Surgery – Instruments – Means for removing – inserting or aiding in the removal or...
Reexamination Certificate
2000-03-22
2002-09-10
Hirsch, Paul J. (Department: 3747)
Surgery
Instruments
Means for removing, inserting or aiding in the removal or...
Reexamination Certificate
active
06447519
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to intraocular lenses and injectors and, more particularly, to apparatus for holding intraocular lenses, apparatus for holding intraocular lens injectors, combinations including such apparatus and methods for loading intraocular lens into injectors using such apparatus and combinations.
BACKGROUND OF THE INVENTION
As is well known, intraocular lenses or IOLs are used in the eye, for example, as an adjunct to the natural lens of the eye or to replace the natural lens of the eye when the natural lens becomes damaged or otherwise incapable of functioning. For example, the natural lens may be removed and an IOL is inserted into the eye as a direct replacement. A typical IOL includes an optic or lens body for focusing light toward the retina of the eye, and one or more fixation members or haptics for fixing the IOL in the desired position within the eye.
The IOL preferably is implanted directly into the eye through a small incision formed in the ocular tissue of the eye. To fit through this small incision, optics of modern IOLs are designed to be deformed, e.g., folded, rolled or the like, to a relatively small profile and then allowed to substantially return to their original shape within the eye.
The IOL is typically provided to the surgeon or other medical personnel in a packaging system which contains the IOL. These packaging devices protect the IOL during handling and transportation to the surgical site and may even allow for accurately folding the IOL along the optic diameter in order to reduce its size. Some of these systems specifically fold the IOL in preparation for grasping by the forceps or other surgical instrument. One form of such a holding and folding device or system is described in Buboltz et al U.S. Pat. No. 5,171,241.
A very useful technique for inserting an IOL into the eye includes the use of an IOL injector or cartridge, such as the IOL injector described in Bartell, U.S. Pat. No. 4,681,102. These IOL injectors include a load chamber which is connected to an injection tube. The load chamber includes an openable first lumen for receiving the IOL. Closure of this first lumen folds the IOL and maintains the IOL in a folded state. The injection tube includes a small diameter distal tip which is insertable into the incision within the eye. The IOL is transferable from the load chamber through the injection tube and into the eye. These IOL injectors simplify the placement of the IOL within the eye and reduce chances of surgeon error.
A very useful IOL packaging system is disclosed in commonly assigned U.S. patent application Ser. No. 08/987,864, filed on Dec. 9, 1997, the disclosure of which is hereby incorporated in its entirety herein by reference. The IOL is placed on the load chamber so that the IOL will be folded when the load chamber is closed.
The technique of transferring the IOL to the load chamber of the injector normally is accomplished by manually manipulating the IOL and/or injector. Such manual manipulation requires a relatively high degree of dexterity and can result in the IOL being incorrectly loaded in the injector. Also, increased handling increases the risk of damaging and/or contaminating the IOL and/or injector.
It would be advantageous to provide an IOL injector holding system so that the IOL could be placed in the injector with reduced, or even substantially no, manual manipulation.
SUMMARY OF THE INVENTION
Apparatus for holding intraocular lens injectors, combinations of intraocular lens injector holding assemblies and intraocular lens holding assemblies, intraocular lens packaging systems and methods for using intraocular lens injector holding apparatus and assemblies have been discovered. The present intraocular lens injector holding apparatus and assemblies provide enhanced ease of use, for example, by requiring reduced dexterity to load an IOL into an injector and/or by simplifying or eliminating individual steps previously required to load the IOL. For example, the IOL injector preferably does not have to be manually handled except to place the injector into an injector system hand piece for insertion of the IOL into the eye. The present invention reduces the risk of dust or other contamination on the IOL, as well as reducing the risk of damaging the IOL injector. Additional benefits include the provision for holding a soft tip for use on a push rod of the IOL injection system. Also, additional lubricants, such as aqueous balanced salt solution (BSS) and/or visco elastic materials, can be added in the injector while it is still being held by the holding apparatus or assembly. The present apparatus, combinations, systems and methods are straightforward in construction and are relatively easy and convenient to manufacture, use and practice.
In one broad aspect of the present invention, apparatus for holding an intraocular lens injector or cartridge having a load or loading chamber, and preferably a pair of generally opposing wings, so that the loading chamber is maintained in an open position are provided. The apparatus comprises a housing and at least one element, preferably a plurality of such elements. The housing is sized and adapted to receive the intraocular lens injector. The element or elements are secured to the housing and are adapted and positioned to stabilize the position of the intraocular lens injector relative to the housing, for example, to hold the intraocular lens injector in or to the housing, with the loading chamber in the open position.
The present apparatus for holding an intraocular lens injector may be considered a package system for such intraocular lens injectors. Thus, the intraocular lens injector may be included with the apparatus at the point of manufacture or assembly of the intraocular lens injector. In this fashion, the surgeon or technician at the surgical site does not need to handle the intraocular lens injector prior to placing the intraocular lens into the injector.
Preferably, the intraocular lens injector has a proximal end, and one of the elements of the present apparatus is positioned to be in proximity, or even substantially abutting relation, to this proximal end. The intraocular lens injector includes an injection tube located distally of the loading chamber. One or more of the elements of the present apparatus preferably are positioned to contact the injection tube, for example, to stabilize the position of the injection tube, and more preferably to hold the injector to the housing. In a useful embodiment, one or more elements are positioned to be in proximity to the proximal end of the injector and one or more elements are positioned to contact the injection tube. Other configurations of these elements may be employed and are included within the scope of the present invention. These elements preferably are positioned so as to facilitate maintaining the injector in a substantially fixed position so that the intraocular lens can be placed in the loading chamber in the proper orientation for insertion into the eye.
The present intraocular lens injector holding apparatus preferably further include support members secured to the housing and adapted and positioned so that at least one of the support members is in close proximity to each of the wings of the received intraocular lens injector. Thus, both wings are provided with such support member or members located in close proximity thereto, for example, so that the wings are effectively positioned to facilitate the use of the injector holding apparatus with the intraocular lens holding assembly, as is discussed elsewhere herein.
The housing may include a base, with the element or elements secured to the base and extending therefrom.
In one embodiment, the housing includes a sidewall extending from, preferably extending generally upwardly from, the base. More preferably, the housing includes a peripheral sidewall which substantially fully or completely circumscribes the base. Such sidewall is effective, for example, to protect the intraocular lens injector during shipment, storage and hand
Brady Daniel G.
Collinson Michael
Gwon Arlene
Plyley Alan K.
Vidal Claude A.
Allergan Sales Inc.
Hirsch Paul J.
Stout, Uxa Buyan & Mullins, LLP
Uxa Franc J.
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