CN111936094A

CN111936094A - Apparatus and method for illuminating an eye

Info

Publication number: CN111936094A
Application number: CN201980023458.XA
Authority: CN
Inventors: 阿尔贝特·达克瑟尔
Original assignee: A ErbeiteDakeseer
Current assignee: A ErbeiteDakeseer
Priority date: 2018-01-31
Filing date: 2019-01-31
Publication date: 2020-11-13
Also published as: WO2019149802A1; EP3746017A1

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 illuminating an eye

Technical Field

The invention relates to a device and a method for irradiating tissue, in particular connective tissue and in particular preferably the cornea of a human eye. The inventive apparatus and the inventive method are intended to cause a change in the structure of corneal tissue, which change reacts to a lesion. Thus, for example, keratoconus is a corneal disease that results in an increasingly weaker mechanical stability of the tissue due to the constant change in the structure of the corneal stroma. This in turn causes changes in the corneal geometry which can lead to significant vision loss or even blindness due to corneal causes. Similar considerations apply to spherical cornea, pellucid cosmetic degeneration (PMD), post-LASIK corneal protrusion, progressive myopia and other eye disorders.

Background

As a prior art, collagen fibers of the cornea are corneal crosslinked by introducing riboflavin into the corneal stroma in conjunction with UV-A irradiation. This should improve the stability of the cornea and prevent the disease from becoming worse. It is also possible to modify the geometry of the cornea by crosslinking and thus to perform a refractive correction on the eye.

Thus WO2012/047307a1 describes an apparatus for irradiating the cornea to cross-link the collagen fibres of the tissue. The disadvantages of such a system are: the system may misilluminate the eye during eye movements and may not accurately maintain the separation from the radiation source during the illumination time.

EP 1561440 a1 and WO 2012/127330 a1 each describe an apparatus for deforming and hardening the cornea by placing a shaped body on the cornea, by means of which both the cornea is irradiated and the shaped body or the irradiation device is positioned on the cornea. Background of the invention is the fact that the refractive power (diopter) of the eye depends strongly on the bending radius of the cornea. Thus, both publications assume that by reshaping the corneal surface with an appropriate shaping body, the refractive power of the eye should be able to be changed to a certain extent by this device. The correctness of this assumption should not be explored here. However, one major drawback of these systems is that: the adsorption on the cornea takes place also exactly where the irradiation takes place, i.e. by the shaped body being adsorbed planarly on the corneal surface. As explained in the two publications of the prior art, adsorption on the corneal surface can easily lead to corneal surface damage, i.e. corneal erosion, which can cause significant pain for the patient for several days. Although the conventional methods for irradiating the cornea, as described for example in WO2012/047307a1, are associated with corneal erosion and considerable pain themselves, there are also newer methods for treating Keratoconus, in which no more corneal erosion occurs and in which the treatment can therefore be carried out painlessly (a.daxer et al. The therapeutic effect is also linked to the presence of oxygen in the tissue to be treated, which is hindered, or even interrupted, by the shaped body. This situation is additionally exacerbated by the fact that the shaped body not only blocks the passage of oxygen to the cornea, but even the shaped body is adsorbed via vacuum (excluding air and oxygen). The two devices known from EP 1561440 a1 and WO 2012/127330 a1 therefore have significant disadvantages due to the adsorption on the corneal surface to be irradiated and the limited oxygen supply of the tissue by the cast.

WO2014/060206a1 enables a compact structure of the irradiation unit and a uniform irradiation of the cornea. Although a 3mW/cm is prescribed for standard treatment²However, recently, up to 45mW/cm is used²Has established its own position. The device according to WO2014/060206a1, although making it possible to provide these different illumination powers, nevertheless makes the adjustment of the illumination power by the operating current of the light source and therefore by the dimensions of the components of the electronic control system. This has advantages in inventory production: it is not necessary to pre-manufacture instruments for a certain radiation power, which may not be required in the market at a later time by this amount and therefore result in high production costs. Devices in which the illumination power can be subsequently adjusted via the operating current of the light source are expensive and increase the instrument outlay. It can no longer be economically manufactured as a disposable instrument. However, if the instrument is not designed as a disposable instrument, it has a disadvantage in terms of health and economy: expensive investment in equipment is required-this often and especially in rare disease cases such as in the case of keratoconus, results in the inability to perform treatment in many areas and to adequately provide treatment to the patient concerned.

Disclosure of Invention

It is therefore an object of the present invention to propose an apparatus and a method for irradiating the cornea of the eye which allow the cross-linking of collagen fibres while overcoming the drawbacks of the prior art.

The invention solves the problems of the prior art by making it possible to adjust the irradiation power or the irradiation time respectively required for the treatment via the length of the preferably exchangeable or length-variable spacers and/or via the relative proportion of the reflection surface on the inner surface of the irradiation channel. This object is achieved in particular by an apparatus for irradiating a cornea, comprising an annular body which furthermore comprises a light source and a spacer body, wherein the spacer body forms an irradiation channel which comprises at least one outlet, wherein: the intensity of the radiation generated by the light source and emitted at the outlet of the illumination channel can be adjusted by the length of the spacer.

This design makes it possible to design a housing for the light source and its functional elements or components uniformly for all desired radiation intensities on the cornea, which results in a significant cost advantage in comparison with the prior art in terms of production and in terms of treatment of the patient.

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

The device of the invention is essentially designed as an annular body which is arranged essentially (substantially) concentrically about a longitudinal axis. In a particularly simple case, the annular body according to the invention is designed as a hollow cylinder, i.e. as a cylindrical housing. The longitudinal axis of the device then corresponds to the cylinder axis. A ring body in the sense of the present invention is however an object with a closed housing, wherein the housing preferably surrounds an axis (longitudinal axis). At least one cavity is provided in the housing interior, which cavity is open on one side, in particular on both sides, in the longitudinal direction. Stipulating: 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 receive functional components, such as light sources, energy sources or energy supplies, electronic systems (electronic control systems).

The functional components can be connected to the ring body and to each other in any desired manner (e.g., firmly or detachably).

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

In order to ensure a defined distance between the light source and the eye in the ready-to-operate state of the device in the case of a construction with a housing, provision can be made for: a receptacle for the spacer is provided on the housing or, conversely, a receptacle for the housing is provided on the spacer, which receptacle has stop limits, 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 defined distance from the housing and thus from the light source by means of the stop limit. In order that the housing does not fall out of the spacer body, away from the stop limit, additional holding means, such as stop teeth, clamping means, a fit, a screw connection, an O-ring or an adhesive, may be provided. Furthermore, provision can be made for: the receptacle has a thread or equivalent means which makes it possible to adjust the spacer continuously or stepwise relative to the housing or the light source.

The equipment is beneficial to that: either only the spacer tube (which may be used synonymously with spacer at all times) or only the sleeve is designed to be sterile, the remaining components of the device may be made non-sterile since these components do not come into contact with the eye. This therefore makes it possible to manufacture the entire device more economically.

The spacer body 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 body in the sense of the present 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 by any means, such as via a fit, a threaded connection, an O-ring, an adhesive connection, etc. However, there are conventions: the spacer may also take other shapes that can serve this function.

The spacer allows the irradiation intensity to be adjusted via its length or the corresponding length of the irradiation channel even if it is firmly connected to the annular body. The length change of the spacer can be achieved, for example, by telescopically extending the spacer, if the spacer is firmly connected to the annular body. The length change of the spacer can be achieved in this case because the spacer is formed from at least two interconnected elements which allow a pulling apart (increasing length) and a telescoping shortening (shortening length) from one another, thereby resulting in a corresponding length change of the irradiation channel.

If the spacer body is to be detachably connected to the annular body, it can be replaced by a further spacer body, which in turn allows the length of the spacer body to be changed. This design can be realized, for example, by a replacement receptacle (preferably limited by a stop) for the spacer in the remaining part of the annular body. Or by a threaded connection.

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

In order to be able to irradiate the cornea, a light source is provided according to the invention. All radiation sources capable of emitting electromagnetic radiation can be considered as light sources. However, it is preferred that 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 advantageous for irradiating the cornea. According to the invention, provision is preferably made for: the light source is capable of emitting ultraviolet light in the UV-A band. Particularly advantageous are: light having a wavelength between 365nm and 375nm, and in particular light having a wavelength between 365nm and 370nm, is emitted by the light source. Light can be generated at virtually any location inside or outside the annular body. The following positions are referred to as positions of the light source in the sense of the invention: from this position, the generated light is directly incident into the irradiation channel. If, for example, light is generated outside the annular body by an external light source and is guided into the annular body via an optical waveguide such that the light emerging from the optical waveguide enters the irradiation channel, the position at which the light leaves the optical waveguide for direct entry into the irradiation channel is regarded as the position of the light source or light source in the sense of the invention. If the concept of a light source is not specified in detail in this disclosure, it should be understood as such 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 is at least partially incident into the irradiation channel. The light emitted by a 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 the irradiation intensity or treatment intensity. These concepts are to be understood as synonymous in the present invention and may thus be used interchangeably. Typically, the intensity of the (UV-A) light at the target tissue in such treatments is at 3mW/cm²And 45mW/cm²In the meantime. In this case, the light radiation is generated by a light source. The light source is preferably designed as an electronic light emitter, 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 running the light source.

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

According to the invention, provision is made for: the spacer at least partially constitutes an irradiation channel. When the light source is directly adjacent to the spacer, the length of the spacer then corresponds exactly 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 must additionally pass through an interval before entering the spacer, the length of the illumination channel is correspondingly extended by this interval between the position of the light source and the spacer. In this case, the irradiation channel is correspondingly longer than the length of the spacer. It should be noted that: the length of the illumination channel naturally also changes correspondingly when the length of the separation channel changes, since the spacers always at least partially form the illumination channel. This means that: when the spacer is lengthened or shortened and thus the length of the spacer is changed, the length of the irradiation channel is also lengthened or shortened accordingly.

In one embodiment of the invention, provision is made for: the radiation intensity of the light source itself, i.e. the radiation intensity emitted by the light source, is not variable, which ensures a simple and economical device production for the reason that the length of the spacers need only be adjusted without changing the overall structure of the instrument device or changing the treatment intensity by a change in the light source itself. This means that: the power of the light source need not be changed to achieve the desired intensity of illumination for treating the target tissue. The adjustment of the appropriate treatment intensity is made solely by the change in length of the spacer.

In a particularly preferred embodiment of the invention, therefore, provision is made for: in order to obtain an intensity that is compatible and suitable for the respective treatment, the length of the spacers is less than 10mW/cm at the intensity of the radiation generated by the light source and emitted at the outlet of the illumination channel²At least 15mm, and the intensity of the radiation generated by the light source and emitted at the outlet of the illumination channel is at least 10mW/cm²And less than 20mW/cm²At least 10mm and the intensity of the radiation generated by the light source and emitted at the outlet of the illumination channel is 20mW/cm²And more at least 5 mm. The length of the spacer is necessary in order to obtain the radiation intensity required for the treatment without having to change the light source itself.

In a particular embodiment of the invention, therefore, provision is made for: in order to be adjusted to an intensity which is adapted to the respective treatment and which is suitable without having to modify the light source itself, the length of the spacers is less than 10mW/cm at the intensity of the radiation generated by the light source and emitted at the outlet of the illumination channel²The time ratio is 20mW/cm relative to the intensity of the radiation generated by the light source and emitted at the outlet of the illumination channel²At least 5mm larger.

In a particular embodiment of the invention, provision is made for: in order to be adjusted to an intensity which is adapted to the respective treatment and which is suitable without having to modify the light source itself, the length of the spacers is less than 10mW/cm at the intensity of the radiation generated by the light source and emitted at the outlet of the illumination channel²The time ratio was 30mW/cm relative to the intensity of the radiation generated by the light source and emitted at the outlet of the illumination channel²At least 10mm larger.

From the above, the following conclusions are drawn: the smaller the length of the spacers or of the irradiation channels, the greater the irradiation intensity at the outlet and vice versa. In other words, this means: the smaller the radiation intensity required for the treatment, the greater the length of the spacer or of the irradiation channel must be, since the light source must be positioned closer to the target tissue, in particular the cornea, for a correspondingly greater intensity, and conversely, the light source must be positioned further away from the target tissue with a correspondingly smaller irradiation intensity. That is, the less intensity is required for treatment, the light source must be positioned further away from the cornea, and vice versa.

In order to make the operation of the device easier for the user and the irradiation process more efficient, provision is made in a preferred embodiment of the invention for: the device further comprises a device with a timer for automatically switching off the light source after the end of the predetermined treatment time. The timer makes it possible to determine the effective treatment time precisely, since possible interruptions are not counted during the time measurement, so that the treatment time always corresponds to the previously specified treatment time.

Provision is made in this connection for: the irradiation time and the effective irradiation time are used synonymously in the present invention. It is however important to distinguish the irradiation time from the treatment time, since interruptions in the irradiation of the cornea may be required to prevent, for example, the cornea from drying out during treatment. It is self-evident that if the (effective) exposure time is set or preset or entered by a program on the device or on a timer installed in the device, this means: the device or a timer in the device when determining the period of effective irradiation time does not take into account possible irradiation interruptions during treatment.

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

Any suitable switch known in the art may be considered, however an electromagnetic switch is preferred, which is operated or triggered or switched by a magnetic field, for example by a small permanent magnet.

According to the invention, in a preferred embodiment: in order to be able to provide the required and suitable irradiation intensity for the corneal irradiation, the length of the irradiation channel, in particular the length of the spacer, is at least 5mm when the effective irradiation time T is at most 300 seconds, at least 10mm when the effective irradiation time T is from 300 seconds to 500 seconds, and at least 15mm when the effective irradiation time T is from 500 seconds or more. In particular because, as mentioned above, the treatment time is correlated with the respective irradiation intensity. This results in a correlation of the treatment time with the irradiation intensity and with the length of the spacers or the length of the irradiation channels, in the case of different lengths. Since the irradiation intensity is associated with the length of the spacer and can be adjusted via this length, the treatment time is also associated with the length of the spacer, since the length of the treatment time results from the necessary irradiation intensity and dose.

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

According to the invention, therefore, in a particularly preferred embodiment: in order to be able to provide the required and suitable irradiation intensity for corneal irradiation, the length of the spacer at an effective irradiation time of 300 seconds or less is at least 5mm shorter than the length of the spacer at an effective irradiation time of 500 seconds and more.

According to the invention, therefore, in a particularly preferred embodiment: in order to be able to provide the required and suitable irradiation intensity for corneal irradiation, the length of the spacer at an effective irradiation time of 300 seconds or less is at least 10mm shorter than the length of the spacer at an effective irradiation time of 900 seconds or more.

This (assuming the radiation dose remains the same) means: the smaller the irradiation intensity, the longer the treatment time has to be and vice versa. The treatment time is accordingly shortened if a high radiation intensity is used.

According to the invention, therefore, in a particularly preferred embodiment: in order to ensure that the liquid or gaseous substance required for the optimal treatment, i.e. for example for preventing the cornea from drying out, is introduced, the annular body comprises at least in some regions at least one through-opening, through which the liquid or gaseous substance can be introduced into the irradiation channel.

The at least one through-opening makes it possible to introduce a liquid or gaseous substance into the irradiation channel continuously or in a pulsed manner via the through-opening. In principle, a plurality of such through-holes may be provided. The through holes may have any shape and size. Ideally, the through-holes are designed as circular holes. The diameter of the through-hole is ideally less than 3mm, more preferably less than 2mm and in particular less than 1 mm. The through-hole may 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 other angles can also be used. A particularly good situation arises if the longitudinal axis of the channel (through-hole) is inclined relative to the longitudinal axis of the annular body such that a penetration through the inner wall of the annular body or of the separating body is located at the proximal end relative to a penetration through the outer wall of the annular body or of the separating body, i.e. if the longitudinal axis of the through-flow channel is inclined from the outside inwards in the direction of the proximal end of the annular body. The through-opening or through-openings can in principle be arranged at any point of the annular body or of the spacer. Preferably, the through hole is provided in the proximal third of the spacer tube. In a special embodiment, the through-opening can also be provided on or in the sleeve or on or in the suction ring.

According to the invention, therefore, in a particularly preferred embodiment: in order to ensure an optimal oxygen supply and thus the best possible treatment of the cornea, the device furthermore comprises a connection element for connecting to an oxygen source for introducing oxygen into the irradiation channel via the through-opening. As such a connecting element for connecting the oxygen supply to the oxygen supply for introducing oxygen, all known devices customary in the art, for example oxygen pumps, can be considered. Oxygen is required in the treatment of the cornea to improve the therapeutic effect.

In a preferred embodiment of the invention, provision is made for: the illumination channel comprises a lateral boundary which at least partially has a reflecting surface, thereby making possible a homogeneous illumination of the cornea.

The illumination channel can thus be at least partially or partially defined by a reflective surface which is able to reflect and/or absorb and/or transmit in a defined manner the light rays which are incident into the illumination channel by the light source. There are possibilities here: the radiation is reflected at an exit angle that either corresponds to or does not correspond to the angle of incidence. This surface can in principle be designed with any material that makes the inventive properties of the device possible. 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.

In a preferred embodiment of the invention, provision is made for: the reflective surface of the lateral boundary of the illumination channel is configured to: incident light rays of a wavelength for treatment are subjected to diffuse reflection, wherein a portion of the light rays are reflected in an exit angle range that does not correspond to the incident angle, thereby making it possible to uniformly irradiate the cornea or target tissue and preventing increased radiation at a certain position of the cornea.

The irradiation intensity can also be adjusted to a certain degree according to these reflection properties. In the case of the predefined ratio of the irradiation time to the length of the spacer or of the irradiation channel, which is preset on the timer, the intensity of the light at the exit of the light from the device or from the irradiation channel can be set at least within certain limits (i.e. at least 2%, preferably at least 3% and ideally at least 5% of the intensity of the light at the exit) by the relative proportion of the reflection surface over the entire lateral boundary surface of the irradiation channel. The device is designed here such that: the greater the proportion of the reflective surface in the total area of the lateral boundary of the irradiation channel, the greater the intensity of the light emerging at the outlet of the irradiation channel. This means that: the illumination intensity can already be increased by the size of the reflecting surface alone.

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

This means that: when adjusting the illumination intensity by the length of the spacer tube or of the illumination channel, not only the length itself but also the length and the position of the reflection surface when the illumination channel comprises this surface in part must be taken into account.

In general, the invention also includes any device for irradiating the cornea, in which an optical barrier is provided which is impenetrable to the wavelengths used for irradiation and which is already provided or can be provided at the proximal end of the light source and at the distal end of the endothelium of the cornea. This optical barrier can also be an embodiment of the inventive device for irradiating the cornea in such a way that an optical barrier that is impenetrable to the wavelength of the light source used for irradiation is already provided or can be provided at the proximal end of the light source and at the distal end of the endothelium of the cornea.

Damage to the endothelium by irradiation should be prevented by this optical barrier in that, for example, the optical barrier is introduced into a corneal pocket. This prevents the irradiation from penetrating deeper and thus prevents the associated damaging effects.

In a preferred embodiment of the invention, provision is made for: the optical barrier is a straight or curved disc having a thickness p of less than 500 μm and a diameter q of at least 2mm and at most 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 has a bottom or top surface which comprises a recess, wherein the thickness r of the disk in the region of the recess is reduced relative to the region of the thickness p which surrounds the recess. This recess makes it possible, after the implantation of the optical barrier, to additionally introduce liquid or gel-like or viscous materials (e.g. riboflavin) into the cornea, a reservoir being formed there and increasing the diffusion or other transport processes into the corneal tissue and the concentration in the tissue.

Furthermore, the object is achieved by a method for treating corneal diseases, in particular keratoconus, by means of the device according to the invention, comprising the following method steps:

-securing the device on the eye; and

-adjusting the intensity of the radiation generated by the light source emitted on the outlet of the irradiation channel as the therapeutic intensity by adjusting the length of the spacer. The device may be fastened before the adjustment of the strength or vice versa.

Additionally, it can be provided that:

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

-gripping the optical barrier with tweezers or placing the optical barrier in a cylindrical container;

-introducing the optical barrier into the corneal space, in particular into the 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, wherein the cavity is located between the front face and the corneal tissue, and

-removing the implant after the irradiation is completed.

Provision can be made here for: a gaseous substance, in particular oxygen, or a liquid substance, in particular riboflavin, can be introduced repeatedly into the recess.

If an optical barrier is used which is impenetrable to the wavelength used for illumination in order to protect the cornea, this barrier is arranged at the proximal end of the light source of the device and at the distal end of the endothelium of the cornea, i.e. introduced into the cornea, before the device for illuminating the eye is fastened on the eye.

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

1. a corneal space or corneal pocket is created with an opening to the corneal surface (epithelium).

2. Forceps are used to grasp the optical barrier 21 (implant) or to place the implant in a generally cylindrical receptacle.

3. The implant (part 21) is introduced into the corneal space or into the corneal pocket via an opening in the cornea.

4. The cornea is irradiated with electromagnetic waves (preferably in the UV band).

5. A gaseous substance (e.g. oxygen) or a liquid substance (e.g. riboflavin) is introduced into the pocket 30, i.e. into the cavity between the front face 22 and the overlying corneal tissue.

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

7. The implant is removed after the irradiation is completed.

Drawings

In order to further elucidate the invention, reference is made in the subsequent part of the description to the drawings in which further advantageous constructional designs, details and developments of the invention can be obtained. In the drawings:

FIG. 1 is a longitudinal section of the apparatus of the present invention;

FIG. 2 is a longitudinal cross-sectional view of the apparatus of the present invention together with a sleeve;

FIG. 3 is a graph of absorption and reflection characteristics on a reflective surface;

FIG. 4 is a longitudinal section through the apparatus of the invention, wherein the spacing tube has a reflecting surface in part;

FIG. 5 is a comparison of the illumination effect between a conventional system (a) and an apparatus (b) of the present invention;

FIG. 6a is a longitudinal cross-sectional view of a spacer body of the apparatus of the present invention;

FIG. 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;

fig. 8a, b, c are diagrams of optical barriers.

In order that the skilled person can easily see the same reference numerals have been used in the different figures. These reference numerals have therefore not been repeated among the corresponding figures for the sake of clarity. This is evident as follows: the switch 3 is shown, for example, in fig. 1, 2 and 4, so that it is only indicated by reference numeral 3 in fig. 1, but also in fig. 2 and 4 for the corresponding switch.

Detailed Description

Various embodiments of the apparatus and a method for treatment are described herein. Each embodiment and the methods associated therewith may also be considered as an initial point of another embodiment, i.e. one or more parts or elements of the described embodiment may be combined with one or more parts or elements of the other embodiment to create a new embodiment.

First, explanation is made: the following specific terms are used for the directional characteristic along the longitudinal axis: in the human anatomy there is the concept of a distal end and a proximal end. Distal means distal from the body, while proximal means towards the body. Thus, for example, the hand is distal to the elbow joint and the shoulder is proximal to the forearm. Since this device is arranged for use on the human body (on the eye), the device has an area which is in contact with the body when the device is in use. This region of the device is that end of the device where the outlet 16 is located, measured along the longitudinal axis, and is referred to as proximal, regardless of the anatomy of the body. Thus, those structures of the device-measured along the longitudinal axis-that are distant from the proximal end, i.e. distant from the eye, are then referred to as distal. Thus, for example, the light source 4 is distal to the outlet 16. In addition, the position designation "lateral" is used in the human anatomy when, for example, a structure extends substantially in the direction of an axis at a distance from the axis. Since the device behaves as a sleeve over the eye in use, this term is also used herein for position definition. Thus, for example, the spacer tube (spacer) 11 serves as a wall of the irradiation channel 2 laterally to the longitudinal axis 6, or the outer wall 40 laterally to the inner wall 7.

According to the invention, provision is made for: the intensity of the radiation emitted at the outlet of the irradiation channel (measured in mW/cm) can be adjusted by the length L of the spacer or the length L of the irradiation channel 2²) In order to be able to precisely match the intensity of the radiation to the respectively required treatment.

Fig. 1 shows a longitudinal section through the device according to the invention, comprising a ring body 1, the ring body 1 further comprising a spacer body 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 arbitrary, however it is designed at least partially along the longitudinal axis 6 preferably as a hollow cylindrical inner space (cavity) and laterally delimited by the inner wall 7 of the annular body 1. The diameter D of the irradiation channel 2, measured perpendicularly to the longitudinal axis 6, should be at least partially between 1mm and 30mm and in a particularly preferred variant between 5mm and 12mm, in a further embodiment between 6mm and 10mm or between 7mm and 9 mm. The diameter of the exit opening (exit surface, irradiation surface) 16 for the light from the irradiation channel 2, measured at the height of the end face 14 of the ring body 1, is as far as possible not more than 12mm, preferably not more than 11 mm. Preferably the diameter of the outlet is between 5 and 10mm, ideally between 7 and 9mm, for example 8 mm. The illumination channel 2 is delimited proximally by the end face 14, distally by the position of the light source 4 and laterally-at least partially-by the inner wall 7 of the ring-shaped body 1. The length L of the irradiation channel is measured between the light source 4 and the end face 14 of the body 1. The lateral dimension of the irradiation channel 2 is at least partially or partially formed by the clear width of the inner space 2, measured perpendicularly to the longitudinal axis 6 of the annular body 1. In particular, the lateral dimension of the irradiation channel 2 may at least partially correspond to the inner diameter D of the spacer body 11 or, in general, of the annular body 1.

All radiation sources that can emit electromagnetic radiation can be considered as light sources 4. However, preferably 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 with a wavelength between 365nm and 375nm, in particular light with a wavelength between 365nm and 370nm, is emitted by the light source 4. The light can be generated in virtually any position inside or outside the body 1. The following positions are referred to as positions of the light source 4 in the sense of the present invention: from this position, the generated light is directly incident into the irradiation channel. Thus, if, for example, light is generated outside the ring body 1 by an external light source 4 and is guided into the interior of the ring body 1 via a light guide such that the light emerging from the light guide is incident into the irradiation channel 2, the position at which the light leaves the light guide so as to be directly incident into the irradiation 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 arranged in the ring body 1 in such a way that the light emitted by the light source is at least partially incident into the irradiation channel 2. The light emitted by the light source 4 in the sense of the present invention can have all arbitrary radiation characteristics. The beneficial results are: the radiation characteristic of the light source 4 has an opening angle for the emitted light which is not zero and is less than 180 °. An opening angle of between 60 ° and 120 °, i.e. for example 80 °, 90 ° or 100 °, is particularly advantageous. The opening angle determines the opening of the radiation cone with the light source 4 on the cone tip, within which at least 90% of the light source 4 is emitted. Particularly advantageous are: the fluctuation in the intensity of the light emitted by the light source 4 is not more than 20%, preferably not more than 10%, measured at the outlet 16. However, it is also possible to emit light rays at an opening angle of 0 °, i.e. with substantially parallel light beams.

The device according to the invention is designed essentially as a ring-shaped body 1, which is arranged essentially (substantially) concentrically about 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. The annular body 1 in the sense of the present invention is however any body with a closed outer envelope, wherein the outer envelope 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 with an end cap 9 at the distal end and/or a transparent window 10 at the proximal end for the light emitted by the light source 4. The housing 8 can also be used to receive functional elements such as the switch 3, the light source 4, the timer 5, the electronic control system 12 or the accumulator 13. The functional elements can also be connected to one another and firmly fixed in the housing or connected to the housing by means of wires (see fig. 1).

The housing 8 can serve as a receptacle limited by a stop for a spacer body 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 may also be firmly connected to the housing 8. Since the shape of the spacer 11 is not specified or defined in the drawings, the spacer 11 is shown as a spacer tube 11 for the sake of simplicity, so that the spacer tube is used synonymously with the concept of spacer in this disclosure. However, there is a convention that: the spacer 11 may also take other shapes that can fulfill this function. Since the inner wall 7 of the spacer tube 11 at least partially defines the irradiation channel 2, the spacer tube 11 at least partially forms a part of the annular body 1 and of the irradiation channel 2. The ring-shaped body 1 is defined at the proximal end of the device on the eye by an end face 14 and at the distal end of the device on the side facing away from the body, preferably by an end cap 9. In principle, the spacer tube 11 may be connected to the housing 8 by any means, such as via a fit, a threaded connection, an O-ring, an adhesive, etc. By means of this configuration, a uniform design or design of the housing 8 and its functional elements can be achieved for all desired radiation intensities on the cornea 20, which results in considerable cost advantages in terms of production 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 light incident into the illumination channel 2 from the light source 4 in a certain manner. This reflecting surface 71 can in principle be designed as a material having any inventive properties allowing for 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. The beneficial results are: the reflection surface 71 has the characteristics that can be realized according to fig. 3: not all of the reflected intensity from a ray incident on face 71 at incident angle E is reflected at an exit angle a corresponding to incident angle E. Fig. 3 shows an exemplary light beam impinging on a reflection surface 71 at an angle of incidence E, which light beam is reflected and absorbed on the reflection surface 71, wherein the reflection surface 71 has the properties explained below. At the same time, a portion X of the light rays emitted by the light source 4 and incident or impinging on the reflection surface 71 at the angle of incidence E is not re-reflected but is absorbed or transmitted. A further portion of the light rays incident at the angle of incidence E and impinging on the reflection surface 71 is reflected at the reflection surface 71 in such a way that a portion of the reflected light rays is reflected at an exit angle a corresponding to the angle of incidence E, while another portion of the reflected light rays 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 inventive wavelength which impinge on the reflection surface 71 at the angle of incidence E are therefore reflected at different angles of emergence.

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 emergence a corresponding to the angle of incidence E.

The light rays incident or impinging on the reflection surface 71 at the angle of incidence E can in this case originate directly from the light source 4 (without prior reflection at the reflection surface 71) or indirectly from the light source 4 after having been previously reflected at the reflection surface 71. The beneficial results are: the fraction X absorbed at the reflecting surface 71, resulting from the light intensity impinging on the surface 71 at the angle of incidence E, is not more than 80%, better not more than 50% and preferably not more than 30% (e.g. 20% or 10%), so that at least 20%, better at least 50% and ideally a residual fraction of 70% or more (e.g. more than 80% or more than 90%) is reflected. Not more than 90%, preferably not more than 80% and ideally not more than 60% of the reflected portion of the light intensity incident at the angle of incidence E or impinging on the reflecting surface 71 should be reflected at an exit angle a corresponding to the angle of incidence E. 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 impinging on the reflecting surface 71 should be reflected by the surface 71 at an exit angle a which does not correspond to the angle of incidence E. Preferably, the light rays emerging from the incident light source and reflected light rays impinging on the reflecting surface 71 at the angle of incidence E should be distributed over an angular range of at least 10 °, preferably at least 20 ° and ideally at least 30 °. This can be most simply achieved under the following conditions: for example, the inner wall 7 of the intermediate tube 11 is designed as a reflection surface 71 having the above-described properties according to fig. 3, for example, by the material of the intermediate tube 11 itself forming a reflection surface 71 having the above-described reflection and absorption properties at least in regions on the inner wall 7, or by the inner wall 7 of the intermediate tube 11 being coated with a corresponding material, for example, in such a way that the lateral boundary of the irradiation channel 2 is formed at least in regions by a reflection surface 71 having the above-described reflection and absorption properties, or by the inner wall 7 of the intermediate tube 11 being provided in regions with a film having a reflection surface 71 having the above-described reflection and absorption properties according to fig. 3, for example (fig. 5). According to an embodiment, the reflecting surface 71 and the inner wall 7 of the spacing tube 11 may be used synonymously.

In a further embodiment, the lateral boundary of the illumination channel 2, which occurs as a reflection surface 71, can be the surface of a reflection layer 70, which has at least in some regions a thickness z. Here, the reflection of the incident light ray E can be performed not only on the reflection surface 71 but also in a deeper region of the reflection layer 70 (see fig. 7). The intensity a reflected by the reflection layer 70 in total is formed here by the sum of the light quantities reflected locally in a certain penetration depth 73. The measured or effective or actual reflection behavior of the reflective layer 70 or of the reflective surface 71 can be correlated with the layer thickness z. In particular, the thicker the reflective layer 70, the smaller the ratio of the intensity of the light ray E impinging on the reflective surface 71 to the intensity of the light ray emitted by the reflective surface 71, which may be at least partially reflected by deeper regions of the reflective layer 70. In other words: the greater the thickness z of the reflective layer 70, the greater the fraction of the light intensity emitted by and/or through the reflective surface 71 into the illumination channel 2 relative to the light intensity incident on the reflective surface by the illumination channel 2. 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 2mm, better not 1 mm. In this case, advantageous properties are achieved with a layer thickness z of between 0.1 and 1mm, for example 0.5 mm. In a very particular embodiment, the annular body 1 or the spacer body 11 can be designed to be partially or completely composed of a material having the properties of this reflective layer 70.

Since the reflection properties of the reflective layer 70 actually and in terms of measurement appear to relate only to the reflection properties of the reflective surface 71, it is explicitly stated here that: all statements in the specific disclosure relate to the reflection, transmission and absorption properties of the reflection surface 71 and are not explicitly intended to refer to an embodiment with a final reflection layer 70 assigned to the thickness z, but also to an embodiment based on a final reflection layer 70 having the thickness z. The same applies in particular to fig. 3. There is also a need to specify: wherever 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 may 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 ray E can be reemitted on the opposite surface. At least the device should be designed to: no light radiation can exit from the irradiation channel 2 through the outer surface or outer boundary surface 40 of the ring body 1. In principle, the reflective layer 70 can be designed to consist of any material with corresponding properties.

The reflective layer 70 is preferably designed at least partially from a plastic. Since plastics are often subjected to ageing processes in the uv irradiation, the device must be designed: no significant aging processes of the material constituting the reflective layer 70 occur during irradiation. In particular, the reflection behavior, i.e. the ratio between the intensity of the light ray E incident on the reflection surface 71 and the intensity of the reflected light ray a, should remain as constant as possible during the illumination time and should not vary by more than 10%, preferably by more than 5%, over the time period T (illumination time).

The reflective layer 70 can be designed with a porous material having cavities with regular or irregular boundaries, so that light is at least partially diffusely reflected there. The cavities have an average size (for example the clear width between two opposite faces or the average diameter over the entire cavity volume, i.e. for example the average diameter is determined by equating the volume of the cavity with the volume of one sphere and thereby determining the corresponding sphere diameter and averaging this sphere diameter over the volume of the entire reflective layer 70), which is predominantly 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 may also be mounted as a deformable membrane on the inner wall 7 of the spacer 11. A cavity can be created between the reflective layer 70 and the spacer 11.

In a further embodiment, in particular the reflective properties of the reflective layer 70 should be as follows: during the entry into the reflective layer 70, the light is reflected at a plurality of scattering centers within the reflective layer 70 in such a way that no interference occurs in the illumination channel 2 with the reflection of the light emitted into the illumination channel 2 from different points or points on the reflective surface 71 or the reflective layer 70. The more heavily the radiation of the reflective layer 71 is diffused, i.e. the more reflected radiation does not exit at exit angles not corresponding to the angle of incidence, the more this is the case.

The reflective layer 70 is desirably inert with respect to various external influences. In particular, the reflective layer 70 should be chemically inert and resistant to acids, bases, organic compounds and, in particular, to riboflavin and UV-a light as far as possible.

In a particular embodiment, the intensity of the light at the outlet 16 for the light from the device or from the irradiation channel 2 can be correlated with the relative proportion of the reflection surface 71 provided on the inner wall 7 of the intermediate pipe 11 over the entire inner wall 7 of the intermediate pipe 11, said reflection surface having particular absorption and reflection properties. The intensity of the light at the exit 16 of the light from the device or from the irradiation channel 2 can also be dependent on the position of the relative proportion of the reflection surface 71 present on the inner wall 7 of the intermediate pipe 11 over the entire inner wall 7 of the intermediate pipe 11, said reflection surface having particular absorption and reflection properties. The device may be designed to: as the length k of the reflecting surface 71 increases, the intensity of the light emitted by the light source 4 at the outlet 16 also increases, wherein the length k can be at most the length l of the spacer tube 11 or the illumination channel 2. In a particular embodiment, the length k coincides with the length L or with the length L.

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

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

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

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

By the absorption and emission properties described above and shown in fig. 3 of the reflection surface 71 as the inner wall 7 of the irradiation channel 2 and the fact that the part of the cornea 20 to be treated protrudes into the irradiation channel 2 at the exit opening 16 for the light, a particularly uniform irradiation situation on the corneal surface can be achieved. The advantages of this device compared to the prior art are shown in fig. 5a and b. This treatment, known as Corneal Crosslinking, is used to strengthen diseased corneas such as keratoconus, where the strength of the cornea 20 decreases and thus increasingly severe vision loss occurs. Clinical studies have shown that: failure rate was 15% (excluding opaque numbers) using traditional treatment methods. That is, despite treatment, the disease often continues to worsen. In fact, it has been demonstrated that one reason can be: keratoconus is characterized by an irregular corneal geometry with a significant slope. However, since the energy transfer by UV to the target tissue (cornea) is related to the angle (by which the incident light intersects the corneal surface), the effect of this energy transfer and thus the treatment is reduced in the case of irregular corneal geometry (as in the case of keratoconus). As shown in fig. 5a, the energy transfer to the cornea 20 is greatest at the tip 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, since, as shown in fig. 5b, the absorption and reflection properties, in particular by the reflection surfaces 71 (which at least partially form the inner wall 7 of the annular body 1 or the lateral boundaries of the illumination channel 2), as in the case of a black body, illuminate the cornea 20 from all directions and thus enable a uniform transfer of energy to the cornea and thus a better therapeutic effect, independently of the respective cornea geometry.

Typically in such treatments (UV-A) the intensity of the light on the target tissue is 3mW/cm²And 45mW/cm²In the meantime. In this case, the light radiation is generated by the light source 4. The light source 4 is preferably designed as an electronic light emitter, 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 a current flowing through or running the light source 4. In a particular embodiment, the intensity of the radiation emitted at the outlet 16 of the illumination channel 2 (treatment intensity or illumination intensity), measured in mW/cm, can be adjusted as a function of the treatment requirements by the length L of the spacer 11 or the length L of the illumination channel 2, with the optical power of the light source 4 preferably being constant or unchanged, measured in mW/cm². In particular embodiments, therefore, for light to be transmitted from the device or vice versaThe intensity of the light exiting the outlet 16 in the irradiation channel 2 can be related to the length l of the spacing tube 11. In a particular embodiment, the intensity or radiation density is less than 30mW/cm²The length L of the spacer tube 11 or the length L of the irradiation channel 2 should be at least 5mm in the case of an intensity or radiation density of less than 20mW/cm²In the case of (2) the length of the spacer tube 11 or of the irradiation channel should be at least 10mm, at an intensity or radiation density of less than 10mW/cm²The length l of the spacer tube 11 or of the irradiation channel 2 should in this case be at least 15 mm. In a further embodiment, less than 6mW/cm at intensity or radiation density²In the case of (2) the length of the spacer tube 11 or of the irradiation channel 2 may be at least 2.0cm and less than 4mW/cm at an intensity or radiation density²The length of the spacer tube 11 or of the irradiation channel 2 in the case of (2) can be at least 3.0 cm. In other words, this means: when the treatment intensity is less than 10mW/cm²In the case of spacers 11 or irradiation channels 2 having a length of at least 15mm and a therapeutic intensity of at least 10mW/cm²And less than 20mW/cm²In the case of spacers 11 or irradiation channels 2 having a length of at least 10mm and at a therapeutic intensity of 20mW/cm²And in the above cases the length of either the irradiation channels 2 of the spacer 11 is at least 5mm, or in a particular embodiment at an intensity of less than 4mW/cm²In the case of spacers 11 or irradiation channels 2 having a length of at least 3.0cm and an intensity of at least 4mW/cm²And less than 6mW/cm²In the case of spacers 11 or irradiation channels 2 having a length of at least 2.0cm and an intensity of at least 6mW/cm²And less than 10mW/cm²In the case of (2) the length of the spacer 11 or of the irradiation channel 2 is at least 1.5 cm. Here, in a preferred embodiment, the therapeutic intensity is less than 10mW/cm²In the case of (1) the length ratio of the spacer 11 or of the treatment channel 2 is 20mW/cm at the treatment intensity²In the case of (a) at least 5mm, and in one further embodiment, at a therapeutic intensity of less than 10mW/cm²In the case of (1) the length ratio of the spacer 11 or the treatment channel 2 at the treatment intensity is 30mW/cm²In the case of (2) is at least 10mm greater. In thatThe measurement unit is mW/cm²Is a characteristic of the medical device in which the characteristic can be adjusted by the length of the irradiation channel 2 or the length of the spacer body 11.

In this disclosure, the units mW or mW/cm are on the outlet 16 of the illumination channel 2²The intensity of the radiation measured is referred to as the medical intensity.

Typically the irradiation time in such treatments is between 3 and 30 minutes. In a specific embodiment, the length L of the spacer body 11 or the length L of the irradiation channel 2 can be adjusted with a preferably constant or constant optical power of the light source 4, such that the irradiation duration of the target tissue can be set according to the respective treatment requirement. In a specific embodiment, provision is made for: the device has a preferably electronic timer 5 which can be set (preset, programmed) in such a way that it switches off the light source 4 after a predetermined period of time (effective exposure time) T, measured since the light source 4 was switched on, wherein the length L of the illumination channel 2 is thus correlated with the period of time T (effective exposure time) preset on the timer 5 and the shorter the exposure time T in the device is set, the shorter the length L of the separating body 11 or of the illumination channel 2 is designed. This can for example provide that: the length of the irradiation channel 2 or of the spacer 11 is at least 0.5cm in the case of an effective irradiation time preset in the apparatus of 180 seconds(s) and above, the length of the irradiation channel 2 or of the spacer 11 is at least 1.0cm in the case of an irradiation time T of 300 seconds and above, and the length of the irradiation channel 2 or of the spacer 11 is at least 1.5cm in the case of an irradiation time T of 500 seconds and above. In a further embodiment, the length of the irradiation channel 2 or of the spacer 11 should be at least 2.0cm in the case of an effective irradiation time T of 900 seconds and above, and the length of the irradiation channel 2 or of the spacer 11 should be at least 3.0cm in the case of an irradiation time T of 1200 seconds and above.

In other words, this means: the length of the irradiation channel 2 or of the spacer 11 is designed such that: the length of the irradiation channels 2 or of the spacers 11 is at least 5mm in the case of an effective irradiation time T of at most 300 seconds, the length L of the irradiation channels 2 or of the spacers 11 is at least 10mm in the case of an effective irradiation time T of 300 seconds or more to 500 seconds and the length of the irradiation channels 2 or of the spacers 11 is at least 15mm in the case of an effective irradiation time T of 500 seconds or more, or in a further embodiment, the length of the irradiation channel 2 or the spacer 11 in the case where the irradiation time is 500 seconds or more and 900 seconds or less is at least 2.0cm, and the length of the irradiation channel 2 or the spacer 11 in the case where the irradiation time is 900 seconds or more and 1200 seconds or less is at least 2.0cm, and the length of the irradiation channel or the spacer is at least 3.0cm in the case where the irradiation time T is 1200 seconds and more. This applies in particular to: in the case of an effective irradiation time of 300 seconds or less, which is preset (programmed) in the device, the length of the irradiation channels or of the spacers is at least 5mm shorter than in the case of an effective irradiation time of 500 seconds and more, or in a further embodiment the length of the irradiation channels 2 or of the spacers 11 in the case of an effective irradiation time of 300 seconds or less is at least 10mm shorter than in the case of an effective irradiation time of 900 seconds and more. In this case, the effective exposure time on the device is to be regarded as preset (programmed) and as a property or characteristic of the device.

The concepts of exposure time and effective exposure time are used synonymously. However, the irradiation time should actually be distinguished from the treatment time, since interruptions in the irradiation of the cornea 20 may be required to prevent, for example, the cornea from drying out during the treatment. However, if the (effective) irradiation time set on the device or on a timer installed in the device or preset or entered by the program is mentioned, this would mean, of course: the device or a timer in the device does not take into account possible interruptions of the irradiation during the treatment when determining the period of time of the effective irradiation time. That is to say that during the 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 is the light source 4 switched off continuously for the respective treatment. The timer 5 should therefore preferably have the possibility of ideally repeatedly interrupting the short term U, preferably via the operating switch 3, and this interruption should at the same time lead to the illumination being switched off within this interruption time U. The preferred repetitive interruption duration U of the irradiation should be counted into the treatment time. The timer 5 should therefore automatically switch off the irradiation, i.e. the light source 4, after a treatment time or an effective irradiation time as observed by:

effective irradiation time in seconds [ dose (mJ/cm) ]²) Intensity (mW/cm)²)]

The dose prescribed for the respective treatment is divided by the radiation intensity applied to the target tissue to yield the effective irradiation time.

For m interrupts each having an interrupt duration Ui,

this means in particular that: in a corresponding embodiment, the irradiation of the target tissue can be interrupted (each time of duration Ui) up to m times 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 irradiation time plus the duration of each interruption.

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

In a specific embodiment, the intensity of the light at the exit of the light from the device or from the irradiation channel can be adjusted, at least to a certain extent, by the relative proportion of the reflection surfaces 71 on the inner or lateral boundary surfaces of the irradiation channel 2 or of the intermediate tube 11 to the entire lateral boundary surface 7 of the irradiation channel 2 or of the intermediate tube 11, in the case of a predefined ratio of the irradiation time to the length L of the intermediate tube 11 or of the irradiation channel L, preset on a timer. The device is designed here such that: the greater the proportion of the reflective surface 71 in the total area of the lateral boundary 7 of the irradiation channel 2, the greater the intensity of the light emerging at the outlet 16 of the irradiation channel 2. In addition to electronic adjustment via the current in the light source 4, the light intensity on the target tissue during treatment can also be adjusted by geometrical adjustment on the device. Thus, in a specific embodiment, the intensity of the light measured at the outlet 16 of the device can be adjusted by varying the distance a or b given the length k of the reflective layer 71. Here, the closer the proximal boundary 17 of the reflective layer 71 is to the exit opening 16, i.e. the smaller the distance a or the larger the distance b, the greater the intensity on the target tissue (or exit opening 16). In a further embodiment, the light intensity at the exit opening 16 can be varied by varying the length k of the reflective layer 71 given a predetermined distance a or b. The following applies in principle: the greater k, the greater the intensity at the outlet 16.

In a further embodiment, the intensity of the light at the exit 16 of the light from the device or from the irradiation channel 2 can be adjusted at least within a certain limit (which is at least 2%, preferably at least 3% and ideally at least 5% of the intensity of the light at the exit of the light from the device or from the irradiation channel without the reflection surface 71) by the relative proportion of the reflection surface 71 on the boundary surface of the irradiation channel 2 or of the intermediate tube 11 over the entire lateral boundary surface 7 of the irradiation channel 2 or of the intermediate tube 11, given the preset ratio of the irradiation time to the length l of the intermediate tube 11 on the timer 5.

On the proximal end of the device a sleeve 15 may be provided, which may define the diameter of the outlet 16 of the irradiation channel 2 (see fig. 2). In the absence of a 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 fitting or a thread with or without limitation by a stop, constitutes the proximal end of the device or the annular body 1 after mounting on the device. The sleeve has an opening 16, which can in principle have any desired shape. The opening 16 may have a diameter which, in the case of a 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 opening 16 may be arranged concentrically or non-concentrically with the longitudinal axis 6. The diameter of the opening 16 may be between 1mm and 12mm, however preferably between 3mm and 11mm and ideally between 5 and 10mm, for example 7 or 8 or 9 mm. The thickness 17 of the sleeve should be as large as possible between 0.1 and 5mm, but may also be greater or smaller. The thickness 17 constitutes a part of the length L of the irradiation channel. The sleeve can also be designed as a sterile element so that the remaining elements in the medical application of the device are not in direct contact with the eye and can be designed to be non-sterile, which significantly reduces the manufacturing costs and the use costs on the eye.

The sleeve 15 can also be designed as a suction ring which allows the device to be fixed to 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 the spacer 11 can have one or more through-openings 50 (through-channels, channels) between the outer space (outside the interface 40) and the irradiation channel 2 through the inner wall 7 of the annular body or the spacer 11. It should therefore be possible to deliver a liquid or gaseous substance into the irradiation channel 2 or onto or into the target tissue during treatment or irradiation (see fig. 6 b). This enables oxygen, for example for improving the therapeutic effect, to be delivered to the target tissue through the through-hole. In a particular embodiment, a device can be mounted in the region of the through-opening on the outer side 40 of the annular body 1 or of the spacer 11, which device allows a hose or tube body to be fastened on the outer side of the annular body or spacer, so that a gaseous or liquid substance, such as oxygen, can be introduced continuously or in pulses into the irradiation channel via the through-opening 50 during the treatment. In principle, a plurality of such through-openings 50 can be provided. The through-holes 50 may have any shape and size. Ideally, the through-holes are designed as circular holes. The size (diameter) of the through-hole 50 is desirably less than 3mm, more desirably less than 2mm and in particular less than 1 mm. Preferably, the through-hole 50 is a circular hole or a cylindrical passage having a diameter of 0.1 to 3 mm. The axis of rotation of one such circular hole or the longitudinal axis of one such channel can be designed at 90 ° to the longitudinal axis 6 of the ring body 1, but other angles can also be used. A particularly good situation arises if the longitudinal axis of the channel (through-hole) is inclined with respect to the longitudinal axis of the ring body such that the penetration 50 through the inner wall of the ring body 1 or of the spacing body (11) is located at the proximal end with respect to the penetration through the outer wall of the ring body 1 or of the spacing body (11), i.e. if the longitudinal axis of the through-flow channel is inclined from the outside inwards in the direction of the proximal end of the ring body 1. The through-hole 50 or through-holes can in principle be arranged at any position of the ring body 1 or of the separating body 11. Preferably, the through hole is provided in the proximal third of the spacer tube. In a particular embodiment, the through-opening 50 can also be provided on or in the sleeve 15 or on or in the suction ring.

One embodiment of the invention provides for: the light source 4 is mechanically connected in a secure, in particular inseparable, manner to an electronic control system for controlling the light source 4, and said electronic control system is likewise installed in the interior of the device defined by the ring body 1 in the ready-to-operate state of the device. The advantages of this embodiment are: a compact construction of the device and at the same time a desired illumination process can be achieved.

In a further embodiment, the functional component light source 4, the energy source 13 or the energy supply for operating the radiation source and the electronic control system 12 are mechanically connected to one another in a secure, in particular inseparable manner, which likewise contributes to a compact design of the device, in particular if the energy source 13 is also arranged within the ring body 1.

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

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

Since the irradiation time of the cornea 20 by the apparatus may be 1 minute or 3 minutes and longer (e.g. up to 30 minutes), there is a risk of the cornea drying out during irradiation with the apparatus. The device is therefore provided with an electronic control system which allows the irradiation of the cornea to be temporarily interrupted for the wetting with liquid, without shortening the total duration of the effective treatment (irradiation) which is necessary, for example, if it is preset in the timer 5 of the device, and without thereby excessively complicating the treatment sequence. For this purpose, in a special embodiment, the switch 3 is preferably designed as an electromagnetic switch which is operated or triggered or switched by a magnetic field, for example by a small permanent magnet which is briefly guided to the end cap 9. After the initial actuation of the switch 3, the light source 4 is switched on and the irradiation process is started. At the same time, a timer 5 is started, wherein the illumination time T is preset in accordance with the slave length L of the illumination channel 2, and the light source is switched off by the timer 5 after the illumination time T has ended, and the illumination process is stopped. The device is designed as follows: after the switch 3 has been actuated again during the irradiation, both the irradiation by the light source 4 and the timer 5 for counting the preset irradiation time are interrupted for a preset duration U, preferably 3 to 20 seconds. The duration U of the illumination interruption 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 is interrupted for this duration T. After the end of the time period U after the non-initial actuation of the switch 3, the light source 4 is switched on again autonomously, i.e. without further assistance from the operator, and the timer 5 likewise continues the counting of the treatment time or the effective irradiation time T autonomously or automatically. Also considered are: the end of the time period U can be triggered or caused by further actuation of the switch 3, which is disadvantageous and complicated, however, since the treating physician has to control and carry out a plurality of procedures during the treatment anyway. The switch 3 for interrupting or for reclosing can also be designed as a switch other than the switch 3. Also considered are: a foot switch is designed to be connected to the housing to effect the switching process.

In a specific embodiment, the switch 3 for switching on the light source 4, for example a UV LED (ultraviolet light emitting diode), is designed as a mechanical switch 3. In a further special embodiment, this switch 3 is designed contactless, for example, in such a way that the housing 8 containing the functional components also accommodates a magnetic sensor with a switch or switching function, which is suitable for switching on the operating current of the light source or triggering the start of the irradiation if the magnetic field is sufficient and, in a further defined embodiment, also triggering the end (completion) of the irradiation.

The energy or radiation power delivered to the cornea 20 is that energy or that radiation power that impinges on the corneal surface. The illumination channel 2 is delimited at the proximal end by the end face 14, at the distal end by the light source 4 and laterally by the inner wall 7 of the ring body 1 or, in the case for example in which a reflective film 71 according to fig. 3 is provided on the inner wall of the spacer tube or of the ring body, by the inner wall 7 of the spacer tube 11.

For conventional irradiation with UV-A light in corneal cross-linking, 5.4J/cm should be used²Is transmitted to the cornea 20. In principle, all suitable electromagnetic radiations having the following characteristics are suitable: a corresponding wavelength having a total dose associated therewith, measured in joules or joules per area based on the target tissue; intensity, measured in watts or based on watts/area of target tissue; and the duration resulting therefrom.

In a further embodiment, the wavelength of the light source 4 is between 200nm and 250nm, for example about 220nm or thereabouts, for example about 222 nm. In particular, the maximum intensity of the light emitted from the light source 4 is between 200nm and 250nm, for example about 220nm or thereabouts, for example about 222 nm. This makes it possible to dispense with the additional use of riboflavin or to achieve an advantageous strength ratio under certain medical conditions.

In a further embodiment, the wavelength of the light source 4 is between 250nm and 300nm, such as between 270nm and 290nm or about 280nm or thereabouts, such as about 282 nm. In particular, the maximum intensity of the light emitted from the light source 4 is between 250nm and 300nm, preferably between 270nm and 290nm, for example about 280nm or thereabouts, for example about 282 nm. This makes it possible to dispense with the additional use of riboflavin or to achieve an advantageous strength ratio under certain medical conditions.

In a further embodiment, the wavelength of the light source 4 is between 300nm and 350nm, such as between 300nm and 330nm or about 310nm or thereabouts, such as about 308 nm. In particular, the maximum intensity of the light emitted from the light source 4 is between 300nm and 350nm, preferably between 300nm and 330nm, for example about 310nm or thereabouts, for example about 308 nm. This makes it possible to dispense with the additional use of riboflavin or to achieve an advantageous strength ratio under certain medical conditions.

In a particular embodiment, the intensity of the light emitted by the light source 4 is at least 1mW/cm at the outlet 16 of the illumination channel 2². Depending on the wavelength and length of the illumination channel 2, the intensity at the outlet 16 of the illumination channel 2 may be at 1mW/cm²And 10W/cm²In the meantime. Preferably, this intensity is 1mW/cm²And 100mW/cm²Or 200mW/cm²In the meantime. This can significantly shorten the treatment time under certain medical conditions.

In a particular embodiment, the timer 5 of the device is set (designed) to: the device will have one of just, less than or more than 5.4J/cm during irradiation of the cornea 20²Is delivered to the cornea 20. The energy transferred to the cornea is more than 5.4J/cm²E.g. 6J/cm²Or more (e.g. 7 or 8 or 10), in order to locally atrophy the tissue in order to reduce the steepness of the cornea or even at 5.4J/cm²In the case of normal energy transfer, e.g. in the case of thin cornea (in the case ofThinnest less than 400 μm) to achieve tissue treatment, it should be recommended that an additional part of the device or of any device for performing a cross-linking of the cornea 20, which is adapted to enter the cornea 20 with a corneal pocket, is provided to limit damaging effects of the radiation on the endothelium of the cornea 20.

One such part (optical barrier 21 or implant) shown in fig. 8a, b, c may be designed as a disc with a thickness p of less than 400 μm, for example 350 μm, 300 μm, 250 μm, and ideally a diameter q of more than 5mm (for example 5.5mm, 6mm, 6.5mm, 7mm, 7.5mm, 8mm), which disc may be designed to be straight, flat or curved. The optical barrier 21 may be transparent to the wavelength used, but is preferably at least partially opaque to the wavelength of illumination, i.e. 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%, still more preferably less than 20%, and ideally less than 10%. A completely impenetrable barrier 21 with a transmission of 0% is perfect. In a particular embodiment, the disc may have a radius of curvature between 3 and 10mm (e.g. 2mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm) at the front and/or back. In a particular embodiment, the portion is designed as a curved lens (lens shape), which is preferably however impermeable to the therapeutic light, or which should be opaque at least to the light of the light source 4. The optical barrier 21 is made of a biocompatible material that is suitable and allows for temporary implantation into the cornea 20. Such material may be a metal such as steel or titanium, a plastic such as PMMA or POM or special glass or any other material meeting the characteristics of the present invention. Particularly good results are produced with materials having a diameter q of from 5mm to 9mm or 10mm and a central thickness r of less than 200 μm, for example 180 μm or 160 μm or 140 μm or 120 μm or 100 μm. A disc with a dorsal radius of less than 8mm and a frontal radius of less than the dorsal radius-but at least 5 mm-is particularly matched to the geometry of the cornea. In this embodiment, the ring thickness p should preferably be less than the center thickness r.

In the simplest case, the optical barrier 21 is designed as a simple metal disc with a diameter of up to 12mm, more preferably up to 10mm (e.g. 8 or 9mm) and a ring thickness p of more than 10 μm or more than 50 μm (e.g. 60 μm or 70 μm or 80 μm or 90 μm or 100 μm) (see fig. 8 a).

In a further embodiment, the optical barrier 21 is designed as: the central thickness r is smaller than the thickness p of the part-regions of the implant located more peripherally (see fig. 8b, 8 c). This makes it possible to implement a bowl function (schalenfanction) which allows: after implantation in the cornea 20, a liquid or gel-like or viscous material (e.g. riboflavin) is preferably introduced into the cornea 20 via a suitable cannula in such a way that it can be filled into the recesses 30 of the implant and can form a reservoir there for a period of at least a few seconds to preferably a few minutes (within 30 minutes), and can enter or penetrate into the corneal tissue from this reservoir, for example by diffusion or other transport processes, and is suitable for increasing the concentration of this material in the corneal tissue. The side with the recess 30 (front face 22) is distal and the opposite side (rear face 23) is proximal. In other words, the portion 21 should be introduced into the cornea such that the front side 22 with the groove 30 is oriented towards the corneal surface (epithelium) and the back side 23 is oriented towards the interior of the eye (corneal back, endothelium). The corners and edges of portion 21 may be rounded so as not to create 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 fig. 8b, there is an annular edge structure with an inner diameter s of between 3mm and 8mm or to 11mm, a diameter q of between 4mm and 9mm or to 12mm, a ring thickness p of between 10 μm and 500 μm (e.g. between 100 and 400 μm, e.g. 150 μm, 200 μm, 250 μm, 300 μm, 350 μm), a disc thickness r of between 50 μm and 400 μm (e.g. 50 μm, 100 μm, 150 μm, 200 μm, 250 μm, 300 μm, 350 μm) and a back radius and a front radius of between 5mm and infinity (flat back or front).

The optical barrier 21, which is preferably designed as a disk, forms an optical barrier that is impenetrable 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 disk (cylinder) with a central thickness p (spacing between the bottom and top faces) of less than 500 μm and with a diameter q of at least 2mm and at most 10mm (for example at most 8 or 9 mm).

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

The optical barrier 21 (disc) may have a cavity inside. These cavities may be connected to the outer space via perforations (holes) in the disc surface. There may also be only one such cavity. When reference is made hereinafter to a cavity, it goes without saying that the provisos are: the corresponding statements also apply to embodiments having only one such cavity. The cavity can be adapted to receive a substance in any physical state, such as liquid, gaseous, gel, foam, or solid, or a mixture thereof. Such substances may be, for example, riboflavin, oxygen, etc. In a further embodiment, the implant is designed such that: which after introduction into the target tissue (e.g. cornea) is able to expel the substance into the surrounding area or onto the surrounding target tissue. In a particular embodiment, the optical barrier 21 or its cavity or recess 30 can be connected to a system (e.g., a hose and/or syringe) that can continuously expel such substances into the implant or into an intermediate space between the implant and the target tissue. From where it should be able to enter the target tissue. In a particular embodiment, the substance is already introduced into the cavity from the beginning (before implantation). However, they may also be combined with the implant material or stored in intermediate lattice locations of the implant material particles. The optical barrier 21 may also be designed as a ring. This is the case when the recess 30 is so deep in fig. 8b that at least at a single location between the front side 22 and the back side 23 there is an open connection in the form of a perforation, i.e. when, for example, the recess 30 (measured as p-r) is equal to p or r is 0. If the portion 21 is designed with a recess 30 or is designed as a ring and is made rotationally symmetrical about the longitudinal axis (axis of rotation, axis of symmetry) 24, respectively, a passage can be provided through the outer wall 25 which makes it possible to feed substances, such as oxygen or other gaseous or liquid substances, through the outer wall into the recess 30 or into the diameter of the ring during treatment. In the simplest case, this is an aperture or a hole 26 which extends from the side, i.e. from the outer wall 25, at least with a directional component towards the axis of symmetry 24. The portion 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 fig. 1 and 2 can be placed with its longitudinal axis 6 at different angles to an eye axis.

The following are explicitly specified: all elements of all embodiments of this disclosure can and do allow for combination, alone or in combination, with all remaining elements of all embodiments into a new embodiment of the invention.

List of reference numerals

1 annular body

2 irradiation channel

3 switch

4 light source

5 timer

6 longitudinal axis

7 inner wall of annular body or of spacer

8 casing

9 end cap

10 window

11 spacing body (spacing pipe)

12 electronic control system

13 accumulator (energy source)

14 end face

15 sleeve, which can also be designed as suction ring

16 outlet

17 proximal end of the reflecting surface

18 distal end of the reflecting surface

19 distal end of the spacer

20 cornea

21 optical barrier

22 front of the optical barrier 21

23 back of the optical barrier 21

24 longitudinal axis of portion 21

25 (lateral) outer wall of the portion 21

26 holes

27-

28-

29-

30 grooves/recesses

40 outer boundary surface of annular body

50 through hole

51 through-hole opening in the outer wall

52 through-hole opening on the inner wall

70 reflective layer

71 reflective surface

72 outer wall of the reflective layer

73 depth of penetration

D diameter of irradiation channel

Length of L irradiation channel

Angle of incidence E

Angle of emergence a

Length of k reflecting surface

Diameter of proximal recess on inner wall of D1

Diameter of proximal recess on outer wall of D2

Outer diameter of D3 spacer

a distance between reflector surface and proximal end of spacer

b spacing between reflector face and distal end of spacer body

d longitudinal dimension of the recess at the inner diameter

h longitudinal dimension of the recess at the outer diameter

p outer side disc thickness

q diameter of optical barrier

r inner side disc thickness

s inner diameter

Claims

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:

-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;

-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.