Applicator for inserting lenses

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DESCRIPTION

Applicator for inserting lenses

The present invention relates to an applicator for introducing optical lenses into the eye of a human or an animal. In different measures to improve the visual acuity of the human eye it is usual to introduce an optical lens into the eye. For example, corrective lenses are placed in a pre-produced pouch on the cornea (eg, by a laser or keratome). A lens introduction device (applicator) is used to insert the lenses into these bags.

Known state-of-the-art applicators operate such that a lens held by the applicator is pushed from the applicator into the corneal pocket. Applicators of this type are shown, for example, in WO 2006/007543 and US 5,123,905.

The ejected lenses must be partially unfolded once they are inside the bag and, furthermore, they usually also need to be precisely positioned in the bag. The inserted lenses are very flexible and can only be handled with difficulty.

Therefore, there is a need for an applicator with which the optical lenses can be introduced into the eye of a human or an animal more simply and accurately.

The above task will be achieved through the applicator according to the invention.

The above invention is based on a completely different principle than the introduction of a lens in the eye: Instead of pushing the lens into the eye with the help of a conventional applicator, as in the state of the art, in the applicator according to In the invention, the lens is already correctly positioned in the eye while it is still within the applicator. The applicator is then withdrawn by a defined amount through the handle, maintaining the position of the lens, thereby releasing the lens in the correct position. The applicator is then removed from the corneal pocket.

In this way, a much simpler and exact positioning of the lens is possible in the desired place of the eye. Rather than positioning the flexible, difficult-to-handle lens after pushing it towards the eye, the applicator is more precisely aligned, which can be handled more easily. The applicator is then removed while the lens remains in place.

This is achieved through a two-piece configuration of the applicator according to the invention. The applicator according to the invention comprises a preload unit that can be loaded with a lens and a handle. The preload unit and the handle can be attached to each other so that the preload unit can be withdrawn by a defined amount while the slide remains in position. This is achieved through a pre-fixation of the lens with the help of a slide that can be moved independently of the rest of the preload unit. Preferably, the preload unit is provided with a lock against twisting, so that the orientation of the lens is also maintained when it is placed on the handle.

According to the present invention, by withdrawn by a defined amount is meant that the corresponding component can be moved inwardly in the handle by a certain length. The length is predetermined by the nature of the handle, but should at least be such that the lens contained in the preload unit can be released from the preload unit.

One aspect of the present invention relates to a preload unit for introducing lenses into the eye of a human or an animal, comprising

i) a housing with means for fixing, preferably in a torsionally resistant manner, the unit on a handle, ii) a lens housing part that is disposed nearby in or within the housing, and a projecting section of the housing with two separate leaf-like units, which, at least at their spaced ends from the housing, are in separable contact with each other and there form a chamber for storing an optical lens, iii) a slider movably disposed within the housing and movable between the blade-like units of the lens housing unit.

According to the present invention, sheet-like unit is to be understood as a component which, analogously to a sheet, is very thin and thus exhibits a corresponding flexibility. According to the present invention, the sheet-like units typically have a thickness of 0.1 to 0.3 mm and typically a length of 20 to 40, preferably 20 to 30 mm.

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According to a preferred embodiment, the two sheet-like units each have at least one, preferably exactly one hole, which is arranged in such a way that the holes lie directly above each other and form an opening through the center of the camera to store an optical lens. In this way, a lens located in the camera can be positioned particularly favorably on the optical axis of the eye. The person inserting the lens sees the lens through the hole and can accurately align it. Typically, the holes may have a diameter of between 0.3 and 0.6 mm. This embodiment is particularly advantageous for intracorneal lenses with a central hole, as described in WO 2009/075685.

According to its particularly preferred embodiments, the present invention comprises a preloading unit with exactly two sheet-like units of this type. However, it is also possible to use preload units with more than two units, for example with four sheet-like units, where the sheet-like units together form a chamber for storing an optical lens.

As described above, the blade-like units of the lens housing part form a chamber for storing an optical lens at its spaced ends from the housing. This chamber must be openable to insert the lens into the chamber, or to remove it again from the chamber. Thus, according to the present invention, the sheet-like units are in the chamber area in loose contact with each other, that is, they can be moved away from each other by applying force. For example, the sheet-like units can be separated by the slider described in more detail below. However, to separate the contact from the blade-like units such an application of force is required.

To keep the lens within the chamber in place, the chamber is at least partially limited by wave-shaped sections found in the two sheet-like units and arranged so that the sections of a sheet-like unit sheet fit with the corresponding sections of the other unit as a sheet. In this way a chamber is formed which is somewhat lattice. Especially preferably, through these limitations a chamber is formed into which the lens to be inserted into the eye can be inserted.

Preferably according to the invention, these aforementioned limitations are arranged on the sheet-like units such that, in the state of contact of the two sheet-like units, a sliding of the lens out of the camera is not possible. and this can be moved in the camera (for example, providing the constraints in all corners of the camera). Preferably, the wave-shaped sections are additionally somewhat raised.

As explained above, the fundamentally new principle of the present invention is based not on pushing the lens into a corneal pocket, but rather on precisely positioning the applicator in the corneal pocket and then removing the part in leaf shape in an exactly defined magnitude holding the lens in place. Therefore, the section of the applicator (or rather of the applicator preload unit) in which the chamber for storing an optical lens is made must be designed so that it can be inserted into a corresponding corneal pocket. Preferably according to the invention, the shape of the applicator area forming this chamber essentially corresponds to the shape of the lens to be fitted, or is even slightly smaller in width than the corresponding lens. This is possible, for example, because the chamber does not have any circular shape and does not present everywhere the limitations described above, that is, the chamber is laterally open between the constraints. In such a case, the lens on the camera may protrude from the camera in some places.

Preferably according to the invention, the sheet-like units of the preload unit have a width of 3 mm or slightly less in the area of ​​the chamber. However, this may vary depending on the lens to be attached.

To enable a chamber opening, the sheet-like units must be separable from each other. Therefore, they must be made of a sufficiently flexible material. According to the present invention, a physiologically compatible plastic material or a physiologically compatible metallic material can be considered as the material for the sheet-like units.

Typically, the sheet-like units are 20 to 40, preferably 20 to 30 mm long. Preferably, said units become, with increasing thickness, a section of the lens housing part fixedly arranged in the housing of the preload unit. However, alternatively, the sheet-like units can also have a constant thickness and be fixed in a section of the lens housing part fixedly arranged in the housing of the preload unit. However, between the sheet-like units there is in any case an intermediate space large enough so that the slider explained later can be freely inside it. Furthermore, the sheet-like units are fixed in any case in the other section of the lens housing part or even

ES 2 623 019 T3 directly into the housing so that their ends spaced apart from the housing touch and form the chamber described above there.

The housing of the preload unit serves to fix the lens housing unit. Preferably according to the invention, the lens housing unit is guided into the housing and locked there through suitable anchoring mechanisms. However, alternatively, the lens housing unit can also be arranged, for example, fixedly in the housing.

The housing of the preload unit has a continuous bore in which the slide can be freely moved, which will be described in detail later.

The preload unit is provided for use in an applicator according to the invention. For this, the housing of the preloading unit has means for fixing the unit to a handle. Said means are arranged at the end of the housing opposite the end with the blade-like units projecting outwards. Preferably, the connection to the handle is configured in such a way that it can only take place in a torsionally resistant manner.

Preferably according to the invention, the fixing means consist of means for manufacturing a bayonet closure with the handle. Of course, other suitable fixing means can also be used.

As indicated above, the principle according to the invention consists in withdrawing the preload unit by a defined amount one that has been positioned in the corneal pocket keeping the lens in place. To do this, the preload unit must be able to move into the handle. This will be explained in detail later. However, preferably according to the invention, the preload unit has a stop element to limit the movement of the preload unit into the handle. By way of example, it may be a rise at a point on the surface of the carcass. Preferably, this elevation is configured in an annular manner around the entire perimeter of the housing. The stop element is arranged at a point on the housing of the preload unit so that the housing can be moved on the handle inwards, at least so that the blade-like units no longer cover the lens that is located in-camera, that is, the lens is uncovered.

Preferably according to the invention, the preload unit is designed for a single use. Accordingly, the preload unit is loaded once with a corresponding lens and then packaged sterile, before being collected from the package and attached to the handle shortly before the use process.

To load the preload unit with a lens, the sheet-like units are separated from each other to allow access to the chamber described above. For this, according to an embodiment of the present invention, a suitable tool, for example a knife, can be inserted into the lateral interspace between the blade-like units. The lens is then placed in the accessible chamber, preferably under a microscope. The tool is then withdrawn through the lateral interspace between the sheet-like units, whereby the sheet-like units again come into contact with each other at their ends and the chamber is closed. For the charging process, for example a charging station can be provided in which the pre-charging unit can be attached. The charging station features a rotary tool (p. g., a knife) that is rotated into the lateral interspace between the blade-like units and can be rotated out of it again.

Preferably according to the invention, at least one sheet-like unit has another hole which is arranged above the limitation of the camera for storing an optical lens. In the previous loading process, this makes it possible to better control the correct positioning of the lens in the camera, since the person who performs the process can see through the hole that the lens is exactly arranged in the camera and not , for example, in one of the constraints. Typically, this second hole may have a diameter of between 0.3 and 0.6 mm.

An essential element of the preload unit according to the invention is a slide which is movably arranged inside the housing and which can be moved between the blade-like units of the lens housing unit. Said slider must be able to move so far forward between the sheet-like units that it comes into contact with the lens on the camera and can fix it. Preferably, the slide tapers toward the end that moves between the sheet-like units. For a better fixation of the lens, the front end of the slider is configured correspondingly complementary to the shape of the lens.

Inside the housing, the slide moves freely and independently of the other components. Preferably, the section of the slide located in the casing of the preload unit has a thickness slightly less than the diameter of the continuous bore in the casing of the preload unit. Within that perforation, the slider is accessible for handling elements of the handle described below.

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As mentioned above, the preload unit is preferably designed for a single use. Therefore, according to another aspect of the present invention, the preload unit is stored in a sterile container from which it is removed immediately before placing the lens in the eye and is attached to the handle.

The present invention also refers to a kit comprising a storage unit and a preload unit described above inside the storage unit, wherein the storage unit is made of a waterproof material and can be closed securely. waterproof by means of a plug.

Especially preferably, the preload unit is loaded with a desired optical lens and then packaged sterile. This facilitates the activity of the person who places the lens.

In order to be able to store the preload unit sterile for a longer period, it is packaged in a storage unit that protects the preload unit from environmental influences. For this, the storage unit is filled with a storage liquid inside that permanently covers at least the lens that is in the chamber of the preload unit. Said liquid can be water; however, physiological saline (NaCl) is preferred as the storage liquid.

The storage unit is made of a waterproof material and thus only allows, if it does, the passage of water vapor to a minimum. This is important to ensure a sufficient storage liquid level within the storage unit throughout the entire storage period. In the case of a non-impermeable material, the storage liquid would evaporate after a certain time and the lens in the chamber of the preload unit would no longer be stored in a sterile way. The person skilled in the art knows waterproof materials. Examples of this are glass or a waterproof plastic material. After inserting the preloading unit, the storage unit is sealed tightly with a suitable plug. Preferably, this plug is made of a waterproof plastic material.

The applicator according to the invention further comprises a handle. Typically, it is an elongated tube shaped to ensure easy grip of the handle in the hand. As mentioned above, the handle is configured at one end so that the preload unit and the handle can be attached to each other so that the preload unit can be moved within the handle. For this, the handle has a diameter that exceeds the diameter of the part of the preload unit that is inserted into the handle. The handle is hollow inside, at least at the end that is attached to the preload unit. However, it is preferably a completely hollow tube.

The preload unit is attached to parts within the handle that are movable. Thus, by means of a movement of these parts, the preload unit also moves. Preferably, this movement is carried out with the aid of a control element located on the surface of the handle. Preferably, the operating element is a slider that is attached to corresponding parts in the internal space of the handle through an elongated opening in the handle.

According to the present invention, the slide of the preload unit moves independently of the rest of the preload unit. This is preferably achieved according to the invention by means of an additional operating element, which is also located on the surface of the handle. Preferably, this operating element is also a slider that is attached to the corresponding inserts in the internal space of the handle through an elongated opening in the handle. These inserts are similar to a gun ejector. If the operating element is moved forward on the surface of the handle, the inserts come into contact with the slide of the preload unit and move it forward independently of the rest of the preload unit.

To secure these inserts in the handle, according to a preferred configuration of the present invention, a pin protruding through an opening in the handle is placed in the inserts and secured there.

According to a particularly preferred embodiment of the present invention, the two operating elements described above are connected to each other such that the second operating element, which moves the preload unit with the exception of the slide, can only be operated when the first operating element, which moves the slide of the preloading unit, it is in a position in which the slide that moves with it is fully pulled out of the casing of the preload unit. Otherwise, the second control element is blocked. This prevents accidental displacement of the blade-like units of the preload unit without prior fixing of the lens in place.

According to an alternative embodiment of the present invention, the handle can have only one operating element. In this embodiment, the single operating element serves to move the slide of the preload unit. The operating element is located on the surface of the handle. Preferably, this is also a slider that is attached to the corresponding inserts in the internal space of the handle through an elongated opening in the handle. These inserts are similar to a gun ejector. If the operating element is moved forward on the surface of the handle, the inserts come into contact with the

ES 2 623 019 T3 slide of the preload unit and move it forward Independently from the rest of the preload unit. The particularity of this embodiment is that a locking mechanism is activated with the operating element through the maximum forward movement of the slide, thereby moving the rest of the preloading unit with the units as a leaves arranged in it. Preferably, activation of the locking mechanism causes automatic movement towards the handle of the remainder of the preload unit with the blade-like units arranged therein, for example by means of a spring mechanism. In this way, the release of the lens is achieved through the maximum forward movement of the single operating element.

The handle of the applicator according to the invention is intended for multiple application. To this end, according to a preferred embodiment of the present invention, the handle can be completely disassembled, so that all components can be completely cleaned and sterilized. According to this embodiment, the operating elements arranged on the surface can be removed, whereby the components attached to the operating elements inside the handle can be removed from the handle. Additionally, in the case of the inserts provided for the movement of the slide, the pin described above must be pressed from the opening in order to be able to remove the inserts.

After cleaning is complete, the handle can be reassembled, where care must be taken that the operating elements are in the correct position.

However, according to an alternative embodiment of the present invention the handle can also be provided for single use as well. Accordingly, in this embodiment the handle need not be removable for cleaning purposes. Preferably, according to this embodiment, the handle is also stored separately in a storage unit analogously to the unit described above until use. However, according to this embodiment, it is also possible that the preload unit and the handle are already stored as a unit (either detachably, as described above, or alternatively, fixedly attached between yes) in a storage unit in the same way as the unit described above until use. For this reason, the applicator according to this alternative embodiment can be structured in another way, being able to replace the previous pieces to join the handle and the preload unit by a fixed connection of these components.

With the aid of the applicator according to the invention, a simpler and more exact positioning of a lens in the eye is possible. Preferably, in this case it is a question of correct positioning of an intracorneal lens in a corneal pocket.

According to another aspect, the present invention also relates to a method for introducing an optical lens, preferably an intracorneal lens, into the eye of a human or an animal, comprising the steps of

a) positioning the applicator described above in the desired location of the eye, preferably in a pocket on the human cornea, so that the center of the optical lens contained in the applicator is located on the optical axis of the eye;

b) pushing the slider forward by means of a first operating element on the handle until the slider comes into contact with the lens without moving it, wherein, at the same time, the blade-like units of the lens housing part separate from each other;

c) extracting the remainder of the preload unit by a defined amount by means of a second operating element on the handle while fixing the slide, thereby releasing the lens from the applicator.

The preload unit, preferably sterilely stored, is removed from the storage container and attached to the handle, preferably in a twist-resistant manner. Subsequently, the applicator obtained in this way is positioned in the desired place of the eye with the lens loaded. Preferably, the ends of the blade-like units of the preload unit that form the chamber with the lens therein are inserted into a pocket previously produced in the cornea of ​​an eye. According to a particularly preferred embodiment of the present invention, the preload unit has an opening which passes through the camera with the lens. This allows the person performing the method to align the lens exactly on the optical axis of the eye while the lens is still in the applicator chamber. According to the invention, this can be carried out much more simply, since the applicator can be handled with much greater ease than a single, small and flexible lens.

The lens is then fixed within the applicator by pushing the first operating element fully forward on the handle, thereby maximally moving the slide of the preload unit forward so that it comes into contact with the lens. found in the chamber. This is possible thanks to the fact that, by the forward movement of the slide, the leaf-like units are separated from each other and thereby the interior of the chamber becomes accessible.

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In the next step, the rest of the preload unit, except the slide, is withdrawn from the eye by a defined amount with the help of the second operating element pushing the rest of the preload unit into the handle. During this step, the slider remains fixed and thereby keeps the lens exactly in the previously aligned position.

By removing the remainder of the preload unit, the lens is released from the applicator exactly in the previously aligned position. With this, the lens is already positioned in the desired way in the eye. According to the present invention, no further alignment step is necessary.

The applicator is then removed from the eye and disassembled into its individual pieces. Preferably, at that time the intended preload unit is discarded for a single use, while the handle is disassembled and cleaned so that it is available for the next use with a new preload unit.

The present invention is primarily intended to insert optical lenses, particularly intracorneal lenses, into corneal pockets. However, the applicator according to the invention can in principle also be used to introduce objects other than a lens into the eye.

As an example, we can mention the introduction of tissue (donor cornea) in the DSAEK 15 method (DESCEMET STRIPPING AUTOMATED ENDOTHELIAL KERA-TOPLASTY). This method is applied in the case of damage to the endothelium (the posterior surface of the cornea) to treat a blinding of the cornea caused by it (overview in Cursiefen / Kruse, Ophthalmologe 2008, 105, 183-192).

In the DSAEK method, not the entire cornea is replaced, but advantageously only the affected layer of the cornea. With the aid of a keratome (as described for example in application EP-1 778 141 A1) a small incision is made in the outer layer of the cornea. The cornea is then uncovered and the area that has become opaque is replaced with a donor cornea.

The donor corneal layer can be introduced with the aid of the applicator according to the invention. In this variant, instead of a lens, the chamber of the preload unit contains a donor cornea which, analogously to that described above for a lens, can be applied to the corneal pocket. In principle, no further adaptations of the applicator or the method performed with the applicator are required.

The present invention is explained in greater detail below by means of figures and non-limiting examples.

In these they show:

Figure 1 Figure 2 Figure 3a Figure 3b Figure 4 Figure 5 Figure 6 Figure 7 an embodiment of the applicator according to the invention;

an embodiment of the preload unit according to the invention;

an embodiment of the front section of the preload unit according to the invention;

the front section of the preload unit according to the invention according to figure 3a in an open state;

a cut through an embodiment of the preload unit according to the invention;

an embodiment of the kit according to the invention formed by the storage unit and the preload unit;

releasing the lens from the preload unit according to the invention;

an alternative embodiment of the handle according to the invention.

In Figure 1 an embodiment of the applicator 1 according to the invention is shown. A preloading unit P is movably arranged on the handle 7. The preloading unit P comprises a housing 2, two blade-like units 3 and a stop element 6. In the blade-like units 3 there is a continuous aperture 4 through the center of the chamber (not visible in this case) to house a lens. Furthermore, another hole 5 is provided which simplifies loading the applicator 1 with a lens. Two operating elements 8 and 9 are arranged in the handle 7. A pin protrudes from the side opening 10 which is attached to the inserts on the handle and secures them to the handle 7.

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In Figure 2 the preload unit P of Figure 1 is shown separately and in greater detail. In the housing 2 the lens housing part 11 is locked. The lens housing part 11 protrudes from the casing 2 and becomes the two units 3 as sheets. At the other end of the casing 2 there are fixing means 12 for attaching the preload unit P to the handle 7. In this case, a bayonet lock is made.

In Figure 3a the front section of the preload unit P according to the invention is shown in detail. In Figure 3b the same previous section is shown in the open state (without the upper unit 3 as a sheet). Lens L is located in chamber 14 between units 3 like sheets. The sheet-like units 3 have constraints 13a to 13d around the chamber 14. The constraints 13a to 13d are wavy shaped and fit one another in a toothed manner. These are raised slightly and thus form a chamber 14 into which a lens L can be inserted.

Figure 4 shows a section through an embodiment of the preload unit P according to the invention. The housing 2 has a continuous perforation on the inside in which the lens housing part 11 is locked. A slide 15 is also arranged inside the housing 2 and can be moved there freely. The slide 15 tapers forward so that it can be moved between the sheet-like units 3 to the camera with the lens L located there.

Figure 5 shows an embodiment of the kit according to the invention, comprising a storage unit 16. Inside the storage unit 16, the preload unit P is stored in a physiological saline solution. The storage unit 16 is made of glass. This is closed in a waterproof way with a cap 17.

Figure 6 shows how a lens L is released from the preload unit according to the invention. The slider 15 is moved forward until it comes into contact with the lens L. Thereby, the sheet-like units 3 are separated from each other. The sheet-like units 3 can then be removed by a defined amount while the slider 15 keeps the lens L in the previously aligned location. At this point the lens L is released and the applicator according to the invention can be removed.

An alternative embodiment of the handle 7 according to the invention is shown in Figure 7. This handle has only one operating element 8. The slide 15 (not shown here) is moved with the aid of the operating element 8. The operating element 8 is attached to corresponding inserts in the interior space of the handle 7, the which are also not shown in this case, through an elongated opening in the handle 7. These inserts are similar to the ejector of a weapon. If the operating element 8 is moved forward on the surface of the handle 7, the inserts come into contact with the slide 15 of the preload unit P and move it forward independently of the rest of the preload unit P. The maximum forward movement of the slide 15 with the operating element 8 activates a locking mechanism (not shown), for example a bolt, whereby the rest of the preload unit P moves with the units 3 like leaves arranged there. Preferably, the release of the locking mechanism causes an automatic movement towards the handle 7 of the rest of the preload unit P with the blade-like units 3 arranged therein, for example by means of a spring mechanism. In this way, by the maximum forward movement of the single operating element 8, the release of the lens is achieved.