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CN111212613A - Intraocular lens (IOL) injector and method of use - Google Patents

Intraocular lens (IOL) injector and method of use Download PDF

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Publication number
CN111212613A
CN111212613A CN201780095064.6A CN201780095064A CN111212613A CN 111212613 A CN111212613 A CN 111212613A CN 201780095064 A CN201780095064 A CN 201780095064A CN 111212613 A CN111212613 A CN 111212613A
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China
Prior art keywords
iol
injector
cartridge
lumen
sleeve
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Granted
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CN201780095064.6A
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CN111212613B (en
Inventor
W·曾
M·沈
W·李
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AST Products Inc
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AST Products Inc
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    • 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 or corneal implants; 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 or corneal implants; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1662Instruments for inserting intraocular lenses into the eye
    • A61F2/1667Instruments for inserting intraocular lenses into the eye with rotatable plungers

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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)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The present invention provides an apparatus and method for inserting an IOL into a patient's eye. The IOL injector is configured to automatically load the IOL into the injector by folding and aligning the IOL into the lens cartridge of the injector without requiring the surgeon to manually manipulate the IOL during surgery. The injector device is configured to properly orient and align the IOL within the injector device and to maintain proper alignment throughout delivery of the IOL to the eye of a patient, thereby ensuring that the IOL is properly positioned and oriented in a predetermined location in the eye.

Description

Intraocular lens (IOL) injector and method of use
Background
Technical Field
The present invention relates generally to ophthalmic surgical devices and methods, and more particularly to devices and methods for inserting an intraocular lens (IOL) into a patient's eye.
Background
Intraocular lens (IOL) injectors are devices designed to insert IOLs into a patient's eye. Such lenses are surgical implants designed to augment or replace the natural lens of the eye and are used to treat certain eye diseases. For example, cataract-induced vision impairment is often treated by surgical removal and replacement of the lens of the eye. In this procedure, a small 1-4mm incision is made in the patient's eye. The surgeon then uses a tool to insert the eye through the incision, emulsify (disintegrate) and remove the natural lens of the eye. Once removed, an intraocular lens is inserted into the eye.
To insert the lens without enlarging the incision, a compressible or foldable lens is used and is typically inserted through the incision using an injector device. The IOL is designed to return to its deployed shape within the eye in a predetermined orientation upon entry into the eye. In this procedure, the placement of the IOL is critical, particularly for toric lenses used to treat astigmatism, which require precise positioning and orientation at a predetermined location in the eye. Incorrect placement requires the surgeon to manually manipulate the positioning of the IOL, which can result in damage to the eye and damage to the IOL.
IOLs are typically shipped and stored in a relaxed state to avoid damaging the lens. Thus, conventional injector devices require the surgeon to load the IOL into the injector device, thereby requiring the surgeon to exercise a great deal of skill in loading the IOL in the correct orientation while avoiding damage to the IOL. Conventional injector devices do not allow the surgeon to control the orientation of the lens during loading and/or delivery of the lens to the eye. Accordingly, there is a need for an improved IOL injector that is easier to use while ensuring proper delivery of the IOL to the eye.
Disclosure of Invention
The present invention addresses the deficiencies of conventional injectors by providing an IOL injector that is optionally preloaded with an IOL in an unfolded state, wherein the injector is configured to automatically fold and properly align the IOL during delivery of the IOL without relying on the skill of the surgeon.
Accordingly, in one aspect, the present invention provides an IOL injector. The syringe comprises a syringe body elongated along a longitudinal axis and provided with a lumen. The lens cartridge is operably connected to the injector body and includes an inner cavity configured to receive the IOL and a positioning mechanism for folding and aligning the IOL within the lens cartridge inner cavity. An injector tip is operably connected with the lens cartridge, the injector tip having a lumen terminating in a distal opening. A plunger having an elongate shaft is slidably disposed in the interior cavity of the syringe body. The plunger is configured to contact a folded IOL loaded in the lens cartridge lumen and push the IOL along the longitudinal axis through the injector tip lumen and out the distal opening when the plunger is pressed into the deployed position. The injector further comprises a sleeve operably connected to the lens cartridge. The lens cartridge is configured to mechanically fold an IOL preloaded in the lens cartridge and align the IOL within the lens cartridge interior cavity via the positioning mechanism upon moving the sleeve from a distal first position in which the sleeve is over the injector tip to a proximal second position in which the sleeve is over the lens cartridge.
In an embodiment, the positioning mechanism comprises a first cartridge portion and a second cartridge portion that are mechanically moved towards each other perpendicular to the longitudinal axis of the device to fold the IOL as the sleeve is moved over the lens cartridge from a distal first position above the injector tip.
In another aspect, the present invention provides a method of implanting an IOL using the injector device of the present invention. The method comprises the following steps: providing an IOL injector having an IOL preloaded in a lens cartridge; translating the sleeve from a distal first position over the injector tip to a proximal second position over the lens cartridge, thereby folding and aligning the IOL within the lens cartridge lumen; and the plunger is depressed to transition it from the undeployed position to the deployed position to push the folded IOL along the longitudinal axis of the device and eject the IOL from the distal opening of the injector tip lumen into the patient's eye.
In yet another aspect of the invention, the invention provides a tool for practicing the method of the invention. The kit comprises an IOL injector of the invention and an IOL optionally preloaded in the injector. In an embodiment, the injector device is preloaded with the IOL such that the sleeve is in the first distal position and the IOL is in a deployed state within the lens cartridge lumen.
Drawings
The present invention will be more readily understood from the following detailed description of exemplary embodiments taken in conjunction with the following drawings.
FIG. 1 is a perspective view of an IOL injector device according to one embodiment of the invention with sleeve 60 in a first position covering injector tip 40;
FIG. 2 is an anterior view of the IOL injector depicted in FIG. 1 in one embodiment of the invention;
FIG. 3 is a rear view of the IOL injector depicted in FIG. 1 in one embodiment of the invention;
FIG. 4 is a left side view of the IOL injector depicted in FIG. 1 in one embodiment of the invention;
FIG. 5 is a right side view of the IOL injector depicted in FIG. 1 in one embodiment of the invention;
FIG. 6 is a top view of the IOL injector depicted in FIG. 1 in one embodiment of the invention;
FIG. 7 is a bottom view of the IOL injector depicted in FIG. 1 in one embodiment of the invention;
FIG. 8 is a perspective view of an IOL injector device according to one embodiment of the invention with sleeve 60 in a second position covering lens cartridge 30;
FIG. 9 is an anterior view of the IOL injector depicted in FIG. 8 in one embodiment of the invention;
FIG. 10 is a rear view of the IOL injector depicted in FIG. 8 in one embodiment of the invention;
FIG. 11 is a left side view of the IOL injector depicted in FIG. 8 in one embodiment of the invention;
FIG. 12 is a right side view of the IOL injector depicted in FIG. 8 in one embodiment of the invention;
FIG. 13 is a top view of the IOL injector depicted in FIG. 8 in one embodiment of the invention;
FIG. 14 is a bottom view of the IOL injector depicted in FIG. 8 in one embodiment of the invention;
FIG. 15 is an exploded view of an IOL injector according to one embodiment of the invention;
FIG. 16 is an enlarged perspective view of the first cartridge portion 34 depicted in FIG. 15 in one embodiment of the invention;
FIG. 17 is an enlarged perspective view of the second cartridge portion 36 depicted in FIG. 15 in one embodiment of the invention;
FIG. 18 is an enlarged top perspective view of the injector body 20 and lens cartridge 30 depicted in FIG. 15 in one embodiment of the present invention;
FIG. 19 is an enlarged bottom perspective view of the injector body 20 and lens cartridge 30 depicted in FIG. 15 in one embodiment of the present invention;
FIG. 20 is an enlarged perspective view of the sleeve 60 depicted in FIG. 15 in one embodiment of the present invention;
FIG. 21 is a front view of the syringe tip 40 depicted in FIG. 15 in one embodiment of the present invention;
figure 22 is an enlarged top view of the distal region of the IOL injector depicted in figure 1 in one embodiment of the invention.
Detailed Description
The present invention is described in preferred embodiments in the following description with reference to the figures, in which like numbers represent the same or similar elements. Reference throughout this specification to "one embodiment," "an embodiment," or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases "in one embodiment," "in an embodiment," and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment.
The described features, structures, or characteristics of the invention may be combined in any suitable manner in one or more embodiments. In the following description, numerous specific details are set forth in order to provide a thorough understanding of embodiments of the invention. One skilled in the relevant art will recognize, however, that the invention may be practiced without one or more of the specific details, or with other methods, components, materials, and so forth. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obscuring aspects of the invention.
In various aspects, the present invention provides an apparatus and method for inserting an IOL into a patient's eye. The IOL injector is configured to automatically load the IOL into the injector by folding and aligning the IOL into the lens cartridge of the injector without requiring the surgeon to manually manipulate the IOL during surgery. The injector device is configured to properly orient and align the IOL within the injector device and to maintain proper alignment throughout delivery of the IOL to the eye of a patient, thereby ensuring that the IOL is properly positioned and oriented in a predetermined location in the eye.
Referring to fig. 1-14, one such IOL injector 10 includes an injector body 20, a lens cartridge 30 operatively connected to the injector body, an injector tip 40 operatively connected to the lens cartridge, a plunger 50, and a sleeve 60 operatively connected to the lens cartridge.
Figure 15 is an exploded view showing the operative association of the components of the IOL injector. As shown, plunger 50, injector body 20, lens cartridge 30, injector tip 40 and sleeve 60 are disposed along the longitudinal axis of the IOL injector with the plunger disposed at the proximal end of the injector and injector tip 40 disposed at the distal end of the injector. In an embodiment, the lumen traverses the entire length of the device such that an IOL loaded into lens cartridge lumen 32 can be pushed by distal tip 56 of elongate shaft 52 of plunger 50 along the longitudinal axis through injector tip lumen 42 and out distal opening 44 into the patient's eye as plunger 50 is advanced distally from the undeployed position to the deployed position.
As discussed herein, the injector is configured to mechanically fold and align the IOL within the lens cartridge such that proper orientation is achieved when the IOL is loaded into the lens cartridge lumen and delivered to the eye. Folding and alignment of the IOL in the lens cartridge lumen is accomplished by a positioning mechanism disposed in the lens cartridge 30 that is operatively connected to the sleeve 60. Transitioning sleeve 60 from a first position, as shown in fig. 1-7, in which sleeve 60 covers injector tip 40, to a second position, as shown in fig. 8-14, in which sleeve 60 covers lens cartridge 30, causes the positioning mechanism to fold the IOL from the first unfolded state to the second folded state and align the IOL within lens cartridge lumen 32. Once the IOL is folded and properly aligned within lens cartridge lumen 32, the IOL can be delivered to the patient's eye by distally advancing plunger 50 from the undeployed position to the deployed position.
In an embodiment, the positioning mechanism may comprise one or more components operatively associated to fold the IOL and interact with the sleeve 60. Fig. 15 shows an embodiment of a syringe comprising a positioning mechanism having a first cartridge portion 34 and a second cartridge portion 36. The first and second cartridge portions 34 and 36 are shown in fig. 16 and 17, respectively. In this embodiment, the first cartridge portion 34 has a surface adapted to contact the inner surface of the sleeve and push the first cartridge portion towards the second cartridge portion 36 when the sleeve 60 is moved from the first position to the second position. As shown in fig. 16, surface 38 is configured to contact an inner surface of sleeve 60 when the sleeve is moved from the first position to the second position. In the embodiment shown in fig. 16, surface 38 has a distal tapered region 39 that facilitates contact with the inner surface of sleeve 60 as it is moved over lens cartridge 30.
As indicated by the arrows in fig. 22, sleeve 60 moves from a first position (as shown in fig. 22) toward lens cartridge 30 to a second position in which sleeve 60 covers the first and second cartridge portions (34 and 36) moving first cartridge portion 34 inwardly toward second cartridge portion 36 perpendicular to the longitudinal axis of the device. Movement of the first cartridge portion 34 causes opposing surfaces ( surfaces 31 and 33 shown in figures 16 and 17, respectively) provided on the first and second cartridge portions to fold the IOL such that the IOL is folded in half along the longitudinal axis of the injector device. Thus, in the folded state, the IOL is substantially folded in half along its major dimension (i.e., length). In embodiments, where the IOL includes haptics, the injector is configured to position the one or more haptics at the correct orientation over the IOL's optical area for delivery. In one embodiment, a properly aligned IOL has anterior haptics that push against the optic and posterior haptics that contact the distal tip 56 of the plunger 50. Thus, a properly oriented IOL "marks" the haptics to the optic area. Those skilled in the art will recognize that it is advantageous to construct distal tip 56 from a material that will not damage the IOL upon contact. In embodiments, the distal tip 56 comprises a polymeric material, such as silicone or other elastically deformable polymer.
In an embodiment, to facilitate alignment of sleeve 60 with lens cartridge 30, one or more raised ridge surfaces may be provided on the inner surface of the sleeve. For example, fig. 20 depicts an embodiment in which the inner surface of the sleeve contains a plurality of ridges 65 for interacting with corresponding grooves provided on lens cartridge 30. An embodiment of lens cartridge 30 having grooves 70 for receiving ridges disposed on the inner surface of the sleeve is shown in fig. 19.
In certain aspects, the IOL injector is provided in the form of a tool with an IOL, optionally preloaded in the lens cartridge of the injector. This reduces the manual handling required by the surgeon while performing the surgical procedure, thereby reducing the risk of contamination and damage to the IOL that may occur during handling of the IOL. Advantageously, placing the injector device in a preloaded state allows the injector device to be sterilized at the factory at the same time as the IOL during packaging. In the pre-loaded injector embodiment, the lens injector is provided with the IOL pre-loaded in the lens cartridge (where the lens is in the deployed state), the sleeve is in the first position covering the injector tip, and the plunger is in the undeployed state. In use, the surgeon need only open the injector package, transfer the sleeve from the first position to the second position to fold and align the IOL in the lens cartridge, and deliver the IOL to the patient's eye by transferring the plunger from the undeployed position to the deployed position. In addition, the IOL injector device may be configured for a single use whereby the injector device is discarded after the IOL is delivered to the eye.
Accordingly, in one aspect, the present invention provides a method of implanting an IOL in an eye of a patient. The method comprises the following steps: providing an IOL injector of the present invention having an IOL preloaded in a lens cartridge; translating the sleeve from a distal first position over the injector tip to a proximal second position over the lens cartridge, thereby folding and aligning the IOL within the lens cartridge lumen; and the plunger is depressed to transition it from the undeployed position to the deployed position to push the folded IOL along the longitudinal axis of the device and eject the IOL from the distal opening of the injector tip lumen into the patient's eye.
In an embodiment, the syringe may be configured to lock the sleeve in the second position. For example, the syringe may include a locking mechanism that prevents movement of the sleeve from the second position to the first position. Those skilled in the art will appreciate that this may be accomplished in a variety of ways, for example, the locking mechanism may comprise a snap lock, wherein the sleeve comprises one or more locking structures that snap into corresponding grooves provided on the lens cartridge.
It will be appreciated that the lumen extending along the longitudinal axis of the syringe need not have a constant diameter. In an embodiment, the lumen has a different diameter at different regions of the syringe. For example, the lens cartridge lumen may have a different diameter than the injector tip lumen. In one embodiment, the diameter of the lens cartridge lumen is greater than the diameter of the injector tip lumen. Further, in embodiments, the syringe tip lumen tapers from a larger diameter at a proximal end of the syringe tip to a smaller diameter at a distal end of the syringe tip where the distal opening is located.
In embodiments, the cross-sectional area of the syringe tip lumen decreases from a larger diameter at the proximal end of the syringe tip to a smaller diameter at the distal end of the syringe tip where the distal opening is located. Additionally, the cross-sectional shape of the syringe tip lumen may be different at the distal end of the syringe tip lumen as compared to the proximal end of the syringe tip lumen.
Fig. 21 is a front view of the syringe tip 40, showing an embodiment in which the distal opening 44 has an elongated circular cross-sectional shape. It should be understood that the cross-sectional shape of the distal opening may be any shape necessary to maintain the proper folding and orientation of the IOL for delivery to the eye. This may depend in part on the type and shape of IOL being delivered. For example, the cross-sectional shape of the distal opening may be square, circular, elliptical, rectangular, triangular, or curvilinear triangular.
The IOL injector may be constructed from a variety of different materials. Those skilled in the art will recognize that different components of the syringe may be constructed of different materials to impart different structural characteristics in different regions of the device. Further, various regions of the delivery lumen may comprise a polymer or lubricious coating.
Some embodiments of the present invention may provide a polyurethane polymer having a polyurethane polymer partially or entirely; styrene related copolymers such as, but not limited to, polyolefins, polyamides, PEBAX, butyl diene styrene Acrylate (ABS), styrene butyl diene styrene (SBS), and/or High Impact Polystyrene (HIPS); a polyester polymer; and their polymer blends or copolymers. Such materials may be sufficiently flexible to enable the creation of small diameter insertion devices, and may also maintain or introduce other beneficial properties.
To ensure that the IOL traverses the delivery lumen without causing damage to the lumen and/or the IOL, the delivery lumen should be able to withstand the forces to which it is subjected during insertion. Thus, the delivery lumen may be formed of a material that is sufficiently flexible to withstand these forces without cracking or rupturing. In addition, to reduce the risk of damage to the IOL, and also reduce the insertion force required to perform insertion, the delivery lumen may be formed of a material that is sufficiently smooth, mixed with a lubricious additive, coated with a lubricious material, or otherwise minimizes the forces that tend to bond the IOL to the inner walls of the lumen. These considerations are particularly applicable to the distal end of the injector tip because the tapering of the delivery lumen increases the normal force experienced by the delivery lumen as the IOL moves distally.
Additionally, to counteract frictional forces that may be experienced during insertion, in some embodiments, a coating made of a hydrophilic polymer material may be applied to the delivery lumen or lens cartridge to provide additional lubricity. For example, in some embodiments, the coating may comprise one or more hydrophilic polymeric materials, such as, but not limited to, hydrophilic polyurethanes, polyvinylpyrrolidones, polyacrylic acids, polyacrylamides, polyhydroxyethylmethacrylate, and/or hyaluronic acid, and the like. It should be noted, however, that the lubricant used in the delivery lumen need not be applied uniformly along the lumen.
Additionally, some embodiments may use materials formed using a co-molding process. Using this process, two or more materials (e.g., polymers) may be extruded and/or injected as a single piece, and may allow for the use of materials having different physical properties. For example, materials having both sufficient toughness and other desired properties may be used. For example, a polyurethane with sufficient toughness may be used, and another polyurethane with the desired lubricating properties may also be used.
In some embodiments, the syringe is constructed using a polymer composition having grafted hydrophilic and lubricating groups as described in U.S. patent application No. 2013/0129953 to Lee, which is incorporated herein by reference. Such compositions utilize polypropylene, polycarbonate, polyamide, cellulose acetate and acrylic polymers or copolymers, which are suitable base polymers for grafting.
The following examples are provided to further illustrate embodiments of the present invention and are not intended to limit the scope of the present invention. While these examples are typical examples that may be used, other processes, methods, or techniques known to those skilled in the art may be used instead.
Example 1
Refractive cataract surgery using an IOL injector with a hydrophobic IOL
Thirty (30) sets of the IOL injector of the present invention were used to deliver thirty (30) hydrophobic folded single-piece intraocular lenses (IOLs) to simulate surgical procedures during refractive cataract surgery. The 30 hydrophobic folded single-piece intraocular lenses consisted of 10 low diopter, 10 medium diopter, 10 high diopter IOLs. All lenses were delivered by the injector of the present invention according to the loading and delivery procedures described in the instructions for use.
The optical properties, sagittal and overall surface and volume uniformity of the IOL, as well as the folded lens opening time were evaluated before and after surgical procedures using the injector of the present invention. The syringe of the present invention was also evaluated for cartridge and tip performance, such as overall cartridge and tip surface and volume uniformity. According to ISO 11979-2 part 2 of the Ophthalmic implant-Intraocular lenses (Ophthalmic implants-Intraocular lenses): optical Properties and test methods (Optical properties and methods) and ISO 11979-3 Ocular implants-Intraocular lenses (ocular implants-Intraocular lenses) part 3: mechanical properties and test methods, IOL optical properties and overall surface and volume uniformity checks were performed.
After delivery, Nikon was usedTMThe SMZ-1 stereomicroscope was used to see if all lenses were likely to be damaged or scratched. All lenses delivered were intact or scratched and met the dimensional specifications. Furthermore, none of the cartridges were damaged after lens delivery. The data resulting from the simulated surgical procedure for injector delivery of hydrophobic intraocular lenses of the present invention show: the injector of the present invention is able to successfully deliver low, medium and even high diopter hydrophobic IOLs without affecting the function of the lens.
Example 2
Refractive cataract surgery using an IOL injector with a hydrophilic IOL
Thirty (30) sets of the injector of the present invention were used to deliver thirty (30) hydrophilic folded single-piece intraocular lenses (IOLs) to simulate surgical procedures during refractive cataract surgery. The 30 hydrophilic folded single-piece intraocular lenses consisted of 10 low diopter, 10 medium diopter, 10 high diopter IOLs. All lenses were delivered by the injector of the present invention according to the loading and delivery procedures described in the instructions for use.
The optical properties, sagittal and overall surface and volume uniformity of the IOL, as well as the folded lens opening time were evaluated before and after surgical procedures using the injector of the present invention. The syringe of the present invention was also evaluated for cartridge and tip performance, such as overall cartridge and tip surface and volume uniformity. According to ISO 11979-2 part 2 of the Ophthalmic implant-Intraocular lenses (Ophthalmic implants-Intraocular lenses): optical Properties and test methods (Optical properties and methods) and ISO 11979-3 Ocular implants-Intraocular lenses (ocular implants-Intraocular lenses) part 3: mechanical properties and test methods, IOL optical properties and overall surface and volume uniformity checks were performed.
After delivery, Nikon was usedTMThe SMZ-1 stereomicroscope was used to see if all lenses were likely to be damaged or scratched. All lenses delivered were intact or scratched and met the dimensional specifications. Furthermore, none of the cartridges were damaged after lens delivery. The data showing the results of the simulated surgical procedure for delivering a hydrophilic intraocular lens by the injector of the present invention show: the injector of the present invention is able to successfully deliver low, medium and even high diopter hydrophilic IOLs without affecting the function of the lens.
Although the present invention has been described with reference to the above examples, it is to be understood that modifications and variations are included within the spirit and scope of the present invention. Accordingly, the invention is not limited except as by the following claims.

Claims (22)

1. An intraocular lens (IOL) injector comprising:
a) a syringe body elongated along a longitudinal axis, the syringe body having an inner cavity disposed along the longitudinal axis;
b) a lens cartridge operably connected to the injector body, the lens cartridge having an inner cavity configured to receive an IOL and a positioning mechanism for folding and aligning the IOL within the lens cartridge inner cavity, wherein the lens cartridge inner cavity is coextensive with the injector body inner cavity;
c) an injector tip operably connected with the lens cartridge, the injector tip having a lumen disposed along the longitudinal axis and terminating in a distal opening, wherein the injector tip lumen is coextensive with the injector body lumen;
d) a plunger having an elongate shaft slidably disposed within the injector body lumen from an undeployed position to a deployed position, wherein the plunger is configured to contact the IOL in the lens cartridge lumen and push the IOL along the longitudinal axis through the injector tip lumen and out of the distal opening when the plunger is transitioned to the deployed position; and
e) a sleeve operably connected to the lens cartridge, wherein the lens cartridge is configured to fold and align the IOL within the lens cartridge cavity via the positioning mechanism upon moving the sleeve on the lens cartridge from a first position to a second position, the sleeve covering at least a portion of the lens cartridge in the second position.
2. The IOL injector of claim 1, wherein said sleeve covers the entire lens cartridge and contacts said injector body in said second position.
3. The IOL injector of claim 1, wherein a surface of the injector tip lumen or the lens cartridge lumen comprises a polymer or a lubricious coating.
4. The IOL injector of claim 3, wherein said lubricious coating is a hydrophilic and lubricious polymer or copolymer matrix.
5. The IOL injector of claim 1, wherein said positioning mechanism comprises a first cartridge portion having a surface adapted to contact an inner surface of said sleeve and to urge said first cartridge portion toward a second cartridge portion when said sleeve is moved from said first position to said second position.
6. The IOL injector of claim 1, wherein the IOL is folded in half along the longitudinal axis when the sleeve is in the second position.
7. The IOL injector of claim 5, wherein said surface of said first cartridge portion has a tapered region.
8. The IOL injector of claim 7, wherein said surface of said tapered region is angled with respect to said longitudinal axis.
9. The IOL injector of claim 5, wherein said second cartridge portion has a recess adapted to receive a raised inner surface of said sleeve.
10. The IOL injector of claim 1, wherein said distal opening of said injector tip lumen is a geometric shape selected from the group consisting of square, circular, oval, rectangular, triangular, curvilinear triangular.
11. The IOL injector of claim 1, wherein a proximal region of said injector tip lumen has an opening, wherein a cross-sectional area of said opening is greater than a cross-sectional area of said distal opening.
12. The IOL injector of claim 1, wherein said plunger further comprises a spring disposed on said elongate shaft.
13. The IOL injector of claim 5, wherein said first cartridge portion and said second cartridge portion form a slot for accessing said lens cartridge lumen at said first location.
14. The IOL injector of claim 13, wherein said slot is configured to receive said IOL when a thickness of said IOL is perpendicular to said longitudinal axis.
15. The IOL injector of claim 1, further comprising a locking mechanism configured to secure the sleeve in the second position.
16. The IOL injector of claim 15, wherein said locking mechanism comprises one or more slots disposed on said lens cartridge or said injector body, said slots configured to receive one or more locking structures disposed on said sleeve.
17. A method of implanting an intraocular lens (IOL), comprising:
a) providing an IOL injector, the injector comprising:
i) a syringe body elongated along a longitudinal axis, the syringe body having an inner cavity disposed along the longitudinal axis;
ii) a lens cartridge operably connected to the injector body, the lens cartridge having an inner cavity configured to receive an IOL and a positioning mechanism for folding and aligning the IOL within the lens cartridge inner cavity, wherein the lens cartridge inner cavity is coextensive with the injector body inner cavity;
iii) an injector tip operably connected with the lens cartridge, the injector tip having a lumen disposed along the longitudinal axis and terminating in a distal opening, wherein the injector tip lumen is coextensive with the injector body lumen;
iv) a plunger having an elongate shaft slidably disposed within the injector body lumen from an undeployed position to a deployed position, wherein the plunger is configured to contact the IOL within the lens cartridge lumen and push the IOL along the longitudinal axis through the injector tip lumen and out of the distal opening when the plunger is transitioned to the deployed position; and
v) a sleeve operably connected to the lens cartridge, wherein the lens cartridge is configured to fold and align the IOL within the lens cartridge cavity by the positioning mechanism upon moving the sleeve on the lens cartridge from a first position to a second position, the sleeve covering at least a portion of the lens cartridge in the second position;
b) inserting an IOL into the lens cartridge lumen when the sleeve is in the first position and the plunger is in the undeployed position;
c) transitioning said sleeve from said first position to said second position thereby folding and aligning said IOL in said lens cartridge lumen; and
d) transitioning the plunger from the undeployed position to the deployed position thereby ejecting the IOL from the distal opening of the injector tip lumen into the patient's eye, the IOL being in a folded state upon exiting the distal opening.
18. The method of claim 17, wherein the positioning mechanism includes a first cartridge portion having a surface adapted to contact an inner surface of the sleeve, and the surface urges the first cartridge portion toward a second cartridge portion when the sleeve is moved from the first position to the second position.
19. The method of claim 18, wherein the second cartridge portion has a recess adapted to receive a raised inner surface of the sleeve.
20. A tool, comprising:
a) the IOL injector of claim 1; and
b)IOL。
21. the tool of claim 20, wherein the IOL comprises an optic and at least one haptic extending from the optic in a curved shape.
22. The tool of claim 20 wherein said injector device is preloaded with said IOL such that said sleeve is in said first position and said IOL is in a deployed state in said lens cartridge lumen.
CN201780095064.6A 2017-10-05 2017-10-05 Intraocular lens (IOL) injector and method of use Active CN111212613B (en)

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WO2019070282A8 (en) 2020-04-23
WO2019070282A1 (en) 2019-04-11

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