Method for producing a patient interface
Patent Information
- Application Number
- EP2024704341
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-02-02
- Filing Date
- 2024-02-02
- Publication Date
- 2025-12-10
AI Technical Summary
Existing methods for producing patient interfaces for short-pulse laser eye surgery are lengthy, expensive, and involve multiple complex steps, including conventional grinding and polishing of glass contact lenses, which are then glued into holders.
A method involving a holder with a receiving cavity for a liquid molding compound that forms a partially transparent contact glass, which is cured in place, eliminating the need for additional fastening and simplifying the production process by forming the contact glass directly at the point of use.
This approach results in a cost-effective, quick, and technically simple production process with a contact glass shape ideally adapted to the holder, reducing production time and costs while ensuring biocompatibility and mechanical stability.
Smart Images

Figure EP2024052664_08082024_PF_FP
Abstract
Description
[0001] Method for producing a patient interface
[0002] Description
[0003] The invention relates to a method for producing a patient interface for fixing an eye to be treated, a patient interface for fixing an eye to be treated and a short-pulse laser eye surgery device with such a patient interface.
[0004] State of the art
[0005] Methods for manufacturing a patient interface or patient interfaces for fixating a treated eye are known. Typically, the patient interface, which is attached to a laser device for treating the eye, contains a contact lens for contacting the eye to be treated. In the prior art, the contact lens is first manufactured from glass using conventional grinding and polishing and then glued into the patient interface or the patient interface holder. The disadvantage of this is that the process, or rather the manufacturing of the patient interface, involves many steps, is time-consuming, and expensive.
[0006] Disclosure of the invention
[0007] The invention is based on the object of providing a method for producing a patient interface, a patient interface for fixating an eye to be treated, or a short-pulse laser eye surgery device with such a patient interface, that is technically simple and cost-effective. This object is achieved by a method for producing a patient interface according to claim 1, a patient interface for fixating an eye to be treated according to claim 21, or a short-pulse laser eye surgery device with such a patient interface according to claim 35.
[0008] In particular, the object is achieved by a method for producing a patient interface for fixing an eye to be treated, wherein the patient interface comprises an at least partially transparent contact lens for contacting the eye to be treated, wherein the patient interface is designed such that the patient interface can be arranged on a short-pulse laser eye surgery device for generating a laser beam for treating the eye to be treated, wherein the method comprises the following steps: providing a holder for the patient interface, wherein a first part of the holder partially delimits a receiving cavity for receiving the material for forming the contact lens, wherein a first sealing element and a second sealing element are or will be arranged such that the first sealing element,The second sealing element and the first part of the patient interface holder together delimit the receiving cavity to the outside; introducing a liquid or viscous molding compound into the receiving cavity; curing the molding compound in the receiving cavity to form the contact lens; and removing the first sealing element and the second sealing element from the formed contact lens.
[0009] One advantage of this is that the process is technically simple and cost-effective. Furthermore, the process can be carried out quickly and in a few steps. Because the patient interface holder forms part of the seal of the filling cavity and the contact lens is formed directly at the point of use, no gluing or any other type of (additional) fastening of the contact lens to the holder or patient interface is required. Consequently, the patient interface can be manufactured very cost-effectively and quickly. Furthermore, the shape of the contact lens is technically easily adapted to the shape of the patient interface holder.In particular, the object is achieved by a patient interface for fixing an eye to be treated, wherein the patient interface is designed such that the patient interface can be arranged on a short-pulse laser eye surgery device for generating a laser beam for treating the eye to be treated, wherein the patient interface comprises an at least partially transparent contact lens for touching the eye, characterized in that the contact lens was formed by introducing a liquid or viscous molding compound into a receiving cavity of the patient interface and subsequently curing the molding compound.
[0010] The advantage of this is that the patient interface can be manufactured quickly and cost-effectively. In particular, no additional fastening (e.g., adhesive) or similar is required to attach the contact lens to the patient interface.
[0011] In addition, by forming the contact lens directly at the point of use, the shape of the contact lens is ideally adapted to the shape of the patient interface or the holder of the patient interface.
[0012] In particular, the object is achieved by a short-pulse laser eye surgery device for treating an eye with a patient interface arranged on the short-pulse laser eye surgery device, which has been described above.
[0013] The advantages of this correspond mutatis mutandis to the advantages of the patient interface described above.
[0014] According to one embodiment of the method, the first sealing element and / or the second sealing element have a coating, wherein the coating remains on the contact lens when the first sealing element and the second sealing element are removed from the formed contact lens. An advantage of this method is that the contact lens already has a coating after production. This allows for the technically simple, rapid, and cost-effective production of a patient interface in which the contact lens has a coating on one or both sides.
[0015] According to one embodiment of the method, the molding compound comprises a plastic, in particular the molding compound is plastic. This is advantageous in that the costs of the patient interface can be kept particularly low. Furthermore, a wide range of materials is available for the molding compound. The plastic can also be easily liquefied for introduction into the receiving cavity. The plastic can, for example, comprise or be a thermoplastic and / or a thermoset.
[0016] According to one embodiment of the process, the molding compound is a biocompatible material. This ensures that the patient interface produced by the process cannot trigger any negative biological reactions upon contact of the eye with the contact lens.
[0017] According to one embodiment of the method, the holder is designed in such a way, and the contact lens is designed in such a way, that a negative pressure can be created between the contact lens and the eye to be treated when the eye is in contact with the patient interface. One advantage of this is that, with the resulting patient interface, the eye can be fixed particularly securely using the patient interface in a technically simple manner.
[0018] According to one embodiment of the method, the first sealing element and / or the second sealing element are detachably fastened to the holder of the patient interface. The advantage of this is that the method is technically even simpler. In particular, the first sealing element or the second sealing element does not have to be arranged separately or additionally; rather, the first sealing element and / or the second sealing element is positioned automatically when the holder is provided. Furthermore, the first sealing element and / or the second sealing element can be released and removed in a technically simple manner after the molding compound has hardened. The detachable fastening can be released, for example, by pulling the first sealing element and / or the second sealing element more forcefully away from the hardened contact lens.
[0019] According to one embodiment of the method, the molding compound is introduced into the receiving cavity through a first recess in the first sealing element and / or a second recess in the second sealing element. One advantage of this is that the molding compound can be introduced into the receiving cavity in a technically simple manner. Since the first sealing element and the second sealing element are removed after the molding compound has cured, no recess (which may need to be sealed) remains in the finished patient interface. The method is therefore technically particularly simple.
[0020] It is conceivable that the first sealing element and / or the second sealing element has a further recess or opening for the escape of air from the receiving cavity when introducing or during the introduction of the molding compound into the receiving cavity. The further recess or opening can connect the receiving cavity to the environment in a gaseous manner or can create a gas-permeable connection between the receiving cavity and the environment. This further recess or opening can preferably be arranged at the highest point of the receiving cavity or one end of the recess or opening can extend up to this point. The highest point of the receiving cavity can in particular be the point that is furthest away from the center of the earth when introducing or during the introduction of the molding compound. In this way, it is ensured that all of the air can escape from the receiving cavity through the further recess or opening.can escape when the molding compound is introduced. Several further recesses or openings for air to escape from the receiving cavity into the environment during the introduction of the molding compound into the receiving cavity are also conceivable. According to one embodiment of the method, the first sealing element and the second sealing element delimit the receiving cavity to the outside on two opposite sides. This ensures that the sides into which the laser light enters and exits at the patient interface are the sides that are in contact with the first sealing element and the second sealing element during manufacture. This makes the method technically particularly simple. In addition, the entry side and the exit side for the laser beam can be designed as desired in a technically simple manner.
[0021] According to one embodiment of the method, the second sealing element is arranged such that the second sealing element is arranged on the side of the contact lens designed to contact the eye to be treated, with the second sealing element having a curved shape in sections. This is advantageous in that the shape of the underside of the contact lens can be adapted to the shape of a human eye in a technically simple manner.
[0022] According to one embodiment of the method, the receiving cavity is designed such that the contact lens formed after curing has no step on its lateral outer surface. This makes the manufactured patient interface particularly stable. Since there is no step on the outer surface of the contact lens, no stress peaks occur. The contact lens is thus particularly shatter-resistant and protected from damage. The lateral outer surface of the contact lens can, in particular, be a side through which no laser beam can enter or exit, or which is in immediate / direct contact with the holder of the patient interface.
[0023] According to one embodiment of the method, a coating is applied to the contact glass after curing. One advantage of this is that the contact glass can be coated in a technically simple manner, making it particularly scratch-resistant and / or anti-reflective.
[0024] According to one embodiment of the method, the first sealing element has at least one projection and / or at least one recess on a side facing the receiving cavity. The advantage of this is that the manufactured contact lens has structures, e.g. edges, on its side or surface facing away from the eye to be treated, i.e. it is not completely even or flat. By means of these structures or recesses (recesses) and / or projections, a laser or laser applicator can be fixed to the patient interface or precisely aligned to the contact lens in a technically simple manner. For example, the laser or laser applicator can be brought into direct or immediate contact with the projection or recess. Thus, the treatment of the eye can be carried out particularly easily and quickly using the manufactured patient interface.
[0025] According to one embodiment of the method, the holder has a light introduction device for introducing light through the holder to the eye to be treated. The advantage of this is that light can be radiated through the holder to the eye in a technically simple manner. Thus, for example, an optical fiber or a light guide can be connected to the light introduction device in order to radiate light through the contact lens produced in the method onto the eye to be treated. In this way, the eye can be aligned in a technically particularly simple and reliable manner with respect to or relative to the patient interface before being fixed by means of the patient interface. Light can thus be coupled into the patient interface in a technically simple manner. The light introduction device can in particular be a structure or a device for introducing light, as described in DE 10 353 264 B4 (in particular in the figures therein).3-10 and the associated description), to which reference is made here and the content of which is hereby explicitly incorporated herein. For example, the light introduction device for the light can comprise an imaging element, e.g. a convex, concave, cylindrical and / or toric imaging element. The light introduction device can have a scattering surface in order to illuminate the negative pressure cavity or the eye to be treated as homogeneously as possible. It is also conceivable for the light introduction device to have a dielectric layer for spectral filtering or reflection reduction. It is conceivable for the light introduction device itself to comprise light sources, e.g. one or more LEDs.A part of the holder, in particular the part that delimits the vacuum cavity, can be designed to be light-reflecting, so that the light introduced by means of the light introduction device is reflected by the holder or a part of the holder. As a result, the vacuum cavity or the eye to be treated is homogeneously illuminated. It is also conceivable to have several light introduction devices that shine light from different angles into the vacuum cavity or towards the eye to be treated or onto the eye to be treated. The light introduction devices or the openings through which the light from the light introduction device reaches the contact lens and finally into the vacuum cavity can be evenly distributed over the circumferential direction of the holder. It is particularly advantageous if the light from the light introduction device or light introduction devices illuminates the vacuum cavity orthe eye to be treated is illuminated as evenly or homogeneously as possible.
[0026] According to one embodiment of the method, the second sealing element comprises a projection element for forming a third recess that extends at least partially around the contact lens, in particular completely around the contact lens, which is formed between the holder and the contact lens and is fluidly connected to a suction channel for sucking the eye to be treated onto the patient interface. This is advantageous in that a third recess can be formed during the manufacture or formation of the contact lens, by means of which the eye to be treated can be fixed to the patient interface by means of negative pressure. Thus, a patient interface can be formed in a technically simple manner that enables the eye to be fixed quickly and easily.According to one embodiment of the method, the holder is designed in such a way and the third recess is designed in such a way that in a first state, in which a lower side of the contact lens is substantially completely covered by the eye to be treated and a first contact pressure presses the contact lens against the eye to be treated, the third recess is unlocked by the eye to be treated, and in a second state, in which the lower side of the contact lens is substantially completely covered by the eye to be treated and a second contact pressure, which is higher than the first contact pressure, presses the contact lens against the eye to be treated, the third recess is closed by the eye to be treated. In this way, after the (immediate or direct) contact has been established between the eye and the contact lens, the patient interface orThe contact lens must be moved relative to the eye, since the eye is not (yet) fixed to the patient interface (by means of negative pressure) (i.e., when the third recess of the eye is not yet closed). Thus, even after full-surface contact between the contact lens and the eye, the eye can be easily repositioned relative to the patient interface before the eye closes the third recess by further pressing the contact lens or the patient interface against the eye, and the eye is fixed by the negative pressure created in the third recess.
[0027] According to one embodiment of the method, during the step of introducing the liquid or viscous molding compound into the receiving cavity, the molding compound is introduced into the receiving cavity through an introduction channel of the holder and / or gas or gas mixture escapes from the receiving cavity through a vent channel of the holder. The advantage of this is that the receiving cavity can be completely filled with molding compound without the formation of defects or cavities or unfilled areas or bubbles. Furthermore, neither the first sealing element nor the second sealing element needs to have channels for introducing the molding compound and / or for allowing air to escape from the receiving cavity. The sealing elements can thus be designed to be particularly simple from a technical perspective. By using suitable pressure conditions, corners in the receiving cavity that are not directly exposed to the molding compound flow can be filled with molding compound.According to one embodiment of the method, during the step of introducing the liquid or viscous molding compound into the receiving cavity, the holder is oriented such that the introduction channel is located at a lower point than the venting channel. One advantage of this is that the formation of voids or bubbles, or areas not filled with molding compound, in the receiving cavity is avoided. Thus, the patient interface or contact lens is of particularly high quality. "Lower" can, in particular, mean that the introduction channel is located closer to the Earth's center than the venting channel.
[0028] According to one embodiment of the method, molding compound is cured in the introduction channel and / or the venting channel. One advantage of this is that the introduction channel and / or the venting channel, or the cured molding compound remaining in the respective channel, serves as a positive connection between the contact lens and the holder. The material in the introduction channel and / or venting channel is integrally formed with the contact lens or is part of the contact lens. The introduction channel and / or the venting channel can be partially or completely filled with cured molding compound. Thus, no geometric undercuts (which make demolding difficult) in the holder or similar are required for a positive connection. Also, no adhesive connection is required between the contact lens and the holder. By completely filling the receiving cavity with molding compound, a tight seal is achieved between the contact lens and the holder.
[0029] According to one embodiment of the method, cured molding compound that protrudes from the insertion channel and / or the venting channel on the outer surface of the patient interface is removed, in particular by grinding. This is advantageous in that the patient interface is technically easily provided with a smooth outer surface. This simplifies handling of the patient interface and prevents injuries. According to one embodiment of the method, the first sealing element comprises a connecting element recess, in particular a circular-cylindrical one, for forming a connecting element of the contact lens, wherein the connecting element has a flat upper side for suction. One advantage of this is that a short-pulse laser eye surgery device, in particular a femtosecond laser device, can be technically easily fixed to the connecting element by means of negative pressure.In addition, light from an applicator of the short-pulse laser eye surgery device or the femtosecond laser device can still be easily coupled or introduced into the holder, allowing the light to reach the eye being treated. The top of the connecting element is located on the side of the connecting element facing away from the eye being treated or the vacuum cavity.
[0030] According to one embodiment of the patient interface, the contact lens is arranged and / or secured and / or encapsulated in the patient interface, in particular in a holder of the patient interface, without bonding and / or adhesive and / or without a form-fitting connection. This is advantageous in that the patient interface has a particularly simple technical design and is easy to manufacture. Furthermore, a chemical reaction between the adhesive and the contact lens is avoided. Potential aging of the adhesive is thus also irrelevant.
[0031] According to one embodiment of the patient interface, the receiving cavity is designed such that the contact lens has no step on its lateral outer surface. One advantage of this is that mechanical stresses occurring in the contact lens are reduced. This provides particularly good protection for the contact lens.
[0032] According to one embodiment of the patient interface, the contact lens has at least one projection and / or at least one recess on a side facing away from the eye to be treated. One advantage of this is that the upper side of the contact lens, or the side facing away from the eye to be treated, is not flat, but has at least one recess (recess) and / or a projection. A part of the laser or laser applicator can be pressed against the projection of the contact lens or inserted into the recess or recess or between two projections. In this way, the laser or laser applicator can be precisely aligned with the patient interface or fixed to the patient interface or contact lens in a technically simple manner. This allows for fast and reliable treatment of the eye using a laser via the patient interface.
[0033] According to one embodiment of the patient interface, the holder has a light introduction device for introducing light through the holder and the contact lens to the eye to be treated. This has the advantage that light can be coupled or introduced into the patient interface in a technically simple manner. The light can be brought through the holder and the contact lens to the eye to be treated. Thus, the treatment area can be illuminated or illuminated. Furthermore, before the eye to be treated is fixed, the patient interface can be aligned in a technically simple manner relative to the eye. The light introduction device can, in particular, be a structure or a device or coupling point for introducing light, as shown and described in DE 10 353 264 B4 (in particular in Figs. 3-10 and the associated description therein), to which reference is made here and the content of which is hereby explicitly incorporated herein.For example, the light introduction device can comprise an imaging element for the light, e.g., a convex, concave, cylindrical, and / or toric imaging element. The light introduction device can have a scattering surface to illuminate the vacuum cavity or the eye to be treated as homogeneously as possible. It is also conceivable for the light introduction device to have a dielectric layer for spectral filtering or reflection reduction. It is conceivable for the light introduction device itself to comprise lighting means, e.g., one or more LEDs. A portion of the holder, in particular the portion that delimits the vacuum cavity, can be designed to be light-reflecting, so that the light introduced by means of the light introduction device is reflected by the holder or a portion of the holder. This homogeneously illuminates the vacuum cavity or the eye to be treated.It is also conceivable to have multiple light-introducing devices that radiate light from different angles into the vacuum cavity or toward the eye to be treated. The light-introducing devices or the openings through which the light from the light-introducing device passes to the contact lens and ultimately into the vacuum cavity can be evenly distributed around the circumference of the holder. It is particularly advantageous if the light from the light-introducing device(s) illuminates the vacuum cavity or the eye to be treated as evenly or homogeneously as possible.
[0034] According to one embodiment of the patient interface, the patient interface comprises a third recess, in particular one that completely surrounds the contact lens. This recess is formed between the holder and the contact lens and is fluidly connected to a suction channel for suctioning the eye to be treated to the patient interface. This is advantageous because it allows the eye to be suctioned onto the patient interface in a technically simple and uniform manner using negative pressure.
[0035] According to one embodiment of the patient interface, the holder and the third recess are designed such that in a first state, in which a lower side of the contact lens is substantially completely covered by the eye to be treated and a first contact pressure presses the contact lens against the eye to be treated, the third recess is unlocked by the eye to be treated, and in a second state, in which the lower side of the contact lens is substantially completely covered by the eye to be treated and a second contact pressure, which is higher than the first contact pressure, presses the contact lens against the eye to be treated, the third recess is closed by the eye to be treated. This means that if the eye completely covers the surface of the lower side of the contact lens, it is possible for the eye to close the third recess or not to close it, depending on how strongly the contact lens orThe patient interface is pressed against the eye. This allows the eye to be moved laterally relative to the contact lens even after the entire surface of the second or lower side of the contact lens has been covered by the eye or the cornea, since the eye is not yet being suctioned into the suction channel.
[0036] According to one embodiment of the patient interface, the holder has a sealing element and / or multiple sealing elements for airtightly connecting the contact lens to the holder. This is advantageous in that the contact lens is connected to the holder in a sealed, particularly airtight, manner. Thus, negative pressure can be reliably generated in the negative pressure cavity. The sealing element can also form a positive connection between the contact lens and the holder. Furthermore, the sealing element can serve as a seal during the manufacture of the holder using a (two-component) injection molding process. The sealing element can comprise an elastic material or be made of an elastic material. This facilitates demolding of the holder during production using a two-component injection molding process.
[0037] According to one embodiment of the patient interface, the holder has an introduction channel for introducing the molding compound into the receiving cavity and / or a venting channel for allowing gas or gas mixture to escape from the receiving cavity. This is advantageous in that no holes or cavities are created in the receiving cavity that are not filled with molding compound or contact lens, but rather the receiving cavity is or could be completely filled with the molding compound before curing. This allows for particularly simple and reliable production of the contact lens.
[0038] According to one embodiment of the patient interface, hardened molding compound is present in the insertion channel and / or in the venting channel for positively fixing the contact lens in the holder. One advantage of this is that it reliably prevents the contact lens from falling out or slipping out of the holder. The holder does not need to have any further elements for a positive fit and can be technically designed to be particularly simple. According to one embodiment of the patient interface, hardened molding compound that protruded from the insertion channel and / or the venting channel on the outer surface of the patient interface was removed by grinding. One advantage of this is that the patient interface has a particularly smooth or flat outer surface. This simplifies handling of the patient interface and avoids possible injuries from sharp edges or points.
[0039] According to one embodiment of the patient interface, the holder comprises a holding element, particularly formed integrally with the holder, which protrudes into the interior of the receiving cavity for positively holding the contact lens in the holder. This is advantageous in that a technically simple, positive connection is provided between the contact lens and the holder. This reliably prevents any relative positional change between the contact lens and the holder. The seal between the contact lens and the holder can be achieved by filling the receiving cavity with the molding compound before curing.
[0040] According to one embodiment of the patient interface, the contact lens comprises a connecting element on its upper side, in particular one that is essentially circular and cylindrical in shape. The connecting element has a flat upper surface for suction attachment. One advantage of this is that a short-pulse laser eye surgery device, in particular a femtosecond laser device, can be easily attached to the contact lens, e.g., by means of vacuum. This allows for particularly precise alignment of the short-pulse laser eye surgery device relative to the patient interface or contact lens.
[0041] According to one embodiment of the patient interface, the holder was manufactured by injection molding, in particular by two-component injection molding. The advantage of this is that the holder is particularly cost-effective. The term "biocompatible material" can mean, in particular, that the material has no negative impact on living organisms or biological material upon contact. In particular, the material can comprise certain materials that are dermatologically compatible and / or do not contain allergens. Allergy substances are materials to which a high percentage (e.g., more than 10%) of the population is allergic.
[0042] The term “partially transparent” can in particular mean that a certain spatial area is transparent, or that only a certain part of the light rays (e.g. only about 80% of the incoming light rays) can pass through.
[0043] The term “sealing element” may in particular mean that the corresponding element can seal an area against the environment in a substantially liquid-tight or substantially airtight manner.
[0044] The term "molding compound" can be understood, in particular, as any type of liquid, viscous, or liquefiable material. After curing, the molding compound can form a body, in this case the contact glass. The manufactured or formed contact glass can subsequently consist, in particular, of the molding compound or parts of the molding compound.
[0045] The term "contact lens" can be understood in particular as an element designed to contact or partially contact the human or animal eye. The term "contact lens" does not specify the material or the material of the "contact lens." The contact lens does not have to be made of glass, but can be made of glass or comprise glass. In particular, the contact lens can be made partially or entirely of plastic. The term "curing" can be understood in particular as meaning that the liquefied, liquid, or viscous material that was introduced into the receiving cavity solidifies or is solidified.
[0046] The term “lateral outer surface” of the contact lens can be understood to mean, in particular, the outer surface or outer face that is in direct or immediate contact with the holder of the patient interface or with the patient interface.
[0047] The statement that “the receiving cavity is designed such that the contact glass does not have a step on its lateral outer surface” or “the receiving cavity is designed such that the contact glass formed after curing does not have a step on its lateral outer surface” can be understood in particular to mean that the contact glass formed in the receiving cavity, in a special embodiment, is essentially flat on its outer side facing the holder, or on its lateral side or its lateral surface. Preferably, the receiving cavity is designed such that the contact glass formed or produced therein is not stepped at any point on the lateral outer surface. A further advantage is that mechanical stress peaks in the contact glass or in the lateral outer surface are avoided. The receiving cavity orThe holder can in particular be designed in such a way that no air bubbles can form or remain when a liquid or viscous molding compound is introduced into the receiving cavity.
[0048] The holder can have multiple venting channels at different locations or in different areas, ensuring that there are no non-vented areas / regions in the receiving cavity, thus preventing cavities, bubbles, or the like from forming in the contact lens or at the edge of the contact lens. Preferred embodiments are set out in the subclaims.
[0049] The invention will be explained in more detail below with reference to drawings of exemplary embodiments.
[0050] Fig. 1 is a schematic cross-sectional view of a first embodiment of a holder for a patient interface before filling with the molding compound;
[0051] Fig. 2 is a schematic cross-sectional view of the holder of the patient interface from Fig. 1 after filling with the molding compound;
[0052] Fig. 3 is a schematic cross-sectional view of the holder of the patient interface from Fig. 1 or Fig. 2 after removal of the first sealing element and the second sealing element;
[0053] Fig. 4 is a schematic cross-sectional view of a second embodiment of a holder for a patient interface before filling the molding compound;
[0054] Fig. 5 is a schematic cross-sectional view of the patient interface holder of Fig. 4 after filling with the molding compound;
[0055] Fig. 6 is a schematic cross-sectional view of the holder of the patient interface from Fig. 4 or Fig. 5 after removal of the first sealing element and the second sealing element;
[0056] Fig. 7 is a schematic cross-sectional view of a third embodiment of a patient interface holder before the molding compound is filled in; Fig. 8 is a schematic cross-sectional view of the patient interface holder from Fig. 7 after the molding compound has been filled in;
[0057] Fig. 9 is a schematic cross-sectional view of the holder of the patient interface from Fig. 7 or Fig. 8 after removal of the first sealing element and the second sealing element;
[0058] Fig. 10 is a schematic cross-sectional view of a fourth embodiment of a patient interface holder after removal of the first sealing element and the second sealing element;
[0059] Fig. 11 is a schematic cross-sectional view of a fifth embodiment of a holder of a patient interface before filling the molding compound;
[0060] Fig. 12 is a schematic cross-sectional view of the patient interface holder of Fig. 11 after filling with the molding compound;
[0061] Fig. 13 is a schematic cross-sectional view of the holder of the patient interface from Fig. 11 or Fig. 12 after removal of the first sealing element and the second sealing element;
[0062] Fig. 14 is a schematic cross-sectional view of a sixth embodiment of a patient interface holder prior to filling with the molding compound; Fig. 15 is a schematic cross-sectional view of a seventh embodiment of a patient interface holder prior to filling with the molding compound;
[0063] Fig. 16 is a schematic cross-sectional view of an eighth embodiment of a holder of a patient interface before filling the molding compound;
[0064] Fig. 17 is a schematic cross-sectional view of the patient interface of Fig. 16 prior to filling with the molding compound, after it has been aligned such that the insertion channel is located at a lower position than the vent channel;
[0065] Fig. 18 is a schematic cross-sectional view of the patient interface of Fig. 16 or Fig. 17 after filling the molding compound and after removing the first sealing element and the second sealing element; and
[0066] Fig. 19 is a schematic cross-sectional view of a ninth embodiment of a holder for a patient interface before filling the molding compound.
[0067] In the following description, the same reference numbers are used for identical and equivalent parts.
[0068] Fig. 1 shows a schematic cross-sectional view of a first embodiment of a holder 20 of a patient interface 10 prior to filling with the molding compound. First, a holder 20 of a patient interface 10 is provided. The holder 20 or the patient interface 10 is designed such that the patient interface 10 can be arranged on a short-pulse laser eye surgery device for generating a laser beam for treating the eye to be treated. The patient interface 10 serves to fix the patient's eye to be treated. The patient interface 10 is arranged, so to speak, between the laser device or short-pulse laser eye surgery device and the eye to be treated. In other words, the patient interface 10 is located between the eye to be treated and the laser device when the eye is placed against the patient interface 10 or the contact lens 35 is applied. The patient interface 10 is usually attached to the laser device.Initially, there is no contact lens in the patient interface 10.
[0069] The patient interface 10 is designed symmetrically with respect to a central axis (not shown), which runs vertically from top to bottom or vice versa in the drawings.
[0070] The patient interface 10 comprises a holder 20 or an outer shape. The holder 20 of the patient interface 10 serves for attachment to the laser device. The holder 20 has a tapered or conical shape from the top (the side that is arranged on the laser device) to the bottom (the side against which the eye is placed). At the lower edge, the holder 20 has a continuous rim. The holder 20 defines a receiving cavity 30 laterally or to the side. The receiving cavity 30 is located in the lower half of the patient interface 10.
[0071] The receiving cavity 30 serves to receive the liquid, liquefied, or viscous molding compound, which, when cured, forms the contact lens 35. The receiving cavity 30 typically extends (except for the outer edge of the holder 20) over almost the entire width of the holder 20 or the patient interface 10, normally at least over 90% of the width of the holder 20 or the patient interface 10 (the width runs from left to right in the drawings).
[0072] The receiving cavity 30 is closed at the top, or sealed or delimited from the outside, by a first sealing element 40. The first sealing element 40, or the outer side / surface of the first sealing element 40, contacts the inside of the holder 20 all the way around. The first sealing element 40 is a type of cover located on the side of the patient interface 10 that will later be closer or close to the laser device when the patient interface 10 is arranged on the laser device (i.e., this is the upper side of the patient interface 10).
[0073] The first sealing element 40 has a plug shape or a downwardly tapered shape that is complementary to the shape of the holder 20 or the shape of the inside of the holder 20 or the inside of the upper part of the holder. The first sealing element 40 protrudes slightly (e.g., 10% of its length) upward beyond the tapered part of the holder 20, so that the first sealing element 40 can be easily removed later (after the contact lens has been formed).
[0074] The holder 20 of the patient interface 10 has an inwardly projecting retaining edge 70 on the underside or near the lower end. The retaining edge 70 additionally holds the contact lens 35 after the contact lens 35 has been formed, preventing it from falling out downward when the patient interface 10 is in use. This is also ensured by the conical shape of the inside of the holder 20. It is also conceivable to omit the retaining edge 70. The function of the retaining edge 70 can be assumed by a corresponding part of the second sealing element 42.
[0075] A second sealing element 42 is or will be arranged centrally at the lower end of the receiving cavity 30. The second sealing element 42 or the upper side of the sealing element projects upwards beyond the holding edge 70. The second sealing element 42 delimits the receiving cavity 30 at the bottom or closes off the receiving cavity 30 at the bottom and outwards or delimits it at the bottom. The second sealing element 42 has a rounded shape on its upper side (top in Fig. 1) so that the contact lens 35 later formed in the receiving cavity 30 has a shape on its underside (which is closer to the second sealing element 42 than to the first sealing element 40) that is more or less complementary to the shape of the eye or the cornea or the eyeball. The contact lens 35 is designed to touch the eye.
[0076] The side surface or outer surface of the second sealing element 42 is linear, or the second sealing element 42 is a circular cylinder except for the curved upper part. The second sealing element 42 protrudes slightly (e.g., 10% of its length from top to bottom) from the holder of the patient interface 10 on the underside of the patient interface, so that the second sealing element 42 can be easily removed later (after the contact lens 35 has been formed).
[0077] The receiving cavity 30 is thus delimited or closed off to the outside by the first sealing element 40, the second sealing element 42, and a first part of the holder 20. The retaining edge 70, if present, also delimits the receiving cavity 30 to the outside.
[0078] The first sealing element 40 has a first recess 50 or a first channel through which the receiving cavity 30 is or can be connected to the environment. The molding compound is introduced into the receiving cavity 30 through the first recess 50. It is also conceivable that the first recess 50 is arranged or formed in the holder 20, in particular in the first part of the holder 20. The first sealing element 40 and / or the second sealing element 42 can be detachably connected to the holder 20 of the patient interface 10. The patient interface 10 can thus already comprise the first sealing element 40 and / or the second sealing element 42. The provided holder 20 can thus be ready-made as shown in Fig. 1. For example, predetermined breaking points (e.g.in the form of webs) which detachably connect the first sealing element 40 and / or the second sealing element 42 to the holder 20 of the patient interface 10.
[0079] However, it is also conceivable for the first sealing element 40 and / or the second sealing element 42 to be brought into their respective positions in the holder 20 of the patient interface 10. This means that the first sealing element 40 is inserted into the holder 20 from above until the receiving cavity 30 is sealed at the top (possibly up to the first recess 50). This means that the second sealing element 42 is inserted into the holder 20 from below, e.g., until a projection abuts the holder 20 and thus determines or specifies the insertion depth of the second sealing element 42 into the holder 20.
[0080] The first sealing element 40 and / or the second sealing element 42 may have a polished or form-polished surface on the side that comes into contact with the molding compound.
[0081] Once the receiving cavity 30 is sealed or delimited by the first part of the holder 20 (to the side), the first sealing element 40 (to the top), and the second sealing element 42 (to the bottom) (and possibly by the retaining edge 70 of the holder 20), the molding compound is introduced into the receiving cavity 30 through the first recess 50. This can be done with or without pressure.
[0082] Fig. 2 shows a schematic cross-sectional view of the holder 20 of the patient interface 10 from Fig. 1 after the molding compound has been filled in. The molding compound can, for example, comprise or be plastic. It is also conceivable for the molding compound to comprise or be glass. The molding compound can be biocompatible. For example, the material can comprise or be CR-39 or polyallyl diglycol carbonate. The molding compound that forms the contact glass 35 after curing can be suitable for the use of short-pulse lasers, in particular femtosecond lasers. The material of the molding compound can be a material that can be cast without stress birefringence and / or striae or can be filled into the receiving cavity 30 and cured.
[0083] The molding compound introduced into the receiving cavity 30 is viscous or liquid, or is liquefied prior to introduction. This can be done, for example, by warming and / or heating the molding compound. The liquid or viscous molding compound is then introduced through the first recess 50 into the receiving cavity 30. It is also conceivable that there is more than one recess 50 for introducing the molding compound. The introduction can be by flowing in or by introduction under pressure, as in injection molding.
[0084] Molding compound is introduced into the receiving cavity 30 until the receiving cavity 30 is completely filled. This can be determined, for example, by the molding compound remaining in the first recess 50 and no longer flowing into the receiving cavity 30. Of course, the volume of the receiving cavity 30 can also be determined or measured, or the volume of the receiving cavity 30 is known, and the amount of molding compound introduced is recorded or adjusted accordingly.
[0085] The first sealing element 40 and / or the second sealing element 42 can have a further recess or opening (not shown) in addition to the first recess or opening 50 for introducing the molding compound. Through this further recess, air or gas can flow out of the receiving cavity 30 during the introduction of the molding compound into the receiving cavity 30 (and / or during the curing of the molding compound in the receiving cavity 30) or into the environment. This further recess or opening can be located at the highest point of the receiving cavity 30. This can mean that the further recess or opening gas-connects or fluid-connects the highest point, i.e., the point furthest from the center of the earth, of the receiving cavity 30 with the environment. The highest point of the receiving cavity 30 may be the respective uppermost point or one of the uppermost points of the receiving cavity 30 in the drawings of the embodiments.This ensures that all the air can escape from the receiving cavity 30 when the molding compound is introduced into the receiving cavity 30.
[0086] The molding compound is then cured to form the contact glass 35. This can be done, for example, by cooling or heat, ultraviolet light, evaporation, or similar means. For example, curing can take place in a water bath or in air. The formed contact glass 35 is transparent or partially transparent, or at least transparent or partially transparent for certain wavelength ranges.
[0087] After the molding compound for forming the contact lens 35 has hardened, the first sealing element 40 and the second sealing element 42 are removed from the formed contact lens 35 and from the holder 20 of the patient interface 10, respectively. For this purpose, any separable or detachable connection between the first sealing element 40 and the second sealing element 42 can be separated or detached. The first sealing element 42 is pulled out or removed upwards from the holder 20 of the patient interface 10. The second sealing element 42 is pulled out or removed downwards from the holder 20 of the patient interface 10.
[0088] The contact lens 35 is molded or manufactured by molding at the location in the patient interface 10 where it is then used or required. Fig. 3 shows a schematic cross-sectional view of the holder 20 of the patient interface 10 from Fig. 1 or Fig. 2 after the removal of the first sealing element 40 and the second sealing element 42.
[0089] The contact glass 35 is now formed. Because the holder 20, or a first part of the holder 20, served as a seal or external barrier during the filling and curing of the molding compound, the contact glass 35 is connected to the holder 20 or secured therein. Gluing the contact glass 35 into the holder 20 or bonding the contact glass 35 to the holder 20 is not necessary. Another (additional) method of securing the contact glass 35 in the holder 20 (e.g., using a locking device or the like) is also not necessary.
[0090] The contact glass 35 is designed to complement the shape of the holder 20 of the patient interface 10 or the inside of the holder 20 of the patient interface 10 or the lateral boundary of the receiving cavity 30.
[0091] After removing the first sealing element 40 and the second sealing element 42, a coating, e.g. a hard coating (to increase scratch resistance), an anti-reflective coating (to suppress unwanted reflections) or one or more other types of coatings, can be applied to the lower side 37 of the contact glass 35 and / or to the upper side 36 of the contact glass 35 opposite the lower side 37.
[0092] It is conceivable that the first sealing element 40 and / or the second sealing element 42 has a coating and / or multiple coatings on the side facing the receiving cavity 30, e.g. a hard coating (to increase scratch resistance or scratch resistance), an anti-reflective coating (to suppress unwanted reflections). The coating(s) or the first sealing element 40 and / or the second sealing element 42 can be designed such that when the first sealing element 40 and / or the second sealing element 42 are removed after the molding compound has been poured in and the molding compound has hardened, the coating remains on the contact glass 35. This means that the coating or coatings detach from the first sealing element 40 and / or the second sealing element 42 and remain on the upper side 36 and / or the lower side 37 of the contact glass 35.As a result of the curing, the coating that was previously present on the first sealing element 40 and / or the second sealing element 42 can bond firmly or permanently to the contact glass 35 or become a part thereof.
[0093] It is possible for the contact glass 35 in this embodiment to have no step on its outer side or lateral surface. This means that the contact glass 35 has no step on its outer or lateral side (which is in direct or immediate contact with the holder 20). The outer lateral surface or outer surface of the contact glass 35, which is contacted by the holder 20, can be substantially planar or flat. It is therefore possible for the outer lateral surface or outer surface of the contact glass 35 to have no edge, but rather for an edge to be present only at the upper end and at the lower end of the lateral outer surface or the lateral surface of the contact glass 35. In this case, every point on the outer lateral surface of the contact glass 35 has the same gradient. This avoids mechanical stress peaks.
[0094] After forming the contact lens 35, the finished patient interface 10 can be arranged on a laser device such that the laser beam or beams enter the contact lens 35 through the first (upper) side 36 of the contact lens 35 and exit through the second (lower) side 37 of the contact lens 35 before the laser beam strikes the eye to be treated or a portion of the eye to be treated. Fig. 4 shows a schematic cross-sectional view of a second embodiment of a holder 20 of a patient interface 10 before the molding compound is poured in.
[0095] The second embodiment of the holder 20 of the patient interface 10 or the second method differs from the first embodiment or the first method described in connection with Figs. 1-3 in that the shape of the holder 20 and the formed contact glass 35 have a different shape, and in that the first recess 50 or the channel for introducing the molding compound is formed at a different location.
[0096] The holder 20 of the patient interface 10 in the second embodiment, or the receiving cavity 30, has a substantially rectangular step in the upper part of the receiving cavity 30. This means that the outer edge of the receiving cavity 30 initially runs straight or vertically upwards and then, at a right angle, runs straight or horizontally outwards.
[0097] The holder 20 thus has, at the level of the receiving cavity 30, a circumferential projection element 32 which, in the cross section shown, is essentially triangular and which projects into the receiving cavity 30 or reduces the size of the receiving cavity 30.
[0098] In the second embodiment, the first recess 50 for filling is located in the lateral first part of the holder 20. Through this first recess 50, the molding compound for forming the contact glass 35 is introduced or introduced into the receiving cavity 30.
[0099] It is conceivable that the first recess 50 is also partially or completely filled with molding compound. Otherwise, the second embodiment is essentially identical to the first embodiment, and the second method is practically identical to the first method.
[0100] After the holder 20 of the patient interface 10 has been prepared, the molding compound is filled into the receiving cavity 30.
[0101] In both embodiments, the eye to be treated is inserted into the holder 20, substantially centrally, slightly into the holder 20 such that the eye can touch the rounded or round lower part of the contact lens 35. By placing the eye in position, a vacuum cavity 60 is created between the eye and the contact lens 35 or the lower part of the holder 20, which is essentially hermetically sealed.
[0102] In both embodiments, a third recess (not shown) may be provided that connects the negative pressure cavity 60 to a tube and / or a device on the outside of the patient interface 10 for generating a negative pressure and / or a filter. Air and / or fluid can be drawn from the negative pressure cavity 60 via the tube, device, or filter, so that the eye is drawn onto the patient interface 10. In this way, the eye can be particularly securely fixed to the patient interface 10.
[0103] Fig. 7 shows a schematic cross-sectional view of a third embodiment of a holder 20 of a patient interface 10 before the molding compound is poured in. Fig. 8 shows a schematic cross-sectional view of the holder 20 of the patient interface 10 from Fig. 7 after the molding compound has been poured in. Fig. 9 shows a schematic cross-sectional view of the holder 20 of the patient interface 10 from Fig. 7 and Fig. 8 after the first sealing element 40 and the second sealing element 42 have been removed. The holder 20 itself of the third embodiment does not differ from the holder 20 itself of the first embodiment. Only the first sealing element 40 differs.
[0104] The first sealing element 40 has, on a side facing the receiving cavity 30, projections and / or recesses (recesses 85), in particular edge-shaped projections and / or edge-shaped recesses (recesses). Thus, the surface of the first sealing element 40 facing the receiving cavity 30 is not flat or planar, but has at least one projection and / or at least one recess (recess 85). By means of the projections and / or recesses 85, complementary structures can be formed in the contact glass 35 or on the (upper) surface of the contact glass 35 during production, i.e. recesses (recesses) complementary to the projections and projections 80 complementary to the recesses (recesses). These structures orTargeted unevennesses on the surface of the contact glass 35 can be designed or used to fix a laser and / or a laser applicator and / or a light guide for irradiating or treating the patient's eye to be treated.
[0105] The contact lens 35 can thus be designed to be (rotationally) asymmetrical due to the at least one projection 80 and / or the at least one recess / the at least one cutout. However, it is also conceivable that the at least one projection 80 and / or the at least one recess / the at least one cutout is designed to be (completely) circumferential around the optical axis of the patient interface 10 or the contact lens 35, and thus the contact lens 35 is designed to be rotationally symmetrical with respect to the optical axis of the patient interface 10 or the contact lens 35.
[0106] The projections and / or recesses allow the laser, laser applicator, or light guide, in particular, to be positioned and fixed laterally or to the side (i.e., in a direction perpendicular to the optical axis of the eye or the patient interface 10) with high precision. The lateral direction runs from left to right or vice versa in the drawings. The laser, laser applicator, or light guide can be positioned against the projection 80 or in the recess / recess of the contact lens 35. In this way, the laser, laser applicator, or light guide can be positioned or aligned relative to the patient interface 10 in a technically simple, reliable, fast, and precise manner. This allows the treatment of the eye to be carried out particularly quickly and reliably.
[0107] The first sealing element 40 can in particular have projections and / or recesses, as described in US 8,944,601 B2 (in particular in connection with Fig. 4 therein), to which explicit reference is made here and the content of which is hereby explicitly incorporated herein.
[0108] The third embodiment shown in Figs. 7-9 differs from the second embodiment shown in Figs. 4-6 only in that the first sealing element 40 has a third recess 92 on its side or surface facing the receiving cavity 30 (the lower surface in Figs. 7-9) and accordingly has a projection 80 on the (first or upper) side 36 or surface of the contact glass 35 (i.e., the side of the contact glass 35 that is assigned to the first sealing element 40 during manufacture). The projection 80 can be triangular in the schematic cross-section shown. Other shapes (angular or rounded) are conceivable.
[0109] Fig. 10 shows a schematic cross-sectional view of a fourth embodiment of a holder 20 of a patient interface 10 after forming the contact glass 35 from the molding compound and removing the first sealing element 40 and the second sealing element 42.
[0110] The fourth embodiment differs from the second embodiment only in that the holder 20 has a light introduction device 90 for coupling in light or for introducing light. This means that the holder 20 has a coupler or a connection point to which a light guide can be or is attached, which brings light to the eye to be treated or into the area below the contact lens 35 (the area where the second sealing element 42 was located during manufacture) or the vacuum cavity 60. The light reaches the eye through the contact lens 35. In this way, light or illumination can be brought into the area being treated by the laser or to the eye. This makes it particularly easy to technically align or position the eye relative to the patient interface 10 or the contact lens 35.In addition, the pupil of the eye can be easily positioned centrally.
[0111] Fig. 11 shows a schematic cross-sectional view of a fifth embodiment of a holder 20 of a patient interface 10 before the molding compound is filled in. Fig. 12 shows a schematic cross-sectional view of the holder 20 of the patient interface 10 from Fig. 11 after the molding compound has been filled in. Fig. 13 shows a schematic cross-sectional view of the holder 20 of the patient interface 10 from Fig. 11 and Fig. 12 after the removal of the first sealing element 40 and the second sealing element 42.
[0112] The fifth embodiment differs from the first embodiment in that a suction channel 95 is shown for sucking in the eye to be treated (this is also present in the first embodiment, but not shown in the drawings) and there is no retaining edge 70. The second sealing element 42 has a circumferential, spike-like projection element 91 on its edge. The projection element 91 projects obliquely upward from the base body of the second sealing element 42. This spike-like projection element 91 distinguishes the second sealing element 42 in this embodiment from the second sealing element 42 in the first embodiment.The holder 20 and the third recess 92 are designed to close the third recess 92, which is still unclosed when contact is made and the lower side 27 of the contact lens 25 is substantially completely covered by an eye to be treated, only by increasing the contact pressure (of the contact lens 35) against the eye. This means that after the eye has contacted the lower side 37 of the contact lens 35, the third recess 92 is initially still unclosed. By further or increased pressure of the contact lens 35 against the eye (or vice versa), the eye finally closes the third recess 92, and only then is the eye sucked through the suction channel 95.
[0113] The projection element 91 can taper away from the main part or base body of the second sealing element 42, in particular can taper to a point. This means that the projection element 91 becomes thinner or its diameter decreases as one approaches the first sealing element 40. As a result, the third recess 92 running around the contact glass 35 or a part of the contact glass 35 is designed to be conical or tapered towards the top, i.e. the diameter of the third recess 92 decreases from bottom to top. The projection element 91 prevents molding compound from getting into this circumferential part when the molding compound is introduced, so that a third recess 92 running around the contact glass 35 or the lower part of the contact glass 35 is created.
[0114] The projection element 91 forms an annular third recess 92 between the lower outer edge of the contact lens 35 (with the lower edge facing the eye to be treated) and the holder 20. This annular third recess 92 is designed such that the annular third recess 92 is in fluid communication with an intake channel 95 formed in the holder 20. Air or a gas mixture is sucked in through the intake channel 95, so that the eye is fixed to the patient interface 10 by means of negative pressure in the negative pressure cavity 60. The holder 20 has a lower section 25 that projects downward beyond the formed contact lens 35. The third recess 92 and the lower section 25 of the holder 20 are designed such that the lower section 25 does not have to touch the eye when the eye substantially completely covers the lower side 37 of the contact lens 35.
[0115] The holder 20 can be designed in such a way and the third recess 92 can be designed in such a way that the third recess 92 does not have to be closed by the eye to be treated, but can be closed when the eye to be treated contacts a lower side 37 of the contact lens 35 essentially over its entire surface.
[0116] The third recess 92 is located above the lowest part of the contact lens 35. It is impossible for the cornea of the eye to be sucked into the third recess 92 by the negative pressure. This also prevents the suction channel 95 from becoming closed. The cornea of the eye can contact the contact lens 35 through mechanical pressure or a mechanical force. When the cornea of the eye is in essentially full-surface contact with the contact lens 35, i.e. the eye is essentially completely covering the lower side 37 of the contact lens 35, the cornea of the eye does not (necessarily) or initially cover the third recess 92 and does not touch the lower or lowest section 25 of the holder 20. Therefore, even after full-surface contact of the cornea with the contact lens 35 has been established, the eye can be repositioned, or the cornea and contact lens 35 can be moved (laterally) relative to one another. Only when the contact glass 35 is moved further oris pressed more strongly against the eye, the cornea of the eye covers the third recess 92 and closes it downwards, so that the eye is fixed to the patient interface 10 by the negative pressure of the suction channel 95. The negative pressure does not essentially change the shape of the cornea of the eye.
[0117] This can be achieved, for example, in that the lower section 25 of the holder 20 neither protrudes nor protrudes with respect to a curved surface that the cornea of the eye has when the eye essentially completely covers the second side 37 of the contact lens 35. The imaginary extension of the curvature of the second side 37 of the contact lens 35 can be flush with the end of the lower section 25 of the holder 20 or aligned with the end of the lower section 25 of the holder 20.
[0118] The suction channel 95 or the diameter of the suction channel 95 can taper upwards, ie when moving away from the eye to be treated.
[0119] The recess can in particular be an “annular gap”, as described in US 8,944,601 B2 (in particular in connection with Fig. 4 therein), to which explicit reference is made here and the content of which is hereby explicitly incorporated herein.
[0120] Fig. 14 shows a schematic cross-sectional view of a sixth embodiment of a holder 20 of a patient interface 10 before filling the molding compound.
[0121] The sixth embodiment differs from the fifth embodiment in that a sealing element 96 is provided surrounding the receiving cavity 30, and in that an introduction channel 100 for introducing the molding compound into the receiving cavity 30 is provided in the holder 20. The introduction channel 100 can be the first recess.
[0122] The sealing element 96 has a circular cross-section. Half of the sealing element 96 protrudes into or into the receiving cavity 30. The other half of the sealing element 96 is received in the holder 20 or is part of the holder 20 and does not protrude into the receiving cavity 30. The sealing element 96 forms a positive connection between the contact glass 35 and the holder 20. The holder 20 can be manufactured using an injection molding process. In particular, the holder 20 can be manufactured using a two-component injection molding process. In this case, the sealing element 96 can also serve as a seal.
[0123] The sealing element 96 can be elastic. This facilitates demolding or detachment after the holder 20 has been manufactured using the injection molding process.
[0124] The introduction channel 100 serves to introduce the liquid or viscous molding compound into the receiving cavity 30. The introduction channel 100 runs from the top right to the bottom left along or past the edge of the first sealing element 40. Additional introduction channels and / or venting channels 105 may be provided for allowing air to exit or escape from the receiving cavity 30.
[0125] The first sealing element 40 has a connecting element recess 110 on its side facing the receiving cavity 30. The connecting element recess 110 is flat or planar. The connecting element recess 110 can have the shape of a right circular cylinder. The manufactured contact glass 35 can have a connecting element 115 on its upper side 36. The connecting element 115 can protrude upward from the upper side 36 of the contact glass 35. It can have the shape of a right circular cylinder. The upper side 116, i.e., the side facing away from the vacuum cavity 60, of the connecting element 115 of the contact glass 35 is flat or planar. The outer surface of the connecting element 115 can be flush with the lateral edges of the remaining receiving cavity 30 (whereby any sealing elements 96 and / or retaining elements 120 are not taken into account here).The connecting element 115 serves to connect the contact lens 35 to a short-pulse laser eye surgery device, in particular a femtosecond laser device. The short-pulse laser eye surgery device can be fixed to the connecting element 115 by compressing or suctioning the upper side 116 of the connecting element 115.
[0126] The area that is suctioned to fix the short-pulse laser eye surgery device can be located outside the optically active or optically relevant area of the contact lens 35, i.e., at the edge of the contact lens 35. The connecting element recess 115 can have a different shape than shown in the drawings. In particular, the connecting element recess 115 can extend over substantially the entire width or the entire diameter of the interior of the holder 20. It is possible for the connecting element recess 115 to extend over a larger area or larger diameter of the holder 20 than the receiving cavity 30. Thus, the connecting element 110 of the contact lens 35 can be located above the triangular projection element 32. Thus, the connecting element 110 is located laterally of the remaining part of the contact lens 35.
[0127] For example, the connecting element 110 can be arranged or rest on the triangular projection element 32. The contact lens 35 can have a projecting edge, so to speak, that extends partially or completely over the triangular projection element 32, and this edge encompasses the connecting element 110 or is the connecting element 110. In this way, when the short-pulse laser eye surgery device is fixed to the contact lens 35 or the connecting element 110 of the contact lens 35, the optically relevant part or the center (located above the receiving cavity 30) of the contact lens 35 is prevented from being scratched or the irradiation of the eye through the contact lens 35 (lens) being negatively affected. The connecting element 110 or the connecting element recess 115 can be stepped or have steps.Alternatively or in addition to the suction of the connecting element 110, it is conceivable that the short-pulse laser eye surgery device is fixed to the holder 20 by suction of a part of the holder 20, in particular by suction of the triangular projection element 32.
[0128] During the introduction of the molding compound through the introduction channel 100, the holder 20 can be aligned such that the introduction channel 100 or the lower part of the introduction channel 100 immediately adjacent to the receiving cavity 30 runs vertically, ie in the direction of gravity, wherein the molding compound is introduced into the receiving cavity 30 through the lower part of the introduction channel 100 opposite to the direction of gravity.
[0129] The air or gas or gas mixture in the receiving cavity 30 can escape through the introduction channel 100 during the introduction of the molding compound. This can occur either continuously during the introduction of the molding compound or iteratively or alternately with the introduction of the molding compound. The introduction channel 100 can thus function simultaneously or additionally as a venting channel.
[0130] Fig. 15 shows a schematic cross-sectional view of a seventh embodiment of a holder 20 of a patient interface 10 before filling the molding compound.
[0131] The seventh embodiment differs from the sixth embodiment in that, in addition to the introduction channel 100, a vent channel 105 is provided for allowing air or gas mixture to escape from the receiving cavity 30. The molding compound is introduced into the receiving cavity 30 through the introduction channel 100. The air present in the receiving cavity 30 escapes from the receiving cavity 30 through the vent channel 105 as the molding compound is gradually poured into the receiving cavity 30. In this way, no cavities, blowholes, open areas, or bubbles are formed in the contact glass 35 or at the edge of the receiving cavity 30 or the contact glass 35. The opening of the introduction channel 100 is opposite the opening of the vent channel 105.
[0132] In Fig. 15, the introduction channel 100 runs partly from top left to bottom right and partly from left to right along the edge of the first sealing element 40 or between the first sealing element 40 and the holder 20. The introduction channel 100 and the venting channel 105 each have roughly the shape of the capital letter L. In Fig. 15, the venting channel 105 runs partly from top right to bottom left and partly from right to left along the edge of the first sealing element 40 or between the first sealing element 40 and the holder 20.
[0133] In addition to the venting channel 105 shown in the drawings, the holder 20 can have additional venting channels. The venting channel(s) ensure that when the molding compound is introduced into the receiving cavity 30, no bubbles, shrinkage cavities, or hollow spaces are formed that are not filled by the molding compound and thus subsequently not filled by the contact glass 35. The venting channel 105 or the venting channels ensure that no hollow spaces, bubbles, or the like are formed in the contact glass 35 or at the edge of the contact glass 35. This ensures that the receiving cavity 30 is completely filled with molding compound. This also achieves a reliable, particularly airtight, seal between the contact glass 35 and the holder 20.
[0134] Fig. 16 shows a schematic cross-sectional view of an eighth embodiment of a holder 20 of a patient interface 10 prior to the filling of the molding compound. Fig. 17 shows a schematic cross-sectional view of the patient interface 10 from Fig. 16 prior to the filling of the molding compound, after it has been aligned such that the insertion channel 100 is located at a lower point than the venting channel 105. Fig. 18 shows a schematic cross-sectional view of the patient interface 10 from Fig. 16 or Fig. 17 after the filling of the molding compound, after the curing of the molding compound, and after the removal of the first sealing element 40 and the second sealing element 42.
[0135] The eighth embodiment differs from the seventh embodiment in that in the eighth embodiment there is no sealing element 96, but rather an undercut or a circumferential projection (as holding element 120) of the holder 20 is present in the receiving cavity 30.
[0136] The circumferential projection or retaining element 120 has a semicircular cross-section. The projection serves to provide a positive connection between the contact glass 35 formed from the molding compound and the holder 20. The molding compound creates a tight, particularly airtight, connection between the projection and the contact glass 35 or between the contact glass 35 and the holder 20. A change in position between the contact glass 35 and the holder 20 is prevented by the circumferential projection or retaining element 120.
[0137] During the introduction of the molding compound, the lower part of the introduction channel 100, which directly borders the receiving cavity 30, as well as the lower part of the venting channel 105, which directly borders the receiving cavity 30, can be aligned in the direction of the earth's gravity, so that the molding compound enters the receiving cavity 30 opposite to the direction of the earth's gravity. This is shown in Fig. 17. In this way, the air can escape particularly well from the receiving cavity 30 through the venting channel 105. Even corners of the receiving cavity 30 that are not directly exposed to air flow are thereby filled with the molding compound. Thus, no cavities and / or bubbles are formed in the receiving cavity 30 or in the contact glass 35. The receiving cavity 30 can thus be completely filled with molding compound in a particularly reliable manner. The twisting or tilting of the holder 20 such that the lower part of the insertion channel 110 orThe part of the introduction channel 110 directly adjacent to the receiving cavity 30 is aligned in the direction of the earth's gravity (so to speak vertically) during the introduction of the molding compound through the introduction channel 110 into the receiving cavity 30, can be carried out in all embodiments, even if this is only shown for the eighth embodiment in a separate drawing (Fig. 17).
[0138] It is also conceivable that the holder 20 is rotated about an axis which runs through the lower parts of the introduction channel 100 as well as the venting channel 105, which are immediately adjacent to the receiving cavity 30 (ie the axis runs from bottom to top in Fig. 17), while the molding compound is introduced into the introduction channel 100 or the receiving cavity 30.
[0139] Fig. 19 shows a schematic cross-sectional view of a ninth embodiment of a holder 20 of a patient interface 10 before filling the molding compound.
[0140] The ninth embodiment differs from the seventh embodiment in that no sealing element 96 is present and that the insertion channel 100 and the venting channel 105 each run, in particular exclusively, horizontally. The insertion channel 100 is located opposite the venting channel 105. It is conceivable that several insertion channels and / or venting channels, e.g., in a star shape, run in the radial direction of the patient interface 10 from the receiving cavity 30 to the outer surface of the patient interface 10.
[0141] When the molding compound is introduced into the receiving cavity 30, molding compound remains in the introduction channel 100 and / or enters the venting channel 105. The introduction channel 100 and / or the venting channel 105 are partially or completely filled with the molding compound. This molding compound is then also cured. After the removal of the first sealing element 40 and the second sealing element 42, a positive connection remains or is created between the contact glass 35 and the holder 20, since the contact glass 35 extends into the introduction channel 100 and / or the venting channel 105. This ensures a secure fixation of the contact glass 35 in the holder 20 in a technically simple manner.
[0142] Cured molding compound protruding from the insertion channel 100 and / or the vent channel 105 from the outer surface of the patient interface 10 can be removed to achieve a smooth outer surface of the patient interface 10. This can be accomplished by machining, shearing, grinding, or the like.
[0143] The introduction channel 100 and / or the venting channel 105 can be produced during the manufacture of the holder 20 in an injection molding process, for example by means of sliders or movable pins in the injection molds.
[0144] List of reference symbols
[0145] 10 Patient interface
[0146] 20 bracket
[0147] 25 lower section of the bracket
[0148] 30 receiving cavity
[0149] 32 triangular projection element
[0150] 35 contact glass
[0151] 36 first (upper) side of the contact glass
[0152] 37 second (lower) side of the contact glass
[0153] 40 first sealing element
[0154] 42 second sealing element
[0155] 50 first recess
[0156] 60 vacuum cavity
[0157] 70 retaining edge
[0158] 80 projection of the contact glass
[0159] 85 Recess of the first sealing element
[0160] 90 Light introduction device Projection element of the first sealing element Third recess Intake channel Sealing element Introduction channel Ventilation channel Connecting element recess Connecting element Top side of the connecting element Holding element
Claims
Claims 1. A method for producing a patient interface (10) for fixing an eye to be treated, wherein the patient interface (10) comprises an at least partially transparent contact lens (35) for contacting the eye to be treated, wherein the patient interface (10) is designed such that the patient interface (10) can be arranged on a short-pulse laser eye surgery device for generating a laser beam for treating the eye to be treated, wherein the method comprises the following steps: providing a holder (20) of the patient interface (10), wherein a first part of the holder (20) partially delimits a receiving cavity (30) for receiving the material for forming the contact lens (35), wherein a first sealing element (40) and a second sealing element (42) are or will be arranged such that the first sealing element (40),the second sealing element (42) and the first part of the holder (20) of the patient interface (10) together delimit the receiving cavity (30) to the outside;, Introducing a liquid or viscous molding compound into the receiving cavity (30); Curing the molding compound in the receiving cavity (30) to form the contact glass (35); and Removing the first sealing element (40) and the second sealing element (42) from the formed contact glass (35).
2. The method according to claim 1, wherein the first sealing element (40) and / or the second sealing element (42) have a coating, the coating remaining on the contact glass (35) when the first sealing element (40) and the second sealing element (42) are removed from the formed contact glass (35).
3. The method according to claim 1 or 2, wherein the molding compound comprises a plastic, in particular the molding compound is plastic.
4. A method according to any one of the preceding claims, wherein the molding compound is a biocompatible material.
5. Method according to one of the preceding claims, wherein the holder (20) is designed in such a way and the contact glass (35) is designed in such a way that a negative pressure can be formed between the contact glass (35) and the eye to be treated when the eye rests against the patient interface (10).
6. Method according to one of the preceding claims, wherein the first sealing element (40) and / or the second sealing element (42) are detachably attached to the holder (20) of the patient interface (10).
7. Method according to one of the preceding claims, wherein the molding compound is introduced into the receiving cavity (30) through a first recess (50) in the first sealing element (40) and / or a second recess in the second sealing element (42).
8. Method according to one of the preceding claims, wherein the first sealing element (40) and the second sealing element (42) delimit the receiving cavity (30) to the outside on two opposite sides.
9. Method according to one of the preceding claims, wherein the second sealing element (42) is arranged such that the second sealing element (42) is arranged on the side of the formed contact lens (35) which is designed to contact the eye to be treated, wherein the second sealing element (42) has a curved shape in sections.
10. Method according to one of the preceding claims, wherein the receiving cavity (30) is designed such that the contact glass (35) formed after curing has no step on its lateral outer surface.
11. Method according to one of the preceding claims, wherein after curing a coating is applied to the contact glass (35).
12. Method according to one of the preceding claims, wherein the first sealing element (40) has at least one projection and / or at least one recess (85) on a side facing the receiving cavity (30).
13. Method according to one of the preceding claims, wherein the holder (20) has a light introduction device (90) for introducing light through the holder (20) to the eye to be treated.
14. Method according to one of the preceding claims, wherein the second sealing element (42) comprises a projection element (91) for forming a third recess (92) which at least partially surrounds the contact glass (35), in particular completely surrounds the contact glass (35), which is formed between the holder (20) and the contact glass (35) and is fluidly connected to a suction channel (95) for sucking the eye to be treated onto the patient interface (10).
15. The method according to claim 14, wherein the holder (20) is designed in such a way and the third recess (92) is designed in such a way that in a first state in which a lower side of the contact glass (35) is substantially completely covered by the eye to be treated and a first contact pressure presses the contact glass (35) against the eye to be treated, the third recess (92) is not closed by the eye to be treated and in a second state in which the lower side of the contact glass (35) is covered by the eye to be treated is substantially completely covered and a second contact pressure, which is higher than the first contact pressure, presses the contact lens (35) against the eye to be treated, the third recess (92) is closed by the eye to be treated.
16. The method according to any one of the preceding claims, wherein in the step of introducing the liquid or viscous molding compound into the receiving cavity (30), the molding compound is introduced into the receiving cavity (30) through an introduction channel (100) of the holder (20) and / or gas or gas mixture escapes from the receiving cavity (30) through a venting channel (105) of the holder (20) from the receiving cavity (30).
17. The method according to claim 16, wherein in the step of introducing the liquid or viscous molding compound into the receiving cavity (30), the holder (20) is aligned such that the introduction channel (100) is located at a lower position than the venting channel (105).
18. The method according to claim 16 or 17, wherein Molding compound is cured in the introduction channel (100) and / or in the venting channel (105).
19. The method according to any one of claims 16-18, wherein cured molding compound which protrudes outward from the introduction channel (100) and / or from the venting channel (105) from the outer surface of the patient interface is removed, in particular by grinding.
20. Method according to one of the preceding claims, wherein the first sealing element (40) comprises a, in particular circular-cylindrical, connecting element recess (110) for forming a, in particular circular-cylindrical, connecting element (115) of the contact glass (35), wherein the connecting element (115) has a flat upper side (116) for being sucked on.
21. Patient interface (10) for fixing an eye to be treated, wherein the patient interface (10) is designed such that the patient interface (10) can be arranged on a short-pulse laser eye surgery device for generating a laser beam for treating the eye to be treated, wherein the patient interface (10) comprises an at least partially transparent contact glass (35) for touching the eye, characterized in that the contact glass (35) was formed by introducing a liquid or viscous molding compound into a receiving cavity (30) of the patient interface (10) and subsequently curing the molding compound.
22. Patient interface (10) according to claim 21, wherein the contact glass (35) is arranged and / or fastened and / or cast in the patient interface (10), in particular in a holder (20) of the patient interface (10), without bonding and / or without adhesive and / or without a form-fitting connection.
23. Patient interface (10) according to claim 21 or 22, wherein the receiving cavity (30) is formed such that the contact glass (35) has no step on its lateral outer surface.
24. Patient interface (10) according to one of claims 21-23, wherein the contact lens (35) has at least one projection (80) and / or at least one recess on a side (36) facing away from the eye to be treated.
25. Patient interface (10) according to any one of claims 21-24, wherein the holder (20) has a light introduction device (90) for introducing light through the holder (20) and the contact lens (35) to the eye to be treated.
26. Patient interface (10) according to one of claims 21-25, wherein the patient interface (10) comprises a third recess (92), in particular the contact glass (35) completely surrounding, which is formed between the holder (20) and the contact glass (35) and is provided with a Suction channel (95) for suctioning the eye to be treated is fluidly connected to the patient interface (10).
27. The patient interface (10) according to claim 26, wherein the holder (20) and the third recess (92) are designed such that in a first state, in which a lower side of the contact lens (35) is substantially completely covered by the eye to be treated and a first contact pressure presses the contact lens (35) against the eye to be treated, the third recess (92) is unlocked by the eye to be treated, and in a second state, in which the lower side of the contact lens (35) is substantially completely covered by the eye to be treated and a second contact pressure, which is higher than the first contact pressure, presses the contact lens (35) against the eye to be treated, the third recess (92) is closed by the eye to be treated.
28. Patient interface (10) according to one of claims 21-27, wherein the holder (20) has a sealing element (96) and / or a plurality of sealing elements (96) for airtightly connecting the contact glass (35) to the holder (20).
29. Patient interface (10) according to one of claims 21-28, wherein the holder (20) has an introduction channel (100) for introducing the molding compound into the receiving cavity (30) and / or a venting channel (105) for allowing gas or gas mixture to escape from the receiving cavity (30).
30. Patient interface (10) according to claim 29, wherein cured molding compound is present in the introduction channel (100) and / or in the venting channel (105) for positively fixing the contact glass (35) in the holder (20).
31. Patient interface (10) according to one of claims 29 or 30, wherein cured molding compound which is discharged from the introduction channel (100) and / or the venting channel (105) from the outer surface of the patient interface protruded outwards and was removed by grinding.
32. Patient interface (10) according to one of claims 21-31, wherein the holder (20) has a holding element (120), in particular formed integrally with the holder (20), projecting into the interior of the receiving cavity (30) for positively holding the contact glass (35) in the holder (20).
33. Patient interface (10) according to one of claims 21-32, wherein the contact glass (35) comprises on its upper side (36) a connecting element (115), in particular one which is substantially circular-cylindrical in shape, wherein the connecting element (115) has a flat upper side (116) for being sucked on.
34. Patient interface (10) according to one of claims 21-33, wherein the holder (20) was manufactured by means of injection molding, in particular by means of a two-component injection molding.
35. A short-pulse laser eye surgery device for treating an eye, comprising a patient interface (10) according to any one of claims 21-34 arranged on the short-pulse laser eye surgery device.