INJECTOR WITH AN INJECTOR TIP FEATURING A CORRUGATED WALL

Description

[0001] The invention relates to an injector for introducing an intraocular lens into the capsular bag of an eye. US 2007 / 0005135 A1 discloses an introduction device for implanting intraocular lenses through small incisions. EP 1 287 792 A1 discloses an introduction device for a deformable intraocular lens. WO 98 / 37830 A2 discloses an implantation device with a deformable nozzle tip for implanting a deformable intraocular lens.

[0002] During cataract treatment, a small incision is traditionally made in the cornea, large enough to allow the tip of an injector to be inserted into the eye. After the incision has been made in the cornea, the lens of the eye is crushed using phacoemulsification and then suctioned out of the capsular bag. An intraocular lens is then inserted into the eye using the injector. The intraocular lens is folded in the injector so that it fits through the tip. The tip is inserted through the incision into the capsular bag, and the folded intraocular lens is pushed through the tip into the capsular bag using the injector. The intraocular lens unfolds and replaces the original lens.

[0003] To minimize the incision in the cornea, the injector tip must be as small as possible. This results in the intraocular lens being severely crushed when the intraocular lens is positioned in the tip. This places high mechanical stress on the tip, which can lead to tip damage. For example, parts of the tip can be irreversibly deformed outward, which in extreme cases can cause the tip to widen the incision and / or damage the eye if the tip is pulled out of the eye.

[0004] The object of the invention is therefore to provide an injector for introducing an intraocular lens into the capsular bag of an eye, wherein a tip of the injector can be made small without the risk of damaging the tip.

[0005] The injector according to the invention for inserting an intraocular lens into the capsular bag of an eye has an injector axis, an injector tip having an opening and a wall delimiting the opening, and a piston which is mounted in the injector so as to be longitudinally displaceable in the direction of the injector axis and is configured to convey the intraocular lens out of the injector via the opening, wherein the wall, in a first section which starts from the end of the injector tip at which the opening is arranged and extends in the direction of the injector axis, has a modulus of elasticity under a tensile load in a range from 10 N / mm 2< to 500 N / mm 2< and is corrugated, so that the wall has a plurality of peaks and a plurality of valleys in a cross-sectional plane whose normal is arranged parallel to the injector axis, wherein the peaks and valleys are arranged alternately in the circumferential direction with respect to the injector axis.

[0006] Because the elastic modulus lies in a range from 10 N / mm 2 to 500 N / mm 2 , preferably between 10 N / mm 2 and 250 N / mm 2 , and particularly preferably between 10 N / mm 2 and 100 N / mm 2 , the wall can be elastically stretched when the intraocular lens is moved into the injector tip. Because the wall is corrugated, the valleys and optionally also the peaks can be displaced outward in the radial direction relative to the injector axis when the intraocular lens is moved into the injector tip, thereby increasing the cross-section of the injector tip. This allows the injector tip, in its state before the intraocular lens is moved into the injector tip, to be made smaller than a conventional injector tip, in which the wall has a higher elastic modulus than 500 N / mm 2 and is not corrugated.Due to the relatively high elasticity of the material of the first section, the compressive force exerted by the crushed intraocular lens on the wall of the first section is lower than in an injector whose first section is made of a material with a modulus of elasticity under tensile load of greater than 500 N / mm². This reduces the risk of damage to the injector tip. It is conceivable that the wall deforms in such a way that the interior space in the injector tip takes on a larger volume than in a conventional injector tip. This means that the intraocular lens is crushed less than with a conventional injector tip, which also reduces the risk of damage to the intraocular lens. Once the intraocular lens has left the injector via the opening, the wall returns to the shape it had before the intraocular lens was moved into the injector tip.This also reduces the risk of damage to the cornea and / or other parts of the eye when the injector tip is removed from the eye.

[0007] It is preferred that the injector tip has a relaxed state in which the intraocular lens is not arranged in the injector tip, a partially tensioned state in which the wall in the first section is subjected to mechanical tensile stress by inserting the intraocular lens into the injector tip, and a maximally tensioned state in which the wall is maximally tensioned by inserting the intraocular lens, wherein the opening in the maximally tensioned state is larger than in the relaxed state. As a result, the opening, as it exists in the relaxed state, can be made smaller than in the conventional injector tip, in which the injector tip does not have a modulus of elasticity in the range of 10 N / mm 2 < to 500 N / mm 2 < and is not corrugated.

[0008] In the first section and in the relaxed state, the injector tip continuously reduces its cross-section, preferably toward the opening, with the normal line parallel to the injector axis. As a result, the cross-section in the area of ​​the opening is smaller than the remaining part of the first section, allowing the tip to be inserted particularly easily into an incision in the cornea. The cross-section can refer to the cross-section on the outside of the wall and / or the inside of the wall.

[0009] It is preferred that in the first section and in the maximally tensioned state, the injector tip continuously increases its cross-section, the normal of which is arranged parallel to the injector axis, towards the opening or keeps it the same size. If the cross-section continuously increases, maximum crushing of the intraocular lens does not occur directly at the opening but away from the opening. If the intraocular lens is displaced at its maximum crush, this can result in the intraocular lens moving uncontrollably and at high speed. By arranging the location of the maximum crushing far away from the opening, it can be prevented that the intraocular lens leaves the injector tip uncontrollably and at high speed. The cross-section can mean the cross-section on the outside of the wall and / or on the inside of the wall.

[0010] In the first section and in the maximum tensioned state, the wall preferably has a circular, elliptical and / or oval shape on its outer side and / or its inner side in the cross-sectional plane.

[0011] The wall preferably has a constant thickness in the circumferential direction relative to the injector axis and in the cross-section. This applies to the relaxed state, the partially tensioned state, and the maximally tensioned state. Particularly preferably, the thickness of the wall is constant throughout the entire first section. It is also preferred that the opening lies entirely within an opening plane, which may be arranged parallel to the cross-sectional plane or whose normal may enclose an angle other than 0° with the normal of the cross-sectional plane, and that the wall in the first section has no further recess apart from the opening.

[0012] The wall preferably has a second section which extends in the direction of the injector axis and in which the wall has a modulus of elasticity under tensile stress of greater than 900 N / mm 2 , in particular greater than or equal to 1.8*10 3 N / mm 2 . The wall provided in the second section is intended to contact the cornea when the intraocular lens is displaced into the injector tip, thereby preventing the cornea from being deformed in the process. A transition of the modulus of elasticity from the first section to the second section can be continuous, for example along a distance of greater than 0.5 mm, greater than 1 mm or more than 2 mm.

[0013] In order to ensure that the wall in the second section has a higher resistance under tensile load, the thickness of the wall in the second section can be greater than in the first section. Alternatively or additionally, it is conceivable for the second section to have a reinforcing piece arranged in the wall. The reinforcing piece is preferably a helix, a cylinder-jacket-shaped part and / or a conical-jacket-shaped part or preferably has the helix, the cylinder-jacket-shaped part and / or the conical-jacket-shaped part. It is particularly preferred that the reinforcing piece comprises a metal or an alloy or consists of the metal or the alloy.

[0014] The thickness of the wall in the first section may be equal to the thickness of the wall in the second section.

[0015] It is preferred that the wall has from four to twelve of the peaks and valleys, in particular from six to ten of the peaks and valleys, or eight of the peaks and valleys.

[0016] The injector preferably has the intraocular lens.

[0017] The invention is explained in more detail below with reference to the attached schematic drawings. Figure 1 a perspective view of an injector in a relaxed state obliquely from the front, Figure 2 a side view of the injector in the relaxed state, Figure 3 the view of the injector according to Figure 1 in a fully tensioned state of the injector, Figure 4 the view of the injector according to Figure 2 in the fully tensioned state, Figure 5 a longitudinal section through a preferred embodiment of the injector, Figure 6 a cross section along the Figure 2drawn plane AA through an injector tip of the injector and Figure 7 a schematic representation of a longitudinal section of the Figure 1 shown injector.

[0018] How it turns out Figures 1 to 7As can be seen, an injector 1 for introducing an intraocular lens 21 into the capsular bag of an eye has an injector axis 4, an injector tip 2 having an opening 3 and a wall 5 delimiting the opening 3, and a piston 19 which is mounted in the injector 1 so as to be longitudinally displaceable in the direction of the injector axis 4 and is designed to convey the intraocular lens 21 via the opening 3 out of the injector 1, wherein the wall 5 in a first section 11, which starts from the end 14 of the injector tip 2, at which the opening 3 is arranged, and extends in the direction of the injector axis 4, has a modulus of elasticity under a tensile load in a range from 10 N / mm 2< to 500 N / mm 2< and is designed to be corrugated, so that the wall 5 in a cross-sectional plane 20, the normal of which is parallel to the Injector axis 4 is arranged, has a plurality of mountains 6 and a plurality of valleys 7,wherein the peaks 6 and the valleys 7 are arranged alternately in the circumferential direction 10 with respect to the injector axis 4. , Figure 1 shows that the valleys 7 can be continuously flatter in the direction away from the opening 3. Figure 7 shows that the injector 1 can have the intraocular lens 21.

[0019] Figures 2 to 5 show that the injector tip 2 can be beveled in the region of the end 14. For example, the wall 5 can have an end face 15 that directly adjoins the opening 3 and whose normal encloses an angle with the injector axis 4 that is different from 0° and that is, for example, from 20° to 70° or from 40° to 50°. In the case that the injector tip 2 is beveled, the cross-sectional plane 20 can be arranged away from the region 22 in which the injector tip 2 is beveled. Figure 6shows that the wall 5 can be designed without interruptions in the cross-sectional plane 20 and in the circumferential direction 10 with respect to the injector axis 4. Furthermore, it can be seen that the wall 5 can have a constant thickness 16 in the cross-sectional plane 20 and in the circumferential direction 10 with respect to the injector axis 4. It is also conceivable that the thickness 16 can be constant in the entire first section 11. Figure 6 also shows that the wall 5 can be point-symmetrical in the cross-sectional plane 20 and thus normal to the injector axis 4.

[0020] In particular from Figures 1 and 3It can be seen that the opening 3 can lie entirely within an opening plane, which can be arranged parallel to the cross-sectional plane or whose normal can enclose an angle other than 0° with the normal of the cross-sectional plane, and that the wall 5 in the first section 11 can have no further recesses except for the opening 3. Furthermore, the end face 15 can lie entirely within the opening plane.

[0021] The wall 5 can have eight of the mountains 6 and the valleys 7, as can be seen, for example, in Figures 1 and 6 It is also conceivable that the wall 5 has from four to twelve of the peaks 6 and valleys 7, in particular from six to ten of the peaks 6 and valleys 7.

[0022] The injector tip 4 can have a relaxed state, which in Figures 1, 2 and 6is shown and in which the intraocular lens is not arranged in the injector tip 4, a partially tensioned state in which the wall 5 in the first section 11 is subjected to mechanical stress by inserting the intraocular lens into the injector tip 2, and a maximally tensioned state which is Figures 3 to 5 and in which the wall 5 is maximally tensioned by the insertion of the intraocular lens, wherein the opening 3 is larger in the maximally tensioned state than in the relaxed state. For the sake of clarity, an intraocular lens 21 causing the mechanical tension of the first section 11 is not shown. The wall 5 can be configured so that the injector tip 2 can be returned to the Figures 1, 2 and 6 shown relaxed state after the intraocular lens 21 has left the injector 1.

[0023] Figure 2shows that in the first section 11, the injector tip 2 can reduce its cross section, the normal of which is arranged parallel to the injector axis 4, in the relaxed state in the direction of the opening 3.

[0024] Figure 4shows that in the first section 11 the injector tip 2 can increase its cross-section in the direction of the opening 3, the normal of which is arranged parallel to the injector axis 4, in the maximum tensioned state. Alternatively, it is conceivable that in the first section 11 the injector tip 2 can leave its cross-section in the direction of the opening 3, the normal of which is arranged parallel to the injector axis 4, the same size in the maximum tensioned state. This can mean the cross-section on the inside 18 of the wall 5 and / or on the outside 17 of the wall. In the first section 11 the wall 5 can have, for example, a circular, elliptical and / or oval shape on its outside 17 and / or its inside 18 in the cross-sectional plane 20 and in the maximum tensioned state.

[0025] How it turns out Figures 1 to 5As can be seen, the wall 5 can have a second section 12, which extends in the direction of the injector axis 4 and in which the wall 5 has a modulus of elasticity under tensile stress of higher than 900 N / mm 2 and is not corrugated. The second section 12 can directly adjoin the first section 11, as is also the case with the Figures 1 to 5 It is conceivable that the wall 5 in the entire first section 1 has a modulus of elasticity under tensile load in the range from 10 N / mm 2 to 500 N / mm 2 . It is also conceivable that the wall 5 is corrugated in the entire first section 11. Alternatively, it is conceivable that the wall 5 is not corrugated only in an area that directly borders the second section 12, as is the case, for example, with Figure 1 is evident.

[0026] The second portion 12 and / or a boundary between the first portion 11 and the second portion 12 are intended to contact a cornea 8 of the eye when the injector tip 2 is inserted into the eye (cf. Figures 2 and 4 ). The injector tip 2 may have a marking 13 to indicate the boundary between the first section 11 and the second section 12 (see Figures 1 to 4 ) .

[0027] The wall 5 in the second section 12 can thus have a modulus of elasticity under tensile load of greater than 900 N / mm 2 . Alternatively, the thickness 16 of the wall 5 in the second section 12 can be greater than in the first section, with the modulus of elasticity corresponding to that of the first section. Alternatively or additionally, the second section 12 can have a reinforcement piece arranged in the wall 5. Figure 5, in which the injector tip 2 is shown in longitudinal section and the reinforcement piece is shown in full, shows that the reinforcement piece can be a helix 9. The pitch of the helix 9 can vary along the injector axis 4. Alternatively, it is conceivable that the reinforcement piece has the helix 9, is or has a cylinder jacket-shaped part and / or is or has a cone-shaped part. The helix 9 has the advantage that, if the wall 5 is transparent, an operator can see into the injector tip 2 and can monitor any displacement of the intraocular lens 21. The cylinder jacket-shaped part and the cone-shaped part have the advantage that they can stiffen the second section particularly well. The reinforcement piece can have a metal or an alloy or can be made of the metal or the alloy. Figure 5also shows that the thickness 16 of the wall 5 in the first section 11 can be equal to the thickness of the wall 5 in the second section 12.

[0028] The injector tip 2 with the reinforcement piece can be manufactured, for example, by an injection molding process. Alternatively, it is conceivable that the injector tip 2 with the reinforcement piece is manufactured by extruding a tube from a polymer material, applying the reinforcement piece to the tube, in particular by winding the spiral, and then applying an outer layer of a polymer material to the tube and the reinforcement piece. Furthermore, an adhesive layer can be applied to the outside of the tube before applying the reinforcement piece. List of reference symbols

[0029] 1 Injector 2 Injector tip 3 Opening 4 Injector axis 5 Wall 6 Mountain 7 Valley 8 Cornea 9 Helix 10 Circumferential direction 11 First section 12 Second section 13 Marking 14 End 15 End surface 16 Thickness 17 Outer surface 18 Inner surface 19 Plunger 20 Cross-sectional plane 21 Intraocular lens 22 Beveled area

Claims

1. Injector for introducing an intraocular lens into the capsular bag of an eye, having an injector axis (4), an injector tip (2) which has an opening (3) and a wall (5) that delimits the opening (3), a piston (19) which is mounted so as to be longitudinally displaceable in the direction of the injector axis (4) in the injector (1) and is designed to convey the intraocular lens out of the injector (1) via the opening (3), wherein the wall (5), in a first portion (11) that proceeds from the end (14) of the injector tip (2) where the opening (3) is disposed and extends in the direction of the injector axis (4), has a modulus of elasticity under a tensile load in a range of 10 N / mm2 to 500 N / mm2 and is corrugated so that the wall (5) in a cross-sectional plane (20), the normal of which is disposed parallel to the injector axis (4), has a plurality of peaks (6) and a plurality of troughs (7), wherein the peaks (6) and the troughs (7) are disposed alternately in the circumferential direction (10) with respect to the injector axis (4), characterized in that the injector tip (2) is bevelled in the region of the end (14) by the wall (5) having an end face (15) which is directly adjacent to the opening (3), the normal of said end face (15) enclosing with the injector axis (4) an angle which is different from 0°.

2. Injector according to Claim 1, wherein the injector tip (4) has a relaxed state in which the intraocular lens is not disposed in the injector tip (4), a partially tensioned state in which the wall (5) in the first portion (11) is subjected to mechanical tension by introducing the intraocular lens into the injector tip (2), and a maximum tensioned state in which the wall (5) is tensioned to the maximum by the introduction of the intraocular lens, wherein the opening (3) is larger in the maximum tensioned state than in the relaxed state.

3. Injector according to Claim 2, wherein in the first portion (11) the injector tip (2) in terms of its cross section, the normal of which is disposed parallel to the injector axis (4), decreases in the direction towards the opening (3) in the relaxed state.

4. Injector according to Claim 2 or 3, wherein in the first portion (11) the injector tip (2) in terms of its cross section, the normal of which is disposed parallel to the injector axis (4), increases or remains the same in the direction towards the opening (3) in the maximum tensioned state.

5. Injector according to one of Claims 2 to 4, wherein in the first portion (11) the wall (5) on its outside (17) and / or its inside (18) in the cross-sectional plane (20) and in the maximum tensioned state has a circular, elliptical and / or oval shape.

6. Injector according to one of Claims 1 to 5, wherein the wall (5) in the circumferential direction (10) with respect to the injector axis (4) has a constant thickness (16) .

7. Injector according to one of Claims 1 to 6, wherein the wall (5) has a second portion (12), which extends in the direction of the injector axis (4) and in which the wall (5) has a modulus of elasticity under the tensile load of more than 900 N / mm2.

8. Injector according to Claim 7, wherein the second portion (12) has a reinforcing piece which is disposed in the wall (5), wherein the reinforcing piece is or has a helix (9), a cylindrical shell-shaped part and / or a conical shell-shaped part.

9. Injector according to one of Claims 1 to 8, wherein the wall (5) has in each case four to twelve of the peaks (6) and of the troughs (7), in particular in each case six to ten of the peaks (6) and of the troughs (7), or in each case eight of the peaks (6) and of the troughs (7) .