FR2820025A1 - Sclera cutting instrument for treating presbyopia has non-cutting separator that is able to slide between sclera and ciliary body - Google Patents

Abstract

The instrument (1), which has a cutting element (2) for making an incision in the sclera of the eye, incorporates a non-cutting separator (4) which is able to slide between the sclera and ciliary body (5) of the eye. The handle (10) and cutting edge of the instrument are positioned more or less perpendicular to the separator. In variants of the design the separator can be in the form of a plate with a rounded leading edge and have curved under and/or upper surfaces, and it can have an additional outer fixing element with claws to hold the sclera against the separator plate.

Description

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DEVICE FOR THE TREATMENT OF PRESBYTIA
The present invention relates to the field of the treatment of presbyopia.

 The present invention relates more particularly to a device for the treatment of presbyopia using a cutting element for cutting the sclera.

 It has been proposed in the prior art to make partial radial incisions of the sclera which allow the re-tensioning of the zonule, element for tensioning the lens.

 The major complication of this operating technique is the lesion, during the incision, of the ciliary body underlying the sclera. To remedy this problem, a measurement of the thickness of the sclera by ultrasound has been proposed. The equipment required for this measurement is expensive and not widely available.

 The present invention intends to remedy these drawbacks of the prior art by proposing a simple and inexpensive device based on a modification of the operating method.

 Indeed, it has been noticed that the sclera and the ciliary body are separable and that it is possible to slide an element in the space between the sclera and the ciliary body in order to position a stop which prevents any sharp body from damaging the ciliary body.

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 In addition, a stop thus positioned between the sclera and the ciliary body allows, by its echogenic properties, a simple measurement of the thickness of the sclera.

 The present invention is of the type described above and it is remarkable, in its broadest sense, in that the device comprises a separation stop, non-cutting, capable of being slid between the sclera and the ciliary body.

 Said separation stop is preferably in the form of a plate having a rounded leading edge.

 The device according to the invention essentially presents two variants.

 In a first variant, the separation stop has a curved, convex lower part and a curved upper part to match the shape of the sclera and the device comprises a handle positioned substantially perpendicular to said plate.

 The cutting element is disposed substantially perpendicular to said plate, against the handle.

 In a second variant, the separation abutment has a curved lower part to match the shape of the ciliary body and a curved upper part to match the shape of the sclera.

 In this variant, the device comprises means for retaining said plate on the sclera.

 The retaining means preferably consist of jaws positioned respectively with a

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 part on the plate and on the other hand on a fixing element.

 The fastening element preferably has two branches separated by a gap, as well as a stabilizing tail.

 This second variant constitutes both a plane of reflection of ultrasonic waves for measurement by ultrasound and a cutting stop for an instrument comprising a cutting element.

 In the first variant, the radius of curvature of the upper face of the plate is approximately 11 millimeters.

 In the second variant, the radius of curvature of said lower face and / or of said upper face of the plate and / or that of said lower face of the fixing element is or are approximately 11 millimeters.

 Advantageously, the present invention makes it possible to operate radial cuts of the sclera, without damaging the ciliary body, in order to allow the lens to be re-tensioned and to suppress presbyopia.

 This re-tensioning restores accommodation by allowing the ciliary muscles to act on the lens.

 Advantageously, the present invention makes it possible to precisely modify the shape and the power of the lens in order to eliminate presbyopia.

 The invention will be better understood using the description, given below for purely explanatory purposes,

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la figure 7 illustre une vue de face de l'élément de fixation de la seconde variante du dispositif selon l'invention ; la figure 8 illustre une vue de dessus de l'élément de fixation de la seconde variante du dispositif selon l'invention ; la figure 9 illustre une vue partielle en coupe de la méthode de mise en oeuvre de la seconde variante du dispositif selon l'invention pour l'opération de mesure de l'épaisseur de la sclère ; et of an embodiment of the invention, with reference to the appended figures: FIG. 1 illustrates a partial front view of the first variant of the device according to the invention; FIG. 2 illustrates a partial side view of the first variant of the device according to the invention; FIG. 3 illustrates a partial view from below of the first variant of the device according to the invention; Figure 4 illustrates a partial sectional view of the method of implementing the first variant of the device according to the invention; FIG. 5 illustrates a partial front view of the second variant of the device according to the invention; Figure 6 illustrates a top view of the second variant of the device according to the invention;

FIG. 7 illustrates a front view of the fixing element of the second variant of the device according to the invention; FIG. 8 illustrates a top view of the fixing element of the second variant of the device according to the invention; FIG. 9 illustrates a partial sectional view of the method of implementing the second variant of the device according to the invention for the operation of measuring the thickness of the sclera; and

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 FIG. 10 illustrates a partial sectional view of the method of implementing the second variant of the device according to the invention for the measurement operation of cutting the sclera.

 The device according to the invention is a device for the treatment of presbyopia using a cutting element (2) for cutting the sclera (3).

 The device according to the invention is characterized in that it comprises a separation stop (4), non-cutting, capable of being slid between the sclera (3) and the ciliary body (5).

 Said separation stop (4) is preferably in the form of a plate (6) having a rounded leading edge (7) whose average thickness is about 0.5 millimeter.

 The plate (6) has a lower part (8) against which the upper surface of the ciliary body (5) slides and an upper part (9) against which the lower surface of the sclera (3) slides.

 In a first variant of the invention, illustrated in FIGS. 1 to 4, the plate (6) has a curved, convex lower face (8) and a curved upper face (9) to conform to the shape of the sclera and the device comprises a handle (10) positioned substantially perpendicular to said plate (6).

 The lower face (8) is formed, for example, by a portion of a sphere with a diameter of 1 millimeter.

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 The radius of curvature C of said upper face (9) is approximately 11 millimeters, to the nearest millimeter.

 The cutting element (2) is arranged substantially perpendicular to said plate (6). It has a height at least equal to and preferably greater than the average thickness of the sclera which is 0.6 to 0.7 millimeter.

 The cutting element (2) is arranged parallax with the axis of the handle (10).

 In a second variant of the invention, illustrated in FIGS. 5 to 10, the separation abutment (4) has a curved lower face (8) to match the shape of the ciliary body and a curved upper face (9) to follow the shape of the sclera.

 The radius of curvature C of said lower face (8) and said upper face (9) is approximately 11 millimeters, to the nearest millimeter.

 In this variant, the device (1) comprises means for retaining said plate (6) on the sclera (3) and on the eyeball.

 The plate (6) must be positioned parallel to the sclera when in use.

 The plate (6) initially allows the thickness of the sclera to be measured by ultrasound using a pachymeter commonly used in ophthalmology.

 The plate (6) allows in a second step, after adjusting a knife to the desired cutting depth calculated from the measure decreed

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 previously, to perform the non-perforating cutting of the sclera, the plate remaining immobile in the virtual space between sclera and the ciliary body.

 The persistence of the plate (6) during cutting shelters from an accidental lesion of the ciliary body which may occur during a handling error or in the event of an undetected variation in the thickness of the sclera.

l'incision concerne la même"ligne"de sclère ; et 'une fixation du globe oculaire par cet instrument. The means of retaining the device on the sclera secure the instrument to the sclera thus allowing:. keeping the plate in place during the performance of the procedure, both in a plane parallel to the sclera to avoid injury to the ciliary body and both in the plane so that the measurement and

the incision concerns the same sclera "line"; and 'fixation of the eyeball by this instrument.

 In a version of the invention, illustrated in FIGS. 5 to 8, the retaining means consist of jaws (11, 11 '), positioned respectively on the one hand on the upper face (9) of the plate (6), at the base of the handle (10) and on the other hand on the lower face (12), curved, of a fixing element (13), so as to cooperate with each other. The jaws (11) of the plate (6) ensure a grip of the sclera in its lower part and the jaws (11 ') ensure a grip of the sclera in its upper part, in order to pinch the sclera by the fixing element (13).

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 The jaws (11, 11 ') are arranged, for example by three, substantially aligned.

 The radius of curvature C of said lower face (12) is approximately 11 millimeters, to the nearest millimeter.

 In this version, the fixing element (13) has two branches (14, 14 ') separated by a gap (15), as illustrated in FIG. 7, the device making a template for measuring the thickness of the sclera and cutting the sclera (3) in the same place by the cutting element (2) of an instrument.

 The front end of the branches (14,14 ') is situated substantially at the same level as the front end of the plate (6) and the width of the gap (15) is substantially equal to the width of the plate (6 ).

 The fixing element (13) preferably further comprises a stabilizing tail (16), positioned substantially opposite the branches (14, 14 ') relative to the axis of the handle (10). This stabilization tail (16) is intended to prevent rotation of the plate (6) along the axis of rotation formed by the alignment of the jaws (11).

 Indeed, this rotation is likely to cause a deformation of the plate (6) with lesion of the ciliary body in return from rotation.

 The rotation in question is illustrated by the arrow R, oriented anti-clockwise, on the implementation diagram illustrated in FIG. 10.

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 The stabilization tail (16) has a length substantially equal to the length of the branches (14, 14 ') and a width substantially equal to the width of the gap (15), as illustrated in FIG. 8.

 The branches (14, 14 ') also prevent rotation of the plate (6) along the axis of rotation formed by the alignment of the jaws (11).

 Indeed, this rotation is likely to cause immediate damage to the ciliary body.

 The rotation in question is illustrated by the arrow R ′, oriented clockwise, in the implementation diagram illustrated in FIG. 10.

 The fixing element (13) preferably has in its center a hole (17) for the passage of the handle (10).

 FIG. 9 illustrates the measurement of the thickness of the sclera using a pachymetry probe (18) and the second variant of the invention.

The operating procedure is as follows:
1. Incision of the sclera (3) over its entire height allowing the establishment of the second variant of the device according to the invention; this incision is carefully started with the usual knife and completed with the first variant of the device according to the invention.

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2. Installation of the second variant of the device according to the invention with fixing of the latter on the sclera
3. Measurement of the thickness of the sclera.

 4. Adjustment of a "keratotomy" knife to the desired incision depth.

 5. Radial scleral incision.

 The invention is described in the foregoing by way of example. It is understood that a person skilled in the art is able to carry out different variants of the invention without going beyond the scope of the patent.

Claims (12)

 CLAIMS 1. Device (1) for the treatment of presbyopia using a cutting element (2) for cutting the sclera (3), characterized in that it comprises a separation stop (4), non-cutting, capable of being slipped between the sclera (3) and the ciliary body (5).  2. Device (1) for the treatment of presbyopia according to claim 1, characterized in that said separation stop (4) is in the form of a plate (6) having a rounded leading edge (7) .  3. Device (1) for the treatment of presbyopia according to claim 1 or claim 2, characterized in that said separation stop (4) has a curved lower face (8).  4. Device (1) for the treatment of presbyopia according to any one of claims 1 to 3, characterized in that said separation stop (4) has an upper face (9) curved.  5. Device (1) for the treatment of presbyopia according to any one of claims 2 to 4, characterized in that it comprises a handle (10) positioned substantially perpendicular to said plate (6).  6. Device (1) for the treatment of presbyopia according to any one of claims 2 to 5, characterized in that the cutting element (2) is arranged substantially perpendicular to said plate (6).  7. Device (1) for the treatment of presbyopia according to any one of claims 2 to 5, <Desc / Clms Page number 12>  characterized in that it comprises means for retaining said plate (6) on the sclera (3).  8. Device (1) for the treatment of presbyopia according to claim 7, characterized in that said retaining means consist of jaws (11, 11 ') positioned respectively on the one hand on the plate (6) and d on the other hand on a fixing element (13).  9. Device (1) for the treatment of presbyopia according to claim 8, characterized in that said fixing element (13) has two branches (14, 14 ') separated by a gap (15).  10. Device (1) for the treatment of presbyopia according to claim 8 or claim 9, characterized in that said fixing element (13) has a stabilizing tail (16).  11. Device (1) for the treatment of presbyopia according to any one of claims 8 to 10, characterized in that said fixing element (13) has a curved lower face (12).  12. Device (1) for the treatment of presbyopia according to any one of claims 3 to 11, characterized in that the radius of curvature C of said lower face (8) and / or of said upper face (9) and / or of said lower face (12) is or are approximately 11 millimeters.