Device and method for disinfecting a lumen by means of UV radiation

Abstract

The invention relates to a device for disinfecting a lumen, which is formed by a flexible tube (7) with a nozzle head (3), which terminates the tube (7) at a front end and has multiple lateral nozzle openings (4) via which a fluid introduced into the tube (7) can exit radially. A UV-radiation-emitting element (1) is arranged on the nozzle head (3) and can emit UV radiation with a disinfecting effect. The invention also relates to a method for disinfecting a lumen, in which method said device is used. With the device and the method, in particular, the disinfection of the inner lumina of medical products can be largely automated and can therefore be validated better than the previous manual preparation process.

Description

[0001] Device and method for disinfecting a lumen using UV radiation

[0002] Technical application area

[0003] The present invention relates to a device for disinfecting a lumen, in particular the inner lumen of a medical device, by means of UV radiation and to a method in which the proposed device is used for disinfecting the lumen.

[0004] Medical devices must be cleaned and disinfected after use on the patient. For medical devices with internal volumes, such as endoscopes, this process is particularly difficult and can usually only be performed manually using round brushes and suitable cleaning and disinfection agents, or semi-automatically. The diameters of the internal volumes of such products vary depending on their intended use. The most common diameters are between 3.2 and 8 mm. In the medical field, the problem is that every reprocessing process must be validated. This is very difficult with manual processes. Random samples from everyday clinical practice show that even after manual reprocessing and disinfection of medical devices, residual germs can sometimes be found in the lumen, which can be problematic during subsequent use. State of the art

[0005] Endoscopes and other medical devices with an inner lumen have generally been cleaned manually or semi-automatically using round brushes and disinfectants, then rinsed with clear or distilled water and dried with compressed air. Approaches are also known that utilize ultrasound to assist cleaning of the inner lumen, as described, for example, in WO 2006 / 031106 A1. However, this ultrasound technology cannot be used to disinfect or even sterilize the inner lumen.

[0006] From US 5637877 A or US 6461569 B1, it is known to sterilize the inner lumen of medical devices using UV radiation. For this purpose, the disinfecting UV radiation is provided by an optical fiber that is inserted into the inner lumen. The fiber is suitably designed to allow the UV radiation to escape.

[0007] The object of the present invention is to provide a device and a method for disinfecting a lumen, which enable disinfection of the inner lumen of medical devices in a largely automated manner.

[0008] Description of the invention

[0009] The object is achieved with the device and the method according to claims 1 and 9. Advantageous embodiments of the device and the method are the subject of the dependent claims or can be found in the following

[0010] Refer to the description and the example of use.

[0011] The proposed device for disinfecting a lumen, hereinafter also referred to as a disinfection probe, is formed by a flexible hose with a nozzle head that closes off the hose at a front end. The front end here is understood to be the end of the hose which is inserted into the lumen when the disinfection probe is used. The nozzle head has a plurality of lateral nozzle openings through which a fluid introduced into the hose from the rear end can radially exit during disinfection. Also located on the nozzle head is a UV radiation emitting element which, when appropriately controlled or operated, emits UV radiation with a disinfecting effect, preferably UVC radiation in a wavelength range between 200 nm and 290 nm. The UV radiation emitting element is preferably a UV radiation source.However, it can also be one end of an optical fiber from which radiation coupled into the fiber by a UV radiation source emerges. Preferably, the UV radiation-emitting element is arranged at the tip of the nozzle head and at least partially enclosed by a potting made of a UV-transparent optical material.

[0012] The proposed device and the associated method enable simultaneous cleaning and disinfection of the lumen by supplying a suitable fluid, in particular a cleaning liquid, while inserting the disinfection probe into the lumen to be disinfected. Disinfection is achieved by the simultaneous emission of suitable UV radiation by the UV-radiation-emitting element, which is preferably permanently connected to the nozzle head.

[0013] In a particularly advantageous embodiment, the nozzle openings are distributed around the circumference of the nozzle head in such a way that a fluid introduced into the tube is discharged radially into the lumen via the nozzle openings, thereby centering the nozzle head within the lumen. The diameter of the tube and the nozzle head is preferably selected to be at least half a millimeter smaller than the inner diameter of the lumen, but still sufficiently large to achieve the appropriate centering.

[0014] In the proposed method, the diameter of the disinfection probe is therefore selected to be suitable for the lumen to be cleaned. The disinfection probe is preferably inserted into the corresponding lumen by a motor at a defined, preferably constant, speed while simultaneously supplying the cleaning fluid and controlling the UV radiation emitting element to emit the UV radiation. When a selectable end point is reached, preferably in the region of the other end of the lumen, the probe is withdrawn again. In the particularly preferred embodiment, the supplied cleaning fluid, for example a cleaning solution or water, fulfills three further tasks or functions in addition to the cleaning effect. For example, the cleaning fluid also fulfills the function of centering the nozzle head within the lumen by a uniform radial release of the fluid.Furthermore, the liquid film itself created by the liquid serves as a type of lubricant, facilitating the movement of the disinfection probe, i.e., the tube with the nozzle head, within the lumen. Third, the nozzle head with the UV radiation-emitting element, in particular a UV radiation source that heats up during operation, is cooled by the fluid flow, which increases the service life of the radiation source, preferably an LED or an LED array. The nozzle head is preferably made of a metallic or ceramic material with high thermal conductivity.

[0015] As already indicated, in the case of a UV radiation source, the UV radiation-emitting element is preferably formed by a semiconductor material whose energetic band gap is used to generate the UV radiation. In a particularly advantageous embodiment, this is an LED chip or an array of LED chips, depending on the desired radiation output. The power supply to the UV radiation source is preferably via electrical conductors that are integrated into the hose of the disinfection probe and enable power supply via the rear end of the hose. If an optical fiber is used, this is preferably also integrated into the hose.

[0016] In a further advantageous embodiment, suitable optical elements for bundling or focusing the UV radiation emanating from the UV radiation-emitting element in the direction of the lateral inner wall of the lumen are integrated into the nozzle head, so that this inner wall experiences the highest possible uniform UV irradiation.

[0017] In the proposed method, the radiation intensity of the UV radiation source is measured immediately before the disinfection probe is inserted into or removed from the lumen to be disinfected, and preferably also immediately after the disinfection probe is removed, for example using at least two independent photosensors. This, in conjunction with the defined speed at which the disinfection probe was inserted into or removed from the lumen, allows the radiation dose to be calculated to ensure that the necessary radiation dose was achieved during the respective disinfection process. This measurement can also be carried out automatically using a suitable feed device for the disinfection probe, as will be explained in more detail in the exemplary embodiment.

[0018] The proposed device and associated method allow for the largely automated disinfection of the inner lumen of medical devices such as endoscopes. The method and device also enable validation of the respective disinfection or reprocessing process.

[0019] The device and method are particularly suitable for disinfecting and cleaning the corresponding internal lumens of medical products or devices, such as endoscopes, gastroscopes, and colonoscopes. Other small cavities or smaller-diameter pipes in other technical fields can also be disinfected with it. With appropriate scaling, the device can also be used for the internal disinfection of piping systems with larger diameters.

[0020] Short description of the drawings

[0021] The proposed device and the associated method are explained in more detail below using an exemplary embodiment in conjunction with the drawings. Herein:

[0022] Fig. 1 shows an example of the design of a front part of the proposed device in side view with and without indication of the internal structure;

[0023] Fig. 2 shows a representation of the nozzle head of the device of Fig. 1 in a view from above (A) and from below (B); and Fig. 3 shows an example of a possible embodiment of a feed module for the disinfection probe, in which photosensors for measuring the irradiation intensity are arranged.

[0024] Ways to implement the invention

[0025] The present exemplary embodiment shows a design of the proposed disinfection probe, as it can be used for disinfecting the inner lumen of medical devices, such as endoscopes, which typically have inner diameters between 3.2 and 8 mm. Disinfection is achieved by irradiation with suitable UV radiation. For disinfection, the disinfection probe is inserted into the inner lumen.

[0026] The exemplary probe consists of a hose 7, to the front end of which a nozzle body 3, also referred to as a nozzle head, is attached. The hose 7 with the nozzle body 3 has a diameter that is smaller than the diameter of the inner lumen to be disinfected. A cleaning solution or water is pumped through the hose 7 via a suitable pump, which is not shown in Figure 1, and then exits radially via corresponding lateral outlets (outlet nozzles) 4 into the inner lumen. In this example, an LED chip 1 is located at the tip of the nozzle body 3, which emits UVC radiation in the wavelength range between 200 nm and 290 nm with a disinfecting effect on microorganisms. For small channels or inner lumens to be disinfected with a diameter of 3.2 mm, a single UVC LED chip the size of, for example, 1200 nm is sufficient. 0 , 5 x 0 , 5 mm with an optical output power of 50 to 100 mW .For larger inner diameters, a UVC LED array consisting of several LED chips can be used. The UV radiation generated by the LED(s) is focused onto the inside of the lumen through a potting 2 made of a UV-transparent optical material in such a way that the highest possible irradiation intensity is achieved on the inside of the lumen. The UVC LED(s) are supplied with power by two electrical conductors 6 for the anode (positive pole) and cathode (negative pole) integrated into the wall of the tube 7. The power supply is via low-voltage direct current < 48 V.

[0027] In this example, the nozzle body 3 is made of metal and has a rear tube section that is inserted into the hose 7. Figure 2A shows a top view of the nozzle or probe head, showing the LED chip 1 on the nozzle body 3 and the two power supply lines 6. Figure 2B shows a bottom view of the nozzle or probe head, showing the nozzle body 3 with the lower tube section, the cleaning fluid channel 5, and also the power supply lines 6.

[0028] For disinfection, the hose 7 including the nozzle body 3 is inserted into the lumen for a cleaning and disinfection process and moved through the lumen with the LED switched on and a fluid flow generated. Since there is not enough space in the disinfection probe, particularly with smaller diameters, to accommodate a UV photo sensor due to the limited installation space, the probe is calibrated externally. Calibration before every disinfection process in the medical field is important to ensure that a sufficient radiation dose is achieved during the irradiation process to sterilize all microbial contamination in the lumen. For this purpose, a separate feed module is used in the present example, as shown in Figure 3. This separate feed module has a recess for the introduction orCentering 8 of the medical device to be disinfected, for example an endoscope, and opposite it a feed channel 11 for the disinfection probe 10. In this example, two photosensors 9 are arranged at the transition from the feed channel 11 to the recess 8 for the introduction or centering of the medical device, which independently of one another measure the intensity and thus the power of the UVC LED(s) before and after the irradiation process. This achieves redundancy, since photosensors can also fail. The achievable irradiation dose in the lumen can then be calculated by a microcontroller or a computer from the intensity measured by the photosensors and the time of irradiation. After the initial measurement of the intensity before the disinfection process, the disinfection probe 10 is introduced into the lumen to be disinfected, for example an endoscope channel to be disinfected.The speed of movement of the detection probe in the lumen or endoscope channel is determined or calculated from the radiation intensity measured by the photosensors during delivery in such a way that with this radiation intensity the necessary radiation dose (intensity x time in J / m) is achieved everywhere in the lumen. 2 ) is achieved. The movement of the detection probe 10 in the lumen or endoscope channel is then carried out by a microcontroller controlled motor at this speed.

[0029] Reference symbol list

[0030] I UVC LED chip / chip array 2 UV-transparent optical encapsulant

[0031] 3 Nozzle body / nozzle head

[0032] 4 outlet nozzles

[0033] 5 Channel for cleaning fluid

[0034] 6 Power supply cables 7 Flexible hose

[0035] 8 Endoscopy insertion / centering

[0036] 9 photo sensors

[0037] 10 Disinfection probe

[0038] II Probe or supply channel

Claims

Patent claims 1. Device for disinfecting a lumen, which is formed by a flexible tube (7) with a nozzle head (3) which closes the tube (7) at a front end and has a plurality of lateral nozzle openings (4) through which a fluid introduced into the tube (7) can exit radially, wherein a UV radiation emitting element is arranged on the nozzle head (3) which can emit UV radiation with a disinfecting effect.

2. Device according to claim 1, characterized in that the UV radiation emitting element is a UV radiation source (1).

3. Device according to claim 2, characterized in that electrical conductors (6) are integrated into walls of the hose (7), which enable an electrical supply of the UV radiation source (1) from a rear end of the hose (7).

4. Device according to claim 2 or 3, characterized in that the UV radiation source (1) is formed by an LED chip or an array of several LED chips.

5. Device according to one of claims 1 to 4, characterized in that the UV radiation emitting element emits UVC radiation in a wavelength range between 200 nm and 290 nm.

6. Device according to one of claims 1 to 5, characterized in that the nozzle openings (4) are arranged distributed around a circumference of the nozzle head (3) in such a way that a uniform radial discharge of the fluid introduced into the tube (7) results in a centering of the nozzle head (3) within the lumen into which the device is introduced.

7. Device according to one of claims 1 to 6, characterized in that the hose (7) with the nozzle head (3) has a diameter which is < 8 mm.

8. Device according to one of claims 1 to 7, characterized in that the nozzle head (3) consists of metal or ceramic.

9. A method for disinfecting a lumen, in which a device (10) according to one or more of the preceding claims is introduced into the lumen via a drive at a defined speed, wherein during the introduction into the lumen and the movement in the lumen, a fluid is pumped through the tube (7) which exits at the nozzle openings (4), and wherein the UV Radiation-emitting element is controlled to emit UV radiation at a defined speed during insertion of the device (10) into the lumen and / or during removal of the device (10) from the lumen.

10. The method according to claim 9, characterized in that the radiation intensity of the UV radiation emitting element is measured immediately before the device (10) is inserted into the lumen and immediately after its removal from the lumen.

11. Method according to claim 10, characterized in that a speed of movement of the device (10) in the lumen is calculated from the measured radiation intensity, with which a predeterminable radiation dose is achieved in the lumen, and the drive for introducing the device (10) into the lumen is controlled at this speed.

12. Method according to claim 11, characterized in that the measurement of the radiation intensity, the calculation of the speed and the control of the drive are carried out automatically.

13. Method according to one of claims 9 to 12, characterized in that that a motor drive is used as the drive.

14. Method according to one of claims 9 to 13, characterized in that a cleaning liquid is used as the fluid.

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