WO2019185645A1 - Licht- oder bildleitkomponenten für einweg-endoskope - Google Patents

Licht- oder bildleitkomponenten für einweg-endoskope Download PDF

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Publication number
WO2019185645A1
WO2019185645A1 PCT/EP2019/057616 EP2019057616W WO2019185645A1 WO 2019185645 A1 WO2019185645 A1 WO 2019185645A1 EP 2019057616 W EP2019057616 W EP 2019057616W WO 2019185645 A1 WO2019185645 A1 WO 2019185645A1
Authority
WO
WIPO (PCT)
Prior art keywords
diagnostic
surgical
plastic
fiber
therapeutic device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2019/057616
Other languages
German (de)
English (en)
French (fr)
Inventor
Bernd Schultheis
Björn Bleisinger
Andreas Dietrich
Markus Kappel
Hubertus Russert
Martin Cramer
Thomas Weingärtner
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Schott AG
Original Assignee
Schott AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Schott AG filed Critical Schott AG
Priority to JP2020552310A priority Critical patent/JP7431745B2/ja
Priority to EP19714192.2A priority patent/EP3773127B1/de
Priority to CN201980023184.4A priority patent/CN111936028B/zh
Publication of WO2019185645A1 publication Critical patent/WO2019185645A1/de
Priority to US17/037,402 priority patent/US11510553B2/en
Anticipated expiration legal-status Critical
Priority to JP2023187607A priority patent/JP2024010148A/ja
Priority to JP2025100228A priority patent/JP2025134817A/ja
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064Constructional details of the endoscope body
    • A61B1/00103Constructional details of the endoscope body designed for single use
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064Constructional details of the endoscope body
    • A61B1/00071Insertion part of the endoscope body
    • A61B1/0008Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00096Optical elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064Constructional details of the endoscope body
    • A61B1/0011Manufacturing of endoscope parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00112Connection or coupling means
    • A61B1/00117Optical cables in or with an endoscope
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00112Connection or coupling means
    • A61B1/00121Connectors, fasteners and adapters, e.g. on the endoscope handle
    • A61B1/00126Connectors, fasteners and adapters, e.g. on the endoscope handle optical, e.g. for light supply cables
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00163Optical arrangements
    • A61B1/00165Optical arrangements with light-conductive means, e.g. fibre optics
    • A61B1/00167Details of optical fibre bundles, e.g. shape or fibre distribution
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00163Optical arrangements
    • A61B1/00165Optical arrangements with light-conductive means, e.g. fibre optics
    • A61B1/0017Details of single optical fibres, e.g. material or cladding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/07Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements using light-conductive means, e.g. optical fibres
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/14Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
    • B29C45/14336Coating a portion of the article, e.g. the edge of the article
    • B29C45/14426Coating the end of wire-like or rod-like or cable-like or blade-like or belt-like articles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29DPRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D11/00Producing optical elements, e.g. lenses or prisms
    • B29D11/00663Production of light guides
    • GPHYSICS
    • G02OPTICS
    • G02BOPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B23/00Telescopes, e.g. binoculars; Periscopes; Instruments for viewing the inside of hollow bodies; Viewfinders; Optical aiming or sighting devices
    • G02B23/24Instruments or systems for viewing the inside of hollow bodies, e.g. fibrescopes
    • G02B23/2407Optical details
    • G02B23/2461Illumination
    • G02B23/2469Illumination using optical fibres
    • GPHYSICS
    • G02OPTICS
    • G02BOPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B23/00Telescopes, e.g. binoculars; Periscopes; Instruments for viewing the inside of hollow bodies; Viewfinders; Optical aiming or sighting devices
    • G02B23/24Instruments or systems for viewing the inside of hollow bodies, e.g. fibrescopes
    • G02B23/26Instruments or systems for viewing the inside of hollow bodies, e.g. fibrescopes using light guides
    • GPHYSICS
    • G02OPTICS
    • G02BOPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B6/00Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings
    • G02B6/04Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings formed by bundles of fibres
    • G02B6/06Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings formed by bundles of fibres the relative position of the fibres being the same at both ends, e.g. for transporting images
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2995/00Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
    • B29K2995/0018Properties of moulding materials, reinforcements, fillers, preformed parts or moulds having particular optical properties, e.g. fluorescent or phosphorescent
    • B29K2995/0026Transparent
    • GPHYSICS
    • G02OPTICS
    • G02BOPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B6/00Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings
    • G02B6/0001Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings specially adapted for lighting devices or systems
    • G02B6/0005Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings specially adapted for lighting devices or systems the light guides being of the fibre type
    • G02B6/0006Coupling light into the fibre
    • GPHYSICS
    • G02OPTICS
    • G02BOPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B6/00Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings
    • G02B6/0001Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings specially adapted for lighting devices or systems
    • G02B6/0005Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings specially adapted for lighting devices or systems the light guides being of the fibre type
    • G02B6/0008Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings specially adapted for lighting devices or systems the light guides being of the fibre type the light being emitted at the end of the fibre
    • GPHYSICS
    • G02OPTICS
    • G02BOPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B6/00Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings
    • G02B6/04Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings formed by bundles of fibres
    • GPHYSICS
    • G02OPTICS
    • G02BOPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B6/00Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings
    • G02B6/24Coupling light guides
    • G02B6/26Optical coupling means
    • G02B6/262Optical details of coupling light into, or out of, or between fibre ends, e.g. special fibre end shapes or associated optical elements
    • GPHYSICS
    • G02OPTICS
    • G02BOPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B6/00Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings
    • G02B6/24Coupling light guides
    • G02B6/26Optical coupling means
    • G02B6/32Optical coupling means having lens focusing means positioned between opposed fibre ends
    • G02B6/325Optical coupling means having lens focusing means positioned between opposed fibre ends comprising a transparent member, e.g. window, protective plate
    • GPHYSICS
    • G02OPTICS
    • G02BOPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B6/00Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings
    • G02B6/24Coupling light guides
    • G02B6/36Mechanical coupling means
    • G02B6/3616Holders, macro size fixtures for mechanically holding or positioning fibres, e.g. on an optical bench
    • G02B6/3624Fibre head, e.g. fibre probe termination

Definitions

  • 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 human or animal blood samples or other body cells, in particular an endoscope or a disposable endoscope, including at least one Illuminating optical fiber and / or image conductor for transmission
  • the illumination light guide or the image guide each having a proximal end surface for coupling or decoupling electromagnetic radiation and a distal end surface for coupling or coupling electromagnetic radiation.
  • Disposable endoscopes or "disposable endoscopes" are increasingly being used today, in particular to increase patient safety during medical examinations, therapies and / or minimally invasive interventions, in which contamination is prevented by a single use.
  • previous endoscopes have been designed so that they can be processed in the sense of medical technology, that is cleanable, sterilizable and above all
  • Document US 3581738 A1 discloses a disposable endoscope comprising a body of synthetic resinous material having a generally tubular side wall forming a speculum and a unitary elongated light guiding element embedded in the side wall, the element being formed of a light guiding material coated with a transparent material having a refractive index different from that of the optical material, the body being formed of two mating halves divided axially by the endoscope, each half having an element encircling element.
  • the document US 4964710 A1 describes a rigid endoscope, which is equipped with a lens system, an ocular lens and an intermediate relay lens.
  • the relay system is a hybrid system that handles both plastic and plastic
  • the plastic elements consist of a uniform plurality (N) of axially aligned lenses, each having a length in the same order as their diameter.
  • the plastic lenses are a plurality (N minus 1) of axially oriented glass plane cylinders whose faces are polished.
  • the document EP 1890173 A1 describes a method for producing a
  • Light guide as it is used in such endoscopes.
  • a plurality of optical fibers are bundled and then cut the fiber bundle on a part of a mouthpiece, which at an intermediate part of the
  • Fiber bundle is attached. So the fiber bundle is in a first optical
  • One of the main components for imaging and illumination are illumination light guides or image conductors. These are currently being mounted or processed in relatively complex process steps. Often it is complex mechanical components, sometimes combined with optical elements, such as lenses, that incorporate these light and image conductors, and sometimes it is also complex processing steps, such as the grinding and polishing of the end surface, make the current illumination fiber or image guide comparatively expensive ,
  • Endoscopes must not exceed maximum limits. For example, in applications at the heart of a max. Leakage current of 10 mA required, which corresponds to a CF classification (see EN 60601 -1, 3rd edition Tab. 3).
  • proximal and / or distal end surfaces of at least partially or partially transparent
  • Suitable plastics are plastics at least one of the material classes cycloolefin copolymers, polycarbonates, polyethylene teraphthalates, perfluoroalkoxy polymers, polyvinylidene fluorides,
  • Polymethyl methacrylates polymethylmethacrylimides
  • Thermoplastic plastics which can be easily injection molded and transparent, such as PC, PMMA, COC etc., but also plastics that can be applied as casting resins. In this way, correspondingly smooth surfaces with a very low roughness value can be realized.
  • plastics as
  • Endoscopes may be provided that the proximal and / or the distal
  • End surface also has a mechanical interface in the form of a remplilsenkontur which consists of plastic or molded by plastic injection to the illumination fiber or image guide, said plastic from the transparent plastic of the proximal or distal end surface at least partially or in sections with respect to material, transparency and / or color can differ.
  • a remplilsenkontur which consists of plastic or molded by plastic injection to the illumination fiber or image guide, said plastic from the transparent plastic of the proximal or distal end surface at least partially or in sections with respect to material, transparency and / or color can differ.
  • it can also be realized locking connections that allow quick installation, which in turn can reduce manufacturing costs.
  • Plastic of the proximal and / or distal end surfaces a typical
  • the transparent plastic of the proximal or distal end surfaces has a refractive index substantially that of the core material of the fibers used in the illumination fiber or image guide used or
  • Fiber components corresponds, reflection losses can be minimized, which leads to an increase in illuminance in the illumination fibers and suppresses artifacts due to reflections in image guides. If the deviation between the refractive index of the fibers or the fiber components and the clear transparent plastic is at most ⁇ 0.1, good results can already be achieved. With a deviation of maximum ⁇ 0.05, the refractive indices are already almost perfectly matched, so that the reflection losses in the
  • the illumination light guides and / or image guides for endoscopes comprise fiber bundles of glass fibers, quartz fibers or plastic fibers.
  • Glass fibers are particularly suitable for the transmission of light or image information in the visible spectral range to the near IR range. This also applies to plastic fibers, although the application length of the plastic fibers to typically a few centimeters to about max. 1 m are limited. Quartz fibers are used in particular when the wavelength of use extends into the IR range to typically 2.2 ⁇ m or when light portions in the near UV range below about 400 nm are also to be used. This is of particular interest in fluorescence applications.
  • Plastics are used, as in the single-use applications no particular thermal / chemical treatment processes, such as autoclaving (typically 130 to 140 ° C in saturated water vapor) and / or thermal disinfector processes (up to 95 ° C, detergent with pH 11) required are. l.d.R. become
  • STERAD plasma-based gas sterilization
  • the plastic for the extruded jacket may consist of an at least partially or partially translucent, opaque or colored plastic. This can be made possible for example with a laterally radiating optical fiber lateral lighting on the endoscope.
  • Running fiber bundles and the jacket at least partially or partially executed as a rigid shell, so that a shaft for a rigid endoscope can be realized.
  • the invention also relates to rigid fiber optic light or image conductors, for example in the form of drawn fiber rods or in the form of pressed
  • Fiber rods which is also advantageously based on the same glass systems, as they are used for corresponding flexible glass fiber bundles.
  • the glass fibers, fiber rods or pressed fiber rods consist of a Pb- or heavy-metal-free core glass and cladding glass.
  • such fiber systems offer a high transmission in the VIS spectral range and show high color fidelity due to the comparatively high transmission in the blue spectral range, which is particularly important in the medical evaluation of tissue. Often, only minor color differences of the tissue decide whether it is a benign or malignant tissue change.
  • the adhesive is designed as a thermosetting or UV-light-curing adhesive having an optical refractive index substantially equal to that of the core material used in the illumination light guide or image guide fibers or fiber components and the deviation to a maximum of ⁇ 0 , 1, preferably at most ⁇ 0.05 and wherein the refractive index of the sleeve is slightly less than that of the adhesive.
  • the refractive index of the sleeve is slightly less than that of the adhesive.
  • Such sleeves can be cheaply produced as an injection molded part, here in particular as a precision injection molded part.
  • End surface in terms of their topography can be implemented in the injection molding tool.
  • Used UV light-curing adhesive short process times can be realized in the range of typically less than 60 s in the mounting or gluing of the fiber components, which can also reduce the manufacturing costs.
  • the sleeve have receiving portions for receiving fiber bundles, which open from a first slightly conical section in a section in the
  • the sleeve further has receptacles for electronic components, and these receiving portions enclose the region of the receptacle for electronic components at least partially.
  • arrangements of fibers and electronic components can be realized in which an electronic component is enclosed by a proximal or distal end face thereof.
  • substantially U-shaped arrangements or arrangements are conceivable, or arrangements in which the electronic component is bordered by two D-shaped distal or proximal end faces opposite one another.
  • 3- or 4-divided distal or proximal end surfaces are conceivable, which enclose the electronic component as circular or oval or kidney-shaped exit surfaces.
  • Fiber fixation and alignment as well as the arrangement of the end surfaces can be incorporated into the technical design of the sleeve or implemented in the tool design. Due to the very small dimensions of this particular precision injection molding tools or machines are advantageous.
  • An alternative embodiment provides that the distal and / or proximal end surface is molded with the mechanical interface in the form of a sleeve by means of injection molding on previously cut cable sections, this process can be designed as a two-stage process, wherein in a first step
  • a second plastic wherein in one of the steps, the distal and / or proximal end surface is formed with the clear transparent plastic.
  • a two-step process can prevent the fibers splitting uncontrollably during the injection molding process, which usually involves pressures of many 10 bar.
  • With the first process step at least one kind of fixed collar can be created at the end of the cable section around the cable, which prevents the splicing.
  • plastics for this purpose also opaque or colored plastics can be used.
  • the actual proximal and / or distal end surfaces are then produced with the clearly transparent plastic.
  • a further alternative embodiment provides that a previously extruded cable is divided at certain intervals corresponding to the final component length, or a corresponding fiber bundle section, which is surrounded by a tube or shrink tube, and the fiber bundles present in the interior of the extruded cable section or fiber bundle section inwards are shifted and the space between fiber bundle end and sheath edge or edge of the hose or shrink tube with a clear transparent self-leveling
  • Plastic is filled.
  • with casting resins can thus light entrance or light exit surfaces realize that form a sufficiently smooth surface.
  • a previously extruded cable is divided at certain intervals corresponding to the final component length or a corresponding fiber bundle portion which is surrounded by a tube or shrink tubing, and the cable sheath, the hose or shrink tubing over the fiber bundle lengthened and the resulting cavity filled with optically clear plastic or a prefabricated clear plastic part or a plastic
  • Light guide rod or fiber rod made of glass or plastic is inserted and fixed in the cavity. Even with this, corresponding light entry or light exit surfaces can be realized.
  • the jacket section, tube or shrink tube section forming the cavity is deformed and forms a specific light entry or exit contour after curing of the plastic or after insertion of the plastic part or the Lichtleitstabs.
  • This can be done using special tools.
  • This can produce different proximal or distal contours, which can be used for example for receiving a camera chip or a working channel at the distal end.
  • Particularly advantageous in terms of a cost-effective but also space-saving optical fiber design is when active electronic elements in the form of LEDs, sensors or camera chips can be integrated into the molded sleeves or attached to them by means of a snap-in connection.
  • LED elements can be integrated, for example, in the proximal end sleeve and thus enable a particularly high coupling efficiency, which is particularly advantageous in terms of illuminance at the distal end of the light guide noticeable.
  • RGB LEDs can be used as LEDs, which can be switched between different colors. This allows not only a normal viewing of tissue but also certain diagnostics
  • proximal and / or distal end surfaces are designed as optical element for achieving a certain beam shaping, and thereby have a plane, convex, concave surface or one with respect to their
  • the proximal sleeve can be equipped with condenser lenses in order, for example, to focus the light of the generally broadly emitting LEDs and corresponding to the numerical aperture of the fibers (between 0.55 and 0.70; for example
  • SCHOTT PURAVIS ® GOF85 with a numerical aperture of 0.68
  • a corresponding design of a convex lens at the distal end can also be used to advantage, for example, an imaging optics for the Realize camera chip.
  • a wide-angle emission characteristic for example with a spherical or annular emission characteristic, can be made possible at the distal end of the optical waveguide with optical elements formed in this way.
  • a spherical radiation characteristic for example, a homogeneous illumination of body cavities can take place.
  • a preferred embodiment provides that additional elements made of glass or plastic are provided for covering the active electronic elements on the proximal or distal end surfaces. In this way, an additional electrical insulation and / or shielding can be achieved with which, in particular, applications with increased insulation or leakage current requirements can be addressed.
  • the distal sleeve with the camera chip is designed as a two-component injection-molded part, the section accommodating the camera chip being in the form of a black-colored or opaque plastic material and the distal end surface being made of transparent plastic Plastic exists.
  • the multi-lumen cable is a flexible portion of the endoscope or the multi-lumen cable from a rigid at room temperature plastic and thus forms a rigid shaft of the endoscope. This makes it particularly cost-effective to realize flexible or rigid disposable endoscopes.
  • the multi-lumen cable is designed to be segmented transparent or opaque in a coextrusion process, it is also possible, for example, to perform illumination or optical detection tasks.
  • the multi-lumen cable can be embodied at least partially or in sections, even within individual lumens, from electrically conductive materials, for example correspondingly filled plastics, and / or surrounded by electrically conductive materials.
  • disposable endoscopes here includes all medical devices with which on the one hand light is directed into the interior of the body and on the other hand by means of optics, image conductors or camera chips image information is output to the surgeon. Examples of this are angioscopes for vascular examinations with flexible endoscope, laparoscopes for examinations in the abdominal cavity and arthroscopes for joint examinations with rigid endoscopes, as well as
  • Ear endoscope, rhino endoscope, sinusoidal or osopharyngoscope for
  • illumination fiber provides in addition to the use in the medical device field also for use in in vitro diagnostic equipment before.
  • light guides can also be used as a detector light guide.
  • illumination or detector light guides are used in one device, for example, for parallel examinations on blood samples.
  • FIG. 1 schematically greatly simplifies a disposable endoscope, which is designed as a flexible endoscope
  • FIG. 3 schematically shows an illumination light guide with a glued-on distal sleeve
  • FIG. 4 schematically shows an illumination light guide with a molded-on distal sleeve
  • FIG. 5 schematically shows an illumination light guide with a distal sleeve
  • FIG. 7 in a schematic sectional view of a distal sleeve with an arrangement like.
  • FIG. 6a
  • FIG. 8 schematically shows an illumination light guide with proximal sleeve and illumination device integrated therein, FIG.
  • FIG. 9 shows in a greatly simplified process sequence a Fierstellmethode of a lighting fiber
  • Figure 10 schematically shows a multi-lumen cable for receiving different
  • FIG 2 also shows schematically and greatly simplified an endoscope 1, which is designed as a rigid endoscope 1.
  • the illumination light guide 30 is guided here in a rigid shaft 25.
  • the imaging or image-transmitting components, as described above, are not shown for the sake of clarity.
  • FIG. 3 shows a lighting light guide 30 in a partial view with a distal sleeve 50.
  • the illumination light guide 30 in this case consists of an extruded cable 31, wherein a sheath of plastic surrounds a fiber bundle 32.
  • the fiber bundle termination takes place here in such a way that the jacket of the extruded cable 31 is insulated at the end, and a clear sleeve, previously made in an injection molding process, is pushed with its receiving portion 52 onto the exposed fiber bundle 32 as a distal sleeve 50 and with
  • a clear sleeve previously made in an injection molding process
  • the sleeve is fixed in this sleeve applied clear transparent resin.
  • the distal end surface 53 of the fiber bundle 32 is covered with a clear transparent plastic.
  • This type of termination can also be on the proximal sleeve 40 of the illumination light guide 30 transmitted. In this case, the proximal end face 43 can thus be covered with a clear, transparent plastic.
  • the fiber bundle 32 of the illumination light guide 30 or the image guide may consist of glass fibers (GOF), quartz fibers or plastic fibers (POF), which is surrounded by an extruded jacket, as shown in Figure 3, a hose or mesh tube fabric.
  • the jacket plastic of the extruded cable 31 consists of an opaque colored plastic.
  • the fiber bundle 32 itself and / or its individual fibers at least partially or in sections an electrically conductive coating
  • the sheath plastic at least partially or in sections be made of or with an electrically conductive material.
  • TPE-A or TPA Thermoplastic Co-Polyamides
  • TPE-E or TPC Thermoplastic Polyester Elastomers / Thermoplastic Co-Polyester
  • TPE-0 or TPO olefin-based thermoplastic elastomers
  • TPE-S or TPS styrene block copolymers (SBS, SEBS, SEPS, SEEPS and MBS)
  • TPE-U or TPU urethane-based thermoplastic elastomers
  • Olefin-based thermoplastic elastomers predominantly PP / EPDM.
  • Disposable endoscopes significantly lower, so these materials are also due to their low material cost and ease of processing for this application are particularly suitable.
  • Disposable medical devices usual sterilization processes, i.d.R. processes
  • the group of inexpensive and medium-term plastics are usually usually available in a wide range in terms of their elasticity and hardness or can be prepared by mixing several types of plastic to a poly blend of desired performance. This has the advantage over the "expensive" plastics, such as FEP, PVDF, that this lighting optical 30 with almost identical properties, however
  • the expensive plastics for example FEP, PFA, PVDF, although universally applicable and have in particular a high continuous temperature resistance, often combined with a high chemical resistance, but are very limited to combine with other plastics or as a poly-blend to mix for example, to increase flexibility.
  • the transparent sleeves in addition to PC and PA and COC is very well suited because it has a high optical quality in terms of high transparency and low turbidity and is used in particular for syringes and pharmaceutical containers. These are also available in particular as biocompatible variants.
  • the glass fiber bundles or the plastic fiber optic cables can also be used in a thin-walled hose or in a heat shrink tube for their protection.
  • shrink tubing extremely thin-walled shrink tubing can be used in an advantageous manner (Example: PET shrink tubing with 6 pm wall thickness).
  • thin-walled mesh fabric tubes of glass silk or plastic silk are also conceivable.
  • FIG. 4 shows a detail of an alternative approach of a
  • Illuminating optical fiber 30 with distal sleeve 50 which may be performed in the same way for the proximal sleeve 40.
  • the fiber bundles for example, previously extruded, that is, the fiber bundle 32 coated with a plastic to a cable 31, cut to length and then fed either an injection molding process in which the cable sections molded directly to the transparent plastic while a sleeve, here a distal sleeve 50, is pronounced.
  • the cable end are packed at least two opposite points by means of semi-circular collets and at least partially overmoulded.
  • a second injection molding process can then be provided to inject the final sleeve geometry.
  • FIG. 5 shows a variant of the embodiment shown in FIG.
  • the receiving region 52 of the fiber bundle 32 is correspondingly flared.
  • optical elements 51 can be formed in the Fier ein the sleeve, or can in a
  • FIG. 6 a shows an arrangement in which the camera chip 70 is essentially enclosed by the distal end surface 53.
  • FIG. 6b shows a substantially U-shaped distal end surface 53.
  • FIG. 6c shows by way of example an arrangement in which the camera chip 70 is surrounded by two D-shaped distal end surfaces 53 opposite one another.
  • 3- or 4-divided distal end surfaces 53 are conceivable that the
  • Camera chip 70 as a circular or oval or kidney-shaped
  • the geometric arrangement is correspondingly predetermined structurally in the distal sleeve 50.
  • Such sleeves can be produced by injection molding particularly cost.
  • FIG. 7 shows, for example, a distal sleeve 50 in the sectional view
  • distal end surface 53 and camera chip 70 shown in FIG. 6 a the distal sleeve 50 is shown as a conclusion of a rigid shaft 25 of the endoscope 1, which may be formed, for example, as a stainless steel tube.
  • the distal end face 53 is arranged substantially annularly around the centrally arranged camera chip 70. The light emitted thereby is reflected, for example, by a tissue surface 90 to be examined and collected by the camera chip 70.
  • the camera chip 70 is on the one hand covered for protection, wherein the cover as an optical element 51, for example as
  • Condensing lens can be executed. Multilinear arrangements are also conceivable as the optical element 51.
  • the camera chip 70 is in this case contacted by electrical leads 210, which are guided through a passage 56 in the distal sleeve 50 into the interior of the shaft 25.
  • the fiber bundle 32 here made of glass fibers with high NA (acceptance angle 2a> 100 °), here is fanned out annularly and arranged in a arranged around the bushing 56 annular
  • Receiving portion 52 fixed.
  • This receiving portion 52 in this case has almost parallel to each other walls, to allow possible parallel alignment of the fibers as possible here.
  • the distal sleeve 50 has conically shaped portions to facilitate threading of the fibers.
  • the fiber bundle 32 is surrounded in the interior of the shaft 25 with a protective cover 33 which an extruded jacket, a mesh hose or a
  • Heat shrink tubing can be. With regard to the only very small space in the shaft 25, it is particularly advantageous if, for example, a protective cover
  • Conduction 56 of the electrical lines 210 It is particularly advantageous in terms of process times and thus the cost when the entire distal sleeve 50 is made of a clear transparent plastic, for example made of PC or PMMA, and as an adhesive or casting resin for the adhesive areas 55 a UV-curing adhesive is used, wherein in particular in the receiving portion 52 for fixing the fibers, an adhesive or a casting resin is used, the optical refractive index substantially adapted to that of the core material of the fibers and a deviation of these refractive indices maximum ⁇ 0.1, preferably maximum ⁇ 0.05 and wherein the refractive index of the sleeve is slightly less than that of the adhesive.
  • the camera chip 70 is mounted on the rear in the distal sleeve 50 and the distal one
  • End face 53 forms a cover. This can be done without additional
  • FIG. 8 shows a proximal sleeve 40 on the illumination light guide 30, in which a LED 60 with an LED controller unit 70 is integrated into the proximal sleeve 40.
  • LED 60 and LED controller unit 70 are in a happy.
  • FIG. 3 wherein the end of the fiber bundle 32 is mounted or fixed in a receptacle 42 which is formed in the proximal sleeve 40.
  • the proximal end face 43 can be provided with a clearly transparent cover, which can be designed as a condenser lens or the LED chip-comprising structure, in order to allow optimal light coupling into the fiber bundle 32.
  • Injection mold 100 is a double-molded plastic sleeve is sprayed. At this point, a double-sleeve is impressed around the cable 31 in a form-fitting manner without an intermediate layer, which by means of separating devices 110 in one subsequent cut process with the cable 31 is disconnected. This is also conceivable directly after the extrusion process, insofar as appropriate, if appropriate
  • Measures are provided to adjust the process speeds or compensate, for example, a buffer zone for
  • Steps are encapsulated by means of a second and a third injection molding tool 120, 130 with the final sleeve design and here in particular with optically clear transparent plastic, so that then including simple
  • Entry or exit optics (optical elements 41, 51) on the proximal and distal end surfaces 43, 53 of the illumination light guide 30 can be realized.
  • this can also be realized in an adhesive process, wherein other components, including, for example, C-MOS cameras or sensors, can be mounted with it.
  • other components including, for example, C-MOS cameras or sensors.
  • multi-lumen cables 200 can be produced, as shown schematically in FIG. These may include fiber bundles 32, quartz fibers 220, electrical cables 210, and a fluid channel 230 for media delivery of gas (eg, nitrogen), water, medications, and rinsing fluids, respectively.
  • the quartz fibers 220 can be used, for example, for optical data transfer or for controlling.
  • Multilumen hoses are already known from the literature. Particularly advantageous here is the integration of light or energy-carrying components, which allow a high functionality here in the smallest space.
  • the cables are targeted in a coextrusion process segmental transparent or opaque and thus can perform lighting or optical detection tasks.
  • crimped sleeves as described in DE 102004048741 B3.
  • plastic crimping or snap-on sleeves which have previously been produced by injection molding and foldable with a folding hinge (here film
  • Hinge are executed. These sleeves are then mounted lockable at the end of the cable section of the extruded cable and can then be poured or ejected with optically transparent adhesive. Also advantageous here are UV-curing adhesives. In addition to a lock can also be provided that the sleeves are fixed by laser welding, ultrasonic welding on the cable.
  • Another method results from the elastic properties of a cable. It is provided to cut an extruded cable and then lengthen the cable sheath and fill the resulting cavity with optically clear adhesive or use a prefabricated clear plastic part or a light guide rod or fiber rod made of glass or plastic in the cavity and fix. In addition, by deliberately deforming the exposed
  • Cable sections are formed a fastener.
  • thermoplastic elastomers TPE
  • elastomers such as rubber or silicone
  • shell material elastomers

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JP2020552310A JP7431745B2 (ja) 2018-03-29 2019-03-26 使い捨て内視鏡のためのライトガイドコンポーネントまたはイメージガイドコンポーネント
EP19714192.2A EP3773127B1 (de) 2018-03-29 2019-03-26 Licht- oder bildleitkomponenten für einweg-endoskope
CN201980023184.4A CN111936028B (zh) 2018-03-29 2019-03-26 用于一次性内窥镜的光或图像引导部件
US17/037,402 US11510553B2 (en) 2018-03-29 2020-09-29 Light guide or image guide components for disposable endoscopes
JP2023187607A JP2024010148A (ja) 2018-03-29 2023-11-01 使い捨て内視鏡のためのライトガイドコンポーネントまたはイメージガイドコンポーネント
JP2025100228A JP2025134817A (ja) 2018-03-29 2025-06-16 使い捨て内視鏡のためのライトガイドコンポーネントまたはイメージガイドコンポーネント

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JP2021146213A (ja) * 2020-03-13 2021-09-27 ショット アクチエンゲゼルシャフトSchott AG 内視鏡および使い捨て内視鏡システム
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JP2025134817A (ja) 2025-09-17
CN111936028A (zh) 2020-11-13
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JP2021517049A (ja) 2021-07-15
US20210022588A1 (en) 2021-01-28
JP2024010148A (ja) 2024-01-23
DE102018107523A1 (de) 2019-10-02
US11510553B2 (en) 2022-11-29
JP7431745B2 (ja) 2024-02-15
EP3773127A1 (de) 2021-02-17

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