WO2020104897A1

WO2020104897A1 - Apex for an optical waveguide assembly

Info

Publication number: WO2020104897A1
Application number: PCT/IB2019/059740
Authority: WO
Inventors: Wolfgang Hufnagel
Original assignee: Wolfgang Hufnagel
Priority date: 2018-11-23
Filing date: 2019-11-13
Publication date: 2020-05-28
Also published as: DE102018129579A1

Abstract

The invention relates to an apex (1, 1', 1 ") for an optical waveguide assembly (2), which guides light (3) for a therapeutic treatment from a proximal end (PE) to a distal end (DE), wherein said apex brings together light from more than one light source (LD) in the region of the treatment site, and wherein light from a first source (LD) is therapeutic light, and light from a second source is light for detection, and wherein said apex brings together more than one optical waveguide (4, 5) at the treatment site. According to the invention, at least one diffractive element is provided within the apex (1, 1'), which decouples the light (3) out of the apex (1, 1').

Description

Apex for an optical fiber arrangement

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, which light brings 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 therapy 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, at the end of the optical waveguide a specially for the Application-adapted optical fiber tip, the so-called apex, is arranged. This fiber optic tip or apex has a special shape, depending on the type of use can be adapted to the therapeutic features by appropriate shaping of the distal end.

The post-published German patent application 10 2017 104 673.9 teaches an apex for an optical waveguide which 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 1 11 708.3 who taught the various apices for an optical fiber that can be used for minimally vasive surgery.

The object of the invention is to provide a universal system for the therapeutic use of light, which enables a multitude of therapeutic uses, that is to say is versatile and still 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 having 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 90 ° heat human or animal tissue so strongly that it changes or optically so strongly that the 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, where the sensorically active elements change when a physical parameter to be measured changes 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 an optical sensor element, or the change in the distance from the interfaces in the cavity or the change in absorption in the surface plasmon sensor result and finally to an observable that can be traced back to the physical parameters prevailing at the treatment site. 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-level optical light for therapy and guiding and returning laser light for the measurement of physical parameters, 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, the one contains coaxially or eccentrically enclosed single-mode fiber with optionally registered optical gratings, for example in the form of fiber Bragg gratings as an optical sensor element, the single-mode 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 singlemode fiber enclosed by a second cladding, the sin glemode fiber having one or more optionally inscribed optical fibers Contains gratings, for example in the form of fiber Bragg gratings as an optical sensor element.

The apex can also be constructed differently, however, 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 is. According to the invention, there is at least one element that is selected from the group consisting of: a refractive element, for example in the form of volume structures with refractive surfaces, such as lenses, prisms or mirrors, or in the form of axicon structures, such as Cones or truncated cones and similar structures, a diffractive element based on microscale and / or nanoscale structures, and a diffuser based on microscale and / or nanoscale structures act. The structure can be chosen as desired so that the light used for Thera pie radially exits as a ring, exits laterally with a preferred direction, or exits diffusely, but has a cylindrical (360 °) or 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 application, it can therefore be provided that the various elements only couple out radially with respect to the longitudinal axis of the apex, so that a ring-shaped moderate emission characteristic, only couple out laterally with respect to the longitudinal axis of the apex, so that an approximately cone-shaped radiation pattern is formed in the radial direction, but only radially with respect to the longitudinal axis of the apex, but diffuse out, so that a cylindrical (<= 360 °) radiation pattern teristics 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 characteristics are determined by the therapeutic purpose. The axial radiation is suitable, for example, for the light-induced opening of totally closed coronary vessels (Coronary Total Occlusion, CTO), in which the optical waveguide arrangement is pushed until just before the coronary occlusion and the occlusion there, which means by fusing, ablating or removing the sealing 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 detects the physical changes in the application zone where therapeutic light is emitted, 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 / surgeon or a specialist , be determined. 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 time and temperature history in the target tissue, is saved and can be entered directly into the patient file. These data can be viewed online and / or made available via block chain, time stamp 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 applications.

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 example treatment a glaucoma, 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 the first optical waveguide is preferably an optical waveguide 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 is the light for measuring the temperature and / or the pressure in the area of the apex through an optical sensor element, for example 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 there prevailing pressure. Especially with therapies that involve heat or that require specific light absorption of the tissue to be treated, it is important to always check 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 recess 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, has atraumatic distal tip through which the apex at the treatment site cannot cause mechanical injuries. The apex encloses the fibers inside hermetically, so that no liquid can penetrate the apex, with the exception of those places that 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. As a reference variable with pulse width modulation as an actuator, the pulse-pause ratio of the therapeutic light is suitable or with a real power control, the control signal as an actuator for the output of the therapeutic light beam. The reflected light in the sensory light guide is used as the measuring element, which is assigned to a physical parameter via a spectral analysis and / or an intensity analysis. As a concrete, but not limitative 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 injected. 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 reaches a certain temperature and if the temperature falls below a certain level, the laser power is increased again. Known control strategies, such as control based on the PID principle, can be used to optimize this control.

For a special purpose 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 of highly temperature-stable polymers or of Ormoceren. In principle, the apex can be manufactured directly or can be obtained using mold inserts and molding processes.

Furthermore, it is provided in an advantageous embodiment of the invention that the apex is composed of at least two directly or by molding individual parts, into which the fibers seen before were inserted during the process of joining and apex individual parts and fibers glued or thermally welded to one another are. 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 in the capillary area by means of monolithic design or by gluing and / or by sealing the capillaries Liquid entry is secured. This allows the apex in principle, are reused because no body fluids are entered into the apex that could no longer be removed and thus made it impossible to use them with another patient without risking infection. An even 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 the optical properties change due to the overlay with blood and / or serum in the area of light absorption of blood and / or serum. If it is guaranteed that the optical properties are stable and that no optical interfaces change, then a high degree of precision can be maintained if the apex on the one hand guides laser light as therapeutic light to the tissue and heat or other light radiation as feedback again out of the apex leads to the proximal end. 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, the average grain size of which 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 subordinate 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 easily 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.

As a total system for the therapeutic use of high-energy light, a laser unit for treating human or animal bodies with light can be considered. 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 regulates 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 as a function of the spectral components changing for the measurement of a physical parameter and / 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 the treatment has been completed with the help 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 undesirably and undesirably overheated in an undesired and undesirable manner and that the ambient conditions during the therapy have been observed. Such a device behaves like a flight recorder whose data cannot be changed subsequently and can therefore even be evaluated for legal purposes. However, this not only enables 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 approach, this documentation of the operating parameters can be very helpful in order to avoid repeated experimentation on the patient during surgery / therapy.

The invention is illustrated by the following figures. It shows:

1 shows a first variant of the apex according to the invention,

2 shows a second variant of the apex according to the invention,

3 shows a third variant of the apex according to the invention with a curved tip,

4 shows a fourth variant of the apex according to the invention with a diffuser,

5 shows a fifth variant of the apex according to the invention with a hollow space, itself acting as a diffuser,

6 shows a laser system having an apex according to the invention on a catheter,

7 shows a first variant of a surgical flange piece having an apex according to the invention,

8 shows a second variant of a surgical piece of flange having an apex according to the invention.

FIG. 1 shows a first variant of the apex 1 according to the invention for a light waveguide arrangement 2 which guides light 3 from a proximal end PE to a distal end DE. This apex 1 essentially has a torpedo shape or a cigar shape with a circular profile P, with an atraumatic tip S being provided at the distal end DE which, when the apex 1 is inserted, for example as part of a catheter 120 into the bloodstream B of the human or animal body K, caused no injury by its shape. The shape of the profile P can be circular, elliptical or organic in shape, with “organic shape” meaning the absence of ridges and edges and all surfaces merging into one another with a constant change in the curvature. In this variant, at the rear end of the apex 1 there are three cutouts 4, '5' and 6 'for one optical fiber 4, 5 and 6 each. The apex hermetically seals the optical fibers 4, 5 and 6. To demonstrate the interior of the Apex 1, a halved Apex 1 is shown below the Apex 1, which would result from an AA cut. Due to the biert form are two optically acting elements, namely a truncated cone 10 reversed with respect to the direction of light propagation and a cone 11 standing on the tip. The truncated cone 10 and the cone 1 1 are molded into the apex 1 by omitting the corresponding volume. With regard to propagating light 3, which first emerges from an optical waveguide 4 into the apex 1, which itself is in the recess 4 ', the lateral surfaces of the conical stump 10 and the cone 1 1 form reflecting surfaces, because these in relation to the Direction of propagation of the emerging light 3 exceed the critical angle of the total reflection. As a result, the light 3 is reflected on the lateral surfaces of the truncated cone 10 and the cone 11. The light 3 changes its direction and emerges laterally from the apex 1 in an approximately radial direction. In the bottom sketch, the halved apex 1 is shown with optical fibers 4, 5 and 6 inserted. The optical waveguide 4, which here has a multimode fiber 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. The high-energy light passes radially through the truncated cone 10 and the cone 11 out of Apex 1. Both cones 10 and 11 each couple out part of the light emitted by the optical waveguide 4, the arrangement of the two or more cones determining the partial ratio of the coupling-out of each cone. The function of the other two optical fibers 5 and 6 is different. These in the case of the optical fibers 5 and 6 are designed as single-mode fibers SMF. At their distal end, which is in the Apex 1, they can have an optical sensor element OS or can absorb light from an optically sensory element monolithically integrated in the Apex, for example in the form of an integrated optical or space-optical grating or an optical cavity and return to the evaluation unit. When writing in an optical grating, for example in the form of a fiber Bragg grating in an optical waveguide 5, 6, the structure of the fiber of the optical waveguide 5, 6 is 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 is slightly different from the refractive index the environment of the same fiber material. As a result, a partial reflection of the light conducted through the fiber of the optical waveguide 5, 6 takes place at the emerging interface between regions of different refractive indexes. If the refractive index of the fiber of the optical waveguide is changed in short, successive sections at a distance of 1/2 in relation to a reference wavelength, so that 5, 6 pairs of sections are formed in the fiber material of the optical waveguide, which together have a length of 1/2 in relation to have 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. If the optical waveguide 5, 6 now heats up at the tip where the optical grating, for example in the form of an optical sensor element, is inscribed, 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 in the back-reflected wavelength, the temperature in the apex 1 can be measured by precisely determining the wavelength of the back-reflected light with the aid of a sensor unit. For the thermometer constructed in this way to function correctly, it is only necessary to write the optical grating, for example in the form of a fiber Bragg grating, only at the tip of the optical waveguide 5, 6. 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 are 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 a 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, the depth of the recess 6 'into the apex 1 is clearly lower fer 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 freely spatial-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 makes it possible to measure the local temperature of the apex 1 at the location of the light exit and the temperature of the apex in the area of the coupling with the optical waveguide arrangement 2. Alternatively, it is possible to measure the temperature with the single-mode fiber 6 and with the single-mode fiber 5 measure another physical parameter, such as pressure or local pH.

FIG. 2 shows a second variant of the apex 1 according to the invention for an optical waveguide arrangement, which guides light 3 from a proximal end to a distal end. This Apex 1 shown here essentially also has a torpedo shape or a cigar shape with a circular profile P, only the halves 1 emerging from the section through the plane A-A being shown here. The apex hermetically encloses the optical fibers 4, 5 and 6.

The apex 1 shown here also has an atraumatic tip S at the distal end, which due to its shape does not cause any injuries when the apex 1 is inserted, for example as part of a catheter 120 into the bloodstream B of the human or animal body K. In contrast to the apex 1 shown in FIG. 1, the apex 1 sketched here has asymmetrically distributed elements, namely a prism with vertical side faces 10 and another prism with vertical side faces 1 1. These are somewhat to the side of an imaginary axis The light 3 emerging from the optical waveguide 4 is arranged to form elements acting as mirrors. These acting as a mirror elements prism 10 and prism 1 1 couple the light from the side, but with a preferred direction. Both prisms 10 and 11 couple part of the mode fiber 4 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 drains through laser-induced apoptosis . Also in this example shown here, the depth of the recess 6 'into the apex 1 is significantly deeper than the depth of the recess 5'. The corresponding single-mode fiber with the optical 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 makes it possible to measure the local temperature of the apex 1 at the location of the light exit and the temperature of the apex in the area of the coupling with the optical waveguide arrangement 2.

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 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 measure the temperature with the single-mode fiber 6 and to measure another physical parameter with the single-mode fiber 5, such as, for example, the pressure or the local pH. The apex 1 from FIG. 2 is further developed in FIG. 3. FIG. 3 shows a third variant of the apex 1 according to the invention for an optical waveguide arrangement, the light 3 conducts from a proximal end to a distal end. This apex 1 shown here essentially also has a torpedo shape or a cigar shape with a circular profile P, only the half attachments 1 resulting from the section through the plane AA being shown here. The apex hermetically closes the optical fibers 4, 5 and 6.

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 1 also couples light 3 laterally with a preferred direction by means of elements prism 10 and prism 11, here again the outcoupling ratio of the light can be optionally distributed between the two prisms 10 and 11 due to the fixed orientation of the light decoupling in relation to kinked, atraumatic tip S, it is easier to determine the preferred direction of the light occurring at the treatment site. When catheterizing or when using a surgical handpiece, the tip can be fixed in a vascular branch by means of a corresponding rotational position, in which case the direction of the outcoupled light 3 can be reliably determined and can thus be directed specifically at a treatment site by the user. As in the previous embodiments, 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 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 makes it possible to measure the local temperature of the apex 1 at the location of the light exit and the temperature of the apex in the area of the coupling with the optical waveguide arrangement 2. Alternatively, it is possible to measure the temperature with the single-mode fiber 6 and with the single-mode fiber 5 measure another physical parameter, such as pressure or local pH. Finally, FIG. 4 shows a fourth variant of the apex 1 according to the invention for an optical waveguide arrangement, which guides 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, an atraumatic tip S being provided at the distal end which, when the apex 1 is inserted, 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 hermetically encloses the optical fibers 4, 5 and 6.

To illustrate the internal structure, only an open half of the apex 1 is shown here, which would result from a section through the plane AA (FIG. 1). Inside, this apex 1 has an axicon structure 12, which generates 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 acts as a diffuser acting element 12 through the nanoscale particles. In order 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 'into 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 makes it possible to measure the local temperature of the apex 1 at the location of the light exit and the temperature of the apex in the area of the coupling with the optical waveguide arrangement 2. Alternatively, it is possible to use the single-mode fiber 6 to measure the temperature to measure and measure another physical parameter with the single-mode fiber 5, such as the pressure or the local pH.

FIG. 5 shows a fifth variant of the apex 1 according to the invention for an optical waveguide arrangement which guides light 3 from a proximal end PE to a distal end DE. This apex 1 also essentially has a torpedo shape or a cigar shape with a circular profile P, with an atraumatic tip S being provided at the distal end DE which guides the apex 1, for example as part of a catheter 120, into the bloodstream B of the apex human or animal body K caused no injuries due to its shape. The apex hermetically encloses the optical fibers 4, 5 and 6.

To illustrate the internal structure, only an open half of the apex 1 is shown here, which would result from a section through the plane AA (FIG. 1). Inside, this apex 1 has an axicon structure 12 'designed as a hollow body. In contrast to the construction of the fourth variant in FIG. 4, in this example the otherwise transparent apex 1 generates scattered light by doping with nanoscale, that is to say with a grain size of less than 100 nm. The hollow truncated cone 11 of the axicon structure 12 ', which is designed as a hollow body, forms an oblique entry surface for the fiber optic cable 4 at the foot of the truncated cone 11 along the lateral surface of the truncated cone 11. At the transition into the doped apex 1, this scatters Light and emerges from Apex 1. In order for the light to be 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, particle 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 'into the apex 1 is significantly deeper than the depth of the recess. saving 5 '. The corresponding single-mode fiber with the optical senso 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 makes it possible to measure the local temperature of the apex 1 at the location of the light exit and the temperature of the apex in the area of the coupling with the optical waveguide arrangement 2. Alternatively, it is possible to measure the temperature with the singlemo defaser 6 and with the singlemode fiber 5 measure another physical parameter, such as pressure or local pH.

Finally, FIG. 6 shows a laser unit 200 which sends laser light from at least one laser light source LD, here laser diodes, from a proximal end to a distal end. For this purpose, the laser unit 200 has a first optical waveguide 4, and two further optical waveguides 5 and 6, which are combined via an appropriate connector V to form an optical waveguide arrangement 2. The optical waveguide arrangement 2 acts together with an apex 1 as a catheter 120, wherein the apex 1 as the distal end of the catheter 120 can be inserted into the bloodstream B of an animal or human body K in order to use the laser light of the laser unit 200 therapeutically in the patient's vascular system . At least one high-energy laser light source LD is arranged in the laser unit 200, which couples the light from the at least one high-energy laser light source LD into the optical waveguide 4 via a multimodemic MMC (Multi Mode Combiner). The lights of the different laser light sources LD can also have different spectral compositions. The light 3 coupled out in the Apex 1 heats the Apex 1 to temperatures of up to 1,000 ° C. In order to avoid that the apex burns the patient internally, it is provided that the optical fibers 5 and 6, which are constructed as single-mode fibers SMF and have an optical sensor element, for example in the form of an optical grating, in the area within the apex Temperature of the Apex 1 measured becomes. Specifically, it should be used when using polymeric materials or

Ormoceres are controlled so that the temperatures in the Apex 1 always remain sufficiently below the melting temperature of the corresponding material. For this purpose, light is sent into the optical waveguides 5 and 6 which, 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, generates a temperature-specific signal to a sensor unit SE send back in the laser unit 200. This sensor unit SE is coupled to a control unit RE, which acts on the multimodem shear or on the laser light sources LD. In this way, a closed control loop is formed, namely laser power, which is converted into heat in the Apex 1, which is sent back to the laser unit based on the measurement of the temperature and acts on the laser power there again via the control unit.

FIG. 7 shows a first variant of a surgical handpiece 100, having an apex 1 according to the invention, which directs the light 3 from an optical waveguide arrangement 2 to the treatment site. For application, the user guides the surgical handpiece 100 with the apex 1 into a corresponding body cavity, into a cut in the opened body or into a vessel where the light 3 for therapy emerges accordingly. 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, for example, to use the apex from FIG. 2 with the surgical handpiece shown here, for example for non-invasive therapeutic treatment or lighting.

FIG. 8 shows a second, special variant of a surgical handpiece 110, having an apex 1 "according to the invention, which guides light 3 from an optical waveguide arrangement 2 to light 3 to the treatment site. The handpiece shown here has an apex 1", which a concave surface points 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 "onto the patient's eye, where the light 3 for the therapy of glaucoma emerges accordingly. The exact application and the 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 pm, 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.

B E Z U G S Z E I C H E N L I S T E

Apex 110 surgical handpiece 'Apex 120 catheter

"Apex

Optical waveguide arrangement 200 laser unit

light

Optical fiber BG blood vessel

'C cladding recess

Optical fiber arrangement DE distal end

'Recess OS optical sensor element fiber optic K body

'Cutout LD laser diode MMC Multimo0 cone demic MMF Multimo defaser

1 truncated cone

P profile

2 Ele acting as a diffuser

ment, axicon structure PE proximal end 2 'RE control unit designed as a hollow body

Axicon structure S tip

3 Ele SE sensor unit acting as a mirror

ment SMF single mode fiber

0 coaxial optical fiber TF carrier fiber

0 eccentric fiber optic V connector

ter

00 surgical handpiece

Claims

Apex for an optical fiber arrangement PATENT CLAIMS

1. Apex (1, 1 1 ") for an optical waveguide arrangement (2), the light (3) for a therapeutic treatment of the human or animal body from a proximal end (PE) to a distal end (DE), this light from more than one light source (LD) in the area of the treatment site, and where

First source (LD) light 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 where

this brings together more than one optical waveguide (4, 5) with different functions at the treatment site, whereby

a first recess (4 ') for a first optical waveguide (4) is arranged inside the apex (1, 1'), and wherein

a second recess (5 ') for a second optical waveguide (5) is arranged inside 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 element in the form of an integrated or free-space 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 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 Lens, prisms, mirrors or cavities or in the form of axial structures, such as cones (10) or truncated cones (1 1),

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 grid 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

the optional element from the group Coupling light (3) individually or in concert from the apex (1, 1 ') or returning it to the sensory measuring unit, wherein

the apex hermetically seals the elements in it and reliably prevents the ingress of liquid.

2. Apex according to 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), for example

Laser light for the treatment of epilepsy and other 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 to treat glaucoma, or

Laser light for the therapy of tumors, e.g. in the urological area, in the area of 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 a coronary total occlusion (CTO), or

Laser light for lipolysis, wherein the first optical waveguide (4) is preferably an optical waveguide based on a multimode fiber (MMF), and

the second recess (5 ') is provided for a second optical waveguide (5), the light for measuring the temperature and / or the pressure in the area of the apex (1, 1') is selected via an optical sensor element (OS) the group consisting of

a fiber Bragg grating, and / or

an integrated or free-space optical grid 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

leads a measuring unit for surface plasmon according to an Otto or Kretschmann arrangement,

wherein the second optical fiber (5) is preferably an optical fiber based on a single mode fiber (SMF).

3. Apex according to claim 1 or 2,

characterized in that

the second optical waveguide (5) has polarization-maintaining properties.

4. Apex according to one of claims 1 to 3,

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 reaching a different depth of the apex (1, 1') than that second recess (5 ').

5. Apex according to one of claims 1 to 4, 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).

6. Apex according to 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.

7. Apex according to one of claims 1 to 6, characterized in that it is made of a temperature-stable and biocompatible material, by direct processes, such as 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 transparent polymers or from Ormocera, or the Apex is manufactured indirectly via mold inserts and impression processes.

8. Apex according to one of claims 1 to 7,

characterized in that

this including the optical elements containing it and the optical fiber entering it is completely closed (hermetically sealed) and is also secured in the capillary area by monolithic design or by gluing and / or by sealing the capillaries against liquid ingress

this is composed of at least two directly or 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.

9. Apex according to one of claims 1 to 8,

characterized in that

the different elements (10, 1 1, 12, 13) light (3)

Only couple radially with respect to the longitudinal axis of the apex (1, 1 ') so that there is an annular radiation pattern,

Only couple laterally with respect to the longitudinal axis of the apex (1, 1 '), so that an approximately conical radiation pattern is formed in the radial direction, only radially with respect to the longitudinal axis of the apex (1, 1 '), but diffuse decoupling, so that there is a cylindrical radiation characteristic which can be set in a radiation angle range from 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.

10. Apex according to one of claims 1 to 7, characterized in that the at least one element acting as a diffuser (12) has nanoscale scattering particles (SP) or surfaces 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.

1 1. Apex according to one of claims 1 to 10, 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.

12. Apex according to one of claims 1 to 1 1, characterized in that by a light mixer, such as a multimode waveguide combiner at the distal or at the proximal end, different light sources are combined with one another, for example where short-wave light for ablative Processes are mixed in the tissue to be treated, long-wave light is mixed in to induce light and / or heat-induced apoptosis processes in the tissue to be treated.

13. Surgical handpiece (100, 1 10),

comprising an apex (1, 1 ', 1 ") according to one of claims 1 to 8.

14. catheter (120),

comprising an apex (1, 1 ', 1 ") according to one of claims 1 to 8.

15. 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 8, at least one laser light source (LD), and

at least one sensor unit (SE),

The sensor unit (SE) measures physical states in the area of the apex (1, 1 ') via the second or further optical waveguide (5, 6), the at least one laser light source (LD) preferably together with the at least one sensor unit (SE) and a control unit (RE) forms a controlled system, so that the control unit (RE) regulates the radiation power of the at least one laser light source (LD) via feedback from the sensor unit (SE).

16. Laser unit according to 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 depending on polarization and / or intensity, whereby

the control unit (RE) controls the power of the laser light of the at least one laser light source (LD) as a function of the reflected light information changing for the measurement of a physical parameter.

17. Laser unit according to one of 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 operating protocol and provides a time stamp, the measuring and operating protocol being provided in real time or after treatment has been completed with the aid of a digital signature, optionally in a public blockchain non-changeable documentation is included.