WO2007030009A2

WO2007030009A2 - Friction-reducing coating

Info

Publication number: WO2007030009A2
Application number: PCT/NL2006/050142
Authority: WO
Inventors: Bernardus Franciscus Maria Wanders
Original assignee: Procornea Nederland B. V.
Priority date: 2005-06-21
Filing date: 2006-06-21
Publication date: 2007-03-15
Also published as: NL1029301C2; WO2007030009A3; EP1906880A2

Abstract

Assembly comprising an insertion device and an IOL. One of these or both is/are provided with a friction-reducing coating. This coating comprises parylene material. This is applied as a coating to the product concerned, as a result of which IOL can be moved more easily into the eye through the insertion device. Because the parylene material provides complete sealing it is possible, when it is applied to the IOL, to make the choice of the material for the IOL such that it is no longer dependent solely on the biocompatible properties. Consequently it is possible to use a plastic which is not biocompatible. In another variant a very hydrophobic material is used. The invention also relates to a method for providing an IOL or insertion device (cartridge) with a parylene material.

Description

Friction-reducing coating

Background

The present invention relates to an assembly comprising an insertion device

(cartridge) and an intraocular lens (TOL), wherein the insertion device comprises an insertion tip with insertion channel and a folding construction adjacent thereto, wherein in said folding construction a receptacle for said IOL is delimited, wherein said IOL is placed in said receptacle. An assembly of this type is generally known in the state of the art. In this case the

IOL is stored in the position for use as far as possible. This may be either in the insertion device or in a separate holder. During use the IOL is rolled up with the aid of the wings and can then be moved into the eye through the channel in the insertion tip by means of, for example, a plunger which is part of an injector, which may or may not be separate. Because there is considerable friction between the IOL and the insertion device and damage to the IOL must be prevented under all circumstances, it is proposed in the state of the art to use a lubricant, whereby movement of the IOL in the channel of the insertion device is made easier.

Because such a lubricant also enters the human body, it has to meet stringent requirements. After insertion in the eye, it is necessary to remove the lubricant concerned by the doctor. This has to be done carefully to avoid a later trauma or other reaction. This takes a comparatively large amount of time.

Moreover, the costs for the lubricant are high and applying the lubricant or lubricating jelly is time-consuming. An example of the application of a lubricant or lubricating jelly of this kind is disclosed in EP 1.481.652.

WO 99/21513 describes an assembly of an IOL and an insertion device. The insertion device has a flexible, deformable sleeve in which the IOL is stored in a liquid. The IOL is brought out of the sleeve for insertion into an eye by pinching together the deformable sleeve, as a result of which the IOL is driven out of the sleeve with the liquid. The flexible, deformable sleeve is preferably made of PTFE and is provided with a friction-reducing layer on the inside.

WO 99/21514 describes an assembly of an IOL and an insertion device, wherein the IOL is put into a sleeve of the insertion device with the aid of a guide. Both the guide and the sleeve are made of flexible, defoπnable and smooth polymer material such as PTFE and are provided with friction-reducing material on the inside.

US Al 2004/267359 describes an assembly of an IOL and an insertion device. The insertion device has a folding part where the IOL is folded by folding together two hinged parts. The insertion device furthermore has an insertion channel through which the IOL is fed in order to insert it into an eye. The insertion device is made of polypropylene and the insertion channel is provided on an inner wall with a lubricating layer of hydrophilic material covalently bonded thereto. WO 01/10352 and WO 96/22062 describe the use of such a covalently bonded coating layer.

The assemblies described, as wells as the implanting of an IOL as well as the IOL itself leave room for improvement.

Summary of the invention

The aim of the present invention is to avoid the disadvantages described above and to provide an assembly where it is possible to fit an IOL ready for immediate use without further measures.

A further aim is to improve the insertion of the IOL. A further aim is to provide an IOL and insertion device which are easier to tolerate.

A further aim is to provide an assembly which is simpler and cheaper to produce. This aim is achieved with an assembly described above in that a friction-reducing coating is applied to the contact surface between IOL and said receptacle. According to the present invention there is a permanent coating on either the IOL or the insertion device or both. Because of this it is in any case no longer necessary to use lubricant and to remove it after the lens has been inserted into the eye. Neither is it any longer necessary to apply the lubricant just before enclosing the lens in the insertion device. The coating can be applied to either the insertion device or the lens in advance. Moreover, by using such a coating or coating layer more freedom arises in the choice of the plastics material for the IOL. This choice can be more directed at the optical properties and less at the problems when installing or the compatibility with the environment (biocompatible), m one embodiment the coating layer is hydrophobic. In one embodiment of the invention the folding construction is a winged construction with two wings connected to one another in a hinged manner.

In one embodiment thereof the insertion channel and the insertion tip are rigid, that is to say rigid enough to insert the insertion channel into an eye.

Such a friction-reducing coating according to the invention can be any coating known in the state of the art which gives reduced friction under the conditions during insertion of a lens into the human body.

The use of a lubricant or lubricating jelly is desirable because the properties of the IOL are primarily determined by subsequent use in the eye. Particularly with hydrophobic IOLs it has been found that they have a very high friction coefficient, making it difficult to move them through the insertion part, with all the associated problems. By applying the friction-reducing coating layer to the IOL, which moreover has a number of other advantages mentioned in this patent application, the IOL is not only easier to insert, but other advantages are also attained.

In one embodiment the coating layer is applied by means of vapour deposition polymerisation (VDP). A layer obtained in this way is also often known as synthetic metarial applied under vacuum or vacuum deposited plastic.

According to a particularly advantageous embodiment of the invention the coating consists of parylene or polyparaxylylene. There are various kinds of parylene, such as parylene type N, C, D or HT. It will be understood that combinations can be used as desired for providing the coating on either the insertion device or the lens.

If the coating is applied to the insertion device, it is obviously applied to the boundary wall between insertion device and lens. The surface of this boundary wall can even be decreased by providing the receptacle with elevations for supporting the IOL. Consequently the surface where friction occurs between the IOL and the receptacle is decreased. In one embodiment thereof the elevation comprises a rib which extends in the receptacle towards the insertion channel. That is to say the rib extends in an insertion direction from proximal to distal direction .

With the correct use it is possible to provide a parylene layer which is completely sealed. Moreover, it is possible to regulate the thickness thereof very precisely during application. A range of between 100 nm and 20 μm and more, in particular between 0.5 and 5 μm, is mentioned as an example of the thickness. Since the parylene layer can form a complete seal it is possible when it is used on the IOL to make this IOL from a material which is not (completely) biocompatible. The same applies to the insertion device or cartridge. There is no longer a risk of material from the cartridge ending up in the eye. In one embodiment the outer surface of the insertion device is for this purpose also at least partially to be provided with a coating layer, preferably a parylene coating layer. In one embodiment the outside of an insertion channel of the insertion device is provided with a coating layer of this type, in particular a sealing coating layer. Because of this the material of the insertion device virtually does not come into contact with the eye.

Moreover, it is now possible to install very hydrophobic lenses without any problem. After all, the stickiness that is observed with hydrophobic materials is no longer of importance owing to the parylene coating. Parylene material can be applied in any way known in the state of the art. According to an advantageous embodiment of the invention parylene material is applied to either the insertion device or the IOL by vapour deposition polymerisation. Starting from a pre-cursor or dimer, in a first.step this pre-cursor is vaporised. This is done at a temperature of 120 - 180⁰C. A pyrolysis reaction then takes place at a temperature of between 650 ⁰C and 700 ⁰C. The vaporised dimer changes into a monomer gas. This monomer gas is then deposited on the part concerned in a PVD chamber. This is preferably done at room temperature at a reduced pressure of 50 mtorr, for example. It will be understood that parylene derivative coatings should also be regarded as parylene.

Short description of the figures

The invention will be described in more detail below with reference to a preferred embodiment. For this description:

Fig. 1 shows an insertion device in opened state for receiving an IOL, also drawn; and

Fig.2 shows the assembly of insertion device and IOL.

Description of embodiments

In Fig. 1, 20 indicates an assembly consisting of an insertion device 1 and an IOL 10.

Said IOL 10 is provided with haptics 11.

The insertion device 1 consists of an insertion tip 2 provided with an internal insertion channel 8. Upstream therefrom are two wings 3 and 4, which can move towards one another according to a hinge line 5 and delimit a receptacle 7 between them. There are ribs 6 in the receptacle 7 extending over the entire length thereof.

The intention is to move the IOL into the eye via channel 8 by first rolling up the IOL and then moving it through the channel 8 with the aid of a plunger. Fig. 2 shows the state where the lens has been rolled up into the desired position with the aid of the wings and possibly the other removable aids and has to be displaced through the channel 8 in the direction of the arrow with the aid of a plunger of an integrated or separate injector.

It has been found that this movement can lead to problems because there is considerable friction between the lens and the receptacle. By making the ribs 6, this friction is indeed reduced and the guiding of the plunger used improved, but as soon as the IOL enters the channel 8 this effect is destroyed. Obviously it is also possible to provide the channel with such ribs. Moreover, these ribs 6 have the result that it can be guaranteed that the plunger grips the IOL and no jamming takes place between the IOL and the wall of the receptacle 7.

To eliminate the problem of the friction, according to the invention it is proposed to provide either the lens or the insertion device 1 with a friction-reducing coating. Likewise both parts can be provided with a friction-reducing coating and this coating comprises in particular polyparaxylylene (parylene). Parylene in particular is found to be favourable because a layer can be made with it which is bio-inert for the eye in particular. Besides, the layer can be excellently defined and a closed layer can be formed. In particular the provision of the coating layer on an IOL is found to be a favourable in preventing so-called secondary cataract.

By using a parylene coating in the insertion device the latter can be injection- moulded from a cheaper material, for example normal injection-mouldable polypropene instead of Class VI approved PP for medical applications) . In this case the outside of the insertion channel, the insertion tip 2, can also be provided with the coating layer. A favourable embodiment can be achieved by providing the entire insertion device with a virtually completely enveloping coating layer. It is also conceivable to apply a similar coating layer by means of a plasma technique.

Although the invention is described above with reference to an assembly consisting of an insertion device and an IOL, rights are also expressly requested for a separate insertion device for an IOL which is provided with a parylene layer and a separate IOL which is provided with a parylene layer.

After reading the above description, variants that fall within the scope of the appended claims will be immediately apparent to those skilled in the state of the art.

Claims

1. Assembly comprising an insertion device (cartridge) and an intraocular lens (IOL), wherein the insertion device comprises an insertion tip with insertion channel and a folding construction adjacent thereto, wherein in said folding construction a receptacle for said IOL is delimited, wherein said IOL is placed in said receptacle, wherein a Motion-reducing coating is applied to the contact surface between IOL and said receptacle.

2. Assembly according to Claim 1 , wherein said folding construction comprises a winged construction with two wings connected to one another in a hinged manner.

3. Assembly according to Claim 1 or 2, wherein the friction-reducing coating comprises parylene. . _{. .}

4. Assembly according to one of the preceding claims, wherein the friction-reducing coating is applied to said IOL.

5. Assembly according to one of the preceding claims, wherein the friction-reducing coating is applied to the boundary wall of said receptacle.

6. Assembly according to one of the preceding claims in combination with Claim 4, wherein said IOL comprises a hydrophobic material.

7. Assembly according to one of the preceding claims in combination with Claim 4, wherein said IOL comprises a non-biocompatible material.

8. Assembly according to one of the preceding claims, wherein said receptacle is provided with elevations for supporting said IOL.

9. Assembly according to one or more of the preceding claims, wherein the insertion device is completely enveloped by the friction-reducing coating.

10. Method for the manufacture of an intraocular lens (IOL) or insertion device

(cartridge) comprising making an IOL or cartridge from a plastic and subsequently applying a parylene coating thereto.

11. Method according to Claim 10, wherein the application of said parylene layer comprises PVD.

12. Method according to one of the preceding claims, wherein an initial product for parylene is heated to 120 - 180⁰C and the vaporised parylene material is deposited on said IOL.

13. Method according to one of Claims 10 - 12, wherein the manufacture comprises the manufacturing out of non-bio-compatible plastic.

14. Method according to one of the preceding claims, wherein the thickness of the layer of the parylene is between 100 nm and 20 μm.

15. Method according to Claim 14, wherein the thickness of the layer of the parylene is between 0.5 - 5 μm.

16. Intraocular lens QOL) comprising a fiiction-reducing coating layer applied to said IOL.

17. Intraocular lens QOL) according to Claim 15, wherein the coating layer envelops the IOL.

18. Intraocular lens QOL) according to Claim 15 or 16, wherein the coating layer completely envelops and seals the IOL.

19. Intraocular lens (IOL) according to one or more of the preceding Claims 15 - 17, wherein the coating layer comprises a parylene coating layer.

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