Lens holder apparatus and system and method

An apparatus for safely retaining an eye implant lens for transport and access for inspection and use in which a holding apparatus has a chamber for holding a lens. In one embodiment the chamber has a pin on which a lens can be placed and a ramp leading to the pin so that a gripping member can slide up the ramp into proper placement to grip the lens and remove it. The gripper can be configured so that after removing the lens from the holding apparatus, it can be used to implant the lens. Also, a system including the apparatus and a bottle assembly that will hold the apparatus in the bottle. A method for holding an eye implant lens in which a lens is placed in the apparatus which can then be placed in a bottle assembly.

BACKGROUND

1. Field of the Invention

The invention relates to holding and transport devices for holding lenses during transport and storage such as from the point of manufacture to the point of usage and to facilitate inspection and access.

2. General Background

In the field of eye surgery, there are two types of eye lens implants, intracorneal and intraocular implants. In each of these a small lens is implanted into the eye in the cornea or in or adjacent the iris. The lenses are very small such as in the case of intracorneal lenses in the range from 1 mm to 4 mm in diameter and in the case of intraocular lenses in the range from 4 mm to 8 mm in diameter. From the point of manufacture to implantation the lens has to be carefully maintained in some kind of container. During the operations from manufacture, shipment and storage to implantation, handling of the lens can be detrimental and risky to the lens itself and is inconvenient for handling such small items. There is a need to reduce any transfer of the lens from one environment to another and to allow access to the lens for testing and for use with the minimum of actual handling of the lens.

DETAILED DESCRIPTION

The invention is in the field of transporting eye implant lenses and the ability to conveniently test and access such lenses. Embodiments include a lens holder apparatus and a system that combines a lens holder apparatus with a container. One feature is that a lens is trapped in a lens holder apparatus for minimum movement. Another feature is to be able to inspect the lens while it is in the lens holder apparatus and also while it is in the container. The invention provides several functions that are important in the transportation, storage and testing of such lenses. The functions include protecting the lens, allowing testing of the lens while it remains retained in the lens holder apparatus and allowing for convenient placement of the lens into the lens holder apparatus and for convenient removal of the lens at the time it is to be used. Embodiments of the lens holder apparatus include two parts that define a chamber into which a lens can be placed, the two parts being separable and joinable to allow a lens to be installed and later removed. Transparent portions of the two parts are aligned so as to allow optical testing and observation of the lens. The lens holder apparatus also has a handle which can be fitted to a part in a bottle assembly so that it will stay in a fixed position in the bottle.

The invention will be further understood from the following description in conjunction with the drawings.

FIGS. 1 and 2show a perspective view and a top view of the lens holder apparatus10in its assembled configuration for holding a lens. It has two parts, an upper case12and a lower case14. InFIGS. 1 and 2the lens holder apparatus10is in its fully assembled form, that is the upper case12and the lower case14are in the final position for holding a lens. In this description the term “lens” refers to all types of eye lens implants.

FIGS. 3 through 7illustrate an embodiment of the lower case14. The lower case14has a generally flat containment portion16(shown within the circle A inFIG. 3) and a handle portion18. With additional reference toFIGS. 16 and 17, the containment portion16has a lower case space element20which is defined by circular partial bosses22aand22b. Within space portion20is a clear window area24and in its center is a post26which has a shoulder28above the window area24. An axis30is defined by the center of the window area, and extending through the post26. The window area is an integral part of the containment portion16and is made transparent during the molding process to make the lower case14in a manner known in the plastic molding art.

The containment portion16of the lower case14has an inner surface29and an outer surface31defining a thickness T. It has slots32and34that extend in a circular shape around the axis30and they are generally oppositely located. Each slot has an opening36and38respectively. A latch is defined by a protrusion39, in this embodiment circular, upward from the inner surface29. The containment portion16has an opening40extending from one side toward the axis and ending at edge41just into the window area24, the opening40serving to facilitate removal of a lens as will be explained below. The handle portion18has a retainer knob44and a tang46, a spacer bar48and support beams50to which the containment portion16is mounted.

The lower case14is molded from a single piece of plastic, a polysulfone; Solvay Advanced Polymers UDEL-P1700 CL2611 and UDEL P1700 NT 06 being exemplary. The clear window area24is made by polishing on each side. The polished surface is achieved by inserting pins with a highly polished surface in the mold.

The upper case12is shown inFIGS. 8-11andFIGS. 16 and 17. It has a containment portion52and a handle54. The containment portion52is built up from a generally flat body53. From a lower side of the body53tabs56and58project. The tabs have rims60and62respectively. The rims60and62have a wedge shape commencing thinner at a front and thicker toward the rear. This wedge shape has the effect of a gradual reducing of the space S between the rim and the surface of the body53. As will be seen, the thickness T of the containment portion16of the lower case14will be gripped in the space S so that the wedge shape accommodates the assembly to result in a secure assembly. A clear circular window area64defines a center at66in a space element68bounded by a circular rim70that defines the upper case space portion. The tabs56and58are circular around the center66. The axis30runs through the center66. The window64has a central aperture into which the post26extends when the upper and lower case are assembled. The upper case has a slot72.

The window areas24and64(also called transparent portions) can be made integral with their respective case portions or can be made separately and installed. They are configured to allow optical testing of the lens inside the chamber.

To employ the lens holder apparatus, the upper case and the lower case are connected after a lens80has been fitted on the post26. The procedure for connecting them is shown inFIGS. 12 and 13.FIG. 12is looking up from under the lower case14. The upper case12is in position with the tabs56and58of the upper case adjacent the openings36and38of the slots32and34of the lower case.FIG. 13is looking down from over the apparatus with the upper and lower cases in the same ready positions as inFIG. 12.

To make the assembly the upper and lower cases12and14are rotated relative to each other as exemplified by arrows L and M inFIG. 12into the final assembled position as shown inFIG. 14. Note the designation “THIS SIDE UP” on the top of upper case12, which is an instruction to hold the parts so that the lens does not fall out before they are connected, and later for inspection and removal. In the step of rotating the upper and lower cases the tabs56and58enter the slots32and34while the rims60and62grip the containment portion16. Also, at the end of the rotation step the latch39pops (a “click” can be heard) into the slot72to provide a positive assembled condition.

FIG. 16shows an enlarged sectional view D of the upper case and the lower case when assembled with a lens80in the storage space which is defined by the space element20of the lower case and the space element68of the upper case. A lens80is in place on the post26seated on the shoulder28.

An alternative embodiment is shown inFIG. 17. In this embodiment, the structure of the lower case74does not have a post to support the lens, instead the lens rests on the floor76of the lower case74, inside the bosses22aand22b. Also, in this embodiment the window64of the upper case12does not have a hole. The difference in this embodiment is that the lens is not positively held, although it is sufficiently secure, as compared to the structure ofFIG. 16in which the lens is secured on the post.

When access to the lens80is desired, as for implanting it, a gripping device such as surgical forceps or lens insertion devices can be moved into the recess40, with one arm above and one arm below the lens, to grip it between the arms. Thus the recess allows the arms of a gripping device access to the lens80.

With the construction of the lens transport apparatus as described above, it can be carried in a custom made or a commercially available container.FIG. 18shows the lens holder apparatus10held in a flexible plastic plug90by the handle portion44being pushed into the grip92of the plug90. Then the plug90is installed in a bottle96and the cap94screwed on. It would also be possible to provide a container96as inFIG. 19having flat sides which would allow inspection through the flat sides without the need to remove the lens holder apparatus from the container. In use the bottle would typically be filled with saline solution or balanced salt solution.

The inspection of the lens can be done using a common lensometer. The lens holder may be inserted in a glass cuvette filled with liquid. Such inspection methods are common for contact lenses measurement of diopter power and resolution.

Lens inspection with the invention is, for example, for optical (diopter) power, size of the lens, and cosmetics such as surface quality. InFIGS. 16 and 17light rays are illustrated to show how measurements can be made.

After the lens transport apparatus has arrived at the point where the lens is to be implanted, the lens is removed with a device specially designed to grip it. In some cases that device will be used just to take lens out, but in most cases that device will also be the insertion device for inserting the lens into the eye. It is at this point that the recess40comes into use because the recess40allows a gripping device to be centered and access to both the top and bottom of the lens to grip it and remove it.

Further embodiments are shown inFIGS. 20-27.

In these embodiments, in one aspect the upper and lower cases form a chamber for holding an eye implant lens in which the lower case has walls defining a well so that a liquid such as saline solution or balanced salt solution can be contained to form a bead whose surface tension keeps the lens in an unfolded state. The well has drainage holes which along with a lengthened pin keeps the lens from floating off the lens holder when it is open.

The case assembly may be contained in a vial as described below and when it is removed from the vial, the bead of saline or balanced salt solution is retained in the chamber around the lens, both under and above its surface.

In another aspect the lower case has a ramp sloping downwardly away from the pin. This allows a gripping device (also called an inserter) to be centered in referenced to the lens and placed on the ramp and readily moved up the ramp into the correct position to grip a lens which is on the pin. The gripping device has an upper fork arm and a lower fork arm. In use the lower fork arm is moved into contact with the ramp and is moved up the ramp into position under the lens, with the upper fork arm over the lens. Then the fork arms can be brought together to grip the lens and remove it.

In a further aspect there is a tab that extends circumferentially away from the pin, on the ramp to further guide the gripping device. The lower fork arm of the gripping device engages the tab between its forks which then guides the gripping device into correct position at the lens as it is moved up the ramp.

The pin, in these embodiments is higher than prior embodiments and extends from the lower case into a recess in the upper case. That way if the lens is lifted by the saline or balanced salt solution it will not lift off the pin. The recess in the upper case can have a transparent window so as to allow optical access for inspection.

For use with the embodiments of the case assembly a lens inserter device is provided. The lens inserter has at a working end two forked members an upper fork arm and a lower fork arm, which are spaced apart. Each of them has two forks which are laterally spaced-apart. In use, the working end is inserted so that the lower fork arm slides along the ramp into position, with its spaced apart forks passing on opposite sides of the pin. In that way, by the ramp raising it to be aligned with the lens and positioning the forks on either side of the pin, the lens on the pin is properly positioned between the upper and lower fork arms. Then, with the lower fork arm beneath the lens and the upper fork arm over the lens, the fork arms are brought together to grip the lens which is then lifted off the pin. The tab contributes additional guidance so that before the forked working end is constrained by the pin, as it is guided up the ramp, the tab is between the forks of the lower fork arm and aligns it with the pin.

Referring toFIGS. 20,21A and21B there is shown a lens holder100having an upper case102and a lower case104in relative position ready to be connected into the final position for holding a lens (as inFIG. 20). A lens106is shown properly positioned to descend onto pin126. The lower case104has a containment portion108(shown within the circle21B inFIG. 21Aand inFIG. 21B) and a handle portion110. The upper case102has a containment portion112and a handle114. The structure for connecting and disconnecting the upper and lower cases is a described above.

FIGS. 21A,21B and22A-C,23A-B,24A-C are detailed views of the lower case104in which walls116(seeFIGS. 22A and 23B) form a well118(shown in slanted lines) for the purpose of containing saline or balanced salt solution bead120or other liquid. Drainage holes122are optionally provided. Curbs124extend upwardly on either side of the well118and the pin126extends upwardly, its centerline CL (seeFIGS. 22C and 25C) defining the center of rotation for connecting and disconnecting the upper and lower casings. In this embodiment, the pin126is higher than shown inFIG. 16(seeFIG. 25C) so as to ensure that the lens106will not be floated off it by the saline or balanced salt bead120.

A ramp128commences from a lower level in the well118and extends upwardly toward the pin126which is at the top of the ramp128. A tab132extends from the pin126diametrically along the ramp128at a height so as to provide a sufficient height as will be appreciated from description below.

FIGS. 25A-Cshow the lens holder with the upper case102in position to connect with the lower case104upon rotation and with a lens106in place. Although not shown, saline or balanced salt could be in it. The upper case102has channels130that upon rotation for connecting will engage with curbs124(seeFIG. 25C). Centerline CL shows that the rotation to connect and disconnect the upper and lower case elements is centered on the pin126. The upper case102has a roof having an aperture135to allow the pin126to project through it. In one form of the roof it comprises a transparent element133(seeFIG. 25C) set into a hole131.

The transparent element133can be a plate or it can be a magnifier in order to allow inspection of the lens.

The upper case102and the lower case104when connected provide a storage chamber103(seeFIG. 25C). To start the storage process, a lens106and if used some saline or balanced salt are put in place in the lower case104. The lens106has a central opening of a diameter that it will drop onto the pin126to a point where it will rest circumferentially on the platform136or shoulders138at sides of the platform136on opposite sides of the well118.

The structure and process for closing the upper and lower cases102and104are similar to that described above with respect to the embodiment shown inFIGS. 1-17. Specifically, in the lower case104are a pair of circumferentially shaped slots32and34which provide openings36and38respectively (seeFIG. 22B). Mating tabs56and58project from the lower side of the upper case102(as shown inFIGS. 10,11and12). To do the connection then, the upper case102is placed so that the tabs56and58are ready to enter the slots32and34, then they (the upper and lower cases) are rotated relatively to close them. At that point the detent39enters and snaps into the opening72(seeFIG. 9) formed as part of the upper case102, to maintain the closing position against inadvertent opening. To open the assembly, the upper and lower case are rotated oppositely to the closing rotation with sufficient force to release the detent39.

Then the lens can be removed. As described above, one procedure is the use of a lens inserter (also called a lens gripper) that can be used to both remove the lens from the lens holder and insert it in the intended eye. In particular the lower fork arm and the upper fork arm each terminate in gripping portions that are operable to be spaced apart and to close together to grip the lens remove it from the lens holder, and then subsequently upon insertion to release the lens in the eye.

Such a lens inserter150is shown inFIG. 26in position at a lens holder100. It has a gripping mechanism152operated by a lever154.

FIGS. 27 and 28show how the inserter is used. InFIG. 27there is no lens shown so as to make it easier to see the gripping mechanism moving on the ramp andFIG. 28shows the gripping mechanism capturing a lens. The gripping mechanism152has a lower fork arm156and an upper fork arm158. The lens inserter150operates through the lever154to allow the upper and lower fork arms156and158to have a separated position and then closes them to grip the lens.

The lower fork arm156has spaced apart forks156A and156B which are mirror configured to provide a slot160between them that extends openly to an end162of the lower fork arm156. The forks156A and156B are spaced apart sufficiently to pass on each side of the pin126. It also can have a curved portion163to facilitate locating it at the pin126.

The upper fork arm158has spaced apart forks158A and158B defining a slot164which has a length such that when the pin126contacts its back end166, the upper and lower fork arms will be in the best gripping position with the lens between them. Then the fork arms can be closed on each other to grip the lens and remove it from the pin. The gripping position has the function of lifting the lens off the pin as well as facilitating inserting the lens into an eye

In use the lens inserter150is moved into a position such that the lower fork arm156is on the ramp128sufficiently away from the pin126as to not cause any unintended hitting of the lens106. It is then moved toward the pin126along the ramp128wherein the slots of the upper and lower fork arms, pass the pin126until the pin126contacts the back end166of the slot164of the upper fork arm158. By using the ramp to guide the upper and lower fork arms in their open position, they will be guided correctly to place the lens between them, and to not contact the lens until they are closed upon it.

At that point the lens will be correctly positioned between the upper fork arm and the lower fork arm which are then operated to close together, grip the lens and allow the lens to be lifted off the pin.

Then the inserter is used to insert the lens into the eye.

While the invention is described in terms of a specific embodiment, other embodiments could readily be adapted by one skilled in the art. Accordingly, the scope of the invention is limited only by the following claims.