Light guide or image guide components for single-use endoscopes

Abstract

To provide a unit equipped with an illumination light guide or an image guide for a single-use endoscope which enables high transmittance and high color reproduction fidelity.SOLUTION: Provided is an illumination device including at least one illumination light guide 30 and / or an image guide for transmitting electromagnetic radiation, wherein the illumination light guide or the image guide has a proximal end face for incidence or emission of the electromagnetic radiation and a distal end face for emission or incidence of the electromagnetic radiation. The proximal end face and / or the distal end face consist at least partially or in some sections of a transparent plastic part or are integrally formed thereon from a transparent plastic, wherein the transparent plastic is biocompatible and / or does not have cytotoxic properties for human or animal cell structures for an action time of less than one day. A unit which can be produced at low cost can thus be realized, in particular for a single-use endoscope 1.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a diagnostic, surgical and / or therapeutic instrument, in particular an endoscope or single-use endoscope, for introduction into a human or animal body or for ex vivo examination of human or animal blood samples or other body cells, which instrument comprises at least one illumination light guide and / or image guide for transmitting electromagnetic radiation, wherein the illumination light guide or image guide has a proximal end face for the entrance or exit of electromagnetic radiation, and a distal end face for the exit or entrance of electromagnetic radiation, respectively. [Background technology]

[0002] Diagnostic, minimally invasive, or therapeutic endoscopes are known to be of rigid or flexible construction and are well described in the literature. Single-use endoscopes, also known as "disposable endoscopes," are increasingly being used today in medical examinations, treatments, and / or minimally invasive interventions, particularly to enhance patient safety, because their single-use nature prevents contamination. While previous endoscopes were designed from a medical technology perspective to be reprocessable, i.e., washable, sterilizable, and autoclavable, there is a risk that, due to incorrect application of reprocessing or an inappropriate design of such devices, the required microbial reduction may not be achieved, resulting in the transmission of microorganisms to the patient during subsequent use. The use of such single-use endoscopes can prevent this from happening.

[0003] Another aspect of the increased use of disposable endoscopes is economic considerations. In particular, the reprocessing process, which is regularly performed after each procedure, requires high costs for the practitioner or clinic. Moreover, the high investment required for cleaning equipment, such as heat disinfectors and autoclaves and / or plasma sterilizers, provides a justification for the use of disposable endoscopes as a whole.

[0004] Further advantages result from the fact that such single-use endoscopes can be used mobile as "handheld" devices and can therefore also be used in emergency medicine, military medical units or in areas that are difficult to access, for example in disaster situations, where reprocessing is particularly not possible.

[0005] Disposable endoscopes of this type, "single-use" or "disposable endoscopes", which are described in the literature, are described, for example, in the following publications:

[0006] U.S. Patent Application Publication No. 3,581,738 discloses a single-use endoscope that includes a body made of a synthetic resin material with a generally tubular sidewall forming a speculum, and an integral, longitudinal light guide member embedded in the sidewall, the light guide member being made of a light guide material that is covered with a transparent material having a refractive index different from that of the light guide material, the body being formed by two paired halves separated axially from the endoscope, each half having an element surrounding the member.

[0007] U.S. Patent Application Publication No. 4,964,710 describes a rigid endoscope with an objective lens system, an eyepiece lens, and an intermediate relay lens. The relay lens system is a hybrid system that uses both plastic and glass components. The plastic component consists of a uniform number (N) of axially oriented lenses, each with a length on the same order as its diameter. The plastic lenses are a number (N-1) of axially oriented flat glass cylinders with polished end faces.

[0008] EP 1 890 173 A1 describes a method for manufacturing a light guide that can be used in the endoscope described above. In this method, a large number of optical fibers are bundled together and then cut at a base attached to the middle of the fiber bundle. In this way, the fiber bundle is divided into a first optical fiber bundle and a second optical fiber bundle. The division surfaces of the first and second optical fiber bundles have the same characteristics and conditions because the first and second optical fiber bundles are formed from fiber bundles obtained by bundling the same optical fibers. The first optical fiber bundle is attached to the insertion section of the endoscope, and the second optical fiber bundle is attached to a flexible tube. Thus, the first light guide is formed in the insertion section of the endoscope, and the second light guide is formed in the flexible tube. This results in separable light-transmitting sections of the light guide.

[0009] Because such endoscopes are single-use, there is a significant cost pressure, and it is therefore necessary to be able to manufacture units or components at an optimal cost. One of the main components for imaging and illumination is the illumination light guide or image guide, which is currently still assembled or processed using fairly cumbersome process steps. Often, on the one hand, complex mechanical components are combined with optical elements such as lenses, including the light guide or image guide, and on the other hand, cumbersome processing steps, such as grinding and polishing of the end faces, make current illumination light guides or image guides quite costly.

[0010] However, when using endoscopes, especially in medical technology, certain light-technical requirements must also be taken into account: not only must the light provided by the light source be delivered to the diagnostic site as loss-free as possible, but also must the diagnostic site be displayed in its true or desired color, and must unnecessary heat be avoided at the diagnostic site.

[0011] Furthermore, when using active electronic components, such as camera chips and / or lighting LEDs, the requirements regarding electrical insulation, electrical shielding and leakage current to the patient must also be taken into account, which must not exceed maximum limits depending on the application area of ​​the endoscope, i.e., for cardiac applications a maximum leakage current of 10 μA is required, which corresponds to the CF classification (see EN60601-1, 3rd edition, Table 3).

[0012] In addition to these optical and electrical requirements, attention must also be paid to the requirement for biocompatibility. Biocompatibility requires that the material is compatible with human tissue. For medical products that may come into contact with the human body, regulations require that possible interactions and unwanted side effects be identified and evaluated. The choice of tests required depends on the type and duration of contact within the human body. According to the European Medical Device Directive MDD93 / 42 EWG, such a biological impact assessment of a product is always required if there is direct contact between the material / product and the patient.

[0013] The regulations for biological testing and evaluation of raw materials are DIN EN ISO 10993 and United States Pharmacopoeia Class VI (USP Class VI) testing. Although the significantly more extensive ISO 10993 was originally intended to replace USP Class VI testing, USP testing is now used most frequently, particularly for evaluating the biocompatible properties of plastics. For this purpose, materials intended for invasive applications are evaluated for their chemical bonds and subjected to cytotoxicity tests to determine their toxic effects on living cell structures. The requirements for this are summarized in DIN EN ISO 10993, particularly in Parts 1 and 5 (DIN EN ISO 10993-1:2010-04). In the United States, this is subject to FDA requirements. The requirements corresponding to DIN EN ISO 10993 are included in USP Class VI in the United States.

[0014] A further advantage of designing the endoscope as a disposable endoscope is that the known reprocessing methods of cleaning / sterilization with strongly basic solvents and sterilization by autoclave, which is typically carried out at temperatures up to 135°C and a steam pressure of approximately 3 bar, do not have to be taken into account in this way when selecting materials, which in particular allows for a more cost-effective selection of materials. Only the RoHS Directive and REACH regulations need to be taken into account when selecting materials. Summary of the Invention [Problem to be solved by the invention]

[0015] The object of the present invention is therefore to provide an illumination light guide or an image guide, or a unit comprising an illumination light guide, an image light guide and / or a camera, for a single-use endoscope, which is particularly cost-effective to manufacture, whilst meeting the typical optical technical requirements for endoscopes in medical technology, in particular high transmittance and high color reproduction fidelity, and which is achieved in accordance with the medical technical requirements and effects, whilst at the same time achieving high biocompatibility and low cytotoxicity. [Means for solving the problem]

[0016] The object of the present invention is achieved by providing a proximal end face and / or a distal end face, at least partially or in part thereof, made of a transparent plastic material or having a transparent plastic integrally molded therein, the transparent plastic being biocompatible and / or non-cytotoxic to human or animal cellular structures for an operating time of less than one day. In this manner, an illumination light guide or image guide can be produced at extremely low cost, while otherwise time-consuming end-processing procedures, i.e., grinding and polishing of the proximal end face or distal end face, can be omitted. The biocompatible or non-cytotoxic properties of the plastic allow for invasive interventions in the body (in vivo) or for ex vivo examination of cellular structures or blood samples without damaging or altering them. Since the temperature resistance of the plastic does not need to be very high, particularly for disposable endoscopes, and thus the selection of the plastic is less restrictive, the selection of the plastic can provide an optically valuable system specifically adapted to the optical technical requirements of the endoscope. Suitable plastics are those from at least one of the following material classes: cyclic olefin copolymers, polycarbonate, polyethylene terephthalate, perfluoroalkoxy polymers, polyvinylidene fluoride, polymethyl methacrylate, polymethyl methacrylimide, acrylic styrene acrylonitrile copolymers, or plastics from at least one of the following: room-temperature crosslinkable silicones, high-temperature crosslinkable liquid silicones, epoxy casting resins or epoxy adhesives, thermally or UV-crosslinkable acrylate casting resins, polyurethane casting resins, and polyester casting resins, or mixtures and / or combinations thereof. When selecting, attention should be paid to correspondingly biocompatible variants that meet the aforementioned standard requirements. Particularly suitable here are thermoplastics that can be easily injection-molded and are transparent, such as PC, PMMA, and COC, although plastics that can be used as casting resins are also suitable.In this way, correspondingly smooth surfaces with significantly lower roughness values ​​can be achieved.Moreover, the above-mentioned plastics are available in biocompatible versions.

[0017] In particular, for the mechanical connection with other components of the endoscope, the proximal and / or distal end faces each have a mechanical interface in the form of a ferrule contour, which is made of plastic or is integrally molded into the illumination light guide or image guide by plastic injection molding, and which plastic can differ at least partially or in sections from the transparent plastic of the proximal or distal end faces in terms of material, transparency, and / or color. This can result in, for example, collars or steps, and even undercut regions, by means of which the illumination light guide or image guide can be connected to the handpiece and / or shaft of the endoscope. This can particularly allow for a locking connection that allows for quick assembly, thereby reducing production costs.

[0018] Particularly preferred is the following variant, in which the transparent plastic of the near and / or far end face has a surface roughness Ra of 1.0 μm or less, preferably 0.5 μm or less, and particularly preferably 0.1 μm or less. This minimizes scattering losses at the surface, which would otherwise result in a reduction in illumination intensity in the case of an illumination light guide, and thus achieves a sharp image of the illuminated object in the case of an image guide.

[0019] If the transparent plastic at the near or far end face has a refractive index that substantially matches the refractive index of the core material of the fiber or fiber component used in the illumination light guide or image guide, reflection losses can be minimized, which in the case of an illumination light guide results in increased illumination intensity, and in the case of an image guide, artifacts caused by reflections can be suppressed. Good results can be achieved even if the refractive index of the fiber or fiber component differs from that of the clear, transparent plastic by a maximum of ±0.1. With a maximum deviation of ±0.05, the refractive indices are already almost perfectly matched, and therefore reflection losses in the illumination light guide can be neglected. In the case of an image guide, ghost images caused by multiple reflections can be particularly eliminated.

[0020] In a preferred embodiment of the present invention, the illumination light guide and / or image guide for an endoscope includes a fiber bundle made of glass, quartz, or plastic fibers. Glass fibers are particularly suitable for transmitting light or image information from the visible spectral range to the near-infrared range. This also applies to plastic fibers, although their application length is typically limited to a few centimeters up to approximately 1 meter. Quartz fibers are particularly used when the application wavelength generally extends into the infrared range up to 2.2 μm, or when light components in the near-ultraviolet range below approximately 400 nm are also to be utilized. This is particularly important for fluorescence applications. In this case, it is particularly advantageous if the bundle or individual fibers are at least partially or in some sections surrounded by a jacket, tube, shrink tube, or mesh tube fabric, or protected by the endoscope shaft. This increases the mechanical rigidity of the system.

[0021] In this case, it is conceivable that the jacket consists of a further plastic material and is configured as an extruded cable, which can be produced particularly inexpensively in an endless process.

[0022] In particular, the aforementioned variants allow the use of less expensive, less temperature-stable plastics for both the cable and the ferrule, since thermal / chemical reprocessing processes such as autoclaving (typically in saturated steam at 130-140°C) and / or thermal disinfection processes (up to 95°C, detergent with a pH of 11) are not necessary, especially for single-use applications. Ethylene oxide fumigation or, in some cases, plasma-based gas sterilization (STERAD with hydrogen peroxide and plasma, or STERIS with hydrogen peroxide alone) are usually used to sterilize disposable devices, which can be carried out at up to 60°C.

[0023] The plastic for the extruded jacket can be made at least partially or in sections of translucent, opaque or colored plastic, so that, for example, side-emitting light guide fibers can be used to provide side illumination in the endoscope.

[0024] If the illumination light guide or image guide is made up of a flexible or semi-flexible fiber bundle and the outer jacket is configured as a rigid sheath at least partially or in some sections, this makes it possible to realize a shaft for a rigid endoscope.

[0025] The invention also relates to rigid fiber optic light or image guides, for example in the form of drawn or pressed fiber rods, which are preferably also based on the same glass systems as those used for the corresponding flexible glass fiber bundles, and in which optical elements and / or ferrules can again be cost-effectively formed at the proximal and / or distal end faces of the light guide using directly molded plastic caps.

[0026] It is particularly advantageous if the glass fiber, fiber rod, or pressed fiber rod is made of lead-free or heavy metal-free core and cladding glass. Such fiber systems provide high transmittance in the visible spectral range and, due to their relatively high transmittance, high color fidelity in the blue spectral range, which is particularly important in medical tissue diagnosis. In this case, even slight differences in tissue color often distinguish between benign and malignant tissue changes. Therefore, it is important that the entire system, consisting of the light source, illumination light guide, and imaging device, has a high CRI value. The CRI (color rendering index) is a characteristic value of a photometric quantity that describes the color rendering quality of light sources with the same correlated color temperature. The above-mentioned glass fiber, fiber rod, or pressed fiber rod can achieve a CRI value of more than 90. Such a fiber system is known by the applicant under the name SCHOTT PURAVIS® and its construction is described in DE 102012100233 and DE 102013208838. A similar fiber system is described in EP 2072477, which is also lead-free.

[0027] It is particularly advantageous for use in endoscopes if the glass fiber, fiber rod, or pressed fiber rod is made of a glass system having an acceptance angle 2α of greater than 80°, particularly preferably greater than 100°, for the light to be guided. On the one hand, the following can be achieved: In particular, the light of LEDs, which usually have a very wide emission angle, can be injected into the glass fiber, fiber rod, or pressed fiber rod without increasing the incidence loss and without the need for complex optics at the proximal end. On the other hand, a wide-angle illumination can be achieved at the distal end without the need for additional optics, which is particularly desirable for endoscopy. In this way, optimal illumination can be achieved at the currently common camera viewing angle (usually 120° obliquely).

[0028] In a particularly preferred variant, the proximal and / or distal end faces with the mechanical interface are configured as separately manufactured ferrules and are fixed to the fiber bundle or fiber rod end of the illumination light guide or image guide by adhesive, the adhesive being configured as a heat-curable or UV-curable adhesive with an optical refractive index substantially corresponding to the refractive index of the core material of the fiber or fiber component used in the illumination light guide or image guide, with a deviation from the refractive index of the core material of at most ±0.1, preferably at most ±0.05, and the refractive index of the ferrule being slightly smaller than the refractive index of the adhesive. In this way, a high coupling coefficient can be achieved. The refractive index of the ferrule being slightly smaller than the refractive index of the adhesive helps to minimize lateral radiation losses from the ferrule. Such ferrules can be manufactured inexpensively as injection-molded parts, particularly precision injection-molded parts. In this case, all functions regarding the fiber accommodation, the mechanical interface, and the formation of the surfaces for the topography of the proximal or distal end faces can be realized in the injection molding tool. The use of heat-curable or ultraviolet light-curable adhesives allows for short process times, typically in the range of less than 60 seconds, for assembling or bonding fiber components, thereby reducing manufacturing costs.

[0029] In this case, a particularly advantageous embodiment is conceivable: the ferrule has a receiving section for receiving a fiber bundle, which initially flows from a somewhat conical section into a section with substantially parallel side walls, and the ferrule further has a receiving section for an electronic component, which receiving section surrounds the receiving section for the electronic component in at least a partial area. Thus, for example, an arrangement of fibers and electronic components can be realized in which the electronic components on the proximal or distal end face are surrounded by them. Furthermore, a substantially U-shaped arrangement is conceivable, or an arrangement in which the electronic components are surrounded on both sides by two D-shaped proximal or distal end faces.

[0030] Additionally, three or four divided distal or proximal end faces are also conceivable, which surround the electronic component as a circular, elliptical, or kidney-shaped exit face. In this case, the entire function of fixing and orienting the fiber and locating the end face can be integrated into the technical design of the ferrule or implemented in the tool design. In this case, precision injection molding tools or machines are particularly advantageous due to the significantly smaller dimensions.

[0031] According to an alternative embodiment, the proximal and / or distal end faces with a mechanical interface in the form of a ferrule can be injection-molded onto a previously shortened cable section, whereby this process can be configured as a two-stage process, where in a first stage, the cable end is fixed at least at two opposing locations using a tool aligned with the cable's outer contour and overmolded at least partially or over a section with a first plastic, and in a second stage, the ferrule geometry is overmolded with a second plastic, whereby in one of these stages, the proximal and / or distal end faces can be overmolded with a clear, transparent plastic. This two-stage process can prevent the fibers from uncontrollably fanning out during the injection molding process, which typically involves pressures of several tens of bar. In the first process stage, at least one fixed collar can be formed around the cable at the cable section end, thereby preventing fanning. The plastic used for this can also be opaque or colored. Then, in a second step, the actual proximal and / or distal end faces are formed from clear, transparent plastic.

[0032] This results in a particularly low-cost process that is particularly advantageous for large quantities: in an endless process, double ferrules are molded into a pre-extruded cable at specific intervals according to the final part length, with respect to its contour, as a mechanical interface; this mechanical interface can then be separated in a subsequent process step; and the proximal and / or distal end faces of the thus-formed cable sections can be molded into them with a clear, transparent plastic using one or more further injection molding processes. This allows for almost fully automated production, which in particular allows for the provision of such light guides at extremely low costs.

[0033] According to a further alternative embodiment, the previously extruded cable or the corresponding fiber bundle section surrounded by a tube or shrink tube is divided at specific intervals according to the final component length, the fiber bundles arranged inside the extruded cable section or fiber bundle section are pressed inward, and the space between the fiber bundle end and the periphery of the jacket or the periphery of the tube or shrink tube is filled with a clear, transparent, self-leveling plastic. In this way, a light entrance or exit surface with a sufficiently smooth surface can be achieved, especially by using a casting resin.

[0034] Alternatively, it is conceivable to divide a pre-extruded cable at specific intervals or a corresponding fiber bundle section surrounded by a tube or shrink tube according to the final component length, making the cable jacket, tube, or shrink tube longer than the fiber bundle, and filling the resulting cavity with an optically clear plastic or inserting and fixing a prefabricated optically clear plastic element or a light guide rod or fiber rod made of glass or plastic into the cavity, thereby also realizing the corresponding light entrance or exit surface.

[0035] In one variant, it is conceivable that the jacket section, tube section, or shrink tube section that forms the cavity is deformed to form a specific light entrance or exit profile after the plastic has hardened or after the plastic member or light guide rod has been installed. This can be done using special tools. Various near-end or far-end profiles can thus be formed, which can be used, for example, to accommodate a camera tip or a working duct at the far end.

[0036] It would be particularly advantageous for a cost-effective and space-saving light guide design if active electronic components in the form of LEDs, sensors, or camera chips could be integrated into the integral ferrule or inserted into this ferrule via a snap-fit ​​connection. Thus, LED components can be integrated, for example, into the proximal ferrule, which allows for particularly high coupling efficiency, particularly advantageously with regard to the illumination intensity at the distal end of the light guide. In addition to white-light LEDs, RGBW LEDs, which can be switched between various colors, can also be used as LEDs. This allows for not only standard illumination of tissue, but also specific diagnostic tests in which tissue is examined at specific wavelengths. A combination of white-light or RGBW LEDs with LEDs emitting in the deep blue spectral region (e.g., 405 nm) or the near-ultraviolet region is also conceivable. This also allows for fluorescence excitation. For thermal management, a metal pin can be used to thermally couple the LED to a heat sink in the endoscope handpiece. The integration of a camera chip into the distal ferrule (chip-on-tip) allows for direct imaging of the tissue surface to be examined.

[0037] It can be advantageous if the proximal and / or distal end faces are configured as optical elements for achieving specific beam shaping, with flat, convex, concave, or topographically freely configured free-form surfaces. By configuring the tool accordingly, for example, a condenser lens can be provided at the proximal ferrule to improve light injection, thereby bundling the light of, for example, a normally rather broad-emitting LED and injecting it into the fiber according to the fiber's numerical aperture (0.55-0.70, e.g., SCHOTT PURAVIS® GOF70 with a numerical aperture of 0.57 and SCHOTT PURAVIS® GOF85 with a numerical aperture of 0.68). A convex lens can also be configured accordingly at the distal end, which can be advantageously used, for example, to realize imaging optics for a camera chip. Furthermore, a wide-angle radiation profile, e.g., with a spherical or annular radiation profile, can also be realized at the distal end of the light guide using optical elements configured in this way. A spherical radiation profile allows, for example, homogeneous illumination of a body cavity.

[0038] In one preferred variant, an additional element made of glass or plastic is provided to cover the active electronic components at the near or far end face, thereby achieving additional electrical insulation and / or electrical shielding, particularly for applications with increased insulation or leakage current requirements.

[0039] It is also possible for the distal ferrule with the camera chip to be formed as a two-component injection-molded part, with the section that accommodates the camera chip being formed from a black-colored or opaque plastic material and the distal end face being made from a transparent plastic, thereby achieving additional shielding of the camera chip from scattered light.

[0040] In connection with single-use endoscopes for medical technology, it can be particularly advantageous to use so-called hybrid cables, in which, in addition to optical light- and / or image-guiding elements, electrical conductors are also guided within the cable, so that, for example, a camera chip can be supplied with voltage or image information can be transmitted to an evaluation unit.

[0041] In one variant, an extruded cable for an illumination light guide or image guide is configured as a multi-lumen cable with various chambers, through which fiber bundles, individual quartz fibers, gas or liquid media in fluid ducts, and / or electrical conductors can be separately guided. In this case, it is particularly advantageous that multiple light- or energy-guiding components are separably and independently integrated, allowing for high functionality in a minimal space. Thus, fiber bundles can be used to guide light, and quartz fibers, for example, for transmitting energy from a laser beam. Electrical conductors can then be used to transmit image signals from a camera chip to a monitor. Such multi-lumen cables can be manufactured at significantly lower cost using appropriate extrusion tools.

[0042] In this case, it is possible to have the multi-lumen cable form the flexible section of the endoscope, or the multi-lumen cable be made of a plastic that is rigid at room temperature and thus form the rigid shaft of the endoscope, thereby making it possible to realize a flexible or rigid single-use endoscope at particularly low cost.

[0043] If the multi-lumen cable is designed to be segment-by-segment transparent or opaque during the coextrusion process, it can also fulfill, for example, a lighting or optical detection function, in which case the multi-lumen cable, at least partially or in some sections, and even in the individual lumens, can be made of electrically conductive material, for example, from a correspondingly filled plastic, and / or can be surrounded by electrically conductive material.

[0044] All of the embodiments mentioned so far are suitable for providing a correspondingly low-cost fiber optic component or fiber optic unit that can be incorporated into a flexible or rigid single-use endoscope. The generic term single-use endoscope herein encompasses all medical devices that, on the one hand, guide light into the body and, on the other hand, transmit image information to the surgeon using an optical system, an image guide, or a camera chip. Such devices can be, for example, an angioscope for flexible endoscopic examination of blood vessels, a laparoscope for rigid endoscopic examination of the abdominal cavity, and an arthroscope for joint examination, as well as an otoscope, nasal endoscope, thoracoscope, or otolaryngoscope for rigid endoscopic examination of the ear, nose, and throat.

[0045] In this case, the aforementioned variants of the illumination light guide and / or image guide can be integrated into the handpiece of the endoscope and, depending on the design of the endoscope, can in part directly form the flexible section or shaft of the endoscope, eliminating sometimes very complex grinding and polishing processes and simplifying the assembly process, with the attendant cost savings.

[0046] In particular, further uses of the illumination light guides described above in various variant embodiments are conceivable for in vitro diagnostic devices in addition to applications in the medical device field. In this case, such light guides can also be used as detector light guides. For example, multiple such illumination or detector light guides are often used in one device for parallel testing of, for example, blood samples. This offers cost advantages, whether as a result of reduced assembly effort or the incorporation of additional functions. For example, biocompatible plastic embodiments can be used directly in this case to bring blood samples or cell structures into direct contact with the illumination or detector light guide. Furthermore, the use of the aforementioned glass or quartz fibers allows spectroscopic testing and / or testing by fluorescence excitation due to their advantages in optical transmission.

[0047] Further examples of use include, inter alia, lighting light guides in household appliances (stoves, dishwashers, refrigerators / freezers, ovens, etc.) or small kitchen appliances (mixers, toasters, stoves, coffee makers, etc.), for example to indicate operating states and / or to illuminate cooking or interior spaces, especially when the lighting light guide is in contact with food, indoor ambient lighting, exterior / interior lighting of automobiles.

[0048] The present invention will now be described in detail with reference to the embodiments shown in the drawings. [Brief explanation of the drawings]

[0049] [Figure 1] FIG. 1 is a simplified schematic diagram of a single use endoscope configured as a flexible endoscope. [Figure 2] FIG. 1 is a simplified schematic diagram of a single use endoscope configured as a rigid endoscope. [Figure 3]FIG. 10 is a diagram illustrating a schematic of an illumination light guide with a distal ferrule bonded thereto. [Figure 4] 10 is a diagram schematically illustrating an illumination light guide with an integrally molded distal end ferrule; FIG. [Figure 5] 1 is a schematic diagram of an illumination light guide with a distal ferrule and an integrated camera chip. FIG. [Figure 6a] 1A-1C are diagrams showing various arrangements of the distal end face with a camera chip. [Figure 6b] 1A-1C are diagrams showing various arrangements of the distal end face with a camera chip. [Figure 6c] 1A-1C are diagrams showing various arrangements of the distal end face with a camera chip. [Figure 7] 6b shows a schematic cross section of a distal ferrule having an arrangement according to FIG. 6a; [Figure 8] 1 is a schematic diagram of an illumination light guide with a proximal ferrule and an illumination device incorporated therein. [Figure 9] 1A to 1C are diagrams showing a simplified process sequence of a method for manufacturing an illumination light guide. [Figure 10] 1A and 1B are schematic diagrams illustrating multi-lumen cables for housing various components or functions. DETAILED DESCRIPTION OF THE INVENTION

[0050] FIG. 1 shows a schematic diagram of an endoscope 1 according to the present invention. By way of example, the drawing shows a simplified, simple, flexible endoscope 1 having a handpiece 10 and a flexible section 20, which can be inserted, for example, into a body cavity. The figure also shows a schematic illumination light guide 30, which includes a proximal ferrule 40 located at an illumination device, configured as an LED 60, in the handpiece 10 and a distal ferrule 50 located at the end of the flexible section 20. Light from the LED 60 enters the end face of the proximal ferrule 40, is guided through the illumination light guide 30 to the distal ferrule 50, and can then be emitted into the body via corresponding output optics. Imaging components are not shown in FIG. 1 . These components can be, for example, multiple CMOS cameras integrated into the distal ferrule 50, which electrically transmit image information to a monitor, also not shown. Also conceivable are optical fiber image guides that transmit image information directly to a camera or to an eyepiece optics. Such image guides consist of several thousand thin individual glass fibers, each only a few microns thick, which transmit the image information pixel by pixel.

[0051] Depending on the type and application of the endoscope, the following general dimensions are contemplated for such a light guide: length 100 mm to 3000 mm, typically 500 to 1000 mm, light guide diameter 0.5 mm to 5 mm, typically 1 to 2 mm.

[0052] 2, an endoscope 1 configured as a rigid endoscope 1 is again shown very simply and diagrammatically. The illumination light guide 30 is guided here in a rigid shaft 25. As already mentioned, in this figure, imaging or image transmission components are not shown for reasons of clarity.

[0053] The following description will be given in particular of embodiments or manufacturing methods relating to the illumination light guide 30. In principle, they can also be used for image guides.

[0054] 3 shows the illumination light guide 30 in a partial view including the distal ferrule 50. The illumination light guide 30 comprises an extruded cable 31, in this case comprising a fiber bundle 32 surrounded by a material made of plastic.

[0055] In this case, the fiber bundle is terminated as follows: the jacket of the extruded cable 31 is stripped at the end, and a clear, transparent ferrule previously manufactured in an injection molding process is pressed into the exposed fiber bundle 32 at its receiving section 52 as the distal ferrule 50. The ferrule is then secured in place by a clear, transparent resin previously applied to the ferrule, preferably in the form of a rapid thermal or UV-crosslinking adhesive. The distal end face 53 of the fiber bundle 32 is thus covered with a clear, transparent plastic. This type of termination can also be used for the proximal ferrule 40 of the illumination light guide 30. In this case, the proximal end face 43 can be covered with a clear, transparent plastic.

[0056] Moreover, the proximal ferrule 40 and the distal ferrule 50 may have a mechanical interface 44, 54 resulting from the outer contours of the proximal ferrule 40 and the distal ferrule 50. This may be an annular groove, a locking protrusion, a notch, a flange, and the like.

[0057] In addition to flat end faces, the ferrules can also be configured with optical elements 51 in the form of lenses (convex or concave) or with irregularly shaped end faces for beam shaping. Fig. 3 shows only diagrammatically a distal ferrule 50 with optical element 51 in the form of a dome-shaped lens formed in an injection molding process, which can bundle the outgoing light, for example. The functionality of the input and / or output ferrules or proximal ferrules 40 and / or distal ferrules 50 can be realized in a particularly cost-effective tool design, which allows for particularly cost-effective termination of the proximal or distal end faces 43 and 53.

[0058] The fiber bundle 32 of the illumination light guide 30, or also the fiber bundle 32 of the image guide, can be made of glass fiber (GOF), quartz fiber, or plastic fiber (POF), and the fiber bundle 32 is surrounded by an extruded jacket as shown in FIG. 3, or by a tube or a mesh-tube woven fabric. The jacket plastic of the extruded cable 31 is made of an opaque, colored plastic. In further embodiments, the fiber bundle 32 itself and / or the individual fibers of the fiber bundle 32 can have, at least partially or in some sections, a conductive coating and / or the jacket plastic can be made of or be formed of, at least partially or in some sections, a conductive material.

[0059] The table below provides an overview of materials suitable for the jacket of cable 31 and for the clear, transparent cover of near-end face 43 or far-end face 53, or for near-end ferrule 40 or far-end ferrule 50.

[0060] Among thermoplastic elastomers (TPEs), the following groups are distinguished: TPE-A or TPA = Thermoplastic Copolyamide TPE-E or TPC = Thermoplastic Polyester Elastomer / Thermoplastic Copolyester TPE-O or TPO = Olefin-based thermoplastic elastomer, preferably PP / EPDM TPE-S or TPS = styrene block copolymers (SBS, SEBS, SEPS, SEEPS and MBS) TEP-U or TPU = urethane-based thermoplastic elastomer TPE-V or TPV = Thermoplastic vulcanizate, or olefin-based thermoplastic crosslinked elastomer, preferably PP / EPDM

[0061] [Table 1] [Table 2] [Table 3] [Table 4]

[0062] The plastic types TPE-E, TPE-V, and TPE-U are particularly important for extrusion molding because they have excellent extrudability and are particularly well suited for medical use. Furthermore, these materials also have relatively favorable material costs for low-cost manufacturing. Low-cost plastics, such as compounds and blends of PVC, PP, PE, and TPE-S (SEBS), are often significantly deficient in terms of temperature resistance. They generally cannot be used above 100°C. However, because the temperature requirements for single-use endoscopes are significantly lower than this, these materials are particularly suitable for use in single-use endoscopes due to their low material costs and easy processing. However, a typical minimum temperature resistance of above 133°C to 137°C, which corresponds to the autoclaving temperature range for reusable or reprocessable medical devices or components, is not required in this case. This is because the common sterilization process for disposable medical products is usually carried out only within the room temperature range up to 60° C. An example of a commonly used sterilization method is fumigation with ethylene oxide.

[0063] A group of low and moderate cost plastics are generally available in a wide range of modulus and hardness, or multiple plastic types can be blended to produce poly blends with desired performance. The advantage this has over "expensive" plastics such as FEP, PVDF, etc. is that the resulting illumination light guide 30 can be manufactured with nearly identical properties but with varying degrees of flexibility.

[0064] Although expensive plastics such as FEP, PFA and PVDF can certainly be used universally and have particularly high sustained temperature resistance, often combined with high chemical resistance, their ability to be combined with other plastics or mixed into polycompounds, for example to increase flexibility, is very limited.

[0065] All of the plastics mentioned here are already used to varying degrees in medical products.

[0066] In addition to PC and PA, COC is also very well suited as a material for transparent ferrules, since it has high optical qualities in terms of high transparency and low turbidity and is used especially for syringes and drug containers. These are also available in biocompatible versions.

[0067] With regard to forming a flat surface as the proximal end face 43 or the distal end face 53, in an advantageous embodiment, a casting resin with a particularly low viscosity and certain self-leveling properties can also be used.

[0068] As an alternative to the extrusion process, the glass fiber bundles or plastic light guides can be housed in thin-walled tubes or shrink tubing to protect them. In the case of shrink tubing, extremely thin-walled shrink tubing can be advantageously used (e.g., PET shrink tubing with a wall thickness of 6 μm). Thin-walled mesh woven tubes made of glass wool or plastic wool are also conceivable.

[0069] Glass fibers, particularly suitable for medical applications, can be composed of lead-free or heavy-metal-free core and cladding glasses, which is particularly advantageous in terms of the RoHS Directive, REACH Regulation, and medical approval. Such glass systems for producing lead-free and heavy-metal-free fibers, known by the applicant under the name SCHOTT PURAVIS®, are described, inter alia, in WO 2013 / 104748 and German Patent No. 102007063463. Lead-free and heavy-metal-free rigid optical fiber components are described in German Patent No. 102013208838. For endoscopy applications, glass fibers with high NA values, i.e., acceptance angles of 2α > 80°, preferably 2α > 100°, are particularly suitable in order to enable wide illumination on the one hand and optimal light input from LEDs on the other. Such fibers are known, for example, under the name SCHOTT PURAVIS® GOF85 or GOF120.

[0070] FIG. 4 partially illustrates an alternative approach for the illumination light guide 30 with the distal ferrule 50, which can also be done for the proximal ferrule 40.

[0071] For this purpose, as already explained in FIG. 3, the fiber bundle is, for example, pre-extruded, i.e., the fiber bundle 32 is covered with plastic to form the cable 31, shortened in length, and then, on the one hand, fed to an injection molding process in which the cable section is directly overmolded with a transparent plastic to form a ferrule, here the distal ferrule 50. To prevent the fiber ends from spreading apart, it may be necessary in a first step to grip the cable end at least at two opposite positions with a semicircular collet and at least partially overmold it. It is then conceivable to overmold the final ferrule geometry in a second injection molding process. In this way, on the one hand, a clear, transparent cover for the distal end face 53 can be formed, possibly incorporating an optical function in the form of a molded lens element (optical element 51), and, optionally, a mechanical interface 54 can be formed by another plastic type, which may be opaque. The same applies to the near-end ferrule 40, in which case these method steps make it possible on the one hand to produce a clear, transparent cover for the near-end face 43, possibly together with an integrally molded optical element 41, and also to produce the mechanical interface 44.

[0072] FIG. 5 shows a variation of the embodiment shown in FIG. 3. The illumination light guide 30, shown as an extruded cable 31 with a fiber bundle 32, is fitted with a distal ferrule 50, also shown by way of example in this figure, which has a central region in which, for example, a camera chip 70 (C-MOS chip) can be integrated. The fiber bundle 32 of the illumination light guide 30 is arranged in a circular, at least partially circular, or at least two partial strands, guided around the camera chip 70. For this purpose, the receiving region 52 for the fiber bundle 32 is correspondingly conically flared. The optical element 51 can be molded into the ferrule during its manufacture or can be attached additionally in a subsequent gluing process. In this way, on the one hand, a particularly shadow-free, optimal illumination of the tissue surface to be examined can be achieved, and on the other hand, imaging optics for the camera chip 70 can be realized. It is also conceivable to integrate a sensing element, such as a photodiode or the like, to detect specific wavelengths of light scattered from the surface to be examined.

[0073] 6a-6c show a schematic representation of a typical arrangement of the distal end face 53 of the illumination light guide 30 in relation to the camera chip 70, where in these embodiments the distal ferrule 50 terminates the shaft 25 of the endoscope 1. FIG. 6a shows an arrangement in which the camera chip 70 is substantially surrounded by the distal end face 53. FIG. 6b shows a distal end face 53 that is substantially U-shaped. FIG. 6c shows, by way of example, an arrangement in which the periphery of the camera chip 70 is surrounded on both sides by two distal end faces 53 that are D-shaped. Additionally, a distal end face 53 divided into three or four segments is also conceivable, with the camera chip 70 being surrounded by these segments forming a circular, elliptical, or kidney-shaped exit face.

[0074] This results in a correspondingly structurally predetermined geometry in the distal ferrule 50. Such a ferrule can be manufactured particularly inexpensively by injection molding.

[0075] FIG. 7 shows an exemplary cross-sectional view of the distal ferrule 50, according to the arrangement of the distal end face 53 and camera chip 70 shown in FIG. 6a.

[0076] For example, in this figure, the distal ferrule 50 is shown as the terminal end of the rigid shaft 25 of the endoscope 1, which can be formed, for example, as a stainless steel tube. In this figure, the distal end face 53 is arranged substantially annularly around the centrally located camera chip 70. Light emitted therefrom is reflected, for example, from the tissue surface 90 to be examined and captured by the camera chip 70. The camera chip 70 is covered for protection, and the cover can be configured as the optical element 51, for example, as a focusing lens. A multi-lens arrangement is also conceivable as the optical element 51. In this case, the camera chip 70 is in contact with electrical conductors 210, which are guided into the interior of the shaft 25 via through-holes 56 in the distal ferrule 50. In this case, a fiber bundle 32, consisting of several glass fibers with a high NA (acceptance angle 2α > 100°), is spread out annularly here and fixed in an annular receiving section 52 arranged around the through-hole 56. The receiving section 52 has walls that are essentially parallel to each other in this case, in order to achieve as parallel a fiber orientation as possible. Following the receiving section 52, the distal ferrule 50 has a conically shaped region to facilitate fiber threading. The fiber bundle 32 is surrounded by a protective sheath 33 inside the shaft 25, which can be an extruded jacket, a mesh tube, or a shrink tube. Since the installation space within the shaft 25 is minimal, it is particularly advantageous to use a thin-walled PET shrink tube as the protective sheath. This tube has a wall thickness of less than 10 μm. The distal ferrule 50 may optionally have an additional mechanical interface 54, for example in the form of a collar, or a diametric protrusion, as shown, at its outer contour, for connecting the distal ferrule 50 to the shaft 25. Furthermore, various adhesive regions 55 are provided for fixing the fibers of the fiber bundle 32 on the one hand and for attaching the camera chip 70 or for additionally sealing the through-hole 56 of the electrical conductor 210 on the other hand.If the entire distal ferrule 50 is made of a clear, transparent plastic, such as PC or PMMA, and an ultraviolet-curable adhesive is used as the adhesive or casting resin for the adhesive region 55, this is particularly advantageous in terms of process time and therefore costs, and in particular, to fix the fiber in the receiving section 52, an adhesive or casting resin is used whose optical refractive index is substantially matched to the refractive index of the core material of the fiber, with a deviation of this refractive index of at most ±0.1, preferably at most ±0.05, and in which case the refractive index of the ferrule is slightly smaller than the refractive index of the adhesive.

[0077] Such an embodiment with these exemplary features is of course also conceivable for the proximal ferrule 40, in which case the LED 60 can be integrated instead of the camera chip 70.

[0078] In an alternative embodiment not shown, it is also conceivable that the camera chip 70 is attached at its rear to the distal ferrule 50, with the distal face 53 forming a cover, thereby achieving improved electrical insulation without the need for an additional cover member.

[0079] In FIG. 8, the illumination light guide 30 is shown with a proximal ferrule 40, in which the LED 60 is integrated together with an LED controller unit 70. This allows for a particularly space-saving light source to be realized. The LED 60 and the LED controller unit 70 are integrated into the separately manufactured proximal ferrule 40 according to FIG. 3, with the end of the fiber bundle 32 attached or fixed in a receiving portion 42 formed in the proximal ferrule 40. In this case, a clear, transparent cover can be provided on the proximal end face 43 to allow optimal light injection into the fiber bundle 32. This cover can be configured as a condenser lens or a structure including an LED chip.

[0080] 9, a very simplified process sequence is also conceivable in an "endless" process: a pre-extruded cable 31 with a fiber bundle 32 is unwound from a reel onto a winder, the unwinding is stopped at specific intervals, and a double-layered plastic ferrule is overmolded by a first injection molding tool 100. At this point, a double ferrule is formed around the cable 31 by positive bonding without an intermediate layer, which is separated together with the cable 31 in a subsequent cutting process by a separation device 110. This can also be done immediately after the extrusion process, provided that appropriate measures are taken to match or compensate for the process speed, if necessary, for example, by providing a buffer zone for temporarily storing the extruded cable. The terminated cable section, which will later correspond to the illumination light guide 30, can then be overmolded in a further step using second and third injection molding tools 120, 130 with the final ferrule design, in this case, particularly with an optically clear, transparent plastic, so that subsequently, particularly simple entrance or exit optics (optical elements 41, 51) can also be realized at the proximal or distal end face 43, 53 of the illumination light guide 30. Alternatively, this can also be realized in a bonding process, in which case additional components, particularly C-MOS cameras or sensors, can also be attached. The advantages of this are, on the one hand, that robust ferrules can be produced, and, in particular, that fixation in the tool for the second, final overmolding process is also simplified by the formation of corresponding mechanical interfaces 44, 54. This allows for a hermetically sealed bundle termination. Thus, particularly simple illumination light guides can be realized in large quantities at significantly lower costs, which is particularly interesting in the disposable and consumer sectors.

[0081] As shown diagrammatically in FIG. 10, in one preferred embodiment, a so-called multi-lumen cable 200 can be produced. This multi-lumen cable 200 can include a fiber bundle 32, a quartz fiber 220, an electrical cable 210, and a fluid duct 230 for guiding a gas (e.g., nitrogen), water, a chemical, or a cleaning liquid. In this case, the quartz fiber 220 can be used, for example, for optical data transmission or control. Multi-lumen tubes are already known in the literature. A particular advantage in this case is the incorporation of multiple light- or energy-guiding components, which allows for high functionality in a minimal space. In particular, it is conceivable that the cable can be formed segment by segment in a coextrusion process, transparent or opaque, as desired, thereby fulfilling the role of illumination or optical detection.

[0082] Another low-cost alternative to terminations is crimped ferrules, as described in German Patent Application No. DE 102004048741. Alternatively, plastic crimps or locking sleeves can be used, which are pre-manufactured by injection molding and configured with a foldable folding hinge (here, a film hinge). These ferrules are then lockably attached to the ends of cable sections of extruded cables, after which an optically transparent adhesive can be poured or injected into the ferrules. UV-curable adhesives are also advantageous in this case. In addition to locking, it is also conceivable to fasten the ferrules to the cable by laser welding or ultrasonic welding.

[0083] Another option is the elasticity of the cable. It is conceivable to cut the extruded cable, then lengthen the cable jacket, and fill the resulting cavity with an optically opaque adhesive or to install and fasten prefabricated opaque, transparent plastic components, or light guide or fiber rods made of glass or plastic. Additionally, attachment elements can be shaped by targeted deformation of the exposed cable section. Thermoplastic elastomers (TPEs), or elastomers such as rubber or silicone, are particularly suitable as jacket materials.

[0084] A further alternative for low-cost termination of light guides is to partially heat a cable filled with gel, in order to harden the gel there, allowing the cable to be cut and, if necessary, deformed, or a ferrule to be overmolded. The cable can also be produced by coextrusion, which can have a transparent section along its axis, through which the gel can then be partially hardened in some sections by UV light, as desired. This also allows for an endless process for termination. [Explanation of symbols]

[0085] 1. Endoscope 10 Handpieces 20 Flexible Section 25 shaft 30 Light guide 31 Cable 32 Fiber bundle 33 Protective Sheath 40 Near-end ferrule 41 Optical Elements 42 Containment area 43 Proximal face 44 Mechanical interface 50 Far-end ferrule 51 Optical Elements 52 accommodation section 53 Far end face 54 Mechanical interface 55 Adhesive area 56 Through hole 60 LED 70 camera chips 80 LED controller unit 90 Tissue surface 100 first injection molding tool 110 Separation equipment 120 Second injection molding tool 130 Third injection molding tool 200 Multi-Lumen Cable 210 Electrical Conductors 220 Quartz fiber 230 Fluid Duct

Claims

1. A diagnostic, surgical and / or therapeutic instrument, in particular an endoscope (1) or disposable endoscope, for introduction into the human or animal body or for examining human or animal blood samples or other body cells ex vivo, 1. A diagnostic, surgical and / or therapeutic instrument, the instrument comprising at least one illumination light guide (30) and / or image guide for transmitting electromagnetic radiation, the illumination light guide or the image guide having a proximal end face (43) for the entrance or exit of electromagnetic radiation and a distal end face (53) for the exit or entrance of electromagnetic radiation, The proximal end surface (43) and / or the distal end surface (53) are at least partially or in part made of a transparent plastic material, or a transparent plastic is integrally molded into the proximal end surface (43) and / or the distal end surface (53), the transparent plastic is biocompatible and / or non-cytotoxic to human or animal cell structures for an action time of less than one day and is selected from the group consisting of cyclic olefin copolymers, polycarbonate, polyethylene terephthalate, perfluoroalkoxy polymers, polyvinylidene fluoride, polymethyl methacrylate, polymethyl methacrylimide, acrylic styrene acrylonitrile copolymers, or room temperature crosslinkable silicones, high temperature crosslinkable liquid silicones, epoxy casting resins or epoxy adhesives, thermally or ultraviolet crosslinkable acrylate casting resins, polyurethane casting resins, polyester casting resins, or mixtures and / or combinations thereof, diagnostic, surgical and / or therapeutic equipment;

2. the proximal end face and / or the distal end face (43, 53) of the illumination light guide (30) and / or the image guide (40) further have a mechanical interface (44, 54) in the form of a ferrule profile, the mechanical interface (44, 54) being made of plastic or being integrally molded into the illumination light guide (30) or the image guide by plastic injection molding; the plastic differs at least partially or in some sections from the transparent plastic of the proximal or distal end face in terms of material, transparency and / or color; 2. Diagnostic, surgical and / or therapeutic instrument according to claim 1.

3. The transparent plastic of the near end surface and / or the far end surface (43, 53) of the illumination light guide (30) and / or the image guide has a surface roughness Ra of 1.0 μm or less, preferably 0.5 μm or less, particularly preferably 0.1 μm or less.

3. A diagnostic, surgical and / or therapeutic instrument according to claim 1 or 2.

4. the transparent plastic of the proximal or distal end face (43, 53) of the illumination light guide (30) and / or the image guide has a refractive index that substantially corresponds to the refractive index of a core material of a fiber or fiber component used in the illumination light guide or the image guide, with a deviation from the refractive index of the core material of at most ±0.1, preferably at most ±0.05; 4. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 1 to 3.

5. The illumination light guide (30) or the image guide is made of a fiber bundle (32) made of glass fiber, quartz fiber or plastic fiber and / or a plurality of individual fibers made of the above materials, and the illumination light guide (30) or the image guide is at least partially or in a section surrounded by a jacket, a tube, a shrink tube or a mesh tube fabric or is protected by the shaft (25) of the endoscope (1).

5. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 1 to 4.

6. The jacket is made of a further plastic material and is configured as an extruded cable (31).

6. Diagnostic, surgical and / or therapeutic instrument according to claim 5.

7. the plastic for the extruded jacket is at least partially or in some sections made of translucent, opaque or colored plastic; 7. Diagnostic, surgical and / or therapeutic instrument according to claim 6.

8. The illumination light guide (30) or the image guide is made of a flexible or semi-flexible fiber bundle, and the jacket is configured as a rigid sheath at least partially or in a section.

8. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 1 to 7.

9. The illumination light guide (30) or the image guide is made of a drawn fiber rod or a pressed fiber rod to form a rigid illumination light guide (30) or image guide.

9. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 1 to 8.

10. the fiber, the fiber bundle, the fiber rod, or the pressed fiber rod is made of a lead-free or heavy metal-free core glass and cladding glass; 10. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 5 to 9.

11. the fiber, the fiber bundle, the fiber rod or the pressed fiber rod is made of a glass system having an acceptance angle 2α of greater than 80°, particularly preferably greater than 100°, for the light to be guided; 10. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 5 to 9.

12. the proximal end face and / or the distal end face (43, 53) having the mechanical interface (44, 54) are configured as separately manufactured ferrules and are fixed to the fiber bundle end or fiber rod end of the illumination light guide (30) or the image guide by adhesive or casting resin; the adhesive is configured as a heat-curable or ultraviolet light-curable adhesive, and the adhesive has an optical refractive index that substantially corresponds to the refractive index of a core material of a fiber or fiber component used in the illumination light guide or the image guide, with a deviation from the refractive index of the core material of at most ±0.1, preferably at most ±0.05; The refractive index of the ferrule is slightly smaller than the refractive index of the adhesive or the casting resin.

12. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 1 to 11.

13. The ferrule has a receiving section (42, 52) for receiving a fiber bundle (32), the receiving section (42, 52) communicating from an initially conical section to a section having side walls arranged substantially parallel to one another, and the ferrule further has a receiving section for an electronic component, the receiving section (42, 52) surrounding the area of ​​the receiving section for the electronic component in at least a partial area.

13. Diagnostic, surgical and / or therapeutic instrument according to claim 12.

14. the proximal end face and / or the distal end face (43, 53) with the mechanical interface (44, 54) in the form of a ferrule are integrally formed by injection molding onto a previously shortened cable section, The process may be configured as a two-stage process, In a first step, the cable end is fixed at at least two mutually opposite locations using a tool aligned with the outer contour of the cable and is overmolded at least partially or in a section with a first plastic; In a second step, the ferrule geometry is molded with a second plastic; In one of the steps, the proximal end surface and / or the distal end surface (43, 53) can be integrally molded with the transparent plastic.

12. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 2 to 11.

15. In an endless process, double ferrules are molded into the pre-extruded cable (31) at specific intervals according to the final part length, in relation to their contour, as mechanical interfaces (44, 54), which can then be separated in a subsequent process step, and the proximal and / or distal end faces (43, 53) can be molded into the cable sections thus formed by one or more further injection molding processes using a clear, transparent plastic.

12. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 1 to 11.

16. The extruded cable (31) is divided into sections at specific intervals or into corresponding fiber bundle sections surrounded by tubes or shrink tubes according to the final part length; The fiber bundle (32) located inside the extruded cable section or fiber bundle section is pushed inward, the space between the end of the fiber bundle and the periphery of the jacket or the periphery of the tube or the shrink tube is filled with a transparent self-leveling plastic; 12. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 1 to 11.

17. The pre-extruded cable (31) is divided into specific intervals or corresponding fiber bundle sections surrounded by a tube or shrink tube according to the final part length; The jacket portion, the tube or the shrink tube of the cable is made longer than the fiber bundle, and the cavity thus formed is filled with an optically transparent plastic, or a pre-fabricated, opaque, transparent plastic member, or a light guide rod or fiber rod made of glass or plastic is incorporated and fixed in the cavity.

12. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 1 to 11.

18. the section of the jacket, the section of the tube or the section of the shrink tube that forms the cavity is deformed to form a specific light entrance or exit profile after hardening of the plastic or after assembly of the plastic member or the light guide rod; 18. Diagnostic, surgical and / or therapeutic instrument according to claim 15 or 17.

19. the proximal or distal end face (43, 53) of the illumination light guide (30) or the image guide has a further active electronic element in the form of an LED (60), a laser diode, a sensor or a camera chip (70), which can be integrated into the ferrule as a single piece or can be plugged into the ferrule by a locking connection; 19. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 1 to 18.

20. an additional member made of glass or plastic is provided to cover the active electronic components at the near end face or the far end face (43, 53); 20. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 1 to 19.

21. The near-end surface and / or the far-end surface (43, 53) are configured as optical elements for achieving specific beam shaping, and have a flat surface, a convex surface, a concave surface, or a free-form surface configured arbitrarily in terms of topography.

21. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 1 to 20.

22. The extruded cable (31) for the illumination light guide (30) or the image guide is configured as a hybrid cable.

22. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 1 to 21.

23. The hybrid cable is configured as a multi-lumen cable (200) that allows separate guidance of fiber bundles (32), individual quartz fibers (220), a medium in the form of gas or liquid in fluid ducts (230) and / or electrical conductors (210).

23. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 1 to 22.

24. The multi-lumen cable (200) forms a flexible section (20) of the endoscope (1), or the multi-lumen cable (200) is made of a plastic that is rigid at room temperature and forms a rigid shaft (25) of the endoscope (1).

24. Diagnostic, surgical and / or therapeutic instrument according to claim 23.

25. The hybrid cable or the multi-lumen cable (200) is configured to be transparent or opaque in some sections during the co-extrusion process.

25. Diagnostic, surgical and / or therapeutic instrument according to any one of claims 22 to 24.

26. Use of an illumination light guide (30) and / or an image guide according to any one of claims 1 to 25 in a flexible or rigid single-use endoscope.

27. Use of an illumination light guide (30) according to any one of claims 1 to 25 for in vitro diagnostic equipment.

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