VITRECTOMY NEEDLE, A VITRECTOME, A VITRECTOMY DEVICE AND A METHOD OF MANUFACTURING A VITRECTOMY NEEDLE

Abstract

A vitrectomy needle comprises a hollow needle with a distal end for insertion into the vitreous body of an eye for performing a vitrectomy. The vitrectomy needle further comprises a laser light guide guided in the hollow needle to the distal end and has a light-emitting surface oriented towards the distal end. A cavity is formed between the light-emitting surface and the axially inward-facing surface of the distal end. In the area of the cavity, the wall of the hollow needle has an aperture extending radially with respect to the middle axis (M) of the hollow needle. The vitrectomy needle, has a straight section at the proximal end, the middle axis (M) defining a central axis (Z) in the region of the straight section. The middle axis (M) of the hollow needle may be spaced apart from the central axis (Z) by a predetermined minimum radial distance (R).

Claims

1-13 (canceled)

14. A vitrectomy needle comprising: a hollow needle with a distal end for insertion into the vitreous body of an eye for performing a vitrectomy; and a laser light guide guided in the hollow needle to the distal end with a light-emitting surface oriented towards a distal end; wherein: a cavity is formed in the hollow needle in the region of the light-emitting surface and the axially inward-facing surface of the distal end; the wall of the hollow needle has an aperture in the region of the cavity which aperture extends radially with respect to the middle axis (M) of the hollow needle; the vitrectomy needle, in particular the hollow needle, has a straight section at the proximal end; the middle axis (M) defines a central axis (Z) in the region of the straight section; and the middle axis (M) of the hollow needle is spaced apart from the central axis (Z) by a predetermined minimum radial distance (R) in the region of the aperture.

15. The vitrectomy needle according to claim 14, wherein, starting from the straight section towards the distal end, the hollow needle has a curvature with a, preferably constant, radius of curvature (K).

16. Vitrectomy needle according to claim 15 wherein the curvature extends from the straight section substantially to the distal end and/or wherein, starting from the straight section to the distal end, the curvature is a continuous curvature.

17. Vitrectomy needle according to claim 15, wherein, starting from the curvature towards the distal end, the hollow needle has at least one further straight section.

18. Vitrectomy needle according to claim 14, wherein the hollow needle has an outer diameter (Da) of 0.55 mm to 0.65 mm, preferably 0.6 mm, and/or wherein the hollow needle has an inner diameter (Di) of 0.35 mm to 0.55 mm, in particular from 0.35 to 0.45 mm, preferably about 0.4 mm, and/or wherein the hollow needle has a length (L), measured along the middle axis (M), of 18 mm to 30 mm, preferably 20 mm to 27 mm, further preferably about 25 mm.

19. Vitrectomy needle according to claim 14, wherein the minimum radial distance (R) is in the range of at least 5 mm to 30 mm.

20. Vitrectomy needle according to claim 14, wherein the aperture is formed on a side of the hollow needle facing the central axis (Z) or on a side of the hollow needle facing away from the central axis (Z).

21. A vitrectome comprising a handpiece and a vitrectomy needle according to claim 14, the vitrectomy needle connected to the handpiece.

22. Vitrectome according to claim 21, wherein the vitrectomy needle is detachably attached to the handpiece, in particular by means of a screw connector formed at the proximal end of the vitrectomy needle, or wherein the vitrectomy needle is firmly connected, in particular glued, to the handpiece.

23. A vitrectomy device comprising: a laser light source; a control unit for controlling the laser light source; and a connection interface for connecting a vitrectome comprising a handpiece and a vitrectomy needle, the vitrectomy needle comprising a hollow needle with a distal end for insertion into the vitreous body of an eye for performing a vitrectomy, and a laser light guide guided in the hollow needle to the distal end with a light-emitting surface oriented towards a distal end; wherein the control unit is configured for controlling at least the laser light source for performing a vitrectomy when the vitrectome is connected.

24. A method of manufacturing a vitrectomy needle with a hollow needle with a distal end for insertion into a vitreous body of an eye for performing a vitrectomy; and a laser light guide guided in the hollow needle to the distal end with a light-emitting surface oriented towards a distal end, the method comprising: providing an elongated solid, in particular cylindrical, blank; creating a hollow body from the blank by drilling a central blind hole extending in longitudinal direction of the blank by means of a drilling tool; creating the aperture, which is radial with respect to the longitudinal direction, at the closed end of the blind hole by means of a milling tool, in such a way that the aperture opens radially into the blind hole; heating the hollow body to a forming temperature, in particular in the range between 60° C. and 140° C., in particular between 100° C. and 130° C., further in particular at about 120° C.; and forming of the hollow body to the final geometry of the vitrectomy needle by means of a forming tool.

25. The method according to claim 24, wherein the blank has an outer diameter of 0.2 mm to 1 mm.

26. The method according to claim 24, wherein the heating comprises resistive electrical heating by means of electric current and/or inductive heating.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Exemplary embodiments of the invention are described below with reference to the accompanying figures, in which:

[0045] FIG. 1 is a vitrectomy needle according to a first embodiment of the invention;

[0046] FIG. 2 a vitrectomy needle according to a second embodiment of the invention;

[0047] FIG. 3 is an enlarged view of a vitrectomy needle with exemplary dimensions;

[0048] FIGS. 4 and 5 two further embodiment variants of a vitrectomy needle;

[0049] FIG. 6 a schematic view of a vitrectomy device with vitrectome;

[0050] FIG. 7 a use of the vitrectomy needle, in a schematic view and not to scale;

[0051] FIG. 8 another embodiment of a vitrectome;

[0052] FIG. 9 an enlarged portion of the distal end of the vitrectomy needle of the vitrectome of FIG. 8; and

[0053] FIG. 10 process steps of a method of manufacturing the vitrectomy needle.

[0054] Unless otherwise explicitly described, identical or functionally identical elements are designated with the same reference signs in the figures. Furthermore, the figures are not necessarily true to scale.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0055] FIG. 1 shows a vitrectomy needle 1 according to a first embodiment of the invention. The vitrectomy needle 1 comprises a hollow needle 2 with a distal end 3 for insertion into the vitreous body 4 of an eye 5 for performing a vitrectomy, which is in particular also shown in FIG. 7.

[0056] The vitrectomy needle 1 shown in the figures comprises, by way of example, at the proximal end 6 of the vitrectomy needle 1 facing away from the distal end 3, a screw connector 7 for detachable attachment to a handle part 8 shown in FIG. 6. Other possibilities for attachment, such as adhesive connections, may also be considered as alternatives or supplements for attaching the vitrectomy needle to a handle part and/or a holder. In particular, the vitrectomy needle may be glued on or glued to the handle.

[0057] The vitrectomy needle 1 further comprises a laser light guide 9 guided in the hollow needle 2 to the distal end 3 and fastened there by means of suitable fastening elements, with a light-emitting surface 10 being oriented towards the distal end 3.

[0058] As can be seen in particular from FIG. 3, a cavity 12 is formed between the light-emitting surface 10 and the axially inward-facing surface 11 of the distal end 3. Furthermore, in the region of the cavity 12, the wall 13 of the hollow needle 2 has an aperture 14 extending radially with respect to the middle axis M of the hollow needle 2, which is only shown in FIG. 6 and FIG. 7 for reasons of clarity. The middle axis M of the hollow needle 2 or of the vitrectomy needle 1 is to be understood as the axis that runs centrally through the hollow needle 2 or the vitrectomy needle 1 following the shape of the hollow needle 2 or vitrectomy needle in its longitudinal direction.

[0059] At the proximal end 6, the hollow needle 2, in particular the vitrectomy needle 1, has a straight section 15. The straight section may, for example, be a connector, such as a screw connector 7, for connection to a handle part 8 (FIG. 6). However, the straight section 15 may also be a section of the hollow needle 2, as shown in the figures.

[0060] As can be seen from the figures, the straight section 15 may have different lengths in different embodiments of the hollow needle 2. In the embodiments shown, the straight section 15 of the hollow needle 2 has a minimum length which corresponds at least to the axial length of a trocar 16, which axial length may for example be in the range from 20 nm to 30 nm, with the trocar 16 through which the hollow needle 2 is inserted into the eye 5 during a vitrectomy being schematically shown in FIG. 7. With the straight section 15, the hollow needle 2 may be rotated about the central axis Z of the vitrectomy needle 1 or the hollow needle 2 after having passed through the trocar 16, without tilting moments being exerted on the trocar 16.

[0061] In the context of the invention, the central axis Z is to be understood as the axis which is defined by, or runs parallel to, the middle axis M in the straight section 15 of the proximal end 6 of the hollow needle 2, or vitrectomy needle 1. In particular, the central axis Z is to be understood as the axis that is defined by the straight line running collinearly to the middle axis M in the straight section 15 at the proximal end 6.

[0062] In the vitrectomy needles 1 of the embodiments according to FIGS. 1 to 7, the middle axis M of the hollow needle 2 or of the vitrectomy needle 1 is spaced apart from the central axis Z by a predetermined minimum radial distance R in the region of the aperture 14. The minimum radial distance R is shown in the figures with respect to the edge of the aperture 14 facing the proximal end. It is also possible that the centre of the opening surface of the aperture 14 is considered for the minimum radial distance R. The term “predetermined minimum radial distance” shall in particular be understood to mean that the minimum distance is not a random deviation of the central axis Z from the middle axis M, but a specific and predetermined distance set during the manufacture of the vitrectomy needle 1 or the hollow needle 2.

[0063] As mentioned and discussed above, the described deviation of the middle axis M from the central axis Z offers advantages with regard to the handling of the vitrectomy needle 1 as well as with regard to the forces acting on the entry incision of the eye 5.

[0064] The vitrectomy needle 1 shown in FIG. 1 has a continuous curvature 17 starting from the straight section 15 towards the distal end 3, the radius of curvature varying along the middle axis M.

[0065] Compared to the vitrectomy needle 1 of FIG. 1, the straight section 15 of the hollow needle 2 of the embodiment according to FIG. 2 is elongated. The straight section 15 of the hollow needle 2 of FIG. 2 is followed by a bend 18, which in turn is followed by a further, albeit short, straight section 15.1.

[0066] In the embodiment according to FIGS. 4 to 7, the hollow needle 2 has a curvature with continuous curvature starting from the straight section 15 towards the distal end 3, wherein, in addition, a substantially constant radius of curvature K is implemented. For clarity, the radius of curvature K is only shown in FIG. 4.

[0067] The embodiments according to FIG. 4 and FIG. 5 differ only in the position of the aperture 14 relative to the central axis Z. Whereas in FIG. 4 the aperture 14 is provided on a side of the hollow needle 2 facing away from the central axis Z, in FIG. 5, the aperture 14 is provided on the side of the hollow needle 2 facing towards the central axis Z.

[0068] Exemplary dimensions of the vitrectomy needle 1 or the hollow needle 2 are shown in FIG. 3. According to FIG. 3, the hollow needle 2 may have an outer diameter Da of 0.4 mm. An inner diameter Di of the hollow needle 2 may be 0.25 mm. Measured along the middle axis M, i.e. following the shape of the hollow needle 2, the hollow needle 2 may have a length L of, for example, 25 mm.

[0069] A wall thickness of the vitrectomy needle may be about 0.1 mm, for example.

[0070] Based on medical terminology, the size of the vitrectomy needle may be in the range from 20 G to 27 G (G: gauge). These sizes correspond to outer diameters in the range between 0.4 mm (at 27 G) and 0.9 mm (at 20 G).

[0071] The minimum radial distance shown with reference to FIGS. 1, 2, 3 and 4 may be in the range of at least 5 mm to 30 mm.

[0072] FIG. 6 shows a vitrectomy device 19 comprising a mobile central unit 20 with a control panel 21, a laser light source 22, an aspiration and irrigation device 23 and a control unit 24, which is set up to control the laser light source 22, the aspiration and irrigation device 23 and possibly other components and units for performing a vitrectomy when the vitrectome 25 is connected. For this purpose, the control unit 24 may comprise a memory with computer-readable instructions stored thereon which, when executed by a processor, may control the corresponding units for performing a vitrectomy, in particular in accordance with a user input via the control panel 21 and/or via the handle part 8 of the vitrectome 25.

[0073] The vitrectome 25 comprises the or a vitrectomy needle 1, and the handle part 8 connected to the vitrectomy needle 1. For example, the vitrectomy needle 1 may be firmly connected to the handle part by an adhesive connection. Other types of connection are also or alternatively possible, as described further above. Through and connected to the handle part 8 is a control and/or signal line 26, hereinafter referred to as line for short, which in turn is connected to the central unit 20. The line 26 is at least designed to transmit laser light, in particular laser pulses, from the laser light source 22 to the laser light guide 9 of the vitrectomy needle 1. For example, a laser light guide (not shown) may be present in the line 26 itself, which laser light guide is coupled to the laser light guide 9 when the vitrectomy needle 1 is connected.

[0074] During operation of the vitrectomy device 19, laser pulses are generated by the laser light source 22, for example, and coupled into the laser light guide 9 of the vitrectomy needle 1 through the line 26. Laser pulses emitted at the light-emitting surface 10 cause photolytic fragmentation of the vitreous material, for example by laser-induced pressure pulses generated by laser absorption in the cavity 12 and impinging on the vitreous material through the aperture 14. The shattered or fragmented vitreous material may be aspirated by the aspiration device, and an irrigation fluid and other media may be introduced by means of the irrigation device.

[0075] As can be seen in particular from FIG. 7, a vitrectomy needle 1 designed in accordance with the invention has, solely by performing a rotation D around the central axis Z, a comparatively large radius of action A due to its special shape, in particular due to the radial distance of the aperture 14 from the central axis Z. Due to the comparatively large radius of action A, when performing a vitrectomy, pivoting movements performed with respect to the central axis Z, through which forces may be exerted on the incision in the eye via the trocar 16, may be reduced to a minimum, combined with the advantages mentioned above.

[0076] FIG. 8 shows a further embodiment of a vitrectome 25. The vitrectome 25 of FIG. 8 comprises a handle part 8 with a connection line or connection 27 for connection, for example, to a central unit 20 as schematically described in connection with FIG. 6.

[0077] The handle part 8 may be designed rotationally symmetric with respect to the central axis Z. Approximately in the middle, when viewed in longitudinal direction, the handle part 8 comprises a circumferential convex indentation or recess which is designed for holding the vitrectome 25 with two or more fingers, in particular in accordance with ergonomic aspects. In embodiments, the handle part may also have a shape other than a rotationally symmetrical shape.

[0078] In the present example, the vitrectomy needle 1 is glued to the handle part 8, and in this respect is firmly, in particular non-rotatably, connected to it.

[0079] Starting from the handle portion 8, the vitrectomy needle 1 of the embodiment of FIG. 8 has a straight section 15 which may extend, for example, over about ⅔ of the length of the vitrectomy needle 1. Adjacent to the straight section 15 is a curvature, specifically a curved section 27, which extends substantially to the distal end. In the present case, the aperture 14 is located on the inner side of the curvature, i.e. the aperture 14 is formed on the side facing the centre(s) of curvature.

[0080] FIG. 9 shows an enlarged section of the distal end of the vitrectomy needle of the vitrectome of FIG. 8. In the present example, the axial inner surface of the distal end 3 has an approximately conical shape, which may be given, for example, by the drilling geometry of the drill used for making the hollow needle 2. The bore is essentially concentric with the central axis Z. The light-emitting surface 10 of the laser light guide 9 is spaced away from the axial inner surface of the distal end 3 by a predetermined distance DL, the cavity 12 being formed between the light-emitting surface 10 and the axial inner surface. The distance DL may be, for example, 0.9 mm to 1.2 mm, the distance DL preferably being dependent on the outer diameter and being the smaller the smaller the outer diameter.

[0081] In the present example, the light-emitting surface 14, when viewed in radial section, projects, towards the distal end 3, beyond the edge of the aperture 14 that faces away from the distal end 3. The laser light guide 9 is fixed in the hollow needle 2 or in the vitrectomy needle 1 by one or more adhesive points. The inner diameter of the hollow needle 2 may be, for example, 0.45 mm. The diameter of the laser light guide 9 is smaller than the inner diameter of the hollow needle 2, so that a channel may be formed between the laser light guide 9 and the inner wall of the hollow needle 2, for example.

[0082] In the present example, the aperture 14 is formed by a cut or incision perpendicular to the central axis Z, which may be produced, for example, by a milling tool positioned or oriented and moved perpendicular to the central axis Z.

[0083] Finally, in connection with FIG. 10, a course of a method of manufacturing a vitrectomy needle according to the invention is described.

[0084] In a first method step 801, a blank is provided which has an elongated shape and is solid. For example, a cylindrical solid blank may be used. A particularly suitable material for the blank is metal, preferably titanium or a titanium alloy. For example, titanium material referred to as Grade 4 or Grade 5 (according to ASTM standard) may be used.

[0085] In a second method step 802, a blind hole running in the longitudinal direction of the blank is drilled into the blank so that a hollow body is formed which is open on one side in the longitudinal direction, i.e. which is closed on one end.

[0086] In a third method step 803, the aperture 14, which is radial with respect to the longitudinal direction, is produced at the closed end of the blind hole by means of a milling tool in such a way that the aperture 14 opens radially into the blind hole.

[0087] In a fourth method step 804, the hollow body is heated or heated to a forming temperature, for example by resistive heating using an electric current.

[0088] In a fifth method step 805, the hollow body is formed to the desired final geometry using suitable forming tools or dies.

[0089] Finally, the laser light guide 9 may be inserted and fixed in the formed hollow body. Furthermore, a screw connection or other possibility for connection with a coupling surface for the laser light guide 9 may be attached to the proximal end 6, so that the vitrectomy needle 1 may be connected in a non-destructive, removable manner to a handle part 8, designed, for example, according to FIG. 6. Instead of a detachable connection, it may also be provided that the hollow needle 2 or the vitrectomy needle 1 is firmly connected, preferably glued, to the handle part 8.

[0090] With the method, the vitrectomy needle proposed herein may be manufactured comparatively efficiently and with high process stability and repeatability. Furthermore, by selecting appropriate forming tools, it is possible to provide different shapes and geometries for different uses and eye sizes.

[0091] In all, it becomes clear that the vitrectomy needle, the vitrectome, the vitrectomy device and the method of manufacturing a vitrectomy needle proposed herein eliminate the disadvantages in the prior art mentioned at the outset.

LIST OF REFERENCE SIGNS

[0092] 1 Vitrectomy needle [0093] 2 Hollow needle [0094] 3 Distal end [0095] 4 Vitreous body [0096] 5 Eye [0097] 6 Proximal end [0098] 7 Screw connector [0099] 8 Handle part [0100] 9 Laser light guide [0101] 10 Light-emitting surface [0102] 11 Inward-facing surface [0103] 12 Cavity [0104] 13 Wall [0105] 14 Aperture [0106] 15 Straight section [0107] 15.1 Further straight section [0108] 16 Trocar [0109] 17 Continuous curvature [0110] 18 Curvature [0111] 19 Vitrectomy device [0112] 20 Central unit [0113] 21 Control panel [0114] 22 Laser light source [0115] 23 Aspiration and irrigation device [0116] 24 Control unit [0117] 25 Vitrectome [0118] 26 Control and/or signal line [0119] 37 Curved section [0120] 801-805 Method steps [0121] A Radius of action [0122] Da Outer diameter [0123] Di Inner diameter [0124] K Radius of curvature [0125] L Length [0126] M Middle axis [0127] R Minimum radial distance [0128] Z Central axis