EP3148900A1 - Système de conditionnement de lio hydrophile - Google Patents

Système de conditionnement de lio hydrophile

Info

Publication number
EP3148900A1
EP3148900A1 EP15722813.1A EP15722813A EP3148900A1 EP 3148900 A1 EP3148900 A1 EP 3148900A1 EP 15722813 A EP15722813 A EP 15722813A EP 3148900 A1 EP3148900 A1 EP 3148900A1
Authority
EP
European Patent Office
Prior art keywords
container
intraocular lens
lens
free water
foldable
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.)
Withdrawn
Application number
EP15722813.1A
Other languages
German (de)
English (en)
Inventor
Robert Glick
Jürgen Zimmermann
Marco Müller
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.)
Carl Zeiss Meditec AG
Aaren Scientific Inc
Original Assignee
Carl Zeiss Meditec AG
Aaren Scientific Inc
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 US14/292,322 external-priority patent/US20150114855A1/en
Application filed by Carl Zeiss Meditec AG, Aaren Scientific Inc filed Critical Carl Zeiss Meditec AG
Priority claimed from PCT/US2015/027130 external-priority patent/WO2015183432A1/fr
Publication of EP3148900A1 publication Critical patent/EP3148900A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • B65D77/003—Articles enclosed in rigid or semi-rigid containers, the whole being wrapped
    • 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
    • B65D81/22—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 in moist conditions or immersed in liquids

Definitions

  • This invention relates generally to packaging methods and systems, and more specifically to packaging methods and systems for foldable intraocular lenses.
  • Intraocular lens polymers can be broadly categorized into two groups: (1) materials that absorb less than 1 percent water and (2) materials that absorb more than 1 percent water. Materials that absorb less than one percent water are typically referred to as hydrophobic polymers. Hydrophobic polymers may be foldable at room temperature. Their "foldability" results from their composition rather than from water acting as a plasticizer. Water absorbing polymers are typically referred to as hydrophilic polymers or hydrogels. The most common materials in this group have approximately 25 percent water by weight. Hydrophilic polymers are usually foldable at room temperature by virtue of absorbed water acting as a plasticizer.
  • Immersion in water or saline in the presence of other plastics needed for retention or insertion of the intraocular lens can result in contamination of the intraocular lens by chemical entities contained in or produced by other plastic components in the packaging system. Being immersed in water or saline, the intraocular lens can "communicate" with plastic components via the liquid phase. Also, when an insertion instrument is removed from the package for use, water can flow from where the instrument was stored within the package to the intraocular lens.
  • the packaging of intraocular lens in water or saline has the additional disadvantage, especially when the intraocular lens is packaged with an insertion instrument, of increasing the weight of the package, thereby increasing shipping costs.
  • implantation systems for hydrophilic intraocular lenses either require some kind of preparation of the injector or they use concepts of partly preloaded injector designs, e.g. with an adaptable cartridge with the preloaded intraocular lens including some preparation steps. All such preparation steps entail risks associated with possible false preparations or other mishandling by the surgeon or nurse. It is therefore advantageous to reduce the number of required preparation steps to as few as possible. This is especially true with so called MICS intraocular lenses - designed for micro incision cataract surgery. These lenses may require prefolding to facilitate advancement through the tubular region of the injector for better reproducibility of the injection process (with regard to tilting and rotation) and for proper folding of the intraocular lens.
  • the invention avoids the aforementioned problems in the prior art.
  • the invention is a hydrophilic intraocular lens storage combination which comprises: a) a substantially air tight container containing a small quantity of free water; and b) a foldable hydrophilic intraocular lens disposed within the container at a location wherein the lens is not immersed in liquid.
  • the invention is a method of maintaining a hydrophilic intraocular lens in a foldable state without being immersed in liquid.
  • the method comprises the step of storing a foldable intraocular lens within a substantially air tight package containing free water, the lens being stored within the package at a location wherein the lens is not immersed in liquid.
  • Figure 1 is a partially cut away perspective view of a combination having features of the invention
  • Figure 2 is a cross-sectional side view of the combination of Figure 1;
  • Figure 3 is an upper side perspective view of a tray usable in the combination of Figure 1 ;
  • Figure 4 is a lower side perspective view of the tray illustrated in Figure 3 ;
  • Figure 5 is a bottom view of the tray illustrated in Figure 3;
  • Figure 6 is a side view of the tray illustrated in Figure 3;
  • Figure 7 is an end view of the tray illustrated in Figure 3.
  • Figure 8 is a perspective top view of the tray illustrated in Figure 3, showing retention of an intraocular lens and an intraocular lens injector.
  • the invention is a method of maintaining a hydrophilic intraocular lens in a foldable state without immersing the intraocular lens in liquid.
  • the method comprises the step of storing the foldable intraocular lens within a substantially air tight container containing free water, the lens being stored within the container at a location wherein the lens is not immersed in liquid.
  • free water means water that is free to move about the interior of the air tight container and its contents; it may evaporate or condense or form drops; it is not bound to any matrix, substrate or absorbing substance; it is not primarily contained in a cavity or reservoir.
  • water means pure water, as well as any aqueous solutions which may contain salts or other solutes.
  • the word "foldable” means sufficiently pliable to allow the lens to be rolled into a cylinder with an external diameter sufficiently small to permit the lens to be injected into the eye of a patient through an injection tube having an external diameter of 2 mm or less.
  • the inventors have discovered the surprising fact that sufficient hydration of a hydrophilic intraocular lens can be maintained to the extent needed for folding and insertion into an eye without immersion of the lens in a liquid.
  • this is accomplished by packaging the lens with water saturated air, or nearly saturated air.
  • Nearly saturated it is meant a humidity level of at least about 90%, preferably at least 95%.
  • saturated such air cannot accept water from a hydrophilic intraocular lens, and when nearly saturated, such air can only accept a minimal amount of water from a hydrophilic intraocular lens.
  • the air within the container is nearly saturated and the volume of such air within the container is minimal (e.g. less than 100 cubic centimeters), the loss of water from the intraocular lens is unimportantly small.
  • the invention is a combination 10 comprising: (a) a substantially air tight container 12 containing free water 14; and (b) a foldable hydrophilic intraocular lens 16 disposed within the container 12 at a location wherein the lens 16 is not immersed in liquid.
  • a substantially air tight container 12 containing free water 14 containing free water 14
  • a foldable hydrophilic intraocular lens 16 disposed within the container 12 at a location wherein the lens 16 is not immersed in liquid.
  • Figures 1 and 2 One embodiment of the combination 10 is illustrated in Figures 1 and 2.
  • the container 12 can be provided by a substantially air tight foil pouch.
  • Other types of substantially air tight containers 12 can be used in the alternative.
  • substantially air tight it is meant that the container 12 is fully enclosed, but, perhaps, very small amounts of air may diffuse through the container walls.
  • the intraocular lens 16 is stored securely within a tray 18.
  • Figures 3-8 illustrate a typical tray 18 in detail.
  • the tray 18 has an elongate compartment 20 bounded by a bottom wall 22, side walls 26 and an elongate top opening 28.
  • the tray 18 can have a length of about 7.8 inches, a width of about 2.75 inches and a maximum depth of about 1.0 inch.
  • the tray 18 can be made from a thermoplastic, such as polypropylene. In the embodiment illustrated in Figures 3-8, the tray 18 can be made from .040" polypropylene.
  • the tray 18 has a circumferential rim 30 with a raised outer lip 32 surrounding a recessed inner band 34. As illustrated in Figure 2, the elongate top opening 28 is left unsealed.
  • the free water 14 is in an amount which barely exceeds that needed to moisture saturate the interior volume of the container 12 at temperatures up to those needed for steam sterilization, as well as to form small water droplets throughout the container 12. This amount of free water 14 should include that which would be lost over the storage duration due to diffusion through the walls of the container 12.
  • the quantity of free water 14 within the container 12 depends on the volume of the container 12. For example, the quantity of (liquid) free water 14 within the container 12 is typically between about 0.1% and about 20% of the interior volume of the container 12. Typically, the amount of free water within the container will range between about 0.5 to about 5 milliliters, most typically between about 0.5 to about 3 milliliters, such as, for example, about 1 milliliter.
  • the combination 10 is preferably autoclavable, that is, it is able to withstand being heated to 121 degrees C or more for a period of half an hour or more.
  • the intraocular lens 16 can be disposed unfolded within an injector 36.
  • the injector 36 is adapted to fold and inject the intraocular lens 16 into the eye of a patient through a cylindrical injection tube 38 having an external diameter sufficiently small to allow for surgical implanting of the lens 16 with minimum trauma to the eye.
  • the cylindrical injection tube 38 has an external diameter of 2 millimeters or less.
  • the injector 36 (loaded with the intraocular lens 16) is placed into the tray 18 and then the tray 18 is placed into the containerlO.
  • the desired amount of free water 14 is delivered (by adding droplets or by spraying) to the interior of the container 12, typically at random locations. Then the containerl2 is sealed.
  • the free water 14 typically clings in tiny droplets to the interior walls of the container 12 and to the exterior and interior of the tray 18 - thereby providing sufficient humidity within the container 12 to maintain the intraocular lens 16 in a foldable state.
  • the invention greatly simplifies the manufacture and storage of hydrophilic intraocular lenses, reduces the costs of storage, reduces the cost of shipping and minimizes the risk of handling errors.

Landscapes

  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un système de rangement (10) de lentille intraoculaire hydrophile comprenant : a) un récipient sensiblement étanche à l'air (12) contenant une petite quantité d'eau libre (14) ; et b) une lentille intraoculaire hydrophile pliable (16) disposée à l'intérieur du récipient à un emplacement au niveau duquel la lentille n'est pas immergée dans un liquide. Le système de rangement peut être utilisé pour conserver la lentille intraoculaire hydrophile dans un état pliable sans être immergée dans un liquide. Le procédé comprend l'étape consistant à ranger la lentille intraoculaire pliable dans un emballage sensiblement étanche à l'air contenant de l'eau libre, la lentille étant rangée à l'intérieur de l'emballage à un emplacement au niveau duquel la lentille n'est pas immergée dans un liquide.
EP15722813.1A 2014-05-30 2015-04-22 Système de conditionnement de lio hydrophile Withdrawn EP3148900A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14/292,322 US20150114855A1 (en) 2013-10-24 2014-05-30 Hydrophilic iol packaging system
PCT/US2015/027130 WO2015183432A1 (fr) 2014-05-30 2015-04-22 Système de conditionnement de lio hydrophile

Publications (1)

Publication Number Publication Date
EP3148900A1 true EP3148900A1 (fr) 2017-04-05

Family

ID=58160070

Family Applications (1)

Application Number Title Priority Date Filing Date
EP15722813.1A Withdrawn EP3148900A1 (fr) 2014-05-30 2015-04-22 Système de conditionnement de lio hydrophile

Country Status (1)

Country Link
EP (1) EP3148900A1 (fr)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014074142A1 (fr) * 2012-11-12 2014-05-15 Hollister Incorporated Hydratation à la vapeur d'un dispositif médical dans l'emballage

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014074142A1 (fr) * 2012-11-12 2014-05-15 Hollister Incorporated Hydratation à la vapeur d'un dispositif médical dans l'emballage

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2015183432A1 *

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