IOL folding device
The IOL folding device addresses the challenges of folding multi-part IOLs by using a mechanism with hooks and cams to apply symmetrical forces, ensuring precise and sterile folding, reducing user error and contamination risks.
Patent Information
- Application Number
- JP2021534191
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2018-12-19
- Filing Date
- 2019-12-13
- Publication Date
- 2025-01-24
- Estimated Expiration
- 2039-12-13
AI Technical Summary
Existing IOL delivery devices face challenges in accurately and sterily folding multi-part IOLs, such as two-piece IOLs, which can lead to user error, contamination, and improper folding due to complex geometry, especially when applying force to the edges of the hollow base.
An IOL folding device with a housing, storage shelves, and a folding channel mechanism that uses hooks and cams to apply symmetrical forces, ensuring uniform folding of IOLs by maintaining the center of mass, and includes a spring for returning to the rest position, compatible with both one-piece and multi-piece IOLs.
The device ensures precise and sterile folding of IOLs, reducing the risk of user error and contamination, and optimally folds complex geometries like two-piece IOLs, maintaining the integrity and sterility until insertion into the eye.
Smart Images

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Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 781,862, filed December 19, 2018, the entire contents of which are incorporated herein by reference.
[0002] The present disclosure relates to systems, devices, and methods for intraocular lens (IOL) injectors. [Background technology]
[0003] The human eye functions, most simply, to provide vision by transmitting and refracting light through a clear outer portion called the cornea, and then focusing the image onto the retina at the back of the eye by means of a lens. The quality of the focused image depends on many factors, including the size, shape, and length of the eye, as well as the shape and transparency of the cornea and lens. When the transparency of the lens decreases due to trauma, age, or disease, vision is reduced because less light can be transmitted to the retina. This defect in the lens of the eye is medically known as a cataract. Treatment for this condition is surgical removal of the lens and insertion of an artificial intraocular lens (IOL).
[0004] Many cataractous lenses are removed by a surgical technique called phacoemulsification. During this procedure, an opening is made in the anterior capsule of the eye and a phacoemulsification cutting tip is inserted into the diseased lens and vibrated ultrasonically. The vibrating cutting tip liquefies or emulsifies the lens so that it may be aspirated from the eye. Once removed, the diseased lens is replaced with an IOL.
[0005] The IOL may be injected into the eye through a small incision, possibly the same incision used to remove the diseased lens. An IOL injector may be used to deliver the IOL to the eye. Summary of the Invention [Means for solving the problem]
[0006] An intraocular lens (IOL) folding device is described. The IOL folding device has a housing and a pair of IOL storage shelves disposed within opposing sides of the housing, each IOL storage shelf adapted to support a portion of an unfolded IOL. The IOL folding device also has an IOL folding channel formed between the IOL storage shelves, each IOL storage shelf coupled to the IOL folding channel by a lip, the IOL folding channel having a longitudinal axis adapted to align with a bore of an IOL injector and having a bottom surface forming a floor. The IOL folding device also has an IOL folding guide axially aligned above the IOL folding channel, the IOL folding guide having a first end adapted to contact an upper surface of the IOL and a second end coupled to the housing or a user-actuable handle. The user-actuable handle has a first end accessible to a user and a second end coupled to the IOL folding guide or the IOL folding channel, and in response to actuation of the lever or button, the floor of the IOL folding channel and the IOL folding guide are adapted to move toward one another such that the IOL folding guide is configured to thereby urge the unfolded IOL into the IOL folding channel and assume a folded configuration within the IOL folding channel.
[0007] The IOL folding channel is disposed within a block, the block coupled to the housing and slidably movable therein. The user-actuatable handle may include a lever having a first end accessible to the user and a second end coupled to the block, and the IOL folding device may include a spring having a first end coupled to the block and a second end coupled to the housing. In response to actuation of the lever, the block may be adapted to move from a rest position in which the channel is aligned with the bore such that a floor of the IOL folding channel moves toward the IOL folding guide, thereby forcing the IOL into the IOL folding channel. The spring is adapted to return the block to the rest position.
[0008] The IOL folding guide may include first and second arms, each arm having a first end and a second end, with an inner hook disposed on the first end, the inner hook adapted to contact an inner edge of the IOL base.
[0009] The IOL folding guide may include first and second arms, each arm having a first end and a second end, with an outer hook disposed on the first end, the outer hook adapted to contact an outer edge of the haptic.
[0010] The IOL may have an IOL base with proximal and distal notches disposed within an inner edge of the IOL base, and the inner hooks may be adapted to contact the IOL base at the proximal and distal notches.
[0011] The IOL folding guide may include first and second cams, each cam having a wedge extending therefrom and pivotally coupled to the beam and pivotally movable along a track, the wedge adapted to contact an inner edge of the IOL base. The user-actuatable handle may include a button slidably disposed within a first side of the housing, the button having a first end depressible by a user and a second end coupled to the beam. The IOL folding device may include a spring having a first end coupled to the button and a second end coupled to the housing. In response to depression of the button, the beam may be adapted to move from a rest position toward a floor of the IOL folding channel, the cam may be adapted to rotate along the track, the wedge may be adapted to contact the IOL base, thereby forcing the IOL into the IOL folding channel and axially stretching the IOL base, and the spring may be adapted to return the button to the rest position.
[0012] The IOL base may include proximal and distal notches disposed within an inner edge of the IOL base, and the wedge portion may be adapted to contact the IOL base at the proximal and distal notches.
[0013] The IOL folding guide may include first and second flexible arms, each having a first end and a second end, with an inner hook formed on the first end, the inner hook adapted to contact an inner edge of the IOL base. The IOL folding device may include a user-actuatable handle having a button slidably disposed within a first side of the housing, the button having a first end depressible by a user and a second end coupled to the second end of the flexible arms, and a spring having a first end coupled to the button and a second end coupled to the housing. In response to pressing the button, the flexible arms may be adapted to move from a resting position toward the floor of the IOL folding channel, the flexible arms may be adapted to bend axially in response to resistance of the unfolded IOL base to assume a folded configuration as the IOL base enters the IOL folding channel such that first ends of the flexible arms move away from each other, the inner hook may be adapted to contact the IOL base and axially stretch the IOL base, and the spring may be adapted to return the button to the resting position.
[0014] The first end of each flexible arm may further include an outer hook adapted to contact an outer edge of the haptic. In response to axial extension of the IOL base, the outer hook may be adapted to hold an inner edge of the haptic in contact with an outer edge of the IOL base.
[0015] The IOL base may include proximal and distal notches disposed within an inner edge of the IOL base, and the inner hooks may be adapted to contact the IOL base at the proximal and distal notches.
[0016] The IOL folding guide may include a beam having a first end and a second end, the beam adapted to contact a top surface of the IOL. The user-actuatable handle may include a button slidably disposed within a first side of the housing, the button having a first end depressible by a user and a second end coupled to the beam, and the IOL folding device may include a spring having a first end coupled to the button and a second end coupled to the housing. In response to depression of the button, the beam may be adapted to move from a rest position toward a floor of the IOL folding channel, thereby pushing the IOL into the IOL folding channel, and the spring may be adapted to return the button to the rest position.
[0017] The first end of the beam may include an outer hook adapted to contact an outer edge of the haptic. In response to the beam forcing the IOL into the IOL folding channel, the outer hook may be adapted to hold the haptic in contact with an outer edge of the IOL base or the IOL optic.
[0018] The lip of each shelf may include an overhang extending from the shelf partially beyond the IOL folding channel, the overhang configured to retain a folded IOL in the IOL folding channel.
[0019] The IOL folding device may be fixedly disposed within the IOL injector or may be removably disposed therein.
[0020] The IOL injector may include an injector body having a body with a proximal end and a distal end and a nozzle with a proximal end and a distal end, the proximal end of the nozzle being coupled to the distal end of the body. The nozzle may include an IOL storage location configured to receive an unfolded IOL and an IOL dwell location located distal to the IOL storage location. The injector body may include a bore having a longitudinal axis extending from the proximal end of the body to the distal end of the nozzle. A distal portion of the bore in the nozzle may form a delivery channel. The IOL injector may also include a plunger movably coupled within the injector body and aligned within the bore, the plunger having a plunger tip adapted to contact the IOL.
[0021] The IOL folding device may be disposed within the nozzle.
[0022] The IOL folding device may be disposed within the IOL housing location.
[0023] The IOL folding device may be configured such that the plunger is axially movable through the IOL folding channel.
[0024] The IOL folding device may be adapted to separately fold the IOL base, the IOL optic, or both.
[0025] The IOL folding device may be adapted to simultaneously fold the IOL base and the IOL optic.
[0026] The floor may be configured to be below the center of gravity of the unfolded IOL when the unfolded IOL is positioned on the shelf.
[0027] For a more complete understanding of the present disclosure, reference is now made to the following descriptions, taken in conjunction with the accompanying drawings, which are not to scale. [Brief description of the drawings]
[0028] [Figure 1] FIG. 1 is a perspective view of an example IOL injector. [Diagram 2] FIG. 2 is a longitudinal cross-sectional view of the exemplary IOL injector of FIG. [Figure 3A] FIG. 3A shows an example one-piece IOL. [Figure 3B] FIG. 3B shows an example two-piece IOL that includes a base and an optic. [Figure 4A] FIG. 4A is a schematic diagram of an example IOL folding device. [Figure 4B] FIG. 4B is another view of the example folding device of FIG. 4A. [Figure 4C] FIG. 4C is another view of the example folding device of FIG. 4A. [Figure 5A] FIG. 5A is a schematic diagram of an example IOL folding device. [Figure 5B] FIG. 5B is another view of the example folding device of FIG. 5A. [Figure 5C] FIG. 5C is another view of the example folding device of FIG. 5A. [Figure 6A] FIG. 6A is a schematic diagram of an example IOL folding device. [Figure 6B] FIG. 6B is another view of the example folding device of FIG. 6A. [Figure 6C] FIG. 6C is another view of the example folding device of FIG. 6A. [Figure 6D] FIG. 6D is a schematic diagram of the operation of the example folding device of FIG. 6A. [Figure 7] FIG. 7 is a schematic diagram of an example IOL folding device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0029] For the purpose of facilitating an understanding of the principles of the present disclosure, reference will now be made to the implementations shown in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation on the scope of the disclosure is intended. Any alternatives and further modifications to the described devices, apparatus, and methods, and any further applications of the principles of the present disclosure, as would normally occur to one skilled in the art to which the disclosure pertains, are fully contemplated. In particular, it is fully contemplated that features, components, and / or steps described with respect to one implementation may be combined with features, components, and / or steps described with respect to other implementations of the present disclosure.
[0030] 1 and 2 are schematic diagrams of an example IOL injector 10 that is actuated by the application of manual force by a user. The IOL injector 10 includes an injector body 20 and a plunger 30 adapted to reciprocate through a bore 40 formed in the injector body 20. The injector body 20 has a body 21 having a proximal end 50 and a distal end 23, and a nozzle 25 having a proximal end 22 and a distal end 60. The proximal end 22 of the nozzle 25 is coupled to the distal end 23 of the body 21. The nozzle 25 has an IOL storage location 80 configured to receive an uncompressed and unfolded IOL 70.
[0031] The bore 40 extends from the proximal end 50 of the body 21 to the distal end 60 of the nozzle 25. The distal portion of the bore 40 within the nozzle 25 forms a tapered delivery channel 31 through which an IOL may be axially advanced, compressed, and delivered into the eye via an opening 29 in the distal tip 27 at the distal end 60.
[0032] The plunger 30 is movably coupled within the injector body 20 and aligned within the bore 40. The plunger 30 has a plunger tip 220 that is adapted to contact the IOL 70.
[0033] The IOL injector 10 also includes a longitudinal axis 75. The longitudinal axis 75 may extend along the plunger 30 and define the longitudinal axis of the plunger 30.
[0034] The IOL storage location 80 may include a door 90 that provides access to the interior of the IOL storage location 80. The door 90 may include a hinge 100 such that the door 90 may pivot about the hinge 100 to open the IOL storage location 80, for example, to allow installation of an IOL 70. In other implementations, the IOL storage location 80 may exclude a door for installing the IOL 70. In such examples, the IOL 70 may be incorporated into the IOL storage location 80 upon assembly of the IOL injector 10. Thus, in such examples, the IOL injector 10 may be a preloaded IOL injector. In such examples, the IOL storage location 80 may have a cover that is not configured to open, rather than the door 90. The IOL storage location 80 may include a hole adapted to allow addition of a viscoelastic to the IOL storage location 80.
[0035] The syringe body 20 may also include a tab 110 formed on the proximal end 50 of the syringe body 20. The tab 110 may be manipulated by the finger, thumb, or hand of a user, such as an ophthalmologist, ophthalmic surgery assistant or nurse, or other medical professional, to advance the plunger 30 through the bore 40.
[0036] The plunger 30 may include a plunger body 200, a plunger rod 210 extending distally from the plunger body 200, and a plunger tip 220 formed at a distal end 230 of the plunger rod 210 and adapted to contact, for example, an IOL disposed in an IOL storage location 80 of the IOL injector 10. The plunger tip 220 of the plunger 30 is adapted to engage and advance an IOL, such as IOL 70, when the plunger 30 is advanced axially, thereby displaced distally within the bore 40 in the direction of arrow 78. In FIGS. 1 and 2, the IOL 70 is shown positioned within the IOL storage location 80. The plunger 30 may also include a flange 240 formed on a proximal end 250 that may be manipulated by a user's finger, thumb, or hand to advance the plunger 30 through the bore 40 by displacing the plunger 30 distally through the bore 40 in the direction of arrow 78.
[0037] In some implementations, IOL 70 may be a one-piece IOL. That is, in some implementations, IOL 70 may include optic 460 and haptics 450, as shown in FIG. 3A. Each haptic 450 includes a tip 452. In some implementations, optic 460 and haptics 450 may be integrally formed from a single piece of material. In other implementations, optic 460 may be formed from one piece of material and haptics 450 may be formed from another piece of material, and optic 460 and haptics 450 may be bonded together prior to delivery into the eye. In some cases, optic 460 and haptics 450 may be securely secured together prior to insertion into an IOL injector and delivery into the eye.
[0038] In other implementations, the IOL 70 may be a multi-piece IOL, for example, as shown in FIG. 3B. For example, in some implementations, the IOL 70 includes two or more separate components. FIG. 3B is an example IOL 70 including two removably attached components. As shown in FIG. 3B, the IOL 70 includes an optic 460 and a hollow ring including haptics 450 and forming a base 461 having a top 498 and a bottom 499. The optic 460 and the base 461 are adapted to be bonded together to form a one-piece IOL. For example, in some cases, the optic 460 and the base 461 are adapted to be bonded together to form a one-piece IOL, such as before or after insertion into the eye. In some cases, the optic 460 can be removed from the base 461 and replaced as needed. In some cases, one or more components of a multi-piece IOL, such as the two-piece IOL 70 shown in FIG. 3B, can be separately injected into a patient's eye. Once in the eye, the components may be assembled into a complete IOL. For example, in the case of a two-piece IOL 70 shown in FIG. 3B, the optic 460 and base 461 can be injected separately into the eye. Once injected, the optic 460 is adapted to be coupled to the base 461 within a groove 479 disposed within the inner edge 471 of the base 461. In some cases, one or more notches 15 are disposed within the outer edge 8. The one or more notches 15 may be configured to mate with the optic 460 and thereby orient the assembly of the optic 460 onto the base 461. The notches 15 may also provide a starting point for the IOL base 461 to begin to assume a folded or compressed configuration. In particular, in some cases, the notch 15 is disposed within the inner edge 8 such that the IOL base 461 assumes a compressed configuration, wherein the distal and proximal haptics 450 are maintained in distal and proximal positions, respectively, within the IOL injector when the IOL base 461 assumes the compressed configuration.In some cases, for example, base 461 can have two notches 15 disposed on either side within inner edge 8, for example, one notch 15 disposed within inner edge 8 adjacent a midpoint of the length of distal haptic 450 and another notch 15 disposed within inner edge 8 adjacent proximal haptic 450. Notches 15 may have other functions. For example, in some cases, a user may contact notches 15 with a surgical tool to manipulate the position of base 461 during insertion.
[0039] At times, a patient may require an exchange of the IOL, and the procedure to exchange the IOL may result in damage to the eye. For example, with a two-piece IOL, the exchange procedure may involve only the exchange of the optic, which allows the base to remain in place in the eye.
[0040] As explained above, in some implementations, IOL 70 may be a two-piece IOL in which base 461 and optic 460 are separately injected into a patient's eye. Thus, in the case of a two-piece IOL, base 461 and optic 460 may be housed in separate IOL injectors 10 for insertion into the eye. In other implementations, the two components of the two-piece IOL may be separately inserted into the eye using a single IOL injector. In the case of a single-piece IOL, optic 460 and haptics 450 form a unitary IOL and are inserted into the eye simultaneously using a single IOL injector.
[0041] Thus, in some implementations, a user may load a one-piece IOL into an IOL injector, for example, by loading the IOL into an IOL storage compartment of the IOL injector, such as IOL storage location 80 of the IOL injector described above. Also, as described, IOL storage location 80 may be accessed through a door, such as door 90.
[0042] In the case of a two-piece IOL, in some implementations, a user may load a base, such as base 461, into an IOL storage compartment of an IOL injector, e.g., through a door. An optic, such as optic 460, may be introduced into an IOL storage compartment of a separate IOL injector, e.g., through a door. In some cases, the IOL storage compartment may be accessed through a door, such as door 90.
[0043] In some implementations, the IOL 70 may be folded into a compressed or collapsed configuration. In the case of a two-piece IOL, in some implementations, one or both of the base 461 and the optic 460 may be folded into a compressed or collapsed configuration.
[0044] As will be appreciated by those skilled in the art, it is important for IOLs to be stored unfolded so as not to permanently deform over time, and therefore IOLs are not typically kept in a folded state, such as in storage, for extended periods of time.
[0045] Some existing IOL delivery devices involve a manual folding mechanism in which a user places the base of an IOL into a folding chamber and closes a door. When the door is closed, its internal features and dimensions fold the base. However, the user's action of loading and folding the base creates the possibility of user error in accurately loading it into the injector and may not ensure that all components remain sterile during the process.
[0046] In some implementations, the IOL may be preloaded into a storage compartment of an IOL injector, for example, during manufacturing or otherwise prior to distribution to an end user. Thus, in the case of a one-piece IOL, the one-piece IOL may be preloaded into a storage compartment in an IOL injector before being received by an end user. In the case of a two-piece IOL, the base may be preloaded into a storage compartment in one IOL injector while the optic may be preloaded into an IOL storage compartment in another IOL injector. As used herein, the term "preloaded" means that an IOL in either a one-piece or multi-piece configuration (including, for example, a two-piece configuration) is not loaded into an IOL injector by a user, but rather, the IOL is placed into the IOL injector before the IOL injector is received by a user and is then already contained within the IOL injector. The IOL injector(s) may be packaged in a sterile package when received by a user.
[0047] As will be appreciated by those of skill in the art upon reading this disclosure, an IOL preloaded into an IOL injector has advantages over manual placement and folding of an IOL into an IOL injector performed by a user. For example, as explained above, manual placement and folding of an IOL can provide more opportunity for error, which can result in unnecessary secondary manipulations or corrections during an already complex procedure. For example, manual placement and folding of an IOL can also introduce the possibility of contamination of the IOL, such as through human error or poor sterilization technique. Contamination of the IOL can compromise the sterile environment for the patient, creating a risk of infection or other harm to the patient.
[0048] Because the IOL base 461 is composed of a hollow ring and two protruding haptics, the base 461 typically has a more complex center of mass than the one-piece IOL 70. For example, the central axis of the base 461 may change when an external force is applied, which may be associated with increased difficulty in properly folding the base 461. For example, most conventional one-piece IOL injectors advance the IOL by applying force directly to the edges of the IOL optic or haptics. This technique is less suited to hollow base designs, because the base may sometimes collapse into a suboptimal configuration when an external force is applied to the edges of the base.
[0049] Thus, the complex geometry of a two-piece IOL typically requires the application of evenly distributed forces on the hollow ring of base 461, which optionally also contains optic 460. Additionally, in some implementations described herein, IOL folding may include the application of symmetric opposing forces to assist in folding haptics 450.
[0050] Thus, the present disclosure provides a folding mechanism that may be compatible with IOLs having a hollow base, and possibly other multi-part IOLs or even traditional single-piece IOLs. The built-in folding mechanisms described herein may also ensure that the IOL remains sterile and intact until insertion into a patient's eye.
[0051] The present disclosure relates to systems, devices, and methods for folding an IOL and delivering the folded IOL into an eye.
[0052] In various implementations described herein, the IOL injector 10 includes an IOL folding device adapted to fold an IOL, such as a two-piece IOL or a one-piece IOL. In some implementations described herein, the IOL folding device described herein is adapted to provide optimal folding of the IOL by stretching the hollow ring of the IOL base 461 by applying opposing outward axial forces to the inner edge 471 of the base 461 to maintain more control of the center of mass of the base 461 during folding. In some implementations, the IOL folding device described herein may also be adapted to provide optimal folding of the IOL by maintaining the haptics 450 in close proximity to or in contact with the outer edge 475 of the base 461 and / or the optic 460. In the implementations described herein, the IOL folding device is adapted to provide optimal folding of the IOL by forcing the IOL into a folding channel 2 adapted to align with the bore 40 of the IOL injector 10. Subsequently, after the IOL has assumed its folded configuration, an IOL injector having an IOL folding device is adapted so that the plunger tip 220 may contact the folded IOL 70 and advance it axially for delivery into the patient's eye.
[0053] 4A-7 are schematic diagrams of various implementations of the presently disclosed IOL folding device that may be incorporated into an IOL injector. In some cases, the IOL folding device may form an integral part of the IOL injector. In other cases, the IOL folding device may be a separate component, such as a detachable component that may be removably connected to the IOL injector.
[0054] When the IOL folding device is in an inactivated state, it may function as an IOL storage compartment within which the IOL (or components thereof) are in an unfolded state. The IOL folding device may be disposed within IOL storage location 80.
[0055] The IOL folding device may be used to fold one or more components of a one-piece or multi-piece IOL. The IOL (or one or more components thereof) may be manually loaded into the IOL folding device by a user, or the IOL (or one or more components thereof) may be preloaded during manufacture or at other time prior to delivery to a user.
[0056] In various implementations, the IOL folding device is contained within an IOL folding device housing 99. The housing 99 may form an integral part of the IOL injector body 20, such as being fixedly disposed within and forming an integral part of the nozzle 25, the IOL storage location 80, or the body 21. In other examples, the IOL folding device may be a separate component contained within the housing 99, such as a removable component that may be removably connected to the IOL injector. The IOL folding device housing 99 may be adapted to be removably disposed within the injector body 20 of the IOL injector 10, such as within the nozzle 25, the IOL storage location 80, or the body 21.
[0057] The IOL folding device has a pair of IOL storage shelves 1 disposed within lateral sides of an IOL folding device housing 99. For example, FIG. 4A shows a cutaway perspective view of an example IOL folding device, the cutaway taken along the longitudinal axis and showing only one of the shelves 1, while FIG. 4B shows a cutaway perspective view of the same example IOL folding device of FIG. 4A, but cut laterally and showing both shelves 1. When the IOL folding device is integrated into an IOL injector, a pair of IOL storage shelves 1 are disposed within lateral sides of an IOL injector body 20, such as within lateral sides of an IOL storage location 80. Each IOL storage shelf 1 is adapted to support a portion of an unfolded IOL 70. The IOL folding device has an IOL folding channel 2 formed between the IOL storage shelves 1. Each IOL storage shelf 1 is coupled to the IOL folding channel 2 by a lip 3. The IOL folding channel 2 has a longitudinal axis adapted to align with the bore 40 of the IOL injector when the IOL folding device is disposed within the IOL injector body 20. Thus, the term "laterally opposed" refers to opposite sides of the IOL folding device that are separated by the IOL folding channel 2. The IOL folding device may include a portion of the bore 40 adapted to axially align with and mate with the bore of the IOL injector 10, for example, as shown in FIG. 4A. The IOL folding device has a bottom surface that forms a floor 4 configured to be below the center of gravity 470 of the unfolded IOL 70 when the unfolded IOL 70 is positioned on the shelf 1. The term "center of gravity" as used herein refers to the center of mass of the unfolded IOL 70. Examples of the center of gravity 470 of an unfolded IOL 70, such as a one-piece or two-piece IOL 70, are shown in FIGS. 3A and 3B, respectively. The IOL folding device has an IOL folding guide 5 axially aligned above the IOL folding channel 2 .In various implementations described herein, the IOL folding guide 5 has a first end 81 adapted to contact the top surface of the IOL 70 and a second end 82 which may be coupled to an IOL folding device housing 99 or a user-actuable handle 101, such as a user-actuable lever 6 or a user-actuable button 7.
[0058] In various implementations of the IOL folding devices described herein, the user-actuable lever 6 or button 7 has a first end accessible to a user and a second end coupled to the IOL folding guide 5 and / or the IOL folding channel 2 and configured to move the floor 4 of the IOL folding channel 2 and the IOL folding guide 5 toward each other in response to actuation of the lever 6 or button 7. The IOL folding guide 5 is configured to thereby urge the unfolded IOL 70 into the IOL folding channel 2, and in response, the IOL 70 assumes a folded configuration within the IOL folding channel 2.
[0059] In some implementations, the IOL folding device may be configured such that the lip 3 of each shelf 1 includes an overhang 33 that extends from the shelf 1 partially beyond the IOL folding channel 2, such that the overhang 33 is configured to retain the folded IOL 70 within the IOL folding channel 2.
[0060] 4A-4C are schematic diagrams of an example IOL folding device of the present disclosure. In some implementations, such as the embodiment shown in FIGS. 4A-4C, the IOL folding channel 2 may be disposed within a block 8 coupled to a housing 99 and slidably movable therein. A user-actuatable lever 6 may have a first end accessible to a user and a second end coupled to the block 8. The IOL folding device may further include a spring 9 having a first end coupled to the block 8 and a second end coupled to the housing 99. In response to a user actuation of the lever 6, e.g., as shown in the direction of arrow 98 in FIG. 4A, the block 8 is adapted to move from a rest position, e.g., as shown in the direction of arrow 97 in FIG. 4A, such that the floor 4 of the IOL folding channel 2 moves toward the IOL folding guide 5. Thus, the first end 81 of the folding guide 5 is then disposed within the folding channel 2, thereby forcing the IOL 70 into the IOL folding channel 2. The rest position may be a position where the folding channel 2 is aligned with the bore 40 of the IOL injector. The spring 9 is adapted to return the block 8 to the rest position. In some implementations, the IOL folding device may include a compression spring adapted to return the block 8 to the rest position, as shown, for example, in FIGS. 4A-4C, or any other type of spring adapted to return the block 8 to the rest position, such as a tension spring or a torsion spring, among others. Upon returning to the rest position, the folding channel 2 is adapted to realign with the bore 4, and the first end 81 of the folding guide 5 exits from the folding channel 2 as the folding channel 2 returns to the rest position. Thus, upon returning to the rest position, the first end 81 of the folding guide 5 no longer extends into the folding channel 2, allowing the plunger 30 to pass therethrough.
[0061] The folding channel 2 may form part of the bore 40 when disposed within the IOL injector, thereby enabling axial movement of the plunger 30 through the bore 40 to advance the folded IOL axially through the injector body towards the distal end 60 of the nozzle 25 and into the patient's eye.
[0062] For example, as shown in FIGS. 4A-4C, in some implementations, the IOL folding guide 5 may have a first end 81 adapted to contact a top surface of the IOL 70, such as a top surface 498 of the IOL base 461, and a second end 82 coupled to the IOL folding device housing 99. The folding guide 5 may form first and second arms 5a adapted to contact the top surface 498 of the IOL base 461. Each arm 5a may have a first end 81 and a second end 82, and an inner hook 90a and / or an outer hook 90b may be disposed on the first end 81. For example, as shown in FIG. 3B, the inner hook 90a is adapted to contact an inner edge 471 of the IOL base 461, and the outer hook 90b is adapted to contact an outer edge 472 of the haptic 450. Thus, hooks 90a / b are adapted to control the folding of IOL base 461 as it is forced into folding channel 2. Inner hook 90a is adapted to stabilize the hollow ring of base 461 and apply uniform opposing axial outward forces to inner edge 471 of IOL base 461 to maintain a more stable center of mass of IOL base 461. Outer hook 90b is adapted to stabilize haptics 450 and hold haptics 450 near outer edge 475 of the ring of base 461 as IOL base 461 is folded.
[0063] 4A-4C , the inner hooks 90a may be absent and the IOL folding device may be adapted to fold a one-piece IOL 70 or an IOL base 461 having an optic 460 coupled to the IOL base 461. The inner hooks 90b are adapted to contact the inner edge 471 of the hollow ring of the IOL base 461, however, it will be understood that they may not be suitable for use with a one-piece IOL 70 or an IOL base 461 having an optic 460 disposed within the base 461 in some implementations.
[0064] In some implementations, the IOL base 461 may include proximal and distal notches 473 disposed in an inner edge 471 of the IOL base 461, and the inner hooks 90a may have a size and shape adapted for insertion into the notches 473, also providing a more stable contact or coupling between the inner hooks 90a and the IOL base 461. Thus, the notches 473 have utility for assembling the optic 460 onto the base 461, as described above, and may also have synergistic and / or unexpected functions that allow for contact or coupling between the IOL base 461 and the inner hooks 90a of the folding guide 5.
[0065] 5A-5C are schematic diagrams of another example IOL folding device of the present disclosure. In some implementations, such as the embodiment shown in FIG. 5A-5C, the IOL folding guide 5 may include first and second cams 51, each having a wedge portion 52 extending therefrom and pivotally coupled to a beam 53, as shown, for example, in the direction of arrow 96 in FIG. 5A. The cams 51 are pivotally movable along a track 54, and the wedge portion 52 is adapted to contact an inner edge 471 of the IOL base 461. The IOL folding device may have a user-actuable button 7 slidably disposed within a first side of the housing 99. The button 7 may have a first end accessible by a user, and the button 7 may be depressible, such as in the direction of arrow 95 in FIG. 5A. The button 7 has a second end 83 coupled to the beam 53. The IOL folding device may include a spring 55 having a first end coupled to the button 7 and a second end coupled to the housing 99. The IOL folding device may be configured such that, in response to depression of the button 7, the beam 53 is adapted to move from a rest position toward the floor 4 of the IOL folding channel 2, the cam 51 is adapted to pivot along the track 54, and the wedge portion 52 is adapted to contact the IOL base 461 and extend into the folding channel 2, forcing the IOL 70 into the IOL folding channel 2 while elongating the IOL base 461 axially. Thus, the wedge portion 52 of the cam 51 is adapted to apply uniform opposing axially outward distal and proximal forces against the inner edge 471 of the IOL base 461 to maintain a more stable center of mass of the IOL base 461 while forcing the IOL into the folding channel 2. The spring 55 is adapted to return the button 7 to the rest position. In response to button 7 returning to the rest position, beam 53 of folding guide 5 returns to the rest position and, in response, cam 51 of folding guide 5 is adapted to pivot in a direction opposite to the direction of arrow 96 such that cam 5 exits folding channel 2, as shown in Figure 5A. Thus, upon returning to the rest position, cam 51 no longer extends into folding channel 2, allowing plunger 30 to pass therethrough.After folding the IOL, the IOL folding device is configured such that the folded IOL is held within folding channel 2 and ready to be advanced axially by plunger 30.
[0066] In some implementations, the IOL base 461 may include proximal and distal notches 473 disposed in an inner edge 471 of the IOL base 461, and the wedge portion 53 may have a size and shape adapted for insertion into the notches 473, also providing a more stable coupling between the wedge portion 53 and the IOL base 461. Thus, the notches 473 have utility for assembling the optic 460 onto the base 461, as described above, and may also have synergistic and / or unexpected functions to enable contact or coupling between the IOL base 461 and the wedge portion 53 of the folding guide 5.
[0067] In some implementations, the IOL folding guide with cam 51 may further include an outer hook coupled to the folding guide 5, such as outer hook 90b described above, which is adapted to contact the outer edge 472 of the haptic 450 and is configured to stabilize the haptic 450 and hold the haptic 450 near the outer edge 475 of the ring of the base 461 when the IOL base 461 is folded.
[0068] 6A-6D are schematic diagrams of another example IOL folding device of the present disclosure. In some implementations, such as the embodiment shown in FIGS. 6A-6D, the IOL folding guide 5 includes first and second flexible arms 5b. Each flexible arm 5b has an inner hook 90a formed at a first end 81 of the flexible arm 5b. The inner hook 90a is adapted to contact an inner edge 471 of the IOL base 461. The IOL folding device may include a user-actuable button 7 slidably disposed within a first side of the housing 99, the button 7 having a first end depressible by a user and a second end coupled to the second end 82 of the flexible arm 5b. The IOL folding device may include a spring 55 having a first end coupled to the button 7 and a second end coupled to the housing 99. The IOL folding device may be adapted such that in response to a user pressing of button 7, the flexible arm 5b is adapted to move from a resting position above the IOL folding channel 2 toward the floor 4 of the IOL folding channel 2 in a manner similar to that described above for the implementation exemplified by the IOL folding device shown in Figures 5A-5C.
[0069] The unfolded IOL base 461 may be forced into the folding channel 2 and exhibit some resistance to assuming a folded configuration. In response to movement of the flexible arms 5b toward the floor 4 of the IOL folding channel 2, the flexible arms 5b are adapted to flex axially in response to the resistance of the unfolded IOL base 461 to assume a folded configuration as the IOL base 461 enters the IOL folding channel 2 such that the first ends 81 of the flexible arms 5b move away from each other, e.g., as shown in the direction of arrow 94 in FIG. 6D. For example, the upper panel of FIG. 6D shows the flexible arms 5b in an unflexed orientation, such as a resting position in which the folding device is not actuated. The lower panel of FIG. 6D shows the flexible arms 5b in an axially bent orientation, such as in response to actuation of the folding device by movement of the button 7 in the direction of arrow 95. For example, when the IOL folding device is disposed in an IOL injector, the distally oriented flexible arms 5b are adapted to bend axially towards the distal end 60 of the injector body 20, and the proximally oriented flexible arms 5b are adapted to bend axially towards the proximal end 50 of the injector body 20. For a given IOL base 461, the flexibility of the flexible arms 5b can be optimized such that they are able to push the IOL base 461 into the folding channel 2, while also having the ability to bend in response to the resistance of the IOL base 461. It will be appreciated that the type of material, such as flexible plastic, and its weight or thickness can be selected to optimize the performance of the flexible arms to achieve these desired properties.
[0070] The inner hook 90a of the IOL folding device as shown in Figures 6A-6D is adapted to contact the inner edge 471 of the IOL base 461 and axially stretch the IOL base 461, similar to that described above with respect to the example implementation shown in Figures 4A-4C. Also similar to that described above, the spring 55 of the example IOL folding device shown in Figures 6A-6D is adapted to return the button 7 to a rest position, in response to which the flexible arm 5b is adapted to exit the folding channel 2, thereby allowing movement of the plunger 30 of the IOL injector 10 therethrough.
[0071] 6A-6D , the first end 81 of each flexible arm 5b may further include an outer hook 90b adapted to contact an outer edge 472 of the haptic 450. As described above, in response to axial extension of the IOL base 461, the outer hook 90b is adapted to hold the inner edge 474 of the haptic 450 adjacent to or in contact with the outer edge 475 of the IOL base 461.
[0072] Also, as described above, the IOL base 461 may include proximal and distal notches 473 disposed within the inner edge 471 of the IOL base 461, and the inner hooks 90a of the example IOL folding device of Figures 6A-6D may be adapted to contact the IOL base 461 at the proximal and distal notches 473.
[0073] 7 is a schematic diagram of yet another example IOL folding device of the present disclosure. In some implementations, such as the embodiment shown in FIG. 7, rather than having a pair of actuators adapted to contact the IOL 70, such as a pair of arms 5a, or a pair of cams 51, or a pair of flexible arms 5b, the IOL folding guide 5 may include a single actuator, such as a beam 53, adapted to contact the top surface 498 of the IOL 70. The IOL folding device may include a user-actuable button 7 slidably disposed within a first side of the housing 99, the button 7 having a first end depressible by a user and a second end coupled to the beam 53. As described above, the IOL folding device may further include a spring 55 having a first end coupled to the button 7 and a second end coupled to the housing 99. The IOL injector may be adapted such that, in response to pressing of button 7, beam 53 is adapted to move from a rest position toward floor 4 of the IOL folding channel 2, thereby pushing IOL 70 into the IOL folding channel 2, and spring 55 is adapted to return button 7 to the rest position.
[0074] It will be understood that an IOL folding device having a beam 53, such as that of FIG. 7, is suitable for folding a one-piece IOL 70, or an IOL base 461, or an IOL base 461 having an optic 460 coupled to the IOL base 461.
[0075] In some implementations, such as that shown in FIG. 7, the beam 53 may further include outer hooks 90b at first and second ends of the beam 53 that are adapted to contact the outer edges 472 of the haptics 450.
[0076] Thus, in various implementations, the IOL folding device may be adapted so that the inner edge 474 of the haptic 450 substantially abuts and matches the outer circumference of the IOL base 461 or the outer edge 475 of the IOL optic 460, such that the outer hooks 90b are adapted to press the inner edge 474 of the haptic 450 close to or in contact with the outer edge 475 of the IOL base 461, or close to or in contact with the IOL optic 460.
[0077] In some implementations, the outer hooks 90b may be adapted to contact the outer edge 472 of the haptics 450 before the beams 53 contact the top surface 498 of the ring of the base 461, or before the beams 53 contact the optic 460 of a one-piece IOL, or before the beams 53 contact the optic 460 coupled to the base 461. Thus, the outer hooks 90b may be adapted to urge the inner edge 474 of the haptics 450 adjacent to or in contact with the outer edge 475 of the IOL base 461, or adjacent to or in contact with the IOL optic 460, before the IOL is forced into the folding channel 2 and assumes its folded configuration.
[0078] After folding the IOL, the IOL folding device is configured so that the folded IOL is retained within folding channel 2, ready to be advanced axially in the folded configuration by plunger 30, and does not re-deploy and / or exit the folding channel before being engaged by plunger 30 and advanced through injector body 20. In some implementations, folding channel 2 may have a surface that provides sufficient friction in contact with the folded IOL when disposed within folding channel 2 to prevent unfolding of the folded IOL and / or exit of the folded IOL from folding channel 2.
[0079] In some implementations, the IOL folding device may be adapted to inject the IOL base 461, the IOL optic 460, or both separately. In some implementations, the IOL folding device may be adapted to inject the IOL base 461 and the IOL optic 460 simultaneously.
[0080] In use, in various implementations, when an IOL folding device of the present disclosure is disposed within an IOL injector, a user may actuate lever 6 or button 7 of the IOL folding device described herein, thereby placing the IOL 70 in a folded configuration. The user may then slide plunger 30 axially such that plunger tip 220 contacts the folded IOL 70, thereby advancing the IOL 70 through delivery channel 31 and out the distal end 60 of the IOL injector 10 to deliver the IOL 70 into the patient's eye.
[0081] Non-limiting examples of IOL injectors that may be adapted in accordance with the present disclosure include those described in U.S. Pat. No. 7,156,854 and U.S. Patent Application Publication No. 2016 / 0256316, the disclosures of each of which are incorporated herein by reference in their entirety.
[0082] The subject matter disclosed above should be considered as illustrative rather than restrictive, and the appended claims are intended to cover all such modifications, enhancements, and other implementations that fall within the true spirit and scope of the present disclosure. Accordingly, to the maximum extent permitted by law, the scope of the present disclosure should be determined by the broadest permissible interpretation of the following claims and their equivalents, and should not be restricted or limited by the foregoing detailed description. The present disclosure also includes the following inventions. The first aspect is 1. An intraocular lens (IOL) folding device, comprising: Housing and a pair of IOL storage shelves disposed within opposing sides of the housing, each IOL storage shelf adapted to support a portion of an unfolded IOL; an IOL folding channel formed between said IOL storage shelves, each IOL storage shelf being coupled to said IOL folding channel by a lip, said IOL folding channel having a longitudinal axis adapted to align with a bore of an IOL injector and having a bottom surface forming a floor; an IOL folding guide axially aligned above the IOL folding channel, the IOL folding guide having a first end adapted to contact an upper surface of an IOL and a second end coupled to the housing or a user-actuatable handle, the user-actuatable handle having a first end accessible to a user and a second end coupled to the IOL folding guide or the IOL folding channel; An IOL folding device wherein in response to actuation of the lever or button, the floor of the IOL folding channel and the IOL folding guide are adapted to move toward each other, whereby the IOL folding guide is configured to push an unfolded IOL into the IOL folding channel and assume a folded configuration within the IOL folding channel. The second aspect is the IOL folding channel is disposed within a block, the block being coupled to the housing and slidably movable therewithin; the user-actuable handle comprises a lever having a first end accessible to a user and a second end coupled to the block; the IOL folding device further comprises a spring having a first end coupled to the block and a second end coupled to the housing; In a first aspect of the IOL folding device, in response to actuation of the lever, the block is adapted to move from a rest position in which the channel is aligned with the bore so that the floor of the IOL folding channel moves toward the IOL folding guide, thereby pushing the IOL into the IOL folding channel, and the spring is adapted to return the block to the rest position. The third aspect is In a first aspect of the IOL folding device, the IOL folding guide comprises first and second arms, each arm having a first end and a second end, and an inner hook is disposed on the first end, the inner hook being adapted to contact an inner edge of the IOL base. The fourth aspect is In a first aspect of the IOL folding device, the IOL folding guide comprises first and second arms, each arm having a first end and a second end, and an outer hook is disposed on the first end, the outer hook being adapted to contact an outer edge of a haptic. The fifth aspect is In a third aspect of the IOL folding device, the IOL has an IOL base with proximal and distal notches disposed within an inner edge of the IOL base, and the inner hook is adapted to contact the IOL base at the proximal and distal notches. The sixth aspect is the IOL folding guide comprises first and second cams, each cam having a wedge portion extending therefrom and pivotally coupled to a beam and pivotally moveable along a track, the wedge portion adapted to contact an inner edge of the IOL base; the user-actuable handle comprises a button slidably disposed within a first side of the housing, the button having a first end depressible by a user and a second end coupled to the beam; the IOL folding device further comprises a spring having a first end coupled to the button and a second end coupled to the housing; An IOL folding device in a first aspect, wherein in response to pressing the button, the beam is adapted to move from a rest position toward the floor of the IOL folding channel, the cam is adapted to rotate along the track, the wedge portion is adapted to contact the IOL base thereby pushing the IOL into the IOL folding channel and axially extending the IOL base, and the spring is adapted to return the button to the rest position. The seventh aspect is An IOL folding device in a sixth aspect, wherein the IOL base has proximal and distal notches disposed within the inner edge of the IOL base, and the wedge portion is adapted to contact the IOL base at the proximal and distal notches. The eighth aspect is the IOL folding guide comprises first and second flexible arms, each flexible arm having a first end and a second end, an inner hook formed on the first end, the inner hook adapted to contact an inner edge of an IOL base; The IOL folding device may further include: a user-actuatable handle comprising a button slidably disposed within a first side of the housing, the button having a first end depressible by a user and a second end coupled to the second end of the flexible arm; a spring having a first end coupled to the button and a second end coupled to the housing; 1. An IOL folding device in a first aspect, wherein in response to pressing the button, the flexible arms are adapted to move from a resting position toward the floor of the IOL folding channel, the flexible arms are adapted to bend axially in response to resistance of the unfolded IOL base to assume a folded configuration as the IOL base enters the IOL folding channel such that the first ends of the flexible arms move away from each other, the inner hook is adapted to contact the IOL base and stretch the IOL base axially, and the spring is adapted to return the button to the resting position. The ninth aspect is the first end of each of the flexible arms further comprising an outer hook adapted to contact an outer edge of a haptic; In an eighth aspect of the IOL folding device, the outer hook is adapted to hold the inner edge of the haptic in contact with the outer edge of the IOL base in response to axial extension of the IOL base. A tenth aspect is the IOL base comprises proximal and distal notches disposed within the inner edge of the IOL base; An IOL folding device in an eighth aspect, wherein the inner hooks are adapted to contact the IOL base at the proximal and distal notches. An eleventh aspect is the IOL folding guide comprises a beam having a first end and a second end, the beam adapted to contact a top surface of the IOL; the user-actuatable handle comprises a button slidably disposed within a first side of the housing, the button having a first end depressible by a user and a second end coupled to the beam; the IOL folding device further comprises a spring having a first end coupled to the button and a second end coupled to the housing; In response to depression of the button, the beam is adapted to move from a rest position toward the floor of the IOL folding channel, thereby pushing the IOL into the IOL folding channel, and the spring is adapted to return the button to the rest position. 1 is a first embodiment of an IOL folding device. A twelfth aspect is the first end of the beam further comprises an outer hook adapted to contact an outer edge of a haptic; In an eleventh aspect of the IOL folding device, the outer hook is adapted to hold the haptic in contact with the outer edge of the IOL base or the IOL optic in response to the beam pushing the IOL into the IOL folding channel. A thirteenth aspect is In a first aspect of the IOL folding device, the lip of each shelf includes an overhang extending from the shelf partially beyond the IOL folding channel, the overhang configured to hold a folded IOL within the IOL folding channel. A fourteenth aspect is The IOL folding device is fixedly or removably disposed within an IOL injector, the IOL injector comprising: A syringe body, comprising: a body having a proximal end and a distal end; a nozzle having a proximal end and a distal end, the proximal end of the nozzle being coupled to the distal end of the body, the nozzle further having an IOL storage location configured to receive an unfolded IOL, and an IOL dwell location located distal to the IOL storage location; a syringe body having a bore having a longitudinal axis extending from the proximal end of the body to the distal end of the nozzle, a distal portion of the bore within the nozzle forming a delivery channel; An IOL folding device in a first aspect, comprising: a plunger movably coupled within the injector body and aligned within the bore, the plunger having a plunger tip adapted to contact an IOL. The fifteenth aspect is The IOL folding device in a first aspect, wherein the floor is configured to be below the center of gravity of an unfolded IOL when the unfolded IOL is positioned on the shelf.
Claims
1. 1. An intraocular lens (IOL) folding device, comprising: Housing and a pair of IOL storage shelves disposed within opposing sides of the housing, each IOL storage shelf adapted to support a portion of an unfolded IOL; an IOL folding channel formed between said IOL storage shelves, each IOL storage shelf being coupled to said IOL folding channel by a lip, said IOL folding channel having a longitudinal axis adapted to be aligned with a bore of an IOL injector and having a bottom surface forming a floor; an IOL folding guide axially aligned above the IOL folding channel, the IOL folding guide having a first end adapted to contact a top surface of an IOL and a second end coupled to the housing or a user-actuable handle comprising a lever or button, the user-actuable handle having a first end accessible to a user and a second end coupled to the IOL folding guide or the IOL folding channel; the IOL folding guide comprises first and second flexible arms, each flexible arm having a first end and a second end, an inner hook disposed on the first end, the inner hook adapted to contact an inner edge of an IOL base; An IOL folding device, wherein in response to actuation of the lever or button, the floor of the IOL folding channel and the IOL folding guide are adapted to move toward each other, and the IOL folding guide is configured to thereby push an unfolded IOL into the IOL folding channel and assume a folded configuration within the IOL folding channel.
2. 1. An intraocular lens (IOL) folding device, comprising: Housing and a pair of IOL storage shelves disposed within opposing sides of the housing, each IOL storage shelf adapted to support a portion of an unfolded IOL; an IOL folding channel formed between said IOL storage shelves, each IOL storage shelf being coupled to said IOL folding channel by a lip, said IOL folding channel having a longitudinal axis adapted to be aligned with a bore of an IOL injector and having a bottom surface forming a floor; an IOL folding guide axially aligned above the IOL folding channel, the IOL folding guide having a first end adapted to contact a top surface of an IOL and a second end coupled to the housing or a user-actuable handle comprising a lever or button, the user-actuable handle having a first end accessible to a user and a second end coupled to the IOL folding guide or the IOL folding channel; in response to actuation of the lever or button, the floor of the IOL folding channel and the IOL folding guide are adapted to move toward one another, and the IOL folding guide is configured to thereby urge an unfolded IOL into the IOL folding channel and assume a folded configuration within the IOL folding channel; the IOL folding channel is disposed within a block, the block being coupled to the housing and slidably movable therewithin; the user-actuatable handle comprises a lever having a first end accessible to a user and a second end coupled to the block; the IOL folding device further comprises a spring having a first end coupled to the block and a second end coupled to the housing; An IOL folding device, wherein in response to actuation of the lever, the block is adapted to move from a rest position in which the channel is aligned with the bore such that the floor of the IOL folding channel moves toward the IOL folding guide, thereby forcing the IOL into the IOL folding channel, and the spring is adapted to return the block to the rest position.
3. 10. The IOL folding device of claim 1, further comprising an outer hook disposed on the first end of each of the first and second flexible arms and adapted to contact an outer edge of a haptic.
4. 2. The IOL folding device of claim 1, wherein the IOL has an IOL base with proximal and distal notches disposed within an inner edge of the IOL base, and the inner hook is adapted to contact the IOL base at the proximal and distal notches.
5. 1. An intraocular lens (IOL) folding device, comprising: Housing and a pair of IOL storage shelves disposed within opposing sides of the housing, each IOL storage shelf adapted to support a portion of an unfolded IOL; an IOL folding channel formed between said IOL storage shelves, each IOL storage shelf being coupled to said IOL folding channel by a lip, said IOL folding channel having a longitudinal axis adapted to be aligned with a bore of an IOL injector and having a bottom surface forming a floor; an IOL folding guide axially aligned above the IOL folding channel, the IOL folding guide having a first end adapted to contact a top surface of an IOL and a second end coupled to the housing or a user-actuable handle comprising a lever or button, the user-actuable handle having a first end accessible to a user and a second end coupled to the IOL folding guide or the IOL folding channel; in response to actuation of the lever or button, the floor of the IOL folding channel and the IOL folding guide are adapted to move toward one another, the IOL folding guide thereby urging an unfolded IOL into the IOL folding channel and assuming a folded configuration within the IOL folding channel; the IOL folding guide comprises first and second cams, each cam having a wedge portion extending therefrom and pivotally coupled to a beam and pivotally moveable along a track, the wedge portion adapted to contact an inner edge of an IOL base; and the user-actuable handle comprises a button slidably disposed within a first side of the housing, the button having a first end depressible by a user and a second end coupled to the beam; the IOL folding device further comprises a spring having a first end coupled to the button and a second end coupled to the housing; An IOL folding device, wherein in response to pressing the button, the beam is adapted to move from a rest position toward the floor of the IOL folding channel, the cam is adapted to rotate along the track, the wedge portion is adapted to contact the IOL base, thereby pushing the IOL into the IOL folding channel and axially extending the IOL base, and the spring is adapted to return the button to the rest position.
6. 6. The IOL folding device of claim 5, wherein the IOL base comprises proximal and distal notches disposed within the inner edge of the IOL base, and the wedge portion is adapted to contact the IOL base at the proximal and distal notches.
7. 1. An intraocular lens (IOL) folding device, comprising: Housing and a pair of IOL storage shelves disposed within opposing sides of the housing, each IOL storage shelf adapted to support a portion of an unfolded IOL; an IOL folding channel formed between said IOL storage shelves, each IOL storage shelf being coupled to said IOL folding channel by a lip, said IOL folding channel having a longitudinal axis adapted to be aligned with a bore of an IOL injector and having a bottom surface forming a floor; an IOL folding guide axially aligned above the IOL folding channel, the IOL folding guide having a first end adapted to contact a top surface of an IOL and a second end coupled to the housing or a user-actuable handle comprising a lever or button, the user-actuable handle having a first end accessible to a user and a second end coupled to the IOL folding guide or the IOL folding channel; In response to actuation of the lever or button, the floor of the IOL folding channel and the IOL folding guide are adapted to converge toward one another, the IOL folding guide thereby urging an unfolded IOL into the IOL folding channel and into a folded configuration within the IOL folding channel; the IOL folding guide comprises first and second flexible arms, each flexible arm having a first end and a second end, an inner hook formed on the first end, the inner hook adapted to contact an inner edge of an IOL base; The IOL folding device further comprises: a user-actuatable handle comprising a button slidably disposed within a first side of the housing, the button having a first end depressible by a user and a second end coupled to the second end of the flexible arm; a spring having a first end coupled to the button and a second end coupled to the housing; An IOL folding device, wherein in response to pressing the button, the flexible arms are adapted to move from a rest position toward the floor of the IOL folding channel, the flexible arms are adapted to bend axially in response to resistance of the unfolded IOL base to assume a folded configuration as the IOL base enters the IOL folding channel such that the first ends of the flexible arms move away from each other, the inner hook is adapted to contact the IOL base and axially stretch the IOL base, and the spring is adapted to return the button to the rest position.
8. the first end of each of the flexible arms further comprising an outer hook adapted to contact an outer edge of a haptic; The IOL folding device of claim 7 , wherein in response to axial stretching of the IOL base, the outer hooks are adapted to hold the inner edges of the haptics in contact with the outer edges of the IOL base.
9. the IOL base comprises proximal and distal notches disposed within the inner edge of the IOL base; The IOL folding device of claim 7 , wherein the inner hooks are adapted to contact the IOL base at the proximal and distal notches.
10. the IOL folding guide comprises a beam having a first end and a second end, the beam adapted to contact a top surface of an IOL; the user-actuatable handle comprises a button slidably disposed within a first side of the housing, the button having a first end depressible by a user and a second end coupled to the beam; the IOL folding device further comprises a spring having a first end coupled to the button and a second end coupled to the housing; In response to depression of the button, the beam is adapted to move from a rest position toward the floor of the IOL folding channel, thereby pushing the IOL into the IOL folding channel, and the spring is adapted to return the button to the rest position. The IOL folding device of claim 1 .
11. the first end of the beam further comprises an outer hook adapted to contact an outer edge of a haptic; The IOL folding device of claim 10 , wherein the outer hooks are adapted to hold the haptics in contact with an outer edge of an IOL base or an IOL optic in response to the beams pushing the IOL into the IOL folding channel.
12. 2. The IOL folding device of claim 1, wherein the lip of each shelf includes an overhang extending from the shelf partially beyond the IOL folding channel, the overhang configured to retain a folded IOL within the IOL folding channel.
13. The IOL folding device is fixedly or removably disposed within an IOL injector, the IOL injector comprising: A syringe body, comprising: a body having a proximal end and a distal end; a nozzle having a proximal end and a distal end, the proximal end of the nozzle being coupled to the distal end of the body, the nozzle further having an IOL storage location configured to receive an unfolded IOL, and an IOL dwell location located distal to the IOL storage location; a syringe body having a bore having a longitudinal axis extending from the proximal end of the body to the distal end of the nozzle, a distal portion of the bore within the nozzle forming a delivery channel; 10. The IOL folding device of claim 1, comprising: a plunger movably coupled within the injector body and aligned within the bore, the plunger having a plunger tip adapted to contact an IOL.
14. The IOL folding device of claim 1 , wherein the floor is configured to be below a center of gravity of an unfolded IOL when the unfolded IOL is positioned on the IOL storage shelf.
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