Light instrument for illuminating the intraocular space

Abstract

Device (2) for an ophthalmic illumination system (1) comprising a light instrument (3) for illuminating the intraocular space of a human or animal eye (33), wherein the device (2) comprises a housing (4) with a proximal housing end (5), a distal housing end (6), and an opening (7) in the proximal housing end (5), wherein the housing (4) defines a receiving space (8) which extends from the opening (7) in the proximal housing end (5) along a longitudinal direction (L) towards the distal housing end (6), and wherein the receiving space (8) for receiving the light instrument (3) is formed through the opening (7) in the proximal housing end (5), wherein the housing (4) comprises at least one translucent material at least in the region (10) of the distal housing end (6), wherein the device (2) is designed for indentation of the ocular tissue (34), in particular the sclera (9), wherein the distal housing end (6) with respect to a central longitudinal axis (A) of the housing (4) defines an opening angle (α) for emerging light of the light instrument (3) of approximately 110° according to EN-ISO 15752:2010, and wherein the distal housing end (6) is substantially dome-shaped or has the form of a sphere that is substantially flattened at least on one side, and / or wherein the housing (4) defines a canonical solid angle (β) in the region of the distal housing end (6) which is 2·π steradians, wherein this solid angle (β) forms a lateral surface of a right circular cone with a half, planar opening angle (α) of 90 degrees, such that within this solid angle (β) the radiance of the light (38) emerging from the region of the distal housing end (6) of the light instrument (3) is at least 60% of the radiance of the light (38) of the light instrument (3) within this solid angle (β).

Description

TECHNICAL AREA

[0001] The present invention relates to a device for an ophthalmic illumination system comprising a light instrument for illuminating the intraocular space of a human or animal eye according to claim 1. The present invention further relates to an ophthalmic illumination system comprising such a device according to claim 13 and to a method for manufacturing a device for an ophthalmic illumination system comprising a light instrument for illuminating the intraocular space of a human or animal eye according to claim 15. STATE OF THE ART

[0002] Due to the physiological structure of the eye, the peripheral areas of the retina are not visible through the operating microscope. Even with the use of additional wide-angle optics, the field of view of the optics used in the operating microscope is too small. To be able to operate in the peripheral areas nonetheless, the corresponding area must be within the operator's field of view, and the operator must simultaneously be able to access this precise area with instruments. Several state-of-the-art techniques exist for this surgical situation. One such technique is the so-called 4-port technique, in which illumination is provided by a light instrument fixed in the eye, and indentation is achieved using a scleral depressor. Disadvantages of this technique include the use of an expensive light instrument and the additional injury to the patient's eye due to the fourth access point.The scleral depressor is typically designed in the form of a pen or thimble, see, for example, US 2008 / 0081952 A1. This patent also discloses that a light source, such as an LED, can be integrated into the scleral depressor to improve illumination in the operating room. Another option is to enlist the assistance of a resident. This can involve illumination via an endodontic light instrument and, alternatively, the resident performing indentation or protrusion using an unilluminated instrument. However, the resident must possess the necessary skills for this. Furthermore, even a highly coordinated team of surgeon and resident cannot achieve the same speed and precision as when the surgeon performs all surgical steps independently. Additionally, the presence of a resident increases the cost of the procedure. PRESENTATION OF THE INVENTION

[0003] It is an object of the present invention to overcome the disadvantages of the prior art. In particular, a device for an ophthalmic illumination system is to be provided which ensures safe and simple handling and at the same time good illumination.

[0004] This problem is solved by a device according to claim 1. A device for an ophthalmic illumination system comprising a light instrument for illuminating the intraocular space of a human or animal eye is specified, wherein the device comprises a housing with a proximal housing end, a distal housing end, and an opening in the proximal housing end. The housing defines a receiving space which extends longitudinally from the opening in the proximal housing end towards the distal housing end. The receiving space is configured to receive the light instrument through the opening in the proximal housing end. The housing comprises at least one translucent material, at least in the region of the distal housing end.

[0005] A translucent material is a material that is partially transparent to light. Or, put another way, the translucent material allows some light to pass through. Put yet another way, the translucent material is not transparent, but partially transparent. By incorporating at least one translucent material into the housing, particularly in the distal end, a very uniform light distribution of the light emitted by the light instrument is achieved. This is due to the intrinsic properties of translucent material, which causes strong scattering and reflection of incident light. Light reflections that would otherwise disturb the user are thus avoided. Because the light instrument is housed within the device, the user does not need to operate multiple instruments. The device therefore allows for safe and easy handling while simultaneously ensuring good illumination.

[0006] Preferably, the device consists of at least one translucent material in the region of the distal housing end. Furthermore, it is preferred that the entire housing comprises at least one translucent material, and particularly preferably consists of at least one translucent material.

[0007] The translucent material is preferably a translucent plastic, in particular a translucent engineering plastic, more preferably a translucent semi-crystalline plastic, and most preferably a polyoxymethylene copolymer. Additionally or alternatively, it is also conceivable to provide the translucent material in the form of a plastic and / or a silicone containing particles, preferably metal oxides such as titanium dioxide (TiO2). The particles are preferably configured to scatter the light emitted from the light instrument. These particles can therefore also be referred to as scattering particles. If the translucent material is provided by a plastic containing scattering particles, the plastic can also be a transparent plastic, wherein the translucency or partial transparency of at least the distal end of the housing is provided by the scattering of light by the scattering particles.Possible transparent plastics include thermoplastics, engineering plastics, or semi-crystalline plastics as known to those skilled in the art. It is conceivable that the device, at least in the region of the distal end of the housing, but also in other areas or entirely, consists of only a single translucent material or of a mixture of two or more translucent materials.

[0008] Additionally or alternatively, it is preferred that the translucent material has an absorption coefficient of approximately 10⁻³ in the visible wavelength range. It is conceivable that the absorption coefficient lies between approximately 1 × 10⁻³ and 9 × 10⁻³ in the visible wavelength range. Additionally or alternatively, it is also conceivable that the distal housing end has a transmission of at least 60%, preferably at least 70%, and particularly preferably at least 80% in the visible wavelength range. It should be understood that the term "transmission" refers to the total transmission, the main component of which originates from the translucent material, although additional minor components such as the geometric design of the distal housing end also play a role. This aspect will be explained in more detail later.

[0009] Preferably, the device is designed for indenting the ocular tissue, particularly the sclera. Indentation, also called indentation or protrusion, is the spatial displacement of the ocular tissue using an auxiliary instrument. This displacement brings tissue of interest into the user's field of vision, i.e., the surgeon's. This allows the surgeon to perform the desired procedures in the displaced area. Preferably, the device is therefore both a lighting instrument and a so-called scleral depressor, which is designed for indenting the sclera. Or, in other words, the device is preferably an illuminated scleral depressor. This has the advantage that light can reach the posterior segment of the eye without a trocar and thus without an access point or port in the eye.Further advantages include low costs, as a scleral depressor can be used without an additional illumination instrument, and as the user does not require a physician assistant. If the translucent material is provided by a semi-crystalline polymer such as polyoxymethylene copolymer, the device also exhibits good sliding properties due to a low coefficient of friction.

[0010] The housing preferably comprises at least a first region and a second region adjoining it, wherein the distal end of the housing is arranged in the first region, wherein the outer diameter of the first region is larger than the outer diameter of the second region, and wherein the ratio between the outer diameter of the first region and the outer diameter of the second region is particularly greater than 1. Additionally or alternatively, it is preferred that the ratio between the outer diameter of the first region and the outer diameter of the second region is between 1.1 and 2.0, preferably between 1.3 and 1.7, and particularly preferably about 1.5. A possible outer diameter of the first region is preferably between 2 mm and 8 mm, particularly about 6 mm. A possible outer diameter of the second region is preferably between 0.5 millimeters and 6 millimeters, especially between about 1 millimeter and 4 millimeters.

[0011] This means that the first, or distal, section of the housing has a larger outer diameter than the subsequent second section, or the second section is thinner than the first. This ensures sufficient space between the outer surfaces of the eye, such as the tissue and the eye sockets, including the skull bones, muscles, eye wall, fatty tissue, etc., and any additional instruments, such as a lid speculum. This allows the device freedom of movement and enables it to move easily across the eye surface during indentation.

[0012] Preferably, the distal end of the housing is substantially dome-shaped or has the form of a sphere that is substantially flattened on at least one side. Additionally or alternatively, it is preferred that the distal end of the housing defines an opening angle for the emitted light of the light instrument of greater than 100°, preferably approximately 110°, in the longitudinal direction according to EN-ISO 15752:2010.Additionally or alternatively, it is preferred that the housing defines a canonical solid angle in the region of the distal housing end, which is 2π (Pi) steradians, wherein this solid angle forms the lateral surface of a right circular cone with a half-planar opening angle of 90°, such that within this solid angle the radiant intensity of the light emerging from the region of the distal housing end of the light instrument is at least 30%, preferably at least 60%, most preferably at least 90% of the radiant intensity of the light from the light instrument within this solid angle. This design results in a low power loss of the light over a large angular range. As already mentioned at the outset, the device is characterized by very low light loss, which is made possible on the one hand by the translucent material itself. On the other hand, the spherical or...The dome shape causes the light to be reflected to a different spatial location. This means that the combination of translucent material and a spherical or dome shape homogenizes the emerging light, with any loss of radiant intensity occurring primarily due to the (minimal) absorption of the translucent material. The flattened side of the sphere allows for an increase in the sphere's width, or in other words, its thickness. This has the advantage of creating shallower angles between the ocular tissue and the spherical surface at the distal end of the housing, resulting in lower rolling resistance and correspondingly less wrinkling. Furthermore, a larger area of ​​the ocular tissue can be indented, allowing the procedure to be performed more quickly and more distant areas of the ocular tissue to be reached.

[0013] A dome-shaped or spherical design offers the advantage that the distal end has rounded edges and no slits or other irregularities. This reduces or even prevents the risk of conjunctival injury and wrinkling. Furthermore, these designs result in essentially symmetrical light emission from the device. The user can therefore concentrate on the indentation or the actual surgical steps and does not need to worry about aligning the device. In addition, these designs result in lower operating resistance.

[0014] Preferably the housing comprises a third area, wherein the proximal housing end is arranged in the third area, and wherein the third area, viewed from the proximal housing end towards the distal housing end, is at least partially tapered inwards in the longitudinal direction.

[0015] This means that the housing preferably comprises a first or distal region with a spherical or at least one-sidedly flattened shape, a second or middle region adjoining this with a smaller outer diameter than the first or distal region, and a third or proximal region tapering conically to this second or middle region. Preferably, the second region is substantially cylindrical and longer in the longitudinal direction than the first and third regions. The second region can be considered an elongated shaft. The receiving space preferably extends completely through the third region and the second region and at least partially into the first region.

[0016] It is preferred that the clear width of the receiving space decreases substantially continuously from the proximal end of the housing towards the distal end. This increasing inner diameter of the housing, viewed from the distal end towards the proximal end, also increases its bending strength. Furthermore, the ratio between the outer diameter of the second or middle section and the inner diameter of this second or middle section is preferably greater than 1, and in particular greater than 1.1.

[0017] Preferably, the housing has a wall thickness of approximately 0.5 mm to 3 mm, particularly approximately 1.5 mm, in the region of the distal housing end with respect to a transverse direction perpendicular to the longitudinal direction. Additionally or alternatively, the housing has a wall thickness of approximately 0.5 mm to 3 mm, particularly approximately 1 mm, in the region of the distal housing end along the longitudinal direction.

[0018] This means that the housing, at least in the distal end (i.e., the first or distal region), is designed with a thin material. This thin material reduces light loss through absorption and leads to an increase in the light output emitted by the device.

[0019] The housing preferably has a surface roughness of approximately 0.2 to 2.2 Ra according to EN ISO 1302, preferably approximately 0.4 to 2 Ra according to EN ISO 1302, and particularly preferably approximately 0.6 to 0.8 Ra according to EN ISO 1302, on at least one outer surface in the region of the distal housing end. Preferably, the second and / or third regions of the housing each have the same surface roughness as the first region or the region of the distal housing end, respectively. Alternatively, it is also conceivable to provide these regions with different surface roughness.

[0020] Preferably, the device is detachably connectable to the light instrument, with the housing being designed in particular to form a positive-locking and / or force-locking connection with the light instrument. The device can be a disposable item that is removed from the light instrument and disposed of after use. In the event of a new procedure, a new device can be connected to the light instrument. This allows for multiple uses of the light instrument.

[0021] Furthermore, it is conceivable to select the dimensions of the third, or proximal, section of the housing such that they essentially correspond to the dimensions of the light instrument at the point of connection with the device. Essentially the same dimensions in this context means that the third section of the housing has an inner diameter that is slightly larger than the outer diameter of the light instrument at the point of connection with the device. Slightly larger, in turn, means that the section of the light instrument to be connected can be accommodated in the proximal, or third, section of the housing with virtually no play. This type of design allows for a secure and simple connection, with the device, for example, being attached to the light instrument.

[0022] Preferably, the device is completely enclosed except for the opening in the proximal end of the housing. In other words, the housing completely surrounds the light instrument it contains, thus protecting the light instrument from contamination. This also allows for simple and safe reuse of the light instrument. That is, the device can be temporarily removed from the light instrument during a procedure on the same patient and reattached to the light instrument at a later time. The device can therefore be used several times during the same procedure.

[0023] The housing preferably has at least one reinforcing rib on an inner surface facing the receiving area in the region of the proximal housing end. Particularly preferably, several reinforcing ribs are present, each extending parallel to the longitudinal direction. The reinforcing ribs increase the bending stiffness of the device. Furthermore, it is advantageous if a gap is formed between the reinforcing ribs, into which appropriately shaped projections on the light instrument can be received. In this case, the reinforcing ribs provide a positive locking mechanism to prevent unintentional rotation of the device relative to the light instrument. This prevents the device from unintentionally detaching from the light instrument.

[0024] In another aspect, an ophthalmic illumination system comprising a device as described above and a light instrument is specified, wherein the light instrument preferably includes a light guide for directing light, for example, a light beam. The light guide is preferably a fiber.

[0025] It should be understood that all statements made above regarding the device apply analogously to the device in the ophthalmic illumination system.

[0026] The optical fiber is mounted in the receiving space of the device such that the ratio between i) the distance between a distal end of the optical fiber and the center of the distal housing end, in particular the center of the substantially dome-shaped distal housing end or the distal housing end in the form of a substantially flattened sphere at least on one side, and ii) the outer diameter of the first region of the housing, in particular the outer diameter in the region of the center of the substantially dome-shaped distal housing end or the distal housing end in the form of a substantially flattened sphere at least on one side, is less than 1.5. Additionally or alternatively, the distal end of the optical fiber is preferably arranged in the center of the substantially dome-shaped distal housing end or the distal housing end in the form of a substantially flattened sphere at least on one side.The center is understood here to be the point within the recording space where the distal end of the housing has its maximum extent or largest outer diameter with respect to a transverse direction perpendicular to the longitudinal direction.

[0027] This design, or arrangement, in combination with the homogeneously scattering material, results in the widening of light reflections and a reduction in luminance. This avoids reflections that could disturb the user during operation. Because there is a gap between the distal end of the light guide and the distal end of the housing, the distal or first part of the device is not completely surrounded by the eye tissue. Consequently, light is not absorbed by the tissue, or only partially so.

[0028] In another aspect, a method for manufacturing a device for an ophthalmic illumination system comprising a light instrument, in particular a device as described above, for illuminating the intraocular space of a human or animal eye, is specified, wherein the method comprises the step of: Injection molding of a housing with a proximal housing end, a distal housing end, and an opening in the proximal housing end using an injection mold, wherein a receiving space is formed in the housing which extends from the opening in the proximal housing end along a longitudinal direction towards the distal housing end, and wherein at least one translucent material is used at least for the area of ​​the distal housing end. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Preferred embodiments of the invention are described below with reference to the drawings, which serve only for illustration and are not to be interpreted restrictively. The drawings show: Fig. Figure 1 shows a partial sectional view of an ophthalmic illumination system comprising a light instrument and a device according to a first embodiment during a surgical application; Fig. Figure 2 shows a perspective view of the ophthalmic illumination system according to Fig. 1, wherein the device is separate from the light instrument; Fig. Figure 3 shows a perspective view of the ophthalmic illumination system according to Fig. 1, wherein the device is connected to the light instrument; Fig. Figure 4 shows a partial sectional view through the device according to Fig. 1; Fig. Figure 5a shows a central longitudinal section through the device and part of the light instrument according to Fig. 1 with the light instrument in a first position; Fig. Figure 5b shows a central longitudinal section through the device and part of the light instrument according to Fig. 1 with the light instrument in a second position; Fig. Figure 6 shows another central longitudinal section through the device according to Fig. 1; Fig. Figure 7 shows another central longitudinal section through a part of the device according to Fig. 1; Fig. Figure 8 shows a further central longitudinal section through a part of a device according to a second embodiment; Fig. Figure 9 shows a perspective view of a device according to a third embodiment; Fig. Figure 10a shows a partial perspective view of the light instrument according to the first embodiment; Fig. Figure 10b shows a side view of the light instrument according to Fig. 10a; Fig. Figure 10c shows a partial sectional view of the light instrument according to Fig. 10a; Fig. Figure 10d shows another perspective view of the light instrument according to Fig. 10a; Fig. Figure 11a shows a partial perspective view of the light instrument according to a second embodiment; Fig. Figure 11b shows a side view of the light instrument according to Fig. 11a; Fig. Figure 11c shows a partial sectional view through the light instrument according to Fig. 11a; Fig. Figure 12 shows a schematic partial view of the device according to the first embodiment and its radiation characteristics illustrated by a solid angle and half of its planar opening angle; Fig. 13a shows measurements of the normalized radiant intensity in [%] of a light instrument according to the first embodiment in a first orientation with respect to the opening angles in polar coordinates; Fig. Figure 13b shows measurements of the normalized radiant intensity in [%] from the light instrument according to Fig. 13a in a concerning the in Fig. The second orientation shown in 13a is rotated by 90 degrees with respect to the opening angles in polar coordinates; Fig. Figure 14 shows measurements of the normalized radiant intensity in [%] of a light instrument according to the second embodiment with respect to the opening angles in polar coordinates; Fig. 15a shows measurements of the normalized radiant intensity in [%] of a device according to the first embodiment with a first wall thickness with different types of light instruments according to the first and second embodiments with respect to the opening angles in polar coordinates; Fig. Figure 15b shows the measurements of the normalized radiant intensity in [%] with respect to the opening angles of the device and the different types of light instruments according to Fig. 15a in Cartesian coordinates; Fig. 16a shows measurements of the normalized radiant intensity in [%] of a device according to the first embodiment with a second wall thickness with different types of light instruments according to the first and second embodiments with respect to the opening angles in polar coordinates; Fig. Figure 16b shows the measurements of the normalized radiant intensity in [%] with respect to the opening angles of the device and the different types of light instruments according to Fig. 16a in Cartesian coordinates. DESCRIPTION OF PREFERRED EXECUTION FORMS

[0030] In connection with the Fig. 1 to 16 discuss various aspects of an ophthalmic illumination system 1 comprising a light instrument 3 and a device 2 for illuminating the intraocular space of a human or animal eye 33.

[0031] As can be seen in particular from the Fig. As can be seen from Figure 1, the device 2 serves a dual function. On the one hand, the device 2 is designed for indenting the ocular tissue 34, in particular the sclera 9. That is, the device 2 is a so-called scleral depressor or indenter, by means of which the ocular tissue 34 can be spatially displaced. This displacement brings the tissue of interest into the user's field of vision, usually that of the surgeon, so that the desired procedure can be performed in this area. In other words, the device 2 allows peripheral areas of the eye, such as the retina and the vitreous, to be visualized in order to perform surgical procedures in these areas. On the other hand, the device 2 also serves as an illumination device. The device is connected to the light instrument 3 of the illumination system 1, with light from the light instrument 3 being emitted into the interior of the eye via the device 2.The device 2 can thus be described as an illuminated scleral indenter or an illuminated scleral depressor, which enables transscleral illumination of the peripheral areas of the eyeball. As will be explained in more detail later, the light exits at the distal end 17 of the light instrument 3 and transmits through a distal area 10 of the scleral depressor 2 through the indented ocular tissue 34 into the interior of the eye. As in . Fig. As indicated in Figure 1, the user can observe the operation through the eyepiece 19 of an operating microscope 20, with his field of view in Fig. 1 is represented by the beam path 21. Areas that are not in the user's field of vision are brought into the field of vision by spatial displacement using the scleral depressor 2 according to the invention. Since the spatial displacement and illumination are performed with the same device 2 and with only one hand, the user has one free hand with which to operate other instruments, such as a vitrectomy 22 for vitreous removal, which is inserted into the eye through a trocar 23.

[0032] How good in Fig. As can be seen in Figure 2, the ophthalmic illumination system 1, in addition to the scleral depressor 2 and the light instrument 3, comprises a light source (not shown) with a socket. In the illustrated embodiment, the light instrument 3 comprises a handle 24, a light guide 16, a cannula 25, and a connector 26. The light guide 16 is provided here in the form of a fiber and has a proximal end 18 for coupling light from the light source and a distal end 17 for emitting the coupled light. The light guide 16 is permanently connected to the connector 26 of the light instrument 3, and light is coupled into the light guide 16 via the light source. Furthermore, the cannula 25 is attached to the handle 24, and the light guide 16 is connected to the handle 24 and the cannula 25. The light guide 16 extends through the handle 24 and the cannula 25 to the distal end 27 of the cannula 25.The distal end 17 of the light guide 16 is thus located in the region of the distal end 27 of the cannula 25, whereby light can be coupled out from the light guide 16. In particular from the . Fig. Figures 3 to 6 show that the scleral depressor 2 comprises a housing 4 with a proximal housing end 5, a distal housing end 6, and an opening 7 in the proximal housing end 5. The housing 4 defines a receiving chamber 8, which extends from the opening 7 in the proximal housing end 5 along a longitudinal direction L towards the distal housing end 6. The light instrument 3, specifically the cannula 25 and the light guide 16 housed therein, are received into the receiving chamber 8 of the scleral depressor 2 through the opening 7 in the proximal housing end 5. In the received state, the distal end 27 of the cannula 25, and consequently the distal end 17 of the light guide 16, lies within the region of the distal housing end 6.Because the housing 4 comprises at least one translucent material in the region of the distal housing end 6, light is emitted from the distal end 17 of the light guide 16 via the distal end 27 of the cannula 25 and through the distal housing end 6.

[0033] The scleral depressor 2 can be detachably connected to the light instrument 3, in particular to a distal region 28 of the handle 24. For this purpose, the proximal region 12 of the housing 4 and the distal region 28 of the handle 24 are designed to be complementary to each other. In particular, the proximal region 12 of the housing 4 tapers inwards conically from the proximal housing end 5 towards the distal housing end 6 in the direction of the longitudinal direction L of the scleral depressor 2. The distal area 28 of the handle 24 is also designed to taper inwards towards the distal end 29 of the handle 24, with the dimensions of the tapered areas 12, 28 being chosen such that a positive fit is formed between the tapered areas 12, 28 when the distal area 28 of the handle 24 is received in the proximal area 12 of the scleral depressor 2.To connect the handle 24 to the scleral depressor 2, the scleral depressor 2 can be attached to the distal region 28 of the handle 24 along a connection direction V. To detach the scleral depressor 2 from the handle 24, the user pulls the scleral depressor 2 away from the distal region 28 of the handle 24 along a separation direction T that runs opposite to the connection direction V. Thanks to this type of connection, the scleral depressor 2 does not need to be held during a procedure.

[0034] In the Fig. 2 and Fig. Figure 4 clearly shows that the housing 4 of the scleral depressor 2 has several reinforcing ribs 15 on an inner surface 14 facing the receiving chamber 8 in the region 12 of the proximal housing end 5. The reinforcing ribs 15 extend from the inner surface 14 of the housing 4 facing the receiving chamber 8 parallel to the longitudinal direction L and at least partially into the receiving chamber 8. The reinforcing ribs 15 serve to increase the bending strength of the scleral depressor 2. As can be seen from Fig. As can be seen from Figure 4, a gap 30 is formed between each pair of adjacent reinforcing ribs 15. Corresponding projections 31, which are arranged on an outer side 32 in the distal region 28 of the handle 24, are received in these gaps 30, see Figure 4. Fig. 2. This provides a further positive locking mechanism and an anti-rotation device to prevent the scleral depressor 2 from rotating relative to the handle 24 and thus to the cannula 25 and the light guide 16 housed therein. As further explained below Fig. As can be seen from Figure 4, the housing 4 of the scleral depressor 2 comprises ribs 39 extending along the longitudinal direction L on its inner side 14 in the region of the proximal housing end 5. These ribs 39 essentially limit the inner diameter of the housing 4 to the outer diameter 40 of the handle 24 (see Figure 4). Fig. 2), so that a force-fit connection is formed between the housing 4 at the location of the ribs 39 and the handle 24 at the location of the housing 4 in the case of a dent 2 connected to the handle 24. In the Fig. In the exemplary embodiment of the device shown in Figure 9, in the form of the sclera depressor 2, a tactile marking 35 is located in the region 12 of the proximal housing end 5 on an outer surface 13. This marking is designed as a protrusion and allows the user to intuitively align the sclera depressor 2. This is particularly advantageous for a sclera depressor with a spherical shape that is flattened on one side. Fig. 8.

[0035] Preferably, the scleral depressor 2 is a disposable item that is discarded after a surgical procedure. In the present examples, the scleral depressor 2 is completely closed except for the opening 7 in the proximal end 5 of the housing. That is, apart from this opening 7, the scleral depressor 2 has no other openings. The cannula 25, which is held in the receiving chamber 8 of the housing 4, and the light guide 16 stored therein are protected from external influences by the housing 4 of the scleral depressor 2. This ensures simple and safe reuse of the light instrument 3 during the same operation. For example, the user can first use the light instrument 3 with the scleral depressor 2 according to the invention, wherein the light guide 16 and the cannula 25 are received in the receiving chamber 8 of the scleral depressor 2 and are completely enclosed by the housing 4 of the scleral depressor 2.The user can then withdraw the cannula 25 and the light guide 16 stored therein from the receiving chamber 8 of the scleral depressor 2 and insert them, for example, into a trocar 23, whereby the cannula 25 and the light guide 16 stored therein are used for endoillumination inside the eye.

[0036] For example, from the Fig. 5a, Fig. 5b and Fig. As can be seen from Figure 6, the housing 4 of the scleral depressor 2 has an elongated shape, with the regions of the proximal housing end 12 and the distal housing end 10 each having a larger outer diameter a1, a3, compared to the central region 11 formed between these end regions 10, 12. In other words, the housing 4 comprises a first region 10 and a second region 11 adjoining it, with the distal housing end 6 being located in the first region 10, and with an outer diameter a1 of the first region 10 being larger than an outer diameter a2 of the second region 11. Furthermore, the ratio between the outer diameter a1 of the first region 10 and the outer diameter a2 of the second region 11 is greater than 1, here approximately 1.5. Different embodiments for the distal region 10 of the housing 4 are conceivable. As shown in the Fig. As shown in Figures 5 to 7 and 8, the distal region 10 of the housing 4 can be essentially dome-shaped or have the form of a sphere that is essentially flattened on one side. The adjoining central region, or second region 11, can be essentially cylindrical and can be referred to as the shaft. As mentioned previously, the region 12 adjoining the central region, or second region 11, i.e., the third region 12 encompassing the proximal housing end 5, tapers conically inwards from the proximal housing end 5 towards the distal housing end 6. The outer diameter a3 of the third region 12 at the location of the proximal housing end 5 is larger than the outer diameter a3 of the third region 12 at a location adjacent to the second region 11.Furthermore, the outer diameter a3 of the third region 12 at the location of the proximal housing end 5 is larger than the outer diameter a1 of the first region 10 at the location of the distal housing end 6.

[0037] As from the Fig. 5a and Fig. As shown in Figure 5b, the light instrument 3, specifically its cannula 25 with the light guide 16 housed therein, is positioned in the receiving chamber 8 of the device 2 such that the distal end 17 of the light guide 16 lies at or near the center Z of the spherical or dome-shaped distal housing end 6. Center Z is understood here to be the point within the receiving chamber 8 where the distal housing end 6 has its maximum extent or largest outer diameter az with respect to a transverse direction Q perpendicular to the longitudinal direction L. Specifically, the ratio between i) a distance S between the distal end 27 of the cannula 25 and the center Z and ii) the outer diameter az of the distal region 10 of the housing 4 in the region of the center Z of the essentially dome-shaped distal housing end or the distal housing end in the form of the essentially at least one-sidedly flattened sphere is less than 1.5.In the one in . Fig. In the case shown in Figure 5a, the distal end 27 of the cannula 25, and consequently the distal end 17 of the light guide 16 located in the cannula 25, is located at the center Z. In the case shown in Fig. In the case shown in Figure 5b, the distal end 27 of the cannula 25, and consequently the distal end 17 of the light guide 16 housed in the cannula, is located a distance S from the center Z. In this specific example, this distance S is approximately 0.5 mm, although other distances are of course conceivable. These configurations or arrangements, in combination with the homogeneously scattering material of the indenter 2, result in the widening of light reflections and a reduction in luminance. This prevents light reflections that would disturb the user during use. The disturbing reflections originate in the area of ​​the scleral depressor 2 where the distal end 27 of the cannula 25 is located, i.e., in the first area or distal area 10. The light transmitted from the light instrument 3 is reflected at the inner interface of the housing 4 and reaches the user's eye.Since the distal end 27 of the cannula 25 in the scleral depressor 2 according to the invention is not located at the distal housing end 6, but in the center Z or near the center Z of the first region or the distal region 10, this part of the scleral depressor 2 is not constantly completely surrounded by the eye tissue and the light is consequently not absorbed by the tissue or only partially absorbed.

[0038] A loss of light intensity is further prevented by selecting the wall thicknesses dl1, dq1, of the scleral depressor 2 in the areas where light must transmit through the housing 4 of the scleral depressor 2. It is preferred to form the distal region 10 of the housing 4 with a small material thickness, thereby reducing light losses due to absorption by the material. For example, the housing 4 in region 10 of the distal housing end 6 can have a wall thickness dq1 of approximately 0.5 mm to 3 mm, particularly approximately 1.5 mm, with respect to a transverse direction Q perpendicular to the longitudinal direction L, and / or the housing 4 in region 10 of the distal housing end 6 can have a wall thickness dl1 of approximately 0.5 mm to 3 mm, particularly approximately 1 mm, along the longitudinal direction L.

[0039] How well in the Fig. 5 and Fig. As can be seen in Figure 6, the wall thickness dq2, dq3 remains constant in the second and third sections 11, 12 along the transverse direction Q, and is approximately the same in the second section 11 as in the third section 13. However, the clear width W of the receiving space 8 decreases essentially continuously from the proximal housing end 5 towards the distal housing end 6. One reason for this lies in the manufacturing process. The core must be demolded, which requires a constant angle. In injection molding, a consistent wall thickness is almost a mandatory prerequisite for such demanding components. Furthermore, the bending stiffness increases due to the ever-increasing inner diameter, i.e., the clear width W.

[0040] The scleral depressor 2 according to the invention, in particular an outer surface 13 in the region 10 of the distal housing end 6, is preferably provided with a roughness of approximately 0.2 to 2.2 Ra according to EN ISO 1302, more preferably of approximately 0.4 to 2 Ra according to EN ISO 1302, and more preferably of approximately 0.6 to 0.8 Ra according to EN ISO 1302. This roughness is significantly influenced by the manufacturing process during the production of the device by injection molding, as well as by milling and EDM processes. In addition to the favorable sliding properties of the translucent material, such a surface roughness enables very easy movement of the scleral depressor 2 on the eyeball without the ocular tissue adhering to the scleral depressor 2.

[0041] In connection with the Fig. Sections 10a to 10d and 11a to 11c discuss various aspects of the light instrument 3, in particular its cannula 25 and the light guide 16. The resulting emission characteristics are discussed in relation to the Fig. 12 to 16b explained. As by comparing the Fig. As shown in Figures 10a to 10c and 11a to 11d, the cannula 25 and the light guide 16 located therein differ by its distal ends 17 and 27. Specifically, the cannula 25 and the light guide 16 according to the Fig. 10a to 10d each have a conically ground light guide 16 and an obliquely ground cannula 25, which, in contrast to the flat ground light guide 16 and the flat ground cannula 25 according to the Fig. Figures 11a to 11c describe the following. Light instruments 3 comprising a cannula 25 and a light guide 16, each with planar ground distal ends 27, 17, are referred to as "90° light instruments," while light instruments 3 comprising a cannula 25 and a light guide 16 with obliquely ground or conically ground distal ends 27, 17 are referred to as "wide-angle light instruments." The oblique bevel of the cannula 25 in the case of the wide-angle light instrument results in the distal end 27 of the cannula 25 having a shortened and an extended cannula section with respect to a central longitudinal axis B running through the cannula 25. The extended section can also be referred to as a shielded section, which, in the case of conventional devices from the prior art, is directed towards the user to protect them from glare from the light.

[0042] The geometric design of the distal region 10 of the housing 4, together with the translucent material from which the distal region 10 of the housing 4 is formed, causes the distal region 10 of the housing 4 to emit light almost like a diffuse spherical radiator. This, in turn, results in uniform illumination of the indented eye tissue 34, regardless of the light instrument 3 used. This will now be demonstrated using measurement examples.

[0043] In particular, the measurement examples each show the radiation pattern of 90° light instruments 3 as well as of wide-angle light instruments 3 with and without the use of the sclera depressor 2 according to the invention. The radiation pattern is illustrated in each case by reference to the opening angle α of a canonical solid angle β. That is, and as can be seen from the schematic Fig. As can be seen from Figure 12, the device or scleral depressor 2 emits light 38 from the light instrument 3 housed therein through its distal housing end 6. The geometric design and the properties of the distal housing end 6 are such that the housing 4 defines a canonical solid angle β in the region of the distal housing end 6, which is 2π steradians, where this solid angle β forms a lateral surface of a right circular cone with a half-plane opening angle α of 90 degrees. The measurements shown in the figures show the radiance for various opening angles α with respect to the central longitudinal axis B through the light instrument 3 ( Fig. 13a to 14) respectively with respect to the central longitudinal axis A by the device or the scleral depressor 2 ( Fig. 15a to 16b).

[0044] As from Fig. As can be seen from Figure 14, a 90° light instrument has a symmetrical radiance with respect to its central longitudinal axis B. The same applies to the wide-angle light instrument if the light intensity measurement is taken on the shortened section 36 of the cannula, see Figure 14. Fig. 13b. In the case of a light power measurement on the extended or shielded area of ​​the cannula 37, the light power behaves asymmetrically due to the area of ​​the cannula forming the shield, see Fig. 13a. As can now be seen from a comparison of the Fig. 13a to 14 with the Fig. As shown in Figures 15a to 16b, the scleral depressor 2 according to the invention is able to compensate for the asymmetry of the light output for a light instrument 3 comprising a cannula 25 and a light guide 16 with an obliquely ground or conically ground distal end 27, 17. The scleral depressor according to the invention thus effectively widens the light beam.

[0045] That is to say, and as can be seen from the Fig. As can be seen from Figures 15a to 16b, the emission characteristic of the scleral depressor 2 according to the invention is such that the deviation in luminous intensity between the so-called 90° light instrument and the so-called wide-angle light instrument is approximately 20% or less for different types of light instruments. As can be seen from the legends in the Fig. As can be seen from Figures 15a to 16b, these different types of light instruments are the 20G, 23G, 25G, and 27G types known to those skilled in the art, where "G" stands for Gauge. The device 2, or the scleral depressor, which is used for measuring the Fig. The scleral depressor used in sections 15a to 16b differs in its wall thickness. That is to say, the scleral depressor according to the Fig. 15a and Fig. 15b comprises a housing 4 which, viewed along the longitudinal direction L in the region of the distal housing end, has a wall thickness dl1 of approximately 0.8 millimeters, while the wall thickness dl1 of the scleral depressor according to the Fig. 16a and Fig. 16b measures approximately 2.2 millimeters. In both cases, the scleral depressor has a dome-shaped distal end. As can also be seen from the Fig. As shown in Figures 15a to 16b, the sclera-depressor 2 according to the invention achieves a further radiation intensity over a large angular range. In particular, the sclera-depressor 2 according to the invention allows light to be emitted through its distal region 10 of the housing 4 with a radiation intensity of approximately 20% or more for the sclera-depressor according to the inventive figure. Fig. 15a and Fig. 15b (wall thickness dl1 of approximately 0.8 millimeters) or of approximately 80% or more for the scleral depressor 2 according to Fig. 16a and Fig.16b (wall thickness dl1 of approximately 2.2 millimeters) for an opening angle α of greater than 100°. Because the scleral depressor 2 has a very uniform emission characteristic, the further advantage is that the permissible treatment time can be significantly increased without causing phototoxic reactions in the tissue of the eye. REFERENCE MARK LIST 1 ophthalmic illumination system 2 Device 3 Light instrument 4 cases 5 proximal housing end 6 distal end of housing 7 Opening 8 Recording room 9 Sclera 10 first area 11 second area 12 third area 13 Outside 14 Inside 15 Reinforcing ribs 16 optical fibers 17 distal end 18 proximal end 19 eyepiece 20 operating microscopes 21 Beam path 22 Vitrectomy 23 trocar 24 handles 25 cannulas 26 plugs 27 distal end 28 distal area 29 distal end 30 space 31 protrusions 32 Outside 33 Eye 34 Eye tissue 35 Marking 36 shortened area 37 extended area 38 light 39th rib 40 outer diameter A central longitudinal axis of the device B central longitudinal axis of the light instrument S distance L Longitudinal direction T Separation direction V Connection direction Q transverse direction W clear width Z Center dl1 wall thickness dq1 wall thickness dq2 wall thickness dq3 wall thickness a1 Outer diameter a2 outer diameter a3 outer diameter az outer diameter α Opening angle β solid angle QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] US 2008 / 0081952 A1

[0002]

Claims

[1] Device (2) for an ophthalmic illumination system (1) comprising a light instrument (3) for illuminating the intraocular space of a human or animal eye (33), wherein the device (2) comprises a housing (4) with a proximal housing end (5), a distal housing end (6), and an opening (7) in the proximal housing end (5), wherein the housing (4) defines a receiving space (8) which extends from the opening (7) in the proximal housing end (5) along a longitudinal direction (L) towards the distal housing end (6), and wherein the receiving space (8) for receiving the light instrument (3) is formed through the opening (7) in the proximal housing end (5), wherein the housing (4) comprises at least one translucent material at least in the region (10) of the distal housing end (6), wherein the device (2) is designed for indentation of the ocular tissue (34), in particular the sclera (9), wherein the distal housing end (6) with respect to a central longitudinal axis (A) of the housing (4) defines an opening angle (α) for emerging light of the light instrument (3) of approximately 110° according to EN-ISO 15752:2010, and wherein the distal housing end (6) is substantially dome-shaped or has the form of a sphere that is substantially flattened at least on one side, and / or wherein the housing (4) defines a canonical solid angle (β) in the region of the distal housing end (6) which is 2·π steradians, wherein this solid angle (β) forms a lateral surface of a right circular cone with a half, planar opening angle (α) of 90 degrees, such that within this solid angle (β) the radiance of the light (38) emerging from the region of the distal housing end (6) of the light instrument (3) is at least 60% of the radiance of the light (38) of the light instrument (3) within this solid angle (β). [2] Device (2) according to claim 1, wherein the translucent material is a translucent plastic, in particular a translucent engineering plastic, preferably a translucent semi-crystalline plastic, most preferably a polyoxymethylene copolymer, and / or wherein the translucent material is a plastic and / or a silicone containing particles, wherein the particles are configured to scatter incident light emitted by the light instrument (3), and / or the translucent material has an absorption constant (k) of about 10^(-3) in the visible wavelength range. [3] Device (2) according to one of the preceding claims, wherein the housing (4) comprises at least a first region (10) and a second region (11) adjoining it, wherein the distal housing end (6) is arranged in the first region (10), wherein an outer diameter (a1) of the first region (10) is larger than an outer diameter (a2) of the second region (11), and wherein the ratio between the outer diameter (a1) of the first region (10) and the outer diameter (a2) of the second region (11) is in particular greater than 1, and / or wherein the ratio between the outer diameter (a1) of the first region (10) and the outer diameter (a2) of the second region (11) is in particular between 1.1 and 2.0, preferably between 1.3 and 1.7, and in particular preferably about 1.

5. [4] Device (2) according to one of the preceding claims, wherein the housing (4) comprises a third region (12), wherein the proximal housing end (5) is arranged in the third region (12), and wherein the third region (12) is formed at least partially tapering inwards in the longitudinal direction (L) from the proximal housing end (5) towards the distal housing end (6). [5] Device (2) according to one of the preceding claims, wherein the clear width (W) of the receiving space (8) preferably decreases substantially continuously from the proximal housing end (5) towards the distal housing end (6). [6] Device (2) according to one of the preceding claims, wherein the housing (4) has a wall thickness (dq1) of about 0.5 mm to 3 mm, in particular about 1.5 mm, in the region of the distal housing end (6) with respect to a transverse direction (Q) extending perpendicular to the longitudinal direction (L), and / or wherein the housing (4) has a wall thickness (dll) of about 0.5 mm to 3 mm, in particular about 1 mm, in the region of the distal housing end (6) as seen along the longitudinal direction (L). [7] Device (2) according to one of the preceding claims, wherein the housing (4) has on an outer side (13) at least in the region of the distal housing end (6) a roughness of about 0.2 to 2.2 Ra according to EN ISO 1302, preferably of about 0.4 to 2 Ra according to EN ISO 1302, particularly preferably of about 0.6 to 0.8 Ra according to EN ISO 1302. [8] Device (2) according to one of the preceding claims, wherein the device (2) is detachably connectable to the light instrument (3), and wherein the housing (4) is designed in particular to form a positive-locking and / or force-locking connection with the light instrument (3). [9] Device (2) according to one of the preceding claims, wherein the device (2) is completely closed except for the opening (7) in the proximal housing end (5). [10] Device (2) according to one of the preceding claims, wherein the housing (4) has at least one reinforcing rib (15) on an inner side (14) facing the receiving space (8) in the area of ​​the proximal housing end (5). [11] Ophthalmic illumination system (1) comprising a device (2) according to one of the preceding claims and a light instrument (3), wherein the light instrument (3) preferably comprises a light guide (16) for guiding light. [12] Ophthalmic illumination system (1) according to claim 11, wherein the light guide (16) is mounted in the receiving chamber (8) of the device (2) such that a ratio between i. a distance (S) between a distal end (17) of the optical fiber (16) and a center (Z) of the distal housing end (6), in particular the center (Z) of the substantially dome-shaped distal housing end (6) or the distal housing end (6) in the form of the substantially flattened sphere at least on one side, and ii. the outer diameter (a1) of the first region (10) of the housing (4), in particular the outer diameter (az) in the region of the center (Z) of the substantially dome-shaped distal housing end (6) or of the distal housing end (6) in the form of the substantially flattened sphere at least on one side is less than 1.5, and / or wherein the distal end (17) of the optical fiber (16) is arranged in the center (Z) of the substantially dome-shaped distal housing end (6) or of the distal housing end (6) in the form of the substantially flattened sphere at least on one side.

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