Sterile volume control system

Abstract

System (26) for controlling the asepsis of a sterile volume (23), the system (26) comprising: - at least one detection sensor (28) configured to detect an intrusion (30) into the sterile volume (23), and to deliver a signal (34a) relating to said detection, - a system (32) for determining an asepsis fault of the sterile volume (23) configured to receive the at least one signal (34a) from the at least one detection sensor (28) and determine an asepsis fault of the sterile volume (23) on the basis of the at least one signal (34a) received. Figure to be published with the abstract: Fig. 2

Description

Title of the invention: Sterile volume control system FIELD OF THE INVENTION

[0001] The present invention relates to an asepsis control system. More particularly, the system controls asepsis in a sterile volume. STATE OF THE ART

[0002] Asepsis control in the surgical field is exercised personally through a person, who may be a nurse, called a circulating dresser, who exercises human visual control. The circulating dresser will subsequently be referred to as a dresser.

[0003] The dresser ensures that persons performing a surgical procedure do not come into contact with a non-sterile element during a surgical procedure.

[0004] If the dresser observes an asepsis fault due to inappropriate contact of one of the persons participating in the surgical intervention with a non-sterile element, she must announce the asepsis fault and remedy it by applying a protocol that depends on the fault. The asepsis fault results in the breach of asepsis in the sterile volume. This breach can be in the form of contact with a non-sterile element inside or outside the so-called sterile volume, or the intrusion of a non-sterile element into the sterile volume. This inappropriate contact can concern any element likely to be in contact with the patient.

[0005] The other role of the circulating dresser is to assist the people performing the surgical intervention by providing them with the elements necessary for carrying out the intervention, such as instruments, drapes, staple wires, catheters, balloons, etc.

[0006] The dresser may have to leave the room to retrieve the item to be provided.

[0007] During this movement, the dresser can no longer carry out her observation mission aimed at determining whether there has been an asepsis error.

[0008] Furthermore, the dresser may not have detected an asepsis error, exposing the patient to a care-related infection which, in the worst case, may take the form of massive contamination of the surgical wound.

[0009] The same observations apply in all situations where monitoring of compliance with rigorous asepsis is required, such as radiology, interventional cardiology or the implantation of a catheter in intensive care.

[0010] It would be useful to improve and secure the monitoring of a sterile volume and the detection of a possible asepsis fault and thus assist the dresser in this monitoring task, for example when the dresser is absent out of necessity.

[0011] Monitoring a sterile volume is required in circumstances other than during a surgical intervention, such as in all industrial clean rooms or in agri-food operations.

[0012] For economic and safety reasons, it would be useful to have a means of asepsis control that does not depend entirely on the human monitoring abilities of a single person.

[0013] The present invention aims to propose a new system for controlling asepsis in a sterile volume meeting this need.

[0014] BRIEF DESCRIPTION OF THE INVENTION

[0015] To this end, a first aspect of the present invention relates to a system for controlling the asepsis of a sterile volume, for example in the medical, industrial and agri-food fields, the system comprising: - at least one detection sensor configured to detect an intrusion into the sterile volume, and to deliver a signal relating to said detection. - a system for determining an asepsis fault of the sterile volume configured to receive the at least one signal from the at least one detection sensor and determine an asepsis fault of the sterile volume on the basis of the at least one signal received.

[0016] The system for controlling asepsis in a sterile volume may also comprise one or more of the following features, considered individually or in all technically possible combinations: - the system for monitoring asepsis in a sterile volume comprises at least one contact sensor linked to at least one non-sterile element and configured to allow the detection of any type of contact of an element located at least partly in the sterile volume with the at least one non-sterile element, the system for determining an asepsis fault of the sterile volume being configured to receive at least one signal from the at least one contact sensor and determine an asepsis fault of the sterile volume on the basis of the signals received from the at least one contact sensor, and / or - the control system comprises an alert device, the alert device being configured to issue an alert when an asepsis fault of the sterile volume is determined, and / or - the alert device is manually deactivated, and / or - the alert device reactivates automatically, if no manual reactivation has taken place during a predetermined period of time, and / or - the asepsis fault includes an intrusion into the sterile volume, and / or - intrusion into the sterile volume corresponds to the intrusion of an element, for example non-sterile, into the sterile volume, and / or - the asepsis fault includes contact between a sterile element located in the sterile volume and at least one non-sterile element, for example located outside the sterile volume, and / or - the at least one detection sensor comprises a camera, and / or a reflective photosensitive sensor, and / or an infrared shower, and / or a distance sensor, and / or - the at least one contact sensor comprises a chemical sensor, and / or an ink visible under certain frequencies, and / or an electrostatic sensor, and / or a pressure sensor, and / or a proximity sensor, and / or an inertial sensor, and / or - in which at least one detection sensor is located outside the sterile volume, - the control system is used in a surgical operating room, and / or - the control system is used in a clean room, and / or - the system includes a configured information storage device to store over time the data of the at least one signal coming from the at least one detection sensor and / or of the at least one signal coming from the at least one contact sensor, and / or - the system comprises a display device, the display device being configured to display a representation of the stored data.

[0017] A second aspect of the present invention relates to a method for controlling the asepsis of a sterile volume, for example in the medical, industrial and agri-food fields, by a control system, the system comprising: - at least one detection sensor, - a system for determining an asepsis fault in the sterile volume, the method comprising: - - a step of detecting an intrusion into the sterile volume by said at less one control system detection sensor, - - a step of reception by the determination system of a signal relating to an intrusion delivered by at least one detection sensor, and - - a step of determining an asepsis fault of the sterile volume by the system for determining the control system based on at least one received signal.

[0018] The method for controlling asepsis in a sterile volume may also comprise one or more of the following characteristics, considered individually or in all technically possible combinations: - the asepsis control system in a sterile volume comprises at least one contact sensor linked to at least one non-sterile element, and the method comprises: • a step of detecting any type of contact of an element located at least partly in the sterile volume with at least one non-sterile element by said at least one contact sensor of the control system, • a step of reception by the system of determining a signal relating to a contact delivered by the at least one contact sensor, and • a step of determining an asepsis fault of the sterile volume by the determination system of the control system on the basis of the signals received from the at least one contact sensor, and / or - the control system comprises an alert device and the method comprises a step of issuing an alert by the alert device of the control system when an asepsis fault of the sterile volume is determined, and / or - the method comprises a step of manually deactivating the alert device, and / or - the method comprises a step of automatically reactivating the alert device if no manual reactivation has taken place during a predetermined period of time, and / or - the method comprises a step of detection by the at least one detection sensor of an intrusion into the sterile volume of an element, for example non-sterile, and / or - the method comprises a step of detection by the at least one contact sensor of a contact of a sterile element located in the sterile volume with at least one non-sterile element, for example located outside the sterile volume causing an asepsis fault by the at least one contact sensor, and / or - the control system comprises at least one detection sensor chosen from a camera, and / or a reflective photosensitive sensor, and / or an infrared shower, and / or a distance sensor, and / or - the control system comprises at least one contact sensor chosen from a chemical sensor, and / or an ink visible at certain frequencies, and / or an electrostatic sensor, and / or a pressure sensor, and / or a proximity sensor, and / or an inertial sensor, and / or - the control system includes at least one detection sensor located outside the sterile volume, and / or - the control method is used in a surgical operating room, and / or - the control process is used in a clean room, and / or - the system comprises an information storage device, and the method comprises a step of storing over time the data of the at least one signal coming from the at least one detection sensor and / or of the at least one signal coming from the at least one contact sensor on an information storage device, and / or - the system comprises a display device, and the method comprises a step of graphically displaying the stored data on a display device.

[0019] A third aspect of the present invention relates to a system for controlling the asepsis of a sterile volume, for example in the medical, industrial and agri-food fields, the system comprising: - at least one contact sensor linked to at least one non-sterile element and configured to allow detection of any type of contact of an element located at least partly in the sterile volume with the at least one non-sterile element, - a system for determining an asepsis fault of the sterile volume being configured to receive at least one signal from the at least one contact sensor and determine an asepsis fault of the sterile volume on the basis of the at least one signal received from the at least one contact sensor.

[0020] The system for controlling asepsis in a sterile volume may also comprise one or more of the following features, considered individually or in all technically possible combinations: - at least one detection sensor configured to detect an intrusion into the sterile volume, and to deliver a signal relating to said detection, the system for determining an asepsis fault of the sterile volume configured to receive the at least one signal from the at least one detection sensor and determine an asepsis fault of the sterile volume on the basis of the signals received, and / or - the control system comprises an alert device, the alert device being configured to issue an alert when an asepsis fault of the sterile volume is determined, and / or - the alert device is manually deactivated, and / or - the alert device reactivates automatically, if no manual reactivation has taken place during a predetermined period of time, and / or - the asepsis fault includes an intrusion into the sterile volume, and / or - intrusion into the sterile volume corresponds to the intrusion of an element, for example non-sterile, into the sterile volume, and / or - the asepsis fault includes contact between a sterile element located in the sterile volume and at least one non-sterile element, for example located outside the sterile volume, and / or - the at least one detection sensor comprises a camera, and / or a reflective photosensitive sensor, and / or an infrared shower, and / or a distance sensor, - the at least one contact sensor comprises a chemical sensor, and / or an ink visible under certain frequencies, and / or an electrostatic sensor, and / or a pressure sensor, and / or a proximity sensor, and / or an inertial sensor, and / or - which at least one detection sensor is located outside the sterile volume, and / or - the control system is used in a surgical operating room, and / or - the control system is used in a clean room, and / or - the system includes a configured information storage device to store over time the data of the at least one signal coming from the at least one detection sensor and / or of the at least one signal coming from the at least one contact sensor, and or - the system comprises a display device, the display device being configured to display a representation of the stored data

[0021] A fourth aspect of the present invention relates to a method for controlling the asepsis of a sterile volume, for example in the medical, industrial and agri-food fields, by a control system comprising - at least one contact sensor linked to at least one non-sterile element, and - a system for determining an asepsis fault in the sterile volume,

[0022] the method comprising: - a step of detecting any type of contact of an element located at least partly in the sterile volume with at least one non-sterile element by said at least one contact sensor of the control system, - a step of reception by the system of determination of a signal relating to a contact delivered by the at least one contact sensor, and - a step of determining an asepsis fault of the sterile volume by the determination system of the control system on the basis of a signal received from the at least one contact sensor.

[0023] The method for controlling asepsis in a sterile volume may also comprise one or more of the following characteristics, considered individually or in all technically possible combinations: - the control system comprises at least one detection sensor, and the method comprises: • a step of detecting an intrusion into the sterile volume by said at least one detection sensor of the control system, • a step of reception by the determination system of a signal relating to an intrusion delivered by the at least one detection sensor, and • a step of determining an asepsis fault of the sterile volume by the determination system of the control system on the basis of the signals received, and / or - the control system comprises an alert device and the method comprises a step of issuing an alert by the alert device of the control system when an asepsis fault of the sterile volume is determined, and / or - the method comprising a step of manually deactivating the alert device, and / or - the method comprising a step of automatically reactivating the alert device if no manual reactivation has taken place during a predetermined period of time, and / or - the method comprising a step of detection by the at least one detection sensor of an intrusion into the sterile volume of an element, for example non-sterile, and / or - the method comprising a step of detection by the at least one contact sensor of a contact of a sterile element located in the sterile volume with at least one non-sterile element, for example located outside the sterile volume causing an asepsis fault by the at least one contact sensor, and / or - the control system comprises at least one detection sensor chosen from a camera, and / or a reflective photosensitive sensor, and / or an infrared shower, and / or a distance sensor, and / or - the control system comprises at least one contact sensor chosen from a chemical sensor, and / or an ink visible at certain frequencies, and / or an electrostatic sensor, and / or a pressure sensor, and / or a proximity sensor, and / or an inertial sensor, and / or - the control system includes at least one detection sensor located outside the sterile volume, and / or - the control method is used in a surgical operating room, and / or - the control process is used in a clean room, and / or - the system comprises an information storage device, and the method comprises a step of storing over time the data of the at least one signal coming from the at least one detection sensor and / or of the at least one signal coming from the at least one contact sensor on an information storage device, and / or - the system comprises a display device, and the method comprises a step of graphically displaying the stored data on a display device. BRIEF DESCRIPTION OF THE FIGURES

[0024] The invention will be better understood in the light of the following description in the context of a surgical operation, which is given for information purposes only and which is not intended to limit said invention, accompanied by the figures below:

[0025] [Fig.l] is a schematic representation of a surgical operating room according to the prior art,

[0026] [Fig.2] is a schematic representation of a surgical operating room according to a first embodiment of the invention,

[0027] [Fig.3] is a schematic representation of a surgical operating room according to a second embodiment of the invention,

[0028] [Fig.4] is a partial schematic representation of an operating room surgical according to a third embodiment of the invention.

[0029] In the various figures, similar elements are designated by identical references. Furthermore, the various elements are not necessarily shown to scale in order to present a view making it easier to understand the invention. DETAILED DESCRIPTION OF THE INVENTION

[0030] [Fig.l] is a schematic representation of a surgical operating room 10 according to the prior art. The surgical operating room 10 comprises an operating table 12 and a tool support table 14. An element 16 is arranged on the table 14. The element 16 may more particularly be an instrument intended to be used by a person 18 in charge of the surgical intervention. A person named dresser 20 participates and assists the people 18 performing the surgical intervention. The dresser 20 defines a volume called sterile volume 22. The dresser 20 ensures that the people 18 performing the surgical intervention do not come into contact with a non-sterile element 24.

[0031] The non-sterile element 24 may be located in the sterile volume 22 defined by the dressing machine 20 as illustrated in [Fig.l]. But this non-sterile element 24, coming into contact with at least one of the persons 18, may be located outside the sterile volume 22.

[0032] The dressing machine 20 cannot ensure permanent monitoring of the sterile volume 22 if the dressing machine 20 is required to perform a task that causes it to take its eyes off the sterile volume 22. It is therefore necessary to compensate for the break in monitoring of the dressing machine 20 when it is performing other tasks.

[0033] [Fig. 2] is a schematic representation of a surgical operating room 10 according to a first embodiment of the invention.

[0034] In the same way as [Fig.l], the surgical operating room 10 illustrated in [Fig.2] comprises an operating table 12 and a tool support table 14. An element 16 (illustrated in [Fig.l]) may be arranged on the table 14. The element 16 may more particularly be an instrument intended to be used by a person 18 in charge of the surgical intervention. A dressing machine 20 assists the persons 18 carrying out the surgical intervention. The dressing machine 20 may be located outside the sterile volume 23.

[0035] A control system 26 for asepsis in a sterile volume 23 is shown in [Fig. 2]. The control system 26 predefines a sterile volume 23. In a particular embodiment, the dresser can predefine the sterile volume 23 by means of a graphical interface 46 (shown in [Fig. 4]). This sterile volume 23 defines a sanctuary zone 27 delimited by the contours of the sterile volume 23. The sanctuary zone is considered separately from the sterile volume 23. In this way, the sanctuary zone 27 can comprise a non-sterile element 24 within the volume 23. The sanctuary zone can further comprise a person, for example the dresser 20 or the persons 18 carrying out the surgical intervention.In this way, when predefining the sterile volume 23, comprising the sanctuary zone 27, a non-sterile element or a person can be present in the sterile volume 23 without triggering an alert by the simple fact of the presence in the sterile volume. The elements arranged in the sanctuary zone 27 are considered by the control system 26 to be sterile. The control system 26 comprises at least one detection sensor 28. The detection sensors 28 are intended to detect an intrusion 30 of a non-sterile element 24 into the sterile volume 23.

[0036] The control system 26 further comprises a system 32 for determining an asepsis fault in a sterile volume 23. The determination system 32 is configured to receive at least one signal 34a from the at least one detection sensor 28. During an intrusion 30, into the sterile volume 23, of an external element 36, for example a non-sterile element 24 as illustrated in [Fig. 2], the signal 34a from the at least one sensor 28 received by the determination system 32 allows it to detect that an external element 36 has been introduced into the sterile volume 23. From this signal 34a and the detection of an intrusion which is deduced therefrom, the determination system 32 determines the presence of an asepsis fault in the sterile volume 23.

[0037] Advantageously, such a determination system 32 makes it possible to continuously monitor any possible intrusion 30 into the sterile volume 23, even if the dresser 20 has to move to look for an instrument or any element necessary to continue the intervention. This makes it possible to overcome the problem of the temporary absence of the dresser during her movement; she can no longer carry out her task of monitoring the sterile volume.

[0038] Indeed, thanks to the prior definition of the sterile volume and the processing of the data, 34a, the system 32 determines whether the sanctuary zone 27 has been crossed. For example, if the sensors 28 are cameras, the system 32 will measure, using image processing algorithms, whether the boundaries defining the sterile volume 23 have been crossed. Unlike human control, this device will be able to verify the integrity of the sanctuary zone from several points of view at the same time.

[0039] The determination system 32 may comprise a process comprising an image processing step and a step of detecting intrusion 30 into the sterile volume 23. This image processing step may be carried out in real time. More particularly, the detection of the intrusion 30 is carried out by the detection sensors 28.

[0040] [Fig. 3] is a schematic representation of a surgical operating room 10 according to a second embodiment comprising the characteristics of the first embodiment illustrated in [Fig. 2].

[0041] Furthermore, the control system 26 comprises at least one contact sensor 38 linked to a non-sterile element 24. The non-sterile element 24 may be, for example, an instrument placed on the table 14 or a surgical light 40, of which only one handle is sterilized.

[0042] A person 18 may be provided with equipment, more particularly a hairnet, which could involuntarily come into contact with a part of the surgical light 40 which is not sterile.

[0043] This non-sterile element 24 may be located in the sanctuary zone 27 as illustrated in [Fig.3] or at least partially outside the sanctuary zone 27 and therefore the sterile volume 23. The non-sterile element 24, linked to a contact sensor 38, can also be located completely outside the sterile volume 23 (not shown).

[0044] When a non-sterile element 24 provided with a contact sensor 38 comes into contact with a person 18, 20, a signal 34b is transmitted to the determination system 32. The determination system 32 is configured to receive the signal 34b emitted by the contact sensor 38 and determine an asepsis fault on the basis of the signals 34b received from at least one contact sensor 38.

[0045] Optionally, the asepsis fault is determined on the basis of the signals 34a, 34b of at least one contact sensor 38 and at least one detection sensor 28.

[0046] The at least one contact sensor 38 makes it possible to detect the contact of a person with a non-sterile element 24 already present in the sanctuary zone 27 or outside the sterile volume 23.

[0047] This second embodiment is complementary to the first and makes it possible to detect a possible asepsis fault independently of the intrusion 30 of an element into the sterile volume 23 and in addition to the supervision of the dressing machine 20.

[0048] [Fig. 4] is a partial schematic representation of a surgical operating room 10.

[0049] The control system 26 may comprise an alert device 42. The alert device 42 is configured to issue an alert when an asepsis fault of the sterile volume is determined by the determination system 32.

[0050] The monitoring device 44 may comprise the determination system 32.

[0051] In a particular embodiment, the alert device 42 may also be a device 42a disposed on a monitoring device 44 located in the surgical operating room 10.

[0052] The monitoring device 44 is a fixed device, preferably arranged in the surgical operating room 10.

[0053] The monitoring device 44 is included in the control system 26, and makes it possible to transmit an alert signal to the dressing machine 20, using the alert device 42a, when an asepsis fault of the sterile volume 23 is determined.

[0054] The alert signal of the alert device 42a may be visual and / or audible and / or vibratory.

[0055] In a particular embodiment of the invention, the determination system 32 and the monitoring device 44 are arranged in the same enclosure.

[0056] In another particular embodiment, the alert device 42 may also be a portable alert device 42b.

[0057] The alert device 42b is connected by a wireless link to the determination system 32 and can emit a visual and / or audible alert signal and / or in the form of a vibration when an asepsis fault of the sterile volume 23 is determined.

[0058] Optionally, as illustrated in [Fig.4], the surgical operating room 10 comprises a monitoring device 44 provided with an alert device 42a and the dressing machine 20 has a portable alert device 42b.

[0059] The alert signal may be visual and / or audible and / or a vibration of the portable alert device 42b. The portable device 42b may be a vibrating and / or audible connected bracelet, and / or an electronic tablet.

[0060] Advantageously, the alert device 42, 42a, 42b makes it possible to alert the dressing machine 20 that a risk of asepsis failure has been determined.

[0061] In this way, the dressing machine 20 can act to re-establish asepsis, for example it can indicate to the person 18 involved in the asepsis fault to carry out a sterilization procedure in order to be fully in a sterile environment again.

[0062] Advantageously, to avoid an untimely alert signal from the alert device 42, the dressing machine 20 has the possibility of manually deactivating the alert device 42, for example to allow the voluntary introduction of a sterile element into the sterile volume 23. The dressing machine 20 can also manually decide to deactivate at least one detection sensor 28 or contact sensor 38. In addition, the dressing machine 20 can also indicate using the graphical interface 46 that an intrusion 30 of an element or a person into a predefined zone, using the graphical interface 46, of the sterile volume 23 does not constitute an asepsis fault.

[0063] This one-off deactivation can be done using a telephone application, a computer program, a connected object, or a mechanical or electronic actuator arranged on a fixed element of the control system such as the monitoring device 44 or on a portable element such as the portable alert device 42b, or other.

[0064] The alert device 42 reactivates automatically, if no manual reactivation has taken place during a predetermined period of time.

[0065] The predetermined period of time may be of the order of 1 minute and, more preferably, of the order of 30 seconds.

[0066] Advantageously, if the dressing machine 20 forgets to reactivate the alert system 42, the control system 26 can be operational again. If the control system had not been reactivated, the dressing machine would not have been able to benefit from the assistance in detecting an asepsis fault in the sterile volume 23.

[0067] In a particular case of the invention, the asepsis fault in the sterile volume 23 is caused by an intrusion 30 into the sterile volume.

[0068] Advantageously, as indicated in the description of [Fig.2], an intrusion 30 into the sterile volume 23 is detected using at least one detection sensor 28.

[0069] Preferably, the control system 26 is capable of determining that the intrusion 30 into the sterile volume 23 corresponds to the intrusion 30 of a non-sterile element 24 into the sterile volume 23.

[0070] This determination can be carried out for example by means of RFID markers or any other type of marker (bar codes, markers sensitive to a specific light, etc.), which can be detected by the detection sensor 28, arranged on a container of an element introduced into the sterile volume 22.

[0071] The dressing machine 20 can also indicate to the control system 26 before or during the surgical procedure that the element which is going to be introduced corresponds to a sterile element. In this way, the control system 26 is optimized so as not to transmit an alert signal to the dressing machine 20 when the introduced element is provided with a marker indicating that the contents are sterile.

[0072] In a particular case of the invention, the asepsis fault comprises contact of a sterile element located in the sterile volume 23 with at least one non-sterile element 24, for example located outside the sterile volume 23. Advantageously, the presence of a contact sensor 38 on the non-sterile elements 24 makes it possible to detect contact of the person 18, or one of their items of equipment with the non-sterile element 24.

[0073] The non-sterile element 24 provided with a contact sensor 38 may be located within the sanctuary zone 27 delimited by the contours of the sterile volume 23 or outside the sterile volume 23.

[0074] The at least one detection sensor 28 comprises a camera, and / or a reflective photosensitive sensor, and / or an infrared shower, and / or a distance sensor. An arrangement of several types of detection sensors 28 can be considered.

[0075] In one embodiment, the detection sensor 28 may be a camera, the signal of which corresponds to the images recorded by the camera or anamorphic images.

[0076] The camera may be a wide-angle camera.

[0077] Preferably, the detection sensors 28 are at least three in number and arranged in a specific manner to allow triangulation.

[0078] The arrangement of the sensors can make it possible to define a sterile volume 23 in a three-dimensional manner in a first step and to detect in real time an intrusion of an element into the sterile volume 23 in a second step.

[0079] The sterile volume 23 can be predefined in advance by the dressing machine 20 using the control system 26.

[0080] In a particular embodiment, the sterile volume 23 is configured using a graphical interface 46 included in and / or associated with the monitoring device 44.

[0081] The dressing machine 20 can redefine the sterile volume 23 at any time before and during the surgical procedure. The sterile volume 23 can be configured as the volume formed by a polyhedron whose vertices are defined on the graphical interface 46.

[0082] Several other methods are also possible for defining the sterile volume: - the definition of a two-dimensional geometric shape (circle, oval, square, rectangle, ellipse, etc.) from a plane or a top view using a detection sensor 28, in such a way that the sterile volume 23 is delimited laterally (along an X axis illustrated in [Fig.4]) and in depth (along a Y axis illustrated in [Fig.4]) by the two-dimensional geometric shape and in height by a predetermined height, - the sterile volume 23 can also be formed from an addition or subtraction of volumes (cylinders, spheres, cube, right paving stone, etc.).

[0083] The examples of definition of the sterile volume 23 mentioned above are not limiting, any other mode of definition of the sterile volume 23 can also be considered by the present invention.

[0084] In a particular embodiment, the definition of the sterile volume 23 can be made from QR Code tape type markers placed, for example by the dressing machine 20, in the surgical operating room 10 and detected by the detection sensors 28. The control system detects the position of the QR Code tapes and defines the sterile volume 23. The predefined sterile volume 23 is then verified by the dressing machine 20.

[0085] In a particular embodiment, the definition of the sterile volume 23 is carried out automatically by the control system 26 and subject to validation by the dressing machine 20.

[0086] Regardless of the method of defining the sterile volume 23, its height can either be defined precisely using the graphical interface or by the spatial limits of the surgical operating room, namely the floor and the ceiling.

[0087] In one embodiment of the invention, the height of the sterile volume 23 is defined by the floor and the ceiling of the surgical operating room 10. It is possible for the dressing machine 20 to readjust the height of the sterile volume 23 so as not to include the surgical light 40 if the latter is moved. In this way, if a person 18 maneuvers the surgical light 40 by its sterile handle to lower it, the surgical light 40 does not enter the redefined sterile volume 23.

[0088] Whatever the method of defining the sterile volume 23, the definition can be done using the graphical interface 46 and independently or with the use of at least one image capture obtained by at least one of the detection sensors 28.

[0089] The intrusion detection is carried out using the control system 26 which has enabled the definition of the sterile volume 23 and the detection sensors 28 which by their arrangement allow triangulation. The control system 26 can implement an image processing method from the signals 34a, in the form of image capture. From these real-time image captures, the determination system 32 can determine whether there has been an intrusion of an element into the sterile volume 23 predefined for example by an image processing algorithm which detects the crossing of lines.

[0090] In a particular embodiment, the at least one detection sensor 28 comprises a camera. Preferably, several cameras to allow triangulation.

[0091] Advantageously, the use of cameras is elementary and does not require significant skill for the dresser 20 or an external operator installing the control system 26 in the surgical operating room 10. In addition, moving the cameras is simple to perform.

[0092] In the event that there is triangulation of the cameras, recalibration of the system may be necessary following the movement of the cameras.

[0093] The signal 34a perceived from the camera allows the determination system 32 to detect an intrusion 30 into the sterile volume 23. Preferably, the cameras are capable of detecting information on a specific marker such as a sticker and thus recognizing whether an element introduced into the sterile volume 23 is a sterile element or a non-sterile element 24 lacking the specific marker characterizing the sterile elements. The cameras can be easily connected to each other or to the determination system 32 to carry out triangulation.

[0094] According to another embodiment, at least one detection sensor 28 is a reflective photosensitive sensor. This type of sensor makes it possible to define immaterial barriers delimiting the sterile volume 23. These sensors allow the detection of any type of intrusion through the barrier.

[0095] In the event that a person 18 moves back sufficiently, the detection sensor 28 detects a crossing outside the sterile volume. The sensor 28 then transmits a signal 34b to the determination system 32 which then determines the presence of an asepsis fault. The alert device 42 is configured to emit an alert when an asepsis fault of the sterile volume is determined by the monitoring device 32.

[0096] In the case where a person 18 moves back sufficiently, the detection sensor 28 detects a crossing outside the sterile volume. The sensor 28 then transmits a first signal 34b, coming from the photosensitive sensor, to the determination system 32. The presence of another detection sensor 28 in the form of a camera 28 allows the transmission of a second signal 34b, coming from the camera, to the determination system determination 32. The determination system 32 determines from the combined first and second signals 34b whether there has actually been an asepsis fault.

[0097] Advantageously, the reflective photosensitive sensors are very reliable.

[0098] According to another embodiment, at least one detection sensor 28 is an infrared shower. Such a type of sensor is often used for automatic door opening as soon as a person is detected nearby. Advantageously, these sensors are easy to install and highly accurate.

[0099] According to another embodiment, at least one detection sensor 28 is a distance sensor. These sensors may more particularly be ultrasonic sensors which make it possible to detect whether an element is present close to the sensor and to determine whether it is close to the sterile volume 23 by determining its distance from the sterile volume 23. Thus, the ultrasonic distance sensors may be placed on the floor or on the ceiling so as to define the section of the sterile volume on the floor. If an element or a person comes close to the sensor, and more particularly above the distance sensor, then the detection sensor 28 sends a signal 34a to the determination system 32 to indicate to it that a person or an element has approached the sensor at a distance less than a predefined threshold value. The determination system 32 thus determines whether an intrusion 30 into the sterile volume 23 has taken place.

[0100] According to another embodiment, at least one detection sensor 28 is a distance sensor, and more particularly a laser sensor. Advantageously, the laser sensors are provided with significant precision.

[0101] According to the second embodiment of the invention, the control system 26 comprises at least one contact sensor 38. The at least one contact sensor 38 may comprise a chemical sensor, and / or an electrostatic sensor, and / or a pressure sensor, and / or a proximity sensor, and / or an inertial sensor. The non-sterile elements 24 intended to be provided with a contact sensor are for example a liquid bag, a mat or even a surgical light.

[0102] According to a particular mode of the second embodiment, at least one contact sensor 38 is a chemical sensor. The equipment of a person 18 can be coated with an invisible sterile ink which leaves a mark on a non-sterile element 24 when the coated equipment of the person 18 comes into contact with a non-sterile element 24. In combination with an image capture means, such as a camera acting as a detection sensor 28, the mark can be detected by the control system 26 and an alert signal informing of a possible asepsis fault will be transmitted to the dressing machine 20 via the alert device 42. The mark can be a colored mark or an invisible mark detected in the ultraviolet range. In an alternative, it is the non-sterile elements 24 which are coated with the ink.

[0103] According to another embodiment of the second embodiment, at least one contact sensor 38 is an electrostatic sensor. These sensors can be arranged on the equipment of the people 18, such as connected clothing. Any sterile element is defined at the same electrical potential and different from the electrical potential of the non-sterile elements 24. Thus the contact of electrostatic sensors having a potential allows the transmission of a signal 34b, via wireless transmission, to the determination system 32 to warn it of a change in potential. The determination system 32 deduces therefrom a contact of a person 18 with a non-sterile element 24 and transmits an alert signal via the alert device 42 to warn the dressing machine 20.

[0104] According to another embodiment of the second embodiment, at least one contact sensor 38 is a pressure sensor. The pressure sensor is disposed on the non-sterile element configured to detect pressure from a person 18 on said contact sensor 38 upon contact with the non-sterile element 24. Wireless transmission of a signal 34b indicating that pressure has been detected by one of the sensors 38 allows the determination system 32 to determine that a person 18 has come into contact with a non-sterile element 24. The determination system 32 can then transmit an alert signal via the alert device 42 to warn the dressing machine 20.

[0105] According to another embodiment of the second embodiment, at least one contact sensor 38 is a proximity sensor. A proximity sensor can be positioned at a risk zone, and more precisely a non-sterile element 24. Thus, as soon as a person 18 approaches the proximity sensor at a distance less than a predefined threshold, a signal 34b is transmitted, via wireless transmission, to the determination system 32 which deduces an asepsis fault in the sterile volume 23. The determination system 32 can then transmit an alert signal via the alert device 42 to warn the dressing machine 20.

[0106] According to another embodiment of the second embodiment, the at least one contact sensor 38 is an inertial sensor, such as a gyroscope.

[0107] The inertial sensor is connected to a non-sterile element 24. In this way, if a person 18 comes into contact with the non-sterile element 24, the latter undergoes a displacement which can be measured by the inertial sensor. The inertial sensor transmits, via wireless transmission, a signal 34b indicating the displacement of the non-sterile element 24, to the determination system 32. The determination system 32 then determines that a person 18 has come into contact with a non-sterile element 24 and can then transmit an alert signal via the alert device 42 to warn the dressing machine 20.

[0108] Preferably, the dressing machine 20 has a contact sensor 38 on each of the non-sterile elements which risk coming into contact with one of the people 18 during the surgical intervention.

[0109] The contact sensors 38 may comprise an adhesive portion for being bonded to a non-sterile element 24. Preferably, the contact sensors 38 are in the form of stickers.

[0110] It should be noted that the invention is not limited to the sensors mentioned and covers any type and any combination of detection sensors 28 and contact sensors 38. Several types of detection sensors 28 can be used in a surgical operating room 10. In the same way several types of contact sensors 38 can be used in a surgical operating room 10.

[0111] The at least one detection sensor 28 and the at least one contact sensor 38 may be located in or outside the predefined sterile volume 23.

[0112] The at least one detection sensor 28 and the at least one contact sensor 38 may also be located partly inside the sterile volume 23.

[0113] In a particular embodiment, the asepsis control system is used in a surgical operating room 10.

[0114] The object of the invention is not limited to the embodiment described above concerning the detection of an asepsis fault in a surgical operating room 10.

[0115] The invention may also relate to the industrial or agri-food sector.

[0116] Advantageously, the control system 26 has an information storage device 48 configured to store over time the data of the at least one signal 34a coming from the at least one detection sensor 28 and / or of the at least one signal 34b coming from the at least one contact sensor 38.

[0117] Preferably, the image capture obtained by the detection sensors 28 is continuously stored on the information storage device 48 in the form of video during the surgical intervention. In the same way, the signals 34b transmitted by the contact sensors 38 are stored on the information storage device 48.

[0118] In a particular embodiment, all the information stored on the storage device 48 corresponding to signals 34a, 34b coming from the at least one detection sensor 28 and / or from the at least one contact sensor 38 dating back more than 6 hours are erased, continuously.

[0119] Preferably, the information corresponding to the signals 34a, 34b is stored throughout the duration of the operation without being erased.

[0120] In a particular embodiment, the control system 26 comprises a display device. The display device is configured to display a representation of the stored data.

[0121] Preferably, the display device is formed by the graphical interface 46. In this way, the control system 26 can provide the dressing machine 20, at the time of an alert, via the graphical interface 46, with a graphical representation corresponding to each of the signals 34a, 34b from each of the at least one detection sensor 28 and at least one contact sensor 38.

[0122] Preferably, the graphical representation corresponding to the at least one detection sensor 28 is an image capture. The image captured by each of the detection sensors 28 present in the surgical operating room 10 is displayed on the graphical interface 46. Concerning the graphical representation, on the graphical interface 46, corresponding to the signals 34b of the contact sensors 38 present in the surgical operating room 10, a change in color of a character string can be associated with a change in the signal 34b linked to an event is detected by a contact sensor 38. In another embodiment, the display corresponding to the signals 34b of the contact sensors 38 can be in the form of a specific display, such as a numerical value as soon as an event is detected by a contact sensor 38.

[0123] In a particular embodiment, the dressing machine 20 references, using the graphical interface 46, the position of non-sterile elements 24 provided with a contact sensor 38. A movement of the at least one referenced contact sensor 38 then results in a flashing or a change in color of the latter at the level of the graphical interface 46. The dressing machine can thus directly know the area where contact with a non-sterile object has taken place. Preferably, an area around the referencing of the initial position of the non-sterile element 24 provided with the contact sensor 38 is highlighted on the graphical interface to indicate the area where the contact has taken place.

[0124] In one embodiment, the representation corresponding to the signals 34b of the contact sensors 38, on the graphical interface 46, is in the form of a colored display linked to said contact sensor 38, when an asepsis fault is detected. Preferably, a color is assigned to each contact sensor 38 to allow the dressing machine 20 to easily determine the location of the possible asepsis fault.

[0125] In one embodiment, the dressing machine 20, when defining the sterile volume 23 using the control system 26, indicates on the representation comprising the sterile volume 23 the position of the contact sensor 38. If the signal 34b emitted by a detection sensor 38 leads to the determination of an asepsis fault by the determination system 32, the graphical interface displays a sphere, a cylinder, or any other geometric shape, around the position where the contact sensor 38 is defined by the dressing machine when defining the volume. The geometric shape displayed on The graphical interface allows the dresser to be shown an area where the asepsis error has potentially occurred.

[0126] The dressing machine 20 can, from these graphical representations, displayed on the graphical interface 46, determine whether the alert emitted by the alert device 42 actually corresponds to an asepsis fault in the sterile volume 23.

[0127] In one embodiment, for each alert, the dressing machine 20 can, from an image capture of the at least one detection sensor 28, have the possibility of seeing in the form of a video what happened 5 seconds before and 5 seconds after the image capture of an alert, more particularly 3 seconds before and 3 seconds after the image capture. Preferably, the dressing machine 20 has the possibility of stopping this video and obtaining an image capture at any time during the 10-second period, more particularly 6 seconds, of the video. The dressing machine also has the possibility of consulting the videos recorded by each of said detection sensors 28 at any time. The dressing machine 20 has the possibility of reducing the playback speed. In a particular embodiment, the video can also be viewed with reverse playback, so as to see a later event before a prior event.The dressing machine 20 may obtain an image capture from each of the at least one detection sensor 28 when it pauses the playback of the video.

[0128] In one embodiment, for each alert, the dresser 20 can, from an image capture of the at least one detection sensor 28, have the possibility of seeing in the form of a video corresponding to all the information recorded on the information storage device 48 during the surgical intervention. The dresser 20 has the possibility of reducing the playback speed. In a particular embodiment the video can also be viewed with reverse playback, so as to see a later event before a prior event. The dresser 20 can obtain an image capture of each of the at least one detection sensor 28 when it pauses the playback of the video.

[0129] The implementation of a control system 26 in a surgical operating room 10 comprises a first step of setting up the control system 26 in the surgical operating room 10. This step particularly concerns the arrangement of the sensors, and more particularly of the detection sensors 28 to, for example, allow triangulation.

[0130] Once the control system 26 is arranged at least partly in the surgical operating room 10, the implementation of the control system 26 comprises a second step called the initialization step. The initialization can be done outside the future sterile volume 23 to be defined. Alternatively, the initialization of the control system 26 comprises a third step of defining the sterile volume 23. The initialization step also serves to initialize the detection sensors 28 and the sensors contact 38. This step makes it possible to verify that the signals 34a, 34b from the detection sensors 28 and contact 38 are correctly transmitted to the control system 26 and to verify that the alert signal is correctly transmitted to the dressing machine 20 in the event of intrusion into the sterile volume 23 or contact with a non-sterile element 24.

[0131] The third step consisting of defining the sterile volume 23 can be done manually via the graphical interface 46, semi-automatically by placing tapes provided with a QR Code allowing the control system to define the sterile volume 23, or the definition of the sterile volume 23 can be done completely automatically. Whether the definition of the sterile volume 23 is manual, semi-automatic, or automatic, confirmation from the dressing machine 20 remains necessary to ensure that the sterile volume 23 has been defined.

[0132] Furthermore, during a surgical intervention, the dressing machine 20 may also be required to intervene on the control system so as to redefine the sterile volume 23 or to deactivate the alert.

[0133] Furthermore, when the dressing machine 20 receives an alert signal, the dressing machine can see in video form, the events occurring shortly before and after corresponding to the selected image capture. This video corresponds to the signal 34a continuously acquired by the detection sensor 28 whose image capture was selected by the dressing machine 20.

[0134] Furthermore, in a particular mode of use, the dressing machine 20 can review the acquired data coming from the signals 34a, 34b of the detection sensors 28 and contact 38 corresponding to a previous alert.

Claims

Claims

1. System (26) for controlling the asepsis of a sterile volume (23) in the medical, industrial and agri-food fields, the system (26) comprising: - at least one detection sensor (28) configured to detect an intrusion (30) into the sterile volume (23), and to deliver a signal (34a) relating to said detection, - a system (32) for determining an asepsis fault of the sterile volume configured to receive at least one signal (34a) from the at least one detection sensor (28) and determine an asepsis fault of the sterile volume (23) on the basis of the at least one signal (34a) received, characterized in that it further comprises a graphical interface (46) configured to define said sterile volume (23).

2. System for controlling (26) the asepsis of a sterile volume (23) according to claim 1, comprising at least one contact sensor (38) linked to at least one non-sterile element (24) and configured to allow the detection of any type of contact of an element located at least partly in the sterile volume with the at least one non-sterile element (24), the system for determining (32) an asepsis fault of the sterile volume (23) being configured to receive at least one signal (34b) from the at least one contact sensor (38) and determine an asepsis fault of the sterile volume (23) on the basis of the signals (34a, 34b) received from the at least one contact sensor (38).

3. A system (26) for controlling the asepsis of a sterile volume (23) according to claim 1 or 2, comprising an alert device (42, 42a, 42b), the alert device (42, 42a, 42b) being configured to emit an alert when an asepsis fault of the sterile volume (23) is determined.

4. A system for controlling (26) the asepsis of a sterile volume (23) according to claim 3, wherein the alert device (42, 42a, 42b) is configured to be manually deactivated.

5. System for controlling (26) the asepsis of a sterile volume (23) according to claim 3 or 4, in which the alert device (42, 42a, 42b) is configured to reactivate automatically, if no manual reactivation has not occurred within a predetermined period of time.

6. System for controlling (26) the asepsis of a sterile volume (23) according to one of claims 1 to 5, in which the at least one detection sensor (28) comprises a camera, and / or a reflective photosensitive sensor, and / or an infrared shower, and / or a distance sensor.

7. System for controlling (26) the asepsis of a sterile volume (23) according to one of claims 2 to 6, in which the at least one contact sensor (38) comprises a chemical sensor, and / or an electrostatic sensor, and / or a pressure sensor, and / or a proximity sensor, and / or an inertial sensor.

8. System for controlling (26) the asepsis of a sterile volume (23) according to one of claims 1 to 7, in which the at least one detection sensor (28) is located outside the sterile volume (23), when the sterile volume is predefined by the control system (26).

9. System for controlling (26) the asepsis of a sterile volume according to one of claims 1 to 8, comprising an information storage device (48) configured to store over time the data of the at least one signal (34a) coming from the at least one detection sensor (28) and / or of the at least one signal (34b) coming from the at least one contact sensor (38).

10. A system (26) for controlling the asepsis of a sterile volume (23) according to the preceding claim, comprising a display device, the display device being configured to display a representation of the stored data.

11. A method of controlling the asepsis of a sterile volume (23) by a control system (26) according to any one of the preceding claims, the method comprising: - a step of defining the sterile volume (23), during which the sterile volume (23) is defined using a graphical interface (46), - a step of detecting an intrusion (30) into the sterile volume (23) by said at least one detection sensor (28) of the control system (26), - a step of receiving a signal (34a) relating to an intrusion (30) delivered by the at least one detection sensor (28) by the determination system (32), and a step of determining an asepsis fault of the sterile volume by the determination system (32) of the control system (26) on the basis of the at least one signal (34a) received.

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