WO2007027499A2

WO2007027499A2 - Preloaded injector for intraocular lenses and methods of making and using

Info

Publication number: WO2007027499A2
Application number: PCT/US2006/033088
Authority: WO
Inventors: Benoît BESSIERE; Sandra Previtali; Christophe Cesses
Original assignee: Bausch & Lomb Incorporated
Priority date: 2005-08-29
Filing date: 2006-08-24
Publication date: 2007-03-08
Also published as: CN101252895A; EP1928352A2; WO2007027499A3; TW200738222A; US20070050023A1

Abstract

Apparatus and method for preloading an intraocular lens (30, 30') in a component of an injector device (10) and for reducing the force used to eject the intraocular lens (30, 30') therefrom are disclosed. The intraocular lens (30, 30') is positioned in a shuttle (16, 16') which is positioned inside a distal section (14, 14') of the device (10). The shuttle (16, 16'), IOL (30, 30'), and distal section (14, 14') are positioned and sealed in a vial (11) of solution that comprises a surfactant. At the time of use, a user opens the vial (11) and attaches a proximal section (12) having a plunger (20) to the distal section (14, 14') located in the vial (11). The proximal section (12) is then lifted away from the vial (11) together with the distal section (14, 14'), and the shuttle (16, 16') and IOL (30, 30') located in the distal section (14, 14'). The plunger (20) is advanced to express the IOL (30, 30') from the distal tip (14c, 14c') of the distal section (14, 14').

Description

PRELOADED INJECTOR FOR INTRAOCULAR LENSES AND METHODS OF

MAKING AND USING

BACKGROUND OF THE INVENTION

The present invention relates to ophthalmic surgical devices and methods. More particularly, the present invention relates to a device and method for inserting an intraocular lens (IOL) into an eye, wherein the IOL may be conveniently preloaded in and packaged together with the injector device.

IOLs are artificial lenses used to replace the natural crystalline lens of the eye when the natural lens has cataracts or is otherwise diseased. IOLs are also sometimes implanted into an eye to correct refractive errors of the eye in which case the natural lens may remain in the eye together with the implanted IOL. The IOL may be placed in either the posterior chamber or anterior chamber of the eye. IOLs come in a variety of configurations and materials. Some common IOL styles include the so-called open-looped haptics which include the three-piece type having an optic and two haptics attached to and extending from the optic; the one-piece type wherein the optic and haptics are integrally formed (e.g., by machining the optic and haptics together from a single block of material); and also the closed looped haptic IOLs. Yet a further style of IOL is called the plate haptic type wherein the haptics are configured as a flat plate extending from opposite sides of the optic. The IOL may be made from a variety of materials or combination of materials such as PMMA, silicone, hydrogels and silicone hydrogels, etc. Various instruments and methods for implanting the IOL in the eye are known. In one method, the surgeon simply uses surgical forceps having opposing blades which are used to grasp the IOL and insert it through the incision into the eye. While this method is still practiced today, more and more surgeons are using more sophisticated IOL injector (also called "inserter") devices which offer advantages such as affording the surgeon more control when inserting the IOL into the eye. IOL injector devices have recently been developed with reduced diameter insertion tips which allow for a much smaller incision to be made in the cornea than is possible using forceps alone. Smaller incision sizes (e.g., less than about 3mm) are preferred over larger incisions (e.g., about 3.2 to 5+mm) since smaller incisions have been attributed to reduced post-surgical healing time and complications such as induced astigmatism.

Since IOLs are very small and delicate articles of manufacture, great care must be taken in their handling. In order for the IOL to fit through the smaller incisions, they need to be folded and/or compressed prior to entering the eye wherein they will assume their original unfolded/uncompressed shape. The IOL injector device must therefore be designed in such a way as to permit the easy passage of the IOL through the device and into the eye, yet at the same time not damage the delicate IOL in any way. Should the IOL be damaged during delivery into the eye, the surgeon will most likely need to extract the damaged IOL from the eye and replace it with a new IOL, a highly undesirable surgical outcome.

Thus, as explained above, the IOL injector device must be designed to permit easy passage of the IOL therethrough. It is equally important that the IOL be expelled from the tip of the IOL injector device and into the eye in a predictable orientation and manner. Should the IOL be expelled from the tip too quickly or in the wrong orientation, the surgeon must further manipulate the IOL in the eye which could result in trauma to the surrounding tissues of the eye. Therefore, it is highly desirable to have an injector device which allows for precise loading of the IOL into the injector device and which will pass and expel the IOL from the injector device tip and into the eye in a controlled, predictable and repeatable manner.

To ensure controlled expression of the IOL through the tip of the 1OL injector device, the IOL must first be loaded into the IOL injector device. The loading of the IOL into the injector device is therefore a precise and very important step in the process. Incorrect loading of an IOL into the injector device is oftentimes cited as the reason for a failed IOL delivery sequence. Many IOL injector devices on the market today require the IOL to be loaded into the injector at the time of surgery by the attending nurse and/or surgeon. Due to the delicate nature of the IOL, there is a risk that the nurse and/or surgeon will inadvertently damage the IOL and/or incorrectly load the 1OL into the injector device resulting in a failed implantation. Direct handling and/or loading of the IOL into the injector by the nurse and/or surgeon is therefore undesirable. In addition, as explained above, as the incision size continues to decrease, it becomes very desirable that the IOL be easily expelled through a smaller injector tip. There remains a need for an IOL injector and method, which deliver the IOL substantially uninhibitedly through a small incision and which remove the need for direct handling of the IOL by the eye care provider.

SUMMARY OF THE INVENTION

In a broad aspect of the invention, an injector device is provided having proximal and distal sections which are packaged separately and then assembled together at the time of surgery. The injector device provides an IOL preloaded in the distal section of the device, which is stored in a solution (such as a sterile saline solution or buffered solution) that comprises a surfactant. At the time of surgery, a user of the injector device, such as a nurse or a surgeon, simply opens the packages containing the distal and proximal sections and attaches the proximal and distal sections together. The injector device is then ready to deliver the IOL from the injector device and into an eye. No other injector components are required to ready the device for delivery of the IOL therethrough.

In one aspect, an IOL is expelled more easily (such as with a smaller amount of force) or with a lower risk of being damaged from an injector device of the present invention than from other injector devices.

At the injector device manufacturing site, an IOL is placed in the distal section of the device which is placed in a container (e.g., a vial) of hydrating solution, which comprises a surfactant, and sealed. Particularly, the distal section includes a shuttle component having an IOL loading area in which the IOL is placed, preferably in an unstressed condition, i.e., in a condition where at least the IOL optic is not compressed or folded. The shuttle and IOL are inserted into a nozzle section which includes a distal tip through which the IOL is ultimately expelled from the injector device. Each of the shuttle and nozzle includes a longitudinal passageway, which preferably lies along a common longitudinal axis when the shuttle and nozzle sections are assembled together. The assembled shuttle (with IOL placed therein) and nozzle section together comprise the distal section of the injector device which is placed in a vial of hydrating solution (e.g., buffered saline) that comprises a surfactant. The package or vial is then sealed and sterilized. The hydrating solution maintains the IOL in a hydrated state until it is ready for use in a surgical procedure, a necessary requirement for IOLs made of certain materials such as hydrogels.

The proximal section of the injector device is provided in a separately sealed and sterilized package although the proximal section and package or vial containing the distal section may be provided in a single "kit" type of package if desired for the sake of convenience to the user. The proximal section of the injector device includes a tubular body having a longitudinal passageway extending between opposite, open ends thereof. A plunger component is inserted into the proximal open end of the tubular body and telescopes within the longitudinal passageway thereof. The plunger includes a finger press at the proximal end thereof for manually applying a force and advancing the plunger through the passageway, and a plunger tip at the opposite, distal end thereof for engaging and pushing the IOL through and out the distal tip of the nozzle section of the injector device. At the time of surgery, a user, such as a nurse or a surgeon, removes the outer packaging from the proximal section of the device and opens the package or vial containing the distal section of the device. The distal, open end of the proximal section is inserted into the open end of the package or vial with the proximal section being snapped onto the distal section of the injector device. With the proximal and distal sections thus attached together, the proximal section is lifted away from the package or vial and thereby also removing the distal section from the vial. The package or vial and hydrating solution may then be discarded or recycled. With the proximal and distal sections of the device attached together, the device is ready to be used to implant the IOL into a patient's eye. No further attachment or removal of injector component parts is necessary as is required in more complicated prior art devices.

The injector device includes means for compressing or otherwise urging the IOL into a smaller cross-section for delivery through the injector. In one embodiment of the invention, the shuttle and nozzle passageways are configured with a narrowing taper towards the distal tip. The plunger is advanced at the proximal end of the injector device causing the distal tip of the plunger to engage the IOL optic. As the plunger is advanced further, the IOL is pushed through the narrowing passageway, thereby compressing the IOL into a smaller cross- section and finally exiting at the distal end of the injector body and expressed into the eye in the intended manner.

The relative positioning of the IOL shuttle, the IOL and the injector device is such that upon attaching the proximal and distal sections of the injector device together, the IOL becomes preferentially positioned inside the injector device. The IOL thus becomes positioned in a particular orientation inside the injector device relative to the plunger tip. This IOL loaded position results in the leading haptic being correctly aligned in the shuttle, and the trailing haptic and optic aligning with the plunger tip so that upon advancement of the plunger, the plunger tip will engage the IOL optic in the intended manner without obstruction or jamming of the trailing haptic.

Other features and advantages of the present invention will become apparent from the following detailed description and claims, and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is an exploded, side elevational view of a first embodiment of the injector device showing main components of injector device.

Figure 2 is a perspective view of the fully assembled injector device of Figure 1 showing the IOL expressed from the distal tip thereof.

Figure 3a is an enlarged perspective view of the proximal section of the injector device of Figures 1 and 2.

Figure 3b is a side elevational view thereof.

Figure 3c is an end view thereof. Figure 4a is a side elevational view of the plunger component of the injector device.

Figure 4b is a perspective view thereof.

Figures 5a is a perspective, top view of a first embodiment of the shuttle component of the injector device with IOL loading area in the open position and an IOL positioned therein.

Figure 5b is a perspective view of the shuttle component of Figure 5a with the IOL loading area shown in the closed position and the shuttle being rotated 18Oo from the position shown in Figure 5a.

Figure 5c is a top plan view of the shuttle component of Figures 5a, b with the IOL loading area in the open position.

Figure 5d is an end view of Figure 5c taken from the left side thereof.

Figure 6a is a perspective view of the distal section of the injector device of the previous Figures.

Figure 6b is a top plan view thereof.

Figure 6c is a side elevational thereof.

Figure 6d is an end view thereof. Figure 7 is a perspective view of the distal section and shuttle component positioned in a first embodiment of the vial component of the invention.

Figure 8a is a side elevational view of the proximal section and plunger components of the injector device in the process of coupling to the distal section located in the vial.

Figure 8b is a perspective view thereof.

Figure 9a is a perspective view of a second embodiment of the shuttle component with the IOL loading area in the open position and another style of IOL positioned therein.

Figure 9b is the view of Figure 9a with the shuttle IOL loading area in the closed position.

Figure 9c is the view of Figure 9b with a second embodiment of the distal section of the device shown coupled to the shuttle; and

Figure 10 is a perspective view of the first embodiment of the distal section shown coupled to the first embodiment of the shuttle component.

DETAILED DESCRIPTION

In a first, broad aspect, the invention comprises a preloaded injector device for injecting an IOL into an eye. The term "preloaded" as used herein means that a packaged component of the injector device includes an IOL positioned therein. Therefore, direct handling and loading of an IOL into the injector device is not necessary.

Reference being made to Figures 1 , 2, 3a, 5a, and 9a, the injector device 10 includes a proximal section 12 and a distal section 14 which are packaged separately and then attached together at the time of surgery to ready the device for delivery of an IOL 30 or 30' therethrough and into a patient's eye (see Figures 2, 5a and 9a). The IOL 30 or 30' is preloaded into the distal section 14 of the device, which is packaged in a hydrated state in a vial 11 containing a solution that comprises a surfactant to maintain the IOL in a hydrated state until the IOL 30, 30' is ready for use in a surgical procedure. Examples of IOL materials which may require wet storage include acrylic polymers, such as a copolymer of 2- hydroxyethyl acrylate (HEMA) and methyl methacrylate (MMA).

Suitable surfactants are non-ionic and ionic surfactants. Desirably, the surfactants are compatible with the IOL materials and non-toxic. Non-limiting examples of surfactants suitable for use in the present invention are amino acids (e.g., leucine), poly(amino acids), sorbitan esters (e.g., sorbitan laurate, sorbitan stearate, sorbitan oleate) and their polyoxyethylene derivatives (e.g., polyoxyethylene sorbitan monooleate or Polysorbate 80), polysiloxanes, alginic acid, polyoxyethylene alkylphenol (e.g., polyoxyethylene octylphenol commonly known as Triton X100TM), polyethylene glycol (e.g., PEG 200, 400, 600), polyethylene glycol distearate, benzalkonium chloride, propylene glycol, and their derivatives or equivalents. The surfactant concentration in the solution can range from about 0.001 % (by weight) to about 5% (by weight). In one embodiment, the surfactant concentration ranges from about 0.01% (by weight) to about 1 % (by weight). In another embodiment, the surfactant concentration ranges from about 0.05% (by weight) to about 0.5% (by weight). Typically, the solutions are aqueous, such as saline solution or borate buffered solution.

The proximal section 12 includes a longitudinal passageway 12a extending between the open proximal and distal ends 12b, 12c thereof, respectively. The passageway 12a may assume any desired cross-sectional shape such as a rounded rectangular shape as shown.

The distal section 14 includes a longitudinal passageway 14a extending between the open proximal end 14b and open distal tip 14c thereof. The passageway 14a tapers inwardly toward distal tip 14c so that the IOL is gradually compressed to a very small cross-section as it exits the device at tip 14c.

A first embodiment of the shuttle component 16 is provided into which an IOL 30 is loaded and held in an uncompressed condition. This will be described in more detail below. Shuttle 16, with an IOL 30 loaded therein, is positioned in distal section passageway 14a. Shuttle 16 also includes a longitudinal passageway 16a extending between the open proximal end 16b and open distal end 16c thereof. When shuttle 16 is positioned in distal section 14, it is preferred, though not necessary, that the longitudinal passageways 16a, 14a of each are aligned along the same axis X-X. When the proximal section 12 is attached to the distal section 14, the longitudinal passageway 12a is aligned along the common axis X-X of the distal and shuttle passageways 14a, 16a (Figure 2). Reference being made again to proximal section 12, as shown in Figures 3a-3c, a finger flange 17 may be formed at the proximal end 12b thereof for ease in operating the injector device in the manner of a syringe. Finger flange is preferably configured with a straight edge 17a as shown (Figure 3a) for resting device 10 on a flat surface.

A plunger 20 having proximal and distal lengths 20a, 20b, respectively, a distal plunger tip 22, and a thumb press 24 telescopes within the proximal section 12. When the proximal and distal sections 12, 14 are attached together, the plunger 20 extends sequentially through proximal section passageway 12a and the shuttle passageway 16a so as to engage and push the IOL 30 through passageway 16a and out distal tip 14c. Although the applicants do not wish to be bound by any particular theory, it is believed that the surfactant in the solution adsorbs at the internal surfaces of the shuttle passageway 16a, distal section passageway 14a, and the surface of IOL 30. Adsorbed surfactant reduces the friction force between the internal surface of tip 14c and the surface of IOL 30, allowing IOL 30 to be compressed easily through tip 14c, and allowing a significant reduction in the force required to express IOL 30 through tip 14c, thus avoiding possible damage thereto. The present invention can allow the incision size to be reduced below 2 mm. The IOL delivery sequence will be explained in more detail below.

It is understood that the overall configuration of the injector body 12 may vary from that shown and described herein. It is furthermore understood that the components of the injector device may be made of any suitable material (e.g., polypropylene) and may be wholly or partly opaque, transparent or translucent to better visualize the IOL within the injector device and the IOL delivery sequence. In a preferred embodiment of the injector device, the components thereof are steam sterilized, requiring that the components are made from a material which can withstand the heat applied during steam sterilization. Examples of such materials include, but are not limited to, polypropylene, polycarbonate, polysulfone, polymers or copolymers comprising fluoroethylene or fluoropropylene, and polyoxymethylene (POM). Non-limiting suitable polymers and copolymers comprising fluoroethylene and/or fluoropropylene are polytetrafluoroethylene (PTFE), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), ethylene-tetrafluoroethylene copolymer (ETFE), tetrafluoroethylene-perfluorovinylether copolymer (PFA), polyvinylidene fluoride (PVDF), polychlorotrifluoroethylene (PCTFE), ethylene-chlorotrifluoroethylene copolymer (ECTFE), and tetrafluoroethylene-perfluoro alkylvinyl ether copolymer (PFE). These polymers are commercially available.

A first embodiment of shuttle 16 is used for holding an IOL 30 in the preloaded position. The shuttle 16, with IOL 30 held thereby, is positioned in the distal section 14 through opening 14a thereof. As seen best in Figures 5a-d, shuttle 16 includes an IOL loading area 16d wherein the IOL 30 is positioned in an unstressed state. Loading area 16d is in open communication with longitudinal passageway 16a and is configured to position the IOL 30 along axis X-X in an unstressed state and may include one or more optic support elements 16e,f each having a radius or other feature for aligning the IOL optic 31 along passageway 16a (and hence also axis X-X) about the periphery 31a thereof. Alternatively or in addition to the optic support elements, one or more haptic support elements 16g-j are provided on shuttle 16, each of which include a radius or other feature for aligning one or more haptics 30b-e which attach to and extend from the optic 31. In this regard, it is understood that the two IOL configurations 30, 30' shown and described herein is for discussion purposes only, and that the present invention is not to be limited thereby. The invention may be easily adapted to IOLs of any configuration and type (e.g., IOLs with plate, open or closed loop haptics, anterior chamber IOLs, posterior chamber IOLs, accommodating IOLs (including single and double lens types), etc.). The overall configuration of the IOL shuttle 16 and IOL loading area 16a may thus likewise vary so as to be cooperatively configured with and align the particular IOL style being used with the device. For ease of description, the first invention embodiment will be described with reference to IOL 30. In all embodiments, the shuttle 16 holds at least the IOL optic 31 in the unstressed state. It is furthermore preferable that shuttle 16 hold the IOL haptics at the correct vault angle (i.e., the angle from which they normally extend from the IOL optic periphery). It is even furthermore preferable that, in the case of an IOL having open looped haptics, such as IOL 30' seen in Figure 9a, the haptic support elements maintain the looped haptics 30b', 30c' at the correct angle of curvature. In Figures 5a and 9a, it is seen that the haptic support elements constrain the haptics along the outer curved edges thereof. This ensures that the haptic curvature, which is designed and set at manufacture of the haptics, does not increase or bend out of specification during storage of the IOL and shuttle. The embodiment of Figures 9a-c will be described more fully below.

At manufacture, the IOL 30 is placed in the shuttle 16. Positioning the IOL 30 in the shuttle 16 may be done by a worker using a pair of tweezers, for example, although other methods may be used as desired, including automated or semi- automated means in an assembly line. To facilitate loading of the IOL in the shuttle, the IOL loading area 16a may be formed with two wall sections 16k and 161 which are pivotally connected (e.g., via a living hinge 16m) to enable opening and closing of the IOL loading area 16d. Wall sections 16k and 161 are spread open in a coplanar relationship in the open position of the shuttle loading area 16d. In this open position, IOL loading area 16d is easily accessible and an IOL 30 may be simply placed upon one of the two sections, preferably upon section 16k. This may be done by aligning the IOL optic 31 with the IOL supporting elements 16g,j and aligning the haptics 30b-e with the haptic support elements 16e, 16f, respectively.

Once the IOL 30 is properly positioned in the shuttle IOL loading area 16a, the two sections 16k, 161 are pivoted together (in the direction of arrow "a" in Figure 5a) to the closed position which encases IOL 30 between the now facing wall sections 16k, 161 (Figure 5b). With the IOL 30 thus positioned in the shuttle 16, the shuttle 16 is closed and is then inserted into the distal section passageway 14a as seen in Figure 1 while Figure 10 shows the distal section 14 and shuttle 16 attached together. When fully coupled together, the proximal end 16b of the shuttle extends outwardly of the proximal end 14b of the distal section. To assist in attaching the shuttle to the distal section in the correct manner, a longitudinal groove 14h (Figure 6d) may be formed on an inner wall surface of distal section 14 which aligns with a longitudinal flange 16h formed on an outer wall surface of shuttle 16 (Figure 5b). As such, the shuttle 16 may be slidingly received within distal section 14 with groove 14h and flange 16h providing a "key" to prevent incorrect coupling between the shuttle and distal section. Furthermore, the shuttle 16 and distal section 14 may be fixed in the assembled condition through suitable mechanical locking features. For example, the shuttle 16 may be provided with a detent 16n and the distal section provided with a slot 14n which engage upon full advancement of the shuttle within the distal section. It will thus be realized that the shuttle 16 is fixed to the distal section 14.

As stated above, the shuttle 16 and IOL 30 are positioned in the distal section 14 at manufacturing and then placed in a dry package or a vial of storage solution for storage and delivery to the surgeon. For wet packaging, to ensure storage solution reaches the IOL 30, the shuttle and distal section may each include one or more through-holes 14p, 16p which are in open communication with the IOL 30. One of many possible embodiments of a vial is seen in Figures 7 and 8a, b, wherein a vial 11 having an open end 11a and an internal cavity 11b is provided to accept the distal section 14 and shuttle 16 with the shuttle proximal end 16b thereof lying adjacent the open end 11a of the vial. One or more longitudinally extending fins or other similar features (not shown) may be formed on the inside surface of vial 11 to align and maintain the distal section 14 at the desired orientation within vial 11. A rigid cover or a flexible cover sheet such as a foil seal 11c is attached to open end 11a to seal the vial. Seal 11c may be tethered to vial 11 by a flexible hinge (not shown) if desired. This feature keeps the seal with the vial after vial opening and thereby prevents having a "loose" part in the operating suite. At the time of surgery, the package or vial 11 and distal section 14 are removed from any outer packaging in a sterile field and the vial cover seal 11c is removed to open vial 11 and access distal section 14 and shuttle 16. The proximal section 12 is likewise removed from its packaging in a sterile field. The nurse or surgeon proceeds to assemble the proximal and distal sections together by inserting the distal end 12c of the proximal section 12 into the open end 11a of the vial 11 (see Figures 8a, b). With the distal section 14 and shuttle 16 still in the vial, the proximal section open end 12c telescopes first over the shuttle proximal end 16b and then also over the distal section proximal end 14b. It is noted that the shuttle 16 may be provided with a proximal flange 16q at proximal end 16b to assist in maintaining proper alignment between the proximal section passageway 12a and the shuttle 16. Flange 16q may or may not touch the inner wall surface defining proximal section passageway 12a.

Further pressing of proximal section 12 against distal section end 14b results in the two sections attaching together. Various mechanical connection features may be employed to permit the quick and easy attachment of the proximal section 12 to the distal section 14 by simply pressing the two sections together as described above. Such features may include cooperating detents and recesses or a friction fit between the two sections, for example. In the embodiment shown in the Figures, a pair of detents 14d,e (Figures 6a-d) are provided on the outer wall surface of distal section 14 which align with and engage a pair of through-holes 12d,e formed on proximal section 12 adjacent open distal end 12c thereof (Figures 3a, b). When the proximal section 12 is pressed against the distal section 14, the detents 14d,e engage the through- holes 12d,e, respectively, and the sections become attached together. A radial flange 14f may be provided on distal section 14 to act as a stop against further advancement of the proximal section 12 on the distal section 14, i.e., to prevent advancement beyond the point of detent engagement. Once the proximal and distal sections have attached together, the proximal section 12 is lifted away from the vial 11 to remove the distal section (together with shuttle 16 and IOL 30 still coupled thereto) from the vial 11. The vial 11 and storage solution (or dry package) may then be discarded or recycled. The assembly of the injector device is now complete and the surgeon may proceed to inject the IOL 30 into a patient's eye by inserting tip 14c into an incision formed in the eye and pressing plunger 20 to advance the IOL 30 through and out the nozzle tip 14c (see Figure 2; the eye not shown for sake of clarity).

Reference being made to Figures 4a, b, the plunger 20 includes distal and proximal plunger shaft lengths 20a, 20b, respectively, having a plunger tip 22 at the distal end thereof and a thumb press 24 at the proximal end thereof for manually operating the injector device. The plunger tip 22 is configured for engaging the IOL optic 31 at the periphery 31a thereof as the plunger 20 is advanced toward the distal tip 14c of distal section 14. It is very important that the plunger tip 22 not damage the IOL optic 31. The plunger tip 22 is thus designed to prevent damage to the IOL optic 31. In the preferred embodiment, the tip is bifurcated into first and second tip portions 22a and 22b, whereby the IOL optic periphery 31a becomes engaged between tip portions 22a, 22b as seen in Figure 2B. It is understood that other plunger tip designs may be used with the present invention as desired. In one embodiment, the plunger shaft may be rotationally fixed by forming the proximal shaft length 20a and passageway 12a non-circular in cross-section. The non-circular cross-section of proximal shaft length 20a and passageway 12a prevents unwanted rotation of shaft 20 and ensure the correct orientation of tip portions 22a and 22b for grasping lens 30 every time.

Furthermore, it is also advantageous to reduce the friction force between proximal shaft length 20a and the inner surface of proximal section 12 by reducing the contact area therebetween. This can be achieved by many plunger designs.

In a particularly advantageous embodiment, the proximal length 20a of the plunger shaft is provided with one or more elongated flanges 20a' which align with a like number of slots 12a^! formed between radially extending fins 21a-d formed on the inner wall surfaces of proximal section 12 adjacent proximal end 12b thereof (Figure 3c). The purpose of flanges 20a' and slots 12a' is to provide tactile resistance therebetween and thereby allowing the surgeon more precise control and feel when advancing the plunger. The fins 21a-d may be made flexible yet resilient to provide the amount of tactile resistance desired. It is understood that other ways of providing tactile resistance between the plunger and injector body are within the scope of this invention. This provides the surgeon with continuous tactile feedback allowing the surgeon to advance the plunger (and thus the IOL) through the injector device in a very concise and controlled manner. Additionally, the flanges 20a' and slots 12a' help provide proper centering of the plunger shaft 20 and tip 22 relative to axis X-X along which the passageways of the components lie as explained above. Upon full advancement of the plunger, it is desirable to have the plunger automatically retract to some degree upon release of finger pressure against plunger finger press 24. In this regard, a spring 20c may be provided on a finger 2Od on shaft length 20a. As the plunger is advanced, the spring 20c will interact with the one or more of the fins 21a-d as the plunger 20 is advanced therethrough.

When it is time to use the injector device, the surgeon selects a package or vial 11 having the appropriate IOL style and power preloaded in the shuttle and distal section stored in the vial as described above. The outer packaging is removed in a sterile field of the surgical suite. The proximal section having the plunger coupled thereto is also removed from its associated packaging in the sterile filed. The nurse or surgeon then attaches the proximal section 12 to the distal section 14 located in the vial in the manner described above. Once the proximal and distal sections 12,14 are attached together as shown in Figure 2, the surgeon inserts the distal tip 14c into an incision cut into the eye and begins advancing the plunger 20. As the plunger 20 is advanced, the plunger tip 22 engages the optic periphery 31a and pushes IOL 30 forwardly. Upon continued advancement of the plunger 20, the IOL 30 is pushed through the shuttle passageway 16a and is expressed from distal tip 14c and into the eye (Figure 2). As stated above, the spring 20c provides increasing bias in the reverse direction as the plunger reaches the fully advanced position. This occurs as spring 20c is compressed against one or more of the fins 21a-d. This assists the surgeon in maintaining precise control over plunger (and hence IOL) advancement and allows automatic retraction of the plunger upon relieving the pushing pressure being exerted against the plunger thumb press 24. This is useful for easily executing a second stroke of the plunger in order to engage and manipulate the trailing haptic into place in the eye. This feature, together with the bifurcated plunger tip 22, allows a more precise control and manipulation of the IOL with the plunger tip in-situ than would be possible with an injector device not having these features.

As discussed above, the device may be used for IOLs of any type and style. The configuration of the various component parts may likewise vary to accommodate the particular IOL style being employed with the device. Another embodiment of distal section 14' and shuttle 16' is seen in Figures 9a-c for holding an IOL 30' having open loop haptics 30a' and 30b' extending from optic 31 '. This configuration of shuttle 16' includes a longitudinal passageway 16a' extending between proximal ends 16b' and 16c', respectively. The shuttle is divided into two longitudinal sections 16d',e' which are hinged together about living hinge 16f. In the open condition of shuttle 16' seen in Figure 9a, IOL loading area 16g' is accessible to position IOL 30' thereon, on section 16d', for example. IOL loading area 16g' opens into and communicates with longitudinal passageway 16a' which is formed when shuttle 16' is in the closed condition seen in Figures 9b, c. In this regard, registration pins 16h' may be provided to engage holes 16i' on sections 16d', 16e' to assist in aligning and correctly closing shuttle 16'. Various IOL placement features such as curved radius 1Gj' and alignment pin 16k', for example, may be formed on one or both sections 16d', 16e' to assist in proper placement of IOL 30' in IOL loading 16g'.

Reference being made to Figure 9c, the distal section 14' may likewise vary in configuration to accommodate the configuration of shuttle being used. In this embodiment, distal section 14' includes a longitudinal passageway 14a^! extending between proximal and distal ends 14b', 14c', respectively. Furthermore, one or more fingers 14d', 14e' extend from proximal end 14b' and include a catch or other feature 14e", 14f" at the terminal end thereof to engage with the proximal end 16b' of shuttle 16'. Mechanical locking features such as one or more detents 14f, 14g' may be formed on the outer surface of fingers 14d', 14e' to engage an associated recess or slot 12d, 12e formed on the proximal section 12.

Examples: Testing of Injector Devices with Surfactants

In this testing, Bausch and Lomb Incorporated's Akreos AdaptTM lenses were used with injectors of the type shown in Figures 1 and 2. The injector components were made of PFA. The procedure was as follows. A lens 30 (having various optical power in the range from +10.0d to +23.5d) was immersed in a surfactant solution for a few seconds and then loaded in shuttle 16, which was then positioned in distal section 14. Distal section 14 with shuttle 16 and lens 30 positioned therein was placed in the surfactant solution for a few minutes. A proximal section 12 having a plunger 20 inserted therein was attached to distal section 14, and ejection of lens 30 was tested. The ease of ejection, as judged qualitatively by a required amount of force, was noted. All reported surfactant concentrations are in percent by weight.

Ejection was easy with a +11.0d-power lens using 1 % Polysorbate 80 solution; a +10d-power lens and a +21.0d-power lens using 2% Ophtasiloxane® solution (Alcon Laboratories); a +10.0d-power lens using 1 % Dimeticone (polydimethylsiloxane) solution; a +11.0d-power lens and a +22.0d-power lens using 2% Triton X100 (polyoxyethylene octylpheno!) solution; a +10.0d-power lens and a +17.0d-power lens using 1% polyethylene glycol distearate solution; +18.5d-, +19.Od-, +20.5d-, and +23.0d-power lenses using 1 % benzalkonium chloride solution; and +18.5d-, +20.Od-, +22.5d-, +23.Od-, and +23.5d-power lenses using 1 % Brij 30TM solution (polyoxyethylene lauryl ether).

While specific embodiments of the present invention have been described in the foregoing, it will be appreciated by those skilled in the art that many equivalents, modifications, substitutions, and variations may be made thereto without departing from the scope of the invention as defined in the appended claims.

Claims

What is claimed is:

1. An injector device adapted to receive an intraocular lens (30, 30') in a portion thereof, and reconfigurable from a storage condition to an injection condition, said injector device (10) comprising:

a) a proximal section (12) having a longitudinal passageway (12a);

b) a distal section (14, 14') having a longitudinal passageway (14a, 14a^!);

c) a shuttle (16, 16') having a longitudinal passageway (16a, 16a'), said shuttle (16, 16') being adapted to hold said intraocular lens (30, 30') therein, said shuttle (16, 16') and intraocular lens (30, 30') being positioned inside said distal section (14, 14'); said distal section (14, 14') together with said shuttle (16, 16') and said intraocular lens (30, 30') disposed therein being contained in a vial (11 ) having an open end (11 a) leading into an internal cavity (11 b) adapted to hold a quantity of a solution and a closure (11c) for removably sealing said open end (11a), said solution comprising a surfactant;

wherein when said injector device (10) is in a storage condition, said shuttle (16, 16'), said intraocular lens (30, 30') and said distal section (14, 14') are positioned and sealed in said vial of solution, and when said injector device (10) is in said injection condition, said proximal section (12) is attached to said distal section (14, 14').

2. The device (10) of claim 1 , wherein said proximal (12) and distal (14, 14') sections are colinearly attached, and said distal section (14, 14') includes a distal tip (14c, 14c') at the end thereof opposite said proximal section (12), through which distal tip (14c, 14c') said intraocular lens (30, 30') is expressed, and wherein the injector device (10) further comprises a plunger (20) in telescoping relation within said proximal (12) and distal (14) sections, said plunger (20) being capable of advancing entirely through said distal section (14, 14') and thereby expressing said intraocular lens (30, 30') from said distal tip (14c, 14c').

3. The device (10) of claim 1 , wherein each of said proximal section (12), said distal section (14, 14'), and said shuttle (16, 16') includes a longitudinal passageway (12a, 14a, 14a^!, 16a, 16a'), said longitudinal passageways (12a, 14a, 14a', 16a, 16a') of said proximal section (12), said distal section (14, 14'), and said shuttle (16, 16') lie along a common axis in said injection condition of said injector device (10).

4. The device (10) of claim 1 , wherein said proximal section (12) is packaged separately from said vial (11 ).

5. The device (10) of claim 1 , wherein said shuttle (16, 16') and said distal section (14, 14') are coaxially arranged.

6. The device (10) of claim 1 , wherein said shuttle (16, 16¹) is attached to said distal section (14, 14') in coaxial relationship.

7. The device (10) of claim 1 , wherein a package containing said shuttle (16, 16'), said intraocular lens (30, 30'), and said distal section (14,14') is sterilized.

8. The device (10) of claim 6, wherein said shuttle (16, 16') is snap fit to said distal section (14, 14').

9. The device (10) of claim 6, wherein said proximal section (12) and said distal section (14, 14') are snap fit together in collinear relationship when in said injection condition.

10. An injector device (10) component preloaded with an intraocular lens (30, 30') comprising:

a) a distal section (14, 14');

b) a shuttle (16, 16') adapted to receive an intraocular lens (30, 30') therein, said shuttle (16, 16') being attached to said distal section (14, 14'); and

c) a vial (11) containing a solution that comprises a surfactant, wherein said shuttle (16, 16'), intraocular lens (30, 30'), and distal section (14, 14') are positioned and sealed in the vial (11 ).

11. The injector device (10) component of claim 10, further comprising a proximal section component (12) adapted to be attached to said distal section (14, 14') in colinear relationship.

12. The injector device (10) component of claim 10, wherein each of said shuttle (16, 16') and said distal section (14, 14') includes one or more through- holes (14p, 14p', 16p, 16p') allowing fluid communication of said solution with said intraocular lens (30, 30') in said shuttle (16, 16').

13. The injector device (10) component of claim 10, wherein said intraocular lens (30, 30') is positioned in said shuttle (16, 16') in an unstressed condition.

14. A kit of components of a medical device (10), said kit comprising:

a) a proximal section (12) of said medical device (10), said proximal section (12) being contained in a first package and having a proximal-section internal passageway (12a);

b) a distal section (14, 14') of said medical device (10), said distal section (14, 14') being contained in a second package and having a distal-section internal passageway (14a, 14a'); a shuttle (16, 16') being disposed in said distal-section internal passageway (14a, 14a') and having a shuttle passageway (16a, 16a'); an intraocular lens (30, 30') being positioned in said shuttle passageway (16a, 16a'); and said distal section (14, 14') together with said shuttle (16, 16') and said intraocular lens (30, 30') being disposed in a sealed vial (11) that contains a solution comprising a surfactant;

wherein said proximal section (12) and said distal section (14, 14') are adapted to be attached together at a point of use such that said passageways (12, 14a, 14a', 16a, 16a') of said proximal section (12), said distal section (14, 14'), and said shuttle (16, 16') align on a common longitudinal axis.

15. A method of packaging an intraocular lens (30, 30') in a portion of an intraocular lens (30, 30') injection device (10), the method comprising:

a) providing an injector device (10) having a distal section (14, 14');

b) providing a shuttle (16, 16') and positioning the intraocular lens (30, 30') therein;

c) attaching said shuttle (16, 16') to said distal section (14, 14');

d) depositing said shuttle, intraocular lens (30, 30') and distal section in a vial (11 ) containing a solution that comprises a surfactant; and

e) sealing the vial (11 ).

16. A method for ejecting an intraocular lens (30, 30') from an injector device (10), the method comprising:

a) providing the injector device (10) having separately packaged proximal section (12) and distal section (14,14'); wherein the proximal section (12) comprises a plunger (20) slidably received therein; the distal section (14, 14') comprises a shuttle (16, 16') disposed therein, the shuttle (16, 16') has the intraocular lens (30, 30') prepositioned therein, and the distal section (14,14') with the shuttle (16, 16') and intraocular lens (30, 30') disposed therein are packaged in a solution comprising a surfactant;

b) attaching the proximal section (12) to the distal section (14, 14'); and

c) applying a force to a proximal end (24) of the plunger (20) to advance the plunger (20) toward the distal section (14, 14') and to push the intraocular lens (30, 30') therethrough, thereby ejecting the intraocular lens (30, 30') through an opened distal tip (14c, 14c') of the distal section (14, 14').

17. A method of packaging and subsequently preparing an injector device (10) for use, said injector device (10) being adapted to receive an intraocular lens (30, 30') in a portion thereof, said injector device (10) being reconfigurable from a storage condition to an injection condition, said method comprising:

a) providing a proximal section (12) having a longitudinal passageway (12a);

b) providing a distal section (14, 14') having a longitudinal passageway (14a, 14a'); c) providing a shuttle (16, 16') having a longitudinal passageway . (16a, 16a'), positioning an intraocular lens (30, 30') in said shuttle (16, 16'), and positioning said shuttle (16, 16') and intraocular lens (30, 30') together inside said distal section (14, 14');

d) providing a vial (11) having an open end (11c) leading into an internal cavity (11 b) and dispensing a quantity of a solution in said internal cavity (11b), said solution comprising a surfactant; thereafter sealing said vial (11 );

wherein when said injector device (10) is in the storage condition, said shuttle, said intraocular lens (30, 30') and said distal section (14, 14') are positioned and sealed in said vial (11) of solution, and

wherein reconfiguring said injector device (10) from said storage condition to said injection condition comprises the steps of:

(i) opening said vial (11 );

(ii) attaching said proximal section (12) to said distal section (14, 14'); and

(iii) lifting said proximal section (12) away from said vial (11 ) and thereby removing said distal section (14, 14'), said shuttle (16, 16') and said intraocular lens (30, 30') from said vial (11).