US20210259828A1 - Defined removal site on sterile blister pack - Google Patents

Defined removal site on sterile blister pack Download PDF

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Publication number
US20210259828A1
US20210259828A1 US17/313,245 US202117313245A US2021259828A1 US 20210259828 A1 US20210259828 A1 US 20210259828A1 US 202117313245 A US202117313245 A US 202117313245A US 2021259828 A1 US2021259828 A1 US 2021259828A1
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Prior art keywords
blister pack
sterile
eye surgery
pressure point
marked
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Pending
Application number
US17/313,245
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Marec Weber
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Alcon Inc
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Alcon Inc
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Priority to US17/313,245 priority Critical patent/US20210259828A1/en
Assigned to ALCON INC. reassignment ALCON INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: 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 US20210259828A1 publication Critical patent/US20210259828A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1691Packages or dispensers for intraocular lenses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26Accessories or devices or components used for biocidal treatment
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B69/00Unpacking of articles or materials, not otherwise provided for
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B69/00Unpacking of articles or materials, not otherwise provided for
    • B65B69/005Unpacking of articles or materials, not otherwise provided for by expelling contents, e.g. by squeezing the container
    • B65B69/0058Solid contents
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS 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
    • B65D75/00Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32Articles 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
    • B65D75/325Articles 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
    • B65D75/326Articles 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B2050/005Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0051Containers, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B2050/005Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0065Peelable cover
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B2050/3008Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments having multiple compartments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, 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
    • A61B90/08Accessories or related features not otherwise provided for
    • A61B2090/0807Indication means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/12Apparatus for isolating biocidal substances from the environment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/18Aseptic storing means
    • A61L2202/181Flexible packaging means, e.g. permeable membranes, paper
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/18Aseptic storing means
    • A61L2202/182Rigid packaging means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/21Pharmaceuticals, e.g. medicaments, artificial body parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/24Medical instruments, e.g. endoscopes, catheters, sharps

Definitions

  • FIG. 3 is an elevation view of the front of a blister pack with defined pressure points

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (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)
  • Chemical & Material Sciences (AREA)
  • Composite Materials (AREA)
  • Packages (AREA)

Abstract

A system and method for systematic, controlled removal of sterile products from blister packs for use during surgery is disclosed.

Description

    TECHNICAL FIELD
  • The present disclosure relates to systems and methods for systematic, controlled removal of sterile products from blister packs for use during eye surgery.
  • BACKGROUND
  • During eye surgery, such as refractive surgery, sterile products are often provided in blister packs. These products of have sensitive surfaces, such as a lens.
  • Currently, a 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.
  • SUMMARY
  • 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.
  • In one embodiment, 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.
  • In another embodiment, 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.
  • In another embodiment, 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.
  • Other technical advantages will be apparent to those of ordinary skill in the art in view of the following specification, claims, and drawings.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • For a more complete understanding of the present invention and its features and advantages, reference is now made to the following description, taken in conjunction with the accompanying drawings, and in which:
  • 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 an elevation view of the front of a blister pack with defined pressure points;
  • FIG. 4 is an elevation view of the back of the blister pack of FIG. 3;
  • FIG. 5 is flow chart of a method for using a blister pack with defined pressure points.
  • DETAILED DESCRIPTION
  • 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.
  • In the following description, details are set forth by way of example to facilitate discussion of the disclosed subject matter. It should be apparent to a person of ordinary skill in the field, however, that the disclosed embodiments are exemplary and not exhaustive of all possible embodiments.
  • Referring now to the drawings, FIG. 1 and FIG. 2 are blister pack 100. In the embodiment shown in FIG. 1, 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. In the embodiment show in FIG. 2, 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, as shown, 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.” Optionally, 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. In the case of a package design with simple sterile barriers, 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. By allowing controlled removal of the sterile eye surgery instrument using the pressure points, the sterile eye surgery instrument should drop out at a controlled time and in a controlled manner.
  • In another embodiment, not shown, 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. In the embodiment shown in FIG. 3, 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. In the embodiment show in FIG. 4, the back 290 of blister pack 200 is shown. The location of sterile holding areas 220 and 230 and pressure points 240, 250, and 260, are 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.
  • In this embodiment, operating room (OR) preparation or an eye surgery procedure is begun, 302.
  • A protective cover is removed from the blister pack, 304.
  • Then 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.
  • Next, 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.
  • Finally, the blister pack is removed from the sterile surface, 310.
  • The above disclosed subject matter is to be considered illustrative, and not restrictive, and the appended claims are intended to cover all such modifications, enhancements, and other embodiments which fall within the true spirit and scope of the present disclosure. Thus, to the maximum extent allowed by law, the scope of the present disclosure is to be determined by the broadest permissible interpretation of the following claims and their equivalents, and shall not be restricted or limited by the foregoing detailed description. For instance, many example embodiments herein are depicted and described using a blister pack. It will be apparent to one of ordinary skill in the art that a variety of types of sterile eye surgery instruments, may be used in such embodiments with corresponding increases in the complexity of blister pack design.

Claims (11)

1.-10. (canceled)
11. A method for removing a sterile eye surgery instrument from a blister pack comprising:
removing the protective layer from the blister pack;
inverting the blister pack;
placing the blister pack on a sterile surface;
applying pressure to at least one defined pressure point on the back of the blister pack; and
removing the blister pack while the eye surgery instrument is still sterile.
12. The method of claim 11, wherein the sterile eye surgery instrument is a lens.
13. The method of claim 11, wherein the pressure point is marked.
14. The method of claim 13, wherein the step of applying pressure to at least one defined pressure point on the back of the blister pack comprises:
pressing a first pressure point marked to indicate it should be used first; and
pressing a second pressure point marked to indicate it should be used second.
15. The method of claim 11, wherein the pressure point is a movable lug.
16. The method of claim 15, wherein applying pressure to at least one defined pressure point on the back of the blister pack comprises pulling on the lug.
17. The method of claim 15, wherein applying pressure to at least one defined pressure point on the back of the blister pack comprises unscrewing the lug.
18. The method of claim 15, wherein applying pressure to at least one defined pressure point on the back of the blister pack comprises actuating the lug.
19. The method of claim 15, wherein the sterile eye surgery instrument is a lens.
20. The method of claim 15, wherein the step of applying pressure to at least one defined pressure point on the back of the blister pack comprises:
moving a first lug marked to indicate it should be used first;
moving a second lug marked to indicate it should be used second.
US17/313,245 2016-07-18 2021-05-06 Defined removal site on sterile blister pack Pending US20210259828A1 (en)

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PCT/IB2016/054273 WO2018015784A1 (en) 2016-07-18 2016-07-18 Defined removal site on sterile blister pack
US201816309124A 2018-12-12 2018-12-12
US17/313,245 US20210259828A1 (en) 2016-07-18 2021-05-06 Defined removal site on sterile blister pack

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US16/309,124 Division US20190298513A1 (en) 2016-07-18 2016-07-18 Defined removal site on sterile blister pack

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EP3484531B1 (en) 2021-11-10
AU2016415948B2 (en) 2021-09-30
US20190298513A1 (en) 2019-10-03
CN109414520A (en) 2019-03-01
JP2019520911A (en) 2019-07-25
WO2018015784A1 (en) 2018-01-25
EP3484531A1 (en) 2019-05-22
AU2016415948A1 (en) 2018-12-06
JP6904985B2 (en) 2021-07-21
CA3025432A1 (en) 2018-01-25
ES2902057T3 (en) 2022-03-24

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