration of at least 0.5 seconds; c. turning off UV irradiation for a duration of at least twice the duration of the preceding step b; and d. repeating steps b and c for a total duration of at least 1 hour.

[0060] Some embodiments further comprise turning off the ultraviolet radiation when the medical device is removed from contact with the sterilization device and / or when the sterilization device is opened.

[0061] Embodiments and advantages described with reference to the first aspect also apply to the second aspect, and vice versa, unless stated otherwise. [Brief explanation of the drawings]

[0062] [Figure 1] FIG. 1 shows a perspective view of a sterilization device attached to a section of catheter tubing. [Figure 2a] 2 shows a side view of the sterilization device and catheter tube of FIG. 1. [Figure 2b] 2b shows a side cross-sectional view of the sterilization device and catheter tube along section line BB in FIG. 2a. [Figure 3] 1 shows a perspective view of the sterilization device in an open configuration, without a catheter. [Figure 4a] 4 shows a side view of the sterilization device of FIG. 3. [Figure 4b] 4a shows a cross-sectional view of the sterilization device along the cross-sectional line CC in FIG. 4a. [Figure 4c] 4b shows a cross-sectional view of the sterilization device along the cross-sectional line DD in FIG. 4a. [Figure 5] 1, but showing another embodiment of the sterilization device. [Figure 6] 3, but showing the embodiment of FIG. [Figure 7] 7 shows the disinfection device of FIGS. 5 and 6 being used on a urinary catheter. [Figure 8a] 1 illustrates an embodiment of a disinfection cycle. [Figure 8b] 10 illustrates another embodiment of a disinfection cycle. [Figure 8c] 10 illustrates another embodiment of a disinfection cycle. [Figure 8d] 10 illustrates another embodiment of a disinfection cycle. [Figure 8e] 10 illustrates another embodiment of a disinfection cycle. DETAILED DESCRIPTION OF THE INVENTION

[0063] 1 and 2a, a sterilization device 1 is shown with a medical device 9 in the form of a catheter tube 9 extending therethrough. While reference will be made primarily to a catheter tube 9, it will be understood that this is merely exemplary and that the sterilization device may also be used with wires or other elongated items that protrude into a patient's body.

[0064] The sterilization device 1 includes 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 face the patient when the sterilization device is in use, and the distal end 2b of the housing 2 is intended to face the opposite side of the patient. The outer surface 28 of the housing 2 faces the outside of the sterilization device 1 and has a streamlined, curved shape without sharp edges or corners from the proximal end 2a to the distal end 2b. This is to prevent bedsores from forming when the sterilization device 1 is placed underneath a patient. The housing 2 includes a through-hole 24. The through-hole 24 has 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.

[0065] 2b, a 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 centerline of the through-hole 24. The through-hole 24 has a circular cross-section perpendicular to the central axis 26 all the way 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.

[0066] The housing 2 comprises a mounting portion 21, a sterilization chamber 22, and a through-hole 24 that extends through both the mounting 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 tubing 9 is held within the through-hole 24 by the mounting portion and a centering member 27.

[0067] The sterilization chamber 22 includes a wall 23 extending between the UV (ultraviolet)-LEDs 6 and a distal opening 24b. The wall 23 forms an inner surface extending in the circumferential and axial directions of the through-hole 24. The distal opening 24b forms a boundary of the wall 23.

[0068] Referring to FIG. 3 , the sterilization device 1 is shown in an open configuration. The housing 2 includes a floating hinge 5 interconnecting the first and second housing halves 41 and 42. The halves 41 and 42 of the housing 2 are movable about a hinge axis 51 of the hinge 5. The hinge axis 51 is parallel to the central axis 26. The hinge 5 allows the sterilization device 1 to be set to the open configuration shown in FIGS. 3 and 4 a - 4 c and the open configuration shown in FIGS. 1 and 2 a - 2 b. The open configuration allows radial access to the through-hole 24, allowing a section of a catheter tube or other elongated medical device to be inserted radially into the through-hole 24 and attached to the housing 2 by the attachment portion 21 of the housing 2. In the open configuration, the two halves 41 and 42 radially surround the catheter tube 9, thereby radially holding the catheter tube 9 within the through-hole 24.

[0069] In this embodiment, as shown in Figure 3, the sterilization device 1 includes a centering member 27 in the form of a tube holder. In the closed position, the centering member 27 is attached to the catheter tube 9 by elastically deforming to engage the outer surface 92 of the catheter tube 9. The centering member 27 biases the catheter tube 9 toward the center line, or central axis 26, of the sterilization chamber 22, as best shown in Figure 2b. The centering member 27 consists essentially of a UV-semi-transparent or UV-transparent material.

[0070] The mounting portion 21 in this embodiment includes three ribs 210 configured to hold a section of the catheter tube 9 positioned within the through-hole 24. The diameter of the through-hole 24 is larger at the ribs 210 of the mounting portion 21 of the housing 2 in the sterilization chamber portion of the housing. Therefore, when the catheter tube 9 is held within the through-hole by the mounting portion 21 of the housing 2, an air gap 3 is formed between the sterilization chamber 22 and the catheter tube 9, as can be seen in Figure 2b between the centering member 27 and the wall 23 of the sterilization chamber 22.

[0071] The UV-LED 6 is in the form of a light-emitting diode and is configured to irradiate sterilization chamber 22 of housing 2 with germicidal ultraviolet light having a wavelength in the range of 100 to 400 nm, preferably 200 to 315 nm, and more preferably 260 to 300 nm. The UV-LED 6 is disposed within sterilization chamber 22 and irradiates the interior of sterilization chamber 22 with light to sterilize a portion of catheter tube 9 present within the sterilization chamber.

[0072] The control unit 83 is configured to control the UV-LEDs 6 to emit ultraviolet light in a number of disinfection cycles, each cycle comprising an ON period during which ultraviolet light is emitted and an OFF period during which ultraviolet light is not emitted, as will be described in further detail with reference to Figures 8a-8e.

[0073] The walls 23 of the sterilization chamber 22 consist essentially of a polymeric material configured to at least partially absorb ultraviolet light.

[0074] As best shown in Figures 3 and 4c, the UV-LEDs 6 are positioned in a light well 63. As shown by the dashed line in Figure 4c, this ensures that light emitted from the UV-LEDs 6 substantially exits the light well 63 as a light column 61 centered on the optical axis 62 of the UV-LEDs 6. Because the optical axis 62 of the UV-LEDs 6 is substantially perpendicular to the central axis, as shown in Figure 4c, light emitted directly from the UV-LEDs 6 is received and at least partially absorbed by the opposite side of the sterilization chamber 22, the centering member 27, or the outer surface 92 of the catheter tube 9. This has the advantage that the luminous intensity / illuminance of the UV light reaching the distal opening 24b of the through-hole 24 is kept to a minimum.

[0075] As best shown in Figures 4a-4c, the disinfection device 1 further comprises an actuator 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 cell battery. A circuit interconnects the control unit 83, the switch 82, the UV-LEDs 6, and the power source 7. The power source is configured to provide power to the circuit, and thus to the control unit 83 and the UV-LEDs 6. The actuator 81 is located in the second half 42 of the housing 2, and the switch 82 is located in the first half 41 of the housing 2.

[0076] 3, the actuator 81 is positioned at a distance from the switch 82. This disconnects the power supply 7 from the UV-LEDs 6, causing the UV-LEDs 6 to stop emitting ultraviolet light.

[0077] In the closed configuration, as shown in Figures 1 and 2a-2b, the actuator 81 contacts the switch 82 which connects the power supply 7 to the UV-LEDs 6, causing the UV-LEDs 6 to begin emitting ultraviolet light in a pre-programmed disinfection cycle.

[0078] Alternatively, instead of disconnecting the power supply 7 from the UV-LEDs 6, the control unit 83 may turn the UV-LEDs 6 on and off via a switch 82. In this case, the device 1 preferably has two or more switches 82 of the same or different types. This provides a redundant safety mechanism that turns off UV radiation from the UV-LEDs 6 when the device 1 is in an open configuration, making the device 1 safe against single-fault conditions. Examples of switches suitable for this application are Hall-effect sensors and reed switches.

[0079] Different embodiments of the sterilization device 1' are shown in Figures 5 to 7. In these figures and in the description relating thereto, features having the same function use the same reference numerals as in Figures 1 to 4, even if they are not identical. To avoid unnecessary repetition, only the differences between the embodiment of Figures 5 to 7 and the one described with reference to Figures 1 to 4 will be described in detail.

[0080] Figure 5 shows the sterilization device 1' mounted on a catheter tube 9. In Figure 6, the sterilization device is shown in an open configuration. As can be seen, this sterilization device 1' has a less rounded profile than the sterilization device 1 of Figures 1-4. The cross section of the through hole 24 through the device 1 is not perfectly circular.

[0081] In order to attach the sterilization device 1' to the catheter tube 9 as close as possible to the opening 101 in the patient's body 100 (see FIG. 7), thereby minimizing the area of ​​the catheter tube through which microorganisms can bypass the device, a soft and 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 other elongated medical device, is inserted through the opening 101 in the patient's body 100, the proximal portion 29 is positioned near the opening 101 in the patient's body 100, as shown in FIGS. 5 and 7. In FIG. 7, the catheter tube 9 is a urinary catheter inserted into the urethra of a male patient, but could equally be used for female patients and for different types of elongated medical devices, such as abdominal catheters or temporary pacemaker wires.

[0082] The proximal portion 29 reduces the risk of the sterilization device 1' exerting pressure on the patient's body, which can cause discomfort, especially when used on the genitals as shown in Figure 7, and can lead to skin damage and an increased risk of infection.

[0083] Another advantage of the soft and elastic proximal portion 29 is that it reduces the risk of the catheter tube being pulled or pushed in when the patient moves. In the example of FIG. 7, the catheter tube 9 is held in place in the patient's bladder 102 by a balloon 93 located at the section of the catheter tube that extends into the bladder. The balloon prevents the catheter tube 9 from being pulled out, but does not prevent it from being pushed in further. The proximal portion 29 allows the sterilization device 1' to be positioned very close to the opening in the patient's body, in this example, approximately 1 mm from the opening. This essentially reduces the risk of the catheter tube 9 being pushed inward. Additionally, the elasticity of the material of the proximal portion 29 allows some movement to be compensated for.

[0084] As described above with reference to the figures, the sterilization device 1' in Figures 5-7 also consists of two halves 41, 42, which are interconnected by a hinge 5, as shown in Figure 6. The proximal part 29 also consists of two halves 29a, 29b, each associated with a respective half 41, 42 of the device.

[0085] A male locking portion 43 is provided on the first half 41 and a female locking portion 44 is provided on the second half to ensure that the sterilizer 1' closes tightly around the catheter tube 9. These two locking portions snap-lock together when the sterilizer is moved from the open configuration of Figure 6 to the open configuration of Figure 5. One half 29b of the proximal part 29 is also provided with adhesive (not shown) and is covered by a cover sheet 292. Before the sterilizer 1' is closed around the catheter tube 9, the cover sheet is removed so that the two halves 29a, 29b of the proximal part 29 adhere to each other in the open configuration.

[0086] Other means for locking the two halves 41, 42 together and / or connecting the two halves 29a, 29b of the proximal portion 29 are also possible. These include the use of tape or hook-and-loop fasteners such as Velcro. As shown in Figure 6, the sterilization device 1' of this embodiment includes a series of centering members 27 protruding from the inner wall surface 23 at its distal end. Each of these centering members 27 contacts the catheter tube 9 and helps to keep it centered relative to the sterilization device. The advantage of using these centering members is that the contact area with the catheter tube is reduced.

[0087] The embodiment of Figures 5-7 includes an ultraviolet reflective zone 25 on the inner wall surface 23. The zone extends from the rib labeled 210' of the mounting portion 21 to the centering member 27. The surface of the ultraviolet reflective zone is made of a material that reflects ultraviolet light. Due to the reflection of ultraviolet light emitted by the UV-LEDs 6, the catheter tube 9 extending through the sterilization chamber 22 is exposed to a greater amount of ultraviolet light than when using a corresponding sterilization device that does not have an ultraviolet reflective zone or when using a corresponding sterilization device that has walls configured to absorb ultraviolet light as described with reference to Figures 3 and 4.

[0088] The embodiment of Figures 5-7 also includes a control unit 83. As described with reference to Figure 4, the control unit 83 is configured to control the UV-LEDs 6 to emit UV light in a plurality of sterilization cycles, each comprising an ON period during which UV light is emitted and an OFF period during which UV light is not emitted. The device 1' further includes an actuator 81' and a switch unit 82' configured to cause the UV-LEDs 6 to stop emitting UV light when the sterilization device 1' is opened, as described with reference to Figures 4a-4c. The switch unit 82' shown with reference to Figure 6 includes two switches. Because both of these operate in conjunction with the actuator, if one of the switches fails, the device 1' still has a positive safety mechanism that turns off UV light emission from the UV-LEDs 6 when the device 1' is in the open configuration. In the illustrated embodiment, the switches are reed switches and Hall-effect sensors, and the actuator 81' is a magnet. However, the selection of other types of actuators and switches is equally conceivable within the scope of the present invention.

[0089] Although the actuator 81' and switch unit 82' described with respect to this embodiment are positioned separate from the male locking portion 43 and the female locking portion 44, it is also possible to envision designs for the device 1' in which the actuator 81' and switch unit 82' are integrated into the male locking portion 43 and the female locking portion 44. Similarly, both the actuator 81' and the switch unit 82' may be integrated into either the first half 41 or the second half 42 of the device 1'.

[0090] Finally, reference is made to Figures 8a-8e, which illustrate some examples of disinfection cycles that may be pre-programmed into the control unit 83 and implemented.

[0091] The purpose of performing multiple sterilization cycles is to expose an area of ​​a medical device, such as the catheter described above, to a sufficient amount of UV light over a period of time to eliminate a majority of harmful microorganisms present and traveling along the area, while limiting the amount of UV light that is applied. Limiting UV light exposure reduces power consumption and heat generation by the device 1, and limits UV exposure to the surrounding environment.

[0092] A sterilization cycle consists 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. In each of Figures 8a-8e, the horizontal axis represents time, and the vertical axis represents light intensity. Multiple sterilization cycles are shown in Figures 8a-8e. As light is emitted, the graph displays a constant light intensity. During each off-period, the light intensity is zero. Over a period of time, the light intensity of each on-period accumulates to reach the desired UV dose, defined by the area under the graph. There are several ways to achieve the desired UV dose. Figure 8a shows a case where the on-period and off-period are equal in duration. In Figure 8b, the duration of the off-period is twice that of the on-period. Figure 8c shows a case where the duration of the off-period is several times longer than the on-period, approximately 10 times longer in this example. While Figures 8a-8c exemplarily illustrate possible configurations of multiple sterilization cycles, other relationships between the durations of the on-period and off-period are equally conceivable. This includes relationships in which the off periods are shorter in duration than the on periods in each sterilization cycle. It is also important to note that consecutive sterilization cycles need not be identical, and multiple sterilization cycles may be combined, as shown in FIG. 8d. The on and off periods may vary in duration from one sterilization cycle to the next, and within each sterilization cycle. Finally, as shown in FIG. 8e, the maximum light intensity reached in each on period may increase or decrease over a portion of the on period's duration. The light intensity may also increase or decrease gradually, resulting in a curved graph. Similarly, the increase and decrease sequences may be of different durations, resulting in unequal on periods for multiple sterilization cycles. Multiple sterilization cycles may include both sterilization cycles with varying light intensity from 0 to 100% and sterilization cycles with increasing light intensity, in any combination desired. These may include on periods with lower light intensity than others.

[0093] To obtain a sufficiently high sterilization quality, different device configurations can be applied. Those skilled in the art will understand that there are many ways to configure the device and design the sterilization cycle to achieve this purpose. Taking into account the wavelength and intensity of the ultraviolet light emitted by the UV-LED, as well as the on-time and off-time of the sterilization cycle, some examples of complete device configurations are provided below. Example 1: 275-280 nm, 30 seconds on, 300 seconds off, 1 mJ / s / cm 2 . Example 2: 275-280 nm, 3 seconds on, 30 seconds off, 1 mJ / s / cm 2 . Example 3: 275-280 nm, 1 second on, 5 seconds off, 2 mJ / s / cm 2 . Example 4: 275-280 nm, 60 seconds on, 600 seconds off, 0.5 mJ / s / cm 2 .

[0094] Below is a list of reference signs used in this specification: In case of doubt, the reference signs in the following list apply. 1 Sterilizer 2. Housing 2a proximal end 2b distal end 21 Mounting part 210 Ribs 22 Sterilization Chamber 23 Wall 24 through holes 24a Proximal opening 24b Distal opening 25 reflective zones 26 Central axis 27 Centering member 28 Exterior 29 Proximal 29a First half of proximal part 29b Second half of proximal part 292 Proximal Cover Sheet 3. Air gap 41 First half 42 Second half 43 Locking part of the first half 44 Locking part of the second half 5 Hinge 51 Hinge shaft 6 UV LEDs 61 Light Cylinder 62 Optical axis 63 Mitsui 7 Power 81 Actuator 82 Switch 82' Switch Unit 83 Control Unit 9 Catheter Tube 92 External surface 93 Balloon 100 Patient's Body 101 Patient's mouth opening 102 Bladder

Claims

1. A sterilization device for sterilizing medical devices, 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 direct ultraviolet light into the sterilization chamber; a control unit configured to control the UV-LEDs; a built-in power supply connected to the UV-LED; The sterilization device, wherein the control unit is further configured to implement a plurality of sterilization cycles, each of which includes an on-period in which ultraviolet light is emitted from the UV-LED and an off-period in which ultraviolet light is not emitted from the UV-LED.

2. 10. The sterilizer of claim 1, wherein at least one sterilization cycle of the plurality of sterilization cycles comprises an on period having a duration of at least 0.5 seconds.

3. 3. A sterilizer according to claim 1 or 2, wherein for each sterilization cycle of the plurality of sterilization cycles, the off period has a duration at least twice the duration of the on period.

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

5. The total amount of UV radiation emitted by the UV-LED is at least 20.833 mJ / cm when measured over a 30-minute period ２ , or 41.66 mJ / cm when measured over 1 hour. ２ or 1000 mJ / cm when measured over 24 hours. ２ The sterilization apparatus according to any one of claims 1 to 4.

6. 6. A sterilization apparatus according to any one of claims 1 to 5, wherein the housing comprises a through bore extending therethrough adapted to surround at least a section of an elongated medical device such as a catheter, a tube, a cable or a wire, and the sterilization chamber forms part of the through bore.

7. The sterilizer according to any one of claims 1 to 6, wherein the built-in power source is a primary battery.

8. 8. The sterilizer of claim 7, wherein the sterilizer is a disposable device and the primary cell battery has a power capacity sufficient 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. The sterilizer has a maximum length of 0.0015 m ３ The sterilizer according to any one of claims 1 to 8, having a total volume of

10. A sterilizer according to any preceding claim, wherein the sterilizer has an open configuration and a closed configuration, the sterilizer being in the closed configuration during use.

11. 1. A method for sterilizing at least one area of ​​a medical device, comprising: placing a sterilization device in contact with at least an area of ​​the medical device such that the sterilization device at least partially surrounds the area of ​​the medical device; and causing a control unit provided in the sterilization device to execute a plurality of sterilization cycles, each of which includes an ON period during which ultraviolet light is emitted from the UV-LED and an OFF period during which ultraviolet light is not emitted; The method, wherein the ultraviolet light irradiated during the on period is irradiated directly onto the area of ​​the medical device intended to be sterilized.

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

13. 13. The method of claim 11 or 12, wherein in each disinfection cycle, the off periods have a duration at least twice the duration of the on periods.

14. 14. The method of any one of claims 11 to 13, further comprising conducting a plurality of said sterilization cycles for at least one hour.

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

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