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. To avoid damaging the IOL, the plunger may include a soft tip. These soft tip plungers should be gentle on the IOL even where large amounts of force can be required to push the IOL through the nozzle of the insertion tool. However, the use of soft tip plungers can have drawbacks. As the soft tip plunger moves through the nozzle in engagement with the IOL, the soft tip can compress, storing spring energy. Upon exit from the nozzle, the soft tip can rapidly expand releasing the spring energy. Since the soft tip is engagement with the IOL, this spring energy can be transferred to the IOL leading to a sudden or self-ejection of the IOL from the nozzle, which is highly undesirable and can lead to complications as the insertion IOL into the eye should be performed in a controlled manner.

<CIT> relates to an injector with transmission mechanism, in particular a gear train. This document teaches a particular arrangement and combination of features including a piston rod, transmission and actuation element. The tip of the piston rod may include a deformable plunger, in particular, an elastic or viscoelastic or silicone plunger.

The scope is in accordance with the claims. Accordingly, there is provided an apparatus for delivery of a lens component as defined in claim <NUM>. Further features are set-out in the dependent claims.

In an exemplary embodiment, the present disclosure provides an apparatus for delivery of a lens component into an eye. The apparatus comprises a housing; a plunger at least partially disposed in the housing, wherein the plunger comprises an elongated portion and a viscoelastic soft tip at a distal end of the elongated portion, wherein the viscoelastic soft tip has a durometer value of about <NUM><NUM> to about <NUM> D on the Shore hardness scale, wherein the viscoelastic soft tip has a storage modulus of about <NUM> megapascal to about <NUM> megapascals, and wherein the viscoelastic soft tip has a loss modulus of about <NUM> megapascal to about <NUM> megapascals; a drive mechanism operatively coupled to plunger and configured to cause the plunger to translate in the housing; and a nozzle operatively coupled to the housing through which the plunger delivers the lens component into the eye.

Also disclosed but not claimed in the appended claims is a method for delivery of a lens component into an eye. The method may include inserting a nozzle of an insertion tool into the eye. The method may further include actuating the insertion tool to move a plunger through the nozzle such that the plunger drives a lens component through the nozzle and into the eye, wherein a viscoelastic soft tip of the plunger engages the lens component, wherein the viscoelastic soft tip has a storage modulus of about <NUM> MPa to about <NUM> MPa and a loss module of about <NUM> MPa to about <NUM> MPa. The method may further include placing lens component with a capsular bag in the eye.

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.

For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the implementations illustrated in the drawings and specific language will be used to describe them. It will nevertheless be understood that no limitation of the scope of the disclosure may be intended. Any alterations and further modifications to the described devices, instruments, methods, and any further application of the principles of the present disclosure are fully contemplated as would normally occur to one skilled in the art to which the disclosure relates. In particular, it may be fully contemplated that the features, components, and/or steps described with reference to one or more implementations may be combined with the features, components, and/or steps described with reference to other implementations of the present disclosure. For simplicity, in some instances the same reference numbers are used throughout the drawings to refer to the same or like parts.

Embodiments may generally relate to eye surgery. More particularly, embodiments may generally relate to systems, methods, and devices for inserting an intraocular lens (IOL). Embodiments may include an insertion tool for preparation and delivery of the IOL assembly into a patient's eye that includes a plunger, a nozzle, and an IOL holder. Embodiments of the IOL may include a modular IOL that includes a base portion and a lens portion. In some embodiments, the plunger may include a viscoelastic soft tip. The viscoelastic soft tip may engage a lens component and drive the lens component through the nozzle. The lens component may be the IOL itself or an individual component of a modular IOL, such as a base portion of a lens portion. Advantageously, the viscoelastic soft tip should reduce the tendency for a soft tip plunger to have an undesirable sudden or self-ejection of the IOL, for example, due to release of spring energy stored from compression of the soft tip. By proper selection of the viscoelastic properties of the viscoelastic soft tip, the stored spring energy should be slowly released, thus reducing, or potentially even eliminating, the undesirable sudden and self-ejection of the IOL.

<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 intraoperatively or post-operatively. 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 arms (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 schematic of an insertion tool <NUM>. In some embodiments, the insertion tool <NUM> may include a drive mechanism <NUM>, a plunger <NUM>, a lens holder <NUM>, and a nozzle <NUM>. The plunger <NUM> may be disposed at least partially in a housing <NUM>. For example, plunger <NUM> may extend from housing <NUM> to engage the drive mechanism <NUM> outside the housing <NUM>. In other embodiments, the plunger <NUM> may disposed within the housing <NUM>. In some embodiments. The drive mechanism <NUM> may be operatively coupled to the plunger. As illustrated, the plunger <NUM> may include a viscoelastic soft tip <NUM>. The insertion tool <NUM> may be operable for delivery of a lens component <NUM> into a patient's eye. The lens component <NUM> may include any suitable component of an IOL, including the IOL itself or a component of the modular IOL10 shown on <FIG>, such as the base portion <NUM> or the lens portion <NUM>.

The drive mechanism <NUM> may be any suitable combination of components to actuate the plunger <NUM>. For example, the drive mechanism <NUM> may utilize a lever and/or pneumatic systems. The plunger <NUM> may be operatively coupled to the drive mechanism <NUM>. The drive mechanism <NUM> may actuate the plunger <NUM> through any suitable technique including, but not limited to, an electric drive, a mechanical drive, a hydraulic drive, a pneumatic drive, and/or combinations thereof. The plunger <NUM> may be actuated to move through the lens holder <NUM>. The lens holder <NUM> may be disposed at any suitable location within the insertion tool <NUM>, for example, the lens holder <NUM> may be contained in or inserted into the housing <NUM> through which the plunger <NUM> is driven. In some embodiments, the lens holder <NUM> may be located between the drive mechanism <NUM> and the nozzle <NUM>. In some embodiments, the lens holder <NUM> may contain a lens component <NUM>. In some embodiments, the lens component <NUM> may be loaded in the lens holder <NUM> in an unfolded configuration. The lens holder <NUM> may be actuated to fold the lens component <NUM> for delivery 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>. As the plunger <NUM> moves through the lens holder <NUM>, the plunger <NUM> may displace the lens component <NUM> through the nozzle <NUM>. The viscoelastic soft tip <NUM> should engage the lens component <NUM> as it moves 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 a lens component <NUM> (e.g., modular IOL <NUM>, base portion <NUM>, 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 lens holder <NUM>.

An example 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>, 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> millimeters. For example, the incision <NUM> may have a suitable width and/or length of from about <NUM> millimeter to about <NUM> millimeters, about <NUM> millimeter to about <NUM> millimeters, from about <NUM> millimeters to about <NUM> millimeters, or from about <NUM> millimeters to about <NUM> millimeters. 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>. For example, the plunger <NUM> with the viscoelastic soft tip <NUM> may engage the base portion <NUM> to 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>. While not shown on <FIG>, the inserter tool <NUM> shown on <FIG> or other suitable inserter may be used for delivery of the lens portion <NUM> into the eye <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 (not shown).

<FIG> illustrates the plunger <NUM> in accordance with embodiments of the present disclosure. In the illustrated embodiment, the plunger <NUM> includes an elongated portion <NUM> and a viscoelastic soft tip <NUM>. The elongated portion <NUM> may be formed from any suitable material. For example, suitable materials for the elongated portion <NUM> may include, for example, a metal, such as stainless steel or titanium. However, the elongated portion <NUM> may be formed from any suitable material, including, but not limited to, a polymer, metal, ceramic, or other suitable material. The viscoelastic soft tip <NUM> may be coupled at a distal end <NUM> of the elongated portion <NUM>. Any suitable technique may be used for coupling the viscoelastic soft tip <NUM> and the elongated portion <NUM>. For example, coupling the viscoelastic soft tip <NUM> and the elongated portion <NUM> may be accomplished with extrusion, casting, molding, injection molding, insert molding, welding, adhesives, or other desired or suitable methods. In some embodiments, the coupling may be accomplished using a combination of two or more of these methods. In some embodiments (not shown), the viscoelastic soft tip <NUM> and the elongated portion <NUM> may be unitary with the viscoelastic soft tip <NUM> being an extension of the elongated portion <NUM>.

The elongated portion <NUM> may have any suitable dimensions. For example, the elongated portion <NUM> may have a length of about <NUM> centimeters to about <NUM> centimeters. By way of further example, the elongated portion <NUM> may have an outer diameter of about <NUM> centimeters to about <NUM> centimeters. The viscoelastic soft tip <NUM> may also have any suitable dimensions. For example, the viscoelastic soft tip <NUM> may have a length of about <NUM> centimeters to about <NUM> centimeter. By way of further example, the viscoelastic soft tip <NUM> may have an outer diameter of about <NUM> centimeters to about <NUM> centimeters. Further, an exterior size and shape of the viscoelastic soft tip <NUM>, in some embodiments, may correspond to the size and shape of the elongated portion <NUM>, thereby producing a smooth transition between the elongated portion <NUM> and the viscoelastic soft tip <NUM>.

The viscoelastic soft tip <NUM> may be adapted to provide a cushioning and/or non-abrasive engagement with lens component <NUM> (e.g., shown on <FIG>), such as the base portion <NUM> (e.g., shown on <FIG>) or the lens portion <NUM> (e.g., shown on <FIG>). Thus, the hardness of the viscoelastic soft tip <NUM> may be selected, for example, to provide for a cushioning and/or non-abrasive engagement with the lens component <NUM>. The material forming the viscoelastic soft tip <NUM> has a durometer value of about <NUM> OO to <NUM> D on the Shore hardness scale. As used herein, durometer values are Shore hardness values.

In addition to hardness, the viscoelastic soft tip <NUM> may also be characterized by viscoelasticity. For example, the viscoelastic soft tip <NUM> may be exhibit both viscous and elastic characteristics when undergoing deformation. Due to pressure applied when forcing the lens component <NUM> through the nozzle <NUM> (e.g., shown on <FIG>), the viscoelastic soft tip <NUM> can deform, for example, compress as it is forced through the nozzle <NUM> in engagement with the lens component <NUM>. By having elastic characteristics, the viscoelastic soft tip <NUM> should return to its original state once the stress is removed, for example, after exit from the nozzle <NUM>. However, if the viscoelastic soft tip <NUM> does not include sufficient viscous properties, the viscoelastic soft tip <NUM> can return to its original state too quickly thus undesirably pushing lens component <NUM> as the viscoelastic soft tip <NUM> springs back to its original state. Accordingly, embodiments may include selection of the viscous properties so that the viscoelastic soft tip <NUM> should slowly return to its original state without undesired auto ejection of the lens component caused by spring back to its original state too quickly.

The viscoelasticity of the viscoelastic soft tip <NUM> may be characterized by its storage (or elastic) modulus (G') and loss modulus (G"). By way of example, the storage modulus and the loss modulus of the viscoelastic soft tip <NUM> may be selected to provide desired viscoelasticity. According to the present invention, the storage modulus for the viscoelastic soft tip <NUM> at room temperature (<NUM>) is from <NUM> MPa from <NUM> MPa. Suitable loss modulus for the viscoelastic soft tip <NUM> at room temperature (<NUM>) range from <NUM> MPa to <NUM> MPa. As used herein, storage modulus and loss modulus are measured at a frequency of <NUM> using the standardized test procedure described in ASTM D <NUM> for Dynamic Mechanical Analysis ("DMA"). One of ordinary skill in the art with the benefit of this disclosure should be able to select appropriate storage modulus and loss modulus for the viscoelastic soft tip <NUM> for a particular application.

In accordance with present embodiments, the viscoelastic soft tip <NUM> may be formed from any suitable viscoelastic material. Particularly, in some embodiments, the viscoelastic soft tip <NUM> may be formed from any medically compatible viscoelastic material. The viscoelastic soft tip <NUM> may be formed from materials including, for example, polyurethane, acetate, acrylate, polyester, polyamide, and combinations thereof. In some embodiments, the viscoelastic soft tip <NUM> may comprise a viscoelastic polymer. Foams of the same material classes may be considered as well. In some embodiments, the elongated portion <NUM> and the viscoelastic soft tip <NUM> may comprise the same or similar materials.

<FIG> illustrates the plunger <NUM> in accordance with another embodiment of the present disclosure. In the illustrated embodiment, the plunger <NUM> includes an elongated portion <NUM> and a viscoelastic soft tip <NUM>. In contrast to the viscoelastic soft tip <NUM> shown on <FIG>, the viscoelastic soft tip <NUM> is disposed around the distal end <NUM> of the plunger <NUM>. Any suitable technique may be used for disposing the viscoelastic soft tip <NUM> around the distal end <NUM> of the plunger <NUM>, including, but not limited to, extrusion, casting, molding, injection molding, insert molding, welding, adhesives, or other desired or suitable methods. In some embodiments, two or more of these methods may be used for attaching the viscoelastic soft tip <NUM> around the distal end <NUM> of the plunger <NUM>.

<FIG> illustrates a plunger <NUM> having a viscoelastic soft tip <NUM> pushing a lens component <NUM> through a nozzle <NUM> in accordance with embodiments of the present disclosure. As illustrated, the plunger <NUM> may include a viscoelastic soft tip <NUM> at its distal end <NUM>. In the illustrated embodiment, the viscoelastic soft tip <NUM> engages the lens component <NUM> to push the lens component <NUM> through the nozzle <NUM>. Due to the force required to force the viscoelastic soft tip <NUM> and lens component <NUM> through the nozzle <NUM>, the viscoelastic soft tip <NUM> can compress or otherwise deform. As a result of this deformation, the viscoelastic soft tip <NUM> can store spring energy. The viscoelastic soft tip <NUM> should be advanced through the nozzle <NUM> until the lens component <NUM> is ejected from nozzle outlet <NUM>. By tuning the viscoelasticity of the viscoelastic soft tip <NUM>, the stored spring energy should not be undesirably released upon release of this compressive force when the viscoelastic soft tip <NUM> exits the nozzle outlet <NUM>. As a result, problems typically associated with a soft tip resulting in undesirable sudden and self-ejection of the lens component <NUM> can be reduced or potentially even avoided from use of the viscoelastic soft tip <NUM>. Additionally, as shown in <FIG>, a plunger <NUM> having a soft tip <NUM> without tuning of viscoelasticity may rapidly expand after exit from the nozzle outlet <NUM>, thus preventing retraction of the soft tip <NUM> into the nozzle <NUM> for exit from the patient's eye. However, as shown in <FIG>, the plunger <NUM> having a viscoelastic soft tip <NUM> should slowly expand after exit from the nozzle outlet <NUM>, allowing retraction into the nozzle <NUM> so that the nozzle <NUM> can be removed from the patient's eye.

While the preceding description is generally directed to use of the plunger <NUM> having a viscoelastic soft tip <NUM> (e.g., shown on <FIG>) with a modular IOL <NUM> (e.g., shown on <FIG>), it is contemplated that the viscoelastic soft tip <NUM> can be used in any suitable application for delivery of lens components, such as lens component <NUM> (e.g., <FIG>). While the lens component <NUM> can be a modular IOL <NUM> are particular component thereof (e.g., base portion <NUM> on <FIG> or lens portion <NUM> on <FIG>), the lens component <NUM> can also comprise a non-modular IOL in which base and the lens portions of the IOL are fixed to another where the lens portion cannot be exchanged without removal of the.

Claim 1:
An apparatus (<NUM>) for delivery of a lens component (<NUM>) into an eye, comprising:
a housing (<NUM>);
a plunger (<NUM>) at least partially disposed in the housing, wherein the plunger comprises an elongated portion (<NUM>) and a viscoelastic soft tip (<NUM>) at a distal end of the elongated portion, wherein the viscoelastic soft tip has a durometer value of about <NUM> OO to about <NUM> D on the Shore hardness scale, wherein the viscoelastic soft tip has a storage modulus of about <NUM> megapascal to about <NUM> megapascals, at room temperature (<NUM>), and wherein the viscoelastic soft tip has a loss modulus of about <NUM> megapascal to about <NUM> megapascals; at room temperature (<NUM>);
a drive mechanism (<NUM>) operatively coupled to plunger and configured to cause the plunger to translate in the housing; and
a nozzle (<NUM>) operatively coupled to the housing through which the plunger delivers the lens component into the eye.