Compression drawer for IOL injector

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DESCRIPTION

Compressor drawer for IOL injector.

Background of the invention

The present invention relates to ophthalmic surgical devices and methods. More specifically, the present invention relates to a device and method for introducing an infraocular lens (IOL) into an eye and where the IOL can be conveniently preloaded and packaged together with the injector device.

IOLs are artificial lenses used to replace the eye's natural lens when the natural lens has cataracts or has another disease. IOLs are also sometimes implanted in an eye to correct refractive errors in the eye in which case the natural lens may remain in the eye along with the implanted IOL. The IOL can be placed in the posterior chamber or the anterior chamber of the eye. IOLs come in various configurations and materials. Some common types of IOLs include so-called open-loop haptics which include the three-piece type having one optic and two haptics attached and extending from the optic; the one-piece type where the optics and haptics are integrally formed (eg, by machining the optics and haptics together from a single block of material); and also closed-loop haptic IOLs. Another style of IOL is called the plate-type haptic where the haptics are configured as a flat plate extending from opposite sides of the optic. The IOL can be made of various materials or combination of materials such as PMMA, silicone, hydrogels and silicone hydrogels, etc.

Various instruments and methods are known for implanting the IOL in the eye. In one method, the surgeon simply uses surgical forceps that have opposing blades that are used to grasp the IOL and insert it through the incision in the eye. Although this method is still practiced today, more and more surgeons are using more sophisticated IOL insertion devices that offer advantages such as greater surgeon control when inserting the IOL into the eye. Recently, IOL insertion devices have been developed with reduced diameter insertion tips that allow a much smaller incision to be made in the cornea than is possible using forceps alone. Smaller incisions (eg, less than about 3mm) are preferable to larger incisions (eg, about 3.2 to 5+ mm) as smaller incisions lead to shorter post healing times. -Surgical and fewer complications such as induced astigmatism.

Since IOLs are very small and delicate items to manufacture, great care must be taken when handling them. To insert the IOL through the smallest incisions, they must be folded and / or compressed before entering the eye where they will assume their original unfolded / uncompressed shape. Therefore, the IOL introduction device should be designed in such a way that it allows easy passage of the IOL through the device and into the eye, but without damaging the delicate IOL in any way. If the IOL is damaged during placement in the eye, the surgeon will most likely have to remove the damaged IOL from the eye and replace it with a new IOL, a highly undesirable surgical result.

Thus, as explained above, the IOL introducer device should be designed to allow easy passage of the IOL through it. Equally important is that the IOL is ejected from the tip of the IOL inserter and into the eye in a predictable orientation and shape. If the IOL is ejected from the tip too quickly or in the wrong orientation, the surgeon must further manipulate the IOL in the eye, which could cause trauma to the surrounding tissues of the eye. Therefore, it is highly desirable to have an introducer device that allows exact loading of the IOL into the introducer device and passes and ejects the IOL from the tip of the introducer device and into the eye in a controlled, predictable, and repeatable manner.

To ensure controlled expulsion of the IOL through the tip of the IOL introducer, the IOL must first be loaded into the IOL introducer. Therefore, loading the IOL into the introducer device is a very important and precise step in the process. Improper loading of an IOL into the introducer device is often considered the reason for a failed IOL placement sequence. Many IOL introducer 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 accidentally damage the IOL and / or incorrectly load the IOL into the injector device resulting in a failed implant. Therefore, direct handling and / or loading of the IOL into the injector by the nurse and / or surgeon is undesirable.

In a typical IOL introducer device, the IOL introducer uses a plunger that has a tip that engages the IOL (which has been preloaded and compressed to the introducer lumen) to pass it through the introducer lumen. The IOL thus communicates with the tip of the plunger as well as the lumen of the introducer device. The lumen is typically sized with a taper towards its open tip in order to further compress the IOL as it advances through the lumen. The tip of the lumen is sized for introduction through the surgical incision which, as noted above, is currently preferred to be in the range of less than 3mm. Thus, the introducer lumen will typically be larger in the IOL loading zone and its diameter will gradually decrease towards the tip of the lumen where the IOL is delivered into the eye. It will be appreciated that the compressed diameter of the IOL at the tip of the lumen is the same as the inside diameter of the tip of the lumen, preferably less than 3

ES 2 318 596 T3 mm, as indicated above. Each of these component connections is dynamic in the sense that the forces acting between the connecting components (i.e., the IOL, the plunger tip, and the introducer lumen) will vary as the IOL is pushed through the lumen. . Therefore, control of these dynamic forces is of utmost importance or else the IOL may be damaged during placement due to excessive compressive forces acting on it. For example, when the plunger advances the IOL through an increasingly smaller diameter lumen, the IOL is compressed while at the same time increasing the forces required to push the IOL through the lumen. This can result in excessive force between the plunger tip and the IOL leading to possible IOL damage and / or uncontrolled release of the IOL from the lumen tip. In addition, the force of the plunger tip can cause the IOL to twist and / or twist when moved through the introducer, thus the force between the IOL and the plunger tip and / or the introducer lumen may increase. uncontrollably to the point of damaging the IOL.

Several introducer devices have been proposed that attempt to solve these problems, but there remains a need for an IOL introducer and method that eliminates the need for direct manipulation of the IOL by the nurse and / or surgeon and generally simplifies the operation of the IOL. IOL injector device and the IOL placement process.

US 2002/082609 describes an injector device that can operate to deliver said IOL to an eye, which has a compressed drawer attached and movable between a fully open position, a partially closed position and a fully closed position with respect to said injector body , said IOL being compressed when said compressor drawer is moved to said fully closed position.

Summary of the invention

According to the present invention, a compressor drawer is provided for compressing an IOL in an injector device, the injector device being operable to deliver said IOL to an eye, said compressor drawer being attached to said injector device and being able to move between a fully open position, a partially closed position and a fully closed position with respect to said injector body, said IOL being compressed when said packer drawer is moved to said fully closed position, characterized in that the packer drawer includes an elastic arm having an edge configured to support a feature of said injector device when said packer drawer is in said partially closed position with the in order to avoid the additional closure of said compressor drawer until said edge is released from said feature of said injector device.

An injector device is provided that has a preloaded IOL and where the injector device and IOL are packaged together as a single unit. The IOL is releasably retained by an IOL retainer in a "preloaded" position in the unstressed state; that is, in a state where substantially no stress acts on its optical portion. In this embodiment, the device is in the preloaded position from the time of final assembly and packaging at the manufacturing site, during transportation and actual use of the device by a surgeon. The storage position is thus the position of the IOL while it is being retained by the IOL retainer.

The injector body includes an IOL loading hole and bay where the retainer is removably attached to the introducer body with the IOL captured by the retainer and retained by it in the preloaded position. The IOL retainer includes features to detachably support the IOL optics. In IOLs that include one or more haptics attached and extending from the optic periphery, the IOL retainer includes other features to releasably support the haptic (s) as well as the optic. In the preferred embodiment, the haptics are supported by the IOL retainer in the preloaded position at the correct vault angle (ie, the angle that they normally extend from the optic periphery).

In fabrication, the IOL is releasably attached to the IOL retainer with the optics and haptics retained by the IOL support members of the retainer. The retainer is then removably attached to the introducer body in its hole and loading bay. An extractor member extends between the IOL optic and retention body to prevent the IOL from becoming engaged with the retainer when the retainer is removed from the introducer body. This will be better explained later.

Once the device is ready for use, the package is opened in a sterile environment in the operating room and viscoelastic substance is applied, as required, around the IOL and / or injector body according to the wishes of the surgeon and / or the usage guidelines provided on the container. The IOL retainer is then detached from the injector device. This can be done by manually removing the IOL retainer from the injector device. In this regard, a finger traction member or other member is provided on the IOL retainer body to facilitate manual disengagement of the retainer from the injector body.

As noted above, an extractor element is disposed between the retainer and the IOL optic. As such, when the retainer is moved away from the injector body, the IOL optic presses against the extractor element thereby preventing the IOL from remaining with the retainer when the retainer is disengaged from the injector body. Thus, the movement of the retainer when disengaging from the injector device causes the IOL optic to press against the extractor element and subsequently release from the IOL retainer's optic support element, in addition to releasing the haptic (s) from the IOL from the haptic support elements of the IOL retainer. Once completely released from the retainer, the IOL is in the "loaded" position within the injector device and is ready to be compressed and placed through a small incision in one eye.

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In an alternative embodiment, the retainer and the IOL attached to it can be packaged separately from the injector device, whereby the retainer and IOL are attached to the injector body at the time of surgery rather than at the time of manufacture. .

The injector includes means for compressing, coiling, or otherwise pushing the IOL into a smaller cross section for administration through the injector. In a preferred embodiment of the invention, the injector device includes a compressor that extends laterally from the IOL loading bay of the injector body. The compressor can be moved between fully open and fully closed positions and is in the open position when the injector device is packed and the IOL is in the storage position. After the package is opened and the IOL retainer is disengaged from the injector device, the compressor moves to the closed position compressing the IOL optic. A plunger is advanced at the proximal end of the injector device causing the tip of the plunger to engage the proximal end of the compressed optics. As the plunger is advanced further, the IOL is pushed through the distal end of the injector body and ejected into the eye in the intended manner.

In another embodiment, a haptic tractor is provided at the distal end of the injector body that includes a finger for engaging the forward haptic of the IOL. Before fully advancing the plunger, the haptic tractor is manually pulled away from the distal tip of the injector device by causing its finger portion to pull the forward haptic and straighten it within the distal tip of the injector device. This eliminates the possibility of the forward haptic jamming within the injector body when the plunger has been fully advanced through the injector device.

The relative placement of the IOL retainer, IOL, and injector device is such that by uncoupling the IOL retainer from the injector device (and thereby releasing the IOL from the retainer), the IOL is preferably positioned within the injector device. The IOL is thus positioned in a particular orientation within the injector device relative to the plunger tip and the haptic tractor. This "IOL release position" results in the forward haptic properly engaging the haptic tractor, and the outlet haptic extending rearward of the plunger tip so that, as the plunger advances, the plunger tip engage the IOL optic as intended without obstruction or jamming of the exit haptic.

Brief description of the drawings

Figure 1 is a perspective view of an embodiment of the invention depicting the device with the retainer and IOL attached to the injector body in the storage position.

Figure 2A is a partial plan view of the injector body depicting its IOL loading bay portion.

Figure 2B is a partial sectional side elevation view showing the exit haptic residing in a recess located adjacent the tip of the plunger that engages the IOL optic.

Figure 3A is an enlarged perspective view of the loading bay area of ​​the injector device of Figure 1.

Figure 3B is a cross-sectional view taken through the IOL loading bay of the injector device with the packer drawer in the fully open position.

Figure 3C is a cross-sectional view taken along line 3C-3C of Figure 3A.

Figure 3D is the view of Figure 3C with the squeeze drawer shown in the fully closed position.

Figure 3E is a cross-sectional view taken through the IOL loading bay area and depicting an alternate embodiment of the extractor finger component of the injection device.

Figure 4 is the view of Figure 1 depicting the removal of the IOL retainer from the injector body and the squeeze drawer in the fully closed position.

Figures 5A-5C are perspective, top, and side views of the IOL retainer with an IOL releasably retained by it.

Figure 6 is a perspective view showing the injector device in the process of ejecting an IOL from it.

Figure 7 is the view of Figure 6 showing the IOL fully ejected from the injector device.

Figures 8 and 9 are perspective and plan views of the compressor drawer and extractor finger component of the injector device, respectively.

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Figure 10 is a side elevational view of the partially preloaded embodiment of the invention depicting the retainer and IOL coupled together and sealed in a single package.

Figure 11 is a plan view of the preloaded embodiment of the invention depicting injector body 12, retainer 40, and IOL 30 coupled together and sealed in a single package.

Figure 12 is a cross-sectional view of the package of Figure 11 taken generally along line 12-12 in Figure 11.

Figure 13A is a perspective view of another embodiment of the lens retainer depicting an IOL coupled thereto in the intended manner.

Figure 13B is a top plan view of Figure 13A.

Figure 13C is a side elevation view thereof.

Figure 13D is a perspective view of the retainer and IOL in spaced relationship to a retainer cover.

Figure 13E is a perspective view showing the retainer and cover coupled together.

Figure 13F is a bottom plan view of the retainer cover.

Figure 13G is a plan view of a representative IOL for use with the present invention.

Figure 14 is a plan view of another embodiment of the injector device with the compressor drawer shown in the fully open position relative to the injector body.

Figure 15A is a perspective view of the injector device of Figure 14.

Figure 15B is a perspective view of the injector device of Figures 14 and 15A showing the compressor drawer in the partially closed position relative to the injector body.

Figure 15C is a front elevation view of Figure 15B.

Figure 15D is a top plan view of Figures 15B and 15C.

Figure 15E is a cross-sectional side elevation view of Figure 15D depicting the relative placement of the detent extractor fingers, IOL, plunger tip, and haptic tractor when the packer drawer is in the partially position. closed.

Figure 15F is a perspective view of the injector device of Figures 14-15E showing the compressor drawer in the partially closed position and the retainer removed from the injector device, leaving the IOL with the injector device.

Figure 16A is a top plan view of the injector device of Figures 14-15E after removal of the retainer and the squeegee moved to the fully closed position.

Figure 16B is a perspective view of the box of the embodiment of Figures 14-16A.

FIG. 16C is a cross-sectional view showing the IOL as it engages the through hole 150a of the optical extractor 150 when the retainer is removed from the injector device.

Figure 17 is a perspective view of another embodiment of the haptic tractor component.

And Figure 18 is a perspective view of another embodiment of the plunger component.

Detailed description

Referring now to the drawing, a preferred embodiment of the invention generally denoted by reference numeral 10 is depicted in the figures. In a first broad aspect, the invention includes a preloaded injector device for injecting an IOL into an eye. The term "preloaded" as used herein means that the injector body 12 is packaged together with an IOL where the IOL 30 is retained by a retainer 40 in a storage position in the injector body (see also Figures 11 and 12). In an alternative embodiment of the invention, the injector device is "partially preloaded", which means that the IOL 30 and retainer 40 are coupled and packed together, but not yet coupled to the injector body 12 (see also Figure 10) . In this alternate embodiment, the retainer and IOL are attached to the injector body by the doctor or nurse at the time of surgery.

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Injector body 12 includes a longitudinal lumen 14 extending from proximal end 16 to its distal end 18. The lumen may assume any desired cross-sectional shape, although circular or oval shapes are preferred. Lumen 14 tapers inward toward distal tip 18 so that IOL 30 is gradually compressed to a very small cross section as it exits tip 18a. Tip 18a may include one or more longitudinally extending slits 18a 'to allow gradual expansion of IOL 30 as it exits tip 18a into the eye. This prevents uncontrolled expansion of the IOL in the eye that could potentially damage the delicate surrounding tissues of the eye. Proximal end 16 may include a finger clamp flange 17 preferably configured with a straight edge 17a as shown so that device 10 rests on a flat surface. A plunger 20 having distal and proximal lengths 20a, 20b, respectively, and a distal plunger tip 22 (see Figure 2) and proximal thumb pressure element 24 telescopes into lumen 14 to engage and push IOL 30 to through lumen 14 and eject it through distal tip 18a. The IOL delivery sequence will be explained in more detail later. It is understood that the general configuration of injector body 12 may vary from that depicted and described herein. It is also understood that the components of the injector device can be made of any suitable material (eg, polypropylene) and can be completely or partially opaque, transparent or translucent to better match the IOL within the injector device and the delivery sequence of the IOL. .

Injector body 12 further includes a hole 26 that opens to lumen 14. Hole 26 is configured to receive an IOL 30 for delivery of the IOL from distal tip 18a. The explanation will now refer to the preloaded position of the IOL followed by the explanation of the IOL loading and delivery sequence.

The preloaded condition of the IOL

In a preferred embodiment, device 10 includes an IOL retainer 40 used to releasably hold an IOL 30 in the preloaded position relative to injector body 12. IOL retainer 40, with IOL 30 releasably retained by it, is attached removably to injector body 14 in hole 26. As best seen in Figures 5A-C, the IOL retainer 40 includes one or more, but preferably two, optic support elements 42a and 42b each having a lip 42a ', 42b' or other feature to releasably support the optic of the IOL 31 in its periphery 31a. Alternatively or in addition to the optics support elements, one or more, but preferably two, haptic support elements 44a and 44b are disposed on the detent 40, each including a finger 44a ', 44b' or other feature for releasably supporting one or more, but preferably two haptics 33a and 33b joining and extending from the optic 31. In this regard, it is understood that the IOL configuration depicted and described herein is for explanatory purposes only, and that the present invention is not to be limited thereto. The invention can be easily adapted to IOLs of any configuration and type (e.g., plate IOLs, open or closed loop haptics, anterior chamber IOLs, posterior chamber IOLs, accommodative IOLs (including single or double lens types). ), etc). The overall configuration of the IOL retainer 40 can thus likewise be varied such that it is cooperatively configured and releasably retains the particular IOL configuration that is used with the device. In all embodiments, the detent 40 holds at least the IOL optic 31 in the unstressed state. It is also preferable that the retainer 40 retains the haptics of the IOL at the correct vault angle (ie, the angle that they normally extend from the optic periphery of the IOL). It is even more preferable that the haptic support members retain the loop haptics at the correct angle of curvature. In Figures 5AC it is seen that the haptic support elements retain the haptics along their curved outer edges. This ensures that the curvature of the haptic, which is designed and set when manufacturing the haptics, does not increase or curve from specification during storage of the IOL and retainer.

In manufacture, the IOL 30 is releasably attached to the IOL retainer 40. This can be done by engaging the IOL optic 31 with the IOL support members 42a, 42b, and / or by engaging the haptics 33a, 33b with the elements. haptic support 44a, 44b, respectively. For descriptive purposes, haptic 33a will be referred to as the forward haptic since it is located distally in the injector body while haptic 33b will be referred to as the outlet haptic as it is located proximally in the injector body (see Figure 2).

The releasable attachment of the IOL 30 to the IOL retainer 40 can be accomplished by an operator using a pair of forceps, for example, although other methods can be used if desired, including automatic or semi-automatic means.

As explained above, in the preloaded embodiment of the invention, retainer 40 and IOL 30 are coupled to injector body 12 during manufacture and sealed and sterilized in the same package for delivery to the surgeon. For example, as seen in Figures 11 and 12, a thermoformed plastic package 11 is provided to include a cavity 11a in the general shape of the injector device 10 as the packaging device 10 together with the retainer 40 and IOL. 30 attached to it. A flexible cover sheet 11b is sealed around the perimeter of the cavity 11a to seal the package. At the time of surgery, the cover 11b is removed to access the device 10.

Thus, once the IOL 30 has been releasably attached to the retainer 40 as described above, the IOL retainer 40 is removably attached to the injector body at hole 26. This can be done by suitable mechanical clamping features that will connect removably retainer 40 to injector body 12, examples including friction fit, snap fit, interference fit, cooperating tabs and clips, retainers, etc. As seen in Figures 1 and 3A, retainer 40 is held in position in hole 26 by frictional engagement between the surfaces defining hole 26 and opposite outer wall surfaces 41a and 41b of the

ES 2 318 596 T3 retainer 40. It will be seen that when retainer 40 and IOL 30 are coupled together and attached to injector body 12, the optic of IOL 31 is not stressed and furthermore does not touch any part of the body of the injector 12. This ensures that the delicate optics 31 of the IOL are not damaged during storage.

When the retainer 40 and IOL 30 are coupled together and attached to the injector body 12, an extractor finger 50 is positioned between the optic of the IOL 31 and the central wall surface 46 of the retainer 40 as best seen in FIGS. 1, 3A and 3C. The primary function of the extractor finger 50 is to prevent the IOL 30 from lifting with the retainer 40 when the retainer is separated from the injector body (this will be described below). In a preferred embodiment of the invention, the extractor finger 50 is attached to the squeeze drawer 60 which is movable relative to the injector body 12 between a fully open position as seen in Figure 3B, an intermediate position shown in Figures 1 , 3A, 3C and 3E, and the fully closed position shown in Figures 3D, 4, 6 and 7. The extractor finger 50 is located between the IOL optic 31 and the central wall surface 46 when the compressor 60 is in the intermediate position, which is also the preloaded position of the injector device as described herein. When the squeeze drawer 60 is moved to the fully closed position, the extractor finger 50 moves with it and rests in a position laterally adjacent to the injector body 12 as seen in Figures 3D, 4, 6 and 7.

In an alternative embodiment, the extractor finger 50 can be formed separate from the squeeze box 60 if desired. Said example is seen in Figure 3B where the extractor finger 50 has been formed with a clip 50a that can be mounted on the injector body 12 opposite and separately from the compressor box 60. In this embodiment, the extractor finger 50 is removed from the injector body 12 after removal of the retainer 40 and before closing the compressor drawer 60. Other embodiments will be apparent to those skilled in the art for removing the IOL 30 from the retainer 40 when the retainer is removed from the injector body 12 and thus fall within the scope of this invention.

Referring to Figures 1, 2, 4, 6, and 7, it is seen that plunger 20 includes distal and proximal plunger shaft portions 20a, 20b, respectively, having a plunger tip 22 at its distal end and an element thumb 24 at its proximal end to manually operate the injector device. Plunger tip 22 is configured to engage IOL optic 31 at its periphery 31a when plunger 20 is advanced toward distal tip 18a of injector body 12. It is very important that the plunger tip 22 does not damage the optic of the IOL 31. The plunger tip 22 is so designed in order to avoid damage to the IOL optic 31. In the preferred embodiment, the tip is bifurcated to first and second tip portions 22a and 22b, whereby the optical periphery of IOL 31a engages between tip portions 22a, 22b as seen in FIG. 2B. It is understood that other plunger tip designs can be used with the present invention, if desired. It is also preferred that the plunger shaft is rotationally fixed within lumen 14 to avoid unexpected rotation of the shaft (and hence tip 22) with lumen 14. The plunger shaft may be rotationally fixed making the shaft proximal run 20b and lumen 14 of non-circular cross section.

In an especially advantageous embodiment, the proximal length 20b of the piston shaft is provided with one or more elongated fingers 23a, 23b that form springs that are pushed radially outward against the inner wall of the lumen 14 (see Figures 1 and 6). The purpose of the spring fingers 23a, 23b is to provide proper centering of the plunger shaft and tip, as well as tactile resistance between plunger 20 and lumen 14 as plunger 20 is advanced therethrough. In the storage position, the plunger 20 is withdrawn to the position depicted in Figure 1. To ensure that the plunger is not inadvertently dislodged from the injector body or inadvertently advanced into lumen 14, the free ends 23a 'and 23b' they are located within respective holes 21a, 21b (hole 21b not shown) formed in injector body 12 adjacent its proximal end 16. When the device is to be used, the surgeon presses on the pressure element with the thumb 24 whereby the free ends 23a ', 23b', assisted by their inclined edge faces, disengage from the respective holes 21a, 21b, leaving The plunger freely advances in a controlled manner through lumen 14. The thrust of the elastic fingers 23a, 23b against the inner wall of the lumen 14 provides the surgeon with continuous tactile feedback allowing him to advance the plunger (and thus the IOL) through the lumen 14 in a very concise and controlled manner.

Referring again to the plunger / IOL engagement, it is important that the exit haptic of the IOL 33b does not interfere with the optic / plunger tip engagement. In this regard, the end portion of the exit haptic is positioned rearward of the plunger tip upon removal of retainer 40 and release of IOL 30. In a preferred embodiment, a recessed area 25 is provided rearward of the tip 22 on the piston shaft section 20a (FIG. 2A). With the plunger 20 in the ready position shown in Figure 1, the recessed area 25 of the plunger is generally aligned with the exit haptic 33b of the IOL 30 retained by the retainer 40. As such, upon releasing the retainer 40 from the injector body 20, outlet haptic 33b will release from haptic support member 44b and fall into recessed area 25 of plunger 20. Thus, when plunger 20 is advanced during use of the device while performing surgery, exit haptic 33b will reside in recessed area 25 and will not entangle or otherwise interfere with proper engagement of the plunger tip and optic of the plunger. the IOL (Figure 2B).

With reference to the forward haptic 33a, it is important that the forward haptic does not "squeeze" into the continuous taper injector tip 18 when the IOL 30 is pushed through. One way to avoid this is to straighten the forward haptic 33a within the tip 18. To accomplish this, a haptic tractor 80 has been provided which is the subject of US Patent No. 6,491,697, to the same assignee. The haptic tractor 80 has a shaft 82, a tip 84, and a finger pull member 86. In assembly, the tip 84 is inserted into the injector tip with the finger pull member positioned outward and adjacent. (see figure 4). Tip 84 is configured with a lip to engage forward haptic 33a (see FIG. 2A). At the time of using the device

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10, the haptic tractor 80 is grasped on the traction member with finger 86 and is pulled away from the injector body 12 in the direction of the arrow in Figure 6, thereby engaging and straightening the forward haptic 33a within the tip. 18, so the haptic tractor 80 can be scrapped.

To ensure that the forward haptic 33a engages with the tip of the haptic tractor 84 when the IOL retainer 40 is removed from the injector body 12, the tip of the haptic tractor 84 is positioned on the injector tip 18 in alignment with the forward haptic 33a when retained by haptic support member 44a of IOL retainer 40. Thus, upon releasing the IOL retainer 40 from the injector body 12, the forward haptic 33a is released from the haptic support member 44a and falls into position at the tip of the haptic tractor 84 as shown in FIG. 2A.

The IOL loading and delivery condition sequence

When it is time to use the injector device 10, the surgeon selects the injector device with the appropriate IOL preloaded in it, as described above. The outer packaging is removed in a sterile setting in the operating room. To load the IOL into the delivery position depicted in Figure 2A, the nurse or surgeon grasps and removes the IOL retainer 40 from the injector body 12. This is accomplished by manually grasping the finger grip 41 and pulling the detent 40 away from the injector body 12, as shown by the directional arrow 1 in Figure 4. As described above, the extractor finger 50 serves to prevent removal. IOL 30 is raised in conjunction with retainer 40. Thus, the IOL optic 31 will be released from the IOL support element optic 42a, 42b and the leading and exit haptics 33a, 33b will be released from their respective haptic support elements 44a, 44b. Once the retainer 40 has been completely separated from the injector body 12, it can be disposed of or recycled. With the IOL 30 thus fully released from the detent 40, the optic of the IOL 31 rests in the loading bay area 27 of the injector lumen 14, engaging the forward haptic 33 to the tip of the haptic tractor 84 and positioning the exit haptic 33b in the recessed area 25 adjacent the tip of the plunger 22 as previously described. In this regard, it is noted that upon release of IOL 30 from retainer 40, IOL 30 will fall slightly into lumen 14. This is best seen in Figures 3C and 3D where, in Figure 3C, the IOL 30 is retained by the retainer 40 with the optical periphery 31a positioned slightly above the slot 14a that has been formed and extends longitudinally along the inner wall of lumen 14. Upon removal of retainer 40 and release of IOL 30 from it, optical periphery 31a aligns with slot 14a along one side of the lumen. Then, as the shrink drawer 60 is moved to the fully closed position (see directional arrow 2 in FIG. 4), the opposite edge of the optical periphery 31a engages in the slot 60a of the drawer 60 (see also FIG. 8). Thus, lumen 14 conjoins lumen slot 14a, drawer slot 60a, and top wall 60b of the drawer compresses and encloses the IOL optic 31 within lumen 14. The location of the optic periphery 31a within opposing grooves 14a and 60a ensures a smooth delivery of the IOL 30 through lumen 14 and through the tip 18. This form of smooth delivery of the IOL is described in more detail in the US Pat. United States number 6,491,697, from the same assignee, cited above.

Before removing the retainer 40, closing the drawer 60, and compressing the IOL 30 within the injector body, it may be desirable to apply viscoelastic substance to the area surrounding the IOL 30 to facilitate delivery of the IOL through the injector body. This is common practice in the industry, and the amount and position of application of a viscoelastic substance varies according to the instructions for use provided with the device as well as the wishes of the surgeon. In any case, in a preferred embodiment, one or more viscoelastic substance access holes are arranged in the injector device to facilitate the application of the viscoelastic substance in the area of ​​the IOL. Thus, one or more access holes P₁ in the form of a through hole in the extractor finger 50. The access hole P₁ is accessible by an injection nozzle inserted into the viscoelastic substance hole P₁. Alternatively or in addition to the access holes P₁, one or more access holes P₂ at any desired position through tip wall 18 (see Figures 3B-D). Alternatively or in addition to the viscoelastic substance holes P1 and P2, viscoelastic substance can be applied in the loading bay 27 at the holes P₃ And p₄ defined between the optic and haptic support elements of the retainer 40 (see FIG. 3A). Once the viscoelastic substance is applied as desired, the retainer 40 is removed and the squeeze drawer 60 is moved to the fully closed position, whereby the IOL optic 31 is compressed and prepared for administration through a small incision formed in one eye. The fully closed position of drawer 60 and the compressed position of IOL 30 are depicted in Figure 3D, as described above. Drawer 60 is slidably received between cooperatively formed drawer slides 61a, 61b extending laterally from injector body 12 adjacent hole 26. Catches or other elements (not shown) may be provided on opposite surfaces of drawer slides 61a, 61b, and drawer 60 to facilitate holding drawer 60 in the fully open and intermediate positions, respectively. Such drawer fasteners are especially useful to prevent inadvertent sliding and / or complete closing of the drawer 60 before the required time (eg, during storage or removal of the device 10 from its associated packaging).

The haptic tractor 80 then moves away from the injector body 12 (FIG. 6) and the forward haptic 33a straightens within the injector tip 18. If desired or necessary, the plunger 20 can be advanced slightly before pulling out. haptic tractor 80. The surgeon inserts injector tip 18a into the incision made in the eye and begins to advance plunger 20. As plunger 20 is advanced, plunger tip 22 engages optic periphery 31a and pushes IOL 30 forward, with exit haptic 33b being positioned in recess 25 in plunger 20. As plunger 20 continues to advance, IOL 30 it is pushed through the injector tip 18a and is finally ejected from it and into the eye (FIG. 7). A coil spring 27 may be arranged around the distal portion of the plunger shaft 20a to increase thrust in the reverse direction when the plunger reaches the fully advanced position. This takes place when the spring 27 is compressed between the leading edge 20b 'of the proximal length of the shaft 20b and the

ES 2 318 596 T3 radial extension 12a of injector body 12 (see Figures 1 and 6). This helps the surgeon maintain accurate control of the advancement of the plunger (and therefore the IOL) and allows automatic retraction of the plunger by relieving the pushing pressure exerted against the plunger pressure element with the pressure element 24. This is useful for easily executing a second stroke of the plunger to engage and manipulate the exit haptic into position in the eye. This feature, in conjunction with the bifurcated plunger tip 22, allows for more accurate control and manipulation of the IOL with the plunger tip in situ than would be possible with an injector device that does not have these features.

The partially preloaded condition

In an alternative embodiment of the invention, instead of being fully preloaded as described above, the injector device is "partially preloaded", meaning that the IOL 30 and retainer 40 are engaged together as depicted in Figures 5A. -C and sealed in a package 51, as shown in Figure 10, which is separate from another package in which the injector body 12 is supplied. Package 51 may be thermoformed to include cavity 51a in the general shape of retainer 40 and IOL 30 coupled together. A flexible cover sheet 51b is sealed around the perimeter of cavity 51a to seal the retainer 40 and IOL 30 in the package 51. This embodiment allows the doctor to choose a package that contains a specific retainer and IOL model. It is subsequently combined with the separately packaged injector body 12 that is common to all IOL models. Thus, in this alternate embodiment, the doctor or nurse removes the cover 51b to retrieve the retainer 40 and IOL 30. The injector body 12 is removed from its respective container, and the retainer 40 that already has an IOL 30 attached is attached to injector body 12 at the time of performing surgery. It will be appreciated that direct handling and manipulation of the IOL 30 itself is not necessary in the preloaded or partially preloaded embodiments of the invention.

In the partially preloaded embodiment, the injector body 12 is supplied with the squeeze drawer 60 in the fully open position shown in Figure 3B such that the extractor finger 50 is located laterally adjacent to the hole 26 (or the extractor finger not yet attached to injector body 12 where the extractor finger is a separate component). The nurse or doctor subsequently opens the package that houses the introducer body and proceeds to couple the retainer and IOL to the injector body through hole 26. Once the retainer 40 and IOL 30 are attached to the introducer body 12, The extractor finger 50 is inserted between the wall surface 46 of the retainer and the optic of the IOL 31. This can be done by advancing the compression drawer 60 to the intermediate position shown in Figures 1, 3A and 3C. In the embodiment depicted in Figure 3B, this is accomplished by attaching the combined extractor finger 50 and clip 50a to the injector body 12 opposite the drawer 60.

Figures 13A-16A illustrate another preferred embodiment of the invention. For ease of understanding, the reference numerals used in the embodiments of Figures 1-12 above will be used for similar parts of Figures 13A-16B increased by 100. Unless otherwise indicated, the description of other embodiments will also applies to this embodiment.

Referring to Figures 13A-13F, it is appreciated that a retainer 140 for releasably holding an IOL includes one or more, but preferably two, optic support elements 142a and 142b each having a slot 142a ', 142b' or other element. to releasably support the optics of IOL 131 at its periphery 131a. Slots 142a ', 142b' are spaced above support surface 146 such that optic 131 is equally spaced above support surface 146. The distance between the support surface and the optic is selected to allow the extractor finger 150 of the shrink drawer 160 to extend therebetween, as further explained below. Top surfaces 142a "and 142b" are sloped downward to provide an "inlet" that facilitates placement of optical periphery 131a in slots 142a ', 142b'.

Alternatively, or in addition to the optics support elements, one or more, but preferably two, haptic support elements 144a and 144b are disposed in retainer 140, each including a slot 144a ', 144b' or other element to support releasably one or more, but preferably two, haptics 133a and 133b joining and extending from the optic 131. The retainer 140 holds at least the optic of the IOL 131 in the unstressed state. It is more preferable that the retainer 140 holds the haptics of the IOL at the correct vault angle (ie, the angle that they normally extend from the optic periphery of the IOL). It is even more preferable that the haptic support elements keep the loop haptics at the correct lens diameter di (see FIG. 13G). In Figures 13A-D, it is seen that haptic support members 144a, 144b retain haptics 144a ', 144b' along their curved outer edges, respectively. This ensures that the lens diameter d₁, which is designed and established at manufacture, does not go up or out of specification during storage of the IOL and retainer.

In addition to maintaining the diameter of the lens as described above, it is preferred that the optic 131 remain stationary with respect to the retainer 140 to prevent damage to the IOL and to ensure proper alignment of the optic 131 with the hole 126 in the body of the lens. injector 112 by attaching the retainer to the injector body. As best seen in Figures 13A, B and D, a slot 143 is provided in at least one optic support member 142b where the respective haptic 133b extends adjacent to the optic 131. The slot 143 serves to inhibit translation lateral or counterclockwise rotation of the IOL 130 (as seen in Figures 13A and B) while it is coupled to the retainer 140, particularly during transport and storage. If the IOL 130 begins to translate or rotate to the left, the haptic 133b will encounter and abut the side wall 143 'defining the slot 143, thus preventing translation and rotation. Similarly, translation or rotation of the IOL in the right direction is prevented by the walls

ES 2 318 596 T3 interiors 142a ", 142b" that the haptics will find and support if they start to translate or move in the right direction.

With the IOL 130 attached to the retainer 140, the retainer and IOL combination is ready to be attached to the injector device 112. As described above in relation to prior embodiments, this can be done at the time of manufacture, at the time of use by part of the surgeon or nurse, or at any time in between.

Detent 140 may further include first and second attachment legs 145a, 145b extending from opposite edges of surface 146. Legs 145a and 145b are spaced a distance that allows detent 140 to be removably attached to device 112 as seen in the Figures 15A-15D mounting drawer slides 161a, 161b extending laterally to injector body 112 next to hole 126. Legs 145a, 145b may be provided with clips 145a ', 145b' at their ends to provide a snap fit engagement between retainer 140 and drawer slides 161a, 161b, respectively. The snap-fit ​​engagement should be strong enough to prevent detent 140 from inadvertently disengaging from body 112, but also allow detent 140 to be manually disengaged from it without using excessive force. As best seen in Figures 15A and 16A, first and second tabs 165a, 165b are arranged at the junctions of drawer slides 161a, 161b and body 112 of the device, respectively, and serve to accurately position legs 145a, 145b with it and thus precisely position the catch 140 in the body 112 of the device. The retainer 140 may further include first and second tabs 147a, 147b, which rest on drawer slides 161a, 161b when the retainer 140 is properly positioned on the body 112 of the device, as described above. The tabs 147a, 147b help stabilize the retainer 140 on the body 112 of the device and also assist the user in pivoting the retainer out of the device around the flange corners 147a ', 147b' which act as the pivot points (see also Figure 15c).

In the case where the retainer 140 is to be packaged and shipped separately from the injector 112, a protective cover 200 is placed that can be removably coupled to the retainer 140 (Figures 13E-F). Cover 200 includes a finger grip flange 204 extending from enclosure 202 with four side walls 206a, 206b, 206c, and 206d and a top wall 206e defining a central hole 208. Each of the opposite side walls 206b and 206d includes a flange 206b ', 206d' adjacent to the hole 208. Each of the flanges 206b ', 206d' includes a slot 206b ", 206d" where the first and second connecting legs 145a , 145b of the retainer 140 are free to slide, respectively. Thus, to initially attach cover 200 to retainer 140, the two parts are aligned as seen in Figure 13D and brought together until retainer surface 146 rests on tabs 206b ', 206d' and clips 145a ', 145b. 'engage the top wall 202e of the cover as seen in FIG. 13E. In the attached condition of the retainer and cover shown in FIG. 13E, the IOL optic 131 remains coupled to retainer 140. As seen in FIG. 13F, the interior of the upper wall 206e 'may be provided with elements that contribute to providing clearance and / or support for the IOL. For example, a circular recess 210 may be provided that aligns with the optic position of the IOL 131 to ensure that there is sufficient clearance to prevent the optic of the IOL 131 from touching the inner wall 206e '. One or more projections such as at 212 and 214 may also be provided to serve as auxiliary supports for the peripheral edge 131a of the optics. One or more projections 218, 220 may be provided to serve as auxiliary supports for haptics 133a and 133b, respectively. At the time of surgery, cover 200 is removed by pulling retainer 140 away from cover 200. Cover 200 can then be discarded.

Prior to attaching the combination of retainer 140 and IOL 130 to device 112, the packer drawer 160 is placed in the open position as seen in Figures 14 and 15A. The squeeze drawer 160 includes opposing side rails 161a, 161b with a spring arm 161c extending therebetween, a finger pressure element 160c, an optical extractor finger 150, and first and second haptic extractor fingers 151 and 153 that generally extend. parallel and spaced on either side of the optical extractor finger 150. When in the open position, the leading edges of the optic and haptic extractor fingers 150, 151, 153 are laterally spaced from the hole 126 as best seen in Figure 14. As best seen in Figure 15A, the edge The front 163a of the arm 163 has a slot that engages the leading edge 161d of the shelf 161c to prevent unintended further advancement of the drawer 160 relative to the device 112. This feature allows the drawer 160 to be properly set to the open position during manufacture and prevents premature advancement of the drawer during shipping and handling. With drawer 160 in the open position, the latch and IOL combination can be mounted therein over hole 126 by grasping latch 140 with finger grip 141 and mounting legs 145a, 145b around drawer slides 161a, 161b as described above.

When it is time to use the device in surgery, the surgeon or nurse depresses the pressure element with finger 160c while also exerting upward pressure on the arm 163 (for example, with the thumb) to disengage the leading edge 163a from the arm. from the leading edge 161d of the shelf. Once this is done, the drawer 160 is advanced further into the hole 126 of the device 112, the arm 163 passing over the shelf 161c. Advancement of the drawer is continued until extractor fingers 150, 151, and 153 have been extended between IOL 130 and retainer surface 146 as best seen in Figures 15B, 15D, and 15E. This position will be achieved by the user when vertically extending flange 160d of drawer 160 (see Figures 15D and 16B) contacts edge 146a of retainer surface 146 (see Figure 15D).

With the extractor fingers 150, 151 and 153 positioned between the IOL 130 and the retainer surface 126, the retainer 140 can be disengaged from the device 112 by grasping the traction element with finger 141 and away from the device 112 as seen in the figure. 15F. It is noted that the detent 140 can be pushed straight (arrow in FIG. 15F) or in a pivotal movement (arrow in FIG. 15C) relative to the body 112 of the device. Before and / or after

By disengaging retainer 140, the surgeon can apply viscoelastic substance to IOL 130 through hole 126 and / or hole 150a. It will be noted that the central extractor finger 150 serves to remove the IOL optic 131 from the retainer 140 while the extractor fingers 151 and 153 serve to remove respective haptics 133a and 133b from it. In addition to serving to remove the IOL from the retainer, the extractor fingers also help to keep the IOL submerged, at least partially, in the viscoelastic bath applied by the surgeon. Without this assistance from the extractor fingers, the IOL can “float” on top of the viscoelastic substance, which can be detrimental to the success of IOL placement. It is also noted that the hole 150a in the optical extractor finger 150 helps to stabilize the optics of the IOL 31 as it is being pulled away from the detent. 140. To explain, when detent 140 is disengaged from injector body 112, the two haptics can be released from their respective haptic support elements at different times, causing the optic to "rock" in the direction of the haptic when released from its associated support element. The hole 150a thus helps prevent tilting of the optics by providing a 360 ° surface against which the 360 ​​° peripheral edge 131a can press during the extraction process. The hole 150a 'may also be provided with a sloping leading edge 150a' (Figure 16C) to enhance this stabilizing effect.

Once retainer 140 is disengaged from the device, IOL 130 is positioned in hole 126 in the manner previously described (see FIG. 2A) and prepared for folding and placement in one eye. The user thus continues to advance the drawer 160 to the fully closed position by exerting inward pressure with the finger on the drawer pressure element 160c. It is noted that a side hole 155 is provided in the body 112 opposite the drawer 60 (see Figures 14 and 15F). The hole 155 is provided so that the free end of the exit haptic 133b can pass through it if the closure of the drawer 160 begins to catch this haptic. A finger grip 170 may be provided on device 112 in front of drawer 160 to assist the user in holding the device while closing the drawer. The fully closed position of drawer 160 is depicted in FIG. 16A. In this position, extractor fingers 150, 151, and 153 are now positioned laterally to device 112 on flange 170. IOL 130 is compressed and ready for placement.

The haptic tractor 180 then moves away from the injector body 112 (see FIG. 6) and the forward haptic 133a straightens within the injector tip 118. As seen in FIG. 17, the haptic tractor 180 includes a finger traction element 186 and a shaft 182 and tip 184. Upon assembly, the tip 184 is inserted into the injector tip with the finger traction member positioned outwardly next to it (see figure 14 ). Tip 184 is configured with a lip to engage forward haptic 133a (see FIG. 14 and 15E). While using the device 110, the haptic tractor 180 grasps the traction member with finger 186 and pulls away from the injector body 112, thereby engaging and straightening the forward haptic 133a within the tip 118, thereby the haptic tractor 180 can be scrapped.

To ensure that the forward haptic 133a engages with the tip of the haptic tractor 184 when the IOL retainer 140 is removed from the injector body 12, the tip of the haptic tractor 184 is positioned on the injector tip 118 in alignment with the forward haptic 133a when retained by haptic support member 144a of IOL retainer 140. Thus, upon releasing the IOL detent 140 from the injector body 112, the forward haptic 133a is released from the haptic support member 144a and falls into position at the tip of the haptic tractor 184. A positioning button 183 is formed at the traction member with finger 186 and contacts tip 118 when haptic tractor shaft 182 is fully inserted into introducer tip 118. Button 183 substantially inhibits lateral movement of shaft 182 within tip 118 and thereby ensures proper and stable alignment of haptic push tip 184 with detent 140 and forward haptic 133a retained by it.

If desired or required, the plunger 120 can be advanced slightly before the haptic tractor 180 is removed. The surgeon inserts the injector tip 118a into the incision made in the eye and begins to advance the plunger 120. As the plunger 120, plunger tip 122 engages optic periphery 131a and pushes IOL 130 forward, positioning exit haptic 133b in recess 125a of plunger 120. It is noted that plunger 120 may also include a recess 125b opposite recess 125a (see FIG. 18). The second recess 125b is provided so that if the exit haptic 133b does not align and is in the first recess 125a, the exit haptic is instead positioned in the second recess 125b and thus has clearance to traverse and exit the device lumen. On continued advancement of plunger 120, IOL 130 is pushed through injector tip 118a and is finally ejected and positioned in the eye.

A pair of spring springs 220a, 220b with respective tips 220a ', 220b' may be arranged on the plunger shaft. The injector body 112 may also be provided with a pair of through holes 112a, 112b where the tips may be to establish the initial position (transport) of the plunger 120. These features are more fully described in our copending application number Serial 10 / 744,981 filed 12/22/03 (WO 2005 065 589). The pressure of the plunger causes the tips to pop out of the holes 112a, 112b and then push against the interior of the body 112. This helps the surgeon to maintain exact control of the advancement of the plunger (and therefore the IOL). A spring (not shown) may also be disposed around the plunger axis 120 to allow automatic retraction of the plunger by relieving the biasing pressure exerted against the plunger pressure element 24 with the thumb as described above.