WO2017181081A2 - Récipient d'emballage stérile - Google Patents

Récipient d'emballage stérile Download PDF

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Publication number
WO2017181081A2
WO2017181081A2 PCT/US2017/027727 US2017027727W WO2017181081A2 WO 2017181081 A2 WO2017181081 A2 WO 2017181081A2 US 2017027727 W US2017027727 W US 2017027727W WO 2017181081 A2 WO2017181081 A2 WO 2017181081A2
Authority
WO
WIPO (PCT)
Prior art keywords
container
open end
closure
container body
sterile
Prior art date
Application number
PCT/US2017/027727
Other languages
English (en)
Other versions
WO2017181081A3 (fr
Inventor
David LOOMIS
Morton ALBERT
Original Assignee
Nuvasive, 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
Application filed by Nuvasive, Inc. filed Critical Nuvasive, Inc.
Publication of WO2017181081A2 publication Critical patent/WO2017181081A2/fr
Publication of WO2017181081A3 publication Critical patent/WO2017181081A3/fr
Priority to US16/159,110 priority Critical patent/US11324580B2/en
Priority to US17/662,121 priority patent/US11707350B2/en
Priority to US18/329,777 priority patent/US12070381B2/en

Links

Classifications

    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/20—Holders specially adapted for surgical or diagnostic appliances or instruments
    • 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
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08—Radiation
    • A61L2/081—Gamma radiation
    • 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
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A61L2/206—Ethylene oxide
    • 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
    • A61B2050/0051—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
    • A61B2050/0053—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 of two concentric parallelepipeds about a common longitudinal axis
    • 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
    • A61B2050/0054—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 about the central longitudinal axis perpendicular to the lid plane
    • 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
    • A61B2050/0058—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 translation
    • A61B2050/006—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 translation perpendicular to the lid plane, e.g. by a downward movement
    • 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
    • A61B2050/0062—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 a combination of rotation and translation
    • A61B2050/0064—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 a combination of rotation and translation by screwing
    • 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
    • A61B2050/0066—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover with additional sealing means, e.g. O-ring
    • 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
    • A61L2202/23—Containers, e.g. vials, bottles, syringes, mail

Definitions

  • the field of the invention generally relates to sterile packaging for maintaining the sterility of medical implants prior to implantation.
  • implants are often housed and delivered, unsterilized, in large sterilization trays (together with the instruments used to facilitate their use) that are steam sterilized at the hospital just before surgery and delivered directly to the operating room. Implants used to replenish the trays are typically delivered in a disposable package that is discarded upon opening, the implant being placed in the tray for sterilization and eventual use.
  • each of the implants may be individually packaged in some form of disposable packaging (e.g. plastic pouches or blister packs) that are opened directly in the operating room, with the packaging being discarded.
  • disposable packaging e.g. plastic pouches or blister packs
  • sterile tubes such as those described in U.S. Patent 9,265,579, have been developed that have the sterility characteristics of the blister packs but are easier to handle and open in the operating room while also reducing overall waste.
  • the tube includes at least a portion formed of, or covered, by a membrane that prevents the passage of bacteria but is permeable to gas.
  • gaps may be designed within the threading between the tube and associated caps allow gas passage at a similar particle level to Tyvek® paper, the current standard used in blister packs, to prevent the passage of bacteria. While such tubes are very effective, they are currently limited to use with smaller implants because of constraints in the manufacturing process.
  • the injection molding process used to create the tubes requires draft angle be imparted in the tube structure to allow the tube to be removed from the molding pieces.
  • the length of the tube is directly tied to the diameter of the tube in that the larger length tube injection molded on z-axis is constrained by aspect ratio to correlate to a larger diameter as well.
  • a sterile packaging container for maintaining the sterility of medical implants prior to implantation that is manufactured so that the length is irrespective to the diameter of the, which in turn, provides for the smallest possible volume for the container.
  • a sterile packaging container configured for sterilization and gas permeation comprising a container body, a cover and a closure assembly.
  • the container body has a longitudinal axis, a first open end, and a second open end, and the container body has a cross-sectional shape that is uniform along the majority of the length of the longitudinal axis.
  • the cover and the closure assembly provide microbe-tight seals with the container body.
  • the sterile packaging container described herein may be placed within a second sterile packaging container.
  • Such embodiments comprise a second sterile packaging container containing the sterile packaging container described above. This embodiment adds the additional feature of allowing the sterilization of the exterior of the first sterile packaging container.
  • a method of manufacturing a sterile packaging container via a mechanical process is provided, to create a polymeric container body having a first open end, a second open end, and a cross-sectional shape that is constant along the majority of its longitudinal axis.
  • the container body is allowed to harden, and, the cover is hermetically sealed to the first open end of the container body.
  • the closure base is subsequently hermetically sealed to the second open end of the container body.
  • the removable closure cap is connected to the closure base, creating a gas permeable seal that inhibits microbial entry. Finally, the interior of the container body is sterilized.
  • An alternative embodiment of the method of manufacturing a sterile container comprising: extruding or pultruding a polymeric container body having a first open end, a second open end, and a cross-sectional shape that is constant along the majority of the longitudinal axis; allowing the container body to harden; sealing a cover to the first open end to create a first microbe-tight seal; sealing a closure to the second open end to create a second microbe-right seal; and sterilizing the interior of the container; wherein at least one of the first microbe-tight seal and the second microbe-tight seal is air permeable.
  • FIG. 1 illustrates an isometric view of an embodiment the sterile packaging container.
  • FIG. 2 illustrates an isometric view of the container body of the embodiment of the sterile packing container shown in FIG. 1.
  • FIG. 3 illustrates a cross-sectional side view of the container body of the embodiment of the sterile packing container shown in FIG. 1.
  • FIG. 4 illustrates a front view from the first open end of the container body of the embodiment of the sterile packing container shown in FIG. 1.
  • FIG. 5 illustrates an isometric view of the cover of the embodiment of the sterile packing container shown in FIG. 1.
  • FIG. 6 illustrates a cross-sectional side view of the cover cap of the embodiment of the sterile packing container shown in FIG. 1.
  • FIG. 7 illustrates a cross-sectional side view of the cover cap and stopper element of the embodiment of the sterile packing container shown in FIG. 1.
  • FIG. 8 illustrates a cross-sectional side view of the first open end of the container body with the cover attached thereto of the embodiment of the sterile packing container shown in FIG. 1.
  • FIG. 9 illustrates an isometric view of the closure assembly of the embodiment of the sterile packing container shown in FIG. 1.
  • FIG. 10 illustrates a cross-sectional side view of the closure assembly of the embodiment of the sterile packing container shown in FIG. 1.
  • FIG. 11 illustrates an isometric view of the closure base of the embodiment of the sterile packing container shown in FIG. 1.
  • FIG. 12 illustrates a cross-sectional side view of the closure base of the embodiment of the sterile packing container shown in FIG. 1.
  • FIG. 13 illustrates a side cross-sectional view of the closure cap of the embodiment of the sterile packing container shown in FIG. 1.
  • FIG. 14 illustrates a side cross-sectional view of the second open end of the container body with the closure assembly attached thereto of the embodiment of the sterile packing container shown in FIG. 1.
  • FIG. 15 illustrates a second embodiment of the sterile packaging container.
  • FIG. 16 illustrates a third embodiment of the sterile packaging container.
  • FIG. 17 illustrates a side cross-sectional view of the sterile packaging container of the embodiment shown in FIG. 16.
  • FIG. 18 illustrates an isometric view of the container body of the embodiment of the sterile packing container shown in FIG. 16.
  • FIG. 19 illustrates a front view of the container body of the embodiment of the sterile packing container shown in FIG. 16.
  • FIG. 20 illustrates a side view of the cover of the embodiment of the sterile packing container shown in FIG. 16.
  • FIG. 21 illustrates a side view of the closure assembly of the embodiment of the sterile packing container shown in FIG. 16.
  • FIG. 22 illustrates a side cross-sectional view of the closure assembly of the embodiment of the sterile packing container shown in FIG. 16.
  • the present disclosure provides a sterile packaging container 1000 that allows for more flexibility in the manufacture of sterile packaging for implants.
  • the sterile packaging container 1000 comprises: a container body 100, a cover 200, and a closure assembly 500.
  • the container body 100 may be generally cylindrical with a longitudinal axis 108, a first open end 101 and a second open end 102. In the example illustrated in Fig. 2, the first open end 101 and the second open end 102 have identical radii 107. Furthermore, the cross- sectional shape of the container body 100 is constant along the majority of the length 105 of the longitudinal axis 108. The purpose of the container body 100 is to house the desired implant for delivery while maintaining the sterility of said implant. Moreover, the radius 107 of the container body 100 is constant irrespective to the length 105 of the container body 100. The radius 107 has no specific dimension, but must be sufficient to house the desired implant. Likewise, the length 105 has no specific measurement as long as the container body 100 is sufficient to house the desired implant.
  • the internal geometry of the container body 100 is invariant to the external geometry of the container body 100 for the length 105 of the majority of the longitudinal axis 108.
  • an engagement feature such as a recess 109 that encircles the container body 100, which serves a guide for the placement of the cover 200 and closure assembly 500 upon fusion.
  • the cover 200 may be comprised of a cover cap 201 and stopper element 204.
  • the cover 200 has no specific size or shape so long as size is sufficient to fit accordingly with the container body 100.
  • the cover cap 201 like the cover 200, has no specific shape or size, as long as the cover cap 201 has a width 210 that exceeds the diameter 107 of the container body 100.
  • the cover cap 201 may be a cylinder with an aperture 205 that extends partially through the cover cap 201.
  • the cover cap 201 may also include a projection 212 that forms a ring along the interior surface
  • the stopper element 204 has a radius 208 that is sufficient to provide a seal or barrier to the interior surface 103 of the container body 100 as shown in Fig. 8.
  • the stopper element 204 is attached to the bottom surface 206 of the cover cap 201 and extends perpendicularly from the bottom surface 206 of the cover cap 201.
  • the stopper element 204 has a length 209 which is the distance that it extends from the cover cap 201 and that is sufficient to adequately form the airtight seal with the interior surface 103 of the container body 100.
  • a space 207 with a width 211 is sufficient to accept the wall 106 of the container body 100.
  • the sterile packaging container 1000 also includes a closure assembly 500, Figs. 9 -10.
  • the closure assembly 500 may be comprised of a closure cap 400 and a closure base 300.
  • the closure base 300 like the cover 200, has no specific shape or size as long the closure base 300 is large enough to encircle the second open end 102 of the container body 100.
  • the closure base 300 may be generally cylindrical in shape with an aperture 302 that extends the length 306 of the closure base 300, and a diameter 307 sufficient to encircle the second open end 102 of the container body 100.
  • Located on the exterior surface 303 of the closure base 300 is a threaded portion 301 for connection to the closure cap 400.
  • a projection 305 Located on the interior surface 304 of the closure base 300 is a projection 305 that forms a ring along the interior surface 304 of the closure base 300. Like the cover cap projection 212, the closure base projection 305 engages the recess 109 on the second open end 102 of the container body 100 during fusion.
  • the closure assembly 500 may include a closure cap 400, Fig. 13.
  • the closure cap 400 has no specific shape or size as long as the closure cap 400 is large enough to encircle the closure base 300.
  • the closure cap 400 may be generally cylindrical with an aperture 404 that extends partially through the closure cap 400 with a diameter 405 sufficient to encircle the closure base 300.
  • the closure cap 400 may contain an internal thread 401 that is mated to the external thread 301 on the closure base 300.
  • the threading between the closure cap 400 and closure base 300 is configured to form a microbe-tight seal that inhibits the passage of bacteria and viruses. Additionally, the seal may be an airtight (hermetic) seal.
  • An example of a manufacturing method of a container 1000 that comprises a closure assembly 500 with a closure cap 400 is as follows.
  • the cover cap 201 is attached to the first open end 101 of the container body 100.
  • the wall 106 of the container body fits between the exterior surface of the stopper element 204 and the interior surface 103 of the wall 106 of the cover cap 201.
  • the stopper element 204 forms an airtight seal with the interior surface 103 of the container body wall 106.
  • the exterior surface 104 of the container body wall 106 is hermetically sealed to the cover cap 201.
  • the cover cap 201 is in snap fit engagement with the first open end 101.
  • the closure base 300 On the opposite end of the container body 100, at the second open end 102 the closure base 300 encircles a portion of the container body 100 forming a hermetic seal, Fig. 14.
  • the closure cap 400 is affixed to the closure base 300 via the external threading 301 of the closure base 300 that is mated to the internal threading 401 on the closure cap 400.
  • the closure cap 400 forms a gas permeable seal with the closure base 300 which allows for sterilization.
  • a method of making a sterile container comprises creating, by a mechanical process, a polymeric container body 100 having a first open end, a second open end, and a cross-sectional shape that is constant along the majority of the longitudinal axis. In some embodiments of the method the radius 107 is consistent throughout the length 105 of the container body 100.
  • a polymer will be used that is acceptable for the desired method of sterilization, such as gamma or ethylene oxide sterilization.
  • the preferred method of a manufacture is extrusion or pultrusion, although other methods could be used that produce a cross-sectional shape that is constant along the majority of the longitudinal axis 108.
  • Either of the aforementioned methods allows the user to manufacture the container body 100 without the need of a draft profile which is often needed to remove the object from the mold, and results in a container body with an increasing radius throughout the length of the container body.
  • the container body 100 is allowed to harden, completing the manufacture process of the container body 100.
  • the cover 200 is hermetically sealed to the first open end 101 of the container body 100.
  • the cover 200 may be manufactured by various methods known in the art, such as the process of injection molding, or a similar process.
  • the cover 200 may be affixed to the container body 100 via ultrasonic, friction welding, or other fusion welding techniques known in the art.
  • the method involves hermetically sealing the closure base 300 to the second open end 102 of the container body 100.
  • the closure base 300 may be manufactured via the traditional process of injection molding, or a similar process known within the art.
  • the closure base 300 may be affixed to the container body 100 via ultrasonic, friction welding, or other fusion welding techniques known in the art.
  • the closure cap 400 may be attached to the closure base 300 by various means.
  • the cap and the base each have complementary engagement elements, such as complimentary screw threads. The threading is mated so that upon attaching the closure base 300 to the closure cap 400, the two elements form a gas permeable seal between the two that inhibits microbial entry.
  • the sterile packaging container 1000 is sterilized by the method of gamma radiation, ethylene oxide or any other method known in the art.
  • Another method for the manufacturing of a sterile container comprises: extruding or pultruding a polymeric container body having a first open end, a second open end, and a cross-sectional shape that is constant along the majority of the longitudinal axis; allowing the container body to harden; sealing a cover to the first open end to create a first microbe- tight seal; sealing a closure to the second open end to create a second microbe-right seal; and sterilizing the interior of the container; wherein at least one of the first microbe-tight seal and the second microbe-tight seal is air permeable.
  • the sterile packaging container 3000 comprises: a container body 3100, a cover 3200, and a closure assembly 3500.
  • the container body 3100 may be a hexagonal prism with a longitudinal axis 3108, a first open end 3101 and a second open end 3102.
  • the first open end 3101 and the second open end 3102 have identical radii 3107.
  • the cross-sectional shape of the container body 100 is constant along the length 3105 of the longitudinal axis 3108.
  • an engagement feature such as an internal recess 3109 that forms a ring along the interior surface 3103 the container body 3100, which serves a guide for the placement of the cover 3200 and closure assembly 3500 upon fusion.
  • the cover 3200 is comprised of a cover cap 3201 and stopper element 3204, as shown in Figs. 16, 17, and 21.
  • the cover cap 3201 like the cover 3200, has no specific shape or size.
  • the cover cap 3201 may be a cylinder.
  • the stopper element 3204 may generally be a cylinder with a radius 3208 that is sufficient to provide a seal or barrier to the internal recess 3109 of the container body 3100 as shown in Fig. 17.
  • the stopper element 3204 is adjacent to the cover cap 3201 and extends horizontally from the cover cap 3201.
  • the sterile packaging container 3000 also includes a closure assembly 3500, Figs. 22 -23.
  • the closure assembly 3500 may be comprised of a closure cap 3400 and a closure base 3300.
  • the closure base 3300 like first embodiment, has no specific shape or size, but the closure base 3300 no longer needs to encircle the second open end 3102 of the container body 3100.
  • the closure base 3300 is generally cylindrical in shape with an aperture 3302 that extends the length 3306 of the closure base 3300.
  • Located on the exterior surface 3303 of the closure base 3300 is a projection 3305 that encircles the exterior surface 3303 of the closure base 3300.
  • the closure base projection 3305 engages the internal recess 3109 on the second open end 3102 of the container body 3100 during fusion.
  • the closure assembly 3500 may include a closure cap 3400, Figs.
  • the closure cap 3400 has no specific shape or size as long as the closure cap 3400 is large enough to encircle the closure base 3300.
  • the closure cap 3400 may be generally cylindrical with an aperture 3404 that extends partially through the closure cap 3400 with a diameter 3405 sufficient to encircle the closure base 3300.
  • the closure cap 3400 may be affixed to the closure base 3300 via friction fit that is also configured to form a microbe-tight seal that inhibits the passage of bacteria and viruses. Additionally, the seal may be an airtight (hermetic) seal. It should be noted that the manufacture of this embodiment is identical to that of the original 1000.
  • a sterile packaging container 2000 that is configured to allow for the external sterilization of a similar sterile packaging container 1000.
  • the sterile packaging container 2000 as illustrated in Fig. 15 comprises: a second container body 2100, a second cover 2200, and a second closure assembly 2500.
  • the dimensions are dependent on the varying size of the original sterile packaging container 1000.
  • the container body while still having a longitudinal axis, a first open end, and a second open end, wherein the container body has a cross-sectional shape that is uniform along the entire length of the longitudinal axis, now has a radius that must exceed the radii of the cover 200 and closure assembly 500 of the first sterile packaging container 1000.
  • the remaining elements like the first sterile packaging container 1000, must be dimensioned to accommodate the container body 2100.
  • the first sterile packaging container 1000 is placed within the container body 2100.
  • the sterile packaging container 2000, and the exterior of the first sterile packaging container 1000 is sterilized using by the method of gamma radiation, ethylene oxide or any other method known in the art.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Closures For Containers (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

Selon un aspect, la présente invention concerne un récipient d'emballage stérile comprenant un corps de récipient ayant une forme en coupe transversale qui est constante le long de la majeure partie de l'axe longitudinal, un couvercle et un ensemble de fermeture qui empêche le passage d'agents de contamination microbiens. Le récipient est conçu de telle sorte que l'intérieur du récipient peut être stérilisé. Le récipient d'emballage stérile décrit ici permet de fabriquer un tube d'emballage stérile présentant le plus petit volume possible.
PCT/US2017/027727 2016-04-14 2017-04-14 Récipient d'emballage stérile WO2017181081A2 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US16/159,110 US11324580B2 (en) 2016-04-14 2018-10-12 Sterile packaging container
US17/662,121 US11707350B2 (en) 2016-04-14 2022-05-05 Stertile packaging container
US18/329,777 US12070381B2 (en) 2016-04-14 2023-06-06 Sterile packaging container

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662322682P 2016-04-14 2016-04-14
US62/322,682 2016-04-14

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US16/159,110 Continuation US11324580B2 (en) 2016-04-14 2018-10-12 Sterile packaging container

Publications (2)

Publication Number Publication Date
WO2017181081A2 true WO2017181081A2 (fr) 2017-10-19
WO2017181081A3 WO2017181081A3 (fr) 2017-11-23

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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