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WO2019237036A1 - Récipient pour médicament scellé par compression hermétique - Google Patents

Récipient pour médicament scellé par compression hermétique Download PDF

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Publication number
WO2019237036A1
WO2019237036A1 PCT/US2019/036112 US2019036112W WO2019237036A1 WO 2019237036 A1 WO2019237036 A1 WO 2019237036A1 US 2019036112 W US2019036112 W US 2019036112W WO 2019237036 A1 WO2019237036 A1 WO 2019237036A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
medicament container
housing
medicament
container
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.)
Ceased
Application number
PCT/US2019/036112
Other languages
English (en)
Inventor
Christopher Joseph KUEHN
Thomas R. Prentice
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.)
Adrenacard Inc
Original Assignee
Adrenacard 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 Adrenacard Inc filed Critical Adrenacard Inc
Publication of WO2019237036A1 publication Critical patent/WO2019237036A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M2005/314—Flat shaped barrel forms, e.g. credit card shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback

Definitions

  • APIs active pharmaceutical ingredients
  • complete drug formulations is a growing field, spanning high-volume API storage containers (e.g., bags, drums, etc.), to complex end-user oriented mechanical delivery mechanisms (e.g., injectors, pumps, syringes, etc.).
  • high-volume API storage containers e.g., bags, drums, etc.
  • complex end-user oriented mechanical delivery mechanisms e.g., injectors, pumps, syringes, etc.
  • FIG. 1 illustrates an isometric view of one embodiment of a needle injection system (NIS) including a medicament container visible through a viewing port in the outer housing.
  • NIS needle injection system
  • FIG. 2 illustrates an isometric view of one embodiment of an NIS in a state in which medicament is injected.
  • FIG. 3 illustrates an isometric view one embodiment of a
  • FIG. 4 illustrates an isometric, sectional view of a medicament container for use in an NIS.
  • FIG. 5 illustrates an open-face sectional view of an NIS in a stored state.
  • FIG. 6 illustrates an open face sectional view of one embodiment of an NIS in a post injection and sharps protection lockout state.
  • FIG. 7 illustrates an example injection method for the NIS disclosed herein. DETAILED DESCRIPTION
  • Traditional medicament (e.g., active pharmaceuticals ingredients, drugs, etc.) containers include borosilicate glass containers, including cartridges, syringes, vials, etc.
  • Borosilicate glass has a low coefficient of thermal expansion and high chemical resistance, such as compared to common silicate glass. Molded polymers can be used for short-term medicament containment
  • Molded polymers are less prone to fracture than glass, such as from pressure or impact, and can be constructed in unique geometrical designs, such as to assist in mechanical delivery system integration.
  • Layered laminates such as used in intravenous delivery bags, bulk powder API storage bags, and blister packs, can provide water vapor, oxygen, light, and other degradation protection.
  • Impermeable metallic containers such as used in implantable drug pumps, etc., may provide adequate medicament compatibility and strength to maintain a complex internal shape.
  • the present inventors have recognized, among other things, systems, apparatus, and methods to utilize an opaque material to majorly contain a drug, in combination with a hermetically-sealed secondary
  • a majorly-opaque medicament container e.g., having an outside surface with a greater opaque surface area than translucent surface area, etc.
  • a hermitically e.g., having an outside surface with a greater opaque surface area than translucent surface area, etc.
  • compression-sealed translucent material e.g., a viewing port, such as a window, etc.
  • a viewing port such as a window, etc.
  • compression-sealed translucent material can provide visibility of medicament, such as to allow a user to have visual access to inspect the medicament prior use, for example, in a drug pump or needle injection system.
  • FIG. 1 illustrates an isometric view of an example Needle-Injection System (NIS) in a stored state having a safety cap 21.
  • NIS Needle-Injection System
  • One embodiment contains two sections of housing, a top housing 20 and a bottom housing 19, which contain the components held within.
  • the housing sections may be held together by fasteners, snap features, or other mechanism such as precision welding, etc.
  • the NIS includes a medicament container visible through a viewing port in a top housing 20 of the NIS, with the NIS in a stored state (e.g., prior to use).
  • the viewing port can include a window 2, such as a hermetic compression- sealed window composed of a translucent ceramic or glass that allows visualization of medicament stored in a medicament container through the window 2.
  • the viewing port can include a cut-out configured to enable viewing of an underlying window 2 in the medicament container, or otherwise include a translucent material, such as a window 2, itself, in addition to an underlying translucent portion of the medicament container stored within the NIS.
  • Translucence is a physical property that allows light to pass through. Transparency is a subset of translucence, allowing light to pass through without being scattered.
  • the viewing port or window 2 can be round, such as illustrated in FIG. 1, or one or more other shapes (e.g., square, rectangular, etc.).
  • the viewing port or window 2 can be in a bottom housing 19 of the NIS, or the NIS can include a second viewing port or window 2 in the bottom housing 19.
  • the safety cap 21 optionally includes grip features and is configured to cover a needle guard comprising a needle port.
  • the safety cap 21 can have mechanical features, such as cutouts or grooves, etc., configured to engage with corresponding mechanical features of the underlying needle guard, such as ramped abutments 15, etc.
  • the embodiment of FIG. 1 includes a relatively flat NIS and primary medicament container. In other embodiments, the NIS can include one or more other shapes or profiles.
  • FIG. 2 illustrates an isometric view of an example NIS in an activated state where a needle 14 has been extended but a sharps protection mechanism has not yet extended to cover it (e.g., a state in which medicament is injected).
  • the safety cap 21 has been removed exposing the needle guard 17.
  • pressure on the needle guard 17 can trigger application of force, such as from a spring, to eject the needle 14 from inside of the NIS to outside of the NIS through a needle port of the needle guard 17.
  • Medicament can be delivered through a channel of the needle 14.
  • such element can include a cannula or other tubular structure comprising a channel configured to deliver or inject a medicament into tissue.
  • FIG. 3 illustrates an isometric view of an example medicament container 1 for use in an NIS, such as illustrated in FIGS. 1 and 2.
  • the medicament container 1 can be constructed of a material (header material), including stainless or rolled steel, titanium, or one or more other drug- compatible materials configured to receive, store, and provide a drug- compatible inner surface to store a medicament.
  • Provide the drug-compatible inner surface can include electropolishing, passivation, plasma-etching, extrude-honing, or applying specialty vapor or plasma deposited coatings, such as Parylene or Silicone Dioxide, to the interior surface of the medicament container 1.
  • the medicament container 1 can be subtractive manufactured from bulk material or molded, such as using an injection molding and sintering process to gain equivocal chemical purity of the metallic surface.
  • the medicament container 1 can include a window 2, such as described above.
  • the window 2 can be composed of a translucent material, such as a ceramic or glass, translucent enough for visualization of a
  • the window 2 may be manufactured separately from the medicament container, from a separate component header material, and installed in the medicament container 1 after a hermetic seal has been established.
  • the medicament container may include a side cap to be welded or otherwise installed to seal a fluid line configured to fill the medicament container 1.
  • the NIS can include a sterility mechanism, components configured to maintain sterility, including the medicament container 1, a fluid line sterility housing 3, a cap 4, a needle sterility shield 5, a needle hub 6, and a plunger rod 7.
  • the fluid line sterility housing 3 allows for the use of a non-standard fluid path, from a stationary (with reference to the housing of the NIS) medicament container 1 through a needle and into a subject.
  • the needle sterility shield 5 can be threaded or press-fit on or into the medicament container 1.
  • the cap 4 can optionally anchor the needle sterility shield 5 in place.
  • the needle hub 6 is configured to apply pressure to move the needle through the fluid line sterility housing 3.
  • the plunger rod 7 is configured to apply pressure to the medicament container 1.
  • the housing can be opened, and the used sterility mechanism can be removed and replaced with a new sterility mechanism (e.g., including a new or reloaded medicament, a new needle, etc.).
  • a new sterility mechanism e.g., including a new or reloaded medicament, a new needle, etc.
  • FIG. 4 illustrates an isometric view of an example medicament container 1 for use in an NIS, similar to that in FIG. 3, cut-away to reveal additional components associated with the medicament container 1, including additional components of the sterility mechanism.
  • the needle hub 6 can be coupled to the fluid line sterility housing 3 with a sterility housing cap 12.
  • the fluid line sterility housing 3 can be sealed about the needle hub by a sterility housing O-ring 11 and the sterility housing cap 12.
  • the needle hub 6 can be further coupled to a needle 14 including a channel coupled to a communication channel 13. In the stored state (such as illustrated in FIGS.
  • the communication channel 13 is isolated from the medicament container 1 from one of a set of O-rings 10 (e.g., a top O-ring of the set of O- rings 10 illustrated in FIG. 4.
  • Sterility can be maintained inside the fluid line sterility housing 3 by the sterility housing O-ring 11 and a needle sterility shield 5.
  • the fluid communication channel 13 can couple the medicament storage 1 to a channel in the needle 14.
  • the fluid communication channel 13 can contain a seal to prevent fluid flow from the medicament container 1 to the needle 14 until the NIS is intentionally activated via a set of O-rings 10 that can act as an on/off fluid switch.
  • the seal can include a frangible seal that configured to be punctured to enable fluid communication.
  • the medicament container 1 can further include a side cap 9 configured to seal the medicament container 1, such as after filling with a medicament, if not otherwise filled through one or more other openings, such as before the plunger rod 7 and stopper 8 are installed, etc.
  • FIGS. 5 and 6 illustrate open-face views of an example NIS.
  • FIG. 5 illustrates the NIS in a stored state
  • FIG. 6 illustrates the NIS in a post activation and sharps protection lockout state.
  • a set of actuation rods 32 anchored to a needle guard 17 via two anchoring pins 18, can provide distally- oriented force on the needle guard 17.
  • two major springs 27 can be used to store energy for the needle hub 6 and plunger rod 7, which can be held back by a set of flippers 25 through interfaces with flipper pins 24 and the actuation rods 32.
  • a second set of springs 26 apply pressure to the actuation rods 32, providing resistance during activation as well as extending the actuation rods 32 after an injection is complete so that the sharps protection hooks 22 can anchor into the sharps protection lockout grooves 33 in the housing, effectively locking the needle guard 17 over an extended needle 14.
  • Anchoring bolt 30 and nut 29, which interface with the housing, and an anchoring bar 28 can provide force necessary to store both sets of springs 26 and 27.
  • the anchoring bolt 30 can be backed by a cap 31 to ensure a tamper proof device design.
  • a set of flanges 23 can ensure mechanical stability of the actuation rods, biased by the sharps protection springs 26.
  • the set of flanges 23 can be retracted out of their anchor points in the housing during injection, allowing sharps protection mechanisms (e.g., the needle guard 17) to extend.
  • FIG. 7 illustrates an example injection method for the NIS disclosed herein.
  • An injection procedure may contain several steps.
  • an outer protective casing can be removed.
  • the outer casing can protect the NIS from mechanical stresses during storage and ensure an unused device.
  • safety units such as a safety pin or a safety cap 21, can be removed, which can be anchored to a needle guard 17 via ramped abutments 15 to facilitate removal of the safety cap 21, protecting against accidental or unintended activation.
  • the NIS can be positioned at a proper, intended injection site.
  • the NIS can be activated, either by placing pressure on a proximal end of the NIS (e.g., a needle end of the device) or by using a separate activation button, lever, or other actuator positioned elsewhere on the NIS.
  • the embodiment illustrated herein can utilize pressure on the proximal end of the device (needle guard 17 ) to distally move two actuation rods 32.
  • the needle guard 17 (e.g., a sharps protection unit) can automatically extend to cover an extended needle 14.
  • the NIS e.g., the needle guard 17 or the housing
  • the housing can include features for intuitive and mistake- proof activation, including one or more of chamfered edges along a contact surface, one or more abutments on the needle guard 17 to indicate needle port location, flanges on the housing to dictate where a user's fingers should be located, or a grip-free needle guard design.
  • the housing also may contain one or more viewing ports or windows by which to see through one or more hermetically-sealed windows, such as the window 2.
  • Example 1 is a system comprising: a medicament container comprising a first material and a second material forming a compression-style hermetic seal for the medicament container, wherein the first material is at least partially translucent to facilitate visual analysis of content of the container.
  • Example 2 the subject matter of Example 1, wherein the medicament container comprises a metallic material comprising a deposited coating to provide a non-reactive drug contact surface.
  • Example 3 the subject matter of any of Examples 1-2, comprising a drug pump, wherein the medicament container is disposed inside the drug pump.
  • Example 4 the subject matter of any of Examples 1-3, comprising a needle-injection system, wherein the medicament container is disposed inside the needle-injection system.
  • Example 5 the subject matter of Example 4, wherein the needle- injection system comprises a housing having a top housing and a bottom housing, wherein the medicament container is contained between the top housing and the bottom housing.
  • Example 6 the subject matter of Example 5, wherein the housing includes a viewing port located over the first material of the medicament container.
  • Example 7 the subject matter of any of Examples 5-6, wherein the housing includes a first viewing port on the top housing and a second viewing port on the bottom housing, wherein the first and second viewing ports are over first material of the medicament container to facilitate visual analysis of content of the container.
  • Example 8 the subject matter of any of Examples 5-7, comprising: a sterility mechanism comprising the medicament container, a needle hub, a plunger rod, and a needle; a first spring configured to apply pressure to the needle hub; and a second spring configured to apply pressure to the needle hub, wherein the sterility mechanism is contained between the top housing and the bottom housing, and the medicament container is static with respect to the housing.
  • Example 9 the subject matter of any of Examples 4-8, wherein the needle-injection system comprises: a needle guard; an actuation rod; and a mechanical release, wherein the needle guard is configured to apply pressure to the actuation rod to activate the mechanical release to activate the first and second springs to extend the needle from the needle-injection system and to deliver medicament through the extended needle.
  • Example 10 the subject matter of Example 9, comprising a third spring configured to apply pressure to the needle guard to extend over the needle after the needle is extended.
  • Example 11 is at least one machine-readable medium including instructions that, when executed by processing circuitry, cause the processing circuitry to perform operations to implement of any of Examples 1-10.
  • Example 12 is an apparatus comprising means to implement of any of Examples 1-10.
  • Example 13 is a system to implement of any of Examples 1-10.
  • Example 14 is a method to implement of any of Examples 1-10.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne, entre autres, des systèmes, un appareil et des procédés comprenant un récipient pour médicament qui comporte un premier matériau et un second matériau formant un joint hermétique de type à compression pour le récipient pour médicament. Le premier matériau est au moins en partie translucide afin de faciliter l'analyse visuelle d'un médicament contenu dans le récipient. La présente invention se rapporte également à des procédés de formation de cet appareil, ainsi qu'à des systèmes incluant cet appareil, et à des procédés de fonctionnement, et elle comprend d'autres modes de réalisation.
PCT/US2019/036112 2018-06-07 2019-06-07 Récipient pour médicament scellé par compression hermétique Ceased WO2019237036A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862682057P 2018-06-07 2018-06-07
US62/682,057 2018-06-07

Publications (1)

Publication Number Publication Date
WO2019237036A1 true WO2019237036A1 (fr) 2019-12-12

Family

ID=68770708

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2019/036112 Ceased WO2019237036A1 (fr) 2018-06-07 2019-06-07 Récipient pour médicament scellé par compression hermétique

Country Status (1)

Country Link
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2294574A (en) * 1941-07-18 1942-09-01 Abbott Lab Container for light-unstable solutions
US4129228A (en) * 1976-04-05 1978-12-12 Stoneback John W Medication container with quick release closure
US20180099093A1 (en) * 2015-04-03 2018-04-12 Adrenacard, Inc. Compartmentalized auto-injection system

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2294574A (en) * 1941-07-18 1942-09-01 Abbott Lab Container for light-unstable solutions
US4129228A (en) * 1976-04-05 1978-12-12 Stoneback John W Medication container with quick release closure
US20180099093A1 (en) * 2015-04-03 2018-04-12 Adrenacard, Inc. Compartmentalized auto-injection system

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