CN118000966A

CN118000966A - Sterile wet packaging and packaging method for hydrophobic intraocular lenses

Info

Publication number: CN118000966A
Application number: CN202410158026.2A
Authority: CN
Inventors: Y·酷斯林; B·哈什; A·马里亚罗夫; E·伊万尼尔
Original assignee: Hanita Lens Co
Current assignee: Hanita Lens Co
Priority date: 2022-08-23
Filing date: 2023-08-22
Publication date: 2024-05-10
Also published as: CN117580548A

Abstract

A sterile, moist package and packaging method for an intraocular lens (IOL) is disclosed. In some embodiments, the method comprises steam sterilizing within the outer bag, wherein the IOL is within the open inner bag. The inner bag comprises a material having a thermal conductivity greater than or equal to 1.1 times that of the IOL material. The method further includes sealing the inner bag via the outer bag, thereby trapping humidified air (having an RH of greater than or equal to 70% at 25 ℃) within the inner bag. In other embodiments, the method comprises ethylene oxide sterilization and humidification within a first sealed region of the sealable pouch, the first sealed region comprising a permeable window, the first sealed region comprising an IOL preloaded in an IOL injector. The method further includes sealing the sealable pouch with a second seal such that the second sealed region of the sealable pouch does not include a permeable window, thereby trapping humidified air (having an RH of greater than or equal to 60% at 25 ℃) within the second sealed region of the sealable pouch.

Description

Sterile wet packaging and packaging method for hydrophobic intraocular lenses

Case division information

The application is a divisional application of an application patent application with the application number of 20238012684. X and the application name of 'sterile wet packaging and packaging method for hydrophobic intraocular lenses' filed on 22 days of 2023 and 8.

RELATED APPLICATIONS

The present application claims priority from U.S. provisional application 63/406,843 filed on 8/23 of 2022 and filed on 9/15 of 2022. These two priority applications are incorporated herein by reference.

Technical Field

The present invention relates generally to a sterile package and packaging method suitable for intraocular lenses. More particularly, the present invention relates to a moisture-filled sterile package for an intraocular lens and a method of packaging the same.

Background

An intraocular lens (IOL) is an artificial lens that replaces the natural lens of the eye that is removed during cataract surgery or refractive lens Replacement (RLE) surgery. IOLs typically include a polymer-based lens and polymer-based jambs or extensions (referred to as haptics) to hold the lens in place in the capsular bag within the eye. In most cases, the haptic is the same material as the lens, and the IOL is referred to as a one-piece IOL. The optical zone of an IOL can have different designs: monofocal, multifocal refractive, multifocal diffractive, with or without toric corrective elements (for correcting pre-existing corneal astigmatism prior to surgery). The IOL design may have a constant mechanical configuration or may include an accommodation mechanism designed to allow the eye to restore some partial focusing power to change focus from distance vision to near vision through the use of ciliary muscle movement or other external energy sources.

Generally, modern soft or flexible IOLs are made from a variety of polymers such as acrylate backbone-based polymers, polypropylene-based polymers with various hydrophilic side chains (such as methyl methylol or hydrophobic methyl methacrylate), polypropylene-based polymers with aromatic or other waxy side chains (such as ethyl ethoxy methyl acrylate), and combinations of silicone and siloxane-based lenses or other polymers.

Modern IOLs are made of soft materials so that they can be injected into the eye through small incisions. Known polymeric materials for ophthalmic use have a certain amount of water content ranging from approximately 0% water content considered extremely hydrophobic up to about 40% considered extremely hydrophilic.

The IOL is sterilized in its primary package and may be sterilized in different forms by steam sterilization, ethylene oxide (EtO), gamma irradiation, and various plasma sterilization methods. Hydrophilic IOLs have a high water content and are typically provided in water or saline solutions, the water content supporting the hydrophilic IOL maintaining its flexibility. Thus, hydrophilic lenses are provided in water/saline, while hydrophobic lenses provide sterilization primarily in dry packaging (primarily using EtO sterilization).

Soft IOLs have been found to be more flexible once hydrated. Hydrophilic IOLs must remain in water or saline in order to be implanted because in the non-hydrated state, the lens is rigid rather than flexible. Soft IOLs made of hydrophobic materials are not as flexible as in their hydrated state when maintained in a sterile dry environment. This lack of flexibility of hydrophobic IOLs compromises the smoothness of injection of the IOL into the lens capsule.

Thus, there is a need for a new form of packaging an IOL in a sterile, moist environment that will ensure that the IOL can be provided for implantation under optimal conditions.

Disclosure of Invention

Some aspects of the invention relate to a package for an article, such as an intraocular lens (IOL), comprising: an inner sealed sterile pouch comprising an IOL and air having a Relative Humidity (RH) of at least 75% at 25 ℃; and an outer sealed sterile pouch surrounding the inner sealed sterile pouch, wherein at least one edge of the inner sealed sterile pouch is sealed via at least one surface of the outer sealed sterile pouch. In some embodiments, the air in the inner sealed pouch is at least 80% RH.

In some embodiments, the inner sealed sterile bag comprises a material having a thermal conductivity at least 1.1 times that of the IOL material. In some embodiments, the inner sealed sterile pouch is made from at least one of aluminum foil and a polyester laminate having an aluminum layer. In some embodiments, the IOL within the inner sealed sterile bag is non-flashy.

In some embodiments, the outer sealed sterile pouch is a steam sterilized pouch. In some embodiments, the outer sealed sterile bag comprises a permeable window, such as a web of paper or polyethylene fibers. In some embodiments, the seal comprises a polymeric adhesive suitable for steam sterilization. In some embodiments, the IOL is held by a retainer inserted into the inner sealed sterile bag.

Some additional aspects of the invention relate to a method for packaging an intraocular lens (IOL), comprising: inserting the IOL into the inner sealable pouch; inserting the inner sealable bag into the outer sealable bag; sealing the outer sealable pouch; steam sterilizing the inner sealable bag and steam sterilizing the outer sealable bag; and sealing at least one opening of the inner sealable pouch via at least one surface of the outer sealable pouch.

In some embodiments, the method further comprises: the IOL is placed on the retainer and the retainer is inserted into the inner sealable pouch prior to insertion of the IOL into the inner sealable pouch. In some embodiments, the thermal conductivity of the inner sealed sterile pouch is at least 1.1 times the thermal conductivity of the IOL material. In some embodiments, prior to sealing, the method further comprises inserting the retainer portion further into the inner sealable pouch such that the surfaces of the at least one opening of the inner sealable pouch are free to attach and seal with each other.

In some embodiments, sealing the at least one opening of the inner sealable pouch together via the surface of the outer sealable pouch comprises welding the openings using a polymeric adhesive. In some embodiments, the outer sealable pouch further comprises a permeable window.

Some additional aspects of the invention relate to another method for packaging an intraocular lens (IOL), comprising: inserting the IOL into the inner sealable pouch; inserting the inner sealable bag into the outer sealable bag; sealing the outer sealable pouch; sterilizing the inner sealable bag and the outer sealable bag; inserting the sterilized package into a humidity chamber; introducing moisture into the inner sealable pouch, thereby producing a relative humidity of at least 75% at 25 ℃; and sealing at least one opening of the inner sealable pouch via at least one surface of the outer sealable pouch.

In some embodiments, the method further comprises: the IOL is placed on the retainer and the retainer is inserted into the inner sealable pouch prior to insertion of the IOL into the inner sealable pouch. In some embodiments, sterilization is accomplished by EtO sterilization. In some embodiments, the outer sealable pouch further comprises a permeable window.

Some additional aspects of the invention relate to a package for an article, such as a hydrophobic intraocular lens (IOL), comprising: a pouch containing a hydrophobic IOL, the pouch being sterile and sealed, wherein the hydrophobic IOL has been sterilized by steam sterilization while in the pouch; and 1) a bag; 2) A retainer for the IOL; and 3) at least one of the metal objects adjacent the pocket during steam sterilization comprises a material having a thermal conductivity at least 1.1 times that of the hydrophobic IOL material; and the hydrophobic IOL in the sterile sealed pouch is non-sparkling. In some embodiments, the air in the bag has a relative humidity of at least 75% at 25 ℃. In some embodiments, the air in the bag has a relative humidity of at least 80% at 25 ℃.

In some embodiments, the sealed pouch comprises two flexible layers bonded together along at least a portion of their circumference. In some embodiments, the two flexible layers are made of aluminum foil, polyester laminate with an aluminum layer, or any combination thereof.

Some additional embodiments relate to a method for packaging a hydrophobic intraocular lens (IOL), comprising: inserting a hydrophobic IOL into the pocket; steam sterilizing the hydrophobic IOL in the pocket; and sealing the bag, wherein 1) the bag; 2) A retainer for a hydrophobic IOL; and 3) at least one of the metal objects adjacent the sealed pouch during steam sterilization comprises a material having a thermal conductivity at least 1.1 times that of the hydrophobic IOL material; and the hydrophobic IOL in the sterile sealed pouch is non-sparkling.

In some embodiments, the stage is attached to the holder prior to placing the IOL on the holder. In some embodiments, the stage is made of a material having a thermal conductivity that is at least 1.1 times the thermal conductivity of the IOL material.

Some additional aspects of the invention relate to a packaged intraocular lens (IOL) comprising: an IOL; an inner sealed sterile bag comprising an IOL and air having a relative humidity of at least 75% at 25 ℃; and an outer sealed sterile pouch surrounding the inner sealed sterile pouch, wherein at least one edge of the inner sealed sterile pouch is sealed via at least one surface of the outer sealed sterile pouch.

Some additional aspects of the invention relate to a packaged hydrophobic intraocular lens (IOL) comprising: a hydrophobic IOL; a pouch containing a hydrophobic IOL, the pouch being sterile and sealed, wherein 1) the pouch; 2) A retainer for a hydrophobic IOL; and 3) at least one of the metal objects adjacent the pocket during steam sterilization comprises a material having a thermal conductivity at least 1.1 times that of the hydrophobic IOL material; prior to sealing the pouch, the hydrophobic IOL is sterilized by steam sterilization while in the pouch; and the hydrophobic IOL in the sterile sealed pouch is non-sparkling.

Some additional aspects of the invention relate to a method for packaging an IOL (or other article) comprising: placing the IOL within a sealable pouch, the sealable pouch comprising an impermeable portion and a first permeable window; sealing the sealable pouch with the first seal, whereby the IOL and at least a portion of the first permeable window are within the first sealed portion of the sealable pouch; sterilizing the sealable pouch in a sterilization environment that is transmitted through the first breathable window and sterilizes the IOL; and sealing the sealable pouch with the second seal, whereby the first air permeable window is outside the second sealed portion of the sealable pouch and the IOL is within the second sealed portion of the sealable pouch, wherein the air within the second sealed portion is at least 60% relative humidity at 25 ℃. In some embodiments, the air within the second sealing portion is at least 80% relative humidity at 25 ℃.

In some embodiments, the IOL is composed of a hydrophobic material. In some embodiments, performing sterilization is accomplished by ethylene oxide (EtO) sterilization.

In some embodiments, the method further comprises placing the sealable pouch in a humid environment, whereby the humid environment is permeable to the first gas permeable window and the first sealed portion is humidified to at least the relative humidity.

In some embodiments, the method further comprises holding the IOL by the IOL retainer. In some embodiments, the method further comprises loading the IOL into an IOL injector or IOL injector cartridge.

In some embodiments, the method further comprises placing the IOL retainer, the IOL injector, or the IOL injector cartridge into an internal receiver having a second permeable window. In some embodiments, the internal receiver comprises a blister pack with a gas permeable backing. In some embodiments, the front portion of the blister pack is impermeable.

In some embodiments, the method further comprises separating a residue from the sealable pouch, the residue being outside the second sealing portion.

In some embodiments, the sterile environment and the humid environment are provided by steam sterilization. In some embodiments, 1) an impermeable portion of the sealable pouch; 2) A retainer; and 3) at least one of the metal objects adjacent to the retainer has a thermal conductivity at least 1.1 times that of the IOL.

In some embodiments, the method further comprises placing a humidity control packet in the sealable pouch, thereby effecting or adjusting the relative humidity in the second sealed portion of the sealable pouch.

Some aspects of the invention relate to a package for an IOL (or other article) comprising: a sealable pouch comprising an impermeable portion and a first permeable window, the sealable pouch configured for placement of an IOL therein; the sealable pouch is further configured to be sealed with the first seal, whereby the article and at least a portion of the first permeable window are within the first sealed portion of the sealable pouch, wherein: the sealable pouch is configured for placement in a sterilization environment whereby the sterilization environment is permeable to the first breathable window and sterilizes the article; the sealable pouch further comprises a second seal, wherein the first permeable window is outside the second sealed portion of the sealable pouch and the article is within the second sealed portion of the sealable pouch; and the humidity in the second seal portion is at least 60% relative humidity at 25 ℃.

In some embodiments, the IOL is composed of a hydrophobic material. In some embodiments, sterilization is accomplished by ethylene oxide (EtO) sterilization.

In some embodiments, the sealable pouch is further configured for placement in a humid environment whereby the humid environment is permeable to the first gas permeable window and humidifies the first sealed portion to at least the relative humidity.

In some embodiments, the IOL is retained in the IOL retainer. In some embodiments, the IOL is loaded in the IOL injector or IOL injector cartridge. In some embodiments, the package further comprises an inner receptacle within the sealed pouch containing the IOL holder, the IOL injector or the IOL injector cartridge, the inner receptacle having a second permeable window. In some embodiments, the internal receiver comprises a blister pack with a gas permeable backing. In some embodiments, the front portion of the blister pack is impermeable.

In some embodiments, the residue of the sealable pouch outside the second sealing portion is separable.

In some embodiments, sterilization and humidification is accomplished by steam sterilization. In some embodiments, one or more of the impermeable portion of the sealing bag and the retainer has a thermal conductivity at least 1.1 times that of the IOL.

In some embodiments, the package further comprises a humidity control pack in the second sealed portion to achieve or adjust the relative humidity.

Some aspects of the invention relate to a packaged IOL comprising: an IOL; and a sealable pouch comprising an impermeable portion and a first permeable window, the sealable pouch configured for placement of an IOL therein; the sealable pouch is further configured to be sealed with the first seal, whereby the IOL and at least a portion of the first permeable window are within the first sealed portion of the sealable pouch, wherein the sealable pouch is configured for placement in a sterile environment, whereby the sterile environment enters the first permeable window and disinfects the IOL; and the sealable pouch further comprises a second seal, wherein the first permeable window is outside the second sealed portion of the sealable pouch and the article is within the second sealed portion of the sealable pouch; and the air in the second seal portion is at least 60% relative humidity at 25 ℃. In some embodiments, the relative humidity is at least 80% at 25 ℃.

Some embodiments further comprise an IOL injector or IOL injector cartridge into which the IOL is preloaded. In some embodiments, the IOL injector includes a hydrophilic coating at its distal end.

Drawings

The invention, both as to organization and method of operation, together with objects, features, and advantages thereof, may best be understood by reference to the following detailed description when read with the accompanying drawings in which:

figures 1A-B depict an intraocular lens (IOL) sterile wet package according to some embodiments.

Fig. 1C depicts an IOL retainer to be inserted into an inner bag according to some embodiments.

Fig. 2A is a flow chart of a method for packaging an IOL according to some embodiments.

Fig. 2B depicts an IOL package during several steps of the method of fig. 2A, according to some embodiments.

Figure 3 is a flow chart of another method of packaging an IOL according to some embodiments of the invention.

Figures 4A-D depict sterile wet packaging for articles at various stages of the packaging process according to some embodiments.

Figures 5A-F depict sterile wetting packages for an IOL loaded in an IOL injector at various stages of the packaging process according to some embodiments.

Fig. 6 is a flow chart of a method for aseptic wet packaging of articles according to some embodiments.

It will be appreciated that for simplicity and clarity of illustration, elements illustrated in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.

Detailed Description

Those skilled in the art will recognize that the invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are, therefore, to be considered in all respects illustrative rather than limiting on the invention described herein.

A. First group of embodiments

Steam sterilization has the advantage that it can provide sterilization and hydration. However, disinfecting an IOL with steam will likely result in micro-cavitation (also known in the industry as sparkle) in the material of the optic portion of the lens, thereby compromising the optical quality of the lens. Currently, the most common method for disinfecting a sparkling hydrophobic IOL is to use ethylene oxide (EtO), a toxic gas that should be completely removed from the lens in the package after disinfection before sealing the lens in the package. The result of this process is a completely dry lens, as any liquid disinfected by EtO will dissolve EtO residues therein, forming ethylene glycol (thereby rendering it toxic). Sterilization of wet loads by EtO and by plasma, x-rays, gamma rays or electron beams is not feasible. Thus, after these sterilization methods, additional post-sterilization humidification of the lens and its storage environment may be required.

Aspects of the invention relate to a sterile wetting package for hydrophobic IOLs and a method of packaging an IOL so as to ensure both a wet environment and sterile conditions. IOLs packaged in sterile wet packages can be non-flashy even after having been sterilized with steam. This may be accomplished by selecting a material for the inner pocket holding the IOL that has a thermal conductivity at least 1.1 times that of the IOL material. Such an IOL package would maintain the IOL sterile throughout its shelf life and would therefore not form mold, fungus, or any other moisture-related contaminants within the sterile bag.

In some embodiments, the IOL package may include two pouches: an inner bag and an outer bag, the inner bag holding the IOL and the inner bag being inserted into the outer bag suitable for steam sterilization.

As used herein, "pouch" refers to a package made of two flexible layers that are bonded together circumferentially along at least a portion of their circumference. The "pouch" may be an enclosure, package, packet, container, wrap, or any other type of enclosure. In the "open" state, the pocket may have at least one opening in the bonded circumference to allow an item (e.g., an IOL or other pocket) to be inserted into the "pocket".

Referring now to fig. 1A and 1B, an intraocular lens (IOL) sterile wetting package 100 is depicted according to some embodiments. IOL package 100 may include an inner sealed sterile pouch 10 comprising IOL 20 and air having a relative humidity of at least 75% at 25 ℃. In some embodiments, the air within the inner bag 10 may have a relative humidity of at least 80% at 25 ℃, 85% at 25 ℃, 90% at 25 ℃, 95% at 25 ℃, 100% at 25 ℃, or any value therebetween. In some embodiments, one or more gases in addition to air may be mixed with or replace air.

In some embodiments, the inner sealed sterile bag 10 comprises a material having a thermal conductivity at least 1.1 times that of the IOL material. In some embodiments, the thermal conductivity index of the material of the inner sealed sterile bag 10 can be at least 1.5 times, 1.8 times, 2 times, 2.5 times, 3 times, 4 times, 5 times, 10 times, 50 times, 100 times, 200 times, 500 times, 1000 times, 2000 times, 4000 times, and any value in between the thermal conductivity index of the IOL material under the same environmental conditions. For example, if the IOL is made from any type of hydrophobic acrylate, the inner bag may be made from at least one of aluminum foil, polyester laminate with an aluminum layer, and the like. In a non-limiting example, the thermal conductivity of an IOL is-0.2W/(m.K), while the thermal conductivity of an inner bag made of aluminum foil is-240W/(m.K).

This requirement for the thermal conductivity of the inner sealed sterile bag 10 may not be applicable to EtO sterilization in which condensation evaporation (as opposed to steam sterilization, as further described herein) is not considered.

The inner sealing bag 10 may be rectangular as shown, or may have any suitable shape, allowing the IOL 20 and IOL retainer 25 and stage 26 holding the IOL 20 to be inserted into the bag 10, as shown in the image of FIG. 1C. In some embodiments, IOL retainer 25 and stage 26 may also be made of a material having a thermal conductivity index that is at least 1.1 times the thermal conductivity index of the IOL material.

IOL package 100 may also include an outer sealed sterile pouch 30 surrounding inner sealed sterile pouch 10. In some embodiments, at least one edge 12 of the inner sealed sterile bag 10 is sealed via at least one surface 31 of the outer sealed sterile bag 30 by a seal 40. In some embodiments, the outer sealed sterile pouch 30 may be a steam sterilized pouch. In some embodiments, the outer sealed sterile bag 30 may be an EtO sterilization pouch. In a non-limiting example, the outer sealed sterile bag 30 may include a breathable window (not shown), such as a web of paper or polyethylene fibers, to enable moisture to penetrate the outer bag to the inner bag. For example, one (e.g., front) surface 31 of the outer sterile bag 30 may include an impermeable layer, while the opposite (e.g., back) surface may include a web of paper or polyethylene fibers that serves as a permeable window.

In some embodiments, the seal 40 may be formed from a polymeric adhesive suitable for steam sterilization. In a non-limiting example, the seal may comprise polypropylene.

In some embodiments, IOL 20 is non-shiny, although in a moist environment, for example, due to sterilization by steam or by introducing moisture into inner sealed sterile bag 10 after a dry sterilization process.

Reference is now made to fig. 2A and 2B, which are a flow chart of a method of packaging an IOL and a depiction of an IOL package during steps in a method, respectively, according to some embodiments of the invention. In step 210, the IOL may be inserted into the inner sealable pouch. In some embodiments, the thermal conductivity of the inner sealable pouch can be at least 1.1 times the thermal conductivity of the IOL material. In some embodiments, the IOL is placed on the retainer and the retainer is inserted into the inner sealable pouch prior to insertion of the IOL into the inner sealable pouch. For example, as shown in FIG. 1C, IOL 20 may be placed on stage 26, which may then be attached to retainer 25 for insertion into inner bag 10 via at least one opening 15. In some embodiments, the inner bag 10 may include two openings 15 from two opposite sides of the inner bag 10.

In step 220, an inner sealable pouch may be inserted into an outer sealable pouch. For example, as shown in step 220 of fig. 2B, the inner sealable pouch 10 may be inserted into the outer sealable pouch 30 via the opening 34. In a non-limiting example, as shown in fig. 2B, first the adhesive portion 36 facing the outer bag 30 is inserted into the opening 15 of the inner bag 10.

In step 230, the outer sealable pouch may be sealed. For example, the first seal 35 may then be made to close the lip of the outer bag 30. In some embodiments, the seal 35 may comprise any adhesive suitable for steam sterilization.

In step 240, the inner sealable pouch and the outer sealable pouch may be steam sterilized using any known method. For example, at least one open segment 15 (shown in fig. 1A and 2B) in the inner bag 10 may be used to introduce steam into the inner bag 10.

As is known in the art, during steam sterilization, the vacuum cycles therein cause rapid evaporation of condensate (or any other liquid water droplets) deposited on the coldest material. In order to evaporate the condensed droplets, it may be necessary to add evaporation calories (heat) extracted from the material, so that the material can be cooled rapidly. In some embodiments, placing the IOL in close proximity to high thermal conductivity materials (such as inner bag 10 and/or retainer 25) during steam sterilization allows for avoiding pre-condensation of water vapor on the IOL. In some embodiments, this arrangement will prevent any condensation on the IOL because the highly thermally conductive material (e.g., pouch 10 and/or retainer 25) has a significantly larger surface area than the IOL surface area and thus can cool before the IOL cools. Preventing condensation on the IOL will prevent any form of glare and thus maintain the optical quality of the IOL.

In some embodiments, in the case of heating package 100, the heating may evaporate water from the surface of the highly thermally conductive material, rather than boiling water on the IOL surface.

A metal object (or other object having a thermal conductivity at least 1.1 times that of the IOL material) may be placed adjacent to the inner bag 10 during steam sterilization 240 instead of or in addition to the inner bag and/or retainer having a thermal conductivity at least 1.1 times that of the IOL material. The metal object may be inside or outside the inner bag 10.

In step 250, at least one opening 15 of the inner sealable pouch may be sealed via at least one surface of the outer sealable pouch. For example, the openings 15 of the inner bag 10 are sealed via (through) the surface of the bag 30 by the seal 40, e.g., by welding all of the openings together using a polymeric adhesive. In some embodiments, if two openings 15 are included in the inner bag 10, two seals 40 may be used, one for sealing one opening. In some embodiments, prior to sealing, the method further comprises inserting the retainer 25 portion further into the inner sealable pouch 10 such that the surfaces of the at least one opening 15 of the inner sealable pouch 15 can be freely attached and sealed to each other.

Reference is now made to fig. 3, which is a flow chart of another method of packaging an intraocular lens (IOL) according to some embodiments of the present invention. In some embodiments, intraocular lens (IOL) package 100 may be packaged using any of the methods of fig. 2A, 3 or using any suitable method that enables the addition of moisture to a sterile sealed bag while maintaining sterile conditions.

Steps 310, 320 and 330 of the method of fig. 3 may be substantially similar to steps 210, 220 and 230 of the method of fig. 2A. In step 340, the inner sealable pouch and the outer sealable pouch may be sterilized. For example, the sterilization may be performed using an EtO process, wherein EtO gas is provided during the sterilization process. EtO is a toxic gas and therefore must be completely removed before the IOL is sealed in the package. After EtO removal, inner bag 10 includes a completely dry IOL 20.

In step 350, the sterilized package may be inserted into a humidity chamber. In step 360, moisture may be introduced into the inner sealable pouch, thereby creating a relative humidity of at least 75% at 25 ℃.

In step 370, at least one opening of the inner sealable pouch may be sealed via at least one surface of the outer sealable pouch. For example, the openings 15 of the inner bag 10 are sealed via (through) the surface of the bag 30 by the seal 40, e.g., by welding all of the openings together using a polymeric adhesive. In some embodiments, the retainer 25 is partially inserted further into the inner sealable pouch 10 prior to sealing such that the surfaces of the at least one opening 15 of the inner sealable pouch 15 can be freely attached and sealed to each other.

B. Second group of embodiments

Most existing IOL delivery systems (e.g., IOL injectors) and sometimes the IOL itself cannot withstand temperatures above 45 ℃. In this case steam and dry heat sterilization is not feasible. Most IOL delivery systems are also not compatible with radiation, plasma, and ozone sterilization. EtO sterilization may be a suitable sterilization process, but the most important limitation of EtO sterilization is the inability to sterilize liquid, wet and moist objects, as the liquid dissolves EtO residues into itself.

Some embodiments relate to a hydrophobic intraocular lens packaging procedure for various IOL configurations, such as: non-preloaded lenses (IOLs, which may be mounted in an IOL holder), fully preloaded lenses (lenses in an IOL injector) and semi-loaded lenses (lenses loaded into an IOL injector cartridge to be loaded into an IOL injector by a practitioner). This procedure may require EtO sterilization (in some embodiments, steam sterilization is required) and packaging methods that, when combined, enable the introduction of the liquid contents into the package containing the IOL after EtO sterilization, thereby: 1) Preventing drying of the IOL injector and its material (e.g., coating) that may lead to unintended behavior during IOL injection, such as blocking, discontinuous movement, and abrupt ejection; and 2) maintain high flexibility and smooth translation of the IOL during injection.

Some embodiments require a package comprising a sterile barrier impermeable to steam and gas, suitable for EtO (and possibly steam) sterilization through a sealable, steam and gas permeable window (hereinafter referred to as a "breathable window"). The package may be used to transport and store hydrophobic intraocular lenses that are free of sparkle (typically caused by steam sterilization). The packaged hydrophobic IOL may be sealed with entrapped water vapor obtained during the humidification process, which allows for very high relative humidity levels to be maintained while the final sterile environment may be maintained within the sealed pouch until such time as use is made in an ophthalmic surgical procedure. In some embodiments, the IOL configuration is also nested in a sterile barrier system that includes an internal receiver having a permeable window, the internal receiver being placed within a sealed bag.

Referring now to fig. 4A-4D, a package for sterile, moist packages of an article 420, such as an IOL, is depicted at various stages of the packaging process, according to some embodiments.

The package includes a sealable pouch 410. Sealable bag 410 includes an impermeable portion 413 and at least one permeable window 415 (hereinafter first permeable window 415). The first permeable window 415 may be formed from synthetic flash spun high density polyethylene fibers (commercially known as) And the like. Sealable pouch 410 may be an aluminum laminate pouch, referred to in the art as a header pouch, having a Moisture Vapor Transmission Rate (MVTR) of 0. The first permeable window 415 may be on any portion of the sealable bag 410. In some embodiments of the package, the degree of breathability varies across the surface of the breathable opening 415.

The article 420 may be placed within a sealable bag 410, as shown in fig. 4A. The item 420 may be placed through the insertion opening 412 of the sealable bag 410. The insertion opening 412 may be at the edge of the sealable bag 410 or at any other location of the sealable bag 410.

The sealable pouch 410 may be sealed with at least one seal 440 (hereinafter first seal 440). At least a portion of the article 420 and the first permeable window 415 are within the first sealing portion 445 of the sealable bag 410 that is sealed by the first seal 440, as shown in fig. 4B.

It should be appreciated that the first seal 440 may include multiple seals (e.g., if multiple louvers are present) so long as the first seal portion 445 is completely sealed by the first seal 440 and at least a portion of one first louver 415 is within the first seal portion 445.

If the nature of the article 420 (e.g., size, shape, non-frangible of the article 420) permits, the first seal 440 may be a complete seal around the edges of the two separate layers of the sealable bag 410 with the article 420 between the two layers.

Sealable bag 410 with first seal 440 may be sterilized by placing sealable bag 410 in a sterilization embodiment. The first gas permeable window allows the sterile environment to permeate into the first sealing portion 445 of the sealable bag 410. The sterilization environment sterilizes the interior surface area of the first sealing portion 445 of the sealable pouch 410 and the surface of the article 420. The article 420 may remain sterile until the package is opened.

The sterilization may be, for example, etO sterilization or steam sterilization. EtO sterilization may be used, for example, when the article 420 cannot withstand the high temperatures reached during steam sterilization.

In the case where steam sterilization is used to sterilize an IOL, such as a hydrophobic IOL, the thermal conductivity of the material of sealable pouch 410 (e.g., impermeable portion 413) may be at least 1.1 times the thermal conductivity of the IOL material. Alternatively or additionally, the thermal conductivity of the material of the retainer holding the IOL (as further described herein (including with reference to FIGS. 1A-C)) in sealable pouch 410 is at least 1.1 times the thermal conductivity of the IOL material.

The interior of sealable bag 410 may be humidified. Humidification may be achieved by placing sealable bag 410 in a humid environment, such as in a humidifier, incubator, or climate chamber. The moist environment thereby permeates the first permeable window 415 and humidifies the interior of the sealable bag 410.

In the case of steam sterilization, steam sterilization may be used to sterilize and humidify the interior of the sealable bag 410.

Alternatively or additionally, humidification may be achieved by a humidity control substance in the second sealing portion 455. For example, a humidity control package (such as that provided by Boveda company) is inserted into sealable bag 410 along with item 420. In some embodiments, a humidity control packet of 84% RH is inserted into sealable bag 410. In some embodiments, another humidification method (i.e., steam sterilization, humidifier) is initially used, and a humidity control package is inserted to regulate the RH at a constant level.

Sealable pouch 410 may be sealed with a second seal 450. The first permeable window 415 may be outside of the second sealing portion 455 of the sealable bag 410 sealed by the second seal 450; article 420 may be within second sealed portion 455 as shown in fig. 4C. The second seal 450 may prevent any gas or vapor from exiting or entering the second sealing portion 455 of the sealable bag 410. Moisture may thereby be trapped in the second sealing portion 455 until the package is opened. The air within the second seal portion 455 may be at least 60% Relative Humidity (RH) at 25 ℃. In some embodiments, RH is at least 65% at 25 ℃. In some embodiments, RH is at least 80% at 25 ℃. In some embodiments, RH is at least 84% at 25 ℃. In some embodiments, the package, when sealed with the second seal 450, enables at least 90% of the initial humidity level within the second sealing portion 455 to be maintained for five years after sealing with the second seal 450. In some embodiments, the gas and vapor in second sealing portion 455 are overpressurized (e.g., by maintaining a cold environment and sealing second seal 450 during humidification) to prevent the environment surrounding the package from entering second sealing portion 455.

Optionally, after the second seal 450 is made, the residue 460 of the sealable bag 410 is separated from the rest of the bag 410 (e.g., by cutting), as shown in fig. 4D. The residue 460 is outside the second seal portion 455, and preferably the residue 460 does not include any portion of the second seal 450. Separating the residue 460 reduces the amount of packaging material, thereby facilitating storage and transportation of the package.

Referring now to fig. 5A-5F, a sterile wetting package 500 for an IOL loaded in an IOL injector is depicted at various stages of the packaging process, according to some embodiments.

The package includes a sealable pouch 510. Sealable bag 510 includes an impermeable portion 513 and a permeable window 515 (hereinafter first permeable window 515). The first permeable window 515 may be formed from synthetic flash spun high density polyethylene fibers (commercially known as) And the like. Sealable bag 510 may be an item known in the art as a header pouch, commonly used for sterilization of medical devices.

The package 500 may include an internal receiver 505. The internal receiver 505 may include a second permeable window 507. The internal receiver 505 may be a blister pack, such as a blister pack made of polyethylene terephthalate glycol (PET-G). The second permeable window 507 may be a permeable backing 507 of the blister.

The first louvers 515 may comprise synthetic flash spun high density polyethylene fibers (commercially known as) And the like. In some embodiments, the inner receiver 505 is made of an impermeable material in addition to the second permeable window 507. In some embodiments, the inner receiver 505 is made entirely of a gas permeable material.

During packaging, an intraocular lens (IOL, not shown) may be placed in the internal receiver 505. In some embodiments, the IOL is made from a hydrophobic material.

In some embodiments, the IOL is preloaded in IOL injector 512, which may be inserted into internal receiver 505 as shown in FIG. 5A. In other embodiments, the IOL is preloaded in an IOL injector cartridge (not shown) that may be inserted into the internal receiver 505. The injector cartridge is intended for use, for example, by insertion into a reusable IOL injector.

In some embodiments, preloaded IOL injector 512 or IOL injector cartridge is placed directly in sealable bag 510 (i.e., not in the internal receiver).

In some embodiments, the IOL mounted on the IOL retainer is placed directly into sealable pouch 510. In some embodiments, the holder is attached to the stage, as further described herein.

In some embodiments, the holder (and stage, if present) is placed in an internal receiver 505, such as a blister pack (of a suitable mating shape and size), having a gas-permeable backing 507.

During packaging, sealable bag 510 may be sealed with first seal 540, as shown in fig. 5D. At least a portion of the inner receptacle 505 and the first permeable window 515 are within a first sealed portion (depicted as 445 in fig. 4B) of the sealable bag 510 that is sealed by a first seal 540.

The interior of the interior receptacle 505 may be accessible to the atmosphere outside of the sealable bag 510 through the second and first permeable windows 507, 515.

The sealable bag 510 containing the internal receiver 505 may be placed in a sterile environment, and then sterilization may be performed. Sterilization the sealable pouch 510 and its contents are sterilized.

In particular, the following surfaces may be sterilized:

1. the inner surface area of the pouch 510 may be sealed.

2. An inner surface and an outer surface of the inner receptacle 505.

Inner and outer surface areas of IOL injector 512.

The outer surface area of the IOL on both sides of the IOL.

In some embodiments, sterilization is performed by ethylene oxide (EtO) sterilization. In other embodiments, the sterilization is performed by steam sterilization. Where the sealable pouch contains an IOL injector 512, etO sterilization may be preferred because many IOL injectors are not capable of withstanding the temperatures of steam sterilization. EtO sterilization may also be preferred in cases where the IOL itself is not capable of withstanding steam sterilization temperatures.

After sterilization, sealable bag 510 containing internal receptacle 505 may be placed in a humidity chamber. In some embodiments, moisture is introduced into the humidity chamber until the air within the first sealed portion (including the interior of the interior receptacle 505) is at least 60% relative humidity at 25 ℃. Humidification may be particularly beneficial in the packaging of IOL injectors: keeping the hydrophilic coating on the syringe tip wet prevents the coating from cracking. In some embodiments, the relative humidity is at least 65% at 25 ℃. In some embodiments, the relative humidity is at least 80% at 25 ℃.

It should be noted that one or more gases other than air may be mixed with or replace air.

In some embodiments, after humidification, sealable bag 510 is sealed with second seal 550, whereby second gas-permeable opening 515 is outside of the second sealed portion (depicted by 455 in fig. 4C) of sealable bag 510, and internal receiver 505 is within the second sealed portion, as shown in fig. 5E. The second seal 550 prevents any gas or vapor from exiting or entering the second sealed portion of the sealable pouch 510. Air having a humidity level established by humidification may thereby be trapped within the second sealing portion until the package is opened.

The second permeable window 520 may be removed from the sealable bag 510 by cutting the sealable bag 510 with a cut 560 out of the second seal 550, as shown in fig. 5F.

Reference is now made to fig. 6, which is a flow chart of a method 600 for aseptic wet packaging of articles. The method 600 includes:

1. The article is placed 610 within a sealable bag that includes an impermeable portion and a first permeable window.

2. The sealable bag 620 is sealed with the first seal whereby the article and at least a portion of the first permeable window are within the first sealed portion of the sealable bag.

3. The sealable bag is sterilized 630 in a sterilization environment, whereby the sterilization environment is transmitted through the first breathable window and the item is sterilized.

4. The sealable pouch 640 is sealed with the second seal whereby the first air permeable window is outside the second sealed portion of the sealable pouch and the article is within the second sealed portion of the sealable pouch, and wherein the air within the second sealed portion may be at least 60% relative humidity at 25 ℃.

Unless explicitly stated, the method embodiments described herein are not limited to a particular order or sequence. Moreover, all formulas described herein are intended to be examples only, and other or different formulas may be used. In addition, some of the method embodiments or elements thereof may occur or be performed at the same point in time.

Although certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will now occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.

Various embodiments have been presented. Each of these embodiments may include features from other presented embodiments, including the exchange of features between embodiments under the heading "first set" and "second set" in this particular embodiment. Embodiments not specifically described may include various features described herein.

Although the description of the package embodiments herein refers to packages for intraocular lenses, it should be understood that the present packages are applicable to any medical device or other article that requires sterilization and/or benefits from storage in a humid environment.

Claims

1. An intraocular lens package comprising:

an inner sealed sterile bag comprising the intraocular lens and air having a relative humidity of at least 75% at 25 ℃; and

An outer sealed sterile pouch surrounding the inner sealed sterile pouch,

Wherein at least one edge of the inner sealed sterile bag is sealed via at least one surface of the outer sealed sterile bag.

2. The intraocular lens package of claim 1, wherein the inner sealed sterile bag comprises a material having a thermal conductivity at least 1.1 times higher than a thermal conductivity of the intraocular lens material.

3. The intraocular lens package of claim 1 or 2, wherein the inner sealed sterile pouch is made of at least one of aluminum foil and a polyester laminate with an aluminum layer.

4. The intraocular lens package of any one of claims 1-3, wherein the intraocular lens within the inner sealed sterile pouch is sparkless.

5. The intraocular lens package of any one of claims 1-4, wherein the outer sealed sterile pouch is a steam sterilized pouch.

6. The intraocular lens package of any one of claims 1-5 wherein the outer sealed sterile pouch comprises polypropylene with paper fibers.

7. The intraocular lens package of any one of claims 1-6, wherein the seal comprises a polymeric adhesive suitable for steam sterilization.

8. The intraocular lens package of any one of claims 1-7, wherein the intraocular lens is held by a retainer inserted into the inner sealed sterile bag.

9. A method for packaging an intraocular lens, comprising:

(a) Inserting the intraocular lens into an inner sealable bag;

(b) Inserting the inner sealable pouch into the outer sealable pouch;

(c) Sealing the outer sealable pouch;

(d) Steam sterilizing the inner sealable pouch and the outer sealable pouch; and

(E) At least one opening of the inner sealable pouch is sealed via at least one surface of the outer sealable pouch.

10. The method of claim 9, further comprising: the intraocular lens is placed on a holder prior to insertion of the intraocular lens into the inner sealable pouch, and the holder is inserted into the inner sealable pouch.

11. The method of claim 9 or 10, wherein the thermal conductivity of the inner sealed sterile bag is at least 1.1 times higher than the thermal conductivity of the intraocular lens material.

12. The method of claim 10, wherein prior to the sealing, the method further comprises: the retainer portion is further inserted into the inner sealable pouch such that surfaces of the at least one opening of the inner sealable pouch are free to attach and seal with each other.

13. The method of any one of claims 9 to 12, wherein sealing the at least one opening of the inner sealable bag together via the surface of the outer sealable bag comprises welding the openings using a polymeric adhesive.

14. A method for packaging an intraocular lens, comprising:

(a) Inserting the intraocular lens into an inner sealable bag;

(b) Inserting the inner sealable pouch into the outer sealable pouch;

(c) Sealing the outer sealable pouch;

(d) Sterilizing the inner sealable pouch and the outer sealable pouch;

(e) Inserting the sterilized package into a humidity chamber;

(f) Introducing moisture into the inner sealable pouch, thereby producing a relative humidity of at least 75% at 25 ℃; and

(G) At least one opening of the inner sealable pouch is sealed via at least one surface of the outer sealable pouch.

15. The method of claim 14, further comprising: the intraocular lens is placed on a holder prior to insertion of the intraocular lens into the inner sealable pouch, and the holder is inserted into the inner sealable pouch.