METHODS FOR DETECTING A MEDICAL INSTRUMENT IN A DISINFECTION SYSTEM AND DISINFECTION SYSTEMS IMPLEMENTING THE METHODS

Abstract

The present description relates to a disinfection system (300) configured to implement a disinfection cycle of a medical instrument (200) by UV radiation. The disinfection system (300) includes a disinfection chamber (310) configured to receive at least one portion of the medical instrument (200), a suspension means (320) for suspending said at least one portion of the medical instrument (200) in said disinfection chamber (310), a detection device (330) configured to detect, in a predetermined detection area of the disinfection system (300), a marker (210) integral with said medical instrument (200), and a controller (370) configured to generate a non-detection signal in case of non-detection of said marker (210) in said predetermined detection area.

Claims

1. A disinfection system configured to implement a disinfection cycle of a medical instrument by UV radiation, the disinfection system comprising: a disinfection chamber configured to receive at least one portion of the medical instrument; a suspension means for suspending said at least one portion of the medical instrument in said disinfection chamber; a detection device configured to detect a marker integral with said medical instrument, in a predetermined detection area of the disinfection system; and a controller configured to generate a non-detection signal in case of non-detection of said marker in said predetermined detection area.

2. The disinfection system according to claim 1, wherein the detection device comprises an optical detection device.

3. The disinfection system according to claim 2, wherein the detection device further comprises a source for emitting light radiation configured to illuminate said predetermined detection area.

4. The disinfection system according to claim 2, wherein the detection device comprises a barcode reader.

5. The disinfection system according to claim 1, wherein the detection device comprises radio frequency acquisition means.

6. The disinfection system according to claim 1, comprising at least one source of UV radiation.

7. A detection kit for a medical instrument to be disinfected in a disinfection system according to claim 1, said medical instrument comprising a head and a connection cable of the head, the detection kit comprising: a marker configured to be integrally affixed to a portion of the connection cable adjacent the head for detection by said detection device; and a protective ring of said marker, said protective ring further interacting with said suspension means for suspending the connection cable.

8. The detection kit of claim 7, wherein the marker comprises an identification code of said medical instrument.

9. A disinfection kit for a medical instrument comprising the disinfection system according to claim 2, said medical instrument comprising a head and a connection cable of the head, the detection kit comprising: a marker configured to be integrally affixed to a portion of the connection cable adjacent the head for detection by said detection device; and a protective ring of said marker, said protective ring further interacting with said suspension means for suspending the connection cable.

10. A method for detecting a medical instrument in a disinfection system according to claim 1, the method comprising the following steps: detecting said marker integral with said medical instrument in said predetermined detection area of the disinfection system, by means of said detection device; and in case of non-detection of said marker in said predetermined detection area of the disinfection system, generating a non-detection signal.

11. The detection method according to claim 10, wherein generation of the non-detection signal results in issuing an alert to one or more users and/or stopping a disinfection cycle in progress and/or prohibiting the launch of a cycle.

12. The detection method according to claim 10, wherein the marker comprises an identification code of the medical instrument and the method further comprises: reading the identification code using the detection device.

13. The detection method according to claim 10, comprising a prior step of marking the medical instrument, by affixing the marker integrally to said medical instrument.

14. The detection method according to claim 10, wherein the detection is optical detection or radio detection.

15. The detection method according to claim 10, further comprising detecting, in said detection area, a position of the marker relative to a reference position.

16. The detection method according to claim 15, further comprising one or more actions, based on said position of the marker in the detection area, comprising: issuing a positioning error alert to one or more user(s) and/or reconfiguring a disinfection cycle to take account of said position and/or stopping the disinfection cycle in progress and/or prohibiting the launch of a disinfection cycle.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0050] Further advantages and features of the invention will become apparent from the description, illustrated by the following Figures:

[0051] FIG. 1 (previously described), a diagram of a disinfection enclosure according to the state of the art;

[0052] FIGS. 2A through 2D (previously described), diagrams illustrating positions of a medical instrument including a head and a cable for connecting the head in a disinfection system according to the state of the art, in cases where the head is positioned in a central and optimized region of the chamber (FIG. 2A), in cases where the head is positioned in a region of the chamber that is too high (FIG. 2B), and in cases where the head is positioned in a region of the chamber that is too low (FIGS. 2C, 2D);

[0053] FIGS. 3A, 3B, diagrams illustrating an example of a disinfection system according to the present description, with a medical instrument suspended and detected by the detection device in a first case (FIG. 3A) and a medical instrument suspended and not detected by the detection device in a second case (FIG. 3B);

[0054] FIGS. 4A, 4B, diagrams illustrating a protective ring of a medical instrument detection kit according to the present description;

[0055] FIGS. 5A, 5B, diagrams illustrating an example support of a disinfection system suspension means according to the present description, intended to interact with a protective ring as illustrated in FIGS. 4A, 4B;

[0056] FIG. 6, a diagram diagram illustrating another exemplary embodiment of a disinfection system according to the present description;

[0057] FIGS. 7A, 7B, 7C, 7D, diagrams illustrating examples of implementation of methods for detecting a medical instrument in a disinfection system, according to the present description.

DETAILED DESCRIPTION

[0058] FIG. 3A schematically depicts an example of a disinfection system 300 according to the present description, in a cross-sectional view.

[0059] The disinfection system 300 is configured to implement a disinfection cycle of at least one medical instrument, designated by reference 200 in FIG. 3A.

[0060] Although the present description is not limited to disinfection methods or systems for disinfecting critical and semi-critical medical instruments, the methods and systems described in the present description are specifically suited for HLD or ILD of reusable medical devices and instruments, including, for example, ultrasound, endotracheal, and other endo-cavity probes such as ENT endoscopes.

[0061] Such a medical instrument comprises an active portion or “head” 201, for example, and a head connection cable, designated 202, although medical instruments without connection cables may also be disinfected using the disinfection methods and systems described in this description.

[0062] In the example of FIG. 3A, the disinfection system 300 comprises one or more disinfection chamber(s) 310 with an enclosure 302 of the type shown in FIG. 1, for example. The disinfection chamber 310 comprises side walls and a ceiling 306. The disinfection chamber 310 is configured to receive at least one portion of the medical device within an interior volume 312, such as the head 201, and one portion of the connection cable 202.

[0063] In the present description, the methods and systems described in the present description use ultraviolet (“UV”) radiation to rapidly perform high-level disinfection without generating excessively high temperatures on the surface of the instruments to be treated and inside them.

[0064] Thus, in the example of FIG. 3A, the disinfection system is configured to implement a UV radiation disinfection cycle.

[0065] In a manner known in the state of the art, it comprises one or more UV radiation sources, referenced generally by reference 350, and one or more sensors of said UV radiation, referenced generally by reference 350. The disinfection system may include other sensors in a manner known in the state of the art, such as temperature sensors.

[0066] Radiation sources that may be used in methods and systems according to the present description are sources known in the state of the art, for example, and include radiation sources for emitting UV-A, UV-B or UV-C radiation, for example.

[0067] UV-C radiation sources, also referred to as “lamps” or “tubes”, are commercially available and can be obtained in various shapes, sizes, radiation and output energy. Examples of UV-C tubes suitable for use as UV-C radiation sources include low pressure mercury vapor discharge lamps. However, in the methods and systems according to the present description, any source capable of emitting UV-C radiation in the selected UV-C wavelength at an output energy that contributes to the disinfection of a target medical instrument 200 could be used. For example, in addition to or instead of one or more UV-C tubes, one or more lasers or photodiodes, or arrays of sources, or combinations of types of sources designed to emit UV-C light may be used to deliver radiation into the disinfection chamber.

[0068] The source(s) 350 may also comprise one or more indirect sources of UV radiation (e.g., dedicated radiation reflectors).

[0069] The one or more UV radiation sensors 340, such as one or more photodiodes, may be fixedly or movably positioned within the interior volume of the disinfection chamber 310, and are adapted to determine an amount of UV radiation, for example a radiation amount measured in joules on a selected surface or, in some cases, a surface-specific radiation amount for example, measured in joules/cm.sup.2. The one or more UV radiation sensors arranged within the interior volume of the disinfection chamber 310 may be configured to have a bandpass optical filter or other electromagnetic filter so that only radiation in a spectrum of interest is detected.

[0070] In other embodiments, the sensor(s) 340 may comprise one or more light conducting components such as lenses, optical fibers, mirrors, filters, and/or other optical elements used to collect radiation in the interior volume of the chamber 310 to a detector, such as a photodiode.

[0071] The disinfection chamber 310 is sized and configured to help achieve disinfection of instruments 200 placed therein within a desirable, possibly selectable period of time such that the surfaces of the instruments are exposed to a desired radiation level, referred to as “dosage” in this description. A radiation exposure level, or dosage, refers to both the intensity of the radiation and the duration of the exposure. For example, the instrument to be disinfected, the UV radiation source(s), and/or the UV radiation sensor(s) are positioned (e.g., inserted, interposed, suspended, or located) in the disinfection chamber at fixed or non-stationary positions, the positions being able to be non-stationary during a disinfection cycle, to better expose each of the surface portions of the instrument to specific, pre-determined disinfection levels of UV radiation.

[0072] The disinfection system further comprises a detection device 330 configured to detect a marker 210 in a predetermined detection area of the disinfection system, integral with a medical instrument 200 that is to undergo a disinfection cycle. Examples of markers 210 and detection device 330 will be described in more detail later.

[0073] As will be described in more detail by means of FIGS. 7A - 7D, a controller 370 is configured to generate a non-detection signal, before and/or during and/or after a disinfection cycle, in the event of non-detection of the marker 210 in the predetermined detection area, and generate one or more actions, if necessary.

[0074] Generally, the disinfection chamber 310 and/or radiation source(s) 350 and/or UV radiation sensor(s) 340 and/or detection device 330 and/or other sensors arranged in the disinfection chamber are coupled in communication with the controller 370. In addition to exchanging data with the disinfection chamber, radiation sources, sensors, and marker detection device, the controller 370 may also communicate with one or more databases 360 and/or an input interface 380 for data/information related to the control of the disinfection operation, to perform its operations.

[0075] The information relating to the control of the disinfection operation may include information characterizing the decontamination cycle, such as information identifying the probe and/or the enclosure, each enclosure then being assigned a specific identification number stored therein, time-stamping information of the cycle enabling, for example, the acquisition of the date of the cycle, the daily number of the cycle, the start time and the end time of the cycle, from a clock-forming circuit, etc. The decontamination cycle characterization information may also include information relating to the UV dose emitted during a cycle if the enclosure is a disinfection enclosure provided with means of generating disinfection UV radiation. For example, in order to ensure the traceability of the cycle, the information relating to the control of the disinfection operation may include information identifying the probe and/or the enclosure, information identifying the patient who will benefit from the disinfection, as well as information identifying the operator who performed the disinfection.

[0076] In this way, the controller can control the execution of a disinfection cycle, determine a minimum dosage to be applied in the disinfection chamber, for optimal disinfection of the instrument, and control the positioning of the instrument.

[0077] The controller 370 may comprises a processor 372, as known in the state of the art, one or more storage units or memories 376, and an interface 374 configured to communicate with the disinfection chamber 310, the radiation source(s) 350, the sensor(s) 340, the detection device 330. The interface 374 includes a CAN converter, for example, for converting analog data such as data detected by the sensors into digital data that can be processed by the processor 372. A processor 372 as described in this description includes any device such as a central processing unit (CPU), microprocessor, microcontroller (MCU), digital signal processor (DSP), application specific integrated circuit (ASIC), or portion thereof, that controls at least one operation; it may be implemented as hardware, firmware, or software, or a combination. The functionality associated with a specific processor may be centralized or distributed, either locally or remotely. A processor may refer interchangeably to any type of electronic control circuit configured to execute programmed software instructions. The one or more memories 376 may comprise any combination of volatile and non-volatile computer-readable media for reading and writing, as known in the state of the art. Volatile computer-readable media include random access memory (RAM), for example. Non-volatile computer-readable media includes one or more ROMs, magnetic media such as a hard disk, optical disk, flash memory device, CD-ROM, etc., for example, Some or all stored contents of a memory may include software instructions executable by a processing device to perform one or more specific acts.

[0078] Among the stored instructions, indicatively but without limitation, these instructions may include a plurality of accepted probes and a plurality of doses to be applied.

[0079] The marker 210 is integral with the medical device, i.e., it cannot be removed and/or moved without damage to the marker itself and/or the medical instrument to which it is affixed. The marker may be an external element affixed integrally to the instrument, by bonding or integration within the instrument for example, such as a label or an electronic chip. The marker can also be a portion of the instrument itself. With a marker integral with the instrument, the position of the medical instrument in the disinfection system can be monitored reliably.

[0080] The marker 210 may be carried by the active portion 201 of the instrument or alternatively by the connection cable 202 of the instrument, as shown in FIG. 3A.

[0081] The detection device 330 may be positioned outside the interior volume of the disinfection chamber, as illustrated in FIG. 3A, or within the interior volume 312, at the side walls thereof for example, if the marker is positioned on or near the active portion of the instrument for example.

[0082] Generally, the marker may comprise any element that can be specifically detected by the detection device.

[0083] For example, the marker may be an electronic chip of the RFID (“radio frequency identification”) type and in this case the detection device may comprise radio frequency acquisition means configured for the detection of the electronic chip.

[0084] According to other examples, the detection device 330 is an optical detection device, sensitive to visible or infrared radiation.

[0085] It may comprise one or more point detector(s), for example, such as one or more photodiode(s) and/or one or more array detector(s), such as a line camera or a two-dimensional camera, such as a CCD or CMOS camera. The detection device 330 may also include a one- or two-dimensional barcode reader for identifying the medical device, as will be described in more detail later.

[0086] Generally, the detection device is adapted according to the marker.

[0087] According to one or more examples and in a non-limiting manner, the marker may comprise an element selected from the group comprising: a colored element, a fluorescent element, a silk-screen print, a reflective element, a diffractive element, a barcode, or a combination of these elements.

[0088] For example, one or more cameras are adapted to a marker formed from a structural element of the medical instrument itself and identified as a marker for the instrument. A point detector, such as a photodiode, is adapted to a point marker such as a wave absorbing or reflecting point in a different proportion than the rest of the probe elements, while a barcode reader is adapted to a barcode marker. Another non-limiting example of optical detection may include a laser.

[0089] According to one or more exemplary embodiments, the detection device further comprises one or more light emission source(s) configured to illuminate said detection area. The emission source enables detection even when the detection area is in a non-illuminated region of the disinfection system, during an operating cycle, such as a space closed to daylight.

[0090] According to one or more exemplary embodiments, the detection device is further configured to detect a position of the marker relative to a reference position, in said detection area. In this case, the controller 370 may be configured to generate the reconfiguration of a disinfection cycle, based on said position of the marker in the detection area, to take into account said position.

[0091] According to an example of the present description, the marker 210 integral with the medical instrument comprises an identification code for the instrument. This identification code may be stored as a one- or two-dimensional bar code or in an electronic radio frequency tag, for example.

[0092] The detection device 330 and the controller 370 are then configured to acquire the identification information carried by the instrument identification code, in addition to detecting whether the instrument is present in the detection area. For example, the detection device 330 comprises a barcode reader in the case of a barcode type marker or radio frequency acquisition means in the case of a radio frequency electronic tag. The identification information of the medical instrument can be acquired when the medical instrument is placed in the disinfection chamber and/or when it is removed from the disinfection chamber and/or at the beginning and/or end of a disinfection cycle.

[0093] The information identifying the or each instrument, coupled with information detecting the instrument and characterizing the disinfection cycle, enables the generation of traceability information for the disinfection of the or each instrument referenced 390 in FIG. 3A. This traceability information makes it possible to relate each instrument to the conditions under which the corresponding disinfection cycle took place, for example, and may optionally be associated with information relating to the identity of the patient who benefited from the disinfection, and/or with information relating to the operator who performed the disinfection. This traceability information can be stored, visualized on a display or transmitted to one or more remote operators. It enables the passage of the instrument in the disinfection chamber to be guaranteed and the information characterizing the disinfection cycle undergone by the instrument to be checked, i.e. the specific moment when this disinfection took place, the chamber in which the disinfection cycle took place, the validation of good positioning of the instrument in the disinfection chamber, the UV dose received by the instrument, the temperature during the cycle, the fact that the instrument was well cleaned before the disinfection cycle.

[0094] According to one or more exemplary embodiments, the marker may be provided in the form of a detection kit for a medical instrument to be disinfected in a disinfection system according to the present description. The detection kit thus includes a marker configured to be integrally affixed to said medical instrument for detection by the detection device.

[0095] The detection kit may be used by an operator upstream of a disinfection cycle to “mark” a medical instrument for detection in the disinfection system before and/or during and/or after a disinfection cycle.

[0096] Advantageously, the detection kit marker can include an identification code of the medical device.

[0097] In practice, an operator may affix the marker integrally to the medical instrument at a predetermined position thereof. For example, an installer of the disinfection system could apply a barcode-type label at a certain point on the instrument's cable, cover this label with an element that encloses the cable and makes the label non-removable under normal use conditions. This element may be configured to allow for systematically repeatable attachment. According to one or more exemplary embodiments, the element may form a male-female pair with one of the portions of the enclosure, and may be provided with a transparent portion, for example a glass pane, which allows the rays of the identification code reader to pass through, for example, the rays of the bar code reader.

[0098] According to one or more exemplary embodiments, an RFID chip may be applied to a predetermined cable location and coupled to an RFID reader with a straight and restricted detection field. This embodiment may perform the function of detecting a marker position relative to a reference position within the detection area.

[0099] According to other exemplary embodiments, marked medical instruments configured to be disinfected in a disinfection system according to the present description may also be designed. Each marked medical instrument includes a marker integrally affixed to a region of said medical instrument for detection by the detection device. The marker is thus formed of an element external to the instrument and configured for detection of the medical instrument when positioned in the disinfection system, for a disinfection cycle. According to one or more exemplary embodiments, the marker comprises an identification code for the medical instrument. Such a marked medical instrument may be provided with the disinfection system, for example.

[0100] According to other exemplary embodiments, a marker may be integrated into already manufactured medical instruments. For example, according to one or more exemplary embodiments, a probe may incorporate an identifier in a cable, in a shape that may fit into a portion of interest of the disinfection chamber enclosure, positioning the identifier within the reader's detection field.

[0101] In the example of FIG. 3A, the marker 210 comprises a label with an identification code, for example; it is carried by the connection cable and is detected, in operation, by the detection device 330 such as a barcode reader arranged outside the interior volume of the disinfection chamber. The barcode reader presents a given field that defines a detection area.

[0102] As illustrated in FIG. 3B, if for some reason the medical instrument is not in the predefined position for disinfection, the optical sensor 330 does not detect in the detection area the marker, causing the controller 370 to generate a non-detection signal.

[0103] In the example of FIG. 3A, the disinfection chamber 310 is configured to allow the medical instrument to be suspended in the interior volume 312, by means of a ring 220 interacting with a suspension means 320 for example, as further described by means of FIGS. 4A, 4B and 5A, 5B.

[0104] The suspension means 320 shown in two views in FIGS. 5A and 5B comprises a body in which a cavity of complementary shape to at least a portion of the medical instrument is defined.

[0105] The suspension means interacts with the ring 220 configured to be attached to the cable 202 of the medical instrument 200, for example, so as to leave the marker 210 exposed. For example, in the case of optical detection of the marker 210, the ring 220 comprises a window 221 intended to be placed at the level of the marker. If the ring 220 slides unintentionally on the cable, as shown for example in FIG. 3B, the marker 210 integral with the medical instrument 200 will no longer be detected by the detection device 330.

[0106] Of course, other means may be contemplated for positioning the medical instrument in the chamber 310.

[0107] Thus, in the exemplary embodiment of a disinfection system in FIG. 6, a ring-shaped suspension means 620 housed in a ceiling opening 306 is illustrated.

[0108] FIGS. 7A through 7D depict diagrams illustrating examples of implementation of methods for detecting a medical instrument in a disinfection system according to the present description.

[0109] A method for detecting a medical instrument according to the present description generally comprises the detection 74 of a marker integral with said medical instrument in a predetermined detection area of the disinfection system, by means of a detection device; and, in case of non-detection of said marker in said predetermined detection area of the disinfection system, the generation 76 of a non-detection signal.

[0110] Detection of the marker may occur before and/or during and/or at the end of a disinfection cycle.

[0111] FIGS. 7A and 7B illustrate examples of methods wherein marker detection is done prior to initiation of a detection cycle. FIG. 7C illustrates an example of a method in which detection of the marker is done during a detection cycle and FIG. 7D illustrates an example of a method in which detection of the marker is done after a detection cycle. Of course, these examples are not limiting and may be combined.

[0112] Specifically, the example method illustrated in FIG. 7A comprises the detection 74 of the marker integral with the medical device, in the detection area, after positioning 70 of the medical device. If the marker is detected, the cycle may be enabled (712). If the marker is not detected in the detection area, the method includes generating 76 a non-detection signal. This may result in the generation of an alert (784) to a user who may check and correct the position of the medical instrument in the disinfection system.

[0113] The example method illustrated in FIG. 7B represents a variant of that illustrated in FIG. 7A in which, in the event of detection of the marker in the detection area, there is also a detection 714, in said detection area, of a position of the marker relative to a reference position. Based on said position of the marker in the detection area, one or more actions follow, including, for example: authorizing the launch of the cycle (712), issuing 718 a positioning error alert to one or more users and/or reconfiguring 716 a disinfection cycle to take account of said position.

[0114] The example method illustrated in FIG. 7C includes, after positioning 70 the medical instrument and initiating a cycle (722), detecting 74 within the detection area the marker integral with the medical device. If the marker is detected, the cycle can continue normally (724). If the marker is not detected in the detection area, the method comprises the generation 76 of a non-detection signal. This may result in the generation of an alert (784) to a user, for example, or the blocking of the cycle (782).

[0115] The example method shown in FIG. 7D comprises, after positioning 70 the medical instrument and completing a disinfection cycle (722, 724), detecting 74 in the detection area the marker integral with the medical instrument. If the marker is detected, the cycle is validated (714). If the marker is not detected in the detection area, the method comprises the generation 76 of a non-detection signal. This may result in the generation of an alert (784) to a user, for example, or an invalidation of the cycle (786).

[0116] In the example methods described above, the detection of the marker may occur according to any of the examples described above. For example, it may involve an optical detection of a marker that may take a variety of forms, including an external element (e.g., a label) for example, integrally affixed to the instrument, such as by bonding or integration within the instrument, or an element of the instrument itself.

[0117] In each of the example methods described by means of FIGS. 7A-7D, when the marker comprises a medical device identification code, the method may further comprise the detection device reading the identification code (a step not shown in the Figures).

[0118] The described methods may further comprise a prior step of marking the medical device, by affixing said marker integrally to said medical device, when the marker is an external element to the device (step not shown in the Figures).

[0119] Although described through a number of embodiments, the methods for detecting a medical instrument and the disinfection devices configured for implementing these methods comprise different variants, modifications and improvements that will be obvious to the person skilled in the art, it being understood that these different variants, modifications and improvements are within the scope of the invention as defined by the following claims.

[0120] Thus, for example, medical instruments without connection cables can also be disinfected by means of the disinfection methods and systems described in the present description, by creating a receptacle transparent to UV radiation for example, or by attaching to the medical instrument an element in the form of a “cap” which is then suspended.

[0121] In addition, instead of UV radiation such as that obtained from a UV radiation source such as UV-C, embodiments may use a “flash” type energy source emitting extremely high intensity radiation, including electron beam radiation, gamma radiation, x-radiation, or plasma gas radiation. For example, the flash-type energy source may include a light emitting diode (LED).