Light guide component or image guide component for disposable endoscopes

Abstract

To provide a diagnostic, surgical and / or therapeutic instrument, in particular an endoscope or a disposable endoscope, for introduction into a human or animal body or for ex vivo examination of a human or animal blood sample or other body cells.SOLUTION: An instrument comprises at least one illumination light guide and / or image guide for transmitting electromagnetic radiation, in which the illumination light guide or the image guide each has a proximal end face for the entry or exit of electromagnetic radiation and a distal end face for the exit or entry of electromagnetic radiation. The proximal end face and / or the distal end face is made of a transparent plastic material at least partially or in some sections, or is integrally formed on them from a transparent plastic. In this case, the transparent plastic is biocompatible and / or has no cytotoxic properties for human or animal cell structures for a duration of action of less than one day.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to diagnostic, surgical and / or therapeutic devices, in particular endoscopes or disposable endoscopes, for introduction into the human or animal body or for in vitro examination of human or animal blood samples or other somatic cells. The device includes at least one illumination light guide and / or image guide for transmitting electromagnetic radiation, wherein the illumination light guide or image guide each has a proximal end face for the incidence or emission of electromagnetic radiation and a distal end face for the emission or incidence of electromagnetic radiation.

Background Art

[0002] Endoscopes for diagnosis, minimally invasive intervention or treatment are known in rigid or flexible configurations and are well described in the literature. Disposable endoscopes, also referred to as "single-use endoscopes", are increasingly being used today in medical examinations, treatments and / or minimally invasive interventions, particularly for the purpose of enhancing patient safety, since contamination is prevented by single-use. Of course, previous endoscopes have been conceived to be reprocessable from a medical technology perspective, i.e., washable, sterilizable and even autoclaveable. Nevertheless, in this case, due to incorrect application of reprocessing or inconvenient design of such devices, the required microbial reduction may not be achieved, and there is a sporadic risk that microorganisms may be transmitted to the patient during the next application. By using disposable endoscopes as described above, this can be prevented.

[0003] Another aspect of the increased use of disposable endoscopes is the economic consideration. In particular, the reprocessing process, which is routinely performed after each procedure, incurs significant costs for practitioners or clinics. Moreover, cleaning equipment such as heat sterilizers, autoclaves, and / or plasma sterilizers requires a high investment, so overall there is a rationale for using disposable endoscopes as described above.

[0004] Further advantages arise from the following: such disposable endoscopes can be used as "handheld" devices, and therefore can be used in emergency medicine, by military medical units, or in areas that are difficult to access, such as during disaster response, where reprocessing is not possible.

[0005] This type of disposable endoscope, described in the literature as a "single-use" endoscope or "disposable endoscope," is mentioned in publications such as the following:

[0006] Disposable endoscopes disclosed in U.S. Patent Application Publication No. 3581738 include a body made of a synthetic resin material having generally tubular sidewalls forming a microscope, and an integral, elongated light guide member embedded in the sidewall. The light guide member is made of a light guide material, which is covered with a transparent material having a refractive index different from that of the light guide material, and the body is formed of two paired halves separated axially from the endoscope, each half having an element surrounding the member.

[0007] U.S. Patent Application Publication No. 4964710 describes a rigid endoscope comprising an objective lens system, an eyepiece, and an intermediate relay lens. The relay lens system is a hybrid system using both plastic and glass components. The plastic component consists of a uniform number (N) of lenses oriented axially, each having a length on the order of its diameter. The plastic lens is a number (N-1) of flat glass cylinders oriented axially, with polished end faces.

[0008] European Patent Application Publication No. 1890173 describes a method for manufacturing a light guide that can be used in an endoscope as described above. In this method, a number of optical fibers are bundled together, and then the fiber bundle is cut at a portion of the fiber bundle that is 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 dividing 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, so that 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 creates a separable optical transmission section of the light guide.

[0009] Because such endoscopes are single-use devices, they face significant cost pressures, and therefore, the units or components must be manufactured at the optimal cost. One of the main components for imaging and illumination is the illumination light guide or image guide. These are currently still assembled or manufactured through fairly complicated process steps. Often, on the one hand, complex mechanical components are combined with optical elements such as lenses, including the aforementioned light guide or image guide, and on the other hand, complicated machining steps such as grinding and polishing of the end faces are also performed, making current illumination light guides or image guides quite expensive.

[0010] However, on the other hand, especially when using endoscopes in medical technology, specific optical technology requirements must also be considered. These requirements include delivering light from the light source to the diagnostic site with as little loss as possible, representing the diagnostic site in its true color or a colored version as intended, and avoiding the introduction of unnecessary heat to the diagnostic site.

[0011] Furthermore, when using active electronic components such as camera chips and / or illumination LEDs, additional considerations must be given to electrical isolation, electrical shielding, and leakage current to the patient, and such leakage current must not exceed a maximum limit depending on the application area of ​​the endoscope. For example, in 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, biocompatibility requirements must also be considered. For biocompatibility, it must be ensured that the material is compatible with human tissue. For medical products that may come into contact with the human body, regulations require the identification and evaluation of possible interactions and undesirable side effects. The selection of necessary tests will depend on the type and duration of contact within the human body. According to the European Medical Devices Directive MDD93 / 42EWG, such biological impact assessments of a product are always required when there is direct contact between the material / product and the patient.

[0013] Regulations for the biological testing and determination of raw materials are based on DIN EN ISO 10993 and United States Pharmacopeia Class VI (USP Class VI) testing. Although the remarkably broad ISO 10993 was originally intended to replace USP Class VI testing, USP testing is now very frequently used, particularly to determine the biocompatibility of plastics. For this purpose, materials intended for invasive applications are evaluated for their chemical bonding, and cytotoxicity tests are performed on the materials, examining 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 under the jurisdiction of FDA requirements. The requirements corresponding to DIN EN ISO 10993 are included in USP Class VI in the United States.

[0014] Furthermore, the advantage of designing endoscopes as disposable endoscopes is that, as a reprocessing method, there is no need to consider known cleaning / sterilization methods using strong basic solvents, and sterilization by autoclaving, which is generally performed at temperatures up to 135°C and a vapor pressure of approximately 3 bar, when selecting materials. This allows for the selection of materials at a lower cost. In terms of materials, only the RoHS Directive and the REACH Regulation need to be considered. [Overview of the project] [Problems that the invention aims to solve]

[0015] Therefore, the object of the present invention is to provide an illumination light guide or image guide for disposable endoscopes, or a unit equipped with an illumination light guide, an image light guide and / or a camera, that is particularly low-cost in manufacturing while enabling the general optical technical requirements for endoscopes in medical technology, especially high transmittance and high color fidelity. Furthermore, this is achieved in accordance with medical technical requirements and effects, while simultaneously having high biocompatibility and low cytotoxicity. [Means for solving the problem]

[0016] The problems of the present invention are solved as follows: The near end face and / or far end face are made of a transparent plastic material in at least partially or partially, or transparent plastic is integrally molded to the near end face and / or far end face, in which case the transparent plastic is biocompatible and / or does not have cytotoxic properties to human or animal cell structures for an exposure time of less than one day. In this way, an illumination light guide or image guide can be manufactured at an extremely low cost, and otherwise time-consuming end processing, i.e., grinding and polishing of the near end face or far end face, can be omitted. The biocompatible or non-cytotoxic properties of the plastic enable invasive intervention in the body (in vivo) or enable in vitro examination of cell structures or blood samples without damaging or altering them. Particularly for disposable endoscopes, the temperature resistance of the plastic does not need to be very high, and therefore the constraints on selection are reduced, and the selection of plastic can provide an optically valuable system that meets the optical technical requirements, especially for endoscopes. Suitable plastics are those comprising at least one of the following material classifications: cyclic olefin copolymers, polycarbonates, polyethylene terephthalate, perfluoroalkoxy polymers, polyvinylidene fluoride, polymethyl methacrylate, polymethyl methacrylimide, acrylic styrene acrylonitrile copolymers, or plastics comprising at least one of the following: room-temperature crosslinkable silicones, high-temperature crosslinkable liquid silicones, epoxy casting resins or epoxy adhesives, thermally crosslinkable or UV-crosslinkable acrylate casting resins, polyurethane casting resins, or polyester casting resins, or mixtures and / or combinations thereof. In selection, attention should be paid to appropriately biocompatible variations that meet the standard requirements mentioned at the beginning. In particular, thermoplastics that are easily injection-molded and transparent, such as PC, PMMA, and COC, are suitable, as are plastics that can be used as casting resins.In this way, a surface with a remarkably low roughness value and a correspondingly smooth surface can be achieved. Moreover, the aforementioned plastic can be obtained in a biocompatible version.

[0017] In particular, for mechanical coupling with other components of the endoscope, the following can be considered: the near end face and / or far end face each have a mechanical interface in the form of a ferrule contour, which is made of plastic or integrally molded with the illumination light guide or image guide by plastic injection molding, in which case this plastic can be made different from the transparent plastic of the near end face or far end face in terms of material, transparency and / or color, at least partially or partially. In this way, for example, a color or stepped section can be created, and an undercut area can be formed, which can connect the illumination light guide or image guide to the handpiece and / or shaft of the endoscope. In particular, this can be done to achieve a locking coupling that enables rapid assembly, which in turn can reduce manufacturing costs.

[0018] Particularly preferred is the following modified embodiment. In this embodiment, the transparent plastic on the near end surface and / or far end surface 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 loss on the surface, which would otherwise lead to a reduction in illumination intensity in the case of an illumination light guide. Thus, in the case of an image guide, a sharp image of the illuminated object can be achieved.

[0019] If the transparent plastic on the near or far end face has a 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, reflection losses can be minimized, resulting in increased illumination intensity in the case of illumination light guides and suppression of artifacts caused by reflections in the case of image guides. Good results can already be achieved if the deviation between the refractive index of the fiber or fiber component and the refractive index of the clear, transparent plastic is at most ±0.1. If the deviation is at most ±0.05, the refractive indices are already almost perfectly matched, and therefore reflection losses in the illumination light guide can be ignored. In particular, in the case of image guides, ghost images caused by multiple reflections can be eliminated.

[0020] In an advantageous embodiment of the present invention, the illumination light guide and / or image guide for an endoscope comprises a fiber bundle consisting of glass fiber, quartz fiber, or plastic fiber. Glass fiber is particularly suitable for transmitting light or image information from the visible spectral region to the near-infrared region. This is also true for plastic fiber, although in that case the applicable length of the plastic fiber is typically limited to a few centimeters to a maximum of about 1 m. Quartz fiber is used particularly when the applicable wavelength generally reaches the infrared region up to 2.2 μm, or when it is also desired to utilize light components in the near-ultraviolet region shorter than about 400 nm. This is particularly important in fluorescence applications. In this case, it is particularly advantageous if the bundle or individual fibers are surrounded at least partially or partially by a sheath, tube, heat-shrink tubing, or mesh tubing fabric, or protected by the shaft of the endoscope. This increases the mechanical rigidity of the system.

[0021] In this case, it is conceivable that the outer sheath is made of an additional plastic material and is constructed as an extruded cable. Such a cable can be manufactured in an endless process, particularly at low cost.

[0022] In particular, in the modified embodiments described above, inexpensive plastics with poor temperature stability can be used for both the cables and ferrules. This is because, especially for single-use applications, thermal / chemical reprocessing processes such as autoclaving (typically 130-140°C in saturated steam) and / or heat sterilization processes (up to 95°C with pH 11 cleaning agents) are unnecessary. Typically, disposable equipment is sterilized using ethylene oxide fumigation, or in some cases plasma-based gas sterilization (STERAD with hydrogen peroxide and plasma, or STERIS with hydrogen peroxide alone), which are performed at temperatures up to 60°C.

[0023] The plastic for the extruded outer casing can be made of a translucent, opaque, or colored plastic in at least part or in some sections. Thus, for example, by using a light guide fiber that emits light laterally, lateral illumination can be performed in an endoscope.

[0024] If the illumination light guide or image guide consists of a flexible or semi-flexible fiber bundle, and the outer sheath is configured as a rigid sheath in at least part or part of its length, then a shaft for a rigid endoscope can be realized.

[0025] The present invention also relates to a light guide or an image guide of a rigid optical fiber in the form of, for example, an elongated fiber rod or a pressed fiber rod. Advantageously, this is also based on the same glass system as is used for corresponding flexible glass fiber bundles. Also in this case, a plastic cap directly integrally formed can be used to form optical elements and / or ferrules at a low cost on the proximal end face and / or the distal end face of the light guide.

[0026] It is particularly advantageous if the glass fiber, fiber rod or pressed fiber rod consists of lead-free or heavy metal-free core glass and cladding glass. Such a fiber system particularly provides a high transmittance in the visible spectral region and, due to the relatively high transmittance, shows a high color fidelity in the blue spectral region, which is particularly important in the medical determination of tissues. In this case, often the difference between a benign tissue change and a malignant tissue change is distinguished by a very slight color difference in the tissue. Therefore, it is important that the entire system consisting of a light source, an illumination light guide and an imaging device has a high CRI value, where CRI (color rendering index) is a characteristic value of the photometric quantity, by which the color rendering quality of a light source of the same correlated color temperature is represented. By means of the above-mentioned glass fiber, fiber rod or pressed fiber rod, a CRI value greater than 90 can be achieved. Such a fiber system is known by the name of SCHOTT PURAVIS® by the applicant, and its configuration is described in the specification of German Patent Invention No. 102012100233 and the specification of German Patent Invention No. 102013208838. A similar fiber system is also described in the specification of European Patent No. 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 a light-receiving angle 2α greater than 80° with respect to the light to be guided, and especially preferably greater than 100°. On the one hand, the following can be achieved: In particular, the light from an LED, which usually has a remarkably wide radiation angle, can be incident on the glass fiber, fiber rod, or pressed fiber rod without increasing incident loss, without providing a complex optical system at the near end. On the other hand, wide-angle illumination can be achieved at the far end without the need to provide an additional optical system, which is particularly preferable in endoscopic examinations. In this way, optimal illumination can be achieved in the currently common camera field of view (usually 120° obliquely).

[0028] In a particularly preferred modified embodiment, the following can be considered: the near-end and / or far-end faces having a mechanical interface are configured as separately manufactured ferrules, which are fixed to the fiber bundle end or fiber rod end of the illumination light guide or image guide by an adhesive, wherein the adhesive is a thermosetting or UV-curing adhesive having 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 being at most ±0.1, preferably at most ±0.05, and the refractive index of the ferrule being slightly smaller than that of the adhesive. In this way, a high coupling coefficient can be achieved. The fact that the refractive index of the ferrule is only slightly smaller than that of the adhesive helps to minimize radiation loss from the ferrule at the side. Such ferrules can be manufactured at low cost as injection-molded members, in this case particularly as precision injection-molded members. In this case, all of these functions regarding fiber accommodation, mechanical interfaces, and the formation of those surfaces for the topography of the near or far end faces can be realized in the injection molding tool. By using thermosetting or UV-curing adhesives, short process times, generally less than 60 seconds, can be achieved in the assembly or bonding of fiber components, thereby reducing manufacturing costs.

[0029] In this case, in a particularly advantageous embodiment, the following can be considered. That is, the ferrule has an accommodation section for accommodating the fiber bundle, and this accommodation section communicates from an initially somewhat conical section to a section having side walls arranged substantially parallel. The ferrule further has an accommodation part for the electronic component, and the above-mentioned accommodation section surrounds at least a part of the area of the accommodation part for the electronic component. Thus, for example, an arrangement of the fiber and the electronic component can be realized in which the electronic components on the proximal end face or the distal end face are surrounded by them. Furthermore, a substantially U-shaped arrangement can also be considered, or an arrangement in which the electronic component is surrounded from both sides by two proximal end faces or distal end faces formed in a D shape can also be considered.

[0030] In addition to this, a distal end face or a proximal end face divided into three or four parts is also conceivable, by which the electronic component is surrounded as a circular or elliptical or kidney-shaped emission surface. In this case, the entire function of the fixation and orientation of the fiber and the arrangement of the end faces can be incorporated into the technical design of the ferrule or realized in the tool design. In this case, since the dimensions are extremely small, a particularly precise injection molding tool or a precise injection molding machine is advantageous.

[0031] According to one alternative modification embodiment, the following can be considered: the near-end and / or far-end faces having a mechanical interface in the form of a ferrule are integrally injection-molded onto a pre-shortened cable section, and this process can be configured as a two-step process, in which case, in the first step, the cable end is fixed at at least two opposing points using a tool aligned with the outer contour of the cable and overmolded at least partially or partially with a first plastic, and in the second step, the geometry of the ferrule is integrally molded with a second plastic, in which case, in one of these steps, the near-end and / or far-end faces can be integrally molded with a clear plastic. The two-step process can prevent the fibers from uncontrollably scattering during the injection molding process, which typically involves pressures of several tens of bar. The first process step can form at least one kind of fixed collar around the cable at the end of the cable section, thereby preventing scattering. Opaque or colored plastic can be used for this purpose. Next, in the second step, the original near end surface and / or far end surface are formed using clear, transparent plastic.

[0032] The following method yields an exceptionally low-cost process, particularly advantageous for large quantities: In an endless process, a double ferrule is integrally molded as a mechanical interface to a pre-extruded cable at specific intervals according to the final part length, with respect to its own contour. This mechanical interface is then separable in the next process step, and the near and / or far end faces of the thus formed cable section can be integrally molded with clear plastic using one or more further injection molding processes. This enables nearly fully automated manufacturing, which in turn allows such light guides to be provided at an extremely low cost.

[0033] In a further alternative embodiment, the following can be considered: Pre-extruded cables are divided at specific intervals, or corresponding fiber bundle sections surrounded by tubes or heat shrink tubing are divided according to the final part length, and the fiber bundles located inside the sections of extruded cables or fiber bundle sections are pushed inward, and the space between the fiber bundle ends and the periphery of the outer sheath or the periphery of the tube or heat shrink tubing is filled with a clear, transparent, self-leveling plastic. In this way, a light incident surface or light output surface can be realized that forms a sufficiently smooth surface, especially with casting resin.

[0034] Alternatively, the following approach can be considered: pre-extruded cables are divided at specific intervals, or corresponding fiber bundle sections surrounded by tubing or heat shrink tubing are divided according to the final component length, the cable sheath, tubing, or heat shrink tubing is made longer than the fiber bundle, and the resulting cavity is filled with optically clear, transparent plastic, or a pre-manufactured, optically clear, transparent plastic component, or a light guide rod or fiber rod made of glass or plastic is incorporated and fixed into the cavity. This also allows for the realization of a corresponding light incident or light emission surface.

[0035] In one modified embodiment, the outer sheath section, tubing section, or heat-shrink tubing section forming the cavity may be deformed to create a specific light incidence or light emission contour after the plastic has cured or after the plastic component or light guide rod has been assembled. This can be done using special tools. Thus, various near-end or far-end contours can be formed, which can be used, for example, to house a camera tip or work duct at the far end.

[0036] If active electronic elements in the form of LEDs, sensors, or camera chips can be integrated into a single-piece ferrule, or inserted into this ferrule by a locking coupling, it offers a particularly advantageous configuration for a light guide that is both low-cost and space-saving. Therefore, LED elements can be integrated, for example, into the near-end ferrule, enabling exceptionally high incidence efficiency, which is particularly advantageous with respect to the irradiation intensity at the far end of the light guide. In addition to white light LEDs, RGBW-LEDs capable of switching between various colors can also be used. This allows for specific diagnostic examinations where tissue is examined at a particular wavelength, in addition to normal tissue illumination. Combinations of white light LEDs or RGBW-LEDs with LEDs emitting in the blue spectral region (e.g., 405 nm) or near-ultraviolet regions are also conceivable. This allows for fluorescence excitation. For thermal management, a metal pin can be used to thermally couple the LED to a heat sink within the endoscope handpiece. Integrating a camera chip into the far-end ferrule (tip-on-tip) allows for direct imaging of the tissue surface to be examined.

[0037] It can be advantageous if the near-end and / or far-end faces are configured as optical elements for achieving specific beam shaping, and have flat, convex, concave, or arbitrarily configured free-form surfaces with respect to topography. By configuring the tool accordingly, for example, a condenser lens can be provided on the near-end ferrule to improve light incidence, thereby, for example, bundling the light from an LED, which usually emits a relatively wide beam, and directing it into the fiber according to the numerical aperture of the fiber (0.55 to 0.70, e.g., SCHOTT PURAVIS® GOF70 has a numerical aperture of 0.57, SCHOTT PURAVIS® GOF85 has a numerical aperture of 0.68). Configuring a convex lens appropriately at the far end can also be advantageous, for example, to realize an imaging optical system for a camera chip. Furthermore, wide-angle emission characteristics with, for example, spherical or annular emission characteristics can also be realized at the far end of the light guide by using optical elements formed in such a way. Spherical emission characteristics allow for, for example, homogeneous illumination of a cavity in a body.

[0038] In one preferred variant embodiment, an additional member made of glass or plastic is provided to cover the active electronic element at the near or far end face. This would achieve additional electrical insulation and / or electrical shielding, thereby addressing applications in particular where the requirements for insulation or leakage current are heightened.

[0039] Another possibility is that the far-end ferrule, which houses the camera chip, is formed as an injection-molded component consisting of two parts, in which case the section housing the camera chip is formed from a black-colored or opaque plastic material, and the far-end face is made of transparent plastic. This would allow for additional shielding of the camera chip with respect to scattered light.

[0040] In relation to disposable endoscopes for medical technology, the use of so-called hybrid cables can be particularly advantageous. In such hybrid cables, in addition to optical light guide members and / or image guide members, electrical conductors are also guided within the cable. Therefore, for example, voltage can be supplied to a camera chip, or image information can be transmitted to an evaluation unit.

[0041] In one modified embodiment, the following can be considered: an extruded cable for illumination or image guidance is configured as a multi-lumen cable having various chambers, which can separately guide fiber bundles, individual quartz fibers, a medium in the form of a gas or liquid in a fluid duct, and / or an electrical conductor. In this case, a particular advantage is that the multiple components guiding light or energy are incorporated separately and independently of each other, enabling high functionality in minimal space. Thus, fiber bundles can be used to guide light, and quartz fibers can be used, for example, to transmit the energy of a laser beam. Electrical conductors can be used to transfer image signals from a camera chip to a monitor. Such a multi-lumen cable can be manufactured at a significantly lower cost using appropriate extrusion molding tools.

[0042] In this case, the following approach can be considered: the multi-lumen cable constitutes a flexible section of the endoscope, or the multi-lumen cable is made of rigid plastic at room temperature, thus forming the rigid shaft of the endoscope. This approach makes it possible to realize flexible or rigid disposable endoscopes at a particularly low cost.

[0043] If a multi-lumen cable is constructed in a co-extrusion process with each segment transparent or opaque as intended, it can also fulfill roles such as illumination or optical detection. In this case, the multi-lumen cable can be constructed from a conductive material, such as appropriately filled plastic, and / or surrounded by a conductive material, at least partially or partially in some sections, and even within individual lumens.

[0044] All embodiments described herein are suitable for providing reasonably low-cost optical fiber components or optical fiber units that can be incorporated into flexible or rigid disposable endoscopes. The general term "disposable endoscope" here 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, image guide, or camera chip. Such devices could be, for example, an angioscope for vascular examinations using a flexible endoscope, a laparoscope for intra-abdominal examinations and an arthroscope for joint examinations using a rigid endoscope, and further, an otoscope, nasal endoscope, ring venoscope, or otopharyngoscope for otolaryngological examinations using a rigid endoscope.

[0045] In this case, the aforementioned modified embodiments of the illumination light guide and / or image guide can be incorporated into the handpiece of the endoscope, and depending on the structure of the endoscope, these modified embodiments can partially form the flexible section or shaft of the endoscope. This can sometimes eliminate significantly complex grinding and polishing processes, simplifying assembly and consequently saving costs.

[0046] In particular, with further use of illumination light guides as described in various modified embodiments, applications for in vitro diagnostic devices can be considered in addition to applications in the medical device field. In this case, such light guides can also be used as detector light guides. In this case, for example, multiple such illumination light guides or detector light guides are often used to examine, for example, blood samples in parallel within a single device. In this case, cost advantages can be cited, whether as a result of reduced assembly effort or as a result of incorporating additional functions. For example, a biocompatible plastic embodiment can be used in this case to bring blood samples or cell structures into direct contact with the illumination light guide or detector light guide. Moreover, by using the aforementioned glass fibers or quartz fibers, spectroscopic examination becomes possible due to their advantages in optical transmission, and / or examination by fluorescence excitation also becomes possible.

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

[0048] Next, the present invention will be described in detail based on the embodiments shown in the drawings. [Brief explanation of the drawing]

[0049] [Figure 1] This is a very simplified diagram illustrating a disposable endoscope configured as a flexible endoscope. [Figure 2] This is a very simplified diagram illustrating a disposable endoscope configured as a rigid endoscope. [Figure 3]This diagram schematically shows an illumination light guide with a far-end ferrule attached. [Figure 4] This diagram schematically shows an illumination light guide with an integrally molded far-end ferrule. [Figure 5] This diagram schematically shows an illumination light guide with a far-end ferrule and an integrated camera chip. [Figure 6a] This diagram schematically shows various arrangements of the far end face equipped with a camera chip. [Figure 6b] This diagram schematically shows various arrangements of the far end face equipped with a camera chip. [Figure 6c] This diagram schematically shows various arrangements of the far end face equipped with a camera chip. [Figure 7] This figure schematically shows a cross-section of a far-end ferrule having the arrangement shown in Figure 6a. [Figure 8] This diagram schematically shows an illumination light guide with a near-end ferrule and an illumination device incorporated therein. [Figure 9] This diagram shows a very simple process sequence illustrating the manufacturing method of a lighting guide. [Figure 10] This diagram schematically illustrates a multi-lumen cable for housing various components or functions. [Modes for carrying out the invention]

[0050] Figure 1 schematically shows the structure of the endoscope 1 according to the present invention. Exemplarily, this figure shows a very simplified representation of a simple and flexible endoscope 1, which has a handpiece 10 and a flexible section 20, in which case the flexible section 20 can be inserted, for example, into a body cavity. The figure schematically shows an illumination light guide 30, which has a near-end ferrule 40 provided at the illumination device configured as an LED 60 in the handpiece 10, and a far-end ferrule 50 provided at the end of the flexible section 20. Light from the LED 60 is incident on the end face of the near-end ferrule 40, guided through the illumination light guide 30 to the far-end ferrule 50, and then radiated into the body via a corresponding emission optical system. Imaging components are not shown in Figure 1. These components could be, for example, multiple C-MOS cameras incorporated into the far-end ferrule 50, which electrically transmit image information to a monitor, also not shown. Similarly, an optical fiber image guide can be used to directly transmit image information to a camera or eyepiece optical system. Such an image guide consists of thousands of thin individual glass fibers, each only a few micrometers thick, and these glass fibers transmit image information to each pixel accordingly.

[0051] Depending on the type and application of the endoscope, the following general dimensions can be considered for such a light guide: namely, the length is 100mm to 3000mm, generally 500 to 1000mm, and the light guide diameter is 0.5mm to 5mm, generally 1 to 2mm.

[0052] Figure 2 also shows a very simplified schematic of the endoscope 1 configured as a rigid endoscope. The illumination light guide 30 is shown here within the rigid shaft 25. As previously mentioned, the imaging component or image transmission component is not shown in this figure for the sake of clarity.

[0053] The following describes specific examples or manufacturing methods related to the lighting guide 30. These can also be adapted for use as image guides.

[0054] Figure 3 shows a partial view of the illumination light guide 30, including the far-end ferrule 50. In this example, the illumination light guide 30 consists of an extruded cable 31, in which a fiber bundle 32 is surrounded by a plastic material.

[0055] In this case, the fiber bundle is terminated as follows: The outer sheath of the extruded cable 31 is peeled off at the end, and a clear, transparent ferrule, previously manufactured in an injection molding process, is pressed into the exposed fiber bundle 32 in its housing section 52 as the far end ferrule 50. The ferrule is then fixed in place by a clear, transparent resin that has been previously applied to the ferrule, preferably in the form of an adhesive that rapidly thermally or ultravioletly crosslinks. Thus, the far end face 53 of the fiber bundle 32 is covered with clear, transparent plastic. This type of termination can also be applied to the near end ferrule 40 of the lighting light guide 30. In this example, the near end face 43 can be covered with clear, transparent plastic.

[0056] Furthermore, the near-end ferrule 40 and the far-end ferrule 50 may have mechanical interfaces 44, 54 resulting from the outer contours of these near-end ferrules 40 and far-end ferrules 50. These may be annular grooves, locking projections, notches, flanges, and the like.

[0057] These ferrules can be configured not only as flat end faces, but also as optical elements 51 in the form of lenses (convex or concave), or as end faces irregularly formed for beam shaping. Figure 3 schematically shows a far-end ferrule 50 having an optical element 51 in the form of a dome-shaped lens formed in an injection molding process, which can, for example, focus the emitted light. The functions of the incident ferrule and / or the exit ferrule or the near-end ferrule 40 and / or the far-end ferrule 50 can be incorporated into tool design and implemented, particularly at low cost, thereby enabling exceptionally low-cost termination of the near-end face 43 or the far-end face 53.

[0058] The fiber bundle 32 of the illumination light guide 30, or the fiber bundle 32 of the image guide, may consist of glass fiber (GOF), quartz fiber, or plastic fiber (POF), and the fiber bundle 32 may be surrounded by an extruded sheath as shown in Figure 3, or by a tube or mesh tubing fabric. The plastic sheath of the extruded cable 31 consists of an opaquely colored plastic. In further embodiments, the fiber bundle 32 itself and / or the individual fibers of the fiber bundle 32 may have a conductive coating in at least partially or partially of a section, and / or the plastic sheath may consist of or be formed of a conductive material in at least partially or partially of a section.

[0059] The following table provides a material overview of plastics suitable for the sheath of the cable 31, as well as for the clear, transparent cover of the near end face 43 or the far end face 53, or for the near end ferrule 40 or the far end ferrule 50.

[0060] In 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 Copolymer (SBS, SEBS, SEPS, SEEPS, and MBS) TEP-U or TPU = urethane-based thermoplastic elastomer TPE-V or TPV = thermoplastic vulcanized material, or olefin-based thermoplastic crosslinked elastomer, preferably PP / EPDM

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

[0062] In particular, plastic types TPE-E, TPE-V, and TPE-U are especially important for extrusion molding because they have remarkably good extrusion properties and are well-suited, or remarkably well-suited, especially for medical use. Moreover, in terms of low-cost manufacturing, these materials have relatively favorable material costs. Low-cost plastics such as compounds and formulations consisting of PVC, PP, PE, and TPE-S (SEBS) are indeed remarkably inadequate in terms of temperature resistance in some cases. They usually cannot be used above 100°C. However, since the temperature requirements for disposable endoscopes are considerably lower, these materials are particularly suitable for use as disposable endoscopes because of their low material cost and ease of processing. Rather, a general minimum temperature resistance higher than 133°C to 137°C, which corresponds to the temperature bandwidth for autoclaving reusable or reprocessable medical devices or components, is not required in this case. This is because the sterilization processes common for disposable medical products typically involve processes that proceed only within the room temperature range, up to a maximum of 60°C. An example of a commonly used sterilization method is fumigation with ethylene oxide.

[0063] A group of low- and mid-priced plastics are usually available with a wide bandwidth of elasticity and hardness, or can be manufactured by mixing multiple plastic types to create polycompositions with the desired performance. The advantage of this over "expensive" plastics such as FEP and PVDF is that it allows for the manufacture of lighting guides 30 that have nearly identical properties but differ in flexibility.

[0064] For example, expensive plastics such as FEP, PFA, and PVDF can certainly be used for general purposes and often have high chemical resistance, as well as particularly high sustained temperature resistance. However, combining them with other plastics or mixing them as poly-compounds, for example, to increase flexibility, is only possible in very limited ways.

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

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

[0067] With regard to forming a flat surface as the near end surface 43 or the far end surface 53, in an advantageous embodiment, a casting resin that is particularly low in viscosity and has predetermined self-leveling properties can be used.

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

[0069] Glass fibers can be made of lead-free or heavy metal-free core glass and clad glass, which is particularly preferable in terms of the RoHS Directive, REACH Regulation and medical authorization. Such glass systems for producing lead-free and heavy metal-free fibers, known by the applicant as SCHOTT PURAVIS®, are described in particular in International Publication No. 2013 / 104748 and German Patent Invention No. 102007063463. Rigid lead-free and heavy metal-free optical fiber members are described in German Patent Invention No. 102013208838. For applications in the field of endoscopy, glass fibers with a high NA value, i.e., glass fibers with a light-receiving angle of 2α > 80°, preferably 2α > 100°, are particularly suitable for the purpose of enabling broad illumination on the one hand and optimal light incidence by LED on the other hand. Such fibers are known, for example, as SCHOTT PURAVIS® GOF85 or GOF120.

[0070] Figure 4 partially illustrates an alternative approach for the illumination light guide 30 with a far-end ferrule 50, which can be done similarly for a near-end ferrule 40.

[0071] For this purpose, as already explained in Figure 3, the fiber bundle is, for example, pre-extruded, i.e., the fiber bundle 32 is covered with plastic to become a cable 31 and shortened in length, and then, on the one hand, fed into an injection molding process, in this process the cable section is directly overmolded with transparent plastic, thereby forming a ferrule, in this case a far-end ferrule 50. In order to avoid the fiber ends from spreading, it may be necessary in the first step to grip the cable ends at least at two opposing points with semicircular collets and overmolde them at least partially. Then, in the second injection molding process, it may be conceivable to overmolde the final ferrule geometry. In this way, on the one hand, a clear and transparent cover for the far-end face 53 can be formed, while optionally incorporating the optical function in the form of a molded lens element (optical element 51), and further, optionally, a mechanical interface 54 can be formed with another plastic, which may be of a different type and may be opaque. The same applies to the near-end ferrule 40, in which case these method steps make it possible to manufacture, on the one hand, a clear and transparent cover for the near-end surface 43, possibly together with an integrally molded optical element 41, and also to manufacture a mechanical interface 44.

[0072] Figure 5 shows a variation of the embodiment shown in Figure 3. Where the illumination light guide 30, shown as an extruded cable 31 together with the fiber bundle 32, is located, the far-end ferrule 50, also shown exemplary in this figure, has a central region into which, for example, a camera chip 70 (C-MOS chip) can be incorporated. In this case, the fiber bundle 32 of the illumination light guide 30 is guided and arranged around the camera chip 70 in an annular, at least partially annular, or as at least two partial strands. For this purpose, the accommodating region 52 of the fiber bundle 32 is appropriately widened in a conical shape. The optical element 51 can be integrally molded during the manufacture of the ferrule, or it can be added in a subsequent bonding process. In this way, on the one hand, optimal illumination of the tissue surface to be inspected, especially without shadows, can be achieved, and on the other hand, an imaging optical system for the camera chip 70 can be realized. Similarly, a sensing element, such as a photodiode or similar, can be incorporated to detect specific wavelengths of light scattered from the surface to be inspected.

[0073] Figures 6a and 6c schematically show typical arrangements of the far end faces 53 of the illumination light guide 30 in relation to the camera tip 70, where in these embodiments the far end ferrule 50 forms the end portion of the shaft 25 of the endoscope 1. Figure 6a shows an arrangement in which the camera tip 70 is substantially surrounded by the far end faces 53. Figure 6b shows a far end face 53 that is substantially U-shaped. Figure 6c exemplifies an arrangement in which the periphery of the camera tip 70 is surrounded on both sides by two D-shaped far end faces 53. In addition, there are also far end faces 53 divided into three or four sections, which surround the camera tip 70 as a circular, elliptical, or kidney-shaped exit surface.

[0074] According to this, the geometric arrangement of the far end ferrule 50 is structurally predetermined. Such a ferrule can be manufactured at a particularly low cost by injection molding.

[0075] Figure 7 shows an exemplary cross-sectional view of the far end ferrule 50, following the arrangement of the far end surface 53 and the camera chip 70 shown in Figure 6a.

[0076] For example, in this figure, the far end ferrule 50 is shown as the end of the rigid shaft 25 of the endoscope 1, and this shaft 25 can be formed, for example, as a special steel pipe. In this figure, the far end surface 53 is arranged substantially in an annular manner around a centrally located camera tip 70. Light emitted from here is reflected, for example, from the tissue surface 90 to be examined and captured by the camera tip 70. The camera tip 70 is covered for protection, in which case the cover can be configured as an optical element 51, for example, as a focusing lens. Similarly, a multi-lens arrangement of optical elements 51 is also possible. In this case, the camera tip 70 is in contact with electrical conductors 210, which are guided into the interior of the shaft 25 through through holes 56 in the far end ferrule 50. In this case, a fiber bundle 32, composed of multiple glass fibers with a high NA (receiving angle 2α > 100°), is here spread out in an annular manner and fixed within an annular housing section 52 arranged around the through holes 56. The housing section 52 has walls that are substantially parallel to each other, in order to achieve the most parallel orientation possible for the fibers. Following the housing section 52, the far end ferrule 50 has a conically shaped region to facilitate fiber passage. The fiber bundle 32 is surrounded inside the shaft 25 by a protective sheath 33, which can be an extruded outer sheath, a mesh tube, or a heat-shrink tube. Using a thin-walled PET heat-shrink tube as the protective sheath is particularly advantageous, given the limited space available within the shaft 25. This tube has a wall thickness of less than 10 μm. The far end ferrule 50 optionally has a further mechanical interface 54, for example in the form of a collar, or a diametrical projection as shown, on its outer contour, for the purpose of connecting the far end ferrule 50 to the shaft 25. Furthermore, various adhesive regions 55 are provided, on the one hand for fixing the fibers of the fiber bundle 32, on the other hand for attaching the camera tip 70, or for additionally sealing the through-hole 56 for the electrical conductor 210.The entire far-end ferrule 50 is made of a clear, transparent plastic, such as PC or PMMA, and if an ultraviolet-curable adhesive is used as the adhesive or casting resin for the bonding area 55, it is particularly advantageous in terms of process time and thus cost, especially when the following adhesive or casting resin is used to fix the fiber within the housing section 52, namely, its optical refractive index substantially matches that of the fiber core material, and the deviation of this refractive index is at most ±0.1, preferably at most ±0.05, and furthermore, the refractive index of the ferrule is slightly smaller than the refractive index of the adhesive.

[0077] Such embodiments having these exemplary features can, of course, also be considered for the near-end ferrule 40, in which case the LED 60 can be incorporated instead of the camera chip 70.

[0078] In a modified embodiment not shown, the camera chip 70 may be attached to the far-end ferrule 50 on its rear side, with the far-end surface 53 forming a cover. In this way, improved electrical insulation can be achieved without providing an additional cover member.

[0079] In Figure 8, a near-end ferrule 40 is shown at the location of the illumination light guide 30, and in this case, the LED 60 is incorporated into the near-end ferrule 40 together with the LED controller unit 70. This makes it possible to realize a space-saving light source. In this case, the LED 60 and the LED controller unit 70 are incorporated into the near-end ferrule 40 which is manufactured separately according to Figure 3, and the end of the fiber bundle 32 is attached to or fixed to a housing portion 42 formed inside the near-end ferrule 40. In this case, a clear and transparent cover can be provided on the near-end surface 43 to enable optimal light incidence to the fiber bundle 32, and this cover can be configured as a structure including a condenser lens or an LED chip.

[0080] As shown in Figure 9, an alternative, highly simplified process sequence can be considered in an "endless" process as follows: The pre-extruded cable 31 having the fiber bundle 32 is rewound from the feeder to the winder, the rewounding is stopped at a specific interval, and a double-layered plastic ferrule is overmolded by the first injection molding tool 100. At this point, a double ferrule is formed around the cable 31 by shape bonding without an intermediate layer, and this is separated together with the cable 31 in the subsequent cutting process by the separation device 110. This could also be done immediately after the extrusion process, but only if appropriate measures are taken to match or compensate for the process speed, such as a buffer zone for temporarily storing the extruded cable, as needed. 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 to finalize the ferrule design, here in particular with optically clear, transparent plastic, thereby enabling the subsequent implementation of simple incident or exit optical systems (optical elements 41, 51) at the near end face 43 or far end face 53 of the illumination light guide 30. Alternatively, this can be implemented in a bonding process, in which case additional components, particularly a CMOS camera or sensor, can also be attached together. The advantage in this case is that, on the one hand, a robust ferrule can be manufactured, and in particular, fixing in the tool for the second final overmolding process is also made easier by the formation of appropriate mechanical interfaces 44, 54. This enables the termination of a sealed bundle. Thus, particularly simple illumination light guides can be manufactured in large quantities at a significantly lower cost, which is of great interest, especially in disposable applications and in the consumer sector.

[0081] As schematically shown in Figure 10, in one preferred embodiment, a so-called multi-lumen cable 200 can be manufactured. This multi-lumen cable 200 may have a fiber bundle 32, quartz fibers 220, electrical cables 210, and a fluid duct 230 for guiding a medium such as gas (e.g., nitrogen), water, chemicals, or cleaning fluid. In this case, the quartz fibers 220 can be used, for example, for optical data transmission or control. Multi-lumen tubes are already known from the literature. A particular advantage in this case is that multiple components for guiding light or energy are incorporated, and in this case, these components can achieve high functionality in the smallest space. In particular, in this case, the cable can be formed in a co-extrusion process so that each segment is transparent or opaque as desired, and thus it can also fulfill the role of illumination or optical detection.

[0082] A further alternative to low-cost termination is a crimped ferrule, as described in German Patent Invention No. 102004048741. Alternatively, a plastic crimp or locking sleeve can be used, which is pre-manufactured by injection molding and configured with a foldable hinge (in this case, a film hinge). These ferrules are then lockably attached to the ends of cable sections of extruded cables, and an optically transparent adhesive can then be injected or injected into these ferrules. In this case, UV-curable adhesives are also advantageous. In addition to locking, the ferrules can also be fixed to the cable by laser welding or ultrasonic welding.

[0083] Further methods arise from the elastic properties of the cable. In this case, an extruded cable is cut, followed by lengthening of the cable sheath, and the resulting cavity is filled with an optically clear adhesive, or a pre-fabricated, clear plastic component, or a light guide rod or fiber rod made of glass or plastic is fitted and fixed into the cavity. In addition, the mounting component can be formed by deforming the exposed cable section as desired. In this case, thermoplastic elastomers (TPE), or elastomers such as rubber or silicone are particularly suitable as sheath materials.

[0084] A further low-cost alternative for light guide termination can be partial heating of a gel-filled cable, the purpose of which is to cure the gel therein, thereby cutting the cable, deforming it as needed, or overmolding the ferrule. The cable can also be manufactured by co-extrusion, and this cable may have a transparent section along the cable axis, through which the gel in some sections can be partially cured by ultraviolet light as intended. In this way, an endless process for termination can also be achieved. [Explanation of symbols]

[0085] 1 Endoscope 10 Handpieces 20 Flexible section 25 shaft 30 Lighting Guide 31 Cables 32 fiber bundles 33 Protective Sheath 40 Near-end ferrule 41 Optical elements 42 Accommodation Sections 43 Proximal face 44 Mechanical interface 50 Far end ferrule 51 Optical elements 52 Accommodation Sections 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 disposable endoscope for introduction into the human body or animal body, The disposable endoscope includes at least one illumination light guide (30) and / or image guide for transmitting electromagnetic radiation, wherein the illumination light guide (30) or the image guide each has a near end face (43) for the incidence or emission of electromagnetic radiation and a far end face (53) for the incidence or emission of electromagnetic radiation. The near end surface (43) and the far end surface (53) are made of a transparent plastic material in at least part or in part. The transparent plastic is biocompatible and / or non-cytotoxic to human or animal cell structures over an exposure period of one day or less, and is selected from the group consisting of cyclic olefin copolymers, polycarbonates, 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 crosslinkable or UV-crosslinkable acrylate casting resins, polyurethane casting resins, polyester casting resins, or mixtures thereof and / or combinations thereof. The illumination light guide (30) and / or the image guide's near end face (43) and far end face (53) each further have interfaces (44, 54) in the form of a ferrule contour, The illumination light guide (30) or the image guide is surrounded by an outer covering (31) in at least part or in part of its length. The outer covering portion (31) is made of thermoplastic elastomer. Disposable endoscope.

2. The interface (44, 54) is made of plastic, or is injection molded from plastic to the illumination light guide (30) or the image guide. The plastic differs from the transparent plastic of the near end surface (43) or the far end surface (53) in terms of material, transparency and / or color, at least partially or partially in some sections. A disposable endoscope according to claim 1.

3. The transparent plastic of the near end face (43) and far end face (53) of the illumination light guide (30) and / or the image guide has a surface roughness Ra of 1.0 μm or less. A disposable endoscope according to claim 1 or 2.

4. The transparent plastic of the near end face (43) or far end face (53) of the illumination light guide (30) and / or the image guide has a refractive index substantially corresponding to the refractive index of the core material of the fiber or fiber component used in the illumination light guide (30) or the image guide, and the deviation from the refractive index of the core material is at most ±0.

1. A disposable endoscope according to any one of claims 1 to 3.

5. The illumination light guide (30) or the image guide comprises a single fiber bundle (32) made of glass optical fiber, quartz optical fiber, or plastic optical fiber, and / or a plurality of individual fibers made of these materials, and the illumination light guide (30) or the image guide is surrounded in at least part or part of a section by a tube, heat shrink tubing, or netting tubing, or is protected by the shaft (25) of the endoscope (1). A disposable endoscope according to any one of claims 1 to 4.

6. The outer sheath is made of a further plastic material and is provided in the form of an extruded cable (31). A disposable endoscope according to claim 5.

7. The plastic for the extruded outer covering consists of a translucent, opaque, or colored plastic in at least partially or partially. A disposable endoscope according to claim 6.

8. The illumination light guide (30) or the image guide consists of a flexible or semi-flexible fiber bundle, and the outer sheath is in the form of a rigid sheath in at least part or part of its length. A disposable endoscope according to any one of claims 1 to 7.

9. The illumination light guide (30) or the image guide consists of an extended fiber rod or a pressed fiber rod, forming a rigid illumination light guide (30) or image guide. A disposable endoscope according to any one of claims 1 to 8.

10. The aforementioned fiber, fiber bundle, fiber rod, or pressed fiber rod consists of lead-free or heavy metal-free core glass and clad glass. A disposable endoscope according to claim 4.

11. The fiber, fiber bundle, fiber rod, or pressed fiber rod is made of a glass system having a light-receiving angle 2α greater than 80° with respect to the light to be guided. A disposable endoscope according to claim 4.

12. The near end surface (43) and far end surface (53) having the interfaces (44, 54) are in the form of 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 in the form of a thermosetting or ultraviolet light-curing adhesive, and the adhesive has 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 (30) or the image guide, with a deviation of up to ±0.1 from the refractive index of the core material. The refractive index of the ferrule is slightly smaller than the refractive index of the adhesive or the casting resin. A disposable endoscope according to any one of claims 1 to 11.

13. The ferrule has a housing section (42, 52) for housing a fiber bundle (32), the housing section (42, 52) communicates from a section that is initially conical to a section having substantially parallel side walls, and the ferrule further has a housing for an electronic component, the housing section (42, 52) at least partially encloses the area of ​​the housing for the electronic component. A disposable endoscope according to claim 12.

14. The near end face (43) and far end face (53) having the interface (44, 54) in the form of a ferrule are formed by injection molding on a cable section that has been shortened in length beforehand. In the first step, the cable end is secured at at least two opposing locations using a tool aligned with the outer contour of the cable, and is overmolded with the first plastic in at least part or part of its length. In the second step, the geometry of the ferrule is molded to it by the second plastic, In one of the steps described above, the near end surface (43) and the far end surface (53) are moldable from the transparent plastic. A disposable endoscope according to claim 6 or 7.

15. In a continuous process, the double contour ferrule is overmolded onto a pre-extruded cable (31) at specific intervals according to the final part length, forming interfaces (44, 54), which are then separable in the next process step, and the near end face (43) and the far end face (53) are moldable onto the cable section thus produced using clear plastic in one or more further injection molding processes. A disposable endoscope according to any one of claims 1 to 11.

16. The extruded cable (31) is divided at specific intervals, or the corresponding fiber bundle sections surrounded by a tube or heat shrink tubing are divided according to the final part length. The fiber bundle (32) located inside the section of the extruded cable or the fiber bundle section is offset inward. The space between the end of the fiber bundle and the peripheral edge of the outer sheath or the tube or the peripheral edge of the heat shrink tube is filled with a transparent, self-leveling plastic. A disposable endoscope according to any one of claims 1 to 11.

17. The pre-extruded cable (31) is divided at specific intervals, or the corresponding fiber bundle sections surrounded by a tube or heat shrink tubing are divided according to the final part length. The outer sheath, tube, or heat-shrink tubing of the cable is made longer than the fiber bundle, and the resulting cavity is filled with optically transparent plastic, or a pre-fabricated, cloud-free transparent plastic member, or a light guide rod or fiber rod made of glass or plastic is incorporated and fixed into the cavity. A disposable endoscope according to any one of claims 1 to 11.

18. The section of the outer covering that forms the cavity, the section of the tube or the heat-shrinkable tube is deformed to form a specific light incidence contour or light emission contour after the plastic has hardened or after the plastic member or the light guide rod has been assembled. A disposable endoscope according to claim 17.

19. The illumination light guide (30) or the near end face (43) or far end face (53) of the image guide has further active electronic elements in the form of LEDs (60), laser diodes, sensors or camera chips (70), the active electronic elements can be incorporated into the overmolded ferrule or inserted into the ferrule by locking coupling. A disposable endoscope according to any one of claims 1 to 18.

20. An additional glass or plastic member is provided on the near end surface (43) or the far end surface (53) to cover the active electronic element. A disposable endoscope according to claim 19.

21. The near end surface (43) and the far end surface (53) are forms of optical elements for achieving a specific beam shaping, and have a flat surface, a convex surface, a concave surface, or a free-form surface of any desired topography. A disposable endoscope 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 in the form of a hybrid cable. A disposable endoscope according to any one of claims 1 to 21.

23. The hybrid cable is in the form of a multi-lumen cable (200), which allows for the separate guidance of a fiber bundle (32), individual quartz fibers (220), a medium in the form of a gas or liquid in a fluid duct (230), and / or an electrical conductor (210). A disposable endoscope according to claim 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 rigid plastic at room temperature and forms a rigid shaft (25) of the endoscope (1). A disposable endoscope according to claim 23.

25. The hybrid cable or the multi-lumen cable (200) is manufactured in a co-extrusion process in which some sections are transparent or opaque. A disposable endoscope according to claim 23 or 24.

Images