Patent Description:
The human eye can suffer a number of maladies causing mild deterioration to complete loss of vision. While contact lenses and eyeglasses can compensate for some ailments, ophthalmic surgery may be required for others. Generally, ophthalmic surgery may be classified into posterior segment procedures, such as vitreoretinal surgery, and anterior segment procedures, such as cataract surgery. Vitreoretinal surgery may address many different eye conditions, including, but not limited to, macular degeneration, diabetic retinopathy, diabetic vitreous hemorrhage, macular hole, detached retina, epiretinal membrane, and cytomegalovirus retinitis.

For cataract surgery, a surgical procedure may require incisions and insertion of tools within an eye to replace the clouded lens with an intraocular lens (IOL). An insertion tool can be used for delivery of the IOL into the eye. By way of example, the insertion tool may include a plunger for forcing the IOL out of the nozzle of the insertion tool. In some instances, the IOL may be pre-loaded in the insertion tool. In other instances, a separate bay may be loaded into the insertion tool. The plunger may engage the IOL to advance the IOL from the bay, through the nozzle, and into the eye. The bay (or insertion tool) may include a folding chamber configured to cause the IOL to fold, for example, when the IOL advances through the folding chamber. In some instances, a separate action may cause folding of the IOL.

Delivery of the IOL from the insertion tool can be a multi-step process. For example, the delivery may include two stages, which may be referred to as an advancing stage and a delivery stage. In the advancing stage, the IOL can be advanced from a storage position in the bay to a dwell position. The IOL may be pre-folded or may be folded when advanced from the storage position to the dwell position. At the dwell position, advancement of the IOL may be halted. With the nozzle positioned in the eye, the IOL may then be further advanced from the dwell position, in the delivery stage, which may include advancing the IOL through the nozzle and into the eye. However, this multi-step process can be problematic. For example, the user may be required to make a judgement on whether the IOL has been advanced to a proper dwell position in the advancing stage. Thus, the exact position of the IOL in the dwell position can vary from procedure to procedure. In addition, multiple actions by the user can increase time in the operation room and, thus, increase cost of the procedure.

Reference Is made to documents <CIT>, <CIT> and <CIT> cited by the examiner. <CIT> provides an intraocular lens implanting device for inserting an intraocular lens into an eyeball through an incision in the eyeball tissue, said intraocular lens implanting device characterized in comprising: a cylindrical main body; a storage part for the intraocular lens that is integrated with or is separate from the main body; and a plunger for pushing out the intraocular lens stored in the storage part and discharging the lens into the eyeball, wherein a distal end of the plunger has a base part and a protuberance.

It will be appreciated that the scope is in accordance with the claims.

In an exemplary embodiment, the present disclosure provides an apparatus for delivery of a lens component into an eye. The apparatus includes a housing; a nozzle operatively coupled to the housing; a first cylinder movably disposed within the housing; a second cylinder movably disposed within the housing, wherein the second cylinder is in fluid communication with the first cylinder; a plunger at least partially and movably disposed within the first cylinder; and a shaft movably disposed within the second cylinder, wherein the shaft is configured to move toward the lens component. In another exemplary embodiment, the present disclosure provides an apparatus for delivery of a lens component into an eye. The apparatus includes a housing comprising a threaded passage; a nozzle operatively coupled to the housing; a threaded sleeve disposed concentrically within the threaded passage; and a plunger assembly coupled to the threaded sleeve, the plunger assembly comprising: a first cylinder; a second cylinder, wherein the second cylinder is in fluid communication with the first cylinder; a plunger at least partially disposed within the first cylinder; and a shaft movably disposed within the second cylinder, wherein the shaft is configured to move toward the lens component.

In another exemplary embodiment, the present disclosure provides a method for delivery of a lens component into an eye. The method includes providing an insertion tool, wherein the insertion tool comprises a housing; a first cylinder movably disposed within the housing, wherein the first cylinder comprises a hydraulic fluid; a second cylinder movably disposed within the housing, wherein the second cylinder is in fluid communication with the first cylinder; a plunger at least partially disposed within the first cylinder; and a shaft movably disposed within the second cylinder, wherein the shaft is configured to move towards the lens component. The method further includes actuating the plunger to move the hydraulic fluid from the first cylinder into the second cylinder to axially move the shaft to drive the lens component in the nozzle.

These drawings illustrate certain aspects of some of the embodiments of the present disclosure and should not be used to limit or define the disclosure.

The present invention relates to an insertion tool for preparation and delivery of the IOL into a patient's eye and allow for a sterile transfer of the IOL from storage until it is placed within the capsular bag of a patient.

Any suitable IOL may be used, including, but not limited to, IOLs that include a lens portion and haptic extensions. The haptic extensions may be side struts (or other suitable extensions) that extend from the lens portion to hold the lens portion in place when implanted in the eye. In at least one embodiment, the IOL may be modular. Embodiments of a modular IOL may include a base portion and a lens portion. The base portion may include the haptic extensions. The lens portion may be coupled to the base portion to form the modular IOL.

In many typical syringe or push type injectors, a user applied force may be directly proportional to an IOL travel speed. With these typical syringe or push type injectors, users may compensate (e.g., by increasing a pressing force on the plunger in an axial direction) to perceived higher forces during advancement as the IOL exits the nozzle, resulting in sudden ejection of the IOL. This can result in a sudden injection of the IOL into a patient's eye and can cause damage to the patient's eye.

Further, a large pressure release may occur when the IOL exits the nozzle. In some cases, this may cause the IOL to eject at a high velocity thereby reducing a user's control of the insertion tool. These pressure and force fluctuations may reduce a user control of the insertion tool and ultimately the IOL delivery.

Due to the sensitivity and delicacy of ocular tissues and structures, it may be desired to advance the IOL with acceptable peak speed and force. Embodiments of the present disclosure are directed to an advancement technique that utilizes a hydraulic mechanism that force-assists a user by allowing a controlled fluid flow through a small orifice.

Particular embodiments of the hydraulic mechanism(s) as described herein maintain a constant fluid flow rate without varying a user's force input. The hydraulic mechanism(s) may provide a steady force feedback to a user, and may limit occurrences of sudden ejection. In addition, the hydraulic mechanism(s) may allow an application of a reasonable amount of force throughout delivery of the IOL, thereby reducing a user's fatigue.

Certain embodiments may be directed to propelling the IOL in a controlled and consistent manner. An initial advancement to dwell may be performed via a rotation of the plunger via a head, knob, or cap that may include a geometry (e.g., ridges) that conforms to a user's fingers and/or thumb. This should improve ergonomic handling. The rotation of the head moves the plunger and the IOL toward the nozzle along a threaded interior portion (passage) of the housing, thereby reducing an overall length of the insertion tool. This overall length adjustment should also improve ergonomic handling. The overall length of the insertion tool before final implantation or delivery of the IOL may be optimized for syringe type insertion tool grip profiles and may allow a user to be as close to a patient's eye as possible while affording the user greater balance. The syringe type grip profile should allow single handed grip during advancement to implantation.

Once the IOL has reached the dwell position, the plunger may be unlocked. A user may rotate the head (e.g., clockwise) until the user hears a "click". This indicates that the plunger is unlocked and ready for the final advancement by a surgeon (i.e., injection of the IOL into a patient's eye). The final advancement of the IOL may be performed via an axial push of the plunger head.

<FIG> illustrates an embodiment of a modular IOL <NUM>. The modular IOL <NUM> may be any suitable modular interocular lens. As illustrated, the modular IOL <NUM> may include a base portion <NUM> and a lens portion <NUM>. In the illustrated embodiment, the lens portion <NUM> is positioned in the base portion <NUM>. In operation, the modular IOL <NUM> can allow for the lens portion <NUM> to be modified or adjusted while leaving the base portion <NUM> in place, either intra-operatively or postoperatively. By way of example, the modular IOL <NUM> may be implanted into an eye. After implantation, the lens portion <NUM> may be modified, adjusted, and/or replaced while leaving the base portion <NUM> positioned in the eye. In at least one embodiment, the modular IOL <NUM> may be assembled in the eye. For example, the base portion <NUM> may first be implanted in the eye. The lens portion <NUM> may then be delivered into the eye and attached to the base portion <NUM>.

<FIG> illustrates the base portion <NUM> of the modular IOL <NUM> of <FIG> in accordance with embodiments of the present disclosure. In the illustrated embodiment, the base portion <NUM> includes a base <NUM> and haptic extensions <NUM>. The haptic extensions <NUM> may be side struts (or other suitable extensions) extending from the base <NUM> that may stabilize the base portion <NUM> when it may be disposed within the patient's eye. In the illustrated embodiment, the base <NUM> may define a hole <NUM>, which may be centrally located in the base <NUM> as shown on <FIG>. While the hole <NUM> is shown as a through hole extending through the base <NUM>, embodiments also contemplate hole <NUM> being a blind hole that does not extend through the base <NUM>. For example, the base <NUM> may be a solid disc with the hole <NUM> being a blind hold that does not extend through the base <NUM>, rather than an annular ring with the hole <NUM> extending through the base <NUM>. Hole <NUM> may be defined by inner perimeter surface <NUM> of the base <NUM>. In at least one embodiment, a recessed groove <NUM> is formed in inner perimeter surface <NUM>. Recessed groove <NUM> may include a lower rim <NUM> and an upper rim <NUM>. The upper rim <NUM> may have an insider diameter that is the same as or greater than the outside diameter of the lens portion <NUM> (excluding tabs <NUM> shown on <FIG>) such that the lens portion <NUM> can rest inside the hole <NUM> of the base <NUM>. All or a portion of the lower rim <NUM> can have an inside diameter that is less than the outside diameter of the lens portion <NUM> (excluding tabs <NUM> shown on <FIG>) such that the lower rim <NUM> can act as a ledge or backstop for the lens portion <NUM> when placed in the hole <NUM> of the base <NUM>. The base portion <NUM> may be unitary or may be formed from component parts that are combined or attached in any suitable manner.

With reference to <FIG>, the lens portion <NUM> of the modular IOL <NUM> of <FIG> is illustrated in accordance with embodiments of the present disclosure. In the illustrated embodiments, the lens portion <NUM> includes an optic portion <NUM> and one or more tabs <NUM>. While <FIG> illustrates two of the tabs <NUM>, embodiments may include only one of the tabs <NUM> or alternatively three, four, or more of the tabs <NUM>. In addition, the tabs <NUM> on the lens portion <NUM> may be the same or different from one another. The tabs <NUM> are shown as being fixed to the optic portion <NUM>; however, it should be understood that one or more of the tabs <NUM> may be actuated to move from a compressed position for delivery into the hole <NUM> of the base <NUM> (e.g., shown on <FIG>) to an uncompressed extended position for deployment into the recessed groove <NUM> of the base <NUM> (e.g., shown on <FIG>), thus forming an interlocking connection between the base portion <NUM> and the lens portion <NUM>. The outside curvature of the tabs <NUM> may have a radius conforming to the inside radius of the recessed groove <NUM>. This arrangement should limit relative movement between the base portion <NUM> and the lens portion <NUM> once connected. In embodiments, a suitable optic portion <NUM> may be in a shape similar to that of a natural lens within the eye and made from a suitable material such as silicone, acrylic, and/or combinations thereof. While the optic portion <NUM> is shown as being circular, the optic portion <NUM> may be any suitable shape, such as oval or ellipsoidal, for example, with the tabs <NUM> positioned adjacent the long axis. This arrangement would thus define a gap between the edge of the optic portion <NUM> along its short axis and the inner perimeter surface <NUM> in the base <NUM>. The gap may enable access for a probe or similar device to pry apart the lens portion <NUM> from the base portion <NUM> if separation were needed.

<FIG> illustrates a top view of an insertion tool <NUM> in accordance with exemplary embodiments. The insertion tool <NUM> may include a housing <NUM>, a plunger <NUM> at least partially disposed axially within the housing <NUM>, and a nozzle <NUM>. The plunger <NUM> is slidably disposed within the housing <NUM> and may move axially along a longitudinal axis of the housing <NUM>. A plunger head <NUM> may be coupled to the plunger <NUM> and may be positioned exterior to the housing <NUM>. The nozzle <NUM> may be disposed on an end of the insertion tool <NUM> that is opposite to the plunger head <NUM>, as shown. In other words, the plunger <NUM> and the plunger head <NUM> may extend from a first end of the housing <NUM>, and the nozzle <NUM> may extend from a second opposite end of the housing <NUM>, as shown. A user may depress the plunger head <NUM> to move the plunger <NUM> axially (toward the nozzle <NUM>) within the housing <NUM>. The housing <NUM> may be configured to receive the nozzle <NUM>. In some embodiments, the nozzle <NUM> may be attachable the housing <NUM> so that the nozzle <NUM> can be coupled and decoupled from the housing <NUM>. The housing <NUM> may include handles <NUM> (e.g., see <FIG>) that extend from the housing <NUM>. The handles <NUM> may be positioned opposite to each other. In certain embodiments, the handles <NUM> may be positioned <NUM>° apart along the circumference of the housing <NUM>. The handles <NUM> allow for an ergonomic fit within a single hand of a user. The syringe-type configuration of the handles <NUM> allows single handed grip during advancement to both dwell and implantation.

<FIG> are cross-sections of the top view of the insertion tool <NUM> of <FIG> in accordance with exemplary embodiments. The cross-sections are taken in a downward direction along the dashed line between A and A' (along an entire length of the insertion tool <NUM>), as shown.

A first cylinder <NUM> and a second cylinder <NUM> may be movably disposed within the housing <NUM> (e.g., an interior portion of the housing <NUM> including a passage 33a, as shown). The first cylinder <NUM> may be adjacent to, coupled to, and/or axially aligned with the second cylinder <NUM>, as shown. An orifice <NUM> may be positioned between the first cylinder <NUM> and the second cylinder <NUM> and may allow fluid communication between both cylinders. The first cylinder <NUM> may contain a hydraulic fluid F, such as a saline solution, for example. The second cylinder <NUM> is configured to receive the hydraulic fluid F from the first cylinder <NUM> via the orifice <NUM>. That is, the second cylinder <NUM> is downstream to the first cylinder <NUM>.

The plunger <NUM> may be at least partially disposed within the first cylinder <NUM>. The plunger <NUM> may initially be positioned at a first end <NUM> of the first cylinder <NUM>. The plunger <NUM> may be configured to move within the first cylinder <NUM> in an axial direction toward a second end <NUM> of the first cylinder <NUM>, thereby displacing the hydraulic fluid F into the second cylinder <NUM> via the orifice <NUM>, as the plunger <NUM> is depressed by a user. This axial movement is indicated by arrow <NUM>.

The first cylinder <NUM> and the second cylinder <NUM> may allow a controlled fluid flow rate through the orifice <NUM> thereby regulating a maximum flow rate and thus regulating the maximum allowable speed of plunger travel. Regulating the plunger travel may prevent the IOL from traveling faster than a flow rate allowed by the cylinders <NUM>, <NUM> and the orifice <NUM>, regardless of an applied force to the plunger <NUM> by a user.

A shaft <NUM> may be disposed within the second cylinder <NUM>. The shaft <NUM> may be configured to move axially within the second cylinder <NUM> as the second cylinder <NUM> receives the hydraulic fluid F. The shaft <NUM> may include a first portion <NUM> and a second portion <NUM>, as shown. The outer diameter of the second portion <NUM> may be less than the outer diameter of the first portion <NUM>.

The first portion <NUM> may be positioned closer to the orifice <NUM> than the second portion <NUM>. The second portion <NUM> may be an elongated member including a distal end <NUM> configured to contact and move (e.g., push) a lens component <NUM>. The lens component <NUM> may include at least one component of the modular IOL <NUM> shown on <FIG>, such as the base portion <NUM> or the lens portion <NUM>. The lens component <NUM> may be positioned within a bay <NUM> of the insertion tool <NUM>, as shown.

The bay <NUM> may be a compartment that is positioned between the second cylinder <NUM> and the nozzle <NUM>. The bay <NUM> may include a lumen <NUM> that is in fluid communication with a folding chamber <NUM> that is positioned in the bay <NUM>, as shown. In at least one embodiment, the folding chamber <NUM> may include surface features (e.g., contours <NUM>) or other topography configured to fold the lens component <NUM>. In some embodiments, the lens component <NUM> may be folded and then placed into the folding chamber <NUM>.

In certain embodiments, the bay <NUM> may be a detachable cartridge that may be coupled and decoupled to the housing <NUM>. In other embodiments, the bay <NUM>, may include the folding chamber <NUM> that includes surface topography (e.g., contours <NUM>) used for folding the lens component <NUM> may be integrally formed in or a permanent part of the housing <NUM>. In some embodiments, the bay <NUM> may contain the lens component <NUM>. In some embodiments, the lens component <NUM> may be loaded in the bay <NUM> in an unfolded configuration. The bay <NUM> may be actuated to fold the lens component <NUM> for delivery via the nozzle <NUM>. As used herein, folding of the lens component <NUM> is also intended to encompass rolling of the lens component <NUM>. For example, the haptic extensions <NUM> of the base portion <NUM> shown on <FIG> may be folded onto the base <NUM>, which may then be folded or rolled. By way of further example, the lens portion <NUM> shown on <FIG> may be folded or otherwise rolled into a folded configuration for delivery through the nozzle <NUM>.

In some embodiments, the insertion tool <NUM> may be preloaded. That is, when provided to an end-user, the insertion tool <NUM> may have the lens component <NUM> (e.g., modular IOL <NUM>, base portion <NUM>, and/or lens portion <NUM>) in an unfolded state already present there within and ready to deliver. Having the insertion tool <NUM> preloaded with the lens component <NUM> should reduce the number of steps a user may be required to accomplish before delivering the lens component <NUM> into a patient. With a reduced number of steps, error and risk associated with delivery of the lens component <NUM> into a patient may be reduced. Further, an amount of time required to deliver the lens component <NUM> may also be reduced. In some embodiments, the lens component <NUM> may be pre-loaded into the bay <NUM>.

The lumen <NUM> may be aligned with a deployment channel <NUM> of the nozzle <NUM>. The deployment channel <NUM> may receive the lens component <NUM> from the bay <NUM> during depression of the plunger <NUM>. An opening <NUM> may provide an exit for the deployment channel <NUM> so that the lens component <NUM> can be delivered through the nozzle <NUM> into an eye. The nozzle <NUM> may be positioned adjacent to the bay <NUM>. In some embodiments, the nozzle <NUM> (or a portion thereof) may be integrally formed in or a permanent part of the housing <NUM> and/or the bay <NUM>.

The first portion <NUM> may initially be positioned adjacent to the orifice <NUM> prior to the plunger <NUM> moving the hydraulic fluid F from the first cylinder <NUM> into the second cylinder <NUM>. The second portion <NUM> may extend through an opening <NUM> that is positioned at a distal end <NUM> of the second cylinder <NUM>. As the plunger <NUM> is depressed and the second cylinder <NUM> receives the hydraulic fluid F, the shaft <NUM> is forced to move, causing the first portion <NUM> to move away from the orifice <NUM> (toward the opening <NUM>) and causing the second portion <NUM> to move through the opening <NUM> and into the bay <NUM> to contact and move the lens component <NUM> axially. In other words, as the plunger <NUM> is depressed, the hydraulic fluid F is displaced from the first cylinder <NUM> into the second cylinder <NUM> via the orifice <NUM> and flows against the shaft <NUM> thereby moving the shaft <NUM> axially. The shaft <NUM> moves axially to contact and push the lens component <NUM> from the bay <NUM> through the folding chamber <NUM>. The lens component <NUM> may continue to move through the lumen <NUM> and the deployment channel <NUM> and out the nozzle <NUM> (via the opening <NUM>) for delivery into an eye.

Additionally, the first portion <NUM> may be configured (upon depression of the plunger <NUM>) to form a seal upon contacting the opening <NUM>, thereby preventing the hydraulic fluid F from entering the bay <NUM>. Also, the distal end <NUM> may be configured as a physical stop to prevent axially movement of the shaft <NUM> beyond the distal end <NUM>. That is, the diameter of the opening <NUM> may be less than the outer diameter of the first portion <NUM>. The shaft <NUM> may continue to move until first portion <NUM> contacts the distal end <NUM> or when a user stops applying force to the plunger <NUM>.

With reference to <FIG>, in an initial position, the lens component <NUM> may be positioned in the folding chamber <NUM> prior to the advancement stage. The folding chamber <NUM> is configured to fold or roll the lens component <NUM> with the contours <NUM>. The lens component <NUM> may be rolled or folded to reduce a size of the lens component <NUM>. This reduction in size allows delivery of the lens component <NUM> through a minimally sized incision in the eye.

With additional reference to <FIG>, in the advancement stage, the plunger <NUM> may advance the lens component <NUM> from the folding chamber <NUM> to a dwell position <NUM> in a deployment channel <NUM> of the nozzle <NUM>. In some embodiments, the lens component <NUM> may be folded in the advancement stage. While the dwell position <NUM> is shown in the nozzle <NUM>, the dwell position <NUM> of the lens component <NUM> may be otherwise situated, for example, in the bay <NUM>.

With additional reference to <FIG>, in the deployment stage, the plunger <NUM> may advance the lens component <NUM> from the dwell position <NUM> and out the opening <NUM> of the nozzle <NUM> into a patient's eye.

The insertion tool <NUM> may also include a locking mechanism for a plunger assembly <NUM>. The plunger assembly <NUM> may be movably disposed (e.g., axial movement) within the housing <NUM>. In certain embodiments, the plunger assembly <NUM> may move axially upon depression of the plunger <NUM>.

During a locked position, a member <NUM> may extend from the plunger assembly <NUM> and abut a tab <NUM> movably disposed within a recess <NUM>, as shown on <FIG>. The plunger assembly <NUM> may include the plunger <NUM>, the first cylinder <NUM>, the second cylinder <NUM>, the orifice <NUM>, and the shaft <NUM>. During the locked position, a first portion of the second cylinder <NUM> may extend out of the passage 33a and a second portion of the second cylinder <NUM> may extend into the passage 33a.

The tab <NUM> prevents axial movement of the plunger assembly <NUM> by preventing the member <NUM> from moving upon the plunger <NUM> being depressed (e.g., the plunger <NUM> may be in a locked or unlocked position). The tab <NUM> may be pulled away (indicated by arrow <NUM> on <FIG>) from the member <NUM> to disengage the member <NUM> and unlock the plunger assembly <NUM> and allow axial movement of the plunger assembly <NUM> upon depression of the plunger <NUM>.

The plunger assembly <NUM> may include a protrusion <NUM> that extends circumferentially about an exterior surface of the first cylinder <NUM>. The protrusion <NUM> is configured to contact a portion 33b of a passage 33a of the housing <NUM>. The portion 33b may be an interior wall of the passage 33a that extends inward in a direction toward a longitudinal axis of the passage 33a. The portion 33b may prevent the plunger assembly <NUM> from moving beyond the portion 33b, as shown on <FIG>. For example, the portion 33b may be an inner ring that abuts the protrusion <NUM> that may be an external or outer ring. An outer diameter of a portion of the plunger assembly <NUM> that includes the protrusion <NUM> (e.g., the external ring) is larger than in inner diameter of the passage 33a at the portion 33b (e.g., the inner ring).

According to the present invention as shown on <FIG>, the insertion tool <NUM> includes a locking mechanism <NUM> for the plunger <NUM>. The locking mechanism <NUM> may be coupled to the housing <NUM> or that may be a separate component. The locking mechanism <NUM> includes a tab <NUM> that resembles the shape of the letter "L". The tab <NUM> may extend from the housing <NUM>. During a locked position, the tab <NUM> protrudes into a groove <NUM> of the plunger <NUM>, thereby preventing axial movement of the plunger <NUM> relative to the housing <NUM>. For unlocking, the tab <NUM> is rotated away from the groove <NUM> (with a threshold amount of force) thereby allowing axial movement of the plunger <NUM>. That is, the groove <NUM> is configured to disengage from the tab <NUM> upon rotation of the plunger <NUM>. As noted, a minimum amount of force may be utilized by a user to unlock or break free the tab <NUM> from the groove <NUM>. This rotation removes the tab <NUM> from the groove <NUM> and produces an audible sound including a "snap," "pop," or "click. " This alerts a user that the plunger <NUM> is unlocked without the user viewing the insertion tool <NUM>.

<FIG> illustrates a top view of an insertion tool <NUM> in accordance with exemplary embodiments. <FIG> is a cross-section of a top view of the insertion tool <NUM> of <FIG> in accordance with exemplary embodiments. The cross-section is taken in a downward direction along the dashed line between B and B', as shown. The insertion tool <NUM> may be similar to the insertion tool <NUM>, however, the insertion tool <NUM> may include a threaded sleeve <NUM> that mates with a threaded portion <NUM> (e.g., a threaded passage) of the housing <NUM>. The threaded sleeve <NUM> may be concentrically positioned within the threaded portion <NUM>. The threaded sleeve <NUM> may be a tubular including exterior threads. The threaded portion <NUM> may be a tubular including interior threads configured to mate with the exterior threads of the threaded sleeve <NUM>. The outer diameter of the threaded sleeve <NUM> is less than the inner diameter of the threaded portion <NUM>. In other words, the threaded sleeve <NUM> screws into the threaded portion <NUM>. This allows adjustment of the overall length of the insertion tool <NUM> to allow users with different hand sizes to utilize the insertion tool <NUM> with improved ergonomics, for example.

The plunger <NUM> may include a plunger head <NUM> that is attached to tubular portion <NUM>, as shown. The plunger head <NUM> may be rotated to axially move the threaded sleeve <NUM> forward (or backward) along threaded portion <NUM>, thereby moving the plunger assembly <NUM> axially. The plunger head <NUM> can also be rotated to unlock the insertion tools, as described herein. The threaded sleeve <NUM> may be coupled to the plunger assembly <NUM>. The tubular portion <NUM> may be initially locked into place with at least one of the mechanisms, as described above (e.g., the locking mechanisms <NUM> and/or <NUM>). This allows rotation of the threaded sleeve <NUM> by a user to adjust an overall length of the insertion tool <NUM>. Once unlocked, the plunger head <NUM> may be depressed causing the tubular portion <NUM> to move along passage <NUM>, as shown. The plunger head <NUM> may include ridges <NUM> to improve grip by a user (i.e., improved ergonomics).

An exemplary technique for implantation of the modular IOL <NUM> into an eye <NUM> of a patient will now be described with respect to <FIG>.

As illustrated on <FIG>, an insertion tool <NUM> (e.g., the insertion tool <NUM> or the insertion tool <NUM>) may first dispense the base portion <NUM> into the eye <NUM> of a patient. In embodiments, an incision <NUM> may be made in the eye <NUM> by a surgeon. For example, the incision <NUM> may be made through the sclera <NUM> of the eye <NUM>. The incision <NUM> may be a suitable width or length. Without limitation, the suitable width and/or length may be less than about <NUM> microns (<NUM> millimeters). For example, the incision <NUM> may have a suitable width and/or length of from about <NUM> microns to about <NUM> microns, from about <NUM> microns to about <NUM> microns, from about <NUM> microns to about <NUM> microns, or from about <NUM> microns to about <NUM> microns. After the incision <NUM> is made, the nozzle <NUM> of the insertion tool <NUM> may be inserted through the incision <NUM> into an interior portion <NUM> of the eye <NUM>. The insertion tool <NUM> may be actuated to dispense the base portion <NUM> into a capsular bag <NUM> of the eye <NUM>. This initial movement of the base portion <NUM> may be performed at any suitable time, for example, before the incision <NUM> is made. Once the insertion tool <NUM> is positioned with the nozzle <NUM> in the eye <NUM>, the insertion tool <NUM> may then drive the base portion <NUM> (in a folded or rolled configuration) through the nozzle <NUM> and into the interior portion <NUM> of the eye <NUM>. Upon dispensation, the base portion <NUM> should unfurl and settle within the capsular bag <NUM> of the eye <NUM>, as shown on <FIG>. The haptic extensions <NUM> may be manipulated, for example, to engage the inside equator <NUM> of the capsular bag <NUM>. The haptic extensions <NUM> may engage the capsular bag <NUM> to secure the base portion <NUM> in the capsular bag <NUM>.

As illustrated on <FIG>, the lens portion <NUM> may be positioned in the interior portion <NUM> of the eye <NUM>. In the illustrated embodiment, the lens portion <NUM> is shown positioned in the base <NUM> of the base portion <NUM>. The lens portion <NUM> may be delivered in a folded (or rolled configuration) and allowed to unfurl after ejection from the inserter. The lens portion <NUM> may be positioned in the base <NUM> of the base portion <NUM> and secured to the base portion <NUM>, for example, by use of the tabs <NUM> shown on <FIG>, to form the modular IOL <NUM>. However, embodiments should not be limited to use of the tabs <NUM> for interlocking the lens portion <NUM> and the base portion <NUM> and other suitable locking mechanisms may be used for securing lens portion <NUM> to the base portion <NUM> for forming the modular IOL <NUM>. The base portion <NUM> may hold the lens portion <NUM> within the eye <NUM> so that the lens portion <NUM> may refract light to be focused on the retina.

Claim 1:
An apparatus (<NUM>) for delivery of a lens component into an eye, comprising:
a housing (<NUM>);
a nozzle (<NUM>) operatively coupled to the housing;
a first cylinder (<NUM>) movably disposed within the housing;
a second cylinder (<NUM>) movably disposed within the housing, wherein the second cylinder is in fluid communication with the first cylinder;
a plunger (<NUM>) at least partially and movably disposed within the first cylinder;
a shaft (<NUM>) movably disposed within the second cylinder, wherein the shaft is configured to move toward the lens component;
and further comprising
a locking mechanism (<NUM>) for the plunger (<NUM>), the locking mechanism (<NUM>) including a tab (<NUM>) that resembles the shape of the letter "L",
the locking mechanism configured such that:
the tab (<NUM>) protrudes into a groove (<NUM>) of the plunger (<NUM>) to prevent axial movement of the plunger (<NUM>) relative to the housing (<NUM>) when the plunger (<NUM>) is in a locked position;
the tab (<NUM>) is disengaged from the groove (<NUM>) when the plunger (<NUM>) is rotated, to unlock the plunger, to allow axial movement of the plunger (<NUM>) relative to the housing (<NUM>), and
further wherein the locking mechanism (<NUM>) is configured to produce an audible sound output when the tab (<NUM>) is disengaged from the groove (<NUM>) to alert a user when the plunger (<NUM>) is unlocked.