EP4577155A1 - Emballage humide stérile et procédé d'emballage pour lentille intraoculaire hydrophobe - Google Patents

Emballage humide stérile et procédé d'emballage pour lentille intraoculaire hydrophobe

Info

Publication number
EP4577155A1
EP4577155A1 EP23856828.1A EP23856828A EP4577155A1 EP 4577155 A1 EP4577155 A1 EP 4577155A1 EP 23856828 A EP23856828 A EP 23856828A EP 4577155 A1 EP4577155 A1 EP 4577155A1
Authority
EP
European Patent Office
Prior art keywords
iol
bag
sealable bag
gas
sealed
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23856828.1A
Other languages
German (de)
English (en)
Inventor
Yakir KUSHLIN
Boris HASH
Alexander MALIAROV
Eran IVANIR
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hanita Lenses Ltd
Original Assignee
Hanita Lenses Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from IL295879A external-priority patent/IL295879B2/en
Application filed by Hanita Lenses Ltd filed Critical Hanita Lenses Ltd
Priority claimed from PCT/IL2023/050890 external-priority patent/WO2024042519A1/fr
Publication of EP4577155A1 publication Critical patent/EP4577155A1/fr
Pending legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D77/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/04—Articles or materials enclosed in two or more containers disposed one within another
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1691—Packages or dispensers for intraocular lenses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/04—Heat
    • A61L2/06—Hot gas
    • A61L2/07—Steam
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/16—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A61L2/206—Ethylene oxide
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/12—Sterilising contents prior to, or during, packaging
    • B65B55/18—Sterilising contents prior to, or during, packaging by liquids or gases
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/18—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient
    • B65D81/20—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas
    • B65D81/2069—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas in a special atmosphere
    • B65D81/2084—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas in a special atmosphere in a flexible container
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/23—Containers other than laboratory or medical, e.g. bottles or mail
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B2220/00—Specific aspects of the packaging operation
    • B65B2220/16—Packaging contents into primary and secondary packaging
    • B65B2220/20—Packaging contents into primary and secondary packaging the primary packaging being bags, the secondary packaging being further bags, the primary bags being either finished or formed concurrently with the secondary bags

Definitions

  • the present invention relates generally to a sterile package and method of packaging suitable for intraocular lenses. More specifically, the present invention relates to a sterile package filled with moisture for intraocular lens and method of packing same.
  • An intraocular lens is an artificial lens that replaces the eye's natural lens which is removed during cataract surgery or refractive lens exchange (RLE) surgery.
  • lOLs usually comprise 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.
  • the haptics are of the same material as the lens and the lOLs are called one-piece lOLs.
  • IOLs’ optical zones 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 may include an accommodating mechanism, designed to allow the eye to regain some partial focusing ability in order to change focus from distance to near vision by using the ciliary muscle movement or other external energy source.
  • modem soft or flexible IOLs are made from various polymers, such as those based an acrylate backbone, polypropylene-based 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- and siloxane-based lenses or other combinations of polymers.
  • polymers such as those based an acrylate backbone, polypropylene-based 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- and siloxane-based lenses or other combinations of polymers.
  • Modem 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 40% as the extreme hydrophilic.
  • Soft IOLs are found to be more flexible once hydrated. Hydrophilic IOLs must be kept in water or saline in order to be implanted, as in the non-hydrated state the lens is rigid and not flexible. Soft IOLs made of a hydrophobic material, when kept in a sterile dry environment, are less flexible than in their hydrated state. Such lack of flexibility of the hydrophobic IOL impairs the smoothness of injection of the IOL into the lens capsule.
  • Some aspects of the invention are directed to a package for an item such as an intraocular lens (IOL), comprising: an inner sealed sterile bag comprising the IOL and air having at least 75% relative humidity (RH) 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.
  • the air in the inner sealed bag is at least 80% RH.
  • 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.
  • the inner sealed sterile bag is made from at least one of: aluminum foil and polyester laminate with an aluminum layer.
  • the IOL inside the inner sealed sterile bag is glistening-free.
  • the outer sealed sterile bag is a steam sterilization pouch.
  • the outer sealed sterile bag comprises a gas-permeable window such as a web of paper or polyethylene fibers.
  • the seal comprises polymeric adhesives suitable for steam sterilization.
  • the IOL is held by a holder inserted into the inner sealed sterile bag.
  • 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.
  • 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.
  • the inner sealed sterile bag has a thermal conductivity higher by at least 1.1 times than the thermal conductivity of the IOL material.
  • the method prior to the sealing, 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.
  • 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.
  • the outer sealable bag further comprises a gas- permeable window.
  • 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.
  • IOL intraocular lens
  • 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.
  • the sterilization is done by EtO sterilization.
  • the outer sealable bag further comprises a gas-permeable window.
  • Some additional aspects of the invention are directed to a package for an item such as a hydrophobic intraocular lens (IOL), comprising: a bag containing the hydrophobic IOL, the bag being sterile and sealed, wherein the hydrophobic IOL has been sterilized by steam sterilization while inside the bag; and at least one of 1) the bag; 2) a holder of the IOL; and 3) a metallic object near the bag during the steam sterilization, comprises a material having a thermal conductivity higher by at least 1.1 times than the thermal conductivity of the hydrophobic IOL material; and the hydrophobic IOL in the sterile sealed bag is glistening- free.
  • the air in the bag has a relative humidity of at least 75% at 25 °C. In some embodiments, the air in the bag has a relative humidity of at least 80% at 25 °C.
  • the sealed bag comprises two flexible layers bonded together along at least a portion of their circumference.
  • the two flexible layers are made of aluminum foil, polyester laminate with an aluminum layer, or any combination thereof.
  • Some additional embodiments are directed to a method for packaging a hydrophobic intraocular lens (IOL), comprising: inserting the hydrophobic IOL into a bag; conducting steam sterilization of the hydrophobic IOL inside the bag; and sealing the bag, wherein at least one of 1) the bag; 2) a holder of the hydrophobic IOL; and 3) a metallic object near the sealed bag during the steam sterilization, comprises a material having a thermal conductivity higher by at least 1.1 times than the thermal conductivity of the hydrophobic IOL material; and the hydrophobic IOL in the sterile, sealed bag is glistening- free.
  • IOL intraocular lens
  • Some additional aspects of the invention are directed to a packaged intraocular lens (IOL), comprising: an IOL; 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.
  • IOL intraocular lens
  • Some additional aspects of the invention are directed to a packaged hydrophobic intraocular lens (IOL), comprising: a hydrophobic IOL; a bag containing the hydrophobic IOL, the bag being sterile and sealed, wherein at least one of 1) the bag; 2) a holder of the hydrophobic IOL; and 3) a metallic object near the bag during the steam sterilization, comprises a material having a thermal conductivity higher by at least 1.1 times than the thermal conductivity of the hydrophobic IOL material; the hydrophobic IOL, while inside the bag, was sterilized by steam sterilization, before the sealing of the bag; and the hydrophobic IOL in the sterile sealed bag is glistening-free.
  • IOL intraocular lens
  • Some additional aspects of the invention are directed to a method for packaging an IOL (or other item), comprising: placing the IOL inside a sealable bag, the sealable bag comprising an impermeable portion and a first gas-permeable window; sealing the sealable bag with a first seal, whereby the IOL and at least a portion of the first gas-permeable window are inside a first-sealed portion of the sealable bag; sterilizing the sealable bag in a sterilizing environment, the sterilizing environment permeating the first gas-permeable window and sterilizing the IOL; and sealing the sealable bag with a second seal, whereby the first gas-permeable window is outside the second-sealed portion of the sealable bag and the IOL is inside the second-sealed portion of the sealable bag, wherein the air inside the second-sealed portion is at least 60% relative humidity at 25 °C. In some embodiments, the air inside the second-sealed portion is at least 80% relative humidity at 25 °C. In
  • the IOL is composed of a hydrophobic material.
  • performing of sterilization is done by ethylene oxide (EtO) sterilization.
  • the method further comprises placing the sealable bag in a humid environment, the humid environment thereby permeating the first gas-permeable window and humidifying the first-sealed portion to at least said relative humidity.
  • the method further comprises placing the IOL holder, IOL injector, or IOL injector cartridge into an inner receptacle having a second gas-permeable window.
  • the inner receptacle comprises a blister pack with a gas- permeable backing.
  • the front part of the blister pack is impermeable.
  • the method further comprises detaching a remnant from the sealable bag, the remnant being outside of the second-sealed portion.
  • the sterilization is by ethylene oxide (EtO) sterilization.
  • the sterilization is by steam sterilization.
  • EtO sterilization may be preferred where the sealable bag contains an IOL injector 512, since many IOL injectors cannot withstand temperatures of steam sterilization.
  • EtO sterilization may also be preferred where the IOL itself cannot withstand temperatures of steam sterilization.
  • the sealable bag 510 containing the inner receptacle 505 may be placed in a humidity chamber.
  • humidity is introduced into the humidity chamber until the air inside the first-sealed portion, including the interior of the inner receptacle 505, is at least 60% relative humidity at 25 °C.
  • Humidification can be of particular benefit in the packaging of an IOL injector: keeping the hydrophilic coating of the injector tip moist can prevent the coating from cracking.
  • relative humidity is at least 65% at 25 °C. In some embodiments, the relative humidity is at least 80% at 25 °C.
  • the sealable bag 510 is sealed with a second seal 550, whereby the second gas-permeable 515 opening is outside a second- sealed portion (depicted by 455 in Fig. 4C) of the sealable bag 510 and the inner receptacle 505 is inside the second-sealed portion, as shown in Fig. 5E.
  • the second seal 550 prevents any gases or vapors from leaving or entering the second-sealed portion of the sealable bag 510. Air with the humidity level established by humidification may thereby be trapped inside the second-sealed portion until the package is opened.
  • the second gas-permeable window 520 may be removed from the sealable bag 510 by cutting sealable bag 510 with a cut 560 outside of the second seal 550, as shown in Fig. 5F.
  • FIG. 6 a flowchart of a method 600 for sterile, most packaging an item.
  • the method 600 comprises:
  • packaging embodiments herein is in reference to packaging of an intraocular lens, it is understood that the packaging is suited to any medical device or other item requiring sterilization and/or benefiting from humid-environment storage.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Packages (AREA)
  • Prostheses (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

La présente invention concerne un emballage humide stérile et un procédé d'emballage pour une lentille intraoculaire (LIO). Dans certains modes de réalisation, le procédé comprend la réalisation d'une stérilisation à la vapeur à l'intérieur d'un sac externe, avec une LIO à l'intérieur d'un sac interne ouvert. Le sac interne comprend un matériau dont la conductivité thermique est supérieure à 1,1 fois celle du matériau de la LIO. Le procédé comprend en outre le scellement du sac interne par le biais du sac externe, emprisonnant ainsi de l'air humidifié (> 70 % HR à 25 °C) à l'intérieur du sac interne. Dans d'autres modes de réalisation, le procédé comprend la réalisation d'une stérilisation à l'oxyde d'éthylène et d'une humidification à l'intérieur d'une première région scellée d'un sac scellable comprenant une fenêtre perméable aux gaz - contenant une LIO préchargée dans un injecteur de LIO. Le procédé comprend en outre le scellement du sac scellable avec un second scellement, de sorte qu'une seconde région scellée du sac scellable exclut la fenêtre perméable au gaz, emprisonnant l'air humidifié (> 60 % HR à 25 °C) à l'intérieur de la seconde région scellée du sac scellable.
EP23856828.1A 2022-08-23 2023-08-22 Emballage humide stérile et procédé d'emballage pour lentille intraoculaire hydrophobe Pending EP4577155A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IL295879A IL295879B2 (en) 2022-08-23 2022-08-23 Sterile moist package for hydrophobic intraocular lens and method of packing same
US202263406843P 2022-09-15 2022-09-15
PCT/IL2023/050890 WO2024042519A1 (fr) 2022-08-23 2023-08-22 Emballage humide stérile et procédé d'emballage pour lentille intraoculaire hydrophobe

Publications (1)

Publication Number Publication Date
EP4577155A1 true EP4577155A1 (fr) 2025-07-02

Family

ID=95250177

Family Applications (1)

Application Number Title Priority Date Filing Date
EP23856828.1A Pending EP4577155A1 (fr) 2022-08-23 2023-08-22 Emballage humide stérile et procédé d'emballage pour lentille intraoculaire hydrophobe

Country Status (3)

Country Link
EP (1) EP4577155A1 (fr)
JP (1) JP2025527684A (fr)
IL (1) IL319095A (fr)

Also Published As

Publication number Publication date
JP2025527684A (ja) 2025-08-22
IL319095A (en) 2025-04-01

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