Sterile wet package and packaging method for hydrophobic intraocular lenses - Patent Application 20070122999

Abstract

A sterile wet package and packaging method for an intraocular lens (IOL). In some embodiments, the method includes steam sterilizing the interior of an outer pouch with the IOL inside the open inner pouch. The inner pouch comprises a material having a thermal conductivity greater than 1.1 times the thermal conductivity of the material of the IOL. The method further includes sealing the inner pouch via the outer pouch and trapping humidified air (having a RH greater than 70% at 25°C) inside the inner pouch. In other embodiments, the method includes performing ethylene oxide sterilization and humidification inside a first sealed region of a sealable pouch including a gas-permeable window that houses an IOL preloaded into 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 excludes the gas-permeable window and trapping humidified air (having a RH greater than 60% at 25°C) inside the second sealed region of the sealable pouch.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to Israel Application No. 295879, filed August 23, 2022, and U.S. Provisional Application No. 63 / 406843, filed September 15, 2022. Both priority applications are incorporated herein by reference.

[0002] FIELD OF THE INVENTION The present invention relates generally to sterile packaging and packaging methods suitable for intraocular lenses, and more particularly to a moisture-filled sterile package for intraocular lenses and packaging methods therefor. [Background technology]

[0003] An intraocular lens (IOL) is an artificial lens that replaces the eye's natural lens, which is removed during cataract surgery or refractive lens exchange (RLE) surgery. IOLs typically comprise a polymer-based lens with polymer-based lateral struts or extensions, called haptics, to hold the lens in place within the eye's internal lens capsule. In most cases, the haptics are the same material as the lens, and the IOL is referred to as a one-piece IOL. The optical zone of an IOL can be of different designs: monofocal, multifocal-refractive, multifocal-diffractive, with or without a toric correction element (used to correct existing corneal astigmatism before surgery). IOL designs can be constant-mechanism designs or can include an accommodation mechanism designed to allow the eye to regain some partial focusing ability to change focus from distance to near vision using ciliary muscle movement or other external energy sources.

[0004] In general, modern soft or flexible IOLs are made from a variety of polymers, including polymers based on an acrylate backbone, various side chains consisting of hydrophilic compounds such as hydroxy-methyl-meth-acrylate or hydrophobic methyl methacrylate, polypropylene-based polymers with aromatic side chains or other waxy side chains such as ethyl-ethoxy-meth-acrylate, as well as silicone- and siloxane-based lenses or other combinations of polymers.

[0005] Modern IOLs are made of soft materials that allow them to be injected into the eye through a small incision. Known polymeric materials used in ophthalmology have a water content ranging from close to 0%, which is considered extremely hydrophobic, to approximately 40% or less, which is considered extremely hydrophilic.

[0006] IOLs are sterilized in their primary packaging and can 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 usually supplied submerged in water or saline, which helps the IOL maintain its flexibility. Thus, hydrophilic lenses are supplied submerged in water / saline, while hydrophobic lenses are most often supplied in dry packaging, primarily using EtO sterilization.

[0007] Soft IOLs are known to be more flexible when hydrated. Because the lenses are rigid and inflexible in the non-hydrated state, hydrophilic IOLs must be stored in water or saline for implantation. Soft IOLs made of hydrophobic materials are less flexible than when hydrated when stored in a sterile, dry environment. This lack of flexibility in hydrophobic IOLs can impair the smoothness of their insertion into the capsular bag.

[0008] Therefore, there is a need for new forms of packaging IOLs in a sterile, moist environment that will ensure that the IOL is provided in optimal conditions for implantation. Summary of the Invention

[0009] Some aspects of the present invention are directed to packages for articles such as intraocular lenses (IOLs), the packages including an inner sealed sterilization pouch containing the IOL and air having a relative humidity (RH) of at least 75% at 25° C., and an outer sealed sterilization pouch surrounding the inner sealed sterilization pouch, wherein at least one edge of the inner sealed sterilization pouch is sealed through at least one surface of the outer sealed sterilization pouch. In some embodiments, the air within the inner sealable pouch has a RH of at least 80%.

[0010] In some embodiments, the inner sealed sterilization pouch comprises a material having a thermal conductivity at least 1.1 times greater than the thermal conductivity of the IOL material. In some embodiments, the inner sealed sterilization pouch is made of at least one of aluminum foil and a polyester laminate with an aluminum layer. In some embodiments, the IOL inside the inner sealed sterilization pouch is glistening-free.

[0011] In some embodiments, the outer sealed sterilization bag is a steam sterilization pouch. In some embodiments, the outer sealed sterilization bag comprises a gas-permeable window, such as paper or a polyethylene fiber web. In some embodiments, the seal comprises a polymer adhesive suitable for steam sterilization. In some embodiments, the IOL is held by a holder inserted into the inner sealed sterilization bag.

[0012] Some additional aspects of the present invention are directed to a method of packaging an intraocular lens (IOL), the method including inserting the IOL into an inner sealable bag, inserting the inner sealable bag into an outer sealable bag, sealing the outer sealable bag, steam sterilizing the interior of the inner sealable bag and the outer sealable bag, and sealing at least one opening of the inner sealable bag via at least one surface of the outer sealable bag.

[0013] In some embodiments, the method further comprises placing the IOL on a holder and inserting the holder into the inner sealable bag prior to inserting the IOL into the inner sealable bag. In some embodiments, the inner sealable sterilization bag has a thermal conductivity at least 1.1 times greater than the thermal conductivity of the IOL material. In some embodiments, the method further comprises inserting a portion of the holder further into the inner sealable bag prior to sealing, such that surfaces of at least one opening of the inner sealable bag are freely attached to and sealed to each other.

[0014] In some embodiments, sealing the at least one opening of the inner sealable bag through a surface of the outer sealable bag comprises soldering the opening using a polymer adhesive. In some embodiments, the outer sealable bag further comprises a gas permeable window.

[0015] Some additional aspects of the present invention are directed to another method of packaging an intraocular lens (IOL), the method including inserting the IOL into an inner sealable bag, inserting the inner sealable bag into an outer sealable bag, sealing the outer sealable bag, sterilizing the inner sealable bag and the outer sealable bag, inserting the sterile packaging into a humidity chamber, introducing moisture into the inner sealable bag to achieve a relative humidity of at least 75% at 25°C, and sealing at least one opening of the inner sealable bag via at least one surface of the outer sealable bag.

[0016] In some embodiments, the method further comprises placing the IOL on a holder prior to inserting the IOL into the inner sealable bag, and inserting the holder into the inner sealable bag. In some embodiments, sterilization is performed by EtO sterilization. In some embodiments, the outer sealable bag further comprises a gas-permeable window.

[0017] Some additional aspects of the present invention are directed to a package for an article such as a hydrophobic intraocular lens (IOL), comprising a sterile-sealed bag containing the hydrophobic IOL, wherein the hydrophobic IOL is sterilized by steam sterilization while inside the bag, and at least one of (1) the bag, (2) a holder for the IOL, and (3) a metal object proximate the bag during steam sterilization comprises a material having a thermal conductivity at least 1.1 times higher than the thermal conductivity of the hydrophobic IOL material, and the hydrophobic IOL in the sterile-sealed bag is glistening-free. In some embodiments, the air in the bag has a relative humidity of at least 75% at 25° C. In some embodiments, the air in the bag has a relative humidity of at least 80% at 25° C.

[0018] In some embodiments, the sealed pouch comprises two flexible layers bonded along at least a portion of their perimeter, hi some embodiments, the two flexible layers are made of aluminum foil, a polyester laminate with an aluminum layer, or any combination thereof.

[0019] Some additional aspects are directed to a method of packaging a hydrophobic intraocular lens (IOL), comprising inserting the hydrophobic IOL into a bag, steam sterilizing the hydrophobic IOL within the bag, and sealing the bag, wherein at least one of (1) the bag, (2) a holder for the hydrophobic IOL, and (3) a metal object in proximity to the sealed bag during steam sterilization comprises a material having a thermal conductivity at least 1.1 times greater than the thermal conductivity of the hydrophobic IOL material, and wherein the hydrophobic IOL within the sterile sealed bag is glistening-free.

[0020] In some embodiments, the method further comprises connecting a stage to the holder before placing the IOL on the holder, hi some embodiments, the stage is made of a material having a thermal conductivity at least 1.1 times greater than the thermal conductivity of the IOL material.

[0021] Some additional aspects of the present invention are directed to a packaged intraocular lens (IOL) comprising an IOL, an inner sealed sterilization bag containing the IOL and air having a relative humidity of at least 75% at 25°C, and an outer sealed sterilization bag surrounding the inner sealed sterilization bag, wherein at least one edge of the inner sealed sterilization bag is sealed through at least one surface of the outer sealed sterilization bag.

[0022] Some additional aspects of the present invention are directed to a packaged hydrophobic intraocular lens (IOL), comprising: a hydrophobic IOL; and a sterile-sealed bag for containing the hydrophobic IOL, wherein at least one of (1) the bag, (2) a holder for the hydrophobic IOL, and (3) a metal object near the bag during steam sterilization comprises a material having a thermal conductivity at least 1.1 times greater than the thermal conductivity of the hydrophobic IOL material, and the hydrophobic IOL is sterilized by steam sterilization while inside the bag prior to sealing of the bag, and the hydrophobic IOL in the sterile-sealed bag is glistening-free.

[0023] Some additional aspects of the present invention are directed to methods of packaging an IOL (or other article) comprising placing the IOL within a sealable pouch having an impermeable portion and a first gas-permeable window, sealing the sealable pouch with a first seal such that the IOL and at least a portion of the first gas-permeable window are inside the first sealed portion of the sealable pouch, sterilizing the sealable pouch in a sterile environment such that the sterile environment penetrates through the first gas-permeable window to sterilize the IOL, and sealing the sealable pouch with a second seal such that the first gas-permeable window is outside the second sealed portion of the sealable pouch and the IOL is inside the second sealed portion of the sealable pouch, wherein the air within the second sealed portion is at least 60% relative humidity at 25° C. In some embodiments, the air within the second sealed portion is at least 80% relative humidity at 25° C.

[0024] In some embodiments, the IOL is constructed of a hydrophobic material. In some embodiments, sterilization is performed by ethylene oxide (EtO) sterilization.

[0025] In some embodiments, the method further includes placing the sealable bag in a humid environment such that the humid environment penetrates the first gas-permeable window and humidifies the first sealed portion to at least the above-mentioned relative humidity.

[0026] In some embodiments, the method further comprises holding the IOL with an IOL holder. In some embodiments, the method further comprises loading the IOL into an IOL injector or an IOL injector cartridge.

[0027] In some embodiments, the method further includes placing the IOL holder, IOL injector, or IOL injector cartridge into an inner receptacle having a second gas-permeable window. In some embodiments, the inner receptacle comprises a blister pack having a gas-permeable backing. In some embodiments, the front of the blister pack is impermeable.

[0028] In some embodiments, the method further comprises removing any residue from the sealable pouch that is outside the second sealed portion.

[0029] In some embodiments, the sterile and moist environment is provided by steam sterilization. In some embodiments, at least one of (1) the impermeable portion of the sealable bag, (2) the holder, and (3) a metal object near the holder has a thermal conductivity that is at least 1.1 times the thermal conductivity of the IOL.

[0030] In some embodiments, the method further comprises disposing a humidity control pack within the sealable bag to achieve or adjust the relative humidity within the second sealed portion of the sealable bag.

[0031] Some embodiments of the present invention are directed to a package for an IOL (or other article), comprising a sealable bag having an impermeable portion and a first gas-permeable window configured to have the IOL placed therein and further sealed with a first seal such that the IOL and at least a portion of the first gas-permeable window are inside the first sealed portion of the sealable bag, the sealable bag configured to be placed in a sterile environment such that the sterile environment penetrates the first gas-permeable window to sterilize the article, the sealable bag further comprising a second seal, the first gas-permeable window is outside the second sealed portion of the sealable bag, and the article is inside the second sealed portion of the sealable bag, wherein the humidity within the second sealed portion is at least 60% relative humidity at 25°C.

[0032] In some embodiments, the IOL is composed of a hydrophobic material. In some embodiments, sterilization is performed by ethylene oxide (EtO) sterilization.

[0033] In some embodiments, the sealable bag is further configured to be placed in a humid environment such that the humid environment penetrates the first gas-permeable window and humidifies the first sealed portion to at least the above relative humidity.

[0034] In some embodiments, the IOL is held in an IOL holder. In some embodiments, the IOL is loaded into an IOL injector or an IOL injector cartridge. In some embodiments, the package further comprises an inner receptacle that houses the IOL holder, IOL injector, or IOL injector cartridge within the sealed pouch, the inner receptacle having a second gas-permeable window. In some embodiments, the inner receptacle comprises a blister pack having a gas-permeable backing. In some embodiments, the front of the blister pack is impermeable.

[0035] In some embodiments, the remainder of the sealable pouch outside the second sealed portion is removable.

[0036] In some embodiments, the sterilization and humidification are achieved by steam sterilization. In some embodiments, one or more of the impermeable portion of the sealed pouch and the holder have a thermal conductivity that is at least 1.1 times the thermal conductivity of the IOL.

[0037] In some embodiments, the package further comprises a humidity control pack within the second sealed portion to achieve or regulate relative humidity.

[0038] Some aspects of the present invention are directed to packaged IOLs, comprising: an IOL; a sealable bag configured to place the IOL therein, the sealable bag having an impermeable portion and a first gas-permeable window; and the sealable bag configured to be sealed with a first seal such that the IOL and at least a portion of the first gas-permeable window are inside the first sealed portion of the sealable bag; the sealable bag is configured to be placed in a sterile environment such that the sterile environment penetrates the first gas-permeable window to sterilize the IOL; the sealable bag further comprises a second seal; the first gas-permeable window is outside the second sealed portion of the sealable bag; and an article is inside the second sealed portion of the sealable bag; and the air within the second sealed portion has a relative humidity of at least 60% at 25° C. In some embodiments, the relative humidity is at least 80% at 25° C.

[0039] Some embodiments further comprise an IOL injector or IOL injector cartridge in which the IOL is preloaded. In some embodiments, the IOL injector comprises a hydrophilic coating on its tip.

[0040] The present invention, both as to organization and method of operation, together with its objects, features, and advantages, may best be understood by reference to the following detailed description when read in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0041] [Figure 1A]1 depicts a sterile wet package for an intraocular lens (IOL), according to some embodiments. [Figure 1B] 1 depicts a sterile wet package for an intraocular lens (IOL), according to some embodiments. [Figure 1C] 1 depicts an IOL holder inserted into an inner bag, according to some embodiments. [Figure 2A] 1 is a flowchart of a method for packaging an IOL, according to some embodiments. [Figure 2B] 2B depicts an IOL package during several steps of the method of FIG. 2A, according to some embodiments. [Figure 3] 1 is a flowchart of another method of packaging an IOL, according to some embodiments of the present invention. [Figure 4A] 1A-1D depict sterile wet packages for items at various stages of the packaging process, according to some embodiments. [Figure 4B] 1A-1D depict sterile wet packages for items at various stages of the packaging process, according to some embodiments. [Figure 4C] 1A-1D depict sterile wet packages for items at various stages of the packaging process, according to some embodiments. [Figure 4D] 1A-1D depict sterile wet packages for items at various stages of the packaging process, according to some embodiments. [Figure 4E] 1A-1D depict sterile wet packages for items at various stages of the packaging process, according to some embodiments. [Figure 4F] 1A-1D depict sterile wet packages for items at various stages of the packaging process, according to some embodiments. [Figure 5A] 1A-1D depict sterile wet packages for an IOL loaded into an IOL injector at various stages of the packaging process, according to some embodiments. [Figure 5B] 1A-1D depict sterile wet packages for an IOL loaded into an IOL injector at various stages of the packaging process, according to some embodiments. [Figure 5C] 1A-1D depict sterile wet packages for an IOL loaded into an IOL injector at various stages of the packaging process, according to some embodiments. [Figure 5D] 1A-1D depict sterile wet packages for an IOL loaded into an IOL injector at various stages of the packaging process, according to some embodiments. [Figure 5E] 1A-1D depict sterile wet packages for an IOL loaded into an IOL injector at various stages of the packaging process, according to some embodiments. [Figure 5F] 1A-1D depict sterile wet packages for an IOL loaded into an IOL injector at various stages of the packaging process, according to some embodiments. [Figure 6] 1 is a flowchart of a method for sterile wet packaging of an item, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0042] It will be understood that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some elements may be exaggerated relative to other elements for clarity. Further, where necessary, reference numerals may be repeated among the figures to indicate corresponding or similar elements.

[0043] Those skilled in the art will recognize that the present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. Accordingly, the foregoing embodiments are to be considered in all respects as illustrative rather than limiting on the invention described herein. A. First Set of Embodiments

[0044] The advantage of steam sterilization is that it can provide both sterilization and hydration. However, steam sterilization of IOLs is most likely to cause the development of microvoids (also known in the industry as glistenings) within the lens's optic material, compromising the lens's optical quality. Currently, the most commonly used method for sterilizing glistening-free hydrophobic IOLs uses ethylene oxide (EtO), a toxic gas that must be completely removed from the lens in its packaging before sealing it in place after sterilization. Because EtO sterilized liquids dissolve residual EtO in them to form ethylene glycol (which in turn makes the liquid toxic), the process results in completely dry lenses. Sterilization of humidity loads is not feasible with EtO, nor with plasma, X-ray, gamma ray, or electron beam. Therefore, additional post-sterilization humidification of the lens and its storage environment may be required after these sterilization methods.

[0045] Some embodiments of the present invention are directed to a sterile wet package for hydrophobic IOLs and a method for packaging the IOL to ensure both a moist environment and sterile conditions. IOLs packaged in the sterile wet package can be glistening-free even after steam sterilization. This can be achieved by selecting an inner pouch material that holds the IOL and has a thermal conductivity at least 1.1 times higher than that of the IOL material. Such an IOL pack can keep the IOL sterile throughout its entire storage period, thus preventing the formation of mold, fungi, or other moisture-related contaminants inside the sterile pouch.

[0046] In some embodiments, the IOL package may include two bags, with an inner bag holding the IOL inserted into an outer bag suitable for steam sterilization.

[0047] As used herein, a "pouch" refers to a package made of two flexible layers circumferentially bonded along at least a portion of their perimeter. The "pouch" may be a shell, package, parcel, container, wrap, or any other type of enclosure. In the "open" state, the pouch has at least one opening around the bonded perimeter to allow an item (e.g., an IOL or other pouch) to be inserted into the "pouch."

[0048] Reference is now made to FIGS. 1A and 1B, which depict a sterile wet package 100 for an intraocular lens (IOL) according to some embodiments. The IOL package 100 may include an inner sealed sterilization pouch 10 containing an IOL 20 and air having a relative humidity of at least 75% at 25° C. In some embodiments, the air inside the inner pouch 10 may have a relative humidity of at least 80% at 25° C., 85% at 25° C., 90% at 25° C., 95% at 25° C., 100% at 25° C., or any value therebetween. In some embodiments, one or more gases other than air may be mixed with or replaced by the air.

[0049] In some embodiments, the inner sealed sterilization pouch 10 comprises a material having a thermal conductivity at least 1.1 times higher than that of the IOL material. In some embodiments, the material of the inner sealed sterilization pouch 10 may have a thermal conductivity index at least 1.5, 1.8, 2, 2.5, 3, 4, 5, 10, 50, 100, 200, 500, 1000, 2000, 4000, or any value therebetween higher than that of the IOL material under the same ambient conditions. For example, if the IOL is made of any type of hydrophobic acrylate, the inner pouch may be made of at least one of aluminum foil, a polyester laminate with an aluminum layer, or the like. In a non-limiting example, the thermal conductivity of the IOL is approximately 0.2 W / (m·K), while the thermal conductivity of an inner pouch made of aluminum foil is approximately 240 W / (m·K).

[0050] Such requirements for the thermal conductivity of the inner sealed sterilization bag 10 may not be applicable to EtO sterilization, where (unlike steam sterilization, as explained further herein) there are no concerns about condensation evaporation.

[0051] The inner sealed bag 10 may be rectangular as shown, or may have any suitable shape that allows for insertion of the IOL 20 and the IOL holder 25 and stage 26 that holds the IOL 20 into the bag 10, as shown in the image of Figure 1C. In some embodiments, the IOL holder 25 and stage 26 may further be made of a material that has a thermal conductivity index that is at least 1.1 times higher than the thermal conductivity index of the IOL material.

[0052] The IOL package 100 may further include an outer sealed sterilization pouch 30 surrounding the inner sealed sterilization pouch 10. In some embodiments, at least one edge 12 of the inner sealed sterilization pouch 10 is sealed via at least one surface 31 of the outer sealed sterilization pouch 30 by a seal 40. In some embodiments, the outer sealed sterilization pouch 30 may be a steam sterilization pouch. In some embodiments, the outer sealed sterilization pouch 30 may be an EtO sterilization pouch. In a non-limiting example, the outer sealed sterilization pouch 30 may include a gas-permeable window (not shown), such as a paper or polyethylene fiber web, to allow moisture to penetrate the outer pouch and reach the inner pouch. For example, one surface 31 (e.g., the front) of the outer sterilization pouch 30 may include an impermeable layer, while the opposite surface (e.g., the back) may include a paper or polyethylene fiber web that serves as a gas-permeable window.

[0053] In some embodiments, the seal 40 may be formed from a polymer adhesive suitable for steam sterilization. In a non-limiting example, the seal may include polypropylene.

[0054] In some embodiments, the IOL 20 is glistening-free despite being in a moist environment, for example, by being sterilized by steam or by introducing moisture into the inner sealed sterilization pouch 10 following a dry sterilization method.

[0055] Reference is now made to FIGS. 2A and 2B, which are a flowchart and a depiction of an IOL package, respectively, for steps in a method of packaging an IOL according to some embodiments of the present invention. In step 210, an IOL may be inserted into an inner sealable pouch. In some embodiments, the inner sealable pouch may have a thermal conductivity at least 1.1 times greater than the thermal conductivity of the IOL material. In some embodiments, before inserting the IOL into the inner sealable pouch, the IOL is placed on a holder, and the holder is inserted into the inner sealable pouch. For example, as shown in FIG. 1C, an IOL 20 may be placed on a stage 26, which may then be connected to a holder 25 that is inserted into the inner pouch 10 through at least one opening 15. In some embodiments, the inner pouch 10 may include two openings 15 from two opposing sides of the inner pouch 10.

[0056] In step 220, the inner sealable pouch may be inserted into the 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 through the opening 34. In the non-limiting example shown in FIG. 2B, the opening 15 of the inner pouch 10 is inserted first, facing the adhesive portion 36 of the outer pouch 30.

[0057] The outer sealable pouch may be sealed in step 230. For example, a first seal 35 may then be created to close the lip of the outer pouch 30. In some embodiments, the seal 35 may include any adhesive suitable for steam sterilization.

[0058] In step 240, steam sterilization of the inner and outer sealable pouches may be performed using any known method, for example, at least one opening 15 in inner pouch 10 (shown in FIGS. 1A and 2B) may be used to introduce steam into inner pouch 10.

[0059] As is well known in the art, during steam sterilization, the vacuum cycle therein causes rapid evaporation of condensate (or any other liquid water droplets) deposited on the coolest material. Additional heat is required to evaporate the condensed droplets, allowing the material to cool rapidly. In some embodiments, pre-condensation of water vapor on the IOL can be avoided by placing the IOL in close proximity to a material with high thermal conductivity, such as the inner bag 10 and / or holder 25, during steam sterilization. In some embodiments, such placement prevents condensation on the IOL because the highly conductive material (e.g., the bag 10 and / or holder 25) has a surface area significantly larger than the IOL surface area and therefore may cool before the IOL cools. Preventing condensation on the IOL prevents any form of glistening, thus preserving the optical quality of the IOL.

[0060] In some embodiments, when the package 100 is heated, the heating can evaporate water from the surface of the highly conductive material instead of boiling the water on the surface of the IOL.

[0061] As an alternative to, or in addition to, a pouch and / or holder having a thermal conductivity at least 1.1 times greater than that of the IOL material, a metal object (or other object having a thermal conductivity at least 1.1 times greater than that of the IOL material) may be placed near pouch 10 during steam sterilization 240. The metal object may be inside or outside pouch 10.

[0062] In step 250, at least one opening 15 of the inner sealable bag may be sealed through at least one surface of the outer sealable bag. For example, the openings 15 of the inner bag 10 may be sealed through the surface of the bag 30 with the seal 40, for example, by soldering all openings using a polymer adhesive. In some embodiments, if two openings 15 are included in the inner bag 10, two seals 40 may be sealed, one for sealing each opening. In some embodiments, the method further includes, prior to sealing, inserting a portion of the holder 25 further inside the inner sealable bag 10 so that the surfaces of the at least one opening 15 of the inner sealable bag 15 are freely attached and sealed to each other.

[0063] Reference is now made to Figure 3, which is a flowchart of another method of packaging an intraocular lens (IOL) according to some embodiments of the present invention. In some embodiments, the intraocular lens (IOL) package 100 may be packaged using any one of the methods of Figures 2A, 3, or any suitable method that allows for the addition of moisture to a sterile, sealed pouch while maintaining sterile conditions.

[0064] 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, sterilization of the inner and outer sealable pouches may occur. For example, sterilization may be performed using an EtO method, in which 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 removal of the EtO, the inner pouch 10 contains a completely dry IOL 20.

[0065] The sterilization packaging may be inserted into a humidity chamber in step 350. In step 360, humidity may be introduced into the inner sealable pouch to achieve a relative humidity of at least 75% at 25°C.

[0066] In step 370, at least one opening of the inner sealable bag may be sealed through at least one surface of the outer sealable bag. For example, the openings 15 of the inner bag 10 are sealed through the surface of the bag 30 with the seal 40, for example, by soldering all openings using a polymer adhesive. In some embodiments, prior to sealing, a portion of the holder 25 is inserted further inside the inner sealable bag 10 so that the surfaces of the at least one opening 15 of the inner sealable bag 15 are freely attached and sealed to each other. B. Second Set of Embodiments

[0067] Most existing IOL delivery systems (e.g., IOL injectors) and sometimes the IOLs themselves cannot withstand temperatures above 45°C. In such cases, steam sterilization and dry heat sterilization are not feasible. Also, most IOL delivery systems are not compatible with radiation, plasma, and ozone sterilization. EtO sterilization may be a suitable sterilization process, but its most significant limitation is its inability to sterilize liquids, wet objects, and moist objects, as liquids dissolve EtO residue.

[0068] Some embodiments relate to a hydrophobic intraocular lens packaging procedure for various IOL configurations, such as non-preloaded lenses (IOLs that can be attached to an IOL holder), fully preloaded lenses (lenses in an IOL injector), and semi-loaded lenses (lenses loaded into an IOL injector cartridge that is loaded into an IOL injector by a physician). This procedure may require EtO sterilization (in some embodiments, steam sterilization) and packaging methods, which, when combined, allow for the introduction of liquid contents into the package containing the IOL after EtO sterilization, thereby (1) preventing drying of the IOL injector and its materials (e.g., coatings), which can result in unintended behavior during IOL injection, such as clogging, discontinuous movement, and sudden ejection, and (2) maintaining high flexibility and smooth translation of the IOL during injection.

[0069] Some embodiments require packaging with a vapor-impermeable sterilization barrier suitable for EtO (and possibly steam) sterilization through a sealable vapor-permeable window (hereinafter, "gas-permeable window"). The package can be used for transporting and storing hydrophobic intraocular lenses without glistening (typically caused by steam sterilization). The packaged hydrophobic IOL can be sealed with trapped water vapor obtained during the humidification process, which allows for maintaining very high relative humidity levels while a terminally sterile environment can be maintained within the sealed pouch until the very moment of use during ophthalmic surgery. In some embodiments, the IOL form is further nested within a sterile barrier system comprising an inner receptacle with a gas-permeable window disposed within the sealed pouch.

[0070] Reference is now made to Figures 4A-4F, which depict packaging for sterile wet packaging of an article 420, such as an IOL, at various stages of the packaging process, according to some embodiments.

[0071] The package includes a sealable bag 410. The sealable bag 410 includes an impermeable portion 413 and at least one gas-permeable window 415 (hereinafter, the first gas-permeable window 415). The first gas-permeable window 415 may be made of a material such as a synthetic flash-spun high-density polyethylene fiber commercially known as Tyvek®. The sealable bag 410 may be an aluminum-laminated pouch known in the art as a header bag, having a moisture vapor transmission rate (MVTR) of about 0. The first gas-permeable window 415 may be present in any portion of the sealable bag 410. In some embodiments of the package, the degree of gas permeability varies across the surface of the gas-permeable opening 415.

[0072] 4A, the item 420 can be placed inside the sealable bag 410. The item 420 can be placed through an insertion opening 412 in the sealable bag 410. The insertion opening 412 can be located at the edge of the sealable bag 410 or at any other location on the sealable bag 410.

[0073] The sealable bag 410 can be sealed with at least one seal 440 (hereinafter, first seal 440). The article 420 and at least a portion of the first gas-permeable window 415 are inside a first sealed portion 445 of the sealable bag 410 sealed by the first seal 440, as shown in FIG.

[0074] It should be understood that the first seal 440 may include multiple seals (e.g., if there are multiple gas permeable windows), so long as the first sealing portion 445 is completely sealed by the first seal 440 and at least a portion of one first gas permeable window 415 is within the first sealing portion 445.

[0075] If the nature of the article 420 (e.g., the size, shape, and fragility 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 while the article 420 is between the two layers.

[0076] The sealable pouch 410 with the first seal 440 can be sterilized by placing the sealable pouch 410 in a sterile environment. The first gas permeable window allows a sterile environment to penetrate into the first sealed portion 445 of the sealable pouch 410. The sterile environment sterilizes the interior surface area of ​​the first sealed portion 445 of the sealable pouch 410 and the surface of the article 420. The article 420 can remain sterile until the package is opened.

[0077] Sterilization can be, for example, by EtO sterilization or steam sterilization. EtO sterilization can be used, for example, when the item 420 cannot withstand the high temperatures reached during steam sterilization.

[0078] When steam sterilization is used to sterilize an IOL, such as a hydrophobic IOL, the material of the sealable bag 410 (e.g., impermeable portion 413) may have a thermal conductivity at least 1.1 times that of the material of the IOL. Alternatively, or additionally, the material of a holder (described further herein, including with reference to FIGS. 1A-1C) within the sealable bag 410 that holds the IOL has a thermal conductivity at least 1.1 times that of the material of the IOL.

[0079] The interior of the sealable bag 410 can be humidified. Humidification can be achieved by placing the sealable bag 410 in a humid environment, such as a humidifier, incubator, or climate chamber, which allows the humid environment to penetrate through the first gas-permeable window 415 and humidify the interior of the sealable bag 410.

[0080] If steam sterilization is used, it may serve to both sterilize and humidify the interior of the sealable pouch 410 .

[0081] Alternatively, or additionally, humidification may be achieved by a humidity control material in second sealed portion 455. For example, a humidity control pack (such as those supplied by Boveda) is inserted into sealable bag 410 along with item 420. In some embodiments, an 84% RH humidity control pack is inserted into sealable bag 410. In some embodiments, another humidification method (i.e., steam sterilization, humidifier) ​​is used first, and then the humidity control pack is inserted to adjust the RH to a constant level.

[0082] The sealable bag 410 may be sealed with a second seal 450. The first gas-permeable window 415 may be located outside a second sealed portion 455 of the sealable bag 410 sealed by the second seal 450, as shown in FIG. 4C , and the item 420 may be located inside the second sealed portion 455. The second seal 450 may prevent any gas or vapor from exiting or entering the second sealed portion 455 of the sealable bag 410. This may trap moisture in the second sealed portion 455 until the package is opened. The air inside the second sealed portion 455 may have a relative humidity (RH) of at least 60% at 25° C. In some embodiments, the RH is at least 65% at 25° C. In some embodiments, the RH is at least 80% at 25° C. In some embodiments, the RH is at least 84% at 25° C. In some embodiments, the package, when sealed with second seal 450, is capable of maintaining at least 90% of the initial humidity level inside second sealed portion 455 for five years after sealing with second seal 450. In some embodiments, gases and vapors within second sealed portion 455 are over-pressurized (e.g., by maintaining a cold environment during humidification and sealing second seal 450) to prevent the environment surrounding the package from entering second sealed portion 455.

[0083] Optionally, after second seal 450 is created, a remnant 460 of sealable bag 410 is removed (e.g., by cutting) from the remainder of bag 410, as shown in FIG. 4D. Remnant 460 is outside second sealed portion 455, and preferably, remnant 460 does not include any portion of second seal 450. Removal of remnant 460 reduces the amount of packaging material and facilitates storage and shipping of the package.

[0084] Reference is now made to Figures 5A-5F, which depict a sterile wet package 500 for an IOL loaded into an IOL injector at various stages of the packaging process according to some embodiments.

[0085] The package includes a sealable pouch 510. The sealable pouch 510 includes an impermeable portion 513 and a gas-permeable window 515 (hereinafter, first gas-permeable window 515). The first gas-permeable window 515 may be made of a material such as a synthetic flash-spun high-density polyethylene fiber commercially known as Tyvek®. The sealable pouch 510 may be what is known in the art as a header pouch, which is commonly used in the sterilization of medical devices.

[0086] Package 500 may include an inner receptacle 505. Inner receptacle 505 may include a second gas-permeable window 507. Inner receptacle 505 may be, for example, a blister pack such as one made of glycol-modified polyethylene terephthalate (PET-G). Second gas-permeable window 507 may be the gas-permeable backing 507 of the blister.

[0087] First gas permeable window 515 may comprise a material such as a synthetic flash-spun high-density polyethylene fiber commercially known as Tyvek®. In some embodiments, inner receptacle 505 is made of an impermeable material, except for second gas permeable window 507. In some embodiments, inner receptacle 505 is made entirely of a gas permeable material.

[0088] During packaging, an intraocular lens (IOL, not shown) may be placed within inner receptacle 505. In some embodiments, the IOL is made of a hydrophobic material.

[0089] In some embodiments, the IOL is preloaded into an IOL injector 512, which can be inserted into inner receptacle 505, as shown in FIG. 5A. In other embodiments, the IOL is preloaded into an IOL injector cartridge (not shown), which can be inserted into inner receptacle 505. The injector cartridge is intended to be used, for example, by inserting it into a reusable IOL injector.

[0090] In some embodiments, the pre-loaded IOL injector 512 or IOL injector cartridge is placed directly within the sealable pouch 510 (ie, not within an inner receptacle).

[0091] In some embodiments, the IOL attached to the IOL holder is placed directly within the sealable pouch 510. In some embodiments, the holder is attached to a stage, as described further herein.

[0092] In some embodiments, the holder (and stage, if present) is placed within an inner receptacle 505 such as a blister pack (of an appropriately adapted shape and size) having a gas-permeable backing 507.

[0093] During packaging, the sealable pouch 510 may be sealed with a first seal 540, as shown in Figure 5D. At least a portion of the inner receptacle 505 and the first gas-permeable window 515 are inside a first sealed portion (depicted at 445 in Figure 4B) of the sealable pouch 510 sealed by the first seal 540.

[0094] The interior of inner receptacle 505 may be accessible to the atmospheric environment outside sealable bag 510 through second gas permeable window 507 and first gas permeable window 515 .

[0095] The sealable bag 510 containing the inner receptacle 505 may be placed in a sterile environment and then sterilized. The sterilization sterilizes the sealable bag 510 and the contents therein. In particular, the following surfaces may be sterilized: 1. The inner surface area of ​​the sealable bag 510. 2. The inner and outer surfaces of the inner receptacle 505. 3. The inner and outer surface areas of the IOL injector 512. 4. The external surface area of ​​the IOL on both sides of the IOL.

[0096] In some embodiments, sterilization is by ethylene oxide (EtO) sterilization. In other embodiments, sterilization is by steam sterilization. EtO sterilization may be preferred when a sealable pouch houses the IOL injector 512, as many IOL injectors cannot withstand the temperatures of steam sterilization. EtO sterilization may also be preferred when the IOL itself cannot withstand the temperatures of steam sterilization.

[0097] After sterilization, the sealable bag 510 containing the inner receptacle 505 can be placed in a humidity chamber. In some embodiments, humidity is introduced into the humidity chamber until the air inside the first sealed portion, including the interior of the inner receptacle 505, is at least 60% relative humidity at 25°C. Humidification can be particularly beneficial in packaging IOL injectors; keeping the hydrophilic coating on the tip of the injector moist can prevent the coating from cracking. In some embodiments, the relative humidity is at least 65% at 25°C. In some embodiments, the relative humidity is at least 80% at 25°C.

[0098] It should be noted that one or more gases other than air may be mixed with or replaced by the air.

[0099] In some embodiments, after humidification, the sealable pouch 510 is sealed with a second seal 550, such that the second gas permeable opening 515 is outside the second sealed portion of the sealable pouch 510 (depicted at 455 in FIG. 4C ) and the inner receptacle 505 is inside 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. As a result, air having a humidity level established by humidification can be trapped inside the second sealed portion until the package is opened.

[0100] The second gas permeable window 520 can be removed from the sealable pouch 510 by cutting the sealable pouch 510 at the break 560 outside the second seal 550, as shown in Figure 5F.

[0101] Reference is now made to Figure 6, which is a flow chart of a method 600 for sterile wet packaging of an article. Method 600 comprises: 1. Placing an item inside a sealable bag 610, the sealable bag having an impermeable portion and a first gas-permeable window. 2. Sealing the sealable bag with a first seal 620, whereby the article and at least a portion of the first gas permeable window are inside the first sealed portion of the sealable bag. 3. Sterilizing the sealable pouch in a sterile environment 630, whereby the sterile environment penetrates the first gas permeable window to sterilize the article. 4. Sealing the sealable bag with a second seal 640, whereby the first gas permeable window is on the outside of the second sealed portion of the sealable bag, the item is on the inside of the second sealed portion of the sealable bag, and the air inside the second sealed portion can have a relative humidity of at least 60% at 25°C. Includes.

[0102] Unless explicitly stated, the method embodiments described herein are not limited to a particular order or sequence. Furthermore, all methods described herein are intended as examples only, and other or different methods may be used. In addition, some of the described method embodiments or elements thereof may occur or be performed at the same time.

[0103] While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will 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 that fall within the true spirit of the invention.

[0104] Various embodiments have been presented, each of which may include features of the other presented embodiments, including interchange of features between embodiments under the headings "First Set" and "Second Set" in the Detailed Description. Embodiments not specifically described may include various features described herein.

[0105] Although the description of packaging embodiments herein relates to packaging for intraocular lenses, it is understood that the packaging is suitable for any medical device or other item that requires sterilization and / or benefits from storage in a moist environment.

Claims

1. A method for packaging an intraocular lens (IOL), wherein the method is: The contents to be packaged, comprising an IOL, a loaded IOL injector, or a loaded IOL injector cartridge, are placed within an inner receptacle having a gas-permeable window. The inner receptacle is sterilized in a sterile environment, the sterile environment thereby sterilizing the contents by passing them through the gas permeable window, The inner receptacle is placed inside the sealed bag, The humidity control pack is placed inside the sealed bag, To seal the aforementioned airtight bag, Includes, A method for adjusting the humidity control pack inside the sealed bag to a relative humidity of at least 60% at 25°C.

2. The method according to claim 1, wherein the air inside the airtight bag has a relative humidity of at least 80% at 25°C.

3. The method according to claim 1, wherein the IOL is made of a hydrophobic material.

4. The method according to any one of claims 1 to 3, wherein the sterilization is carried out by ethylene oxide (EtO) sterilization.

5. The method according to claim 1, further comprising holding the IOL with an IOL holder.

6. The method according to claim 1, wherein the inner receptacle comprises a blister pack having a gas-permeable backing material.

7. The method according to claim 6, wherein the front part of the blister pack is impermeable.

8. A packaged intraocular lens (IOL), wherein the packaged IOL is Package contents comprising an IOL, a loading IOL injector, or a loading IOL injector cartridge, An inner receptacle having a gas permeable window, wherein the contents are placed inside the inner receptacle, the inner receptacle is sterilized in a sterile environment, and the sterile environment thereby sterilizes the contents by passing through the gas permeable window, and A sealed bag, Humidity control pack, Equipped with, The sterilized inner receptacle contains the contents, and the humidity control pack is placed inside the airtight bag and sealed. The humidity control pack inside the sealed bag adjusts the humidity of the air inside the sealed bag to a relative humidity of at least 60% at 25°C, and is a packaging IOL.

9. The packaging IOL according to claim 8, wherein the humidity of the air inside the sealed bag is at least 80% relative humidity at 25°C.

10. The packaging IOL according to claim 8, wherein the IOL is made of a hydrophobic material.

11. The packaging IOL according to any one of claims 8 to 10, wherein the sterilization is performed by ethylene oxide (EtO) sterilization.

12. The packaged IOL according to claim 8, further comprising an IOL holder for holding the IOL.

13. The packaging IOL according to claim 8, wherein the inner receptacle comprises a blister pack having a gas-permeable backing material.

14. The packaging IOL according to claim 13, wherein the front part of the blister pack is impermeable.

15. The packaging IOL according to any one of claims 8 and 10, wherein the IOL injector is provided with a tip having a hydrophilic coating.

16. A packaged intraocular lens (IOL), wherein the packaged IOL is IOL and, An internally sealed sterile bag equipped with the aforementioned IOL and having a relative humidity of at least 75% at 25°C, An outer sealed sterile bag surrounding the inner sealed sterile bag, Equipped with, The IOL inside the sealed inner sterilization bag is steam sterilized through at least one opening of the sealed inner sterilization bag. The inner sealed sterilization bag contains a material having a thermal conductivity at least 1.1 times that of the IOL material. Steam-sterilized IOLs are grease-free, packaged IOLs.

17. The packaging IOL according to claim 16, wherein the material of the IOL is hydrophobic.

18. The packaging IOL according to claim 16, wherein the inner sealed sterilization bag is made of at least one of aluminum foil and a polyester laminate having an aluminum layer.

19. The packaging IOL according to claim 16, wherein at least one opening of the inner sealed sterile bag is sealed through at least one surface of the outer sealed sterile bag.

20. The packaging IOL according to claim 16, wherein the outer sealed sterilization bag is a steam sterilization pouch.

21. The packaging IOL according to claim 16, wherein the outer sealed sterile bag comprises a web of paper or polyethylene fibers.

22. The packaging IOL according to claim 19, wherein the seal of at least one opening of the inner sealed sterilization bag comprises a polymer adhesive suitable for steam sterilization.

23. The packaged IOL according to claim 16, wherein the IOL is held by a holder inserted into the inner sealed sterile bag.

24. A method for packaging an intraocular lens (IOL), wherein the method is: a. Inserting the IOL into an internally sealed bag, b. Inserting the inner airtight bag into the outer airtight bag, c. Sealing the outer airtight bag, d. Steam sterilization of the inner airtight bag through at least one opening of the inner airtight bag, Includes, The inner airtight bag contains a material having a thermal conductivity at least 1.1 times that of the IOL material. A method for steam-sterilized IOLs that is grease-free.

25. The method according to claim 24, wherein the material of the IOL is hydrophobic.

26. The method according to claim 24, further comprising placing the IOL on a holder before inserting the IOL into the inner sealable bag, and inserting the holder into the inner sealable bag.

27. ​​The method according to claim 24, further comprising sealing at least one opening of the inner sealable bag through at least one surface of the outer sealable bag.

28. The method according to claim 27, further comprising inserting a portion of the holder further inside the inner sealable bag so that the surfaces of at least one opening of the inner sealable bag are freely attached to and sealed with respect to each other, before sealing at least one opening of the inner sealable bag.

29. The method according to claim 27, wherein sealing at least one opening of the inner sealable bag through at least one surface of the outer sealable bag comprises soldering the opening using a polymer adhesive.

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