Method for determining whether the operating channel of a medical endoscope has been used

Abstract

The invention relates to a method for determining whether an operating channel (8) of an insertion tube (2) of a medical endoscope (1) has been used, the method comprising the following steps: 1) providing a medical endoscope (1) comprising an outer sheath (9) that entirely covers the insertion tube (2) and conforms to the shape thereof so that the outer sheath (9) covers the distal tip (4) with its distal end (9d); 2) acquiring, using the camera (6), images identifying the use of the operating channel (8) in order to determine whether the operating channel (8) has been used. The invention also relates to a method for preparing a medical endoscope (1) for reuse.

Description

Description Title of the invention: METHOD FOR DETERMINING WHETHER THE WORKING CHANNEL OF A MEDICAL ENDOSCOPE HAS BEEN USED Technical Field

[0001] The invention relates to the technical field of medical endoscopes. The medical endoscopes according to the invention allow access to the internal surface of a hollow organ, a cavity or a natural or artificial duct of the human body in order to carry out various operations for therapeutic, surgical or diagnostic purposes. The medical endoscopes according to the invention are used for the inspection of all internal parts of the human body accessible by natural or artificial means. For example, the medical endoscopes according to the invention can be used in the field of the urinary tract, the gastrointestinal tract, the respiratory system, the cardiovascular system, the trachea, the sinus cavity, the female reproductive system, the abdominal cavity or any other part of the human body to be explored by a natural or artificial means. Prior art

[0002] Generally speaking, a medical endoscope comprises, as described for example by patent application WO 2014 / 106510, a control handle to which an insertion tube is attached. This tube comprises a distal head equipped with an optical viewing system for illuminating and examining the organ, cavity or duct of the human body. Upstream of this distal head, the insertion tube comprises a bending structure or deflection portion allowing the orientation of the distal head using one or more actuation cables mounted inside the insertion tube.

[0003] This tubular structure is adapted to allow one or more devices designed to perform different functions such as, for example, fluid supply, fluid suction, etc. to be brought to the distal head. the delivery of instruments, the taking of samples or surgical operations. The distal head of the endoscope is also equipped with at least one so-called operator or working channel to allow the passage of these various devices.

[0004] Thus, such an endoscope is provided with a multifunctional distal head configured to allow the implantation of the vision system and the passage of these various devices. However, this distal head has a passage or space section which is limited by the smallest width of the natural or artificial access route in which the tubular structure is engaged. Given the diversity of functionalities that an endoscope must have and the dimensional constraints imposed by the access route, it appears difficult to configure the distal head so that certain functions of the endoscope can be carried out.

[0005] When used by the practitioner, the insertion tube is inserted into the cavity or natural duct being inspected. After use, the medical endoscope, and in particular the insertion tube, is either discarded, cleaned and disinfected, or even sterilized, for reuse. Various methods for cleaning and disinfecting the insertion tube exist, but their effectiveness is often limited, which can constitute a source of nosocomial infection for the patient.

[0006] It is therefore important to be able to easily reuse a medical endoscope while avoiding any risk of contamination for the patient. To achieve this, it is necessary to find a method to determine whether the medical endoscope can be used safely for the patient, as well as a method to enable its reuse in a safe manner for the patient.

[0007] In this context, the applicant was interested in medical endoscopes whose insertion tube is covered by a sheath. Indeed, these sheaths being waterproof, they make it possible to protect against any contamination during use of the endoscope. For example, document GB 2 336 540 describes a flexible sheath into which an endoscope can be inserted for use by a practitioner. The distal end of the sheath has a transparent window to ensure good visibility. The proximal end has a seal to prevent contamination. US Patent 5,827,177 also describes the use of a sheath to protect the endoscope from contamination during an endoscopy. This sheath has a tip at its distal end, and an insulating sheet inside to limit friction of the actuation cables and the insertion tube in particular, and to ensure that they are held in position. Also worthy of mention is US Patent 8,360,968, which relates to a protective sheath to isolate an endoscope from tissues during use, and thus avoid any cleaning or sterilization between patients. This sheath includes a window at its distal end, as well as at least one light source mounted therein.

[0008] Although these sheaths protect the medical endoscope from contamination, these devices are insufficient to guarantee patient safety and to allow their subsequent reuse. Indeed, nothing allows the practitioner to determine if the sheath is damaged during use of the endoscope, particularly by the passage of a tool in the operating channel. The practitioner therefore cannot easily determine if the medical endoscope is contaminated. Their reuse is therefore not possible safely.

[0009] Document US 10,085,616 describes an endoscope comprising two detection systems to facilitate the handling of the endoscope during a medical procedure. The first makes it possible to detect an “out of range” state of the distal end of the endoscope tube. The second detection system makes it possible to detect whether a treatment tool has been inserted into the working channel. For this, the second detection system comprises a light emitter and a light detector arranged opposite each other in the working channel, so that the tool blocks the detection of light when it is inserted into the channel up to the level of the detector. When the insertion of the tool into the channel and the “out of range” state are detected, the operator is warned by an alert on a screen. Preferably, this alert is issued before the tool protrudes from the distal end of the tube.Thus, detection is preferably done in the proximal part of the tube. This document does not. does not describe a system to determine whether the sheath is intact, since the detection system is located in the proximal part of the insertion tube.

[0010] EP 4 119 933 describes the use of an inspection system to determine whether a medical endoscope has been properly cleaned and disinfected after use. The inspection system comprises an information processing device and an endoscope for inspection. More specifically, the tube of the endoscope for inspection enters the inspected endoscope via a dedicated channel at the end of the insertion tube of the inspected endoscope. The tube of the endoscope for inspection may be covered with a sheath at each inspection. WO 2020 / 096893 describes the use of a borescope to inspect the channel of an endoscope, and thus detect the presence of biological residue or damage in said channel. In both documents, the use of a second tool penetrating the channel of the endoscope is required.

[0011] There is therefore a need for a method for detecting whether the working channel has been used during manipulation of the endoscope, and whether the sheath covering the insertion tube is intact, in order to ensure patient safety. There is also a need for a method for preparing a medical endoscope for reuse in a manner that is safe for the patient. Statement of the invention

[0012] The invention aims to remedy the drawbacks of the state of the art, by proposing a method for determining whether an operating channel of an insertion tube of a medical endoscope has been used, comprising the following steps: 1) have a medical endoscope comprising a distal head equipped with a camera, an insertion tube crossed by an operating channel having a distal part and opening into the distal head, and an external sheath having a distal end, completely covering the insertion tube by matching its shape, so that the external sheath covers the distal head by its distal end, 2) acquire, using the camera, identification images of the use of the operator channel, in order to determine whether the operator channel has been used.

[0013] The method according to the invention has the advantage of making it easy to determine whether the endoscope has been contaminated during its use. In addition, the method used has the advantage of being easy to implement, and of not requiring bulky equipment which could not be present at the distal head of the endoscope. In particular, no additional endoscope or borescope is required in the context of the invention.

[0014] The method according to the invention advantageously has one or other of the following characteristics, or a combination thereof: - the images for identifying the use of the operating channel are images of the distal end of the outer sheath, to determine the presence or absence of the distal end of the sheath; - the images for identifying the use of the operating channel are images of the extension of the operating channel, in order to determine the passage of a tool or a fluid in the distal part of the operating channel; - in step 2, the identification images of the use of the operator channel are displayed on a display screen; - the process includes: - before step 2, a step 1.1) consisting of acquiring, using the camera, and recording images identifying the use of the operating channel before use of the medical endoscope, in order to acquire and record a reference image, - a step 2.1) subsequent to step 2), consisting of comparing the reference image with the identification images of the use of the operator channel; - in step 2.1), an alert signal is issued when the reference image and the identification image of the use of the operator channel are different; - the method comprises a step 3), subsequent to step 2.1), consisting of blocking the use of the medical endoscope when the reference image and the image identifying the use of the operating channel are different; - blocking in step 3) consists of ordering the camera to prohibit image acquisition; - the method comprises a step 4), subsequent to step 3), of unlocking consisting of entering a name or a code; - the medical endoscope in step 1) is such that the distal end of the outer sheath has a marking area capable of being viewed by the camera; - the reference image in step 1.1) incorporates a marking area present on the distal end of the outer sheath; - the medical endoscope in step 1) comprises at least one internal sheath completely covering and matching the shape of the insertion tube, the at least one internal sheath having a marking area capable of being viewed by the camera, distinct from the marking area of ​​the external sheath; - the medical endoscope in step 1) is such that the distal end of the outer sheath is made of a plastic material having a transparency index ranging from 40% to 100%, allowing an image to be viewed identifying the use of the operating channel.

[0015] The invention also relates to a method for preparing a medical endoscope for reuse, comprising the following steps: i) determining, according to the method according to the invention, whether the working channel passing through an insertion tube of a medical endoscope has been used, the medical endoscope comprising a distal head equipped with a camera, an insertion tube crossed by a working channel having a distal part and opening into the distal head, and an outer sheath having a distal end, completely covering the insertion tube by matching its shape, so that the outer sheath covers the distal head by its distal end, ii) totally or partially removing the outer sheath if the working channel has been used, to allow reuse of the medical endoscope.

[0016] The method according to the invention has the advantage of being safe for the patient and easy to implement.

[0017] The method according to the invention advantageously has one or other of the following characteristics, or a combination thereof: - in step i), the outer sheath surrounds at least one inner sheath covering integrally and conforming to the shape of the insertion tube, the at least one internal sheath having a distal end, and, in step ii), the at least one internal sheath is totally or partially removed if the working channel has been used; - the outer sheath, and the at least one inner sheath when the latter is present, have a tearing system in order to partially or totally remove the outer sheath and the at least one inner sheath when the latter is present; - the tearing system surrounds the distal end of the outer sheath and of the at least one inner sheath when the latter is present; - the tearing system extends over all or part of the length of the insertion tube, in order to completely remove the external sheath and at least one internal sheath when present. Brief description of the drawings

[0018] [Fig. 1] Figure 1 is a side view of a medical endoscope whose insertion tube is provided with a sheath in accordance with the invention.

[0019] [Fig. 2] Figure 2 is a sectional view of an insertion tube provided with a sheath made in one piece, without welding or exogenous filler.

[0020] [Fig. 3A] Figure 3A is a sectional view of an insertion tube provided with a sheath made by assembling a sleeve and a closing portion in the form of a flat element completely covering the distal face of the distal head.

[0021] [Fig. 3B] Figure 3B is a sectional view of an insertion tube provided with a sheath made by assembling a sleeve and a closing part in the form of a flat element having a rim.

[0022] [Fig. 3C] Figure 3C is a sectional view of an insertion tube provided with a sheath made by assembling a closure portion and a sleeve having a return in order to hold the closure portion in position.

[0023] [Fig. 4] Figure 4 is a sectional view of an insertion tube provided with five superimposed sheaths made in a single piece, without welding or exogenous contribution

[0024] [Fig. 5] Figure 5 is a plan view of the distal head taken from its distal face.

[0025] [Fig. 6A] Figure 6A is a side view of a sheath having a tear system including a line of weakness surrounding the distal end of the sheath.

[0026] [Fig. 6B] Figure 6B is a side view of a sheath having a tear system including a line of weakness extending the length of the sleeve.

[0027] [Fig. 7] Figure 7 is a side view of a sheath having a tear system comprising a line of weakness and a notch.

[0028] [Fig. 8] Figure 8 is a sectional view of an insertion tube provided with a sheath in which the distal end of the sheath is not integral. Description of the embodiments

[0029] Figure 1 illustrates a medical endoscope 1 that can be used in the context of the invention, designed to access the interior of a body such as a cavity or a canal for example. Conventionally, a medical endoscope 1 comprises an insertion tube 2 having, on one side, a proximal part 2p connected to a housing of a control handle 3, on the opposite side, a distal part 2d which is equipped with a distal head 4. The distal head 4 has a distal face. The distal head 4 is orientable by means of actuating cables 5. The distal head 4 is equipped with an optical viewing system for illuminating and examining the organ, cavity or duct of the human body being inspected. In the context of the invention, the optical viewing system comprises a camera 6. In the example illustrated in Figure 5, the optical viewing system further comprises two light sources 7.Conventionally, the endoscope 1 also comprises an operating or working channel 8 in the insertion tube 2, extending from the control handle 3 to the distal head 4 to allow the supply of various tools and / or fluids and / or the suction of. fluids. The operating channel 8 opens into the distal head 4 through an outlet. The operating channel 8 has a distal portion 8d and a proximal portion 8p.

[0030] In the context of the invention, the insertion tube 2 is completely covered with at least one sheath or sock 9, and preferably from one to five sheaths 9. When the insertion tube 2 is covered with several sheaths 9, these are stacked on top of each other. The outermost sheath is referred to as the outer sheath, and, when these are present, the sheath(s) located between the insertion tube and the outer sheath are called inner sheaths. In the description, “sheath” without mention of “outer” or “inner” designates not only the outer sheath but also the inner sheath(s) when these are present.

[0031] Each sheath 9 has a distal end 9d and a proximal end 9p. Each sheath covers the distal face of the distal head by its distal end 9d. In order to be used in endoscopy, the distal end 9d of the sheath 9 must be transparent to ultrasound and light waves. Also, the entire sheath 9 or only a part (therefore including at least the distal end 9d) is transparent to ultrasound and light waves. Thus, despite the presence of one or more sheaths 9, the use of the endoscope 1 is not disturbed, and in particular that of the visualization system.

[0032] For the purposes of the invention, a material or area or element (such as a sheath or sleeve or a closure part for example) "transparent" means that this material or area or element has a transparency index ranging from 40% to 100%. A transparency index can be determined using a UV / visible / near IR spectrophotometer, by carrying out a transmission measurement of the emitted light and the light having passed through the material. The transmission index is then determined by the percentage of light having passed through the material compared to the emitted light.

[0033] In the context of the invention, each sheath 9 is sealed in order to protect the insertion tube 2 (and possibly one or more internal sheath(s)) from any contamination. In addition, each sheath 9 must be biocompatible in order to be used in endoscopy. Advantageously, each sheath is flexible and stretchable. so as not to hinder the movements of the insertion tube, particularly at the level of the flexion structure or the bending part.

[0034] Each sheath 9 comprises a tubular sleeve 10 closed at one of its ends by a closing part 11. This closing part 11 is either an added element or integrated so that the tubular sleeve 9 and the closing part 10 form a single piece.

[0035] In the context of the invention, the tubular sleeve 10 is flexible and stretchable so as not to disturb the movements of the distal head of the insertion tube 2, and in order to be able to adapt and match the shape of the insertion tube 2 which it envelops. The sleeve 10 must be made of biocompatible material in order to be able to be used in endoscopy. The sleeve 10 is also waterproof in the context of the invention, in order to preserve the insertion tube 2 (and possibly one or more internal sheath(s)) from any contamination. For this, the sleeve 10 has a hardness ranging from 1 to 70 Shore D, and preferably from 20 to 40 Shore D, and a thickness of 10 μm to 300 μm, and preferably from 100 μm to 200 μm. In the context of the invention, the resistance is measured with a durometer according to the ISO 7619-1:2010 standard, and the thickness is measured using a micrometer.

[0036] Preferably, the sleeve 10 is made of a heat-shrinkable thermoplastic elastomer material, such as, for example, polyurethanes, polyamides, polyvinyl chlorides, polytetrafluoroethylenes (PTFE), or polyamide-polyether block copolymers.

[0037] The closure portion 11 must be made of biocompatible material in order to be used in endoscopy. The closure portion 11 is also sealed in the context of the invention, in order to preserve the insertion tube 2 (and possibly one or more internal sheath(s)) from any contamination. The closure portion 11 must also have sufficient strength properties to prevent any tearing during endoscopy.

[0038] The closing part 11 can be flexible and stretchable in order to fit the shape of the distal face of the distal head 4, or on the contrary rigid.

[0039] According to a first preferred embodiment of the invention illustrated in Figure 2, the sheath 9 is made in a single piece, without welding or exogenous addition. According to this embodiment, the sheath 9 then consists of the sleeve 10 and a closing part 11 of the same nature. According to this embodiment, the entire sheath 9 is transparent to ultrasonic and light waves. The entire sheath 9 is then made of the same material, which is flexible and stretchable, and has the same hardness. According to this embodiment, the entire sheath 9 can have the same thickness, or on the contrary have areas of lesser thickness in order, for example, to facilitate the bending of the insertion tube 2.

[0040] According to a second embodiment illustrated in Figures 3A-C, the closing part 11 and the tubular sleeve 10 are not of the same nature, that is to say that the sheath 9 is not made in a single piece. The tubular sleeve 10 and the closing part 11 are then two separate elements assembled together in a non-removable and sealed manner, for example by welding or by gluing or by heating. In order to ensure sealing, it is preferable that there is an overlap between the sleeve 10 and the closing part 11. The sleeve 10 is as described above, and may be transparent to ultrasonic and / or light waves although this is not obligatory. The closing part 11 is transparent to ultrasonic and light waves, and is placed opposite the optical viewing system.According to this embodiment, the closing part can be made of glass; polymethyl methacrylate (PMMA); polycarbonate (PC); elastomeric thermoplastic material such as polyurethanes, polyamides, polyvinyl chlorides, polytetrafluoroethylenes (PTFE), or polyamide-polyether block copolymers. According to a particular embodiment, the closing part 11 and the sleeve 10 are made of the same material.

[0041] The closing portion 11 is advantageously attached to the distal face of the distal head 4. Preferably, the closing portion 11 covers the entire distal face of the distal head 4. However, although not preferred, it could be envisaged that the closing portion 11 only covers part of the face distal of the distal head 4 including the visualization system. In the latter case, the operating channel 8 is either covered by the closing part 11 or by the sleeve 10.

[0042] As illustrated, the closure portion 10 may be in the form of a flat element with or without flanges. Although not illustrated, the closure portion may be in the form of a curved element to adapt to the shape of the distal face of the distal head, it being understood that this element comprises a flat area at the level of the viewing system to avoid any optical aberration. In the description of the invention, when mention is made of the flat element, it is understood that a curved element with a flat area intended to be opposite the viewing system could be used instead of this flat element.

[0043] According to a first embodiment illustrated in Figure 3A, the closing part 11 is in the form of a flat element (without rim), of the same dimensions and same shape as the distal face of the distal head 4. Thus, according to this embodiment, the closing part 11 and the distal face of the distal head 4 are intended to be placed in a superimposed or coincident position. The sleeve 10 covers the insertion tube 2 up to its distal part 2d. The sleeve 10 is assembled to the closing part 11 without overlapping between the sleeve 10 and the closing part 11.

[0044] According to a second embodiment illustrated in Figure 3B, the closing part 11 is in the form of a flat element 11a extended at right angles by a rim 11b. According to this embodiment, the flat element 11a of the closing part 11 has the same dimensions and the same shape as the distal face of the distal head 4. Thus, the flat element 11a of the closing part 11 and the distal face of the distal head 4 are intended to be placed in a superimposed or coincident position. The sleeve 10 covers the insertion tube 2, preferably up to its distal part 2d. The rim 11b partially covers the sleeve 10, which makes it possible to guarantee the sealing of the sheath 9.

[0045] According to a third embodiment illustrated in Figure 3C, the closing part 11 is in the form of a flat element (without rim), preferably of the same dimensions and the same shape as the distal face of the distal head 4, although it is possible that it is of smaller dimension than the distal face of the distal head 4. According to this embodiment, the sleeve 10 projects beyond the distal part 2d of the insertion tube 2 and is extended at right angles by a return 10b which presses the closing part 11 against the distal head 4. The operating channel 8 is then covered by the closing part 11 and / or by the return 10b of the sleeve 10.

[0046] Each tubular sleeve 10 matches the shape of the insertion tube 2. In other words, the sleeve 10 and the insertion tube are joined (or two sleeves together in the case where the insertion tube 2 is covered with several sheaths), so that no space is present between the sleeve 10 and the insertion tube 2 (or two sleeves together in the case where the insertion tube 2 is covered with several sheaths).

[0047] According to a first embodiment illustrated in figures 2 and 3A-C, the insertion tube 2 is covered with a single sheath 9.

[0048] According to a second embodiment, the insertion tube 2 is covered with several sheaths 9, and typically two to five sheaths 9. When several sheaths 9 are present, they are advantageously of substantially the same dimensions and the same shape. According to this embodiment, the different sheaths are superimposed on each other and on the insertion tube 2. In other words, a first sheath 9 covers the insertion tube 2, called internal, then a second sheath 9 covers the first sheath 9, and any subsequent successive sheaths cover the previous sheath. According to the example illustrated in Figure 4, the insertion tube 2 is covered with five sheaths 9 superimposed on each other: an external sheath and four internal sheaths. Due to the flexible and stretchable nature of the sleeves, the five sheaths conform to the shape of the insertion tube 2 without disturbing the movements of the distal head 4.

[0049] According to one embodiment, the sheath 9 comprises a marking zone 12 capable of being viewed by the camera 6. For this, the marking zone 12 is typically located on a part of the distal end 9d of the sheath 9, as illustrated in FIG. 5, and preferably in the field of vision peripheral of the camera 6 so as not to obstruct the viewing of the cavity or the inspected conduit. This marking area 12 does not extend over the entire distal end 9d of the sheath 9 in order to allow the practitioner to view the cavity or the inspected conduit using the viewing system. This marking area 12 can for example be produced by laser, by screen printing, by hot stamping or by molding.

[0050] In the case where the insertion tube 2 is covered with several sheaths 9, each sheath 9 comprises a marking zone 12 on a part of its distal end 9d. Preferably, the marking zones 12 of the different sheaths 9 are not placed in a position of superposition or coincidence, so that it is possible to visualize each of the marking zones corresponding to each sheath 9 using the visualization system, and in particular the camera 6. Whatever the positioning of the marking zones 12 of the different sheaths 9, it is essential that all of these marking zones 12 do not extend over the entire distal end, and allow the practitioner to visualize the conduit or cavity inspected using the visualization system despite the presence of the different non-superimposed marking zones.Preferably, the marking zones 12 of the sheaths 9 are in the peripheral field of the camera 6 so as not to hinder the viewing of the cavity or the inspected conduit.

[0051] According to one embodiment, each sheath 9 has a tearing system 13 in order to make it easier to remove, totally or partially, the sheath(s) 9 after use of the medical endoscope 1.

[0052] The tearing system 13 may consist of one or more lines of lesser strength, for example pre-cut lines or lines of lesser thickness. Alternatively, the tearing system 13 may consist of one or more lines of greater strength. Alternatively, the tearing system 13 may consist of a tearing element incorporated in the sheath or between two sheaths 9 (or between the sheath 9 and the insertion tube 2), for example a wire of greater strength than the strength of the sheath 9. Alternatively, the tearing system 13 may consist of a notch.

[0053] According to a particular embodiment illustrated in figure 7, the tearing system 13 consists of: - at least one line of lesser resistance, for example pre-cut lines or lines of lesser thickness and / or at least one line of greater resistance, and / or at least one tearing element incorporated in the sheath 9 or placed between two sheaths 9 (or between a sheath 9 and the insertion tube 2) such as, for example, a wire of resistance greater than the resistance of the sheath, - and at least one 13c notch contiguous to at least one line of least resistance or at least one line of greater resistance.

[0054] In the context of the invention, the lines of lesser resistance and the notches can be produced using a cutting member such as, for example, knives, punches or serrated blades. The lines of greater resistance can be produced by coextrusion of two materials of different hardnesses, the first for producing the sheath 9 and the second, having a harderness greater than that of the sheath, for producing the line of greater resistance. When the tearing system 13 comprises at least one tearing element, this can be produced by inserting, in the sheath 9 or between two sheaths 9 (or between the sheath and the insertion tube), a wire having a harderness greater than that of the material constituting the sheath 9.

[0055] According to a first embodiment, the tearing system 13 surrounds the distal end 9d of the sheath 9, or of all the sheaths if the insertion tube 2 is covered by several sheaths. According to this embodiment, it is then possible to remove only the distal end of the sheath(s) to allow the passage of tools and / or fluids through the outlet of the operating channel. According to the example illustrated in FIG. 6A, the tearing system 13 consists of a circumferential line of least resistance 13a surrounding the distal end 9d of the sheath 9.

[0056] According to a second embodiment, the tearing system 13 of each sheath 9 extends over all or part of the length of the insertion tube 2. According to this embodiment, it is possible to remove all, or only part, of the sheath(s). According to the exemplary embodiment illustrated in FIG. 6B, the tearing system 13 consists of a longitudinal line of least resistance 13b extending over part of the length of the sleeve 10.

[0057] The invention relates to a method for determining whether the operating channel 8 of the insertion tube 2 has been used for supplying equipment or tools, fluid, or suctioning fluid. Thus, the method according to the invention makes it possible to determine whether the medical endoscope 1, and in particular the insertion tube 2, has been contaminated or not. More specifically, the method according to the invention comprises the following steps: 1) have a medical endoscope 1 as described above, and 2) acquiring, using the camera 6, images identifying the use of the operator channel 8 in order to determine whether the operator channel 8 has been used.

[0058] In the context of the invention, the images identifying the use of the operating channel 8 are images, taken by the camera 6 located in the distal head 4, of the extension of the operating channel 8 and / or images of the distal end 9d of the at least one sheath covering the insertion tube 2 of the medical endoscope 1 (i.e. the external sheath and possibly the internal sheath(s)). These images are acquired using the camera 6.

[0059] The images of the distal end 9d of the sheath 9 make it possible to determine whether the distal end 9d of the sheath 9 is present or not, and to conclude whether the sheath 9 is intact or not. Indeed, any modification of the image (for example, disappearance of the marking zone) indicates that the sheath 9 is not intact, and that, consequently, the working channel 8 has been used. This is illustrated in Figure 8 for the case where the insertion tube is covered with a single outer sheath, but this could be the case in a similar manner when the insertion tube 2 is covered with an outer sheath 9 and at least one inner sheath 9.

[0060] Images of the extension of the working channel 8 are taken from the distal head and make it possible to visualize whether a tool or fluid is present at the distal head, and thus to determine whether the working channel has been used. These images are acquired using the camera 6 located in the distal head 4, and make it possible to visualize beyond the distal face of the distal head 4.

[0061] The identification images of the use of the operator channel 8 acquired using the camera 6 are recorded in a processing unit which comprises image processing software.

[0062] The use identification images of the operating channel 8 can be displayed on a display screen (not shown in the figures). Thus, the practitioner can easily view any change in the use identification image of the operating channel 8, and deduce therefrom whether the operating channel 8 has been used. In particular, when the sheath(s) 9 comprise a marking area 12, this can be viewed on the display screen. Thus, if the operating channel 8 is used and the marking area 12 cannot be viewed, then this means that the distal end 9d of the sheath 9 is no longer intact, and therefore that the operating channel has been used.

[0063] Alternatively, the image processing software is configured to enable recognition of shapes in the images in order in particular to recognize the tools or the flow of fluid leaving the operating channel 8, or to recognize any modification of the distal end 9d of the sheath 9. This second embodiment is notably used in the absence of a display screen, but can also be used in the case where a display screen is used.

[0064] According to a particular embodiment, the method according to the invention comprises a step 1.1), between step 1) and step 2), consisting of acquiring, using the camera 6, and recording images identifying the use of the operating channel 8 (i.e. images of the distal end 9d of the sheath 9 and / or images of the extension of the operating channel 8) before using the medical endoscope 1. This step then makes it possible to acquire a reference image and to record it. This recording can be carried out in the unit of treatment present in the tablet, or in the handle. According to this embodiment, the method then comprises a step 2.1), subsequent to step 2), consisting of comparing the reference image with the image of the use of the operating channel 8. Advantageously, the image identifying the use of the operating channel 8 and the reference image cover the same area: either the image identifying the use of the operating channel 8 and the reference image are images of the distal end 9d of the sheath 9, or the image identifying the use of the operating channel 8 and the reference image are images of the extension of the operating channel 8, or the image identifying the use of the operating channel 8 and the reference image are images of the distal end 9d of the sheath 9 and the extension of the operating channel 8.For the particular case where the distal end 9d of the sheath 9 comprises a marking zone 12, the reference image then integrates this marking zone 12 and the comparison with the image identifying the use of the operating channel 8 will preferably be carried out at the level of this marking zone 12. Thus, the method makes it possible to automatically determine whether the operating channel 8 has been used.

[0065] In step 2.1), it may be envisaged that an alert signal, audible or luminous, is delivered when the image identifying the use of the operator channel 8 differs from the reference image.

[0066] According to a particular embodiment, the method according to the invention comprises a step 3), subsequent to step 2.1) consisting of blocking the use of the medical endoscope when the reference image and the image identifying the use of the operating channel 8 are different. For example, the blocking may consist of controlling the camera 6 to prohibit image acquisition. This blocking then makes it possible to reinforce safety for the patient. According to this particular embodiment of the invention, the method may further comprise a step 4) subsequent to step 3), of unlocking to allow the use of the medical endoscope even if the reference image and the image identifying the use of the operating channel 8 are different. This unlocking may be carried out by entering a name or a code for example.

[0067] The invention also relates to a method for preparing a medical endoscope for reuse. The method according to the invention comprises the following steps: i) determining, according to the method of the invention, whether the working channel 8 passing through an insertion tube 2 of a medical endoscope 1 as described above has been used, ii) completely or partially removing the outer sheath 9 if the working channel 8 has been used, to allow reuse of the endoscope 1.

[0068] In the case where the insertion tube 2 is covered by several sheaths 9, that is to say by an external sheath and at least one internal sheath, the external sheath and the at least one internal sheath are removed, totally or partially, if the operating channel 8 has been used.

[0069] The outer sheath, and where appropriate the inner sheath(s), are advantageously removed using the tearing system 13 described above.

[0070] The method according to the invention may further comprise a step iii) subsequent to step ii), consisting of placing the medical endoscope 1 in sterile packaging in order to protect it from any contamination. Packaging that can be used in the context of the invention is described in particular in patent application FR 22 09870.

Claims

Claims

1. A method for determining whether a working channel (8) of an insertion tube (2) of a medical endoscope (1) has been used, comprising the following steps: 1) having a medical endoscope (1) comprising a distal head (4) equipped with a camera (6), an insertion tube (2) crossed by an operating channel (8) having a distal part (8d) and opening into the distal head (4), and an external sheath (9) having a distal end (9d), completely covering the insertion tube (2) by matching its shape, so that the external sheath (9) covers the distal head (4) by its distal end (9d), 2) acquiring, using the camera (6), images identifying the use of the operator channel (8), in order to determine whether the operator channel (8) has been used.

2. Method according to claim 1, according to which the images for identifying the use of the operating channel (8) are images of the distal end (9d) of the outer sheath (9), to determine the presence or absence of the distal end (9d) of the sheath (9).

3. Method according to claim 1 or 2, according to which the images for identifying the use of the operating channel (8) are images of the extension of the operating channel (8), in order to determine the passage of a tool or a fluid in the distal part (8d) of the operating channel (8).

4. A method according to any preceding claim, wherein in step 2 the images identifying the use of the operator channel (8) are displayed on a display screen.

5. A method according to any preceding claim, comprising: - before step 2, a step 1.1) consisting of acquiring, using the camera (6), and recording images identifying the use of the operating channel (8) before use of the medical endoscope (1), in order to acquire and save a reference image, - a step 2.1) subsequent to step 2), consisting of comparing the reference image with the identification images of the use of the operator channel (8).

6. Method according to the preceding claim, according to which in step 2.1), an alert signal is delivered when the reference image and the identification image of the use of the operator channel (8) are different.

7. Method according to claim 5 or 6, comprising a step 3), subsequent to step 2.1), consisting of blocking the use of the medical endoscope (1) when the reference image and the image for identifying the use of the operating channel (8) are different.

8. Method according to the preceding claim, according to which the blocking consists of controlling the camera (6) to prohibit image acquisition.

9. Method according to claim 7 or 8, comprising a step 4), subsequent to step 3), of unlocking consisting of entering a name or a code.

10. A method according to any one of the preceding claims, wherein the medical endoscope (1) in step 1) is such that the distal end (9d) of the outer sheath (9) has a marking area (12) capable of being viewed by the camera (6).

11. Method according to any one of claims 5 to 10, according to which the reference image in step 1.1) incorporates a marking zone (12) present on the distal end (9d) of the outer sheath (9).

12. Method according to claim 10 or 11, according to which the medical endoscope (1) in step 1) comprises at least one internal sheath (9) completely covering and matching the shape of the insertion tube (2), the at least one internal sheath (9) having a marking zone (12) capable of being viewed by the camera (6), distinct from the marking zone (12) of the external sheath (9).

13. A method according to any preceding claim, wherein the medical endoscope (1) in step 1) is such that the distal end (9d) of the external sheath (9) is made of a plastic material having a transparency index ranging from 40% to 100%, making it possible to visualize an image identifying the use of the operating channel (8).

14. Method for preparing a medical endoscope (1) for reuse comprising the following steps: i) determining, according to the method according to any one of the preceding claims, whether the working channel (8) passing through an insertion tube (2) of a medical endoscope (1) has been used, the medical endoscope (1) comprising a distal head (4) equipped with a camera (6), an insertion tube (2) traversed by a working channel (8) having a distal portion (8d) and opening into the distal head (4), and an outer sheath (9) having a distal end (9d), completely covering the insertion tube (2) by matching its shape, so that the outer sheath (9) covers the distal head (4) by its distal end (9d), ii) totally or partially removing the outer sheath (9) if the working channel (8) was used, to allow the reuse of the medical endoscope (1).

15. Method according to the preceding claim, according to which, in step i), the outer sheath (9) surrounds at least one inner sheath (9) completely covering and matching the shape of the insertion tube (2), the at least one inner sheath (9) having a distal end (9d), and, in step ii), the at least one inner sheath (9) is totally or partially removed if the operating channel (8) has been used.

16. Method according to claim 14 or 15, according to which the outer sheath (9), and the at least one inner sheath (9) when the latter is present, have a tearing system (13) in order to partially or totally remove the outer sheath (9) and the at least one inner sheath (9) when the latter is present.

17. Method according to the preceding claim, according to which the tearing system (13) surrounds the distal end (9d) of the sheath (9) external and at least one internal sheath (9) when the latter is present.

18. Method according to claim 16, according to which the tearing system (13) extends over all or part of the length of the insertion tube (2), in order to completely remove the external sheath (9) and the at least one internal sheath (9) when the latter is present.

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