Patent Description:
The present disclosure relates to devices, methods, and systems for delivering an intraocular lens into an eye. More particularly, the invention relates to a device as set forth in the appended claims.

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 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 delivery device 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 push rod. Some inserters do without the cartridge. The inserter may be wholly or partly reusable, in which case the inserter or delivery device 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. One particularly useful arrangement wherein the cartridge folds over an IOL is disclosed in <CIT> 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>.

One problem encountered with existing inserters is difficulty in loading the IOL into the inserter or cartridge. The IOL is typically manually moved from a sterile environment to an inserter or associated cartridge using forceps or tweezers. Manual transfer of the IOL presents difficulties in maintaining both sterility of the IOL and the correct orientation of the IOL, especially the haptics, within the cartridge or inserter. A wide variety of performance and outcomes results even with highly skilled personnel, and those having less training are more likely to perform poorly. Improper orientation of the IOL can result in inadequate surgeon control and even damage to the IOL during delivery into the eye.

These problems may be mitigated by preloading the IOL at the manufacturer into a cartridge or container that is designed to be included directly in the inserter. The cartridge or container may be attached to the inserter either at the manufacturer or by the user just prior to surgery. The IOL is stored directly in the inserter in an unstressed state in a sterile package in order to prevent deformation of the optic element. With such configuration, a transfer process would not generally be necessary for loading the IOL into the inserter. One 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. <CIT> describes an intraocular lens insertion instrument including main bodies for housing an intraocular lens and a push-out shaft for pushing the intraocular lens out from the tip of the main bodies into the eye. Inside the main bodies, a movement block part is provided for blocking the movement backwards of the push-out shaft. The movement block part comprises a plurality of parts dividable in a shaft rotating direction of the main bodies. <CIT> describes apparatuses, systems, and methods for implanting an intraocular lens into an eye. The intraocular lens injector may include a plunger lock. <CIT> describes an insertion system having a handpiece, a pushrod assembly, a cartridge, and a cap with a window and a port. The insertion system may also have a pushrod with a plunger having a marker configured and dimensioned to indicate axially translation of the pushrod assembly within the handpiece.

Despite some advances in this area, there remains a need for devices, systems, and methods that facilitate the placement of IOLs into an inserter or cartridge to reduce the problems associated with manual IOL manipulation.

The present disclosure addresses this need. The present invention provides a handpiece for an intraocular insertion system according to clam <NUM>. The present invention also comprises a system according to claim <NUM> and a kit according to claim <NUM>.

The drawings described below are for illustration purposes only. The drawings are not intended to limit the scope of the present disclosure. Like reference characters shown in the figures designate the same parts in the various embodiments. <FIG> and <FIG> show an embodiment of a handpiece for an intralocular lens insertion system in accordance with the present invention. <FIG>, <FIG> show an embodiment of an intralocular lens insertion system in accordance with the present invention.

According to aspects of the disclosure, a system for delivering an intraocular lens (IOL) is disclosed, comprising: a handpiece including a barrel defining an elongate passage, a pushrod disposed inside the elongate passage, and a plunger coupled to the pushrod; and a delivery unit coupled to a first end of the barrel, the delivery unit including a delivery tube and a lens holder coupled to the delivery tube, the lens holder including a lead haptic shelf arranged to receive a lead haptic of an IOL that is contained inside the lens holder, wherein the lead haptic shelf is configured to fold the lead haptic of the IOL over a body of the IOL while permitting the IOL to travel under the lead haptic shelf when the IOL is displaced from the lens holder to the delivery tube by the pushrod during delivery of the IOL into a patient's eye.

According to aspects of the disclosure, a system for delivering an intraocular lens (IOL) is disclosed, comprising: a handpiece including a barrel defining an elongate passage having D-shaped cross-section, a pushrod having a pushrod head disposed inside the elongate passage, and a plunger coupled to the pushrod head, the pushrod head also having a D-shaped cross-section, the pushrod head having an O-ring disposed around a perimeter of the pushrod head; and a delivery unit coupled to the barrel of the handpiece, the delivery unit including a lens holder coupled to a delivery tube, the lens holder having a cavity that is arranged to receive an IOL, the delivery tube being configured to fold the IOL when the IOL is displaced from the lens holder into the delivery tube by the pushrod, wherein the elongate passage includes a first section configured to maintain the O-ring in an uncompressed state when the pushrod head is located in the first section, and a second tapered section configured to compress the O-ring when the pushrod head is displaced from the first section to the second tapered section by the plunger.

According to aspects of the disclosure, a system for delivering an intraocular lens (IOL) is disclosed, comprising: a handpiece including a barrel defining an elongate passage, a pushrod having a pushrod head disposed inside the elongate passage, and a plunger coupled to the pushrod head; a delivery unit coupled to a first end of the barrel, the delivery unit including a lens holder coupled to a delivery tube, the lens holder having a cavity that is arranged to receive an IOL, the delivery tube being configured to fold the IOL when the IOL is displaced from the lens holder into the delivery tube by the pushrod; and a retention nut coupled to a second end of the barrel that is opposite the first end, the retention nut having at least one retention clip that is configured engage the pushrod head to prevent the pushrod from moving while the system is not being used on a patient, the at least one retention clip being further configured to disengage from the pushrod head during normal use of the system on a patient.

According to aspects of the disclosure, a method for selling an intraocular lens (IOL) is provided, comprising: providing an IOL delivery unit that is pre-loaded with an IOL, the IOL delivery unit including a delivery tube and a lens holder coupled to the delivery tube, the lens holder including a cavity inside which the IOL is disposed and a mounting interface for attaching the lens holder to compatible IOL insertion handpieces; providing a first IOL insertion handpiece that is compatible with the IOL delivery unit, the first IOL insertion handpiece including a first barrel defining a first elongate passage, a first pushrod disposed inside the first elongate passage, a first plunger coupled to the first pushrod, and a first receiving interface arranged to receive the IOL delivery unit, wherein the first pushrod is configured to push the IOL through the delivery tube when the IOL delivery unit is mounted in the first receiving interface via the mounting interface and the first plunger is actuated; and providing a second IOL insertion handpiece that is compatible with the IOL delivery unit, the second IOL insertion handpiece including a second barrel defining a second elongate passage, a second pushrod disposed inside the second elongate passage, a second plunger coupled to the second pushrod, and a second receiving interface arranged to receive the IOL delivery unit, wherein the second pushrod is configured to push the IOL through the delivery tube when the IOL delivery unit is mounted in the second receiving interface via the mounting interface and the second plunger is actuated.

According to aspects of the disclosure, a method for selling an intraocular lens (IOL) is provided, comprising: providing a disposable IOL delivery unit that is pre-loaded with an IOL, the IOL delivery unit including a delivery tube and a lens holder coupled to the delivery tube, the lens holder including: (i) a cavity inside which the IOL is disposed and (ii) a mounting interface that is compatible with a plurality of IOL insertion handpieces that are available on the market; and providing a reusable first IOL insertion handpiece that is compatible with the disposable IOL delivery unit, the first IOL insertion handpiece including a first barrel defining a first elongate passage, a first pushrod disposed inside the first elongate passage, a first plunger coupled to the first pushrod, and a first receiving interface arranged to receive the IOL delivery unit, wherein the first pushrod is configured to push the IOL through the delivery tube when the IOL delivery unit is mounted in the first receiving interface via the mounting interface and the first plunger is actuated.

Examples of different systems for delivering an IOL will be described more fully hereinafter with reference to the accompanying drawings. These examples are not mutually exclusive, and features found in one example can be combined with features found in one or more other examples to achieve additional implementations. Accordingly, it will be understood that the examples shown in the accompanying drawings are provided for illustrative purposes only and they are not intended to limit the disclosure in any way.

As used throughout the disclosure the term "distal end" may refer to the end of an IOL delivery system or component thereof, which would be the closest to a patient when the IOL delivery system is used, by an operator, to operate on the patient. As use throughout the disclosure the term "proximal end" may refer to the end of an IOL delivery system or component thereof, which is opposite the distal end, and which would be the closest to the operator when the IOL delivery system is used, by the operator, to operate on the patient.

It will be understood that when an element such as a layer, region or substrate is referred to as being "on" or extending "onto" another element, it can be directly on or extend directly onto the other element or intervening elements may also be present. It will be understood that these terms are intended to encompass different orientations of the element in addition to any orientation depicted in the figures.

Relative terms such as "below" or "above" or "upper" or "lower" or "horizontal" or "vertical" may be used herein to describe a relationship of one element, layer or region to another element, layer or region as illustrated in the figures. It will be understood that these terms are intended to encompass different orientations of the device in addition to the orientation depicted in the figures.

<FIG> is a diagram of an example of a handpiece <NUM>, according to aspects of the disclosure. The handpiece <NUM> includes a cradle <NUM>, a body <NUM>, and a plunger <NUM>. The cradle <NUM> includes a retention fork <NUM> and a holding base <NUM>. The retention fork <NUM> includes a respective hook <NUM> on each of its prongs and the holding base <NUM> includes a latch <NUM> formed at its distal end. The body <NUM> includes a barrel <NUM> and retention nut <NUM> disposed at the proximal end of the barrel. The plunger <NUM> includes a threaded shaft <NUM> and a thumb nut <NUM> disposed at the proximal end of the threaded shaft <NUM>.

<FIG> is a diagram of an example of a handpiece <NUM>, according to aspects of the disclosure. The handpiece <NUM> includes a cradle <NUM>, a body <NUM>, and a plunger <NUM>. The cradle <NUM> includes a retention fork <NUM> and a holding base <NUM>. The retention fork <NUM> includes a respective hook <NUM> formed at the end each of its prongs and the holding base <NUM> includes a respective latch <NUM> formed on its distal end. The body <NUM> includes a barrel <NUM> and retention nut <NUM> disposed at the proximal end of the barrel <NUM>. The plunger <NUM> includes a threaded plunger shaft <NUM> and a thumb nut <NUM> disposed at the proximal end of the plunger shaft <NUM>.

<FIG> shows the handpiece <NUM> with a delivery unit <NUM> installed in the cradle <NUM>. The delivery unit <NUM> includes a lens holder <NUM> and a cartridge <NUM>. The lens holder <NUM> includes a plurality of latches <NUM> disposed in a slot <NUM> (shown in <FIG>). The cartridge <NUM> includes a delivery tube <NUM> and wing sections <NUM>. As illustrated in <FIG>, when the delivery unit <NUM> is mounted onto the handpiece <NUM>, the delivery unit <NUM> is placed in the cradle <NUM> of the handpiece <NUM> by inserting the distal ends of the wing sections <NUM> into the hooks <NUM> and then pressing the delivery unit <NUM> down until the latches <NUM> have engaged the latch <NUM>. When the delivery unit <NUM> is installed in the handpiece <NUM>, the delivery tube <NUM> of the cartridge <NUM> is situated between the prongs of the retention fork <NUM>.

<FIG> shows the handpiece <NUM> with a delivery unit <NUM> installed in the cradle <NUM>. As illustrated in <FIG>, when the delivery unit <NUM> is mounted onto the handpiece <NUM>, the delivery unit <NUM> is placed in the cradle <NUM> of the handpiece <NUM> by inserting the distal ends of the wing sections <NUM> into the hooks <NUM> and then pressing the delivery unit <NUM> down until the latches <NUM> have engaged the latch <NUM>. When the delivery unit <NUM> is installed in the handpiece <NUM>, the delivery tube <NUM> of the cartridge <NUM> is situated between the prongs of the retention fork <NUM>.

The handpieces <NUM> and <NUM> are both adapted to receive the same IOL delivery unit, and they may have a similar structural composition. However, in some implementations, the handpiece <NUM> may be reusable, and the handpiece <NUM> may be disposable. The handpiece <NUM> may be formed of titanium, steel, and/or any other durable material. By contrast, the handpiece <NUM> may be formed of polypropylene and/or another similar material. The handpiece <NUM> may be pre-loaded with a delivery unit by the manufacturer, and shipped to hospitals and other health management facilities where it can remain in storage until it needs to be used. After the delivery device is used on a patient, it can be discarded at a minimal cost. According to aspects of the disclosure, the handpieces <NUM> and/or <NUM> may be ordered separately from the delivery unit so that ophthalmologists can select her/his handpiece to use with the delivery unit. According to aspects of the disclosure, in some implementations, the only difference between the handpieces <NUM> and <NUM> may be in the materials used to make each.

<FIG> is a top-down view of an IOL <NUM>, which can be implanted in the eye of a patient by using any of the handpieces <NUM> and <NUM>. The IOL includes a body <NUM>, a lead haptic <NUM> and a trailing haptic <NUM>. The body <NUM> includes a small plastic lens which can be used to replace or supplement the patient's natural intraocular lens. The haptics <NUM> and <NUM> may be small struts that are used to hold the lens in place within the capsular bag inside the patient's eye. The lead haptic <NUM> is provided with a cutout <NUM> which permits the lead haptic to fold there when sufficient pressure is applied on the lead haptic <NUM>. The trailing haptic <NUM> is provided with a cutout <NUM> which permits the trailing haptic <NUM> to fold there when sufficient pressure is applied on the trailing haptic <NUM>.

<FIG> show the handpiece <NUM> in further detail. As illustrated in <FIG>, the handpiece <NUM> may be provided with a flat top surface <NUM> that allows the operator using the handpiece <NUM> to determine its orientation with or without visual verification. Shown in <FIG> is the IOL <NUM>, which is disposed inside the delivery unit <NUM>. Adjacently to the IOL <NUM>, a pushrod <NUM> is received inside an elongate passage <NUM> of the barrel <NUM>. The pushrod <NUM> includes a tip <NUM> and a pushrod head <NUM> that is coupled to the plunger shaft <NUM> of the plunger <NUM>. When the handpiece <NUM> is used to implant the IOL <NUM> into the eye of a patient, the pushrod is actuated by the plunger <NUM>, which causes the pushrod <NUM> to translate axially through the passage <NUM> and urge the IOL <NUM> from the lens holder <NUM>, through the delivery tube <NUM> of the cartridge <NUM>, and into the eye of the patient.

<FIG> is a perspective side view of the retention nut <NUM>, according to aspects of the disclosure. As illustrated, the retention nut <NUM> includes a cap <NUM>, a flat top surface <NUM>, tab guides <NUM>, retention clips <NUM> formed on the distal end of the retention nut <NUM>, and an interior thread <NUM>. The cap <NUM> is arranged to engage a lip that is formed on the proximal end of the barrel <NUM> in order to affix the retention nut <NUM> to the barrel <NUM>. The flat top surface <NUM> may be provided to orient the retention nut <NUM> in the correct position. In some implementations, the flat top surface <NUM> may also engage a flat interior surface of the passage <NUM> in order to prevent the retention nut <NUM> from rotating once the retention nut <NUM> is installed in the barrel <NUM>. The tab guides <NUM> are provided to align the pushrod head <NUM> with the retention nut <NUM>. The retention clips <NUM> are arranged to engage the pushrod head <NUM> in order to prevent the pushrod <NUM> from moving while the handpiece <NUM> is being transported. The interior thread <NUM> may be arranged to engage the threads on the threaded plunger shaft <NUM> of the plunger <NUM> when the plunger <NUM> is pushed into the body <NUM> of the handpiece <NUM>.

<FIG> is a planar side view of the barrel <NUM> when viewed from the direction DF and <FIG> is a perspective side view of the barrel <NUM>. The direction DF is denoted by the arrow in <FIG>. As illustrated, the passage <NUM> has a D-shaped cross-section characterized by a first diameter D1 and a second diameter D2 that may be greater than or equal to the diameter D1. The passage <NUM> may have an aspect ratio A = D2/D1. In some implementations the aspect ratio A may be equal to or greater than <NUM>. Additionally or alternatively, in some implementations the aspect ratio A may in the range from about <NUM> to about <NUM> or from about <NUM> to about <NUM> or from about <NUM> to about <NUM>. As those in the art will appreciate, other aspect ratios may also be appropriate, and the present disclosure is not limited to any particular size for the diameters D1 and D2. For the purposes of these measurements, D2 is measured at the greatest diameter; D1 is measured at the smallest diameter, and the diameter is taken <NUM> degrees from the flat section, so that the full diameter may be measured.

In some implementations, the passage <NUM> of the barrel <NUM> may have a slightly tapered shape. As a result, each of the diameters D1 and D2 may slightly decrease from the proximal end towards the distal end of the barrel <NUM>. For example, the diameter D1 may be larger near the proximal end of the barrel <NUM> than near the distal end of the barrel <NUM>. Similarly, the diameter D2 may be larger near the proximal end of the barrel <NUM> than near the distal end of the barrel <NUM>. In other words, the passage <NUM> may gradually become narrower towards the distal end of the barrel <NUM>.

<FIG> is a cross-sectional view of the barrel <NUM>, according to aspects of the disclosure. As shown, the passage <NUM> includes a longitudinal axis A-A which runs in the center of the passage <NUM>. Furthermore, the passage <NUM> includes a first tapered section <NUM> and a second tapered section <NUM>. The interior walls of the first tapered section <NUM> of the passage <NUM> are oriented at an angle B1 relative to the longitudinal axis A-A. The interior walls of the second tapered section <NUM> are oriented at an angle B2 relative to the longitudinal axis A-A. In some implementations, the angles B1 and B2 may be different from one another. By way of example, the angle B2 may be greater than the angle B1. Additionally or alternatively, in some implementations, the angle B1 may be in the range from about <NUM> or about <NUM> degrees to about <NUM> or about <NUM> or about <NUM> degrees, and the angle B2 may be in the range from about <NUM> or about <NUM> degrees to about <NUM> or about <NUM> or about <NUM> degrees.

Furthermore, in some implementations, the first tapered section <NUM> may have a length L1 and the second tapered section L2 may have a length L2. In some implementations, the length L1 may be different than the length L2. Additionally or alternatively, in some implementations, the length L1 may be greater than the length L2. Additionally or alternatively, in some implementations, the length L1 may be less than the length L2. Additionally or alternatively, in some implementations, the length L1 may be in the range from about <NUM> to about <NUM> and the length L2 may be in the range of from about <NUM> to about <NUM>. As is further discussed below, the tapered sections <NUM> and <NUM> are provided in order to vary the resistance against the movement of the pushrod <NUM> (or pushrod head <NUM>) when the plunger <NUM> is depressed, in order to provide better tactile feedback and reduce popping.

The pushrod <NUM> is shown in further detail in <FIG>. As illustrated, the pushrod <NUM> is designed to blend from a round section at the rear of the tip <NUM> to a rectangular section. The pushrod head <NUM> includes a recess <NUM> having a bore <NUM> formed at the bottom of the recess <NUM>. Lips <NUM> are overhanging the recess <NUM> and alignment tabs <NUM> are provided on the sides of the pushrod head <NUM>. Furthermore, the pushrod <NUM> includes a channel <NUM> that is formed around the circumference of the pushrod head <NUM> to accommodate an O-ring <NUM> (shown in <FIG>). As shown in <FIG>, the tip <NUM> of the pushrod <NUM> includes a fork <NUM> and a clearance <NUM>, which is used to accommodate material (e.g., balanced salt solution) that is displaced when the pushrod <NUM> is actuated. A flat surface <NUM> is provided on one of the prongs of the fork <NUM> to engage the trailing haptic <NUM> when the pushrod <NUM> is actuated.

<FIG> is a cross-sectional side view illustrating an example of a reduced friction joint that is used to connect the plunger <NUM> to the pushrod <NUM>. As illustrated, the front end <NUM> of the plunger shaft <NUM> is inserted into the bore <NUM> that is formed in the pushrod head <NUM>. When the plunger shaft <NUM> is inserted into the pushrod head, the arrow snaps <NUM> compress as they pass through the lip <NUM> to enter the recess <NUM> in the pushrod head <NUM> and expand once they have made it past the lip <NUM> and into the recess <NUM> in order to prevent the plunger shaft <NUM> from being pulled out of the pushrod head <NUM>. As can be readily appreciated, the front end <NUM> of the plunger shaft <NUM> may have any suitable type of shape that would permit it to rotate inside the bore <NUM>, such as a spherical shape, a cylindrical shape, etc. In the present example, the front end of the plunger shaft <NUM> is shaped as a cylinder and is provided with a chamfered edge. In some aspects, inserting the front end <NUM> of the plunger shaft <NUM> in the bore <NUM> may help stabilize the plunger and prevent it from wobbling.

In addition, when the plunger is pushed far enough towards the distal end of the handpiece <NUM>, the thread on the plunger shaft <NUM> will come in contact with the interior thread <NUM>, which is formed inside the retention nut <NUM>. At this time, the plunger shaft <NUM> can be screwed into the retention nut <NUM> to ensure more stable control over the advancement of the pushrod <NUM> in the final stages of the implantation of the IOL <NUM>. In some implementations, to further stabilize the plunger and prevent it from wobbling, the plunger shaft <NUM> and the retention nut <NUM> may be provided with double lead threads that are used to reduce the distance between the thread profiles. The addition of the second lead may provide additional support for the unthreaded length of the plunger, thereby improving the overall stability of operation of the handpiece <NUM>.

<FIG> illustrate the manner in which the pushrod <NUM> is coupled to the retention nut <NUM> when the handpiece <NUM> is held in storage. When the pushrod <NUM> is coupled to the retention nut <NUM>, the retention clips <NUM> are received in the recess <NUM> to prevent the pushrod <NUM> from accidentally moving when the handpiece <NUM> is being transported or held in storage. Furthermore, the alignment tabs <NUM> are received in the tab guides <NUM>, as shown. As can be readily appreciated, the alignment tabs <NUM> may help orient the pushrod head <NUM> relative to the retention nut <NUM>, so that the retention clips <NUM> can snap in place inside the recess <NUM>. <FIG>, in particular, shows the manner in which the retention clips <NUM> engage the lip <NUM> of the recess <NUM>. As illustrated each retention clip <NUM> includes a surface <NUM> that is arranged at an angle relative to the lip <NUM>. This permits the retention clips <NUM> disengage from the pushrod head <NUM> when the plunger <NUM> is depressed during normal use of the handpiece <NUM> on a patient. Stated succinctly, the retention clips <NUM> may increase the dependability of the handpiece <NUM> by ensuring that the pushrod <NUM> cannot move unless the plunger <NUM> is intentionally depressed with a certain amount of force by an operator. This amount of force is greater than the amount of force which the plunger <NUM> might normally experience as a result of shaking of a package containing the handpiece <NUM> during storage or transportation.

Also shown in <FIG> and <FIG> is the O-ring <NUM>, which is disposed in the channel <NUM> of the pushrod head <NUM> in order to inhibit the movement of the pushrod <NUM> inside the passage <NUM> of the barrel <NUM>. In some aspects, the O-ring <NUM> may be used to provide a smooth feel during delivery of the IOL <NUM> in the eye of a patient and prevent the plunger <NUM> from unwinding during forward rotation of the thumb nut <NUM>. Furthermore, in some implementations, the tapered sections <NUM> and <NUM> of the passage <NUM> may be arranged to engage the O-ring <NUM> in a manner that is advantageous to the operation of the handpiece <NUM>. More specifically, the first tapered section <NUM> of the passage <NUM> may be arranged to allow the O-ring <NUM> to remain uncompressed when the handpiece <NUM> is in storage (e.g., when the pushrod head <NUM> is coupled to the retention nut <NUM>), in order to prevent the O-ring <NUM> from taking a set shape (while the handpiece <NUM> is in storage). The second tapered section <NUM>, on the other hand, may be arranged to compress the O-ring in order to cause the pushrod <NUM> to move smoothly inside the passage <NUM>, while also preventing backup of the pushrod <NUM> towards the proximal end of the handpiece <NUM>.

In some aspects, when an operator desires to implant the IOL <NUM> in the eye of a patient, the operator may depress the plunger <NUM> until the threads on the plunger shaft <NUM> reach the interior thread <NUM> which is formed inside the retention nut <NUM>. Afterwards, the operator may begin screwing the plunger <NUM> into the retention nut <NUM> by turning the thumb nut <NUM>. Doing so may cause the plunger to advance gradually forward towards the distal end of the handpiece <NUM>. In some aspects, the ability to screw the plunger <NUM> into the retention nut <NUM> affords the operator greater precision and control over the rate at which plunger is advanced. This in turn increases the safety of the device with respect to the patient and makes it easier to operate.

As noted above, the plunger performs two types of movements in the forward direction: (i) a translation movement and a (ii) rotation movement. The pushrod <NUM>, on the other hand, performs only one type of movement - namely, a translation movement. This is made possible by the coupling between the pushrod and the plunger (shown in <FIG>), which permits the front end <NUM> of the plunger <NUM> to rotate inside to the pushrod head <NUM>. Furthermore, this is made possible by the shape of the pushrod head (shown in <FIG>) and the shape of the passage <NUM> (shown in <FIG>) which prevent the pushrod head from rotating inside the barrel. Although in the present example, both the pushrod head <NUM> and the passage <NUM> have a D-shaped cross-section, alternative implementations are possible in which the pushrod head <NUM> and/or the passage <NUM> may have another type of shape that would prevent the pushrod head <NUM> from turning when inside the passage <NUM>. The present disclosure is thus not limited to any particular type of shape for the pushrod head <NUM> and/or the passage <NUM>.

Furthermore, it should be noted that both the arrow snaps <NUM> and the retention clips <NUM> are received in the recess <NUM>. This is made possible by the recess <NUM> having an opening that extends along the entire width of the pushrod head <NUM>, which permits the retention clips <NUM> to engage the lip <NUM> of the recess <NUM> near the edge of the pushrod head <NUM>.

<FIG> are perspective top-down views of the of the lens holder <NUM> when lens holder <NUM> is open. As illustrated, the lens holder <NUM> includes a base <NUM> and a cover <NUM> that are coupled by a pair of living hinges <NUM>. The base <NUM> includes a pair of bifurcated fingers <NUM> that meet, at the living hinges <NUM>, with a similar pair of bifurcated fingers <NUM> extending from the cover <NUM>. The opposed pairs of aligned fingers are shaped so as to form a slot <NUM> when folded about the living hinges <NUM> for receiving the cartridge <NUM>.

<FIG> show in greater detail how the lens holder <NUM> and the cartridge <NUM> are assembled together to form the delivery unit <NUM>. More particularly, the cartridge <NUM> may be placed in the slot <NUM> when the cover <NUM> is open, such that an alignment pin <NUM> is received in a recess <NUM> that is formed in one of the wing sections <NUM>. The alignment pin <NUM> and the recess <NUM> may prevent the cartridge <NUM> from being inserted incorrectly while also creating an interference fit that can hold the cartridge <NUM> in place while the cover <NUM> is folded over the base <NUM>. After the cover <NUM> is folded over the base <NUM>, the latches <NUM> are snapped into mating recesses <NUM> to lock the base <NUM> and the cover <NUM> together.

<FIG> shows a perspective view of the delivery unit <NUM> after it is assembled. As illustrated, the delivery unit <NUM> includes a port <NUM>, which includes a concave portion <NUM>, a convex portion <NUM>, and an opening <NUM>. According to aspects of the disclosure, the opening <NUM> may be used to introduce balanced salt solution (BSS) into the delivery unit <NUM> in order to keep the IOL <NUM> lubricated and/or hydrated.

Returning to <FIG>, the base <NUM> includes a cavity <NUM> that is arranged to contain the IOL <NUM>. Inside the cavity <NUM>, a lead haptic shelf <NUM> and a trailing haptic shelf <NUM> are disposed on opposite sides of the cavity <NUM>. Furthermore, a ledge <NUM> is formed on the sidewalls of the cavity <NUM> to provide support for the body <NUM> of the IOL <NUM>. <FIG> is a cross-sectional partial view of the base <NUM>, which shows the manner in which the IOL <NUM> is retained within the cavity <NUM> of the lens holder <NUM> prior to the handpiece <NUM> being used on a patient (e.g., when the handpiece <NUM> is in storage or being transported from the manufacturer to a healthcare provider). As illustrated, the body <NUM> of the IOL <NUM> is rested on the ledge <NUM> such that the central portion of the body <NUM> is suspended above the bottom surface of the cavity <NUM> to prevent the central portion of the body <NUM> from being damaged as a result of coming in contact with the bottom surface of the cavity <NUM>. The lead haptic <NUM> is placed on the lead haptic shelf <NUM>, and the trailing haptic <NUM> is placed on the trailing haptic shelf <NUM>.

<FIG> shows the lead haptic shelf <NUM> in further detail. The lead haptic shelf includes a base <NUM> and a sidewall <NUM>. When the IOL <NUM> is placed inside the lens holder <NUM>, the tip of the lead haptic <NUM> is disposed on the base <NUM> and adjacently to the sidewall <NUM>. In some aspects, this configuration of the lead haptic shelf <NUM> is advantageous because it allows the lead haptic <NUM> of the IOL <NUM> to be assembled from above without post-assembly haptic manipulation. As is discussed further below, the lead haptic shelf <NUM> is used to fold the lead haptic <NUM> over the body <NUM> of the IOL <NUM> when the plunger <NUM> of the handpiece <NUM> is depressed.

<FIG> are perspective cross-sectional views of the delivery unit <NUM>. The arrow shown in <FIG> denotes direction DR. <FIG> is a cross-sectional side view of the delivery unit <NUM> when viewed from direction DR. <FIG> illustrates that the lead haptic shelf <NUM> is spaced apart from the bottom of the cavity <NUM> by a distance D that is greater than the thickness T of the IOL <NUM>. Furthermore, as shown in <FIG>, the lead haptic shelf <NUM> may overhang the sidewall <NUM> of the cavity <NUM>, thereby permitting the IOL <NUM> to travel underneath the lead haptic shelf <NUM> when the plunger <NUM> of the handpiece <NUM> is depressed.

<FIG> are partial schematic cross-sectional views of the delivery unit <NUM>, when viewed from above, which show the transformations of shape undergone by the IOL <NUM> when the plunger <NUM> is depressed to eject the IOL <NUM> from the delivery unit <NUM>. <FIG>, in particular, illustrates the storage position of the IOL <NUM> inside the lens holder <NUM>. As noted above, when the IOL <NUM> is in the storage position, the body <NUM> of the IOL <NUM> is rested on the ledge <NUM>, the end of the lead haptic <NUM> is disposed on the lead haptic shelf <NUM>, and the end of the trailing haptic <NUM> is disposed on the trailing haptic shelf <NUM> (not shown in <FIG>). Now, with reference to <FIG>, when plunger <NUM> is depressed, the pushrod head <NUM> is disengaged from the retention nut <NUM>. As the pushrod <NUM> moves along, the flat surface <NUM> of the tip <NUM> of the pushrod <NUM> pushes the trailing haptic <NUM> causing it to fold over the body <NUM> of the IOL. After the trailing haptic <NUM> is folded over the body <NUM> of the IOL <NUM>, the fork <NUM> of the pushrod <NUM> engages the edge of the body <NUM> of the IOL.

As seen in <FIG>, as the pushrod <NUM> continues to move along, it pushes the body <NUM> of the IOL <NUM>, while also causing the lead haptic <NUM> to press against the sidewall <NUM> of the lead haptic shelf <NUM>, and eventually fold as a result. As the pushrod <NUM> continues to apply pressure on the IOL <NUM>, the IOL <NUM> begins to rotate. Concurrently with the rotation of the IOL <NUM>, the lead haptic <NUM> is folded over the body <NUM> of the IOL <NUM> and the IOL <NUM> travels underneath the lead haptic shelf <NUM>. After the IOL <NUM> passes under the lead haptic shelf <NUM>, it enters a loading chamber <NUM> of the cartridge <NUM>.

<FIG> shows the IOL <NUM> after it has been transferred into the loading chamber <NUM> of the cartridge <NUM>. The size of the loading chamber <NUM> is desirably smaller than the diameter of the body <NUM>, and therefore acts on and causes the body <NUM> to curl upward into a "taco" shape. The transition of the body <NUM> from its original planar configuration to a curled configuration prevents the haptics <NUM> and <NUM> from elastically rebounding back to their original positions. In other words, the haptics <NUM> and <NUM> are captured over the top of the body <NUM> by its curled configuration. In this shape, the IOL <NUM> can be inserted into the eye of a patient. Importantly, when the body <NUM> is curled up, its overall footprint is reduced, which permits the use of a smaller incision into the patient's eye to insert the IOL <NUM>.

<FIG> is a diagram illustrating an example of a storage tray <NUM> for storing the delivery unit <NUM>. As illustrated, the storage tray includes ribs <NUM> that are arranged to provide extra structural support to the tray and a well <NUM> arranged to receive the delivery unit <NUM>. When the delivery unit <NUM> is disposed into storage tray <NUM>, the well <NUM> may be flooded with BSS to keep the IOL inside the delivery unit <NUM> hydrated. As noted above, in some implementations, while the delivery unit <NUM> is disposed in the storage tray <NUM>, the BSS may enter the delivery unit <NUM> through the port <NUM>.

The above-described design opens new opportunities for marketing and using intraocular lens (IOL) implants. Specifically, the design permits IOL implants to be prepackaged in a delivery unit (e.g., the delivery unit <NUM>) and sold separately from any particular IOL insertion handpiece. The pre-packaging may be performed by the manufacturer, before the IOL implants are sold to hospitals and other medical facilities. Under this arrangement, IOL implants need not be directly handled by medical personnel after they leave the manufacturer's premises. Rather, medical personnel may simply mount a delivery unit containing a pre-loaded IOL onto a selected IOL insertion handpiece, and use the selected handpiece to implant the IOL in a well-known fashion.

The delivery unit may be universally compatible with many different IOL insertion handpieces (e.g., the handpiece <NUM> and the handpiece <NUM>), thereby giving ophthalmologists the freedom to select a handpiece of their own choosing. Ophthalmologists very often have specific preferences with respect to the IOL insertion handpiece they use. For example, some ophthalmologists may prefer handpieces that are heavier, while other may prefer handpieces that are lighter. As another example, some ophthalmologists may prefer handpieces that are larger, while other may prefer handpieces that are smaller. As another example, some ophthalmologists may prefer to squeeze the plunger of the handpiece during the final stages of the implantation, while others may prefer to twist it. These preferences may often be dictated by the ophthalmologists' physical strength, physical size, and/or motor skills. Accordingly, providing ophthalmologists with the handpiece they prefer may enable to ophthalmologists to operate with greater precision.

Furthermore, ophthalmologists may often have preferences for a specific IOL. However, many IOL insertion systems that are available on the market require the use of the respective IOL insertion handpiece that is part of each system. Thus, if a given ophthalmologist prefers to use IOL implants that are produced by one manufacturer/producer and an IOL insertion handpiece that is produced by another manufacturer/producer, the given ophthalmologist may be not be able to do so, as the preferred IOL implant may not be readily transferable to the preferred handpiece. In other words, the given ophthalmologist may be forced to choose one or the other of her/his preferred IOL insertion handpiece and IOL implant.

By contrast, in some instances, the modular nature of the above-described design may permit ophthalmologists to mix-and-match a given pre-loaded IOL delivery unit with various compatible IOL insertion handpieces that might be available on the market. More specifically, the above-described system permits ophthalmologists to find the IOL handpiece that works best and use only that handpiece, while obtaining additional IOL delivery unit refills as they go. The IOL insertion handpiece and the delivery units may be produced by the same manufacturer/producer or by different manufacturers/producers.

<FIG> is a flowchart of an example of process <NUM> for selling IOL implants, according to the aspects of the disclosure. At step <NUM>, an IOL delivery unit is provided that includes a mounting interface for affixing the delivery unit to a compatible handpiece. In some instances, the IOL delivery unit may be the same or similar to the delivery unit <NUM>. Additionally or alternatively, in some instances, the mounting interface may include one or more of cartridge wing portions (e.g., wing portions <NUM>) which are configured to engage retention hooks (e.g., hooks <NUM> or hooks <NUM>) that are provided on the compatible handpiece. Additionally or alternatively, in some implementations, the mounting interface may include a recess (e.g., recess <NUM>) that is configured to receive one or more coupling elements (e.g., holding base <NUM>, holding base <NUM>, latches <NUM>, and/or latches <NUM>) that are provided on the compatible handpiece. Additionally or alternatively, in some implementations, the mounting interface may include coupling elements (e.g., latches <NUM>) configured to mate with corresponding coupling elements (e.g., latches <NUM>) that are provided on the compatible handpiece.

At step <NUM>, a first IOL insertion handpiece is provided that is compatible with the IOL delivery unit. In some instances, the first compatible piece may be the same or similar to the handpiece <NUM>. At step <NUM>, a second IOL insertion handpiece is provided that is compatible with the IOL delivery unit. In some instances, the second compatible handpiece may be the same or similar to the handpiece <NUM>. According to aspects of the disclosure, each of the first IOL insertion handpiece and the second IOL insertion handpiece may have a respective receiving interface for receiving the mounting interface of the IOL delivery unit provided at step <NUM>. In the present example, the receiving interface of the first IOL insertion handpiece may be the same or similar to the cradle <NUM>. Furthermore, the receiving interface of the second IOL insertion handpiece may be the same or similar to the cradle <NUM>.

According to aspects of the disclosure, a handpiece is compatible with the IOL delivery unit when the IOL delivery unit may be mounted on the handpiece in a manner in which permits the implantation of an IOL contained within the IOL delivery unit. Although in the examples provided above a system of hooks and latches is used to affix the delivery unit <NUM> to one of the handpiece <NUM> and the handpiece <NUM>, the present disclosure is not limited to this type of arrangement. In this regard, it will be understood that any other suitable interface for affixing the delivery unit to the first and second handpieces may be used instead. Similarly, it will be understood that any other suitable receiving interface for affixing the delivery unit to the first and second handpieces may be used, as well.

According to aspects of the disclosure, the first handpiece and the second handpiece may differ from one another in at least one of: (i) weight, (ii) length of barrel, (iii) type of plunger, (iv) type of material used to make the handpieces, (v) overall length of the handpieces, and/or (vi) reusability. For example, in some instances, the two handpieces may have different respective weights. Additionally or alternatively, the respective barrels of the first and second handpieces may have different lengths. Additionally or alternatively, in some instances, the two handpieces may include different plungers. More particularly, the first handpiece may include a plunger which has no threads formed on it, and the second handpiece may have a threaded plunger (e.g., plunger <NUM>). As noted above, having threads on the plunger may permit ophthalmologists to use a twisting motion to drive the IOL during the final stages of its implantation. Additionally or alternatively, in some instances, the two handpieces may be made, at least in part, of different materials; more particularly, the first handpiece may include one or more plastic components, whereas the second handpiece may include only metal components. Additionally or alternatively, in some instances, the two handpieces may have different overall lengths. Additionally or alternatively, in some instances, the first handpiece may be disposable and the second handpiece may be reusable.

According to aspects of the disclosure, providing the pre-loaded delivery unit may include selling the delivery unit. Providing the first handpiece may include one of selling the first handpiece or giving the first handpiece away for free and/or at a reduced cost. Providing the second handpiece may include one of selling the second handpiece or giving the second handpiece away for free and/or at a reduced cost. Any of the pre-loaded delivery unit, the first handpiece, and the second handpiece may be sold via an online storefront, a brick-and-mortar storefront, a catalog, and/or any other suitable method for selling supplies to hospitals and medical professionals.

According to aspects of the disclosure, in some instances, the pre-loaded IOL delivery unit may be provided separately from any of the first handpiece and the second handpiece. For example, the pre-loaded IOL delivery unit may be packaged separately from each of the first handpiece and the second handpiece. As another example, the pre-loaded IOL delivery unit may be sold by itself (or together with other delivery units), without an accompanying IOL insertion handpiece. As another example, the pre-loaded IOL delivery unit may be provided before and/or after any of the first handpiece and the second handpiece is provided.

According to aspects of the disclosure, in some instances, the pre-loaded IOL delivery unit and at least one of the first handpiece and the second handpiece may be provided in the same kit. For example, the pre-loaded IOL delivery unit and at least one of the first handpiece and the second handpiece may be provided in the same carrying case. In addition, the kit may include other supplies and consumables, such as a bottle of balanced salt solution, etc..

Claim 1:
A handpiece (<NUM>; <NUM>) for an intraocular lens insertion system, the handpiece comprising:
a barrel (<NUM>) defining an elongate passage, a pushrod (<NUM>) having a pushrod head (<NUM>) disposed inside the elongate passage, and a plunger (<NUM>) coupled to the pushrod head; and
a retention nut (<NUM>) coupled to a proximal end of the barrel, the retention nut having at least one retention clip (<NUM>) that is configured to engage the pushrod head to prevent the pushrod from moving while the handpiece is not being used on a patient, the at least one retention clip being further configured to disengage from the pushrod head during normal use of the handpiece on a patient.