Patent Description:
It is estimated that <NUM>% of Americans between the ages of <NUM> to <NUM> get cataracts. A cataract is a clouding of the eye's lens that impairs a person's vision and, if left untreated, causes blindness. As a result, each year approximately <NUM> million people in the United States alone undergo cataract surgery, whereby the clouded natural crystalline lens is removed and replaced with an intraocular lens (IOL) implant.

Surgeons implant IOLs not only as a replacement for the natural crystalline lens but also to alter the optical properties of (provide vision correction to) an eye with an existing IOL or in which the natural lens remains. IOLs often include an optically clear disk-like optic of about <NUM> in diameter, and preferably at least one flexible fixation member or haptic which extends radially outward from the optic and becomes affixed in the eye to secure the lens in position.

The optics may be constructed of rigid biocompatible materials such as polymethyl methacrylate (PMMA) or deformable materials such as silicone polymeric materials, acrylic polymeric materials, hydrogel polymeric materials, and the like. The deformable materials allow the IOL to be rolled or folded for insertion through an injector or insertion cartridge and an incision into the eye. Once within the chamber of the eye, the IOL is expulsed from the injector and returns to its original shape.

Injectors or inserters for delivering IOLs into the eye typically employ a handpiece and a removable cartridge that receives the IOL and has a hollow insertion tube or cannula through which the folded IOL is passed using a pushrod. Some inserters do without the cartridge. The inserter may be wholly or partly reusable, in which case the inserter or handpiece is usually made of some type of metal alloy that can be sterilized. Alternatively, disposable inserters made of less expensive materials, such as plastics, remain in a sterile package until ready for use. In some cases, the IOL is stored separately and transferred to a load chamber in the inserter or cartridge just prior to delivery. One particularly useful arrangement wherein the cartridge folds over an IOL is disclosed in <CIT> to Bartell. A cartridge opens to receive an IOL in a load chamber, and then folds closed and fits into an injector. A syringe-like plunger in the injector pushes the IOL from the load chamber through a tapered tube into the eye. The IOL unfolds as it emerges from the tip of the tapered tube. Another such insertion system is disclosed in <CIT>. An example of storing an IOL in an inserter component is seen in <CIT>. In the '<NUM> patent, a nozzle portion <NUM> along with a removable stop <NUM> retains the IOL therein during storage and has internal ramps that assist in folding the IOL optic during an implant procedure. Also, <CIT>, discloses a number of configurations for preloading IOLs for transfer to an insertion apparatus. Another preloaded insertion system is illustrated in <CIT>. <CIT> discloses a device for inserting deformable intraocular lenses. Said device comprises a housing for receiving an intraocular lens in an elastically deformed state, a cannula, and an advancing mechanism for transporting the intraocular lens through the cannula into an eye. The injector is suitable for a two-stage working method wherein one person prepares the injector and another person injects the intraocular lens into the eye. Furthermore, the advancing mechanism is embodied in such a way that the intraocular lens can be transported into the cannula by means of a translatory actuating movement on an actuating head, and the intraocular lens can be ejected from the cannula by means of a rotatory actuating movement on a pivoting part.

Despite the advances in the area of insertion devices, there remains a need for devices and systems that increase the ease of use of inserters, including facilitating the insertion of IOLs, while reducing the risk of damage to both the insertion device and the IOL.

The present inventions disclose an insertion system, comprising a handpiece having a longitudinal axis, a distal end, and a proximal end, a pushrod assembly having a distal end and a proximal end, wherein the push rod assembly comprises a pushrod and a plunger; wherein the pushrod assembly couples with the handpiece along the longitudinal axis; wherein the pushrod is coupled with the plunger and the pushrod is located on the distal end of the push rod assembly and the plunger is located on the proximal end of the pushrod assembly; a cartridge comprising a delivery tube at a distal end; wherein the cartridge is configured and dimensioned to couple with the distal end of the handpiece; a cap comprising a window and a port; wherein the cap is configured and dimensioned to couple with the distal end of the cartridge. According to an embodiment, the cartridge may further comprise one or more wings and the cap may further comprise one or more clips, wherein the one or more clips are configured and dimensioned to couple with the one or more wings. According to another embodiment, the cap may further comprise an internal bevel inside the cap at a distal end, wherein the internal bevel is configured and dimensioned to couple with a bevel at the distal end of the delivery tube.

In an embodiment, a device comprises a cap have a longitudinal axis, a distal end, and a proximal end, wherein the cap comprises window and a port; wherein the window comprises a fill indicator. According to an embodiment, the port may be located at the distal end. In an embodiment, the cap may further comprise one or more clips, wherein the clips are configured and dimensioned to couple with one or more wings of a cartridge. In another embodiment, the cap may further comprise an internal bevel inside the cap near the distal end, wherein the internal bevel is configured and dimensioned to couple with a bevel at a distal end of a delivery tube.

According to an embodiment, an insertion system comprises a handpiece having a longitudinal axis, a distal end, and a proximal end, a pushrod assembly having a distal end and a proximal end, wherein the push rod assembly comprises a pushrod and a plunger; wherein the pushrod assembly couples with the handpiece along the longitudinal axis; wherein the pushrod is coupled with the plunger and the pushrod is located on the distal end of the push rod assembly and the plunger is located on the proximal end of the pushrod assembly; wherein the plunger comprises a marker configured and dimensioned to indicate axially translation of the pushrod assembly within the handpiece; and a cartridge comprising a delivery tube at a distal end; wherein the cartridge is configured and dimensioned to couple with the distal end of the handpiece.

According to another embodiment, an insertion system includes a handpiece having a longitudinal axis, a distal end, and a proximal end; and a pushrod assembly having a distal end and a proximal end, wherein the pushrod assembly comprises a pushrod and a plunger; wherein the pushrod assembly couples with the handpiece body along the longitudinal axis; wherein the pushrod is coupled with the plunger and the pushrod is located on the distal end of the pushrod assembly and the plunger is located on the proximal end of the pushrod assembly; and wherein the pushrod or the handpiece comprises one or more guide rails, wherein the one or more guide rails are configured and dimensioned to couple with one or more channels of the pushrod or the handpiece. In an embodiment, the one or more guide rails have a substantially rectangular shape. In another embodiment, the one or more channels have a substantially rectangular shape. In an embodiment, there are two guide rails and two channels and wherein one channel and one guide rail are larger than the other rail and channel. In another embodiment, the handpiece comprises the one or more channels and further comprises a holding station and wherein at least a portion of the one or more channels are located within the holding station; or the handpiece comprises the one or more guide rails and the pushrod comprises the one or more channels, and wherein the handpiece further comprises a holding station wherein at least a portion of the one or more guide rails are located within the holding station.

According to an embodiment, a pushrod includes a top jaw having a first side and a second side along a longitudinal axis of the pushrod; and a bottom jaw having a first side and a second side along the longitudinal axis of the pushrod; wherein the top jaw and the bottom jaw are coupled together; and wherein the top jaw comprises a notch on the first side along the longitudinal axis of the pushrod that is configured and dimensioned to couple with an intraocular lens when the pushrod tip is passed through a lumen. In an embodiment, the notch is L-shaped. In another embodiment, the notch extends beyond the top jaw into a body of the pushrod. In another embodiment, the bottom jaw comprises a notch along a longitudinal axis of the pushrod that is configured and dimensioned to couple with an intraocular lens when the pushrod tip is passed through a lumen. In another embodiment, the top jaw comprises a second notch on the second side along the longitudinal axis of the pushrod. In another embodiment, the bottom jaw is longer than the top jaw. In an embodiment, the notch extends into a portion of the bottom jaw. In another embodiment, the top jaw comprises a second notch on the second side along the longitudinal axis of the pushrod. In another embodiment, the second notch extends into a portion of the bottom jaw.

According to an embodiment, an insertion system includes a handpiece having a longitudinal axis, a distal end, and a proximal end, a pushrod assembly having a distal end and a proximal end, wherein the pushrod assembly comprises a pushrod and a plunger; wherein the pushrod assembly couples with the handpiece along the longitudinal axis; wherein the pushrod is coupled with the plunger and the pushrod is located on the distal end of the push rod assembly and the plunger is located on the proximal end of the pushrod assembly; wherein the plunger is configured and dimensioned to advance the pushrod toward the distal end of the handpiece along the longitudinal axis by rotation of the plunger and translational movement of the plunger; wherein the plunger comprises threads and one or more safety detents, wherein the one or more safety detents are located on a distal end of the plunger on one or more of the threads; and wherein the one or more safety detents are configured and dimensioned to prevent advancement of pushrod with rotation of the plunger until such rotation is desired. In an embodiment, the one or more safety detents are located within the first two or three threads from the distal end of the plunger. In another embodiment, the threads comprise one to six safety detents. The threads may also comprise four safety detents.

The present invention is best understood with reference to the following detailed description of the invention and the drawings in which:.

Reference will now be made in detail to embodiments of the invention, examples of which are illustrated in the accompanying drawings. While the invention will be described in conjunction with the embodiments, it will be understood that they are not intended to limit the invention to those embodiments. On the contrary, the invention is intended to cover alternatives and modifications, which may be included within the scope of the invention as defined by the appended claims.

<FIG> illustrate varying views of an exemplary IOL insertion system <NUM> of the present invention comprising a twist/syringe-style device having, generally, a handpiece <NUM>, a plunger <NUM>, and a delivery tube <NUM> on a distal end/portion thereof. As illustrated in <FIG>, IOL insertion system <NUM> may also include puller pin <NUM>, which will be described in greater detail below. As illustrated in <FIG>, system <NUM> also may comprise port <NUM> to enable application or insertion of a fluid, such as water, balance salt solution, and/or viscoelastic. <FIG>illustrates an alternative IOL insertion system <NUM> of the present invention. The IOL insertion system <NUM> illustrated in <FIG> does not include puller pin <NUM> or port <NUM>. It is also envisioned that IOL insertion system <NUM> may include only one of the puller pin <NUM> or the port <NUM>. The system <NUM> is also shown in an exploded view in <FIG>.

IOL <NUM> is shown in <FIG> and may be positioned between two halves of a holding station <NUM>. IOL <NUM> may comprise a central circular optic <NUM> having a leading haptic <NUM> and a trailing haptic <NUM> generally spirally extending therefrom. One exemplary IOL as illustrated is a one piece acrylic Tecnis® brand of aspheric IOL available from Abbott Medical Optics Inc. of Santa Ana, CA. It is also envisioned that any IOL may be used with the insertion system disclosed herein.

With reference to <FIG> and <FIG>, the system <NUM> defines a longitudinal axis from an end cap <NUM> of a pushrod assembly <NUM> at a proximal end to the delivery tube <NUM> at a distal end. The pushrod assembly <NUM> includes a plunger <NUM>, an end cap <NUM>, a nut lock <NUM>, and a pushrod <NUM>. Pushrod <NUM> may have a distal tip <NUM>. In an embodiment, a portion of distal tip <NUM> may be flexible as described in greater detail below. In the illustrated embodiment, the distal tip <NUM> is forked to enable reliable capture of a proximal edge of the IOL optic <NUM> and/or trailing haptic <NUM>. The plunger <NUM> and/or pushrod <NUM> translates axially through an elongate passage defined within the inserter handpiece <NUM> and is configured to urge the IOL from a holding station <NUM> through the distal delivery tube <NUM>. In a general sense, the plunger <NUM> represents any actuator capable of displacing the IOL from the holding station <NUM> in a distal direction through a delivery tube or other such device. The plunger <NUM> therefore may be generally termed an actuator so as to encompass other prime movers that can perform the same function, such as a rotary actuators, threaded actuators, levers, etc..

<FIG> is an exploded view of the components of the system <NUM> in the orientation in which they will be assembled. However, a preferred mold configuration results in a total of six (or possibly fewer) components for the entire system, not counting the IOL. It is also envisioned that the mold configuration results in a total of seven or more components for the entire system, not counting the IOL depending upon many factors, including but not limited to manufacturing requirements. The six components shown in <FIG> include the plunger <NUM>, the pushrod <NUM>, the cartridge <NUM>, the nut lock <NUM>, the upper body <NUM>, and the lower body <NUM>. Lower body <NUM> may include the holding station <NUM> and base portion <NUM>. Cartridge <NUM> comprises delivery tube <NUM> and wings <NUM>. It is possible that the handpiece upper body <NUM> could be formed along with the remainder of the handpiece, though the mold would be fairly complicated and expensive. Likewise, the cartridge <NUM> could be incorporated into the handpiece <NUM>, but again for reasons of manufacturing economy they are separate.

The one half of the holding station <NUM> comprises a base <NUM> that, in a preferred embodiment, forms a distal extension of a base portion <NUM> of the handpiece <NUM>. The upper half of the holding station <NUM> comprises a cover <NUM> that abuts the upper body <NUM> of the inserter handpiece <NUM>. In the illustrated embodiment, as seen in <FIG>, the cover <NUM> and upper body <NUM> fit directly over the base <NUM> and base portion <NUM> to form the elongated handpiece <NUM>. The overall shape of handpiece <NUM> may be of any shape to accommodate proper gripping of the device. According to an embodiment, the holding station cover <NUM> may be connected by a pair of living hinges 80a, 80b to the base <NUM>. The base <NUM> includes a pair of bifurcated fingers 82a, 82b that meet a similar pair of bifurcated fingers 84a, 84b extending from the cover <NUM> at the living hinges 80a, 80b. The opposed pairs of aligned fingers <NUM>, <NUM> are shaped so as to form slots therebetween when folded about the living hinges <NUM> and a central cavity <NUM> (shown in <FIG>) for receiving a delivery tube <NUM>, the combination of which is best seen in the assembled view of <FIG> and <FIG>. In this regard, the delivery tube <NUM> desirably comprises a rear-loading cartridge as shown, and as described in co-pending <CIT>, which is hereby incorporated by reference in its entirety. In an embodiment, hinges 80a and 80b may be a snap feature instead of living hinges. In such an embodiment, holding station cover <NUM> may be molded as a separate part from base portion <NUM> and base <NUM>.

The handpiece may further include a pair of proximal finger tabs 60a, 60b, one on the base portion <NUM> and one on the upper body <NUM>. When an operator desires to depress the plunger <NUM>, he or she places the thumb of one hand on the end cap <NUM>, and index and middle fingers on respective finger tabs 60a, 60b. Squeezing the hand closed depresses the end cap <NUM> and moves the rest of pushrod assembly <NUM> along a lumen of the IOL insertion system <NUM> toward the distal end of the delivery tube <NUM>.

<FIG> illustrate different views of system <NUM> with puller cap <NUM>. Puller cap <NUM> fits over the holding station <NUM> and cartridge <NUM> in order to protect these components, and in particular the delivery tube <NUM>, while also facilitating the insertion of fluid as further described below.

<FIG> and <FIG> show two views of puller cap <NUM> of the present invention. In <FIG>, puller cap <NUM> has a top <NUM>, a bottom <NUM>, a proximal end <NUM>, and a distal end <NUM>. Puller cap <NUM> includes lock 95A, 95B, grips <NUM>, snap <NUM>, and port <NUM>. Puller cap <NUM> may be made of any material known in the art, but preferably polypropylene, polycarbonate, polyethylene, or polyethylene terephthalate; more preferably polypropylene and polycarbonate; most preferably polypropylene. Puller cap <NUM> may also be of any color, preferably translucent or clear to enable a user to visualize the features inside puller cap <NUM> and anything housed within puller cap <NUM>. Puller cap <NUM> may be the shape as illustrated in the embodiment in <FIG>, but the invention also envisions that puller cap <NUM> may be of any shape or size to accommodate the needs of the insertion system the puller cap is used with or the needs of the user the puller cap is designed for. For example, the puller cap may be of an arrow shape as illustrated in the embodiment in <FIG>, may be more of a round shape, triangular shape, square shape, or shaped to meet the needs for shipping and/or handling. The puller cap may also include one or more hook features (not shown) to aid in the removal of the puller cap from an inserter. The hook feature may be located on any location on the puller cap, including but not limited to the top, bottom, on or near the snap, or near the distal or proximal ends. The hook feature may be of any shape or size to accommodate for the shape or size of the puller cap and may be of any shape or size to accommodate the fingers of a user.

The lock 95A and 95B may be of any design or configuration known in the art. According to an embodiment of the present invention, a portion <NUM> of locks 95A, 95B are configured and dimensioned to cam outwardly when external pressure is placed on the snaps in a perpendicular plane with respect to the longitudinal plane of system <NUM> from proximal end <NUM> to distal end <NUM>. (See <FIG>). Locks 95A, 95B may comprise a texture design or feature to ease gripping and/or actuation of the snaps and removal of puller cap <NUM> from an insertion system, such as insertion system <NUM> as illustrated in <FIG> and <FIG>. In an embodiment, puller cap <NUM> may have one or more grips having a texture design or feature and the lock 95A and 95B are separated from the one or more grips, such that squeezing of the grips does not deactivate locks 95A and 95B.

As shown in <FIG>, the snap <NUM> is designed and configured to couple with pin <NUM> (see <FIG> and <FIG>). Snap <NUM> may be of any shape or size as long as it is configured and dimensioned to mate with pin <NUM>. According to the embodiment in <FIG>, snap <NUM> comprises a canopy <NUM> and a keyway <NUM>. In another embodiment, snap <NUM> does not have a canopy and only has keyway <NUM>.

Puller cap <NUM> may include one or more ports <NUM> to aid in the insertion of a fluid, including but not limited to balanced salt solution, water, and/or viscoelastic. The one or more ports <NUM> mate with ports located on the insertion system <NUM> to assist with filling a portion of the system with fluid to provide lubrication to the internal features of the insertion system to aid in delivery of the IOL. With respect to port <NUM> as illustrated in <FIG>, port <NUM> acts a funnel mechanism into the distal end of delivery tube <NUM>. <FIG> illustrates a bottom view of puller cap <NUM> comprising port <NUM> and a window <NUM>. The puller cap may also comprise one or more windows to provide the users with a visual indicator of the amount of fluid inserted into a portion of the insertion system, as well as provide viewing of the distal end of a cannula tip, which is typically used to inject a fluid. In an embodiment, the one or more windows may be located on the top, bottom or sides of the puller cap, preferably on the top or the bottom. The one or more windows may also comprise a measuring devise such as a ruler to allow a user to measure or see the amount of fluid inserted into the inserter. The window <NUM> may also have a fill indicator <NUM> such that a user fills a portion of the insertion system until the fluid reaches fill indicator <NUM> indicating a proper and/or maximum fill has been reached. The one or more windows may also comprise a material such that when a fluid is inserted into the insertion system and viewed through the window light that is emitted through the window to the fluid is polarized providing a visual indicator of the fluid within the inserter.

As is well known in the art, the small nature of the ports of insertion systems known in the art can make it very difficult for doctors, nurses, and/or staff to locate openings for inserting fluids. The puller cap of the present invention solves this problem by providing a larger port with a funnel feature that leads into the smaller ports of the insertion system. This enables a user to more easily direct a cannula tip <NUM> into a delivery tube <NUM> or ports <NUM>, <NUM> as illustrated in <FIG> and <FIG>.

<FIG> shows pin <NUM> which includes top <NUM>, stem <NUM>, key <NUM>, and lock <NUM>. Top <NUM> comprises key <NUM> that may be of any shape or configuration so as to mate with snap <NUM>. Lock <NUM> may be of any shape or size and is configured to mate with grove <NUM> of haptic sweep slot <NUM> of cover <NUM> (see <FIG>). Lock <NUM> may also be located anywhere along stem <NUM> and the present invention also envisions more than one lock feature. Haptic sweep slot <NUM> may also be of any shape or size as long as it is configured to mate with pin <NUM>. According to an embodiment, haptic sweep slot <NUM> runs along the same longitudinal axis of system <NUM>. In an embodiment, the length of the haptic sweep slot is longer in length than the width the slot. In an embodiment, the length of the haptic sweep slot is between about <NUM> inches (in. ) (<NUM> millimeters (mm)) to about <NUM> in. (<NUM>), preferably about <NUM> in. (<NUM>), more preferably about <NUM> in. In an embodiment, the width of the haptic sweep slot is about <NUM> in. (<NUM>) to about <NUM> in. (<NUM>), preferably about <NUM> in. (<NUM>), more preferably about <NUM> in. Pin <NUM> is configured and dimensioned to be inserted into haptic sweep slot <NUM> such that lock <NUM> and groove <NUM> are coupled together securing the two parts together, but still enabling the pin <NUM> to move within haptic sweep slot <NUM>. Groove <NUM> may also be of any shape or size as long as it is configured to mate with lock <NUM>. In an embodiment, there may be more than one groove in the haptic sweep slot. Groove <NUM> enables pin <NUM> to maintain a substantially perpendicular orientation with respect to the longitudinal axis of system <NUM>. According to an embodiment, the substantially perpendicular orientation assists with sweeping or folding of trailing haptic <NUM> as further described below.

Pin <NUM> may comprise leg feature <NUM> (see <FIG>); such that pushrod <NUM> is capable of passing step <NUM> once pin <NUM> has been advanced forward to sweep trailing haptic <NUM>. The leg feature <NUM> results in stem <NUM> having a cut out or offset portion as shown in <FIG>, B, C and E. To ensure that this leg feature <NUM> is in the correct orientation during manufacture, lock <NUM> may comprise a one-way directional snap feature or poke-oke as illustrated in an embodiment in <FIG>.

In an embodiment, pin <NUM> is configured and dimensioned to penetrate or extend through cover <NUM> and base <NUM> or another portion of system <NUM> or similar device to sweep or fold a trailing or leading haptic or similar feature of an IOL.

As shown in <FIG> and <FIG>, as puller cap <NUM> is placed on system <NUM> to cover cartridge <NUM> and delivery tube <NUM>, snap <NUM> mates or couples with pin <NUM> via key <NUM> and keyway <NUM>. See <FIG> for a cross-sectional view showing pin <NUM> coupled with snap <NUM> in keyway <NUM> and lock <NUM> coupled with groove <NUM>. In addition to the functions described above, puller cap <NUM> with pin <NUM> function to fold or sweep the trailing haptic <NUM> in the distal direction prior to folding or moving the IOL in the distal direction to insert the IOL into the eye. Folding or sweeping trailing haptic <NUM> in the distal direction controls the location of the haptic and prevents damage to the haptic during delivery of the IOL. Pin <NUM> may also sweep the trailing haptic <NUM> over a portion of optic <NUM> such that during movement of the IOL down the lumen of tube <NUM> at least a portion of the trailing haptic <NUM> is captured in the fold or folds of the optic <NUM>. Prior to the present invention a user would have to manually use the distal end of a cannula to fold or sweep the trailing haptic, which was difficult to do due to the small nature of the slot. Moreover, it was difficult to visualize whether the haptic was in fact in place once the cannula moved the haptic. The present invention overcomes these problems. Once puller cap <NUM> is coupled with pin <NUM> a user may use the easy to access one or more ports <NUM>, <NUM> to insert/inject fluid into system <NUM>. Next, to sweep trailing haptic <NUM> a user may grasp and squeeze locks 95A, 95B to release the internal lock features, e.g. portion <NUM> of lock 95A, B from wings <NUM>. As puller cap <NUM> is advanced distally from system <NUM> along the longitudinal axis of system <NUM> pin <NUM> slides along haptic sweep slot <NUM> and lock <NUM> slides in groove <NUM> as shown in <FIG>. When pin <NUM> reaches the end of haptic sweep slot <NUM>, pin <NUM> will release from snap <NUM>, releasing puller cap <NUM> from system <NUM> as shown in <FIG>. At this point, trailing haptic <NUM> has been swept or folded into the proper position without the use of another tool and the IOL is now ready for insertion into the eye.

In an alternate embodiment, pin <NUM> may release from cover <NUM> with puller cap <NUM>. It is also envisioned that pin <NUM> may be connected to one or more arms and one or more hinges to aid in its connection to puller cap <NUM> and its release from system <NUM>. <FIG> shows such an alternate embodiment of the present invention. In <FIG>, pin <NUM> is connected to arm <NUM> which is connected to arm <NUM> via hinge <NUM>. Arms <NUM> and <NUM> may further be coupled with puller cap <NUM> with hinge <NUM> and <NUM> (as shown in <FIG> and <FIG>) or by any other mechanism known in the art. As puller cap <NUM> is moved distally along the longitudinal axis of system <NUM> to sweep trailing haptic <NUM> pin <NUM> is advanced along haptic sweep slot <NUM>. When pin <NUM> reaches the end of haptic sweep slot <NUM>, further advancement of puller cap <NUM> causes arm <NUM> to lift up thereby lifting arm <NUM> and lifting pin <NUM> from haptic sweep slot <NUM> and releasing puller cap <NUM> from system <NUM>. In an embodiment, haptic sweep slot <NUM> may comprise a ramp at one or both ends of the slot. In particular, a haptic sweep slot <NUM> may comprise a ramp at the distal end <NUM> of the slot to aid in the release of pin <NUM> and/or puller cap <NUM> after trailing haptic <NUM> has been swept or folded. According to another embodiment, only a single arm or a single hinge may be used with pin <NUM>. In another embodiment, one or more arms or one or more hinges may used with pin <NUM>.

In an embodiment, pin <NUM> maintains trailing haptic <NUM> in the proper orientation for delivery and even if a user decides to place puller cap <NUM> back onto system <NUM>, the internal features of system <NUM> still maintain trailing haptic <NUM> in the proper orientation. This allows a user to determine when she would like to use and/or the order in which she will use the haptic sweep feature, the port features, and the tip protection feature, which will be described further below.

<FIG> illustrates a pushrod capable of being used with the system <NUM>. Pushrod <NUM> comprises a top jaw <NUM> and a bottom jaw <NUM> that form mouth <NUM>. Top jaw <NUM> may also comprise a lip <NUM> that protrudes from an upper portion <NUM> of top jaw <NUM>. In an embodiment, lip <NUM> is configured and dimensioned to help catch trailing haptic <NUM> and keep trailing haptic <NUM> in a swept/folded configuration. <FIG> illustrates an exemplary pushrod of the present invention modifying the features of <FIG>. In <FIG> a portion of the distal end of pushrod <NUM> is removed resulting in cutout portion or notch <NUM> to allow room for the IOL as it is folded and/or compressed during insertion of the IOL into an eye. The cutout portion <NUM> of pushrod <NUM> provides for less force on the walls of delivery tube <NUM> and less force on the IOL as it delivered preventing damage to the IOL and delivery tube <NUM>. In an embodiment, cutout portion <NUM> comprises approximately half the diameter of the top jaw <NUM> for a portion of the distal end including the lip <NUM>, while bottom jaw <NUM> remains intact. Cutout portion <NUM> may extend proximally beyond top jaw <NUM> into the body of pushrod <NUM>. In an embodiment, a notch or cutout portion may also extend or be placed into bottom jaw <NUM>. It is also envisioned that an additional notch or cutout similar to notch <NUM> can be made on the opposite side of top jaw <NUM>. Bottom jaw <NUM> may also have one or more notches. In an embodiment, a cross-section view of cutout portion <NUM> shows an L-shaped seat (see <FIG>).

In an embodiment, lip <NUM> is configured to ride along at least a portion of an internal channel or groove located within handpiece <NUM>. Lip <NUM> provides more stability for the pushrod <NUM> as it is advanced within a lumen of the handpiece <NUM> towards the distal end of the handpiece. By having the lip <NUM> engage at least a portion of the internal channel, the distal end of the pushrod is less likely to move from its desired location within the lumen as the pushrod is advanced towards the distal end of the handpiece.

According to an embodiment, the distal end of pushrod <NUM> may have a top jaw <NUM> and a bottom jaw <NUM> that form mouth <NUM> as illustrated in <FIG>. As shown in <FIG>, top jaw <NUM> is shorter in length than bottom jaw <NUM> and includes cutout portion <NUM>. For such an embodiment sweeping of the trailing haptic by pin <NUM> or another means is unnecessary because the design of the distal end of pushrod <NUM> causes the trailing haptic of an IOL to be swept or folded over the optic as the pushrod assembly <NUM> travels down the lumen of the insertion system towards the distal end of the delivery tube. In an embodiment, the top jaw is designed to engage the trailing haptic of an IOL before the bottom jaw engages the lens body or edge of the optic. In an embodiment, the height of the top jaw is such that it configured to couple with at least a portion of an internal channel of the handpiece, preferably the top jaw is configured to couple with at least a portion of an internal channel located in the staging area, more preferably the top jaw is configured to couple with an internal channel extending through the staging area. In another embodiment, the blunt tip may a height that is larger than the height of a haptic, e.g. a trailing haptic.

In an embodiment, the distal end of pushrod <NUM> may comprise another cutout portion <NUM> on the opposite side of the first cutout portion. The second cutout portion <NUM> may also provides for less force on the walls of delivery tube <NUM> and less force on the IOL as it delivered preventing damage to the IOL and delivery tube <NUM>. For example, as the IOL is advanced down the delivery tube, the IOL is compressed. The second cutout portion <NUM> provides space for an edge of the IOL to wrap around the top jaw <NUM> and tuck into the second cutout portion <NUM>. The second cutout portion may be shorter or longer in length than the first cutout portion <NUM>, preferably shorter than the first cutout portion <NUM>. The width of the second cutout portion may be larger or smaller than the width of the first cutout portion, preferably small that the width of the first cutout portion. The second cutout portion <NUM> may create a substantially L-shaped seat. In an embodiment, a notch or cutout portion may also extend or be placed into bottom jaw <NUM>. It is also envisioned that an additional notch or cutout similar to cutout portion <NUM> and <NUM> can be made on one or both sides of bottom jaw <NUM>.

Similar to the lip <NUM> discussed above, in an embodiment, the top jaw <NUM> illustrated in <FIG> is configured to ride along at least a portion of an internal channel or groove located within handpiece <NUM>. Coupling of the top jaw <NUM> with at least a portion of an internal channel provides more stability for the pushrod <NUM> as it is advanced within a lumen of the handpiece <NUM> towards the distal end of the handpiece. By having the at least a portion of top jaw <NUM> engage at least a portion of the internal channel, the distal end of the pushrod is less likely to move from its desired location within the lumen as the pushrod is advanced towards the distal end of the handpiece. The forces generated by moving the IOL down the lumen of the staging area and/or lumen of the cartridge can have a tendency to push or offset the distal end of the pushrod. Coupling the top jaw <NUM> with at least a portion of the internal channel or groove helps to counter this movement and maintain the distal end of the pushrod in proper alignment, e.g. maintaining the distal end of the pushrod substantially on center of the lumen of the handpiece. In an embodiment, the internal channel or groove runs the length of the staging area.

In an embodiment, the top jaw <NUM> may have a blunt tip <NUM> and a rounded top portion <NUM>. The blunt tip <NUM> sweeps or folds the trailing haptic of an IOL over the optic as the pushrod assembly <NUM> travels down the lumen of the insertion system towards the distal end of the delivery tube. The top jaw <NUM> and the bottom jaw <NUM> may have a rounded leading edge <NUM>. Rounding the leading edge prevents damage to an IOL as it is moved down the lumen of an insertion system.

In an embodiment, pushrod <NUM> has a tapered portion around the circumference of the pushrod starting at or near the back of mouth <NUM> and extends a long a length of the pushrod. In an embodiment, the tapered portion extends approximately <NUM>/<NUM> the total length of pushrod <NUM>. As shown in <FIG>, beginning at or proximally near the back of the mouth <NUM>, the diameter of the tapered portion gradually gets smaller until approximately the midline of the tapered portion and then begins to gradually get larger until it reaches the largest diameter of the pushrod <NUM>. The smallest diameter of the tapered portion may occur at the halfway point of the entire length of the tapered portion. In an embodiment, the smallest diameter occurs beyond the halfway point of the entire length of the tapered portion in the proximal direction. The length of the tapered portion may be between about <NUM> in. (<NUM>) and about <NUM> in. The diameter of the pushrod at its largest diameter may be between about <NUM> in. (<NUM>) and about. (<NUM>), preferably <NUM> in. (<NUM>); and the smallest diameter of the tapered portion may be between about <NUM> in. (<NUM>) and about <NUM> in. The tapered portion provides for space and/or allows for a trailing haptic to wrap around the pushrod should the haptic not fold over the optic, which prevents the IOL from being damaged or broken off from the rest of the IOL.

In an embodiment, cutout portion or notch <NUM> may extend into a portion of the tapered portion. Cutout portion <NUM> is designed as a safety feature to (<NUM>) provide space for the folding IOL as it is advanced down a tapered lumen; (<NUM>) allow for a trailing haptic to wrap around the pushrod and/or guide the trailing haptic around the tapered portion should the haptic not fold over the optic; (<NUM>) allow for extension of a trailing haptic that does not get folded; and/or (<NUM>) allow space for shoulder or bend that is created near the optic-haptic junction when the trailing haptic is folded over the optic, which prevents the IOL from being damaged or broken off from the rest of the IOL. In an embodiment, the cutout portion <NUM> may have a length between about <NUM> in. (<NUM>) and about <NUM> in. (<NUM>), a height between about <NUM> in. (<NUM>) and about <NUM> in. (<NUM>), and a width between about <NUM> in. (<NUM>) and about <NUM> in. The length of the cutout portion <NUM> may also be longer or shorter than the full extension of an IOL haptic. Cutout portion <NUM> may begin at or near the tip of pushrod <NUM> or at or near the back of the mouth <NUM> and continue a length of the pushrod <NUM>. The cutout portion <NUM> may continue a length of the pushrod <NUM> with its width gradually tapering out or becoming smaller until it meets the side of the pushrod (see <FIG>).

The features of pushrod <NUM> as shown in <FIG> may have various dimensions. The length of the cutout portions <NUM> may be between about <NUM> in. (<NUM>) to about <NUM> in. (<NUM>), preferably between about <NUM> in. (<NUM>) to about <NUM> in. (<NUM>), more preferably about <NUM> in. (<NUM>) or about <NUM> in. The width of upper portion <NUM> of top jaw <NUM> may range from about <NUM> in. (<NUM>) to about <NUM> in. (<NUM>), preferably about <NUM> in. The diameter or width A of cutout portion <NUM> as shown in <FIG> may be between about <NUM> in. (<NUM>) to about <NUM> in. (<NUM>), preferably about <NUM> in. According to an embodiment, the diameter A of cutout portion <NUM> may be inversely proportional to the width of the upper portion <NUM> of top jaw <NUM>. The height of lip <NUM> that protrudes up may be between about <NUM> in. (<NUM>) to about <NUM> in. (<NUM>), preferably about <NUM> in. In an embodiment, there may be a radius on the back side of lip <NUM> where lip <NUM> and upper portion <NUM> meet. The radius may be sharp to <NUM>. In an embodiment, the radius of mouth <NUM> that engages a lens may range between <NUM>. 012R - <NUM>. 020R, preferably about <NUM>. The length of top jaw <NUM> and the bottom jaw <NUM> from the back of mouth <NUM> may be between about <NUM> in. (<NUM>) and about <NUM> in. In an embodiment the length of top jaw <NUM> is preferably about <NUM> in. The top jaw length may have a relationship (ratio) to the bottom jaw which is about <NUM> to <NUM> (Top to Bottom). In an embodiment, the relationship may be <NUM> to <NUM> or <NUM> to <NUM> (Top to Bottom).

The features of pushrod <NUM> as shown in <FIG> may have various dimensions. The length of the cutout portions <NUM> may be between about <NUM> in. (<NUM>) to about <NUM> in. (<NUM>), preferably between about <NUM> in. (<NUM>) to about <NUM> in. (<NUM>), more preferably about <NUM> in. The diameter or width of cutout portion <NUM> as shown may be between about <NUM> in. (<NUM>) to about <NUM> in. (<NUM>), preferably about <NUM> in. In an embodiment, the radius of mouth <NUM> that engages a lens may range between <NUM>. 010R - <NUM>. 018R, preferably about <NUM>. The width of the top jaw may be between about <NUM> in. (<NUM>) and about <NUM> in. (<NUM>) and the width of the bottom jaw may be between about <NUM> in. (<NUM>) and about <NUM> in. The top jaw may be offset from a centerline along the longitudinal axis of the pushrod. The top jaw length may have a relationship (ratio) to the bottom jaw which is about <NUM> to <NUM> (Top to Bottom). In an embodiment, the relationship may be <NUM> to <NUM> or <NUM> to <NUM> (Top to Bottom). The width of the top jaw may have a relationship to the width of the bottom jaw which is about <NUM> to <NUM> (Top to Bottom). In an embodiment, where the top portion of the top jaw meets the side wall of the notch, the radius of curvature or blending may be about <NUM>. Also, in another embodiment the length of the notch may be about <NUM>% of the total length of the pushrod.

As discussed above, <FIG> shows an exploded view of pushrod assembly <NUM> which comprises pushrod <NUM>, plunger <NUM>, and nut lock <NUM>.

According to an embodiment of the present invention, pushrod <NUM> comprises distal tip <NUM> at the distal end of pushrod <NUM> that has a top jaw <NUM> and a bottom jaw <NUM>, which is shown in <FIG>. Top jaw <NUM> of distal tip <NUM> is capable of flexing toward bottom jaw <NUM> shown by arrow "B" to allow the distal tip <NUM> (or distal end) of pushrod <NUM> to pass through the tapered lumen of delivery tube <NUM>. Top jaw <NUM> may comprise a lip <NUM> that protrudes from an upper portion <NUM> of top jaw <NUM> and is capable of making contact with the lumen of delivery tube <NUM>. <FIG> illustrates lip <NUM> coming in contact with the lumen <NUM> of delivery tube <NUM> and top jaw <NUM> flexing toward bottom jaw <NUM>. Lip <NUM> may make continuous or substantially continuous contact with the lumen of delivery tube <NUM> while pushrod <NUM> is moved longitudinal through delivery tube <NUM> to eject the IOL out the distal end of the delivery tube. <FIG> illustrates that once lip <NUM> of top jaw <NUM> exits delivery tube <NUM> at the distal end, top jaw <NUM> will flex substantially back into its original position. Lip <NUM> can be any configuration or shape that will allow for the flexing of top jaw <NUM> toward bottom jaw <NUM>. Preferably top jaw <NUM> is slightly longer or longer than bottom jaw <NUM> to prevent the IOL from being captured between the two jaws and held after the IOL exits from the delivery tube. According to an embodiment, bottom jaw <NUM> may remain substantially stationary with respect to the rest of pushrod <NUM>. In an embodiment, the flexible top jaw <NUM> allows for further folding of the trailing haptic of the IOL over the optic during implantation of the IOL. The distal tip keeps the trailing haptic in a stable position.

In an embodiment, lip <NUM> may be located on the bottom jaw <NUM> depending upon the geometry of the IOL and/or haptic. For example, if instead of the trailing haptic being in a "C" configuration if you look at the IOL in an insertion device from the top, the trailing haptic is in reversed "C" configuration, the lip <NUM> may function better or properly if it is located on the bottom jaw <NUM>.

In an embodiment, the bottom jaw <NUM> may also flex or be capable of flexing toward top jaw <NUM> to allow the distal tip (or distal end) of pushrod <NUM> to pass through the tapered lumen of delivery tube <NUM>. It is also envisioned that both the top jaw <NUM> and bottom jaw <NUM> flex towards each other as the pushrod <NUM> is passed through the tapered lumen of delivery tube <NUM>.

An advantage of puller cap <NUM> is it acts as a tip protector to prevent damage or deformation. As illustrated in <FIG>, a certain amount of clearance or space is provided around the distal end of delivery tube <NUM> when puller cap <NUM> is placed onto system <NUM>. The clearance or space <NUM> is maintained by contact between the internal structures of puller cap <NUM> at the proximal end and system <NUM>. In an embodiment, clearance or space <NUM> between delivery tube <NUM> and the distal end of puller cap <NUM> is maintained by contact between wall <NUM> through window <NUM> shown in <FIG> and wings <NUM> and portion <NUM> of lock 95A, B shown in <FIG>. It is also envisioned that other similar structures may be used to maintain clearance <NUM> to protect the tip of delivery tube <NUM>.

<FIG>, <FIG>, <FIG>, <FIG>, and <FIG> illustrate a protective cap <NUM> of the present invention. Protective cap <NUM> has similar advantages of puller cap <NUM> of protecting the tip from damage or deformation. Protective cap <NUM> may be used instead of puller cap <NUM> when the trailing haptic is swept or folded by means of the pushrod or the trailing haptic does not require sweeping or folding. Protective cap <NUM> comprises finger grips <NUM>, window <NUM>, and port <NUM>. Protective cap <NUM> may also comprise one or more of the following: clips (or snaps) <NUM>, relief slots <NUM>, and/or guides <NUM>. Protective cap <NUM> may also comprise a fill indicator <NUM> and/ or a material relief <NUM>.

Protective cap <NUM> may be made of any material known in the art, preferably polypropylene, polycarbonate, polyethylene, or polyethylene terephthalate; more preferably polypropylene and polycarbonate; most preferably polypropylene. Protective cap <NUM> may also be of any color, preferably translucent or clear to enable a user to visualize the features inside protective cap <NUM> and anything housed within protective cap <NUM>. Protective cap <NUM> may be the shape as illustrated in the embodiment in <FIG>, but the invention also envisions that protective cap <NUM> may be of any shape or size to accommodate the needs of the insertion system the protective cap is used with or the needs of the user the puller cap is designed for. For example, the protective cap may be of an arrow shape as illustrated in the embodiment in <FIG>, may be more of a round shape, triangular shape, square shape, or shaped to meet the needs for shipping or handling.

The finger grips <NUM> may be of any design or configuration known in the art. According to an embodiment of the present invention, finger grips <NUM> may comprise a texture design or feature to ease gripping or actuation of the clip <NUM> and removal of protective cap <NUM> from an insertion system, such as system <NUM> as illustrated in <FIG> and <FIG>. The protrusion <NUM> of finger grips <NUM> may also be of any shape, including but not limited to square, rounded, triangle, and any other shape known in the art that may assist in grasping protective cap <NUM>. Finger grips <NUM> may have inner walls that are sized and shaped to couple with at least a portion of the wings <NUM> that run along the longitudinal axis of cartridge <NUM>. The inner walls are configured and dimensioned to avoid damaging the distal end of the tip of the delivery tube <NUM> when protective cap <NUM> is placed on the insertion device. In an embodiment, finger grips <NUM> may have a radius of curvature that is similar to or mirrors the curvature of a user's finger to assist with gripping and removal of the protective cap <NUM>.

In an embodiment, protective cap <NUM> comprises tapered portion <NUM> (shown in <FIG>, <FIG>, <FIG>, and <FIG>). Tapered portion <NUM> may be configured and dimensioned to mirror or substantially mirror the shape and size of the cartridge and/or insertion device. In an embodiment, tapered portion <NUM> comprises a bevel <NUM> which mirrors bevel <NUM> (shown in <FIG>, and <FIG>). The internal and external walls of tapered portion <NUM> may also remain uniform or substantially uniform with respect to each other from the beginning of the tapered portion to at or near the distal end of cartridge such that the walls run parallel to each other. It is also envisioned that the internal walls of the tapered portion mirror the external features of the cartridge or distal end of the insertion device and the external walls of the tapered portions remain substantial linear, for example without a bevel.

As shown in <FIG>, the distal end <NUM> of protective cap <NUM> may comprise internal bevel <NUM>. Internal bevel <NUM> is configured and dimensioned to match or substantially match or mate with the bevel of the tip (at the distal end) of delivery tube <NUM> of cartridge <NUM>. When protective cap <NUM> is placed on system <NUM>, internal bevel <NUM> is coupled with the bevel of the tip of delivery tube <NUM> of cartridge <NUM> and port <NUM>, and with its funnel feature it creates a larger opening. As discussed above, the small nature of ports can make it very difficult for doctors, nurses, and/or staff to locate openings for inserting fluids. Port <NUM> with internal bevel <NUM> enables a user to more easily direct a cannula tip <NUM> into a delivery tube <NUM> or port <NUM> as illustrated in <FIG>.

As illustrated in <FIG>, C, E, and G, the distal end of protective cap <NUM> may also comprise a material relief <NUM>. Material relief <NUM> helps prevent distortion of the tip at the distal end of protective cap <NUM> during the molding process. It is also envisioned, that the distal end of the protective cap <NUM> does not comprise a material relief.

As illustrated in <FIG>, protective cap <NUM> may also have inner walls comprising one or more internal guides <NUM> that run along at least a portion of the longitudinal axis and are configured and dimensioned to mate or couple with features on the outer portions of the insertion device. Internal guides <NUM> help keep the protective cap substantially aligned in a horizontal and vertical direction when the cap is placed on or removed. This helps to protect the distal end or tip of cartridge <NUM> or insertion system <NUM>. The internal guides <NUM> may be of any width or of any length suitable to couple with external features of the insertion system and/or cartridge. According to an embodiment, there may be two internal guides on the internal wall of the protective cap along the longitudinal axis, and the distance between each of the guides may be any distance as long as it matches the external features on the insertion system. In an embodiment, the distance between the guides may be about <NUM> in. (<NUM>) apart. The width of a guide may be between about <NUM> in. (<NUM>) and about <NUM> in. (<NUM>), preferably about <NUM> in (<NUM>). In an embodiment, the length of a guide may be between about <NUM> in. (<NUM>) and about <NUM> in. The length of a guide may also be between about <NUM> in. (<NUM>) and about <NUM> in. (<NUM>), preferably about <NUM> in. (<NUM>) The length of the guide may also be between about <NUM> in. (<NUM>) and <NUM> in. (<NUM>), preferably about <NUM> in. (<NUM>) In another embodiment, one or more guides may begin at or near the distal end of relief slot <NUM> (see <FIG>) and extend for a distance toward the distal end of the protective cap.

As discussed above, the small nature of ports can make it very difficult for doctors, nurses, and/or staff to locate openings for inserting fluids. The protective cap <NUM> of the present invention solves this problem by providing a larger port <NUM> with a funnel feature that leads into the smaller port of the insertion device. This enables a user to more easily direct a cannula tip <NUM> into a delivery tube <NUM> or port <NUM> as illustrated in <FIG>. The protective cap may also include one or more additional ports.

Protective cap <NUM> may also have one or more windows <NUM> to provide the users with a visual indicator of the amount of fluid inserted into the insertion system, as well as provide viewing of the distal end of a cannula tip. The one or more windows may be located on the top, bottom or sides of the protective cap, preferably on the top or the bottom. The one or more windows may also comprise a measuring devise such as a ruler to allow a user to measure the amount of fluid inserted into the inserter. The one or more windows may also comprise a <NUM> material such that when a fluid is inserted into the inserter and viewed through the window light that is emitted through the window to the fluid is polarized providing a visual indicator of the fluid within the inserter. The window <NUM> may also comprise a fill indicator <NUM> to provide a maximum fill line.

In order to secure protective cap <NUM> to an insertion system, such as the system <NUM> shown in <FIG> and <FIG>, clip <NUM> may be used. Clip <NUM> is configured and dimensioned to mate with a distal portion of wings <NUM> of cartridge <NUM> (cartridge <NUM> is shown in <FIG>). In an embodiment illustrated in <FIG>, relief slots <NUM> of protective cap <NUM> couple with the vertical elements <NUM> (shown in <FIG>) of wings <NUM> of cartridge <NUM>. Relief slots <NUM> may be of any shape or size to couple with the shape or size of the vertical elements <NUM>. Clip <NUM> may also extend beyond the proximal end of finger grips <NUM> as illustrated in <FIG>.

In an embodiment, when the protective cap <NUM> is placed on the distal end of the system <NUM>, clips <NUM> act as a cantilever snap by riding along the vertical elements <NUM> of the wings <NUM> of cartridge <NUM> until the clips <NUM> are over center and then snapping down over the end of the wings <NUM>. In an embodiment, the clip <NUM> is not located on the grip <NUM> to allow for easier removal of the protective cap. It is also envisioned that clip <NUM> may be located or coupled with the grip <NUM> depending upon the design and/or function of the clip <NUM> and whether the grip <NUM> is an extension of the clip <NUM>.

<FIG> and <FIG> illustrate additional embodiments of a protective cap with similar features as shown in <FIG>, <FIG>, and <FIG>. <FIG> and <FIG> illustrate additional embodiments of a puller cap with similar features as shown in <FIG>.

As illustrated in <FIG> and <FIG>, plunger <NUM> may comprise a marker or indicator <NUM>. As discussed above, the plunger <NUM> and/or pushrod <NUM> (pushrod assembly <NUM>) translates axially through an elongate passage defined within the inserter handpiece <NUM> and is configured to urge the IOL from a holding station <NUM> through the distal delivery tube <NUM>. In an embodiment, system <NUM> may operate in a push and/or twist fashion. With a push and twist mechanism, the plunger <NUM> may first be advanced axially along the longitudinal axis to a predetermined point and then the plunger <NUM> may be rotated for further advancement. Such a further advancement via rotation may provide additional control in the delivery of the IOL. In such a scenario, it would be helpful to provide an indication of when the axial translation of the plunger <NUM> or pushrod assembly <NUM> has reached the predetermined point. In such an embodiment, a marker <NUM> is placed on plunger <NUM> such that when the plunger <NUM> is advanced or displaced along the longitudinal axis of the system <NUM> a user will be able to visualize that the plunger has reached the predetermined point when marker <NUM> lines up with the proximal end <NUM> of handpiece <NUM> (see <FIG>) or disappears within handpiece <NUM> (see <FIG>). Marker <NUM> may be placed on any location on plunger <NUM> and may be of any shape, size or color. The predetermined point may be the proximal end <NUM> as described in the above embodiment, but it is also envisioned to be any location along the handpiece <NUM>. This may be possible if handpiece <NUM> is made of a translucent or transparent material such that marker <NUM> is visible through handpiece <NUM>.

According to an embodiment, the present invention provides one or more guide rails to provide support for the pushrod on the distal end of the inserter body. <FIG> shows a cross-sectional view of insertion system <NUM> with pushrod <NUM> and handpiece <NUM>. According to an embodiment, pushrod <NUM> may comprise one or more guide rails <NUM>, preferably a guide rail on opposite sides of pushrod <NUM>. To mate with guide rails <NUM>, one or more channels <NUM> on the upper and/or lower portions of lens holding station <NUM> may be included. The top and/or bottom channels <NUM> may be of any shape to mate with the shape of the one or more guide rails. Preferably the guide rails and channels are substantially rectangular in shape. Preferably, the lower channel is wider than the upper channel, although the width of the channels can be of any size and the channels can be of any shape. The guide rails on the pushrod mate to the channels and may have substantially the same shape. The guide rails may be on any portion of the pushrod and may make up any percentage of the pushrod. The channels may be located on other locations of the handpiece <NUM>, including but not limited to base <NUM> and/or delivery tube <NUM>.

According to an embodiment, it is also envisioned that one or more guide rails may be located on the handpiece <NUM> and corresponding channels may be located on the pushrod <NUM>. In an embodiment, the channels may be located a long a portion of the pushrod <NUM> and may be found on any location around the circumference of the pushrod. The one or more guide rails may be located anywhere within the handpiece such that the guide rails are configured and dimensioned to mate with the one or more channels located on the pushrod <NUM>.

In insertion systems, advancing an IOL through a delivery tube involves a significant amount of force. To allow for advancement of an IOL from a lens storage area/holding station to a loading area the same mechanism described above can be used. For ease of use a pushing mechanism may be used to advance a lens from a storage/holding station into a delivery tube for insertion and then the same mechanism can be used to insert the IOL using a twisting mechanism. To allow for the push and twist and accommodate the high amount of force, the present invention incorporates a nut lock to prevent the pushrod from moving proximally as the pushrod is rotated to move the IOL distally.

<FIG> illustrates an embodiment of the present invention. Nut lock <NUM> may have an internal thread of a load bearing quality. Nut lock <NUM> may be cylindrical in shape and have a centrally located groove <NUM> that allows interlock and/or detent with external/internal features of handpiece <NUM>. On the distal portion of nut lock <NUM> there may be a series of radial keyways <NUM> that are capable of mating with keys (not shown) protruding inward from handpiece <NUM> that prevent it from counter rotating. Nut lock <NUM> may be made of any material known in the art, including but not limited to plastic, metal, and ceramic. Nut lock <NUM> may be coupled with the plunger <NUM> via load bearing threads and is sandwiched between plunger <NUM> and pushrod <NUM>, which may be snapped together or coupled together in any way known in the art.

According to an embodiment, nut lock <NUM> may comprise a single lead thread, but may comprise more (multiple). Nut lock <NUM> may also have varying thread pitch.

According to an embodiment, when the insertion system is delivered to a physician's office, pushrod assembly <NUM> is in a first position. In this first position, the pushrod assembly <NUM> is in its most proximal position and groove <NUM> of nut lock <NUM> mates with one or more proximal detents <NUM> located at or near the most proximal end of handpiece <NUM> and prevents accidental movement of pushrod assembly <NUM>. At this point, plunger <NUM> can be rotated in any direction without causing longitudinal movement of pushrod <NUM>. When the pushrod assembly is moved into a second position between the most proximal detent <NUM> and a second distal detent <NUM>, pushrod assembly <NUM> is movable in a longitudinal direction between detents, but rotation of plunger <NUM> in any direction does not longitudinally move pushrod <NUM>. When pushrod assembly <NUM> is moved distally in a longitudinal direction to a third position, wherein groove <NUM> of nut lock <NUM> mates with one or more distal detents <NUM> (second detent position) (see FIG. 33A), pushrod assembly <NUM> is prevented from further distal or proximal movement by pushing or pulling on end cap <NUM>. Once in the second detent position, the pushrod assembly cannot be pulled from this position back to the first proximal position. At this point the only way to advance pushrod <NUM> longitudinally to insert the IOL is to rotate plunger <NUM> via end cap <NUM> in either a clockwise or counter-clockwise direction (depending upon the configuration of the threads). This is to prevent reuse of a one time use insertion system and/or improper activation of the pushrod.

The detents are one way snaps (cantilever snaps) that provide the strength to prevent the pushrod assembly <NUM> from being pulled back from the second detent <NUM> (see FIG. The proximal detent(s) <NUM> also provide biasing for the proximal end of the plunger <NUM> as it is advanced longitudinally or rotated and provide a little resistance (see <FIG>). The proximal detents <NUM> may be the same or similar to the second detent <NUM>. The proximal detents <NUM> may have a different configuration or shape from the second detent <NUM>. The detents may be of any shape or size suitable for its function.

According to an embodiment, to help prevent advancing the pushrod with rotation of plunger <NUM> until desired, detents <NUM> are added to the plunger. Detents <NUM> are located on the distal end or portion of plunger <NUM>. According to an embodiment, the detents are located within the first two to three threads of plunger <NUM>. <FIG> illustrates detents <NUM> at the distal end or portion of plunger <NUM>. The number of detents can range between <NUM>-<NUM>, preferably <NUM>.

Claim 1:
An intraocular lens insertion system, comprising:
a handpiece (<NUM>) having a longitudinal axis, a distal end, and a proximal end,
a pushrod assembly (<NUM>) having a distal end and a proximal end,
wherein the pushrod assembly (<NUM>) comprises a pushrod (<NUM>) and a plunger (<NUM>);
wherein the pushrod assembly (<NUM>) couples with the handpiece (<NUM>) along the longitudinal axis;
wherein the pushrod (<NUM>) is coupled with the plunger (<NUM>) and the pushrod (<NUM>) is located on the distal end of the push rod assembly (<NUM>) and the plunger (<NUM>) is located on the proximal end of the pushrod assembly (<NUM>);
wherein the plunger (<NUM>) is configured and dimensioned to advance the pushrod (<NUM>) toward the distal end of the handpiece (<NUM>) along the longitudinal axis by rotation of the plunger (<NUM>) and translational movement of the plunger (<NUM>);
wherein the plunger (<NUM>) comprises threads and one or more safety detents (<NUM>), wherein the one or more safety detents (<NUM>) are located on a distal end of the plunger (<NUM>) on one or more of the threads; and
wherein the one or more safety detents (<NUM>) are configured and dimensioned to prevent advancement of pushrod with rotation of the plunger until such rotation is desired.