Modular intraocular lens injector device

ES 2 631 981 T3

DESCRIPTION

Modular intraocular lens injector device

Technical field

The present invention relates generally to an intraocular lens injector device for surgically injecting an intraocular lens into an eye, and more particularly to an intraocular lens injector device in modules to allow cleaning of internal components after surgery.

Background

The human eye works to provide vision by transmitting light through a transparent outer part called the cornea, and focusing the image through a crystalline lens on the retina. The quality of the focused image depends on many factors including the size and shape of the eye, and the transparency of the cornea and lens. When age or disease makes the lens less transparent, vision deteriorates due to the decrease in light that can be transmitted to the retina. This deficiency in the lens of the eye is known medically as a cataract. An accepted treatment for this condition is surgical removal of the natural lens of the eye and replacement of the lens' function with an artificial intraocular lens (IOL).

In the United States, most cataract lenses are removed by a surgical technique called phacoemulsification. During this procedure, an opening is made in the anterior capsule and a thin phacoemulsification cutting tip is inserted into the affected lens and vibrated with ultrasound. The vibrating cutting tip liquefies or emulsifies the lens so that the lens can be aspirated out of the eye. The affected lens, once removed, is replaced by an artificial IOL.

An IOL injector device injects the artificial IOL into the eye through the same small incision used to remove the affected lens. The IOL injector device typically includes a tubular housing with an injector stem disposed therein and a lens cartridge containing the artificial IOL. With the tip of the lens cartridge inserted into the incision, the IOL injector device physically translates the injector stem into the lens cartridge, thereby displacing the artificial IOL from the lens cartridge and into the eye.

During surgery, substances often accumulate on the internal components of the IOL injector device, including for example the injector stem. For example, in cataract surgery, viscoelastic substances (eg, ophthalmic viscoelastic devices, OVDs) having high viscosity and elasticity are widely used to create and reserve space for, or to coat, the artificial IOL. Consequently, when the injector stem displaces the artificial IOL from the lens cartridge, viscoelastic substances inevitably accumulate on the stem surface. If the injector stem is not reprocessed (i.e. cleaned) to remove accumulated viscoelastic substances, the substances can contaminate and cause complications in subsequent cataract surgery patients with the same device.

The state of the art is represented by EP-A-1 832 247.

Summary

The present invention provides a modular device for injecting an intraocular lens (IOL) into the lens capsule of an eye, according to the following claims. The device is in modules to allow cleaning of internal components, such as an injector stem, after surgery.

According to an exemplary embodiment, an IOL injection device includes a tubular housing comprising a first module and a second module. The first module is arranged at a front end of the housing and the second module is arranged behind the first module, for example, at a rear end of the housing. These modules collectively define a passageway that extends from the second module, through the first module, to the front end of the housing. An injector stem is longitudinally arranged within and movably along this passage.

The first module is further configured to house a lens cartridge module at or near the front end of the housing. The lens cartridge module has an IOL disposed within it, aligned with the pitch defined by the first and second modules. Aligned with the passage, the IOL travels from the lens cartridge module via the injector stem as the stem moves through the passage and into the lens cartridge module.

More particularly, the injector stem moves along the passage by an operative extension between a retracted position and an extended position. A front portion of the injector stem remains substantially surrounded by the first module in the retracted position. However, as the injector rod moves

ES 2 631 981 T3 from the retracted position to the extended position, this front part of the stem moves into the cartridge module and displaces the IOL therefrom.

When the IOL is injected into the eye in this way, substances used during surgery (eg, viscoelastic substances) accumulate on the internal components of the IOL injector device, especially the front of the injector stem. To allow cleaning of these internal components, the first module is configured to separate from the second module, thereby exposing the front of the injection stem in the retracted position for cleaning. After the front of the injector stem is cleaned, the first and second modules can be configured to then be reattached for surgical use.

In some cases of surgical use of the device, the internal components of the device can be adequately cleaned of accumulated substances as described above. However, in another case, substances can also accumulate on unexposed internal component parts by separating the first and second modules as described. Accordingly, in other embodiments of the present invention, the second module is configured to, when not attached to the first module, removably attached to a cleaning module (e.g., a syringe filled with a balanced salt solution and a tube to inject that solution). The cleaning module is configured to inject a cleaning fluid onto various internal components of the device, eg, the injector stem, including those parts not otherwise exposed when the injector stem is in the retracted position.

Obviously, those skilled in the art will appreciate that the present invention is not limited to the foregoing features, advantages, contexts, or examples, and will recognize additional features and advantages upon reading the following detailed description and upon viewing the accompanying drawings.

Brief description of the drawings

Figure 1A is an isometric view of an exemplary IOL injection device, with a lens cartridge module installed.

Figure 1B is an enlarged view of the lens cartridge module and a first module of the exemplary IOL injection device illustrated in Figure 1A.

Figure 1C is a cross-sectional view of Figure 1A, taken along the line XX.

Figures 2A and 2B are cross-sectional views of an IOL injection device, respectively illustrating an injector stem in a retracted position and an expanded position.

Figures 3A and 3B are respectively an isometric view and a cross-sectional view of an IOL injection device in modules to allow cleaning of the internal components after surgery, according to an embodiment of the present invention.

Figures 4A and 4B are respectively an isometric view and a cross-sectional view of an IOL injection device with various attachment features to removably attach the modules of the device, in accordance with an embodiment of the present invention.

Figures 5A-5E are various views of an IOL injection device configured to removably attach to a cleaning module for cleaning, in accordance with one embodiment of the present invention.

Figure 6 illustrates an injection stem including a removable plunger tip in accordance with some embodiments of the present invention.

Detailed description

Figures 1A-1C illustrate a device 10 for injecting an artificial intraocular lens (IOL) into the anterior capsule of an eye. The IOL injection device 10 includes a tubular housing 12 comprising a first module 14 and a second module 16. The first module 14 is arranged at a front end 18 of the housing 12 and the second module 16 is arranged behind the first module 14 , for example, at a rear end 20 of housing 12.

Modules 14, 16 are configured to house various internal components of the IOL injection device 10. Modules 14, 16, for example, house an injector stem 22. More particularly, modules 14, 16 collectively define a passageway 24 extending from the second module 16, through the first module 14, to the front end 18 of the housing 12. The injector stem 22 is longitudinally arranged within and can move along this passage 24.

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The first module 14 is further configured to house a lens cartridge module 26 at or near the front end 18 of the housing 12. In some embodiments, for example, the first module 14 includes a lens cartridge module holder 28 which is press fit into front end 18 of housing 12. This lens cartridge module holder 28 removably supports the lens cartridge module 26 at the front end 18 of housing 12, for example, through a single notch configured to hold the lens cartridge module 26.

The lens cartridge module 26 has an intraocular lens (IOL) disposed within it, aligned with the passage 24 defined by the modules 14, 16. Aligned with the passage 24, the IOL travels from the lens cartridge module 26 by injector stem 22 as stem 22 moves along passage 24 and into lens cartridge module 26.

Specifically, as shown in Figures 2A-2B, injector stem 22 moves along passage 24 by an operative extension between a retracted position (Figure 2A) and an extended position (Figure 2B). In some embodiments, an electric drive system 30 housed in the second module 30 and powered by a set of cables 32 allows the injector stem 22 to move in this manner. The electric drive system 30 may include, for example, an electric motor and be configured to cause longitudinal translation of the injector stem 22 along the passage 24 for the operative extension between the retracted position and the extended position. The movement of the injector stem 22 along the passage 24 may be limited to the operative extension between the retracted position and the extended position by one or more mechanical stops 34, by electrical control signals, or a combination of both.

Regardless of the means by which the stem 22 moves, a front portion 22a of the stem 22 remains substantially surrounded by the first module 14 in the retracted position. As the stem 22 moves from the retracted position to the extended position, the front portion 22a of the stem 22 moves into the lens cartridge module 26 and displaces the IOL therefrom and into the eye.

When the IOL is injected into the eye in this way, the internal components of the IOL injector device 10, especially the front portion 22a of the injector stem 22, can accumulate in the same substances used during surgery (eg, viscoelastic substances). . If the injector stem 22 is not cleaned to remove accumulated substances, the substances can contaminate and cause complications in subsequent patients undergoing cataract surgery with the same device 10.

Accordingly, device 10 is modularized as shown in Figures 3A-3B to allow cleaning of internal components such as injector stem 22 after surgery. As illustrated, the first module 14 is configured to separate from the second module 16, thereby exposing the front portion 22a of the injector stem 22 in the retracted position for cleaning. Cleaning may simply involve removing accumulated substances on the front portion 22a of the injector stem 22, or more completely involving washing, soaking, and ultrasonic sterilization of the front portion 22 of the injector stem 22. Once the portion is cleaned front 22a of injector stem 22, the first module 14 and the second module 16 may be configured to then be reattached for surgical use.

In some embodiments, for example, the first module 14 includes a first attachment feature and the second module 16 includes a second attachment feature. These bonding features are configured to bond with each other, for surgical use, and to separate from each other, for cleaning. In one embodiment, the first and second attachment features are respective parts of a snap-fit ​​mechanism that allows the first module 14 to fit into the second module 16, and likewise to be released from the second module 16. In another embodiment, the first bonding feature comprises mechanical threads arranged on an inner surface of the first module 14, while the second bonding feature comprises mechanical threads arranged on an outer surface of the second module 16. These mechanical threads are configured to be coupled to each other, to allow the union and separation of the first and second modules 14, 16. Still another embodiment includes a combination of these snap-in mechanisms and mechanical threads.

Consider, for example, the embodiments illustrated in Figures 4A-4B. In Figures 4A-4B, the second module 16 includes an injector stem sleeve 36 concentric therewith. The injector stem sleeve 36 protrudes from the second module 16, towards the front end 18 of the housing 12, cantilevered, and surrounds at least a portion of the stem 22 arranged longitudinally therein. Injector stem sleeve 36 includes mechanical threads 38 disposed on an outer surface thereof. These mechanical threads 38 are configured to mate with mechanical threads 40 disposed on an inner surface of the first module 14. Additionally, the first and second modules 14, 16 include respective parts of one or more snap-in mechanisms 42 which, when engaged , fit or secure the modules 14, 16 together. Accordingly, the modules 14, 16 are configured to bond together in these embodiments by overlapping the first module 14 and threading onto the injector stem sleeve 36, through the mechanical threads 38, 40, until it engages. (n) the snap-in mechanism (s) 42. When modules 14, 16 are attached in this way, first module 14 surrounds injector stem sleeve 36 and front portion 22a

ES 2 631 981 T3 of the Injector stem 22. The modules 14, 16 are configured to reverse apart from each other, to again expose the injector stem sleeve 36 and the front portion 22a of the injector stem 22 to cleaning.

In most cases of surgical use of the device, the internal components of the device 10, for example the injector stem 22, can be adequately cleaned of accumulated substances as described above. In fact, in most cases, the substances accumulate only in the most front parts of the internal components, such as the front part 22a of the injector stem 22, and therefore, it is often appropriate to expose only these parts to Cleaning.

In other cases, however, the substances can also accumulate in the parts of the internal components not exposed by the previous embodiments. In the embodiments illustrated in Figures 4A-4B, for example, substances can accumulate on the portions of the injector stem 22 surrounded by the injector stem sleeve 36. Thus, simply separating the first module 14 from the second module 16 as described above does not expose these parts to a sufficient extent when the injector stem 22 is in the retracted position for cleaning.

Accordingly, Figures 5A-5E illustrate embodiments that relate to cleaning the internal components of device 10 not exposed to a sufficient extent by separating the first module 14 from the second module 16. In these embodiments, the second Module 16 is configured to removably attach to cleaning module 44 when separated from first module 14. The cleaning module 44 is configured to inject a cleaning fluid onto various internal components of the device 10, for example, the injector stem 22, including the unexposed portions when the injector stem 22 is in the retracted position and when the second module 16 has been separated from the first module 14.

More particularly, in these embodiments the first and second modules 14, 16 may be configured to join and separate in the same manner as described above; that is, through mechanical threads 38 arranged on an external surface of an injector stem sleeve 36 that engage with mechanical threads 40 arranged on an internal surface of the first module 14, and / or through respective parts of one or more snap-in mechanisms 42. Additionally, however, injector stem sleeve 36 may be configured to removably attach to cleaning module 44 when not attached to first module 14. For example, injector stem sleeve 36 may further include an injector connector. cleaning module 36a protruding from second module 16 toward front end 18 of cantilevered housing 12. This cleaning module connector 36a is sized and configured to removably join cleaning module 44.

As illustrated, the cleaning module 44 includes a syringe 46 filled with a cleaning fluid (eg, a sterile balanced salt solution) and a tube 48. One end 48a of the tube 48 is configured to join the syringe 46. The other end 48b of the tube 48 is configured to pass over the front portion 22a of the injector stem 22 in the retracted position and to be attached to the second module 16, for example, through the cleaning module connector 36a of the stem sleeve. injector 36, which is sized and configured for such a junction. With the syringe 46 attached to the second module 16 in this way, the syringe can inject cleaning fluid into the injector stem sleeve 36 and onto those internal components of the device 10 not exposed by the separation of the first module 14.

In some embodiments, the injector stem sleeve 36 has at least one fluid outlet port 36b in a side wall thereof. Fluid outlet port 36b is configured to disperse cleaning fluid injected into injector stem sleeve 36 and onto injector stem 22 by cleaning module 44. As illustrated, for example, cleaning fluid flows from syringe 46, through tube 48, into injector stem sleeve 36, over otherwise unexposed portions of injector stem 22 and other non-internal components. exposed from device 10, and exits fluid outlet port 36b.

To prevent the cleaning fluid injected by the cleaning module 44 from flowing into unwanted parts of the device 10, for example, near the electrical drive system 30 at the rear end 20 of the housing 12, various embodiments such as the one illustrated in Figure 5E includes a sealing element 50. The sealing element 50 may comprise for example a compression seal made from an elastomeric sleeve and a metal channel ring. In the embodiment of Figure 5E, the sealing element 50 is disposed within the passage 24 near a front end 16a of the second module.

16. With this arrangement, the sealing member 50 and the injector stem 22 are configured to engage with each other when the stem 22 is in the retracted position. Coupled in this way, sealing member 50 prevents cleaning fluid injected onto stem 22 from passing past front end 16a of second module 16 toward rear end 20 of housing 12. Therefore, the sealing element 50 also in certain embodiments, facilitates the dispersion of the cleaning fluid out of a fluid outlet port 36b.

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Those skilled in the art will appreciate that, although the injector stem 22 was described above for illustrative purposes comprising a single integral part, the injector stem 22 may comprise two or more parts as shown in FIG. 6. As shown in FIG. Figure 6, the front portion 22a of the injector stem 22 comprises a plunger tip that is configured to removably engage a residual portion 22b of the injector stem 22. In some embodiments, the plunger tip may comprise a removable plastic sleeve that snaps onto the residual portion 22b of stem 22, and may be discarded after use. Additionally, the end of the plastic sleeve that engages the IOL is more flexible than an uncovered metal plunger tip would be, and has a smooth surface finish, thus preventing damage to the IOL as it is pushed into. through the lens cartridge module 26 and into the eye. The use of a disposable plastic sleeve can also facilitate cleaning of the IOL injection device 10 between uses, since fewer parts of the injector stem 22 need to be cleaned as described above.

Therefore, the above description of various embodiments of an intraocular lens injection device has been provided by way of illustration and example. Those skilled in the art will appreciate that the present invention may be carried out in ways other than those specifically set forth herein without departing from the essential features of the invention.