WO2018091461A1

WO2018091461A1 - An inserter for an eye implant

Info

Publication number: WO2018091461A1
Application number: PCT/EP2017/079197
Authority: WO
Inventors: Joonas Mikkonen; Taina TJÄDER; Mikael Stolt; Manja Ahola
Original assignee: Bayer Oy
Priority date: 2016-11-18
Filing date: 2017-11-14
Publication date: 2018-05-24

Abstract

The present invention relates to an inserter for an eye implant, comprising a hollow cover (31) having a first end and a second end; a slider (35) movably arranged inside the cover, having a first end and a second end; sliding means (36) movably arranged on the cover and attached to the slider, for moving the slider; a needle (32) having a first end and a second end, arranged to move within the slider; and a plunger (38) arranged inside the slider, partially inside the needle and attached to the cover; wherein the slider is arranged to move in relation to the plunger.

Description

AN INSERTER FOR AN EYE IMPLANT

FIELD OF THE INVENTION

The invention relates to an inserter for an eye implant. The inserter comprises a cover, a plunger arranged inside the cover and a needle. The eye implant is arranged inside the needle.

BACKGROUND OF THE INVENTION

Inserters for eye implants are known in the art. The known inserters are based on a structure where a plunger is arranged inside a needle, the needle is attached to a handle, and the implant is pushed out of the fixed needle by the moving plunger. Such structures apply a considerable amount of force on the implant, which due to its size and constitution, is rather fragile. Another problem that may be encountered with this kind of inserter is that when the implant is inserted, the implant is pushed into the eye tissue on its own.

Another known inserter has a needle and a plunger therein, wherein the needle is retracted to release the implant from the needle. In this inserter however, the plunger passes through the whole inserter (i.e. including the handle), and for a small needle, the small plunger can easily bend and thus jam.

A further problem with the known inserters for eye implants is their ergonomic. Indeed, an inserter that is used in a manner similar to a syringe may not be ergonomically optimal for eye insertion. OBJECTS AND SUMMARY OF THE INVENTION

There exists thus a need to provide an inserter for eye implants that is safe and ergonomic to use, easy to manufacture and that does not damage the eye implant during its insertion. The present description relates to an inserter for an eye implant, comprising

- a hollow cover having a first end and a second end,

- a slider movably arranged inside the cover, having a first end and a second end,

- sliding means movably arranged on the cover and attached to the slider, for moving the slider,

- a needle having a first end and a second end, arranged to move within the slider, and

- a plunger arranged inside the slider, partially inside the needle and attached to the cover, wherein the slider is arranged to move in relation to the plunger.

The present description also relates to a kit comprising an inserter as described above and at least one eye implant.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1A-1D schematically illustrate an inserter according to an embodiment and the basic principle of insertion.

Fig. 2A-2C schematically illustrate different cross-sections of implants within a needle. Fig. 3 schematically illustrates an inserter according to an embodiment.

Fig. 4 shows the inserter of Figure 3 as a cross-sectional view.

Fig. 5A-5B schematically illustrate the inserter of Figure 3 during the insertion.

Fig. 6 illustrates one example of mechanical means limiting the movement of the slider with respect to the cover.

Fig. 7 illustrates another example of mechanical means limiting the movement of the slider with respect to the cover. Fig. 8A-8D illustrate an inserter according to a further embodiment.

Fig. 9 illustrates an inner part of an inserter according to yet another embodiment.

Fig. 10 illustrates a partial cross-section of an inserter comprising the inner part of Figure 9, in a first position. Fig. 11 illustrates a partial cross-section of the inserter of Figure 10, in a second position.

DETAILED DESCRIPTION OF THE INVENTION

The present description relates to an inserter for an eye implant, comprising - a hollow cover having a first end and a second end,

- a slider movably arranged inside the cover, having a first end and a second end, - sliding means movably arranged on the cover and attached to the slider, for moving the slider,

It is believed that the present inserter overcomes the problems in prior art inserters. Indeed, as the plunger is attached to the cover (either directly or via a supporting part), only a minimal length of the plunger is left unsupported, and thus there is a lesser risk for the plunger to bend or to get jammed inside the needle.

In the present description, by first ends are meant the proximal ends, i.e. the ends that are closer to the eye when the inserter is used for inserting an eye implant. The second ends are the opposite ends to the first ends, i.e. the distal ends that are closer to the user of the inserter when an eye implant is being inserted.

The cover of the inserter functions also as a handle of the inserter. It preferably has a form suitable for handling, such as a cylinder or with a proximal part that is cylindrical and a distal part having a larger, rounded shape, making it suitable for handling. The cover thus preferably has a longitudinal shape, i.e. its length (the distance between its first end and its second end) is significantly larger than its other dimensions. According to an embodiment, the cover also has at least one cover slot along its longitudinal direction, for allowing movement of the slider together with the sliding means. The length of the cover slot is defined by the dimensions of the other parts as will be discussed below. The width of the cover slot is rather small, for example up to 40 %, preferably up to 30 %, more preferably up to 20 % of the circumference of the handle, or in case the cover has a rectangular cross-section, of the width of the side of the rectangle it is located on. The cover slot extends through the thickness of the hollow cover's wall, i.e. from the outside of the cover to its inside. According to another embodiment, the cover comprises two cover slots along its longitudinal direction. Preferably the two cover slots are diametrically opposed to each other and have essentially the same size and shape.

The slider is arranged inside the cover, in a manner that it can move therein. It also has a longitudinal shape as the cover. It is moved with the help of the sliding means, which is arranged on the cover slot in a movable manner. The sliding means can be for example in the form of a button or a rounded piece arranged around the cover of the inserter.

The sliding means is attached to the slider. It may be attached to it in a releasable manner, i.e. detaching the sliding means from the slider requires an active action from the user. According to an embodiment, the slider comprises at least one slider slot along its longitudinal direction, for allowing movement of the slider in relation to the plunger. The slider may also comprise two slider slots along its longitudinal direction, preferably the two slider slots are diametrically opposed to each other and have essentially the same size and shape.

According to another embodiment, the sliding means is attached to the slider by a first pin. Preferably, the first pin is arranged to pass through the at least one cover slot and in in case of two cover slots, through both cover slots. The needle is dimensioned such that the eye implant is arrangeable inside the needle for insertion. The needle is typically manufactured from a metallic material, such as stainless steel.

In the present case, the plunger is attached to the cover of the inserter. The plunger is arranged inside the cover and partially inside the slider. The plunger is also arranged partially inside the needle. Further, the slider is arranged to move with respect to the plunger.

According to an embodiment, the plunger is attached to the cover by a second pin. When such second pin is used, it can be arranged to pass through the at least one slider slot. In case of two diametrically opposed slider slots, the pin may pass through both slider slots. Most preferably, the attachment is done via the part of the plunger that is not inside the needle.

The inserter may also comprise an elastic element arranged inside the cover, between the second end of the slider and the second end of the cover. This elastic element, which may be for example a spring or a strip of an elastic material such as silicone rubber, can create a resistance for the movement of insertion, thus preventing accidental injection of the implant at a too early stage.

In another embodiment, the slider comprises a further slot into which the first pin can be arranged. The first pin (connected to the cover) then restricts and control the movement of the slider, while the movement is allowed by the further slot. Such a slider can also comprise an actioning part that is configured to be pressed down by the surface of the cover at the beginning of the slider movement, and kept pressed down during insertion of the implant. At the end of the slider movement, there is a slot in the cover where the actioning part is moving, and from which it cannot be retracted back. Movement of the slider and in consequence that of the needle is then locked by the actioning part and the slot in the cover. This embodiment is illustrated in more detail below in the Figures. In the present inserter, the sliding means can be positioned in an optimal distance from the inserter proximal tip for the easiest use for the user. Also the length of the plunger can be as short as possible without compromising the length of the cover, thus giving a more ergonomic experience for the user. After the needle has been injected in the implantation site, the user can pull the sliding button back which retracts also the needle. Because the fixed plunger inside the needle does not allow the implant to move with the needle, the implant is leaved in position inside the tissue. The insertion depth can be adjusted by the length the plunger tip. The spring(s) used in the present invention are preferably made of metallic wire in a coil form. Any elastic element can be either a spring or a block or strip made of an elastic material, such as silicone. Majority of the other parts, with exception to the needle, are made in plastic materials such as polyolefins or polyamides. They may also be made of fiber reinforced plastic materials or metal, such as stainless steel, titanium or titanium alloys.

According to yet another embodiment, the inserter also comprises frictional means limiting the movement of the slider with respect to the cover. The inserter may also or instead comprise mechanical means limiting the movement of the slider with respect to the cover. These mechanical means can be for example a slope element or a combination of a threaded rod and a bolt. These means are thus means for adjusting the movement of the needle. Indeed, before insertion, it may be beneficial to fix the needle in such a manner that it does not retract while the needle is injected into the eye. The means adjusting the movement of the needle can be achieved for example by friction between the components or a mechanical shape between the cover and the sliding parts (slider and/or sliding means). It is also possible to place a spring between the end of the inserter cover and the slider to prevent a retracting movement of the needle happening too easily. The spring can be position either between the first end of the inserter cover and the slider or between the second end of the inserter cover and the slider. Another option could be to use a slope element that restricts the movement of the slider. A yet further possibility is to retract the movement with a threaded rod and a bolt that the moving slider needs to wind along the threaded rod, increasing the friction of the slider movement.

The inserter should be designed to be such that the eye implant is always inserted to a correct depth. This insertion depth can for example be adjusted by the length of the plunger. It could also be adjusted by the size of the other components of the inserter. A person skilled in the art would be readily able to design the size of the inserter to achieve the correct insertion depth.

The inserter according to the present description functions as follows. In the beginning of the insertion process, the tip of the needle is outside the inserter . The user injects the needle into the eye. Then the user moves the sliding means backwards and the needle retracts while the implant and the plunger remain at their positions, thus allowing the needle to release the implant into the eye at a certain depth. The retraction of the needle is caused by releasing the sliding means from the slider. In a final, optional step, the plunger also retracts.

It might also be necessary to press the injection site a few minutes after the insertion has been done, in order to ensure that the small incision is correctly closed. This could be done by using the tip of the inserter, i.e. by maintaining the inserter in place a few minutes after the needle has been retracted. The tip of the inserter may be designed to optimise this step, too.

A possibility for insertion of two implants could also be required if a higher drug dose is required. One solution for this would be two parallel needles that both insert a single implant using the embodiments described earlier. It would also be possible to position two implants inside one needle, one after another. When releasing the distal implant, the needle would preferably have a flange or a mark to show the correct insertion depth for the first implant. There could be a mechanical stopper of the movement of the slider that tells the user that the first implant is released. For the second implant, the needle would then be inserter fully into the eye and the needle could then be retracted fully, releasing the second implant.

According to an embodiment, the inserter thus further comprises means for indicating that a first implant has been released from the inserter. The inserter may also further comprise means for stopping the movement of the sliding means when a first implant has been released from the inserter. In a yet another embodiment, the inserter comprises a second needle arranged to move within the slider and in contact with the plunger. After the eye implant has been inserted and the needle has retracted, it would be preferable, for hygienic reasons, to prevent re-use of the inserter. To this end, the movement of the needle after retraction could be blocked with a mechanical shape or similar, as described above. For example a mechanical shape or a slope could lock the slider inside the inserter. In some embodiments, it might also be necessary or preferable to attach the eye implant inside the needle, in order to prevent it from falling out before insertion. This could be achieved for example in a mechanical manner, by using eye implants with cross-sections that fit snugly inside an essentially cylindrical needle. For example, the cross-section of the eye implant could oval, triangular or square. Thereby friction would hold the implant inside the needle, while the implant would still be easily released using the plunger, due to a small contact area between the implant and the needle, i.e. only a small force is needed to overcome the friction.

Another option could be to arrange a small protrusion at the tip of the needle, to prevent the eye implant from falling out of its own. A yet further option could be to use a small amount of glue to attach the implant or part of the implant to the inner surface of the needle. Similarly, a small amount of a solvent capable of dissolving the surface of the implant in order to attach it to the inner surface of the needle could be used. Furthermore, it may be suitable to use a small cap at the tip of the inserter or at the tip of the needle, to ensure that the implant is maintained in correct position during transportation of the inserter in its package. The cap may comprise for example a small metallic spike inserted inside the tip of the needle.

The present description relates also to a kit comprising an eye inserter as has been described above, and at least one eye implant arranged inside the needle of the inserter. The eye implant can be any suitable eye implant, such as made of an elastomeric material comprising a therapeutically active agent. The eye implant could also be made of a degradable material that releases the therapeutically active agent when it degrades. Furthermore, the eye implant can be made of a material which degrades so slowly that it can first release the therapeutically active agent (for example by diffusion) and only after essentially all of the therapeutically agent is released, the implant material degrades.

DETAILED DESCRIPTION OF THE DRAWINGS

Figures 1A to ID schematically illustrate an inserter according to an embodiment and the basic principle of insertion using an inserter according to an embodiment of the present disclosure. Figure 1A shows an outer surface of the eye 10, against which needle 12 will be pressed. The implant 13 is inside the needle 12. The implant 13 is arranged at the tip of the plunger 14. In Figure IB, the needle 12 has already been inserted inside the eye, but the implant 13 is still inside the needle. In Figure 1C the implant is being released. Indeed, as can be seen, the needle 12 has been retracted and the implant 13 is outside of the needle, but still in contact with the plunger. In Figure ID, the implant 13 is released and both the plunger 14 and the needle 12 are retracted within the cover 11.

Figures 2A to 2C schematically illustrate different cross-sections of implants 23a, 23b and 23c within a needle 22. These cross-sections, which are triangular for the implant 23a, rectangular for the implant 23b and oval for the implant 23c create a certain amount of friction between the implant and the inner wall of the needle, thus keeping the implant in place within the needle. Figure 3 illustrates an inserter according to an embodiment, as an exploded view. The Figure shows a hollow cover 31 having a first end 31a and a second end 31b. The slider 35 also has a first end 35a and a second end 35b. In this embodiment, the sliding means 36 is in the form of a knob surrounding the cover 31. It has a larger part that is arranged on its first end, i.e. the end that is towards the tip of the cover (its proximal end). The sliding means 36 is attached to the slider 35 by a first pin 37. A needle 32 that also has a first end 32a and a second end (not visible in the Figure) is arranged to move within the slider. Further, a plunger 38 is arranged inside the slider 35, partially inside the needle 32 and it is attached to the cover 31. This attachment is done by a second pin 39. The slider 38 is arranged to move in relation to the plunger 35 and in this embodiment, the plunger 35 is arranged in front of the sliding means 36, i.e. at the proximal end of the sliding means.

The Figure also shows one cover slot 40 arranged on the cover and two slider slots 41 arranged on the slider 38. The second pin 39 passes through the slider slots 41 and the first pin 37 passes through the outer surface of the sliding means 36, the cover slot 40 and a pair of openings 42 arranged in the slider 35.

Figure 4 shows the inserter of Figure 3 as a cross-sectional view, to further illustrate the position of the various parts with respect to each other. As can be seen, the plunger 38 is positioned in front of the sliding means 36, and the needle 32 passes through a part of the slider 35.

Figures 5A and 5B schematically illustrate the inserter of Figure 3 during the insertion. In Figure 5A, the inserter is ready for insertion. The needle 32 is in its outmost position and the implant is inside the needle. The sliding means 36 is at its proximal position on the cover 31. In Figure 5B, the needle has been injected into the implantation site and the user has pulled the sliding means 36 backwards (towards the second end of the cover). As the plunger is fixed, the needle does not allow the implant 33 to move with the needle but rather, the implant 33 remains at the implantation site while the needle is retracted

Figure 6 illustrates one example of mechanical means limiting the movement of the slider with respect to the cover. At the cover slot 40 can be seen a slope element 61, which is arranged on a side of the cover slot. When the first pin 37 comes into contact with the slope element 61, the movement of the sliding means 36 is stopped.

Figure 7 illustrates another example of mechanical means limiting the movement of the slider with respect to the cover. In this embodiment, the means is a combination of a rack and pinion 71, which creates a certain limit for the force to be applied on the sliding means in order to move it.

Figures 8A-8D illustrate an inserter according to a further embodiment. In this embodiment, the inserter further comprises a locking means 81 for locking the movement of the slider 85 during insertion of the needle. The locking is made in such a manner that the movement of the slider does not require a force that is too high for handling the inserter. In Figure 8A, the locking means 81 is shown as detached from the rest of the inserter. As can be seen, it has a general U-shaped form, and it is sized to fit on the (narrowed) tip of the slider 88. There are two locking wedges 89 (one being visible in Figure 8A), each arranged to fit in a recess 90 (one being visible in Figure 8A) of the narrow tip of the slider 88. Figures 8B and 8C show the locking means 81 being arranged on the narrow tip of the slider 88. In the position shown in Figure 8B, the locking means 81 restricts the movement of the slider 85 and sliding means 86 during insertion of the needle (not shown). In figure 8C the locking means 81 is moved in such manner that the locking wedges 89 move out from the recess 90 allowing movement of the slider 85. In Figure 8D is illustrated a situation where the sliding means 86 and slider 85 have been retracted, and the locking means 81 has remained in its original position (due to the fact that is passes through the outer cover of the inserter and hence cannot move). Figure 9 illustrates an embodiment of the slider. The slot 96 allows movement of the slider 90, restricted by the first pin (not shown in the Figure) connected to the cover like in the previous embodiments. The actioning part 92 is pressed down by the surface of the cover at the beginning of the slider movement. At the end of the slider movement, there is a slot in the cover (not shown in the Figure) where the actioning part 92 is moving and the movement of the slider is locked by the actioning part 92 and the slot in the cover. -The actioning part 92 has the function of locking the needle once it has been retracted inside the inserter after insertion. Figure 10 illustrates a partial cross-section of an inserter comprising the inner part of Figure 9, in a first position and Figure 11 illustrates a partial cross-section of the same inserter, in a second position. These Figures show partially the inner part 90 as well as the sliding means 91. Moreover, the plunger 94 is illustrated in two different positions, a first position in Figure 10, where the needle (not shown) is still out of the inserter, and a second position in Figure 11, where the needle (not shown) has been retracted within the inserter. As can be seen, the actioning part 92 is, in the second position of Figure 11, arranged in the slot 93 of the inserter cover 95. The movement of the inner part 90 is then prohibited and the needle is safely stored inside the inserter.

Claims

1. An inserter for an eye implant, comprising

- a hollow cover having a first end and a second end,

2. An inserter according to claim 1, wherein the cover comprises at least one cover slot in its longitudinal direction, for allowing movement of the slider together with the sliding means.

3. An inserter according to claim 1 or 2, wherein the sliding means is attached to the slider by a first pin.

4. An inserter according to claims 2 and 3, wherein the first pin is arranged to pass through the at least one cover slot.

5. An inserter according to any of the preceding claims, wherein the slider comprises at least one slider slot along its longitudinal direction, for allowing movement of the slider in relation to the plunger.

6. An inserter according to any of the preceding claims, wherein the plunger is attached to the cover by a second pin.

7. An inserter according to claims 5 and 6, wherein the second pin is arranged to pass through the at least one slider slot.

8. An inserter according to any of the preceding claims, further comprising an elastic element arranged inside the cover, between the second end of the slider and the second end of the cover.

9. An inserter according to any of the preceding claims, further comprising frictional means limiting the movement of the slider with respect to the cover.

10. An inserter according to any of the preceding claims, further comprising mechanical means limiting the movement of the slider with respect to the cover.

11. An inserter according to claim 10, wherein the mechanical means is a slope element or a threaded rod and a bolt.

12. An inserter according to any of the preceding claims, further comprising means for indicating that a first implant has been released from the inserter.

13. An inserter according to any of the preceding claims, further comprising means for stopping the movement of the sliding means when a first implant has been released from the inserter.

14. An inserter according to any of the preceding claims, further comprising a second needle arranged to move within the slider and in contact with the plunger.

15. A kit comprising an eye inserter according to any of the claims 1-14 and at least one eye implant arranged inside the needle of the inserter.