WO2018219391A1 - Apex pour système de guidage d'ondes lumineuses, instrument chirurgical et unité laser présentant ledit apex - Google Patents

Apex pour système de guidage d'ondes lumineuses, instrument chirurgical et unité laser présentant ledit apex Download PDF

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Publication number
WO2018219391A1
WO2018219391A1 PCT/DE2018/100437 DE2018100437W WO2018219391A1 WO 2018219391 A1 WO2018219391 A1 WO 2018219391A1 DE 2018100437 W DE2018100437 W DE 2018100437W WO 2018219391 A1 WO2018219391 A1 WO 2018219391A1
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WO
WIPO (PCT)
Prior art keywords
apex
light
fiber
optical waveguide
optical
Prior art date
Application number
PCT/DE2018/100437
Other languages
German (de)
English (en)
Inventor
Ruzin AGANOGLU
Stephan Kufner
Original Assignee
Lab-On-Fiber Gmbh
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Application filed by Lab-On-Fiber Gmbh filed Critical Lab-On-Fiber Gmbh
Publication of WO2018219391A1 publication Critical patent/WO2018219391A1/fr

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Classifications

    • G—PHYSICS
    • G02—OPTICS
    • G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B6/00—Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings
    • G02B6/24—Coupling light guides
    • G02B6/36—Mechanical coupling means
    • G02B6/3616—Holders, macro size fixtures for mechanically holding or positioning fibres, e.g. on an optical bench
    • G02B6/3624—Fibre head, e.g. fibre probe termination
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • A61B18/245—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter for removing obstructions in blood vessels or calculi
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00057—Light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00386—Coronary vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00404—Blood vessels other than those in or around the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/0063—Sealing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00779—Power or energy
    • A61B2018/00785—Reflected power
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B2018/2238—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with means for selectively laterally deflecting the tip of the fibre
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B2018/2255—Optical elements at the distal end of probe tips
    • A61B2018/2261—Optical elements at the distal end of probe tips with scattering, diffusion or dispersion of light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B2018/2255—Optical elements at the distal end of probe tips
    • A61B2018/2266—Optical elements at the distal end of probe tips with a lens, e.g. ball tipped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B2018/2255—Optical elements at the distal end of probe tips
    • A61B2018/2272—Optical elements at the distal end of probe tips with reflective or refractive surfaces for deflecting the beam
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B2018/2255—Optical elements at the distal end of probe tips
    • A61B2018/2272—Optical elements at the distal end of probe tips with reflective or refractive surfaces for deflecting the beam
    • A61B2018/2277—Optical elements at the distal end of probe tips with reflective or refractive surfaces for deflecting the beam with refractive surfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B2018/2255—Optical elements at the distal end of probe tips
    • A61B2018/2294—Optical elements at the distal end of probe tips with a diffraction grating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00885—Methods or devices for eye surgery using laser for treating a particular disease
    • A61F2009/00891—Glaucoma
    • G—PHYSICS
    • G02—OPTICS
    • G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B6/00—Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings
    • G02B6/0001—Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings specially adapted for lighting devices or systems
    • G02B6/0005—Light 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
    • G02B6/0008—Light 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
    • G—PHYSICS
    • G02—OPTICS
    • G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B6/00—Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings
    • G02B6/02—Optical fibres with cladding with or without a coating
    • G02B6/02057—Optical fibres with cladding with or without a coating comprising gratings
    • G02B6/02076—Refractive index modulation gratings, e.g. Bragg gratings
    • G02B6/0208—Refractive index modulation gratings, e.g. Bragg gratings characterised by their structure, wavelength response

Definitions

  • the invention relates to an apex for an optical waveguide arrangement which directs light for a therapeutic treatment of the human or animal body from a proximal end to a distal end, a surgical instrument and a laser unit comprising this apex.
  • the invention relates to the use of optical waveguide arrangements which have an optical grating, for example in the form of a fiber Bragg grating, for constructing such an apex.
  • High-energy laser light has been increasingly used therapeutically for several years in numerous application examples.
  • laser light is used as a scalpel replacement, but also for the treatment of tumors or for the treatment of inflammatory processes.
  • Eventually vessels will be obliterated if necessary or reopened by ablative therapy.
  • the number of therapeutic missions is steadily increasing.
  • this optical fiber tip or apex has a special shape that can be adapted to the therapeutic features by appropriate shaping of the distal end. Since these apices can certainly have a complex shape, these are usually molded from plastic and holes and threads are introduced after injection into the respective apex. Plastic apices are not suitable for transmitting laser light for ablation or cutting biological tissue, as absorption of the laser light by the plastic would destroy the apex itself. Clear plastics are usually polymethyl methacrylate (PMMA), polycarbonate (PC) or polystyrene (PS).
  • PMMA polymethyl methacrylate
  • PC polycarbonate
  • PS polystyrene
  • the apex thus constructed allows the ophthalmic surgeon to reproducibly apply the optical waveguide to the human eye so that both the focal point of a lens incorporated in the distal end of the optical waveguide and the angle at which the laser light is incident on the human eye, can be reproduced during manual placement between individual treatments.
  • the use of this apex thus improves the treatment success compared to a hands-free placement of an unshaped optical fiber tip.
  • PCT International Application WO 2014/162268 A1 discloses an apex with a hockey stick shape intended to improve the application of laser light to laser ablation of human tissues.
  • laser light is derived from the apex through internal reflection and refraction.
  • the apex disclosed therein is suitable for the ablation of tissue of larger organs, wherein in WO 2014/162268 A1 as an application example the treatment is called benign prostatic hyperplasia and differs in its structure from the apex presented here.
  • the object of the invention is to provide a universal system for the therapeutic use of light, which allows a variety of therapeutic uses, that is versatile and still allows the measurement of physical parameters in real time.
  • the object of the invention is achieved in that the apex brings together light from more than one light source in the region of the treatment site, wherein light from a first source is therapeutic light with high optical energy density, and light from a second source light for detecting a physical parameter in the region of the treatment site is. Further advantageous embodiments are specified in the subclaims to claim 1.
  • the object of the invention is also achieved by a chirguric handpiece according to claim 12, a catheter according to claim 13 and a laser system according to claim 14, all having such an apex.
  • the apex fulfills various functions at the same time.
  • the apex is designed to direct high-energy light, ie light with high optical energy density, to the treatment site for therapeutic use.
  • high optical energy density is meant an energy density sufficient to be less than or equal to a irradiance E, measured in W / m 2 , in a typical therapeutic application from a distance of up to 5 cm from the treatment site and an exit angle of the light 90 ° thermally heated human or animal tissue so that it changes or optically exposed so strongly that optically induced apoptosis effects of the illuminated cells occur.
  • the apex should also conduct light from another light source for the measurement of physical parameters to the treatment site, reflect there, wherein the reflection by an optical grating, for example in the form of a fiber Bragg grating, which occurs when changing a to be measured physical parameter in a comprehensible manner and depending on the size of the parameter changed.
  • an optical grating for example in the form of a fiber Bragg grating, which occurs when changing a to be measured physical parameter in a comprehensible manner and depending on the size of the parameter changed.
  • the change in the lattice constant of the optical grating for example the fiber Bragg grating, finally leads to an observable, which can be attributed to the physical parameter prevailing at the treatment location.
  • the apex according to the invention can be constructed in various ways. Thus, it is possible to combine all optical waveguide functions, such as directing high-energy light for therapy and directing and returning laser light for the measurement of physical parameters in a fiber, or it is possible to merge different fibers only in the apex.
  • the fiber may be selected from the group consisting of: a coaxial or eccentric fiber based on a multimode fiber having a coaxial or eccentrically confined singlemode fiber with inscribed optical grating, for example Form of a fiber Bragg grating, wherein the singlemode fiber of the Multimode fiber is separated by a cladding, a coaxial or eccentric optical fiber based on a multimode fiber with inscribed optical grating, for example in the form of a fiber Bragg grating, and a carrier fiber, which comprises a first cladding enclosed by a multi-mode fiber and a second cladding enclosed singlemode fiber, wherein the single mode fiber includes an optical grating, for example in the form of a fiber Bragg grating.
  • the apex can also be constructed differently, in that this brings together only at the treatment site, different, independent optical fibers.
  • At least one element is present which is selected from the group consisting of: a refractive element, for example in the form of volume structures with refractive surfaces, such as lenses, prisms or mirrors, or in the form of axicon structures, such as cones or Truncated cones and similar structures, a diffractive element and a diffuser acting.
  • a refractive element for example in the form of volume structures with refractive surfaces, such as lenses, prisms or mirrors, or in the form of axicon structures, such as cones or Truncated cones and similar structures
  • a diffractive element and a diffuser acting a diffractive element and a diffuser acting.
  • the structure can be chosen as desired, so that the light used for Threapie emerges radially as a ring, exits laterally with a preferred direction, or diffuse emerges, but it has a cylindrical Abstrahlprofil.
  • the apex can be individually designed for the intended use.
  • the various elements decouple only radially with respect to the longitudinal axis of the apex so that an annular emission characteristic results, only decoupling laterally with respect to the longitudinal axis of the apex, so that an approximately conical emission characteristic is formed in the radial direction, only radially with respect to the longitudinal axis of the apex, but diffuse decoupling, so that there is a cylindrical radiation pattern, or only axially with respect to the longitudinal axis of the apex, so that there is an approximately conical emission in the axial direction.
  • the radiation characteristic is determined by the therapeutic purpose.
  • the axial radiation is suitable, for example, for the light-induced opening of totally closed coronary vessels (English: Coronary Total Occlusion, CTO), in which the light wave ladder assembly is pushed to just before the coronary closure and there the closure ablative, which means by fusing, Ablat Schlieren or removal of the occluding plug, is opened.
  • CTO Coronary Total Occlusion
  • At least one first optical waveguide which conducts high-energy light to the treatment site
  • at least one second optical waveguide via which physical parameters can be measured, such as, for example, by using a singlemode fiber with inscribed optical grating, for example in the form of a fiber optic grating.
  • Bragg gratings, or a grating written directly into the apex creates a system with a very wide range of applications.
  • the first recess may be provided for a first optical waveguide which conducts light for the treatment of the animal or human body, for example laser light for sclerotherapy of blood vessels, or laser light for the exemplary treatment of glaucoma, or laser light for example therapy of tumors in the urological area, triggering a light-induced apoptosis, laser light for treating a coronary total occlusion (CTO), or laser light for lipolysis
  • the first optical waveguide is preferably a fiber optic based on a multi-mode fiber
  • the second recess is provided for a second optical waveguide, which conducts light for measuring the temperature and / or the pressure in the region of the apex via an optical grating, for example in the form of a fiber Bragg grating, wherein the second optical waveguide is preferred Lichtw is based on a single-mode fiber.
  • the temperature at the treatment site it may be necessary to measure not only the temperature at the treatment site, but also other parameters, such as the reflectivity or the light scattering of the tissue to be treated, the prevailing pH at the treatment site, or the pressure prevailing there.
  • other parameters such as the reflectivity or the light scattering of the tissue to be treated, the prevailing pH at the treatment site, or the pressure prevailing there.
  • the atraumatic form preferably has a circular or elliptical profile and preferably a round, atraumatic distal Has tip through which the apex at the treatment site can not cause mechanical injury.
  • the atraumatic distal tip is angled to simplify by twisting an introduction into a branch of the human or animal blood or vascular system.
  • the apex is made of a temperature-stable and biocompatible material, such as made by a sol-gel method quartz glass or Ormocere.
  • the at least one element acting as a diffuser has nanoscale scattering particles whose average grain size is less than 100 nm, wherein preferably a narrow particle size distribution is provided with a standard deviation of the grain diameter of less than 20 nm nanoscale structure of the scattering particles is a particularly uniform and diffuse light scattering caused, which also acts depolarizing.
  • the depolarizing effect can convert the commonly polarized laser light to diffuse, but high-energy light, so that the therapeutic effect is changed, which is dependent on the Lichtpolarisation especially in structured or anisotropic tissue.
  • polarization of light is of minor importance for laser-induced interstitial thermotherapy (LITT), in other therapies the polarization of therapeutic light may play an important role, as for example in the activation of pharmaceutically active substances at the treatment site.
  • LITT laser-induced interstitial thermotherapy
  • a surgical handpiece may have an apex as above is constructed.
  • a catheter may have an apex described above.
  • a laser unit is used to treat the human or animal body with light.
  • This comprises: at least one apex described above and at least one laser light source, as well as at least one sensor unit.
  • the sensor unit measures physical conditions in the area of the apex via the second or further optical waveguide.
  • the at least one laser light source forms a controlled system together with the at least one sensor unit and a control unit.
  • the control unit regulates the radiation power of the at least one laser light source via a feedback by the sensor unit itself.
  • the sensor unit itself can be adapted to the measurement purpose.
  • the sensor unit is, for example, an interrogator, a spectrometer or an optical or optoelectronic filter arrangement which decomposes light from the second or further optical waveguide into its spectral components.
  • the control unit can regulate the power of the laser light of the at least one laser light source as a function of the spectral components which change for the measurement of a physical parameter. Optionally, however, it can only display the physical parameters to the attending physician.
  • FIG. 3 shows a third variant of the apex according to the invention with a curved tip
  • FIG. 5 shows a fifth variant of the apex according to the invention with a cavity, itself acting as a diffuser
  • FIG. 6 shows a laser system having an apex according to the invention on a catheter
  • 7 shows a first variant of a surgical handpiece having an apex according to the invention
  • FIG. 8 shows a second variant of a surgical handpiece having an apex according to the invention
  • FIG. 12 shows an apex of a catheter for treating a coronary total occlusion (English: Coronary Total Occlusion, CTO).
  • FIG. 1 shows a sketch of a first variant of the inventive apex 1 for an optical waveguide arrangement 2, which guides light 3 from a proximal end PE to a distal end DE.
  • This apex 1 essentially has a torpedo shape or a cigar shape with a circular profile P, wherein an atraumatic tip S is provided at the distal end DE, which during insertion of the apex 1, for example as part of a catheter 120 in the bloodstream B of the human or animal body K, caused by its shape no injuries.
  • the shape of the profile P can be circular, elliptical or organically shaped, whereby the term "organically shaped” refers to the absence of burrs and edges and all surfaces merge into one another with a constant change of the curvature.
  • the apex 1 At the rear end of the apex 1 there are in this variant three recesses 4 ', 5' and 6 'for one optical waveguide 4, 5 and 6.
  • a halved apex 1 is shown below the apex 1, which would arise through a cut AA.
  • two optically active elements namely a reverse in relation to the light propagation direction truncated cone 10 and a cone standing on the tip 1 1 can be seen.
  • Truncated cone 10 and cone 1 1 are formed in the apex 1 by leaving the corresponding volume.
  • the lateral surfaces of the truncated cone 10 and the cone 1 1 form reflective surfaces, because these with respect to the propagation direction of the passing light 3 exceed the critical angle of total reflection.
  • the light 3 is reflected on the lateral surfaces of the truncated cone 10 and the cone 1 1.
  • the light 3 changes its direction and emerges laterally in an approximately radial direction out of the apex 1.
  • the bottom sketch shows the halved apex 1 with inserted optical waveguides 4, 5 and 6.
  • the optical waveguide 4 which has a multimode laser MMF here, conducts high-energy laser light from a proximal end PE, the source of the laser light, to a distal end DE of the apex 1.
  • the high-energy light emerges radially out of the apex 1.
  • the function of the two other optical fibers 5 and 6 is another.
  • These two optical waveguides 5 and 6 are designed as a single-mode fiber SMF and have at their distal end, which is inserted in the apex 1, an inscribed optical grating, for example in the form of a fiber Bragg grating FBG.
  • the structure of the fiber of the optical waveguide 5, 6 is changed with a short-time laser, so that the refractive index of the fiber material of the optical waveguide. 5 , 6 differs slightly at the location treated with the short-term laser from the refractive index of the environment of the same fiber material. As a result, partial reflection of the light conducted through the fiber of the optical waveguide 5, 6 takes place at the resulting interface between regions of different refractive index.
  • the refractive index of the fiber of the optical waveguide in short, successive sections at a distance of ⁇ / 2 with respect to a reference wavelength changed so that form in the fiber material of the optical waveguide 5, 6 pairs of sections, which together have a length of ⁇ / 2 with respect to have a reference wavelength, so does this optical grating, for example in the form of a fiber Bragg grating FBG, as a partially transmissive mirror whose reflection wavelength is very narrow band, however. The reflection wavelength is reflected and sent back to the source of the light.
  • FBG fiber Bragg grating
  • the optical waveguide 5, 6 now heats up at the tip, where the optical grating is inscribed, for example in the form of a fiber Bragg grating FBG, then the length of the section pairs changes due to the thermal expansion, so that the back-reflected wavelength changes .
  • the temperature in the apex can be determined 1 measure, in which using a sensor unit, the wavelength of the reflected light is accurately determined.
  • a control loop may be provided, in which the laser light as a heating source and the detection of the temperature by the sensor unit form a control loop, which will be described in more detail below.
  • the depth of the recess 6 'into the apex 1 is significantly deeper than the depth of the recess 5'.
  • the corresponding single-mode fiber with the optical grating for example in the form of a fiber Bragg grating FBG, thus extends into the region in which the light of the multimode fiber is coupled out.
  • FBG fiber Bragg grating
  • FIG. 2 shows a sketch of a second variant of the inventive apex 1 for an optical waveguide arrangement, which guides light 3 from a proximal end to a distal end.
  • This apex 1 shown here also essentially has a torpedo shape or a cigar shape with a circular profile P, only the half attachments 1 resulting from the section through the plane A-A being shown here.
  • the apex 1 shown here also has an atraumatic tip S at the distal end, which does not cause any injuries when inserting the apex 1, for example as part of a catheter 120 into the bloodstream B of the human or animal body K.
  • the apex 1 sketched here has asymmetrically distributed elements, namely likewise an asymmetrical truncated cone 10 and an asymmetrical cone 11. These are something arranged laterally to an imaginary axis of the emerging from the optical waveguide 4 Liche- tes 3 and thus form elements acting as a mirror. These elements acting as a mirror truncated cone 10 and cone 1 1 also couple the light radially, but with a preferred direction.
  • This apex 1 can be used for treatment of blood vessels, for example venous sclerotherapy or sclerotherapy, or in urological surgery to treat tumors in the urethra or urinary bladder, as well as in the ureters as kidney outflows through laser-induced apoptosis. Also in this example shown here, the depth of the recess 6 'in the apex 1 is significantly deeper than the depth of the recess 5'.
  • the corresponding single-mode fiber with the optical grating for example in the form of a fiber Bragg grating, thus extends into the region in which the light of the multimode fiber is coupled out.
  • the apex 1 of Figure 2 is further developed in Figure 3.
  • a third variant of the apex 1 according to the invention for an optical waveguide arrangement is sketched in FIG. 3, which guides light 3 from a proximal end to a distal end.
  • This apex 1 shown here also essentially has a torpedo shape or a cigar shape with a circular profile P, only the half attachments 1 resulting from the section through the plane AA being shown here.
  • the atraumatic tip is asymmetrical and is bent in a preferred direction. This tip shape, when used as a tip of a catheter, helps insert it into branches of blood vessels.
  • this apex 1 coupled by elements truncated cone 10 and cone 1 1 light 3 radially with a preferred direction. Due to the fixed orientation of the light extraction in relation to the bent, atraumatic tip S, it is easier to determine the preferred direction of the incident light at the treatment site.
  • the tip When catheterized or when used with a surgical handpiece, the tip may have been fixed in a vascular branch by a corresponding rotational position, in which case the direction of the decoupled light 3 can be determined safely and thus can be targeted by the user to a treatment location.
  • the depth of the recess 6 'into the apex 1 is significantly deeper than the depth of the recess 5'.
  • the corresponding single-mode fiber with the optical grating for example in the form of a fiber Bragg grating, thus extends into the region in which the light of the multimode fiber is coupled out.
  • the optical grating for example in the form of a fiber Bragg grating
  • FIG. 4 outlines a fourth variant of the inventive apex 1 for an optical waveguide arrangement, which guides light 3 from a proximal end to a distal end.
  • This apex 1 also has substantially a torpedo shape or a cigar shape with a circular profile P, wherein at the distal end an atraumatic tip S is provided which upon insertion of the apex 1, for example as part of a catheter 120 in the bloodstream B of the human or animal body K caused no injury by its shape.
  • an open half of the apex 1 is shown, which would arise from a section through the plane AA (FIG. 1).
  • this apex 1 has an axicon structure 12, which generate scattered light by doping with nanoscale, that is with a particle size of less than 100 nm, particles.
  • the truncated cone 1 1 as an axicon structure acts through the nanoscale particles acting as a diffuser element 12.
  • the nanoscale particles have a narrow particle size distribution, the standard deviation of less with an imputed Gaussian distribution of the grain size than 20 nm.
  • grain size distributions are distributed differently on an RRSB network. The Gaussian distribution of the grain sizes and the standard deviation are approximated here.
  • the depth of the recess 6 'in the apex 1 is significantly deeper than the depth of the recess 5'.
  • the corresponding single mode fiber with the optical grating for example in the form of a fiber Bragg grating extends so far into the area in which the light of the multimode fiber is coupled out. This makes it possible to measure the local temperature of the apex 1 at the location of the light exit and the temperature of the apex in the region of the coupling with the optical waveguide arrangement 2. Alternatively, it is possible to measure the temperature with the single-mode fiber 6 and with the single-mode fiber 5 a other physical parameters, such as pressure or local pH.
  • FIG. 5 shows a fifth variant of the inventive apex 1 for an optical waveguide arrangement which guides light 3 from a proximal end PE to a distal end DE.
  • This apex 1 also has substantially a torpedo shape or a cigar shape with a circular profile P, wherein at the distal end DE an atraumatic tip S is provided, which in the insertion of the apex 1, for example as part of a catheter 120 in the bloodstream B of the human or animal body K caused no injury by its shape.
  • an open half of the apex 1 is shown, which would arise from a section through the plane AA (FIG. 1).
  • this apex 1 has an axicon structure 12 'formed as a hollow body.
  • the otherwise transparent apex 1 generates scattered light by doping with nanoscale particles, that is to say with a particle size of less than 100 nm.
  • the hollow truncated cone 1 1 formed as a hollow body Axikon Jardin 12 'forms for the from the optical waveguide 4 at the foot of the truncated cone 1 1 an oblique entrance surface along the lateral surface of the truncated cone 1 first When passing into the doped apex 1, the light scatters and exits the apex 1.
  • the nanoscale particles have a narrow particle size distribution which, given an assumed Gaussian distribution of the grain size, has a standard deviation of less than 20 nm.
  • grain size distributions are redistributed on an RRSB network as in the previous example.
  • the Gaussian distribution of the grain sizes and the standard deviation are approximated here.
  • the depth of the recess 6 'into the apex 1 is significantly deeper than the depth of the recess. 5 '.
  • the corresponding single-mode fiber with the optical grating for example in the form of a fiber Bragg grating, thus extends into the region in which the light from the multimode fiber is coupled out.
  • This makes it possible to measure the local temperature of the apex 1 at the location of the light exit and the temperature of the apex in the region of the coupling with the optical waveguide arrangement 2.
  • FIG. 6 finally shows a laser unit 200 which sends laser light from at least one laser light source LD, in this case laser diodes, from a proximal end to a distal end.
  • the laser unit 200 has a first optical waveguide 4, and two further optical waveguides 5 and 6, which are combined via a corresponding connector V to form an optical waveguide arrangement 2.
  • the optical waveguide assembly 2 cooperates with an apex 1 as the catheter 120, and the apex 1 can be inserted as the distal end of the catheter 120 into the bloodstream B of an animal or human body K to therapeutically apply the laser light of the laser unit 200 to the patient's vasculature.
  • At least one high-energy laser light source LD is arranged, which couples the light of the at least one high-energy laser light source LD into the optical waveguide 4 via a multi-mode mixer MMC (English: Multi Mode Combiner).
  • MMC Multi Mode Combiner
  • the lights of the different laser light sources LD can also have different spectral compositions.
  • the apex 1 heats up to temperatures of up to 1, 000 ° C.
  • the temperature of the apex 1 is measured.
  • a sensor unit SE in the laser unit 200 by the temperature-induced change of the inscribed optical grating, for example in the form of a fiber Bragg grating FBG.
  • This sensor unit SE is coupled to a control unit RE which is connected to the multimotor demischer or on the laser light sources LD acts.
  • a closed control loop namely laser power, which is converted into heat in the apex 1, which is sent back to the laser unit based on the measurement of the temperature and there again acts on the laser power via the control unit.
  • FIG. 7 shows a first variant of a surgical handpiece 100, comprising an apex 1 according to the invention, which guides light 3 from an optical waveguide connection 2 to the treatment site.
  • the user guides the surgical handpiece 100 with the apex 1 into a corresponding body cavity, into a cut in the opened body or into a vessel, where the light 3 escapes accordingly for therapy.
  • This surgical handpiece is suitable for the therapeutic application of high-energy laser light in the field of urological surgery, in the field of photodynamic therapy and interstitial laser therapy.
  • FIG. 8 shows a second, special variant of a surgical handpiece 110 having an apex 1 "according to the invention, which guides light 3 from an optical waveguide arrangement 2 to the treatment site 3.
  • the handpiece shown here has an apex 1", which has a concave surface and is therefore suitable as an application apex for the therapeutic treatment of glaucoma.
  • the user guides the surgical handpiece 100 with the apex 1 "onto the eye of the patient where the light 3 escapes for the therapy of glaucoma.
  • the exact application and the destination of the high-energy light radiation is left to the therapeutic art of the attending physician.
  • FIGS. 9, 10 and 11 show different variants of optical waveguides, which combine more than one function.
  • FIG. 9 shows one end of a coaxial optical waveguide 20.
  • This consists of a multi-mode fiber MMF, here without the typical border, which is usually with English.
  • "Jacket" designated coat is outlined.
  • the multimode fiber MMF which is used for the transmission of high-energy light, such as infrared light with a Wavelength of 1 .064 nm of a Nd: YAG laser, infrared light with a wavelength of 1 .470 nm of a thulium laser or infrared light with a wavelength of 2100 nm of a holmium laser is suitably coated in a concentric manner a single mode fiber SMF is separated from the multimode fiber MMF by a "cladding" C acting as a sheath and an insulating layer, generally English.
  • the single mode fiber SMF is separated from the multimode fiber MMF by the cladding C.
  • the single-mode fiber SMF for example, light having a wavelength in the wavelength range of 1 .550 nm could be coupled in to measure changes in a physical parameter which are typical of a fiber optic grating, for example in the form of a fiber Bragg grating FBG.
  • the end of the coaxial optical waveguide 20 is shown on the left in a perspective view and on the right in a plan view.
  • Below the plan is a principle diagram in which the refractive index n is plotted on the radius r.
  • the refractive index n of the single-mode fiber SMF has a higher refractive index n than the surrounding multimode fiber MMF only in this example. The diagram is intended to make clear that the multi-mode fiber MMF and the single-mode fiber SMF differ from one another.
  • FIG. 10 shows one end of a coaxial optical waveguide 30.
  • This consists of a multi-mode fiber MMF, which is also in this example without the typical border, which is usually with Engl. "Jacket" designated coat is outlined.
  • the multimode fiber MMF which also in this example for the transmission of high-energy light, for example infrared light with a wavelength of 1 .064 nm Nd: YAG laser, infrared light with a wavelength of 1 .470 nm Thulium laser or infrared light with a Wavelength of 2,100 nm of a holmium laser, concentrically encloses an area containing an optical grating inscribed with a femtosecond laser, for example in the form of a fiber Bragg grating FBG in the multimode fiber area.
  • the diameter of the multimode fiber MMF is small enough, it is possible to illuminate within the same multimode fiber MMF both a high-energy laser light beam having a first wavelength and a lower-energy laser light beam having a second wavelength, wherein the optical grating, for example in the form of a fiber -Bragg grating In its dimensions of the lattice spacings interacts only with the less energy-rich laser light, without resulting in crosstalk.
  • This fiber is particularly suitable for the treatment of total coronary occlusion, which usually occurs in very narrow vessels with a diameter of 200 ⁇ m and less.
  • a perspective view of the end of the coaxial optical waveguide 30 is also shown on the left in FIG. 10, while a plan view of the end of the coaxial optical waveguide 30 is sketched on the right side.
  • FIG. 1 1 Optical waveguide in Figure 1 1 consists of a functionally independent for the guidance of the light carrier TF. This encapsulates a first multimode fiber MMF, which is separated from the carrier fiber TF by a first cladding C. Furthermore, the carrier fiber TF surrounds a single-mode fiber SMF, which is likewise encased by the carrier fiber by a second cladding. As in the preceding FIG. 9, a perspective view of the end of the optical waveguide is also shown on the left in FIG. 11, whereas a plan view of the end of this optical waveguide is sketched on the right side.
  • the principle diagram below looking at the end, shows that the refractive indices, denoted by n, the single-mode fiber SMF and the multi-mode fiber MMF both differ from one another and differ from the refractive index of the carrier fiber which is functionless for the light pipe.
  • the apex 1 essentially consists of a multimode fiber MMF, which has a very small diameter d, in this case 100 ⁇ . Only around the area of the apex 1 "is an optical lattice, for example in the form of a fiber Bragg grating, located approximately in the center of the multimode fiber MMF, which has the construction like the optical waveguide shown in FIG. 10.
  • axicon structure MMF multi-mode fiber 2 acting as a diffuser element, axicon structure MMF multi-mode fiber 2 'designed as a hollow body P profile

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Abstract

La présente invention concerne un apex (1, 1', 1") pour un système de guidage d'ondes lumineuses (2) qui guide une lumière (3) d'une extrémité proximale (PE) jusqu'à une extrémité distale (DE) pour effectuer un traitement thérapeutique du corps humain ou animal, un instrument chirurgical (100, 110), un cathéter (120) ainsi qu'une unité laser (200) présentant ledit apex (1, 1', 1"). L'invention concerne enfin l'utilisation de systèmes de guidage d'ondes lumineuses qui présentent un réseau optique, par exemple sous forme de réseau de Bragg sur fibre optique (FBG) pour constituer un tel apex (1, 1', 1"). Selon l'invention, il est prévu que cette lumière de plus d'une source lumineuse (LD) converge vers la zone du site à traiter, la lumière d'une première source (LD) étant une lumière thérapeutique ayant une forte densité énergétique optique, et la lumière d'une seconde source étant une lumière pour détecter un paramètre physique dans la zone du site à traiter.
PCT/DE2018/100437 2017-05-30 2018-05-08 Apex pour système de guidage d'ondes lumineuses, instrument chirurgical et unité laser présentant ledit apex WO2018219391A1 (fr)

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DE102017111708.3A DE102017111708A1 (de) 2017-05-30 2017-05-30 Apex für eine Lichtwellenleiteranordnung, chirurgisches Instrument und Lasereinheit aufweisend diesen Apex
DE102017111708.3 2017-05-30

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Cited By (2)

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Publication number Priority date Publication date Assignee Title
CN111110346A (zh) * 2019-12-31 2020-05-08 华科精准（北京）医疗科技有限公司 用于激光间质热疗系统的装置
WO2020104897A1 (fr) * 2018-11-23 2020-05-28 Wolfgang Hufnagel Apex pour un ensemble de guidage d'ondes lumineuses

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US20020045811A1 (en) * 1985-03-22 2002-04-18 Carter Kittrell Laser ablation process and apparatus
US20100185187A1 (en) * 2006-08-07 2010-07-22 Hamamatsu Photonics K.K. Light irradiation apparatus
EP2301439A1 (fr) * 2003-03-05 2011-03-30 InfraReDx, Inc. Agencement de sonde de cathéter pour l'analyse de tissus par application d'énergie rayonnante et par collecte d'énergie rayonnante
WO2014162268A2 (fr) 2013-04-01 2014-10-09 Biolitec Pharma Ip & Investment Ltd. Dispositif d'extraction tissulaire

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US5292320A (en) * 1992-07-06 1994-03-08 Ceramoptec, Inc. Radial medical laser delivery device
DE102017104673B4 (de) 2017-03-06 2018-12-27 Lab-On-Fiber Gmbh Aufsatz für einen Lichtwellenleiter zur Behandlung eines Glaukoms, Verfahren zur Herstellung des Aufsatzes und Lichtwellenleiteranordnung

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US20020045811A1 (en) * 1985-03-22 2002-04-18 Carter Kittrell Laser ablation process and apparatus
EP2301439A1 (fr) * 2003-03-05 2011-03-30 InfraReDx, Inc. Agencement de sonde de cathéter pour l'analyse de tissus par application d'énergie rayonnante et par collecte d'énergie rayonnante
US20100185187A1 (en) * 2006-08-07 2010-07-22 Hamamatsu Photonics K.K. Light irradiation apparatus
WO2014162268A2 (fr) 2013-04-01 2014-10-09 Biolitec Pharma Ip & Investment Ltd. Dispositif d'extraction tissulaire

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020104897A1 (fr) * 2018-11-23 2020-05-28 Wolfgang Hufnagel Apex pour un ensemble de guidage d'ondes lumineuses
CN111110346A (zh) * 2019-12-31 2020-05-08 华科精准（北京）医疗科技有限公司 用于激光间质热疗系统的装置
CN111110346B (zh) * 2019-12-31 2021-03-09 华科精准（北京）医疗科技有限公司 用于激光间质热疗系统的装置

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