CN111936094A - Apparatus and method for irradiating the eye - Google Patents

Abstract

The invention relates to a device for irradiating a cornea (20), comprising a ring-shaped body (1), the ring-shaped body (1) further comprising a light source (4) and a spacer body (11), wherein the spacer body (11) forms an irradiation channel (2), the irradiation channel (2) comprising at least one outlet (16), wherein the intensity of the radiation generated by the light source (4) and emitted at the outlet (16) of the irradiation channel (2) as a treatment intensity can be adjusted by the length (l) of the spacer body (11).

Description

Apparatus and method for irradiating the eye

technical field

The present invention relates to an apparatus and method for irradiating tissue, in particular connecting tissue and especially, preferably, the cornea of the human eye. The device of the present invention and the method of the present invention are intended to effect changes in the structure of the corneal tissue that counteract the lesions. Thus, for example, keratoconus is a corneal disease in which the mechanical stability of the tissue is increasingly weakened due to constant changes in the structure of the corneal stroma. This in turn causes changes in corneal geometry that can lead to significant loss of vision and even corneal-based blindness. Similar content applies to spherical cornea, pellucid marginal degeneration (PMD) (clear marginal corneal degeneration), post-LASIK corneal herniation, progressive myopia and other eye diseases.

Background technique

As a prior art, the collagen fibers of the cornea are cross-linked cornea by introducing riboflavin into the corneal stroma in combination with UV-A irradiation. This should improve corneal stability and prevent disease progression. It is also possible to change the geometry of the cornea by cross-linking and thereby perform refractive correction on the eye.

Thus WO 2012/047307 A1 describes a device for irradiating the cornea to cross-link the collagen fibers of the tissue. The disadvantage of such a system is that it may mis-illuminate the eye during eye movement and also cannot maintain a precise distance from the radiation source during the illumination time.

EP 1561440 A1 and WO 2012/127330 A1 respectively describe a device for deforming and hardening the cornea by placing a plastid on the cornea, by means of which the cornea is both irradiated and a plastomer or an irradiation device is positioned on the cornea. The background of this invention is the fact that the refractive power (refraction) of the eye is largely dependent on the curvature radius of the cornea. Therefore, both publications postulate that, by reshaping the corneal surface with an appropriate shaping body, it should be possible to change the refractive power of the eye to a certain degree by this device. Whether this assumption is correct or not should not be discussed here. A major disadvantage of these systems, however, is that the adsorption on the cornea is also exactly where the irradiation takes place, ie the adsorption is planar on the surface of the cornea by the plastomer. As explained in two prior art publications, adsorption on the corneal surface can easily lead to corneal surface damage, ie corneal erosion, which can cause significant pain for the patient for several days. While traditional methods for irradiating the cornea - as described for example in WO 2012/047307 A1 - are themselves associated with corneal erosion and significant pain, there are also newer methods for the treatment of keratoconus in which Corneal erosions no longer occur and can therefore be treated painlessly in this method (A. Daxer et al. Corneal Crosslinking and Visual Rehabilitation in Keratoconus in One Session Without Epithelial Debridement: New Technique. CORNEA 2010;29:1176-1179). The therapeutic effect is also related to the presence of oxygen in the tissue to be treated, impeding or even interrupting the delivery of oxygen to the shaped body. This situation is additionally exacerbated by the fact that the shaped body not only blocks the oxygen channel to the cornea, but even the shaped body is adsorbed via a vacuum (exclusion of air and oxygen). The two devices known from EP 1561440 A1 and WO 2012/127330 A1 therefore have significant disadvantages due to adsorption on the surface of the cornea to be irradiated and the limited oxygen supply to the tissue due to the shaped bodies.

WO2014/060206A1 enables a compact structure of the irradiation unit and a uniform irradiation of the cornea. Although an irradiation power of 3 mW/cm ² is prescribed for standard therapy, different treatment regimens utilizing irradiation powers as high as 45 mW/cm ² have established themselves in recent years. Although the device according to WO 2014/060206 A1 makes it possible to provide these different irradiation powers, the adjustment of the irradiation power is still carried out by the operating current of the light source and thus by the dimensions of the components of the electronic control system. This has the advantage in stock production: it is not necessary to prefabricate instruments for a certain irradiation power, which may not later be required by the market in this quantity and thus incur high production costs. Devices in which the irradiation power can be subsequently adjusted via the operating current of the light source are expensive and increase the instrument outlay. Therefore it can no longer be produced economically as a disposable instrument. However, if the instrument is not designed as a single-use instrument, it has the disadvantage of health and economics: an expensive instrument needs to be invested - which often and especially in the case of rare diseases such as in the case of keratoconus results in many regions Treatment is not available and treatment is not adequately provided to the patient concerned.

SUMMARY OF THE INVENTION

The object of the present invention is therefore to propose a device and a method for irradiating the cornea of the eye, which allows the cross-linking of collagen fibers while overcoming the disadvantages of the prior art.

The present invention solves the stated problems of the prior art in that the illumination can be adjusted via the length of the spacers, which are preferably replaceable or whose lengths can be changed, and/or via the relative proportion of the reflecting surfaces on the inner surface of the illumination channel Power or irradiation time required for treatment, respectively. This object is achieved in particular by a device for irradiating the cornea, which comprises an annular body which furthermore comprises a light source and a spacer, wherein the spacer forms an illumination channel which comprises at least one outlet, wherein Provision: The intensity of the radiation generated by the light source and emitted at the exit of the illumination channel can be adjusted by the length of the spacer.

This configuration makes it possible to uniformly design a housing for the light source and its functional elements or components for all desired irradiation intensities on the cornea, which is in contrast to the prior art in terms of production and in terms of the treatment of the patient Form a clear cost advantage.

In a particularly simple embodiment, the annular body according to the invention comprises at least one light source and one spacer. The annular body or spacer may be made of any suitable material, preferably metal, ceramic or plastic such as POM (polyoxymethylene) or PMMA (polymethyl methacrylate).

The device according to the invention is basically designed as an annular body which is arranged substantially (substantially) concentrically around a longitudinal axis. In a particularly simple case, the annular body of the invention is designed here as a hollow cylinder, ie as a cylindrical housing. The longitudinal axis of the device then corresponds to the cylinder axis. However, an annular body in the sense of the present invention is an object having a closed housing, wherein the housing preferably surrounds an axis (longitudinal axis). Inside the housing there is at least one cavity which is open on one side, in particular on both sides, in the longitudinal direction. Provision is made that one end (proximal end) of the annular body can be arranged on the eye for the treatment and thus rest on the eye in the operating state.

The annular body can have a concentric sleeve, which can also be designed as a suction ring, which is arranged, for example, at the proximal end of the hollow cylinder. It can also accommodate functional components, such as light sources, energy sources or energy supplies, electronic systems (electronic control systems).

In this case, the functional components can be connected to the annular body and to each other in any desired manner (eg firmly or detachably).

However, in order to achieve a device structure that is as compact as possible, it can be provided that the light source, the electronic control system for the light source (eg a device with a timer for automatically switching off the light source) and, if necessary, an energy source are composed of a common enclosed by the shell. The housing can be an integral part of the annular body.

In order to ensure a predetermined distance between the light source and the eye in the case of a design with a housing when the device is ready for operation, it can be provided that a receptacle for a spacer is arranged on the housing, or vice versa. A receptacle for the housing is provided on the spacer, which has a stop limit so that the light source can establish a defined distance from the tissue to be irradiated (eye, cornea). The spacer can be fixed at a predetermined distance from the housing and thus from the light source by means of the stop limit. In order to prevent the housing from falling out of the spacer body - leaving the stop limit - additional retaining means, such as detent teeth, clamping means, fittings, screw connections, O-rings or adhesives, can be provided. Furthermore, it can be provided that the receptacle has a thread or an equivalent device which makes it possible to adjust the spacer continuously or in steps relative to the housing or the light source.

It is beneficial on this device that either the spacer tube (which can always be used synonymously with the spacer) or the sleeve is designed to be sterile and the rest of the device can be made non-sterile, because These components are not in contact with the eyes. This thus makes it possible to manufacture the entire device more economically.

The spacer according to the invention, which forms part of the annular body according to the invention, is preferably a hollow cylinder in the form of a spacer tube. The longitudinal axis of the device then corresponds to the cylinder axis. However, the spacer in the sense of the invention is not limited to the shape of a hollow cylinder, but can be an object having a closed housing, wherein the housing preferably surrounds a longitudinal axis. The spacer can be detachably or firmly connected to the remaining annular body. In principle, the spacer tube can be connected to, for example, the housing in any desired manner, such as via fittings, screw connections, O-rings, gluing or the like. There is a convention, however, that the spacers can also take other shapes that fulfill this function.

The spacer allows adjustment of the irradiation intensity via its length or the corresponding length of the irradiation channel, even when it is firmly connected to the annular body. If the spacer is firmly connected to the annular body, a change in the length of the spacer can be achieved, for example, by telescopically extending the spacer. In this case a variation in the length of the spacer is possible because it consists of at least two interconnected elements that allow pulling apart (lengthening) and shrinking (lengthening) of the sleeve, whereby A corresponding change in length of the illumination channel results.

If the spacer should be detachably connected to the annular body, the spacer can be replaced with a different spacer, which in turn allows the length of the spacer to be changed. This design can be realized, for example, by a replacement receptacle for the spacer (preferably limited by a stop) in the remainder of the annular body. Or via a threaded connection.

The spacer at least partially forms part of the annular body. The inner wall of the spacer at least partially defines the illumination channel.

In order to be able to illuminate the cornea, a light source is provided according to the invention. All radiation sources capable of emitting electromagnetic radiation can be considered light sources. Preferably, however, electromagnetic radiation in the wavelength band from ultraviolet radiation to infrared radiation should be emitted by the light source. Ultraviolet radiation in particular is particularly beneficial for irradiating the cornea. According to the invention, it is preferably provided that the light source is capable of emitting ultraviolet rays in the UV-A range. It is particularly advantageous to emit light with wavelengths between 365 nm and 375 nm, and in particular between 365 nm and 370 nm, by the light source. Light can be generated at virtually any arbitrary location inside or outside the annular body. The position of the light source in the sense of the present invention is referred to as the position from which the generated light rays enter the illumination channel directly. Thus, if, for example, light is generated outside the ring body by an external light source and introduced into the interior of the ring body via a light guide so that the light emerging from the light guide enters the illumination channel, the light exits the illumination channel for direct entry into the illumination channel. That position of the conductor is regarded as the position of the light source or the light source in the sense of the present invention. If the concept of a light source is not specified in detail in this disclosure, it should be understood as this light source in the sense of the present invention. The light source is preferably mounted in the annular body in such a way that the light emitted by it enters the illumination channel at least partially. The light emitted by the light source in the sense of the present invention can have all arbitrary radiation characteristics.

The radiation emitted by the light source for irradiating the cornea is also referred to as irradiation intensity or treatment intensity. These concepts should be understood as synonymous in the present invention, and thus can also be used interchangeably. Typically the intensity of the (UV-A) light on the target tissue in such treatments is between 3 mW/cm ² and 45 mW/cm ² . Here, light radiation is generated by the light source. The light source is preferably designed as an electroluminescent body, for example in the form of a light-emitting diode. The optical power emitted by the light source is measured in mW and preferably determined by the current flowing through or operating the light source.

The shape of the irradiation channel can in principle be arbitrary, however it is designed at least partially along the longitudinal axis, preferably as an inner space (cavity) of a hollow cylinder and (laterally) bounded by the inner wall of the annular body. The diameter of the irradiation channel, measured perpendicular to the longitudinal axis, should be at least partially between 1 mm and 30 mm and in a particularly preferred variant embodiment between 5 mm and 12 mm, in a further embodiment between 6 mm and 10 mm or in Between 7mm and 9mm. The diameter of the exit (exit face, irradiation face) of the light rays from the irradiation channel, measured at the height of the end face of the annular body, should as far as possible not exceed 12 mm, more preferably not more than 11 mm. Preferably the diameter of the outlet is between 5 and 10 mm, ideally between 7 and 9 mm, eg 8 mm. The illumination channel is defined at the proximal end by the end face, at the distal end by the position of the light source and laterally - at least in part - by the inner wall of the annular body. The length L of the illumination channel is measured between the light source and the end face of the annular body. The lateral dimension of the irradiation channel is formed at least in part or in part by the clear width of the inner space, which is measured perpendicular to the longitudinal axis of the annular body. In particular, the lateral dimension of the irradiation channel can correspond at least in part to the inner diameter of the spacer or, in general, the inner diameter of the annular body.

According to the invention it is provided that the spacer forms at least partially the irradiation channel. When the light source directly adjoins the spacer, the length of the spacer then corresponds precisely to the length of the illumination channel. This means that the radiation does not have to pass through a further interval before it reaches the spacer. If the light source is not positioned directly adjacent to the spacer, so that the radiation has to pass an additional interval before entering the spacer, the length of the illumination channel extends this interval accordingly between the position of the light source and the spacer. In this case, the illumination channel is correspondingly longer than the length of the spacer. It should be pointed out that the length of the illumination channel naturally also changes when the length of the spacer channel changes, since the spacer always forms the illumination channel at least partially. This means that when the spacer is lengthened or shortened and thus the length of the spacer changes, the length of the irradiation channel is correspondingly lengthened or shortened.

In this case, in one embodiment of the invention, it is provided that the radiation intensity of the light source itself, ie the radiation intensity emitted by the light source, is immutable, which ensures a simple and economical production of the device for the following reasons, ie only adjustment of the spacing is required The length of the body can be adjusted without changing the overall structure of the instrument or changing the treatment intensity by changing the light source itself. This means that it is not necessary to change the irradiation power of the light source in order to achieve the desired irradiation intensity for the treatment target tissue. Adjustment of the appropriate treatment intensity is made only by changes in the length of the spacer.

In a particularly preferred embodiment of the invention it is therefore provided that in order to obtain a suitable and suitable intensity for the respective treatment, the length of the spacer and the intensity of the radiation generated by the light source and emitted at the exit of the irradiation channel are At least 15mm when less than 10mW/ ^cm2 , at least 10mm when the intensity of the radiation generated by the light source at the exit of the illumination channel is at least 10mW/ ^cm2 and less than 20mW/ ^cm2 , and , The intensity of the radiation emitted at the exit of the illumination channel is at least 5 mm at 20 mW/cm ² and greater. The length of the spacer is necessary in order to obtain the radiation intensity required for the treatment without changing the light source itself.

It is therefore provided in a special embodiment of the invention that in order to adjust the intensity to the corresponding treatment without changing the light source itself, the length of the spacer is equal to the length of the spacer produced by the light source at the length of the irradiation channel. The intensity of the radiation emitted at the outlet is less than 10 mW/cm ² at least 5 mm greater than when the intensity of the radiation emitted by the light source at the outlet of the illumination channel is 20 mW/cm ² .

In a special embodiment of the invention it is provided that in order to adjust the intensity to the corresponding treatment without changing the light source itself, the length of the spacer is at the exit of the irradiation channel, which is produced by the light source. The intensity of the radiation emitted on is less than 10 mW/cm ² at least 10 mm greater than when the intensity of the radiation emitted by the light source at the exit of the illumination channel is 30 mW/cm ² .

It follows from the above that the smaller the length of the spacer or the illumination channel, the greater the illumination intensity at the outlet and vice versa. In other words, this means that the lower the radiation intensity required for the treatment, the greater the length of the spacer or the illumination channel must be, since the light source must be positioned closer to the target tissue, in particular the cornea, for a correspondingly higher intensity, and vice versa. The light source must be positioned further from the target tissue with correspondingly lower illumination intensities. That is, the less intensity required for treatment, the further the light source must be positioned from the cornea, and vice versa.

In order to make the operation of the device easier for the user and to make the irradiation process more efficient, it is provided in a preferred embodiment of the invention that the device additionally includes a timer with a timer for after a predetermined treatment time has elapsed. A device that automatically turns off the light source. The timer makes it possible to precisely determine the effective treatment time, since possible interruptions are not taken into account during the timing, so that the treatment time always corresponds to the previously specified treatment time.

In this context, it is stipulated that the irradiation time and the effective irradiation time are used synonymously in the present invention. It is important, however, to separate the irradiation time from the treatment time, as interruptions in the irradiation of the cornea may be required to prevent, for example, drying out of the cornea during treatment. Therefore, if one refers to the (effective) exposure time that is regulated or preset on the device or on a timer installed in the device or entered via a program, it goes without saying that: The device or the timer in the device does not take into account possible interruptions in irradiation during treatment when the time period is measured.

In order to further simplify the treatment process and make it possible to trigger the timer and thus switch the light source on and off, it is provided according to the invention that the device additionally includes a switch for switching the light source on or off. This switch makes it possible to interrupt the irradiation of the target tissue. The radiation output process by the light source is thus interrupted, which makes it possible to interrupt and subsequently continue the treatment process.

Any suitable switch known in the prior art is conceivable, however preferably an electromagnetic switch, which is operated or activated or switched by means of a magnetic field, eg by a small permanent magnet.

According to the invention, it is provided in a preferred embodiment that in order to be able to provide the required and suitable irradiation intensity for the irradiation of the cornea, the length of the irradiation channel, in particular the length of the spacer, for an effective irradiation time T of at most 300 seconds, is At least 5 mm, at least 10 mm when the effective irradiation time T is 300 seconds or more to 500 seconds, and at least 15 mm when the effective irradiation time T is 500 seconds or more. Especially since, as mentioned above, the treatment time is associated with the corresponding irradiation intensity. This results in a correlation of the treatment time with the irradiation intensity and with the length of the spacer or the length of the irradiation channel, where these lengths differ. Since the irradiation intensity is related to and can be adjusted via the length of the spacer, the treatment time is also related to the length of the spacer, since the length of the treatment time is derived from the necessary irradiation intensity and dose.

Since the length of the irradiation channel varies according to the preset irradiation time, a particularly advantageous and reliable irradiation process can be achieved while the device is relatively simple to manufacture.

Therefore, according to the present invention, in a particularly preferred embodiment, in order to provide the required and suitable irradiation intensity for corneal irradiation, the length ratio of the spacer when the effective irradiation time is 300 seconds or less is 500 seconds than the effective irradiation time The length of the spacer for clocks and more is at least 5 mm shorter.

Therefore, according to the present invention, in a particularly preferred embodiment, in order to provide the required and suitable irradiation intensity for corneal irradiation, when the effective irradiation time is 300 seconds or less, the length ratio of the spacer to the effective irradiation time is 900 seconds The length of the spacer for clocks and more is at least 10 mm shorter.

This (assuming the radiation dose remains constant) means: the lower the irradiation intensity, the longer the treatment time must be and vice versa. The treatment time is therefore shortened accordingly if high irradiation intensities are used.

According to the invention, it is therefore provided in a particularly preferred embodiment that, in order to ensure the introduction of liquid or gaseous substances required for optimal treatment, ie, for example to prevent the cornea from drying out, the annular body at least partially comprises at least one through-hole through which Liquid or gaseous substances of the through hole can be introduced into the irradiation channel.

The at least one through-opening makes it possible to introduce liquid or gaseous substances into the irradiation channel continuously or in pulses via this through-opening. In principle, a plurality of such through holes can be provided. The vias can have any shape and size. Ideally, through holes are designed as round holes. The diameter of the through hole is ideally less than 3 mm, better less than 2 mm and in special cases less than 1 mm. The through hole can also be a cylindrical channel with a diameter of 0.1 to 3 mm. The axis of rotation of such a circular hole or the longitudinal axis of such a channel can be designed at 90° to the longitudinal axis 6 of the annular body, but a different angle can also be used. If the longitudinal axis of the channel (through hole) is inclined relative to the longitudinal axis of the annular body such that the penetration through the inner wall of the annular body or of the spacer is at the proximal end relative to the penetration through the outer wall of the annular body or of the spacer A particularly favorable situation occurs if the longitudinal axis of the through-flow channel is inclined from the outside to the inside in the direction of the proximal end of the annular body. The through-hole or through-holes can in principle be provided at any position on the annular body or the spacer body. Preferably the through hole is provided in the proximal third of the spacer tube. In a special embodiment, the through hole can also be provided on or in the sleeve or on or in the suction ring.

According to the invention, it is therefore provided in a particularly preferred embodiment that, in order to ensure an optimal oxygen supply and thus the best possible treatment of the cornea, the device additionally includes a connecting element for connecting to an oxygen source for Oxygen is introduced into the irradiation channel via the through hole. As such connecting elements for the introduction of oxygen to an oxygen source, all conventional devices known from the prior art, such as oxygen pumps, are conceivable. Oxygen is required in the treatment of the cornea in order to enhance the therapeutic effect.

In a preferred embodiment of the invention, provision is made for the illumination channel to comprise a lateral boundary which at least in sections has a reflective surface, thereby enabling a uniform illumination of the cornea.

The illumination channel can thus be at least partially or partially delimited by a reflective surface capable of reflecting and/or absorbing and/or transmitting light incident into the illumination channel by the light source in a defined manner. There is the possibility here that the radiation is reflected at an exit angle that corresponds or does not correspond to the angle of incidence. This face can in principle be designed with any material that makes possible the inventive properties of the device. Such materials may be, for example, metals such as aluminium, rhodium or platinum, dielectrics such as MgF2 or plastics such as SA85 or ODM, among others.

In a preferred embodiment of the invention, it is provided that the reflective surfaces of the lateral boundaries of the illumination channel are designed to diffusely reflect incident light rays of wavelengths used for treatment, wherein a portion of the light rays are at an exit angle that does not correspond to the angle of incidence. This makes it possible to irradiate the cornea or the target tissue uniformly and prevents increased radiation at certain positions of the cornea.

The irradiation intensity can also be adjusted to a certain extent according to these reflection properties. In the case of the existing ratio between the irradiation time preset on the timer and the length of the spacer or the irradiation channel, the relative proportion of the reflecting surface on the entire lateral boundary of the irradiation channel can be at least The light intensity at the exit of the light from the device or the illumination channel is adjusted within certain limits (ie at least 2%, better at least 3% and ideally at least 5% of the light intensity at the exit). In this case, the device is designed such that the greater the proportion of the reflecting surface in the total area of the lateral boundary of the illumination channel, the greater the intensity of the light emitted at the exit of the illumination channel. This means that the illumination intensity can already be increased simply by the size of the reflective surface.

Furthermore, the irradiation intensity can be adjusted by the position of the reflective surface in the spacer. The closer the reflective surface is to the exit, the greater the illumination intensity on the target tissue (or exit). The principle applies: the greater the length of the reflective surface, the greater the intensity of the treatment at the outlet.

This means that not only the length itself, but also the length and position of this surface, if the illumination channel locally includes a reflective surface, must be taken into account when adjusting the intensity of the radiation via the length of the spacer tube or of the illumination channel.

In general, the present invention also includes any device for irradiating the cornea in which an optical barrier is provided that is impermeable to the wavelengths used for illumination and that has been or can be positioned proximal to the light source and distal to the endothelium of the cornea. This optical barrier can also be an embodiment of the device according to the invention for irradiating the cornea in that an optical barrier that is impermeable to the wavelength of the light source used for irradiation has been arranged or can be arranged at the light source the proximal end of the cornea and the distal end of the corneal endothelium.

The damaging effect of radiation on the endothelium is to be prevented by this optical barrier in that, for example, the optical barrier is introduced into a corneal capsule. In this way, the penetration of the radiation and the consequent damaging effects can be prevented.

In a preferred embodiment of the invention it is provided that the optical barrier is a straight or curved disk having a thickness p of less than 500 μm and a diameter q of a minimum of 2 mm and a maximum of 10 mm. These dimensions are particularly effective in protecting the endothelium from radiation damage.

In a preferred embodiment of the invention, provision is made for the optical barrier to have a bottom or top surface which includes a recess, wherein the thickness r of the disk in the region of the recess is relative to the amount of the recess. The area with thickness p that is enclosed at is reduced. This recess makes it possible to additionally introduce liquid or gelatinous or viscous material (eg riboflavin) into the cornea after implantation of the optical barrier, where a reservoir is formed and raised into the corneal tissue diffusion or other transport processes and increase the concentration in the tissue.

Furthermore, the object is achieved by a method for the treatment of corneal diseases, in particular keratoconus, with the aid of the device according to the invention, which comprises the following method steps:

- fasten the device to the eye; and

- Adjustment of the intensity of the radiation generated by the light source, emitted at the exit of the illumination channel, as treatment intensity by adjusting the length of the spacer. The device can be fastened before strength adjustments are made, or vice versa.

In addition, it is possible to provide:

- creating a corneal space or corneal capsule with an opening to the corneal surface;

- grip the optical barrier with tweezers or place the optical barrier in a cylindrical container;

- introduction of the optical barrier into the corneal space, in particular into the corneal capsule, via an opening in the cornea;

- irradiating the cornea with electromagnetic waves, preferably ultraviolet light waves;

- the introduction of gaseous substances, in particular oxygen or liquid substances, in particular riboflavin, into the recess, wherein this recess is located between the front and the corneal tissue, and

- Implants are removed after irradiation is complete.

It can be provided here that gaseous substances, in particular oxygen or liquid substances, in particular riboflavin, can be introduced repeatedly into the recess.

If an optical barrier that is impermeable to the wavelengths used for irradiation is used in order to protect the cornea, then this barrier is placed at the proximal end of the light source of the device before the device for illuminating the eye is fastened to the eye and At the distal end of the endothelium of the cornea, ie into the cornea.

The following method having at least one of the following steps is claimed:

1. Creation of a corneal space or corneal capsule with an opening to the corneal surface (epithelium).

2. Grasp the optical barrier 21 (implant) with tweezers or place the implant in a generally cylindrical container.

3. The implant (portion 21) is introduced into the corneal space or into the corneal capsule through an opening in the cornea.

4. Irradiate the cornea with electromagnetic waves (preferably in the UV band).

5. Introducing a gaseous substance (eg oxygen) or a liquid substance (eg riboflavin) into the recess 30, ie the cavity between the front face 22 and the upper corneal tissue.

6. Step 5 may be repeated repeatedly before or during irradiation of the cornea.

7. Remove the implant after irradiation is complete.

Description of drawings

In order to further illustrate the invention, reference is made in the remainder of the description to the accompanying drawings, from which further advantageous constructional designs, details and developments of the invention can be obtained. In the attached picture:

Fig. 1 is the longitudinal sectional view of the apparatus of the present invention;

Fig. 2 is the longitudinal sectional view of the apparatus of the present invention together with the sleeve;

Figure 3 is a diagram of absorption characteristics and reflection characteristics on a reflective surface;

FIG. 4 is a longitudinal sectional view of the device of the present invention, wherein the spacer tube partially has a reflecting surface;

Figure 5 is a comparison of the irradiation effect between the conventional system (a) and the device (b) of the present invention;

Fig. 6a is the longitudinal sectional view of the spacer of the apparatus of the present invention;

Figure 6b is a longitudinal cross-sectional view of a spacer tube including two through holes;

Fig. 7 is a longitudinal sectional view of the reflective layer;

Figures 8a,b,c are illustrations of optical barriers.

The same reference numerals are used in the different figures for ease of understanding by the expert. For reasons of clarity, these reference numerals have therefore not been repeated in all corresponding figures. It is obvious that switch 3 is shown, for example, in FIGS. 1 , 2 and 4 , so that it only bears the reference number 3 in FIG. 1 , but also refers to the corresponding switch in FIGS. 2 and 4 .

Detailed ways

Different embodiments of the device and in connection therewith a method for treatment are described here. Each embodiment and the method associated therewith can also be regarded as a starting point for further embodiments, ie one or more parts or elements of the described embodiment can be combined with one or more parts or parts of other embodiments or Elements are combined to create new implementations.

First note: The following specific terminology is used for directional properties along the longitudinal axis: In human anatomy has the concepts of distal and proximal. Distal means away from the body, while proximal means towards the body. This way, for example, the hand is at the distal end of the elbow joint, and the shoulder is at the proximal end of the forearm. Since the device is intended for use on the human body (on the eyes), the device possesses an area that is in contact with the body when the device is in use. This region of the device is that end, measured along the longitudinal axis, where the outlet 16 is located and is referred to as the proximal end irrespective of the anatomy of the body. Therefore, the regions of the device - measured along the longitudinal axis - from the proximal end, ie those structures further from the eye, are then referred to as distal. Thus, for example, the light source 4 is the distal side of the outlet 16 . In addition, in human anatomy there is the position designation "lateral", which is used when, for example, a structure extends substantially in the direction of an axis at a distance from the axis. Since the device is in use like a sleeve over the eye, this term is also used here for the position definition. Thus, for example, the wall of the spacer tube (spacer) 11 as the irradiation channel 2 is lateral to the longitudinal axis 6 , or the outer wall 40 is lateral to the inner wall 7 .

According to the invention, it is provided that the intensity of the radiation emitted at the exit of the illumination channel (measured in mW/cm ² ) can be adjusted by the length l of the spacer or the length L of the illumination channel 2 , so that the intensity of the radiation can be adjusted to the corresponding requirements. The treatment performed is precisely matched.

FIG. 1 shows a longitudinal sectional view of the device according to the invention, which comprises an annular body 1 which further comprises a spacer 11 and a receptacle for a switch 3 , a timer 5 , a light source 4 and An electronic control system 12 and an energy source 13 .

In principle, the shape of the irradiation channel 2 can be any desired, but is designed at least partially along the longitudinal axis 6 , preferably as a hollow-cylindrical interior (cavity) and laterally bounded by the inner wall 7 of the annular body 1 . The diameter D of the irradiation channel 2, measured perpendicular to the longitudinal axis 6, should be at least partially between 1 mm and 30 mm and in a particularly preferred variant embodiment between 5 mm and 12 mm, in a further embodiment between 6 mm and 10 mm between 7mm and 9mm. The diameter of the exit (exit face, irradiation face) 16 for the light rays exiting the irradiation channel 2 , measured at the height of the end face 14 of the annular body 1 , does not exceed 12 mm as far as possible, better still does not exceed 11 mm. Preferably the diameter of the outlet is between 5 and 10 mm, ideally between 7 and 9 mm, eg 8 mm. The illumination channel 2 is defined at the proximal end by the end face 14 , at the distal end by the location of the light source 4 and laterally - at least in part - by the inner wall 7 of the annular body 1 . The length L of the illumination channel is measured between the light source 4 and the end face 14 of the annular body 1 . The lateral dimension of the irradiation channel 2 , measured perpendicularly to the longitudinal axis 6 of the annular body 1 , is formed at least partially or partially by the clear width of the inner space 2 . In particular, the lateral dimension of the illumination channel 2 can correspond at least in part to the inner diameter D of the spacer 11 or, in general, the annular body 1 .

All radiation sources that can emit electromagnetic radiation can be considered light sources 4 . Preferably, however, electromagnetic radiation in the wavelength band from ultraviolet radiation to infrared radiation should be emitted by the light source 4 . In particular, ultraviolet radiation can be particularly advantageous for the irradiation of the cornea 20 . In a particularly preferred embodiment, the light source 4 is capable of emitting ultraviolet light in the UV-A band. It is particularly advantageous if light having a wavelength between 365 nm and 375 nm, in particular between 365 nm and 370 nm, is emitted by the light source 4 . Light can be generated virtually anywhere inside or outside the annular body 1 . The position of the light source 4 in the sense of the present invention is referred to as the position from which the generated light rays enter the illumination channel directly. Thus, if, for example, light is generated outside the ring body 1 by an external light source 4 and introduced into the interior of the ring body 1 via a light guide, so that the light emerging from the light guide enters the illumination channel 2 , the light leaves the light guide for direct incidence. That position into the illumination channel 2 is regarded as the position of the light source 4 or the light source 4 in the sense of the present invention. If the concept of a light source 4 is not specified in detail in this disclosure, it should be regarded as this light source 4 in the sense of the present invention. The light source 4 is preferably mounted in the annular body 1 in such a way that the light emitted by the light source is at least partially incident into the illumination channel 2 . The light emitted by the light source 4 in the sense of the invention can have all arbitrary radiation characteristics. Advantageously, the radiation characteristic of the light source 4 has an opening angle for the emitted light, which is non-zero and less than 180°. An opening angle between 60° and 120°, ie for example 80°, 90° or 100° is particularly advantageous. The opening angle determines the opening at the tip of the cone with the radiation cone of the light source 4 in which at least 90% of the light of the light source 4 is emitted. It is particularly beneficial that the fluctuations in the intensity of the light emitted by the light source 4 do not exceed 20%, better not exceed 10%, measured at the outlet 16 . However, it is also possible to emit light rays with an opening angle of 0°, ie with substantially parallel beams.

The device according to the invention is basically designed as an annular body 1 which is arranged substantially (substantially) concentrically around a longitudinal axis 6 . In a particularly simple case, the annular body 1 is designed as a hollow cylinder. The longitudinal axis 6 of the device then corresponds to the cylinder axis. However, a ring-shaped body 1 in the sense of the present invention is any body having a closed housing, wherein the housing preferably surrounds a longitudinal axis 6 .

The annular body 1 can have a housing 8 for a receptacle for the light source 4 . This housing 8 is preferably provided at the distal end with an end cap 9 and/or at the proximal end with a transparent window 10 for the light emitted by the light source 4 . The housing 8 can also be used to accommodate functional elements such as switches 3 , light sources 4 , timers 5 , electronic control systems 12 or batteries 13 . The functional elements can also be connected to one another and fixed firmly in or to the housing by means of wires (see FIG. 1 ).

The housing 8 can be used as a receptacle delimited by a stop for a spacer 11 having a length l, which is preferably designed as a hollow cylinder in the sense of a spacer tube 11 . However, the spacer 11 can also be firmly connected to the housing 8 . Since the shape of the spacer 11 is not specified or limited in the drawings, the spacer 11 is shown as the spacer tube 11 for simplicity, so the concept of the spacer tube and the spacer is used synonymously in this disclosure. However, there is an agreement that the spacer 11 can also take other shapes that can fulfill this function. Since the inner wall 7 of the spacer tube 11 at least partially delimits the irradiation channel 2 , the spacer tube 11 at least partially forms part of the annular body 1 and the irradiation channel 2 . The annular body 1 is delimited by an end face 14 at the proximal end where the device is placed on the eye and preferably by an end cap 9 at the distal end on the side of the device facing away from the body. In principle, the spacer tube 11 can be connected to the housing 8 in any desired manner, such as via fittings, screw connections, O-rings, gluing or the like. This structure enables a uniform design or configuration of the housing 8 and its functional elements for all desired irradiation intensities on the cornea 20 , which results in significant cost advantages in terms of manufacturing and patient treatment compared to the prior art.

The illumination channel 2 can be at least partially or partially delimited by a reflective surface 71 , which, as shown in FIG. 4 , can reflect and/or absorb and/or transmit in a certain way the incident from the light source 4 into the illumination channel 2 . in the light. This reflective surface 71 can in principle be designed with any material that allows the inventive properties of the device. Such materials may be, for example, metals such as aluminum, rhodium or platinum, dielectrics such as MgF2 or plastics such as SA85 or ODM, among others. Advantageously, the reflective surface 71 has a characteristic which, according to FIG. 3 , makes it possible to realize that not all reflected intensities from rays incident on the surface 71 at an angle of incidence E are reflected at an angle of exit A corresponding to the angle of incidence E. be reflected. FIG. 3 shows by way of example a light beam impinging on a reflective surface 71 at an angle of incidence E, which light beam is reflected and absorbed on the reflective surface 71 , wherein the reflective surface 71 has the properties described below. At the same time, a part X of the light rays emitted by the light source 4 and incident at the incident angle E or on the reflective surface 71 is not re-reflected, but is absorbed or transmitted. A further portion of the light incident at the angle of incidence E and incident on the reflecting surface 71 is reflected on the reflecting surface 71 in such a way that a portion of the reflected light is reflected at the exit angle A corresponding to the angle of incidence E, while Another part of the reflected light is reflected at a preferably different or other exit angle which does not correspond to the angle of incidence E. The light beams of the wavelengths of the invention which impinge on the reflection surface 71 at the angle of incidence E are thus reflected at different angles of exit.

In a particular variant embodiment, preferably all the intensity incident at the angle of incidence E can be reflected in the direction of the angle of exit A corresponding to the angle of incidence E.

The light incident at the angle of incidence E or onto the reflection surface 71 can in this case emerge directly from the light source 4 (without prior reflection on the reflection surface 71 ) or indirectly after having previously been reflected on the reflection surface 71 . Advantageously, the fraction X of the light intensity impinging on the surface 71 at the angle of incidence E which is absorbed on the reflective surface 71 does not exceed 80%, better does not exceed 50% and preferably does not exceed 30% (eg 20% or 10%), so that at least 20%, better at least 50% and ideally 70% or more (eg more than 80% or more than 90%) of the remaining shares are reflected. No more than 90%, preferably no more than 80% and ideally no more than 60% of the reflected portion of the light intensity incident at the angle of incidence E or incident on the reflective surface 71 should be at an exit angle corresponding to the angle of incidence E A is reflected. At least 10%, preferably at least 20% and ideally at least 40% of the reflected portion of the light intensity incident at the angle of incidence E or onto the reflective surface 71 should be at an exit angle A that does not correspond to the angle of incidence E The bottom is reflected by surface 71. Preferably the incident light rays and the reflected light rays impinging on the reflective surface 71 at the angle of incidence E should be distributed over an angular region of at least 10°, better at least 20° and ideally at least 30°. This can be achieved most simply if, for example, the inner wall 7 of the spacer tube 11 is designed as a reflective surface 71 with the above-mentioned properties according to FIG. 3 , eg, the material of the spacer tube 11 itself is at least partially on the inner wall 7 . A reflective surface 71 with said reflective and absorbing properties is formed, or, for example, the inner wall 7 of the spacer tube 11 is coated with a corresponding material, so that the lateral boundary of the illumination channel 2 is at least partially covered by a reflective surface 71 with said reflective and absorbing properties. The reflecting surface 71 is formed or, for example, a film with a reflecting surface 71 having the above-mentioned reflecting and absorbing properties according to FIG. 3 is mounted locally on the inner wall 7 of the spacer tube 11 ( FIG. 5 ). Depending on the embodiment, the reflective surface 71 and the inner wall 7 of the spacer tube 11 may be used synonymously.

In a further embodiment, the lateral boundary of the illumination channel 2 , which appears as a reflective surface 71 , can be the surface of a reflective layer 70 which has a thickness z at least in regions. Here, the incident light beam E can be reflected not only on the reflection surface 71 but also in a deep region of the reflection layer 70 (see FIG. 7 ). In this case, the total intensity A reflected by the reflective layer 70 is formed by the sum of the light quantities reflected locally in a certain penetration depth 73 . In this case, the measured or effective or actual reflection properties of the reflection layer 70 or the reflection surface 71 can be related to the layer thickness z. In particular, the thicker the reflective layer 70, the ratio of the intensity of the ray E impinging on the reflective surface 71 to the intensity of the light emitted by the reflective surface 71, which may be reflected at least in part by deeper regions of the reflective layer 70, will be smaller. In other words: the greater the thickness z of the reflective layer 70 , the greater the proportion of the light intensity emitted by and/or through the reflective surface 71 into the illumination channel 2 relative to the light intensity incident from the illumination channel 2 on the reflective surface. Preferably the thickness z of the reflective layer is between 0.1 and 10 mm. In a particular embodiment, the layer thickness z should not exceed 2 mm, better not exceed 1 mm. Advantageous properties are achieved in this case with a layer thickness z between 0.1 and 1 mm, eg 0.5 mm. In a very specific embodiment, the ring body 1 or the spacer body 11 can be designed partially or completely from a material having the properties of this reflector layer 70 .

Since the reflective properties of the reflective layer 70 actually and appear to be related only to the reflective properties of the reflective surface 71 in terms of measurement technology, it is clearly stipulated here that all descriptions in the specific disclosure relate to the reflective properties, transmission properties of the reflective surface 71 . and absorption properties, and does not specifically refer to an embodiment with a final reflective layer 70 assigned to thickness z, but also applies to embodiments based on a final reflective layer 70 of thickness z. In particular this also applies to FIG. 3 . It also needs to be explicitly stated that, as far as possible, the description of the reflective surface 71 also applies to the embodiment with the reflective layer 70 and vice versa. The concepts of reflective surface 71 and reflective layer 70 can then be used synonymously for optical properties, in particular for radiation properties, reflection properties, transmission properties and absorption properties.

The reflective layer 70 can be designed as a transmissive reflector in which a portion of the incident light E can be re-emitted on the opposite surface. At least the device should be designed such that no light radiation can emerge from the illumination channel 2 through the outer surface or the outer interface 40 of the annular body 1 . In principle, the reflective layer 70 can be designed to consist of any material with corresponding properties.

The reflector layer 70 is preferably designed to consist at least partially of a plastic. Since plastics are often subjected to an aging process during UV irradiation, the device must be designed such that no significant aging process of the material making up the reflective layer 70 occurs during the irradiation. In particular the reflective properties, ie the ratio between the intensity of the ray E projected on the reflective surface 71 and the intensity of the reflected ray A, should be kept as constant as possible during the irradiation time and should remain as constant as possible during the time period T (irradiation time) The variation should never be more than 10%, and better not more than 5%.

The reflective layer 70 can be designed with a porous material having cavities with regular or irregular boundaries, such that light is at least partially diffusely reflected there. The cavity has an average size (such as the clear width between two opposing faces or the average diameter over the entire cavity volume, i.e., the average diameter is determined, for example, by making the volume of the cavity equal to the volume of a sphere and by This determines the corresponding spherical diameter and averages this spherical diameter over the entire volume of the reflective layer 70 ), the mean size being mainly between 0.1 and 100 micrometers (μm), preferably between 1 and 50 μm. In a further embodiment, these average dimensions of the cavities are between 1 and 20 μm.

The reflective layer 70 can also be mounted on the inner wall 7 of the spacer 11 as a deformable film. A cavity can be produced here between the reflector layer 70 and the spacer 11 .

In a further embodiment, in particular the reflective properties of the reflective layer 70 should be such that the light rays, during their entry into the reflective layer 70 , are reflected at a number of scattering centers within the reflective layer 70 such that in the illumination channel 2 no interaction with the Interference of reflections of light rays emitted into the illumination channel 2 from different points or locations on the reflective surface 71 or the reflective layer 70 . The more the radiation from the reflective layer 71 is diffused, ie the more the reflected radiation does not exit at an exit angle that does not correspond to the angle of incidence, the more this is the case.

The reflective layer 70 is ideally inert with respect to various external influences. In particular, the reflective layer 70 should be chemically inert and as resistant as possible to acids, alkalis, organic compounds and especially riboflavin and UV-A light.

In a particular embodiment, the intensity of the light at the outlet 16 for the light coming out of the device or out of the illumination channel 2 can be comparable to the reflective surface 71 provided on the inner wall 7 of the spacer tube 11 over the entire inner wall 7 of the spacer tube 11 . Depending on the relative proportion, the reflective surface has particular absorption and reflection properties. The light intensity at the exit 16 of the light from the device or from the irradiation channel 2 can also be related to the position of the relative share of the reflective surface 71 on the inner wall 7 of the spacer tube 11 on the entire inner wall 7 of the spacer tube 11, so The reflective surface has special absorption and reflection properties. The device can be designed such that as the length k of the reflective surface 71 increases, the intensity of the light emitted by the light source 4 on the outlet 16 also increases, wherein the length k can be the maximum length l of the spacer tube 11 or the illumination channel 2 . In a particular embodiment, the length k corresponds to the length l or to the length L.

In a further embodiment, there is a distance a between the outlet 16 on the end face 14 of the spacer tube 11 and the proximal end 17 of the reflection face 71 . In addition, there may be a distance b between the distal end portion 18 of the reflective surface 71 and the distal end portion 19 of the spacer tube.

In a further embodiment the distance a is equal to zero.

Here, the closer the distal end 18 of the reflection surface 71 is to the outlet 16 and the greater the length k of the reflection surface 71, the greater the intensity of the light emitted at the outlet 16 of the irradiation channel 2.

In a further embodiment (see Figures 6a and b) the spacer tube 11 is designed with an enlargement of the irradiation channel 2 provided on its distal end, having a diameter D1 and a longitudinal dimension d. At the same time, the diameter D1 is preferably smaller than the outer diameter D3 of the spacer tube. The diameter D1 is preferably larger than the inner diameter D of the spacer tube 11 or the irradiation channel 2 . The enlarged length d of the irradiation channel 2 should be no more than 10 mm, better no more than 5 mm and ideally no more than 2 mm or 3 mm. The transition from the inner diameter D to the inner diameter D1 in the enlarged region of the illumination channel 2 can be designed arbitrarily, but is preferably as follows: This expansion of the illumination channel 2 is not smaller in its clear width than D, measured perpendicular to the longitudinal axis 6 along the length d. section. The proximal outer wall 40 of the spacer tube 11 , which corresponds to a section of the interface 40 of the annular body 1 , can have a longitudinal recess for receiving the sleeve 15 , which has a length h in the direction of the longitudinal axis 6 . and depths D3-D2. The diameter D1 is preferably at least 1 mm or at least 2 mm larger than the diameter D in order to ensure the best possible illumination of the cornea 20 . Preferably, the illumination channel 2 has no reflection layer 70 in section d, so that the length k of the reflection layer 70 in this embodiment is at most: the length l of the spacer 11 minus the enlarged length d of the illumination channel 2 , or the illumination channel 2 The length L minus the enlarged length d of the illumination channel 2.

Due to the above-mentioned absorption and emission properties of the reflecting surface 71 of the inner wall 7 of the illumination channel 2 and shown in FIG. 3 and the fact that the part of the cornea 20 to be treated faces the illumination channel at the outlet 16 for the light rays 2 inner protrusions, enabling a particularly uniform illumination situation on the corneal surface. The advantages of this device compared to the prior art are shown in Figures 5a and b. This treatment, known as Corneal Crosslinking, is used to strengthen diseased corneas such as keratoconus, in which the strength of the cornea 20 decreases and therefore progressively worse vision loss occurs. Clinical studies show a 15% failure rate with conventional treatments (not including opaque figures). This means that despite treatment, the disease often continues to worsen. In fact it has been proven that one reason can be that keratoconus is characterized by an irregular corneal geometry with a pronounced slope. However, since the energy transfer by UV irradiation to the target tissue (cornea) is related to the angle (the angle between the incident light and the corneal surface), the effect of this energy transfer and thus the treatment in the case of irregular corneal geometry lower (as in the case of keratoconus). As shown in Figure 5a, the energy transfer to the cornea 20 is greatest at the apex of the cone and then decreases according to the edge steepness of the cornea 20. This disadvantage of conventional light sources can be overcome by the present invention because - as shown in FIG. 5 b - in particular by the reflection surface 71 (which at least partially forms the inner wall 7 of the annular body 1 or the lateral boundary of the illumination channel 2 ) ), as in the case of a black body, irradiates the cornea 20 from all directions and thus enables a homogeneous transfer of energy to the cornea irrespective of the corresponding corneal geometry and thus a better the therapeutic effect.

Typically in such treatments the (UV-A) light intensity on the target tissue is between 3 mW/cm ² and 45 mW/cm ² . In this case, light radiation is generated by the light source 4 . The light source 4 is preferably designed as an electroluminescent body, for example in the form of a light-emitting diode. The optical power emitted by the light source 4 is measured in mW and is preferably generated by the current flowing or operating the light source 4 . In a specific embodiment, when the optical power of the light source 4 is preferably constant or constant, the emission at the outlet 16 of the irradiation channel 2 can be adjusted according to the treatment needs through the length l of the spacer 11 or the length L of the irradiation channel 2 The intensity of the radiation (treatment intensity or irradiation intensity), measured in mW/cm ² . Therefore, in certain embodiments, the light intensity at the outlet 16 for light to exit the device or from the illumination channel 2 can be related to the length l of the spacer tube 11 . Here, in a special embodiment, the length 1 of the spacer tube 11 or the length L of the irradiation channel 2 should be at least 5 mm at an intensity or radiation density of less than 30 mW/cm ² , and at an intensity or radiation density of less than 20 mW/cm The length l of the spacer tube 11 or the irradiation channel 2 should be at least 10 mm in the case of cm ² and at least 15 mm in the case of an intensity or radiation density less than 10 mW/cm ² . In a further embodiment, the length of the spacer tube 11 or the illumination channel 2 may be at least 2.0 cm in the case where the intensity or radiation density is less than 6 mW/cm ² and intermediate where the intensity or radiation density is less than 4 mW/cm ² The length of the spacer 11 or the irradiation channel 2 may be at least 3.0 cm. In other words, this means that the length of the spacer 11 or the irradiation channel 2 is at least 15 mm in the case of treatment intensities less than 10 mW/cm ² , the spacer in the case of treatment intensities of at least 10 mW/cm ² and less than 20 mW/cm ² The length of the body 11 or the irradiation channel 2 is at least 10 mm, and the length of the spacer 11 or the irradiation channel 2 is at least 5 mm in the case of treatment intensities of 20 mW/cm ² and above, or in a particular embodiment The length of the spacer 11 or the irradiation channel 2 is at least 3.0 cm in the case of intensities less than 4 mW/cm ² , and the length of the spacer 11 or the irradiation channel 2 in the case of intensities of at least 4 mW/cm ² and less than 6 mW/cm ² The length of the spacer 11 or the illumination channel 2 is at least 1.5 cm in the case of an intensity of at least 6 mW/cm ² and less than 10 mW/cm ² . Here, in a preferred embodiment, the length of the spacer 11 or of the treatment channel 2 in the case of a treatment intensity of less than 10 mW/cm ² is at least 5 mm greater than in the case of a treatment intensity of 20 mW/cm ² , and In a further embodiment, the length of the spacer 11 or the treatment channel 2 is at least 10 mm greater in the case of a treatment intensity of less than 10 mW/cm ² than in the case of a treatment intensity of 30 mW/cm ² . In this case, the intensity or radiation density or treatment intensity of the emission, measured in mW/cm ² , is a property of the medical device in which it can be adjusted by the length of the irradiation channel 2 or the length of the spacer 11 .

In this disclosure, that radiation intensity measured at the outlet 16 of the illumination channel 2 in units of mW or mW/cm ² refers to the medical intensity.

Usually the irradiation time in such treatments is between 3 and 30 minutes. In a specific embodiment, when the optical power of the light source 4 is preferably constant or constant, the length l of the spacer 11 or the length L of the irradiation channel 2 can be adjusted as follows, that is, the target can be set according to the corresponding treatment requirements Tissue exposure duration. In a specific embodiment, provision is made for the device to have a preferably electronic timer 5 which can be adjusted (preset, programmed) in such a way that it has a predetermined time period (effective irradiation time) T - measured from switching on the light source 4 - then switching off the light source 4, the length L of the irradiation channel 2 is thus linked to the time period T (effective irradiation time) preset on the timer 5 and the irradiation time T in the device is adjusted The shorter it is, the shorter the length l of the spacer 11 or of the irradiation channel 2 is designed. Thus, for example, it can be provided that in the case of an effective irradiation time preset in the device of 180 seconds (s) and above, the length of the irradiation channel 2 or of the spacer 11 is at least 0.5 cm, and the irradiation time T is 300 s. The length of the irradiation channel 2 or the spacer 11 is at least 1.0 cm in the case of bell and above, and at least 1.5 cm in the case of the irradiation time T of 500 seconds and above. In a further embodiment, the length of the irradiation channel 2 or the spacer 11 should be at least 2.0 cm in the case where the effective irradiation time T is 900 seconds and above, and the length of the irradiation channel 2 in the case where the irradiation time T is 1200 seconds and above In this case the length of the irradiation channel 2 or of the spacer 11 should be at least 3.0 cm.

In other words, this means that the length of the irradiation channel 2 or of the spacer 11 is designed such that the length of the irradiation channel 2 or of the spacer 11 is at least 5 mm in the case of an effective irradiation time T of at most 300 seconds, and the effective irradiation time T is at most 300 seconds. The length L of the irradiation channel 2 or the spacer 11 is at least 10 mm in the case where T is 300 seconds or more to 500 seconds and the length L of the irradiation channel 2 or the spacer 11 in the case where the effective irradiation time T is 500 seconds or more The length is at least 15 mm, or in a further embodiment, the length of the irradiation channel 2 or the spacer 11 is at least 2.0 cm in the case of an irradiation time of more than 500 seconds and within 900 seconds, and the irradiation time is The length of the irradiation channel 2 or the spacer 11 is at least 2.0 cm in the case of 900 seconds or more and within 1200 seconds, and the length of the irradiation channel or the spacer in the case where the irradiation time T is 1200 seconds and more is At least 3.0cm. This applies in particular: in the case of an effective irradiation time preset in the device (entered by the program) of less than 300 seconds, the length of the irradiation channel or of the spacer is longer than in the case of an effective irradiation time of 500 seconds and more At least 5mm short in the middle, or in a further embodiment, the length of the irradiation channel 2 or the spacer 11 in the case of an effective irradiation time of 300 seconds or less is longer than that in the case of an effective irradiation time of 900 seconds and more. The case is at least 10mm short. Here, the effective exposure time on the device should be considered as preset (entered by the program) and as a characteristic or characteristic of the device.

The concepts of exposure time and effective exposure time are used synonymously. In practice, however, the irradiation time should be distinguished from the treatment time, as interruptions in the irradiation of the cornea 20 may be required to prevent, for example, drying out of the cornea during treatment. However, if one speaks of the (effective) irradiation time set on the device or on a timer installed in the device or pre-set or entered via a program, it goes without saying that the device or the device The timer in does not take into account possible interruptions in irradiation during treatment when determining the period of effective irradiation time. That is to say, during an irradiation interruption, the timer 5 of the device (which measures or counts the effective irradiation time) is also interrupted for the duration of the irradiation interruption in order to calculate the correct irradiation time and only then continue for the corresponding treatment. Light source 4 is turned off. The timer 5 should therefore preferably have the possibility of being repeatedly interrupted, preferably via the operating switch 3 , for a short period of time U, and this interruption should at the same time lead to the interruption of the irradiation within this interruption time U. The preferably repeated interruption duration U of the irradiation should be included in the treatment time. The timer 5 should therefore automatically switch off the irradiation, ie the light source 4, after the treatment time or the effective irradiation time, which is obtained from the following observations:

Effective irradiation time (seconds) = [dose (mJ/cm ² )/intensity (mW/cm ² )]

The effective exposure time is obtained by dividing the pre-specified dose for the corresponding treatment by the radiation intensity applied to the target tissue.

For m interrupts each with interrupt duration Ui,

This means in particular that, in a corresponding embodiment, the irradiation of the target tissue can be interrupted up to m times (each duration Ui) by operating the switch 3 . For each of these interruptions, the timer (timer) that measures the exposure time should also be interrupted so that this timer only counts the effective exposure time. The actual treatment time including the target tissue irradiation interruption is then derived from the sum of the effective exposure time plus the duration of each interruption.

Rather, this means that the irradiation time or effective irradiation time is derived from the treatment time by subtracting the sum of the durations of interruptions during the individual treatment of the target tissue from the treatment time.

In a specific embodiment, the irradiation time through the irradiation channel 2 or the spacer tube 11 can be passed through the irradiation channel 2 or the spacer tube 11 with an existing ratio between the irradiation time preset on the timer and the length l of the spacer tube 11 or the length L of the irradiation channel. The relative proportion of the reflection surface 71 on the inner or lateral boundary surface over the entire lateral boundary surface 7 of the illumination channel 2 or of the spacer tube 11 regulates, at least within certain limits, the exit of the light from the device or from the illumination channel on the light intensity. In this case, the device is designed such that the greater the share of the reflecting surface 71 in the total area of the lateral boundary 7 of the illumination channel 2, the greater the intensity of the light emitted at the exit 16 of the illumination channel 2. In addition to the electronic adjustment via the current in the light source 4, the light intensity on the target tissue during treatment can also be adjusted by geometric adjustment on the device. In this way, in a specific embodiment, the intensity of the light measured at the outlet 16 of the device can be adjusted by changing the distance a or b with a predetermined length k of the reflective layer 71 . Here, the closer the proximal boundary 17 of the reflective layer 71 is to the outlet 16, ie, the smaller the distance a or the larger the distance b, the greater the intensity on the target tissue (or the outlet 16). In a further embodiment, the intensity of the light at the outlet 16 can be changed by changing the length k of the reflective layer 71 if the distance a or b is predetermined. The principle applies: the larger the k, the greater the strength on the outlet 16.

In a further embodiment, an existing ratio between the irradiation time preset on the timer 5 and the length l of the spacer tube 11 can be passed through the irradiation channel 2 or on the boundary surface of the spacer tube 11 . The relative share of the reflecting surface 71 over the entire lateral boundary surface 7 of the illumination channel 2 or of the spacer tube 11 is at least within a certain limit (the limit being the light exiting the device without the reflecting surface 71 or the light exiting the illumination channel) The intensity of the light coming out of the device or at the exit 16 of the light coming out of the illumination channel 2 is adjusted within at least 2%, better at least 3% and ideally at least 5% of the intensity.

A sleeve 15 may be provided on the proximal end of the device, which may define the diameter of the outlet 16 of the illumination channel 2 (see Figure 2). In the absence of the sleeve, the diameter of the outlet 16 of the irradiation channel 2 corresponds to the inner diameter D of the spacer tube 11 measured on the end face 14 of the device. The sleeve 15 , which can be firmly or detachably connected to the spacer tube 11 via an arbitrary, suitable fastening such as a fit with or without a stop limit or a thread, forms a close proximity to the device or the annular body 1 after being mounted on the device. end. The sleeve has an opening 16 which can in principle have an arbitrary shape. The opening 16 may have a diameter which, in the case of the sleeve 15 mounted on the device, constitutes the diameter of the outlet of the irradiation channel 2 . The end face of the sleeve then corresponds to the end face 14 of the device. The openings 16 can be arranged concentrically or non-concentrically with respect to the longitudinal axis 6 . The diameter of the opening 16 may be between 1 mm and 12 mm, however preferably between 3 mm and 11 mm and ideally between 5 and 10 mm, eg 7 or 8 or 9 mm. The thickness 17 of the sleeve should as far as possible be between 0.1 and 5 mm, but it can also be larger or smaller. The thickness 17 forms part of the length L of the illumination channel. The sleeve can also be designed as sterile elements so that in medical applications of the device the remaining elements are not in direct contact with the eye and these elements can be designed to be non-sterile, which significantly reduces manufacturing and ocular use costs.

The sleeve 15 can also be designed as a suction ring, which allows the device to be fixed on the eye by applying a negative pressure relative to the ambient pressure (atmospheric pressure). The sleeve 15 is an integral part of the annular body 1 .

In a further embodiment, the annular body or spacer 11 may have one or more passages through the inner wall 7 of the annular body or spacer 11 between the outer space (outside the interface 40 ) and the irradiation channel 2 Holes 50 (through channel, channel). It should therefore be possible to deliver liquid or gaseous substances into the irradiation channel 2 or onto or into the target tissue during treatment or irradiation (see FIG. 6 b ). This enables, for example, oxygen to be delivered to the target tissue through the through-hole for improving the therapeutic effect. In a particular embodiment, a device can be mounted on the outer side 40 of the annular body 1 or of the spacer body 11 in the region of the through hole, which device allows a hose or a pipe body to be fastened to the annular body or the spacer body On the outside of the , so that a gaseous or liquid substance, such as oxygen, can be introduced continuously or in pulses into the irradiation channel via the through-hole 50 during the treatment. In principle, a plurality of such through holes 50 can be provided. The through holes 50 may have any shape and size. Ideally, through holes are designed as round holes. The size (diameter) of the through hole 50 is ideally less than 3 mm, more preferably less than 2 mm and in particular cases less than 1 mm. Preferably the through hole 50 is a circular hole or a cylindrical channel with a diameter of 0.1 to 3 mm. The axis of rotation of such a circular hole or the longitudinal axis of such a channel can be designed at 90° to the longitudinal axis 6 of the annular body 1 , but a different angle can also be used. If the longitudinal axis of the passage (through hole) is inclined relative to the longitudinal axis of the annular body such that the penetration 50 through the annular body 1 or the inner wall of the spacer ( 11 ) is relative to the passage through the annular body 1 or the spacer ( 11 ). The penetration of the outer wall of 11) is located at the proximal end, which is particularly favorable if the longitudinal axis of the through-flow channel is inclined from the outside to the inside in the direction of the proximal end of the annular body 1 . In principle, a through-hole 50 or a plurality of through-holes can be provided at any position of the annular body 1 or of the spacer body 11 . Preferably the through hole is provided in the proximal third of the spacer tube. In a particular embodiment, the through hole 50 can also be provided on or in the sleeve 15 or on or in the suction ring.

One embodiment of the invention provides that the light source 4 is mechanically connected firmly, in particular inseparably, to the electronic control system for controlling the light source 4 and that the electronic control system is likewise installed in a state where the device is ready for operation. in the device lumen delimited by the annular body 1 . The advantage of this embodiment is that a compact structure of the device and at the same time the desired irradiation process can be achieved.

In a further embodiment, the functional component light source 4 , the energy source 13 for operating the radiation source or the energy supply and the electronic control system 12 are mechanically connected to each other firmly, in particular inseparably, which likewise facilitates The compact construction of the device, especially when the energy source 13 is also arranged in the annular body 1 .

The annular body 1 can be designed as a die-cast part of a biocompatible material, for example plastic or metal, for example PMMA or a further suitable plastic such as POM. In principle, the device can be designed to consist of all any suitable materials.

The window 10 can consist of any material through which the radiation from the light source 4 can pass at least partially, for example from UV-transmissive PMMA or from quartz glass. In a special embodiment, the window 10 can also be omitted, so that the inner space of the housing 8 is connected to the inner wall 7 of the spacer 11 and forms a common cavity.

Since the irradiation time of the cornea 20 by the device can be 1 minute or 3 minutes and longer (eg up to 30 minutes), there is a risk of drying out the cornea during irradiation with the device. The device is therefore provided with an electronic control system that allows a temporary interruption of the irradiation of the cornea for wetting with liquid, without shortening the effective treatment (irradiation), necessary as it is preset in the timer 5 of the device The overall duration and thus does not overcomplicate the treatment process. For this purpose, in a particular embodiment, the switch 3 is preferably designed as an electromagnetic switch, which is actuated or activated or switched by means of a magnetic field, for example by means of a small permanent magnet that is briefly guided to the end cap 9 . After the switch 3 is operated for the first time, the light source 4 is switched on and the irradiation process is started. At the same time a timer 5 is started, wherein the irradiation time T is preset according to the slave length L of the irradiation channel 2 , and after the irradiation time T has elapsed the light source is switched off by the timer 5 and the irradiation process is stopped. The device is designed in such a way that, after operating the switch 3 again during the irradiation process, both the irradiation by the light source 4 and the timer 5 which counts the preset irradiation time are interrupted by a preset, preferably between 3 and 20 seconds The duration of U. The duration U of the interruption of irradiation is ideally between 5 and 15 seconds, for example about 10 seconds. Not only the light output of the light source 4 into the illumination channel 2, but also the counting of the illumination time T in the timer interrupts this duration t. After the duration U after the non-initial actuation of the switch 3 has expired, the light source 4 is switched back on autonomously, ie without further auxiliary actions by the operator, and the timer 5 also continues to be effective for the treatment time or effect autonomously or automatically. Count of irradiation time T. It is also conceivable that a further actuation of the switch 3 can trigger or lead to the end of the time period U, but this is unfavorable and complicated for the treatment sequence, since the treating physician has to control and execute a number of procedures during the treatment anyway. The switch 3 for interrupting or restarting can also be designed as a switch other than the switch 3 . Also consider: designing a foot switch connection to the housing to implement the switching process.

In a specific embodiment, the switch 3 for switching on the light source 4 (eg UV LED (ultraviolet light-emitting diode)) is designed as a mechanical switch 3 . In a further special embodiment, the switch 3 is designed to be non-contact, for example, in that the housing 8 containing the functional components also accommodates a magnetic sensor with a switch or switching function, which is suitable for use in a magnetic field. In sufficient cases, the operating current of the light source is switched on or triggers the start of the irradiation and, in a further defined embodiment, also triggers the end (completion) of the irradiation.

The energy or radiation power delivered to the cornea 20 is that energy or radiation power that impinges on the surface of the cornea. The illumination channel 2 passes at the proximal end through the end face 14 , at the distal end through the light source 4 and laterally through the inner wall 7 of the annular body 1 or - in the case of, for example, a reflector 71 according to FIG. 3 arranged on the inner wall of the spacer tube or annular body In the above case - defined by the inner wall 7 of the spacer tube 11 .

For conventional irradiation with UV-A light in corneal cross-linking surgery, a total energy of 5.4 J/cm ² should be delivered to the cornea 20 . In principle, all suitable electromagnetic radiations are suitable which have the following characteristics: a corresponding wavelength, which has a total dose associated therewith, measured in Joules or based on joules/area of the target tissue; intensity, measured in units in watts or watts/area based on the target tissue; and the resulting duration.

In a further embodiment, the wavelength of the light source 4 is between 200 nm and 250 nm, eg about 220 nm or so, eg about 222 nm. In particular, the highest intensity of the light emitted from the light source 4 is between 200 nm and 250 nm, eg about 220 nm or so, eg about 222 nm. As a result, the additional use of riboflavin can be dispensed with or an advantageous intensity ratio can be achieved under certain medical conditions.

In a further embodiment, the wavelength of the light source 4 is between 250 nm and 300 nm, eg between 270 nm and 290 nm or around 280 nm or around, eg around 282 nm. In particular the maximum intensity of the light emitted from the light source 4 is between 250 nm and 300 nm, preferably between 270 nm and 290 nm, eg about 280 nm or so, eg about 282 nm. As a result, the additional use of riboflavin can be dispensed with or an advantageous intensity ratio can be achieved under certain medical conditions.

In a further embodiment, the wavelength of the light source 4 is between 300 nm and 350 nm, eg between 300 nm and 330 nm or around 310 nm or around, eg around 308 nm. In particular the maximum intensity of the light emitted from the light source 4 is between 300 nm and 350 nm, preferably between 300 nm and 330 nm, eg about 310 nm or around, eg about 308 nm. As a result, the additional use of riboflavin can be dispensed with or an advantageous intensity ratio can be achieved under certain medical conditions.

In a particular embodiment, the intensity of the light emitted by the light source 4 is at least 1 mW/cm ^{2 at the exit 16 of the illumination channel 2} . Depending on the wavelength and the length of the illumination channel 2, the intensity at the outlet 16 of the illumination channel 2 may be between 1 mW/cm ² and 10 W/cm ² . Preferably this intensity is between 1 mW/cm ² and 100 mW/cm ² or 200 mW/cm ² . As a result, the treatment time can be significantly shortened under certain medical conditions.

In a particular embodiment, the timer 5 of the device is set (designed) such that the device delivers an energy (dose) of exactly, less than or more than 5.4 J/cm ² to the cornea 20 during irradiation on the cornea 20 . In cases where the energy delivered to the cornea is more than 5.4 J/cm ² , eg 6 J/cm ² or more (eg 7 or 8 or 10), in order to locally atrophy the tissue in order to reduce the steepness of the cornea or even in In the case of a normal energy transfer of 5.4 J/ ^cm2 , such as in cases where the cornea is thin (less than 400 μm at its thinnest) and still achieves the treatment of the tissue, either the device or any one should be recommended for the treatment of the cornea 20 . An additional part of the apparatus for cross-linking, adapted to enter the cornea 20 in the presence of a corneal capsule, to limit the damaging effect of irradiation on the endothelium of the cornea 20 .

One such part (optical barrier 21 or implant) shown in Figures 8a, b, c can be designed to have a thickness p of less than 400 μm, eg 350 μm, 300 μm, 250 μm and ideally greater than 5 mm (eg 5.5 mm) mm, 6mm, 6.5mm, 7mm, 7.5mm, 8mm) of diameter q discs, which can be designed straight, flat or curved. The optical barrier 21 may be transparent to the wavelengths used, but preferably is at least partially impermeable to the wavelengths of illumination, ie configured to transmit less than 100%. For example, the transparency (transmission) of the wavelength used for irradiation is less than 50%, more preferably less than 30%, further more preferably less than 20% and ideally less than 10%. A completely impenetrable barrier 21 with 0% transmission is perfect. In a particular embodiment, the disc may have a bend radius of between 3 and 10mm (eg 2mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm) on the front and/or back. In a particular embodiment, the part is designed as a curved lens (lens shape), which lens is however preferably impermeable to the treatment light, or the lens should be at least opaque to the light of the light source 4 . The optical barrier 21 is made of a biocompatible material that is suitable for and allows temporary implantation in the cornea 20 . Such materials may be metals such as steel or titanium, plastics such as PMMA or POM or special glasses or any other material satisfying the characteristics of the present invention. A particularly good situation arises with materials having a diameter q of 5 mm to 9 mm or 10 mm and a central thickness r of less than 200 μm (eg 180 μm or 160 μm or 140 μm or 120 μm or 100 μm). The dorsal radius is less than 8 mm and the anterior radius is smaller than the dorsal radius - however at least 5 mm - the discs are specifically matched to the geometry of the cornea. In this embodiment, the ring thickness p should preferably be smaller than the central thickness r.

In the simplest case, the optical barrier 21 is designed with a diameter of up to 12 mm, better up to 10 mm (eg 8 or 9 mm) and a ring thickness p of more than 10 μm or more than 50 μm (eg 60 μm or 70 μm or 80 μm or 90 μm or 100 μm) Simple metal discs (see Figure 8a).

In a further embodiment, the optical barrier 21 is designed such that the central thickness r is smaller than the thickness p of the more peripheral partial regions of the implant (see Figures 8b, 8c). As a result, a bowl function can be achieved, which allows, after implantation in the cornea 20 , liquid or gel-like or viscous materials, such as riboflavin, to be placed into the cornea 20 , preferably via a suitable cannula. Introduced into the cornea 20 so that it can be filled in the groove 30 of the implant and can constitute a reservoir there for a period of at least a few seconds to preferably a few minutes (within 30 minutes), and can be passed from this reservoir, for example, by Diffusion or other delivery processes into or soak into the corneal tissue and are suitable for increasing the concentration of such materials in the corneal tissue. Here, the side with the groove 30 (front face 22 ) is distal and the opposite side (back face 23 ) is proximal. In other words, the portion 21 should be introduced into the cornea such that the anterior surface 22 with the grooves 30 is oriented towards the corneal surface (epithelium) and the posterior surface 23 is oriented towards the inside of the eye (dorsal corneal, endothelium). The corners and edges of the portion 21 may be rounded so as not to produce compressive atrophy in the target tissue (cornea).

The optical barrier 21 is preferably designed to be rotationally symmetrical about a central axis. In the embodiment shown in Figure 8b, there is an annular edge structure with an inner diameter s between 3mm and 8mm or between 11mm, a diameter q between 4mm and 9mm or between 12mm, between 10μm and 500μm (eg Ring thickness p between 100 and 400 μm, e.g. 150 μm, 200 μm, 250 μm, 300 μm, 350 μm), disk thickness r from 50 μm to 400 μm (e.g. 50 μm, 100 μm, 150 μm, 200 μm, 250 μm, 300 μm, 350 μm) and 5 mm to infinity (flat back or front) back radius and front radius.

The optical barrier 21 , preferably designed as a disc, forms an optical barrier, which is impermeable to the wavelengths used for illumination and is arranged at the proximal end of the light source 4 and at the distal end of the endothelium of the cornea 20 .

The optical barrier 21 is preferably designed as a straight or curved disc (cylinder) with a central thickness p (spacing between bottom and top) of less than 500 μm and with a minimum of 2 mm and a maximum of 10 mm (eg a maximum of 8 or 9 mm) ) of the diameter q.

In this case, the bottom surface or the top surface can have a recess 30 so that in the region of the recess the thickness of the disk b is reduced relative to the region a surrounding the recess.

The optical barrier 21 (disk) may have a cavity inside. These cavities can be connected to the external space via perforations (cavities) in the surface of the disc. There may also be only one such cavity. When referring to cavities below, it goes without saying that the corresponding explanations also apply to embodiments with only one such cavity. The cavity can be adapted to receive substances in any physical state such as liquid, gaseous, gelatinous, foamy or solid or mixtures thereof. Such substances may be, for example, riboflavin, oxygen, and the like. In a further embodiment, the implant is designed such that it is capable of expelling substances into the surrounding area or onto surrounding target tissue after introduction into the target tissue (eg, the cornea). In a particular embodiment, the optical barrier 21 or its cavity or recess 30 can be connected to a system (eg a hose and/or a syringe) that can continuously expel such substances into the implant Or in an intermediate space between the implant and the target tissue. From there it should be able to get into the target organization. In a particular embodiment, the substance is introduced into the cavity from the beginning (prior to implantation). However, they can also be combined with the implant material or stored in the intermediate lattice sites of the implant material particles. The optical barrier 21 can also be designed as a circular ring. When, in FIG. 8b, the recess 30 is so deep that there is an open connection in the form of a perforation at least at a single location between the front face 22 and the rear face 23, that is when, for example, the recess 30 (measured in p-r This is the case when ) is equal to p or r=0. If the part 21 is designed with a recess 30 or as a ring and is made rotationally symmetrical in each case about the longitudinal axis (axis of rotation, axis of symmetry) 24, a passage can be provided through the outer wall 25 which allows the substance to be transported during treatment For example, it is possible to feed oxygen or other gaseous or liquid substances through the outer wall into the groove 30 or into the diameter of the ring. In the simplest case, this is an eyelet or a cavity 26 which extends laterally, ie from the outer wall 25 , in at least one directional component towards the axis of symmetry 24 . The part 21 can be designed such that it is mechanically flexible and can be deformed by external pressing, for example with a pair of tweezers.

The device shown in FIGS. 1 and 2 can be placed with its longitudinal axis 6 at different angles to an eye axis.

It is expressly stated that all elements of all embodiments of this disclosure can and are permitted to be combined individually or collectively with all remaining elements of all embodiments into new embodiments of the invention.

List of reference signs

1 ring

2 irradiation channels

3 switches

4 light sources

5 timer

6 longitudinal axis

7 The inner wall of the annular body or of the spacer body

8 shell

9 End caps

10 windows

11 Spacer (spacer tube)

12 Electronic Control System

13 battery (energy source)

14 End face

15 sleeve, can also be designed as a suction ring

16 exports

17 Proximal end of reflective surface

18 Distal end of reflective surface

19 Distal end of spacer

20 Cornea

21 Optical barriers

22 Front of optical barrier 21

23 Backside of optical barrier 21

24 Longitudinal axis of part 21

25 (lateral) outer wall of part 21

26 holes

27-

28-

29-

30 grooves/recesses

40 The outer interface of the annular body

50 through hole

51 Through hole opening in outer wall

52 Through hole opening on inner wall

70 Reflector

71 Reflector

72 The outer wall of the reflective layer

73 Injection Depth

D Diameter of the illumination channel

L length of illumination channel

E Incident angle

A Exit angle

k Length of reflecting surface

Diameter of proximal recess on inner wall of D1

D2 Diameter of proximal recess in outer wall

D3 outer diameter of spacer

a Spacing between reflector face and proximal end of spacer

b Spacing between reflector face and distal end of spacer

d Longitudinal dimension of recess on inner diameter

h Longitudinal dimension of recess on outer diameter

p Outer disk thickness

q Diameter of optical barrier

r Medial Disc Thickness

s inner diameter

Claims (20)

1. An apparatus for illuminating a cornea (20), the apparatus comprising an annular body (1), the annular body (1) further comprising a light source (4) and a spacer body (11), wherein the spacer body (11) constitutes an illumination channel (2), the illumination channel (2) comprising at least one outlet (16), characterized in that: the intensity of the radiation generated by the light source (4) and emitted at the outlet (16) of the illumination channel (2) can be adjusted by means of the length (l) of the spacer body (11).

2. An apparatus for irradiating a cornea (20) as defined in claim 1, wherein: the length (l) of the spacer (11) is less than 10mW/cm at an intensity of radiation generated by the light source (4) and emitted on the outlet (16) of the illumination channel (2)²At least 15mm, and the intensity of the radiation emitted by the light source (4) at the outlet (16) of the illumination channel (2) is at least 10mW/cm²And less than 20mW/cm²At least 10mm and the intensity of the radiation emitted by the light source (4) at the outlet (16) of the illumination channel (2) is 20mW/cm²And more at least 5 mm.

3. Apparatus for irradiating a cornea (20) according to any one of the preceding claims, characterized in that: the length (l) of the spacer (11) is less than 10mW/cm at an intensity of radiation generated by the light source (4) and emitted on the outlet (16) of the illumination channel (2)²The time-to-time ratio is 20mW/cm relative to the intensity of the radiation generated by the light source (4) and emitted at the outlet (16) of the illumination channel (2)²At least 5mm larger.

4. Apparatus for irradiating a cornea (20) according to any one of the preceding claims, characterized in that: the length of the spacer (11) is such that the intensity of the radiation generated by the light source (4) and emitted at the outlet (16) of the illumination channel (2) is less than 10mW/cm²The time-to-time ratio is 30mW/cm relative to the intensity of the radiation generated by the light source (4) and emitted at the outlet (16) of the illumination channel (2)²At most, the time is as large as10mm less.

5. Apparatus for irradiating a cornea (20) according to any one of the preceding claims, characterized in that: the device further comprises means for automatically switching off the light source (4) after the end of a predetermined treatment time, said means comprising a timer (5).

6. Apparatus for irradiating a cornea (20) according to any one of the preceding claims, characterized in that: the length (L) of the irradiation channel, in particular the length (L) of the spacer (11), is at least 5mm at an effective irradiation time T of at most 300 seconds, at least 10mm at an effective irradiation time T of 300 seconds or more to 500 seconds, and at least 15mm at an effective irradiation time T of 500 seconds or more.

7. Apparatus for irradiating a cornea (20) according to any one of the preceding claims, characterized in that: the length (l) of the spacer (11) when the effective irradiation time is 300 seconds or less is shorter by at least 5mm than the length (l) of the spacer (11) when the effective irradiation time is 500 seconds and more.

8. Apparatus for irradiating a cornea (20) according to any one of the preceding claims, characterized in that: the length (l) of the spacer (11) when the effective irradiation time is 300 seconds or less is shorter by at least 10mm than the length (l) of the spacer (11) when the effective irradiation time is 900 seconds and more.

9. Apparatus for irradiating a cornea (20) according to any one of the preceding claims, characterized in that: the annular body (1) comprises at least in some regions at least one through-opening (50) through which a liquid or gaseous substance can be introduced into the irradiation channel (2).

10. An apparatus for irradiating a cornea (20) as defined in claim 9, wherein: the device further comprises a connecting element for connecting to an oxygen source for introducing oxygen into the irradiation channel (2) via the through-hole (50).

11. Apparatus for irradiating a cornea (20) according to any one of the preceding claims, characterized in that: the illumination channel (2) comprises a lateral boundary (7) which has a reflection surface (71) at least in some regions.

12. An apparatus for irradiating a cornea (20) as defined in claim 11, wherein: the reflection surfaces (71) of the lateral boundaries (7) of the illumination channel (2) are configured such that incident light rays of the wavelength used for the treatment are diffusely reflected, wherein a portion of the light rays are reflected in a range of exit angles which does not correspond to the angle of incidence.

13. An apparatus for irradiating a cornea (20), characterized by: an optical barrier (21) is provided, which is impenetrable to the wavelengths used for irradiation and is arranged at the proximal end of the light source (4) and at the distal end of the endothelium of the cornea (20).

14. An apparatus for irradiating a cornea (20), characterized by: an optical barrier (21) is provided, which is impenetrable to the wavelength used for irradiation and can be arranged at the proximal end of the light source (4) and at the distal end of the endothelium of the cornea (20).

15. Apparatus for irradiating a cornea (20) according to any one of claims 1 to 12, characterized in that: an optical barrier (21) impenetrable to the wavelength of the light source (4) used for illumination is arranged at the proximal end of the light source (4) and at the distal end of the endothelium of the cornea (20).

16. Apparatus for irradiating a cornea (20) according to any one of the preceding claims 1 to 12, characterized in that: an optical barrier (x) impenetrable to the wavelength of the light source (4) used for illumination can be arranged at the proximal end of the light source (4) and at the distal end of the endothelium of the cornea (20).

17. Apparatus for irradiating a cornea (20) according to any of claims 13 to 16, characterized in that: the optical barrier (21) is a straight or curved circular disc having a thickness p of less than 500 μm and having a diameter q of at least 2mm and at most 10 mm.

18. Apparatus for irradiating a cornea (20) according to any of claims 13 to 17, characterized in that: the optical barrier (21) has a bottom surface (23) or a top surface (22) which comprises a recess (30), wherein the thickness (r) of the disc in the region of this recess (30) is reduced relative to the thickness (p) of the region surrounding the recess (30).

19. Method for treating corneal diseases, in particular keratoconus, with the aid of a device according to one of claims 1 to 18, comprising the following method steps:

-securing the device on the eye; and

-adjusting the intensity of the radiation generated by the light source (4) emitted on the outlet (16) of the irradiation channel (2) as a treatment intensity by adjusting the length (l) of the spacer (11).

20. The method of claim 19, wherein at least one of the following treatment steps is included:

-creating a corneal space or corneal pocket with an opening to the corneal surface;

-gripping the optical barrier (21) with tweezers; or arranging the optical barrier (21) in a cylindrical container;

-introducing an optical barrier (21) into a corneal space, in particular into a corneal pocket, via an opening in the cornea;

-irradiating the cornea with electromagnetic waves, preferably with ultraviolet light waves;

-introducing a gaseous substance, in particular oxygen, or a liquid substance, in particular riboflavin, into the cavity (30), wherein the cavity (30) is located between the front face (22) and the corneal tissue, and

-removing the optical barrier (21) after the irradiation is completed.

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