WO2015112146A1

WO2015112146A1 - Apparatus and method for manipulating an ophthalmic device

Info

Publication number: WO2015112146A1
Application number: PCT/US2014/012719
Authority: WO
Inventors: Carolyn Finney; Eric Nguyen; Jensen Buck; Manthan Patel; Anand Doraiswamy
Original assignee: Santen Pharmaceutical Co., Ltd.
Priority date: 2014-01-23
Filing date: 2014-01-23
Publication date: 2015-07-30

Abstract

An apparatus for manipulating an ophthalmic device is provided that includes an injector, and a shuttle assembly having a shuttle bottom securable to a shuttle top, wherein the shuttle bottom includes a bottom lens cavity and the shuttle top includes a top lens cavity, an interior perimeter wall formed in the bottom lens cavity, wherein the interior perimeter wall includes a curved rear portion that is shaped to conform to a first support arm of the ophthalmic device, a haptic ramp configured to guide at least a portion of the second support arm upwards as the ophthalmic device is advanced through the folding chamber; an injector cavity situated in the injector; and a plunger assembly including a plunger rod having a plunger first end surface, wherein actuation of the plunger rod extends the plunger first end surface into the folding chamber to translate the ophthalmic device through the folding chamber and into the folded arrangement.

Description

APPARATUS AND METHOD FOR MANIPULATING

AN OPHTHALMIC DEVICE

FIELD

[0001] The method and device relate to the manipulation of ophthalmic devices.

BACKGROUND

[0002] The need for ophthalmic devices has dramatically increased as a significant portion of the population has reached an age where cataracts and other eye diseases are prevalent. In addition, the advancement of technology related to repairs to the eyes has created an increased demand for ophthalmic devices, such as intraocular lenses. Generally, intraocular lenses are inserted into a patient's eye using an injector apparatus. Some of the most commonly used injectors require the user to manually fold the lens in half prior to insertion in the injector apparatus. While other injectors require the user to carefully manipulate the intraocular lens within the injector in an unfolded state, relying solely on a plunger and injector tip to fold the lens. Folding the lens in one of the aforementioned manners can provide inconsistent results and a lack of reliability. More particularly, at times, such actions result in damage to the lens, such as a broken haptic due to improper placement of the lens inside the injector. If the lens is injected into the eye with a broken haptic, the lens is typically removed and replaced immediately. As such, an improved method and device for folding and securing a lens in a consistent and reliable manner prior to insertion into an injector is desired.

BRIEF SUMMARY

[0003] The apparatus and method for manipulating an ophthalmic device utilizes a shuttle assembly for interfacing with an injector, wherein the shuttle assembly includes a folding chamber that provides a repeatable and efficient method of manipulating an ophthalmic device prior to implantation (injection) into a patient's eye.

[0004] In at least some embodiments, an apparatus for manipulating an ophthalmic device in an injector having an injector body is provided that includes a shuttle assembly having a shuttle bottom securable to a shuttle top, wherein the shuttle bottom includes a bottom lens cavity and the shuttle top includes a top lens cavity, and wherein the bottom lens cavity and top lens cavity together form a folding chamber, and wherein the folding chamber is configured to guide an ophthalmic device into a folded arrangement; an interior perimeter wall formed in the bottom lens cavity, wherein the interior perimeter wall includes a curved rear portion that is shaped to conform to a first support arm of the ophthalmic device, wherein the curved rear portion maintains the position of the first support arm prior to advancement of the ophthalmic device through the folding chamber; a haptic ramp formed in the bottom lens cavity and adjacent to the interior perimeter wall for receiving a second support arm of the ophthalmic device, wherein the haptic ramp is configured to guide at least a portion of the second support arm upwards as the ophthalmic device is advanced through the folding chamber; an injector cavity situated in the injector, for receiving the shuttle assembly therein; and a plunger assembly interconnected with the injector body and including a plunger rod having a plunger first end surface, wherein actuation of the plunger rod extends the plunger first end surface into the folding chamber to translate the ophthalmic device through the folding chamber and into the folded arrangement.

[0005] In at least some embodiments, a method of manipulating an ophthalmic device is provided that includes receiving an ophthalmic device in a first cavity of a shuttle bottom that includes a left guide and a right guide, wherein the ophthalmic device includes an optic with a first haptic and second haptic extending therefrom; positioning the first haptic against a curved rear portion of an interior perimeter wall of the first cavity to secure the first haptic in a stored position; positioning the second haptic on a haptic ramp formed in the first cavity and adjacent to the interior perimeter wall; securing a shuttle top with a second cavity to the shuttle bottom to form a shuttle assembly, wherein the first cavity and second cavity are joined to form a folding chamber with an inlet at a first end and an outlet at a second end; inserting the shuttle assembly into an injector cavity of an injector, wherein the injector includes a plunger rod; actuating a plunger first end surface of the plunger rod into the inlet; folding the ophthalmic device as it is moved through the folding chamber by the plunger first end surface; and ejecting the folded ophthalmic device from the folding chamber.

[0006] In at least some embodiments, an apparatus for manipulating an ophthalmic device is provided that includes a shuttle assembly comprising: a shuttle bottom having a bottom lens cavity and a first mating surface, a shuttle top having a top lens cavity and a second mating surface configured to be secured to the first mating surface, wherein the bottom lens cavity and top lens cavity are combined to form a folding chamber for receiving an ophthalmic device; a left guide and a right guide, the left and right guides situated in the folding chamber and configured to guide the ophthalmic device into a folded arrangement; an interior perimeter wall that extends from a shuttle inlet to a shuttle outlet and is in communication with the left guide and right guide, wherein the interior perimeter wall provides a tapered guide for the ophthalmic device as the interior perimeter wall extends from the shuttle inlet to the shuttle outlet; a curved rear portion extending along the interior perimeter wall, the curved rear portion shaped to conform to a trailing support arm of the ophthalmic device, wherein the curved rear portion maintains the position of the trailing support arm prior to advancement of the ophthalmic device through the folding chamber; and a hap tic ramp formed in the bottom lens cavity and adjacent to the interior perimeter wall for receiving at least a portion of a leading support arm of the ophthalmic device, wherein the haptic ramp is configured to guide the leading support arm of the ophthalmic device into a position over a central portion of the ophthalmic device.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Embodiments of the apparatus and method for manipulating an ophthalmic device are disclosed with reference to the accompanying drawings and are for illustrative purposes only. The apparatus and method are not limited in their application to the details of construction or the arrangement of the components illustrated in the drawings. The apparatus and method are capable of other embodiments or of being practiced or carried out in other various ways. In the drawings, like numerals are used to refer to like structures shown in its various drawings:

[0008] FIG. 1 illustrates a top perspective view of an exemplary apparatus for manipulating an ophthalmic device, including an exemplary injector and an exemplary shuttle assembly;

[0009] FIG. 2 illustrates a bottom perspective view of the apparatus of FIG. 1 ;

[0010] FIG. 3 illustrates an unassembled perspective view of the shuttle assembly of FIG. 1, including a shuttle bottom and a shuttle top;

[0011] FIG. 4 illustrates a left side view of the shuttle top of FIG. 3;

[0012] FIG. 5 illustrates a right side view of the shuttle top of FIG. 3;

[0013] FIG. 6 illustrates a front view of the shuttle top of FIG. 3;

[0014] FIG. 7 illustrates a rear view of the shuttle top of FIG. 3;

[0015] FIG. 8 illustrates a top view of the shuttle top of FIG. 3;

[0016] FIG. 9 illustrates a bottom view of the shuttle top of FIG. 3; [0017] FIG. 10 illustrates a left side view of the shuttle bottom of FIG. 3;

[0018] FIG. 1 1 illustrates a right side view of the shuttle bottom of FIG. 3;

[0019] FIG. 12 illustrates a front view of the shuttle bottom of FIG. 3;

[0020] FIG. 13 illustrates a rear view of the shuttle bottom of FIG. 3;

[0021] FIG. 14 illustrates a bottom view of the shuttle bottom of FIG. 3;

[0022] FIG. 15 illustrates a cross-sectional view of the shuttle bottom taken along line 15-15 of

FIG. 10;

[0023] FIG. 16 illustrates a cross-sectional view of the shuttle bottom taken along line 16-16 of

FIG. 1 1;

[0024] FIG. 17 illustrates a left top perspective view of the shuttle bottom of FIG. 3;

[0025] FIG. 18 illustrates a right top perspective view of the shuttle bottom of FIG. 3;

[0026] FIG. 19 illustrates a top view of the shuttle bottom with the lens in a pre-loaded position;

[0027] FIG. 20 illustrates a top view of the lens as it is moved through the shuttle bottom via a plunger;

[0028] FIG. 21 illustrates a front view of the lens and shuttle bottom as positioned in FIG. 20;

[0029] FIG. 22 illustrates a top view of the lens in a folded state prior to ejection from the shuttle bottom;

[0030] FIG. 23 illustrates a front view of the lens in a folded state prior to ejection from the shuttle bottom;

[0031] FIG. 24 illustrates a top left perspective view of the lens in a folded state prior to ejection from the shuttle bottom;

[0032] FIG. 25 illustrates a bottom view of another exemplary shuttle top;

[0033] FIG. 26 illustrates a left top perspective view of another exemplary shuttle bottom;

[0034] FIG. 27 illustrates a right top perspective view of the shuttle bottom of FIG. 26;

[0035] FIG. 28 illustrates a top view of the shuttle bottom of FIG. 26 with a lens in a pre- loaded position;

[0036] FIG. 29 illustrates a cross-sectional view of the shuttle bottom taken along line 29-29 of

FIG. 28; and

[0037] FIG. 30 illustrates a cross-sectional view of the shuttle bottom taken along line 30-30 of

FIG. 28. DETAILED DESCRIPTION

[0038] Referring to FIGS. 1 and 2, top and bottom perspective views of an exemplary apparatus 100 for manipulating an ophthalmic device are illustrated. Apparatus 100 includes an exemplary injector 102 and an exemplary shuttle assembly 104. Injector 102 includes an injector body 105 having an injector front portion 107 and a plunger assembly 108. Plunger assembly

108 includes a plunger rod 106, having a longitudinal axis 103 that extends therethrough, and a plunger first end surface 109 that is situated inside injector body 105 and a plunger second end 1 1 1 situated outside injector body 105. Shuttle assembly 104 is configured to load into an injector cavity 121 situated at the injector front portion 107. The shuttle assembly 104 houses an ophthalmic device, such as an intraocular lens 126, for insertion into a patient's eye. When activated, plunger assembly 108 is configured to extend plunger first end surface 109 through a plunger outlet 1 13 and into shuttle assembly 104. Plunger first end surface 109 then abuts lens 126 and pushes it out of shuttle assembly 104 and through an injector tip 122 and an injector tip outlet 124, at the injector front portion 107, and into the patient's eye. Plunger first end surface

109 is in at least some embodiments, substantially planar, while in other embodiments it can be convex or concave. In at least some embodiments, plunger first end surface 109 lacks a surface portion that is ramped or otherwise angled and therefore not perpendicular to the longitudinal axis 103. Further, in at least some embodiments, plunger first end surface 109 lacks a surface portion that generates a vertical movement of an object as the object slides along the plunger first end surface 109 surface during actuation of plunger assembly 108.

[0039] Injector cavity 121 is configured to receive shuttle assembly 104 and includes injector cavity bottom surface 131 and injector cavity sidewalls 134. Injector cavity sidewalls 134 can include one or more shuttle guide portions (not shown) for receiving complementary cavity guide portions (not shown) of shuttle assembly 104, wherein shuttle guide portions and cavity guide portions can provide aligning assistance during insertion of shuttle assembly 104 into injector cavity 121. In at least some embodiments, the grooves and guide portions can take one of various complementary shapes, such as rectangular, curved, etc. In addition, mating perimeter geometry can be utilized to facilitate proper alignment and orientation during insertion of shuttle assembly 104 into injector cavity 121. [0040] In at least some embodiments, injector cavity 121 can be formed in a shuttle carrier 132, wherein shuttle carrier 132 is configured to matingly secure to injector front portion 107. In contrast, injector cavity 121 can be integrally formed with injector body 105. Shuttle carrier 132 can be removably or permanently securable to front support tray 130 to allow for disposal of shuttle carrier 132 and re-use of injector body 105, if desired.

[0041] Referring to FIG. 3, an unassembled view of shuttle assembly 104 is illustrated, along with exemplary lens 126, which can be included in shuttle assembly 104. Although lens 126 is discussed herein as an exemplary ophthalmic device, the ophthalmic device can include any device suited for, or adaptable to ophthalmic insertion, such as intracorneal rings, shunts, etc. Lens 126 includes an optic 156, a leading haptic 158, and a trailing haptic 160, wherein leading haptic 158 includes a leading end portion 162 and trailing haptic 160 includes a trailing end portion 164. Optic 156 further includes an optic dome 161 supported by an optic support surface 163 formed along an outer perimeter. The optic support surface 163 extending from optic dome 161, further includes a first perimeter edge portion 165 and a second perimeter edge portion 166. Shuttle assembly 104 includes a shuttle top 170 and a shuttle bottom 172. A folding chamber 168 is formed within the shuttle top 170 and shuttle bottom 172 and is configured to receive, secure, and fold lens 126, as described below. More particularly, folding chamber 168 is configured to guide lens 126 into a folded arrangement as it passes therethrough, via actuation of the plunger first end surface 109 against lens 126.

[0042] Shuttle top 170 and shuttle bottom 172 are configured to be fastened together after lens 126 has been inserted in folding chamber 168. The fastening of shuttle top 170 and shuttle bottom 172 can be accomplished in one of various manners. In at least one embodiment, shuttle bottom 172 includes one or more fastening protrusions 174 extending therefrom that are matingly received in complementary fastening apertures 176 situated in shuttle top 170, thereby providing a latching engagement. In at least some embodiments, shuttle assembly 104 can be reopened and refilled after use, wherein other embodiments, a permanent latching engagement can be used to prevent reuse.

[0043] In at least some embodiments, shuttle top 170 and shuttle bottom 172 are pivotally secured with one or more hinges (not shown), or pivoting mechanisms, for example, a barrel hinge, a butterfly hinge, a butt hinge, a rod hinge, a rod and claw, a ball and joint, etc. In other embodiments, shuttle top 170 and shuttle bottom 172 can be at least partially integrally formed having an alternative lens 126 insertion point. The geometry of shuttle assembly 104 can be varied to accommodate one of various lens 126 designs, styles, and diopters, although in at least some embodiments, the geometry can remain fixed for a particular diopter range among the same lens 126, style, or design.

[0044] Referring to FIGS. 4-9, various views of shuttle top 170 are provided, including a left side, a right side, a front, a rear, a top, and a bottom view, respectively. As shown in the figures, shuttle top 170 includes a tab 180 having a plurality of linear ridges 182 provided to assist with grasping the shuttle top 170 to insert it into injector cavity 121. Tab 180 further includes a front bevel portion 184 to provide an orientation indication for purposes of proper insertion of shuttle assembly 104 into injector cavity 121.

[0045] Shuttle top 170 includes a top lens cavity 186 that in combination with a bottom lens cavity 188 (see FIG. 17), forms folding chamber 168. Shuttle top 170 further includes a first channel 190 extending from a shuttle top front 192 to a shuttle top back 194. First channel 190 is shaped and sized to accommodate at least a portion of lens 126 and to assist with guiding lens 126 during expulsion from shuttle assembly 104. First channel 190 is in at least some embodiments, arc-shaped and ramps downwards as it extends from shuttle top back 194 to shuttle top front 192. In addition, top lens cavity 186 includes a top ramp portion 196 and a top securement portion 198, wherein each portion 196, 198 is bisected by first channel 190. Top ramp portion 196 provides a ramped surface for guiding at least a portion of lens 126 (e.g., optic 156, trailing haptic 160, etc.) during expulsion from shuttle assembly 104. Top ramp portion 196 angles downwards as it extends towards shuttle top front 192 and can assist with folding, as well as guiding lens 126. Top securement portion 198 provides a substantially planar surface to assist with securing lens 126 prior to use. In addition, top lens cavity 186 includes a top inner perimeter wall 202 that extends from top ramp portion 196 and top securement portion 198 to a shuttle top mating surface 204. Top inner perimeter wall 202 can be shaped and sized to conform partially to lens 126 to provide sufficient fitment for securement and manipulation. Further, shuttle top 170 includes a top exterior perimeter wall 203 that extends from shuttle top mating surface 204 to an upper surface 205.

[0046] Referring now to FIGS. 10-14, various views of shuttle bottom 172 are provided, including a left side, a right side, a front, a rear, and a bottom view, respectively. As shown in the figures, shuttle bottom 172 includes a bottom surface 206 and a shuttle bottom mating surface 207, the shuttle bottom mating surface is configured to interface with shuttle top mating surface 204. A bottom exterior perimeter wall 208 extends between bottom surface 206 and shuttle top mating surface 204, with a protruding lip 212 formed on a rear portion of bottom exterior perimeter wall 208. Bottom exterior perimeter wall 208 and top exterior perimeter wall 203 are configured to be substantially aligned to facilitate insertion of shuttle assembly 104 into injector cavity 121. As shown, exterior perimeter walls 203, 208 provide shuttle assembly 104 with a substantially rectangular-shape, although in at least some embodiments, shuttle assembly 104 can include one of various other shapes, such as square, oval, etc. A shuttle inlet 210 is provided that extends through the bottom exterior perimeter wall 208, adjacent to protruding lip 212. Shuttle inlet 210 provides an aperture for receiving plunger first end surface 109 therethrough as it extends into folding chamber 168. For additional reference, cross-sectional views of shuttle bottom 172 are provided in FIGS. 15 and 16.

[0047] Referring to FIGS. 17 and 18, left and right top perspective views of shuttle bottom 172 are illustrated. Shuttle bottom 172 includes the bottom lens cavity 188 that in combination with top lens cavity 186 forms folding chamber 168, which is configured to secure, guide, and fold lens 126 as it is pushed through shuttle assembly 104. The shape of the haptics 158, 160 and optic 156 are accommodated by the geometry of bottom lens cavity 188 and top lens cavity 186, which serve as geometric interfaces to substantially limit horizontal, vertical, and rotational movement within shuttle assembly 104.

[0048] Shuttle bottom 172 further includes a main channel 220 extending from a shuttle outlet 222 to a back wall portion 224. Main channel 220 is shaped and sized to accommodate at least a portion of lens 126 and to guide lens 126 during expulsion from shuttle assembly 104. Main channel 220 includes a left guide 226 (FIG. 18) and a right guide 228 (FIG. 17). Left guide 226 includes a left lower guide wall 230 that extends upwards from a main channel bottom surface 232 to a left guide ramp 234. Right guide 228 includes a right lower guide wall 236 that extends upwards from main channel bottom surface 232 to a right guide ramp 238. Lower guide walls 230, 236 taper inwards towards each other as they extend towards main channel bottom surface 232. In addition, main channel bottom surface 232 is tapered as it extends between back wall portion 224 and shuttle outlet 222. More particularly, the distance Dl (FIG. 14) between the lower guide walls 230, 236 at main channel bottom surface 232, adjacent back wall portion 224, is greater than distance D2, adjacent shuttle outlet 222. The tapered shape of main channel bottom surface 232 and guide walls 230, 236 serve to guide lens 126 into a folded position as it moves though main channel 220. The aforementioned tapering of various surfaces can be as illustrated, or can include variations that include greater or lesser degrees of taper to

accommodate various shapes and sizes of ophthalmic devices.

[0049] The bottom interior perimeter wall 240, as mentioned above, extends upwards from left guide ramp 234 and right guide ramp 238 to the shuttle bottom mating surface 207. Bottom interior perimeter wall 240 extends along guide ramps 234, 238 and back wall portion 224, and can include one or more portions configured to secure or restrict lens 126 during storage, folding, and ejection. More particularly, in at least some embodiments, the bottom interior perimeter wall 240 includes a curved rear portion 242 that conforms in shape to the trailing haptic 160 and therefore, provides a fitted abutting surface for trailing haptic 160 (see FIG. 19). This configuration serves to position trailing haptic 160 as desired prior to and during the folding and ejection process. Other portions of bottom interior perimeter wall 240 can also be shaped and sized to secure, position, and/or guide lens 126 prior to or during ejection. Further, bottom interior perimeter wall 240 also includes one or more retaining portions, such as curved retaining portion 244, configured to receive and temporarily restrain leading end portion 162 of the leading haptic 158 during the folding and ejection process. A haptic ramp 246 is also provided that extends between retaining portion 244 and right guide ramp 238. Further, bottom interior perimeter wall 240 tapers along left and right guide ramps 234, 283 as it approaches shuttle outlet 222, with distance D3 being greater than distance D4 (see FIGS. 15 and 16).

[0050] Referring further to FIGS. 17 and 18, left guide ramp 234 includes a left planar surface portion 248 connected to a left ramped surface portion 250. Similarly, right guide ramp 238 includes a right planar surface portion 252 connected to a right ramped surface portion 256. The planar surface portions 248, 252 provide initial securement. Ramped surface portions 250, 256 ramp downwards towards the main channel bottom surface 232 as they extend from the planar surface portions 248, 252 towards shuttle outlet 222. In this manner, ramped surface portions 250, 256 serve to assist with guiding and folding lens 126 as it moves through folding chamber 168 towards shuttle outlet 222.

[0051] Referring to FIG. 19, a top view of shuttle bottom 172 is illustrated with lens 126 in a pre-loaded position. Pre-loading of lens 126 into shuttle assembly 104 is performed to store lens 126 to prepare for installing shuttle assembly 104 into injector cavity 121 of injector 102. Pre- loading is performed by inserting lens 126 into folding chamber 168 in a securable position. More particularly, the first perimeter edge portion 165 of optic support surface 163 is positioned in abutment with a first portion 270 of bottom interior perimeter wall 240, and the second edge perimeter portion 166 of optic support surface 163 is abutted with a second portion 272 of bottom interior perimeter wall 240. In addition, trailing haptic 160 is positioned in abutment with curved rear portion 242, and the optic support surface 163 is generally rested on the guide ramps 234, 238. Shuttle bottom 172 is then secured to shuttle top 170, thereby securing top lens cavity 186 to shuttle bottom cavity 188, forming folding chamber 168. In this manner, top ramp portion 196 and top securement portion 198, both in top lens cavity 186, are positioned over lens 126 to provide securement from above. Shuttle assembly 104 provides secure storage until folding and ejection of lens 126 through shuttle outlet 222 is desired. Lens 126 can be situated in shuttle assembly 104 either in a hydrated or dry state.

[0052] After lens 126 has been pre-loaded, shuttle assembly 104 can be inserted into the injector cavity in preparation for implantation. Prior to ejection from shuttle assembly 104, lens 126 is folded in folding chamber 168 to allow for insertion through a small incision in a patient's eye. Insertion is provided via the injector tip outlet 124, which is positioned inside the capsular bag of the patient's eye during an implantation procedure. A folding and ejection process is utilized to simultaneously fold lens 126 as it is pushed through folding chamber 168 to shuttle outlet 222. The exemplary folding and ejection process is illustrated at least in part in FIGS. 19- 24, showing lens 126 in varied states as it is folded. The illustrations provided in FIGS. 19-24 depict the position of lens 126 as it progresses through shuttle bottom 172. Although shuttle top 170 would be secured to shuttle bottom 172 during this process, it has not been shown in these figures for clarity purposes.

[0053] In at least some embodiments, to begin the folding and ejection process, the plunger second end 1 1 1 is depressed towards injector body 105, thereby advancing plunger first end surface 109 from injector body 105 into shuttle inlet 210. As shown in FIG. 19 (see FIGS. 1 and 2), prior to contact with plunger first end surface 109, lens 126 is in the pre-loaded storage position. Advancement of plunger first end surface 109 into folding chamber 168 provides contact with trailing haptic 160, which is guided upwards and over optic 156, via the top securement portion 198. This movement of trailing haptic 160 occurs prior to enough force being applied to lens 126 to move optic 156 from its storage position. [0054] Referring to FIGS. 20 and 21, top and front views are provided illustrating lens 126 in a further manipulated position as a result of additional pressure on lens 126 from plunger first end surface 109, during the folding and ejecting process. As the advancement of plunger first end surface 109 through folding chamber 168 progresses, optic 156 begins to move through folding chamber 168, pushing leading haptic 158 up haptic ramp 246 to force the leading haptic 158 over the optic 156, effectively tucking leading haptic 158. Meanwhile, optic support surface 163 is manipulated as it is pressed against the various surfaces in folding chamber 168. More particularly, the tapering of bottom interior perimeter wall 240 forces the first perimeter edge portion 165 and second perimeter edge portion 166 to buckle inwards, pushing optic dome 161 down towards main channel bottom surface 232. As lens 126 continues to be pushed through folding chamber 168, optic dome 161 is driven into abutment with, or adjacent to, the main channel bottom surface 232, and the left guide 226 and right guide 228 fold the first perimeter edge portion 165 and second perimeter edge portion 166 upwards and inwards manipulating the optic support surface 163 into a folded configuration at the shuttle outlet 222. The final disposition of lens 126 inside the folding chamber, prior to ejection, is illustrated in FIGS. 22, 23, and 24, which provide top, front, and top perspective views of shuttle bottom 172, lens 126, and plunger first end surface 109. Further advancement of plunger first end surface 109 ejects lens 126 through shuttle outlet 222 and into injector tip 122, and finally out injector tip outlet 124 and into a patient's eye.

[0055] Referring to FIGS. 25-30, an additional exemplary embodiment of the shuttle assembly 104 is illustrated. Various components forming the geometry of bottom lens cavity 188 and top lens cavity 186, as discussed above, can be modified as shown in FIGS. 25-30, to store, guide, and fold lens 126 inside folding chamber 168. In at least some embodiments, as shown in FIGS. 25-30, the geometry of bottom lens cavity 188 and top lens cavity 186 can be configured without retaining portion 244 and haptic ramp 246. In this regard, advancement of leading haptic 158 occurs along right guide ramp 238, such that leading haptic 158 is tucked on optic 156 of lens 126 in a controlled fashion. The controlled tucking is achieved by careful selection of the inward angle of bottom interior perimeter wall 240 and downward angles of guide ramps 234, 238. The ramp features of bottom interior perimeter wall 240 and ramps 234, 238 reduce the tendency of leading haptic 158 in remaining straight when plunger first end surface 109 is advanced into shuttle assembly 104. [0056] Further, as shown in FIGS. 25-30, shuttle bottom 172 can include an additional fastening protrusion 174 for engagement with an additional fastening aperture 176. The additional fastening aperture 176 on shuttle bottom 172 is accommodated by shortening the length of curved rear portion 242 along bottom interior perimeter wall 240 to provide a widened shuttle bottom mating surface 207.

[0057] The aforementioned components can be comprised of various materials suitable for achieving manufacturing efficiencies, product securement, transport, and proper interaction with an ophthalmic device. In at least some embodiments, one or more components of apparatus 100 are comprised of any of various grades of polypropylene, including medical grade gamma stable polypropylene, various grades of polycarbonate, polyacrylates, polystyrene, and other medical plastics, while in other embodiments, various other and/or additional types of plastic composites, metals, etc., can be utilized. In at least some embodiments, the materials utilized are waterproof or water resistant.

[0058] The size and shape of the aforementioned components can vary to accommodate numerous design criteria for various ophthalmic devices. It is specifically intended that the method and device for folding and injecting ophthalmic devices not be limited to the

embodiments and illustrations contained herein, but include modified forms of those

embodiments including portions of the embodiments and combinations of elements of different embodiments as come within the scope of the following claims.

Claims

WE CLAIM:

1. An apparatus for manipulating an ophthalmic device, the apparatus comprising:

an injector having an injector body;

a shuttle assembly having a shuttle bottom securable to a shuttle top, wherein the shuttle bottom includes a bottom lens cavity and the shuttle top includes a top lens cavity, and wherein the bottom lens cavity and top lens cavity together form a folding chamber, and wherein the folding chamber is configured to guide an ophthalmic device into a folded arrangement;

an interior perimeter wall formed in the bottom lens cavity, wherein the interior perimeter wall includes a curved rear portion that is shaped to conform to a first support arm of the ophthalmic device, wherein the curved rear portion maintains the position of the first support arm prior to advancement of the ophthalmic device through the folding chamber;

a haptic ramp formed in the bottom lens cavity and adjacent to the interior perimeter wall for receiving a second support arm of the ophthalmic device, wherein the haptic ramp is configured to guide at least a portion of the second support arm upwards as the ophthalmic device is advanced through the folding chamber;

an injector cavity situated in the injector, for receiving the shuttle assembly therein; and a plunger assembly interconnected with the injector body and including a plunger rod having a plunger first end surface, wherein actuation of the plunger rod extends the plunger first end surface into the folding chamber to advance the ophthalmic device through the folding chamber and into the folded arrangement.

2. The apparatus of claim 1, wherein the ophthalmic device includes an optic having an optic support surface extending around a perimeter of an optic dome, and the first support arm is a trailing haptic and the second support arm is a leading haptic, wherein the haptics extend from the optic.

3. The apparatus of claim 2, wherein the shuttle assembly includes a shuttle inlet at a first end and a shuttle outlet at a second end.

4. The apparatus of claim 3, wherein the bottom lens cavity includes a main channel with a left guide and a right guide for guiding the ophthalmic device through the folding chamber from a storage position into the folded arrangement.

5. The apparatus of claim 4, wherein the left guide and right guide are interconnected by a main channel bottom surface, and wherein the left guide includes a left lower guide wall that extends upwards from the main channel bottom surface to a left guide ramp, and right guide includes a right lower guide wall that extends upwards from the main channel bottom surface to a right guide ramp.

6. The apparatus of claim 5, wherein the right and left lower guide walls taper inward towards each other as they extend towards the main channel bottom surface.

7. The apparatus of claim 6, wherein the main channel bottom surface is tapered as it extends towards the shuttle outlet.

8. The apparatus of claim 7, wherein the ophthalmic device is an intraocular lens.

9. The apparatus of claim 8, wherein the interior perimeter wall extends between the guide ramps and a shuttle bottom mating surface.

10. The apparatus of claim 9, wherein the plunger first end surface is substantially planar and the actuation of the plunger first end surface raises the trailing haptic above the optic prior to movement of the optic in the folding chamber.

1 1. The apparatus of claim 4, wherein actuation of the plunger first end surface positions the trailing haptic and the leading haptic completely over the optic, prior to ejection of the ophthalmic device from the folding chamber via the shuttle outlet.

12. A method of manipulating an ophthalmic device, the method comprising: receiving an ophthalmic device in a first cavity of a shuttle bottom that includes a left guide and a right guide, wherein the ophthalmic device includes an optic with a first haptic and a second haptic extending therefrom;

positioning the first haptic against a curved rear portion of an interior perimeter wall of the first cavity to secure the first haptic in a stored position;

positioning the second haptic on a haptic ramp formed in the first cavity and adjacent to the interior perimeter wall;

securing a shuttle top with a second cavity to the shuttle bottom to form a shuttle assembly, wherein the first cavity and second cavity are joined to form a folding chamber with an inlet at a first end and an outlet at a second end;

inserting the shuttle assembly into an injector cavity of an injector, wherein the injector includes a plunger rod;

actuating a plunger first end surface of the plunger rod into the inlet;

folding the ophthalmic device as it is moved through the folding chamber by the plunger first end surface; and

ejecting the folded ophthalmic device from the folding chamber.

13. The method of claim 12, further including moving the first haptic into a position over the optic with actuation of the plunger first end surface.

14. The method of claim 13, further including moving the second haptic into a position over the optic as the ophthalmic device is moved through the folding chamber with actuation of the plunger first end surface.

15. The method of claim 14, wherein the second haptic moves up a ramped surface to guide the second haptic over the optic.

16. The method of claim 15, wherein the left guide and right guide each include a plurality of tapered surfaces for guiding the ophthalmic device into a folded configuration.

17. The method of claim 15, wherein the plunger first end surface is substantially

perpendicular to a longitudinal axis of the plunger rod.

18. An apparatus for manipulating an ophthalmic device, the apparatus comprising:

a shuttle assembly comprising:

a shuttle bottom having a bottom lens cavity and a first mating surface;

a shuttle top having a top lens cavity and a second mating surface configured to be secured to the first mating surface, wherein the bottom lens cavity and the top lens cavity are combined to form a folding chamber for receiving an ophthalmic device; a left guide and a right guide, the left and right guides situated in the folding chamber and configured to guide the ophthalmic device into a folded arrangement;

an interior perimeter wall that extends from a shuttle inlet to a shuttle outlet and is in communication with the left guide and right guide, wherein the interior perimeter wall provides a tapered guide for the ophthalmic device as the interior perimeter wall extends from the shuttle inlet to the shuttle outlet;

a curved rear portion extending along the interior perimeter wall, the curved rear portion shaped to conform to a trailing support arm of the ophthalmic device, wherein the curved rear portion maintains the position of the trailing support arm prior to

advancement of the ophthalmic device through the folding chamber; and

a haptic ramp formed in the bottom lens cavity and adjacent to the interior perimeter wall for receiving at least a portion of a leading support arm of the ophthalmic device, wherein the haptic ramp is configured to guide the leading support arm of the ophthalmic device into a position over a central portion of the ophthalmic device.

19. The apparatus of claim 18, wherein the leading support arm of the ophthalmic device is a leading haptic and the central portion of the ophthalmic device is an optic.

20. The apparatus of claim 19, wherein the shuttle assembly is configured for insertion into the an injector, wherein the injector includes a plunger rod having a plunger first end surface that is configured to enter the shuttle inlet and move the ophthalmic device through the folding chamber and out the shuttle outlet.