Cover for an endoscope, kit comprising said cover for an endoscope and method of placing the endoscope in the cover

Abstract

The invention relates to a cover for an endoscope (2) of the type comprising a probe (2.1), an attachment section (2.2), at least one internal working channel (2.3) configured to receive a tool, and an optical system (2.5) arranged at a distal end (2.4) of the endoscope (2). The cover (1) comprises an outer sheath (1.1) configured to surround the probe (2.1) of an endoscope; a cone (1.2) configured to surround the attachment section (2.2) of the endoscope; at least one working channel tube (1.3), which is a conduit intended to be housed in the working channel (2.3) of an endoscope; and a lens (1.4) configured to protect the optical system (2.5) of the endoscope. The invention also relates to a kit comprising said cover (1) for an endoscope, a connector (5) and a stylet (6). The invention further relates to a method for placing the cover (1) on the endoscope (2).

Description

[0001] ENDOSCOPE COVER, KIT COMPRISING SAID ENDOSCOPE COVER AND METHOD OF PLACING THE COVER ON THE ENDOSCOPE DESCRIPTION OBJECT OF THE INVENTION

[0002] The present invention discloses an endoscope cover that, when placed on an endoscope, protects it and ensures its sterility with each use. The invention also relates to a kit comprising said cover, a connector, and a stylet. The stylet allows for the correct placement of the cover, the method of which is also part of the present invention, and the connector allows for irrigation and the passage of the tools necessary to perform the corresponding test.

[0003] TECHNICAL PROBLEM TO BE SOLVED AND BACKGROUND OF THE INVENTION

[0004] Endoscopy is a procedure widely used by medical professionals. One example of endoscopy is cystoscopy, a procedure performed with a cystoscope, an endoscopic imaging device that requires irrigation, illumination (via fiber optics, integrated light, etc.), and an optical system. These devices comprise an internal channel (working channel) through which a working instrument is inserted. Numerous instruments with different functions exist (scissors, forceps, probes, etc.). Thus, at the distal end of the cystoscope, there is an opening through which the appropriate instrument is inserted. Also located at this distal end are the illumination and optical system of the cystoscope, allowing the physician, for example, to remove small bladder stones or take bladder tissue biopsies.

[0005] In addition to cystoscopy, other endoscopic procedures use similar instruments and serve different purposes. For example, in a colonoscopy, the doctor uses a colonoscope to examine the colon and can perform tissue biopsies or remove polyps using forceps or snares. In a bronchoscopy, a bronchoscope is inserted into the airways to visualize the trachea and bronchi; in this case, brushes or needles are used to obtain samples from the bronchial walls. Another example is gastroscopy, which allows for the inspection of the esophagus, stomach, and duodenum; in this case, forceps can be used to perform biopsies, or techniques can be used to stop bleeding by introducing coagulation devices. These endoscopic tools, adapted to the type of procedure, allow professionals to make accurate diagnoses and provide specific treatments in a minimally invasive manner.

[0006] Although rigid and flexible endoscopes exist, the most commonly used today are flexible ones because they have a passive flexible zone and another zone that is directed by commands, making them more comfortable for the patient than rigid endoscopes, in addition to allowing the distal end, where the working channel outlet, the illumination and the optical system are located, to be directed in any direction.

[0007] For health reasons, it is essential to sterilize endoscopes between procedures. Since endoscopies are almost routine and frequently performed, many sterilizations must be carried out throughout the day. This causes the endoscopes to deteriorate, significantly shortening their lifespan, which is very detrimental given that they are expensive devices.

[0008] Currently, sterile, single-use disposable endoscopes are available on the market, but they are extremely expensive devices that also generate a lot of waste, making them very unsustainable.

[0009] Some sterile sheaths for endoscopes are also known from the prior art. However, currently available sheaths create several shortcomings in the use of flexible endoscopes. These sheaths disable the endoscope's working channel, and therefore, the sheath itself has an additional channel used for inserting the instrument. This arrangement creates two problems. First, the addition of the external tube increases the overall diameter of the endoscope, making the procedure more painful for the patient. Second, the external channel for inserting the instrument misaligns the instrument and the endoscope's optics.While the optics, being located at the very end of the endoscope and this end being flexible, will be directed where the professional guides it, the tool, not passing through the endoscope and being positioned parallel to the optics, will not follow exactly the same path, which means that the tool (forceps, scissors, loop, etc.) is not at the focal point, making the correct use of the device much more difficult for the professional, in a test that, in itself, is very delicate.

[0010] On the other hand, there are no known endoscope sheaths that also protect the working channel of the instrument (i.e., the inner channel). This channel suffers greatly because the instruments, which often have sharp or pointed edges, must be constantly inserted and removed, promoting damage to the working channel wall.

[0011] DESCRIPTION OF THE INVENTION

[0012] The invention relates to an endoscope cover, a kit comprising said cover, and a method of placing the cover on an endoscope.

[0013] The endoscope sheath is of the type that has an endoscope probe with a proximal end, attached to a joining section and having a distal end, and inside the endoscope extends at least one working channel, which extends between the proximal end and the distal end, and the endoscope has an optical system at the distal end.

[0014] The case includes:

[0015] an outer sheath, configured to externally cover the endoscope probe;

[0016] a cone, arranged below the outer sheath and configured to cover the endoscope's joining section;

[0017] at least one working channel tube intended to be housed in and protect the working channel of the endoscope, and configured to allow the passage of a tool and irrigation fluid through it; and

[0018] a lens, intended to cover the distal end of the endoscope in which it is installed and configured to protect the optical system of said endoscope;

[0019] and where the lens is attached to one end of the working channel tube and one end of the outer sheath.

[0020] Ideally, the outer sheath is made of an elastic material. Examples of such materials include silicone and polyurethane. The outer sheath is durable and has a low thickness (preferably between 0.35 mm and 0.30 mm if made of silicone and 0.05 mm if made of polyurethane), so it barely increases the overall thickness of the endoscope when installed (compared to the thickness of an endoscope without a sheath). Furthermore, it does not reduce the endoscope's flexibility once in place.

[0021] The length of the outer sheath is sufficient to cover the probe lengthwise.

[0022] 5 of the standard endoscopes that have a length measurement that, depending on

[0023] Its type varies little. We can highlight, as a list of types of endoscopes, not exhaustive, but of main interest due to their applicability to the present invention: cystoscopes, bronchoscopes, hysteroscopes, nephroscopes and rhinolaryngoscopes.

[0024] 10 Thus, in the case of cystoscopes, the length is generally between 370 mm

[0025] and 400 mm. Regarding the outer diameter of the probe of standard cystoscopes, this is between 14.6 Fr and 16.5 Fr (4.87 mm and 5.5 mm), so the inner diameter of the outer sheath (which is placed around the cystoscope probe) is between 6 mm and 6.5 mm. To adapt to the variations in probe diameter of the endoscopes, it is recommended that the inner diameter of the sheath be 1 mm above the maximum diameter of the probe of each type of endoscope.

[0026] The following table compiles the dimensions of interest for different types of endoscopes, and the recommended dimensions of the sheath associated with each type:

[0027] 20

[0028]

[0029] Therefore, to accommodate variations in the usable length of endoscopes, a length shorter than the shortest probe length for each type of endoscope is recommended. Ideally, this should be 40 mm shorter than the shortest probe length for each type of endoscope.

[0030] For example, for cystoscopes, which, as we have seen, range in length from 370 mm to 400 mm, in a preferred embodiment the length of the outer sheath is between 360 mm and 330 mm, and more preferably 330 mm. This length allows the outer sheath to extend appropriately to the length of the cystoscope probe, preventing wrinkles from forming when the probe is bent. Furthermore, it ensures that a distal (flat) wall of the sheath lens (described later) contacts the distal end of the endoscope before the sheath cone is positioned to correspond with the endoscope's connecting section. This allows for free rotation and precise alignment of the lens with the endoscope's optical system. This facilitates the correct attachment of the sheath to the endoscope by coupling the sheath cone with the endoscope's connecting section, while the stretching of the outer sheath helps maintain this alignment during use.

[0031] Regarding the sheath's cone, it is attached to the outer sheath at one end (the end closest to the proximal end of the endoscope when the sheath is in place). The cone shape facilitates a secure and effective connection to the endoscope's joint section.The material (preferably silicone or polyurethane, due to its flexibility and because it guarantees a comfortable and stable fit during medical procedures) and the internal configuration of the cone, with internal stepping, preferably comprising a plurality of annular protrusions of different diameters inside, allow the necessary friction to be generated with the joining section of the endoscope once the sheath is placed to keep the sheath firmly attached to the cystoscope during use (containing the force generated by the stretching of the outer sheath that stretches from its length, preferably for cystoscope sheaths of 330 mm until it is attached around the cystoscope probe which has a length generally between 370 mm and 400 mm).

[0032] These types of flexible silicone elements with an internal stepped design are widely used in medical and laboratory applications to provide secure, leak-proof connections between tubes of different diameters. The cone of the sleeve is preferably made of silicone due to its flexibility and resistance to various chemical and thermal conditions. The interior of the sleeve cone comprises a plurality of stepped cylindrical indentations (of varying diameters) that improve the distribution of contact forces when the sleeve expands upon coupling to the endoscope. These indentations of varying diameters significantly increase friction between the sleeve and the endoscope's connecting section, ensuring that the sleeve remains firmly attached to the endoscope during use.By concentrating force in smaller areas along the cone, the annular protrusions prevent any slippage or accidental movement, providing a stable and secure connection crucial for accurate and effective procedures.

[0033] Furthermore, the staggered arrangement of the inlets allows for flexible adaptation to various sizes and shapes of standard endoscope connectors, facilitating compatibility with different models without additional complications. This design feature enables an efficient and adaptable connection, essential for the fast pace of medical environments, ensuring seamless application and an optimal experience for both the medical professional and the patient.

[0034] The smaller diameter ring projection can be used as a stop for the outer sleeve. It is sized to make contact with the outer sleeve, facilitating the assembly of the sleeve components during the manufacturing process. To ensure correct positioning, the diameter of this ring projection must be smaller than the diameter of the outer sleeve.

[0035] Furthermore, the conical shape of the cone facilitates the generation of greater clamping forces when inserted more deeply, thus improving the stability of the sheath in its position once placed on the endoscope. In a preferred embodiment, the cone comprises a plurality of annular protrusions within it, which increase friction between this part of the sheath and the endoscope, further securing the sheath's position during use on the endoscope.

[0036] The working channel tube is the part of the sheath that is housed within the endoscope's working channel once the sheath is in position. The outer diameter of the working channel tube is therefore determined by the diameter of the endoscope's working channel. Another requirement is that the inner diameter of the tube must be sufficient to allow the passage of an instrument (approximately 5 Fr) that the physician wishes to use during the endoscopy and to permit irrigation (which is essential for endoscopic procedures). It is recommended to maintain a clear passage area for irrigation of approximately 0.72 mm². 2 , for a 5 Fr tool represents a working channel tube with an inner diameter greater than or equal to 1.92mm. With a wall thickness of 0.1mm, it represents a tube with an outer diameter of 2.12mm.

[0037] Another requirement that the working channel tube must meet is that it must be of sufficient length to allow the sheath to be placed on the endoscope using a stylet, which is part of the invention kit.

[0038] The minimum length of the working channel tubing is that of the working channel of an endoscope, from the distal tip to the proximal tip of that endoscope. Furthermore, when the sheath is fitted to an endoscope, it is used with a connector (explained in more detail later in this description) that is generally located less than 145 mm from the endoscope's junction section.

[0039] The stylet included in the kit is used to facilitate the placement of the sheath on the endoscope. To do this, the stylet is inserted through the working channel (the proximal end of the endoscope), through the opening through which the instrument will later be inserted during the procedure. To ensure that the sheath's working channel tube remains sterile, it is important that the stylet is not too long, so that it is inserted only as far as necessary to guide it through the endoscope's working channel. Once the sheath is in place, the working channel tube protrudes from the proximal end of the endoscope. This protruding portion is the part that was previously in contact with the stylet, and once it is removed, it is cut off.This ensures that the working channel tube of the sheath (through which the tool subsequently passes) is completely sterile.

[0040] In one embodiment, the stylet includes a stop at one end to prevent it from being accidentally inserted too far into the endoscope's working channel and becoming lost. Thus, continuing with the specific example of the cystoscope, the total length of the working channel tube is preferably between 690 mm and 720 mm, and more preferably 700 mm (covering 400 mm of the maximum cystoscope length, 145 mm of the average distance between the endoscope cone base and the tool (and irrigation) inlet at the proximal end of the endoscope, and an additional 145 mm of space for the stylet, totaling approximately 690 mm). This ensures that the length of the sheath's working channel tube is sufficient to safely and effectively place the sheath onto the cystoscope using a stylet.

[0041] Applying this same principle, the working channel tube length for each endoscope type is determined by adding the length of the longest probe for that endoscope type to twice the stylet length. The table below summarizes the recommended dimensions for the working channel tube of each endoscope type, as well as other relevant specifications:

[0042]

[0043] The length of the probe varies among different types of endoscopes, while the length of the stylet is similar for all of them, as it is designed to reach from the Lt / er inlet of the endoscope's working channel to the base of the junction section between the probe and the endoscope's control body. Since this part has similar dimensions in different types of endoscopes, the stylet can have a single length compatible with any sheath of the invention, allowing its use in cystoscopes, gastroscopes, and other endoscopes without needing to vary the stylet size depending on the type of device.

[0044] The working channel tube is made of a low-friction, compression-resistant, and torsion-resistant material. Additionally, the wall thickness of the working channel tube is preferably between 0.10 mm and 0.14 mm. In one possible embodiment, the working channel tube is made of silicone or polyurethane and reinforced with stainless steel. More specifically, in a preferred embodiment, the thermoplastic polyether block amide (PEBA) with a Shore D hardness of 70 according to ISO 7619-1 is used.

[0045] The sheath lens is a particularly important component. It is designed to fit around the distal end of the endoscope, where the endoscope's optical system is located. The lens is attached to the working channel tube and the outer sheath.

[0046] The lens is the sheath component that protects the endoscope's optical system and must ensure that the images captured by this system are of sufficient quality for the tests determined by the physician. This is a critical element because not all endoscopes on the market, even within the same type (cystoscopes, bronchoscopies, etc.), have the same geometry at their distal end. Therefore, a lens is needed that adapts to the different distal end geometries of standard endoscopes without causing any distortion that would impede the correct functioning of the endoscope's optical system (which generally comprises an illumination system and a camera). The sheath lens of the present invention covers the endoscope's optical system without reducing either the field of vision or the illumination.

[0047] To this end, a lens has been designed that is adaptable to the distal ends of standard endoscopes. It is made of optical-grade silicone or polyurethane (preferably optical-grade polyurethane), ensuring that images captured by the camera of the endoscope's optical system are transmitted without distortion, maintaining clear visibility during the medical procedure. This material also makes the lens flexible, resistant to the high temperatures generated by the endoscope's optical system, suitable for medical use, and sterilizable (in one example, using ethylene oxide (EtO)). The connection between the lens, the outer sheath, and the working channel tube is airtight (preferably achieved with adhesive).

[0048] The distal ends of standard endoscopes are classified as flat or tapered, and in both cases the dimensions are very similar, so the proposed lens is universal for all. It comprises a flat front wall that abuts the distal end of endoscopes with a flat distal end when the sheath is placed around the endoscope, and only partially contacts the distal end of endoscopes with a tapered distal end when the sheath is placed around the endoscope.

[0049] In one embodiment, a bulbous protrusion is included in the adhesion area with the working channel tube to increase the contact surface between the two elements, thereby improving the seal and facilitating endoscope insertion. The adhesion area is the area where the lens and the working channel tube of the sheath come into contact, preferably joined together by bonding. In another embodiment of the invention, the end of the working channel tube comprises an L-shaped geometry at its distal end, thereby increasing the adhesion area. Furthermore, it allows the bulbous protrusion (which creates the contact surface for the working channel tube / lens connection) to be replaced by a flat lens. The outer diameter of the L-shape must not obstruct the endoscope's optical system. In one embodiment, this outer diameter is less than 1.8 mm and preferably less than 1.6 mm.

[0050] Preferably, the lens comprises a hollow cylindrical probe with a distal wall and an opening at the proximal end intended to receive the distal end of the endoscope. Furthermore, the lens comprises a cylindrical recess with an internal cylindrical through-hole, wherein an inner face of the distal wall is intended to be at least partially in contact with a front surface of the distal end of an endoscope in which the sheath is placed, and the cylindrical recess is intended to be at least partially housed in the working channel of the endoscope in which the sheath is placed and allow the passage of a tool through it.

[0051] Once the sheath is in place, and with the lens properly aligned with the endoscope's optical system camera, the sheath is pulled (made possible by the elasticity of the material) so that the sheath's cone rests on the endoscope's connection section. This pulling force ensures the lens is perfectly aligned with the endoscope's camera and cannot move (since the sheath itself exerts pressure on that part of the endoscope). Furthermore, as previously described, the sheath's cone has a specific geometry, with multiple stepped, annular protrusions that allow for a secure fit on the endoscope's connection section.

[0052] Also an object of the invention is a kit comprising the previously described sheath, a connector, and a stylus.

[0053] The working channel of endoscopes is used for irrigation, suction, and for passing the instruments necessary for the procedure the physician will perform. For this purpose, endoscopes are generally used with a connector, usually a Luer-type connector. The present invention proposes a kit comprising a disposable connector, intended to remain attached to the sheath during use, preferably to the working channel tube. The connector is configured to allow connection of the Luer-type connector used with the endoscope, ensuring the necessary sterile conditions.

[0054] Some of the requirements for the kit connector include a compact, low-profile design to maximize comfort during endoscope handling, and a short length (to minimize the impact on the working length of the tools). It must also allow access for a tool up to 5 Fr to the working channel tube while simultaneously permitting irrigation. Ideally, it includes an internal sealing valve that facilitates the passage of tools of various sizes without requiring manual rotation adjustment.

[0055] The sheath connector is designed to connect to a Luer Lock connector on the endoscope, allowing the insertion of the working instrument while simultaneously connecting to the irrigation fluid (essential in these procedures). The connector is threaded to both the sheath and the endoscope to ensure a secure connection, as the endoscope will be moved by the practitioner during the procedure, and the connector must follow these movements. Therefore, the kit's connector is designed to fit through the endoscope's Luer Lock connection, allowing the saline inlet to be directed according to the endoscope's movements and preventing backflow of saline solution into a straight section of the connector's T-shaped fitting. This prevents splashing onto the user and avoids pressure loss that could impede dilation of the patient's cavity during the procedure.

[0056] It is important that the kit connector is short so as not to lose length of the working tool since it has to pass through the connector to reach the working channel tube, travel through said tube and come out through the distal end of the sheath (where the lens is located).

[0057] As previously described, the connector attaches to a Luer-type connector on the endoscope, allowing the tool to pass through. Inside the connector is a rubber grommet (acting as the female element) into which the endoscope's connector (male element) is inserted. This creates the channel through which the tool is inserted. Not all tools have the same diameter, and it's also necessary to ensure that the irrigation fluid doesn't leak out the other side. Therefore, the connector has a non-return valve that prevents the irrigation fluid from escaping and also allows the insertion of any tool without needing to adjust the connector's threading to fit a specific diameter, unlike what is currently required.

[0058] Additionally, the portion of the connector that connects to the irrigation system includes a tube of a specific length that facilitates the use of the endoscope. This tube moves as the irrigation channel is oriented, making it easier for the practitioner to use the device. Another design option to meet this requirement would be to use a freely rotating connector, eliminating the need for the longer tube section. However, these connectors are very expensive and therefore not a preferred solution in this case.

[0059] Regarding the stylet included in the kit, it is designed to facilitate the placement of the sheath on the endoscope. The stylet is configured to guide the working channel tubing from the distal end of the endoscope to the connector (i.e., in the reverse direction to how the tool is subsequently inserted into the working channel tubing). During the journey from the distal tip to the Luer port, obstacles may be encountered, such as internal bifurcations within the endoscope (some endoscopes have suction ports that are separate from the irrigation / tool ​​ports, which can complicate navigation), valves that may have been accidentally closed by the operator, and internal features with stepped sections of varying diameters (which can cause unwanted contact).Furthermore, it is necessary to maintain the sterility of the sheath at all times, even when it is being placed (since if it becomes contaminated this is irreversible and the entire sheath would have to be discarded) and, as the stylet passes through the working channel which is considered a contaminated environment, it also becomes contaminated, so contact of the stylet with certain parts of the sheath must be avoided (they should only come into contact at the exact point where it is designed to make contact), the stylet is easy to handle and install and is designed to simplify the medical procedure and reduce preparation time.

[0060] Preferably, the sheath, connector, and stylet are sterilized before storage. In one embodiment, the kit comprises a pouch containing the sterilized sheath, connector, and stylet. In another embodiment, the kit also includes a lubricant, which may be individually packaged for use by the user when attaching the sheath to the endoscope. In other embodiments, the sheath, connector, and / or stylet may be pre-lubricated (i.e., a lubricant may have been applied to them before packaging them in the kit).

[0061] A method of placing the sheath on the endoscope is also an object of the invention.

[0062] As previously described, the sheath of the invention is designed to prevent contamination of the endoscope between tests, while also protecting it. It is therefore a disposable product, intended to be placed on the endoscope before each test and removed and discarded afterward. Therefore, a simple and routine procedure for attaching the sheath is necessary. To this end, once the container / bag is opened and the sheath, connector, and stylet are removed, the method for attaching the sheath from the kit to an endoscope comprises at least the following steps:

[0063] a) insert the stylet through the proximal opening of the endoscope;

[0064] b) insert the working channel tube through the distal end of the endoscope, through the working channel of the endoscope;

[0065] c) When the working channel tube makes contact with the stylet, push the sheath so that the stylet acts as a guide, until the stylet is extracted and the working channel tube protrudes from the proximal end (through which the tool will later be inserted into the endoscope);

[0066] d) orient the lens of the sheath in accordance with the optical system of the endoscope;

[0067] e) Stretch the outer sheath until the cone of the sheath is positioned in correspondence with a joining section of the endoscope.

[0068] Preferably, the working channel tube of the sheath is longer than the working channel of the endoscope. Therefore, once the sheath is correctly positioned, the placement method involves cutting off the excess length of the working channel tube (the section that extends beyond the working channel). This excess length is the portion that comes into contact with the stylet at its end during sheath placement. Cutting this section ensures complete sterility without any possibility of contamination through contact.

[0069] Additionally, once the excess section has been cut, an additional step can be taken to place the connector in the working channel, in the tool's entry hole (at the proximal end) and join the connector to one end of the working channel tube, while at the other end, two inlets remain free, one to introduce the corresponding tool (the tool that the doctor considers necessary) and another to introduce the irrigation fluid.

[0070] As previously described, it is a disposable cover, so once the test is performed, the cover is removed and discarded.

[0071] This ensures that the endoscope is sterile during all tests. This reduces the time between tests, which was previously longer for proper sterilization. Furthermore, it significantly extends the endoscope's lifespan, as both the external part and the working channel are fully protected from friction and excessive cleaning.

[0072] Ideally, the entire kit is lubricated before packaging. This way, the user only needs to open the package and place the cover on the endoscope. This ensures the use of the most suitable lubricant, in the correct quantity and distribution. It is important that the lubricant be very transparent so as not to affect the optics.

[0073] In a preferred embodiment, a silicone with a low coefficient of friction is used for the outer sleeve of the tube. In another embodiment, a coating is applied to the outer sleeve during the tube's manufacturing process. Other options include the application of dry lubricant, liquid lubricant, single-dose gel lubricant, aerosol lubricant, or lubricating wipes. In one embodiment, described previously, an individually packaged lubricant may be included in the kit.

[0074] Therefore, the proposed sheath is designed for use with flexible endoscopes. It is a disposable sheath that allows users (generally physicians) to use the same endoscope multiple times throughout the day without needing to sterilize it after each use and without compromising the sterility of the procedure or the use of the endoscope's working channel. Thus, the use of the proposed sheath and kit guarantees consistent sterility for as many uses as necessary without any waiting time between procedures (i.e., sterilization time after each procedure is eliminated; simply remove the used sheath, clean it, and replace it with a new one).

[0075] The described cover protects both the exterior and interior (working channel) of the endoscope. Once in place, the cover does not affect the endoscope's functionality and is compatible with all endoscopes (by adjusting the cover's dimensions to fit each type of endoscope).

[0076] As an added benefit, time is saved (no more transfers or waiting time for endoscope sterilization after each use). Furthermore, the number of endoscopes needed in each clinic / health center is reduced, since a single endoscope can perform all the necessary tests each day.

[0077] The cover prevents the main causes of endoscope deterioration, which are wear and tear of the working channel (which is protected by the cover) and wear caused by continuous sterilization (which is no longer necessary because simply discarding a used cover and putting on a new one guarantees the sterility of the test).

[0078] The sheath ensures complete coverage and protection of the endoscope, as it covers both the interior (working channel) and exterior, guaranteeing the proper functioning of the endoscope's optical system (maintaining correct illumination and vision). The sheath is the only element that comes into contact with the patient during the procedure; the endoscope remains fully protected and does not come into contact with either the patient or the instrument, which does come into contact with the patient.

[0079] The cost of discarding a cover after each test is very low compared to the cost of having vaporized endoscopes, having to sterilize each endoscope after each test, etc.

[0080] Thus, the costs of endoscope breakdowns and sterilization are reduced, as are the costs associated with the use of disposable endoscopes. Waiting time between different tests is also reduced, proper endoscope sterilization is guaranteed throughout the day, and it can be used with any type and brand of endoscope (as previously described, adapting the measurements to each type / brand of endoscope). It is important to note that the proposed cover, once placed on the endoscope, does not reduce its flexibility.

[0081] The proposed sheath ensures the repeatability of the sheath placement method on the endoscope with identical quality, without risk of cross-infection. At the end of the day, the endoscopes can be sent for sterilization for the following day.

[0082] BRIEF DESCRIPTION OF THE FIGURES

[0083] To complete the description and to aid in a better understanding of the characteristics of the invention, a set of drawings is included with this descriptive document as an integral part thereof, in which, for illustrative and non-limiting purposes, the following has been represented:

[0084] Figure 1 represents an endoscope (in this case a cystoscope), the sheath of the invention, and the connector and stylet which, together with the sheath, form part of the kit of the invention.

[0085] Figure 2 shows a cross-sectional view of the distal end of the endoscope with the sheath on, where the lens of the sheath, also cross-sectioned, can be seen.

[0086] The following is a list of the numerical references shown in the figures:

[0087] 1: sheath; 1.1: outer sheath; 1.2: cone; 1.3: working channel tube; 1.4: lens; 2: cystoscope; 2.1: probe; 2.2: joining section; 2.3: working channel; 2.4: distal end; 2.5: optical system; 2.6: proximal end; 3: distal wall; 4: proximal end of lens; 5: connector; 6: stylet

[0088] DETAILED DESCRIPTION

[0089] The present invention is not limited to the embodiment described herein. Other configurations may be realized by those skilled in the art in light of this description. Accordingly, the scope of the invention is defined by the following claims.

[0090] Figure 1 shows an endoscope (2) and the sheath (1) of the invention. A connector (5) and a stylet (6), which are part of a kit with the sheath (1), are also shown. The embodiment shown is an endoscope (2) that is a cystoscope.

[0091] The endoscope sheath (1) (2) is intended to be placed on a flexible endoscope (2), of the type comprising: a probe (2.1), a joining section (2.2), at least one working channel (2.3) passing internally through the endoscope (2) between a proximal end (2.6) and a distal end (2.4) thereof and configured to receive a tool through it, and an optical system (2.5) disposed at the distal end (2.4).

[0092] The sheath (1) comprises, as can be seen in Figure 1, an outer sheath (1.1), a cone (1.2), at least one working channel tube (1.3) and a lens (1.4).

[0093] Gastroscopes and colonoscopes are types of endoscopes that generally have two working channels (2.3). The sheath (1) of the present invention would cover, in these cases (gastroscopes and colonoscopes), the other channels that are not working channels and are used for suction and irrigation. In these cases, the sheath (1) would have at least two working channel tubes (1.3).

[0094] The outer sheath (1.1) is made of a flexible material and is configured to enclose the probe (2.1) of an endoscope (2). The cone (1.2) comprises an interior space of increasing diameter, from a smaller diameter at the end of the cone (1.2) that is in contact with the outer sheath (1.1) to a larger diameter at the opposite end, and comprises a plurality of annular projections in the interior space. The cone (1.2) is configured to be arranged around the connection section (2.2) of the endoscope (2).

[0095] Preferably, the inner diameter of the outer sheath (1.1) is 1 mm larger than the maximum diameter of the endoscope probe (2.1), and more preferably, the length of the outer sheath (1.1) is 40 mm shorter than the length of the probe (2.1) of the endoscope on which it is to be fitted. Also preferably, when the sheath is stretched (in position), the length of the outer sheath (1.1) is sufficient to longitudinally cover the probe (2.1) of the endoscope on which the sheath (1) is to be fitted.

[0096] The working channel tube (1.3) is a conduit configured to be housed in the working channel (2.3) of the endoscope (2), completely covering one wall of the working channel (1.3) of the endoscope (2) and allowing the passage of a tool through it.

[0097] The lens (1.4) of the sheath (1), which can be seen in Figure 2, is made of optical grade silicone, and is configured to be arranged in correspondence with the distal end (2.4) of the endoscope (2), covering the optical system (2.5) of the endoscope (2) in which the sheath (1) is placed and which is attached to the outer sheath (1.1) and the working channel tube (1.2).

[0098] In one embodiment, the outer sheath (1.1) has a thickness of between 0.35 mm and 0.30 mm. In another embodiment where the sheath is intended for use with a cystoscope, the length of the outer sheath (1.1) is between 360 mm and 330 mm, and more preferably 330 mm. In another embodiment, the working channel tube (1.3) has a length of between 690 mm and 720 mm, and more preferably 700 mm. Furthermore, the working channel tube (1.3) may have a thickness of between 0.10 mm and 0.14 mm.

[0099] In one embodiment, at least one of the elements selected from the outer sheath (1.1), the working channel tube (1.3), and the cone (1.2) is made of silicone. In another embodiment, at least one of these elements is made of polyurethane. In one possible embodiment, the working channel tube (1.2) is made of silicone or polyurethane and is reinforced with stainless steel. In another possible embodiment, the working channel tube (1.2) is made of PEBA.

[0100] In one possible embodiment, as shown in Figure 2, the lens (1.4) comprises a hollow cylindrical probe with a distal wall (3) and an opening at a proximal end of the lens (4) intended to receive the distal end (2.4) of the endoscope, and the lens (1.4) comprises a cylindrical recess, with an internal cylindrical through-hole, wherein an inner face of the distal wall (3) is intended to be at least partially in contact with a front surface of the distal end (2.4) of an endoscope (2) in which the sheath is placed, and the cylindrical recess is intended to be at least partially housed in the working channel (2.2) of the endoscope (2) in which the sheath (1) is placed and allow the passage of a tool through it.

[0101] The lens (1.4) can be joined to the outer sheath (1.1) and to the working channel tube (1.2) using adhesive, forming a hermetic seal. In this case, the lens (1.4) may include a protrusion at the end of the cylindrical recess that is attached to the working channel tube (1.3), thereby increasing the contact area between the lens (1.4) and the working channel tube (1.3). In another embodiment, the distal end of the working channel tube (1.3) may have an L-shaped geometry, further increasing the contact area with the lens (1.4). As previously described, a kit comprising a sheath (1), a connector (5), and a stylus (6) is also an object of the invention. The kit may also include a pouch for housing the remaining kit components.Preferably, the kit comprises a bag containing a sterile sheath (1), connector (5), and stylet (6). These items are sterilized after being placed in the bag and sealed, ensuring the sterility of all components for the procedure. This is achieved using a bag designed to sterilize its contents with EtO gas. The gas is introduced through pores in the bag that allow the passage of the gas but prevent the passage of microorganisms, thus ensuring the sterility of the contents after the sterilization process.

[0102] In one embodiment, the kit includes a lubricant. In another embodiment, the sheath (1), connector (5), and stylet (6) may already be lubricated to ensure that a suitable lubricant is used that does not affect the view through the lens (1.4) of the sheath and that all elements are properly lubricated to prevent problems during the procedure.

[0103] In one embodiment, the working channel tube (1.3) of the sheath (1) of the kit has a length determined by adding the length of the probe (2.1) of the endoscope on which the sheath is to be placed to twice the length of the stylet (6).

[0104] Furthermore, a method for placing an endoscope sheath (1), as described above, onto an endoscope (2) is an object of the invention. Preferably, the method comprises the following steps:

[0105] a) insert a stylet (6) through the proximal entrance (2.6) of the endoscope (2); b) insert the working channel tube (1.3) of the sheath (1) through the distal end (2.4) of the endoscope (2), through the working channel (2.3);

[0106] c) when the working channel tube (1.3) contacts the stylet (6), push the sheath (1), such that the stylet (6) acts as a guide, until the stylet (6) is extracted and the working channel tube (1.3) protrudes from the proximal end (2.6) of the endoscope (2);

[0107] d) orient the lens (1.4) of the sleeve in correspondence with the optical system (2.5) of the endoscope (2) so that the cylindrical recess of the lens (1.4) is housed, at least partially, in the working channel (2.3);

[0108] e) stretch the outer sheath (1.1) until the cone (1.2) of the sheath (1) is positioned in correspondence with a joining section (2.2) of the endoscope (2).

[0109] Preferably, when the working channel tube (1.3) protrudes from the proximal end (2.6) of the endoscope (2), a step is made to cut off the excess length of said working channel tube (1.3).

[0110] Preferably, when the excess length of the working channel tube (1.3) has been cut off, an additional step is performed by placing the connector (5) on the working channel tube (1.3) and joining the connector (5) at one end to the working channel tube (1.3) so that the other end, with two inlets, is accessible outside the endoscope. One of the inlets allows the passage of the corresponding tool, and the other allows the passage of an irrigation fluid.

Claims

CLAIMS 1. A flexible endoscope sheath (1) of the type comprising a probe (2.1), a connecting section (2.2), at least one working channel (2.3) passing internally through the endoscope (2) between a proximal end (2.6) and a distal end (2.4) thereof and configured to receive a tool through it, and an optical system (2.5) disposed at the distal end (2.4), wherein the sheath (1) is characterized in that it comprises: - an outer sheath (1.1) of a flexible material, configured to enclose the probe (2.1) of an endoscope (2); - a cone (1.2) with an inner space of increasing diameter from a smaller diameter at the end of the cone (1.2) that is in contact with the outer sheath (1.1) and with a larger diameter at the opposite end, and comprising a plurality of annular projections in the inner space, and the cone (1.2) is configured to be arranged around the joining section (2.2) of the endoscope (2); - at least one working channel tube (1.3) which is a conduit configured to be housed in the working channel (2.3) of the endoscope (2), completely covering one wall of the working channel (2.3) and allowing passage of a tool and irrigation fluid through it; - a lens (1.4), made of optical-grade silicone, configured to be arranged in correspondence with the distal end (2.4) of the endoscope (2), covering the optical system (2.5) of the endoscope (2) in which the sheath (1) is placed and which is attached to the outer sheath (1.1) and to the working channel tube (1.2). 2.- Sheath according to claim 1 wherein the outer sheath (1.1) has a thickness of between 0.35 mm and 0.30 mm. 3.- Sheath according to any one of the preceding claims wherein the length of the outer sheath (1.1) is 40 mm less than the length of the probe (2.1) of the endoscope in which it is to be placed. 4.- Sheath according to any one of the preceding claims wherein at least one of the elements selected from the outer sheath (1.1), the working channel tube (1.3) and the cone (1.2) is made of silicone. 5.- Sheath according to any one of the preceding claims wherein the inner diameter of the outer sheath (1.1) is 1 mm greater than the maximum diameter of the probe (2.1) of the endoscope in which it is to be placed. 6.- Cover according to any one of the preceding claims wherein the thickness of the working channel tube is between 0.10 mm and 0.14 mm. 7.- Cover according to any one of the preceding claims wherein the working channel tube (1.2) is made of silicone or polyurethane and is reinforced with stainless steel or is made of PEBA. 8.- Sheath according to any one of the preceding claims wherein the lens (1.4) comprises a hollow cylindrical probe with a distal wall (3) and with an opening at a proximal end of the lens (4) intended to receive the distal end (2.4) of the endoscope, and the lens (1.4) comprises a cylindrical recess, with an internal through-hole also cylindrical, wherein an inner face of the distal wall (3) is intended to be at least partially in contact with a front surface of the distal end (2.4) of an endoscope (2) in which the sheath is placed and the cylindrical recess is intended to be at least partially housed in the working channel (2.2) of the endoscope (2) in which the sheath is placed and allow the passage of a tool through it. 9.- Cover according to any one of the preceding claims wherein the joining of the lens (1.4) with the outer sheath (1.1) and with the working channel tube (1.2) is made by means of adhesive and is a hermetic joint. 10.- Cover according to claims 8 and 9 wherein the lens (1.4) comprises a protrusion at the end of the cylindrical recess that is attached to the working channel tube (1.3) so as to increase the contact area between the lens (1.4) and the working channel tube (1.3). 11.- Cover according to claims 8 and 9 wherein the distal end of the working channel tube (1.3) comprises an “L” shaped geometry such that it increases the contact area with the lens (1.4). 12.- Kit characterized in that it comprises a case as described in any one of claims 1 to 11, a connector (5) and a stylus (6). 13.- Kit according to claim 12 comprising a bag inside which the sterile sheath (1), connector (5) and stylet (6) are housed. 14.- Kit according to any one of claims 12 or 13 comprising a lubricant. 15.- Kit according to any one of claims 12 to 14 wherein the working channel tube (1.3) of the sheath (1) has a length determined by adding the length of the probe (2.1) of the endoscope in which the sheath is to be placed to twice the length of the stylet (6).

16. Method of placing an endoscope sheath on an endoscope according to any one of claims 1 to 11, comprising the following steps: a) insert a stylet (6) through the proximal opening (2.6) of the endoscope (2); b) insert the working channel tube (1.3) of the sheath (1) through the distal end (2.4) of the endoscope (2), through the working channel (2.3) of the endoscope (2); c) when the working channel tube (1.3) makes contact with the stylet (6), push the sheath (1), such that the stylet (6) acts as a guide, until the stylet (6) is extracted and the working channel tube (1.3) protrudes from the proximal end (2.6) of the endoscope (2); d) orient the lens (1.4) of the sleeve in correspondence with the optical system (2.5) of the endoscope (2) so that the cylindrical recess of the lens (1.4) is housed, at least partially, in the working channel (2.3); e) stretch the outer sheath (1.1) until the cone (1.2) of the sheath (1) is positioned in correspondence with a joining section (2.2) of the endoscope (2). 17.- Method according to claim 16 comprising, when the working channel tube (1.3) protrudes from the proximal end (2.6) of the endoscope (2), cutting off the excess length of said working channel tube (1.3).

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