EP1898839A2

EP1898839A2 - Insertion device for an iol and also packaging

Info

Publication number: EP1898839A2
Application number: EP06747600A
Authority: EP
Inventors: Bernardus Franciscus Maria Wanders
Original assignee: MEDICAL DEVICE PRODUCTION BV
Current assignee: Oculentis Holding BV
Priority date: 2005-07-01
Filing date: 2006-06-27
Publication date: 2008-03-19
Also published as: WO2007037689A3; NL1029402C2; WO2007037689A2

Abstract

Insertion device for inserting an IOL. It consists of a pointed part and connected thereto wing parts which can be moved towards one another from an open position for folding an IOL which is then inserted into the insertion channel of the pointed insertion part of the insertion device. To lock the IOL in the correct position there are retainer means which consist of a retaining lip fitted to a wing part. The wing parts are to be locked to one another only after the retaining lip has been removed. The invention also relates to a packaging in which there is the combination of insertion device and retainer means, including lens, so mat before the lens is positioned the user has only to move the wing parts towards one another when the retaining Hp is removed and then insert the insertion device with IOL into an injector.

Description

Insertion device for an IOL and also oackasine

Background to the invention

The present invention relates to an insertion assembly for an IOL (intraocular lens) comprising an insertion device for inserting an intraocular lens (IOL) comprising a pointed or tip-shaped insertion part with an insertion channel and a folding part located upstream thereof, said folding part comprising a first wing part, which is rigidly connected to said insertion part, and a second wing part which is hingingly connected to said first wing part, wherein each of the wing parts comprises a receptacle part, said receptacle parts together forming a receptacle for a folded IOL, and also retainer means for the IOL, to be fitted on a wing part, said retainer means comprising engagement means for engaging with said wing part.

Such an insertion assembly is disclosed in US 6,129,733. In the state of the art intraocular lenses are supplied in a separate packaging. There may possibly be an insertion device with said packaging. In the operating room the lens is subsequently removed from the packaging (may be a bottle filled with fluid) and placed in the insertion device. Only afterwards is the lens folded and put into the eye with the aid of an injector. As a result of this the lens is in the adverse position of being folded up for only a very short time.

This method has the disadvantage that hospital staff have to handle the lens. This can lead to problems and errors.

An improvement is found by supplying in a packaging both the insertion device and a separate accessory in which the lens is accommodated (US 6,129,733A). At the site of use the accessory is placed over the insertion device and linked to it The accessory is hinged such that the lens can be delivered from it and can be conveyed between the wings of the insertion device. Because of its rigid construction and considerable size the accessory is considerably easier to handle than the loose lens. There is still the problem of handling the lens before it can be inserted with the insertion device (or cartridge) into the injector

Summary of the invention

It is the aim of the present invention to prevent this disadvantage. This aim is achieved with an above-described insertion assembly in that said retainer means engage with only one wing part and said engagement elements are fitted for engaging with said one wing part on two opposite sides.

According to the present invention an insertion assembly is provided, wherein with the aid of the retainer means the lens is already positioned in the correct position in the insertion device. The retainer means prevent the lens escaping from the insertion device. On the other hand the insertion device can be in the desired open position, in other words in the optimum position for the lens, so the optical properties thereof are not disadvantageously influenced. Because it is supplied in this way, it is no longer necessary to place the lens in the insertion device at the site of use, since it is already in the insertion device. It is necessary only to remove the retainer means from the insertion device at the moment of use. This can be done by a simple sliding, snapping or clicking action. Once the retainer means have been removed, the positioning of the lens inside the insertion device is admittedly less secure, but during or immediately after the retainer means have been removed the wing parts of the insertion device are moved towards one another, resulting in the lens being securely locked in the insertion device. Subsequently the movement of the lens into the eye through the pόintof the insertion device can take place in the normal way with an injector.

According to one advantageous embodiment of the invention the width of the retainer means is substantially identical to the width of the wing part concerned or smaller. In other words the retainer means have a dimension which is just sufficient for handling thereof but a dimension which is far smaller than the construction of the accessory shown in American patent specification 6,129,733.

The retainer means can be fitted to either the wing part fixed with respect to the pointed insertion part or to the hinged wing part. However, it should be understood that the retainer means are fitted to only one of these wing parts.

It is further found possible create a retainer for the IOL which can continue to support the IOL when the insertion device is being closed and may even form a stop to guide the lens during closing. According to a fiirther advantageous embodiment of the invention the retainer consists of a first part extending from the engagement elements and a second part extending therefrom. The length of the two parts is identical, wherein the first part extends towards the receptacle for the lens part and the second part extends outwards. The first part can, moreover, be provided with a recess for the lens part for positioning it in a secured manner.

According to a further advantageous embodiment of the invention the receptacle part is provided near the hinge between the wing parts with an elevation supporting the IOL. This protects the IOL. Moreover, this has the effect that when the plunger is moved into the injector it is certain that the plunger engages with the lens with the front face thereof and the lens does not get stuck between the plunger and the receptacle. It is also possible to provide meticulous guiding for the plunger. Moreover, by means of such an elevation the friction drag between the IOL and the receptacle is reduced. It should be understood that the use of such an elevation can also be executed separately from the measures described in Claim 1 and express rights are requested for this.

According to a further advantageous embodiment of the invention there are locking means to lock the two wing parts jointly after they have been moved towards one another. These locking means are preferably executed such that one of the locking means comprises an elevation and the other a corresponding recess, wherein said locking means can click or snap into one another. The elevation is preferably fitted on the wing part that is not provided with the retainer means and positioned such that it cooperates with the retainer means. Consequently the wing parts cannot be moved towards one another because the locking cam concerned strikes against the retainer means. The user will then clearly understand that before he can move the wing parts closer together it is first necessary to remove the retainer means.

It should be understood that the use of such locking means can also be executed separately from the measures described in Claim 1 and rights are expressly requested for this. The invention therefore further relates, among other things, to an insertion assembly for the IOL (intraocular lens) comprising an insertion device for inserting an intraocular lens QOL) comprising a pointed insertion part with an insertion channel and a folding part located upstream thereof, said folding part comprising a first wing part which is rigidly connected to said insertion part and a second wing part which is hingingly connected to said first wing part, wherein each of the wing parts comprises a receptacle part, said receptacle parts together forming a receptacle for a folded IOL, as well as retainer means for the IOL to be fitted to one wing part, said retainer means comprising engagement elements for engaging with said wing part, wherein said retainer means engage with only one wing part and comprise a first part extending from said engagement elements in one receptacle part as far as in front of the other receptacle part.

In one embodiment thereof the insertion device comprises a hinge and the first part extends as far as in front of said hinge. In one embodiment the receptacle part is provided near said hinge between said wing parts with an elevation supporting an IOL.

In one embodiment the first part comprises a rim extending in the direction of the insertion channel, preferably an end rim which extends as far as between the supporting elevation and a hinge. In one embodiment the first part extends as far as over approximately a quarter of the

IOL.

In one embodiment the first part is provided with recess for the IOL.

These embodiments support the IOL during the closing of the insertion device. They also guide folding or rolling up of the IOL in the receptacle in the correct way. The invention further relates, among other things, to an insertion assembly for an IOL

(intraocular lens) comprising an insertion device for inserting an intraocular lens (IOL) comprising a pointed insertion part with an insertion channel and a folding part located upstream thereof, said folding part comprising a first wing part which is rigidly connected to said insertion part and a second wing part which is hingingly connected to said first wing part, wherein each of the wing parts comprises a receptacle part, said receptacle parts together forming a receptacle for a folded 1OL₅ and also retainer means for the IOL to be fitted to the wing part, said retainer means comprising engagement elements for engaging with said wing part, wherein said retainer means further comprise a first part extending from the engagement means, wherein said first part extends as far as into the receptacle part and there form a stop for an IOL during folding of the wing parts.

The invention also relates to a packaging comprising a holder part with an insertion part fitted therein for inserting an intraocular lens (IOL) comprising a pointed insertion part with an insertion channel and a folding part located upstream thereof, said folding part comprising a first wing part which is rigidly connected to said insertion part and a second wing part which is hingingly connected to said first wing part, wherein each of the wing parts comprises a receptacle part, said receptacle parts together forming a receptacle for a folded IOL, and also retainer means for the IOL, fitted to one wing part, said retainer means comprising engagement elements for engaging with said wing part and a lock placed on said holder part.

According to the present invention the combination of lens and insertion device is delivered to the site of use in the desired position by the presence of the retainer means.

The packaging may be a sterile packaging. If the lens is a hydrophilic lens it may be packed in a fluid. In order to pack the construction consisting of lens insertion device and retainer means stably, the holder part of the packaging may be provided with guides for clamping accommodation of both the retainer means and the insertion device. The lens is not, of course, touched by the packaging.

Brief description of the drawings

The invention will be explained in more detail below with reference to an illustrative embodiment depicted in the drawings. For this explanation:

Fig. 1 shows in perspective the insertion assembly according to the invention; Fig. 2 shows a detail of Fig. 1 ;

Fig.3 shows an injector combined with the insertion device according to the invention;

Fig.4 shows placing of the insertion assembly in a packaging;

Fig. 5 shows the opened packaging in top view and Fig. 6 shows the closed packaging ready for transport.

Description of an embodiment

In Fig. 1 an insertion assembly according to the present invention is illustrated by 9. This consists of an insertion device or cartridge 10 and retainer means or a retaining Hp 11.

The insertion device 10 consists of a pointed part 19 which is inserted into an incision in the eye. This part 19 is provided internally with an insertion channel 23. Part 19 is rigidly connected to a wing 12. Wing 13 is hingingly connected to wing 12 by hinge 14. Whig 12 is provided with an upright, slightly undercut locking cam 16. Wing part 13 is provided with a corresponding slightly undercut recess 17. Consequently the two wing parts can snap into one another.

Lip 11 is provided with a first part 31 and a second part 32. The first part 31 projects slightly into the space delimited by the receptacles 29 and 30. Part 31 is provided with a recess 18, by which an intraocular lens indicated by 21 can be accommodated in a secured manner. The haptics of the IOL 21 are indicated by 22. Lens 21 is additionally locked to some extent between grooves 20 fitted to each wing. This locking is, however, insufficient for the transport of lens 21. Therefore, according to the present invention a retaining lip 11 is fitted. As appears from Fig. 2, the retaining lip is provided with hook-shaped parts 25 which engage under the wing 13.

If a lens 21 has to be inserted in the eye, the wings 12 and 13 are moved out of the position shown in Fig. 1 towards one another. At the same time the lens will be folded over. This is further encouraged by the guide of the first part 31 of the retaining lip 11, since it presses the lens downwards into the receptacle 30 on approximately a quarter of the lens. Complete closing of the wings 12 and 13 is not possible because cam 16 strikes against retaining lip 11. At that moment it is, however, certain that the lens is retained in a secured manner inside the receptacle delimited by the receptacle parts 29 and 30 and by the grooves 20. Subsequently retaining lip 11 is removed by the nursing staff by simply pushing it in the direction of arrow 26. After this the wings 12 and 13 can be moved closer together when parts 16 and 17 are locked. Subsequently opening is no longer possible. After this the various elements are placed in the injector 27. This is provided with a plunger 28. Because the lens in the rolled up state rests on the elevations 15, the injector will always engage with the IOL 21 and the IOL is prevented from getting stuck between the front of the plunger 28 and the wall of the receptacle parts 29, 30.

Fig. 4 shows that the construction 9 including IOL 21 is fitted in the holder 2 as a whole at the place of production. Said holder 2, as is seen in Fig. 5, is provided with ribs 4 with grooves 5 for secured positioning of both the insertion device 10 and the retaining lip 11. Retaining lip 11 and insertion device 10 are here already in the position shown in Fig. 1 with respect to one another. Subsequently a lid 3 is placed, possibly after the holder 2 has been filled with a fluid. After closing, the various elements can be sterilised in the normal way.

It should be understood that the packaging can also be designed such that the injector is included in it

Moreover, it should be understood that further variants of the above-described concept are possible. Moreover, the measures in the dependent claims can be applied independently of the measure described in the main claim and protection is expressly requested for this.

Claims

SClaims

1. Insertion assembly for an IOL (intraocular lens) comprising an insertion device (10) for inserting an intraocular lens (IOL 21) comprising a pointed insertion part (19) with an insertion channel (23) and a folding part located upstream thereof, said folding part comprising a first wing part (12) which is rigidly connected to said insertion part (19) and a second wing part (13) which is hingingly (14) connected to said first wing part, wherein each of the wing parts comprises a receptacle part (29, 30) , said receptacle parts together forming a receptacle for a folded IOL, and also retainer means (11) for the IOL to be fitted to a wing part, said retainer means comprising engagement elements (25) for engaging with said wing part, characterised in that said retainer means (11) engage with only one wing part (13) and said engagement elements (25) are fitted for engaging with said one wing part (13) on two opposite sides.

2» Insertion assembly according to Claim 1, wherein the width (b) of said retainer means (11) is substantially identical to or smaller than the width (c) of said wing part.

3. Insertion assembly according to one of the preceding claims, wherein said retainer means comprise a first part (31) extending from said engagement elements

(25) into said receptacle parts (29, 30) and a second part (32) extending from said engagement elements (25) past said one wing part (13), wherein the length of said first and second part is substantially identical.

4. Insertion assembly according to one of the preceding claims, wherein said receptacle part (29, 30) is provided near said hinge (14) between said wing parts (12, 13) with an elevation (15) supporting the IOL.

5. Insertion assembly according to one of the preceding claims comprising locking means (16, 17) for locking together the wing parts (12, 13), wherein said locking parts comprise on said wing part (12) not provided with retainer means a projection (16) cooperating with said retainer means.

6. Insertion assembly for an IOL (intraocular lens) comprising an insertion device (10) for inserting an intraocular lens (IOL 21) comprising a pointed insertion part (19) with an insertion channel (23) and a folding part located upstream thereof, said folding part comprising a first wing part (12) which is rigidly connected to said insertion part (19) and a second wing part (13) which is hingingly (14) connected to said first wing part, wherein each of the wing parts comprises a receptacle part (29, 30) , said receptacle parts together forming a receptacle for a folded IOL, and also retainer means (11) for the IOL, to be fitted to a wing part, said retainer means comprising engagement elements (25) for engaging with said wing part, characterised in that said retainer means (11) engage with only one wing part (13) and comprise a first part (31) extending from said engagement elements (25) in one receptacle part (30) as far as in front of the other receptacle part (29).

7. Insertion assembly according to the preceding claim, wherein the insertion device comprises a hinge (14) and the first part extends as far as in front of said hinge

(14).

8. Insertion assembly according to one of preceding Claims 6 to 7, wherein the receptacle part (29, 30) is provided near said hinge (14) between said wing parts (12, 13) with an elevation (15) supporting the IOL.

9. Insertion assembly according to Claim 8, wherein the first part (31) comprises a rim extending into the insertion channel, preferably an end rim which extends as far as between the supporting elevation (15) and a hinge (14).

10. Insertion assembly according to one of preceding Claims 6 to 9, wherein the first part (31) extends as far as over approximately a quarter of the IOL.

10. (sic) Insertion assembly according to one of preceding Claims 6 to 9, wherein the first part (31) is provided with a recess for the IOL.

11. Insertion assembly for an IOL (intraocular lens) comprising an insertion device (10) for inserting an intraocular lens (IOL 21) comprising a pointed insertion part (19) with an insertion channel (23) and a folding part located upstream thereof, said folding part comprising a first wing part (12) which is rigidly connected to said insertion part (19) and a second wing part (13) which is hingingly (14) connected to said first wing part, wherein each of the wing parts comprises a receptacle part (29, 30) , said receptacle parts together forming a receptacle for a folded IOL, and also retainer means (11) for the IOL to be fitted to a wing part, said retainer means comprising engagement elements (25) for engaging with said wing part, characterised in that said retainer means (11) further comprise a first part (31) extending from the engagement elements (25), wherein the first part (31) extends as far as into the receptacle part (29, 30) and there form (sic) a stop for an IOL during folding of the wing parts (12, 13).

12. Packaging (1) comprising a holder part (2) with fitted therein an insertion device (10) for inserting an intraocular lens (IOL 21) comprising a pointed insertion part (19) with an insertion channel (23) and a folding part located upstream thereof, said folding part comprising a first wing part (12) which is rigidly connected to said insertion part (19) and a second wing part (13) which is hingittgly (14) connected to said first wing part, wherein each of the wing parts comprises a receptacle part (29, 30) , said receptacle parts together forming a receptacle for a folded IOL, and also retainer means (11) for the IOL to be fitted to a wing part, said retainer means comprising engagement elements (25) for engaging with said wing part and a lock placed on said holder part.

13. Packaging according to the preceding claim, wherein said holder part is provided with guides (5) for accommodating said retainer means and the insertion device by clamping.

14. Packaging according to one of the two preceding claims, wherein said IOL is a hydrophilic lens and said holder part is filled with a fluid.