Light or image guide components for disposable endoscopes

Abstract

The invention relates to a diagnostic, surgical and / or therapeutic device for introduction into the human or animal body or for in vitro examination of a human or animal blood sample or other body cells, in particular to an endoscope or a disposable endoscope, comprising at least one illuminating light conductor and / or image conductor for transmitting electromagnetic radiation, wherein the illuminating light conductor or image conductor has a proximal end face for coupling in and / or out coupling out of electromagnetic radiation and a distal end face for coupling out and / or in coupling in of electromagnetic radiation, respectively. The proximal and / or distal end face consists of an at least partially or sectionally transparent plastic element or is molded thereon with a transparent plastic, wherein the transparent plastic is biocompatible and / or has no toxicity to human or animal cell cultures within an action time of less than one day. Thus, a component for a disposable endoscope can be produced at low cost.

Description

Technical Field

[0001] The present invention relates to a diagnostic, surgical and / or therapeutic device, in particular an endoscope or a disposable endoscope, for introduction into the human or animal body or for in vitro examination of human or animal blood samples or other body cells, comprising at least one illumination light conductor and / or image conductor for transmitting electromagnetic radiation, wherein the illumination light conductor or image conductor has a proximal end face for coupling in and / or out coupling out of the electromagnetic radiation and a distal end face for coupling in and / or out coupling out of the electromagnetic radiation. Background Art

[0002] As is known, endoscopes for diagnosis, minimally invasive intervention or treatment are of rigid or flexible design and have been fully described in the literature. Today, disposable endoscopes (or also called disposable endoscopes, disposable Endoscopes) are increasingly used, in order to improve patient safety, especially in medical examinations, treatments and / or minimally invasive interventions, where contamination is prevented by the disposable use. Nevertheless, endoscopes to date have been conceived to be disposable in the sense of medical technology, i.e., cleanable, sterilizable and in particular autoclave-sterilizable.

[0003] However, due to incorrect handling or inconvenient design of such devices, it may occasionally happen that the required reduction in the number of bacteria is not achieved and thus bacteria may be transferred to the patient at the next use. This can be prevented by using such a disposable endoscope.

[0004] Another aspect of the increased use of disposable endoscopes is also economic considerations. In particular, the treatment process, which is carried out according to regulations and regularly after each operation, also requires high costs in the practitioner or clinic. In addition, high investments in purification equipment (such as thermal disinfection devices and high-pressure disinfection equipment and / or plasma disinfection equipment) are required, so it is generally more cost-effective to use such disposable endoscopes.

[0005] Another advantage is that such a disposable endoscope can be used flexibly as a "handheld" device and can therefore also be used in emergency medicine, military health applications or in difficult-to-reach areas, such as disaster relief missions, where no handling options are available.

[0006] Such disposable endoscopes, also called "single-use" endoscopes or "disposable endoscopes" as described in the literature, have been described, for example, in the following documents:

[0007] Document US 3581738 A1 discloses a disposable endoscope, which includes a main body made of a synthetic resin material, the main body having a basically tubular side wall constituting a dilator and a uniform elongated light-guiding element embedded in the side wall, wherein the element is composed of a light-guiding material coated with a transparent material having a refractive index different from that of the light-guiding material, wherein the main body is composed of two paired halves separated from the endoscope in the axial direction, wherein each half has an element-encapsulating element.

[0008] A rigid endoscope is described in document US 4964710 A1, which is equipped with an objective lens system, an eyepiece and an intermediate relay lens. The relay system is a hybrid system using plastic elements and glass elements. The plastic element consists of an even number (N) of axially oriented lenses, each of which has a length in the same order of magnitude as its diameter. The plastic lens is a plurality of (N-1) axially oriented glass flat cylinders whose end faces are polished.

[0009] Document EP 1890173 A1 describes a method for manufacturing a light conductor, which can be used in such endoscopes. Here, a plurality of optical fibers are bundled and then the fiber bundle is separated at a part of a die mouth fixed to the middle part of the fiber bundle. Thus, the fiber bundle is divided into a first optical fiber bundle and a second optical fiber bundle. The separation surfaces of the first and second optical fiber bundles have the same characteristics and conditions, because the first and second optical fiber bundles are composed of fiber bundles obtained by bundling the same optical fibers. The first optical fiber bundle is installed in the introduction section of the endoscope and the second optical fiber bundle is installed in a flexible tube, whereby the first light conductor is formed in the introduction section of the endoscope and the second light conductor is formed in the flexible tube. Thus, a separable light transmission section of the light conductor is produced.

[0010] Since such endoscopes are expensive due to their single use, the individual components and parts must be produced in a cost-optimized manner. The main components for imaging and illumination include the illumination light conductor or image conductor. The assembly and processing steps of these components are still relatively complex at present. Due to the complex mechanical components, which are partly combined with the optical elements (e.g. lenses) that form the light conductor or image conductor, and partly involve complex processing steps, such as grinding and polishing of the end faces, the current illumination light conductors or image conductors are relatively expensive.

[0011] On the other hand, however, certain optical requirements in the use of endoscopes, especially in medical technology, must also be taken into account. In addition to providing the light provided by the light source to the examination site as losslessly as possible and displaying the examination site in color-true or targeted colors, the introduction of unnecessary heat into the examination site must also be prevented.

[0012] In addition, when using active electronic components (e.g. camera chips and / or LEDs for illumination), requirements must also be taken into account with regard to electrical insulation, electrical shielding, and patient leakage currents, which must not exceed maximum limit values ​​depending on the area of ​​use of the endoscope. Thus, for example, when used in the heart, a maximum leakage current of 10 μA is required, which corresponds to the CF class (see EN 60601-1, 3rd edition, Table 3).

[0013] In addition to these optical and electrical requirements, the requirements in terms of biocompatibility must also be taken into account. For biocompatibility, it must be ensured that the material is compatible with human organs. For medical products that may come into contact with the human body, regulations require that possible interactions and undesirable side effects be determined and evaluated. The selection of the required tests is derived from the type and duration of contact in the human body. In accordance with the European regulatory guide MDD 93 / 42EWG for medical products, a biological evaluation of the product is always required when the material / product is in direct contact with the patient.

[0014] The main regulations for biological research and evaluation of materials are DIN EN ISO 10993 and tests according to the United States Pharmacopoeia Class VI (USP Class VI). Although the significantly wider ISO 10993 was originally supposed to replace the tests according to USP Class VI, the USP test is now particularly commonly used to evaluate biocompatible plastics. For this reason, materials that are set for traumatic applications are evaluated on the one hand in terms of their compounds and on the other hand are subjected to cytotoxicity tests, in which possible toxic effects are studied on living cell cultures. Its requirements are summarized in DIN EN ISO 10993, especially in Parts 1 and 5 (DIN EN ISO 10993-1:2010-04). In the United States, materials are subject to FDA requirements. There, the requirements corresponding to DIN EN ISO 10993 are recorded in USP Class VI.

[0015] Furthermore, the design of the endoscope as a disposable endoscope is advantageous in that the known cleaning / disinfection methods with strongly alkaline solutions and sterilization by autoclaving at temperatures of up to 135° C. and a typical steam pressure of about 3 bar do not have to be taken into account to such an extent when selecting the materials, which in particular also allows the selection of cost-effective materials. Only the RoHS (Restriction of Hazardous Substances) and REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulations need to be taken into account in the materials. Summary of the invention

[0016] The object of the present invention is therefore to provide an illumination light conductor or image conductor for a disposable endoscope or an assembly having an illumination light conductor, an image conductor and / or a camera which is particularly cost-effective to produce and which also achieves the typical optical requirements of endoscopes in medical technology, in particular high transmittance and high color reproducibility. This should be combined with high biocompatibility and low cytotoxicity in order to meet medical requirements and effects.

[0017] The object of the invention is achieved in that the proximal and / or distal end face is at least partially or sectionally made of a transparent plastic element or a transparent plastic is molded thereon, wherein the transparent plastic is biocompatible and / or non-toxic to human or animal cell cultures for an action time of less than one day. Thus, the illumination light conductor or image conductor can be produced in a cost-effective manner, in which complex end processing, i.e. grinding and polishing of the proximal or distal end face can be omitted. The plastic has biocompatible and non-toxic properties, so that invasive interventions can be carried out in the body (in vivo) or cell cultures or blood samples can be examined in vitro without damaging or changing them. By appropriately selecting the plastic, a high-quality optical system can be provided that meets the optical technical requirements of the endoscope, especially because in the case of disposable endoscopes, the temperature resistance of the plastic only needs to be slightly higher, which limits the range of choices less. Suitable plastics are plastics selected from at least one of the following material categories: cycloolefin copolymers, polycarbonate, polyethylene terephthalate, perfluoroalkoxy polymers, polyvinylidene fluoride, polymethyl methacrylate, polymethacrylimide, acrylic acid-styrene-acrylonitrile copolymers or room temperature crosslinked silicones, heat crosslinked liquid silicones, epoxy casting resins or adhesives, heat crosslinked or UV crosslinked acrylate casting resins, polyurethane casting resins, polyester casting resins or mixtures and / or combinations thereof. When selecting, attention must be paid to ensure that there are corresponding biocompatibility variants to meet the above-mentioned standard requirements. In this respect, especially suitable materials are thermoplastic materials that are easy to injection molding and transparent, such as PC, PMMA, COC etc., but can also be plastics that can be used as casting resins. This means that it is allowed to realize the corresponding smooth surface with very low roughness value. In addition, the above-mentioned plastics have biocompatibility.

[0018] In particular, for the mechanical connection to other components of the endoscope, it is conceivable that the proximal and / or distal end face also has a mechanical interface in the form of a sleeve profile, which is made of plastic or injection-molded onto the illumination light conductor or image conductor, which plastic can differ at least partially or in sections from the transparent plastic of the proximal or distal end face in terms of its material, transparency and / or color. For example, a collar or a shoulder and also an undercut region can be produced in this way, with which the illumination light conductor or image conductor can be connected to the handpiece and / or the shaft of the endoscope. In addition, a snap-on connection can be achieved in this way, which in particular allows for rapid assembly and thus helps to reduce manufacturing costs.

[0019] In a particularly preferred embodiment variant, the typical surface roughness of the transparent plastic of the proximal and / or distal end face is Ra ≤ 1.0 μm, preferably ≤ 0.5 μm, most preferably ≤ 0.1 μm. This minimizes scattering losses on the surface, which would otherwise lead to a reduction in the illumination when illuminating the light conductor. With the image conductor, a sharp image of the illuminated object can thus be obtained.

[0020] The refractive index of the transparent plastic of the proximal or distal end face is substantially matched to the refractive index of the fiber or fiber component used in the core material of the illumination light conductor or image conductor, so that reflection losses are minimized, thereby increasing the illumination in the case of illumination light conductors and suppressing reflection-induced artifacts in the case of image conductors. Good results can be achieved if the difference in refractive index between the fiber or fiber component and the clear transparent plastic is maximum ±0.1. In the case of deviations of maximum ±0.05, the refractive index is almost completely matched, so that reflection losses in the illumination light conductor are negligible. In the case of image conductors, this can eliminate ghost images caused by multiple reflections.

[0021] In a preferred embodiment of the invention, the illumination light conductor and / or image conductor for the endoscope comprises a fiber bundle made of glass optical fibers, quartz optical fibers or plastic optical fibers. Glass optical fibers are particularly suitable for transmitting light or image information in the visible spectral range to the near IR range. This also applies to plastic fibers, but the application length of plastic fibers is usually limited to a few centimeters to a maximum of about 1 meter. Quartz fibers are used in particular when the application wavelength extends into the IR range of typically 2.2 μm or when light components in the near UV range below about 400 nm are to be used. This is of particular interest in fluorescence applications. It is particularly advantageous if the bundle or the individual fibers are at least partially or sectionally surrounded by a sheath, tube, shrink tube or mesh tube, or if they are protected by the shaft of the endoscope. This increases the mechanical strength of the system.

[0022] It is conceivable that the sheath is made of another plastic material and is in the form of an extruded cable. Such a cable can be produced in an endless process in a particularly cost-effective manner.

[0023] In particular, inexpensive, low-temperature-stable plastics can be used for the cables and sleeves in the above-described embodiment variants, since single-use applications do not require thermal and / or chemical preparation treatments, such as autoclaving (usually 130 to 140° C. in saturated steam) and / or thermal disinfection (to 95° C., pH 11 decontamination agents). Disposable instruments are usually sterilized using ethylene oxide fumigation or partial plasma-based gas sterilization (STERAD, with hydrogen peroxide and plasma; or STERIS, with hydrogen peroxide alone), which is carried out at a temperature of maximum 60° C.

[0024] The plastic used for the extruded sheath may include a plastic that is at least partially or sectionally translucent, opaque or colored. For example, this allows the use of side-emitting optical fibers to provide side illumination of the endoscope.

[0025] If the illumination light conductor or the image conductor comprises a flexible or semi-flexible fiber bundle and the sheath comprises an at least partially or sectionally rigid covering, a shaft for a rigid endoscope can thereby be realized.

[0026] The invention also relates to rigid optical fiber light guides or image guides, for example in the form of drawn fiber rods or pressed fiber rods, which are advantageously based on the same glass system as the corresponding flexible glass fiber bundles. Here, the optical element and / or the sleeve can also be formed cost-effectively with a plastic cover molded directly on the proximal and / or distal end of the light guide.

[0027] It is particularly advantageous if the glass fibers, fiber rods or pressed fiber rods consist of lead-free or heavy metal-free core glass and cladding glass. Such a fiber system provides high transmittance in particular in the VIS spectral range and, due to the relatively high transmittance in the blue spectral range, exhibits high color fidelity, which is particularly important for the medical evaluation of tissues. Often, only slight color differences in tissues determine whether they are benign or malignant tissue changes. Therefore, it is very important for the entire system, including light source, illumination light conductor and imaging device, to have a high CRI value, wherein the CRI (Color Rendering Index) is a key indicator of the photometric parameter, which describes the color rendering quality of light sources with the same correlated color temperature. Using the above-mentioned glass fibers, fiber rods or pressed fiber rods, CRI values ​​of >90 can be achieved. It is known that according to the applicant's invention under the name SCHOTT These fiber systems and their compositions have been described in DE 102012100233 B4 and DE 102013208838 B4. Similar fiber systems that are also lead-free are further described in EP 2072477 B1.

[0028] Particularly for use in endoscopes, it is advantageous if the glass fiber, fiber rod or pressed fiber rod is made of a glass system which has an acceptance angle 2α for the light to be guided of greater than 80°, most preferably greater than 100°. This allows, on the one hand, the light of LEDs, which usually have very wide emission angles, to be injected into the glass fiber or fiber rod or pressed fiber rod without increasing coupling losses and without requiring complex optics at the proximal end. On the other hand, wide-angle illumination can be achieved at the distal end without requiring additional optics, which is particularly preferred for endoscopic examinations. This allows optimized illumination at currently common camera viewing angles (usually 120° diagonal).

[0029] In the most preferred embodiment variant, it is conceivable that the distal and / or proximal end face with the mechanical interface is in the form of a sleeve, which is produced separately and fixed to the fiber bundle end or fiber rod end of the illumination light conductor or image conductor by means of an adhesive, wherein the adhesive is in the form of a heat-curing or UV-curing adhesive, whose optical refractive index is substantially matched to the optical refractive index of the core material consisting of the fiber or fiber component used in the illumination light conductor or image conductor, with a maximum deviation of ±0.1, preferably a maximum of ±0.05, and wherein the refractive index of the sleeve is slightly lower than the refractive index of the adhesive. In this way, a high coupling efficiency can be achieved. Compared with the adhesive, the slightly lower refractive index of the sleeve helps to minimize the radiation losses through the side of the sleeve. Such a sleeve can be produced as an injection molded part at low cost, in particular as a precision injection molded part. The complete function of accommodating the fibers, providing the mechanical interface and defining the proximal and distal end faces according to the morphology of the proximal and distal end faces can be implemented in an injection molding tool. By using heat-curing or UV light-curing adhesives, short processing times for the assembly or gluing of the fiber components, typically in the range of approximately less than 60 seconds, can be achieved, which can further reduce production costs.

[0030] According to a particularly advantageous embodiment, it is conceivable that the sleeve has a receiving section for accommodating a fiber bundle, which flows from a first slightly tapered section into a section with substantially parallel side walls, and the sleeve also has a receiving portion for an electronic component, and the above-mentioned receiving section at least partially surrounds the receiving portion for the electronic component. This can realize, for example, an arrangement of fibers and electronic components, in which the electronic component is surrounded by a proximal or distal end face. In addition, it is conceivable to have a substantially U-shaped arrangement, or an arrangement in which the electronic component is surrounded by two D-shaped distal or proximal end faces opposite to each other. In addition, it is conceivable to have a three-piece or four-piece distal or proximal end face, which surrounds the electronic component in the form of a circular or elliptical or kidney-shaped outlet face. The complete function of the arrangement of the fiber fixing and orientation and the end face can be integrated into the technical design of the sleeve and implemented in the tool design. Due to the very small size, a precision injection molding tool or machine is particularly advantageous here.

[0031] In an alternative embodiment variant, it is conceivable that the distal and / or proximal end face with the mechanical interface in the form of a sleeve is molded on a cable segment previously cut to length by means of injection molding, wherein the process can be implemented in two stages, wherein in a first step the cable end is fixed at at least two opposite points by means of a tool adapted to the outer contour of the cable and is at least partially or sectionally injection molded with a first plastic, and in a second step the sleeve geometry is molded by means of a second plastic, wherein in one of these steps the distal and / or proximal end face can be formed with a clear transparent plastic. The two-stage process can prevent the fibers from unravelling in an uncontrolled manner during the injection molding process, which generally involves pressures of several tens of bars. With the first step, at least one type of firm collar can be produced at the end of the cable segment around the cable, which collar prevents unravelling. For this purpose, opaque or colored plastics can also be used. In a second step, the actual proximal and / or distal end face is then produced using a clear transparent plastic.

[0032] In particular for large quantities, a particularly cost-effective process is advantageous if, in an endless process, a double-profile sleeve is molded onto the previously extruded cable at specific intervals according to the final component length to form a mechanical interface which can be separated in the next process step and the proximal and / or distal end faces can be molded onto the cable sections produced in this way using one or more further injection molding processes with clear transparent plastic. This makes it possible to achieve almost completely automated production and, in particular, to provide such optical waveguides in a very cost-effective manner.

[0033] In another alternative embodiment, it is conceivable that the previously extruded cable or the corresponding fiber bundle section surrounded by the tube or shrink tube is separated at specific intervals according to the final component length, and the fiber bundles present inside the extruded cable section or fiber bundle section are offset inwards, and the space between the fiber bundle end and the edge of the sheath or between the edge of the tube or shrink tube is filled with a clear and transparent self-leveling plastic. In particular, the casting resin is suitable for forming a light entrance face or light exit face with a sufficiently smooth surface.

[0034] Optionally, it can be provided that the previously extruded cable or the corresponding fiber bundle sections surrounded by a tube or shrink tube are separated at specific intervals according to the length of the final component, and the cable sheath, tube or shrink tube is stretched relative to the fiber bundle, and the formed cavity is filled with optically transparent plastic, or a prefabricated clear transparent plastic part or a light guide rod or fiber rod made of glass or plastic is inserted and fixed in the cavity. In this way, the corresponding light entrance surface or light exit surface can be realized.

[0035] In a variant embodiment, it can also be provided that the sheath section, tube or shrink tube section forming the cavity is deformed and forms a specific light entry profile or light exit profile after the plastic is cured or after the plastic part or light guide rod is inserted. This can be done using special tools. Thus, different proximal and / or distal profiles can be produced, which can be used, for example, to accommodate a camera chip or an operating channel at the distal end.

[0036] In addition, for the low-cost and space-saving fiber design, it is particularly advantageous that active electronic components in the form of LEDs, sensors or camera chips can be integrated into the molded sleeve, or can be assembled to the molded sleeve by snap-on connection. For example, LED elements can be integrated into the proximal sleeve and achieve particularly high coupling efficiency, which is particularly evident in the illumination of the distal end of the optical conductor. In addition to white light LEDs, RGBW-LEDs that can switch between different colors can also be used. In addition to the conventional inspection of tissues, this also provides a specific diagnostic inspection, in which tissues are inspected at a specific wavelength. It is also conceivable that white light LEDs or RGBW-LEDs are combined with LEDs that emit light in the deep blue spectral range (for example, at 405nm) or in the near UV range. This can even achieve fluorescence excitation. Regarding thermal management, it is conceivable that the LED is thermally connected to the heat sink in the handheld portion of the endoscope by a metal pin. The camera chip is integrated in the distal sleeve (chip on the tip, Chip on Tip) and can directly image the tissue surface to be inspected.

[0037] It may be advantageous for the proximal and / or distal end faces to be in the form of optical elements to achieve a specific beam shaping and thus have a flat, convex, concave surface or a free-form surface of any desired topography. For example, by appropriate tool design, the proximal sleeve may be formed to include a focusing lens for better injection of light, for example to bunch the light of a typically wide-emitting LED, so that the optical fiber has a numerical aperture (between 0.55 and 0.70; for example, The numerical aperture is 0.5, The light beam is coupled into the optical fiber using a convex lens (with a numerical aperture of 0.68). A corresponding convex lens formed at the distal end can also be used advantageously, for example, to realize imaging optics for a camera chip. In addition, a wide-angle emission characteristic, such as a spherical or annular emission characteristic, can be provided at the distal end of an optical fiber with an optical element formed in this way. For example, a uniform illumination of a body cavity can be implemented with a spherical emission characteristic.

[0038] In a preferred embodiment variant, an additional glass or plastic component is provided on the proximal or distal end face for covering the active electronic components, thereby achieving additional electrical insulation and / or shielding, which can be particularly suitable for applications with higher insulation or leakage current requirements.

[0039] Furthermore, it is conceivable that the distal sleeve with the camera chip is formed as a two-part injection molded part, wherein the section accommodating the camera chip is made of black or opaque plastic material and the distal end face is made of transparent plastic material. This can additionally protect the camera chip from stray light.

[0040] In conjunction with disposable endoscopes for medical technology, it is particularly advantageous to use a so-called hybrid cable in a single cable, in which, in addition to the optical light-guiding and / or image-guiding elements, electrical conductors can also be routed through the hybrid cable. This makes it possible, for example, to supply power to a camera chip and transmit image information to an evaluation unit.

[0041] In a variant embodiment, the extruded cable for the illumination light conductor or the image conductor can be in the form of a multi-cavity cable with different cavities, with which fiber bundles, individual quartz fibers, media in the form of gas or fluid in the fluid channel and / or wires can be arranged separately. It is particularly advantageous here that the optical transmission components or the power-carrying components can be integrated separately, which achieves multifunctionality in a very limited space. The fiber bundle can be used to guide the light, and the quartz fibers can be used, for example, to transmit the energy of a laser beam. The wires can be used to forward the image signal from the camera chip to the monitor. Such a multi-cavity cable can be produced very cost-effectively by suitable extrusion tools.

[0042] It can be provided that the multi-lumen cable forms the flexible section of the endoscope, or the multi-lumen cable can be made of a plastic material that is rigid at room temperature and thus forms the rigid shaft of the endoscope. Thus, a flexible or rigid disposable endoscope can be provided particularly cost-effectively.

[0043] If the multi-lumen cable is embodied as transparent or opaque in a targeted manner in sections during the coextrusion process, this even allows, for example, lighting or optical detection tasks to be performed. The multi-lumen cable can be made at least partially or in sections (also in individual lumens) of an electrically conductive material, for example of a correspondingly filled plastic, and / or can be surrounded by an electrically conductive material.

[0044] All the examples given above are applicable to providing corresponding low-cost fiber optic components or assemblies that can be installed in flexible or rigid disposable endoscopes. Here, the general term "disposable endoscope" is intended to cover any medical device with which it is possible to introduce light into the human body on the one hand and output image information to the surgeon via optics, image conductors or camera chips on the other hand. This can be an angioscope with a flexible endoscope for vascular examination, a laparoscope for abdominal examination, and an arthroscope with a rigid endoscope for joint examination, and an ear endoscope, a nasal endoscope, a sinus endoscope or a nasopharyngeal endoscope, respectively, with a rigid endoscope for otolaryngology examination.

[0045] Depending on the design of the endoscope, the above-described embodiment variants of the illumination light conductor and / or image conductor can be integrated in the handpiece of the endoscope and can be partially directly configured as a flexible part or shaft of the endoscope. Costs can thus be saved by eliminating some of the very complex grinding and polishing processes and by simplifying the assembly itself.

[0046] As described above in various embodiment variants, the illumination light conductor is used in addition to the field of medical devices, in particular also for in vitro diagnostic devices. For this reason, such a light conductor can also be used as a detector light conductor. For example, a large number of such illumination or detector light conductors are often used in a single device for parallel testing of blood samples, for example. In particular, cost advantages should be mentioned here, whether due to reduced assembly costs or due to the integration of additional functions. Plastics with biocompatibility can be used directly here, for example, to bring blood samples or cell cultures into direct contact with the illumination or detector light conductor. In addition, the above-mentioned glass optical fibers or quartz optical fibers can be used for spectral examinations and / or for examinations using fluorescence excitation due to their advantages in light transmission.

[0047] Further application examples include, in particular: lighting photoconductors in household appliances (cookers, dishwashers, refrigerators, freezers, cooking ovens, etc.) or small kitchen appliances (blenders, toasters, tabletop cooking appliances, coffee machines, etc.) (e.g. for indicating operating conditions and / or for illuminating cooking chambers or interiors, in particular when they come into contact with food); household lighting; automotive exterior / interior lighting. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The invention will now be explained in more detail with reference to exemplary embodiments shown in the accompanying drawings, in which:

[0049] Figure 1 A highly simplified schematic diagram of a disposable endoscope in the form of a flexible endoscope is shown;

[0050] Figure 2 A highly simplified schematic diagram of a disposable endoscope in the form of a rigid endoscope is shown;

[0051] Figure 3 A schematic diagram of an illumination light conductor having a distal sleeve bonded with an adhesive is shown;

[0052] Figure 4 A schematic diagram of an illumination light conductor having a molded distal sleeve is shown;

[0053] Figure 5 shows a schematic diagram of an illumination light guide with a distal sleeve and an integrated camera chip;

[0054] Figures 6a to 6c Schematic diagrams showing different arrangements of the distal end surface with the camera chip;

[0055] Figure 7 Shows that according to Figure 6a A schematic cross-sectional view of a sleeve distal to the arrangement of;

[0056] Figure 8 A schematic diagram of an illumination light conductor with a proximal sleeve and an illumination device integrated therein is shown;

[0057] Fig. 9 A highly simplified process sequence of a method of manufacturing an illumination light conductor is shown; and

[0058] Fig.10 A schematic diagram of a multi-lumen cable for accommodating different components or functional parts is shown. DETAILED DESCRIPTION

[0059] Figure 1The construction of an endoscope 1 according to the invention is shown schematically. A simple flexible endoscope 1 is shown here in a highly simplified manner by way of example, and comprises a handle 10 and a flexible section 20, which can be inserted into a body cavity, for example. An illumination light conductor 30 is shown schematically here, which has a proximal sleeve 40 adjacent to an illumination device in the form of an LED 60 in the handle 10, and a distal sleeve 50 located at the end of the flexible section 20. The light of the LED 60 is coupled into the end face of the proximal sleeve 40, guided to the distal sleeve 50 via the illumination light conductor 30, and can then be emitted into the interior of the human body via suitable decoupling optics. Figure 1 The imaging component is not shown. This imaging component can be, for example, a C-MOS camera, which is integrated in the distal sleeve 50 and transmits the image information electrically to a monitor (not shown). Also conceivable is a fiber optic image conductor, which transmits the image information to the camera or directly to the eyepiece. Such an image conductor consists of thousands of tiny individual glass fibers, which are only a few micrometers thick, and which transmit the image information pixel by pixel.

[0060] Depending on the type and application of the endoscope, the following typical dimensions are conceivable for such light guides: length between 100 mm and 3000 mm, typically 500 to 1000 mm, light guide diameter between 0.5 mm and 5 mm, typically 1-2 mm.

[0061] Figure 2 The endoscope 1 is again schematically shown in a highly simplified manner in the form of a rigid endoscope 1. Here, the illumination light conductor 30 is guided inside the rigid shaft 25. For the sake of clarity, the imaging components or image transmission components as described above are also not shown here.

[0062] In the following, in particular, exemplary embodiments or production methods will be described which primarily relate to the illumination light conductor 30. In principle, these can also be transferred to the image conductor.

[0063] exist Figure 3 2 shows a partial view of an illumination light conductor 30 with a distal sleeve 50. In this case, the illumination light conductor 30 is produced from an extruded cable 31, wherein a sheath made of plastic surrounds a fiber bundle 32.

[0064] In this case, the fiber bundle is terminated in such a way that the sheath of the extruded cable 31 is stripped of insulation at the end and a clear sleeve previously produced in an injection molding process is fitted as a distal sleeve 50 with a receiving section 52 onto the exposed fiber bundle 32 and the sleeve is fixed with a clear resin previously applied to the sleeve, for example in the form of a preferably fast-curing thermal or UV-curing adhesive. Thus, the distal end face 53 of the fiber bundle 32 is covered with a clear plastic. This type of termination can also be applied to the proximal sleeve 40 of the illumination light conductor 30. In this case, the proximal end face 43 can be covered with a clear plastic.

[0065] Furthermore, the proximal and distal sleeves 40, 50 may have a mechanical interface 44, 54 created by the outer contours of the proximal and distal sleeves 40, 50. This may include circumferential grooves, locking ears, notches, flanges, and the like.

[0066] Besides planar end faces, the sleeves can also be embodied as optical elements 51 in the form of lenses (convex or concave) or irregularly structured end faces for beam shaping. Figure 3 Only schematically shown is the distal sleeve 50, which has an optical element 51 in the form of a lens dome formed in the injection molding process, with which the emerging light is, for example, bundled. The function of the coupling-in sleeve and / or coupling-out sleeve or the proximal and / or distal sleeve 40, 50 can be implemented in a particularly cost-effective manner in the design of the tool and allows an extremely cost-effective termination of the proximal and / or distal end faces 43, 53.

[0067] The fiber bundle 32 of the illumination light conductor 30 or the image conductor can be formed by a glass optical fiber (GOF), a quartz optical fiber or a plastic optical fiber (POF). Figure 3 As shown, it is surrounded by an extruded sheath, or surrounded by a tube or a mesh tube fabric. The sheath plastic of the extruded cable 31 is formed by an opaque colored plastic. In another embodiment, the fiber bundle 32 itself and / or its individual fibers can have a conductive coating at least partially or in sections, and / or the sheath plastic can be constructed to be made of a conductive material or have a conductive material at least partially or in sections.

[0068] The following table provides a material overview of plastics which are suitable for the sheathing of the cable 31 and for the clear and transparent covering of the proximal and distal end faces 43 , 53 or for the proximal and distal sleeves 40 , 50 .

[0069] Thermoplastic elastomers (TPE) are divided into the following categories:

[0070] -TPE-A or TPA = Thermoplastic copolyamide

[0071] -TPE-E or TPC = Thermoplastic polyester elastomer / thermoplastic copolyester

[0072] -TPE-O or TPO = Olefin-based thermoplastic elastomers, mainly PP / EPDM

[0073] -TPE-S or TPS = Styrene block copolymer (SBS, SEBS, SEPS, SEEPS and MBS)

[0074] -TPE-U or TPU = Thermoplastic elastomer based on polyurethane

[0075] - TPE-V or TPV = olefin-based thermoplastic vulcanizates or crosslinked thermoplastic elastomers, mainly PP / EPDM.

[0076]

[0077] In particular, TPE-E, TPE-V and TPE-U plastics are particularly suitable for extrusion because they have very good extrudability and have good or even very good adaptability, especially for medical applications. With regard to low-cost production, these materials also have relatively low material costs. Cheap plastics such as PVC, compounds and blends made of PP, PE, TPE-S (SEBS) sometimes have significant deficiencies, especially in terms of temperature resistance. Most of them cannot be used at temperatures above 100 ° C. However, the temperature requirements of disposable endoscopes are significantly lower, making these materials particularly suitable for this application due to their low material cost and easy processing. In this case, the minimum temperature resistance of more than 133 ° C to 137 ° C corresponding to the temperature range during the high-pressure steam sterilization of reusable or reprocessable medical devices or parts is not required here, because the treatment for the sterilization treatment commonly used as disposable medical products is only performed in a temperature range from room temperature to no more than 60 ° C. An example of a commonly used sterilization method is ethylene oxide fumigation.

[0078] A group of cheap and medium-priced plastics are generally available in a wide range with respect to their elasticity and hardness specifications, or can be produced by mixing several types of plastics to form a polymer blend with the required properties. The advantage of these plastics over "expensive" plastics (such as FEP, PVDF) is that they can be used to produce illumination light conductors 30 with almost the same properties but different flexibility.

[0079] Although noble plastics such as FEP, PFA, PVDF can be commonly used, especially with high permanent temperature resistance (often combined with high chemical resistance), they can only be combined with other plastics to a very limited extent or mixed into polymer blends, for example to increase flexibility.

[0080] All of the plastics mentioned are already used in medical products to one degree or another.

[0081] In addition to PC and PA, COC is also very suitable as a material for transparent sleeves, especially for syringes and pharmaceutical packaging, due to its high optical qualities, such as high transparency and low haze. These materials are also available as biocompatible variants.

[0082] With regard to the formation of a planar surface as the proximal or distal end face 43 , 53 , in an advantageous embodiment, a casting resin, in particular a low-viscosity casting resin having particularly self-leveling properties, can also be used.

[0083] As an alternative to the extrusion process, the glass fiber bundles or plastic optical fibers can also be enclosed in thin-walled tubes or shrink tubes for their protection. In the case of shrink tubes, it is advantageous to be able to use very thin-walled shrink tubes (e.g. PET shrink tubes with a wall thickness of 6 μm). Thin-walled mesh fabric tubes made of glass or plastic filaments are also conceivable.

[0084] Most preferably, for medical applications, the glass fibers can be made of lead-free or heavy metal-free core glass and cladding glass, which is particularly advantageous in view of RoHS and REACH regulatory requirements and medical approvals. These glass systems for producing lead-free or heavy metal-free fibers are described in particular in documents WO 2013 / 104748 A1 and DE 102007063463 B4 and are available from SCHOTT GmbH under the name of the present applicant. Such glass systems are known. Lead-free or heavy metal-free rigid optical fiber components are described in DE 10 2013 208838 B4. Glass fibers with high NA values, i.e. acceptance angles 2α>80°, preferably 2α>100°, are particularly suitable for use in the field of endoscopy, so that on the one hand wide illumination and on the other hand optimized light coupling of LEDs can be achieved. For example, such fibers are known under the name SCHOTT GOF85 or GOF120.

[0085] Figure 4 An alternative of the illumination light guide 30 with a distal sleeve 50 is shown in section, which can also be designed similarly for the proximal sleeve 40 .

[0086] For this purpose, for example, as already combined Figure 3The previously extruded fiber bundle described, i.e. the fiber bundle 32 coated with plastic to form the cable 31, is divided into a length and then subjected to an injection molding process, in which the cable section is directly injection molded with a transparent plastic to form a sleeve, i.e. the distal sleeve 50 in this case. In order to prevent the fiber ends from spreading, the cable ends may need to be packaged at least at two opposite points with the help of semicircular chucks and at least partially injection molded. A second injection molding process can then be carried out to inject the final sleeve geometry. This makes it possible on the one hand to form a clear and transparent cover for the distal end face 53, which optionally has an integrated optical function in the form of a shaped lens element (optical element 51), and another plastic can be used to form a mechanical interface 54, which can optionally be a different type of plastic, even opaque. The same applies to the proximal sleeve 40, in which, by these method steps, on the one hand, a clear and transparent cover of the proximal end face 43 with a molded optical element 41, as well as a mechanical interface 44 can be manufactured.

[0087] Figure 5 Shows Figure 3 Variant of the embodiment shown. Here, the distal sleeve 50 shown by way of example on the illumination light conductor 30 (illumination light conductor 30 is shown as an extruded cable 31 with a fiber bundle 32) has a central region in which, for example, a camera chip 70 (C-MOS chip) can be integrated, wherein the fiber bundle 32 of the illumination light conductor 30 is arranged in an annular shape, at least partially annularly or guided around the camera chip 70 in the form of at least two sub-strands. For this purpose, the receiving section 52 for the fiber bundle 32 is correspondingly tapered. Moreover, the optical element 51 can be molded during the manufacture of the sleeve or can be additionally applied in a subsequent bonding process. In this way, on the one hand, an optimized, in particular shadow-free illumination of the tissue area to be examined can be achieved, and on the other hand, an imaging optical device for the camera chip 70 can be realized. In addition, it is conceivable to integrate sensor components such as photodiodes to detect specific wavelengths of light scattered back from the surface to be examined.

[0088] Figures 6a to 6c A typical arrangement of a distal end face 53 of an illumination optical fiber 30 with an image sensor chip 70 is schematically shown, wherein in these examples the distal sleeve 50 represents the end of the shaft 25 of the endoscope 1 . Figure 6a An arrangement is shown in which camera chip 70 is substantially surrounded by distal end face 53 . Figure 6b An essentially U-shaped distal end face 53 is shown. Figure 6cAn exemplary arrangement is shown in which the camera chip 70 is surrounded by two mutually opposing D-shaped distal end faces 53. In addition, a three- or four-piece distal end face 53 is conceivable, which surrounds the camera chip 70 in the form of a circular or oval or kidney-shaped exit face.

[0089] The geometrical arrangement is accordingly predetermined by the design of the distal sleeve 50. Such a sleeve can be produced particularly cost-effectively by injection molding.

[0090] Figure 7 In the cross-sectional view, the corresponding Figure 6a The distal end face 53 and the arrangement of the camera chip 70 are shown on the distal sleeve 50 .

[0091] As an example, the distal sleeve 50 is shown here as the terminal end of the rigid shaft 25 of the endoscope 1, which can be constructed as a stainless steel tube, for example. Here, the distal end face 53 is arranged to surround the centrally arranged camera chip 70 in a substantially annular manner. The light emitted from the distal end face is reflected by the tissue surface 90 to be examined and captured by the camera chip 70, for example. The camera chip 70 is covered to be protected, wherein the covering can be implemented as an optical element 51, for example, a converging lens. A multi-lens arrangement can also be conceived as an optical element 51. The camera chip 70 is in contact with the wire 210, which is guided into the interior of the shaft 25 through the feedthrough 56 in the distal sleeve 50. Here, the fiber bundle 32 composed of glass fibers with high NA (acceptance angle 2α>100°) is spread out in an annular manner and fixed in an annular receiving section 52 arranged around the feedthrough 56. The receiving section 52 has walls that are almost parallel to each other to achieve the orientation of the fibers parallel to each other. The distal sleeve 50 has a tapered area adjacent to the receiving section 52 to facilitate the passage of the fibers. The fiber bundle 32 is surrounded by a protective sheath 33 inside the shaft 25, which protective sheath 33 can be an extruded sheath, a mesh tube or a shrink tube. Considering the very small installation space in the shaft 25, it is particularly advantageous to use, for example, a thin-walled PET shrink tube as a protective sheath. The wall thickness of such a shrink tube is <10 μm. If necessary, the outer contour of the distal sleeve 50 can have an additional mechanical interface 54, for example in the form of a collar or a diameter step as shown in the figure, to connect the distal sleeve 50 to the shaft 25. In addition, various bonding areas 55 are provided, on the one hand for fixing the fibers of the fiber bundle 32 and on the other hand for fixing the camera chip 70 or for additionally sealing the feedthrough 56 for the wire 210. It is particularly advantageous with regard to processing time and thus costs if the entire distal sleeve 50 is made of a clear transparent plastic (e.g. PC or PMMA) and a UV-curing adhesive is used as adhesive or casting resin for the bonding area 55, wherein the optical refractive index of the adhesive or casting resin used to fix the fibers, in particular in the receiving section 52, is essentially matched to the optical refractive index of the core material consisting of the fibers and the deviation in the refractive index is a maximum of ±0.1, preferably a maximum of ±0.05, and wherein the refractive index of the sleeve is slightly lower than the refractive index of the adhesive.

[0092] It is self-evident that such an embodiment with the above-described features is also conceivable for the proximal sleeve 40 , wherein an LED 60 can be integrated here instead of the camera chip 70 .

[0093] In a variant not shown here, it is conceivable that the camera chip 70 is mounted at the rear in the distal sleeve 50 and that the distal end face 53 is designed as a cover. In this way, the electrical insulation can be improved without requiring an additional covering element.

[0094] Figure 8 The proximal sleeve 40 on the illumination light conductor 30 is shown, wherein an LED 60 with an LED controller unit 70 is integrated into the proximal sleeve 40. In this way, a space-saving light source can be achieved in particular. Here, the LED 60 and the LED controller unit 70 are combined as shown in FIG. Figure 3 The described is integrated in a separately produced proximal sleeve 40, wherein the end of the fiber bundle 32 is mounted or fixed in a receiving portion 42 formed in the proximal sleeve 40. The proximal end face 43 can be provided with a clear transparent cover, which is implemented as a focusing lens or a structure enclosing an LED chip to achieve optimal light injection into the fiber bundle 32.

[0095] Alternatively, if Fig. 9 As shown in the highly simplified process sequence in FIG. 1 , an “endless” process can be implemented, so that the previously extruded cable 31 with the fiber bundle 32 is rewound from the unwinder onto the winding machine, and the rewinding is stopped at defined intervals and a plastic double sleeve is injection-molded thereon by means of the injection molding tool 100. At this point, without an intermediate layer, the double sleeve is pressed around the cable 31 in a form-fitting manner, which is separated together with the cable 31 in the subsequent cutting process by means of the separating device 110. This is conceivable directly after the extrusion process, if appropriate measures are provided to adjust or compensate the process speed, for example a buffer for intermediate storage of the extruded cable is provided. Later, the cable section corresponding to the lighting light conductor 30 terminated in this way can then be designed with the final sleeve by means of the second and third injection molding tools 120, 130, and in particular, be injection molded in another step with optically clear and transparent plastic, so that a simple incident or emission optical device (optical element 41, 51) can be arranged on the proximal or distal end face 43, 53 of the lighting light conductor 30 in this way. Alternatively, this can also be achieved in the bonding process, wherein other components, such as C-MOS cameras or sensors, can also be installed together with this. Here, the advantage is that, on the one hand, a firm sleeve can be manufactured, and in particular, the fixing in the tool for the second final injection molding coating process is made easier by molding the corresponding mechanical interface 44, 54. A tight bundle termination is thus achieved. In this way, a large number of simple lighting light conductors 30 can be obtained very cost-effectively, which is particularly meaningful for the disposable field and also in the consumer goods field.

[0096] According to a preferred embodiment, Fig.10Schematically shown, a cable called a multi-lumen cable 200 can be produced. Such a cable can have a fiber bundle 32, a quartz fiber 220, an electric wire 210 and a fluid channel 230 for guiding a medium such as a gas (e.g., nitrogen), water, a medicament, and a flushing liquid. The quartz fiber 220 can be used, for example, for optical data transmission or for control. Multi-lumen tubes are already known from the literature. Particularly advantageous is the integration of an integrated light or energy guiding component, which achieves high functionality in a minimal space. In addition, it can be provided that the cable is specifically implemented as transparent or opaque in sections during the coextrusion process, and therefore can meet lighting or optical detection tasks.

[0097] Another alternative for cost-effective termination is a crimping sleeve as described in DE 10 2004 048741 B3. As an alternative thereto, a plastic crimping sleeve or locking sleeve can be used, which is manufactured by an injection molding process and is designed to be foldable with a folding hinge (living hinge). These sleeves are then snap-fitted to the end of the cable section of the extruded cable and then poured or injected with an optically transparent adhesive in a casting or injection molding process. UV-curing adhesives are also advantageous here. In addition to the snap-fit, it is also conceivable to fix the sleeve on the cable by laser welding or ultrasonic welding.

[0098] Another approach has emerged based on the elastic properties of the cable. In this case, the extruded cable is cut and the cable sheath is subsequently stretched and the resulting cavity is filled with an optically transparent adhesive, or a prefabricated clear transparent plastic part or a glass or plastic light guide rod or fiber rod is inserted and fixed in the cavity. In addition, the fastening element can be formed by targeted deformation of the exposed cable section. Thermoplastic elastomers (TPE) or elastomers such as rubber or silicone are particularly suitable as sheath materials here.

[0099] Another alternative for cost-effective termination of optical conductors can include local heating of the cable filled with gel so that the gel cures there and the cable can be cut and, if necessary, reshaped or molded into a sleeve. The cable can also be produced by coextrusion and can have a transparent section along the cable axis, through which the gel can be cured in sections in a targeted manner by means of UV light. This allows an endless process for termination.

[0100] List of reference numerals:

[0101] 1 Endoscope

[0102] 10 Handheld

[0103] 20 Flexible Sections

[0104] 25 Axis

[0105] 30 Lighting light conductor

[0106] 31 Cables

[0107] 32 Fiber bundle

[0108] 33 Protective case

[0109] 40 Proximal sleeve

[0110] 41 Optical Components

[0111] 42 Accommodation Section

[0112] 43 Proximal end face

[0113] 44 Mechanical interface

[0114] 50 Distal sleeve

[0115] 51 Optical Components

[0116] 52 Accommodation Section

[0117] 53 Distal end face

[0118] 54 Mechanical interface

[0119] 55 bonding area

[0120] 56 Feedthrough

[0121] 60 LED

[0122] 70 Camera Chip

[0123] 80 LED Controller Unit

[0124] 90 tissue surface

[0125] 100 First injection molding tool

[0126] 110 Separation Device

[0127] 120 Second injection molding tool

[0128] 130 Third injection molding tool

[0129] 200 Multi-lumen cable

[0130] 210 Wire

[0131] 220 Quartz Fiber

[0132] 230 Fluid Channel

Claims

1. A diagnostic, surgical and / or therapeutic device for introduction into a human or animal body or for in vitro examination of a human or animal blood sample or other body cells, the diagnostic, surgical and / or therapeutic device comprising at least one illumination light conductor (30) and / or image conductor for transmitting electromagnetic radiation, wherein the illumination light conductor or image conductor has a proximal end face (43) for coupling in and / or out coupling out of the electromagnetic radiation and a distal end face (53) for coupling in and / or out coupling out of the electromagnetic radiation, It is characterized in that The proximal and / or distal end face (43, 53) is made of an at least partially or sectionally transparent plastic element or is molded with a transparent plastic; wherein the transparent plastic is biocompatible and / or has no cytotoxicity to human or animal cell cultures within an exposure time of less than one day, and is selected from the group consisting of cyclic olefin copolymers, polycarbonates, polyethylene terephthalate, perfluoroalkoxy polymers, polyvinylidene fluoride, polymethyl methacrylate, polymethacrylimide, acrylic acid-styrene-acrylonitrile copolymers, or room temperature cross-linked silicones, thermal cross-linked liquid silicones, epoxy casting resins, thermally cross-linked or UV cross-linked acrylate casting resins, polyurethane casting resins, polyester casting resins, or combinations thereof; wherein the proximal and / or distal end faces (43, 53) of the illumination light conductor (30) and / or the image conductor also have mechanical interfaces (44, 54), respectively; wherein the sheath is made of a thermoplastic elastomer; and The distal and / or proximal end faces (43, 53) having the mechanical interface (44, 54) are implemented as sleeves, which are produced separately and fixed to the fiber bundle end or fiber rod end of the illumination light conductor (30) or image conductor by means of an adhesive or casting resin implemented as a heat-curing or UV-curing adhesive, the adhesive having an optical refractive index that essentially matches the optical refractive index of the core material of the fibers or fiber components used in the illumination light conductor or image conductor with a maximum deviation of ±0.1, and the refractive index of the sleeve is slightly lower than the refractive index of the adhesive or casting resin.

2. The diagnostic, surgical and / or therapeutic device according to claim 1, It is characterized in that The diagnostic, surgical and / or therapeutic device is an endoscope (1).

3. The diagnostic, surgical and / or therapeutic device according to claim 2, It is characterized in that The diagnostic, surgical and / or therapeutic device is a disposable endoscope.

4. The diagnostic, surgical and / or therapeutic device according to claim 3, It is characterized in that The adhesive has an optical refractive index which is substantially matched to the optical refractive index of the core material of the fibers or fiber components used in the illumination light guide or image guide and deviates by a maximum of ±0.

05.

5. Diagnostic, surgical and / or therapeutic device according to any one of claims 1 to 4, It is characterized in that The mechanical interface (44, 54) is in the form of a sleeve profile, the mechanical interface (44, 54) is made of plastic or is molded onto the illumination light conductor (30) or the image conductor by means of plastic injection molding; In this case, the plastic differs at least partially or in sections from the transparent plastic of the proximal or distal end face in terms of its material, transparency and / or color.

6. Diagnostic, surgical and / or therapeutic device according to any one of claims 1 to 4, characterized in that The surface roughness R of the transparent plastic of the proximal and / or distal end faces (43, 53) of the illumination light conductor (30) and / or the image conductor a ≤1.0μm.

7. Diagnostic, surgical and / or therapeutic device according to any one of claims 1 to 4, characterized in that The surface roughness R of the transparent plastic of the proximal and / or distal end faces (43, 53) of the illumination light conductor (30) and / or the image conductor a ≤0.5μm.

8. Diagnostic, surgical and / or therapeutic device according to any one of claims 1 to 4, It is characterized in that The surface roughness R of the transparent plastic of the proximal and / or distal end faces (43, 53) of the illumination light conductor (30) and / or the image conductor a ≤0.1μm.

9. The diagnostic, surgical and / or therapeutic device according to any one of claims 1 to 4, It is characterized in that The transparent plastic of the proximal or distal end face (43, 53) of the illumination light conductor (30) and / or image conductor 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 conductor or image conductor, with a maximum deviation of ±0.

1.

10. The diagnostic, surgical and / or therapeutic device according to any one of claims 1 to 4, It is characterized in that The transparent plastic of the proximal or distal end face (43, 53) of the illumination light conductor (30) and / or image conductor 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 conductor or image conductor, with a maximum deviation of ±0.

05.

11. Diagnostic, surgical and / or therapeutic device according to any one of claims 2 to 4, It is characterized in that The illumination light guide (30) or the image conductor is made of a fiber bundle (32) consisting of glass optical fibers, quartz optical fibers or plastic optical fibers and / or the illumination light guide (30) or the image conductor is made of individual fibers made of these materials, the fiber bundle being at least partially or sectionally surrounded by a sheath or a tube or being protected by means of the shaft (25) of the endoscope (1).

12. Diagnostic, surgical and / or therapeutic device according to any one of claims 1 to 4, It is characterized in that The illuminating light conductor (30) or image conductor is produced from a fiber bundle (32) which is at least partially or sectionally surrounded by a shrink tube or a mesh-like tube fabric.

13. The diagnostic, surgical and / or therapeutic device according to claim 11, It is characterized in that The sheath is made of another plastic and is embodied in the form of an extruded cable (31).

14. Diagnostic, surgical and / or therapeutic device according to claim 13, It is characterized in that The plastic used for the extruded sheath is made of at least partially or sectionally translucent, opaque or colored plastic.

15. Diagnostic, surgical and / or therapeutic device according to any one of claims 1 to 4, It is characterized in that The illumination light conductor (30) or the image conductor is made of a flexible or semi-flexible fiber bundle, and the sheath is at least partially or sectionally implemented as a rigid sheath.

16. Diagnostic, surgical and / or therapeutic device according to any one of claims 1 to 4, It is characterized in that The illuminating light conductor (30) or the image conductor is made of a drawn fiber rod or a pressed fiber rod and is configured as a rigid illuminating light conductor (30) or the image conductor.

17. The diagnostic, surgical and / or therapeutic device according to claim 11, It is characterized in that The fibers, fiber bundles or fiber rods are made of lead-free core glass and cladding glass.

18. The diagnostic, surgical and / or therapeutic device according to claim 11, It is characterized in that The fibers, fiber bundles and fiber rods are made of heavy metal-free core glass and cladding glass.

19. The diagnostic, surgical and / or therapeutic device according to claim 11, It is characterized in that The fibers, fiber bundles, fiber rods are made of a glass system which has an acceptance angle 2α of greater than 80° for the light to be guided.

20. The diagnostic, surgical and / or therapeutic device according to claim 11, It is characterized in that The fibers, fiber bundles, fiber rods are made of a glass system which has an acceptance angle 2α of greater than 100° for the light to be guided.

21. The diagnostic, surgical and / or therapeutic device according to claim 19, It is characterized in that The sleeve has a receiving section (42, 52) for receiving the fiber bundle (32), which merges from an initially conical section into a section having substantially parallel side walls, and the sleeve also has a receiving part for an electronic component, and the receiving section (42, 52) at least partially surrounds the area of ​​the receiving part for the electronic component.

22. The diagnostic, surgical and / or therapeutic device according to claim 5, It is characterized in that The distal and / or proximal end faces (43, 53) having the mechanical interface (44, 54) in the form of a sleeve are molded onto a cable segment previously cut to a certain length by means of injection molding, wherein the process can be carried out in two stages, wherein in a first step the cable end is fixed at at least two opposite points by means of a tool suitable for the outer contour of the cable and is at least partially or sectionally injection-molded with a first plastic, and in a second step the sleeve geometry is molded by means of a second plastic, wherein in one of the steps the distal and / or proximal end faces (43, 53) can be molded with the transparent plastic.

23. Diagnostic, surgical and / or therapeutic device according to any one of claims 1 to 4, It is characterized in that In an endless process, a double-profile sleeve is molded onto the previously extruded cable (31) at specific intervals depending on the final component length to form the mechanical interface (44, 54), which is detachable in the next process step and the proximal and / or distal end faces (43, 53) can be molded onto the cable segment produced in this way using one or more further injection molding processes using clear transparent plastic.

24. Diagnostic, surgical and / or therapeutic device according to any one of claims 1 to 4, It is characterized in that The extruded cable (31) is divided at specific intervals or the corresponding fiber bundle sections surrounded by the tube according to the final component length, and the fiber bundles (32) existing inside the extruded cable section or the fiber bundle section are offset inwardly, and the space between the fiber bundle end and the edge of the sheath or the edge of the tube is filled with a transparent self-leveling plastic.

25. Diagnostic, surgical and / or therapeutic device according to any one of claims 1 to 4, It is characterized in that The previously extruded cable (31) is separated at specific intervals or corresponding fiber bundle sections surrounded by a tube according to the final component length, and the cable sheath, the tube is extended relative to the fiber bundle, and the cavity formed thereby is filled with optically transparent plastic or a prefabricated clear transparent plastic part, or a light guiding rod made of glass or plastic, or a fiber rod made of glass or plastic is inserted and fixed in the cavity.

26. The diagnostic, surgical and / or therapeutic device according to claim 23, It is characterized in that The jacket section or tube section that forms the cavity is deformed and forms a specific light entry or light exit contour after the plastic is cured or after the plastic part or light guiding rod is inserted.

27. Diagnostic, surgical and / or therapeutic device according to any one of claims 1 to 4, It is characterized in that The proximal or distal end face (43, 53) of the illumination light conductor (30) or image conductor also has an active electronic component in the form of an LED (60), a laser diode, a sensor or a camera chip (70), which can be integrated into a molded sleeve or can be mounted on the sleeve by means of a snap-on connection.

28. Diagnostic, surgical and / or therapeutic device according to any one of claims 1 to 4, It is characterized in that On the proximal or distal end face (43, 53) an additional component made of glass or plastic is provided for covering the active electronic components.

29. Diagnostic, surgical and / or therapeutic device according to any one of claims 1 to 4, It is characterized in that The proximal and / or distal end faces (43, 53) are implemented as optical elements for achieving a specific beam shaping and have a flat, convex or concave or free-form surface of any desired morphology.

30. Diagnostic, surgical and / or therapeutic device according to any one of claims 2 to 4, It is characterized in that The extruded cable (31) for the illumination light conductor (30) or the image conductor is designed as a hybrid cable.

31. The diagnostic, surgical and / or therapeutic device according to claim 30, It is characterized in that The hybrid cable is designed as a multi-lumen cable (200), with which fiber bundles (32), individual quartz fibers (220), media in the form of gas or fluid in fluid channels (230), and / or electrical lines (210) can be guided separately.

32. The diagnostic, surgical and / or therapeutic device according to claim 31, It is characterized in that 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).

33. The diagnostic, surgical and / or therapeutic device according to claim 30, It is characterized in that The hybrid cable or multi-lumen cable (200) is implemented in a coextrusion process so as to be sectionally transparent or opaque.

Images