US20050006255A1 - Contact lens packages containing additives - Google Patents

Contact lens packages containing additives Download PDF

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Publication number
US20050006255A1
US20050006255A1 US10/731,258 US73125803A US2005006255A1 US 20050006255 A1 US20050006255 A1 US 20050006255A1 US 73125803 A US73125803 A US 73125803A US 2005006255 A1 US2005006255 A1 US 2005006255A1
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US
United States
Prior art keywords
package
pvp
concentration
average roughness
maleic anhydride
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.)
Abandoned
Application number
US10/731,258
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English (en)
Inventor
James Peck
Dharmesh Dubey
Michael Tokarski
Qiang Zhang
Yufu Li
Steven Arnold
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.)
Individual
Original Assignee
Individual
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32713054&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US20050006255(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Priority to US10/731,258 priority Critical patent/US20050006255A1/en
Publication of US20050006255A1 publication Critical patent/US20050006255A1/en
Priority to US12/342,506 priority patent/US20090165427A1/en
Priority to US14/594,558 priority patent/US20150121809A1/en
Abandoned legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A45—HAND OR TRAVELLING ARTICLES
    • A45C—PURSES; LUGGAGE; HAND CARRIED BAGS
    • A45C11/00—Receptacles for purposes not provided for in groups A45C1/00-A45C9/00
    • A45C11/005—Contact lens cases
    • A—HUMAN NECESSITIES
    • A45—HAND OR TRAVELLING ARTICLES
    • A45C—PURSES; LUGGAGE; HAND CARRIED BAGS
    • A45C11/00—Receptacles for purposes not provided for in groups A45C1/00-A45C9/00
    • A—HUMAN NECESSITIES
    • A45—HAND OR TRAVELLING ARTICLES
    • A45C—PURSES; LUGGAGE; HAND CARRIED BAGS
    • A45C11/00—Receptacles for purposes not provided for in groups A45C1/00-A45C9/00
    • A45C11/04—Spectacle cases; Pince-nez cases
    • A—HUMAN NECESSITIES
    • A45—HAND OR TRAVELLING ARTICLES
    • A45C—PURSES; LUGGAGE; HAND CARRIED BAGS
    • A45C11/00—Receptacles for purposes not provided for in groups A45C1/00-A45C9/00
    • A45C11/04—Spectacle cases; Pince-nez cases
    • A45C11/046—Spectacle cases; Pince-nez cases with contact lens holders
    • 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
    • A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
    • A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
    • 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
    • A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
    • A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
    • A61L12/086—Container, accessories or devices therefor
    • 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
    • B65B25/00—Packaging other articles presenting special problems
    • 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
    • B65B25/00—Packaging other articles presenting special problems
    • B65B25/008—Packaging other articles presenting special problems packaging of contact lenses
    • 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
    • B65B55/22—Immersing contents in protective liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes

Definitions

  • This invention related to packages for storing contact lenses as well as methods of using and preparing these packages.
  • FIG. 1 illustrates the data for Lens A in different packages
  • FIG. 2 illustrates the data for Lens B in different packages
  • FIG. 3 illustrates the data for Lens C in different packages
  • This invention includes a package for storing medical devices in a solution comprising, consisting essentially of, or consisting of, a molded base wherein the molded base comprises an additive, provided that the medical device is not a contact lens consisting of acqualfilcon A coated with polyHema.
  • a “medical device” is any device that is stored or packaged in a solution and is used to treat a human disease.
  • medical devices include but are not limited to ophthalmic devices that reside in or on the eye.
  • Ophthalmic devices includes but are not limited to soft contact lenses, intraocular lenses, overlay lenses, ocular inserts, and optical inserts. These devices can provide optical correction or may be cosmetic.
  • the preferred medical devices of the invention are soft contact lenses made from silicone elastomers or hydrogels, which include but are not limited to silicone hydrogels, and fluorohydrogels.
  • Soft contact lens formulations are disclosed in U.S.
  • the particularly preferred medical devices of the invention are soft contact lenses made from etafilcon A, genfilcon A, lenefilcon A, polymacon, balafilcon A, lotrafilcon A. and silicone hydrogels as prepared in U.S. Pat. No. 5,998,498, U.S. patent application Ser. No. 09/532,943, a continuation-in-part of U.S. patent application Ser. No. 09/532,943, filed on Aug. 30, 2000, U.S. Pat. No. 6,087,415, U.S. Pat. No. 5,760,100, U.S. Pat. No. 5,776, 999, U.S. Pat. No. 5,789,461, U.S. Pat. No.
  • the more particularly preferred medical devices of the invention are soft contact lenses, balafilcon A, lotrafilcon A, galyfilcon A, senofilcon A, or those made as described in U.S. patent application Ser. No. 60/318,536, entitled Biomedical Devices Containing Internal wetting Agents,” filed on Sep. 10, 2001 and its non-provisional counterpart of the same title, filed on Sep. 6, 2002.
  • the most particularly preferred medical devices are soft contact lenses made from either galyfilcon A or senofilcon A.
  • molded base refers to any polymer, rubber, or plastic that can be formed into a receptacle for medical devices, where the size and shape of the base are determined by the device and other considerations known those who are skilled in the art of making or designing molded bases.
  • molded bases may be individual blister packages, secondary packages, or hydrating trays.
  • the molded base may be prepared from any number of materials provided that those materials are compatible with the chemical and physical properties of the device. Examples of suitable materials include but are not limited to polypropylene, polyethylene, nylons, olefin co-polymers, acrylics, rubbers, urethanes, polycarbonates, or fluorocarbons.
  • the preferred materials are metallocenes polymers and co-polymers made of polypropylene, polyethylene, having a melt flow range of about 15 g/10 minutes to about 44 g/10 minutes as determined by ASTM D-1238.
  • examples of suitably shaped bases are disclosed in the following patents which are hereby incorporated by reference in their entirety, U.S. Pat. Nos.
  • Flexible cover sheets can be made from can be an adhesive laminate of an aluminum foil and a polypropylene film or any other extruded or co-extruded film that can be sealed to the top surface of the flange in order to form a hermetic seal for the medical device and the solution.
  • the base can be formed by any of a number of known methods which include but are not limited to injection molding, transfer molding, skin packaging, blow molding, coinjection molding, film extrusion, or film co-extrusion.
  • additive refers to a substance that is added to the polymer, rubber, or plastic prior to forming the molded base, where the material inhibits sticking, adherence, or adhesion of the medical device to the molded base.
  • the additive is mixed with the remainder of the molded base material and amount of additive present by weight percentage based on the total weight of the molded base material is greater than about 0.25 to about 10 weight percent, preferably greater than about 0.25 to about 5 weight percent, most preferably about 0.25 to about 3 weight percent.
  • the preferred additives are glycerol monostearate (2%), polyvinylpyrolidone (1% to 5%), polyvinylpyrolidone/maleic anhydride (1/1% to 5/5%), and succinic acid (5%).
  • Polyvinylpyrolidinone has a variety of molecular weight ranges (as indicated by the KD#) and consistencies (flake, powdered/micronized). When PVP KD90 is used as an additive, it is preferred that it is powered/micronized.
  • solution refers to any liquid medium in which a medical device is stored.
  • the preferred solutions are aqueous solutions contain physiological buffers.
  • the particularly preferred solution is saline solution.
  • the medical device is a contact lens
  • the molded base is transparent to the degree necessary to permit visual inspection, UV sterilization or both.
  • the preferred additives are glycerol monostearate present at about 2 weight percent, succininc acid present at about 5 weight percent, PVP KD90 present at about 1-5 weight percent, PVP/maleic anhydride present at about 1/1 to about 5/5 weight percent. If the inner surface of the medical device has a roughness of about 0.2 ⁇ m to about 4.5 ⁇ m, the preferred additives are maleic anhydride or PVP/maleic anhydride, most preferably maleic anhydride.
  • the invention includes a method of reducing the adherence of a medical device to its packaging, comprising, consisting essentially of, or consisting of, storing said medical device in a solution in a package comprising, consisting essentially of, or consisting of, a molded base wherein said molded base comprises an additive, provided that the medical device is not a contact lens consisting of acqualfilcon A coated with polyHema.
  • molded base, medical device, solution and additive all have their aforementioned meanings and preferred ranges.
  • soft contact lenses When soft contact lenses are prepared, the lenses cured to a hard disc and subsequently hydrated with water to give the non-sterilized final product. During this hydration step, soft contact lenses often stick to the surface of the hydration chamber and it would useful to find a method of hydrating soft contact lenses which alleviates this problem.
  • the invention includes a method of hydrating a contact lens comprising, consisting essentially of, or consisting of hydrating said lens in a molded base wherein said molded base comprises an additive.
  • molded base, medical device, solution and additive all have their aforementioned meanings.
  • the preferred values for the medical device, the solution and the additive are as listed above.
  • the preferred molded base is a square or a rectangle.
  • Ampacet 40604 fatty acid amide ATOFINA Finacene Nucleated polypropylene having a melt 3924CWZ flow of 55 g/10 minutes, ASTM D1238.
  • This material contains an antistat and a lubricant Atmer 163 fatty alkyl diethanolamine Reg. No. 107043-84-5 Dow Siloxane a silicone dispersion MB50-321 Epolene E43-Wax, maleic anhydride produced by Eastman Chemical Erucamide fatty acid amide Registry No.
  • Lens C Contact lenses prepared as described in U.S. Pat. App. No. 60/318,536, entitled Biomedical Devices Containing Internal wetting Agents,” filed on September 10, 2001 and its non-provisional counterpart of the same title, filed on September 6, 2002, containing by weight percent 28% Simma 2, 31% mPDMS, 23.5% DMA, 7% PVP (MW 360,000), 1.5% TEDGMA, 0.98% CGI 1850, 2.0% Norbloc, 6 HEMA, 0.02% Blue Hema.
  • Additives (identity and amounts listed in Table 1) were mixed with polypropylene (listed below).
  • the material was injection molded to form the base portion of a contact lens package.
  • the configuration of the package is as illustrated in FIG. 1 of U.S. Pat. No. 5,467,868 which is hereby incorporated by reference.
  • Packages containing 2% weight percent GMS and Exxon 1605 were prepared using the method of Example 1. Contact lenses of types A, B, and C were added to individual blister packages along with 950 ⁇ L of saline solution. The filed packages were heat sealed with flexible covers and sterilized. The packaged lenses were submitted to consumers. The consumers opened the packages and evaluated the lenses for ease of removal of the lens from the package using the following criteria and grading system
  • FIG. 1 illustrates the testing results for a comparison of Lens A in a polypropylene package (control), Lens A in a package containing 2.0% GMS where the package has an average surface roughness (Ra) of about 2.0 ⁇ m, and Len A in a package containing 2.0% GMS. This figure shows that the roughened package containing GMS has the highest consumer rating.
  • FIG. 2 illustrates the testing results for a comparison of Lens B in a polypropylene package (control), Lens B in a package containing 2.0% GMS where the package has an average surface roughness (Ra) of about 2.0 am, and Len B in a package containing 2.0% GMS. This figure shows that the package containing 2.0%GMS has the highest consumer rating.
  • FIG. 3 illustrates the testing results for a comparison of Lens C in a polypropylene package (control), Lens C in a package containing 2.0% GMS where the package has an average surface roughness (Ra) of about 2.0 ⁇ m, and Len C in a package containing 2.0% GMS. This figure shows that the package containing 2.0% GMS has the highest consumer rating.
  • Example 1 The testing methods and preparations of Example 1 were repeated with different additives and lens types as per Table 2. If “(UP)” appears in an entry, that bowl of the blister is shaped as in U.S. Pat. No. D 458,023. When the term “Rough Bowl” appears, the inside surface of the bowl is roughened to an Ra of 0.5 mm to 0.8 mm.

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  • Health & Medical Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • General Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Eyeglasses (AREA)
  • Packaging Frangible Articles (AREA)
  • Packages (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
US10/731,258 2002-12-23 2003-12-09 Contact lens packages containing additives Abandoned US20050006255A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US10/731,258 US20050006255A1 (en) 2002-12-23 2003-12-09 Contact lens packages containing additives
US12/342,506 US20090165427A1 (en) 2002-12-23 2008-12-23 Contact lens packages containing additives
US14/594,558 US20150121809A1 (en) 2002-12-23 2015-01-12 Contact lens packages containing additives

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US43610902P 2002-12-23 2002-12-23
US10/731,258 US20050006255A1 (en) 2002-12-23 2003-12-09 Contact lens packages containing additives

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US12/342,506 Division US20090165427A1 (en) 2002-12-23 2008-12-23 Contact lens packages containing additives

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US20050006255A1 true US20050006255A1 (en) 2005-01-13

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US10/731,258 Abandoned US20050006255A1 (en) 2002-12-23 2003-12-09 Contact lens packages containing additives
US12/342,506 Abandoned US20090165427A1 (en) 2002-12-23 2008-12-23 Contact lens packages containing additives
US14/594,558 Abandoned US20150121809A1 (en) 2002-12-23 2015-01-12 Contact lens packages containing additives

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US12/342,506 Abandoned US20090165427A1 (en) 2002-12-23 2008-12-23 Contact lens packages containing additives
US14/594,558 Abandoned US20150121809A1 (en) 2002-12-23 2015-01-12 Contact lens packages containing additives

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US (3) US20050006255A1 (fr)
EP (10) EP2283876A1 (fr)
JP (1) JP4776926B2 (fr)
KR (1) KR101229813B1 (fr)
CN (1) CN100384484C (fr)
AR (1) AR043320A1 (fr)
AU (2) AU2003296355B2 (fr)
BR (1) BR0317631B1 (fr)
CA (3) CA2510567C (fr)
DE (1) DE60331170D1 (fr)
HK (4) HK1080399A1 (fr)
TW (1) TWI350187B (fr)
WO (1) WO2004060099A2 (fr)

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US20080015315A1 (en) * 2006-07-12 2008-01-17 Frank Chang Novel Polymers
US20080143958A1 (en) * 2006-12-13 2008-06-19 Arturo Norberto Medina Production of ophthalmic devices based on photo-induced step growth polymerization
US20080174035A1 (en) * 2006-06-08 2008-07-24 Lynn Cook Winterton Silicone hydrogel contact lenses
US20090059165A1 (en) * 2007-08-31 2009-03-05 John Dallas Pruitt Contact lens products
US20090057164A1 (en) * 2007-08-31 2009-03-05 Kasey Jon Minick Contact lens packaging solutions
US20090086160A1 (en) * 2007-09-28 2009-04-02 Enns John B Methods of sterilizing ophthalmic lenses
US8051978B2 (en) 2008-10-21 2011-11-08 Menicon Co., Ltd. Contact lens storage container
US9829723B2 (en) 2015-12-03 2017-11-28 Novartis Ag Contact lens packaging solutions

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US20050205451A1 (en) * 2004-03-18 2005-09-22 Brown-Skrobot Susan K Contact lens packages
US20060051454A1 (en) * 2004-08-26 2006-03-09 Ansell Scott F Molds for producing ophthalmic lenses
US7426993B2 (en) 2005-08-09 2008-09-23 Coopervision International Holding Company, Lp Contact lens package
US8414804B2 (en) 2006-03-23 2013-04-09 Johnson & Johnson Vision Care, Inc. Process for making ophthalmic lenses
US7572841B2 (en) 2006-06-15 2009-08-11 Coopervision International Holding Company, Lp Wettable silicone hydrogel contact lenses and related compositions and methods
US7540609B2 (en) 2006-06-15 2009-06-02 Coopervision International Holding Company, Lp Wettable silicone hydrogel contact lenses and related compositions and methods
US8231218B2 (en) 2006-06-15 2012-07-31 Coopervision International Holding Company, Lp Wettable silicone hydrogel contact lenses and related compositions and methods
GB2493017B (en) * 2011-07-19 2016-08-03 Carl Zeiss Meditec Sas Cassette for an intraocular lens and injector device for an intraocular lens
CN102502091A (zh) * 2011-10-27 2012-06-20 广州科甫眼镜有限公司 具有放大作用的透明接触镜贮存和摆放器具及其制备方法

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