DE102017111708A1 - Apex for an optical fiber array, surgical instrument and laser unit comprising this apex - Google Patents

Abstract

The invention relates to an apex (1, 1 ', 1 ") for an optical waveguide arrangement (2), which guides light (3) from a proximal end (PE) to a distal end (DE) for a therapeutic treatment of the human or animal body , a surgical instrument (100, 110), a catheter (120) and a laser unit (200) comprising this apex (1, 1 ', 1 "). Finally, 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 (FBG), for constructing such an apex (1, 1 ', 1 ") Combining light from more than one light source (LD) in the region of the treatment site, wherein light from a first source (LD) is therapeutic light of high optical energy density, and light from a second source is light for detecting a physical parameter in the area of the treatment site Characteristics spreads the use spectrum.

Description

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. Finally, 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. Thus, 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. In order to direct laser light, which is used for ablation or for cutting, depending on the treatment technique of the corresponding tissue, to the application site, it is known to provide the laser light with the aid of optical waveguides, wherein at the end of the optical waveguide a specially to the application adapted optical fiber tip, the so-called apex, is arranged. Depending on the type of use, 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). In order to avoid the penetration of the plastic by the high-energy laser light, an opening to a channel is provided approximately in the middle of known apices for optical waveguides, through which protrudes one end of the optical waveguide. For example, 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.

In the international PCT 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. In this apex, 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 the WO 2014/162268 A1 as an application example the treatment is called benign prostate hyperplasia and differs in its structure from the apex presented here.

In the post-published German patent application 10 2017 104 673.9 An apex is taught for an optical fiber that is suitable for the therapy of glaucoma and has special spherical-concave surfaces for placement on the sclera of the human eye.

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.

According to the invention, it is thus provided that 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. By "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 heat up 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. 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.

In constructing the apex as part of the tip of a fiber having different functions, 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 single mode fiber is separated from the multimode fiber 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 multi-mode fiber enclosed by a first cladding and a single-mode fiber enclosed by a second cladding, the single-mode fiber containing an optical grating, for example in the form of a fiber Bragg grating.

However, the apex can also be constructed differently, in that this brings together only at the treatment site, different, independent optical fibers. In this case, provision is made for the apex to combine more than one optical waveguide with different functions at the treatment location, a first recess for a first optical waveguide being arranged inside the apex, and a second recess for a second optical waveguide being arranged inside the apex. According to the invention, it is provided that 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 e.g. Lenses, prisms or mirrors, or in the form of axicon structures, such as cones or truncated cones and similar structures, a diffractive element and acting as a diffuser. 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. Depending on the type of therapeutic use, the apex can be individually designed for the intended use. Depending on the type of use, it can thus be provided that 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 out decoupling, so that there is a cylindrical radiation characteristic, 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 optical waveguide assembly is pushed to just before the coronary closure and there ablative closure, that means by fusing, Ablatieren or ablation of closing plug, is opened.

In combination with the use of at least one first optical waveguide, which conducts high-energy light to the treatment site, and 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.

In a first variant of the invention, provision may be made for the first recess to 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, wherein the first optical waveguide is preferably a fiber optic based on a multi-mode fiber , and the second recess is provided for a second optical fiber, the light for measuring the temperature and / or the pressure in the region of the apex over an optical grating, for example in the form of a fiber Bragg grating, wherein the second optical waveguide is preferably a single-mode fiber based optical waveguide.

Depending on the type of application, it may be necessary to measure not only the temperature at the treatment site, but also other parameters, such as the reflectivity or light scattering of the tissue to be treated, the prevailing pH at the treatment site, or the pressure prevailing there. Especially with therapies that involve heat, or require a specific light absorption of the tissue to be treated, it is important to always control these parameters during the therapeutic application of light. For this purpose, it can be provided in a further variant of the apex that at least one further recess is arranged for a further optical waveguide within the apex.

Depending on the type of use, for example when used as a catheter tip or for use in openings of the body or in cut-open tissue, it is advantageous if it has an atraumatic form, wherein 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.

For a special purpose as a catheter tip can be provided that the atraumatic distal tip is angled to simplify by twisting an introduction into a branch of the human or animal blood or vascular system. It can be provided that the apex is made of a temperature-stable and biocompatible material, such as produced by a sol-gel method quartz glass or Ormocere.

For a further special application, it can also be provided that 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. Especially with the use of laser light, 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. Although 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.

To easily apply the light in surgical procedures by the surgeon, a surgical handpiece may have an apex constructed as above. Also for diagnostic or combined diagnostic / therapeutic procedures, a catheter may have an apex described above.

As a complete system for the therapeutic use of high-energy light, 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. In a preferred embodiment, it is provided that the at least one laser light source forms a controlled system together with the at least one sensor unit and a control unit. In this way, 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. It has proven to be very versatile if 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.

• 1 eine erste Variante des erfindungsgemäßen Apex,
• 2 eine zweite Variante des erfindungsgemäßen Apex,
• 3 eine dritte Variante des erfindungsgemäßen Apex mit gekrümmter Spitze,
• 4 eine vierte Variante des erfindungsgemäßen Apex mit Diffusor,
• 5 eine fünfte Variante des erfindungsgemäßen Apex mit einem Hohlraum, selbst als Diffusor wirkend,
• 6 ein Lasersystem aufweisend einen erfindungsgemäßen Apex an einem Katheter,
• 7 eine erste Variante eines chirurgischen Handstücks aufweisend einen erfindungsgemäßen Apex,
• 8 eine zweite Variante eines chirurgischen Handstücks aufweisend einen erfindungsgemäßen Apex,
• 9 ein erste Lichtwellenleiteranordnung,
• 10 eine zweite Lichtwellenleiteranordnung,
• 11 eine dritte Lichtwellenleiteranordnung,
• 12 einen Apex eines Katheters zur Behandlung eines koronaren Totalverschlusses (engl.: Coronary Total Occlusion, CTO).

The invention will be explained in more detail with reference to the following figures. It shows:

• 1 a first variant of the apex according to the invention,
• 2 a second variant of the apex according to the invention,
• 3 a third variant of the apex according to the invention with a curved tip,
• 4 A fourth variant of the apex according to the invention with diffuser,
• 5 A fifth variant of the apex according to the invention with a cavity, itself acting as a diffuser,
• 6 a laser system having an apex according to the invention on a catheter,
• 7 a first variant of a surgical handpiece having an apex according to the invention,
• 8th a second variant of a surgical handpiece having an apex according to the invention,
• 9 a first optical waveguide arrangement,
• 10 a second optical waveguide arrangement,
• 11 a third optical waveguide arrangement,
• 12 an apex of a catheter for the treatment of coronary total occlusion (CTO).

In 1 is a first variant of the invention Apex 1 for an optical waveguide arrangement 2 sketched, the light 3 from a proximal end PE to a distal end DE passes. This apex 1 essentially has a torpedo shape or cigar shape with a circular profile P on, being at the distal end DE an atraumatic tip S is provided when inserting the apex 1 for example, as part of a catheter 120 into the bloodstream B of the human or animal body K , caused by its shape no injuries. The shape of the profile P may be circular, elliptical or organically shaped, where by "organically shaped" is meant the absence of ridges and edges and all surfaces merge into one another with a constant change in curvature. At the rear end of the apex 1 There are three recesses in this variant 4 ' 5 ' and 6 ' for each one optical fiber 4 . 5 and 6 , To demonstrate the inner workings of the apex 1 is under the apex 1 a halved apex 1 represented, which would arise through a section AA. By the halved shape are two optically active elements, namely a reverse with respect to the light propagation direction truncated cone 10 and a cone standing on top 11 to recognize. truncated cone 10 and cones 11 are in the apex 1 formed by leaving the corresponding volume. In terms of spreading light 3 that initially consists of an optical fiber 4 in the apex 1 leaking out, even in the recess 4 ' stuck, form the lateral surfaces of the truncated cone 10 and the cone 11 reflecting surfaces because these are in relation to the propagation direction of the exiting light 3 exceed the critical angle of total reflection. As a result, the light becomes 3 on the lateral surfaces of the truncated cone 10 and the cone 11 reflected. This changes the light 3 its direction and exits sideways in approximately radial direction from the apex 1 out. In the bottom sketch is the halved apex 1 with inserted fiber optic cables 4 . 5 and 6 shown. The optical fiber 4 who here is a multimode fiber MMF Here, directs high-energy laser light from a proximal end PE , the source of the laser light, to a distal end DE of the apex 1 , Through the truncated cone 10 and the cone 11 The high energy light passes radially out of the apex 1 out. The function of the other two optical fibers 5 and 6 is another. These two fiber optic cables 5 and 6 are as singlemode fiber SMF designed and pointing at its distal end, that in the apex 1 inserted, an inscribed optical grating, for example in the form of a fiber Bragg grating FBG on. When writing an optical grating, for example in the form of a fiber Bragg grating FBG in an optical fiber 5 . 6 becomes the structure of the fiber of the optical fiber 5 . 6 changed with a short-time laser, so that the refractive index of the fiber material of the optical waveguide 5 . 6 at the location treated with the short-term laser differs slightly from the refractive index of the environment of the same fiber material. As a result, at the resulting interface between regions of different refractive index, a partial reflection of the fiber through the optical waveguide 5 . 6 guided light instead. If the refractive index of the fiber of the optical waveguide in short, successive sections at a distance of λ / 2 with respect to a reference wavelength changed, so that in the fiber material of the optical waveguide 5 . 6 Forming pairs of sections, which together have a length of λ / 2 with respect to a reference wavelength, so acts this optical grating, for example in the form of a fiber Bragg grating FBG as a partially transmissive mirror whose reflection wavelength is very narrowband, however. The reflection wavelength is reflected and sent back to the source of the light. Now warms the optical fiber 5 . 6 at the top, where the optical grating, for example in the form of a fiber Bragg grating FBG is inscribed, then the length of the section pairs changes due to the thermal expansion, so that the back-reflected wavelength changes. On the basis of the change of the reflected back wavelength, the temperature in the apex can be determined 1 measure, in which using a sensor unit, the wavelength of the back-reflected light is accurately determined. For the correct functioning of the thus constructed thermometer, it is only necessary to use the optical grating, for example in the form of a fiber Bragg grating FBG only at the top of the fiber optic cable 5 . 6 enroll.

When operating the apex, for example, in the treatment of coronary arterial occlusions or vascular decay, this heats up by the high-energy laser light and can, although for a short time, reach temperatures of up to 1,000 ° C. In order to avoid overheating of the apex, 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. In the example shown here is the depth of the recess 6 ' in the apex 1 in 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 extends to the area in which the light of the multimode fiber is coupled out. This makes it possible to determine the local temperature of the apex 1 to measure 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 with the singlemode fiber 6 to measure the temperature and using the singlemode fiber 5 to measure another physical parameter, such as pressure or local pH.

In 2 is a second variant of the apex according to the invention 1 sketched for an optical fiber array, the light 3 from a proximal end to a distal end. This apex shown here 1 essentially also has a torpedo shape or cigar shape with a circular profile P on, here only the half essays resulting from the section through the plane AA 1 are shown.

Also the apex shown here 1 has an atraumatic tip at the distal end S on when inserting the apex 1 for example, as part of a catheter 120 into the bloodstream B of the human or animal body K no injury caused by its shape. Unlike the apex 1 in 1 is provided has the apex sketched here 1 asymmetrically distributed elements, namely also an asymmetric truncated cone 10 and an asymmetric cone 11 , These are slightly laterally to an imaginary axis of the optical fiber 4 leaving Lichetes 3 arranged and thus form elements acting as a mirror. These elements acting as a mirror truncated cone 10 and cones 11 also couple the light radially, but with a preferential direction. This apex 1 is applicable for treatment of blood vessels, for example venous sclerotherapy or sclerotherapy, or in urological surgery for the treatment of tumors in the urethra or urinary bladder, as well as in the ureters as renal outflows through laser-induced apoptosis. Also in this example shown here is the depth of the recess 6 ' in the apex 1 in 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. This makes it possible to determine the local temperature of the apex 1 to measure 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 with the singlemode fiber 6 to measure the temperature and using the singlemode fiber 5 to measure another physical parameter, such as pressure or local pH.

The apex 1 out 2 is in 3 further trained. In 3 is a third variant of the invention Apex 1 sketched for an optical fiber array, the light 3 from a proximal end to a distal end. This apex shown here 1 essentially also has a torpedo shape or cigar shape with a circular profile P on, here only the half essays resulting from the section through the plane AA 1 are shown. Especially in the variant shown here is that 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. Also this apex 1 coupled by elements truncated cone 10 and cones 11 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 preferential direction of the illuminating light at the treatment site. 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 outcoupled light 3 can be reliably determined and thus can be targeted by the user to a treatment location. As in the previous embodiments, in the example shown here is the depth of the recess 6 ' in the apex 1 in 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. This makes it possible to determine the local temperature of the apex 1 to measure 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 with the singlemode fiber 6 to measure the temperature and using the singlemode fiber 5 to measure another physical parameter, such as pressure or local pH.

In 4 Finally, it is a fourth variant of the apex according to the invention 1 sketched for an optical fiber array, the light 3 from a proximal end to a distal end. This apex 1 also essentially has a torpedo shape or a cigar shape with a circular profile P with an atraumatic tip at the distal end S is provided when inserting the apex 1 for example, as part of a catheter 120 into the bloodstream B of the human or animal body K by its form none Injuries caused. To illustrate the internal structure is here only an open half of the apex 1 represented by a section through the plane AA ( 1 ) would arise. Inside, this apex points 1 an axicon structure 12 which, by doping with nanoscale, that is with a particle size of less than 100 nm, particles generate scattered light. The truncated cone 11 As an axicon structure, the nanoscale particle acts as a diffuser 12 , In order for the light to be scattered uniformly, it may be provided that 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. In fact, grain size distributions are distributed differently on an RRSB network. The Gaussian distribution of the grain sizes and the standard deviation are approximated here. Finally, it is also provided in this embodiment that in the 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. This makes it possible to determine the local temperature of the apex 1 to measure 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 with the singlemode fiber 6 to measure the temperature and with the singlemode fiber 5 to measure another physical parameter, such as pressure or local pH.

In 5 is a fifth variant of the invention Apex 1 sketched for an optical fiber array, the light 3 from a proximal end PE to a distal end DE passes. This apex 1 also essentially has a torpedo shape or a cigar shape with a circular profile P on, being at the distal end DE an atraumatic tip S is provided when inserting the apex 1 for example, as part of a catheter 120 into the bloodstream B of the human or animal body K no injury caused by its shape. To illustrate the internal structure is here only an open half of the apex 1 represented by a section through the plane AA ( 1 ) would arise. Inside, this apex points 1 a trained as a hollow body axicon structure 12 ' on. In contrast to the structure of the fourth variant in 4 produces in this example the otherwise transparent apex 1 by doping with nanoscale, that is with a particle size of less than 100 nm, scattered light particles. The hollow truncated cone 11 the formed as a hollow body axicon structure 12 ' forms for the out of the optical fiber 4 at the foot of the truncated cone 11 an oblique entrance surface along the lateral surface of the truncated cone 11 , At the transition into the doped apex 1 scatter the light and exit the apex 1 out. In order for the light to be scattered uniformly, it can also be provided in this variant that 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. In fact, 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. Finally, it is also provided in this embodiment that in the 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. This makes it possible to determine the local temperature of the apex 1 to measure 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 with the singlemode fiber 6 to measure the temperature and with the singlemode fiber 5 to measure another physical parameter, such as pressure or local pH.

In 6 is finally a laser unit 200 illustrated, which laser light from at least one laser light source LD , here laser diodes, sends from a proximal end to a distal end. For this purpose, the laser unit 200 a first optical fiber 4 on, and two more optical fibers 5 and 6 that have a corresponding connector V to an optical fiber array 2 are summarized. The optical waveguide arrangement 2 works together with an apex 1 as a catheter 120 , where the apex 1 as the distal end of the catheter 120 into the bloodstream B of an animal or human body K can be introduced to the laser light of the laser unit in the patient's vascular system 200 to use therapeutically. In the laser unit 200 is at least one high-energy laser light source LD arranged over a multimode mixer MMC (English Multi Mode Combiner) the light of at least one high-energy laser light source LD in the optical fiber 4 couples. Thereby the lights of different laser light sources can LD also have different spectral compositions. By the apex 1 decoupled light 3 the apex heats up 1 to temperatures up to 1,000 ° C. To prevent the apex from burning the patient internally, it is envisaged that over the fiber optic cables 5 and 6 as single mode fibers SMF are constructed and in the area within the apex an optical grating, for example in the form of a fiber Bragg grating FBG exhibit the temperature of the apex 1 is measured. For this purpose, light is transmitted to the optical fibers 5 and 6 sent by the temperature-induced change of the inscribed optical grating, for example in the form of a fiber Bragg grating FBG a temperature-specific spectrum to a sensor unit SE in the laser unit 200 return. This sensor unit SE is with a control unit RE coupled to the multimode mixer or to the laser light sources LD acts. In this way, a closed loop, namely laser power, forms in the apex 1 is converted into heat, which is returned to the laser unit based on the measurement of the temperature and there again acts on the control unit on the laser power.

In 7 is a first variant of a surgical handpiece 100 represented, comprising an apex according to the invention 1 , the light 3 from an optical waveguide arrangement 2 the light 3 leads to the treatment site. For application, the user guides the surgical handpiece 100 with the apex 1 in a corresponding body cavity, in a cut in the opened body or in a vessel where the light 3 for therapy accordingly emerges. 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. Finally, it is also possible, for example, the apex 2 to use with the surgical handpiece shown here, for example, for a non-invasive therapeutic treatment or lighting.

In 8th is a second, special variant of a surgical handpiece 110 represented, comprising an apex according to the invention 1" , the light 3 from an optical waveguide arrangement 2 the light 3 leads to the treatment site. 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. For application, the user guides the surgical handpiece 100 with the apex 1" on the eye of the patient where the light 3 for the treatment of glaucoma accordingly emerges. The exact application and the destination of the high-energy light radiation is the therapeutic art of the treating physician.

The figures 9 . 10 , and 11 show different variants of optical fibers, which combine more than one function in itself.

In 9 is one end of a coaxial fiber optic cable 20 shown. This consists of a multi-mode fiber MMF here without the typical outline, usually with English. "Jacket" designated coat is outlined. The multimode fiber MMF suitable for the transmission of high-energy light, for example infrared light with a wavelength of 1,064 nm of an Nd: YAG laser, infrared light with a wavelength of 1,470 nm of a thulium laser or infrared light with a wavelength of 2,100 nm of a Holmium laser, concentrically encases a single mode fiber SMF , which acts by acting as a sheath and insulating layer, usually Engl. termed "cladding" C from the multimode fiber MMF is disconnected. The single mode fiber SMF is through the cladding C from the multimode fiber MMF separated. In the single mode fiber SMF For example, light with a wavelength in the wavelength range of 1550 nm could be coupled in order to detect changes in an optical grating, for example in the form of a fiber Bragg grating FBG to measure typical changes in a physical parameter.

The end of the coaxial fiber optic cable 20 is shown on the left in 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 only in this example a higher refractive index n than the surrounding multimode fiber MMF , The diagram should clarify that the multimode fiber MMF and the single mode fiber SMF differ from each other.

In 10 is one end of a coaxial fiber optic cable 30 shown. This consists of a multi-mode fiber MMF , which also in this example without the typical border, usually with Engl. "Jacket" designated coat is outlined. The multimode fiber MMF also in this example for the transmission of high-energy light, for example infrared light with a wavelength of 1,064 nm of an Nd: YAG laser, infrared light with a wavelength of 1,470 nm of a Thulium laser or infrared light with a wavelength of 2,100 nm of a Holmium Lasers, concentrically encapsulates a region of an optical grating inscribed with a femtosecond laser, for example in the form of a fiber Bragg grating FBG in the multi-mode fiber area. Unless the diameter of the multimode fiber MMF small enough, it is possible within the same multimode fiber MMF illuminate both a high-energy laser light beam having a first wavelength and a low-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 only interacts with the less energy-rich laser light, without it comes to cross-talk. This fiber is particularly suitable for the treatment of total coronary occlusion, which is usually in very narrow vessels with a Diameter of 200 microns and less occurs. As in 9 is also in 10 left a perspective view of the end of the coaxial optical waveguide 30 however, on the right side is a plan view of the end of the coaxial fiber optic cable 30 outlined.

Yet another optical fiber is in 11 shown. Fiber optic cable in 11 consists of a carrier fiber that does not function in itself to conduct the light TF , This encases a first multimode fiber MMF by a first cladding C from the carrier fiber TF is disconnected. Furthermore, the carrier fiber surrounds TF a single mode fiber SMF , which is also encased by a second cladding of the carrier fiber. As in the previous one 9 is also in 11 on the left a perspective view of the end of the optical waveguide shown, however, is outlined on the right side a plan view of the end of this optical waveguide. The principle diagram below the plan view of the end shows that the indices of refraction, denoted by n, are the singlemode fiber SMF and the multimode fiber MMF both differ from each other and differ from the refractive index of the non-functional carrier fiber for the light pipe.

In 12 is a special embodiment of an apex 1" for an optical fiber 30 shown. The apex 1" consists essentially of a multi-mode fiber MMF , which has a very small diameter d, here of 100 microns. Only around area of the apex 1" is located approximately in the center of the multimode fiber MMF an optical grating, for example in the form of a fiber Bragg grating. This has the construction like the optical fiber, which in 10 is shown. For an atraumatic design of the end, it is provided that the end is melted and thereby forms a lenticular structure of the surface. With a diameter of less than 100 microns, the term "atraumatic" barely meaningful to apply because a tip with this small diameter always has the potential to break a fine vein wall.

LIST OF REFERENCE NUMBERS

1

apex

1'

apex

1"

apex

2

Optical fiber array

3

light

4

optical fiber

4 '

recess

5

Optical fiber array

5 '

recess

6

optical fiber

6 '

recess

10

cone

11

truncated cone

12

Diffuser-acting element, axicon structure

12 '

formed as a hollow body axicon structure

13

element acting as a mirror

20

coaxial fiber optic cable

30

eccentric optical fiber

100

surgical handpiece

110

surgical handpiece

120

catheter

200

laser unit

BG

blood vessel

C

cladding

DE

distal end

FBG

Fiber Bragg Grating

K

body

LD

laser diodes

MMC

Multimode mixer

MMF

Multimode fiber

P

profile

PE

proximal end

RE

control unit

S

top

SE

sensor unit

SMF

Single-mode fiber

TF

carrier fiber

V

Interconnects

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• WO 2014/162268 A1 [0003]
• DE 102017104673 [0004]

Claims (16)

Apex (1, 1 ', 1 ") for an optical waveguide arrangement (2), which guides light (3) for a therapeutic treatment of the human or animal body from a proximal end (PE) to a distal end (DE), characterized that this light from more than one light source (LD) in the region of the treatment site merges, wherein - light from a first source (LD) is therapeutic light with high optical energy density, and - light from a second source light for the detection of a physical parameter in the region of the treatment is. Apex for an optical waveguide arrangement according to Claim 1 , characterized in that it has an optical grating, for example in the form of a fiber Bragg grating (FBG) for the light of the second source for the detection of a physical parameter in the region of the treatment location. Apex for an optical waveguide arrangement according to Claim 1 or 2 , characterized in that this part of an optical waveguide arrangement (2), wherein the optical waveguide arrangement (2) is selected from the group consisting of: - a coaxial or eccentric optical waveguide (20) based on a multimode fiber having a coaxially or eccentrically enclosed singlemode with inscribed optical grating, for example in the form of a fiber Bragg grating (FBG), wherein the single mode fiber (SMF) is separated from the multimode fiber (MMF) by a cladding (C), - a coaxial or eccentric optical waveguide (30) Basis of a multimode fiber (MMF) with inscribed optical grating, for example in the form of a fiber Bragg grating (FBG), - a carrier fiber (TF), the one of a first cladding (C) enclosed multi-mode fiber (MMF) and one of a second cladding (C) has enclosed single mode fiber (SMF), wherein the single mode fiber (SMF) an optical grating, for example in the form of a fiber Bragg grating (FBG) e nthält. Apex after Claim 1 , characterized in that - this more than one optical waveguide (4, 5) merges with different functions at the treatment site, wherein - a first recess (4 ') for a first optical waveguide (4) within the apex (1, 1') is arranged , and wherein - a second recess (5 ') for a second optical waveguide (5) within the apex (1, 1') is arranged, characterized in that within the apex (1, 1 ') - at least one refractive element, recordable 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, and / or - at least one diffractive element, and / or - at least one element acting as a diffuser ( 12) and / or - at least one reflective element (13) acting as a mirror is present, wherein - the at least one refractive element and / or - the at least one diffractive element and / or - the at least ens acting as a diffuser element (12) and / or - the at least one acting as a mirror reflective element (13) individually or cooperatively coupling light (3) from the apex (1, 1 '). Apex after Claim 4 , characterized in that the first recess (4 ') for a first optical waveguide (4) is provided which directs light (3) for the treatment of the animal or human body (K), such as - laser light for the desquamation of blood vessels ( BG), or - laser light for the treatment of glaucoma, or - laser light for the treatment of tumors in the urological area, - laser light for the treatment of coronary total occlusion (English: Coronary Total Occlusion, CTO), or - laser light for lipolysis, wherein the first optical waveguide (4) is preferably an optical fiber based on a multi-mode fiber (MMF), and the second recess (5 ') for a second optical waveguide (5) is provided, the light for measuring the temperature and / or pressure in the region of the apex (1 , 1 ') via an optical grating, for example in the form of a fiber Bragg grating (FBG), wherein the second optical waveguide (5) is preferably an optical waveguide based on a single-mode fiber (S MF). Apex after Claim 4 or 5 , characterized in that at least one further recess (6 ') for a further optical waveguide (6) within the apex (1, 1') is arranged, wherein the further recess (6 ') preferably a different depth of the apex (1, 1 ') is sufficient as the second Ausparung (5'). Apex after one of Claims 4 to 6 , characterized in that it has an atraumatic shape, wherein the atraumatic form preferably has a circular or elliptical profile (P) and preferably has a round, atraumatic distal tip (S). Apex after Claim 7 , characterized in that the atraumatic distal tip (S) is angled to provide an insertion into it by twisting to simplify a diversion of the human or animal blood system. Apex after one of Claims 1 to 8th , characterized in that it is made of a temperature-stable and biocompatible material, such as made by a sol-gel process quartz glass or Ormocere. Apex after one of Claims 1 to 9 , characterized in that the different elements (10, 11, 12, 13) light (3) - only radially decouple with respect to the longitudinal axis of the apex (1, 1 '), so that there is an annular radiation characteristic, - only laterally with respect to Decouple longitudinal axis of the apex (1, 1 '), so that an approximately conical emission characteristic is formed in the radial direction, - only radially with respect to the longitudinal axis of the apex (1, 1'), but decoupled diffuse, so that there is a cylindrical radiation pattern, or - only axially with respect to the longitudinal axis of the apex, so that results in an approximately conical emission in the axial direction. Apex after one of Claims 1 to 10 , characterized in that the at least one acting as a diffuser element (12) nanoscale scattering particles (SP) whose average grain size is less than 100 nm, preferably a narrow particle size distribution is provided with a standard deviation of the grain diameter of less than 20 nm. A surgical handpiece (100, 110) comprising an apex (1, 1 ', 1 ") according to any one of Claims 1 to 8th , Catheter (120), having an apex (1, 1 ', 1 ") according to one of Claims 1 to 8th , Laser unit (200) for treating the human or animal body with light (3), comprising - at least one apex (1, 1 ', 1 ") according to one of Claims 1 to 8th at least one laser light source (LD), and at least one sensor unit (SE), the sensor unit (SE) measuring physical states in the region of the apex (1, 1 ') via the second or further optical waveguide (5, 6) Preferably, the at least one laser light source (LD) together with the at least one sensor unit (SE) and a control unit (RE) forms a controlled system, so that the control unit (RE) the radiation power of the at least one laser light source (LD) via a feedback by the sensor unit ( SE) regulates. Laser unit after Claim 14 , characterized in that the sensor unit (SE) is an interrogator, a spectrometer or an optical or optoelectronic filter arrangement which decomposes light from the second or further optical waveguide (5, 6) into its spectral components, the control unit (RE) depending on the spectral components which change for the measurement of a physical parameter regulate the power of the laser light of the at least one laser light source (LD). use - A coaxial or eccentric optical fiber (20) based on a multi-mode fiber (MMF) containing a coaxially or eccentrically enclosed singlemode fiber (SMF) with inscribed optical grating, for example in the form of a fiber Bragg grating (FBG), wherein the single mode fiber (SMF) is separated from the multimode fiber (MMF) by a cladding (C), a coaxial or eccentric optical waveguide (30) based on a multimode fiber (MMF) with inscribed optical grating, for example in the form of a fiber Bragg grating (FBG), a carrier fiber (TF) comprising a multimode fiber (MMF) enclosed by a first cladding (C) and a single mode fiber (SMF) enclosed by a second cladding (C), the single mode fiber (SMF) comprising an optical grating, for example in Form of a fiber Bragg grating (FBG), for constructing an apex (1 ") for an optical waveguide assembly (2), the light (3) for a therapeutic treatment of the human or animal body from a proximal end (PE) to a distal end (DE), such as a catheter for light therapeutic treatment of coronary total occlusion (CTO).

Images