IL295879B1

IL295879B1 - Sterile moist package for hydrophobic intraocular lens and method of packing same

Info

Publication number: IL295879B1
Application number: IL295879A
Authority: IL
Inventors: Maliarov Alex; Hash Boris
Original assignee: Hanita Lenses R C A; Hanita Lenses Ltd; Maliarov Alex; Hash Boris
Priority date: 2022-08-23
Filing date: 2022-08-23
Publication date: 2023-10-01
Also published as: IL295879A; IL295879B2

Description

295879/1 1 STERILE MOIST PACKAGE FOR HYDROPHOBIC INTRAOCULAR LENS AND METHOD OF PACKING SAME FIELD OF THE INVENTION[001] The present invention relates generally to sterile package for intraocular lenses and the method of packing same. More specifically, the present invention relates to a sterile package filled with moist for intraocular lens and method of packing same.

BACKGROUND OF THE INVENTION[002] An Intra-Ocularocular Lens (IOL) is an artificial lens that replaces the eye's natural lens which is removed during cataract surgery or refractive lens exchange (RLE) surgery. IOLs usually consist of a polymer based lens with polymer based side struts, or extensions, called haptics, to hold the lens in place in the capsular bag inside the eye. IOLs optical part can be of different designs, monofocal, multifocal-refractive, multifocal-diffractive with or without a toric correction element (used to correct preexisting corneal astigmatism prior to the surgery). IOL designs may be of constant mechanics or accommodating, designed to allow the eye to regain some partial focusing ability in order to change focus from distance to near by using the ciliary muscle movement or other external energy source. [003] In general, modern soft or flexible IOLs are made from various polymers based on backbone such as acrylate backbone, polypropylene with various side chains made of hydrophilic nature such as Hydroxy-Methyl-Meth-Acrylate or hydrophobic MethylMethacrylate, aromatic side chains or other waxy side chains such as Ethyl-Ethoxy-Meth-Acrylate and also silicone based lenses siloxane based or siloxane integrated with or other combinations of polymers etcetera. [004] Modern IOLs are made of a soft material enabling it to be injected into the eye through a small incision. Known polymeric materials used in ophthalmology have a certain amount of water content ranging from close to 0% of water content considered as the extreme hydrophobic up to around 70% as the extreme hydrophilic. [005] IOLs are sterilized in their primary packaging and can be sterilized in different forms, either by steam sterilization, Ethylene Oxide (EtO), gamma irradiation and various plasma sterilization methods. Hydrophilic IOLs have high water content and usually supplied in a water solution, the water content support them to receive their flexibility thus 295879/1 2 hydrophilic lenses are supplied in water solution while hydrophobic lenses are mostly supplied in a dry packaging, mostly using EtO sterilization. [006] All soft IOLs are found to be more flexible once hydrated. Hydrophilic IOLs must be kept in saline in order to be implanted, as the non-hydrated state of the lens is rigid and not flexible. IOLS made of a hydrophobic nature material when kept in a sterile dry environment are harder and less flexible then in their hydrated state. Sterilizing the IOLs with steam will most likely cause a development of micro-vacuoles inside the material of the optical part of the lens, also referred to in the industry as glistening, thus harming the optical quality of the lens. The most commonly used method for sterilizing glistening-free hydrophobic IOLs is using ethylene oxide (EtO) which is a toxic gas that should be totally removed prior to sealing the lens in a package. The outcome of this process is a totally dry lens as any liquid sterilized by EtO will dissolve EtO residue in it forming Ethylene Glycol (thus making it toxic). Forming sterilization (by EtO, Plasma, Xray, Ebeam) on the humid load is impossible. [007] Accordingly, there is a need for a new form of packaging IOLs in a sterile and moist environment that will ensure that the IOL can be provided at optimal conditions for implanting.

SUMMARY OF THE INVENTION[008] Some aspects of the invention may be directed to an intraocular lens (IOL) package, comprising: an inner sealed sterile bag comprising the IOL and air having at least 75% relative humidity at 25 C, and an outer sealed sterile bag encompassing the inner sealed sterile bag, wherein at least one edge of the inner sealed sterile bag is sealed via at least one surface of the outer sealed sterile bag. [009] In some embodiments, the inner sealed sterile bag comprises a material having a thermal conductivity higher by at least 1.1 times than the thermal conductivity of the IOL material. In some embodiments, the inner sealed sterile bag is made from at least one of: aluminum foil and polyester laminate with an aluminum layer. In some embodiments, the IOL inside the inner sealed sterile bag is glistening-free. [0010] In some embodiments, the outer sealed sterile bag is a steam sterilization pouch. In some embodiments, the outer sealed sterile bag comprises polypropylene with paper fibers. In some embodiments, the seal comprises polymeric adhesives suitable for steam 295879/1 3 sterilization. In some embodiments, the IOL is held by a holder inserted into the inner sealed sterile bag. [0011] Some additional aspects of the invention are directed to a method for packing an intraocular lens (IOL), comprising: inserting the IOL into an inner sealable bag; inserting the inner sealable bag into an outer sealable bag; sealing the outer sealable bag; conducting steam sterilization of the inner sealable bag and inside the outer sealable bag; and sealing at least one opening of the inner sealable bag via at least one surface of the outer sealable bag. [0012] In some embodiments, the method further comprises, prior to inserting the IOL into the inner sealable bag, placing the IOL on a holder, and inserting the holder into the inner sealable bag. In some embodiments, the inner sealed sterile bag has a thermal conductivity higher by at least 1.1 times than the thermal conductivity of the IOL material. In some embodiments, prior to the sealing, the method further includes inserting the portion of the holder further inside the inner sealable bag, such that surfaces of the at least one opening of the inner sealable bag are free to be attached and to be sealed to each other. [0013] In some embodiments, sealing together the at least one opening of the inner sealable bag via the surface of the outer sealable bag comprises soldering the opening using polymeric adhesives. [0014] Some additional aspects of the invention are directed to another method for packing an intraocular lens (IOL), comprising: inserting the IOL into an inner sealable bag; inserting the inner sealable bag into an outer sealable bag; sealing the outer sealable bag; conducting sterilization of the inner sealable bag and the outer sealable bag; inserting the sterilized packing into a humidity chamber; introducing humidity into the inner sealable bag, resulting in at least 75% relative humidity at 25 C; and sealing at least one opening of the inner sealable bag via at least one surface of the outer sealable bag. [0015] In some embodiments, the method further comprises, prior to inserting the IOL into the inner sealable bag, placing the IOL on a holder, and inserting the holder into the inner sealable bag.

BRIEF DESCRIPTION OF THE DRAWINGS[0016] The subject matter regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. The invention, however, both as to organization and method of operation, together with objects, features, and advantages 295879/1 4 thereof, may best be understood by reference to the following detailed description when read with the accompanying drawings in which: [0017] Fig. 1A is an illustration of an intraocular lens (IOL) package according to some embodiments of the invention; [0018] Fig. 1B is an image of the IOL package according to some embodiments of the invention; [0019] Fig. 1C is an image of an IOL holder to be inserted into an inner bag according to some embodiments of the invention; [0020] Fig. 2A is a flowchart of a method of packing IOL according to some embodiments of the invention; [0021] Fig. 2B includes images of several steps of the method of Fig. 2A according to some embodiments of the invention; and [0022] Fig. 3 is a flowchart of another method of packing IOL according to some embodiments of the invention. [0023] It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.

DETAILED DESCRIPTION OF THE PRESENT INVENTION[0024] One skilled in the art will realize the invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting of the invention described herein. Scope of the invention is thus indicated by the appended claims, rather than by the foregoing description, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. [0025] Some aspects of the invention are directed to a sterile moist package for hydrophobic IOL and a method of packing the IOL in order to ensure both a moisture environment and sterile conditions. The IOL packed in the sterile moist package may be glistening-free although being sterile with steam. This may be archived by selecting the material from which an inner bag holding the IOL to have a thermal conductivity higher by at least 1.1 times than 295879/1 the thermal conductivity of the IOL material. Such an IOL pack may keep the IOL sterile during the entire shelf life, thus, no mold, fungus or any other moist-related contaminations will be formed inside the sterile bag. [0026] In some embodiments, the IOL package may include two bags, an inner bag holding the IOL inserted into an outer bag suitable for steam sterilization. [0027] As used herein a "bag" refers to a any package made from two flexible layers circumferentially bonded together at at least a portion of their circumference. A "bag" can be an envelope, a package, a parcel, a container, a wrap or any other type of encapsulation. At an "open" state the bag may have at least one opening in the bonded circumference allowing items (e.g., IOL or other bags) to be inserted into the "bag". [0028] Reference is now made to Figs. 1A and 1B which are an illustration and an image of an IOL package according to some embodiments of the invention. An IOL package 100 may include, an inner sealed sterile bag 10 comprising an IOL 20 and air having at least 75% relative humidity at 25 C. In some embodiments, the air inside inner bag 10 may have at least 80 % relative humidity at 25 C, 85% relative humidity at 25 C, 90% relative humidity at 25 C, 95% relative humidity at 25 C, 100% relative humidity at 25 C, or any value in between. [0029] In some embodiments, inner sealed sterile bag 10 comprises a material having a thermal conductivity higher by at least 1.1 times than the thermal conductivity of the IOL material. In some embodiments, the material of inner sealed sterile bag 10 may have thermal conductivity index higher by at least 1.5, 1.8, 2, 2.5, 3, 4, 5, 10, 50, 100, 200, 500, 1000, 2000, 4000 and any value in between, times than the thermal conductivity index of the IOL material, under the same ambient conditions. For example, if the IOL is made from any type of hydrophobic acrylate the inner bag may be made from at least one of: aluminum foil, a polyester laminate with an aluminum layer and the like. In a non-limiting example, the thermal conductivity of the IOL is ~0.2 W/(m·K) while the thermal conductivity of the inner bag is made from Aluminum foil is ~240 W/(m·K). [0030] In some embodiments, inner sealed sterile bag 10 comprises a material having the same or lower thermal conductivity than the thermal conductivity of the IOL material. [0031] The inner sealed bag 10 can be rectangular, as illustrated, or can have any suitable shape allowing the insertion of IOL 20 and IOL holder 25 and stage 26 holding IOL 20, into bag 10, as shown in the image of Fig. 1C. In some embodiments, IOL holder 25 and stage 295879/2 26 may also be made from a material having a thermal conductivity index higher by at least 1.1 times than the thermal conductivity index of the IOL material. [0032] IOL package 100 may further include an outer sealed sterile bag 30 encompassing inner sealed sterile bag 10. In some embodiments, at least one edge 12 of inner sealed sterile bag 10 is sealed via at least one surface 31 of outer sealed sterile bag 30 by seal 40. In some embodiments, outer sealed sterile bag 30 may be a steam sterilization pouch. In some embodiments, outer sealed sterile bag 30 may be an EtO sterilization pouch. In a non-limiting example, outer sealed sterile bag 30 may include polypropylene with paper fibers. [0033] In some embodiments, seal 40 may be formed by polymeric adhesives suitable for steam sterilization. In a non-limiting example, the seal may include Polypropylene. [0034] In some embodiments, IOL 20 is glistening-free despite being in a moist environment, for example, due to being sterilized by steam or by introducing humidity into inner sealed sterile bag 10 following dry sterilization methods. [0035] Reference is now made to Figs. 2A and 2B which are a flowchart and images of steps in a method of packing an IOL according to some embodiments of the invention. In step 210, the IOL may be inserted into an inner sealable bag. In some embodiments, the an inner sealable bag may have a thermal conductivity higher by at least 1.1 times than the thermal conductivity of the IOL material. In some embodiments, prior to inserting the IOL into the inner sealable bag, placing the IOL on a holder, and inserting the holder into the inner sealable bag. For example, as shown in Fig. 1C an IOL 20 may be placed on stage 26, which then may be connected to holder 25 to be inserted into inner bag 10 via at least one opening 15. In some embodiments, inner bag 10 may include two openings 15 from two opposite sides of inner bag 10. [0036] In step 220, the inner sealable bag may be inserted into an outer sealable bag. For example, as shown in step 220 of Fig. 2B, inner sealable bag 10 may be inserted into outer sealable bag 30 via opening 34. In the non-limiting example, illustrated in Fig. 2B opening of inner bag 10 is inserted first facing the bonded portion 36 of outer bag 30. [0037] In step 230, the outer sealable bag may be sealed. For example, a first seal 35 may then be made as to close the lip of outer bag 30. In some embodiments, seal 35 may include any adhesives suitable for steam sterilization. [0038] In step 240, steam sterilization of the inner sealable bag and the outer sealable bag may be conducted, using any known method. For example, at least one opening section 15 295879/1 7 in inner bag 10 (shown in Fig. 1A and Fig. 2B) may be used for introducing steam into inner bag 10. [0039] As known in the art during steam sterilization, the vacuum causes rapid evaporation of the condensate (or any other liquid water droplets) deposited on the coolest material. In order to evaporate the condensed droplets, an addition of vaporization calories (heat) is required which it draws from the material, which therefore rapidly cools. In some embodiments, placing the IOL in close proximity to a material of high thermal conductivity, such as, inner bag 10 and/or holder 25, during steam sterilization allows for avoiding water vapor pre-condensation on the IOL. In some embodiments, such an arrangement will prevent any condensation from happening on the IOL, since the highly conductive material (e.g., bag 10 and/or holder 25) which further have a significantly larger surface area (compared to IOL surface area) may cool before the IOL. The prevention of the condensation on the IOL will prevent any form of glistening and thus maintain the optical quality of the IOL. [0040] In some embodiments, in the case of heating of package 100, the heating may evaporate the water from the highly conductive material`s surface instead of boiling the water on the IOLs surface. [0041] In step 250, at least one opening 15 of the inner sealable bag may be sealed via at least one surface of the outer sealable bag. For example, opening 15 of inner bag 10 is sealed via (through) the surface of the bag 30 by seal 40, for example, by soldering together all openings using polymeric adhesives. In some embodiments, if two openings 15 are included in inner bag 10, two seals 40 are performed, one for sealing each opening. In some embodiments, prior to the sealing inserting the portion of the holder 25 further inside the inner sealable bag 10, such that surfaces of the at least one opening 15 of the inner sealable bag 15 are free to be attached and to be sealed to each other. [0042] Reference is now made to Fig. 3 which is a flowchart of another method of packing an intraocular lens (IOL) according to some embodiments of the invention. In some embodiments, intraocular lens (IOL) package 100 may be packed using any one of the methods of Fig. 2A, Fig. 3 or using any suitable method that may allow to add humidity to a sterile sealed bag while maintaining the sterile conditions. [0043] Steps 310, 320, and 330 of the method of Fig. 3 may be substantially similar to steps 210, 220 and 230 of the method of Fig. 2A. In step 340, sterilization of the inner sealable bag and the outer sealable bag may be conducted. For example, the sterilization may be 295879/1 8 conducted using the EtO method. EtO gas is provided during the sterilization process. The EtO is a toxic gas therefore must be totally removed prior to sealing the IOL in a package. Following the removal of the EtO inner bag 10 include totally dry IOL 20. [0044] In step 350, the sterilized packing may be inserted into a humidity chamber. In step 360, humidity may be introduced into the inner sealable bag, resulting in at least 75% relative humidity at 25 C. [0045] In step 370, at least one opening of the inner sealable bag may be sealed via at least one surface of the outer sealable bag. For example, opening 15 of inner bag 10 is sealed via (through) the surface of the bag 30 by seal 40, for example, by soldering together all openings using polymeric adhesives. In some embodiments, prior to the sealing inserting the portion of the holder 25 further inside the inner sealable bag 10, such that surfaces of the at least one opening 15 of the inner sealable bag 15 are free to be attached and to be sealed to each other. [0046] Unless explicitly stated, the method embodiments described herein are not constrained to a particular order or sequence. Furthermore, all formulas described herein are intended as examples only and other or different formulas may be used. Additionally, some of the described method embodiments or elements thereof may occur or be performed at the same point in time. [0047] While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents may occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention. [0048] Various embodiments have been presented. Each of these embodiments may of course include features from other embodiments presented, and embodiments not specifically described may include various features described herein. 295879/1 9 CLAIMS1. An intraocular lens (IOL) package, comprising: an inner sealed sterile bag comprising the IOL and air having at least 75% relative humidity at 25 C, and an outer sealed sterile bag encompassing the inner sealed sterile bag, wherein at least one edge of the inner sealed sterile bag is sealed via at least one surface of the outer sealed sterile bag. 2. The IOL package of claim 1, wherein the inner sealed sterile bag comprises a material having a thermal conductivity higher by at least 1.1 times than the thermal conductivity of the IOL material. 3. The IOL package of claim 1 or claim 2, wherein the inner sealed sterile bag is made from at least one of: aluminum foil and polyester laminate with an aluminum layer. 4. The IOL package according to any one of claims 1 to 3, wherein the IOL inside the inner sealed sterile bag is glistening-free. 5. The IOL package according to any one of claims 1 to 4, wherein the outer sealed sterile bag is a steam sterilization pouch. 6. The IOL package according to any one of claims 1 to 5, wherein the outer sealed sterile bag comprises polypropylene with paper fibers. 7. The IOL package according to any one of claims 1 to 6, wherein the seal comprises polymeric adhesives suitable for steam sterilization. 8. The IOL package according to any one of claims 1 to 7, wherein the IOL is held by a holder inserted into the inner sealed sterile bag. 9. A method for packing an intraocular lens (IOL), comprising: (a) inserting the IOL into an inner sealable bag; (b) inserting the inner sealable bag into an outer sealable bag; (c) sealing the outer sealable bag; (d) conducting steam sterilization of the inner sealable bag and inside the outer sealable bag; and (e) sealing at least one opening of the inner sealable bag via at least one surface of the outer sealable bag.

Claims

1.HNL-P-013-IL 9 CLAIMS1. An intraocular lens (IOL) package, comprising: an inner sealed sterile bag comprising the IOL and air having at least 75% relative humidity at 25 °C, and an outer sealed sterile bag encompassing the inner sealed sterile bag, wherein at least one edge of the inner sealed sterile bag is sealed via at least one surface of the outer sealed sterile bag.

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

3. The IOL package of claim 1 or claim 2, wherein the inner sealed sterile bag is made from at least one of: aluminum foil and polyester laminate with an aluminum layer.

4. The IOL package according to any one of claims 1 to 3, wherein the IOL inside the inner sealed sterile bag is glistening-free.

5. The IOL package according to any one of claims 1 to 4, wherein the outer sealed sterile bag is a steam sterilization pouch.

6. The IOL package according to any one of claims 1 to 5, wherein the outer sealed sterile bag comprises polypropylene with paper fibers.

7. The IOL package according to any one of claims 1 to 6, wherein the seal comprises polymeric adhesives suitable for steam sterilization.

8. The IOL package according to any one of claims 1 to 7, wherein the IOL is held by a holder inserted into the inner sealed sterile bag.

9. A method for packing an intraocular lens (IOL), comprising: (a) inserting the IOL into an inner sealable bag; (b) inserting the inner sealable bag into an outer sealable bag; (c) sealing the outer sealable bag; (d) conducting steam sterilization of the inner sealable bag and inside the outer sealable bag; and (e) sealing at least one opening of the inner sealable bag via at least one surface of the outer sealable bag. HNL-P-013-IL 10

10. The method of claim 9, further comprising, prior to inserting the IOL into the inner sealable bag, placing the IOL on a holder, and inserting the holder into the inner sealable bag.

11. The method of claim 9 or claim 10, wherein the inner sealed sterile bag has a thermal conductivity higher by at least 1.1 times than the thermal conductivity of the IOL material.

12. The method of claim 10, wherein prior to the sealing, the method further includes inserting the portion of the holder further inside the inner sealable bag, such that surfaces of the at least one opening of the inner sealable bag are free to be attached and to be sealed to each other.

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

14. A method for packing an intraocular lens (IOL), comprising: (a) inserting the IOL into an inner sealable bag; (b) inserting the inner sealable bag into an outer sealable bag; (c) sealing the outer sealable bag; (d) conducting sterilization of the inner sealable bag and the outer sealable bag; (e) inserting the sterilized packing into a humidity chamber; (f) introducing humidity into the inner sealable bag, resulting in at least 75% relative humidity at 25 °C; and (g) sealing at least one opening of the inner sealable bag via at least one surface of the outer sealable bag.

15. The method of claim 14, further comprising, prior to inserting the IOL into the inner sealable bag, placing the IOL on a holder, and inserting the holder into the inner sealable bag.