DEVICE FOR ILLUMINATION OF THE INTRAOCULAR SPACE

Description

Area the invention

[0001] The invention relates to a device for illuminating the eye according to the preamble of claim 1. Background of the invention

[0002] Endoluminators for illuminating the eye are known, but they have disadvantages. For example, US 2004 / 0004846 A1 discloses a device that has an LED as a light source in a housing. This light source feeds light into an optical fiber, which then illuminates the eye. The disadvantage of such a device is that the light is transmitted from the light source to the area to be illuminated only very inefficiently, so that only about 1% of the original light output reaches the intended location.

[0003] Although good illumination of the eye and the fundus is necessary, care must also be taken to avoid phototoxic damage. Good illumination is based on the color temperature, the radiation characteristics, and the brightness of the emitter in the eye. These factors determine the power that reaches a certain area of ​​the fundus. Bright, high-energy light has high power and can cause damage to the retina, photoreceptors, and optic nerve. While bluish light is preferred for surgery because the environment in the eye is reddish and blue light allows for better contrast perception, bluish light is more energetic and is therefore more likely to cause damage.In other words, very good illumination of a surgical area is desirable, but at the same time the illumination should be as gentle as possible on the eye with regard to the type of radiation used, which can be stressful for the tissue, but also with regard to the extent of the intervention on the eye. High radiation exposure occurs in particular when the light source is too close to the retina and / or when the illumination lasts too long. The DIN standard ISO / DIS15004-2 sets out the requirements for treatments on and in the eye. It is therefore important that not only the light source but also its distance from the retina is defined in every case, since the radiant output of the light source on a defined area of ​​the retina increases the closer it is to the retina.This corresponds to the square law of distance and states in other words that the power falling on an area A increases quadratically with decreasing distance. Inverse square law:

[0004] E ∼ 1 s 2 E irradiance W cm -2< s working distance mm

[0005] DE 10 2006 051 736 A1 discloses a medical handheld device for illumination, in particular for use in ophthalmology, comprising a housing serving as a handle, a probe extending from the housing and a light outlet at the end, as well as a light source integrated into the handheld device, wherein the light source is arranged in the housing and the light emitted by the light source reaches the light outlet via an optical fiber extending through the probe.

[0006] EP 2 060 226 B1 discloses an endoilluminator having a rod-shaped or tubular body which has a proximal and a distal end and can be inserted into a small-sized opening, wherein the endoilluminator comprises an LED chip and the body has a distal, hollow section which begins in front of the distal end and extends to the distal end, as well as a supply section which begins at the proximal end and extends to the distal hollow section, and the LED chip is arranged in the distal hollow section of the rod-shaped or tubular body and is supplied with energy via the supply section.A converter phosphor is arranged between the LED chip and the distal end of the body or at the distal end of the body. Its converter properties with respect to the light emitted by the LED chip are selected such that it converts the light emitted by the LED chip into light with a desired wavelength distribution. The distal hollow section of the body is closed at its distal end by a disc that is transparent at least in the visible spectral range.

[0007] From US 2008 / 0208176 A1 a device for injecting an ophthalmological device into an eye is known, which device has a hollow cylindrical body and a piston insertable therein, wherein the piston in one embodiment comprises a light source, for example designed as an LED, which is attached to a distal end surface of the piston.

[0008] Endoluminators are generally used in ophthalmic surgery, especially in pars plana vitrectomy, to illuminate the intraocular space. The disadvantages of state-of-the-art endoluminators are primarily their insufficient illumination or their high, difficult-to-control radiation exposure to the eye.

[0009] It was therefore an object of the invention to provide an illumination device for ophthalmic surgery, e.g. pars plana vitrectomy, which can illuminate the surgical area in a targeted and optimal manner and protects the sensitive areas of the eye, in particular the retina, as best as possible. A further object of the invention was to provide a device that is flexibly adjustable, in which, for example, the color, intensity, direction and beam angle of the light can be adjusted and which enables illumination with different wavelengths or a combination of wavelengths. A further object of the invention was to provide a device in which the radiation emitted by the light source lies within the limits set by law or regulations.A further object of the invention was to provide a device that is compact and can be used for analysis in the eye even under difficult external conditions.

[0010] These objects are achieved by the device according to claim 1. In particular, a device for the targeted illumination of an intraocular space of a human or animal eye is provided, which device is very flexible in its application and can be used in a simple manner. The device can be adapted to requirements. Furthermore, the device according to the invention offers the advantage that it can be adjusted not only to the respective intended use and for the respective requirements, but that the user also has the option of making adjustments during use. In particular, parameters such as radiation intensity and color of the illuminated area can be adapted for the respective application with the device according to the invention. Furthermore, various parameters of the radiation / light can also be changed as desired during use.The device comprises a base having a shaft at its proximal end and a probe at its distal end. The probe is provided with a light source, which in turn is connected to a power source. The light source has at least one LED, but can also have multiple LEDs, for example, to set a desired color value. It is essential for the present invention that the light source is positioned at the distal end of the probe.

[0011] Further advantageous embodiments can be found in the subclaims. Figures

[0012] Figure 1 shows a sketch of an embodiment of the device according to the invention for targeted illumination of the intraocular space of a human or animal eye. Figure 2 shows a sketch of a further embodiment of the device according to the invention for targeted illumination of the intraocular space of a human or animal eye. Figure 3 shows a sketch of another embodiment of the ophthalmoilluminator according to the invention. Figure 4 shows a sketch of the distal region of the ophthalmoilluminator according to the invention. Figure 5 shows a sketch of an LED suitable for use in the device according to the invention. Figure 6A represents the irradiance of an LED according to the invention at 10 mA as a function of the wavelength of the emitted light at 0 mm distance from the detection surface. Figure 6B shows the irradiance E AR with the evaluation function A(λ), maximum exposure time t max (E AR ), the irradiance E VIS-R using the evaluation function R(λ) and the irradiance without evaluation function (E 300-850 ). Figure 7 shows images of an illumination test with an ophthalmoilluminator according to the invention on a porcine eye. List of reference symbols

[0013] 1Device 2Base 3Shaft 4Probe 5Light source 6Energy source 21Spacer 22Distal end of the base 23Proximal end of the base 24Channel 30Holder 61Cable 62Current limiter 70LED pin 72Base LED pin 73Shaft LED pin 74Probe LED pin 75Light source LED pin 76Switch LED pin 80Trocar 81Trocar holding part 82Trocar cannula Definitions

[0014] The term "intraocular space" as used in this description refers to the entire interior of the eye, especially behind the sclera and including the fundus.

[0015] The term "base" as used herein refers to a holder adapted to receive a probe on one side and a shaft on the other.

[0016] The term "connectable," as used here, means that two parts can be connected or joined together. Any type of connection is suitable, including permanent as well as temporary fixation. Connectable means, in particular, that one part can be temporarily connected to another and, if necessary, can be replaced by another part.

[0017] The term "integral" means belonging to a whole or forming a whole, i.e. parts or devices that are described as integral form a unit.

[0018] The term "probe" refers to a device that is rod-shaped and has at least one channel inside.

[0019] According to the invention, a light source with at least one LED is used. The term "LED" encompasses any type of LED known in the art, e.g., LEDs and OLEDs. The term "LED" includes small-sized LEDs, e.g., micro-LEDs or nano-LEDs. The term LED includes LEDs of any wavelength, e.g., LEDs that emit light of any wavelength from UV to far infrared and beyond.

[0020] The term "light in the visible range" refers to radiation with a wavelength of about 0.38 to about 0.78 µm.

[0021] The term "near-infrared light" refers to infrared radiation with a wavelength of about 0.78 to about 2.5 µm and a wavenumber of about 12,500 to about 4,000 cm -1<.

[0022] The term "mid-infrared light" refers to infrared radiation with a wavelength of about 2.5 to about 25 µm and a wavenumber of about 4000 to about 400 cm -1<.

[0023] The term "light with a wavelength in the far infrared" refers to infrared radiation with a wavelength of about 25 to about 1000 µm and a wavenumber of about 400 to about 10 cm -1<.

[0024] The term "light with a wavelength in the UV" refers to UV radiation with a wavelength of about 0.2 to about 0.38 µm.

[0025] The terms "radiation" and "light" are used interchangeably here. When the term light is used, it encompasses radiation with a wavelength ranging from UV to far infrared. Accordingly, the term light source refers to a source that emits radiation with a wavelength in the UV to far infrared range.

[0026] The term "light source with at least one LED" refers to light sources that have at least one LED, but can also have several LEDs in combination. In particular, this term includes LEDs in all suitable embodiments as well as combinations of LEDs used to generate a desired color, in particular RGB LEDs. Furthermore, this term also includes light sources that have at least one LED that emits infrared radiation, visible light, or UV radiation, or a combination thereof, e.g., light sources that comprise a combination of LEDs that emit light in the visible range (approximately 0.38 to 0.78 µm) and those that emit light in the invisible, i.e., infrared or UV, range.

[0027] An "energy source," as understood here, is any device that can supply energy, in particular electricity, to the light source according to the invention in order to illuminate it. An energy source is, in particular, an element that can supply the amount of electricity required to operate the device and illuminate the light source in a controlled manner. Examples of energy sources include rechargeable batteries, batteries, capacitors, etc.

[0028] In one embodiment, the device according to the invention has the shape of a pen and is therefore referred to as an "LED pen" in this description.

[0029] In this description, the term "distal" refers to areas of the device that are remote from the user, e.g., the surgeon, while "proximal" refers to areas of the device that are closer to the user. Detailed description of the invention

[0030] The present invention provides a device (1) for the targeted illumination of an intraocular space of a human or animal eye, comprising a base (2) with a proximal end (23) and a distal end (22), a shaft (3) with a proximal end and a distal end, a probe (4) with a proximal end and a distal end, a light source (5) with at least one LED, and a power source (6) connected to the light source (5), wherein the shaft is connectable at its distal end to the proximal end of the base, the probe is connectable to the distal end of the base, and the light source (5) is positioned at the distal end of the probe (4) and forms the distal end of the probe and is not arranged within the probe (4) or the shaft (3), so that the light emitted by the light source (5) is irradiated directly into the eye without being guided via a light guide.The beam angle of the at least one LED is limited by a reflector or adjusted by encapsulating the LED with a transparent material. The device according to the invention is thus an ophthalmic illuminator, which is particularly suitable for illuminating the eye.

[0031] The device according to the invention, i.e. the ophthalmoilluminator according to the invention, is characterized by its very flexible use, its adaptability as needed, its ability to precisely and optimally illuminate the surgical area, and its simultaneous protection of the remaining eye, particularly the retina. The ophthalmoilluminator according to the invention is therefore highly suitable for ophthalmic surgery and for analysis, e.g., for staining and removing membranes in the eye, or for interventions on the fundus of the eye, e.g., on the retina, and for any type of pars plana vitrectomy. Furthermore, the ophthalmoilluminator according to the invention is also suitable for differential diagnosis, e.g., for distinguishing between oxygen-rich and oxygen-poor tissue or autofluorescent tissue.The device according to the invention is also characterized by its compactness and the fact that it does not require any external connections to a light source that could interfere with the surgeon. The device is sterile or sterilizable and can be used repeatedly or as a disposable product. This makes it applicable anywhere, even under difficult conditions. Furthermore, it has been demonstrated that the device according to the invention can comply with the limit values ​​prescribed in the aforementioned DIN standard and that a sufficient exposure time is possible.

[0032] The base of the device according to the invention is a part that serves to hold, accommodate, or support a probe at the distal end and a shaft at the proximal end. The base can have an opening or a channel, wherein the opening is preferably round or substantially round, and wherein the channel can be straight or curved, and the cross-section of the channel is preferably round or oval. The outer part of the base can have any shape, but is preferably round or oval. The outer wall can be straight, conical, or biconical, for example. The opening of the base or the channel serves to pass one or more power lines through. The base can have a receiving point for the shaft, be connected to the shaft, or be part of the shaft. The base can serve to pass a probe through or to receive a probe at one end. A shaft can be attached to the other, the proximal end.

[0033] The shaft of the device according to the invention can have any desired shape. It serves to hold and / or navigate the device. For example, the shaft can be larger and house all the electronics and power supply. The shaft can, for example, be an integral part of a pen, which has the necessary controls for radiation flux, hue, frequency, etc. on its outer shell.

[0034] The probe of the device according to the invention is rod-shaped, whereby the cross-section of the rod can have any desired shape. The probe serves to hold or support the light source and, if necessary, to accommodate a connection between the light source and the energy source, e.g., a power line. The probe can be rigid or flexible; it can be designed to be controllable, for example, through the use of memory alloys.

[0035] A key feature of the ophthalmological luminator according to the invention is that it allows for targeted and optimal illumination of the intraocular space. This is achieved, firstly, by locating the light source at the distal end of the device and not within the probe or shaft, but rather forming the distal end of the probe, allowing light to be irradiated directly into the eye without being guided through a light guide. This minimizes losses and ensures high efficiency.

[0036] In addition, the light can be directed directly to where it's needed by moving the probe. This also avoids the need to conduct light from a light source via a cable, which requires relatively rigid cables that can be disruptive during a procedure.

[0037] Another important feature is that the light beam emitted by the light source can be adjusted or guided by the user. This allows the precise area the user, such as the surgeon, needs to see to be illuminated, while other areas of the retina are protected. The light beam or light cone can be navigated by moving the shaft. The size, shape, and direction of the light cone can be changed by selecting and / or adjusting the LED and / or the probe and by navigation.

[0038] The described properties of the device according to the invention allow the device to be used for a wide variety of purposes, as the light beam can be focused and dosed more precisely than with prior art devices. Furthermore, it has been found that the vitreous body is sufficiently transparent not only to visible light but also to IR and UV radiation, ensuring that sufficient radiation reaches the desired location during both invasive and non-invasive transscleral use.

[0039] One way to vary an LED is to adjust the beam angle. The beam angle of an LED can be calculated using the formula α = 2 ∗ arctan d l ∗ 2 be calculated, where α = beam angle d = diameter of the object / room to be illuminated l = distance of the light source to the illuminated surface arctan = inverse function of the tangent function

[0040] Accordingly, a suitable LED can be selected for the respective purpose. The beam angle can be changed according to the invention, e.g., limited by the reflector. The light beam can be scattered by a lens, or the light cone can be widened or collimated by a lens. The direction of the light beam / light cone can be changed by appropriately shaping the area of ​​the light source that emits the light cone. These adjustments are known to those skilled in the art. The beam angle (aperture angle) α of the light source can also be adjusted according to the invention by appropriately encapsulating the LED.

[0041] The LED is suitably selected so that the eye is not or hardly exposed to any thermal stress.

[0042] Another way to influence the incidence of light is to coat part of the LED's surface so that little or no light escapes in undesired areas, allowing the majority of the light to escape over a desired area. This allows the illumination to be directed even more precisely to the desired area, while excluding more sensitive areas from the light.

[0043] In a further embodiment, the light cone is influenced by attaching the light source to the probe at an angle ß. The angle ß refers to the angle formed between the longitudinal axis (A) of the probe and the underside of the light source. For example, the light source (5) can be mounted at an angle ß of 0° or 5° to 90°, preferably from 10° to 80°, preferably from 20° to 70°, preferably from 30° to 60°, preferably from 40° to 50°, for example at an angle of 45° or 0°. By way of example, Figure 4 an arrangement of the light source (5) on the probe (4) at an angle ß of 90° ( Figure 4a ) , 45° ( Figure 4b ) or 0° ( Figure 4c ) is shown.

[0044] The light cone emitted by the light source can be manually and precisely navigated via the device's shaft by rotating or tilting. Local alignment of the light cone by rotating is particularly effective when the light source is not directly positioned on the front of the probe, but rather mounted at an angle to it. Local alignment can also be achieved by tilting the device. For this purpose, in a preferred embodiment, the shaft is designed so that it can be easily operated by the surgeon. For example, the shaft can have longitudinal ribs to improve its grip.

[0045] The ease of use, i.e., rotation or tilting, is achieved by the fact that the device according to the invention can be "anchored" or held in tissue via the base. In other words, the base can be inserted into tissue, particularly tissue in the pars plana. In this embodiment, the base can, for example, be single- or double-conical in shape to facilitate "anchoring." Anchoring here means that the base is pushed into a tissue area and remains there in place. The probe of the device according to the invention can also be guided into a trocar already inserted into the tissue, with the trocar then providing anchoring.

[0046] Due to the light source positioned at an angle of ß, the surgical field can be optimally illuminated in a tissue-friendly manner in areas inaccessible with conventional devices, such as areas near the insertion site or at the periphery of the retina. A spacer on the base prevents the probe with the LED from coming too close to the sensitive retina.

[0047] This makes it possible to direct the light cone extremely precisely to the area to be illuminated. Sensitive areas, such as the macula, can also be specifically excluded from the illumination. At the same time, the targeted navigation and limited size of the light cone prevent further tissue from being unnecessarily exposed to light and heat radiation.

[0048] The LED can be encapsulated in any material suitable for this type of light source, especially transparent materials. Suitable materials include transparent glass, ceramic, or a polymer such as epoxy resin, acrylic resin, Plexiglas, polymethyl methacrylate, polyurethane, or silicone. The choice of material determines the optical quality, which is generally higher with harder materials like glass, and the tissue compatibility, which is higher with softer materials like silicone. A material can also be used that acts as a diffuser or modifies the light in the desired way through diffraction.

[0049] The light source can have a flat, concave, or convex surface with a round, rounded, or polygonal cross-section. The edges of the light source or the light source encapsulation are advantageously rounded or chamfered to prevent mechanical irritation and chipping during use of the ophthalmic illuminator on the eye.

[0050] Both the capsule material and the capsule shape can be specifically selected to influence the light guidance, beam direction and light quality of the light source.

[0051] The device according to the invention can further comprise a control device via which the color temperature and / or wavelength and / or brightness and / or intensity of the light can be adjusted. The control device can be designed in a conventional manner. It can, for example, be a wireless interface that can be controlled via a remote control. Any possible type of control is possible here, e.g., even control via voice or movement.

[0052] To adjust the color temperature of the light, you can either select a specific LED with the desired color temperature or combine two or more LEDs to create the desired color. One example is a light source known as an RGB LED, which consists of three LEDs connected in series, from which a wide variety of desired colors can be mixed. Changing the color temperature can be advantageous, for example, to better identify specific tissue structures under special light, to better identify and use surgical instruments under special light, to better identify dyes specifically used to color structures, or to be able to adjust the color temperature specifically to a user. For example, the wavelength can be adjusted before and / or during an operation to suit the dyes, color pigments or nanoscale fluorescent particles or liquids used.

[0053] Furthermore, the brightness of the light source can be adjusted using a targeted circuit with different currents.

[0054] The control device, which can be used to adjust the color temperature and / or brightness of the light, can be designed as a switch with various switching levels. In another embodiment, the switching is done electronically, e.g., via a voice control unit or a remote control. This can be external or integrated into the shaft.

[0055] The adjustment of the parameters exit angle of the light, beam angle of the light, color temperature and brightness enable the best possible illumination of the surgical area in the eye while at the same time providing the best possible protection of the affected and adjacent tissue, as well as the best possible macular protection.

[0056] The various components of the device according to the invention can be flexibly designed to create a device particularly well-suited for a particular purpose. Key components for this purpose are the probe, the base, the shaft, and the light source. All parts of the device can be made from materials commonly used for this application. The respective material should be biocompatible and sterilizable.

[0057] The base serves to hold and / or anchor the device in the tissue during intraocular use and to hold the probe on the distal side and the shaft on the proximal side. For this purpose, the base is designed as a part with an opening. The base can be made from common biocompatible and preferably also electrically insulating materials. For example, the base can be made from tissue-compatible elastomeric material, e.g. elastomeric silicone, elastomeric polymers, etc. A certain degree of elasticity allows the base to adapt to the environment. However, the material must not be too flexible, as the passage, i.e. the opening, must be accessible. With a suitable shape, a thermoset is also a suitable material for the base. In addition, the base can serve to hold the device at a desired location in the tissue, e.g. in the pars plana region, and at a suitable distance.

[0058] A probe can be positioned on the distal side of the base. The probe serves to carry the light source at its front and to allow the connection between the light source and the energy source within. Connectors, such as wires or a conductive polymer, are typically used to connect the light source to the energy source located proximal to the base. The probe should be as thin as possible to minimize tissue damage. The probe material should be electrically insulating.

[0059] Preferably, the thickness of the probe is in the range of 20 to 30 gauge, more preferably 23 to 27 or 28 gauge.

[0060] Another essential part of the device according to the invention is a shaft which is positioned on the proximal side of the base. The shaft can either be rigidly connected to the base or the base can be designed to accommodate and hold the shaft. The shaft serves to operate the device, i.e. to position, rotate and tilt it. In one embodiment, the shaft is therefore designed to have recessed grips, grip ribs, grip surfaces or the like so that it can be easily rotated and held by the user. The shaft can be made of any material as long as the material is biocompatible. Sterilizable and / or insulating material is preferably used for the shaft. Sterilization can be carried out, for example, with gas and / or gamma rays.

[0061] In one embodiment, the device according to the invention can, in addition to the shaft, also have a handle for easier insertion, which can be removably positioned on the shaft or on the base. After insertion of the device, the handle can be removed. It is also possible for a handle to be initially positioned on the base for inserting the device and then, after insertion, the handle to be replaced by the shaft. The handle is generally larger than the shaft and could be obstructive during a procedure, so it is advantageous to remove it after insertion.

[0062] The light source (5) is electrically connected to an energy source, wherein the light source is positioned distally on a probe, while the energy source is preferably arranged outside the intraocular space on the device, e.g. in the proximal region of the shaft. The connection between light source and energy source can be contactless or via electrical lines. In one embodiment, the light source is connected to an energy source (6) via a switch. The energy source (6) can comprise one or more batteries, one or more rechargeable batteries, one or more capacitors or combinations thereof. In a preferred embodiment, the energy source has at least one battery. Batteries such as those used for medical devices are suitable. Lithium-ion batteries or batteries orPower sources with comparable properties are used because they deliver a very continuous current, thus keeping the light source's luminous intensity fairly constant. A constant light intensity contributes to the advantageous properties of the ophthalmic illuminator according to the invention.

[0063] In order to further improve the stability of the emitted light and to keep the light intensity constant, a current limiter or LED driver can additionally be used in a further preferred embodiment.

[0064] Preferably, the energy source is located in a dedicated housing. The housing is preferably fixed near the proximal region of the shaft or integrated into the shaft to provide the most compact device possible. It is also possible to use at least one rechargeable battery or capacitor that can be charged contactlessly or by connecting it to a charger. Thus, the housing, which contains the energy source and is connected to the light source, can be glued near the device during a procedure, e.g., to the patient's forehead.

[0065] The use of batteries or rechargeable batteries as an energy source enables the versatile use of the ophthalmoilluminator according to the invention.

[0066] In one embodiment of the device according to the invention, the probe is attached to the base and is guided through the tissue, e.g., in the pars plana region, via a holder and / or the shaft. In this embodiment, an opening is first created in the tissue, e.g., through an incision, through which the probe with the base can then be pushed.

[0067] In another embodiment, the tissue is first punctured using a conventional puncture instrument, e.g., a trocar. The probe according to the invention is then pushed through the trocar into the intraocular space. For this embodiment, the probe with light source must have a smaller diameter than the trocar in order to be able to pass through. In this embodiment, the probe (4) is preferably designed with a reduced outer diameter, e.g., 18 to 30 gauge, preferably 23 to 27 or 28 gauge.

[0068] The above-described designs offer many advantages over prior art devices: they are easy to use, highly flexible, and adaptable to a wide variety of conditions. They can be introduced into the intraocular space using minimally invasive techniques, provide optimal illumination, and can also be adjusted to various parameters during the procedure.

[0069] In one embodiment of the ophthalmoilluminator according to the invention, all parts, i.e. base, shaft, probe, light source, energy source and housing, are already pre-assembled and compact in a housing, i.e. all components form a single unit, are integrated and can be referred to as an integral device. This embodiment is suitable for transscleral illumination. The device according to the invention can be designed like a pen with a light source at the tip. The housing can have essentially the same outer diameter over its entire length. This embodiment can be used in particular to illuminate the intraocular space transsclerally. For this purpose, the device can be guided in the conjunctival pocket and illuminate the intraocular space via the sclera. The pen is guided by hand, i.e. the user can direct the light exactly where it is needed. The light passes through the sclera.This pen is used for diagnostics, for illumination, and also as a dent repair tool. In this design, the retina is illuminated from the outside, making tears and holes clearly visible to the user. This design is therefore well suited for non-invasive examination. Another advantage of this device is that no external wires, connections, or mounts are required. The pen can be manufactured as a disposable product. It is removed from the packaging, is sterile, used, and then discarded. It is therefore well suited for use in the field, in difficult areas, in hospitals, etc.

[0070] In one embodiment of this pen-shaped device, multiple LEDs, such as RGB LEDs, can be used, as there is enough space for them. The color of the light can then be adjusted by the user as desired.

[0071] In another embodiment, a proximal region (11) of the shaft is configured as a handpiece (42) for navigating the light cone. The handpiece preferably has a larger outer diameter than the rest of the shaft. In a further embodiment, the surface of the handpiece and / or the shaft is modified to achieve a better grip for navigating the shaft and thus the light cone. Alternatively, a small handle in the form of a rod mounted perpendicular to the shaft or another protrusion can be attached to the handpiece to facilitate fine navigation.

[0072] Furthermore, in a further embodiment of the device according to the invention, a holder (42) is mounted in the proximal region of the shaft (11). This holder serves to improve handling, e.g., when inserting the ophthalmoilluminator according to the invention into an insertion made in the pars plana. The holder is attached to the shaft in such a way that it can be unlocked and removed as soon as it is no longer needed. The shaft or the handpiece from the alternative embodiment then remains, allowing fine navigation of the shaft or the light cone.

[0073] Fig. 1shows an embodiment of the device according to the invention for illuminating an intraocular space of a human or animal eye. Base 2 carries a probe 4 at its distal end 22. Also located on the base is a spacer 21, which ensures that the probe cannot be pushed too far into the intraocular space, thereby preventing excessive radiation exposure or injuries caused by the probe. An LED 5 serves as a light source at the distal end of the probe 4. The light source is connected to a power source 6 arranged outside the device via a line 61. The line leads from the LED 6 through the probe 4 and a channel 24 in the base 2 to the battery housing 6, which may contain one or more batteries (not shown) as a power source. The battery housing 6 also has a current limiter 62.On the proximal side 23 of the base 2 is a shaft 3, which is intended for navigating the light cone when the device is activated for illumination. A holder 30 is attached to the shaft 3, which serves to apply the device and can be removed once the device is anchored in the tissue.

[0074] A further embodiment of the device according to the invention is shown in Fig. 2 The Fig. 2The device shown for the targeted illumination of an intraocular space of a human or animal eye has a base 2 which, at its proximal end 23, carries a shaft 3 suitable for navigating the light cone. A holder 30 is attached to the shaft 3 and is used to apply the device. This holder can be removed once the device is anchored in the tissue. At its distal end 21, the base 2 carries a probe 4, at whose distal end an LED 5 is positioned such that it forms an angle ß of 45° with the axis of the device. Wires 61 lead from the LED 5 through a channel (not shown) in the probe 4 into the base 2 and out of the device via an angled channel provided in the base to a battery housing 6 which contains one or more batteries (not shown). The LED 5 is thereby connected to a power source, the battery housing 6.The battery housing 6 also has a current limiter 62. The probe 4 leads in the embodiment of the . Fig. 2through a trocar 80 anchored in the tissue. The trocar 80 consists of a holding part 81 and a cannula 82. The cannula 82 serves to pierce the tissue and to guide and hold the probe of the ophthalmological luminator according to the invention. During use, the probe 4 of the device according to the invention is guided through the channel formed in the trocar 80 and the cannula 82 into the intraocular space to provide intraocular illumination. When illumination is no longer required, the device can be withdrawn and other instruments can be inserted through the channel 82 of the trocar 80. As soon as illumination is required again, the probe can be inserted again.This design is very gentle and flexible, as an inserted trocar can be used for various purposes. The trocar serves as a stop to prevent the probe from being inserted too far into the ocular space, and only one tissue incision is required for the illumination and instruments. This advantageous design allows for the instrument channel to be first inserted into the incision in the eye during ophthalmoillumination of the pars plana. Then, in a second step, the ophthalmoilluminator can be gently inserted into the eye through the instrument channel and rotated freely without further friction on the sclera.

[0075] Fig. 3 shows a further embodiment of the device according to the invention, which contains all components essential to the invention in a pen-shaped housing - an LED pen 70. This very compact embodiment, which does not require any external sources of energy or light, can be used anywhere. Fig. 3shows the housing 70 with a probe 74, to whose distal end a light source 75 (LED) can be attached. A conical base 72 is located between the probe 74 and the shaft 73. A switch can be attached to the proximal end of the shaft 73, with which the light source can be turned on and off. Located in the housing is a power source (not shown), which is connected to the light source via a cable (also not shown). The LED of the pen can be guided into the conjunctival pocket and illuminates the retina from behind, allowing the user to clearly see tears and holes.

[0076] All designs were tested in the laboratory and met the required limits and allowed illumination of the intraocular space to the desired extent.

[0077] The device according to the invention is suitable for use in surgical and diagnostic procedures on the eye, in particular for minimally invasive, intraocular illumination of the intraocular space of the human or animal eye.

[0078] The device according to the invention is suitable for use in surgical and diagnostic procedures on the eye, both invasive and non-invasive procedures, e.g. it is suitable for non-invasive, transscleral illumination of the intraocular space of the human or animal eye.

[0079] For non-invasive applications, device versions featuring a light source with a rounded tip are particularly suitable. This can then also be used to apply targeted pressure to the retina during transscleral illumination, both to improve vision and to fix the retina, for example, during laser treatment.

[0080] Due to the numerous options for adjusting and navigating the LEDs, focusing and dosing the light, and combining wavelengths, the device according to the invention is versatile. The design of the device and the positioning of the light source allow light to be directed to a specific location, limiting both the light intensity and duration. This makes it possible, for example, to use UV light to detect fluorescent compounds in the ocular space without damaging the eye. The detection of fluorescent compounds can be advantageous, for example, for detecting autofluorescent tissues or fluorescent markers.

[0081] The device according to the invention can be advantageously used for diagnostics in the ocular space, e.g., in tumor diagnostics. Tumor tissue differs from "normal" tissue in terms of oxygen consumption and oxygen saturation. Oxygen-rich tissue can be differentiated from oxygen-poor tissue using IR radiation. Since the device according to the invention can be operated with infrared LEDs, it is possible to non-invasively and very gently examine the ocular space for oxygen-rich tissue using transcleral irradiation, thus contributing to the detection of tumor tissue and the formation of new tumor tissue.

[0082] The advantage of all devices according to the invention is that no connection to a stationary device is necessary, in particular no connection of optical fibers to a light source. The device can be designed as a pen, which is preferably a sterile, disposable product. The device can therefore be used anywhere, regardless of infrastructure, and is easy to handle.

[0083] The invention is also described and explained by the following examples, devices and uses and methods, as well as components thereof, without being limited thereto. Examples Example 1: Power supply from a battery reservoir

[0084] Power is supplied by a battery reservoir. This can be configured with several functions: ∘ Simple switch for starting the illuminator ∘ Circuit with various fixed currents, e.g.: ▪ I = 5 [mA] ▪ I = 10 [mA] ▪ I = 15 [mA] ▪ I = 20 [mA] ▪ Continuous or step-by-step control via microcontroller ∘ Remote control Example 2: Performance data of a suitable LED:

[0085] An LED suitable for use in the device according to the invention has the following technical data: Luminous color: White Color coordinates: x=0.31 y=0.31 Light output: Typical 98 mcd Color temperature: typ. 5500 K Tension: typ. 2.9 volts Electricity: max. 10 mA Beam angle: 135° Working temperature: -40°C to +85°C Soldering temperature: 5 seconds 260°C Mass: 0.65 x 0.35 x 0.2 mm Example 3: Design data of a suitable LED

[0086] Figure 5 shows an example of an LED suitable for use in the device according to the invention. The Figure 4The LED shown has a flat surface with a polygonal, here octagonal, cross-section and separated or rounded edges to prevent chipping of the edges during use on the eye. Example 4: Irradiance of the LED:

[0087] The irradiance of the entire LED was determined using an integrating sphere and averaged values ​​of a calibration lamp at a specified maximum current of I = 10 [mA].

[0088] Table 1 shows the irradiances determined in this way, which were measured at distances of 0-18 mm: Table 1: Photochemical hazard Thermal hazard Distance [s] Irradiation [ E 300-850 nm ] Light flux [ φ V ] Irradiation [ E AR ] Max. exposure time [ tmax ] Irradiation [ E VIS-R ] mm µW cm-2 mim µW cm -2< h µW cm -2< 0 1982.93 584.94 591.98 4.7 1972.24 1 385.07 107.76 127.51 21.8 383.10 2 163.14 47.80 49.50 57.9 162.25 3 76.30 22.31 23.26 120.8 75.89 4 44.79 13.02 13.78 204.6 44.55 5 26.51 7.68 8.22 338.5 26.36 6 16.89 4.88 5.23 533.0 16.80 7 12.21 3.51 3.83 727.5 12.14 8 9.37 2.70 2.93 949.4 9.33 9 7.46 2.11 2.43 1147.0 7.42 10 5.99 1.69 1.96 1425.0 5.95 11 4.80 1.35 1.57 1787.1 4.77 12 4.06 1.15 1.29 2156.1 4.04 13 3.44 0.97 1.13 2466.2 3.43 14 2.91 0.82 0.95 2959.0 2.90 15 2.56 0.72 0.86 3232.2 2.54 16 2.21 0.62 0.71 3903.4 2.20 17 1.92 0.54 0.61 4608.5 1.92 18 1.71 0.48 0.53 5232.7 1.71 Limit for endoilluminators 220.00 350 000.00

[0089] Figure 6Arepresents the irradiance measured at 10 mA currents as a function of the wavelength of the emitted light at 0 mm distance from the detection surface. In Figure 6B The irradiance curve is shown with increasing distance from the irradiation surface. In addition to the irradiance (300-850 nm) in the visible spectral range over a 1 mm area, the curve shows the weighted irradiance according to "Ophthalmic instruments - Basic requirements and test methods - Part 2: Protection against hazards due to light (ISO / DIS 15004-2:2014); German version prEN ISO 15004-2:2014." Example 5: Assessment according to ISO EN DIN15000-2.2104:

[0090] The LED was tested and evaluated for its photochemical hazard. The measured values ​​were determined using an integrating sphere and averaged values ​​from a calibration lamp. The measured values ​​were determined using a 1 mm aperture, and the remaining evaluations were calculated.

[0091] Table 1 shows the values ​​determined in this way as a function of the distance between emitter and detector. A distance of 0 mm represents the "worst-case" value. This would be the case if the light source were to touch the retina. Possible times of between 4.7 h and 5232.7 h arise here, which are realistic for successful clinical application. The determined values ​​show that with the LED selected here, no danger to the eye tissue is to be expected when used in the device according to the invention. Table 1 shows that the limit values ​​regarding photochemical hazards were met for all measured samples, even when there is no longer any distance to the retina, i.e. when in contact with the retina. However, when using the device for eye examinations, contact with the retina should be avoided.The determination of the maximum emission time t max by the determined irradiance E AR and the permissible total energy quantity per area of ​​10 J / cm 2< , according to DIN EN ISO 15004-2:2014 shows that the light source is suitable for use in the intraocular space.

[0092] The obtained values ​​show that exposure times of well over 30 minutes are possible for the devices according to the invention. This allows for their widespread use in ophthalmic surgery and diagnostics. Example 6: Testing micro-LED illumination on a porcine eye

[0093] Figure 7Figure 1 shows images of an illumination test using an ophthalmic illuminator according to the invention on a porcine eye. A and B show images taken with an eyepiece camera using a very low exposure time on a Zeiss surgical microscope. C and D were taken with a cell phone camera and reflect the brightness perception very well. In Figure D, the LED cone was not pointing toward the optic nerve, as can be seen from the bright spot on the side of the eye.

Claims

1. Device (1) for a targeted illumination of an intraocular space of a human or animal eye comprising a) a base (2) with a proximal end and a distal end, b) a shaft (3), with a proximal end and a distal end, c) a probe (4), with a proximal end and a distal end, d) a light source (5) with at least one LED, and e) an energy source (6) connected to the light source (5), wherein the shaft is connectable at its distal end to the proximal end of the base, the probe is connectable at its proximal end to the distal end of the base and wherein the light source (5) is positioned at the distal end of the probe (4) and forms the distal end of the probe and is not arranged within the probe (4) or the shaft (3) so that the light emitted by the light source (5) is emitted directly into the eye without being guided via a light guide, characterised in that the beam angle of the at least one LED is limited by a reflector or is adjusted by an encapsulation the LED, in particular with a transparent material.

2. Device (1) according to claim 1, characterised in that the light source (5) features an underside which is arranged in such a way that an angle β of 0° to 90" is formed between the underside of the light source and a longitudinal axis (A) of the shaft.

3. Device (1) according to any one of claims 1 or 2, characterised in that the base and probe are integral.

4. Device (1) according to any one of the preceding claims, characterised in that the device (1) has an interface, which can be connected to a control instrument with which the wavelength, colour temperature, intensity and / or brightness of the light can be adjusted.

5. Device (1) according to any one of the preceding claims, characterised in that the light source comprises at least one LED that emits light with a wavelength in the near, mid or far infrared range, light in the visible range or UV light.

6. Device (1) according to any one of the preceding claims, characterised in that the probe (4) has an outer diameter of at most 20 to 30 gauge.

7. Device (1) according to any one of the preceding claims, characterised in that a proximal region (11) of the shaft is designed as a handpiece (30) for navigating the light cone.

8. Device (1) according to any one of the preceding claims, characterised in that a holder (30) is attached in the proximal region of the shaft (11), wherein the holder (30) can be de-locked and removed.

9. Device (1) according to any one of the preceding claims, characterised in that the energy source (6) comprises one or more batteries, one or more accumulators, one or more capacitors or combinations thereof.

10. Device (1) according to any one of the preceding claims, characterised in that the energy source is integrated into the shaft in the proximal area of the shaft or that the energy source is integrated into a casing.

11. Device (1) according to any one of the preceding claims, characterised in that the device (1) has a current limiter.

12. Device (1) according to any one of the preceding claims, characterised in that the device (1) has an instrument channel which is not connected to the shaft and in which at least the distal region of the shaft is rotatably guided, with the instrument channel on the shaft extending from distal to proximal and having an opening at the distal end for the output of the light.

13. Device (1) according to any one of the preceding claims, characterised in that the device (1) comprises all components integrally and / or is designed as a disposable article.

14. Device (1) according to any one of the preceding claims, characterised in that some or all components a), b), c), d) and e) of the device (1) can be present separately and the device (1) is sectional.

15. Device (1) according to any one of the preceding claims, characterised in that the distal end of the shaft is designed in such a way that it does not damage tissue when brushing over it.