DE102018129579A1 - Apex for an optical fiber arrangement - Google Patents

Abstract

The invention relates to 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). According to the invention it is provided that within the apex (1, 1 ') at least one diffractive element in the form of an integrated or free-space-optical grating, and optionally no or at least one element selected from the group consisting of a refractive element acting as a lens, for example in the form of Volume structures with refractive surfaces, such as lenses, prisms, mirrors or cavities or in the form of axicon structures, such as cones (10) or truncated cones (11), an element (12) acting as a diffuser, a reflective element acting as a lens, mirror or prism (13) is present, with the at least one diffractive element in the form of an integrated or free-space grating and the element that is optionally available from the group t Decouple light (3) individually or in combination from the apex (1, 1 ') or return it to the sensory measuring unit.

Description

The invention relates to an apex for an optical waveguide arrangement which guides light for a therapeutic treatment of the human or animal body from a proximal end to a distal end, this light bringing together light from more than one light source in the region of the treatment site, and wherein light from a first source is therapeutic light, and light from a second source is light for the detection of a physical parameter in the area of the treatment site, and this brings together more than one optical waveguide with different functions at the treatment site, a first recess for a first optical waveguide being arranged within the apex, and wherein a second recess for a second optical waveguide is arranged within the apex. Furthermore, the invention relates to a surgical handpiece, a catheter and a laser unit having this apex.

High energy laser light has been used therapeutically in numerous application examples for several years. Laser light is used as a scalpel substitute, but also for the treatment of tumors or for the treatment of inflammatory processes. Finally, vessels are obliterated with the help of laser radiation, if necessary, or vessels are reopened by ablative therapy after closure due to illness. The number of therapeutic uses is steadily increasing. In order to guide laser light that is used for ablation or for cutting the corresponding tissue, depending on the treatment technique, to the application site, it is known to provide the laser light with the aid of optical waveguides, with a special one at the end of the optical waveguide for the application adapted optical fiber tip, the so-called apex, is arranged. Depending on the type of application, this optical waveguide tip or apex has a special shape that can be adapted to the therapeutic features by appropriate shaping of the distal end.

Republish in the German patent application 10 2017 104 673.9 teaches an apex for an optical fiber that is suitable for the treatment of glaucoma and has special spherical-concave surfaces for placement on the sclera of the human eye.

In the post-published German patent application 10 2017 111 708.3 are taught various apices for an optical fiber that can be used for minimally invasive surgery.

The object of the invention is to provide a universal system for the therapeutic use of light, which enables a large number of therapeutic uses, that is to say is versatile and also allows the measurement of physical parameters in real time.

The object of the invention is thereby achieved by an apex according to claim 1. Further advantageous refinements are specified in the subclaims to claim 1.

The object of the invention is also achieved by a surgical handpiece according to claim 13, a catheter according to claim 14 and a laser system according to claim 15, all of which have such an apex.

According to the invention, it is provided that the apex fulfills different functions simultaneously. The apex is intended to guide high-energy light, i.e. light with a high optical energy density for therapeutic use to the treatment site. “High optical energy density” is understood to mean an energy density which is sufficient for an irradiance E, measured in W / m ² , for a typical therapeutic application from a distance of up to 5 cm from the treatment site and an exit angle of the light less or equal Thermally heat human or animal tissue to such an extent that it changes or illuminates it so strongly that optically induced apoptosis effects of the illuminated cells or coagulation, ablation, evaporation or other therapeutic effects occur. However, the apex is also intended to guide light from a further light source for measuring physical parameters to the treatment site, to reflect there, the reflection being effected by optical sensor elements, for example in the form of an optical grating which is in the form of an integrated optical or free-space optical grating or a fiber -Bragg grating can be shaped as an optical sensor element, in the form of an optical cavity with at least two interfaces, for example in the form of an interferometer or a polarization-dependent waveplate retarder, or in a measuring unit for surface plasmon according to an Otto or Kretschmann arrangement, whereby change the sensorically active elements when changing a physical parameter to be measured in a comprehensible manner and depending on the size of the parameter. The change in the grating constant of the optical grating, for example the integrated optical or free-space grating or the fiber Bragg grating as the optical sensor element, or the change in the distance between the interfaces in the cavity or the change in the absorption in the case of the surface plasmon sensor, finally lead to an observable that relates to the physical parameters prevailing at the treatment site can be returned. In a previously mentioned "integrated optics" light is guided in waveguides (such as fibers, waveguide chips). On the other hand, in free space optics, which include diffractive (optical grating structures) and refractive (lenses, prisms, mirrors, etc.) free space optics, light is reflected, refracted, diffracted, scattered, collimated, focused, etc. at free optical elements.

The apex according to the invention can be constructed in various ways. It is possible to combine all fiber optic functions, such as guiding high-energy light for therapy and guiding and returning laser light for the measurement of physical parameters in one fiber, or it is possible to combine different fibers in the apex.

When building the apex as part of the tip of a fiber with different functions, the fiber can be selected from the group consisting of: a coaxial or eccentric optical fiber based on a multimode fiber, which is a coaxially or eccentrically enclosed single-mode fiber with optionally inscribed optical gratings, for example contains in the form of fiber Bragg gratings as an optical sensor element, the singlemode fiber being separated from the multimode fiber by cladding, a coaxial or eccentric optical waveguide based on a multimode fiber with optionally inscribed optical gratings, for example in the form of fiber Bragg gratings , and a carrier fiber which has a multimode fiber enclosed by a first cladding and a single-mode fiber enclosed by a second cladding, the single-mode fiber having one or more optionally inscribed optical gratings, for example in the form of fiber Bragg gratings as an optical sensor element e contains.

However, the apex can also be constructed differently, in that it only brings together different, independent optical fibers at the treatment site. In this case, it is provided that the apex brings together more than one optical waveguide with different functions at the treatment site, a first recess for a first optical waveguide being arranged within the apex, and a second recess for a second optical waveguide being arranged within the apex. According to the invention, there is at least one element 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 based on micro and / or nanoscale structures, and one acting as a diffuser based on micro and / or nanoscale structures . The structure can be chosen as desired, so that the light used for the therapy exits radially as a ring, exits laterally with a preferred direction, or exits diffusely, but has a cylindrical (360 °) or a partially cylindrical (<360 °) radiation profile. Depending on the type of therapeutic use, the apex can be designed individually for the intended purpose. Depending on the type of use, provision can therefore be made for the various elements to be coupled out only radially with respect to the longitudinal axis of the apex, so that an annular radiation characteristic results, to be coupled out only laterally with respect to the longitudinal axis of the apex, so that an approximately conical radiation characteristic is formed in the radial direction. only couple radially with respect to the longitudinal axis of the apex, but diffuse, so that a cylindrical (<= 360 °) radiation characteristic results, or only axially with respect to the longitudinal axis of the apex, so that there is an approximately conical radiation characteristic in the axial direction. The radiation pattern is determined by the therapeutic purpose. The axial radiation is suitable, for example, for the light-induced opening of completely closed coronary vessels (Coronary Total Occlusion, CTO), in which the optical waveguide arrangement is pushed until shortly before the coronary closure and there the closure is ablative, i.e. by fusing, ablating or ablating the occluding plug, is opened.

Another use of the system can include the treatment of benign prostatic hypertrophy (BPH). The laser system is used to irradiate soft urological tissue within the prostate using imaging methods such as magnetic resonance imaging (MRI) or ultrasound (US) or any surgical navigation system or without instructions. The sensor element in the apex recognizes the physical changes in the application zone, where therapeutic light couples out, such as temperature and / or pressure. An interrogator connected to the sensory light guide captures this data in real time. The interface between the interrogator and the laser device enables the control of at least one of the therapeutic light properties such as intensity, wavelength, frequency etc. The limits of the desired therapy parameters such as maximum tissue temperature and / or applicable therapeutic light intensity can be determined by the surgeon or a specialist . It follows that the desired therapeutic effect, such as necrosis or apoptosis or coagulation or ablation, can be realized safely and safely in order to avoid side effects, such as injuries to nerve bundles, for example in the rectal area. The acquired therapy protocol, consisting of information such as the time and temperature profile in the target tissue, is saved and can be entered directly into the patient file. These dates can be viewed online and / or secured via blockchain, time stamps and / or other relevant cryptographic procedures with high data security.

In combination with the use of at least one first optical waveguide, which guides high-energy light to the treatment site, and at least one second optical waveguide, via which physical parameters can be measured, such as by using a single-mode fiber with optional inscribed optical gratings, for example in the form of a fiber -Bragg grating as an optical sensor element or an optical grating inscribed directly into the apex creates a system with a very wide range of uses.

In a first variant of the invention it can be provided that the first recess is provided for a first optical waveguide that guides light for the treatment of the animal or human body, such as laser light for the obliteration of blood vessels, or laser light for the treatment of glaucoma, for example, or laser light for example therapy of tumors in the urological area with triggering a light-induced apoptosis, laser light for the treatment of a coronary total occlusion (English: Coronary Total Occlusion, CTO), laser light for the treatment of thyroid nodules or laser light for lipolysis, whereby the first optical fiber is preferably an optical fiber is based on a multimode fiber, in coronary areas or in the brain, where many curvatures have to be overcome, but can also be designed as a single-mode fiber, preferably as a photonic crystal fiber, and the second recess is provided for a second optical waveguide st, the light for measuring the temperature and / or pressure in the area of the apex by an optical sensor element, e.g. an optical grating, which can be shaped in the form of an integrated optical or free-space optical grating or a fiber Bragg grating, or in the form of an optical cavity with at least two interfaces, the second optical waveguide preferably being an optical waveguide based on a single-mode fiber.

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

Depending on the type of application, for example when used as a catheter tip or for use in openings in the body or in cut tissue, it is advantageous if it has an atraumatic shape, the atraumatic shape preferably having a circular or elliptical profile and preferably a round, atraumatic distal Tip, through which the apex cannot cause mechanical injuries at the treatment site. The apex hermetically encloses the fibers inside so that no liquid can penetrate the apex, with the exception of those places which are intended to allow the targeted penetration of body fluids, especially for diagnostic purposes. The hermetic seal enables regulation of the therapeutic light beam in such a way that the performance of the therapeutic light is controlled as a controlled variable. The reference variable for pulse width modulation as an actuator is the pulse-pause ratio of the therapeutic light or, in the case of real power control, the control signal as an actuator for the power of the therapeutic light beam. The reflected light in the sensory light guide is used as the measuring element and is assigned to a physical parameter via a spectral analysis and / or via an intensity analysis. As a concrete, but not limiting example, the therapeutic light for laser ablation of tissue can be regulated via a temperature measurement via the sensory light guide into which another light is emitted. Depending on the temperature of the tissue to be treated on the apex, which is increased as a disturbance variable by the therapeutic light on the apex, the lattice constant of a fiber Bragg grating, for example at the distal end of the sensory light guide, changes. By analyzing the light reflected back by the fiber Bragg grating, a temperature can be clearly determined and used to regulate the power of the laser. The power of the laser is reduced when it is determined that a certain temperature has been reached and the laser power is increased again when the temperature falls below a certain temperature. Known control strategies, such as control based on the PID principle, can be used to optimize this control.

For a special application as a catheter tip, it can be provided that the atraumatic distal tip is angled in order to simplify an introduction into a branch of the human or animal blood or vascular system by twisting. It can be provided that the apex is made of a temperature-stable and biocompatible material, such as quartz glass produced by a sol-gel process or from high temperature stable polymers or from Ormoceren. In principle, the apex can be manufactured directly or can be obtained using mold inserts and impression processes.

Furthermore, it is provided in an advantageous embodiment of the invention that the apex is composed of at least two individual parts made directly or by molding, into which the fibers provided were inserted during the process of joining and apex individual parts and fibers are glued or thermally welded to one another. Regardless of the manufacturing method, it is particularly advantageous if the apex including the optical elements it contains and the optical fibers entering it are completely closed (hermetically sealed) and also secured in the capillary area by monolithic design or by gluing and / or by sealing the capillaries against liquid ingress . In principle, the apex can be reused because no body fluids are entered into the apex that could no longer be removed, making it impossible to use it with another patient without taking any risk of infection. A much more important aspect of the closed embodiment is that it does not cover the optical elements within the apex with a liquid film, which can change the optical properties of the optical elements in the apex because either the refractive index difference between the interior of the optical element and the optically effective interface of the optical element changes or else the optical properties change due to the superposition with blood and / or serum in the area of the light absorption of blood and / or serum. If it is guaranteed that the optical properties are stable and no optical interfaces change, then a high level of precision can be maintained if the apex on the one hand leads laser light as therapeutic light to the tissue and heat or other light radiation as feedback again out of the apex proximal end leads. Only this precision makes it possible to use plastic as the material for the apex, for example, because the power of the laser light can be regulated by the feedback so that the temperature at the apex just does not reach the melting temperature of the apex. But even when using low-melting glass, the very precise feedback has the advantage that tissue is only heated to such an extent that apoptosis of the tissue destroyed by thermolysis occurs in the desired manner. Unlike tissue burning, tissue that undergoes apoptosis can be broken down by the body.

For a further special purpose, 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, a narrow grain size distribution preferably being provided with a standard deviation of the grain diameter of less than 20 nm The nanoscale structure of the scattering particles causes a particularly uniform and diffuse light scattering, which also has a depolarizing effect. Especially when using laser light, the depolarizing effect can convert the usually polarized laser light into diffuse but high-energy light, so that the therapeutic effect is changed, which is dependent on the light polarization, particularly in the case of structured or anisotropically structured tissue. Although light polarization is of minor importance for laser-induced interstitial thermotherapy (LITT), the polarization of therapeutic light can play an important role in other therapies, such as when activating pharmaceutically active substances only at the treatment site.

In order to be able to simply apply the light in surgical treatments by the surgeon, a surgical handpiece can have an apex that is constructed as above. A catheter can also have an apex described above for diagnostic or combined diagnostic / therapeutic methods.

A laser unit for treating the human or animal body with light can be considered as the overall system for the therapeutic use of high-energy light. This has: at least one previously described apex and at least one laser light source, and at least one sensor unit. The sensor unit measures physical states 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 controls the radiation power of the at least one laser light source via feedback from the sensor unit itself. The sensor unit itself can be adapted to the measurement purpose. It has proven to be versatile when the sensor unit is, for example, an interrogator, a spectrometer or an optical or optoelectronic filter arrangement that breaks down light from the second or further optical waveguide into its spectral components or can evaluate interferometric and / or polarization-dependent information. The control unit can, depending on the spectral components and / or or the interferometric and / or polarization-dependent information regulate the power of the laser light of the at least one laser light source. Optionally, however, the physician can only display the physical parameters.

In a special embodiment of the laser unit, it can be provided that a further device of the overall system records the operating parameters of the control unit over a coherent treatment period as a measurement and operation protocol and provides a time stamp, the measurement and operation protocol in real time or after treatment has been completed with the aid of a digital signature is optionally included in a public blockchain for non-changeable documentation. It can be documented that the temperature at the treatment site has never risen above an accepted maximum. This can be important in order to document critical operations, for example in the field of neurosurgery, that no tissue has been unwantedly overheated in an unwanted and undesired manner and that the environmental conditions during the therapy have been observed. Such a device behaves like a flight recorder, the data of which cannot be changed subsequently and can therefore even be evaluated for judicial purposes. However, this not only provides documentation for legal purposes, but also documentation of the operating parameters, which can be repeated for later post-treatment with identical parameters. Especially for patients whose physiology requires an individual therapeutic dose and an individual procedure, this documentation of the operating parameters can be very helpful in order to avoid repeated experimentation on the patient during the operation / under therapy.

The invention is illustrated by the following figures.

• 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.

It shows:

• 1 a first variant of the apex according to the invention,
• 2nd a second variant of the apex according to the invention,
• 3rd a third variant of the apex according to the invention with a curved tip,
• 4th 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.

In 1 is a first variant of the apex according to the invention 1 for an optical fiber arrangement 2nd outlines the light 3rd from a proximal end PE to a distal end DE directs. This apex 1 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 , caused no injuries due to its shape. The shape of the profile P can be circular, elliptical or organic in shape, whereby “organic shaped” means the absence of burrs and edges and all surfaces merge into one another with a constant change in curvature. At the back end of the apex 1 there are three recesses in this variant 4th , ' 5 ' and 6 ' for one optical fiber each 4th , 5 and 6 . The apex encloses the optical fibers 4th , 5 and 6 hermetically sealed. To demonstrate the interior of the apex 1 is under the apex 1 a halved apex 1 shown by a cut AA would arise. The halved shape means that there are two optically active elements, namely a truncated cone that is reversed with respect to the direction of light propagation 10th and a cone standing on top 11 to recognize. Truncated cone 10th and cone 11 are in the apex 1 molded in by omitting the corresponding volume. In terms of spreading light 3rd , which initially consists of an optical fiber 4th in the apex 1 emerges, even in the recess 4 ' stuck, form the lateral surfaces of the truncated cone 10th and the cone 11 reflective surfaces because these are in relation to the direction of propagation of the emerging light 3rd exceed the critical angle of total reflection. As a result, the light 3rd on the lateral surfaces of the truncated cone 10th and the cone 11 reflected. The light changes 3rd its direction and emerges laterally in an approximately radial direction from the apex 1 out. In the bottom sketch is the halved apex 1 with inserted optical fibers 4th , 5 and 6 shown. The optical fiber 4th which is a multimode fiber here MMF here, guides 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 10th and the cone 11 the high-energy light radially emerges from the apex 1 out. Both cones 10th and 11 couple a part of each through the optical fiber 4th emitted light, the arrangement of the two or more cones determines the partial ratio of the coupling of each cone. The function of the two other optical fiber 5 and 6 is another. These two optical fibers 5 and 6 are as single mode fiber SMF designed. You can at their distal end that in the apex 1 is an optical sensor element OS have or receive light from an optically sensory element monolithically integrated in the apex, for example in the form of an integrated optical or free-space optical grating or an optical cavity and return it to the evaluation unit. When writing an optical grating, for example in the form of a fiber Bragg grating into an optical waveguide 5 , 6 becomes the structure of the fiber of the optical fiber 5 , 6 changed with a short-term 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 surroundings of the same fiber material. This results in a partial reflection of the fiber through the optical waveguide at the resulting interface between regions of different refractive index 5 , 6 guided light instead. If the refractive index of the fiber of the optical waveguide is changed in short, successive sections at a distance of λ / 2 with respect to a reference wavelength, so that the fiber material of the optical waveguide changes 5 , 6 Forming pairs of sections, which together have a length of λ / 2 in relation to a reference wavelength, this optical grating, for example in the form of a fiber Bragg grating, acts like an anti-reflective coating on a photographic lens, which is, however, very wavelength-specific. The reference wavelength is reflected and sent back to the source of the light. Now the optical fiber heats up 5 , 6 at the tip, where the optical grating is inscribed, for example in the form of an optical sensor element, 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 from the change in the back-reflected wavelength 1 measure by precisely determining the wavelength of the back-reflected light using a sensor unit. For the thermometer constructed in this way to function correctly, it is only necessary to have the optical grating, for example in the form of a fiber Bragg grating, only at the tip of the optical waveguide 5 , 6 to enroll. Or alternatively, the optical grating can be integrated or can be monolithically integrated directly in the apex.

When the apex is in operation, for example when treating coronary artery occlusions or when vessels become blocked, it heats up due to the high-energy laser light and can reach temperatures of up to 1,000 ° C, albeit for a very short time. In order to avoid overheating of the apex, a control loop can be provided, in which the laser light as the heating source and the detection of the temperature by the sensor unit form a control loop, which is described in more detail below. In the example shown here is the depth of the recess 6 ' in the apex 1 significantly deeper than the depth of the recess 5 ' . The corresponding single-mode fiber with the optical sensor element, for example in the form of an integrated or free-space optical grating or an optical cavity or a surface plasmon sensor, thus extends into the area in which the light of the multimode fiber is coupled out.

This enables the local temperature of the apex 1 to measure at the location of the light emission and the temperature of the apex in the area of the coupling with the optical waveguide arrangement 2nd . Alternatively, it is possible to use the single mode fiber 6 to measure the temperature and with the single mode fiber 5 measure another physical parameter, such as pressure or local pH.

In 2nd is a second variant of the apex according to the invention 1 sketched for an optical fiber arrangement, the light 3rd conducts from a proximal end to a distal end. This apex shown here 1 also essentially has a torpedo shape or a cigar shape with a circular profile P on, with only the cut through the plane AA emerging half essays 1 are shown. The apex encloses the optical fibers 4th , 5 and 6 hermetically sealed.

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 caused no injuries due to its shape. Unlike the apex 1 in 1 the apex outlined here 1 asymmetrically distributed elements, namely a prism with vertical side surfaces 10th and another prism with vertical side faces 11 . These are somewhat to the side of an imaginary axis of the fiber optic 4th emerging light 3rd arranged and thus form elements acting as mirrors. These prism elements acting as mirrors 10th and prism 11 couple the light from the side, but with a preferred direction. Both prisms 10th and 11 couple a part of each through the multimode fiber 4th emitted light, the arrangement of the two or more prisms determining the partial ratio of the coupling of the prisms.

This apex 1 can be used for the treatment of blood vessels, for example the obliteration of veins or the obliteration of vein branches or in urological surgery for the treatment of tumors in the urethra or in the bladder, as well as in the ureters as kidney outflows due to laser-induced apoptosis. In this example, too, the depth of the recess is shown 6 ' in the apex 1 significantly deeper than the depth of the recess 5 ' . The corresponding single-mode fiber with the optical sensor element, for example in the form of an integrated or free-space optical grating or an optical cavity or a surface plasmon sensor, thus extends into the area in which the light of the multimode fiber is coupled out. This enables the local temperature of the apex 1 to measure at the location of the light emission and the temperature of the apex in the area of the coupling with the optical waveguide arrangement 2nd .

For a very precise therapy it can be provided that the arrangement and size of the optical elements on the optical axis of the apex determine the light distribution, so that a certain amount of light / light output is supplied to each optical element. It is also possible for a light mixer to combine different light sources with one another at the distal or proximal end. This can be, for example, short-wave light in order to trigger ablative processes in the tissue to be treated and long-wave light can also be mixed in order to induce light and / or heat-induced apoptosis processes in the tissue to be treated. Such a light mixing can be done with so-called "multimode waveguide combiners".

Alternatively, it is possible to use the single mode fiber 6 to measure the temperature and with the single mode fiber 5 measure another physical parameter, such as pressure or local pH. The apex 1 out 2nd is in 3rd further educated. In 3rd is a third variant of the apex according to the invention 1 sketched for an optical fiber arrangement, the light 3rd conducts from a proximal end to a distal end. This apex shown here 1 also essentially has a torpedo shape or a cigar shape with a circular profile P on, with only the cut through the plane AA emerging half essays 1 are shown. The apex encloses the optical fibers 4th , 5 and 6 hermetically sealed.

What is special about the variant shown here is that the atraumatic tip is asymmetrical and is bent in a preferred direction. This tip shape helps when inserted as a tip of a catheter to be inserted into branches of blood vessels. This apex too 1 couples through elements prism 10th and prism 11 light 3rd laterally with a preferred direction, again the coupling ratio of the light optionally to the two prisms 10th and 11 Can be distributed Due to the fixed orientation of the light decoupling in relation to the bent, atraumatic tip S it is easier to determine the preferred direction of the light at the treatment site. When catheterizing or when using a surgical handpiece, the tip can be fixed in a vascular branch by a corresponding rotational position, in which case the direction of the outcoupled light 3rd is reliably determinable and can therefore be directed specifically at a treatment location by the user. As in the previous embodiments, the depth of the recess is in the example shown here 6 ' in the apex 1 significantly deeper than the depth of the recess 5 ' . The corresponding single-mode fiber with the optical sensor element, for example in the form of an integrated or free-space optical grating or an optical cavity or a surface plasmon sensor, thus extends into the area in which the light of the multimode fiber is coupled out. This enables the local temperature of the apex 1 to measure at the location of the light emission and the temperature of the apex in the area of the coupling with the optical waveguide arrangement 2nd . Alternatively, it is possible to use the single mode fiber 6 to measure the temperature and with the single mode fiber 5 measure another physical parameter, such as pressure or local pH.

In 4th is finally a fourth variant of the apex according to the invention 1 sketched for an optical fiber arrangement, the light 3rd conducts 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 caused no injuries due to its shape. The apex encloses the optical fibers 4th , 5 and 6 hermetically sealed.

Here too, only an open half of the apex is used to show the internal structure 1 represented by a cut through the plane AA ( 1 ) would arise. Inside this apex points 1 an axicon structure 12 which produce scattered light by doping with nanoscale, that is to say with a grain size of less than 100 nm. The truncated cone 11 As an axicon structure, the nanoscale particles act as a diffuser 12 . So that the light is evenly scattered, it can be provided that the nanoscale particles have a narrow grain size distribution which, with 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 approximately meant here. Finally, this embodiment also provides 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 one Single-mode fiber with the optical sensor element, for example in the form of an integrated or free-space optical grating and / or an optical cavity and / or a surface plasmon sensor, thus extends into the area in which the light of the multimode fiber is coupled out. This enables the local temperature of the apex 1 to measure at the location of the light emission and the temperature of the apex in the area of the coupling with the optical waveguide arrangement 2nd . Alternatively, it is possible to use the single mode fiber 6 to measure the temperature and with the single mode fiber 5 measure another physical parameter, such as pressure or local pH.

In 5 is a fifth variant of the apex according to the invention 1 sketched for an optical fiber arrangement, the light 3rd from a proximal end PE to a distal end DE directs. 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 caused no injuries due to its shape. The apex encloses the optical fibers 4th , 5 and 6 hermetically sealed.

Here too, only an open half of the apex is used to show the internal structure 1 represented by a cut through the plane AA ( 1 ) would arise. Inside this apex points 1 an axicon structure designed as a hollow body 12 ' on. In contrast to the construction of the fourth variant in 4th creates the otherwise transparent apex in this example 1 by doping with nanoscale, ie with a grain size of less than 100 nm, scattered light particles. The hollow truncated cone 11 the axicon structure designed as a hollow body 12 ' forms for that from the optical fiber 4th at the foot of the truncated cone 11 an inclined entry surface along the outer surface of the truncated cone 11 . At the transition to the endowed apex 1 scatters the light and emerges from the apex 1 out. To ensure that the light is evenly scattered, it can also be provided in this variant that the nanoscale particles have a narrow grain size distribution which, with an assumed Gaussian distribution of the grain size, has a standard deviation of less than 20 nm. In fact, as in the previous example, grain size distributions are distributed differently on an RRSB network. The Gaussian distribution of the grain sizes and the standard deviation are approximately meant here. Finally, this embodiment also provides 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 sensor element, for example in the form of an integrated or free-space optical grating and / or an optical cavity and / or a surface plasmon sensor, thus extends into the area in which the light of the multimode fiber is coupled out. This enables the local temperature of the apex 1 to measure at the location of the light emission and the temperature of the apex in the area of the coupling with the optical waveguide arrangement 2nd . Alternatively, it is possible to use the single mode fiber 6 to measure the temperature and with the single mode fiber 5 measure another physical parameter, such as pressure or local pH.

In 6 is a laser unit after all 200 shown which laser light from at least one laser light source LD , here laser diodes, from a proximal end to a distal end. The laser unit points to this 200 a first optical fiber 4th on, and two more optical fibers 5 and 6 that have a corresponding connector V to an optical fiber arrangement 2nd are summarized. The fiber optic arrangement 2nd works together with an apex 1 as a catheter 120 , 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 apply therapeutically. In the laser unit 200 is at least one high-energy laser light source LD arranged using a multimodemixer MMC (English Multi Mode Combiner) the light of at least one high-energy laser light source LD in the optical fiber 4th couples. The lights of different laser light sources can be used LD also have different spectral compositions. Through that in the apex 1 decoupled light 3rd the apex heats up 1 to temperatures up to 1,000 ° C. In order to avoid that the apex burns the patient internally, it is provided that via the optical fiber 5 and 6 that as singlemode fibers SMF are constructed and in the area within the apex have an optical sensor element, for example in the form of an optical grating, the temperature of the apex 1 is measured. Specifically, when using polymeric materials or ormocers, it should be controlled that the temperatures in the apex 1 always remain sufficiently below the melting temperature of the relevant material. To do this, light enters the fiber optic cable 5 and 6 sent a temperature-specific signal to a sensor unit due to the temperature-related change in the optical sensor element, for example in the form of an integrated or free-space optical grating and / or an optical cavity and / or a surface plasmon sensor SE in the laser unit 200 send back. This sensor unit SE is with a control unit RE coupled to the multimodemixer or to the laser light sources LD acts. In this way, one forms closed control loop, namely laser power in the apex 1 is converted into heat, which is sent back to the laser unit based on the measurement of the temperature and acts on the laser power there again via the control unit.

In 7 is a first variant of a surgical handpiece 100 shown, having an apex according to the invention 1 , the light 3rd from an optical fiber arrangement 2nd the light 3rd leads to the treatment site. The user guides the surgical handpiece to the application 100 with the apex 1 in a corresponding body cavity, in a cut in the open body or in a vessel where the light 3rd to therapy accordingly emerges. This surgical handpiece is suitable for the therapeutic use 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 to make the apex out, for example 2nd use with the surgical handpiece shown here, for example for non-invasive therapeutic treatment or lighting.

In 8th is a second, special variant of a surgical handpiece 110 shown, having an apex according to the invention 1" , the light 3rd from an optical fiber arrangement 2nd the light 3rd 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. The user guides the surgical handpiece to the application 100 with the apex 1" on the patient's eye where the light 3rd for therapy of glaucoma emerges accordingly. The exact application and destination of the high-energy light radiation is left to the therapeutic art of the treating doctor.

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 µm, the term "atraumatic" can hardly be used meaningfully, since a tip with this small diameter always has the potential to break through a fine vein wall.

Reference symbol list

1

apex

1'

apex

1"

apex

2nd

Optical fiber arrangement

3rd

light

4th

optical fiber

4 '

Recess

5

Optical fiber arrangement

5 '

Recess

6

optical fiber

6 '

Recess

10th

cone

11

Truncated cone

12

element acting as a diffuser, axicon structure

12 '

axicon structure designed as a hollow body

13

element acting as a mirror

20th

coaxial optical fiber

30th

eccentric optical fiber

100

surgical handpiece

110

surgical handpiece

120

catheter

200

Laser unit

BG

Blood vessel

C.

Cladding

DE

distal end

OS

optical sensor element

K

body

LD

Laser diodes MMC Multi-mode 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 documents listed by the applicant has been generated automatically and is only included 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.

Patent literature cited

• DE 102017104673 [0003]
• DE 102017111708 [0004]

Claims (17)

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), this light brings together more than one light source (LD) in the area of the treatment site, and wherein - light from a first source (LD) is therapeutic light, and - light from a second source is light for detecting a physical parameter in the area of the treatment site, and wherein - this brings together more than one optical waveguide (4, 5) with different functions at the treatment site, wherein - a first recess (4 ') for a first optical waveguide (4) is arranged within the apex (1, 1'), and - a second recess (5 ') for a second optical waveguide (5) within the apex (1, 1'), characterized in that within the apex (1, 1 ') - at least one sensor element, for example in the form of a diffractive E. elements in the form of an integrated or free-space-optical grating or an optical cavity with at least two interfaces, for example in the form of an interferometer or a polarization-dependent waveplate retarder, and / or a measuring unit for surface plasmon according to an Otto or Kretschmann arrangement and optionally no or at least an element selected from the group consisting of - a refractive element acting as a lens, for example in the form of volume structures with refractive surfaces, such as, for example, lenses, prisms, mirrors or cavities or in the form of axicon structures, such as cones (10) or truncated cones (11) , - An element (12) acting as a diffuser, - A reflective element (13) acting as a lens, mirror or prism is present, wherein - The at least one sensor element, for example in the form of a diffractive element in the form of an integrated or free-space optical grating or an optical cavity with at least two interfaces, for example el in the form of an interferometer or a polarization-dependent waveplate retarder, and / or a measuring unit for surface plasmon according to an Otto or Kretschmann arrangement and - the element from the group, either individually or in combination, light (3) from the apex (1, 1 ') decouple or return to the sensory measuring unit, the apex hermetically sealing the elements in it and reliably preventing the ingress of liquid. Apex after Claim 1 , characterized in that the first recess (4 ') is provided for a first optical waveguide (4) which guides light (3) for the treatment of the animal or human body (K), such as - laser light for the treatment of epilepsy and others neurological applications - laser light for the treatment of renal denervation - laser light for the treatment of benign thyroid nodules - laser light for the obliteration of blood vessels (BG), or - laser light for the treatment of glaucoma, or - laser light for the treatment of tumors, e.g. in the urological area the pancreas, in the lungs or in other areas of the body - laser light for the treatment of thyroid nodules, - laser light for the treatment of coronary total occlusion (CTO), or - laser light for lipolysis, the first optical fiber (4) is preferably an optical waveguide based on a multimode fiber (MMF), and the second recess (5 ') for A second optical waveguide (5) is provided, the light for measuring the temperature and / or the pressure in the area of the apex (1, 1 ') via an optical sensor element (OS), selected from the group consisting of - a fiber Bragg Grating, and / or - an integrated or free-space-optical grating and / or - an optical cavity with at least two interfaces, for example in the form of an interferometer or a polarization-dependent waveplate retarder, and / or - a measuring unit for surface plasmon according to an Otto or Kretsch mann-Anordn u ng conducts, the second optical fiber (5) is preferably an optical fiber based on a single mode fiber (SMF). Apex after Claim 1 or 2nd , characterized in that the second optical waveguide (5) has polarization-maintaining properties. Apex according to one of the Claims 1 to 3rd , characterized in that at least one further recess (6 ') for a further optical waveguide (6) is arranged within the apex (1, 1'), the further recess (6 ') preferably having a different depth of the apex (1, 1 ') is sufficient as the second recess (5'). Apex according to one of the Claims 1 to 4th , characterized in that it has an atraumatic shape, the atraumatic shape preferably having a circular or elliptical profile (P) and preferably has a round, atraumatic distal tip (S). Apex after Claim 5 , characterized in that the atraumatic distal tip (S) is angled to simplify an introduction into a branch of the human or animal blood system by twisting. Apex according to one of the Claims 1 to 6 , characterized in that it is made of a temperature-stable and biocompatible material, by direct processes, such as, for example, by a sol-gel process or by 3D printing or by laser ablation or by 2-photon absorption, for example in quartz glass or from high-temperature stable ones transparent polymers or from Ormoceren, or the Apex is made indirectly via mold inserts and molding processes. Apex according to one of the Claims 1 to 7 , characterized in that it is completely closed (hermetically sealed) including the optical elements it contains and the optical fibers entering it and is also secured in the capillary area by monolithic design or by gluing and / or by sealing the capillaries against liquid entry, preferably from at least two directly or is assembled by molding individual parts, in which the intended fibers were inserted during the process of joining and apex individual parts and fibers are glued together or thermally welded. Apex according to one of the Claims 1 to 8th , characterized in that the various elements (10, 11, 12, 13) couple light (3) - only radially with respect to the longitudinal axis of the apex (1, 1 '), so that there is an annular radiation characteristic, - only laterally with respect to the Uncouple the longitudinal axis of the apex (1, 1 ') so that an approximately cone-shaped radiation pattern is formed in the radial direction, - only radially with respect to the longitudinal axis of the apex (1, 1'), but decouple diffusely, so that a cylindrical radiation characteristic results. which is adjustable in a radiation angle range of 30 ° to 360 °, or - only axially with respect to the longitudinal axis of the apex, so that there is an approximately conical radiation characteristic in the axial direction. Apex according to one of the Claims 1 to 7 , characterized in that the at least one element (12) acting as a diffuser has nanoscale scattering particles (SP) or surfaces whose mean grain size is less than 100 nm, a narrow grain size distribution preferably being provided with a standard deviation of the grain diameter of less than 20 nm. Apex according to one of the Claims 1 to 10th , characterized in that the arrangement and size of the optical elements on the optical axis of the apex determines the light distribution, so that a certain amount of light / light output is supplied to each optical element. Apex according to one of the Claims 1 to 11 , characterized in that by a light mixer, such as a multimode waveguide combiner, different light sources are combined with one another at the distal or at the proximal end, where, for example, short-wave light is mixed in for ablative processes in the tissue to be treated, long-wave light is mixed in to light and / or to induce heat-induced apoptosis processes in the tissue to be treated. Surgical handpiece (100, 110), having an apex (1, 1 ', 1 ") according to one of the Claims 1 to 8th . Catheter (120), having an apex (1, 1 ', 1 ") according to one of the 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 the 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 area of the apex (1, 1 ') via the second or further optical waveguide (5, 6), wherein the at least one laser light source (LD) preferably forms a controlled system together with the at least one sensor unit (SE) and a control unit (RE), so that the control unit (RE) controls the radiation power of the at least one laser light source (LD) via feedback from the sensor unit ( SE) regulates. Laser unit after Claim 15 , characterized in that the sensor unit (SE) is a spectrometer which decomposes light from the second or further optical waveguide (5, 6) into its spectral components or evaluates it interferometrically and / or polarization-dependent and / or intensity-dependent, the control unit (RE) the power of the laser light of the at least one laser light source (LD) is regulated as a function of the reflected light information that changes for the measurement of a physical parameter. Laser unit according to one of the Claims 15 or 16 , characterized in that a further device records the operating parameters of the control unit over a coherent treatment period as a measurement and operation protocol and provides a time stamp, the measurement and operation protocol being provided in real time or after treatment has been completed with the aid of a digital signature, optionally in a public blockchain for non-changeable documentation.

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