WO2003026542A1

WO2003026542A1 - Eye surgical instrument

Info

Publication number: WO2003026542A1
Application number: PCT/DE2002/001527
Authority: WO
Inventors: Chris Lohmann
Original assignee: Geuder Ag
Priority date: 2001-09-21
Filing date: 2002-04-26
Publication date: 2003-04-03
Also published as: DE20115585U1

Abstract

The invention relates to an eye surgical instrument, especially for laser-epithelial epithelial keratomileusis of the cornea of an eye, comprising an active element (22) which is used to make an incision in the cornea of the eye which is to be operated on. Said active element (22) comprises a blade (28) which enables the cornea epithelium to be incised when the former is placed on the cornea and pressure forces are used. The invention is characterized in that the blade (28) is formed along a self-contained,oval-shaped active edge (24) of the active element (22).

Description

"Ophthalmic surgical instrument"

The invention relates to an ophthalmic surgical instrument, in particular for the laser epithelial keratomileusis of the cornea of an eye, with an active element which serves to cut into the cornea of the eye to be operated on, the active element comprising a cutting edge with which the corneal epithelium, after being placed, is applied the cornea can be cut using pressure.

Ophthalmic surgical instruments (ophthalmic surgical instruments) of the generic type are generally known and enable surgical correction of myopia, i.e. myopia and hyperopia or hypermetropia, i.e. the wide or clear view of the eye. These surgical instruments are used in the so-called LASEK technique (LASEK = laser-epithelial keratomileusis), which is increasingly preferred by ophthalmic surgeons. It is a safe and effective surgical technique, especially for the removal of strong myopia, which avoids the advantages of previously known surgical techniques, such as the so-called photorefractive keratomileusis (PRK) and the so-called laser-in-situ keratomileusis (LASEK) respective disadvantages of these surgical techniques combined. In the LASEK technique, which is also known under the name "Epiflap", the surface epithelium of the cornea is detached after trepanation and alcohol exposure and carefully pushed aside in the form of a detached thin disc, preferably rolled up. After the laser ablation of the Bohrmann lamella and the anterior stroma of the epithelial flaps, the detached epithelial disc is replaced in the original position.

In contrast to the LASIK technique, the LASEK technique does not make a deep cut in the cornea, only the superficial layer, the so-called epithelium, is detached. Very good refractive results can be achieved with the LASEK technique. The visual rehabilitation is similar to the LASIK technique and only minor pain is caused. As with the PRK technique, there is no need to penetrate deep into the cornea with the LASEK technique, so that, in contrast to the use of the LASIK technique, the corneal biomechanisms remain changed.

In contrast to the surgical procedures described above, the LASEK technique can also be better used for so-called "wavefront technology operations", i.e. to eliminate spherical aberrations of the eye by ablating the actual corneal surface, which is analyzed preoperatively.

A disadvantage of the previously known ophthalmic surgical instruments when using the LASEK technique is that the use of these instruments is limited to a correction of the myopia or the hyperopia, which results from the use of ophthalmic surgical instruments having circular active edges.

From DE 198 47 089 A1 an eye suction ring for fastening an electric plane for eye operations is known, which has a suction groove that is open towards the eye for fixing to the eye. This eye suction ring is intended to be used in the LASIK technique which has the above disadvantages, in order to enable the electric planer to be fixed in order to detach the cornea. The eye suction ring is oval in shape, so that the corneal flap separated by means of the electric slicer can be arranged within the eye suction ring which is sucked onto the eye and so that a central circular operating area is optimally accessible to the laser. Laser treatment of astigmatism is not possible with this eye suction ring because of the corneal flap to be arranged within the suction ring without enlarging the operating field and not without causing damage to the corneal epithelium and the cornea. The present invention is therefore based on the object of designing and developing the generic ophthalmic surgical instrument in such a way that it can be used without problems for ophthalmo-operative applications while circumventing the aforementioned problems.

This object is achieved by the features of patent claim 1, namely in that the cutting edge is formed along a self-contained, oval-shaped active edge of the active element.

In this way, an operative correction of the astigmatism with elliptical ablation along the cylinder axis can now also be carried out. H. the ametropia due to astigmatism can be adjusted without causing unnecessary damage to the corneal epithelium or the cornea in surrounding areas. The active edges are expediently elliptical. With the help of such a trepan, the epithelium of the cornea can be incised.

From an operational point of view, it is particularly advantageous if the oval-shaped cutting edge has at least one local recess extending in the circumferential direction thereof, so that the corneal epithelium is not incised in the region of the recess. In this way, after the detachment of the corneal epithelium, the epithelial flap sticks to an epithelial hinge formed in the region of the recess, so that the epithelial flap cannot be handled and stored separately during laser ablation, and otherwise after the laser - Ablation can be pushed back to its original position. This results in a particularly advantageous rehabilitation with rapid regrowth of the corneal epithelium.

Furthermore, particularly advantageous handling and operation options can be achieved if the recess extends over an angle of preferably extends 90 degrees and is arranged offset relative to a minor axis of the active edges by an angle which is preferably 30 degrees.

As an alternative or in addition, the object on which the present invention is based is achieved in particular by the features of the independent claim 4 that the active edges of the funnel are oval in shape, preferably 20% alcohol being used as the liquid. Such a funnel instrument is used, in particular, to achieve after cutting the corneal epithelium with the aid of the trepan after placing the funnel, which preferably has a slightly larger inner diameter, on the cornea and after filling the alcohol in that the alcohol is cut into by cutting Trepan's created slots can penetrate and crawl under the corneal epithelium, with the result that the corneal epithelium can be detached in the area encompassed by the cutting edges. For mobilization for the detachment of the epithelium, a so-called hockey knife is preferably used, which is sharp in the front part and in this area serves to sharply remove the epithelium incised with the cutting edge of the micro-trepan, while the larger rear part of the hockey knife is blunt. With this part, the incised epithelium can be pushed back and also pushed back again after laser ablation. The epithelium is not damaged by the blunt edge of the hockey knife.

In the case of an ophthalmic surgical instrument designed in this way with a funnel, it is also expedient if the active edges are made elliptical.

According to an advantageous development, the respective active element can be designed with opposed flattened active edges. This results in favorable manufacturing and operating conditions.

A particularly simple and inexpensive manufacture of the ophthalmic surgical instruments provided with oval-shaped active edges can be achieved in that the oval-shaped active edges are formed by reshaping a tubular body originally having a circular cross-section. The preferred as a thin wall thickness tubular body can be flattened, for example with the help of opposing and mutually movable pressing tools on both sides, so that the oval-shaped active edges are realized in this way.

Favorable handling and operation options can be achieved in that the manipulation member, which is preferably designed as a grip part, is arranged in the region of one of the secondary apices of the active edges and / or extends in the direction of one of the secondary axes of the active edges.

According to a further solution, the invention relates to an operating set consisting of an ophthalmic surgical instrument designed as a trepan and an ophthalmic surgical instrument designed with a funnel, in particular according to at least one of claims 1 to 8.

With an operation set of this type, it is particularly advantageous if the active edges of the trepan and the funnel each have an inner contour that is coordinated with one another, the operation field determined by the inner contour of the active edges of the funnel being slightly larger than the operation field determined by the inner contour of the active edges of the trepan ,

The above measures enable an ophthalmic surgical instrument or a set of ophthalmic surgical instruments both individually and in any combination with one another, which enable an expanded range of operations.

There are now various possibilities for designing and developing the teaching of the present invention. For this purpose, on the one hand, reference is made to the claims subordinate to claim 1 and, on the other hand, to the following explanation of exemplary embodiments of the invention with reference to the drawing. In connection with the explanation of the preferred exemplary embodiments of the invention with reference to the drawing, preferred refinements and developments of teaching explained. In the drawing shows

1 shows an embodiment of an ophthalmic surgical instrument according to the invention in a side view,

2 shows the object from FIG. 1 in a front view,

3 shows a further embodiment of an eye surgical element according to the invention in a side view,

4 shows the object from FIG. 2 in a front view,

5 is a top view of the active element of the object from FIG. 2 provided with oval-shaped cutting edges,

6 shows a cross section along the section line 6-6 through the active element of the object from FIG. 5,

7 is a side view of the active element of the ophthalmic surgical element from FIG. 2,

8 shows a top view of the object from FIG. 4, the active element of the funnel instrument provided with oval sealing edges being shown there,

Fig. 9 in a cross section along the section line 9-9 the object of Fig. 8 and

Fig. 10 in a side view of the active element of the object

Fig. 4. 1 and 2 show an ophthalmic surgery instrument 21 designed as trepan 20 and in FIGS. 3 and 4 an ophthalmic surgery instrument 51 designed as a funnel instrument, which together form a set and are intended for laser spithelial keratomileusis (LASEK) of the cornea of an eye. Each ophthalmic surgical instrument 21, 51 has an active element 22, 52, the annular active edges 24, 54 of which are oval in shape and each define an operating field 23, 53. The active edges 24, 54 are intended to be brought into contact with the cornea of the eye to be operated on. The active elements 22, 52 are each provided with a handle part 26, 56 serving as manipulation member 25, 55, which is firmly connected via through bores 38, 68 to the active element 22, 52, each designed as a cylindrical ring part 27, 57. The handle parts 26, 56 are used for manual actuation of the respective surgical instrument 21, 51. Each handle part 25, 56 is provided in the region of its end on the active element side with a holder for the respective active element 22, 52, which is at an angle 44, 96 relative to the actual handle element is bent, which is 45 degrees here. This enables favorable handling options to be achieved.

The active edges 24, 54 of the active elements 22, 52 of the ophthalmic surgery instrument 21 designed as trepan 20 or of the ophthalmic surgery instrument 51 designed as a funnel instrument are elliptical in design and have elliptical inner contours 95. The effective edge 24 of the ophthalmic surgery instrument 21 designed as a trepan 20, which is connected here in one piece to the ring part 27, is provided with an elliptical cutting edge 28 at its cutting end 46. The ellipse described by the cutting edge 28 of the active edges 24 is designed with a secondary axis 36 perpendicular to the main axis 34, the two secondary apices 37 and the two main apices 35 being formed with respect to the outer dimensions of the ring part 27. The distance between the two main apices 35 and the length 93 of the ring part 27 is 10 mm here and the distance between the two secondary apices 37 and the width 94 of the ring part 27 is 8 mm here. It goes without saying that these dimensions can be varied depending on the respective operating conditions, in particular in adaptation to the different eye size, and can be, for example, 11 × 9 mm. The wall- thickness 45 of the ring part 27 is 0.5 mm and the height 92 of the ring part is 4.9 mm. The cutting edge 28 has a wedge-shaped cross-section and tapers to the tip-side end 46 (FIG. 6). The cutting edge 28 has a base thickness of 0.1 mm. The height of the cutting edge 28 is 0.3 mm here.

In order to avoid complete detachment of the corneal epithelium, the cutting edge 28 does not run completely around, that is to say it is not designed continuously, but is interrupted by a recess 40 extending in the circumferential direction. This recess 40 extends over an angle 41 which is 90 degrees. The exact arrangement of the cutting edge 28 relative to the minor axis 36 of the active edges 24 or relative to the handle part 26 is advantageously selected in accordance with the needs of the operation and user and is described below.

Starting from the secondary apex 37 or the central axis coinciding with the secondary axis 36 of the bore 38 for the grip part 26, which extends radially outward from the center of the ellipse, the recess 40 begins offset clockwise from an angle 42, which here is 30 degrees to extend.

On the side of the ring part 27 facing away from the cutting edge 28, a recess 50 corresponding to the position of the recess 40 is provided. This enables the surgeon to easily determine the exact position of the recess 40 on the skin side in order to be able to place the cut edges 28 of the trepan 20 exactly on the cornea in the position in which the hinge for the patient has been cut after the incision in the skin Ephithelian lobe should be formed.

In the ring part 27 there are four small through holes which are arranged in a common plane and which are at a distance of 2.2 mm from the end 47 of the ring part 27 facing away from the cutting edge 28. The holes are each offset at the same angle 33 arranged, which is 90 degrees. The angle 32 between the minor axis 36 and the adjacent bore is 45 degrees. The bores serve to receive a cross hair 30, which enables an exact positioning of the ophthalmic surgical instrument 21 associated with the pupil. The crosshair 30 is formed with two thin stainless steel rods, on which markings 31 are provided on the side facing away from the cutting edge 28 at equal intervals, which offer favorable centering options for the operator.

The distance 48 between the bore 38 serving to receive the grip part 26 and the front end 47 of the ring part 27 pointing away from the cutting edge 28 is 1.5 mm and its diameter is 0.5 mm.

As can be seen from the cross-sectional illustration in FIG. 6, the cylindrical inner wall parts of the ring part 27 in the direction of the cutting edge 28 are adjoined by an obliquely outwardly extending wall part, the inclined surface of which is designed with a spherical radius 29, which in the exemplary embodiment is 7.85 mm. The cutting edge or cutting edge 28, which tapers to the outside, then extends from these inclined surfaces. The above measures make it possible to achieve favorable cutting and support conditions during the operation.

The ophthalmic surgery instrument 51 designed as a funnel instrument has an inner contour 85 corresponding to the inner contour of the ophthalmic surgical instrument 21 designed as a trepan 20. However, the active edge 54 forms a sealing edge 58 in order to seal the ring part 57, which is designed as a funnel 70, with respect to the cornea regions surrounding outside the operating field 53. In this way, damage to the cornea by the alcohol to be filled into the funnel 70 to detach the epithelium can be avoided.

The effective edge 54, which is designed as a sealing edge 58, is also oval-shaped, in the present case elliptical. In order for the liquid intended for the detachment of the epithelium to penetrate into the cutters of the trepan 20 To enable the generated gap, the inner contour 85 of the active edges 54 of the ophthalmic surgery instrument 51 designed as a funnel instrument is geometrically similar to the inner contour 95 of the active edges 24 of the ophthalmic surgical instrument 21 designed as Trepan 20, but slightly larger. In this way, the active edges 54 of the ophthalmic surgery instrument 51 form a slightly larger operating field 53.

The sealing edges 58 of the active edges 54 are designed with a spherical radius 59 which in the exemplary embodiment corresponds to the spherical radius 29 of the oblique inner shoulder of the ring part 27 and which accordingly also has a radius of 7.85 mm. In this way, both instruments are optimally adapted to certain eye conditions. It is understood that the ball radii 29 and 59 can be adapted to different eye conditions.

The ring part 57 of the ophthalmic surgery instrument 51 also has a handle part 56 as the manipulation member 55 in order to enable the funnel 70 to be actuated or positioned manually above the eye. It goes without saying that both the ophthalmic surgical instrument 21 and the ophthalmic surgical instrument 51 can be provided instead of a handle part or additionally with a holding and supporting part, which is used to connect to a machine-operated manipulation device or an eye surgery robot and to fasten it there become.

The cylindrical ring part 57 of the ophthalmic surgery instrument 51 has a wall thickness 75 of likewise 0.5 mm and a height 82 of 5.6 mm. The ring part 57 is also provided with four small bores designed as through bores, which are arranged at an identical angle 63 to one another, starting from the secondary axis 66 of the active edges 24, the respective adjacent bore being arranged offset by an angle 62. The bores lie in a common plane and also serve to receive a cross hair 60 in the form of two straight, thin round rods, with the aid of which a favorable, pupil-related positioning of the ophthalmic surgery instrument 51 designed with the funnel 70 can be made possible and, in particular, in particular to enable this to be aligned at exactly the same distance from the cuts or gaps made in the epithelium of the cornea by means of the ophthalmic surgery instrument 21 designed as a trepan 20.

The distance between the bores for the cross hair 60 from the end 77 of the ring part 57 facing away from the active edge 54 is 2.2 mm and the bores also have an inside diameter of 0.2 mm. The distance 78 of the bore 68 for the handle part 56 from said end 77 is 1.5 mm.

The ellipse of the active edges 54 is designed with the main axis 64 and the secondary axis 66 perpendicular thereto, the two main apices 65 and the two secondary apices 67 being formed on the outer circumference of the ring part 57.

The distance between the two main apices 65, thus the length 83 of the ring part 57, is 11.7 mm, while the distance between the two secondary apices, hence the width 84 of the ring part 57, is 9.9 mm.

According to the arrangement of the grip part 26 in the ophthalmic surgery instrument 21 designed as a trepan 20, the grip part 56 of the ophthalmic surgery instrument 51 functioning as a funnel instrument is arranged on the active element 52 designed as a ring part 57 in such a way that the grip part 56 is located in the region of one of the secondary apexes 67 is arranged and extends radially outward in the direction of one of the secondary axes 66.

Claims

Patent claims

1. An ophthalmic surgical instrument, in particular for the laser epithelial keratomileusis of the cornea of an eye, with an active element (22) which serves to cut into the cornea of the eye to be operated on, the active element (22) comprising a cutting edge (28) with which the corneal epithelium can be cut after being placed on the cornea and with the application of compressive forces, characterized in that the cutting edge (28) is formed along a self-contained, oval-shaped active edge (24) of the active element (22).

2. Instrument according to claim 1, characterized in that the oval-shaped cutting edge (28) has at least one recess (40) extending in the circumferential direction of the cutting edge (28), so that in the region of the recess 40) there is no incision in the corneal epithelium he follows.

3. Instrument according to claim 2, characterized in that the recess extends over an angle (41) of preferably 90 degrees and is arranged offset relative to a minor axis (36) of the active edges (24) by an angle (42), which is preferably Is 30 degrees.

4. Instrument for the laser-apithelial keratomileusis of the cornea of an eye, with an active element which has an operative field-defining, annular active edges which are intended to be brought into contact with the cornea of the eye to be operated on, the active element being a funnel comprises, which is intended to be placed on the cornea and absorb a liquid, and with a manual and / or mechanical actuation of the active element and firmly connected to this manipulation member, characterized in that the active edges (24, 54) of the Funnels (70) are oval-shaped.

5. Instrument according to one of claims 1 to 4, characterized in that the active edges (24,54) are elliptical.

6. Instrument according to one of claims 1 to 5, characterized in that the active element (22,52) is designed with opposed flattened active edges (24,54).

7. Instrument according to one of claims 1 to 6, characterized in that the oval-shaped active edges (24,54) are formed by reshaping a tubular body originally having a circular cross section.

8. Instrument according to one of claims 1 to 7, characterized in that the manipulation member (25, 55) designed as a grip part (26, 56) is arranged in the region of one of the secondary apexes (37, 67) of the active edges (24, 54) and / or extends in the direction of one of the secondary axes (36, 66) of the active edges (24, 54).

9. surgical set consisting of an ophthalmic surgery instrument (21) designed as a trepan (20) and an ophthalmic surgical instrument (51) designed with a funnel (70) according to at least one of claims 1 to 8.

10. The surgical set according to claim 9, characterized in that the active edges (24, 54) of the trepan (20) and the funnel (70) each have a coordinated inner contour (95, 85), the through the inner contour (85) the operative edge (54) of the funnel (70) determined operation field (53) is slightly larger than the operative field (23) determined by the inner contour (95) of the active edge (24) of the trepan (20).