Medical endoscope with sheath

Abstract

The invention relates to a medical endoscope (1) comprising an insertion tube (2) that is entirely covered by at least one biocompatible sealed sheath (8) comprising a sleeve (9) and having a distal end that is transparent to ultrasound and light waves, the sleeve (9) being flexible, stretchable, conforming to the shape of the insertion tube (2), having a hardness ranging from 1 to 70 Shore D and a thickness of 10 to 300 µm, and having a tear-away system (11). The invention also relates to a method for preparing a medical endoscope (1) according to the invention. Lastly, the invention relates to a method for preparing a medical endoscope (1) for reuse.

Description

Description Title of the invention: MEDICAL ENDOSCOPE WITH SHEATH Technical Field

[0001] The invention relates to the technical field of medical endoscopes.

[0002] The medical endoscopes according to the invention allow access to the internal surface of a hollow organ, a cavity or a natural or artificial conduit 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

[0003] 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.

[0004] During its use by the practitioner, the insertion tube is inserted into the cavity or natural duct being inspected. After its use, the endoscope medical device, and in particular the insertion tube, is either discarded or cleaned and disinfected, or even sterilized, for reuse.

[0005] Various methods can be used to clean and disinfect the insertion tube. However, disinfection may not be sufficiently effective and may constitute a source of nosocomial infection for the patient. Therefore, alternative methods have been developed. In particular, the use of a sheath or sock enveloping all or part of the insertion tube of the medical endoscope during its use has been described.

[0006] In particular, 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. The sheath is removed after use by pulling on the proximal end, which is not easy for the practitioner and carries risks of damage to the medical endoscope. In addition, this sheath requires precise adjustment during its placement, in order to properly adjust the position of the transparent window, which may be incompatible with life-threatening emergency situations due to the time taken to place the sheath on the endoscope.

[0007] US Patent 5,827,177 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.

[0008] US Patent 8,360,968 relates to a protective sheath for isolating an endoscope from tissue during use, and thus avoiding 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. Again, this sheath requires precise adjustment during its placement, in order to properly adjust the position of the transparent window, which may be incompatible with life-threatening emergency situations due to the time taken to place the sheath on the endoscope.

[0009] Document EP 0 520 743 describes an endoscope provided with a sheath comprising a tubular sleeve and a lens at one end of the sleeve fixed together by heating, or using a solvent or an adhesive. According to a particular embodiment, the sheath is flexible. The sheath does not include a tearing system and is then removed like a stocking is removed from a person's foot, which is not easy for the practitioner and involves increased risks of deterioration and contamination of the medical endoscope. In addition, this sheath requires not only precise adjustment when it is put in place, but also drying or cooling depending on the fixation technique used. Also, the installation and assembly of the sheath are long and require specific equipment.

[0010] These sheaths described in the prior art therefore have the disadvantage of not being able to be easily removed after use of the endoscope, and in view of its reuse by the practitioner.

[0011] Furthermore, document US 2012 / 0010468 describes the use of a sheath covering an insertion tube of a medical endoscope, to prevent any contamination between two uses of the endoscope. The sheath is tubular in shape, has an orifice at each of its ends, and has a flap with an adhesive shape to close it. This sheath is torn to allow the use of the endoscope. This sheath is not suitable for use during endoscopy due to the thickness of the sheath, its rigidity, and the orifices which do not guarantee the absence of contamination by tissues.

[0012] US 2004 / 210110 describes a medical endoscope having a sheath comprising a disposable tubular sleeve and a cap. The sleeve comprises adhesive areas and a tear-off wire, preferably arranged longitudinally from one end of the sleeve to the other.

[0013] WO 97 / 29679 describes an endoscope comprising a thick sheath for isolating the insertion tube from the body of the patient being examined, and which can be removed after use of the endoscope by means of a tear cord. The sheath comprises a first longitudinal channel for the passage of the flexible tube of the endoscope, and a series of longitudinal channels called "working" to allow the passage of fluids or devices.

[0014] There is therefore a need to provide a medical endoscope provided with at least one sheath or sock, preferably several sheaths, for use in endoscopy, each sheath being easily tearable in order to be removed for reuse of the endoscope. Advantageously, each sheath is made in a single piece, which ensures good sealing. [0015JII also exists a need to have a medical endoscope provided with at least one sheath, and advantageously several sheaths, which are easy to use, and which can be reused easily and safely for the patient. There exists a need to have a medical endoscope provided with at least one sheath, each sheath being easily removable, and allowing the reuse of the medical endoscope without requiring the installation of a new sheath, or an additional sterilization step. Statement of the invention

[0016] The invention aims to overcome the drawbacks of the state of the art by proposing a medical endoscope provided with at least one sheath or sock. The sheath has an area transparent to ultrasonic and light waves at least in the distal part, in order to allow satisfactory visualization. The sheath makes it possible to protect the endoscope from any contamination during its insertion into a cavity, a natural duct or a hollow organ. A tearing system makes it possible to easily remove the sheath.

[0017] For the purposes of the invention, a material or area or element (such as a sheath or sleeve or a closure part for example) that is "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 that has passed through the material. The transmission index is then determined by the percentage of light that has passed through the material compared to the light emitted.

[0018] Advantageously, in the context of the invention, the medical endoscope is provided with several sheaths or socks superimposed on each other. Thus, in the context of the invention, after each use of the medical endoscope, the practitioner can easily remove the external sheath himself, and immediately reuse or store the medical endoscope for later reuse, without requiring the installation of a new sheath. This is particularly advantageous insofar as this step of installing a new sheath can be difficult for the practitioner to perform, in particular in the case where the sheath includes a transparent window, then requiring precise adjustment and / or specific equipment for the installation of the sheath. The medical endoscope according to the invention is therefore quickly and easily operational again.

[0019] Advantageously in the context of the invention, this stacking of sheaths makes it possible to dispense with the sterilization step after the placement of a new sheath by the practitioner, as is necessary according to the devices of the prior art, since this sterilization is carried out during the placement of the stacked sheaths. Thus, the medical endoscope according to the invention can be reused in a safer manner for the patient because the risks of contamination are more limited. This reuse is also faster and easier for the practitioner who does not necessarily have the equipment necessary to carry out sterilization of the sheaths.

[0020] Advantageously, within the framework of the invention, thanks to the choice of flexible and stretchable sheaths, the stacking of several sheaths is possible without hindering the movements of the insertion tube, in particular at the level of the bending structure or bending part, nor causing tearing or damage to the sheaths during these movements of the insertion tube.

[0021] More specifically, the medical endoscope according to the invention comprises a control handle and an insertion tube equipped with an adjustable distal head, the insertion tube being completely covered with at least one waterproof sheath, biocompatible, comprising a sleeve and having a distal end transparent to ultrasonic and light waves, the sleeve being flexible, stretchable, conforming to the shape of the insertion tube and having a hardness of 1 to 70 Shore D and a thickness of 10 μm to 300 μm, characterized in that the sleeve has a tearing system.

[0022] The medical endoscope according to the invention advantageously has one or other of the following characteristics, or a combination thereof: - the tearing system comprises at least one line of lesser resistance and / or at least one line of greater resistance and / or at least one tearing element; - the lines of least resistance or greater resistance extend over all or part of the length of the sleeve; - the lines of least resistance are pre-cut lines or lines of lesser thickness; - the tearing system comprises at least one notch possibly adjacent to a line of lesser resistance or greater resistance to facilitate tearing of the sleeve; - at least one sheath is a single piece, without welding or exogenous contribution; - the sleeve is made of a heat-shrinkable thermoplastic elastomer material; - the heat-shrinkable thermoplastic elastomer material is chosen from polyurethanes, polyamides, polyvinyl chlorides, polytetrafluoroethylenes (PTFE), and polyamide polyether block copolymers; - the medical endoscope comprises one to five superimposed sheaths; - the medical endoscope includes a single sheath.

[0023] The invention also relates to a method for preparing an endoscope according to the invention comprising the following steps: a) providing a medical endoscope comprising a control handle and an insertion tube equipped with an orientable distal head, b) disinfecting the medical endoscope, c) putting in place by heating a sheath comprising a sleeve closed at one of its ends by a closing part d) create a tearing system on the sleeve, e) if necessary, repeat steps c) and d.

[0024] The method for preparing a medical endoscope in accordance with the invention advantageously has one or other of the following characteristics, or a combination thereof: - the tearing system is produced by a cutting member, such as knives, punches or serrated blades, by inserting at least one tearing element, or by coextrusion; - the method comprises a step f) subsequent to step e) consisting of sterilizing the sheath(s); - the method comprises a step of sterilizing the sheath, after step d) and before step e); and - the process includes a final step of packaging the medical endoscope.

[0025] Finally, the invention also relates to a method for preparing a medical endoscope for reuse comprising the following steps: i) providing a medical endoscope according to the invention provided with an external sheath already in use, ii) tearing and removing the external sheath to allow reuse of the medical endoscope.

[0026] The method of reusing a medical endoscope 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 which is used when reusing the endoscope; - the method comprises a step iii) subsequent to step ii), consisting of storing the medical endoscope in packaging for reuse. Brief description of the drawings

[0027] [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.

[0028] [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.

[0029] [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.

[0030] [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.

[0031] [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.

[0032] [Fig. 4] Figure 4 is a sectional view of an insertion tube provided with five superimposed sheaths in accordance with the invention.

[0033] [Fig. 5] Figure 5 is a plan view of the distal head taken from its distal face.

[0034] [Fig. 6] Figure 6 is a side view of a sheath having a tear system including a line of weakness.

[0035] [Fig. 7] Figure 7 is a side view of a sheath having a tear system comprising a line of weakness and a notch. Description of the embodiments

[0036] Figure 1 illustrates a medical endoscope 1 according to 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 head distal 4. The distal head 4 has a distal face. The distal head is orientable by means of actuation 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. The optical viewing system may be as described in application FR 20 00444. In the example illustrated in FIG. 5, the optical viewing system comprises light sources 6 and an optical lens or vision sensor 7. Conventionally, the endoscope 1 also comprises an operating or working channel 2c 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.

[0037] In the context of the invention, the insertion tube 2 is completely covered with at least one sheath or sock 8, and preferably from one to five sheaths 8. When the insertion tube 2 is covered with several sheaths 8, these are stacked on top of each other, that is to say they are superimposed on 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.

[0038] Each sheath 8 has a distal end 8d and a proximal end 8p. In order to be used in endoscopy, the distal end 8d of the sheath 8 must be transparent to ultrasound and light waves. Also, the entire sheath 8 or only a portion (therefore including at least the distal end 8d) is transparent to ultrasound and light waves. Thus, despite the presence of one or more sheaths, the use of the endoscope is not disturbed, and in particular that of the visualization system.

[0039] In the context of the invention, each sheath 8 completely covers the insertion tube 2 by matching its shape, so that each sheath 8 covers the distal face of the distal head 4 by its distal end 8d.

[0040] In the context of the invention, each sheath 8 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 8 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, in particular at the level of the flexion structure or bending part.

[0041] Each sheath 8 comprises a tubular sleeve 9 closed at one of its ends by a closing part 10. This closing part 10 is either an added element or integrated so that the tubular sleeve 9 and the closing part 10 form a single piece.

[0042] In the context of the invention, the tubular sleeve 9 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 9 must be made of biocompatible material in order to be used in endoscopy. The sleeve 9 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 9 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 strength is measured with a durometer according to ISO 7619-1:2010, and the thickness is measured using a micrometer.

[0043] Preferably, the tubular sleeve 9 is made of a thermoplastic elastomer material, such as, for example, polyurethanes, polyamides, polyvinyl chlorides, polytetrafluoroethylenes (PTFE), or polyamide-polyether block copolymers. In the context of the invention, the material constituting the tubular sleeve is heat-shrinkable.

[0044] The closure part 10 must be made of biocompatible material in order to be used in endoscopy. The closure part 10 is also sealed in the context of the invention, in order to protect the insertion tube 2 (and possibly one or more internal sheath(s)) from any contamination. The closing part 10 must also have sufficient strength properties to prevent tearing during endoscopy.

[0045] The closing part 10 can be flexible and stretchable in order to fit the shape of the distal head 4, or on the contrary rigid.

[0046] According to a first preferred embodiment of the invention illustrated in Figure 2, the sheath 8 is made in a single piece, without welding or exogenous addition. According to this embodiment, the sheath 8 then consists of the sleeve 9 and a closing part 10 of the same nature. According to this embodiment, the entirety of the sheath 8 is transparent to ultrasonic and light waves. The entirety of the sheath 8 is then made of the same material, which is flexible and stretchable, and has the same hardness. According to this embodiment, the entirety of the sheath 8 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.

[0047] According to a second embodiment illustrated in Figures 3A-C, the closing part 10 and the tubular sleeve 9 are not of the same nature, that is to say that the sheath 8 is not made in a single piece. The tubular sleeve 9 and the closing part 10 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 9 and the closing part 10. The sleeve 9 is as described above, and may be transparent to ultrasonic and / or light waves although this is not obligatory. The closing part 10 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; elastomeric thermoplastic material such as, for example, polyurethanes, polyamides, polyvinyl chlorides, polytetrafluoroethylenes (PTFE), or polyamide-polyether block copolymers. According to a particular embodiment, the closing part 10 and the sleeve 9 are made of the same material.

[0048] The closing portion 10 is advantageously attached to the distal face of the distal head 4. Preferably, the closing portion 10 covers the entire distal face of the distal head 4. However, although not preferred, it could be envisaged that the closing portion 10 covers only a portion of the distal face of the distal head 4 including the visualization system. In the latter case, the operating channel 8 is either covered by the closing portion 11 or by the sleeve 10.

[0049] 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.

[0050] According to a first embodiment illustrated in Figure 3A, the closing part 10 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 10 and the distal face of the distal head 4 are intended to be placed in a superimposed or coincident position. The sleeve 9 covers the insertion tube 2 up to its distal part 2d. The sleeve 9 is assembled to the closing part 10 without overlapping between the sleeve 9 and the closing part 10.

[0051] According to a second embodiment illustrated in Figure 3B, the closing part 10 is in the form of a flat element 10a extended at right angles by a rim 10b. According to this embodiment, the flat element 10a of the closing part 10 has the same dimensions and the same shape as the distal face of the distal head 4. Thus, the flat element 10a of the closing part 10 and the distal face of the distal head 4 are intended to be placed in a superimposed or coincident position. The sleeve 9 covers the insertion tube 2, preferably up to its distal part 2d. The rim 10b partially covers the sleeve 9, which ensures the sealing of the sheath 8.

[0052] According to a third embodiment illustrated in Figure 3C, the closing part 10 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 for it to be of smaller dimension than the distal face of the distal head 4. According to this embodiment, the sleeve 9 projects beyond the distal part 2d of the insertion tube 2 and is extended at right angles by a return 9b which presses the closing part 10 against the distal head 4.

[0053] Each tubular sleeve 9 matches the shape of the insertion tube 2. In other words, the sleeve 9 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 9 and the insertion tube 2 (or two sleeves together in the case where the insertion tube 2 is covered with several sheaths).

[0054] According to a first embodiment illustrated in figures 2 and 3A-C, the insertion tube 2 is covered with a single sheath 8.

[0055] According to a second embodiment, the insertion tube 2 is covered with several sheaths 8, and typically from two to five sheaths 8. When several sheaths 8 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 8, called internal, covers the insertion tube 2, then a second sheath 8 covers the first sheath 8, 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 8 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.

[0056] According to a characteristic of the invention, each sheath 8 has a tearing system 11 in order to allow the sheath 8 to be removed after use of the medical endoscope 1. The tearing system extends over the entire length of the sleeve 9, or only over a part of the length of the sleeve 9. In all cases, this tearing system 11 must allow the user to at least partially tear the sleeve 9 and to partially or, preferably, completely remove the sheath 8 initially present on the insertion tube 2.

[0057] The tearing system 11 may consist of one or more lines of lesser strength, for example pre-cut lines or lines of lesser thickness. Alternatively, the tearing system 11 may consist of one or more lines of greater strength. Alternatively, the tearing system 11 may consist of a tearing element incorporated in the sheath or between two sheaths 8 (or between the sheath 8 and the insertion tube 2), for example a wire of greater strength than the strength of the sleeve 9. Alternatively, the tearing system 11 may consist of a notch. According to a particular embodiment, the tearing system 11 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 8 or placed between two sheaths 8 (or between a sheath 8 and the insertion tube 2) such as, for example, a wire of resistance greater than the resistance of the sleeve 9, - and at least one notch preferably contiguous to at least one line of least resistance or at least one line of greater resistance.

[0058] According to the embodiment illustrated in Figure 6, the tearing system 11 comprises a line of least resistance 11a present over part of the length of the tubular sleeve 9.

[0059] According to the embodiment illustrated in Figure 7, the tearing system 11 includes a line of least resistance 11a as well as a notch 11b.

[0060] Figures 2, 3A-C, 6 and 7 illustrate in a simplified manner embodiments of the invention, and these embodiments are not limited to the use of a single sheath. For reasons of simplification, these embodiments have been illustrated when a single sheath is used, but it is clear that these embodiments can also be used when the insertion tube is covered with several sheaths superimposed on each other.

[0061] The invention also relates to a method for preparing a medical endoscope 1 fully covered with at least one sheath 8 as described above. This method comprises the following steps: a) providing a medical endoscope 1 comprising a control handle 3 and an insertion tube 2 equipped with an orientable distal head 4, b) disinfecting the medical endoscope 1, c) placing by heating a sheath 8 comprising a sleeve 9 closed at one of its ends by a closing part 10, d) producing a tearing system 11 on the sleeve 9, e) optionally repeating steps c) and d).

[0062] In step b), disinfection may in particular be carried out by UV lamp or by cleaning using a disinfectant detergent, for example using wipes impregnated with a disinfectant detergent. During this step, sterilization may also be carried out after disinfection. Sterilization of the medical endoscope 1 may, in this case, be carried out for example using ethylene oxide, according to a method well known to those skilled in the art which will not be detailed here.

[0063] In step c), the sheath 8 is put in place by heating the sleeve 9. More precisely, the insertion tube 2 of the medical endoscope 1 is inserted into the sleeve 9, then the sleeve 9 is heated. Due to the heat-shrinkable nature of the material constituting the sleeve 9, the latter tightens by heating, until it takes the shape of the insertion tube 2.

[0064] The method according to the invention may comprise one or more sterilization steps. According to a first embodiment, a sterilization step is carried out after the placement of each sheath, advantageously after the step d) of realization of the tearing system and before step e). According to this first embodiment, the sterilization can be carried out using radiation, for example gamma, beta or UV radiation. According to a second embodiment, the method comprises a single sterilization step. According to this second embodiment, the sterilization is carried out only once after the installation of all the sheaths after step e), and makes it possible to sterilize all the sheaths at the same time. According to the second embodiment, the sterilization can be carried out for example by radiation, and in particular gamma radiation. Indeed, this type of sterilization makes it possible to sterilize all the sheaths at the same time.

[0065] When the sheath 8 is made in a single piece, without welding or exogenous addition (figure 2), then the entire sheath 8 is made of heat-shrinkable material. According to this embodiment, the entire sheath 8 (i.e. the sleeve 9 and the closing part 10) is heated in step b) in order to attach it to the insertion tube.

[0066] When the sheath 8 is composed of a sleeve 9 and a closing part 10 in the form of a flat element, assembled without overlapping (figure 3A), the sleeve 9 is first put in place by heating thanks to its heat-shrinkable nature. Then, the closing part 10 is assembled to the sleeve 9 by welding or by gluing.

[0067] When the sheath 8 is composed of a sleeve 9 and a closing part 10 in the form of a flat element with a rim, partially covering the sleeve 9 by its rim 10b (figure 3B), the closing part 10 may be made of heat-shrinkable material. According to this embodiment, the tubular sleeve 9 is first put in place by heating, then the closing part 10 is put in place and assembled to the tubular sleeve 9 also by heating, or by gluing or welding.

[0068] When the sheath 8 is composed of a sleeve 9 extending at right angles by a return 9b which presses the closing part 10 against the distal face of the distal head 4 (figure 3C), the closing part is firstly put in place on the distal face of the distal head 4. Then the sleeve 9 is put in place by heating. Thanks to the heat-shrinkable nature of the material constituting the sleeve 9, the latter fits the insertion tube and allows a watertight assembly with the closing part 10.

[0069] When the tearing system 11 comprises at least one line of least resistance, this can be produced by a cutting member such as, for example, knives, punches or serrated blades.

[0070] When the tearing system 11 comprises at least one line of higher resistance, this can be produced for example by coextrusion of two materials of different hardnesses, the first for producing the sheath 8 and the second, having a harderness greater than that of the sheath, for producing the line of higher resistance.

[0071] When the tearing system 11 comprises at least one tearing element, this can be achieved by inserting, in the sheath 8 or between two sheaths 8 (or between the sheath and the insertion tube), a wire having a hardness greater than that of the material constituting the sheath.

[0072] When the tearing system 11 comprises at least one notch, this can be produced by a cutting member such as, for example, knives, punches or serrated blades.

[0073] The method according to the invention may comprise a step f), subsequent to step e), consisting of placing the medical endoscope 1 in sterile packaging in order to protect it from any contamination during its storage and / or its transport. A packaging which can be used in the context of the invention is described in particular in application FR 22 09870.

[0074] The invention also relates to a method for preparing a medical endoscope 1 comprising the following steps: i) providing a medical endoscope 1 in accordance with the invention, and provided with an outer sheath already in use, ii) tearing and removing the outer sheath to allow reuse of the medical endoscope 1.

[0075] According to a first embodiment, the insertion tube 2 is covered with several sheaths 8. According to this embodiment, the external sheath surrounds at least one internal sheath which is then used when reusing the medical endoscope 1.

[0076] According to a second embodiment, the insertion tube 2 is covered with a single sheath 8, called external. In this case, the medical endoscope 1 can be reused only once and then does not have a sheath during this reuse.

[0077] If necessary, disinfection can be carried out between two uses.

[0078] The method according to the invention may comprise a step iii) subsequent to step ii) consisting of placing the medical endoscope 1 in packaging for reuse. Here again, packaging that can be used in the context of the invention is described in particular in application FR 22 09870.

Claims

Claims

1. Medical endoscope (1) comprising a control handle (3) and an insertion tube (2) equipped with an orientable distal head (4), the insertion tube (2) being completely covered with several sheaths (8) superimposed on each other, each sheath being waterproof, biocompatible, comprising a sleeve (9) and having a distal end (8d) transparent to ultrasonic and light waves, each sleeve (9) being flexible, stretchable, conforming to the shape of the insertion tube and having a hardness of 1 to 70 Shore D and a thickness of 10 μm to 300 μm, characterized in that each sleeve has a tearing system (11).

2. Medical endoscope (1) according to claim 1, wherein the tearing system (11) comprises at least one line of lesser resistance and / or at least one line of greater resistance and / or at least one tearing element.

3. A medical endoscope (1) according to the preceding claim, wherein the lines of lesser or greater resistance extend over all or part of the length of the sleeve (9).

4. A medical endoscope (1) according to claim 2 or 3, wherein the lines of lesser resistance are pre-cut lines or lines of lesser thickness.

5. A medical endoscope (1) according to any preceding claim, wherein the tearing system (11) comprises at least one notch (11b) optionally contiguous to a line of lesser or greater resistance to facilitate tearing of the sleeve (9).

6. Medical endoscope (1) according to any one of the preceding claims, according to which each sheath (8) is a single piece, without welding or exogenous addition.

7. A medical endoscope (1) according to any preceding claim wherein the sleeve (9) is made of a heat-shrinkable elastomeric thermoplastic material.

8. Medical endoscope (1) according to the preceding claim, according to which the heat-shrinkable thermoplastic elastomer material is chosen from polyurethanes, polyamides, polyvinyl chlorides, polytetrafluoroethylenes (PTFE), and polyamide polyether block copolymers.

9. Medical endoscope (1) according to any one of the preceding claims, comprising from two to five superimposed sheaths (8).

10. A method of preparing a medical endoscope (1) according to any one of the preceding claims, comprising the following steps: a) providing a medical endoscope (1) comprising a control handle (3) and an insertion tube (2) equipped with an orientable distal head (4), b) disinfecting the medical endoscope (1), c) placing by heating a sheath (8) comprising a sleeve (9) closed at one of its ends by a closing part (10), d) producing a tearing system (11) on the sleeve (9), e) repeating steps c) and d).

11. Method according to the preceding claim comprising a step f) subsequent to step e) consisting of sterilizing the sheath(s) (8).

12. Method according to claim 10, comprising a step of sterilizing the sheath (8), after step d) and before step e).

13. A method according to any one of claims 10 to 11, wherein the method comprises: 12, according to which the tearing system (11) is produced by a cutting member, such as knives, punches or serrated blades, by insertion of at least one tearing element, or by coextrusion.

14. A method according to any one of claims 10 to 11, wherein the method comprises: 13, comprising a final step of packaging the medical endoscope (1).

15. A method for preparing a medical endoscope (1) for reuse comprising the following steps: i) providing a medical endoscope (1) according to any one of claims 1 to 9 with an outer sheath already in use, ii) tearing and removing the outer sheath to allow reuse of the medical endoscope (1).

16. Method according to the preceding claim, according to which, in step i), the outer sheath surrounds at least one inner sheath which is employed during the reuse of the endoscope.

17. Method according to claim 15 or 16 comprising a step iii) subsequent to step ii), consisting of storing the medical endoscope (1) in a package for reuse.

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