US20190298513A1 - Defined removal site on sterile blister pack - Google Patents

Defined removal site on sterile blister pack Download PDF

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Publication number
US20190298513A1
US20190298513A1 US16/309,124 US201616309124A US2019298513A1 US 20190298513 A1 US20190298513 A1 US 20190298513A1 US 201616309124 A US201616309124 A US 201616309124A US 2019298513 A1 US2019298513 A1 US 2019298513A1
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US
United States
Prior art keywords
blister pack
sterile
eye surgery
pressure point
marked
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
US16/309,124
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English (en)
Inventor
Marec Weber
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.)
Alcon Inc
Original Assignee
Novartis AG
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
Application filed by Novartis AG filed Critical Novartis AG
Assigned to NOVARTIS AG reassignment NOVARTIS AG ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: WAVELIGHT GMBH
Assigned to WAVELIGHT GMBH reassignment WAVELIGHT GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: WEBER, MAREC
Publication of US20190298513A1 publication Critical patent/US20190298513A1/en
Assigned to ALCON INC. reassignment ALCON INC. CONFIRMATORY DEED OF ASSIGNMENT EFFECTIVE APRIL 8, 2019 Assignors: NOVARTIS AG
Abandoned legal-status Critical Current

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Classifications

    • 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—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26—Accessories or devices or components used for biocidal treatment
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • 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
    • 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
    • B65B69/00—Unpacking of articles or materials, not otherwise provided for
    • 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
    • B65B69/00—Unpacking of articles or materials, not otherwise provided for
    • B65B69/005—Unpacking of articles or materials, not otherwise provided for by expelling contents, e.g. by squeezing the container
    • B65B69/0058—Solid contents
    • 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
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/325—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
    • B65D75/326—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming one compartment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B2050/005—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0051—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover closable by rotation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B2050/005—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0065—Peelable cover
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B2050/3008—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments having multiple compartments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/12—Apparatus for isolating biocidal substances from the environment
    • 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/18—Aseptic storing means
    • A61L2202/181—Flexible packaging means, e.g. permeable membranes, paper
    • 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/18—Aseptic storing means
    • A61L2202/182—Rigid packaging means
    • 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts
    • 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps

Definitions

  • the present disclosure relates to systems and methods for systematic, controlled removal of sterile products from blister packs for use during eye surgery.
  • sterile products are often provided in blister packs. These products of have sensitive surfaces, such as a lens.
  • non-sterile user such as the operating room nurse
  • opens the blister pack The outside of the blister pack is not sterile and must be touched to open the closed blister pack. Then, non-sterile user must perform hand disinfection before removing items from the opened blister pack. This complicates and lengthens the surgical procedure and makes accidental contamination and loss of sterility more likely.
  • This disclosure provides a way to allow removal of the sterile items with sensitive surfaces from the blister pack without requiring the non-sterile user to perform hand disinfection.
  • the disclosure relates to a method of using a blister pack with sterile products inside, removing the protective layer from the blister pack, inverting the blister pack, placing the blister pack on a sterile surface, pressing on at least one defined pressure point on the back of the blister pack, and removing the blister pack.
  • the disclosure relates to a method of using a blister pack with sterile products inside, removing the protective layer from the blister pack, inverting the blister pack, placing the blister pack on a sterile surface, removing a removable lug from at least one defined point on the back of the blister pack, and removing the blister pack.
  • the disclosure relates to a blister back with a sterile holding area, a sterile eye surgery instrument, and at least one point marked on the back of the back of the blister pack for controlled removal of the sterile eye surgery instrument.
  • FIG. 1 is a not-to-scale schematic view of the front of a blister pack with two sterile eye surgery instruments and defined pressure points;
  • FIG. 2 is a not-to-scale schematic view of the back of the blister pack of FIG. 1 ;
  • FIG. 3 is flow chart of a method for using a blister pack with defined pressure points
  • FIG. 4 is an elevation view of the front of a blister pack with defined pressure points
  • FIG. 5 is an elevation view of the back of the blister pack of FIG. 4 .
  • This disclosure provides a way to allow removal of the sterile items with sensitive surfaces from the blister pack without requiring the non-sterile user to perform hand disinfection.
  • This disclosure provides a blister pack with defined pressure points and methods of its use.
  • FIG. 1 and FIG. 2 are blister pack 100 .
  • the front 110 of a blister pack 100 includes two sterile holding areas 120 , 130 .
  • Each sterile holding area is shown with a single sterile eye surgery instrument (e.g. sterile eye surgery instrument 122 , sterile eye surgery instrument 132 ).
  • Blister packs with a single sterile holding area are also possible. More than the one sterile eye surgery instrument may be placed in a single sterile holding area.
  • the back 190 of blister pack 100 is shown.
  • the location of sterile holding areas 120 and 130 and pressure points 140 , 150 , 160 , and 170 are shown. Pressure points 140 , 150 , 160 , and 170 are located within the sterile holding areas 120 and 130 .
  • Non-limiting examples of sterile eye surgery instruments that could be used during eye surgery, such as refractive surgery, is an applanation cone or a lens.
  • FIG. 1 and FIG. 2 are actually marked with a circled “X” at pressure points 140 , 150 , 160 , and 170 .
  • Such markings are optional for any or all pressure points 140 , 150 , 160 , and 170 , and if marked, other indicators may be used such as an “X” mark or an embossed word, e.g. “push.”
  • pressure points 140 , 150 , 160 , and 170 are marked on the rear surface 190 of blister pack 100 and not on the front surface 110 . If the blister pack requires that the pressure points be pressed in a particular order or in particular combinations, then the blister pack will be so marked.
  • the invention does not require the rear surface 190 of blister pack 100 to be sterile.
  • Pressure points are placed to avoid sensitive spots or brittle spots on the sterile eye surgery instruments.
  • the absence of such defined pressure points means an increased risk of damage, especially to sensitive surfaces during removal of the sterile eye surgery instrument.
  • the sterile eye surgery instrument should drop out at a controlled time and in a controlled manner.
  • blister pack 100 may include movable lugs instead of any one or more of the pressure points.
  • the movable lugs are designed to keep the inside of blister pack 100 sterile when they are moved, e.g. actuated, removed, moved, or unscrewed.
  • FIG. 3 is an elevation view of the front of a blister pack 200 with defined pressure points.
  • the front 210 of a blister pack 200 includes two sterile holding areas 220 , 230 .
  • Each sterile holding area is shown with a single sterile eye surgery instrument (e.g. sterile eye surgery instrument 222 , sterile eye surgery instrument 232 ).
  • Blister packs with a single sterile holding area are also possible. More than one sterile eye surgery instruments may be placed in a single sterile holding area.
  • the location of sterile holding areas 220 and 230 and pressure points 240 , 250 , and 260 are shown.
  • FIG. 4 is an elevation view of the back of the blister pack 200 with defined pressure points.
  • the back 290 of blister pack 200 is shown.
  • Pressure points 240 , 250 , and 260 are located near the sterile holding areas 220 and 230 .
  • FIG. 5 is flow chart of a method of using a blister pack with defined removal sites, such as blister pack 100 .
  • operating room (OR) preparation or an eye surgery procedure is begun, 302 .
  • a protective cover is removed from the blister pack, 304 .
  • the blister pack is inverted onto a sterile surface, 306 . It is important to maintain the surface and the inside of the blister pack as both sterile.
  • At least one and likely all pressure points are pressed, 308 . If the blister pack requires that the pressure points be pressed in a particular order or in particular combinations, then the blister pack will be so marked. In another embodiment, the pressure points are removable lugs that are removed at this step.
  • the blister pack is removed from the sterile surface, 310 .

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mechanical Engineering (AREA)
  • Ophthalmology & Optometry (AREA)
  • Epidemiology (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Composite Materials (AREA)
  • Chemical & Material Sciences (AREA)
  • Packages (AREA)
US16/309,124 2016-07-18 2016-07-18 Defined removal site on sterile blister pack Abandoned US20190298513A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2016/054273 WO2018015784A1 (en) 2016-07-18 2016-07-18 Defined removal site on sterile blister pack

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2016/054273 A-371-Of-International WO2018015784A1 (en) 2016-07-18 2016-07-18 Defined removal site on sterile blister pack

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US17/313,245 Division US20210259828A1 (en) 2016-07-18 2021-05-06 Defined removal site on sterile blister pack

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US20190298513A1 true US20190298513A1 (en) 2019-10-03

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Application Number Title Priority Date Filing Date
US16/309,124 Abandoned US20190298513A1 (en) 2016-07-18 2016-07-18 Defined removal site on sterile blister pack
US17/313,245 Abandoned US20210259828A1 (en) 2016-07-18 2021-05-06 Defined removal site on sterile blister pack
US18/592,481 Active US12458489B2 (en) 2016-07-18 2024-02-29 Defined removal site on sterile blister pack

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US17/313,245 Abandoned US20210259828A1 (en) 2016-07-18 2021-05-06 Defined removal site on sterile blister pack
US18/592,481 Active US12458489B2 (en) 2016-07-18 2024-02-29 Defined removal site on sterile blister pack

Country Status (8)

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US (3) US20190298513A1 (enExample)
EP (1) EP3484531B1 (enExample)
JP (1) JP6904985B2 (enExample)
CN (1) CN109414520A (enExample)
AU (1) AU2016415948B2 (enExample)
CA (1) CA3025432C (enExample)
ES (1) ES2902057T3 (enExample)
WO (1) WO2018015784A1 (enExample)

Cited By (5)

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CN117750922A (zh) * 2021-08-02 2024-03-22 卡尔蔡司医疗技术股份公司 包括具有人工晶状体的眼科注入器的容纳装置
USD1035436S1 (en) 2022-08-26 2024-07-16 Regeneron Pharmaceuticals, Inc. Packaging
USD1042107S1 (en) 2022-08-26 2024-09-17 Regeneron Pharmaceuticals, Inc. Packaging
USD1047700S1 (en) 2022-08-26 2024-10-22 Regeneron Pharmaceuticals, Inc. Packaging
US12458746B2 (en) 2019-07-29 2025-11-04 Regeneron Pharmaceuticals, Inc. Medical device packaging and related methods

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12458746B2 (en) 2019-07-29 2025-11-04 Regeneron Pharmaceuticals, Inc. Medical device packaging and related methods
CN117750922A (zh) * 2021-08-02 2024-03-22 卡尔蔡司医疗技术股份公司 包括具有人工晶状体的眼科注入器的容纳装置
USD1035436S1 (en) 2022-08-26 2024-07-16 Regeneron Pharmaceuticals, Inc. Packaging
USD1042107S1 (en) 2022-08-26 2024-09-17 Regeneron Pharmaceuticals, Inc. Packaging
USD1047700S1 (en) 2022-08-26 2024-10-22 Regeneron Pharmaceuticals, Inc. Packaging

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JP2019520911A (ja) 2019-07-25
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US12458489B2 (en) 2025-11-04
EP3484531B1 (en) 2021-11-10
EP3484531A1 (en) 2019-05-22
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CA3025432A1 (en) 2018-01-25
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