WO2015112144A1 - Apparatus and method for folding and injecting an ophthalmic device - Google Patents

Apparatus and method for folding and injecting an ophthalmic device Download PDF

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Publication number
WO2015112144A1
WO2015112144A1 PCT/US2014/012705 US2014012705W WO2015112144A1 WO 2015112144 A1 WO2015112144 A1 WO 2015112144A1 US 2014012705 W US2014012705 W US 2014012705W WO 2015112144 A1 WO2015112144 A1 WO 2015112144A1
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WO
WIPO (PCT)
Prior art keywords
cavity
shuttle
wing
ophthalmic device
injector
Prior art date
Application number
PCT/US2014/012705
Other languages
French (fr)
Inventor
Jensen Buck
Manthan Patel
Eric Nguyen
Carolyn Finney
Anand Doraiswamy
Original Assignee
Santen Pharmaceutical Co., Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Santen Pharmaceutical Co., Ltd. filed Critical Santen Pharmaceutical Co., Ltd.
Priority to PCT/US2014/012705 priority Critical patent/WO2015112144A1/en
Publication of WO2015112144A1 publication Critical patent/WO2015112144A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1662Instruments for inserting intraocular lenses into the eye
    • A61F2/1678Instruments for inserting intraocular lenses into the eye with a separate cartridge or other lens setting part for storage of a lens, e.g. preloadable for shipping
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1662Instruments for inserting intraocular lenses into the eye
    • A61F2/167Instruments for inserting intraocular lenses into the eye with pushable plungers

Definitions

  • the method and device relate to the injection of ophthalmic devices.
  • intraocular lenses are inserted into a patient's eye using an injector apparatus.
  • 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.
  • the apparatus and method for folding and injecting an ophthalmic device utilizes a shuttle assembly for interfacing with an injector, wherein the shuttle assembly includes a folding mechanism that provides a repeatable and efficient method of folding an intraocular lens when engaged with the injector, and prior to implantation (injection) into a patient's eye.
  • an apparatus for folding and injecting an ophthalmic device includes, an injector having an injector body with an injector front portion; a first cavity situated at the injector front portion; a shuttle assembly having a second cavity for receiving an ophthalmic device, wherein the shuttle assembly is received inside the first cavity; a folding mechanism situated inside the second cavity, wherein the folding mechanism includes one or more pivotable wings for engagement with and folding of the ophthalmic device; and one or more wing guides in the first cavity, wherein the one or more wing guides extend from the first cavity for abutment with the folding mechanism, wherein the abutment is configured to activate the folding mechanism to fold the ophthalmic device inside the second cavity.
  • a method of folding an ophthalmic device includes, inserting an ophthalmic device into a first cavity of a shuttle assembly; securing the ophthalmic device to one or more rotatable wings situated inside the first cavity of the shuttle assembly; inserting the shuttle assembly into a second cavity provided in an injector; rotating the wings inside the first cavity with an abutment of one or more wing guides situated in the second cavity, wherein the abutment occurs during insertion of the shuttle assembly into the second cavity; and folding the ophthalmic device within the first cavity, during rotation of the wings.
  • a shuttle assembly for securing an ophthalmic device includes, a shuttle top securable to a shuttle bottom to form a first cavity; a first wing and second wing rotationally secured to a frame of the shuttle bottom, wherein the first wing and second wing are configured to fold an ophthalmic device situated inside the first cavity, and wherein the frame further includes a back support and a front support, each of the back and front supports having one or more grooves for securing one or more portions of the ophthalmic device to substantially limit at least one of vertical, horizontal, and rotational movement of the ophthalmic device inside the first cavity.
  • FIG. 1 illustrates a perspective view of an exemplary injector apparatus for implanting an ophthalmic device
  • FIG. 2 illustrates an exploded view of the apparatus of FIG. 1;
  • FIG. 3 illustrates a perspective view of an exemplary shuttle assembly of FIG. 1;
  • FIG. 4 illustrates a top view of the shuttle assembly of FIG. 3
  • FIG. 5 illustrates a cross-sectional view of the shuttle assembly taken at line 5-5 of FIG. 4;
  • FIG. 6 illustrates a perspective view of the shuttle assembly of FIG. 1 , with an exemplary ophthalmic device (i.e., an intraocular lens) positioned thereon;
  • an exemplary ophthalmic device i.e., an intraocular lens
  • FIG. 7 illustrates a top view of the shuttle assembly of FIG. 6, with the ophthalmic device positioned thereon;
  • FIG. 8 illustrates a sectional view of the shuttle assembly taken at line 8-8 of FIG. 7;
  • FIG. 9 illustrates the shuttle assembly FIG. 3 in a closed position
  • FIG. 10 illustrates a cross-sectional perspective view of the shuttle assembly partially inserted into the injector, taken along line 10-10 of FIG. 9;
  • FIG. 1 1 illustrates a cross-sectional front view of the shuttle assembly partially inserted into the injector, taken along line 10-10 of FIG. 9;
  • FIG. 12 illustrates a cross-sectional perspective view of the shuttle assembly fully inserted into the injector, taken along line 10-10 of FIG. 9;
  • FIG. 13 illustrates a cross-sectional front view of the shuttle assembly fully inserted into the injector, taken along line 10-10 of FIG. 9.
  • Apparatus 100 includes an injector 102 and a shuttle assembly 104.
  • Injector 102 includes an injector body 106 having an injector front portion 107 and a plunger assembly 108.
  • Plunger assembly 108 includes a plunger first end 109 situated inside injector body 106 and a plunger second end 1 1 1 situated outside injector body 106.
  • 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 intraocular lens 126, for insertion into a patient's eye.
  • plunger assembly 108 When activated, plunger assembly 108 is configured to extend plunger first end 109 through a plunger outlet 1 13 (FIG. 2) situated adjacent to injector front portion 107 and into shuttle assembly 104. Plunger first end 109 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.
  • injector front portion 107 can be comprised of one or more integral and/or securable components. More particularly, injector front portion 107 can include a front support tray 130, forming an injector cavity bottom surface 131 that extends outwardly. Front support tray 130 includes a first wing guide 133 and a second wing guide 135, both of which extend upwards from injector cavity bottom surface 131. In at least some embodiments, a greater or lesser number of wing guides can be utilized. First wing guide 133 includes a first guide inner surface 137, while second wing guide 135 includes a second guide inner surface 139. First guide inner surface 137 and second guide inner surface 139 are curved or otherwise shaped to engage winged portions of shuttle assembly 104 during insertion of shuttle assembly 104 into injector cavity 121, as is described below.
  • a shuttle carrier 132 is provided, having injector cavity sidewalls 134, wherein shuttle carrier 132 is configured to matingly secure to front support tray 130 to form injector cavity 121, comprised of injector cavity bottom surface 131 and injector cavity sidewalls 134.
  • 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 106. In at least some other
  • shuttle carrier 132 can be integrally formed with front support tray 130.
  • injector cavity sidewalls 134 include one or more shuttle guide grooves 141 for receiving complementary guide portions 147 (FIG. 9) of shuttle assembly 104, wherein shuttle guide grooves 141 and guide portions 147 provide aligning assistance and a positive stop for shuttle assembly 104 during insertion into injector cavity 121.
  • the grooves 141 and guide portions 147 can take one of various complementary shapes, such as rectangular, curved, etc.
  • an ophthalmic device such as an intraocular lens 126
  • 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 140, a leading hap tic 1 10, and a trailing haptic 1 12, wherein leading haptic 1 10 includes a leading end portion 1 14 and trailing haptic 1 12 includes a trailing end portion 1 16.
  • Shuttle assembly 104 is configured to receive, secure, and fold lens 126, as described below.
  • the geometry of shuttle assembly 104 can be varied to accommodate various lens designs, styles, and diopters, although in at least some embodiments, the geometry can remain fixed for a particular diopter range among the same lens style or design.
  • Shuttle assembly 104 includes a shuttle bottom 142 and a shuttle top 144.
  • shuttle bottom 142 and shuttle top 144 are pivotally secured with one or more living hinges 145, although in other embodiments, other types of pivoting mechanisms can be used, 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 bottom 142 and shuttle top 144 can be secured together without a pivoting mechanism, for example clasps or latches can be used.
  • Shuttle bottom 142 includes a folding mechanism 146 and shuttle top 144 includes a top inner surface 148, which when combined, form a lens cavity 150 (FIG. 9) for receiving lens 126.
  • shuttle bottom 142 includes the primary lens-holding geometry.
  • the shape of the haptics 1 10, 1 12 and optic 140 are accommodated by the geometry of shuttle bottom 142, which serves as a geometric interface to prevent horizontal and rotational movement within shuttle assembly 104.
  • the geometry of lens cavity 150 is configured to accommodate the haptics 1 10, 1 12 and the central thickness of optic 140, to substantially limit or prevent vertical movement within shuttle assembly 104.
  • Shuttle bottom 142 further includes a frame 152 having a first back support 154, a first front support 156, and a center support 158.
  • First back support 154 includes a first channel 160 situated inside a second channel 162, wherein first channel 160 is ramped to guide plunger first end 109 to into injector cavity 121 and to ensure that trailing haptic 1 12 is fully captured by plunger first end 109.
  • a first haptic stop 166 (FIGS. 4-7) and a second haptic stop 168 are provided on first back support 154, and in communication with second channel 162 for securing trailing haptic 1 12.
  • Stops 166, 168 are sized and shaped to receive portions of trialing haptic 1 12, with trailing end portion 1 16 received by first haptic stop 166 (see FIGS. 6 and 7).
  • a third haptic stop 170 (FIGS. 3, 4, 6, and 7) is provided on first front support 156, and in communication with a third channel 169 formed in the first front support 156, for securing leading haptic 1 10.
  • Third haptic stop 170 is sized and shaped to receive leading end portion 1 14 of leading haptic 1 10 (see FIGS. 6 and 7).
  • Stops 166, 168, 170 provide securement points for haptics 1 10, 1 12, as well as assist with guiding the hap tics 1 10, 1 12 so that they deploy out of the injector tip outlet 124 in a tucked orientation (see below), ensuring that lens 126 deploys within the capsular bag of a patient's eye in a controlled and predictable manner.
  • Folding mechanism 146 includes a first wing 180 and a second wing 182 (FIGS. 3-5), both of which are pivotally secured to center support 158 of frame 152.
  • wings 180, 182 can be pivotally secured to one or more other portions of frame 152.
  • First wing 180 includes a first retaining end 190 and a first hinged end 192.
  • First hinged end 192 is secured to center support 158 by a first hinge 194 (FIGS. 4 and 5) to provide rotational movement therebetween.
  • second wing 182 includes a second retaining end 196 and a second hinged end 198.
  • Second hinged end 198 is secured to center support 158 by a second hinge 200 to provide rotational movement therebetween.
  • First retaining end 190 further includes a first groove 204 formed therein to provide a horizontal and vertical securement point for a first perimeter portion 206 of optic 140.
  • second retaining end 196 further includes a second groove 208 formed therein to provide a horizontal and vertical securement point for a second perimeter portion 210 of optic 140.
  • First wing 180 includes a wing outer surface 226 and an inner surface 228, wherein wing outer surface 226 and inner surface 228 are both curved.
  • second wing 182 includes an outer surface 230 and an inner surface 232, wherein outer surface 230 and inner surface 232 are both curved.
  • First retaining end 190 further includes a first end surface 191 (FIGS. 1 1-13), and second retaining end 196 further includes a second end surface 197.
  • wings 180, 182 can vary in shape and size to accommodate various shapes and sizes of ophthalmic devices and shuttle configurations.
  • first hinge 194 and second hinge 200 can in some embodiments be living hinges, while in other embodiments, first wing 180 and second wing 182 can be interconnected with center support 158 or frame 152 using other types of 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.
  • shuttle top 144 further assists shuttle bottom 142 with securement of lens 126 as well as assisting with the folding and ejection of lens 126 from shuttle assembly 104. More particularly, shuttle top 144 includes a second back support 212 that is complementarily received by first back support 154 when shuttle bottom 142 is folded onto shuttle top 144. Second back support 212 includes a fourth channel 214 that is complementary to second channel 162 to form a shuttle inlet passage 163 (see FIGS. 1 1 and 13) that conforms generally to the shape of plunger first end 109 to allow passage of plunger first end 109 therethrough. Similarly, shuttle top 144 includes a second front support 218 that is
  • Second front support 218 includes a fifth channel 220 that is complementary to third channel 169 to form a shuttle outlet passage 171 (see FIG. 9) that guides lens 126 out of shuttle assembly 104 and into injector tip 122.
  • Second back support 212 further includes a fourth haptic stop 224 (FIG. 4) formed partially in fourth channel 214, which cooperates with second haptic stop 168 to secure the trailing haptic 1 12.
  • top inner surface 148 includes a first inner portion 238 and a second inner portion 240, wherein the inner portions 238, 240 are curved with complementary arcs that accommodate curved wing outer surfaces 226, 230 of the wings 180, 182. In this regard, the inner portions 238, 240 do not interfere with wings 180, 182 when wings 180, 182 are translated upwards into lens cavity 150 to fold lens 126.
  • Top inner surface 148 further includes a sixth channel 241 (FIG. 3) situated between and interconnected with inner portions 238, 240.
  • a ramp portion 242 extends downwards from sixth channel 241 to a flush engagement with fifth channel 220.
  • Sixth channel 241 and ramp portion 242 are curved concavely to assist with guiding lens 126 through shuttle outlet passage 171 (FIG. 9).
  • Extending between inner portions 238, 240 and sixth channel 241 are a first wing stop 248 and a second wing stop 250.
  • Wing stops 248, 250 are positioned for abutment with first end surface 191 and second end surface 197 (FIGS. 1 1-13) of wings 180, 182 upon complete translation of wings 180, 182 and folding of lens 126.
  • lens 126 is pre-loaded into shuttle assembly 104 prior to installing shuttle assembly 104 into injector cavity 121. Pre-loading is performed by placing lens 126 into lens cavity 150, such that the first perimeter portion 206 of optic 140 is situated in first groove 204 and the second perimeter portion 210 of optic 140 is situated in second groove 208.
  • trailing haptic 1 12 is positioned against first haptic stop 166 and second haptic stop 168, and with leading end portion 1 14 of haptic 1 10 positioned in third haptic stop 170.
  • Shuttle top 144 is rotated about hinge 145 and onto shuttle bottom 142 and fastened thereto.
  • shuttle bottom 142 includes one or more barbed protrusions 244 (FIG. 3) extending from frame 152 that are matingly received in complementary apertures 246 situated in second back support 212 and/or second front support 218, thereby providing a latching engagement.
  • barbed protrusions 244 FIG. 3
  • shuttle assembly 104 can be reopened and refilled after use.
  • a permanent latching engagement can be used to prevent reuse.
  • shuttle assembly 104 is illustrated in a closed position.
  • Shuttle assembly 104 provides secure storage for lens 126 in a planar position until folding and insertion is required.
  • Lens 126 can be situated in shuttle assembly 104 either in a hydrated or dry state.
  • Prior to implantation, lens 126 is folded 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 eye.
  • shuttle assembly 104 is inserted into injector cavity 121, wherein wings 180, 182 are engaged by first wing guide 133 and a second wing guide 135, respectively.
  • Shuttle assembly 104 further includes an insertion tab 222 having a front bevel 227.
  • Front bevel 227 provides a positive visual indicator to a user to identify the correct orientation of shuttle assembly 104 prior to installation in injector cavity 121 (i.e., front bevel 227 facing injector tip 122).
  • FIGS. 10 and 1 illustrated are cross-sectional perspective and front views, taken along line 10-10 of FIG. 9, of shuttle assembly 104 partially inserted into injector cavity 121.
  • shuttle assembly 104 is partially inserted into injector cavity 121 until wing outer surface 226 of first wing 180 abuts first guide inner surface 137 of first wing guide 133, and outer surface 230 of second wing 182 abuts second guide inner surface 139 of second wing guide 135.
  • lens 126 remains in an unfolded state, with wings 180, 182 in their resting position and configured to be translated via wing guides 133, 135.
  • shuttle assembly 104 is further advanced into injector cavity 121.
  • first guide inner surface 137 and second guide inner surface 139 fully engage wing outer surfaces 226, 230, respectively, causing a resultant movement of wings 180, 182 towards top inner surface 148.
  • wings 180, 182 are translated towards top inner surface 148, lens 126 is folded.
  • FIGS. 12 and 13 illustrated are cross-sectional perspective and front views taken along line 10-10 of FIG. 9, of shuttle assembly 104 fully inserted into injector cavity 121.
  • lens 126 is folded and therefore ready to be ejected from the injector.
  • plunger second end 1 1 1 is depressed towards injector body 106, thereby advancing plunger first end 109 from injector body 106 through plunger outlet 1 13, a shuttle carrier inlet 165 (FIG. 2), and into first channel 160.
  • First channel 160 includes a ramped surface for plunger first end 109 to pass into injector cavity 121.
  • the ramped surface ensures that trailing haptic 1 12 is fully captured by plunger first end 109. After contact with trailing haptic 1 12, plunger first end 109 continues to push lens 126 through lens cavity 150 with leading haptic 1 10 exiting shuttle outlet passage 171 first, followed by optic 140 and trailing haptic 1 12. Lens 126 continues in this manner into injector tip 122 and finally passes through injector tip outlet 124 and into a patient's eye. After insertion of lens 126, the apparatus 100 can be disposed of, or partially disassembled and reused with a new lens 126 or shuttle assembly 104 and lens 126 combination.
  • the aforementioned components can be comprised of various materials suitable for achieving manufacturing efficiencies, product securement, transport, and proper interaction with an ophthalmic device.
  • 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.
  • the materials utilized can be waterproof or water resistant.
  • 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

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
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  • Prostheses (AREA)

Abstract

An apparatus for folding and injecting an ophthalmic device that includes an injector having an injector body with an injector front portion, a first cavity situated at the injector front portion, a shuttle assembly having a second cavity for receiving an ophthalmic device, wherein the shuttle assembly is received inside the first cavity, a folding mechanism situated inside the second cavity, wherein the folding mechanism includes one or more pivotable wings for engagement with and folding of the ophthalmic device, and one or more wing guides in the first cavity, wherein the one or more wing guides extend from the first cavity for abutment with the folding mechanism, wherein the abutment is configured to activate the folding mechanism to fold the ophthalmic device inside the second cavity.

Description

APPARATUS AND METHOD FOR FOLDING AND
INJECTING AN OPHTHALMIC DEVICE
FIELD
[0001] The method and device relate to the injection 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 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 folding and injecting an ophthalmic device utilizes a shuttle assembly for interfacing with an injector, wherein the shuttle assembly includes a folding mechanism that provides a repeatable and efficient method of folding an intraocular lens when engaged with the injector, and prior to implantation (injection) into a patient's eye.
[0004] In at least some embodiments, an apparatus for folding and injecting an ophthalmic device is provided that includes, an injector having an injector body with an injector front portion; a first cavity situated at the injector front portion; a shuttle assembly having a second cavity for receiving an ophthalmic device, wherein the shuttle assembly is received inside the first cavity; a folding mechanism situated inside the second cavity, wherein the folding mechanism includes one or more pivotable wings for engagement with and folding of the ophthalmic device; and one or more wing guides in the first cavity, wherein the one or more wing guides extend from the first cavity for abutment with the folding mechanism, wherein the abutment is configured to activate the folding mechanism to fold the ophthalmic device inside the second cavity.
[0005] In at least some embodiments, a method of folding an ophthalmic device is provided that includes, inserting an ophthalmic device into a first cavity of a shuttle assembly; securing the ophthalmic device to one or more rotatable wings situated inside the first cavity of the shuttle assembly; inserting the shuttle assembly into a second cavity provided in an injector; rotating the wings inside the first cavity with an abutment of one or more wing guides situated in the second cavity, wherein the abutment occurs during insertion of the shuttle assembly into the second cavity; and folding the ophthalmic device within the first cavity, during rotation of the wings.
[0006] In at least some embodiments, a shuttle assembly for securing an ophthalmic device is provided that includes, a shuttle top securable to a shuttle bottom to form a first cavity; a first wing and second wing rotationally secured to a frame of the shuttle bottom, wherein the first wing and second wing are configured to fold an ophthalmic device situated inside the first cavity, and wherein the frame further includes a back support and a front support, each of the back and front supports having one or more grooves for securing one or more portions of the ophthalmic device to substantially limit at least one of vertical, horizontal, and rotational movement of the ophthalmic device inside the first cavity.
[0007] Other aspects of the apparatus and method for folding and injecting an ophthalmic device will become apparent by consideration of the detailed description and accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] Embodiments of the method and device for folding and injecting an ophthalmic device are disclosed with reference to the accompanying drawings and are for illustrative purposes only. The method and device are not limited in their application to the details of construction or the arrangement of the components illustrated in the drawings. The method and device 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:
[0009] FIG. 1 illustrates a perspective view of an exemplary injector apparatus for implanting an ophthalmic device;
[0010] FIG. 2 illustrates an exploded view of the apparatus of FIG. 1;
[0011] FIG. 3 illustrates a perspective view of an exemplary shuttle assembly of FIG. 1;
[0012] FIG. 4 illustrates a top view of the shuttle assembly of FIG. 3;
[0013] FIG. 5 illustrates a cross-sectional view of the shuttle assembly taken at line 5-5 of FIG. 4;
[0014] FIG. 6 illustrates a perspective view of the shuttle assembly of FIG. 1 , with an exemplary ophthalmic device (i.e., an intraocular lens) positioned thereon;
[0015] FIG. 7 illustrates a top view of the shuttle assembly of FIG. 6, with the ophthalmic device positioned thereon;
[0016] FIG. 8 illustrates a sectional view of the shuttle assembly taken at line 8-8 of FIG. 7;
[0017] FIG. 9 illustrates the shuttle assembly FIG. 3 in a closed position;
[0018] FIG. 10 illustrates a cross-sectional perspective view of the shuttle assembly partially inserted into the injector, taken along line 10-10 of FIG. 9;
[0019] FIG. 1 1 illustrates a cross-sectional front view of the shuttle assembly partially inserted into the injector, taken along line 10-10 of FIG. 9;
[0020] FIG. 12 illustrates a cross-sectional perspective view of the shuttle assembly fully inserted into the injector, taken along line 10-10 of FIG. 9; and
[0021] FIG. 13 illustrates a cross-sectional front view of the shuttle assembly fully inserted into the injector, taken along line 10-10 of FIG. 9.
DETAILED DESCRIPTION
[0022] Referring to FIG. 1, a perspective view of an exemplary apparatus 100 for folding and injecting an ophthalmic device into an eye is illustrated. Apparatus 100 includes an injector 102 and a shuttle assembly 104. Injector 102 includes an injector body 106 having an injector front portion 107 and a plunger assembly 108. Plunger assembly 108 includes a plunger first end 109 situated inside injector body 106 and a plunger second end 1 1 1 situated outside injector body 106. 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 intraocular lens 126, for insertion into a patient's eye. When activated, plunger assembly 108 is configured to extend plunger first end 109 through a plunger outlet 1 13 (FIG. 2) situated adjacent to injector front portion 107 and into shuttle assembly 104. Plunger first end 109 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.
[0023] Referring to FIG. 2, an unassembled view of apparatus 100 of FIG. 1 is illustrated. As shown, in at least some embodiments, injector front portion 107 can be comprised of one or more integral and/or securable components. More particularly, injector front portion 107 can include a front support tray 130, forming an injector cavity bottom surface 131 that extends outwardly. Front support tray 130 includes a first wing guide 133 and a second wing guide 135, both of which extend upwards from injector cavity bottom surface 131. In at least some embodiments, a greater or lesser number of wing guides can be utilized. First wing guide 133 includes a first guide inner surface 137, while second wing guide 135 includes a second guide inner surface 139. First guide inner surface 137 and second guide inner surface 139 are curved or otherwise shaped to engage winged portions of shuttle assembly 104 during insertion of shuttle assembly 104 into injector cavity 121, as is described below.
[0024] A shuttle carrier 132 is provided, having injector cavity sidewalls 134, wherein shuttle carrier 132 is configured to matingly secure to front support tray 130 to form injector cavity 121, comprised of injector cavity bottom surface 131 and injector cavity sidewalls 134. 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 106. In at least some other
embodiments, shuttle carrier 132 can be integrally formed with front support tray 130. In addition, injector cavity sidewalls 134 include one or more shuttle guide grooves 141 for receiving complementary guide portions 147 (FIG. 9) of shuttle assembly 104, wherein shuttle guide grooves 141 and guide portions 147 provide aligning assistance and a positive stop for shuttle assembly 104 during insertion into injector cavity 121. In at least some embodiments, the grooves 141 and guide portions 147 can take one of various complementary shapes, such as rectangular, curved, etc.
[0025] Further referring to FIG. 2, an ophthalmic device, such as an intraocular lens 126, is provided for securement in shuttle assembly 104. Although lens 126 is discussed herein, 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 140, a leading hap tic 1 10, and a trailing haptic 1 12, wherein leading haptic 1 10 includes a leading end portion 1 14 and trailing haptic 1 12 includes a trailing end portion 1 16.
[0026] Referring to FIGS. 3-5, a perspective view of shuttle assembly 104 is illustrated, along with a top view and a sectional view, respectively. Shuttle assembly 104 is configured to receive, secure, and fold lens 126, as described below. The geometry of shuttle assembly 104 can be varied to accommodate various lens designs, styles, and diopters, although in at least some embodiments, the geometry can remain fixed for a particular diopter range among the same lens style or design. Shuttle assembly 104 includes a shuttle bottom 142 and a shuttle top 144. In at least some embodiments, shuttle bottom 142 and shuttle top 144 are pivotally secured with one or more living hinges 145, although in other embodiments, other types of pivoting mechanisms can be used, 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 bottom 142 and shuttle top 144 can be secured together without a pivoting mechanism, for example clasps or latches can be used.
[0027] Shuttle bottom 142 includes a folding mechanism 146 and shuttle top 144 includes a top inner surface 148, which when combined, form a lens cavity 150 (FIG. 9) for receiving lens 126. In at least some embodiments, shuttle bottom 142 includes the primary lens-holding geometry. The shape of the haptics 1 10, 1 12 and optic 140 are accommodated by the geometry of shuttle bottom 142, which serves as a geometric interface to prevent horizontal and rotational movement within shuttle assembly 104. Further, the geometry of lens cavity 150 is configured to accommodate the haptics 1 10, 1 12 and the central thickness of optic 140, to substantially limit or prevent vertical movement within shuttle assembly 104.
[0028] Shuttle bottom 142 further includes a frame 152 having a first back support 154, a first front support 156, and a center support 158. First back support 154 includes a first channel 160 situated inside a second channel 162, wherein first channel 160 is ramped to guide plunger first end 109 to into injector cavity 121 and to ensure that trailing haptic 1 12 is fully captured by plunger first end 109. In addition, a first haptic stop 166 (FIGS. 4-7) and a second haptic stop 168 are provided on first back support 154, and in communication with second channel 162 for securing trailing haptic 1 12. Stops 166, 168, are sized and shaped to receive portions of trialing haptic 1 12, with trailing end portion 1 16 received by first haptic stop 166 (see FIGS. 6 and 7). A third haptic stop 170 (FIGS. 3, 4, 6, and 7) is provided on first front support 156, and in communication with a third channel 169 formed in the first front support 156, for securing leading haptic 1 10. Third haptic stop 170 is sized and shaped to receive leading end portion 1 14 of leading haptic 1 10 (see FIGS. 6 and 7). Stops 166, 168, 170 provide securement points for haptics 1 10, 1 12, as well as assist with guiding the hap tics 1 10, 1 12 so that they deploy out of the injector tip outlet 124 in a tucked orientation (see below), ensuring that lens 126 deploys within the capsular bag of a patient's eye in a controlled and predictable manner.
[0029] Referring to FIGS. 6-8, views of FIGS. 3-5 with lens 126 secured by portions of folding mechanism 146 are illustrated. Folding mechanism 146 includes a first wing 180 and a second wing 182 (FIGS. 3-5), both of which are pivotally secured to center support 158 of frame 152. In at least some embodiments, wings 180, 182 can be pivotally secured to one or more other portions of frame 152. First wing 180 includes a first retaining end 190 and a first hinged end 192. First hinged end 192 is secured to center support 158 by a first hinge 194 (FIGS. 4 and 5) to provide rotational movement therebetween. Similarly, second wing 182 includes a second retaining end 196 and a second hinged end 198. Second hinged end 198 is secured to center support 158 by a second hinge 200 to provide rotational movement therebetween. First retaining end 190 further includes a first groove 204 formed therein to provide a horizontal and vertical securement point for a first perimeter portion 206 of optic 140. Similarly, second retaining end 196 further includes a second groove 208 formed therein to provide a horizontal and vertical securement point for a second perimeter portion 210 of optic 140.
[0030] First wing 180 includes a wing outer surface 226 and an inner surface 228, wherein wing outer surface 226 and inner surface 228 are both curved. Similarly, second wing 182 includes an outer surface 230 and an inner surface 232, wherein outer surface 230 and inner surface 232 are both curved. First retaining end 190 further includes a first end surface 191 (FIGS. 1 1-13), and second retaining end 196 further includes a second end surface 197. In at least some embodiments, wings 180, 182 can vary in shape and size to accommodate various shapes and sizes of ophthalmic devices and shuttle configurations. In addition, first hinge 194 and second hinge 200 can in some embodiments be living hinges, while in other embodiments, first wing 180 and second wing 182 can be interconnected with center support 158 or frame 152 using other types of 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.
[0031] Referring to FIGS. 3-5, shuttle top 144 further assists shuttle bottom 142 with securement of lens 126 as well as assisting with the folding and ejection of lens 126 from shuttle assembly 104. More particularly, shuttle top 144 includes a second back support 212 that is complementarily received by first back support 154 when shuttle bottom 142 is folded onto shuttle top 144. Second back support 212 includes a fourth channel 214 that is complementary to second channel 162 to form a shuttle inlet passage 163 (see FIGS. 1 1 and 13) that conforms generally to the shape of plunger first end 109 to allow passage of plunger first end 109 therethrough. Similarly, shuttle top 144 includes a second front support 218 that is
complementarily received by first front support 156 when shuttle bottom 142 is folded onto shuttle top 144. Second front support 218 includes a fifth channel 220 that is complementary to third channel 169 to form a shuttle outlet passage 171 (see FIG. 9) that guides lens 126 out of shuttle assembly 104 and into injector tip 122. Second back support 212 further includes a fourth haptic stop 224 (FIG. 4) formed partially in fourth channel 214, which cooperates with second haptic stop 168 to secure the trailing haptic 1 12.
[0032] As shown in FIG. 5, top inner surface 148 includes a first inner portion 238 and a second inner portion 240, wherein the inner portions 238, 240 are curved with complementary arcs that accommodate curved wing outer surfaces 226, 230 of the wings 180, 182. In this regard, the inner portions 238, 240 do not interfere with wings 180, 182 when wings 180, 182 are translated upwards into lens cavity 150 to fold lens 126. Top inner surface 148 further includes a sixth channel 241 (FIG. 3) situated between and interconnected with inner portions 238, 240. A ramp portion 242 extends downwards from sixth channel 241 to a flush engagement with fifth channel 220. Sixth channel 241 and ramp portion 242 are curved concavely to assist with guiding lens 126 through shuttle outlet passage 171 (FIG. 9). Extending between inner portions 238, 240 and sixth channel 241 are a first wing stop 248 and a second wing stop 250. Wing stops 248, 250 are positioned for abutment with first end surface 191 and second end surface 197 (FIGS. 1 1-13) of wings 180, 182 upon complete translation of wings 180, 182 and folding of lens 126.
[0033] Referring to FIGS. 6-8 again, lens 126 is pre-loaded into shuttle assembly 104 prior to installing shuttle assembly 104 into injector cavity 121. Pre-loading is performed by placing lens 126 into lens cavity 150, such that the first perimeter portion 206 of optic 140 is situated in first groove 204 and the second perimeter portion 210 of optic 140 is situated in second groove 208. In addition, trailing haptic 1 12 is positioned against first haptic stop 166 and second haptic stop 168, and with leading end portion 1 14 of haptic 1 10 positioned in third haptic stop 170. Shuttle top 144 is rotated about hinge 145 and onto shuttle bottom 142 and fastened thereto. The fastening of shuttle top 144 to shuttle bottom 142 can be accomplished in one of various manners. In at least one embodiment, shuttle bottom 142 includes one or more barbed protrusions 244 (FIG. 3) extending from frame 152 that are matingly received in complementary apertures 246 situated in second back support 212 and/or second front support 218, thereby providing a latching engagement. In the aforementioned latching arrangement, shuttle assembly 104 can be reopened and refilled after use. In other embodiments, a permanent latching engagement can be used to prevent reuse.
[0034] Referring to FIG. 9, shuttle assembly 104 is illustrated in a closed position. Shuttle assembly 104 provides secure storage for lens 126 in a planar position until folding and insertion is required. Lens 126 can be situated in shuttle assembly 104 either in a hydrated or dry state. Prior to implantation, lens 126 is folded 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 eye. To fold lens 126, shuttle assembly 104 is inserted into injector cavity 121, wherein wings 180, 182 are engaged by first wing guide 133 and a second wing guide 135, respectively. Shuttle assembly 104 further includes an insertion tab 222 having a front bevel 227. Front bevel 227 provides a positive visual indicator to a user to identify the correct orientation of shuttle assembly 104 prior to installation in injector cavity 121 (i.e., front bevel 227 facing injector tip 122).
[0035] Referring to FIGS. 10 and 1 1, illustrated are cross-sectional perspective and front views, taken along line 10-10 of FIG. 9, of shuttle assembly 104 partially inserted into injector cavity 121. As shown, shuttle assembly 104 is partially inserted into injector cavity 121 until wing outer surface 226 of first wing 180 abuts first guide inner surface 137 of first wing guide 133, and outer surface 230 of second wing 182 abuts second guide inner surface 139 of second wing guide 135. At this point, lens 126 remains in an unfolded state, with wings 180, 182 in their resting position and configured to be translated via wing guides 133, 135. To fold lens 126, shuttle assembly 104 is further advanced into injector cavity 121. As shuttle assembly 104 is advanced, first guide inner surface 137 and second guide inner surface 139 fully engage wing outer surfaces 226, 230, respectively, causing a resultant movement of wings 180, 182 towards top inner surface 148. As wings 180, 182 are translated towards top inner surface 148, lens 126 is folded.
[0036] Referring to FIGS. 12 and 13, illustrated are cross-sectional perspective and front views taken along line 10-10 of FIG. 9, of shuttle assembly 104 fully inserted into injector cavity 121. As shown, once shuttle assembly 104 is fully inserted, lens 126 is folded and therefore ready to be ejected from the injector. Once lens 126 is folded, plunger second end 1 1 1 is depressed towards injector body 106, thereby advancing plunger first end 109 from injector body 106 through plunger outlet 1 13, a shuttle carrier inlet 165 (FIG. 2), and into first channel 160. First channel 160 includes a ramped surface for plunger first end 109 to pass into injector cavity 121. The ramped surface ensures that trailing haptic 1 12 is fully captured by plunger first end 109. After contact with trailing haptic 1 12, plunger first end 109 continues to push lens 126 through lens cavity 150 with leading haptic 1 10 exiting shuttle outlet passage 171 first, followed by optic 140 and trailing haptic 1 12. Lens 126 continues in this manner into injector tip 122 and finally passes through injector tip outlet 124 and into a patient's eye. After insertion of lens 126, the apparatus 100 can be disposed of, or partially disassembled and reused with a new lens 126 or shuttle assembly 104 and lens 126 combination.
[0037] 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 can be waterproof or water resistant.
[0038] 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 folding and injecting an ophthalmic device, the apparatus comprising: an injector having an injector body with an injector front portion;
a first cavity situated at the injector front portion;
a shuttle assembly having a second cavity for receiving an ophthalmic device, wherein the shuttle assembly is received inside the first cavity;
a folding mechanism situated inside the second cavity, wherein the folding mechanism includes one or more pivotable wings for engagement with and folding of the ophthalmic device; and
one or more wing guides in the first cavity, wherein the one or more wing guides extend from the first cavity for abutment with the folding mechanism, wherein the abutment is configured to activate the folding mechanism to fold the ophthalmic device inside the second cavity.
2. The apparatus of claim 1, wherein the one or more pivotable wings includes a pivotable first wing and a pivotable second wing.
3. The apparatus of claim 2, wherein the wings are hingedely secured to a frame of the shuttle assembly.
4. The apparatus of claim 2, wherein the first cavity includes a first cavity bottom surface and first cavity sidewalls.
5. The apparatus of claim 4, wherein the first cavity bottom surface is integral with the injector body.
6. The apparatus of claim 4, wherein the first cavity sidewalls are securable to the first cavity bottom surface.
7. The apparatus of claim 2, further including a plunger situated at least partially within the injector body, the plunger having a plunger end that is extendible into the injector front portion.
8. The apparatus of claim 1, wherein the shuttle assembly further includes a shuttle top securable to a shuttle bottom, and wherein the one or more pivotable wings includes a first wing and a second wing rotatably secured to the the shuttle bottom.
9. The apparatus of claim 8, wherein the first wing and the second wing each include an outer surface and each wing guide includes a guide surface, wherein the outer surfaces are engageable with the guide surfaces to provide a resultant translation of the first wing and the second wing.
10. The apparatus of claim 9, wherein the first wing and the second wing are secured by living hinges to a frame of at least one of the shuttle top and shuttle bottom.
11. The apparatus of claim 2, wherein the shuttle assembly includes a shuttle top and a shuttle bottom with the first wing and second wing each secured to the shuttle bottom by a hinge.
12. The apparatus of claim 1 1, wherein the shuttle top is securable to the shuttle bottom, and the shuttle top includes a top inner surface having a channel for guiding the ophthalmic device through the shuttle assembly.
13. The apparatus of claim 12, wherein the top inner surface of the shuttle top further includes one or more protrusions positioned to abut end surfaces of the wings to prevent over- translation of the wings during folding of the ophthalmic device.
14. The apparatus of claim 13, wherein the first wing and the second wing are secured to a frame of at least one of the shuttle top and shuttle bottom, the frame includes a back support and a front support, each having one or more grooves for securing one or more portions of the ophthalmic device to substantially limit at least one of vertical, horizontal, and rotational movement inside the second cavity.
15. The apparatus of claim 14, wherein each wing includes one or more grooves for securing the ophthalmic device to substantially limit at least one of vertical, horizontal, and rotational movement inside the second cavity.
16. A method of folding an ophthalmic device comprising, the method comprising:
inserting an ophthalmic device into a first cavity of a shuttle assembly;
securing the ophthalmic device to one or more rotatable wings situated inside the first cavity of the shuttle assembly;
inserting the shuttle assembly into a second cavity provided in an injector;
rotating the wings inside the first cavity with an abutment of one or more wing guides situated in the second cavity, wherein the abutment occurs during insertion of the shuttle assembly into the second cavity; and
folding the ophthalmic device within the first cavity, during rotation of the wings.
17. The method of claim 16, further including actuating a plunger second end of the injector to provide translation of a plunger first end into the shuttle assembly and against the folded ophthalmic device, wherein further actuation of the plunger second end ejects the ophthalmic device from the shuttle assembly and through an injector tip.
18. The method of claim 16, further including guiding the ophthalmic device through the shuttle assembly with one or more curved channels.
19. A shuttle assembly for securing an ophthalmic device, the assembly comprising:
a shuttle top securable to a shuttle bottom to form a first cavity;
a first wing and second wing rotationally secured to a frame of the shuttle bottom, wherein the first wing and second wing are configured to fold an ophthalmic device situated inside the first cavity, and wherein the frame further includes a back support and a front support, each of the back and front supports having one or more grooves for securing one or more portions of the ophthalmic device to substantially limit at least one of vertical, horizontal, and rotational movement of the ophthalmic device inside the first cavity.
20. The assembly of claim 19, wherein at least one of the first wing and the second wing includes one or more grooves for securing the ophthalmic device to substantially limit at least one of vertical, horizontal, and rotational movement of the ophthalmic device inside the first cavity.
PCT/US2014/012705 2014-01-23 2014-01-23 Apparatus and method for folding and injecting an ophthalmic device WO2015112144A1 (en)

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WO2019060294A1 (en) * 2017-09-19 2019-03-28 Bausch & Lomb Incorporated Intraocular lens injector assembly having shuttle assembly retaining intraocular lens in storage vial and operably presenting intraocular lens in injector assembly
US20200197168A1 (en) * 2018-12-19 2020-06-25 Alcon Inc. Iol folding device

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WO2014039326A1 (en) * 2012-09-07 2014-03-13 Bausch & Lomb Incorporated Intraocular lens injector assembly including a shuttle and method of assembling the same

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FR2892920A1 (en) * 2005-11-09 2007-05-11 Sedat Sa INJECTOR AND OPHTHALMIC IMPLANT FOLDING CARTRIDGE
WO2008098384A2 (en) * 2007-02-15 2008-08-21 Medicel Ag Technology For Surgery Device and injector for folding an intraocular lens, cartridge and injector
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WO2019060294A1 (en) * 2017-09-19 2019-03-28 Bausch & Lomb Incorporated Intraocular lens injector assembly having shuttle assembly retaining intraocular lens in storage vial and operably presenting intraocular lens in injector assembly
CN111328274A (en) * 2017-09-19 2020-06-23 博士伦公司 Intraocular lens injector assembly having a shuttle assembly for retaining an intraocular lens within a storage vial and operable to provide an intraocular lens within the injector assembly
US10722346B2 (en) 2017-09-19 2020-07-28 Bausch & Lomb Incorporated Intraocular lens injector assembly having shuttle assembly retaining intraocular lens in storage vial and operably presenting intraocular lens in injector assembly
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US20200197168A1 (en) * 2018-12-19 2020-06-25 Alcon Inc. Iol folding device
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