WO2014074382A2

WO2014074382A2 - Preloaded iol injector

Info

Publication number: WO2014074382A2
Application number: PCT/US2013/067694
Authority: WO
Inventors: Yakir KUSHLIN
Original assignee: Hanita Lenses R.C.A. Ltd.; Klein, David
Priority date: 2012-11-07
Filing date: 2013-10-31
Publication date: 2014-05-15
Also published as: WO2014074382A3

Abstract

An IOL is preloaded in a cartridge, and the IOL/cartridge assembly is pre-sterilized. Afterwards, the IOL/cartridge assembly is mounted in an IOL injector. Final sterilization is performed on the cartridge mounted in the injector.

Description

PRELOADED IOL INJECTOR

FIELD OF THE INVENTION

The present invention relates generally to devices and methods for inserting an intraocular lens (IOL) into an eye, and particularly wherein the IOL is preloaded in the injector device.

BACKGROUND OF THE INVENTION

An IOL injector is a well-known device that inserts an IOL into the eye of a patient during surgical replacement of the natural lens of the eye. Prior to implantation, the IOL must first be loaded into the IOL inserter device. Some IOL injectors require the IOL to be loaded into the injector at the time of surgery by the surgeon or other personnel. However, due to the delicate nature of the IOL, there is a risk of inadvertent damage to the IOL and/or incorrect loading of the IOL into the injector, which can result in a failed implantation and in some cases an adverse event may occur. Moreover, direct handling and/or loading of the IOL into the injector is undesirable in terms of ease of use, ergonomics, sterility and logistics.

Preloaded injector devices have been developed, in which the injector device and IOL are packaged together as a single unit or loaded on a cartridge that is easily loaded into the injector. The IOL is held in a preloaded position in an unstressed state (substantially no stress acts upon the optic or haptic portion of the lens). Before injection into the eye, the IOL may be flushed with saline solution. A viscoelastic liquid may be introduced into the distal end of the injector in order to lubricate movement of the IOL into the barrel of the injector nozzle. The plunger of the injector is then pushed forward, which pushes the lens to the end of the injector tip for subsequent insertion, typically through an incision in the anterior capsule into the bag.

SUMMARY OF THE INVENTION

The present invention seeks to provide a novel preloaded IOL injector, as is described more in detail hereinbelow.

There is thus provided in accordance with an embodiment of the present invention an IOL preloaded in a cartridge, the cartridge being pre- sealed at proximal and distal ends thereof by at least one seal, the cartridge being placed on a receiving member of an injector, the injector including a plunger which is arranged to be pushed distally so as to push the IOL distally. In one embodiment, the plunger can puncture a proximal seal end of the at least one seal, and can be pushed further distally to puncture a distal seal end of the at least one seal and to move the IOL to a tip of the injector. In another embodiment, one or both of the seals is manually opened and the plunger pushes the lens to the tip of the injector.

The seal can be a single seal that seals both the proximal and the distal ends of the cartridge. Alternatively, the seal can include a proximal sealing element that seals the proximal end of the cartridge and a separate distal sealing element that seals the distal end of the cartridge.

In another embodiment, the cartridge is mounted on a raisable base, and a raising member is mechanically linked to the base for moving the IOL into alignment with the plunger.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which:

Figs. 1A and IB are simplified perspective illustrations, respectively, of a cartridge for holding therein an IOL and the cartridge preloaded in a preloaded IOL injector, constructed and operative in accordance with an embodiment of the present invention, wherein the cartridge includes a sealing element that seals both proximal and distal ends of the cartridge;

Figs. 2A and 2B are simplified perspective illustrations, respectively, of a cartridge for holding therein an IOL and the cartridge preloaded in a preloaded IOL injector, constructed and operative in accordance with another embodiment of the present invention, wherein the cartridge includes separate sealing elements for sealing the proximal and distal ends of the cartridge; and

Figs. 3 A and 3B are simplified perspective and close-up illustrations, respectively, of a preloaded IOL injector, constructed and operative in accordance with yet another embodiment of the present invention, wherein the IOL is preloaded in a cartridge on a raisable base.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is now made to Figs. 1A and IB, which illustrate a preloaded IOL injector 10, constructed and operative in accordance with an embodiment of the present invention.

An IOL 12 is preloaded in a cartridge 14 (also called a cassette). Cartridge 14 is pre-sealed at both ends by one integral seal 16 (shown only partially in Fig. 1A). Seal 16 may be made of a medically safe elastomeric material, such as synthetic rubber. Depending on the application, seal 16 can permit or not permit gas flux. Cartridge 14 is placed on a receiving member 18 of injector 10. Cartridge 14 may be secured there by using either mechanical, chemical, magnetic forces or other mediators. Cartridge 14 is pre- sterilized before mounting in injector 10. Afterwards, cartridge 14 is mounted on injector 10 and final sterilization is done. Thus, the lens cassette/cartridge 14 is supplied mounted on the injector 10 after final sterilization for use in the surgery room.

A plunger 20 of injector 10 can be pushed forwards (distally) to puncture the first (proximal) seal end of seal 16, which pushes IOL 12 distally. Continued pushing of plunger 20 punctures the second (distal) seal end of seal 16 and moves IOL 12 to a tip 22 of injector 10, from which IOL 12 can be expelled and injected into the eye (not shown). Instead of using plunger 20 to deploy IOL 12 out of injector 10, in another embodiment, either or both of the proximal and distal seals can be manually opened, and plunger 20 pushes IOL 12 to the tip of injector 10.

Reference is now made to Figs. 2A and 2B. This embodiment is similar to the embodiment of Figs. 1A and IB, except that in this embodiment, cartridge 14 includes separate sealing elements 16a and 16B for sealing the proximal and distal ends of cartridge 14, respectively.

Reference is now made to Figs. 3A and 3B, which illustrate a preloaded IOL injector 30, constructed and operative in accordance with yet another embodiment of the present invention. In this embodiment, IOL 12 is preloaded in a cassette 32 on a raisable base 34. There is a raising member 36 (such as a knob) mechanically linked to base 34. By turning knob 36, base 34 rises and brings IOL 12 into alignment with the plunger 20 for injection into the eye. As similarly described above, cassette 32, base 34 and raising member 36 are mounted with the injector 30 and undergo final sterilization before supplying to the user.

In accordance with an embodiment of the invention, there is provided a method for mounting preloded IOL 12 in injector 10, wherein IOL 12 is placed in cartridge 14 which has an environment free of atmospheric gases (such as an anaerobic environment, or an environment filled with a fluid such as water, oil, viscous polymer, non-atmospheric gas or other suitable liquid or gas).

By preloading IOL 12 in cartridge 14, the assembly of IOL 12 and cartridge 14 can be sterilized with a different sterilization method than that used to sterilize the injector and /or the injector tip.

Claims

CLAIMS What is claimed is:

1. A method comprising:

placing an intraocular lens (IOL) in a cartridge;

pre- sterilizing the cartridge with the IOL therein; and

afterwards mounting said cartridge in an IOL injector and performing final sterilization on said cartridge mounted in said injector.

2. The method according to claim 1, comprising placing said IOL in said cartridge in an environment free of atmospheric gases.

3. The method according to claim 1, comprising placing said IOL in said cartridge in a liquid environment.

4. The method according to claim 1, comprising placing said IOL in said cartridge in a viscous polymer environment.

5. The method according to claim 1, wherein prior to pre- sterilizing the cartridge, said cartridge is pre-sealed at proximal and distal ends thereof by at least one seal.

6. The method according to claim 1, wherein said IOL and said cartridge are pre- sterilized with a different sterilization method than that used to sterilize said injector.

7. An article comprising:

an IOL preloaded in a cartridge, said cartridge being pre-sealed at proximal and distal ends thereof by at least one seal, said cartridge being placed, after pre-sterilization thereof, on a receiving member of an injector, said injector comprising a plunger which is arranged to be pushed distally so as to push said IOL distally.

8. The article according to claim 7, wherein said plunger is arranged to be pushed distally to puncture a proximal seal end of said at least one seal, and to be pushed further distally to puncture a distal seal end of said at least one seal and to move said IOL to a tip of said injector.

9. The article according to claim 7, wherein said at least one seal is manually openable.

10. The article according to claim 7, wherein said at least one seal comprises a single seal that seals both said proximal and said distal ends of said cartridge.

11. The article according to claim 7, wherein said at least one seal comprises a proximal sealing element that seals said proximal end of said cartridge and a separate distal sealing element that seals said distal end of said cartridge.

12. The article according to claim 7, wherein said cartridge is mounted on a raisable base, and a raising member is mechanically linked to said base for moving said IOL into alignment with said plunger.

13. The article according to claim 7, wherein said IOL is sterilized with a different sterilization method than that used to sterilize said injector.