NL2010675C2

NL2010675C2 - Intraocular lens package and method for packaging an iol.

Info

Publication number: NL2010675C2
Application number: NL2010675A
Authority: NL
Inventors: Emerentius Maria Josephus Antonius Dijk
Original assignee: Innovalens B V
Priority date: 2013-04-19
Filing date: 2013-04-19
Publication date: 2014-10-21

Description

Title: Intraocular lens package and method for packaging an IOL

FIELD

The invention relates to an intraocular lens package (IOL-packaging) and to a method for packaging a intraocular lens.

BACKGROUND

US 2009/0057167 Al discloses an IOL-package including a container and a cap. The IOL-package also includes a holder for an intraocular lens (IOL). The holder also forms a cap for the container. A part of the holder the extends into the interior of the container when the holder is mounted on the container. Both the holder and the container have a flat top surface. When the holder is mounted in the container, the flat top surface of the holder extends in the same plane as the flat top surface of the container. Subsequently a hd stock is provided that is connected to both the flat top surface of the holder and the flat top surface of the container. The lid stock may be connected to the container and the holder by any suitable sealing technology (e.g. heat, RF or adhesive). The container and the holder may be of any suitable material (e.g. polypropylene). The subject matter of US 2009/0057167 Al is incorporated herein by reference.

SUMMARY

A disadvantage of US’167 is that the three parts are needed to obtain a sterile IOL-package, i.e. a container, a holder and a lid stock. A further disadvantage is that the position of the holder relative to the container is very critical because when the two flat top surfaces of the container and the holder are not in the same plane when mounting the lid stock, a considerable chance exists that the lid stock is not properly connected to one of the flat top surfaces. Consequently, it is not guaranteed that the interior of the IOL-package remains sterile.

It is advantageous for the surgeon that has to use the IOL-package that the cap can be unscrewed from the container with a minimum effort. For example, it would be very advantageous when the cap only has to be rotated relative to the container over an angle of approximately 90° to dismount the cap from the container. However, when such a requirement is set, it is very difficult to form a hermitical closure between the cap and the container with conventional sealing rings.

It is an object to provide an IOL-package that alleviates the disadvantages of the prior art.

To that end, an IOL-package is provided that includes: • a container; • a cap that closes off an interior of the container when the cap is mounted on the container; • a holder for an intraocular lens (IOL) that is connected to the cap and that extends into the interior of the container when the cap is mounted on the container; wherein both the container and the cap are manufactured from a heat-sealable plastic, wherein in a mounted condition of the cap on the container a heat-seal is formed between the cap and the container that completely seals off the interior of the container from the outside and thus forms a sterile barrier.

In another aspect, a method for packaging an IOL is disclosed. The method includes: • providing a IOL-package according to any one of claims 1-5; • mounting an IOL in or on the holder of the IOL-package; • partly filling the container with a liquid; • mounting the cap on the container thereby immersing the holder with the IOL in the liquid; • providing an heat-seal assembly; • forming a heat-seal between the cap and the container that completely seals off the interior of the container from the outside and thus forms a sterile barrier, wherein the heat-seal is formed by activating the heat-seal assembly.

With such a IOL-package and method for packaging an IOL sterile packaging of an IOL can be obtained that is cheap and requires a minimal number of parts.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 shows a perspective partly broken away view of an exemplary embodiment in which the cap is not yet mounted on the container;

Fig. 2 shows a similar view as shown in figure 1 with the cap in mounted condition;

Fig. 3 shows a combined elevation and cross-section view of the IOL-package with a heat-seal assembly in dot-dash lines; and

Fig. 4 shows a top view of the IOL-package with the heat-seal assembly.

DETAILED DESCRIPTION

The figures show an example of an IOL-package in which various embodiments of the IOL-package are present. In the most general terms, the IOL-package 10 includes a container 12 and a cap 14 that closes off an interior of the container 12 when the cap 14 is mounted on the container 12. The IOL-package further includes a holder 16 for an intraocular lens (IOL) 20 that is connected to the cap 12 and that extends into the interior of the container 12 when the cap 14 is mounted on the container 12. Both the container 12 and the cap 14 are manufactured from a heat-sealable plastic. In a mounted condition of the cap 14 on the container 12 a heat-seal 22 is provided between the cap 14 and the container 12 that completely seals off the interior of the container 12 from the outside and thus forms a sterile barrier.

In an embodiment, of which an example is shown in the drawings, the container 12 may include a substantially cylindrical circumferential wall 24 and a bottom wall 28. In that embodiment the cap 14 may include a substantially cylindrical circumferential wall 30 and a top wall 32. The heat-seal 22 may be a substantially circular seal extending between the circumferential wall 24 of the container 12 and the circumferential wall 30 of the cap 14.

In an embodiment, of which an example is shown in the drawings, the circumferential wall 24 of the container 12 may include a bead 22’ that, when heated will melt and form the heat seal 22 between the cap 14 and the container 22. Instead of a bead 22’ on the circumferential wall 24 of the container 12, a similar bead may be formed on the circumferential wall of the cap 12 at an internal side thereof.

In an embodiment, of which an example is shown in the drawings, the cap 14 may include an upper part 32, 30a and a lower part 30b that may be connected to each other via a plastic film part 30c. The upper part 32, 30a, the lower part 30b and the plastic film part 30c may be integrally formed. The heat-seal 22 between the cap 14 and the container 12 may be formed between the lower part 30b of the cap 14 and the container 12.

An advantage of such an embodiment is that the heat-seal may be formed as a very strong seal because that seal does not have to be broken when dismounting the cap 14 from the container 12. The lower part 30b remains connected to the container 12. The plastic film part 30c is broken when dismounting the cap 14 from the container.

In an alternative embodiment, the circumferential wall 30 and the top wall 32 of the cap 14 may be formed as a single part. In such an embodiment, the heat seal 22 has to be broken to dismount the cap 14 from the container 12. This requires that the heat seal 22 is not so strong that it cannot be broken by hand force exerted by the surgeon or an assistant on the cap 14 and the container 12. For this embodiment, the heat sealing operation is more critical because a heat seal 22 has to be formed that completely closes off the interior of the IOL-package 10 in a sterile manner and that can be broken by exerting a hand force on the cap 14 and the container 12.

In an embodiment, of which an example is shown in the drawings, the cap 14 may include an internal screw thread 34 and the container 12 may include an external screw thread 36 configured to cooperate with the internal screw thread 34. The internal and the external screw threads 34, 36 may be configured so that the cap 14 can be unscrewed from the container 12 by a rotation of the cap 14 over an angle that is in the range of 75°-180°, more particularly in the range of 75-125, even more particular by rotation over an angle of approximately 90°.

In an alternative embodiment the cap 14 may includes an internal bayonet half 34 and the container 12 may include an external bayonet half 36 configured to cooperate with the internal bayonet half 36. The internal and the external bayonet halves 34, 36 may be configured so that the cap 14 can be unscrewed from the container 12 by a rotation of the cap 14 relative to the container 12 over an angle that is in the range of 75°-180°, more particularly in the range of 75-125, even more particular by rotation over an angle of approximately 90°.

Such a relatively small angle of rotation to dismount the cap 14 from the container 12 is easy for the surgeon or his/her assistant when performing the IOL-implantation operation.

In a ready to use condition, the IOL-package includes an intraocular lens (IOL) 38 that is mounted on or in the holder 16. A liquid 40 partly fills the container 12 so that the IOL 38 that is mounted on or in the holder 16 is submerged into the liquid. The liquid may be a sahne solution.

In order to obtain a IOL that is packaged in an IOL-package 10 as described above, the disclosure provides a method for packaging an IOL.

The method include: • providing a IOL-package 10 according to any one of claims 1-5; • mounting an IOL in or on the holder 16 of the IOL-package; • partly filling the container 12 with a liquid; • mounting the cap 14 on the container 12 thereby immersing the holder 16 with the IOL in the liquid; • providing an heat-seal assembly 50; • forming a heat-seal 22 between the cap 14 and the container 12 that completely seals off the interior of the container 12 from the outside and thus forms a sterile barrier, wherein the heat-seal is formed by activating the heat-seal assembly 50.

The heat seal 22 may be formed by heat convection. In such a case, the heat-seal assembly 50 may include two ring-segment 52, 54 that together form a closed ring in a closed condition (see Fig. 4). In an open condition the ring-segments 52, 54 may be moved apart from each other as shown in dotted lines in Fig. 4. In a closed condition of the two ring segments 52, 54 may form a closed ring that engages the circumferential wall 30 of the cap 14, preferably the lower part 30b of the circumferential wall 30 and that conducts heat so that a heat seal 22 is formed. To that end the ring segments 52, 54 may be made from a metal that is heated, for example, by conducting a large amount of electrical power through the closed ring segments 52, 54.

In an alternative embodiment, the heat may be generated by radio waves. In that case, the ring segments 52, 54 may generate the radio waves and the heat seal 22 may be formed by RF-sealing. RF-sealing is quicker than heat sealing by head conduction and has the advantage that, generally, less heat has to be generated to acquire a good and complete heat seal.

Claims

An intraocular lens package (IOL package) (10) comprising: • a container (12); • a cap (14) which seals the interior of the container (12) when the cap (14) is placed on the container (12); • an intraocular lens holder (16) (16) connected to the cap (14) and extending inside the container (12) when the cap (14) is on the container (16) 12); wherein both the container (12) and the cap (14) are made of a heat-sealable plastic, wherein in a condition where the cap (14) is placed on the container (12) a heat-seal (22) is provided between the cap (14) and the container (12) which completely seals the interior of the container (12) from the outside world and thus forms a sterile barrier.

The IOL package according to claim 1, wherein the container (12) comprises a substantially cylindrical peripheral wall (24) and a bottom wall (28), the cap (14) having a substantially cylindrical peripheral wall (30) and a top wall ( 32), wherein the heat seal (22) is a substantially circular seal extending between the peripheral wall (24) of the container (12) and the peripheral wall (30) of the cap (14).

The IOL package according to claim 1, wherein the cap (14) comprises an upper part (32, 30a) and a lower part (30b) which are connected to each other via a plastic film part (30c), the upper part (32, 30a) , the lower part (30b) and the plastic film part (30c) are integrally formed, and the heat seal between the cap (14) and the container (12) are formed between the lower part (30b) of the cap (14) and the container ( 12).

The IOL package according to any one of claims 1-3, wherein the cap (14) is provided with internal screw thread (34), the container is provided with external screw thread (36) configured for cooperation with the internal screw thread ( 34), wherein the internal and external threads (34, 36) are configured such that the cap (14) can be unscrewed from the container (12) by rotating the cap (14) through an angle that is in the range of 75 ° -180 ° degrees, more in particular in the range of 75 ° -125 °, even more particularly by rotation through an angle of about 90 °.

The IOL package according to any of claims 1-3, wherein the cap (14) is provided with an internal bayonet half (34), the container (12) being provided with an external bayonet half (36) configured for cooperation with the internal bayonet half (34), wherein the internal and external bayonet halves (34, 36) are configured such that the cap (14) can be unscrewed from the container (12) by rotating the cap (14) relative to the container (12) over an angle that is in the range of 75 ° -180 ° degrees, more particularly in the range of 75 ° 125 °, even more particularly by rotation through an angle of about 90 °.

The IOL package according to any of claims 1-5, comprising: an intraocular lens (JOL) (38) disposed on or in the container (16); A liquid (40) partially filling the container (12) so that the IOL (38) placed on or in the container (16) is submerged in the liquid.

A method for packaging an IOL, comprising: • providing an IOL package (10) according to any of claims 1-5; • placing an IOL in or on the holder (16) of the IOL package; • partially filling the container (12) with a liquid; Attaching the cap (14) to the container (13), the container (16) with the IOL being immersed in the liquid; • providing a heat seal assembly (50); • forming a heat seal (22) between the cap (14) and the container (12) which completely closes the interior of the container (12) from the outside world and thus forms a sterile barrier, whereby the heat seal is formed by activating the heat seal assembly (50).