Endoscope packaging system with an endoscope and a protective cover part

Abstract

The present disclosure relates to an endoscope packaging system (1). The endoscope packaging system (1) has: an endoscope (2) comprising: an endoscope handle or interface (4); and an insertion cord (6) configured to be inserted into a patient's body cavity, comprising an actively bendable bending section (10) and a distal tip unit (12), the actively bendable bending section (10) comprising a plurality of bending segments (31) made of a polymer material; and a protective sheath (34) configured to accommodate at least the distal tip unit (12) and the actively bendable bending section (10) of the insertion cord (6) of the endoscope (2), and configured to keep the bending section (10) straight during storage and transport.

Description

[0001] The present disclosure relates to an endoscope packaging system comprising: an endoscope comprising: an endoscope handle or interface; and an insertion string configured to be inserted into a patient's body cavity and comprising an actively deflectable flexure portion and a distal tip assembly, wherein the actively deflectable flexure portion comprises a plurality of flexure segments made of a polymeric material; and a protective sheath portion. Related prior art

[0002] Endoscopes and similar specialty instruments such as bronchoscopes, arthroscopes, colonoscopes, laparoscopes, gastroscopes, duodenoscopes, and ureteroscopes are known from the related art and are used for the visual examination and diagnosis of hollow organs and body cavities, as well as to assist in operations, e.g., for targeted tissue sampling. Both reusable and disposable endoscopes (i.e., single-use endoscopes) are known from the related art. Common endoscopes typically comprise an endoscope handle that allows an operator / user to hold and control the endoscope. Typically, an insertion string is connected to the endoscope handle, comprising an insertion tube, an actively bendable flexure section—i.e., a section with increased flexibility—and a distal tip assembly. The insertion string is configured to be inserted into a patient’s hollow organs and body cavities.The distal tip unit often includes an optical module or a camera module for visual examination of hollow organs and body cavities.

[0003] Disposable endoscopes are already known which have an actively bendable bending section comprising a bending section body formed in a single piece or two individual pieces from a polymer material. The bending section body of such a disposable endoscope comprises a number of rigid bending segments held together by bendable hinges. Between adjacent bending segments of the bending section body, two or three hinge elements or hinge parts can be provided, which are arranged approximately diametrically opposite one another with respect to a central axis of the bending section body. The hinge elements can be designed, for example, as foil hinges, i.e. as short strips of bendable material bridges between adjacent bending segments, which allow the material to bend elastically between adjacent bending segments.

[0004] Common endoscopes often contain control wires that are pulled and released to bend the actively bendable bending section of the endoscope to tilt the distal tip unit. To achieve bending of the bending section, a rotational force, e.g., exerted by a user on a handwheel or lever on the proximal endoscope handle, can be converted into a tensile force acting on the control wires in the axial direction of the control wires.

[0005] The insertion tubes of common endoscopes, e.g., bronchoscopes or ureteroscopes, can be long and thin. When the endoscopes are stored, transported, or shipped to the customer or user, the endoscopes are usually packaged in a packaging system. The packaging system may comprise a protective tube into which the insertion tube, or at least part of the insertion tube, is inserted, and a sterile packaging or barrier component, preferably a (semi-permeable) film, into which the endoscope is shrink-wrapped together with the protective tube. Due to its length, there is a risk that the insertion tube will be kinked or folded in the packaging system. The inner diameter of the protective tube is usually significantly larger than the outer diameter of the insertion tube.For disposable endoscopes with polymer-based bending sections, there is a particular risk of (permanent) deformation of the bending section due to transport or storage in a bent or kinked state. The bending section may deform due to aging of the polymer material of the bending section. Furthermore, the endoscope's control wires may exert tensile stress on the bending section, leading to permanent bending of the bending section during transport and storage. In particular, the thin hinge elements of the bending section may become deformed or bent. If a user or surgeon opens the packaging system at the periphery of surgery, a deformed bending section may give the impression of poor endoscope quality.

[0006] Due to the diameter difference between the protective tube and the insertion tube, not only can the bending section and the rest of the insertion tube bend within the protective tube, but relative movement can also occur between the distal tip unit of the endoscope and the protective tube. This can cause the distal tip unit, and especially the camera module within the distal tip unit, to bump into or collide with the protective tube. This can occur especially if the endoscope packaging system is dropped or moved quickly by the user. There is a risk that such repeated impacts could cause damage to the camera module of the distal tip unit.

[0007] Protective covers for a distal section of an endoscope are known from related prior art. For example, US 2021 / 0 378 492 A1 discloses a protective cover part for an endoscope. A distal tip unit of the endoscope can be inserted into the protective cover part to protect the distal tip unit from damage during storage and transport. In particular, a camera or an optical module on the distal tip unit is protected by the protective cover part.

[0008] JP 2007 075 281 A also discloses a protective sheath for an endoscope. The protective sheath consists of two half-shells connected by hinges. The two hinged half-shells can only be closed around the distal tip unit of the endoscope to protect the distal tip unit from damage during handling and transport. Furthermore, the hinged half-shells increase the design and assembly effort of the protective sheath, resulting in high costs. Brief description of the disclosure

[0009] The objects and aims of the present disclosure are to eliminate or at least mitigate the disadvantages of the related art. Specifically, an endoscope packaging system is to be provided that reduces the deformation of a bent portion of an endoscope during storage and transportation and protects a distal tip unit of the endoscope from damage. Furthermore, the endoscope packaging system is to be inexpensive and easy to manufacture, making it suitable for use in disposable endoscopes.

[0010] The objects and aims of the present disclosure are achieved by an endoscope packaging system according to claim 1. Advantageous embodiments are claimed in the dependent claims and / or are explained below.

[0011] The present disclosure relates to an endoscope packaging system comprising an endoscope and a protective sheath member. The endoscope comprises an endoscope handle or interface and an insertion string configured to be inserted into a patient's body cavity, and including an actively deflectable flexure portion and a distal tip assembly, wherein the actively deflectable flexure portion comprises a plurality of flexure segments made of a polymeric material. The protective sheath member is configured to receive at least the distal tip assembly and the actively deflectable flexure portion of the insertion string of the endoscope and is configured to maintain the flexure portion straight during storage and transport.

[0012] Keeping the bending section straight can be understood to mean that the protective sheath part can be configured to surround the distal tip unit and the actively bendable bending section (in a circumferential direction of the bending section) and can prevent (undesired) folding, curvature, or bending, or generally, relative movement of the bending section with respect to the protective sheath part. A straight bending section in this context can be defined as a bending section that has essentially no curvature. Thus, the protective sheath part can have an (inner) size or shape adapted to the (outer) size or shape of the distal tip unit and the actively bendable bending section. Thus, the protective sheath part keeps the actively bendable bending section and the distal tip unit of the endoscope straight after they have been inserted into the protective sheath part.

[0013] The endoscope according to the present disclosure may preferably be a disposable endoscope intended to be disposed of after use. This means that the endoscope is preferably optimized for single use. The endoscope preferably has a limited number of elements, which are preferably made of polymeric materials, e.g., by injection molding, and are easy to assemble. Compared to conventional reusable endoscopes, the focus of the present disclosure is on providing an endoscope that is used only once and is therefore not subject to aggressive cleaning or sterilization processes and general rough handling during the endoscope's life cycle.

[0014] Preferably, the insertion strand of the endoscope is connected to the endoscope handle or interface and comprises an insertion tube, the actively bendable bending section, and the distal tip unit, which extend in that order in the proximal-distal direction. The distal tip unit may contain a camera module or an imaging device. The actively bendable bending section is preferably actively bendable by a number of control wires. The actively bendable bending section of the endoscope may comprise the plurality of bending segments made of a polymer or plastic material. The plurality of bending segments may be connected by (thin) bendable hinges or hinge elements that act as (small / thin) material bridges between the bending segments. The hinges may also be made of a polymer or plastic material.The actively bendable bending section and the distal tip unit of the endoscope are preferably inserted into the protective sheath part.

[0015] The endoscope packaging system according to the present disclosure has the following advantages. The protective sheath part covers and protects the actively bendable bending section and the distal tip unit. During transport or storage of the endoscope packaging system, the protective sheath part minimizes or prevents the relative movement of the actively bendable bending section and the distal tip unit. Therefore, the protective sheath part minimizes the risk of damage to the distal tip unit, and in particular to the camera module or optical module in the distal tip unit. Furthermore, the protective sheath part prevents (unwanted) bending of the bending section. The protective sheath part keeps the bending section straight. In particular, permanent deformation of the actively bendable bending section during storage and transport can be prevented by the protective sheath part.The result is a new and undeformed endoscope despite the endoscope being stored in the packaging.

[0016] Preferably, the actively bendable bending section can have an outer circumference, and the protective sheath part can have an inner circumference. The inner circumference of the protective sheath part can be adapted in size and shape to the outer circumference of the actively bendable bending section, so that the actively bendable bending section is held straight when housed in the protective sheath part.

[0017] In other words, the shape and dimensions of the protective sheath part can be designed to accommodate the actively bendable flexure and are adapted to the (external) shape and dimensions of the flexure. The mating or adapted protective sheath part can surround the actively bendable flexure and minimize the relative movement between the protective sheath part and the flexure. The protective sheath part also keeps the actively bendable flexure straight or in a stretched (unbent) state, thus preventing or minimizing permanent deformation of the flexure or its flexure segments and / or hinges during storage and transport. The minimized relative movement of the endoscope within the protective sheath part, and in particular the distal tip unit, can lead to improved protection of the distal tip unit.The camera module or optical system in the distal tip unit can be protected by the appropriate protective cover.

[0018] According to a preferred aspect of the present disclosure, the protective sheath member may form a hole or channel for the insertion of the distal tip unit and the actively bendable flexure section. The hole or channel of the protective sheath member may be configured to accommodate both the distal tip unit and the actively bendable flexure section of the endoscope and may have an inner diameter / circumference sized and shaped to match the outer diameter / circumference of the actively bendable flexure section. In other words, the protective sheath member may comprise at least one (elongated) tubular portion or member forming the hole or channel for the insertion of the distal tip unit and the actively bendable flexure section. During packaging of the endoscope, the distal tip unit and the actively bendable flexure section may slide into the hole or channel of the protective sheath member.The hole or channel can keep the actively bendable bending section straight.

[0019] Preferably, the protective sheath part can form or include a stop configured to prevent further insertion of the distal tip unit and the actively bendable flexure section when the distal tip unit reaches the stop. During insertion of the distal tip unit and the actively bendable flexure section into the protective sheath part, the stop can stop or limit insertion in an axial insertion direction. Thus, the stop can form an end wall of the protective sheath part that limits the insertion movement of the distal tip unit. The (axial) stop can accommodate or surround the distal tip unit and protect the optical module or the camera module on the distal tip unit from damage or relative movement.

[0020] According to a preferred aspect of the present disclosure, the distal tip unit and the actively bendable bending portion may have an axial length in an axial direction of the insertion string. Furthermore, the protective sheath member may have an axial length, and the axial length of the protective sheath member may be longer than or equal to the axial length of the distal tip unit and the actively bendable bending portion, and may be shorter, in particular significantly shorter, than an axial length of the entire insertion string. Therefore, the protective sheath member may cover the combined length of the bending portion and the distal tip unit. Thus, the entire actively bending portion and the distal tip unit may be protected by the protective sheath member. The actively bending portion may be kept straight by the protective sheath member, while the distal tip unit may be protected from damage and sudden movements.However, it is not absolutely necessary to insert the entire insertion strand into the sheath member, as the bending portion may be the portion of the insertion strand most subject to undesirable deformation or bending. Therefore, in a particularly preferred aspect, the axial length of the sheath member is a maximum of 50%, preferably a maximum of 30%, and most preferably a maximum of 10% longer than the combined axial length of the distal tip unit and the actively bendable bending portion.

[0021] Preferably, the endoscope packaging system may further comprise a protective tube configured to receive and house the insertion strand of the endoscope and the protective sheath member. The protective tube may be formed as a tubular tube or hose, preferably from a transparent polymer or plastic material, and may have a distal opening and a proximal opening. At least a portion of the insertion strand of the endoscope, preferably substantially the entire insertion strand, may be inserted into the protective tube. The protective tube may protect the (portion of) the insertion strand from damage during storage and transport of the endoscope. It should be added that the protective tube is not essential to the present disclosure, since the beneficial effects of the disclosure are achieved through the cooperation of the endoscope and the protective sheath member.

[0022] If a protective tube is provided, the protective sheath part can be an insert that is inserted into the protective tube and arranged radially between the insertion strand of the endoscope and the protective tube. In other words, the protective tube can be configured to receive the protective sheath part. The protective sheath part can be inserted or pushed into the protective tube from a distal side or direction. The distal side or direction in this context can be understood as the side of the protective tube on which the distal tip unit of the endoscope is located when the endoscope is (fully) inserted into the packaging system. Thus, the protective sheath part can be inserted or pushed into the protective tube from the distal opening. An (external) size or dimension of the protective sheath part can be designed to fit within the protective tube.

[0023] After inserting the protective sheath part into the protective tube, the endoscope or the insertion string of the endoscope can be inserted into the protective tube. The actively bendable bending section and the distal tip unit can be inserted into the protective sheath part located inside the protective tube. Thus, the actively bendable bending section and the distal tip unit can be protected by the protective sheath part, while at least a portion of the insertion string, in particular a portion not protected by the protective sheath part, is protected by the protective tube.

[0024] The protective sheath member may radially surround the bending portion and the distal tip unit and form an intermediate piece or part between the bending portion and the distal tip unit on one side and the protective tube on the other side. Thus, the protective sheath member can prevent collision or abutment of the distal tip unit against the protective tube. The inner diameter of the protective tube may be larger than the outer diameter of the bending portion and the distal tip unit. In related prior art documents, a relative (radial) movement of the distal tip unit relative to the protective tube was possible. This could cause the distal tip unit to collide with an inner surface of the protective tube. The protective sheath member can prevent this movement and therefore preferably protects the optical module or the camera module in the distal tip unit from damage caused by repeated collisions with the protective tube.

[0025] The protective sheath part can close the distal opening of the protective tube after insertion. Furthermore, the protective sheath part can serve as an (axial) stop for inserting the endoscope into the protective tube and as an (axial) stop for inserting the protective sheath part into the protective tube.

[0026] Preferably, the axial length of the protective tube can be equal to or longer than the axial length of the insertion string. Thus, the entire insertion string can be arranged inside the protective tube. The protective tube can protect the insertion string from damage or unwanted bending during transport and storage. However, it is also conceivable for only a section of the insertion string to be arranged inside the protective tube.

[0027] Preferably, the protective sheath member may comprise a press-fit piece configured to form an interference fit with the protective tube. An outer diameter of the press-fit piece may be configured to fit within an inner diameter of the (tubular) protective tube. The outer diameter of the press-fit piece may be larger than the inner diameter of the (tubular) protective tube to create the interference fit between the press-fit piece and the protective tube. The press-fit piece may secure the protective sheath member in its preferred / defined position within the protective tube after insertion. Thus, the protective sheath member may be fixed in the desired position after insertion into the protective tube. The press-fit piece may preferably prevent the protective sheath member from being forced out of the protective tube upon insertion of the distal tip unit and the actively bendable flexure portion into the protective sheath member.

[0028] The press-fit piece can be designed as a (press-fit) flange that extends radially outward from a part, preferably the tubular portion or element, of the protective sheath part. The press-fit piece can also consist of a number of struts or lugs that extend radially outward from the preferably tubular part of the protective sheath part. The struts can extend in a longitudinal direction or extension of the protective sheath part and be spaced from one another in a circumferential direction. It can be advantageous to provide the press-fit piece at a distal end portion / distal end region of the protective sheath part so that the insertion of the protective sheath part into the protective tube is not unnecessarily impeded.

[0029] According to a preferred aspect of the present disclosure, the protective sheath part may comprise a guide part configured to guide the protective sheath part into the protective tube. The guide part may extend radially outward, i.e., it may be a radially outwardly extending part of the protective sheath part. An outer diameter of the guide part may be adapted to the inner diameter of the protective tube. Preferably, the outer diameter of the guide part may be smaller than the inner diameter of the protective tube. However, the diameter difference between the guide part and the protective tube may be only small enough to ensure proper insertion of the guide part without jamming. Thus, the guide part may enable smooth insertion of the protective sheath part into the protective tube and prevent twisting or jamming of the protective sheath part in the protective tube during the insertion process.

[0030] Two guide parts can be provided, in particular a distal guide part and a proximal guide part. The guide part can be formed as a tubular outer surface of the protective sheath part.

[0031] Preferably, the protective sheath member may comprise a distal plug member or element, a proximal insertion portion or element, and a tubular intermediate member or element between the distal plug member or element and the proximal insertion portion or element.

[0032] The distal plug part or element can act as an (axial) stop during insertion of the protective sheath part into the protective tube and limit the axial movement of the protective sheath part relative to the protective tube during insertion. The distal plug part or element can be formed as or comprise a radially outwardly extending (plug) flange. The outer diameter of the distal plug part or element can be substantially the same as the outer diameter of the protective tube. Therefore, the distal plug part or element may not be able to fully penetrate the protective tube. Therefore, the distal plug part or element can be positioned at least partially outside, preferably adjacent to, the protective tube, while the remainder of the protective sheath part (and preferably the distal plug part or element) can enter the protective tube.The distal plug part or element can be connected to the distal end of the protective tube and close the distal opening of the protective tube.

[0033] Theoretically, when inserting the endoscope's insertion tube into the protective tube, the distal tip unit could enter the proximal opening of the protective tube and exit the distal opening of the protective tube, especially if the protective tube is shorter than the insertion tube. This would leave the distal tip unit unprotected during storage, transport, and handling. The distal plug portion or element of the protective sheath portion can preferably also limit the possible axial movement of the distal tip unit during insertion.

[0034] The distal plug element or part can form the (plug) flange that covers one (distal) end of the protective tube. Furthermore, the distal plug element or part can have rounded portions or rounded sections on the flange portion. The rounded portions or rounded sections can provide a rounded distal end. The protective tube can have sharp edges. When covered by the flange of the distal plug element or part and its rounded portion, the sharp edges of the protective tube can be prevented from damaging a surrounding sterile barrier component.

[0035] The tubular spacer or element may be shaped as an elongated tube. An inner diameter of the tubular spacer or element may be adapted to accommodate the actively bendable flexure section and the distal tip unit. The tubular spacer or element may form the hole or channel for inserting the actively bendable flexure section and the distal tip unit.

[0036] The proximal insertion section or element can be configured to receive the actively bendable flexure section and distal tip assembly and guide them into the sheath portion. In this way, the proximal insertion section or element reduces the risk of scratching the distal tip assembly or damaging the flexure section during insertion.

[0037] Furthermore, the proximal insertion section or element can be conical or funnel-shaped to guide the distal tip unit and the actively bendable bending section of the endoscope into the sheath part. Preferably, the proximal insertion section or element can be arranged on a proximal side of the sheath part. That is, the proximal insertion section or element can be arranged on the side of the sheath part from which the distal tip unit and the actively bendable bending section are inserted.

[0038] The proximal guide part of the protective sheath part can be positioned or arranged on the proximal insertion section or element. For example, an outer surface or wall surface of the cone or funnel of the proximal insertion section or element can be shaped to function as (at least a portion of) the guide part. For example, a single part or element of the protective sheath part can be designed to function as both the guide part and the insertion section or element.

[0039] The (maximum) outer diameter of the distal plug part or element may be larger than the outer diameter of the press-fit piece. The distal plug part or element may not be configured to enter the protective tube. The press-fit piece, on the other hand, can be designed to enter the protective tube. However, the press-fit piece can only be moved within the protective tube with a certain amount of resistance. The outer diameter of the guide part can be smaller than the outer diameter of the press-fit piece. Therefore, the guide part can also be designed to penetrate the protective tube. In contrast to the press-fit piece, the guide part can be moved within the protective tube with only minimal resistance.

[0040] Furthermore, the sheath part can be an integral part comprising a distal plug section, a proximal insertion section, and a tubing adapter between the distal plug section and the proximal insertion section. Designing the sheath part as an integral component can reduce assembly effort and thus assembly costs. Low component costs can be particularly advantageous for disposable endoscopes.

[0041] Preferably, the integral protective sheath part can be manufactured using an injection molding process, particularly by injection molding. Injection molding can enable cost-effective and rapid production of integral protective sheath parts. Injection molding may be particularly preferred for large-scale production. Injection molding can result in low production costs per part and is therefore advantageous for disposable endoscopes.

[0042] In addition, the press-fit piece can be provided on the pipe adapter. Particularly when the protective sleeve is manufactured as an integral part using the injection molding process, it can be advantageous to position the press-fit piece on the pipe adapter. Preferably, the press-fit piece can be designed as a flange that extends radially outward in an axial region of the pipe adapter. The radially outwardly extending flange can be conveniently manufactured using the injection molding process.

[0043] The distal guide part can be provided on the distal plug section. The distal guide part can thus be attached to a distal section of the protective sheath part. Therefore, the distal guide part can be spaced a certain distance from the proximal guide part. The two spaced guide parts can prevent twisting or jamming of the protective sheath part during insertion into the protective tube. In the injection-molded integral protective sheath part, the distal guide part can be formed as an outer shoulder extending from the plug flange in the proximal direction.

[0044] According to a preferred aspect of the present disclosure, the protective sheath part may comprise a distal plug element, a proximal insertion element, and an intermediate tube element, wherein the distal plug element and the proximal insertion element are both attached to the intermediate tube element. Thus, the protective sheath part may be composed of multiple components, namely the distal plug element, the proximal insertion element, and the central tube element. It is possible to combine different components and thus vary the length and / or inner diameter of the protective sheath part. Therefore, the composite protective sheath part may represent a universal solution for various endoscopes.

[0045] Preferably, the press-fitting piece that creates the press fit between the protective sheath part and the protective tube can be provided on the distal plug element. In other words, the press-fitting piece can be arranged on a portion of the protective sheath part. This eliminates the need to push the press-fitting piece a long distance into the protective tube. As a result, it can be easy for a user to insert the protective sheath part into the protective tube.

[0046] Preferably, the distal plug element can be manufactured by casting, in particular by injection molding. The distal plug element can comprise a tubular receiving portion for receiving the tubular element and a plug flange extending radially outward from the receiving portion. The distal plug element can also include the interference fit. The interference fit can be formed as elongated struts / ribs extending radially outward from the receiving portion. The struts / ribs can be circumferentially spaced from each other. Therefore, the interference fit can be easily formed during manufacture of the distal plug element.

[0047] Preferably, the proximal insertion element can be manufactured by casting, in particular by injection molding. The proximal insertion element can have a tubular outer surface that forms the guide part. Thus, the proximal insertion element can combine the insertion and guide functions in a single component or element.

[0048] In addition, the tubular element can be manufactured by extrusion. Extrusion can be a cost-effective and simple method for producing tubular structures such as the tubular element.

[0049] According to a preferred aspect of the present disclosure, the distal plug element can be secured to the central tubular element by a press fit. The proximal insertion element can also be secured to the central tubular element by a press fit. Assembling the components or elements by a press fit provides a secure and cost-effective assembly process for the sheath part, as no additional connecting material such as screws or adhesives is required. Low assembly costs can be advantageous for disposable endoscopes.

[0050] According to another preferred aspect of the present disclosure, the protective sheath part may include a vent for a disinfectant gas. The vent may be configured so that the disinfectant gas can reach the distal tip unit and the actively bendable bending section housed in the protective sheath part. Before a (single) use of the endoscope, the endoscope may be disinfected. The disinfectant gas can enter the distal tip unit and the actively bendable bending section through the vent.

[0051] Preferably, the endoscope packaging system can further comprise the sterile barrier part, wherein at least the insertion tube of the endoscope, the protective sheath part, and the protective tube can be arranged within the sterile barrier part. The sterile barrier part can be formed as a semi-permeable plastic or polymer film. Preferably, the sterile barrier part can be made of high-density polyethylene (PE-HD), for example, Tyvek. The endoscope, the protective sheath part, and the protective tube can be welded together into the film. The semi-permeable plastic or polymer film of the sterile barrier part can be permeable to the disinfectant gas, but must not allow bacteria, viruses, fungi, or parasites to pass through.

[0052] Preferably, the distal tip unit can comprise the camera module / imaging device. The camera module can be damaged during transport and handling of the endoscope packaging system. In particular, repeated impact of the camera module against the protective tube during transport and handling can cause damage to the camera module. Thus, the protective sheath part can limit relative movement of the distal camera module and protect the camera module.

[0053] Preferably, the endoscope is a disposable endoscope. Disposable endoscopes are often made of a polymer or plastic material. Bent sections made of a polymer or plastic material can deform or age during storage in the endoscope packaging system. Therefore, the protective sheath part can be particularly useful for the storage and transport of such disposable endoscopes.

[0054] Preferably, the endoscope has a long and thin insertion tube. Long and thin insertion tubes can be particularly susceptible to deformation and aging during storage and transport. The actively bendable bending sections and the bending segments of long and thin insertion tubes can be particularly thin and susceptible to deformation.

[0055] The endoscope is preferably a ureteroscope or bronchoscope. Ureteroscopes or bronchoscopes can have particularly long and thin insertion tubes and correspondingly thin, actively bendable sections. Both a ureteroscope and a bronchoscope are often unidirectional endoscopes. A cholangioscope is an example of an endoscope with two bending planes and a relatively thin insertion tube. Short description of the characters

[0056] The disclosure is explained in more detail below using preferred embodiments and with reference to the attached figures. Fig. 1 shows a side view of an endoscope of an endoscope packaging system according to the present disclosure. Fig. 2 shows a perspective view of a protective sheath part of the endoscope packaging system according to a first embodiment of the present disclosure. Fig. 3 shows a perspective view of the endoscope packaging system according to the first embodiment of the present disclosure. Fig. 4 shows a perspective view of a protective sheath part of an endoscope packaging system according to a second embodiment of the present disclosure. Fig. 5 shows a perspective view of the endoscope packaging system according to the second embodiment of the present disclosure. Fig. 6 shows an exploded view of the protective sheath part of the endoscope packaging system according to the second embodiment of the present disclosure.

[0057] The figures are schematic and serve only to facilitate understanding of the disclosure. The features of the various embodiments may be interchangeable. Detailed description of the numbers

[0058] Fig. 1 shows an endoscope 2, preferably a disposable endoscope. The endoscope 2 includes a proximal endoscope handle 4 designed to be held by a user and configured to receive operating parts of the endoscope 2. The endoscope 2 also includes an insertion string 6 designed to be inserted into a patient's body cavity. The insertion string 6 includes an insertion tube 8, a bending portion 10, and a distal tip unit 12 extending in that order from the endoscope handle 4. A light-emitting device 14 and an imaging device 16 are housed within the distal tip unit 12 so that the patient's body cavity can be illuminated and inspected.The images / videos captured by the imaging device 16 can be displayed on a monitor 18, which is provided separately from the endoscope 2 and can be connected to it via a cable or wirelessly. The endoscope 2 has an internal working channel 20, accessible via an access port 22, through which a surgical tool or instrument can be guided into the patient's body cavity.

[0059] The endoscope handle 4 comprises two handwheels, namely a first handwheel 24 and a second handwheel 26, which are arranged coaxially and can be rotated by the user to bend the bending section 10 to control the distal tip unit 12. In particular, one of the handwheels 24, 26, e.g., the first handwheel 24, can be operated by the user to bend the bending section 10 into a first bending plane (e.g., in an up-and-down direction), and the other of the handwheels 24, 26, e.g., the second handwheel 26, can be operated by the user to bend the bending section 10 into a second bending plane (e.g., in a right-and-left direction). The first bending plane is preferably perpendicular to the second bending plane. Fig. The endoscope 2 shown in Figure 1 is therefore an endoscope with two bending planes. It should be understood that the endoscope 2 can often also be a bending endoscope with one plane.

[0060] The endoscope handle 4 further comprises two valves, namely a gas / water injection valve 28 and a suction valve 30. The gas / water injection valve 28 and the suction valve 30 are arranged side by side on an upper side of the housing of the endoscope handle 4.

[0061] The bending section 10 comprises a plurality of bending segments 31 connected to one another by hinges. The bending section main body with the plurality of bending segments 31 and the hinges is made of a polymeric material, in particular a thermoplastic material, and is molded, in particular injection-molded.

[0062] Fig. 2 shows a perspective view of a protective sheath part 34 of an endoscope packaging system 32 according to a first embodiment of the present disclosure. The protective sheath part 34 includes a distal plug portion 36, a proximal insertion portion 38, and a tube adapter 40. The distal plug portion 36 includes a plug flange 42 extending radially outward from the tube adapter 40. The protective sheath part 34 also includes a press-fit portion 44. The press-fit portion 44 is formed as a press-fit flange 46 extending radially outward from the tube portion 40. The proximal insertion portion 38 is conical or funnel-shaped and configured to receive the bending portion 10 and the distal tip unit 12 of the endoscope 2. The proximal insertion section 38 prevents damage or scratching of the bending section 10 and the distal tip unit 12 during insertion into the protective sheath part 34.The proximal insertion section 38 extends radially outward from the intermediate tube 40, and its outer surface or shape forms a proximal guide portion 48. A distal guide portion 50 is provided adjacent to the plug flange 42. The distal guide portion 50 is formed as a circumferential shoulder with a larger outer diameter than the intermediate tube 40. The guide portion 50 shown in FIG. Fig. The protective cover part 34 shown in Figure 2 is designed as a one-piece part and is preferably manufactured by injection molding.

[0063] Fig. 3 shows the endoscope packaging system 32. The protective sheath part 34 is inserted into a protective tube 52. The protective tube 52 is formed as a polymer tube with openings at both ends of the tube. The protective tube 52 is preferably made of a transparent material. The protective sheath part 34 is inserted into the protective tube 52 from a distal opening of the protective tube 52. The distal opening or distal side of the protective tube 52 is understood to be the side opposite the side from which the endoscope is inserted. The plug flange 42 of the distal plug portion 36 limits the (axial) insertion of the protective sheath part 34 into the protective tube 52 because its outer diameter is larger than an inner diameter of the protective tube 52. Therefore, the plug flange 42 cannot penetrate the protective tube 52. The plug flange 42 adjoins the distal end of the protective tube 52 and closes the distal opening of the protective tube 52.Preferably, the outer diameter of the plug flange 42 is the same size as the outer diameter of the protective tube 52.

[0064] The proximal guide portion 48 guides the protective sheath portion 34 into the protective tube 52. Shortly before the plug flange 42 limits the insertion of the protective sheath portion 34 into the protective tube 52, the distal guide portion 50 enters the protective tube 52. The proximal guide portion 48 and the distal guide portion 50 together form a common guide portion that prevents twisting or jamming of the protective sheath portion 34 during insertion into the protective tube 52. The outer diameter of the proximal guide portion 48 and the distal guide portion 50 is approximately the same as the inner diameter of the protective tube 52.

[0065] An outer diameter of the press-fit piece 44 is designed to form a press fit with the inner diameter of the protective tube 52. Therefore, the press-fit piece 44 offers a certain resistance during insertion and must be slid along the protective tube 52. The press-fit piece 44 fixes the protective sheath part 34 in its position within the protective tube 52.

[0066] After inserting the protective sheath part 34 into the protective tube 52, the endoscope 2 is inserted into a proximal opening of the protective tube 52. The actively bendable bending section 10 and the distal tip unit 12 of the endoscope 2 are inserted into the insertion section 38 of the protective sheath part 34. An insertion direction of the endoscope 2 is shown in Fig. 3 is schematically indicated by an arrow. The insertion of the actively bendable bending section 10 and the distal tip unit 12 is limited by the plug flange 42. The inner diameter of the tube adapter 40 keeps the actively bendable bending section 10 straight. The protective sheath part 34 has an axial length l1. The axial length l1 extends from the distal plug section 36 to the proximal insertion section 38, i.e., over the entire axial length of the protective sheath part 34. The actively bendable bending section 10 and the distal tip unit 12 have a combined axial length l2. The axial length l1 of the protective sheath part 34 is longer than the axial length l2 of the actively bendable bending section 10 and the distal tip unit 12 combined. Thus, the actively bendable bending section 10 and the distal tip unit 12 fit completely into the protective sheath part 34. The axial length l1 of the protective sheath part 34 is smaller than an axial length of the insertion strand 8.

[0067] The endoscope packaging system 32 also includes a sterile barrier part 66. The sterile barrier part 66 surrounds the protective tube 52 with the protective sheath part 34 and the endoscope 2. The sterile barrier part 66 is, for example, a semipermeable polymer film. The protective tube 52 with the inserted protective sheath part 34 and the endoscope 2 can be sealed together in the film.

[0068] The protective sheath part 34 can include a vent hole 55 through which disinfectant gas such as ETO (ethylene oxide) can flow. The vent hole 55 is provided, for example, at the distal end of the distal plug element 36. Before the (single) use of the endoscope 2, the endoscope packaging system 32 can be disinfected with the disinfectant gas. The disinfectant gas can pass through the (semi-permeable) sterile barrier part 66 and reach the actively bendable bending section 10 and the distal tip unit 12 embedded in the protective sheath part 34 through the vent hole 55. The vent hole 55 is preferably smaller than the diameter of the distal tip unit 12 so that the distal tip unit 12 does not pass through the vent hole 55 when inserted into the protective sheath part 34. Optionally, the vent hole 55 can also be provided on any other suitable part of the protective sheath part 34.

[0069] Fig. Figure 4 shows a perspective view of the protective sheath portion 34 according to a second embodiment. The protective sheath portion 34 includes a distal plug member 54, a proximal insertion member 56, and an intermediate tubular member 58. The distal plug member 54 includes a tubular receiving portion 60 configured to receive the central tubular member 58 and the plug flange 42. The plug flange 42 extends radially outward from the receiving portion 60. A series of struts 62 extend radially outward from the receiving portion 60 and form the interference fit portion 44. The struts 62 extend longitudinally along the axial direction / extension of the protective sheath portion and are spaced apart from one another in the circumferential direction of the receiving portion 60. A radially outer end of the strut 62 forms an interference fit with the inner diameter of the protective tube 52.The proximal insertion element 56 is substantially tubular and has an inner cone or funnel into which the distal tip unit 12 and the bending section 10 of the endoscope are inserted. A (tubular) outer surface of the proximal insertion element 56 forms a guide portion 64. An outer diameter of the guide portion 64 is approximately the same size as the inner diameter of the protective tube 52.

[0070] Fig. 5 shows the protective sheath part 34 in the protective tube 52. The protective sheath part 34 according to the second embodiment is inserted from the distal opening of the protective tube 52 into the protective tube 52. The guide part 64 guides the protective sheath part 34 into the protective tube 52 and prevents jamming or twisting of the protective sheath part 34 during insertion. The press-fitting piece 44 forms the press fit with the inner diameter of the protective tube 52. Since the press-fitting piece 44 is provided on the distal plug element, the press fit is established at the end of the insertion process. The plug flange 42 closes the opening of the protective tube 52 after the protective sheath part 34 is fully inserted into the protective tube 52. The proximal insertion member 56 is designed to receive the distal tip unit 12 and the bending portion 10 of the endoscope 2, which are inserted into the proximal opening of the protective tube 52.The insertion direction of the distal tip unit 12 and the actively bendable bending section 10 is shown in . Fig. 5 schematically indicated by the arrow. The protective sheath part 34 has the axial length l1. The actively bendable bending section 10 and the distal tip unit 12 have a combined axial length l2. The axial length l1 of the protective sheath part 34 is longer than or equal to the axial length l2 of the actively bendable bending section 10 and the distal tip unit 12 combined.

[0071] Fig. Figure 6 shows an exploded view of the protective sheath part 34 according to the second embodiment. The distal plug element 54 and the proximal insertion element 56 are preferably manufactured by injection molding. The press-fit part 44 is manufactured together with the distal plug element 54 in a single manufacturing step by injection molding. The middle tube element 58 is preferably manufactured by extrusion. The distal plug element 54 and the proximal insertion element 56 are connected by a press fit to the intermediate tube element 58 to form the protective sheath part 34. The distal plug element 54, the proximal insertion element 56, and the middle tube element 58 are in Fig.6 prior to assembly. The tubular receiving portion 60 is configured to receive the intermediate tubular member 58 and form an interference fit between the tubular receiving portion 60 and the intermediate tubular member 58. The proximal insertion member 56 is configured to receive the intermediate tubular member 58.

[0072] A press-fit connection is advantageous because no additional components such as screws or adhesives are required to connect the various components. Furthermore, no threads or similar positive-locking features need to be provided on the components. However, it is also conceivable to use various joining techniques such as gluing, welding, screwing, or similar to connect the distal plug element 54, the proximal insertion element 56, and the intermediate tubular element 58. List of reference symbols 1 endoscope packaging system 2 endoscope 4 Endoscope handle or interface 6 insertion strand 8 Insertion tube 10 Bending section 12 distal tip unit 14 light-emitting device 16 imaging device 18 monitors 20 working channels 22 Access sports 24 first handwheel 26 second handwheel 28 Gas / water injection valve 30 Suction valve 32 Endoscope packaging system 34 protective cover part 36 distal plug section 38 proximal insertion section 40 pipe adapter 42 Plug flange 44 Press fitting 46 Press-fit flange 48 proximal guide part 50 distal guide part 52 protective tube 54 distal plug element 55 Ventilation hole 56 proximal insertion element 58 Intermediate product pipe element 60 Receiver 62 Strut 64 Guide part 66 Sterile barrier part l1 axial length of the protective cover part l2 axial length of the bending section and the distal tip unit QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] US 2021 / 0 378 492 A1

[0007] JP 2007 075 281 A

[0008]

Claims

[1] Endoscope packaging system (1) with: an endoscope (2) comprising: an endoscope handle or interface (4); and an insertion string (6) configured to be inserted into the body cavity of a patient, and comprising an actively bendable flexure section (10) and a distal tip unit (12), wherein the actively bendable flexure section (10) comprises a plurality of flexure segments (31) made of a polymer material; and a protective sheath part (34) configured to receive at least the distal tip unit (12) and the actively bendable bending portion (10) of the insertion strand (6) of the endoscope (2), and configured to keep the bending portion (10) straight during storage and transport. [2] The endoscope packaging system (1) according to claim 1, wherein the actively bendable bending portion (10) has an outer periphery and the protective sheath part (34) has an inner periphery, and the inner periphery of the protective sheath part (34) is adapted in size and shape to the outer periphery of the actively bendable bending portion (10) so that the actively bendable bending portion (10) is kept straight when it is housed in the protective sheath part (34). [3] The endoscope packaging system (1) according to claim 1 or 2, wherein the protective sheath member (34) forms a hole or channel for inserting the distal tip unit (12) and the actively bendable bending portion (10). [4] Endoscope packaging system (1) according to one of the preceding claims 1 to 3, wherein the protective sheath part (34) forms or comprises a stop configured to prevent further insertion of the distal tip unit (12) and the actively bendable bending portion (10) when the distal tip unit (12) reaches the stop. [5] The endoscope packaging system (1) according to any one of the preceding claims 1 to 4, wherein the distal tip unit (12) and the actively bendable bending portion (10) have an axial length (l2) in an axial direction of the insertion string (6), the protective sheath part (34) has an axial length (l1), and the axial length (l1) of the protective sheath part (34) is longer than or as long as the axial length (l2) of the distal tip unit (12) and the actively bendable bending portion (10), and is shorter than an axial length of the entire insertion string (6). [6] The endoscope packaging system (1) according to any one of the preceding claims 1 to 5, further comprising a protective tube (52) configured to receive and house the insertion tube (6) of the endoscope (2) and the protective sheath member (34). [7] Endoscope packaging system (1) according to claim 6, wherein the protective sheath part (34) is an insert which is inserted into the protective tube (52) and is arranged radially between the insertion strand (6) of the endoscope (2) and the protective tube (52). [8] The endoscope packaging system (1) according to claim 6 or 7, wherein the protective sheath member (34) comprises a press-fitting piece (44) configured to form a press fit with the protective tube (52). [9] Endoscope packaging system (1) according to one of the preceding claims 6 to 8, wherein the protective sheath part (34) comprises a guide part (48, 50; 64) configured to guide the protective sheath part (34) into the protective tube (52). [10] Endoscope packaging system (1) according to one of the preceding claims 1 to 9, wherein the protective cover part (34) comprises: a distal plug portion or element (36; 54), a proximal insertion section or element (38; 56) and an intermediate tube portion or member (40; 58) between the distal plug portion or member (36; 54) and the proximal insertion portion or member (38; 56). [11] Endoscope packaging system (1) according to claim 10, wherein the proximal insertion portion or element (38; 56) is conical or funnel-shaped to guide the distal tip unit (12) and the actively bendable bending portion (10) of the endoscope (2) into the protective sheath part (34). [12] The endoscope packaging system (1) according to claim 10 or 11, wherein the press-fitting piece (44) which establishes the press fit between the protective sheath part (34) and the protective tube (52) is provided on the distal plug element. [13] Endoscope packaging system (1) according to one of the preceding claims 1 to 12, wherein the protective sheath part (34) is an integral part comprising a distal plug portion (36), a proximal insertion portion (38) and an intermediate tube portion (40) between the distal plug portion (54) and the proximal insertion portion (56). [14] The endoscope packaging system according to any one of the preceding claims 1 to 12, wherein the protective sheath member (34) comprises a distal plug member (54), a proximal insertion member (56) and a central tube member (58), the distal plug member (54) and the proximal insertion member (56) both being attached to the central tube member (58). [15] Endoscope packaging system (1) according to claim 14, wherein the distal plug element (54) and / or the proximal insertion element (56) is manufactured by molding, in particular injection molding, the middle tube element (58) is manufactured by extrusion and the distal plug element (54) and / or the proximal insertion element (56) is attached to the middle tube element (58) by a press fit.

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