Packaging method for transporting and storing intraocular lens

Abstract

A method of providing an intraocular lens within a package in a sterile and gas-tight manner, in particular:-inserting the intraocular lens into an interior space of the package, a first portion (17) defining a first interior space for storing the intraocular lens within the package comprising a gas-tight first packaging material, a second portion (19) of a second interior space comprising a gas-tight second packaging material, the second packaging material does not allow liquid water to permeate; packaging the first seal to seal the intraocular lens in the packaging internal space; exposing the first sealed package to steam or a mixed gas of steam and other disinfecting gases such that the steam or the mixed gas permeates into the interior of the package through the second subsection (19) for disinfection; and a packaging second sealing, which seals the first part (17) in which the intraocular lens is stored from the second part (19) in a sealed manner, such that the intraocular lens and the moisture that permeates into the packaging in the form of steam during disinfection are packaged in a first gas-tight packaging material.

Description

[0001] This application is a divisional application of the invention patent application filed on September 30, 2020, with application number 202080077140.2 and invention title "Packaging method for transporting and storing artificial lenses". Technical Field

[0002] This invention relates to a method of manufacturing packaging for storing sterile and airtight intraocular lenses, more specifically, the intraocular lens being pre-loaded into a syringe. Further, this invention relates to intraocular lens packaging, and more specifically to syringe packaging containing a sterile intraocular lens, manufactured using the above method. This invention also relates to semi-finished products of intraocular lens packaging or syringe packaging. Background Technology

[0003] Traditionally, hydrophilic intraocular lenses (IOLs) and some hydrophobic IOLs are stored in a humid environment to maintain sufficient moisture and elasticity before injection into the eye. IOLs must remain elastic so they can fold and be injected into the eye.

[0004] When preparing to store medical or surgical instruments, they are typically sterilized and packaged in sterilizable materials, then injected with a sterilizing gas, such as ethylene oxide or vapor, under controlled temperature and pressure (if necessary). Steam sterilization is performed in an autoclave, with common parameters being 121°C / 20 minutes or 134°C / minute, ensuring good vapor permeability of the packaging. The injected gas or vapor leaves the packaging after sterilization. Therefore, gas sterilization is not suitable for packaging and storing artificial lenses that require a humid environment, because the packaging material allows gas or vapor to pass through, meaning that moisture cannot be permanently blocked from entering or leaving, thus failing to guarantee a humid storage environment.

[0005] Materials stored in humid environments are typically sterilized in liquid-filled packages sealed with both watertight and airtight seals. These materials can still be sterilized by steam in an autoclave, but the process differs. Steam cannot penetrate the packaging; instead, heat is transferred from the packaging material to the liquid inside for sterilization via heat exchange. A series of validation steps are required to determine when the liquid reaches the sterilization temperature before sterilization begins. This method requires applying a limited overpressure to prevent the liquid from boiling, even at the sterilization temperature. The packaging is filled with liquid as completely as possible, minimizing residual air, as residual air expands significantly upon heating, exerting immense pressure that could cause the seal to burst. Generally, more air results in greater pressure inside the packaging. However, the seal strength cannot be arbitrarily increased, as it allows users to open the packaging; the autoclave back pressure also cannot be arbitrarily increased, as this could deform the packaging or even the product itself. Therefore, when using heat exchange autoclaving, a large amount of water and minimal air must be used within the packaging. WO2015061401 discloses a packaging method for a foldable hydrophilic intraocular lens, comprising storing the foldable intraocular lens in an airtight container, the airtight container having a water storage area that does not directly contact the intraocular lens. The intraocular lens can also be stored in a syringe without being folded, both the syringe and the intraocular lens being stored in an airtight container with a water storage area that does not directly contact the intraocular lens.

[0006] WO2015183432 also discloses a similar method for maintaining a hydrophilic intraocular lens in a folded state without immersion in a liquid. The method includes storing the foldable lens in an airtight container containing free water. The intraocular lens is placed in the container in a position where it is not immersed in the liquid. This patent further discloses an assembly including an airtight container containing free water and a foldable hydrophilic intraocular lens stored within the container in a position where it is not immersed in the liquid. A packaging method to achieve the above conditions includes the following steps: a) inserting a syringe containing the intraocular lens into a storage holder; b) placing the storage holder in the container; c) introducing an appropriate amount of free water into the container (by dripping or spraying) before closing the container; and d) sealing the container.

[0007] According to WO2016061401, the sealed capsule contains approximately 5ml to 20ml of water, while according to WO2015183432, the water volume is 0.5ml to 3ml. The patent further states that the airtight container containing the artificial lens can be sterilized by autoclaving, in other words, it can withstand heating to 121°C or higher and maintained for 30 minutes or more.

[0008] The aforementioned information mentions autoclaving, but whether it can achieve sterility and meet the requirements for medical and surgical instruments and implantable materials remains questionable. Specifically, according to WO2015061401 and WO2015183432, the heated airtight packaging contains a very small amount of water compared to its capacity before heating. As mentioned earlier, to heat the water inside an airtight container, heat must be transferred from the packaging material to the interior. When the air volume inside the container is much greater than the water volume, heating both the air and liquid to the sterilization temperature takes a relatively long time. Furthermore, because the heated air expands, the internal pressure is very high, requiring the autoclave to operate at extremely high back pressure, or the packaging to be designed to be very robust. Opening the packaging usually involves pulling off the covering film, but if the packaging is designed to be robust, this method becomes almost impossible, causing inconvenience to the user. In addition, it is necessary to determine when the water inside the sealed packaging turns into steam to reach the desired sterilization temperature. Thus, applying this method is very cumbersome and complex, making it too expensive for manufacturers. Specifically, effective sterilization is difficult to guarantee, making it difficult to ensure the sterility of the packaged intraocular lenses. Furthermore, it is uncertain whether a sterilization process actually occurred or whether it was sufficient. In medical applications, especially for packaging materials intended for implantation, this risk is unacceptable. Therefore, the packaging and sterilization methods proposed in WO2015061401 and WO2015183432, which involve heating a large amount of air within an airtight container while using very little water, are unsuitable for intraocular lenses. A safe and cost-effective sterilization method is needed to improve product quality and safety.

[0009] FR28201 18A1 discloses a sterilization package including a first chamber (sterilization chamber) for gas sterilization of medical devices and a second chamber (storage chamber) for storing the sterilized medical devices. The first chamber has perforated walls to allow the contents to be sterilized by gas. The first chamber can be separated from the sterile second chamber by a removable seal, so that the material can be transferred from the first chamber to the second chamber for storage after sterilization. The two chambers are initially separated by a seal, and the completely sealed package is sterilized with gamma rays to make both chambers sterile. Then, the first chamber with perforated walls is opened, the material to be sterilized is placed into the first chamber, and the opening of the first chamber is then sealed. The first chamber and the material inside are then sterilized by autoclaving. After completion, the seal between the two chambers is opened, the sterilized material is transferred from the first chamber to the second chamber, and then a new seal is formed between the two chambers, and the material is stored in the second chamber. This process is relatively complex, involving at least two sealing procedures and one unsealing procedure. Different disinfection methods are used for the two disinfection processes to achieve airtight and disinfected packaging.

[0010] US2007 / 0084144A1 discloses a method for sterilizing and packaging chemically sensitive medical products or devices, such as implantable materials. The method includes coating the medical product or device with a compound derived from vitamin E, fish oil, or a combination thereof. The steps include: providing a medical product or device; providing a bag having an impermeable chamber and a gas-permeable head; placing the medical product or device inside the bag; sealing the bag along the gas-permeable head, allowing communication between the impermeable chamber and the gas-permeable head; introducing a sterilizing medium from the gas-permeable head into the impermeable chamber to sterilize the medical product or device at approximately 20 to 40°C; sealing the medical product or device within the impermeable chamber; optionally removing the head, leaving the packaged and sterilized medical product or device in the impermeable chamber. According to the patent disclosure, the sterilizing medium can be ethylene oxide gas, vapor, gas plasma, vaporized hydrogen peroxide, gamma rays, or electron beam radiation.

[0011] The solution in US2007 / 0084144A1 involves a simple bag, but the bag does not provide sufficient protection for the contents against external physical impacts, such as the bag being squeezed during storage and transportation.

[0012] Purpose of the invention

[0013] One objective of this invention is to provide an alternative method for introducing liquid into packaging and sterilizing the packaging of ready-to-use intraocular lenses, particularly syringe and intraocular lens kits. The method should achieve the following: after sterilization, a certain volume of liquid remains within the packaging, allowing the sterile intraocular lens to be stored in a moist state; the process should be simple, low-cost, and applicable to different packaging conditions and / or different packaging capacities. Therefore, this invention provides a packaged product, specifically a packaged ready-to-use intraocular lens or a packaged ready-to-use syringe and intraocular lens kit, packaged and sterilized using the aforementioned alternative method. One specific objective of this invention is to provide a packaged product in which the intraocular lens can be stored in a sterile and moist environment; another objective is to provide packaging that protects the intraocular lens from physical influences; yet another objective is to provide a space-saving package that protects the intraocular lens from physical influences. Summary of the Invention

[0014] To achieve the above objectives, this invention provides, according to claims 1, 6, 15, and 24, an intraocular lens packaging product or a syringe packaging product; according to claim 33, a packaging; and according to claim 16, a method. Claims 1, 6, 15, and 24 relate to semi-finished and / or finished products of packaging. Specifically, the finished product is a sterile package with a controlled internal environment.

[0015] This invention specifically relates to a method for manufacturing packaging, wherein the packaging contains an artificial lens in a sterile and airtight state, such as a loading chamber pre-loaded with an artificial lens, or a syringe pre-loaded with an artificial lens, hereinafter referred to as artificial lens packaging or syringe packaging, comprising the following steps:

[0016] - An artificial lens (optionally equipped with a storage holder, loading chamber, and / or syringe) is inserted into the internal space of the packaging. The first portion of the packaging includes an airtight first packaging material, and the second portion of the packaging includes a second packaging material that allows the passage of gases or gas mixtures, such as at least vapor, and other optional sterilizing gases.

[0017] - The first sealing of the packaging encloses the artificial lens within the packaging's internal space, which is partially defined by a first section and partially by a second section (in other words, the two sections of the packaging define the aforementioned internal space, forming a continuous internal space).

[0018] - After the initial sealing of the packaging's internal space, sterilization is performed by exposing the packaging to a gas or gas mixture, such as steam (and other optional sterilizing gases), or other sterilizing gases.

[0019] The aforementioned gas can penetrate into the internal space of the packaging through the second section.

[0020] - The second seal of the packaging seals at least a portion of the first section containing the artificial lens, isolating it from the internal space of the second section. The artificial lens is completely enclosed within the airtight first packaging material. (In other words, the second seal of the packaging seals at least a first portion of the internal space, which is located in the airtight first section containing the artificial lens, isolating it from the second portion of the internal space, thereby completely enclosing the artificial lens within the airtight first packaging material.)

[0021] Alternatively, a further step can be chosen: after the second sealing, the second section of the packaging has completed its function of creating a gaseous environment and has no further effect on the finished product; this section can then be removed.

[0022] This method can regulate the humidity inside the packaging after the first sealing. For example, when sterilizing the internal space, it can be used in packaging sections that allow gas permeation to better control humidity.

[0023] Preferably, high-temperature steam-saturated air sterilization is used, and the air can enter the packaging through packaging sections that allow gas permeation. Alternatively, other sterilizing materials can be added to the air, with moisture added directly in the form of gaseous accumulation (i.e., steam), eliminating the need to add liquid water, or using only liquid water as a backup to replenish moisture lost during the product's lifespan. Therefore, the final product or finished product intended for sale will not contain excessive liquid water.

[0024] Sterilization is carried out in an autoclave. The autoclave is a gas-tight container, preferably a pressure vessel, used to process materials at high temperatures, preferably within an overpressure range. Within the autoclave, the gas composition, temperature, and pressure can be adjusted and / or controlled for sterilization.

[0025] The precise hermetically sealed opening (i.e., the second seal) of the artificial lens packaging is only applied after sterilization. Generally, after sterilization, the packaging is cooled (preferably still within the autoclave). During cooling, steam may condense inside the packaging. The material in the second section allows steam and other gases to permeate, but not liquid water; therefore, when the condensed steam turns into liquid water, the moisture cannot leave the packaging. In principle, if necessary, the steam can leave the packaging or be vented outside the packaging before the second seal, keeping the liquid water content of the final product or finished product at a low level.

[0026] Compared to the pre-sealed packaging space in the aforementioned prior art, this method requires a significantly shorter sterilization time.

[0027] Furthermore, this method is quick and efficient, and is not affected by the size of different packaging spaces. Because the relative humidity of the environment is adjusted, the humidity applied to each package is proportional to the size or capacity of the package, eliminating the need for additional water adjustments based on package size.

[0028] The first sealing creates a single, contiguous space, separating this space from the external environment. The packaging includes at least the two different materials mentioned above. This internal space contains the material to be processed, such as the intraocular lens itself, or the intraocular lens plus a syringe and / or loading chamber. Preferably, the intraocular lens is pre-loaded into the loading chamber of the syringe, so that the intraocular lens and the syringe are placed together in the packaging. After a second sealing, the aforementioned single, contiguous space is divided into two spaces, wherein the first space containing the material to be processed is preferably several times larger than the second space, specifically at least three times larger, and the second space can be removed if necessary.

[0029] After the second sealing, the internal space of the packaging is reduced, becoming smaller than the internal space after the first sealing.

[0030] During sterilization, moisture enters the internal space in the form of vapor, which is sealed inside the packaging after the second seal. No additional moisture needs to be added to the packaging to store the artificial lens in the finished product. The moisture added during sterilization and remaining inside the packaging after the second seal is sufficient to maintain a humid environment for the artificial lens. However, since no material or packaging is 100% waterproof or prevents vapor penetration, adding additional moisture before the first seal is also helpful as a backup. This way, even if the product is stored for several years and moisture is lost through the packaging material throughout the storage period, the product can still maintain sufficient humidity.

[0031] Preferably, for the purpose of disinfection, there is at least one steam sterilization.

[0032] The package, which has already been sealed for the first time, is exposed to an environment with a specific humidity level for a specific period of time, which is the actual disinfection cycle time. The humidity can then penetrate into the internal space of the package from the second part to increase the humidity of the internal space.

[0033] The actual disinfection cycle time is the duration during which the temperature remains within the predetermined range or at the predetermined value.

[0034] Specifically, after the first sealing, the packaging is exposed to an environment with a relative humidity of at least 90% for a period of time, preferably a steam-saturated environment, at a temperature of 100°C or above, preferably 110°C or above, and even more preferably 120°C or above.

[0035] The duration refers to a period of time when the temperature is between 100°C and 130°C, specifically 121°C, preferably not exceeding 30 minutes, more preferably not exceeding 25 minutes, or most preferably about 20 minutes. When the temperature exceeds 130°C, specifically 134°C, the duration is not exceeding 15 minutes, more preferably not exceeding 10 minutes, or most preferably 5 minutes.

[0036] Sterilization is performed in an autoclave or processing chamber. This sterilization method is safe and can be performed using commercially available autoclaves with standard sterilization parameters.

[0037] To better protect the intraocular lens (IOL), it is preferable to place the IOL and its storage socket within the packaging, specifically by inserting the IOL into the storage socket. Instead of using any storage socket, a loading chamber is used, pre-loaded with the IOL. The loading chamber can be designed as a core tube, which can be inserted into the syringe or fused with the syringe.

[0038] The advantages of this method are as follows: the intraocular lens is pre-loaded into the storage holder, specifically by inserting it into the storage holder and / or loading chamber, particularly into the loading chamber and / or syringe, especially into the syringe, and then inserted into the packaging. The intraocular lens, storage holder, loading chamber, and / or syringe are sealed in a watertight environment through a first seal, sterilized, and then sealed in an airtight manner through a second seal within the packaging. This method allows intraocular lenses, which are normally stored in liquids, to be stored in air saturated with moisture without being damaged by drying out.

[0039] In addition to using steam alone, other disinfection gases can be added, such as ethylene oxide, formaldehyde, ozone, hydrogen peroxide, or a combination of the above gases, with ethylene oxide being the preferred choice.

[0040] At least a portion of the second portion comprises a material that allows the permeation of steam and optionally other sterilizing gases while being waterproof. For example, at least a portion of the second portion comprises high-density polyethylene (PE-HD). Preferably, the high-density polyethylene is a high-density polyethylene nonwoven fabric bonded by evaporative spinning. Alternatively, other packaging materials commonly used for autoclaving, such as medical autoclaved paper, may be selected, provided that they allow the permeation of steam and optionally other sterilizing gases while being waterproof.

[0041] After the second sealing, you may choose to remove and discard a portion of the packaging, including the second section which is not part of the now reduced interior space.

[0042] Preferably, the second portion constitutes the end area of ​​the packaging and can be easily removed when no longer needed.

[0043] The present invention further relates to intraocular lens packaging, including an intraocular lens contained within the packaging. Preferably, the intraocular lens is stored in a storage holder or preloaded into a loading chamber and / or syringe. The packaging forms a sealed, specifically airtight, internal space containing the intraocular lens, and optionally includes a storage holder, a loading chamber, and / or syringe.

[0044] In addition to the artificial lens, the intraocular lens packaging also includes a syringe, with the artificial lens placed on or within it; this is also called syringe packaging. In a first embodiment, the intraocular lens packaging or syringe packaging can be sterilized by steam pressure. The packaging is characterized by two parts: a first part defining a first internal space containing the artificial lens and optionally including a storage seat, loading chamber, and / or syringe; and a second part defining a second internal space, which has a window allowing steam and other optional sterilizing gases to permeate. The two internal spaces are interconnected, and a transition area in the middle forms a structure, such as a latch, for welding or bonding to seal the two internal spaces, separating them and making them airtight. It should be noted that, except for the window material allowing steam or other sterilizing gases to permeate, the rest of the packaging material is not permeable or airtight. The first embodiment includes two parts forming an adjacent space, functionally representing a semi-finished intraocular lens packaging product that can be sterilized by steam pressure.

[0045] In the first embodiment, the packaging of the artificial lens that can be sterilized by steam pressure is characterized in that: the packaging is designed to seal the first part in which the artificial lens (optionally equipped with a storage seat, loading chamber and / or syringe) is placed and to separate it from the second part, and the first part is airtight and watertight after sealing.

[0046] Preferably, at least one of the two sections, with the second section being more preferred, may provide one or more structures shaped to maintain communication between the channels of the first and second sections of the packaging, allowing gas exchange between the first and second internal spaces. Specifically, it is necessary to prevent the packaging from collapsing and causing the channels to close before or during sterilization. The one or more structures are located inside the packaging to prevent it from collapsing inwards, ensuring gas flow throughout the entire internal space of the packaging during sterilization. The one or more structures are higher than the latch to prevent the packaging from collapsing inwards (especially when no external force is applied) and from pressing against the aforementioned structures or latch structure.

[0047] According to the second embodiment, the intraocular lens packaging, or syringe packaging, is characterized by having two sections: a first section defining a first internal space for placing the intraocular lens and optionally including a storage seat, loading chamber, and / or syringe; and a second section defining a second internal space, the second section having a window allowing steam and other optional sterilizing gases to permeate the material. The two internal spaces are separated by a sealing seam, specifically by welding or bonding the packaging material. In the production process of the second embodiment, welding is performed after autoclaving. Therefore, the intraocular lens packaging of the second embodiment is functionally a packaged intraocular lens that has undergone autoclaving (or sterilization) and sealing (or, relative to the first embodiment, a finished intraocular lens packaging product), with the intraocular lens placed in the first section, which is sealed after autoclaving, separating it from the second section.

[0048] A practical example is as follows: According to the first or second embodiment, the intraocular lens packaging can be a bag, which includes at least a first internal space containing the intraocular lens (or an intraocular lens stored in a storage holder, loading chamber, or syringe), and at least a second internal space. A window is formed in the area of ​​the packaging that constitutes the second internal space (not the first internal space). The second internal space can be separated from the first internal space containing the intraocular lens (or an intraocular lens stored in a storage holder, loading chamber, or syringe), so that the first internal space is separated from the second internal space and the external environment in an airtight manner. This example is referred to as the bag design.

[0049] In the bag design, the intraocular lens, or the loading chamber / syringe containing / preloaded with an intraocular lens, is attached to a storage holder for transport within the storage holder while still in the packaging bag. The storage holder ensures that the intraocular lens in the airtight packaging bag is separated from the surrounding packaging material, and ideally, the entire surface of the intraocular lens is in direct contact with the internal environment (ensuring that direct contact with the packaging material does not prevent contact with the internal packaging air).

[0050] According to the first or second embodiment, in a preferred embodiment, the artificial lens packaging is characterized by: the packaging consisting of a covered container with a circumferential edge for sealing with a lid, the container having at least one first groove defining a first internal space, and at least one second groove defining a second internal space, and a window located in the area of ​​the second internal space covered by the lid.

[0051] The aforementioned welded position used to separate the two internal spaces is located between the latch and the cover.

[0052] The first section has an airtight lid that prevents steam from penetrating, while the second section allows steam to penetrate and may optionally allow other disinfecting gases to penetrate.

[0053] Furthermore, the packaging of artificial lenses is characterized by being watertight as a whole (i.e., not allowing water penetration). The second section allows vapor penetration but not liquid water penetration.

[0054] The intraocular lens packaging is characterized by a latch within the container, separating a first and second section (or a line drawn to separate the first and second sections), preferably on the same plane as or flush with the circumferential edge of the container. This facilitates the simultaneous or subsequent welding of the container and lid together along the circular edge (and along the latch, if necessary). In other words, the sealable surfaces on the container edge and the latch are on the same plane. The latch extends from a first position on the circumferential edge of the container to a second position on the circumferential edge of the container, preferably in a straight line. The two positions are specifically separated from each other.

[0055] To ensure gas exchange between the first and second sections, a structure is provided within the first and / or second section, preferably near the latch and higher than the coplanar plane of the latch or the latch and edge, to raise the lid, which is attached or fixed to the circumferential edge of the container, above the latch, specifically above the coplanar plane of the latch and edge. This keeps the passage between the first and second sections unobstructed between the latch and the lid, allowing gas exchange between the first and second sections. The raised structure may be one or more, located within the first and / or second section. The circumferential edge of the container specifically refers to the periphery of the first and second sections. The lid is a covering film that can be elastically fastened or sealed, and / or loosely placed on the circumferential edge, allowing subsequent fastening or sealing of the latch structure. The raised structure is located inside the packaging to prevent denting of the packaging; specifically, the lid should not dent.

[0056] One or more protruding structures are "preferably close to the latch," meaning that the protruding structures are positioned such that, on a fictitious plane defined by a circular edge, the minimum distance between the protruding structure and the latch is several times shorter than the minimum distance between the protruding structure and the circular edge. The minimum distance between the protruding structure and the circular edge is calculated by extending a fictitious straight line from the circular edge to the minimum distance of the protruding structure.

[0057] In the bag design, an intraocular lens, or a loading chamber or syringe containing an intraocular lens, is placed within a storage seat, which is pushed into the bag to ensure gas exchange between the first and second internal spaces. Specifically, if the bag is sealed along its circumferential edge, the storage seat can slide into a second internal space with a window. The second internal space is smaller or shorter than the storage seat. The storage seat then spans the first and second internal spaces, keeping the transition zone between the two spaces open during autoclaving. Before sealing, to separate the two internal spaces, the storage seat containing the intraocular lens can slide completely back into the first internal space of the bag.

[0058] The packaging is manufactured using a film material. Preferably, at least the lid of the packaging is made of aluminum, specifically aluminum foil; while the window of the lid is made of another material, namely a material that allows gas permeation.

[0059] This invention further discloses an intraocular lens (IOL) package or syringe package, comprising an IOL, optionally pre-loaded into a syringe, and a package for storing the IOL and syringe inside. The package forms a sealed internal space, specifically an airtight internal space containing the IOL, and optionally includes a syringe. The IOL package or syringe package is characterized in that the package airtightly seals the internal space, which is a sterile air environment containing vapor; in other words, the sterile air environment contains humid air. This IOL package or syringe package can be referred to as a finished product. The finished product has a sterile, airtight internal space in which the IOL is internally stored, specifically in a humid environment.

[0060] The packaging has a cut edge located outside the sealed internal space, indicating that although the second section of the packaging is crucial for creating the atmospheric environment, it is no longer relevant to the finished product. The cut edge marks the removal of this second section. This invention discloses an artificial lens packaging or syringe packaging, specifically an artificial lens packaging finished product or a syringe packaging finished product, comprising an artificial lens placed inside the packaging. Preferably, the artificial lens is stored in a storage holder or pre-loaded into a loading chamber and / or syringe. The packaging forms a sealed internal space containing the artificial lens and optionally includes a storage holder, a loading chamber, and / or syringe. The packaging defines the internal space containing the artificial lens and may include a storage holder, a loading chamber, and / or syringe. The internal space is isolated from the external environment by a seal, specifically by welding or bonding the packaging materials. Outside the sealed internal space, there is a cut edge or break edge at the welded or bonded edge.

[0061] Preferably, the sterile air environment is saturated with steam. Specifically, the internal environment is steam-saturated, at room temperature (20°C), and at normal pressure (i.e., 1 atm / 1013.25 mbar / 101.325 kPa). Preferably, the temperature range is at least room temperature to 30°C, more preferably room temperature to 40°C, more preferably room temperature to 50°C, more preferably room temperature to 60°C, and even more preferably room temperature to 120°C.

[0062] Packaging materials, specifically containers and lids, excluding window materials, preferably have a vapor permeability of less than 10 g / m³. 2 / 24h, preferably less than 1g / m 2 / 24h, more preferably less than 0.1 / m 2 / 24h.

[0063] The packaging material, specifically the container, preferably has a wall thickness of more than 0.4 mm, more preferably 0.6 mm, and more preferably more than 0.8 mm. This material may be plastic.

[0064] Packaging materials, specifically containers, with a stable shape. This material may be plastic.

[0065] Packaging materials, specifically containers, may be made of plastic, such as polypropylene (PP), polyethylene terephthalate (PET), or a combination thereof.

[0066] Preferably, the artificial lens or syringe is packaged in a single unit.

[0067] Alternatively, the intraocular lens package or syringe package constitutes the innermost package in the packaging assembly. That is, a second sterile package (e.g., a sterile bag) is placed around the aforementioned single package that serves as the main package, so that the outer periphery of the main package also becomes sterile after autoclaving.

[0068] Preferably, a portion of the packaging is designed to accommodate the syringe, and includes one or more clamping arms to secure the syringe, serving as an additional storage location to hold the syringe within the packaging.

[0069] The syringe package contains a single, sterile syringe, ready for single use in ophthalmic surgery.

[0070] The internal space of the syringe package includes an artificial lens, which is preferably inserted into or preloaded into the syringe or the loading chamber of the syringe.

[0071] The intraocular lens is preferably a hydrophilic intraocular lens. The hydrophilic intraocular lens is stored in a syringe in a relaxed state.

[0072] The air environment inside the intraocular lens packaging or syringe packaging can be manufactured as follows: preferably, the sterile air environment is an air environment sterilized by steam and / or ethylene oxide; for hydrophilic intraocular lenses, a steam-sterilized environment is more preferable. Specifically, the sterile air environment inside the packaging or casing is air containing steam (preferably steam-saturated air), achieved by injecting steam at 100°C or higher, more preferably 110°C or higher, more preferably 120°C or higher, and even more preferably 130°C or higher.

[0073] When an intraocular lens package includes a syringe pre-loaded with the intraocular lens, the package can also be called a syringe package.

[0074] This invention also discloses packaging for intraocular lenses. The packaging has an internal space to accommodate an intraocular lens, particularly one pre-loaded into a loading chamber or syringe, optionally with or without a storage holder. Specifically, the packaging has two sections: a first section defining a first internal space for inserting the intraocular lens, optionally with a storage holder, loading chamber, and / or syringe; and a second section defining a second internal space, the second section having a window material that allows the permeation of vapor and other optional sterilizing gases. The two spaces are interconnected by a structure, such as a latch, located in a transition area between the two internal spaces on the packaging. This structure serves as a welded or adhesive seal to hermetically separate the two internal spaces. Where applicable, the packaging may have further features, or combinations thereof, relating to the intraocular lens packaging or syringe packaging. The packaging can be used according to this method.

[0075] The options mentioned in this invention can be used in any combination without being mutually exclusive. Specifically, the invention has indicated preferred categories, and more preferred categories are derived from the values ​​between the minimum and maximum values ​​mentioned in the categories.

[0076] One of the specific advantages of the packaging method disclosed above is that it manufactures a semi-finished product of an artificial lens package according to the packaging steps. Specifically, it is a syringe-packaged semi-finished product, in which an artificial lens is provided and placed in a watertight but not airtight packaging space. Therefore, the package can still be injected with gas to sterilize the contents before being sealed in an airtight environment. The artificial lens packaged semi-finished product or syringe-packaged semi-finished product produced according to the above steps will be further processed into a syringe-packaged finished product.

[0077] The advantages, features, and preferred embodiments of the present invention will be further illustrated by the following detailed description and accompanying drawings. Attached Figure Description

[0078] The following attached diagrams are for illustrative purposes only and may differ in scale from the actual figures:

[0079] Figure 1 This is a top-down, slanted, three-dimensional diagram of a container without a lid;

[0080] Figure 2 It is a slanted three-dimensional schematic diagram showing that the container contains the syringe and the loading chamber after loading is completed;

[0081] Figure 3 yes Figure 1 Side view of the container;

[0082] Figure 4 yes Figure 1 Front view of the container;

[0083] Figure 5 yes Figure 1 Top view of the container;

[0084] Figure 6 This is a top view of the covering membrane (excluding the container);

[0085] Figure 7 This is a top view of the container covered by a covering film, indicating the location of the sealing seam between the container and the covering film, with the covering film sealing the container along its edge;

[0086] Figure 8 yes Figure 7 A top view of the container covered by a covering film, indicating the location of the sealing seam between the container and the covering film, with the covering film along the edge of the container and latched onto the container;

[0087] Figure 9 This is a top view of the container, indicating the expected location of the sealing seam between the container and the covering film;

[0088] Figure 10 It is a top view of the container covered by a covering film, indicating the location of the sealing seam between the container and the covering film. The covering film seals the container along the edge of the container, and the container has a cut edge outside the sealing seam.

[0089] Figure 11 A bag is shown, featuring an area for gas permeation and a seal;

[0090] The invention is further illustrated by the following detailed description and accompanying drawings. Preferred features are not mutually exclusive and can be used in any combination.

[0091] In the following description, the same reference numerals represent the same or functionally identical parts (in different figures). Detailed Implementation

[0092] Figure 1 Container 11 is shown for holding a preloaded syringe. Figure 3 and Figure 4 Each shows a side view of container 11. Figure 5 A top view of container 11 is shown. (As shown) Figure 6As shown, container 11 can be sealed with cap 13. Container 11 and cap 13 constitute a package for holding a syringe 15 preloaded with an artificial lens. Figure 2 The syringe 15 is shown inserted into the container 11. The container 11 is designed to allow for precise insertion of the syringe and preferably to hold it gently at a minimum point so that the syringe will not slip inside the container, even if the container is inverted. The package loaded with the pre-loaded syringe 15 may be referred to as a syringe package or an intraocular lens package.

[0093] The packaging has two parts, a first part 17 and a second part 19. The two parts are defined by the shape of the container 11 and the matching lid 13. With respect to the container, the first part 17 is defined by a first recess 21 of the container 11, and the second part is defined by a second recess 23 of the container 11, the two recesses being separated by a latch 25. Figure 3 In the container, the separation between the first recess 21 and the second recess 23 is clearly visible because the latch 25 separates them. The first recess 21 and the second recess 23 are each separated by portions 27 and 29 of the container's circumferential edge 31, which extend to and define the latch 25. Regarding the lid, the first portion 17 is defined by the lid 13 portion covering the first recess 21, and the second portion 19 is defined by the lid 13 portion covering the second recess 23.

[0094] The packaging material of the first section 17 includes an airtight material, and the packaging material of the second section 19 includes at least a portion of a gas-permeable material, specifically a vapor-permeable material, but preferably a liquid-permeable material. The lid 13 is partially made of a gas-permeable material. The lid 13 has a portion of gas-permeable material on the second section 19, and the remaining portion of the lid 13 is made of an airtight material.

[0095] Container 11 is preferably made of a shape-stable material to support the packaged items and protect them from shock. The container may be formed by deep drawing. The lid 13 has a material that allows gas permeation, and the container 11 is made of an airtight material. The lid 13 may be made of foil material and must be thin enough to allow bending, so that the lid 13 can be easily pulled away from the container 11.

[0096] Figure 1 and Figure 6 In the illustrated embodiment, preferably, container 11 generally comprises plastic and / or aluminum metal with minimal gas permeability. The container material should minimize gas exchange between the internal and external environments of the packaging; specifically, gas exchange of air and vapor should not be permitted. When using plastic as the packaging material, polypropylene can be used. Preferably, the thickness or wall thickness of the polypropylene packaging material is >0.4 mm, more preferably >0.6 mm, and even more preferably >0.8 mm.

[0097] The lid 13 is mostly made of an airtight material, such as airtight plastic and / or airtight aluminum, especially airtight plastic and / or airtight aluminum foil. However, the lid 13 is provided with a window 33, through which the material allows gas permeation, specifically air and vapor permeation. The window 33 of the lid 13 is located in the second portion 19 of the packaging, preferably on the covering surface of the second portion of the packaging, that is, at the location where the lid 13 covers the second recess 23. This area allowing gas permeation can also be located within or added to the container portion of the second portion 19.

[0098] The latch 25 of the container 11 separates the first groove 21 and the second groove 23 to form a plane that is on the same plane as the circumferential edge 31 of the container 11.

[0099] The coplanarity of the latch 25 and the circumferential edge 31 is suitable for welding or bonding to the lid 13. Specifically, the materials of the container 11 and the lid 13 are preferably selected to be suitable for welding.

[0100] Within the second section 19, one or more protrusions 35 are provided, protruding beyond the plane defined by the circumferential edge 31 of the container 11 and the latch 25. The protrusions 35 should at least protrude from and be located on the nearby latch 25 (or, with the circumferential edge 31 as a reference plane, the protrusions 35 should be higher than the latch 25). If the lid is attached, welded to, or glued to the circumferential edge 31, the protrusions 35 allow the passage between the first and second sections to remain unobstructed between the latch 25 and the lid, facilitating free gas exchange between the first and second sections. The protrusions 35 may, but not necessarily, protrude from the second recess 23, but this facilitates gas exchange. The protrusions 35 may be cylindrical or truncated cones; preferably, at least two or three protrusions 35 are provided, arranged in parallel. The protrusions 35 define a common protrusion height and / or protrude from the same plane. More preferably, the interval between any two adjacent protrusions along the shortest connecting line is no greater than their width, so that the lid 13 will not sag onto the latch 25 due to its own action or gravity. The cover is designed as a covering film, preferably elastically and / or loosely placed on the circumferential edge, so that even with the protrusion 35, the cover 13 can be subsequently pressed onto the latch 25, the cover 13 can be fastened to the latch 25 or sealed together.

[0101] After illustrating container 11 and lid 13 separately, the following will be based on... Figure 7 and Figure 8 This section describes the combined version of both. Components use the same reference numerals as described above. Unless necessary, components do not need to be described again; existing, unchanged reference numerals are sufficient to identify them.

[0102] Figure 7The top view shows container 11 covered by lid 13. Marking 37 indicates the sealing seam 37 between container 11 and lid 13, with container 11 continuously sealed to lid 13 along its circumferential edge. The packaging has two sections: a first section 17 defining a first internal space for storing an artificial lens, optionally equipped with a storage holder, loading chamber, and / or syringe; and a second section 19 defining a second internal space with a window 33 made to allow vapor permeation of the material. Since no weld seam is marked on latch 25 (… Figure 7 (Not indicated in the text) The two internal spaces are connected to each other. The first internal space approximately corresponds to the first recess 21, and the second internal space approximately corresponds to the second recess 23. The two internal spaces actually extend to the cover, while the first recess 21 and the second recess 23 theoretically only extend to the seam. Therefore, the capacity of the two internal spaces is slightly larger than that of the opposing recesses because the protrusion 35 raises the cover 13 above the latch 25, or above the circumference and the coplanar plane of the latch. The latch 25 is located in the transition area between the two recesses for a second welding to separate the two internal spaces in an airtight manner.

[0103] The overall design of the packaging is as follows: the first section 17 is made of an airtight material and contains an artificial lens (optionally with a storage holder, loading chamber, and / or syringe). The first section 17 can be sealed relative to the second section 19. The second section is watertight but not airtight (i.e., allows gas and vapor permeation). Therefore, the contents of the packaging (i.e., the artificial lens, or an artificial lens with a storage holder, loading chamber, and / or syringe) can be sterilized by gas, specifically by steam. In this embodiment, the packaging can be referred to as a semi-finished artificial lens packaging, or if the artificial lens is pre-loaded into a syringe, it can be referred to as a semi-finished syringe packaging, or it can be referred to as an artificial lens packaging or syringe packaging that can be sterilized by gas or steam. The semi-finished product is characterized by: the packaging being divided into a first section 17 and a second section 19, the two sections forming a shared capacity space; the first section 17 is made of an airtight material and contains an artificial lens or a syringe pre-loaded with an artificial lens; the second section 19 can be made of the same material, but at least a portion of the material allows air permeation, such as a material that allows vapor permeation. This vapor-permeable portion is indicated by window 33. Because of the permeable window 33, the packaging or its internal space can be steam sterilized while sealed, or optionally sterilized with other gases by allowing steam and / or other suitable gases to flow into the permeable window before or during sterilization. Sterilization can be carried out in an autoclave, where the composition, pressure, and / or temperature of the air are preferably preset and, if desired, controllable. The packaging is watertight (preventing water penetration), therefore it can be sterilized with ethylene oxide gas.

[0104] The second portion 19 preferably constitutes the end region of the package. In this case, the end region can be understood as the second portion 19 or its internal space being easily separated or removed from the first portion 17 or its internal space by clamping or cutting (e.g., during the second sealing process). For example, if the first and second portions of the package form an elongated shape, the second portion 19 should be located at one end of the elongated shape, such as... Figure 1 , Figure 3 , Figures 5 to 9 The illustrated embodiment. As shown, the two ends of the elongated package, and thus the two sections, can be separated vertically along the longitudinal direction by clamping or cutting.

[0105] Except for the window 33 on the cover 13 that allows steam or other gases to permeate, the cover 13 may be made of aluminum, specifically aluminum foil. The window 33 that allows steam or other gases to permeate may be made of non-woven fabric such as high-density polyethylene (PE-HD) (e.g., It can be made of common steam-pressed paper. Container 11 can be made of low-cost plastic, preferably with low vapor permeability, such as polypropylene or plastic with an ethylene-vinyl alcohol copolymer (EVOH) coating, specifically a plastic with an extruded ethylene-vinyl alcohol copolymer layer in the middle.

[0106] Figure 8 The top view shows the container 11 with the lid 13 on. As previously described, the package has two sections: a first section 17, defining a first internal space for storing an artificial lens, optionally with a storage holder, loading chamber, and / or syringe; and a second section 19, defining a second internal space. Figure 8 and Figure 7 In comparison, both have sealing seams 37 along their edges. Figure 8 A mark 39 is provided between the container 11 and the lid 13, which is an additional sealing seam on the latch 25. In other words, according to Figure 7 The packaging is designed as a continuous internal space, with a first internal space of a first section 17 and a second internal space of a second section 19; according to Figure 8 The packaging includes an additional sealing seam (see reference 39) spanning two locations: a first location 41 and a second location 43 of the circumferential sealing seam (see reference 37). This additional sealing seam separates (or divides) the first interior space from the second interior space, isolating the first interior space from the external environment and the second interior space in an airtight or vapor-impermeable manner. The additional sealing seam (see reference 39) extends from the first location 41 of the circumferential sealing seam (see reference 37), along the latch 25, to the second location 43 of the circumferential sealing seam. Figure 8An additional sealing seam, marked 39, separates the two internal space areas. The latch 25 and cap 13 of container 11 are sealed, either by heat welding or adhesive bonding. The first section 17 of the package, sealed along latch 25, is an airtight package for an intraocular lens or syringe. The second section 19 of the package is no longer functional and can be removed if necessary, for example, by cutting it off with a cutting tool and then discarding it. The airtight package for an intraocular lens or syringe is the final product or finished product.

[0107] Figure 10 This illustrates the finished product of the artificial lens packaging or syringe packaging. The packaging has a cut edge 45 outside its hermetically sealed internal space, which includes a first recess 21; in other words, the cut edge 45 is located outside the first portion 17 of the packaging. The cut edge is formed when the second portion 19, or most of the second portion 19, is separated from the first portion 17, specifically by separating the second portion 19 including the vent window 33. The cut edge 45 is along or near, or on, a weld line or adhesive line of an additional sealing seam 39 on the latch 25, which is located between the cut edge 45 and the finished sealed internal space, i.e., also on the latch 25. Specifically, the cut edge 45 extends and passes through the original container 11 and the original cap 13 attached to the original container, with the remaining container portion and the remaining cap portion 13' being shorter than the original container and cap shapes.

[0108] The syringe package includes a syringe 15 with an artificial lens and a package containing the syringe and the artificial lens. The airtight or vapor-impermeable package forms a sealed airtight or vapor-impermeable shell that defines an internal space containing the syringe 15 and the artificial lens. The sealed internal space contains vapor and sterile air.

[0109] Figures 1 to 9 An embodiment of syringe packaging is shown, comprising at least one impermeable packaging for vapor or gas, which is a covered container (impermeable container for vapor or gas, and a lid), the container having at least one recess and a support structure for securing or holding the syringe, the lid covering the recess containing the syringe. In the syringe packaging, the syringe is airtightly isolated from the environment.

[0110] In another simplified embodiment, such as Figure 11As shown, the packaging for artificial crystals stored in a humid environment can be designed as a bag 51 with a window 53 that allows steam or gas to permeate, while the rest of the material is not allowed to permeate with steam or gas. The bag 51 is designed with a relatively flat structure and has an opening 65 on the side. The window 53, which allows steam or gas to permeate, is located near the opening 65, i.e., close to the side of the bag, thus forming a first portion 57 that does not allow steam or gas to permeate, and a second portion 59 that allows steam or gas to permeate. The bag 51 has two seals, a first seal 60 and a second seal 61, for sealing the bag. The surface of the seals may have a sealable or adhesive material to bond the opposing surfaces of the bag, thereby isolating the internal space of the bag from the outside in an airtight manner. Preferably, the first seal 60 is positioned along the opening 65. The second seal 61 is further away from the first seal 60 and also further away from the opening 65 than the first seal 60. Both seals extend in a straight line from one side of the bag to the other side, parallel to the opening 65. Therefore, the first seal 60 and the second seal 61 are parallel. A window 53 allowing steam or gas to permeate is located between the two seals. At least the second seal 61 is located in the material portion that does not allow steam or gas to permeate. The bag 51 or its internal space is isolated from the outside by the first seal 60. The contents of the bag sealed in this way can be sterilized by introducing hot steam through the window. The second seal 61 makes the first portion 57, which does not allow steam or gas to permeate, an airtight space, separate from the second portion 59, which has a window 53 allowing steam or gas to permeate. The contents of the bag are pushed into the first portion 57 before the second seal is applied to the first portion 57 and the second portion 59. The bag is designed to allow an intraocular lens (preferably supported by a storage holder or preloaded into a syringe / loading chamber) to be inserted into the bag. The size of the bag 51 as a whole and the first portion 57 is at least large enough to accommodate an intraocular lens with a storage holder or preloaded into a loading chamber and / or syringe, without obstructing the isolation of the first portion 57 and the second portion 59 by the seal. Furthermore, the bag is provided with flaps 63, allowing it to be opened after being sealed at the second seal 61. A seam or tear 67 provided for this purpose can be torn open when the flaps 63 are pulled up.

[0111] and Figure 11 The elastic bag 51 shown is different. Figures 1 to 10A shape-stable container 11 is shown, further protecting the contents from physical impacts and, in principle, superior to elastic bags. However, during the development of shape-stable containers, it was learned that while they are sturdy and allow for smooth gas exchange during sterilization, they cannot be separated and sealed from the permeable portion as easily as elastic bags after sterilization. The embodiments disclosed in this invention solve this problem by providing a shape-stable container using a dual-chamber system, where the two sealing surfaces of the two chambers are on the same plane, allowing gas to flow freely from one chamber to the other during sterilization (i.e., before the two chambers are sealed relative to each other). Specifically, if the lid is elastically designed with greater elasticity than the container, gas can flow between the two chambers.

[0112] To produce a package that is sterile and airtight, containing an artificial lens, specifically an airtight artificial lens package or syringe package sterilized by gas and / or steam, the method includes the following steps:

[0113] - Insert an artificial lens (optionally equipped with a storage seat, loading chamber and / or syringe 15) into the internal space of the package, wherein the first portion 17 of the package includes an airtight first package material, and the second portion 19 of the package includes a second package material that allows the permeation of steam and other optional sterilizing gases.

[0114] - The packaging is sealed for the first time, enclosing the artificial lens within the internal space of the packaging. Part of this internal space is defined or divided relative to the external environment by the first section 17, and another part is defined or divided by the second section 19. The packaging does not allow the passage of liquids or solids.

[0115] - After the packaging is first sealed, the internal space is sterilized by exposing the packaging to steam or alternatively other sterilizing gases, allowing the steam or alternative sterilizing gases to penetrate into the internal space of the packaging through the second section 19.

[0116] - The second sealing seals at least part of the first section 17 containing the syringe 15, thereby separating the first section 17 from the second section 19, so that the syringe 15 is completely packaged in the airtight packaging material. The second sealing creates an internal space smaller than the first sealing.

[0117] Preferably, even after the second sealing, the reduced internal space still contains a significant amount of moisture, which enters the internal space as steam during sterilization. Specifically, the weight of moisture inside the packaging (including gaseous water and condensed water) increases after the second sealing compared to after the first sealing and before sterilization.

[0118] After the initial sealing, the packaging is exposed to a specific humidity environment for disinfection for a period of time, allowing moisture to enter the internal space of the packaging through the second section 19, thus increasing the humidity inside. Furthermore, it is preferable that the disinfection temperature is higher than room temperature. Preferably, disinfection is carried out in an autoclave. Therefore, the packaging is placed in the processing chamber of the autoclave, where the relative humidity is at least 90%, or more preferably, a steam-saturated environment. Simultaneously, the temperature of the autoclave processing chamber is 100°C or higher, preferably 110°C or higher, or more preferably 120°C or higher. Disinfection can be carried out under the above conditions (air composition, humidity saturation, and temperature) for a maximum of 30 minutes, preferably a maximum of 25 minutes, or more preferably a maximum of 20 minutes.

[0119] Preferably, the intraocular lens is pre-loaded in the syringe. The syringe pre-loaded with the intraocular lens is inserted into the packaging. In the above embodiments, the intraocular lens, its storage holder, loading chamber, and / or syringe are placed and sealed in the packaging through a first or second sealing.

[0120] At least a portion of the second section 19 includes a material that allows the permeation of steam or other optional sterilizing gases, but not moisture. In practical applications, nonwoven high-density polyethylene (PE-HD) or autoclaved paper is used.

[0121] The packaging, specifically the packaging of a semi-finished product, is designed such that, after sterilization, the first section 17 can be separated from the second section 19 by a sealing method (e.g., pressing), so that the first section 17, containing an artificial lens or a pre-loaded artificial lens syringe, can be completely sealed within an airtight material. This second sealing is achieved by welding or gluing the cap to the latch 25.

[0122] The gas injected into the first section 17 during disinfection, or the gas contained in the first section 17 after disinfection, specifically steam, can be sealed in the first section 17 by sealing the latch 25 as soon as possible.

[0123] After the second sealing, the portion of the packaging containing the second section 19 is no longer functional and can be removed, for example, cut off and discarded. Regardless of whether the second section 19 is removed after the second sealing, the aforementioned steps have created an artificial lens package, providing a sterile artificial lens packaged in an airtight environment. Preferably, the artificial lens is pre-loaded into a syringe, providing a syringe package including a sterile syringe pre-loaded with the artificial lens. Due to the introduction of moisture during sterilization, the internal environment of the package has high humidity. Preferably, (under equilibrium conditions) it is a vapor-saturated environment.

[0124] The sterile air environment inside the syringe packaging mainly consists of humid air.

[0125] The sterile air environment inside the syringe packaging is saturated with vapor, specifically preventing the artificial lens from drying out. The internal space of the syringe packaging is sufficiently moist (or contains water molecules) to ensure saturated vapor at room temperature (specifically 20°C) and normal atmospheric pressure (i.e., 1 atm / 1013.25 mbar / 101.325 kPa). Preferably, the internal space of the syringe packaging is sufficiently moist to ensure saturated vapor in the gaseous environment at normal atmospheric pressure, with a temperature at least room temperature to 30°C, preferably room temperature to 40°C, more preferably room temperature to 50°C, and even more preferably room temperature to 60°C.

[0126] The vapor permeability of the syringe packaging material is less than 10 g / m³. 2 / 24h (can be polyethylene terephthalate (PET) or polypropylene (PP)), preferably less than 1.g / m 2 / 24h, more preferably less than 0.1g / m 2 / 24h (aluminum foil may be used). Maximum vapor permeability not exceeding 0.5g / m³ 2 / 24h, preferably 0.05g / m 2 / 24h or more preferably 0.005g / m 2 Materials or packaging that are nearly airtight or do not allow vapor permeation and are kept for 24 hours.

[0127] The syringe is packaged as a single unit. Alternatively, an airtight or vapor-impermeable package may also constitute the innermost layer of the packaging assembly. Specifically, the syringe package does not have any additional autoclaved outer cover. The internal space of the syringe package contains a single syringe. The syringe contains an intraocular lens, preferably pre-loaded into the syringe or syringe loading chamber.

[0128] Hydrophilic intraocular lenses are preferred because they are beneficial when stored in a controlled humidity environment. However, hydrophobic intraocular lenses containing slightly more water must also be stored in a controlled humidity environment to prevent them from drying out. Properly controlling the humidity conditions of intraocular lens packaging can extend the product's shelf life and improve its safety.

[0129] The intraocular lens is preferably housed within a syringe, allowing for a relaxed state and extending the lifespan of the syringe packaging or the intraocular lens itself.

[0130] The sterile air environment inside the syringe packaging is a steam-sterilized sterile air environment. A sterile air environment combining steam and ethylene oxide is also acceptable. For hydrophilic intraocular lenses, a steam-sterilized sterile air environment is preferred.

[0131] The specific embodiments disclosed in this invention can be combined in different ways, provided that the embodiments are not mutually exclusive.

[0132] The specific embodiments disclosed in this invention can be modified, adjusted, changed, and combined in various ways without departing from the scope of protection of this invention.

[0133] List of reference numerals

[0134] 11 containers

[0135] 13. Lid, specifically a covering film.

[0136] 15 syringes

[0137] 17. First Division (Defining the First Internal Space)

[0138] 19. Second Division (Defining the Second Internal Space)

[0139] 21 First Groove

[0140] 23 Second Groove

[0141] 25 latches

[0142] 27 The circumferential edge of the container in the first section

[0143] 29 The circumferential edge of the container in the second section

[0144] 31. Container circumference edge (parts 27 and 29 of the container circumference edge)

[0145] 33 Gas Permeation Zone (Window)

[0146] 35 bulges

[0147] 37. Seam sealing on the circumferential edge

[0148] 39. Additional sealing seams on the latch

[0149] 41. The first position of the sealing seam

[0150] 43. Second position of sealing seam

[0151] 45 Cutting edge

[0152] 51 bags

[0153] 53 Gas Permeation Zone (Window)

[0154] 57 First Division (Defining the First Internal Space)

[0155] 59 Second Division (Defining the Second Internal Space)

[0156] 60 First Seal

[0157] 61 Second Seal

[0158] 63 Removable bag petals

[0159] 65 Bag opening

[0160] 67. Seams or tears

Claims

1. Method for providing an intraocular lens in a sterile and gas-tight manner in a package, in particular a package comprising inside said intraocular lens, a loading chamber preloaded with said intraocular lens or a syringe (15) preloaded with said intraocular lens; said method comprising the steps of: - inserting said intraocular lens into the inner space of the package, the package comprising inside a first portion (17) delimiting a first inner space for housing the intraocular lens therein comprising a gas-tight first packaging material and a second portion (19) delimiting a second inner space comprising a second packaging material permeable to gases, such as steam and other sterilizing gases, but not permeable to liquid water; - first closing of the package, sealing said intraocular lens inside the inner space of the package, the inner space being delimited in part by the first portion (17) and in part by the second portion (19); - sterilizing the inner space of the package closed for the first time, i.e. exposing the package closed for the first time to steam or a mixture of steam and other sterilizing gases, so that the mixture of steam and other sterilizing gases penetrates into the inner space of the package through the second portion (19) for sterilizing purposes; - second closing of the package, sealing the first portion (17) housing said intraocular lens therein with respect to the second portion (19), so that the first inner space and the second inner space are separated in a gas-tight manner, so that said intraocular lens and the water present in the package in the form of steam during sterilization are enclosed in the gas-tight first packaging material.

2. The method of claim 1, wherein: After sterilization and before the second closing of the package, the package is subjected to cooling, so that the steam condenses in the package in the form of liquid water, so that the liquid water cannot exit the package.

3. The method of claim 1, wherein: After the second closing of the package, the second portion (19) is also removed and discarded.

4. The method of claim 1, wherein: During sterilization, the package is exposed to an environment having a relative humidity of at least 90% and a temperature of 100°C or more.

5. The method of claim 4, wherein: The environment is saturated with steam.

6. The method according to claim 4, wherein: - the temperature of the environment is comprised between 100°C and 130°C and the sterilization time is at most 30 minutes, or - the temperature of the environment is comprised between 130°C and 140°C and the sterilization time is at most 15 minutes.

7. The method of claim 1, wherein: Sterilization is carried out in an autoclave.

8. The method of claim 1, wherein: The intraocular lens is preloaded into the loading chamber or into the syringe or is inserted into another housing seat, so that the intraocular lens and the loading chamber, the syringe or the housing seat are sealed inside the package by the first closing.

9. The method of claim 1, wherein: The second portion (19) constitutes the terminal region of the package.

10. The method of claim 1, wherein: The second packaging material permeable to steam and to other optional sterilizing gases, but not permeable to liquid water, is made of high-density polyethylene (PE-HD) or is autoclave paper.

11. The method of claim 1, wherein: The inner space comprises a single intraocular lens or a single syringe or a loading chamber preloaded with said intraocular lens.

12. The method of claim 1, wherein: The intraocular lens is preloaded into the syringe, the lens of said intraocular lens being loaded into the syringe in a relaxed state.

13. The method of claim 1, wherein: The other sterilizing gas is ethylene oxide gas.

14. The method of claim 1, wherein: The transition between the first inner space and the second inner space forms a structure for sealing, which separates the first inner space and the second inner space in a gas-tight manner.

15. The method of claim 1, wherein: The package is composed of a container (11) having a circumferential edge and a lid (13) which closes the container (11) against the circumferential edge, the container being provided with at least one first recess (21) which delimits a first inner space and with at least one second recess (23) which delimits a second inner space, a window (33) made of a material permeable to gases or vapours being provided in the area of the lid (13) which covers the second inner space.

16. The method of claim 14, wherein: The structure is provided with a surface which can be sealed against the lid to achieve a second closure of the package, the structure lying in the same plane as the circumferential edge of the container.

17. The method of claim 16, wherein: A projection (35) is provided in the area of the structure, which projects beyond the structure and raises the lid above the plane of the structure and the circumferential edge of the container, so that the passage between the first part (17) and the second part (19) remains free for the exchange of gases in the area between the structure and the lid during sterilisation.

18. The method of claim 15, wherein: The container (11) and the lid (13) have a moisture vapor transmission rate of less than 10 g / m 2 / 24h, preferably less than 1 g / m 2 / 24h, more preferably less than 0.1 g / m 2 / 24h.

19. The method of claim 15, wherein: The container (11) has a wall thickness of more than 0.4 mm or more than 0.6 mm or more than 0.8 mm.

20. The method of claim 15, wherein: The container (11) comprises plastic.

21. The method of claim 15, wherein: The container (11) comprises polypropylene (PP), polyethylene terephthalate (PET) or a combination thereof.

22. The method of claim 15, wherein: The lid (13) comprises a foil material, such as aluminium foil.

23. The method of claim 15, wherein: The material of which the window (33) is made comprises non-woven high-density polyethylene or steamed paper.

24. The method of claim 1, wherein: The first closure of the package and the second closure of the package are achieved by welding or adhesion.

25. A package for an injector and an intraocular lens, preferably an injector preloaded with an intraocular lens, comprising a package shell for enclosing the injector and the intraocular lens or the injector preloaded with the intraocular lens, the package forming a sealed inner space which contains the injector and the intraocular lens or the injector preloaded with the intraocular lens, produced in accordance with the method according to claim 2, characterised in that: - the package shell seals the inner space so that it is a gas-tight space, and - the inner space is accessible to steam or a mixture of steam and other sterilising gases and to liquid water during sterilisation, so that the inner space has an environment which contains steam or a mixture of steam and other sterilising gases and liquid water.

26. The syringe package of claim 25, wherein: The environment in the sterilised inner space is saturated with steam.

27. The syringe package of claim 26, wherein: The sterilised inner space is saturated with steam at room temperature and normal pressure, the temperature range being at least room temperature to 30°C.

28. The package of the pre-loaded intraocular lens injector for use in the method of claim 1, wherein, The package forms an inner space for accommodating an injector preloaded with an intraocular lens, with or without a carrier, in the loading chamber of the injector, characterised in that: - the package has two parts, a first part (17) which delimits a first inner space for accommodating an injector preloaded with an intraocular lens and a second part (19) which delimits a second inner space which is provided with a window (33) made of a material which is permeable to steam but not to liquid water, the first inner space and the second inner space being connected to one another with a transition zone which forms a structure which is sealed by welding or adhesion and which gas-tightly separates the first inner space and the second inner space, and - the package shell seals the inner space so that it is a gas-tight space, and - the inner space is accessible to steam or a mixture of steam and other sterilising gases and to liquid water during sterilisation, so that the inner space has an environment which contains steam or a mixture of steam and other sterilising gases and liquid water. The package consists of a container (11) having a circumferential edge and a lid (13) which closes the container (11) against the circumferential edge, the container being provided with at least one first recess (21) delimiting the first inner space and with at least one second recess (23) delimiting the second inner space, the window (33) being provided in the area of the lid (13) covering the second inner space.

29. The package of claim 28, wherein: The structure has a surface which is sealed against the lid (13); the structure is in the same plane as the circumferential edge of the container (11).

30. A semi-finished product for a package for an injector and an intraocular lens, preferably the injector being pre-loaded with the intraocular lens; the package defining a sealed inner space in which the pre-loaded injector and intraocular lens are stored; characterized in that: The package has two sections, including a first section (17) delimiting a first inner space in which the injector pre-loaded with the intraocular lens is stored; and a second section (19) delimiting a second inner space, the second section (19) being provided with a window (33) which is permeable to the passage of vapour but not to the passage of liquid water; the first inner space and the second inner space being connected to one another by a transition zone forming a structure which is sealed by welding or by adhesion, the first inner space and the second inner space being separated from one another in a gas-tight manner; The package consists of a container (11) having a circumferential edge corresponding to the lid (13) and a lid (13) which closes the container (11) against the circumferential edge, the container (11) being provided with at least one first recess (21) delimiting the first inner space and with at least one second recess (23) delimiting the second inner space, the window (33) being provided in the area of the lid (13) covering the second inner space.

31. The syringe package semi-finish of claim 30, wherein: The structure has a surface which is sealed against the lid (13) by welding or by adhesion; the structure is in the same plane as the circumferential edge of the container (11).

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