WO2002056807A1

WO2002056807A1 - Device for sclera ablation

Info

Publication number: WO2002056807A1
Application number: PCT/FR2002/000198
Authority: WO
Inventors: Alain Telandro; Vivien Pollier
Original assignee: Corneal Industrie
Priority date: 2001-01-19
Filing date: 2002-01-18
Publication date: 2002-07-25
Also published as: FR2819716A1; FR2819716B1

Abstract

The invention concerns a device for sclera ablation characterised in that it comprises a mask consisting of a plate (20, 20') produced in a biocompatible material having a substantially planar first surface (20b, 20'b) designed to be pressed against the outer wall of the eye, opposite the sclera; a window (22, 22') arranged in said plate, said window defining the dimensions of the recess to be produced in the sclera, said window having a substantially polygonal contour whereof the greater side is long by at least 3 mm; and means (8, 36) for maintaining said plate so that its first surface is pressed against the outer wall of the eye.

Description

Sclera ablation device

The present invention relates to a device for ablation of the sclera, in particular used for the correction of presbyopia or other similar eye conditions, such as glaucoma.

In order to allow a better understanding of the problem to be solved in order to correct presbyopia or other similar ocular affections linked to defects of accommodation of the eye, a half-view in vertical section is shown in FIG. 1 attached. an eye. This figure shows the cornea 2, the sclera of the eye 4 with its ciliary body 6 and the iris 8 which defines the pupil of the eye. Figure 1 also shows the trabeculum 3, the Schlemm canal 5, the spur sawdust 7 and the ciliary muscle 9. In this figure, we also have the sulcus 10 which constitutes a furrow between the ciliary body 6 and the iris 8 as well as the lens 14 with its capsular bag 16. The lens 14 or more precisely its capsular bag 16, is connected to the ciliary body 6 of the eye by a set of fibers called zonules 18 constituted by fibrils. These fibrils have one end 18a which is connected to the periphery of the capsular bag 16 and another end which is connected to the ciliary body 6. When the eye is in a normal state, the controlled contraction of the ciliary muscle 6 causes the modification of the rays. lens 14 curvature allowing accommodation of the eye depending on the distance at which the object to be looked.

It has been shown that the aging of the eye tends to produce an increase in the outside diameter of the lens. As a result, the zonule becomes "too long" and is "relaxed" and that the impulses applied to the ciliary muscle no longer allow them to contract enough to act on the lens to cause accommodation. It has also been demonstrated that it is the traction exerted on the capsular bag by the zonule which makes it possible to increase the optical power of the lens by causing a reduction in the radius of curvature of its posterior and anterior face.

To solve this problem, it has already been proposed, in document WO 00/40174, to implant in the eye a ring whose edge is supported on the sulcus of the eye and whose other edge is supported on the middle zone of the zonules. Thus, a tension of the zonule is caused such that, when a nerve control impulse is applied to the ciliary muscle, it will effectively cause a change in the radius of curvature of the posterior surface of the lens and therefore the desired accommodation phenomenon.

This technique is quite effective. However, it requires the placement of the implant in the posterior chamber of the eye and therefore it requires the opening of the eyeball. It is known that, to satisfy all the aseptic conditions, this operation must be carried out by taking a large number of precautions. In addition, the mechanical action is limited by default.

An object of the present invention is to provide a device for ablation of the sclera which allows the implementation of a surgical technique also ensuring a re-tensioning of the zonule and therefore the restitution of the accommodation power in the case of presbyopia or a change in the geometry of the eye for other conditions, while avoiding making an incision in the eye.

To achieve this goal, the sclera ablation device is characterized in that it comprises a mask consisting of: - a plate made of a biocompatible material having a first substantially flat face intended to be applied against the external wall of the eye, opposite the sclera;

- A window formed in said plate, said window defining the dimensions of the recess to be produced in the sclera, said window having the shape of a polygon, one of the sides of which is at least 3 mm; and

- Means for holding said plate so that its first face is applied against the outer wall of the eye.

It is understood that the mask constituted by the plate provided with its window makes it possible to define, preferably in the area at the border between the sclera and the cornea, in the particular case of presbyopia, a perfectly defined surface in which the surgeon can achieve a chamber in the sclera, using a laser source whose beam acting on the wall of the eye is limited by the window of the mask. This localized removal of the sclera, that is to say the realization of this chamber in the outer wall of the eye, or sclera, allows relax the ciliary muscle. This operation is preferably repeated at three locations or possibly four locations angularly distributed around the optical axis of the eye. This expansion of the muscles allows an increase in the diameter of the ciliary muscle and therefore produces an effect which tends to tighten the zonule acting on the capsular bag of the lens, by distancing the anchoring zone of the zonule relative to the periphery of the capsular bag. .

In the complete surgical technique, the making of this incision is preferably followed by the placement in it of a gel or of an implant based on hyaluronic acid which will make it possible to avoid a phenomenon of scarring. which would tend to suppress the muscle expansion effect and therefore the re-tensioning effect of the zonule.

In the case of presbyopia, the mask window has the shape of a rectangle. In the case of glaucoma treatment, the window can be in the shape of a triangle or a trapezoid.

Other characteristics and advantages of the invention will appear better on reading the following description of several embodiments of the invention given by way of nonlimiting examples. The description refers to the appended figures, in which:

- Figure 1 already described is a partial longitudinal sectional view of the eye;

- Figure 2A is a front view of a first embodiment of the mask of the sclera ablation device; - Figure 2B is a sectional view along line B-B of Figure 2A;

- Figure 3A shows a first alternative embodiment of the mask in top view;

- Figure 3B is a sectional view along line B-B of Figure 3A;

- Figure 4A shows a second alternative embodiment of the mask in top view;

- Figure 4B is a sectional view along line BB of Figure 4A; - Figure 5 is an axial sectional view of the eye showing the establishment of the sclera ablation device in the case of correction of presbyopia;

- Figure 6 shows in axial section the wall of the eye after the establishment of the implant following the completion of scleral ablation.

- Figure 7A is a side view of a second embodiment of the mask for performing a deep sclerotomy to treat glaucoma; and

- Figure 7B is a bottom view of the mask of Figure 7A.

Referring first to Figures 2A and 2B, we will describe a first embodiment of the sclera ablation device for the treatment of presbyopia. This device, in this embodiment, consists of a plate 20 which is made of biocompatible material, for example PMMA. Preferably also, the material is transparent, which is of course the case with PMMA.

The plate 20 preferably has the general shape of a rectangle of width I and length L. In this plate is formed a window 22 thus defining a mask. The rectangle-shaped window has a length I 'and a width e preferably at least equal to 0.7 mm. The window 22 is closer to the edge 24 of the wafer than to its edge 26. Preferably, the length I ′ of the window 22 is between 3.5 and 4.5 mm, for example equal to 4 mm and the width I of the wafer is between 4.5 and 6 mm, preferably equal to 5 mm. The length L of the plate 20 is, for example, equal to 5.5 mm. Its thickness h is such that it allows the absorption of the laser beam most often used to perform deep sclerectomy so that the area of the sclera treated by the laser beam is effectively defined by the window 22. In the case of PMMA, the thickness h can be between 0.7 and 1 mm and preferably equal to 0.8 mm. On its upper face 20a, the plate also has a relief 28 arranged next to the window 22 to allow the surgeon to grasp the plate with the aid of pliers or any suitable surgical instrument for placing the lower face 20b of this blister at the desired location on the outside of the eye of the patient to be treated. As already explained, the mask is put on the external wall of the eye after making a surface flap of about 200 microns thick in order to define the outline and the dimensions of the removal of the sclera to be performed. This is produced by a laser beam, the shape of which is of course defined by the edge of the window 22.

The use of a laser in the ophthalmic surgical technique is known per se for carrying out various operations which it is not necessary to describe in more detail here. Argon lasers or NdYAG lasers are used in particular to correct abnormalities in the retina or to correct long-term complications of cataract surgery such as secondary cataracts. These lasers make it possible to obtain pulses of very short duration, typically of a few nano or picoseconds and the beam can be focused with very high precision.

The excimer laser is used to correct or modify the radius of curvature of the cornea as part of the so-called "LASIK" technique.

In the sclera ablation device according to the invention, an excimer laser is preferably used. Such lasers are described in particular in "power lasers and their use in medicine Pascal Roi, information notice from the PNR18 of the Swiss National Science Foundation". These lasers use the excitation of molecules consisting of a halogen and a rare gas. These compounds are in particular: ArF; KrF, XeF or XeCI. The beam obtained is most often in ultra violet and has wavelengths between 193 nm for ArF and 351 nm for XeF. The laser beam is rectangular (typically 20 x 3 mm). Pulses of a few nanoseconds with energies of one Joule can be obtained.

Referring now to Figure 5, we will describe a mode of use of the sclera ablation device for the correction of presbyopia.

In this figure, a part of the eye is represented with the cornea 2, the sclera 4, the ciliary body 6 and a part of the iris 8. As has already been succinctly indicated, deep sclerectomy is performed at about 1 mm from the border area between the sclera 4 and the cornea 2 called the sawdust spur. Before putting on the mask 20, the surgeon makes a conjunctival incision parallel to the limbus and he spreads the flap of conjunctiva thus detached, this flap being referenced 30. He also makes an incision and a lamellization to a depth of the order of 250 to 300 μm from the upper part sclera 32 which is also folded back towards the cornea. The surgeon then spots the saw spur 34 and sets up the mask 20 which has been defined previously. Thanks to the fact that the plate 20 is transparent, the surgeon can achieve a more precise positioning of the plate 20 and more precisely of its window 22. In the first embodiment, the plate 20 is held on the wall of the eye by forceps or any other suitable surgical instrument 36. The surgeon then activates the laser 38 of the type defined above so that the laser beam scans the entire surface of the window 22. Thanks to the fact that the plate 20 is transparent, the surgeon can detect, as the limb ablation, the moment when the muscle of the wall of the eye appears naked, this instant being revealed by the swelling of the tissue. At this point, the incision is complete. As shown in FIG. 6, an implant based on hyaluronic acid 40 or one of its salts or a gel based on this same acid is placed in the incision thus produced, then the blades 30 and 32 are put back in place. place and sutured at 42. Any other product intended to occupy the space while the healing phenomena occur can be envisaged, such as for example collagen.

Referring now to Figures 3A and 3B, we will describe an alternative embodiment of the mask. This always includes the plate 20 and the window 22. Near its edge 24, the plate is extended by a curved edge 50 which projects into the upper face 20a of the plate beyond the window 22. When the mask 20 is put in place as shown in Figure 5, the extension 50 of the wafer 20 facilitates the retention of the limb blade 32 and protects the sawmill shutter from the laser.

In FIGS. 4A and 4B, a third embodiment of the mask has been shown. In this, there is provided, in the underside of the wafer 20b, around the window 22, a groove 52 opening into this face and surrounding the periphery of the window 22. The groove 52 is connected to a small nozzle 54 by an internal channel 56. After the mask 20 has been put in place at the desired location on the external wall of the eye, can connect nozzle 54 to a vacuum pump creating a slight vacuum. Thus, the vacuum created in the groove 52 around the window 22 makes it possible to maintain the plate 20 against the wall of the eye by preventing any displacement of the latter without it being necessary for the surgeon to maintain the plate at the desired location. It is also possible to provide one or more pipes opening into the thickness of the periphery of the window 22 and to connect these pipes to a vacuum pump in order to suck up the tissue waste resulting from the action of the laser beam on the sclera and keep the ablation surface dry and bloodless. Indeed, the excimer laser is effective (it performs a photo-ablation of the tissue) only if the sclera is dry.

If the scleral chamber, i.e. local removal of the sclera, is performed opposite the Schlemm canal, it is a deep sclerectomy, which is a known surgical technique for treating glaucoma. The ablation using the laser beam, through the window of the mask, is interrupted when a change in color occurs due to the appearance of a brown color. This corresponds to the appearance of the ciliary body which has become visible through the sclera. In this case, a bulging of the deep plane is observed. One can also very locally perform a complete ablation of the deep plane, until the complete liberation of the ciliary body. In the case of a deep sclerotomy for the treatment of glaucoma, the window of the mask may have a triangular or trapezoidal shape. In all cases, the longest side of this polygon has a length of at least 3 mm. In FIGS. 7A and 7B, a second embodiment of the mask is shown, more particularly adapted to the production of a sclerotomy by excimer laser.

The mask consists of a plate 20 'similar to the plate 20 of FIG. 3A provided with a window 22' which, in this embodiment, has a trapezoidal or triangular shape. The lower face 20'b of the plate has a base 60 in slight projection which has substantially the shape of the surface flap made initially to penetrate into the shallow cavity which results therefrom. The mask also includes a curved rim 50 having the same function as that which is shown in FIGS. 3A and 3B. The plate also preferably includes grooves 62 opening into the lower face 20'b and partially surrounding the base 60 and therefore the window 22 '. These grooves 62 are connected by internal channels 64 to a pipe 66 intended to be connected to a vacuum pump. The depression created in the grooves 62 keeps the mask in place on the sclera at the chosen location.

Another internal pipe 68 opens into the side wall of the window 22 '. This pipe 68 is also intended to be connected to a vacuum source for sucking the liquids produced by the laser beam action in order to dry the surface of the sclera subjected to the laser beam.

Preferably, the height x of the trapezium forming the window 22 ′ is equal to 4.5 mm and its large base there is equal to 3 mm.

Claims

1. Sclera ablation device, characterized in that it comprises a mask consisting of: - a plate (20, 20 ') made of a biocompatible material having a first face (20b, 20'b) substantially planar intended to be applied against the external wall of the eye, facing the sclera;

a window (22, 22 ′) formed in said plate, said window defining the dimensions of the recess to be produced in the sclera, said window having a substantially polygonal outline, the longest side of which has a length at least equal to 3 mm; and

- Means (8, 36) for holding said plate so that its first face is applied against the external wall of the eye.

2. Device according to claim 1, characterized in that the window (22) has a substantially rectangular shape, the length of which is at least equal to 3 mm and the width of which is at least equal to 0.7 mm.

3. Device according to claim 1, characterized in that the window (22 ') has a triangular or trapezoidal contour.

4. Device according to any one of claims 1 to 3, characterized in that it further comprises a laser source (38), the emitted beam being directed towards said window (22, 22 ') of the mask so that the beam covers at least the entire said window.

5. Device according to any one of claims 1 to 4, characterized in that said plate (20, 20 ') is made of a transparent material.

6. Device according to claim 4, characterized in that said plate (20, 20 ') is made of PMMA and its thickness is sufficient to absorb the energy of the laser beam (38).

7. Device according to any one of claims 4 and 6, characterized in that said laser (38) is an excimer laser.

8. Device according to any one of claims 1 to 7, characterized in that said plate (20, 20 ') comprises two edges parallel to the length of said window (22, 22'), at least one of said edge being provided an oversized portion (50) able to keep apart from said window a surface lamella separated from the sclera.

9. Device according to any one of claims 1 to 8, characterized in that the holding means comprise a raised portion (8) projecting out of the second face (20a) of said wafer and outside of said window (22, 22 '), said relief being able to be grasped by surgical forceps.

10. Device according to any one of claims 1 to 9, characterized in that the holding means comprise at least one recess (52, 62) opening into the first face (20b, 20'b) of the plate around at least part of the periphery of said window (22, 22 ') and means (64, 68, 56) for connecting said recess to a vacuum pump.