INJECTOR WITH A SLEEVE WITH A STOPPER, PACKAGING ARRANGEMENT AND METHOD FOR STERILIZING THE INJECTOR

Description

[0001] During cataract treatment, the natural lens of an eye is removed from the capsular bag and replaced with an artificial intraocular lens. An injector for inserting the intraocular lens into the capsular bag can be fully preloaded. This means that the injector is sold together with the intraocular lens already positioned in the injector. If the intraocular lens is a hydrophilic intraocular lens, the intraocular lens must be stored in the injector in a liquid containing or consisting of water. To sterilize the injector, the injector is traditionally placed in a package, for example, and the package is sealed gas-tight. The package, together with the injector, can then be heated in an autoclave. This can cause the liquid to increase in volume or at least partially evaporate.To prevent damage to the packaging, a pressure must be set outside the packaging in the autoclave to prevent the packaging from expanding too far. However, holes and / or tears may still occur in the packaging, delamination of the packaging may occur, and / or the packaging may become creased. If holes, tears, and / or delamination occur, the injector may become contaminated. The injector can then no longer be sold. In addition, conventional packaging, such as that which consists of a tray and an aluminum cap or an aluminum bag, often has the problem that considerable force must be exerted by operating room personnel to remove the aluminum cap or bag.

[0002] US 2007 / 0 250 068 A1 discloses a device comprising a packaging device and an intraocular lens injector. US 2020 / 0 180 800 A1 relates to a method and device for packaging a flexible hydrophilic intraocular lens.

[0003] The object of the invention is therefore to provide an injector for introducing an intraocular lens into the capsular bag of an eye, a packaging arrangement with the intraocular lens and a method for sterilizing the injector, wherein the injector can be sterilized in such a way that subsequent contamination is unlikely.

[0004] The injector according to the invention comprises an injector housing that defines a housing interior and has an injector tip, an intraocular lens that is arranged in the housing interior, a piston that is arranged in the housing interior so as to be longitudinally displaceable along an injector longitudinal axis of the injector and is configured to push the intraocular lens out of the injector housing by displacing the piston toward the injector tip, and a sleeve that defines a sleeve interior in which the injector tip is arranged, and an outer sleeve that has a first state and a second state in which the outer sleeve is more stretched than in the first state, and rests on the outside of the injector housing and has only a single sleeve opening through which the injector housing extends, wherein the outer sleeve seals the sleeve interior outside the injector housing together with the injector housing.the injector housing has a through-hole and the sleeve extends through the through-hole into the housing interior and forms a plug in the housing interior, which plug seals the sleeve interior together with the injector housing, wherein the sleeve is configured to reversibly expand and thus enlarge the sleeve interior and to change from the first state to the second state when the pressure inside the sleeve interior is higher than the pressure outside the sleeve interior.

[0005] To sterilize the injector, the injector can be heated, particularly in an autoclave. A resulting increase in pressure within the shell can be compensated for by moving the outer shell from its first state to its second state. This also causes the plug to be crushed. This results in the plug sealing the shell interior even more effectively. Because the outer shell is designed to expand reversibly, it returns to its first state after the injector has cooled down again. Damage to the shell is unlikely. This also makes contamination of the part of the injector housing located within the shell interior unlikely. The injector can then be shipped. Before performing cataract treatment, it is only necessary to remove the shell from the injector body to prepare the injector for cataract treatment.Because the shell, including the plug, is designed to reversibly expand, the plug can be pulled out of the housing through the through-hole. The injector tip can then be inserted into the capsular bag of an eye, and the intraocular lens can be pushed out of the injector housing and thus into the capsular bag by moving the piston toward the injector tip. The shell can, for example, have a modulus of elasticity in a range of 0.1 MPa to 5 MPa.

[0006] It is preferred that a liquid, particularly water, be arranged in the housing interior in the direction of the injector's longitudinal axis between the injector tip and the plug. The liquid can be, for example, water, particularly demineralized water, a physiological saline solution, and / or a viscoelastic device (OVD, ophthalmic viscoelastic device). Because the volume of the liquid can evaporate upon heating, a particularly large increase in the volume of the shell interior is to be expected, so it is particularly advantageous to provide the shell to compensate for the volume increase.

[0007] In addition, it is advantageous not to moisten the intraocular lens with a liquid before cataract treatment.

[0008] The intraocular lens is preferably a hydrophilic intraocular lens. The hydrophilic intraocular lens is particularly suitable for storage in an injector because, should the intraocular lens become crushed during storage, its good elastic properties allow it to return to its original shape after storage.

[0009] The sleeve preferably comprises or is preferably made of silicone. Silicone has good thermal resistance, so no damage to the sleeve occurs when the injector is heated. Furthermore, silicone has good elastic properties, so no damage to the sleeve occurs when the outer sleeve changes from the first state to the second state and back to the first state.

[0010] The injector housing preferably has an external housing sealing surface which extends completely around the injector housing and is arranged at a distance from the injector tip, and the outer shell preferably has a shell sealing surface which contacts the housing sealing surface completely, whereby the shell interior outside the injector housing is sealed.It is particularly preferred that the sleeve has a first longitudinal sleeve end in the direction of the injector's longitudinal axis, which is arranged in a region of the injector housing in the direction of the injector's longitudinal axis, and a second longitudinal sleeve end, which is arranged in a region outside the injector housing in the direction of the injector's longitudinal axis, wherein the sleeve sealing surface is arranged in a region which, in the first state, extends in the direction of the injector's longitudinal axis, starting from the first longitudinal sleeve end, up to a maximum of 20%, in particular up to a maximum of 10%, of a distance from the first longitudinal sleeve end to the second longitudinal sleeve end. As a result, the sleeve interior can be designed to be particularly large.

[0011] It is preferred that the outer shell is fastened to the injector housing by means of a press fit arranged in a region of the shell sealing surface, by means of at least one screw and / or by means of a fastening ring arranged in a region of the shell sealing surface, which fastening ring is arranged outside the outer shell and clamps the outer shell to the injector housing.

[0012] The plug preferably has a first cross-section and a second cross-section, the normals of which are arranged parallel to the injector's longitudinal axis, the first cross-section being arranged closer to the injector tip than the second cross-section and being smaller than the second cross-section. This is particularly relevant when the plug is arranged in a region of the housing interior that tapers towards the injector tip, because this allows the shape of the plug to be adapted to the shape of the housing interior, resulting in particularly good sealing of the casing interior. It is particularly preferred for the plug to have the shape of a truncated cone.

[0013] It is preferred that the plug has a first longitudinal plug end facing away from the intraocular lens and a second longitudinal plug end facing the intraocular lens, and that the sleeve has a connecting piece extending through the through-hole and spaced from the second longitudinal plug end in the direction of the injector's longitudinal axis. The plug is held in place by the connecting piece. If the pressure within the sleeve interior becomes higher than the pressure outside the sleeve interior, the plug is thereby squeezed, particularly in a region extending from the second longitudinal plug end to the connecting piece.

[0014] The injector housing preferably comprises an injector body and a cartridge that is detachably coupled to the injector body and in which the intraocular lens is arranged. It is particularly preferred that the housing sealing surface is formed by the injector body.

[0015] The packaging arrangement according to the invention comprises a packaging and the injector which is arranged in the packaging.

[0016] The method according to the invention for sterilizing the injector comprises the following step: - Heating the injector. The temperature of the injector can be, for example, up to 132°C and can be maintained for a maximum of 30 minutes. The temperature can be at least 40°C, in particular at least 60°C. The pressure in an area adjacent to the outside of the casing can be, for example, higher than atmospheric pressure. The atmosphere in the area adjacent to the outside of the casing can be, for example, oxygen-free.

[0017] The injector is preferably placed in a package and heated together with the package. This advantageously ensures that the package is also sterilized. The package can, for example, be designed to allow the transfer of heat and moisture from outside the package to inside the package. Such a package is commercially available, for example, under the name Medipeel.

[0018] The invention is explained in more detail below with reference to the attached schematic drawings. Figure 1 an injector according to the invention with an outer shell in a first state and Figure 2 the injector Figure 1 with the outer shell in a second state.

[0019] How it turns out Figures 1 and 2As can be seen, an injector 1 has an injector housing 14, an intraocular lens 12, a piston 9 and a sleeve 2. The injector housing 14 delimits a housing interior 19 and has an injector tip 13. The intraocular lens 12 is arranged in the housing interior 19. The piston 9 is arranged in the housing interior 19 so as to be longitudinally displaceable along an injector longitudinal axis 18 of the injector 1 and is configured to push the intraocular lens 12 out of the injector housing 14 by displacing the piston 9 towards the injector tip 13. The sleeve 2 delimits a sleeve interior 20, wherein the injector tip 13 is arranged in the sleeve interior 20.In addition, the sleeve 2 has an outer sleeve 5, which has a first state and a second state in which the outer sleeve 5 is stretched more than in the first state, and rests externally against the injector housing 14 and has only a single sleeve opening 15 through which the injector housing 14 extends. The outer sleeve 5, together with the injector housing 14, seals the sleeve interior 20 outside the injector housing 14. The injector housing 14 has a through-hole 8, and the sleeve 2 extends through the through-hole 8 into the housing interior 19 and forms a plug 6 in the housing interior 19. The plug 6, together with the injector housing 14, seals the sleeve interior 20 inside the injector housing 14.The shell 2 is configured to reversibly expand and thus enlarge the shell interior 20 and to move from the first state to the second state when the pressure inside the shell interior 20 is higher than the pressure outside the shell interior 20.

[0020] The casing 2 can also have a connecting piece 7 that extends through the through-hole 8 and is firmly connected to the outer casing 5 and the plug 6. The plug 6 can be configured to divide the housing interior 19 into a first partial interior 21, which is part of the casing interior 20, and a second partial interior 22, which are arranged next to one another in the direction of the injector's longitudinal axis 18. Because the plug 6 seals the casing interior 20 within the housing interior 19, no fluid can pass from the first partial interior 21 into the second partial interior 22 and vice versa.

[0021] The casing 2 can, for example, be configured to reversibly expand such that the volume of the casing interior 20 in the second state is at least 10%, in particular at least 15%, greater than in the first state. The casing 2 can, for example, have a modulus of elasticity in a range from 0.1 MPa to 5 MPa. This applies to the outer casing 5 and in particular also to the plug 6 and / or the connecting piece 7. The outer casing 5, the plug 6, and the connecting piece 7 can be formed in one piece and from the same material.

[0022] Figure 1 shows the injector 1 in the first state of the outer shell 5 and Figure 2shows the injector 1 in the second state of the outer shell 5. Heating the injector 1 can cause a fluid located in the injector housing 14 between the injector tip 13 and the plug 6 to expand and pass through the injector tip 13 to the outside of the injector housing 14, thereby expanding the outer shell 5. This can result in areas where the outer shell 5 rests against the injector housing 14 in the first state and is spaced apart from the injector housing 14 in the second state. See Figures 1 and 2. It is also conceivable for the fluid to reach the outside of the injector housing 14 via a gap arranged in the through-hole 8 between the injector housing 14 and the connecting piece 7. In order to heat the injector 1, the injector 1 can, for example, be introduced into an autoclave. In particular, the injector 1 can be arranged in a package. The temperature of the injector 1 can, for example, be from 40 °C or from 60 °C to 132 °C and can, in particular, be maintained for a maximum time of 30 minutes. The pressure in an area adjacent to the outside of the casing can, for example, be higher than atmospheric pressure. The atmosphere in the area adjacent to the outside of the casing can, for example, be oxygen-free.

[0023] A liquid, which in particular comprises water, can be arranged in the housing interior 19 in the direction of the injector's longitudinal axis 18 between the injector tip 13 and the plug 6. The liquid can be, for example, water, in particular demineralized water, a physiological saline solution, and / or a viscoelastic device (OVD, ophthalmic viscoelastic device). The intraocular lens 12 can be a hydrophilic intraocular lens 12. The intraocular lens 12 can be arranged in a folded state or in an unfolded state in the injector housing 14.

[0024] Figures 1 and 2show that the injector housing 14 can have an external housing sealing surface 24 that extends completely around the injector housing 14 and is arranged at a distance from the injector tip 13, and the outer shell 5 can have a shell sealing surface 23 that contacts the housing sealing surface 24 completely, whereby the shell interior 20 is sealed outside the injector housing 14. The shell space 20 is sealed outside the injector housing 14 by the shell sealing surface 23 and the housing sealing surface 24 both in the first state and in the second state.The sleeve 2 can have, in the direction of the injector longitudinal axis 18, a first sleeve longitudinal end 16 which is arranged in the direction of the injector longitudinal axis 18 in a region of the injector housing 14 and at which the sleeve opening 15 can be arranged, and a second sleeve longitudinal end 17 which is arranged in the direction of the injector longitudinal axis 18 in a region outside the injector housing 14, wherein the sleeve sealing surface 23 can be arranged in a region which, in the first state, extends in the direction of the injector longitudinal axis 18, starting from the first sleeve longitudinal end 16 up to a maximum of 20% or 10% of a distance from the first sleeve longitudinal end 16 to the second sleeve longitudinal end 17.The outer shell 5 can be fastened to the injector housing 14 by means of a press fit arranged in a region of the shell sealing surface 23, by means of at least one screw and / or by means of a fastening ring arranged in a region of the shell sealing surface 23, which is arranged outside the outer shell 5 and clamps the outer shell 5 to the injector housing 14. The press fit has the effect that the outer shell 5 is under tensile stress in the region of the shell sealing surface 23 both in the second state and in the first state. It is conceivable that the outer shell 5 is unstretched in the first state. If the press fit is provided, this means that in the first state the outer shell 5 is only stretched in the region of the shell sealing surface 23 due to the press fit.Alternatively, in the first state the outer shell 5 is unstretched, in the first state the outer shell 5 can also be stretched, but less than in the second state.

[0025] It is conceivable that according to a not Figures 1 and 2 In the embodiment shown, the plug 6 has a first cross-section and a second cross-section, the normals of which are arranged parallel to the injector's longitudinal axis 18, the first cross-section being arranged closer to the injector tip 13 than the second cross-section and being smaller than the second cross-section. The plug 6 can, for example, have the shape of a truncated cone.

[0026] How it turns out Figures 1 and 2As can be seen, the plug 6 can have a first plug longitudinal end 25, which is arranged facing away from the intraocular lens 12, and a second plug longitudinal end 26, which is arranged facing the intraocular lens 12, and the sleeve 2 can have a connecting piece 7, which extends through the through-hole 8 and is arranged at a distance from the second plug longitudinal end 26 in the direction of the injector longitudinal axis 18. Furthermore, the connecting piece 7 can be arranged at a distance from the first plug longitudinal end 25 in the direction of the injector longitudinal axis 18. The figures show that in the second state, the plug is squeezed in a region between the second plug longitudinal end 26 and the connecting piece 7.

[0027] Figures 1 and 2show that the injector housing 14 can have an injector body 3 and a cartridge 4, which is detachably coupled to the injector body 3 and in which the intraocular lens 12 is arranged. The through-hole 8 can be arranged in the cartridge 4. The housing sealing surface 24 can be formed by the injector body 3. The piston 9 can be arranged within the injector body 3.

[0028] The piston 9 may have a piston rod 10 and a cushion 11 arranged at the longitudinal end of the piston rod 10 facing the injector tip 13. The cushion 11 may be configured to be squeezed when it enters the tapered region of the housing interior 19. List of reference symbols

[0029] 1 Injector 2 Shell 3 Injector body 4 Cartridge 5 Outer shell 6 Plug 7 Connector 8 Through hole 9 Piston 10 Piston rod 11 Cushion 12 Intraocular lens 13 Injector tip 14 Injector housing 15 Shell opening 16 First shell longitudinal end 17 Second shell longitudinal end 18 Injector longitudinal axis 19 Housing interior 20 Shell interior 21 First partial interior 22 Second partial interior 23 Shell sealing surface 24 Housing sealing surface 25 First plug longitudinal end 26 Second plug longitudinal end

Claims

1. Injector having an injector housing (14) which delimits a housing interior (19) and has an injector tip (13), an intraocular lens (12) which is arranged in the housing interior (19), a piston (9) which is arranged longitudinally displaceably along an injector longitudinal axis (18) of the injector (1) in the housing interior (19) and which, by a displacement of the piston (9) towards the injector tip (13), is designed to push the intraocular lens (12) out of the injector housing (14), and a sleeve (2) which delimits a sleeve interior (20), in which the injector tip (13) is arranged, and has an outer sleeve (5) which bears on the outside of the injector housing (14) and has only a single sleeve opening (15) through which the injector housing (14) extends, wherein the outer sleeve (5) outside the injector housing (14), together with the injector housing (14), seals off the sleeve interior (20), characterized in that the outer sleeve (5) has a first state and a second state in which the outer sleeve (5) is stretched further than in the first state, the injector housing (14) has a through-hole (8), and the sleeve (2) extends through the through-hole (8) into the housing interior (19) and forms a stopper (6) in the housing interior (19), which stopper, inside the injector housing (14), and together with the injector housing (14), seals off the sleeve interior (20), wherein the sleeve (2) is designed to stretch reversibly and thus enlarge the sleeve interior (20) and pass from the first state to the second state when the pressure inside the sleeve interior (20) is higher than the pressure outside the sleeve interior (20).

2. Injector according to Claim 1, wherein a liquid, which in particular contains water, is arranged in the housing interior (19), between the injector tip (13) and the stopper (6) in the direction of the injector longitudinal axis (18), in particular wherein the intraocular lens (12) is a hydrophilic intraocular lens (12).

3. Injector according to Claim 1 or 2, wherein the injector housing (14) has an external housing sealing surface (24) which extends around the entire circumference of the injector housing (14) and is arranged spaced apart from the injector tip (13), and the outer sleeve (5) has a sleeve sealing surface (23) which contacts the housing sealing surface (24) over the entire circumference, as a result of which the sleeve interior (20) is sealed off outside the injector housing (14).

4. Injector according to Claim 3, wherein the sleeve (2) has, in the direction of the injector longitudinal axis (18), a first sleeve longitudinal end (16) which, in the direction of the injector longitudinal axis (18), is arranged in a region of the injector housing (14), and a second sleeve longitudinal end (17) which, in the direction of the injector longitudinal axis (18), is arranged in a region outside of the injector housing (14), wherein the sleeve sealing surface (23) is arranged in a region which, in the first state, and in the direction of the injector longitudinal axis (18), extends from the first sleeve longitudinal end (16) up to a maximum of 20% of a distance from the first sleeve longitudinal end (16) to the second sleeve longitudinal end (17).

5. Injector according to Claim 3 or 4, wherein the outer sleeve (5) is fastened, by means of an interference fit arranged in a region of the sleeve sealing surface (23), on the injector housing (14), by means of at least one screw and / or by means of a fastening ring arranged in a region of the sleeve sealing surface (23), which fastening ring is arranged outside the outer sleeve (5) and clamps the outer sleeve (5) to the injector housing (14).

6. Injector according to any one of Claims 1 to 5, wherein the stopper (6) has a first cross section and a second cross section, of which the normals are arranged parallel to the injector longitudinal axis (18), wherein the first cross section is closer than the second cross section to the injector tip (13) and is smaller than the second cross section, wherein the stopper (6) has in particular the shape of a truncated cone.

7. Injector according to any one of Claims 1 to 6, wherein the stopper (6) has a first stopper longitudinal end (25), which is arranged facing away from the intraocular lens (12), and a second stopper longitudinal end (26), which is arranged facing the intraocular lens (12), and the sleeve (2) has a connecting piece (7) which extends through the through-hole (8) and, in the direction of the injector longitudinal axis (18), is arranged spaced apart from the second stopper longitudinal end (26).

8. Injector according to any one of Claims 1 to 7, wherein the injector housing (14) has an injector body (3) and a cartridge (4) which is releasably coupled to the injector body (3) and in which the intraocular lens (12) is arranged.

9. Packaging arrangement comprising a package and an injector (1) according to any one of Claims 1 to 8, which injector is arranged in the package.

10. Method for sterilizing an injector (1) according to any of Claims 1 to 8, comprising the step of: heating the injector (1) according to any one of Claims 1 to 8.

11. Method according to Claim 10, wherein the injector (1) is arranged in a package and is heated together with the package.