Packaging method for transporting and storing intraocular lenses

Abstract

The present invention relates in particular to a method for producing a package for storing an intraocular lens in a sterile and airtight state, such as a loading chamber provided with a preloaded intraocular lens or a syringe (15) containing a preloaded intraocular lens, hereinafter referred to as an intraocular lens package or syringe package, comprising the following steps: - inserting the syringe (15) into the interior space of the package, wherein a first subsection (17) of the package comprises an airtight first packaging material, and a second subsection (19) comprises a second packaging material, allowing the passage of a gas or a gas mixture, such as steam, and optionally other sterilizing gases, - the first sealing of the package, so that the syringe ( 15) is stored in the interior space of the package, the interior space being partially delimited by the first subsection (17) and partially by the second subsection (19), the interior space of the package sealed by the first seal being sterilized by exposing it to a gas or a gas mixture, such as steam and / or other sterilizing gas, which can penetrate into the interior space of the package through the second subsection, the second seal of the package being sealed to seal at least a portion of the first subsection (17) in which the syringe (15) is stored, separating it from the interior space of the second subsection (19), and the intraocular lens being completely packaged in the airtight first packaging material. The invention further illustrates and describes an intraocular lens package or a syringe package product after completing the above steps, specifically an intraocular lens package semi-finished product or a syringe package semi-finished product, and an intraocular lens package finished product or a syringe package finished product, both of which are produced and / or further processed using the above method, and also discloses a package used according to the method.

Description

Technical Field

[0001] The present invention relates to a method for manufacturing a package for storing a sterile and airtight intraocular lens, more specifically, an intraocular lens preloaded into a syringe. Furthermore, the present invention relates to intraocular lens packaging, and more specifically, to a syringe packaging containing a sterile intraocular lens, manufactured using the above method. The present invention also relates to a semi-finished intraocular lens packaging or syringe packaging. Background Art

[0002] Traditionally, hydrophilic and some hydrophobic IOLs are stored in a humid environment to maintain sufficient moisture and elasticity before the IOL is injected into the eye. The IOL must remain elastic so that it can be folded and injected into the eye.

[0003] When medical or surgical instruments are prepared for storage, they are usually sterilized and packaged in sterilizable materials. Sterilizing gases such as ethylene oxide or steam are injected at controlled temperature and pressure (if necessary). Steam sterilization is carried out in an autoclave, with common parameters being 121°C / 20 minutes or 134°C / minute. It is important to ensure that the packaging has good steam permeability. The gas or steam injected during the sterilization process will leave the packaging after sterilization. Therefore, gas sterilization is not suitable for packaging and storing intraocular lenses that require a humid environment, because the packaging material allows gas or steam to pass through, which means that it cannot permanently block the ingress and egress of moisture, and thus cannot ensure a humid storage environment.

[0004] Materials stored in humid environments are typically sterilized in liquid-filled packaging sealed watertight and airtight. These materials can still be sterilized in an autoclave using steam, but the sterilization process is different. Steam cannot penetrate the packaging, so heat exchange is used to transfer heat from the packaging material to the liquid within. During a series of validation steps, personnel must determine when the liquid reaches the sterilization temperature, and only then does the sterilization process begin. This sterilization method requires a limited overpressure to prevent the liquid within the package from boiling even at the sterilization temperature. The package is filled as full as possible with liquid to minimize trapped air. This trapped air expands significantly when heated, exerting significant pressure on the package interior, enough to burst the seam of the package's sealing lid. Generally speaking, the more air, the greater the pressure within the package. However, the strength of the seam cannot be increased arbitrarily, as it is the user's responsibility to open the package, and the back pressure in the autoclave cannot be increased arbitrarily, as this would deform the package and even the product itself. Therefore, when using heat exchange autoclave sterilization, a large amount of water and very little air are required within the package. WO2015061401 discloses a packaging method for a foldable hydrophilic intraocular lens. The method includes storing the foldable intraocular lens in an airtight container with a water reservoir that is not in direct contact with the intraocular lens. The intraocular lens can also be stored, unfolded, in a syringe. Both the syringe and the intraocular lens are stored in the airtight container, which has a water reservoir that is not in direct contact with the intraocular lens.

[0005] WO2015183432 also discloses a similar method for maintaining a hydrophilic intraocular lens in a folded state without immersing it in liquid. The method includes storing a foldable lens in an airtight container containing free water. The intraocular lens is placed in the container in a position that does not allow the intraocular lens to be immersed in liquid. This patent further discloses a combination, including an airtight container containing free water, and a foldable hydrophilic intraocular lens stored in the container in a position that does not allow the intraocular lens to be immersed in liquid. The packaging method for achieving the above conditions includes the following steps: a) inserting a syringe containing the intraocular lens into a storage seat, b) placing the storage seat in the container, c) before closing the container, adding an appropriate amount of free water into the container (by dripping or spraying), and d) sealing the container.

[0006] According to WO2016061401, the sealed capsule contains approximately 5ml to 20ml of water, while according to WO2015183432, the amount is 0.5ml to 3ml. The patent further states that the airtight container containing the intraocular lens can be autoclaved, meaning it can withstand heating to 121°C or above for half an hour or more.

[0007] While the aforementioned information mentions autoclaving as a method for sterilization, whether it can achieve the sterility required 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 relative to the packaging volume, and then is heated. As previously mentioned, to heat the water within the airtight container, heat must be transferred from the packaging material into the package. When the volume of air within the container is significantly greater than the volume of water, heating the air and liquid to sterilization temperature takes a relatively long time. Furthermore, because the heated air expands, the internal pressure is very high, requiring the autoclave to operate with extremely high back pressure or the packaging to be extremely sturdy. The packaging is typically opened by pulling off the covering film, but if the packaging is designed to be sturdy, this method is almost impossible to reuse, resulting in inconvenience for the user. Furthermore, it is necessary to determine when the water within the sealed package has converted to steam and reached the desired sterilization temperature. This makes this method cumbersome and expensive for manufacturers. Specifically, it is difficult to ensure effective disinfection, and thus difficult to ensure that the packaged intraocular lenses are sterile. In addition, it is uncertain whether the disinfection process actually occurs or whether it is sufficiently disinfected. In medical applications, especially for packaging materials implanted in the human body, this risk is unacceptable. Therefore, the packaging and sterilization methods proposed in WO2015061401 and WO2015183432 heat a large amount of air in an airtight container with very little water, which is not suitable for application to intraocular lenses. A safe and cost-effective disinfection method is needed to improve product quality and safety.

[0008] FR2820118A1 discloses a sterilization package comprising 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 gas sterilization of the contents. A removable seal separates the first chamber from the sterile second chamber, allowing the materials to be transferred from the first chamber to the second chamber for storage after sterilization. The two chambers are initially separated by a seal. The completely sealed package is then sterilized with gamma radiation to create a sterile environment in both chambers. The first chamber with the perforated walls is then opened, and the materials to be sterilized are placed into the first chamber. The first chamber is then sealed, and the first chamber and its contents are sterilized by autoclave. Once completed, the seal between the two chambers is opened, and the sterilized materials are transferred from the first chamber to the second chamber. A new seal is then formed between the two chambers, and the materials are stored in the second chamber. This process is relatively complicated, involving at least two sealing procedures and one unsealing procedure. The two disinfection procedures use different disinfection methods to achieve airtight and sterilized packaging.

[0009] US2007 / 0084144A1 discloses a method for sterilizing and packaging chemically sensitive medical products or devices, such as materials implanted in the human body. The method involves 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 within the bag; sealing the bag along the gas-permeable head so that the impermeable chamber remains in communication with the gas-permeable head; introducing a sterilizing agent from the gas-permeable head into the impermeable chamber to sterilize the medical product or device at a temperature between approximately 20°C and 40°C; then, sealing the medical product or device within the impermeable chamber; optionally removing the head, while the medical product or device remains within the impermeable chamber after packaging and sterilization. According to the patent disclosure, the sterilizing agent may be ethylene oxide gas, steam, gas plasma, vaporized hydrogen peroxide, gamma radiation, or electron beam radiation.

[0010] The solution of US2007 / 0084144A1 involves a simple bag, but the bag cannot provide sufficient protection for the material in the bag from external physical impacts. For example, the bag may be squeezed during storage and transportation.

[0011] Purpose of the Invention

[0012] One of the objects of the present invention is to provide an alternative method for introducing liquid into packaging and sterilizing the packaging of ready-to-use intraocular lenses, in particular syringes and sets of intraocular lenses. The method should be able to achieve the following objectives: after sterilization, a certain amount of liquid remains in 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 volumes. Therefore, the present invention provides a packaged product, specifically a packaged ready-to-use intraocular lens or a packaged ready-to-use syringe and set of intraocular lenses, packaged and sterilized using the above-mentioned alternative method. One of the objects of the present invention is specifically to provide a packaged product in which the intraocular lens can be stored in a sterile and moist environment; another object is to provide a package that protects the intraocular lens from physical impact; another object is to provide a space-saving package that protects the intraocular lens from physical impact. Summary of the Invention

[0013] To achieve the above objectives, the present invention provides an intraocular lens packaging product or a syringe packaging product according to claims 1, 6, 15, and 24; a package according to claim 33; and a method according to claim 16. Claims 1, 6, 15, and 24 relate to semi-finished and / or finished packaged products. The finished product is specifically a sterile package with a controlled internal environment.

[0014] The present invention relates specifically to a method for producing a package containing an intraocular lens in a sterile and airtight state, such as a loading chamber preloaded with an intraocular lens, or a syringe preloaded with an intraocular lens, hereinafter referred to as an intraocular lens package or a syringe package, comprising the following steps:

[0015] - inserting the intraocular lens (optionally with a storage seat, a loading chamber and / or a syringe) into the interior space of the package, wherein the first sub-section of the package comprises a first airtight packaging material, and the second sub-section of the package comprises a second packaging material, which allows the passage of a gas or a mixture of gases, such as at least steam and optionally other sterilization gases,

[0016] - the first sealing of the package, whereby the intraocular lens is enclosed in an interior space of the package, the interior space being defined in part by the first subsection and in part by the second subsection (in other words, the two subsections of the package define the interior space, forming a continuous interior space),

[0017] - sterilization of the package interior after the first seal has been sealed by exposing the package to a gas or gas mixture, such as steam (and other optional sterilizing gases), or other sterilizing gases, which can penetrate into the package interior through the second portion,

[0018] The second seal of the package seals at least a portion of the airtight first subsection storing the intraocular lens, isolating the airtight first subsection from the interior space of the second subsection, and the intraocular lens is completely packaged within the airtight first packaging material. (In other words, the second seal of the package seals at least a first portion of the interior space, which is located in the airtight first subsection storing the intraocular lens, and isolating the first portion of the interior space from the second portion of the interior space, thereby completely packaging the intraocular lens within the airtight first packaging material.)

[0019] In addition, a further step can be selected. After the second sealing, the second portion of the package has completed the function of creating the gas environment and has no effect on the finished product. This portion can be removed.

[0020] This method can be used to control the humidity inside the package after the first seal, for example, when sterilizing the interior space, using a packaging part that allows gas permeability to better control the humidity.

[0021] Preferably, sterilization is performed using high-temperature steam-saturated air, which is allowed to enter the packaging through a gas-permeable portion of the packaging. Alternatively, other sterilizing materials can be added to the air, allowing moisture to accumulate directly in a gaseous (i.e., steam) form, eliminating the need for liquid water. Alternatively, liquid water can be used as a backup to replenish moisture lost during the product's lifespan. Consequently, the final product or finished product intended for sale does not contain excessive amounts of liquid water.

[0022] Sterilization is performed in an autoclave. An autoclave is a hermetically sealed container, preferably a pressure vessel, that processes materials at high temperatures, preferably within the overpressure range. Within the autoclave, the gas composition, temperature, and pressure can be adjusted and / or controlled to achieve the desired sterilization process.

[0023] The true hermetic seal (i.e., the second seal) of an intraocular lens package is only achieved after sterilization. Generally, after sterilization, the package is cooled (preferably still in the autoclave). During cooling, steam may condense inside the package. The material in the second section is permeable to steam and other gases but impermeable to liquid water. Therefore, when the condensed steam becomes liquid water, the water cannot escape the package. In principle, if necessary, the steam can escape or be vented to the outside of the package before the second seal, thereby keeping the liquid water content of the final or finished product low.

[0024] Compared with the pre-sealed packaging space in the aforementioned prior art, the time required for sterilization of this method is significantly shorter.

[0025] Furthermore, this method is fast and efficient, and is not affected by the size of the packaging space. Because the relative humidity of the environment is regulated, the humidity provided to each package is proportional to the package size or capacity, eliminating the need to adjust the water volume based on package size.

[0026] The first seal creates a single, contiguous space that is separated from the external environment by the package, and the package contains at least the two different materials. This internal space contains the material to be processed, such as the intraocular lens itself, or the intraocular lens plus the syringe and / or loading chamber. Preferably, the intraocular lens is preloaded into the syringe's loading chamber, so that the intraocular lens and syringe are placed together in the package. After the second seal, the single, contiguous space is divided into two spaces. The first space containing the material to be processed is preferably several times larger than the second space, specifically at least three times larger. The second space can be removed if necessary.

[0027] After the second sealing, the internal space of the package is reduced and is smaller than the internal space after the first sealing.

[0028] During sterilization, moisture enters the internal space in the form of vapor and is retained within the packaging after the second seal. There's no need to add additional moisture to the packaging to store the finished IOL. The moisture added during sterilization and retained in the packaging after the second seal is sufficient to store the IOL in a humid environment. However, since no material or packaging is 100% waterproof or vapor-proof, adding additional moisture before the first seal is helpful as a backup. This ensures that even over several years, the product maintains adequate humidity despite moisture loss through the packaging material throughout its shelf life.

[0029] Preferably, in the case of sterilization, there is at least one steam sterilization.

[0030] The package that has completed the first seal is exposed to a specific humidity environment for a specific time, which is the actual sterilization cycle time. The humidity can penetrate into the interior space of the package through the second section to increase the humidity of the interior space.

[0031] The actual disinfection cycle duration is the time during which the temperature is within the predetermined range or value.

[0032] Specifically, the package after the first sealing is continuously exposed to an environment with a relative humidity of at least 90%, preferably a steam-saturated environment, at a temperature of 100° C. or above, preferably above 110° C., even more preferably 120° C. or above.

[0033] The sustained period of time refers to when the temperature is between 100° C. and 130° C., specifically 121° C., preferably no more than 30 minutes, more preferably no more than 25 minutes or most preferably about 20 minutes. When the temperature exceeds 130° C., specifically 134° C., the period of time is no more than 15 minutes, more preferably no more than 10 minutes or most preferably 5 minutes.

[0034] Sterilization is performed in an autoclave or in a processing chamber. This method of sterilization is safe and can be performed using commercially available autoclaves and standard sterilization parameters.

[0035] To better protect the IOL, the IOL and its storage receptacle are preferably placed within the packaging, specifically by inserting the IOL into the storage receptacle. Instead of using an arbitrary storage receptacle, a loading chamber is used to preload the IOL. The loading chamber can be designed as a core tube that can be inserted into the syringe or integrated into the syringe.

[0036] The advantages of this method are that the IOL is preloaded into the storage receptacle, specifically inserted into the storage receptacle and / or loading chamber, particularly into the loading chamber and / or syringe, particularly into the syringe, and then inserted into the package. The IOL, storage receptacle, loading chamber, and / or syringe are sealed in a watertight environment via a primary seal, sterilized, and then airtightly sealed within the package via a secondary seal. This method allows IOLs, typically stored in liquid, to be stored in a moisture-saturated atmosphere, preventing them from drying out and becoming damaged.

[0037] In addition to using steam alone, other sterilizing gases may be added, such as ethylene oxide, formaldehyde, ozone, hydrogen peroxide, or a combination of these gases, with ethylene oxide being preferred.

[0038] At least a portion of the second subsection is comprised of a material that is permeable to steam and, optionally, other sterilizing gases, and waterproof. For example, at least a portion of the second subsection is comprised of high-density polyethylene (PE-HD). Preferably, the HDPE is a high-density polyethylene nonwoven fabric bonded by evaporative spinning. Alternatively, other packaging materials commonly used for autoclave sterilization, such as medical autoclaved paper, may be used, as long as they are permeable to steam and, optionally, other sterilizing gases, and waterproof.

[0039] After the second seal, one may choose to remove and discard a portion of the package that includes the second subsection and that is not part of the now reduced interior space.

[0040] Preferably, the second section constitutes an end region of the package and can be easily removed when no longer required.

[0041] The present invention further relates to an intraocular lens package, comprising an intraocular lens contained in the package. Preferably, the intraocular lens is stored in a storage seat, or preloaded into a loading chamber and / or a syringe. The package forms a sealed, specifically airtight, internal space in which the intraocular lens is stored, and optionally is provided with a storage seat, a loading chamber and / or a syringe.

[0042] In addition to the IOL, the IOL package also includes a syringe, with the IOL placed on or within it. This is also referred to as a syringe package. In a first embodiment, the IOL package or syringe package is autoclavable and characterized by having two sections: a first section defining a first internal space, which houses the IOL and may optionally include a storage receptacle, a loading chamber, and / or a syringe; and a second section defining a second internal space, which has a window made of a material permeable to steam and other optional sterilizing gases. The two internal spaces are interconnected, and a transition region in between forms a structure, such as a latch, for welding or gluing to achieve a seal, separating the two internal spaces and maintaining an airtight state after welding. It should be noted that, except for the window material, which is permeable to steam or other sterilizing gases, the remaining packaging material is impermeable to gases or airtight. The first embodiment comprises two sections, forming a contiguous space, functionally representing a semi-finished IOL packaged product that can be autoclaved.

[0043] In the first embodiment, the intraocular lens packaging that can be autoclaved and sterilized is characterized in that the packaging is designed so that the first section in which the intraocular lens (optionally with a storage seat, a loading chamber and / or a syringe) is placed can be sealed and separated from the second section, and after sealing, the first section is airtight and watertight.

[0044] Preferably, at least one of the two sections, preferably the second section, includes one or more structures shaped to maintain interconnected passageways between the first and second sections of the package, allowing for gas exchange between the first and second interior spaces. Specifically, it is necessary to avoid the package from collapsing, which could cause the passageways to close before or during sterilization. The one or more structures are positioned within the package to prevent the package from collapsing inward, ensuring air flow throughout the entire interior space of the package during sterilization. The one or more structures are taller than the latch, preventing the package from collapsing inward (particularly in the absence of external force) and pressuring against the aforementioned structures or the latch.

[0045] According to a second embodiment, the intraocular lens packaging, or syringe packaging, is characterized in that: the packaging has two sections, a first section defining a first internal space for placing the intraocular lens, and optionally having a storage seat, a loading chamber, and / or a syringe; a second section defining a second internal space, the second section having a window, the material of which allows steam and other optional sterilizing gases to penetrate, and the two internal spaces being separated by a sealed seam, specifically by welding or gluing the packaging material. During the production process of the second embodiment, welding is performed after autoclaving. Therefore, the intraocular lens packaging of the second embodiment is functionally an intraocular lens packaging that has been autoclaved (or sterilized) and sealed (or, relative to the first embodiment, a finished intraocular lens packaging product), the intraocular lens being placed in the first section, and the first section being sealed after autoclaving to separate it from the second section.

[0046] In a practical example, according to the first or second embodiment, the intraocular lens package may be a packaging bag, comprising at least a first internal space containing the intraocular lens (or the intraocular lens stored in a storage receptacle, loading chamber, or syringe), and at least a second internal space. A window is formed in a region of the package 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 the intraocular lens stored in the storage receptacle, loading chamber, or syringe), thereby hermetically separating the first internal space from the second internal space and the external environment. This embodiment is hereinafter referred to as a bag design.

[0047] In this bag design, the IOL, or a loading chamber / syringe containing a stored / preloaded IOL, is attached to a storage base for transport within the bag. The storage base ensures that the IOL in the bag is hermetically sealed and separated from the surrounding bag material, with the entire IOL surface in direct contact with the internal environment (without contact with the packaging material and the resulting lack of contact with the internal packaging atmosphere).

[0048] According to the first or second embodiment, in a preferred example, the intraocular lens packaging is characterized in that: the packaging is composed of a container with a lid, the container has a circumferential edge for sealing the lid, the container has at least one first groove defining a first internal space, and at least one second groove defining a second internal space, and the window is provided in the area of ​​the lid covering the second internal space.

[0049] The aforementioned welding position for separating the two inner spaces is located between the latch and the cover.

[0050] In the first section, the lid is airtight and does not allow steam to penetrate, while the second section allows steam to penetrate and optionally allows other sterilizing gases to penetrate.

[0051] Furthermore, the intraocular lens package is characterized in that: the entire package is watertight (ie, does not allow water to penetrate), and the second section allows steam to penetrate but does not allow liquid water to penetrate.

[0052] The intraocular lens packaging is characterized in that a latch is provided within the container, separating the first and second sections (or defining a line separating the first and second sections), preferably coplanar with, or flush with, the circumferential edge of the container. This facilitates simultaneous or subsequent welding of the container and lid along the circumferential edge (and, if necessary, along the latch). In other words, the sealable surfaces on the container edge and on the latch are coplanar. The latch extends from a first location on the circumferential edge of the container to a second location on the circumferential edge of the container, preferably in a straight line. The two locations are specifically spaced apart from each other.

[0053] To ensure that the first and second subdivisions can communicate with each other, a structure is provided within the first and / or second subdivisions, preferably near the latch and at a height relative to the latch or the coplanarity between the latch and the edge. This structure raises the lid, which is fastened or fixed to the circumferential edge of the container, above the latch, specifically above the coplanarity between the latch and the edge. This allows the passage between the first and second subdivisions to remain unobstructed at the location between the latch and the lid, allowing gas exchange between the first and second subdivisions. The raised structure can be implemented as one or more raised structures within the first and / or second subdivisions. The circumferential edge of the container is specifically the periphery of the first and second subdivisions. The lid is a covering film that can be elastically fastened or sealed and / or loosely placed on the circumferential edge so that the latch structure can be subsequently fastened or sealed. The raised structure is located within the package to prevent the package, specifically the lid, from denting.

[0054] One or more raised structures are "preferably located near the latch" if the raised structure is located such that, in an imaginary plane defined by the circumferential edge, the minimum distance between the raised structure and the latch is several times shorter than the minimum distance between the raised structure and the circular edge. The minimum distance between the raised structure and the circular edge is calculated as the minimum distance between an imaginary straight line extending from the circumferential edge and the raised structure.

[0055] In the bag design, the intraocular lens, or the loading chamber or syringe containing the intraocular lens, is placed in the storage seat, which is pushed into the bag, ensuring that gas exchange is possible between the first and second internal spaces. Specifically, if the bag is sealed along the circumferential edge, the storage seat can be slid into the second internal space provided 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, allowing the transition zone between the two internal spaces to remain open during autoclaving. Before sealing, the storage seat containing the intraocular lens can be completely slid back into the first internal space of the packaging bag to separate the two internal spaces.

[0056] The packaging is produced using a film material. Preferably, at least the lid of the packaging is made of aluminum, in particular aluminum foil, while the window of the lid is made of another material, namely a gas-permeable material.

[0057] The present invention further discloses an intraocular lens package or syringe package, comprising an intraocular lens, optionally preloaded into a syringe, and a package for storing the intraocular lens and syringe therein, wherein the package forms a sealed interior space, specifically an airtight sealed interior space, in which the intraocular lens and optionally the syringe are stored. The intraocular lens package or syringe package is characterized in that the package seals the interior space in an airtight manner, and the interior space is a sterile air environment containing steam, in other words, the sterile air environment contains humid air. This intraocular lens package or syringe package can be referred to as a finished product. The finished product has a sterile, airtight interior space in which the intraocular lens is embedded, specifically stored in a humid environment.

[0058] The package has a cutting edge outside the sealed internal space, which means that although the second part of the package is very important for creating an air environment, it has no effect on the finished product, and the cutting edge is used to indicate that the second part has been removed. The present invention discloses an intraocular lens package or a syringe package, specifically an intraocular lens package finished product or a syringe package finished product, including an intraocular lens placed in the package. Preferably, the intraocular lens is stored in a storage seat, or preloaded into a loading chamber and / or a syringe; the package forms a sealed internal space, in which the intraocular lens is stored, and optionally a storage seat, a loading chamber and / or a syringe is attached. The package defines an internal space, in which the intraocular lens is stored, and there may be a storage seat, a loading chamber and / or a syringe. The internal space is isolated from the external environment in a sealed manner, specifically by welding or gluing the packaging material. Outside the sealed internal space, there is a cutting edge or a broken edge at the welded or glued edge.

[0059] 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.

[0060] The packaging material, specifically the container and the lid, excluding the window material, preferably has a vapor permeability of less than 10 g / m 2 / 24h, preferably less than 1g / m 2 / 24h, more preferably less than 0.1 / m 2 / 24h.

[0061] The packaging material, in particular the container, preferably has a wall thickness of more than 0.4 mm, preferably 0.6 mm, more preferably more than 0.8 mm. The material may be plastic.

[0062] The packaging material, specifically the container, has a stable shape and can be made of plastic.

[0063] The packaging material, specifically the container, can be made of plastic, such as polypropylene (PP), polyethylene terephthalate (PET), or a combination thereof.

[0064] Preferably, the intraocular lens package or the syringe package is a single package.

[0065] Alternatively, the intraocular lens packaging or syringe packaging constitutes the innermost packaging in the packaging combination. That is, the second sterile packaging (such as a sterile bag) is placed around the aforementioned single packaging as the main packaging, so that the periphery of the main packaging also becomes sterile after autoclaving.

[0066] Preferably, a portion of the package is designed to receive the syringe and is provided with one or more gripping arms to secure the syringe, providing an additional receptacle to secure the syringe in place within the package.

[0067] The interior of the syringe package contains a single syringe that has been sterilized and is ready for single use in ophthalmic surgery.

[0068] The interior space of the syringe package includes the intraocular lens, which is preferably inserted into or preloaded into the syringe or loading chamber of the syringe.

[0069] The intraocular lens is preferably a hydrophilic intraocular lens. The hydrophilic intraocular lens is stored in the syringe in a relaxed state.

[0070] The air environment within the intraocular lens package or syringe package can be created as follows: Preferably, the sterile air environment is one that has been sterilized with steam and / or ethylene oxide. For hydrophilic intraocular lenses, steam sterilization is preferred. Specifically, the sterile air environment within the package or packaging shell is air containing steam (preferably steam-saturated air) by injecting steam at a temperature of 100°C or higher, more preferably 110°C or higher, more preferably 120°C or higher, and even more preferably 130°C or higher.

[0071] When an IOL package includes a syringe preloaded with the IOL, the package may also be referred to as a syringe package.

[0072] The present invention also discloses a package for an intraocular lens. The package is provided with an internal space for accommodating an intraocular lens, in particular an intraocular lens preloaded into a loading chamber or syringe, optionally with or without a storage seat. Specifically, the package has two parts: a first part, which defines a first internal space, into which the intraocular lens is inserted, and optionally with a storage seat, a loading chamber and / or a syringe; and a second part, which defines a second internal space, wherein the second part has a window, the window material of which allows steam and other optional sterilizing gases to penetrate. The two spaces are connected to each other, and a structure, such as a latch, is provided on the package in a transition area between the two internal spaces. This structure serves as a welding or adhesive seal to hermetically separate the two internal spaces with a welding or adhesive seal. If relevant, the package may have further features, or a combination of features, related to intraocular lens packaging or syringe packaging. The package can be used according to the present method.

[0073] The options mentioned in the present invention can be used in any combination if they are not mutually exclusive. Specifically, the present invention has indicated preferred categories, and more preferred categories are derived from values ​​between the minimum and maximum values ​​mentioned in the categories.

[0074] One particular advantage of the packaging method disclosed above is that the packaging steps produce a semi-finished intraocular lens package, specifically a semi-finished syringe package, containing an intraocular lens within a watertight, but not airtight, packaging space. This allows the package to be injected with gas to sterilize the contents and then sealed in an airtight environment. The semi-finished intraocular lens package or syringe package produced according to the above steps is further processed into a finished syringe package.

[0075] The advantages, features and preferred embodiments of the present invention are further illustrated by the following detailed description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0076] The following figures are schematic diagrams and may differ from the actual scale:

[0077] Figure 1 It is a top-down oblique perspective diagram of the container without a lid;

[0078] Figure 2 It is an oblique perspective schematic diagram showing the container storing the syringe and the loading chamber after loading;

[0079] Figure 3 yes Figure 1 side view of the middle container;

[0080] Figure 4 yes Figure 1 Front view of the middle container;

[0081] Figure 5 yes Figure 1 A top view of the middle container;

[0082] Figure 6 is a top view of the covering film (without the container);

[0083] Figure 7 It is a top view of the container covered with the covering film, indicating the location of the sealing seam between the container and the covering film, and the covering film is sealed around the edge of the container;

[0084] Figure 8 yes Figure 7 a top view of the middle container covered with a cover film, indicating the location of the sealing seam between the container and the cover film, the cover film along the edge of the container, and the latch sealing the container;

[0085] Figure 9 It is a top view of the container, indicating the expected sealing seam location between the container and the cover film;

[0086] Figure 10 A top view of a container covered with a covering film, showing the location of the sealing seam between the container and the covering film, with the covering film sealing the container along the edge of the container, and the container having a cut edge outside the sealing seam;

[0087] Figure 11 A bag is shown with a gas permeable area and a seal;

[0088] The present invention is further illustrated by the following detailed description and accompanying drawings. The preferred features are not mutually exclusive and can be used in any combination.

[0089] In the following description, the same reference numerals represent components that are the same or have the same function (in different figures). DETAILED DESCRIPTION

[0090] Figure 1 A container 11 is shown for holding a fully preloaded syringe. Figure 3 and Figure 4 Each shows a side view of a container 11 . Figure 5 1 shows a top view of the container 11. Figure 6As shown, the container 11 can be sealed with a cover 13. The container 11 and the cover 13 form a package for placing a syringe 15 pre-loaded with an intraocular lens therein. Figure 2 The syringe 15 is shown inserted into the container 11. The container 11 is designed so that the syringe can be inserted precisely and preferably held gently at a minimum point, so that the syringe will not slip within the container even if the container is turned over, etc. The package containing the preloaded syringe 15 may be referred to as a syringe package or an intraocular lens package.

[0091] The package has two sections, a first section 17 and a second section 19. The two sections are defined by the shape of the container 11 and the associated lid 13. In terms of the container, the first section 17 is defined by a first groove 21 of the container 11, and the second section is defined by a second groove 23 of the container 11. The two grooves are separated by a latch 25. Figure 3 In the embodiment, the division between first section 17 and second section 19 is clearly visible because first recess 21 and second recess 23 are separated by latch 25. First recess 21 and second recess 23 are each separated by portion 27 and portion 29 of container circumferential edge 31, which extend to latch 25 and also define latch 25. In the case of the lid, first section 17 is defined by the portion of lid 13 covering first recess 21, and second section 19 is defined by the portion of lid 13 covering second recess 23.

[0092] The packaging material of first section 17 comprises an airtight material, while the packaging material of second section 19 at least partially comprises a gas-permeable material, specifically one that allows vapor permeation but preferably prevents liquid permeation. Lid 13 is partially made of a gas-permeable material. A portion of lid 13 has a gas-permeable material located above second section 19, while the remainder of lid 13 is made of an airtight material.

[0093] Container 11 is preferably made of a dimensionally stable material to support and shock-resistant the packaged items. The container can be formed by deep drawing. Lid 13 can be made of a range of materials that are gas permeable, while container 11 is made of an airtight material. Lid 13 can be made of a metal foil material and must be thin enough to allow for bending and easy removal from container 11.

[0094] Figure 1 and Figure 6 In the illustrated embodiment, container 11 preferably comprises substantially plastic and / or aluminum metal with minimal gas permeability. The container material should minimize gas exchange between the interior of the package and the external environment. Specifically, it should not allow gas exchange between air and vapor. When using plastic as the packaging material, polypropylene can be used. Preferably, the polypropylene packaging material has a thickness or wall thickness greater than 0.4 mm, preferably greater than 0.6 mm, and more preferably greater than 0.8 mm.

[0095] Lid 13 is primarily made of an airtight material, such as airtight plastic and / or airtight aluminum, particularly airtight plastic and / or airtight aluminum foil. However, lid 13 includes a window 33, where the material allows for gas permeability, specifically, air and vapor. Window 33 of lid 13 is located in second subsection 19 of the package, preferably on the covering surface of the second subsection, in other words, where lid 13 covers second recess 23. This gas-permeable area may also be located within or incorporated into the container portion of second subsection 19.

[0096] The latch 25 of the container 11 separates the first groove 21 and the second groove 23 to form a plane that is in the same plane as the circumferential edge 31 of the container 11 .

[0097] The coplanarity of the latch 25 and the circumferential edge 31 is suitable for welding or gluing to the lid 13. Specifically, the materials of the container 11 and the lid 13 are preferably selected to be suitable for welding.

[0098] One or more protrusions 35 are provided within the second section 19, projecting above the plane defined by the circumferential edge 31 of the container 11 and the latch 25. The protrusions 35 should at least protrude above and be located adjacent to the latch 25 (or, with the circumferential edge 31 as the reference plane, the protrusions 35 should be higher than the latch 25). If the lid is fastened, welded, or bonded to the circumferential edge 31, the protrusions 35 maintain a clear passage between the first and second sections at the location between the latch 25 and the lid, allowing for free exchange of gas between the first and second sections. The protrusions 35 may, but need not, protrude from the second recess 23; however, this facilitates gas exchange. The protrusions 35 may be cylindrical or frusto-conical in shape. Preferably, there are at least two or three protrusions 35 arranged in parallel. The protrusions 35 define a common protrusion height and / or protrude from the same plane. More preferably, the distance between any two adjacent protrusions along the shortest connecting line is no greater than their width, preventing the lid 13 from sagging onto the latch 25 due to its own force 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 pressed onto the latch 25 later and the cover 13 can be fastened with the latch 25 or sealed together.

[0099] After schematically explaining the container 11 and the lid 13, the following Figure 7 and Figure 8 The components are denoted by the same reference numerals as above, and if not necessary, the components are not described again and the existing reference numerals can be used to identify the components.

[0100] Figure 7The top view shows the container 11 covered by the lid 13. The mark 37 indicates the sealing seam 37 between the container 11 and the lid 13. The container 11 is continuously sealed to the lid 13 along the circumferential edge. The package has two sections. The first section 17 defines a first internal space, which stores the intraocular lens and optionally includes a storage seat, a loading chamber and / or a syringe. The second section 19 defines a second internal space and is provided with a window 33 made of a material that allows steam to penetrate. Since there is no welding seam marked on the latch 25 ( Figure 7 (Not shown in the figure), the two internal spaces are connected. The first internal space roughly corresponds to the first groove 21, and the second internal space roughly corresponds to the second groove 23. Both internal spaces actually extend to the lid, while the first groove 21 and the second groove 23 theoretically only extend to the seam. Therefore, the capacity of the two internal spaces is slightly larger than that of the corresponding grooves. This is because the protrusion 35 raises the lid 13 above the latch 25, or above the coplanarity of the circumference and the latch. The latch 25 is provided in the transition area between the two grooves to facilitate a second weld, thus separating the two internal spaces in an airtight manner.

[0101] The overall design of the package is as follows: a first section 17 is made of an airtight material and contains an intraocular lens (optionally with a storage receptacle, loading chamber, and / or syringe). The first section 17 is sealed relative to the second section 19, which is watertight but not airtight (i.e., gas and steam permeable). Therefore, the contents of the package (i.e., the intraocular lens, or the intraocular lens with a storage receptacle, loading chamber, and / or syringe) can be sterilized using gas, specifically steam. In this embodiment, the package can be referred to as a semi-finished intraocular lens package, or, if the intraocular lens is preloaded into a syringe, as a semi-finished syringe package, or as a gas- or steam-sterilizable intraocular lens package or syringe package. The semi-finished package is characterized by being divided into a first section 17 and a second section 19, which form a shared volume. The first section 17 is made of an airtight material and contains the intraocular lens or syringe preloaded with the intraocular lens. The second section 19 can be made of the same material, but at least a portion of the material is permeable to air, such as steam. This steam-permeable portion is designated as a window 33. Because of the steam-permeable window 33, the package or its interior can be steam sterilized while sealed, or alternatively, sterilized with other gases, by allowing steam and / or other suitable gases to flow into the steam-permeable window before or during sterilization. Sterilization can be performed in an autoclave, where the composition, pressure, and / or temperature of the atmosphere are preferably preset and, if desired, controllable. The package is watertight (moisture-impermeable) and can therefore be sterilized with ethylene oxide gas.

[0102] The second section 19 preferably forms the end region of the package. In this case, the end region can be understood as the second section 19 or its inner space being easily separable or removable from the first section 17 or its inner space by means of clamping or cutting (for example, during the second sealing process). For example, if the first section and the second section of the package form a long strip, the second section 19 should be located at one of the two ends of the strip, such as Figure 1 、 Figure 3 、 Figures 5 to 9 As shown in the figure, the two ends of the elongated package, or even the two parts, can be separated vertically by clamping or cutting along the longitudinal extension.

[0103] In addition to the window 33 on the cover 13 that allows steam or other gases to penetrate, the cover 13 can be made of aluminum metal, specifically aluminum foil. The window 33 that allows steam or other gases to penetrate can be made of non-woven fabric such as high-density polyethylene (PE-HD) (e.g. ) or conventional autoclaved paper. The container 11 can be made of a low-cost plastic, preferably one with low vapor permeability, such as polypropylene or an EVOH-coated plastic, specifically one with an extruded EVOH layer in the middle.

[0104] Figure 8 This is a top view showing the container 11 covered with a lid 13. As mentioned above, the package has two sections: a first section 17 defining a first interior space in which the intraocular lens is stored, optionally with a storage seat, a loading chamber and / or a syringe; and a second section 19 defining a second interior space. Figure 8 and Figure 7 In comparison, in addition to having a sealing seam 37 along the edge, Figure 8 Between the container 11 and the lid 13, there is a mark 39, 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 the first division 17 and a second internal space of the second division 19; according to Figure 8 The package is provided with an additional sealing seam (see reference 39) extending across two locations, namely, a first location 41 and a second location 43 of the circumferential sealing seam (see reference 37). The additional sealing seam separates (or partitions) the first interior space from the second interior space, making the first interior space airtight or vapor-proof from the external environment and the second interior space. 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 8The additional sealing seam, designated 39, separates the two interior areas. A seal is formed between the latch 25 of the container 11 and the lid 13, which can be heat welded or glued. After being sealed along the latch 25, the first portion 17 of the package becomes a hermetically sealed intraocular lens or syringe package. The second portion 19 of the package is now non-functional and can be removed, for example, with a cutting tool, and then discarded. The hermetically sealed intraocular lens or syringe package is the final product.

[0105] Figure 10 The finished intraocular lens package or syringe package is shown. The package has a cutting edge 45 outside the hermetically sealed interior space, wherein the hermetically sealed interior space includes the first groove 21. In other words, the cutting edge 45 is located outside the first subsection 17 of the package. The cutting edge is formed when the second subsection 19, or a substantial portion of the second subsection 19, is separated from the first subsection 17, specifically when the second subsection 19 including the vent window 33 is separated. The cutting edge 45 is located along, near, or on the weld or bond line of the additional sealing seam 39 on the latch 25. The weld or bond line of the additional sealing seam 39 is located between the cutting edge 45 and the completed sealed interior space, i.e., also on the latch 25. Specifically, the cutting edge 45 extends through the original container 11 and the original lid 13 attached thereto, leaving the remaining container portion and the remaining lid portion 13' shorter than the original container and lid configuration.

[0106] The syringe package includes a syringe 15 provided with an intraocular lens and a package containing the syringe and the intraocular lens. The airtight or steam-impermeable package constitutes a sealed airtight or steam-impermeable shell, defining an internal space, which contains the syringe 15 and the intraocular lens. The closed internal space contains steam and sterile air.

[0107] Figures 1 to 9 An embodiment of a syringe package is shown, comprising at least one vapor- or gas-impermeable package, comprising a covered container (the vapor- or gas-impermeable container and the cover). The container has at least one recess and a support structure for securing or holding the syringe, and the cover covers the recess in which the syringe is stored. In the syringe package, the syringe is hermetically sealed from the environment.

[0108] In another simplified embodiment, Figure 11As shown, intraocular lens packaging for storage 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 impermeable to steam and gas. Bag 51 is designed to be relatively flat, with an opening 65 on the side of the bag. The window 53 that allows steam or gas to permeate is located near the opening 65, that is, close to the side of the bag. This creates a first section 57 that is impermeable to steam and gas, and a second section 59 that is permeable to steam and gas. Bag 51 has two seals, a first seal 60 and a second seal 61, to seal the bag. The seals can be coated with a sealable or adhesive material that adheres to opposing surfaces of the bag, thereby airtightly isolating the interior of the bag from the outside world. Preferably, first seal 60 is located along opening 65. Second seal 61 is located farther from first seal 60 and further from opening 65 than first seal 60. Both seals extend in a straight line from one side of the bag to the opposite side of the bag, parallel to opening 65. Therefore, the first seal 60 and the second seal 61 are parallel. A steam- or gas-permeable window 53 is located between the two seals. At least the second seal 61 is located in the portion of the material that is not steam- or gas-permeable. The bag 51 or its interior is sealed from the outside world by the first seal 60. The contents of the bag sealed in this manner can be sterilized by introducing hot steam through the window. The second seal 61 creates an airtight seal between the steam- or gas-permeable first section 57 and the second section 59, which has the steam- or gas-permeable window 53. Before the second seal seals the first and second sections 57, 59, the bag's contents are pushed into the first section 57. The bag design allows for the insertion of an intraocular lens (preferably supported by a storage holder or preloaded in a syringe / loading chamber). The bag 51 as a whole and the first section 57 are at least large enough to accommodate an intraocular lens with a storage holder or preloaded in a loading chamber and / or syringe, while not hindering the sealed separation between the first section 57 and the second section 59. Further, the bag is provided with a flap 63 so that the bag can be opened after it has been sealed at the second seal 61. The seam or tear 67 provided for this purpose can be torn open when the flap 63 is pulled up.

[0109] and Figure 11 The elastic bag 51 shown is different. Figures 1 to 10A shape-stable container 11 is shown, which further protects the contents from physical impact and is, in principle, better than an elastic bag. However, during the development of shape-stable containers, it was discovered that although shape-stable containers are strong and allow smooth gas exchange during sterilization, they cannot be easily separated and sealed from the breathable portion after sterilization like an elastic bag. The embodiments disclosed in the present invention solve this problem and disclose a shape-stable container that uses a dual-chamber system. The two sealing surfaces of the dual chambers are located on the same plane. During sterilization (i.e., before the dual chambers are relatively sealed), gas can flow freely from one chamber to the other. Specifically, if the lid is designed to be elastic and more elastic than the container, gas can flow between the two chambers.

[0110] A method for producing a sterile and airtight package for placing an intraocular lens, specifically an airtight intraocular lens package or syringe package sterilized by gas and / or steam, comprises the following steps:

[0111] -Insert the intraocular lens (optionally with a storage seat, loading chamber and / or syringe 15) into the interior space of the package, wherein the first section 17 of the package comprises an airtight first packaging material and the second section 19 of the package comprises a second packaging material that allows steam and other optional sterilizing gases to penetrate.

[0112] The package is sealed for the first time, so that the intraocular lens is sealed in the interior space of the package, a part of the interior 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 package does not allow liquids or solids to pass through.

[0113] After the package is sealed for the first time, the inner space is sterilized, that is, the package is exposed to steam or other optional sterilizing gas, so that the steam or other optional sterilizing gas penetrates into the inner space of the package through the second section 19.

[0114] - A second seal is performed to seal at least a portion of the first section 17 in which the syringe 15 is stored, thereby separating the first section 17 from the second section 19, so that the syringe 15 is completely packaged in the airtight packaging material. After the second seal, an internal space smaller than that of the first seal is formed.

[0115] Preferably, a significant amount of water remains within the reduced internal space after the second sealing. This water enters the internal space as vapor during sterilization. Specifically, the weight of the water within the package (including vaporized water and condensed water) increases after the second sealing and is greater than after the first sealing and before sterilization.

[0116] After the initial sealing, the package is exposed to a specific humidity environment for a period of time during sterilization, allowing moisture to enter the package's interior through the second subsection 19, raising the humidity within the package. Furthermore, sterilization is preferably performed at a temperature above room temperature. Preferably, sterilization is performed in an autoclave. Therefore, the package is placed in an autoclave processing chamber with a relative humidity of at least 90%, or more preferably, a steam-saturated environment. Simultaneously, the autoclave processing chamber temperature is 100°C or higher, preferably 110°C or higher, or more preferably 120°C or higher. Sterilization can be performed under the aforementioned conditions (air composition, humidity saturation, and temperature) for a maximum of 30 minutes, preferably 25 minutes, or more preferably 20 minutes.

[0117] Preferably, the intraocular lens is preloaded in the syringe. The syringe preloaded with the intraocular lens is inserted into the package. In the above embodiment, the intraocular lens, the storage seat, the loading chamber, and / or the syringe are placed and sealed in the package through the first or second sealing.

[0118] At least part of the second section 19 comprises a material that allows steam or other optional sterilizing gases to penetrate, but does not allow water to penetrate. In actual application, non-woven high-density polyethylene (PE-HD) or autoclaved paper is used.

[0119] 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 sealing (e.g., by pressing), so that the first section 17 containing the intraocular lens or the preloaded intraocular lens syringe can be completely sealed within the airtight material. This second seal is achieved by welding or gluing the lid to the latch 25.

[0120] The gas injected into the first subsection 17 during sterilization, or the gas contained in the first subsection 17 after sterilization, specifically steam, can be sealed in the first subsection 17 by closing the latch 25 as soon as possible.

[0121] After the second seal, the portion of the package containing the second section 19 is no longer functional and can be removed, for example, cut out and discarded. Regardless of whether the second section 19 is removed after the second seal, the aforementioned steps result in an intraocular lens package, providing a sterile intraocular lens packaged in an airtight environment. Preferably, the intraocular lens is preloaded into a syringe, providing a syringe package comprising a sterile syringe preloaded with the intraocular lens. Due to the introduction of moisture during sterilization, the interior of the package has a high humidity environment. Preferably, (under equilibrium conditions) it is a steam-saturated environment.

[0122] The sterile atmosphere within the syringe package primarily consists of humid air.

[0123] The sterile air environment within the syringe package is saturated with steam, specifically to prevent the intraocular lens from drying out. The interior of the syringe package contains sufficient moisture (or water molecules) to saturate the environment within the syringe package with steam under the following environmental conditions: room temperature (specifically, 20°C) and normal atmospheric pressure (i.e., 1 atm / 1013.25 mbar / 101.325 kPa). Preferably, the interior of the syringe package contains sufficient moisture to saturate the air environment with steam under normal atmospheric pressure at a temperature of 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.

[0124] The vapor permeability of the syringe packaging material is less than 10g / m 2 / 24h (Polyethylene terephthalate (PET) or polypropylene (PP) can be used), preferably less than 1.g / m 2 / 24h, more preferably less than 0.1g / m 2 / 24h (aluminum foil can be used). The maximum vapor permeability does not exceed 0.5g / m 2 / 24h, preferably 0.05g / m 2 / 24h or more preferably 0.005g / m 2 / 24h materials or packaging that are nearly airtight or do not allow steam to penetrate.

[0125] The syringe package is a single package. Alternatively, the aforementioned airtight or steam-impermeable package may also constitute the innermost package in the packaging combination. Specifically, the syringe package is not attached to any autoclaved outer covering. The interior space of the syringe package contains a single syringe. The syringe contains an intraocular lens, preferably preloaded into the syringe or syringe loading chamber.

[0126] Hydrophilic IOLs are preferred because they offer specific benefits when stored in a controlled humidity environment. However, hydrophobic IOLs, which contain slightly more water, must be stored in a controlled humidity environment to prevent drying out. Properly controlling the humidity conditions within IOL packaging can extend the product's shelf life and ensure safety.

[0127] The lens of the intraocular lens is preferably contained in the syringe in a relaxed state, which increases the shelf life of the syringe packaging or the intraocular lens.

[0128] The sterile atmosphere within the syringe packaging is steam sterilized. A mixed steam and ethylene oxide sterile atmosphere is also available. For hydrophilic intraocular lenses, a steam-only sterile atmosphere is preferred.

[0129] The above specific embodiments disclosed in the present invention may be used in different combinations, provided that the embodiments are not mutually exclusive.

[0130] The above-mentioned specific embodiments disclosed in the present invention may be further modified, adjusted, changed and combined without departing from the scope of protection of the present invention.

[0131] Reference Signs List

[0132] 11 Container

[0133] 13. Cover, specifically covering film

[0134] 15 Syringes

[0135] 17. First Division (Definition of the First Internal Space)

[0136] 19 Second Division (Definition of the Second Internal Space)

[0137] 21 First groove

[0138] 23 Second groove

[0139] 25 Latch

[0140] 27 The first part of the container circumference

[0141] 29 The circumferential edge of the container in the second section

[0142] 31 Container circumferential edge (container circumferential edge portions 27 and 29)

[0143] 33 Gas permeable area (window)

[0144] 35 bulge

[0145] 37 Sealing seam on circumferential edge

[0146] 39 Additional sealing seams on latches

[0147] 41 First position of the sealing seam

[0148] 43 Second position of the sealing seam

[0149] 45 cutting edge

[0150] 51 bags

[0151] 53 Gas permeation area (window)

[0152] 57 First Division (Definition of the First Internal Space)

[0153] 59 Second Division (Defining the Second Internal Space)

[0154] 60 First Seal

[0155] 61 Second Seal

[0156] 63 Removable bag flaps

[0157] 65 Bag opening

[0158] 67 Seams or tears

Claims

1. A method for producing a syringe package, wherein a syringe preloaded with an intraocular lens is stored in a sterile and airtight environment, wherein the syringe includes a loading chamber preloaded with the intraocular lens; the method comprising the following steps: - Inserting the syringe (15) pre-loaded with the intraocular lens into the interior space of the package, wherein the first section (17) comprises an airtight first packaging material, and the second section (19) comprises a second packaging material that allows steam and other sterilizing gases to pass through, and providing a protrusion (35) in the first section (17) and / or the second section (19) inside the package so that the package does not collapse inward and the passage between the first section (17) and the second section (19) remains unobstructed; - The first sealing is to seal the syringe (15) pre-loaded with the intraocular lens in the internal space of the package, wherein the internal space is partially defined by the first subsection (17) and partially defined by the second subsection (19). Due to the protrusion (35) provided inside the package, the passage between the first subsection (17) and the second subsection (19) remains unobstructed, allowing gas exchange between the first subsection (17) and the second subsection (19) during the following sterilization step; - sterilizing the package after the first seal is completed, exposing the package after the first seal to steam or a mixture of steam and other sterilizing gases, and the steam or the mixture of steam and other sterilizing gases penetrates into the interior space of the package through the second section to perform sterilization; - A second sealing is performed to seal and separate at least a portion of the first subsection (17) containing the syringe (15) preloaded with the intraocular lens and sealed relative to the second subsection (19), so that the intraocular lens is completely packaged in the airtight first packaging material, while the steam or the mixture of steam and other sterilizing gases remains in the airtight first packaging material.

2. The method according to claim 1, wherein: After the second sealing, the second section (19) is removed by cutting and discarded.

3. The method according to claim 1, wherein: During the sterilization step, after the first sealing, the package is sterilized by exposing it to an environment with a relative humidity of at least 90% and a temperature of 100° C. or above for a period of time.

4. The method according to claim 3, wherein: - When the temperature is between 100°C and 130°C, the sterilization time is up to 30 minutes, or - When the temperature is 130℃ to 140℃, the sterilization time is up to 15 minutes.

5. The method according to claim 1, wherein: Sterilize in an autoclave.

6. The method according to claim 1, wherein: The intraocular lens is preloaded into the loading chamber of the syringe and then inserted into the package to be sealed within the package by the first seal.

7. The method according to claim 1, wherein: The second subsection (19) constitutes the end region of the package.

8. The method according to claim 1, wherein: The second section (19) at least partially comprises a material that is permeable to steam and other sterilizing gases but impermeable to liquid water.

9. The method according to claim 1, wherein: The second section (19) is at least partially made of high-density polyethylene (PE-HD) or autoclaved paper.

10. A syringe package prepared by the method according to claim 1 or 2, wherein a syringe preloaded with an intraocular lens is stored therein, and comprising a packaging shell for sealing the syringe preloaded with the intraocular lens, wherein the package forms a sealed internal space containing the syringe preloaded with the intraocular lens, characterized in that: The packaging shell seals the interior space to make it airtight, and Before the internal space is hermetically sealed, steam or a mixture of steam and other sterilizing gases enters during sterilization, thereby creating an environment containing steam or a mixture of steam and other sterilizing gases.

11. The syringe package according to claim 10, wherein: The sterilized environment is saturated with steam.

12. The syringe package according to claim 10, wherein: The sterilized interior space is saturated with steam at room temperature and normal pressure, specifically at a temperature range of at least room temperature to 30°C.

13. The syringe package according to claim 10, wherein: The packaging contains a material with a vapor permeability of less than 10 g / m 2 / 24h.

14. The syringe package according to claim 10, wherein: The interior space contains a single IOL or a single syringe preloaded with an IOL.

15. The syringe package according to claim 10, wherein: The intraocular lens is stored in liquid. Specifically, the syringe is preloaded with the intraocular lens stored in the liquid, and the lens of the intraocular lens is loaded into the syringe in a relaxed state.

16. The syringe package according to claim 10, wherein: The sterile gas environment is sterilized by steam or steam and ethylene oxide. The sterile environment sterilized by steam is suitable for hydrophilic intraocular lenses.

17. The syringe package according to claim 10, wherein: The package has a cut edge or tear edge outside the sealed interior space.

18. The syringe package according to claim 10, wherein: The inner space is isolated from the outside by a seal, which is a welded or bonded joint of the packaging material. The outer side of the sealed inner space is provided with a cutting edge or a tearing edge at the welded or bonded edge.

19. The packaging of the syringe preloaded with an intraocular lens for use in the method according to claim 1, wherein: The package defines an interior space for storing a syringe preloaded with an intraocular lens, with or without a storage seat, and stored in the loading chamber of the syringe; the package is characterized by: - The package has two parts, the first part (17) defines a first internal space, in which the syringe pre-loaded with the intraocular lens is stored, and the second part (19) defines a second internal space, which is provided with a window (33). The material of the window (33) allows steam to penetrate. The two internal spaces are connected to each other, and the transition area in the middle forms a latch (25) structure, which is sealed by welding or bonding to hermetically separate the two internal spaces; The package is composed of a container (11) and a lid (13), wherein the container (11) has a circumferential edge, and the lid (13) seals the container (11) corresponding to the circumferential edge. The container is provided with at least one first groove (21) defining a first internal space, and is provided with at least one second groove (23) defining a second internal space. A window (33) is provided in the area of ​​the lid (13) covering the second internal space. A protrusion (35) is provided in the first subsection (17) and / or the second subsection (19), which protrudes from the latch (25). The lid (13) is raised above the latch (25), so that the passage between the first subsection (17) and the second subsection (19) remains unobstructed at the position between the latch (25) and the lid (13), thereby allowing gas exchange between the first subsection (17) and the second subsection (19).

20. The package according to claim 19, wherein: The latch (25) is provided with a surface which is sealed to the lid by welding or gluing, and the latch (25) is in the same plane as the peripheral edge of the container.

21. The package according to claim 19, wherein: The projection (35) projects above the same plane as the circumferential edge and the latch.

22. The package according to claim 19, wherein: The protrusion (35) is arranged in the first section (17) and / or the second section (19) at a position close to the latch (25).

23. The package of claim 19, wherein: The vapor permeability of the container (11) and the lid (13), excluding the window (33), is less than 10 g / m 2 / 24h.

24. The package of claim 19, wherein: In the package, the wall thickness of the container (11) is thicker than 0.4 mm and the container (11) is made of plastic.

25. The package of claim 19, wherein: In the package, the container (11) is made of a dimensionally stable material.

26. The package of claim 19, wherein: Inside the package, the container (11) is made of plastic.

27. The package of claim 19, wherein: Inside the package, the lid (13) is made of foil material, specifically aluminum foil, with the exception of the window (33).

28. The package of claim 19, wherein: The window (33) is made of non-woven high-density polyethylene or autoclaved paper.

29. A semi-finished syringe package comprising an intraocular lens (IOL) preloaded into a syringe, the package forming a sealed interior space within which the syringe preloaded with the IOL is stored, the IOL being attached or not attached to a storage receptacle and being stored in a loading chamber of the syringe; characterized in that: The package has two parts, including a first part (17) defining a first internal space in which a syringe pre-loaded with an intraocular lens is stored; a second part (19) defining a second internal space and provided with a window (33) wherein the material of the window (33) allows steam to penetrate. The two internal spaces are connected to each other, and a latch (25) structure is formed in the middle of the transition area for sealing by welding or bonding to hermetically separate the two internal spaces. The package comprises a container (11) and a lid (13), wherein the container (11) has a circumferential edge, and the lid (13) seals the container (11) corresponding to the circumferential edge, the container is provided with at least one first groove (21) defining a first internal space, and is provided with at least one second groove (23) defining a second internal space, and a window (33) is provided in the area of ​​the lid (13) covering the second internal space; A protrusion (35) is provided in the first subsection (17) and / or the second subsection (19), which protrudes from the latch (25). The lid (13) is raised above the latch (25), so that the passage between the first subsection (17) and the second subsection (19) remains unobstructed at the position between the latch (25) and the lid (13), thereby allowing gas exchange between the first subsection (17) and the second subsection (19).

30. The semi-finished syringe packaging product according to claim 29, wherein: The latch (25) is provided with a surface which is sealed with the lid by welding or bonding, and the latch (25) is in the same plane as the circumferential edge of the container.

31. The semi-finished syringe packaging product according to claim 29, wherein: The projection (35) projects above the latch or above the same plane as the circumferential edge and the latch.

32. The semi-finished syringe packaging product according to claim 29, wherein: The protrusion (35) is arranged in the first section (17) and / or the second section (19) at a position close to the latch (25).

33. The semi-finished syringe packaging product according to claim 29, wherein: The protrusion (35) is provided inside the package so that the package does not sag into itself, ie the cover (13) does not sag into the package.

34. A syringe package prepared by the method of claim 1, comprising a syringe preloaded with an intraocular lens, the package forming a sealed interior space for storing the syringe preloaded with the intraocular lens, the intraocular lens being attached or not attached to a storage seat and being stored in the loading chamber of the syringe; characterized in that: The package has two sections: a first section (17) defining a first internal space in which a syringe pre-loaded with an intraocular lens is stored; a second section (19) defining a second internal space and having a window (33) formed therein. The material of the window (33) allows steam to penetrate, thereby forming a seal to separate the internal spaces of the first section (17) and the second section (19). The package is composed of a container (11) and a lid (13), wherein the container (11) has a circumferential edge, and the lid (13) seals the container (11) corresponding to the circumferential edge. The container is provided with at least one first groove (21) defining a first internal space, and is provided with at least one second groove (23) defining a second internal space. A window (33) is provided in the area of ​​the lid (13) covering the second internal space. A latch (25) is formed in the container (11) to separate the first section (17) and the second section (19); the first section (17) and / or the second section (19) are provided with a protrusion (35) that protrudes from the latch (25); the protrusion (35) protrudes from a plane defined by the latch (25) or from a plane defined by a circumferential edge of the container and the latch (25); Furthermore, the environment of the first inner space contains steam or a mixture of steam and other sterilizing gases.

35. The syringe package of claim 34, wherein: The closure is achieved with a latch (25), which is welded or glued to the lid.

36. The syringe package according to claim 34 or 35, wherein: The protrusion (35) is arranged in the first section (17) and / or the second section (19) at a position close to the latch.

37. The syringe package of claim 34, wherein: In the package, the vapor permeability of the container (11) and the lid (13), excluding the window (33), is less than 10 g / m 2 / 24h.

38. The syringe package of claim 34, wherein: In the package, the wall thickness of the container (11) is thicker than 0.4 mm and the container is made of plastic.

39. The syringe package of claim 34, wherein: In the package, the container (11) is made of a dimensionally stable material.

40. The syringe package of claim 34, wherein: In the package, the container (11) is made of plastic.

41. The syringe package of claim 34, wherein: In the package, at least the cover (13) of the package is made of foil material, in particular aluminum foil, with the exception of the window (33), which is made of non-woven fabric.

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