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
  • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
• • 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
  • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
  • A61J1/06—Ampoules or carpules
  • A61J1/067—Flexible ampoules, the contents of which are expelled by squeezing
• • 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
  • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
• • 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
  • A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
• • 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
  • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
  • A61M5/284—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle comprising means for injection of two or more media, e.g. by mixing
• • 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
  • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
• • 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
  • A61M2005/3128—Incorporating one-way valves, e.g. pressure-relief or non-return valves
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
  • B29C49/02—Combined blow-moulding and manufacture of the preform or the parison
  • B29C49/04—Extrusion blow-moulding
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
  • B29C49/42—Component parts, details or accessories; Auxiliary operations
  • B29C49/4273—Auxiliary operations after the blow-moulding operation not otherwise provided for
  • B29C49/428—Joining
  • B29C49/42802—Joining a closure or a sealing foil to the article or pincing the opening
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
  • B29C49/42—Component parts, details or accessories; Auxiliary operations
  • B29C49/4273—Auxiliary operations after the blow-moulding operation not otherwise provided for
  • B29C49/42808—Filling the article
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
  • B29L2031/00—Other particular articles
  • B29L2031/712—Containers; Packaging elements or accessories, Packages
  • B29L2031/7158—Bottles
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
  • B29L2031/00—Other particular articles
  • B29L2031/753—Medical equipment; Accessories therefor
  • B29L2031/7544—Injection needles, syringes

Definitions

• Embodiments of the present invention generally relate to delivery devices for delivering substances, such as medicaments, and, more particularly, to a delivery system including a modular delivery assembly configured to allow delivery of a single dose of a therapeutic agent from a Blow-Fill-Seal (BFS) vial to a patient.
• BFS Blow-Fill-Seal
• Some implementations of immunization programs generally include administration of vaccines via a typical reusable syringe.
• administration of vaccines occur outside of a hospital and may be provided by a non-professional, such that injections are given to patients without carefully controlling access to syringes.
• the use of reusable syringes under those circumstances increases the risk of infection and spread of blood-borne diseases, particularly when syringes, which have been previously used and are no longer sterile, are used to administer subsequent injections.
• WHO World Health Organization
• a delivery system includes a modular delivery assembly for delivering substances, such as medicaments, vaccines and/or therapeutic, restorative, preventative and/or curative agents (collectively“drug agent” or“drug agents” herein) and, more particularly, to a modular, dual-component injection-type delivery system.
• substances such as medicaments, vaccines and/or therapeutic, restorative, preventative and/or curative agents (collectively“drug agent” or“drug agents” herein) and, more particularly, to a modular, dual-component injection-type delivery system.
• the dual component injection-type delivery system may be configured, for example, to allow delivery/injection to a patient of a single dose of a drug agent that is initially stored and transported in the form of two substances: (i) an active substance that is initially stored and transported in a first component of the delivery system (referred to herein as the delivery assembly or the hub component) in a dehydrated, lyophilized, cryodesiccated, desiccated or powdered form; and (ii) an inactive substance (e.g., a diluent such as saline solution) that is initially stored and transported in a second component of the delivery system [e.g., a plastic Blow-Fill-Seal (BFS) vial).
• a first component of the delivery system referred to herein as the delivery assembly or the hub component
• an inactive substance e.g., a diluent such as saline solution
• BFS plastic Blow-Fill-Seal
• the active substance may be eventually reconstituted into a liquid or fluid form just prior to injection into a patient by being mixed or combined with the second, inactive substance (e.g., when the hub component is attached or connected to the BFS vial and the two substances are allowed to mix).
• the modular delivery assembly may be configured to be coupled to a source containing a fluid agent, including, but not limited to, a BFS vial.
• the delivery assembly may include a modular design consisting of separately constructed modular components cooperatively arranged and coupled to one another.
• the components of the delivery assembly may include, for example, a hub member configured to be securely coupled to the BFS vial, a one-way valve member positioned within the hub member and configured to limit fluid flow to an antegrade direction, and an insert positioned within the hub member and configured to receive and retain an administration member for receiving the fluid agent from the BFS vial and administering the fluid agent into a patient.
• the administration member may include, for example, a needle (for subcutaneous, intramuscular, intradermal, or intravenous injection of the fluid agent) or a nozzle (e.g., spray nozzle to facilitate dispersion of the fluid agent into a spray or a droplet nozzle for formation of droplets).
• a needle for subcutaneous, intramuscular, intradermal, or intravenous injection of the fluid agent
• a nozzle e.g., spray nozzle to facilitate dispersion of the fluid agent into a spray or a droplet nozzle for formation of droplets.
• the hub member may include a proximal end defining an inlet port and a distal end defining an outlet port and a channel extending entirely from the proximal end to the distal end, thereby providing a fluid pathway between inlet and outlet ports.
• the inlet port may include a specialty, non-standard (non-Luer-type connection) connection fitting configured to be coupled with a corresponding specialty, non-standard connection fitting of a BFS vial.
• the inlet port may include recesses, depressions, or complete apertures of a particular shape or geometry which are shaped and/or sized to receive correspondingly shaped and/or sized protrusions, projections, or the like on the BFS vial.
• the inlet port may include two opposing apertures on either side of the hub member.
• the BFS vial may generally include a flexible body having an interior volume sufficient to contain at least one dose of the fluid agent within.
• the BFS vial may generally include a neck extending from the body and terminating at a distal end defining an outlet for dispensing the fluid agent upon squeezing of the vial body.
• the vial may include two (2) protrusions defined on opposing sides of the neck adjacent to the distal end and having a general shape corresponding to the apertures on the hub member.
• the protrusions may be shaped so as to slide into engagement with the corresponding apertures but further shaped to prevent withdrawal of the BFS vial from the hub member, thereby effectively locking themselves within the apertures and effectively locking the BFS vial into engagement with the delivery assembly.
• a user need only apply force to (/.e., squeeze) the vial body to cause the fluid agent to flow from the vial, through the delivery assembly, and to the patient.
• the specialty, non-standard connection fitting between the hub member and the BFS vial in some embodiments may allow for only approved sources (e.g., single-dose BFS vials) with a corresponding agent to be used with the modular delivery assembly described herein, thereby adding a layer of security.
• the method of delivery is generally dependent on the type of fluid agent to be delivered.
• some medicaments are best delivered intravenously while some vaccines are best delivered intradermally, and yet still, some fluid agents are administered via droplets or spray.
• the delivery assembly may be configured for delivery of a specific fluid agent and thus the connection fitting on the hub member may be designed so as to only accept and engage a corresponding connection fitting of a BFS vial containing that specific fluid agent.
• the specialty connection fitting design described herein may ensure that only the matching BFS vial (which contains the correct fluid agent for that specific delivery assembly) is able to be connected to the modular delivery assembly, thereby ensuring safety and reducing risk.
• the delivery assembly may include a one-way valve and/or an insert within the hub member.
• the one-way valve may be positioned, for example, within the within the channel of the hub member and/or may be configured to limit fluid flow to an antegrade direction from the inlet port towards the outlet port, thereby ensuring that fluid flows in a single direction when the vial body is squeezed for delivery.
• the insert may, in some embodiments, be positioned within the channel adjacent to the outlet of the hub member.
• the insert may include a proximal end and an opposing distal end and a channel extending entirely through the insert from the proximal end to the distal end.
• the channel of the insert may be in coaxial alignment with the channel of the hub member, such that the fluid pathway extends entirely from the inlet port of the hub member, through the one-way valve, and through the channel of the insert towards the distal end of the insert.
• the administration member e.g., needle, nozzle, etc.
• the administration member may be received and retained within the channel of the insert, such that, upon delivery of the fluid agent from the BFS vial and through the fluid pathway of the delivery assembly, the fluid agent will flow out of the administration member, thereby allowing for delivery of the fluid agent to the patient.
• the delivery assembly may include a safety cover for covering the administration member to prevent contamination and further reduce the risk of needlestick injuries, and thus reduce the potential for spreading blood-borne diseases.
• the delivery assembly may generally be packaged and delivered in a fully assembled state, including the safety cover provided over the needle or nozzle. Accordingly, a user does not have to deal with an exposed needle or nozzle when first attaching a BFS vial to the delivery assembly. Rather, the user need only remove the safety cover once the BFS vial has been securely attached to the delivery assembly to thereby expose the needle or nozzle for fluid agent delivery. The user may then replace the cover once delivery is complete.
• the modular construction of the delivery assembly allows for rapid manufacturing reconfigurations of one or more components with minimal costs to create new delivery assembly configurations that meet specific needs (/.e., different modes of delivery depending on agent to be delivered, such as subcutaneous, intramuscular, intradermal, intravenous injection, spray, or droplet delivery).
• agent to be delivered such as subcutaneous, intramuscular, intradermal, intravenous injection, spray, or droplet delivery
• the hub member and the one-way valve may remain the same construction (dimensions and material), while the insert may be changed to account for different needle sizes and/or nozzle types, depending on the type of delivery and/or type of fluid agent to be delivered.
• the delivery assembly itself may not be not prefilled. As such, the delivery assembly may not be required to be maintained at a certain temperature (e.g., two to eight degrees Celsius (2°C - 8°C)) during shipment or storage, thus cutting down on the overall costs. Rather than maintaining the delivery assembly at a constant temperature, as is the case with current devices, only the source containing the fluid agent (e.g., single dose supply provided in a BFS vial) need by maintained at a constant temperature. Accordingly, a plurality of empty delivery assemblies may be shipped and stored, at a reduced cost, and then filled directly on-site and on an as-needed basis, such that only the single-dose BFS vials need be stored and maintained.
• a certain temperature e.g., two to eight degrees Celsius (2°C - 8°C)
• the delivery device may be sterilized at any point prior to being filled with the fluid agent, which further improves the bulk shipping and storage of such devices.
• the delivery assembly may include a substrate infused with or otherwise carrying an active ingredient in solid form, which may also or alternatively require less stringent storage or transport requirements.
• the delivery assembly may be configured to allow delivery of the agent to the patient in a relatively simple manner, without requiring specialized training for administering the agent.
• the delivery assembly may be designed such that a person administering the fluid agent (e.g., administrator), which could also include self-administration, need only position the device upon the administration site (i e.g ., shoulder, arm, chest, nose, ear, eye, etc.), and then fully compress the BFS vial body containing the dose of fluid agent, thereby delivering the correct predefined dosage to the patient.
• the delivery assembly may also or alternatively be configured such that, in the event that a needle is required (i.e., because the delivery method is an injection), needle penetration is limited to the correct length and orientation within the administration site.
• the needle may be positioned substantially perpendicular relative to a plane along which the distal end of the insert lies, such that the needle is configured to be inserted into a patient's skin at a substantially perpendicular angle and the distal end of the insert is configured to contact the patient's skin indicating adequate depth of penetrating for injection of the fluid agent.
• embodiments of the modular delivery assembly described herein may not require a trained, skilled healthcare profession for administration of vaccines or drugs.
• the delivery assembly may be particularly useful in situations in which vaccines or drugs are being administered in non-healthcare related facilities ⁇ e.g., outside of clinics or hospitals) and given to large numbers of individuals over a short period of time by a non-professional.
• FIG. 1 A is a perspective view of BFS vial package according to some embodiments
• FIG. 1 B is a perspective close-up view of a portion of a BFS vial package according to some embodiments
• FIG. 2A and FIG. 2B are right-side views of a fluid delivery system according to some embodiments.
• FIG. 2C and FIG. 2D are right-side views of a portion of the fluid delivery system according to some embodiments.
• FIG. 2E is an exploded right-side view of a hub assembly of the fluid delivery system according to some embodiments.
• FIG. 2F is a right-side perspective, partially cross-sectional view of the fluid delivery system according to some embodiments.
• FIG. 2G is a right-side perspective cross-sectional assembly view of the hub assembly of the fluid delivery system according to some embodiments.
• FIG. 2H is a right-side perspective cross-sectional view of the hub assembly of the fluid delivery system according to some embodiments
• FIG. 2I is a right-rear perspective cross-sectional view of the hub assembly of the fluid delivery system according to some embodiments
• FIG. 2J is a right-side perspective, partially cross-sectional view of a portion of the fluid delivery system according to some embodiments.
• FIG. 2K is a right-side partially cross-sectional view of a portion of the fluid delivery system according to some embodiments.
• FIG. 2L is a right-front perspective, partially cross-sectional view of a portion of the fluid delivery system according to some embodiments.
• FIG. 2M is a right-side partially cross-sectional view of a portion of the fluid delivery system according to some embodiments.
• FIG. 2N is a top and side view of various substrates for use in the fluid delivery system according to some embodiments.
• FIG. 3A, FIG. 3B, FIG. 3C, FIG. 3D, FIG. 3E, FIG. 3F, FIG. 3G, and FIG. 3H are right-front perspective, top, bottom, left, right, front, back, and front cross-sectional views of a modular hub according to some embodiments;
• FIG. 4A, FIG. 4B, FIG. 4C, FIG. 4D, FIG. 4E, FIG. 4F, FIG. 4G, and FIG. 4H are right-front perspective, top, bottom, left, right, front, back, and front cross-sectional views of a modular valve according to some embodiments;
• FIG. 5A, FIG. 5B, FIG. 5C, FIG. 5D, FIG. 5E, FIG. 5F, FIG. 5G, and FIG. 5H are right-front perspective, top, bottom, left, right, front, back, and front cross-sectional views of a modular insert according to some embodiments;
• FIG. 6A, FIG. 6B, FIG. 6C, FIG. 6D, FIG. 6E, FIG. 6F, and FIG. 6G are right-front perspective, top, bottom, left, right, front, and views of a modular BFS vial according to some embodiments;
• FIG. 7A, FIG. 7B, FIG. 7C, FIG. 7D, FIG. 7E, FIG. 7F, and FIG. 7G are right-front perspective, top, bottom, left, right, front, and views of a modular BFS vial according to some embodiments;
• FIG. 8 is a perspective flow diagram of a method according to some embodiments.
• FIG. 9 is a flow diagram of a method according to some embodiments.
• FIG. 10 is a perspective view of variations of hub assemblies according to some embodiments.
• the delivery system of some embodiments includes a modular drug agent delivery assembly configured to be coupled to a source containing a fluid agent [e.g., vaccine, drug, medicament, diluent, etc.) and further facilitate delivery of a single dose of the fluid agent from the source to a patient.
• a fluid agent e.g., vaccine, drug, medicament, diluent, etc.
• the delivery assembly may be configured to be filled on-site and in the field with a single dose of a fluid agent, while remaining sterile and preventing the potential for contamination during the filling process.
• the delivery assembly may also or alternatively be capable of delivering the fluid agent in a controlled manner and without requiring specialized skill in administering delivery of such agent.
• the modular drug agent delivery system may be configured to deliver drug agents such as to allow delivery/injection to a patient of a single dose of a drug agent that is initially stored and transported in the form of two substances: (i) an active substance that is initially stored and transported in a first component of the delivery system (referred to herein as the delivery assembly or the hub component) in a dehydrated, lyophilized, cryodesiccated, desiccated or powdered form; and (ii) an inactive substance ⁇ e.g., a diluent such as saline solution) that is initially stored and transported in a second component of the delivery system (e.g., a BFS vial).
• a first component of the delivery system referred to herein as the delivery assembly or the hub component
• an inactive substance ⁇ e.g., a diluent such as saline solution
• the active substance may be eventually reconstituted into a liquid or fluid form just prior to injection into a patient by being mixed or combined with the second, inactive substance (e.g., when the hub component is attached or connected to the BFS vial and the two substances are allowed to mix).
• the modular drug agent delivery system may comprise a BFS vial, container, or reservoir.
• BFS technology is a manufacturing technique used to produce small (e.g., 0.1 mL) and large volume (e.g., 500mL+) liquid-filled containers.
• the container is formed, filled, and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine.
• the BFS manufacturing process is multi-step one in which a pharmaceutical-grade plastic resin is vertically heat extruded through a circular opening to form a hanging tube called the parison. This extruded tube is then enclosed within a two-part mold.
• the mold is positioned in the filling zone, or sterile filling space, where filling needles (mandrels) are positioned within the parison and used to fill the plastic container within the mold, which has been shaped by vacuum against the mold walls. Following the partial formation of the container, the mandrel is used to fill the container with liquid. Following filling the parison is dropping with the mold in the BFS machine and a secondary top mold seals the container. All actions take place inside a sterile shrouded chamber inside the machine. The product is then discharged to a non-sterile area for labeling, packaging and distribution.
• filling needles mandrels
• the delivery assembly in accordance with some embodiments may be configured to be coupled to a source containing the fluid agent, including, but not limited to, a BFS vial.
• the delivery assembly may generally include a modular design consisting of separately constructed components cooperatively arranged and coupled to one another.
• the components of the delivery assembly may include, for example, a hub member configured to be securely coupled to the BFS vial, a one-way valve member positioned within the hub member and configured to limit fluid flow to an antegrade direction, and/or an insert positioned within the hub member and configured to receive and retain an administration member for receiving the fluid agent from the BFS vial and administering the fluid agent into a patient.
• the administration member may include, for example, a needle (for subcutaneous, intramuscular, intradermal, or intravenous injection of the fluid agent) or a nozzle [e.g., spray nozzle to facilitate dispersion of the fluid agent into a spray or a droplet nozzle for formation of droplets).
• the hub member may include a substrate infused with or otherwise comprising or carrying an active ingredient in solid form, which may be operable to be reconstituted in the case the hub member is coupled to a BFS vial containing a diluent.
• the modular construction of the delivery assembly may allow for rapid manufacturing reconfigurations of one or more components with minimal costs to create new delivery assembly configurations that meet specific needs ⁇ i.e., different modes of delivery depending on agent to be delivered, such as subcutaneous, intramuscular, intradermal, intravenous injection, spray, or droplet delivery).
• agent to be delivered such as subcutaneous, intramuscular, intradermal, intravenous injection, spray, or droplet delivery.
• the hub member and the one-way valve may remain the same construction (dimensions and material), while the insert may be changed to account for different needle sizes and/or nozzle types, depending on the type of delivery and/or type of fluid agent to be delivered.
• the delivery assembly may generally be configured to allow delivery of the agent to the patient in a relatively simple manner, without requiring specialized training for administering the agent.
• the delivery assembly is designed such that a person administering the fluid agent (e.g., administrator), which could also include selfadministration, need only position the device upon the administration site (e.g., shoulder, arm, chest, nose, ear, eye, etc.), and then fully compress the BFS vial body containing the dose of fluid agent, thereby delivering the correct predefined dosage to the patient.
• a person administering the fluid agent e.g., administrator
• the administration site e.g., shoulder, arm, chest, nose, ear, eye, etc.
• the delivery assembly itself may not be prefilled or may house a solid form of an active ingredient of a drug agent.
• the delivery assembly may not require the maintenance of a certain temperature (e.g., two to eight degrees Celsius (2°C-8°C)) during shipment or storage, thus cutting down on the overall costs.
• a certain temperature e.g., two to eight degrees Celsius (2°C-8°C)
• only the source containing the fluid agent e.g., single dose supply provided in a BFS vial
• the source containing the fluid agent e.g., single dose supply provided in a BFS vial
• a plurality of empty delivery assemblies may be shipped and stored, at a reduced cost, and then filled directly on-site and on an as-needed basis, such that only the single-dose BFS vials need be stored and maintained. Additionally, in the case that the delivery device is not prefilled, it may be sterilized at any point prior to being filled with the fluid agent, which further improves the bulk shipping and storage of such devices.
• FIG. 1A and FIG. 1 B a perspective view of a BFS vial package 102 and a perspective close-up view of a portion of the BFS vial pack or package 102 according to some embodiments are shown.
• the BFS vial package 102 may, for example, comprise a plastic and/or other molded, extruded, and/or formed manifold 104.
• the manifold 104 may comprise a plurality of attachment points 106 via which a plurality of BFS units, containers, and/or vials 110a-e are connected e.g., via a breakaway detachment design.
• FIG. 1A and FIG. 1 B a perspective view of a BFS vial package 102 and a perspective close-up view of a portion of the BFS vial pack or package 102 according to some embodiments are shown.
• the BFS vial package 102 may, for example, comprise a plastic and/or other molded, extruded, and/or formed manifold 104.
• each BFS vial 110a-e may contain a single dose of fluid agent ⁇ e.g., a drug agent or a non-active diluent) and, when a user is ready, a single vial such as the first BFS vial 110a may be removed from the manifold 104 via a tear-away type connection disposed between a first, outlet, or proximate end 110a-1 of the first BFS vial 110a (the proximate end 1 10a-1 being proximate to the manifold 104 and a second or distal end 110a-2 being distal therefrom) and the respective attachment point 106.
• fluid agent e.g., a drug agent or a non-active diluent
• the proximate end 1 10a-1 ⁇ e.g., that may comprise and/or define an outlet; not separately labeled in FIG. 1A and FIG. 1 B) of the first BFS vial 110a may be coupled to the manifold 104 at the attachment point 106.
• a user by simply pulling the desired first BFS vial 1 10a away from the attachment point 106, a user is able to separate the first BFS vial 1 10a from the remaining BFS vials 110b-e and use only the single dose that is required and/or desired, rather than using a larger source of fluid agent (multiple dose syringe or vial; not shown), thereby completely preventing the risk of contaminating the single source of fluid agent ⁇ e.g., a drug agent or a non-active diluent) disposed in the first BFS vial 110a.
• a larger source of fluid agent multiple dose syringe or vial; not shown
• each BFS vial 110a-e may comprise and/or define various features such as features molded, formed, cut, glued, and/or otherwise coupled thereto.
• the first BFS vial 110a may comprise a neck 112a ⁇ e.g., near the proximate end 1 10a- 1 ) upon which various mating features are formed (or otherwise coupled).
• the neck 112a may comprise a first exterior radial flange 1 14a, a second exterior radial flange 1 16a, and/or a mating tab 118a.
• the mating tab 1 18a may comprise a wedge-shaped radial protrusion ⁇ e.g., with an incline increasing from near the proximate end 110a-1 and towards the distal end 110a-2) disposed on, with, or as part of the second exterior radial flange 116a.
• the first BFS vial 1 10a may comprise a fluid reservoir 120a in communication with the neck 112a.
• the fluid reservoir 120a may store, house, and/or accept the single dose of fluid ⁇ e.g., drug agent or non-active diluent) and/or may be coupled to a grip plate 122a.
• the grip plate 122a may, for example, comprise a flat element that permits axial force to be applied to the first BFS vial 110a without causing such axial force to be applied to the fluid reservoir 120a.
• the package 102 may comprise an indicia imprinting (not shown) on the manifold 104 itself and/or upon each individual BFS vial 110a-e ⁇ e.g., on the grip plate 122a of the first BFS vial 110a).
• Exemplary indicia may include, but is not limited to, lot number, expiration date, medication information, security stamp (color changing temperature sensor to provide indication of whether BFS vials 110a-e have or have not been maintained at required temperature), as well as the dose line provided on each BFS vial 110a-e. While five (5) BFS vials 1 10a-e are depicted in FIG. 1A as being coupled to the manifold 104, fewer or more BFS vials 110a-e may be coupled to the manifold 104 as is or becomes desirable and/or practicable.
• the BFS vial package 102 and/or one or more of the BFS vials 110a-e may comprise and/or be coupled to one or more electronic devices (not explicitly shown).
• the electronic devices may comprise, for example, one or more passive inductive, Radio Frequency IDentification (RFID), Near-Field-Communication (NFC), processing, power storage, and/or memory storage devices.
• RFID Radio Frequency IDentification
• NFC Near-Field-Communication
• processing power storage
• the electronic devices may store, process, receive, and/or transmit various data elements such as to track geographical movement of the BFS vial package 102 and/or to verify or confirm that a particular BFS vial 110a-e should be utilized for administration to a particular recipient.
• the user may first open an appropriate app on his/her mobile device (not shown) and tap (or bring into proximity) the first BFS vial 110a and/or the first electronic device to the mobile device to initiate communications therebetween.
• the app may allow, in some embodiments, the app to verify the injection by verifying and/or authenticating one or more of the following: (i) that the fluid or drug agent is the correct fluid or drug agent the patient is supposed to be receiving (e.g., based on a comparison of fluid data stored by the first electronic device and patient information stored in a separate memory device, e.g., of the user’s mobile device); (ii) that the injection is being administered within an appropriate window of time (e.g., by comparing a current time and/or date to a time and/or date stored and/or referenced by data of the first electronic device); (iii) that the first BFS vial 110a and/or fluid therein has not been compromised and/or is not expired.
• any of the foregoing may be verified based on records of the patient stored in the app on the mobile device and/or accessible to the app via the internet or a cloud-based system and/or data stored in the first electronic device.
• the user in the case that the required (or desired) verifications are processed successfully, the user may be authorized to perform the injection (e.g., an approval indicator may be output to the user via a screen of the app). The user may be motivated to only inject upon receiving the approval via the app because the user may only receive rewards via the app if he/she performs approved injections.
• the user may also be requested to upload a photo of the first BFS vial 1 10a and/or the injection site (not shown) after the injection (e.g., to finalize qualification for a reward and/or to qualify for an additional reward).
• a reward may be provided to the user via the user’s mobile device, e.g., in response to receiving data descriptive of the administration of the fluid and/or the use of the first BFS vial 1 10a.
• the configuration of the BFS vials 1 10a-e may permit the BFS vials 1 10a-e to be coupled to a modular delivery system (not shown) as described herein, while enabling functionality despite a wide range of manufactured dimensions.
• reduced costs may be achieved by employing BFS technology while maintaining modular fluid delivery functionality that previous systems could not achieve.
• fewer or more components 104, 106, 1 10a-e, 1 10a-1 , 110a-2, 112a, 114a, 116a, 118a, 120a, 122a and/or various configurations of the depicted components 104, 106, 110a-e, 110a-1 , 1 10a-2, 112a, 114a, 116a, 118a, 120a, 122a may be included in the BFS vial package 102 without deviating from the scope of embodiments described herein.
• the components 104, 106, 110a-e, 1 10a-1 , 1 10a-2, 112a, 114a, 116a, 118a, 120a, 122a may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein.
• the BFS vial package 102 (and/or portion and/or component 104, 106, 110a-e, 110a-1 , 110a-2, 112a, 114a, 116a, 118a, 120a, 122a thereof) may be utilized in accordance with the methods 800, 900 of FIG. 8 and/or FIG. 9 herein, and/or portions or combinations thereof.
• FIG. 2A, FIG. 2B, FIG. 2C, FIG. 2D, FIG. 2E, FIG. 2F, FIG. 2G, FIG. 2H, FIG. 2I, FIG. 2J, FIG. 2K, FIG. 2L, FIG. 2M, and FIG. 2N various views of a fluid delivery system 200 according to some embodiments are shown.
• FIG. 2A and FIG. 2B are right-side views of the fluid delivery system 200
• FIG. 2C and FIG. 2D are right-side views of a portion of the fluid delivery system 200
• FIG. 2E is an exploded right-side view of a portion of the fluid delivery system 200
• FIG. 2F is a right-side cross-sectional view of the fluid delivery system 200
• FIG. 2G is a right-side cross-sectional assembly view of a portion of the fluid delivery system 200
• FIG. 2H is a right-side cross-sectional view of a portion of the fluid delivery system 200
• FIG. 2I is a right-rear perspective cross-sectional view of a portion of the fluid delivery system 200
• FIG. 2J is a right-side perspective cross-sectional view of a portion of the fluid delivery system 200
• FIG. 2K is a right-side cross-sectional view of a portion of the fluid delivery system 200
• FIG. 2L is a right-front perspective cross-sectional view of a portion of the fluid delivery system 200
• FIG. 2M is a right-side cross-sectional view of a portion of the fluid delivery system 200
• FIG. 2G is a right-side cross-sectional assembly view of a portion of the fluid delivery system 200
• FIG. 2H is a right-side cross-sectional view of a portion of the fluid delivery system 200
• FIG. 2I is
• the fluid delivery system 200 may comprise various inter-connected and/or modular components such as a BFS vial 210 (e.g ., having a first end 210-1 and a second end 210-2) comprising and/or defining a vial neck 212, a first flange 214, a second flange 216, a plurality of locking tabs 218a-b, a collapsible reservoir 220, and/or a grip plate 222.
• a BFS vial 210 e.g ., having a first end 210-1 and a second end 210-2
• the fluid delivery system 200 may comprise a delivery or hub assembly 226 comprising a safety cover or cap 228 ⁇ e.g., comprising and/or defining a cylindrical cap body 228-1 , an interior void 228-2, a tapered cap body 228-3, and/or head space 228-4), a hub 230 (e.g., comprising a hub body 232, a hub bore 232-1 defining a hub bore diameter 232-2, a vial bevel 232-3, a plurality of locking slots 234a-b, an assembly flange 236, a valve slot 238, a fluid outlet bore 240 defining a fluid outlet bore diameter 240-1 , a valve seat 240-2, an insert bore 242 defining an insert bore diameter 242-1 , an insert bevel 242-2, an insert recess 242-3, and/or an insert seat 244), a valve 250 (e.g., comprising and/or defining a valve body 252, a valve channel 252-1 , a valve
• the fluid delivery system 200 and/or the hub assembly 226 may include a modular design consisting of separately constructed components 228, 230, 250, 270, 280, 290 cooperatively arranged and coupled to one another.
• the components 228, 230, 250, 270, 280 of the hub assembly 226 may include, for example, the hub 230 being configured to be coupled to a source containing the fluid agent, including, but not limited to, the BFS vial 210, a one-way valve 250 positioned within the hub 230 and configured to limit fluid flow to an antegrade direction, the insert 270 positioned within the hub 230 and configured to receive and retain the administration member 280 for receiving the fluid agent from the BFS vial 210 and administering the fluid agent into a patient (not shown), and the substrate 290 disposed within the hub 230 (e.g., which itself may be sealed (not shown), such as to maintain the purity and/or effectiveness of the active ingredient retained by the substrate 290).
• the administration member 280 may include the needle 284 for at least one of subcutaneous, intramuscular, intradermal, and intravenous injection of the fluid agent into the patient.
• the figures and the description herein generally refer to the administration member 280 as a needle 284.
• the administration member 280 may include a nozzle (not shown) configured to control administration of the fluid agent to the patient.
• the nozzle may include a spray nozzle, for example, configured to facilitate dispersion of the fluid agent into a spray.
• a hub assembly 226 fitted with a spray nozzle may be particularly useful in the administration of a fluid agent into the nasal passage, for example, or other parts of the body that benefit from a spray application ⁇ e.g., ear canal, other orifices).
• the nozzle may be configured to facilitate formation of droplets of the fluid agent.
• a hub assembly 226 including a droplet nozzle may be useful in the administration of a fluid agent by way of droplets, such as administration to the eyes, topical administration, and the like.
• the drug agent may include any type of agent to be injected into a patient (e.g., mammal, either human or non-human) and capable of producing an effect (alone, or in combination with an active ingredient such as may be retained by the substrate 290).
• the agent may include, but is not limited to, a vaccine, a drug, a therapeutic agent, a medicament, a diluent, and/or the like.
• either or both of the fluid agent and the active ingredient may be tracked, monitored, checked for compatibility with each other, etc., such as by utilization of electronic data storage devices (not shown) coupled to the various modules or components such as the BFS vial 210 and the hub 230, as described herein.
• the hub 230 may include a hub body 232 defining a hub bore 232-1 having a first end defining an inlet port and a second end defining an outlet, e.g., along an axis“A-A” as depicted in FIG. 2E.
• the hub bore 232-1 may provide a fluid pathway between the inlet and outlet ports.
• the hub 230 may include a specialty, non-standard (non-Luer-type) connection fitting such as the locking slots 234a-b configured to be coupled with a corresponding specialty, non-standard connection fitting of the BFS vial 210 (shown in FIG. 2A and FIG. 2F) such as the locking tabs 218a-b.
• a portion of the hub body 232 adjacent the first end may include recesses, depressions, or complete apertures (e.g., the locking slots 234a-b) of a particular shape or geometry which are shaped and/or sized to receive correspondingly shaped and/or sized protrusions, projections, or the like (e.g., the locking tabs 218a-b) of the BFS vial 210.
• the hub body 232 may include two locking slots 234a-b defining opposing apertures on either side of the hub body 232 and adjacent to the first end, the locking slots 234a-b being shaped and/or sized to receive and retain corresponding locking tabs 218a-b defined on the neck 212 of a BFS vial 210.
• the hub 230 may comprise one or more window or port portions such as the valve slot 238 formed on the hub body 232 and configured to provide a means for receiving and retaining a portion (e.g., the mounting wing 254a) of the valve 250 within.
• the valve 250 may be generally positioned within the hub bore 232-1 and/or may be formed from a polymer material, such as rubber, synthetic rubber, latex, and/or other elastomeric polymer material.
• the valve 250 may be press-fit into the hub bore 232-1 such that portions (e.g., the mounting wing 254a) of the valve 250 may extend through the valve slot(s) 238 and fill in any gaps so as to provide at least a watertight seal.
• the exposed one or more portions of the valve 250 (and/or of the mounting wing 254a thereof) extending to the outer surface of the hub 230 through the valve slot(s) 238 may generally provide a friction fit for an interior surface interior void 228-2 of the cap 228 in the case that the cap 228 is placed over and/or coupled to the hub assembly 226.
• the exposed polymer material of the valve 250 (and/or of the mounting wing 254a thereof) may generally provide sufficient friction with the cap 228 so as to keep the cap 228 retained on to the hub assembly 226.
• the valve 250 may comprise and/or define a valve channel 252-1 extending therethrough and in coaxial alignment with the hub bore 232-1 , e.g., along axis “A-A”.
• the valve 250 may comprise a valve flap 252-2 provided within the valve channel 252-1 and configured to limit fluid flow to an antegrade direction from the hub 230 towards the administration member 280, thereby ensuring that fluid flows in a single direction when the fluid agent is delivered from the BFS vial 210.
• the insert 270 may be positioned within the hub bore 232-1 adjacent to the second end of the hub 230.
• the insert 270 may, according to some embodiments, comprise and/or define a fluid channel 272-1 extending entirely axially through the insert 270.
• the fluid channel 272-1 may be in coaxial alignment with the hub bore 232-1 and/or the valve channel 252-1 , e.g., along axis“A-A”, such that a fluid pathway extends entirely from the first end of the hub 230, through the hub bore 232-1 , through the valve channel 252-1 of the valve 250, and through fluid channel 272-1 of the insert 270.
• the seating flange collar 278-1 of the insert 270 may be configured to be fitted within the valve channel 252-1 , e.g., in the riser 256.
• the administration member 280 ⁇ e.g., needle 284) may, in some embodiments, be received and/or retained within the fluid channel 272- 1 of the insert 270, such that, upon delivery of the fluid agent from the BFS vial 210 and through the fluid pathways of the hub assembly 226, the fluid agent will flow out of the fluid bore 282-1 of the needle 284, thereby allowing for delivery of the fluid agent to the patient.
• the hub assembly 226 may include the cap 228 for covering the needle 284 to prevent contamination and further reduce the risk of needlestick injuries, and thus reduce the potential for spreading blood-borne diseases.
• the hub assembly 226 may generally be packaged and delivered in a fully assembled state, including the cap 228 provided over the needle 284 and/or including a seal (not shown) such as a foil, plastic, and/or shrink-wrap seal that prevents containments from entering the hub 230 (e.g., until the seal is broken and/or a BFS vial 210 is mated with the hub 230).
• a seal such as a foil, plastic, and/or shrink-wrap seal that prevents containments from entering the hub 230 (e.g., until the seal is broken and/or a BFS vial 210 is mated with the hub 230).
• a user does not have to deal with an exposed needle 284 when first attaching the BFS vial 210 to the hub assembly 226 anf the hub assembly 226 may be sealed to protect any active agent stored therein; e.g., the substrate 290 as depicted in FIG. 2M). Rather, the user need only remove the cap 228 once the BFS vial 210 has been securely attached to the hub assembly 226 to thereby expose the needle 284 for fluid agent delivery. The user may then replace the cap 228 once delivery is complete.
• the hub 230, the valve 250, the insert 270, the substrate 290, and/or the cap 228, may be composed of a medical grade material.
• the hub 230, the insert 270, the substrate 290, and/or cap 228, may be composed of a thermoplastic polymer, including, but not limited to, polypropylene, polyethylene, polybenzimidazole, acrylonitrile butadiene styrene (ABS) polystyrene, polyvinyl chloride, PVC, or the like.
• ABS acrylonitrile butadiene styrene
• FIG. 2A and FIG. 2B right-side views of the fluid delivery system 200 illustrate attachment of the BFS vial 210 to the hub assembly 226.
• the hub assembly 226 may be urged axially along the axis“A-A” ⁇ e.g., to the left in FIG. 2A) in accordance with the arrow such that it engages with and/or becomes selectively indexed and/or coupled to the BFS vial 210.
• the BFS vial 210 may define the collapsible reservoir 220 that may generally include a flexible body having an interior volume sufficient to contain at least one dose of the fluid agent within.
• the BFS vial 210 may, in some embodiments, comprise the neck 212 extending from the body of the collapsible reservoir 220 and terminating at the first end 210-1 defining an outlet for dispensing the fluid agent upon squeezing of the body of the collapsible reservoir 220 ⁇ e.g., in accordance with the radially inward-pointing arrows of FIG. 2F).
• the BFS vial 210 may be formed by BFS technology.
• the BFS vial 210 may be formed by BFS technology, in that the collapsible reservoir 220, the neck 212, and first and second ends 210-1 , 210-2 are formed, filled within a fluid agent, and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine. Accordingly, this process can be used to aseptically manufacture sterile pharmaceutical liquid dosage forms. BFS technology may be particularly attractive in the market, as it reduces personnel intervention making it a more robust method for the aseptic preparation of sterile pharmaceuticals.
• the hub body 232 may generally include a specialty, non-standard connection fitting (locking slots 234a-b) configured to be coupled with a corresponding specialty, non-standard connection fitting ⁇ e.g., locking tabs 218a-b) of the BFS vial 210.
• the BFS vial 210 may include the two (2) locking tabs 218a-b defined on opposing sides of the neck 212 adjacent to the first end 210-1 and having a general shape corresponding to the locking slots 234a-b on the hub 230.
• FIG. 2F is a perspective view, partly in section, illustrating the BFS vial 210 attached to the hub assembly 226 and showing engagement between the connection fittings ⁇ e.g., locking tabs 218a-b and locking slots 234a-b) of the BFS vial 210 and the hub 230 of the hub assembly 226, respectively.
• the locking tabs 218a-b on the neck 212 of the BFS vial 210 may be in engagement with the corresponding locking slots 234a-b of the hub 230.
• the locking tabs 218a-b may be shaped to prevent or inhibit withdrawal of the BFS vial 210 from the hub 230, thereby effectively locking themselves within the locking slots 234a-b and effectively locking the BFS vial 210 into engagement with the hub assembly 226.
• a specialty, non-standard connection fitting between the hub assembly 226 and the BFS vial 210 allows for only approved sources (e.g., single-dose BFS vials 210) with a corresponding agent to be used with the fluid delivery system 200, thereby adding a layer of security.
• approved sources e.g., single-dose BFS vials 2
• a method of delivery is generally dependent on the type of fluid agent to be delivered. Some medicaments are best delivered intravenously, for example, while some vaccines are best delivered intradermally, and yet still, some fluid agents are administered via droplets or spray.
• the hub assembly 226 may be configured for delivery of a specific fluid agent and thus the connection fitting on the hub assembly 226 may be designed so as to only accept and engage a corresponding connection fitting of a BFS vial 210 containing that specific fluid agent. Accordingly, the specialty connection fitting design may ensure that only the matching BFS vial 210 (which contains the correct fluid agent for that specific delivery assembly) is able to be connected to the hub assembly 226, thereby ensuring safety and reducing risk.
• FIG. 2G is an exploded, perspective sectional view of the hub assembly 226.
• FIG. 2FH is a perspective sectional view of the hub assembly 226 illustrating the components assembled to one another and forming a continuous fluid pathway there-between and
• FIG. 2I is another perspective sectional view of the hub assembly 226 illustrating the components assembled to one another.
• the hub 230 may comprise and/or define the hub bore 232-1 extending therethrough.
• the hub 230 may also or alternatively comprise a fluid outlet bore 240 to which the valve 250 and insert 270 are coupled.
• the riser 256 of the valve 250 may be positioned on one side of the fluid outlet bore 240 (e.g., on the left side as-depicted) and the seating flange collar 278-1 of the insert 270 may generally protrude through or into the fluid outlet bore 240 (and/or through or into the riser 256 of the valve 250) and may be positioned on the other side of the fluid outlet bore 240 ( e.g., on the right side as-depicted ).
• the seating flange collar 278-1 of the insert 270 may be received within the valve channel 252-1 of the riser 256 of the valve 250 and extend may generally abut the valve flap 252-2.
• the administration member 280 comprises the elongate body 282 which may be hollow and/or otherwise define the fluid bore 282-1, and/or may comprise a generally blunt second end 282-3 and the piercing tip 284 at the first end 282-2.
• the second end 282-3 of the administration member 280 may be positioned within the fluid channel 272-1 of the insert 270, wherein the fluid channel 272-1 may comprise the channel stop 272-2 or end portion (e.g., interior flange or tapered to a decreasing diameter) which prevents the second end 282-3 of the administration member 280 from traveling too far down the fluid channel 272-1.
• a fluid pathway may extend entirely through the hub assembly 226, from the hub 230 to the tip 284 of the administration member 280, and passing through each of the components therebetween (e.g., through the hub 230, the valve 250, and the insert 270).
• FIG. 2J is an enlarged, perspective view, partly in section, illustrating the locking engagement between the connection fittings of the BFS vial 210 and the hub 230 of the hub assembly 226.
• the hub body 232 may generally include a specialty, non-standard connection fitting (locking slots 234a-b) configured to be coupled with a corresponding specialty, non-standard connection fitting of the BFS vial 210.
• the BFS vial 210 may include two (2) locking tabs 218a-b and/or other protrusions or features defined on opposing sides of the neck 212 adjacent to the first end 210-1 and having a general shape corresponding to the locking slots 234a-b on the hub 230.
• the locking tabs 218a-b may be shaped so as to slide into engagement with the corresponding locking slots 234a-b, respectively. As shown, the locking tabs 218a-b on the neck of the BFS vial 210 may be in engagement with the corresponding locking slots 234a-b of the hub 230.
• the locking tabs 218a-b may, in some embodiments, be further shaped to prevent withdrawal of the BFS vial 210 from the hub 230, thereby effectively locking themselves within the locking slots 234a-b and effectively locking the BFS vial 210 into engagement with the hub assembly 226.
• FIG. 2K and FIG. 2L are enlarged, perspective views, partly in section, illustrating engagement between the first end 210-1 (and outlet) of the BFS vial 210 with the valve 250 of the hub assembly 226 when the BFS vial 210 is securely coupled to the hub assembly 226.
• the outlet of the first end 210-1 of the BFS vial 210 is, according to some embodiments, disposed in direct alignment (e.g., axial alignment) with the valve flap 252-2 of the valve 250.
• the outlet of the BFS vial 210 may be in direct axial alignment with the fluid pathway (e.g., along axis“A-A”).
• BFS vial dimensions may be imprecise.
• the second end 210-1 of any given BFS vial 210 may have different dimensions when compared to one another (on a microscale).
• connection fittings between the BFS vial 210 and the hub 230 further ensure that the first end 210-1 of the BFS vial 210 is positioned against and into engagement with the valve 250 (e.g., the vial flange 260 thereof).
• a seal may be created between the first end 210-1 of the BFS vial 210 and the vial flange 260 of the valve 250, thereby accounting for any imprecise manufacturing of the BFS vial 210.
• the fluid delivery system 200 may be assembled by application of opposing axial forces that urge the hub assembly 226 onto the BFS vial 210 (in accordance with the arrow shown).
• a user (not shown) may take hold of the grip plate 222 and the hub 230 (and/or the cap 228) and push the BFS vial 210 into the hub bore 232-1 of the hub assembly 226.
• a seal (not shown) is disposed to cover the hub bore 232-1 , the insertion of the BFS vial 210 (or a portion thereof, such as the first end 210-1) may break the seal.
• the user may be required to remove the seal prior to assembling the fluid delivery system 200.
• the grip plate 222 may permit the user to apply an axial force in the direction of the hub assembly 226 without requiring force to be applied to the collapsible reservoir 220 (e.g., preventing accidental expelling of the fluid stored in the collapsible reservoir 220).
• the user may apply axial force to the assembly flange 236 of the hub 230 and an opposing axial force to the grip plate 222, causing a coupling or mating of the BFS vial 210 with the hub assembly 226, e.g., as depicted in FIG. 2B.
• the cap 228 may be selectively engaged to couple to the hub assembly 226.
• the hub assembly 226 may be disposed in the interior void 228-2 of the cylindrical cap body 228-1 , for example, and/or the administration member 280 thereof may be disposed in the head space 228-4 of the tapered cap body 228-3, such that the needle 284 is protected and/or shrouded - e.g., for cleanliness and safety.
• an outside diameter of the hub body 232 may be sized to fit within the interior void 228-2 (e.g., may be configured with an outside diameter that is smaller than an inside diameter of the interior void 228-2).
• one or more portions of the valve 250 may extend through the side of the hub body 232 causing a localized increase in outside diameter of the hub assembly 226.
• this localized maximum outside diameter of the hub assembly 226 may be configured to provide a transition fit (e.g., an“H7/j6” or“tight fit”) between the hub body 232 and the cap 228, allowing the cap 228 to be selectively removed (e.g., as depicted in FIG. 2D) and/or installed by hand, as desired.
• the valve 250 comprises rubber or another frictional surface
• the friction coefficient of such material and/or a compression of the material inside of the interior void 228-2 may provide and/or enhance the nature of the fit.
• the fluid delivery system 200 may comprise a hub assembly 226 that is composed of a plurality of modular components such as the hub 230, the valve 250, the insert 270, and the administration member 280.
• the modular components 230, 250, 270, 280 may be coupled together and attached to a BFS vial 210 to form the fluid delivery system 200.
• the modular components 230, 250, 270, 280 may be assembled along an axis“A-A” by alignment and/or coupling of various portions and/or features thereof.
• the hub 230 may comprise the hub body 232 (which may be substantially cylindrical in some embodiments) that may comprise and/or define the hub bore 232-1 having an inside hub bore diameter 232-2, and/or may define a vial bevel 232-3 that engages with the BFS vial 210 upon insertion thereof.
• the first flange 214 of the BFS vial 210 and/or the locking tabs 218a-b may, for example, extend radially outward beyond the hub bore diameter 232-2 and may accordingly engage with the side walls of the hub bore 232-1 as they are inserted deeper into the vial bevel 232-3.
• such engagement may cause the neck 212 of the BFS vial 210 (and/or the first flange 214 and/or the locking tabs 218a-b thereof) to compress radially inward and/or may cause the hub body 232 to expand radially outward (e.g., elastically), to allow continued advancement of the BFS vial 210 into the hub 230, e.g., in accordance with a tight fit and/or interference fit engagement.
• the radial pressure exerted by forcing the neck 212 of the BFS vial 210 into the hub 230 may impart a radial spring effect to the locking tabs 218a-b such that when axial advancement aligns the locking tabs 218a-b with the corresponding locking slots 234a-b, the locking tabs 218a- b spring radially outward and into the corresponding locking slots 234a-b, thereby reducing and/or removing the radial pressure exerted thereon by the difference between the interior hub bore diameter 232-2 and the outside diameter and/or radial extents of the locking tabs 218a-b.
• the hub 230 may comprise the fluid outlet bore 240 having a fluid outlet bore diameter 240-1.
• the fluid outlet bore diameter 240-1 may be smaller than the hub bore diameter 232-2.
• the difference in the fluid outlet bore diameter 240-1 and the hub bore diameter 232-2 may, for example, provide for and/or define the valve seat 240-2 and/or the insert seat 244.
• the valve 250 may be inserted into the hub bore 232-1 and may comprise the valve body 252 having an outside diameter sized to fit within the hub bore 232-1.
• the diameter of the valve body 252 may be larger than the hub bore diameter 232-2 such that the valve 250 must be compressed for an interference fit into the hub bore 232-1.
• the valve 250 may be seated into the valve seat 240-2 and/or the mounting wing 254a may be engaged to fit within and/or through the valve slot 238 in the side wall of the hub body 232, e.g., creating a water-tight seal between the valve body 252 and the hub body 232.
• the hub 230 may comprise the insert bore 242 having an insert bore diameter 242-1.
• the insert 270 may comprise the seating flange 278 that may have an outside diameter larger than the inside diameter of the insert bore 242-1.
• Axial advancement or insertion of the insert 270 into the insert bore 242 may accordingly cause the seating flange 278 to engage the insert bevel 242-2 of the hub 230, which may exert a radially outward force on the insert bevel 242-2 that may cause the hub body 232 to expand ⁇ e.g., elastically) radially to accommodate the seating flange 238.
• the insert recess 242-3 of the hub 230 may be sized to accommodate the seating flange 238 and accordingly, upon advancement of the insert 270 into the insert bore 242 such that the seating flange 238 aligns axially with the insert recess 242-3, the insert 270 may snap into place and the hub body 232 may return to the original diameter thereof.
• the seating flange 278 and/or the seating flange collar 278-1 may engage with and/or create a water-tight seal with the insert seat 244 in the case that the seating flange 238 is seated in the insert recess 242-3.
• the insert 270 may comprise the inlet funnel 276 configured to funnel fluid and/or a drug agent traveling in an antegrade direction into the fluid channel 272-1.
• the administration member 280 may be inserted into the insert 270 by entering the outlet funnel 274 and extending into the fluid channel 272-1 up to the channel stop 272-2.
• FIG. 2H and FIG. 2I the seating and sealing between the hub 230, the valve 250, and the insert 270 is depicted.
• the seating flange collar 278-1 of the insert 270 is shown having a smaller outside diameter than the inside diameter of the valve channel 252-1 in the riser 256 of the valve 250, and in the case that the seating flange 238 is seated in the insert recess 242-3, the seating flange collar 278-1 is disposed within the valve channel 252-1 in the riser 256 of the valve 250.
• the fit between the seating flange collar 278-1 , the riser 256, and the fluid outlet bore 240 may be configured to provide for a water-tight seal such that any fluid directed axially through the valve 250 in an antegrade direction must pass into the inlet funnel 276 and through the fluid bore 282-1 of the administration member 280.
• the valve flap 252-2 may comprise a pliant portion of the valve 250 centered in the path of fluid flow and being free to bend in an antegrade direction by being unencumbered due to free space provided between the valve flap 252-2 and the inlet funnel 276 of the insert 270 and/or may be permitted to travel into the inlet funnel 276 itself.
• the first flange 214 of the BFS vial 210 is depicted having an outside diameter and/or radial extent equal to or greater than the hub bore diameter 232-1 , for example, thus creating a fluid-tight seal within the hub bore 232.
• the second flange 216 and/or the locking tabs 218a-b are depicted as being seated in the hub 230 and as being shaped to prevent retrograde axial movement of the BFS vial 210 with respect to the hub 230, by having features that project radially outward to engage with the side walls of the hub body 232.
• the spatial configuration of the locking tabs 218a-b and the hub bore 232 may cause the first end 210-1 of the BFS vial 210 to contact, coupled with, and/or seat against the vial flange 260 of the valve 250, thereby creating a fluid-tight seal therebetween.
• the valve 250 may create a seal with the valve seat 240-2 and/or the insert 270 (and/or the seating flange 238 thereof) may create a seal with the insert seat 244.
• the valve flap 252-1 may be positioned over and/or biased against the first end 210-1 of the BFS vial 210 such that it prevents any retrograde flow of fluid into the BFS vial 210.
• the first end 210-1 of the BFS vial 210 may, as positioned against the valve 250 and seated in the vial flange 260 in FIG. 2K for example, prevent retrograde movement or axial displacement of the valve flap 252-2 in the direction of the BFS vial 210, thereby preventing any opening in the first end 210-1 of the BFS vial 210 from being uncovered in response to any retrograde force (while the valve flap 252-2 is otherwise free to bend or move in an antegrade direction at least by not being blocked by any objects in the valve channel 252-1.
• Such a configuration in accordance with some embodiments is depicted in FIG.
• collapsible reservoir 220 may provide fluid via the first end 210-1 of the BFS vial 210 by such fluid flow forcing an antegrade displacement of the hinged/flapped valve flap 252-2, while a retrograde flow would not be possible by nature of the first end 210-1 of the BFS vial 210 blocking or preventing retrograde displacement of the valve flap 252-2.
• FIG. 2M a right-side partially cross-sectional view of a portion of the fluid delivery system 200 according to some embodiments is shown.
• the embodiment depicted in FIG. 2M may, for example, be illustrative of a case where a drug agent to be administered is provided in multiple components or substances.
• the BFS vial 210 may retain or be filled with a fluid agent (e.g., a first component or substance; not explicitly shown) such as an inactive carrier fluid (e.g., a saline solution) or a diluent, for example, that is operable to be introduced to a second component or substance (also not explicitly shown) such as a dehydrated, dry, or solid active ingredient to formulate a drug agent to be delivered to a patient (not shown).
• a fluid agent e.g., a first component or substance; not explicitly shown
• an inactive carrier fluid e.g., a saline solution
• a diluent for example
• the BFS vial 210 may be pre-filled with a predetermined amount of the first component or substance that is introduced to the BFS vial 210 during a BFS manufacturing extrusion process, for example, in a manner that allows the first component or substance to remain sterile and/or prevent or minimize the potential for contamination during the filling process.
• the BFS vial 210 (or the first end 210-1 thereof) may comprise the neck 212 upon which the first flange 214, second flange 216, and/or locking tabs 218a-b are disposed and/or formed.
• the BFS vial 210 may be engaged to mate or couple with the hub 230 such as by insertion of the neck 212 into the hub body 232, as shown.
• the assembly flange 238 may be utilized to provide axial leverage to urge the BFS vial 210 into the hub 230.
• the hub 230 may define the fluid outlet bore 240 that may be disposed adjacent to the valve 250 in the hub 230.
• the valve 250 may define a valve channel 252-1 through which the fluid agent (or first component or substance) may be passed in an antegrade direction from the BFS vial 210 and into the fluid outlet bore 240 (e.g., upon a squeezing of the BFS vial 210 as described herein).
• the fluid agent passed into the fluid outlet bore 240 may be prevented from retrograde movement ⁇ e.g., back into the BFS vial 210) via a valve flap 252-2 of the valve 250.
• the fluid agent may be selectively expelled into the fluid outlet bore 240 and into the insert 270.
• the insert 270 may comprise the insert body 272 that houses the administration member 280.
• the fluid agent may travel in an antegrade direction from the BFS vial 210, through the valve 250 and valve channel 252-1 thereof, into the fluid outlet bore 240, into the insert body 272, and through the administration member 280 ⁇ e.g., and ultimately to the patient).
• the second component or substance of the drug agent may be disposed along this fluid pathway to permit interaction between the two components of the drug agent.
• the fluid pathway may comprise multiple pathways (not shown) that permit, direct, and/or enhance introduction or interfacing of the two components.
• more than two components of the drug agent may be provided and/or each fluid pathway may permit, direct, and/or enhance interaction between different components of the drug agent.
• a first fluid pathway may cause introduction of first and second components of the drug agent, for example, and a second fluid pathway may cause introduction of third and fourth components of the drug agent. In some embodiments, these pathways may join such that all drug agent components may be introduced ⁇ e.g., after separate multi-component introductions).
• the fluid delivery system 200 may comprise, house, and/or retain a substrate 290.
• the substrate 290 may comprise, for example, the active ingredient of the drug agent ⁇ i.e., the second component or substance thereof) or an object that retains, carries, or holds the active ingredient.
• the substrate 290 may be disposed in the fluid outlet bore 240 of the hub 230 ⁇ e.g., during the manufacturing process) and/or may be configured in a spiral shape, e.g., to promote interaction of the fluid agent with the active ingredient.
• the substrate 290 may comprise an inactive object such as a bag, pouch, capsule, paper disk, and/or tablet that contains the second component or substance ⁇ e.g., the active ingredient).
• the second component or substance may, for example, be disposed in a powdered, dry, granulated, dehydrated, lyophilized, cryodesiccated, desiccated, powdered, and/or solid form and may be stored in or on the substrate 290.
• the second component or substance may be disposed in a solid and/or compressed shape such as a pill, cake, tablet ⁇ e.g., an annular-shaped tablet), a fine powder, and/or in aerated form.
• the second component or substance may be combined or mixed with other substances ⁇ e.g., inactive and/or non-reactive substances) such as by being combined with large molecule sugars, thickeners,
• the hub 230 may comprise or define a void, channel, projection, groove, track, diffuser, or other feature (not shown) that may house or retain the substrate 290 and/or the active ingredient.
• the substrate 290 may not comprise a separate object from the active ingredient but may be representative of a disposing of the second component or substance in the hub 230 (or fluid outlet bore 240 thereof).
• the second component or substance may, for example, be directly deposited [e.g., printed) on the inside surface of the fluid outlet bore 240, e.g., in one or more patterns such as a spiral ⁇ e.g., rifle) pattern.
• the inside surface of the fluid outlet bore 240 (or a portion thereof) may be coated with the second component or substance (or a mixture containing or carrying the second component or substance).
• the printing or depositing may be conducted in a manner that increases the surface are of the second component or substance exposed to the fluid agent flow (e.g., a raised crisscross pattern, raised rifling ridges).
• An increased surface area of contact between the second component or substance and the fluid agent (or other first component or substance) may, for example, increase dissolution of the second component or substance and/or reduce an amount of time required for a desired dissolution level.
• Various different parameters for the dimension, shape, thickness, and/or dosage of the active ingredient may be selected for different types of active ingredients, the parameter values selected to meet certain goals.
• Examples of such goals may include, without limitation: (i) maximizing the surface area of the second component or substance; (ii) minimizing the dissolution time; (iii) maximizing the percentage of the second component or substance that is dissolved (e.g., within a certain amount of time and/or given a certain amount or type of diluent); and (iv) a desired concentration of the resulting drug agent (e.g., a desired curve of concentration range).
• the amount, pattern or configuration of the second component or substance may be designed such that ninety percent (90%) of the second component or substance (and/or active ingredient) is dissolved in a particular first component or substance (e.g., fluid agent) within five to six (5 - 6) seconds of the first component or substance being released into the fluid outlet bore 240 from the BFS vial 210.
• a particular first component or substance e.g., fluid agent
• the first component or substance and the second component or substance may be filled or manufactured via two distinct manufacturing processes and/or packed and sold as two distinct products.
• the BFS vial 210 may be filled with the first component or substance during a first manufacturing process at a first facility and/or by first machinery (e.g., a BFS machine; not shown), for example, while the second component or substance and/or substrate 290 may be placed or deposited in the hub 230 during a second manufacturing process at a second facility and/or by second machinery (e.g., an active ingredient printing device; not shown).
• first machinery e.g., a BFS machine; not shown
• second machinery e.g., an active ingredient printing device; not shown
• the BFS vial 210 and the hub 230 e.g., housing the substrate may be stored, transported, and/or sold separately.
• the BFS vial 210 and the hub 230 may be manufactured and/or sold together, e.g., in a pack or set (e.g., a blister pack) and/or partially pre-assembled. In some embodiments, the BFS vial 210 and the hub 230 may be individually sealed or sealed together in a package.
• the BFS vial 210 may be sealed during a BFS manufacturing process, for example, and the hub 230 (and/or the fluid outlet bore 240 thereof) may be separately sealed such as by a plastic or foil seal (not shown) that protects and/or isolates the substrate 290 (and/or active ingredient) by closing off one or more ends of the hub 230 (e.g., seals-off the fluid pathway thereof).
• the hub 230 and the substrate 290 may be assembled in a clean environment, for example, and then sealed for protection.
• the BFS vial 210 and the hub 230 may be pre-assembled and any seal may comprise an internal operational seal (paper, foil, air bubble) that maintains separation between the first component or substance and the second component or substance, e.g., until the system 200 is activated by a user to mix, reconstitute, and/or form the drug agent to be delivered to the patient.
• any seal may comprise an internal operational seal (paper, foil, air bubble) that maintains separation between the first component or substance and the second component or substance, e.g., until the system 200 is activated by a user to mix, reconstitute, and/or form the drug agent to be delivered to the patient.
• the hub 230 (and/or a component thereof, such as the valve 250) may comprise an element (not explicitly shown) for piercing a seal (e.g., the first end 210-1 ) of the BFS vial 210.
• a prong, cutter, point, and/or other protrusion e.g., plastic or metal; not shown
• the element may pierce the first end 210-1 of the BFS vial 210, for example, permitting the fluid agent stored therein to flow into the valve channel 252-1 and/or into the fluid outlet bore 240 (e.g., to engage and/or interface with the substrate 290 and/or active ingredient thereof).
• a piercing element may comprise a cutting edge that, upon rotation of the BFS vial 210 within the hub body 232 for example, perforates or cuts a circumference into or through any seal thereof.
• the BFS vial 210 may comprise a cutting or penetration element (not shown) that is disposed on the first end 210-1 thereof such that when engaged with a seal of the hub 230, pierces, cuts, or otherwise undermines the seal such that the BFS vial 210 may enter and/or be coupled to the hub body 232.
• first component or substance in the BFS vial 210 is generally referred to as an inactive components such as a saline solution or other fluid agent and the second component or substance of or on the substrate 290 is generally referred to as an active component or ingredient of the drug agent, in some embodiments, they may be reversed.
• the first component or substance stored in the BFS vial 210 may comprise an active agent, for example, and the substrate 290 may comprise or retain the second component or substance which may be an inactive ingredient (such as a sugar compound).
• both of the first component or substance and the second component or substance may comprise active ingredients, e.g., that react to form the drug agent upon introduction or mixing.
• the substrates 290a-c may comprise, for example, plastic and/or paper inserts or structures upon which the second component or substance is deposited, adhered, infused, and/or otherwise retained or carried.
• the substrates 290a-c may be configured in various manners to promote dissolution and/or dispersal of the second component or substance and/or to direct flow of the fluid agent through the hub 230.
• a first substrate 290a may comprise an axially elongated spiral structure, for example, that defines a first axial flow profile 292a ( e.g ., an axially exposed surface area).
• the first substrate 290a may comprise and/or define a first channel 294a that permits a portion of the fluid agent to flow axially through the fluid pathway without being impeded or redirected by the first substrate 290a.
• a second substrate 290b may comprise an axially elongated spiral structure that defines a second axial flow profile 292b.
• a third substrate 290c may comprise an axially dispersed set of annular structures coupled together to define a third axial flow profile 292c.
• the third substrate 290c may define a second channel 294c, for example, that permits some portion of fluid agent to flow through the third substrate 290c may while other portions of the fluid agent may be forced to interact with one or more of the third axial flow profiles 292c thereof.
• Different substrates 290a-c may be utilized to induce different mixing actions and/or dissolution times for different substances that may be disposed on or retained by the substrates 290a-c, as is or becomes known or practicable.
• the substrates 290a-c may comprise structures inserted into the hub 230 upon which (and/or within which) the second component or substance is deposited or retained.
• the substrates 290a-c may comprise deposited instances of the second component or substance such as structures formed by additive manufacturing utilizing the second component or substance as printing material.
• the second component or substance may be deposited, such as in combination with a structural facilitator such as a sugar compound or protein for example, in a predefined pattern to define one or more of the substrates 290a-c and/or portions thereof.
• a structural facilitator such as a sugar compound or protein for example
• the substrates 290a-c and/or the second component or substance may be disposed in an/or deposited in or on various components of the system 200. While the fluid outlet bore 240 is generally described as the location for the second component or substance, for example, one or more second components or substances may be disposed in various other portions of the hub 230, in the insert 270, in the administration member 280, and/or in other portions of the system 200 as is or becomes known or practicable.
• one or more of the substrates 290a-c comprising and/or retaining a predefined dose or amount of the second component or substance may be inserted or deposited into the hub 230 during a manufacturing process and the BFS vial 210 may be filled with a predefined dose or amount of the first component or substance during a BFS manufacturing process. Whether accomplished during manufacturing assembly or in the field, the BFS vial 210 may then be coupled to the hub 230 such that each of the first component or substance and the second component or substance are exposed to the fluid pathway and/or each other.
• a user will activate the hub 230 and administration member 280 (e.g., by pushing‘down’ on a needle cover (not shown) or on the assembly flange 238 and onto the BFS vial 210), which may cause a puncturing of a seal (not shown) between the BFS vial 210 and the hub 230 and cause an arming of the delivery system 200.
• the user may then clean the injection site if required, insert the injection cannula after removing the needle cover in the correct body position and deploy the system 200 by pinching the BFS vial 210.
• the fluid agent will flow through the hub 230, dissolving the powder (or other form of the second substance) and dispelling it through the administration member 280 and into the patient. This will work well with fast dissolving powders. Slower dissolving formulations may require a longer‘track’ (e.g., longer or more complex fluid pathway through the hub 230 and/or administration member 280) and therefore interaction, flow, eddies, turbulence, to confirm dissolving will occur can be modified as desired. In some embodiments, spray drying or printing the fine particles of powdered drug into the hub 230 and/or onto or as the substrates 290a-c will aid faster dissolving speeds.
• track e.g., longer or more complex fluid pathway through the hub 230 and/or administration member 280
• spray drying or printing the fine particles of powdered drug into the hub 230 and/or onto or as the substrates 290a-c will aid faster dissolving speeds.
• a user may then, for example, squeeze the BFS vial 210, thereby forcing the first component or substance into the hub 230 which has the appropriate dosage/amount of the second component or substance (e.g., the active ingredient), thus causing a reconstitution of the drug agent comprising the active ingredient and the appropriate dose of the drug agent to be injected into the patient via the administration member 280 upon the drug agent being reconstituted as the fluid agent travels through the hub 230 and/or fluid outlet bore 240 that contains the second component or substance.
• the system 200 is generally capable of delivering the multi-component drug agent in a controlled manner and without requiring specialized skill in administering delivery of such agent.
• BFS vials 210 are configured to store and allow for delivery of accurate dosages and amounts of fluid to a very high tolerance, without requiring a user to measure out an accurate amount of the fluid. Further, fluid can be stored in a BFS vial 210 for years and this has been proven over decades of use.
• BFS delivery systems are configured to facilitate the desired or recommended single dose of the drug agent into a patient by a user who needs little or no training (e.g., the patient, in the case of self-injections, or a medical professional with little training or who is working under strained conditions and thus susceptible to user errors).
• the modular dual component delivery system 200 described herein allows for reconstitution of the drug agent without requiring a user to measure the correct dose of diluent and the normal act of squeezing the fluid out of the BFS vial 210 provides the force or action to introduce the inactive fluid substance into the hub 230 and thus allow for the reconstitution of the active substance stored in or on the substrate 290 (or otherwise disposed in the hub 230) without requiring any additional measuring or actions on the part of the user other than what the user would normally do when administering an injection via a BFS vial 210.
• the drug is supplied in a glass vial and the liquid is added with a needle or other device into the vial and shaken to full dissolution.
• 290a-c, 292, 292a-c, 294, 294a, 292c may be included in the fluid delivery system 200 without deviating from the scope of embodiments described herein.
• 274, 276, 278, 278-1, 280, 282, 282-1, 282-2, 282-3, 284, 290, 290a-c, 292, 292a-c, 294, 294a, 292c may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein.
• the fluid delivery system 200 (and/or portion and/or component 210, 210-1, 210-2, 212, 214, 216, 218a-b, 220, 222, 226, 228, 228-1, 228-2, 228-3, 228-4, 230, 232, 232-1, 232-2, 232-3, 234a-b, 236, 238, 240, 240- 1, 240-2, 242, 242-1, 242-2, 242-3, 244, 250, 252, 252-1, 252-2, 254a, 256, 258, 260, 262, 270, 272, 272-1, 272-2,
• 274, 276, 278, 278-1, 280, 282, 282-1, 282-2, 282-3, 284, 290, 290a-c, 292, 292a-c, 294, 294a, 292c thereof) may be utilized in accordance with the methods 800, 900 of FIG. 8 and/or FIG. 9 herein, and/or portions or combinations thereof.
• the modular hub 330 may comprise a modular component of a fluid delivery system as described herein.
• the modular hub 330 may comprise, for example, a cylindrical hub body 332 defining a hub bore 332-1 therethrough, the hub bore 332-1 having an inside hub bore diameter 332-2.
• the modular hub 330 may comprise a vial bevel 332-3 disposed at an opening of the hub bore 332-1 and/or may comprise a plurality of locking slots 334a-b disposed in the sides of the hub body 332.
• the modular hub 330 may comprise an assembly flange 336 disposed at an opening of the hub bore 332-1 and/or may comprise a plurality of valve slots 338a-b disposed in the sides of the hub body 332.
• the modular hub 330 may comprise a fluid outlet bore 340 having an interior fluid outlet bore diameter 340-1.
• a valve seat 340-2 may be formed or disposed in the hub bore 332-1 and/or between the hub bore 332-1 and the fluid outlet bore 340.
• the modular hub 330 may comprise an insert bore 342 having an interior insert bore diameter 342-1 and/or may comprise and/or define an insert bevel 342-2 and/or an insert recess 342-3.
• the insert recess 342-3 may define and/or the insert bore 342 may comprise and/or define an insert seat 344.
• the hub bore 332-1 may comprise a non-circular cross- section such as an oval, square, rectangle, triangle, and/or other shape such as an“eye” shape as shown.
• the hub bore diameter 332-2 may be equal to the insert bore diameter 342-1 and/or the fluid outlet bore diameter 340-1 may be smaller than either or both of the hub bore diameter 332-2 and the insert bore diameter 342-1.
• valve seat 340-2 and/or the insert seat 344 may be shaped to accept a valve and an insert (neither shown), respectively.
• the valve seat 340-2 may be positioned axially adjacent to the valve slots 338a-b such that a portion of a valve inserted into the hub bore 322-1 may seat and/or seal with the valve seat 340-2 while another portion of the valve seats within, protrudes into, and/or is otherwise engaged with each respective valve slot 338a-b.
• the vial bevel 332-3 and the insert bevel 342-2 may be conically shaped portions that act upon objects inserted axially therein.
• the vial bevel 332-3 may provide or exert a radially inward opposing force thereon, causing object to compress, retract, and/or deform - e.g., increasingly as the diameter of the vial bevel 332-3 decreases along the axial insertion path.
• the fluid outlet bore 340 may comprise and/or house an active ingredient (not shown; e.g., the substrate 290 of FIG. 2M and/or FIG. 2N herein).
• the fluid outlet bore 340 may be lined with a solid active ingredient, may house a solid ingredient tablet, and/or may house an inactive substrate upon which an active ingredient is transported (e.g., adhered and/or contained).
• the fluid outlet bore 340 may comprise one or more features (not shown) such as detents, voids, and/or ridges that store, house, and/or retain a solid substance that fluid flowing through the fluid outlet bore 340 may dissolve.
• the length of the fluid outlet bore 340 and/or the interior fluid outlet bore diameter 340-1 may be sized and/or configured to house the active ingredient and/or associated substrate or object.
• fewer or more components 332, 332-1, 332-2, 332-3, 334a-b, 336, 338, 340, 340-1, 340-2, 342, 342-1, 342-2, 342-3, 344 and/or various configurations of the depicted components 332, 332- 1, 332-2, 332-3, 334a-b, 336, 338, 340, 340-1, 340-2, 342, 342-1, 342-2, 342-3, 344 may be included in the modular hub 330 without deviating from the scope of embodiments described herein.
• the components 332, 332-1, 332-2, 332-3, 334a-b, 336, 338, 340, 340-1, 340-2, 342, 342-1, 342-2, 342-3, 344 may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein.
• the modular hub 330 (and/or portion and/or component 332, 332-1, 332-2, 332-3, 334a-b, 336, 338, 340, 340-1, 340-2, 342, 342-1, 342-2, 342-3, 344 thereof) may be utilized in accordance with the methods 800, 900 of FIG. 8 and/or FIG. 9 herein, and/or portions or combinations thereof.
• the modular valve 450 may comprise a modular component of a fluid delivery system as described herein.
• the modular valve 450 may comprise, for example, a cylindrical and/or annular-shaped valve body 452 defining a valve channel 452-1 therethrough, having a valve flap 452-2 disposed therein, and/or one or more mounting wings 454a-b protruding radially from the valve body 452.
• the modular valve 450 may comprise a cylindrical riser 456 extending axially from the valve body 452 and/or an antegrade void 458 formed at the base of the riser 456.
• the modular valve 450 may comprise a vial flange 460 formed and/or disposed on an axial-facing surface of the valve body 452 and/or may comprise a seating surface 462 disposed and/or formed on an opposite axial-facing surface of the valve body 452.
• the valve body 452 may be shaped to fit within a bore of a modular hub member (not shown).
• the valve body 452 may be substantially cylindrically or circularly shaped, for example, or may be“eye” or“almond”-shaped, as depicted in FIG. 4A, FIG. 4B, and FIG. 4C.
• the valve flap 452-2 may comprise a portion of pliable material attached along only a portion of a circumference of the interior of the valve channel 452-1 such that it may be selectively and temporarily axially displaced upon application of an axial force thereto.
• valve flap 452-2 may be utilized to construct the valve flap 452-2 such that larger amounts of axial force are required to bend the valve flap 452-2 and/or such that the valve flap 452-2 may comprise an increased natural spring-effect that urges or biases the valve flap 452-2 to a default or “closed” position, e.g., normal to an axis of the modular valve 450.
• fewer or more components 452, 452-1 , 452-2, 454a-b, 456, 458, 460, 462 and/or various configurations of the depicted components 452, 452-1, 452-2, 454a-b, 456, 458, 460, 462 may be included in the modular valve 450 without deviating from the scope of embodiments described herein.
• the components 452, 452-1 , 452-2, 454a-b, 456, 458, 460, 462 may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein.
• the modular valve 450 (and/or portion and/or component 452, 452-1 , 452-2, 454a-b, 456, 458, 460, 462 thereof) may be utilized in accordance with the methods 800, 900 of FIG. 8 and/or FIG. 9 herein, and/or portions or combinations thereof.
• the modular insert 570 may comprise a modular component of a fluid delivery system as described herein.
• the modular insert 570 may comprise, for example, a cylindricalshaped insert body 572 defining a fluid channel 572-1 therethrough, having an outlet funnel 574 and/or an inlet funnel 576 disposed at opposing ends thereof.
• the outlet funnel 574 may comprise an inside diameter 574-1 configured for various desired fluid delivery applications as described herein (e.g., for acceptance of different gauge needles, nozzles, and/or other delivery methods or applications).
• the modular insert 570 may comprise a seating flange 578 and/or a seating flange collar 578-1. As depicted, the seating flange collar 578-1 may house and/or define the inlet funnel 576.
• the seating flange 578 may be rounded at the radial extents thereof, such as to facilitate insertion of the seating flange 578 into a bore (not shown) with a smaller diameter than that of the seating flange 578.
• fewer or more components 572, 572-1 , 572-2, 574, 574-1 , 576, 578, 578-1 and/or various configurations of the depicted components 572, 572-1 , 572-2, 574, 574-1 , 576, 578, 578-1 may be included in the modular insert 570 without deviating from the scope of embodiments described herein.
• the components 572, 572-1 , 572-2, 574, 574-1 , 576, 578, 578-1 may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein.
• the modular insert 570 may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein.
• the BFS vial 610 may, for example, comprise a generally flask-shaped element comprising a bottom 610-2 at one end and comprising a neck 612, a distal or first flange 614, a proximate or second flange 616, and/or a plurality of indexing or coupling elements 618a-b at an opposite end thereof.
• the first flange 614, second flange 616, and/or coupling elements 618a-b may, in some embodiments, be operable to mate and/or couple with a hub assembly for fluid delivery (not shown), as described herein.
• the modular BFS vial 610 may comprise a flask-shaped fluid reservoir 620 disposed between the bottom 610-2 and the neck 612, and/or a compression foot 622 disposed adjacent to and/or at the bottom 610-2.
• the flask-shaped fluid reservoir 620 may be axially compressed and/or collapsed to expel any fluid (e.g., an inactive diluent or an active ingredient of a drug agent) stored therein, such as by application of an axial force urging the compression foot 622 toward the neck 612.
• the flask-shaped fluid reservoir 620 may be advantageously ergonomic by lending itself to easy operation by a user (not shown) by the user placing two (2) or more fingers (not shown) over the top of the flask-shaped fluid reservoir 620 with their thumb (also not shown) disposed beneath the compression foot 622 at the bottom 610-2.
• a squeezing motion compressing the fingers toward the thumb may then, in some embodiments, compress and/or deform the flask-shaped fluid reservoir 620 such that it achieves a substantially disk-shaped collapsed appearance and accordingly reduces the volume of the flask-shaped fluid reservoir 620 to substantially zero by expelling substantially all fluid previously stored therein.
• fewer or more components 610-2, 612, 614, 616, 618a-b, 620, 622 and/or various configurations of the depicted components 610-2, 612, 614, 616, 618a-b, 620, 622 may be included in the modular BFS vial 610 without deviating from the scope of embodiments described herein.
• the components 610-2, 612, 614, 616, 618a-b, 620, 622 may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein.
• the modular BFS vial 610 (and/or portion and/or component 610-2, 612, 614, 616, 618a-b, 620, 622 thereof) may be utilized in accordance with the methods 800, 900 of FIG. 8 and/or FIG. 9 herein, and/or portions or combinations thereof.
• FIG. 7A, FIG. 7B, FIG. 7C, FIG. 7D, FIG. 7E, FIG. 7F, and FIG. 7G right-front perspective, top, bottom, left, right, front, and views of a modular BFS vial 710 according to some embodiments are shown.
• the BFS vial 710 may, for example, comprise an accordion or“concertina”-shaped element comprising a top or outlet 710-1 and a bottom 710-2.
• the BFS vial 710 may comprise (e.g., at or adjacent to the outlet 710-1) a neck 712, a distal or first flange 714, a proximate or second flange 716, and/or a plurality of indexing or coupling elements 718a-b.
• the first flange 714, second flange 716, and/or coupling elements 718a-b may, in some embodiments, be operable to mate and/or couple with a hub assembly for fluid delivery (not shown), as described herein.
• the modular BFS vial 710 may comprise a“concertina”-shaped fluid reservoir 720a-b disposed between the top 710-1 and the bottom 710-2, and/or a compression foot 722 disposed adjacent to and/or at the bottom 710-2.
• the“concertina”-shaped fluid reservoir 720a-b may comprise and/or define a plurality of segments, volumes, and/or lobes such as an upper or first lobe 720a and a lower or second lobe 720b formed and/or joined therebetween. Fewer or more lobes 720a-b may be utilized in some embodiments.
• the lobes 720a-b may be axially compressed and/or collapsed to expel any fluid stored therein, such as by application of an axial force urging the compression foot 722 toward the neck 712 and/or the top 710-1.
• the lobes 720a-b may be advantageously ergonomic by lending themselves to easy operation by a user (not shown) by the user placing two (2) or more fingers (not shown) over the top of the first lobe 720a with their thumb (also not shown) disposed beneath the compression foot 722 at the bottom 710-2.
• a squeezing motion compressing the fingers toward the thumb may then, in some embodiments, compress and/or deform each of the lobes 720a-b such that they each achieve a substantially disk-shaped collapsed appearance and accordingly reduce the volume of the“concertina”-shaped fluid reservoir 720a-b to substantially zero by expelling substantially all fluid previously stored therein.
• fewer or more components 710-1, 710-2, 712, 714, 716, 718a-b, 720a-b, 722 and/or various configurations of the depicted components 710-1, 710-2, 712, 714, 716, 718a-b, 720a-b, 722 may be included in the modular BFS vial 710 without deviating from the scope of embodiments described herein.
• the components 710-1, 710-2, 712, 714, 716, 718a-b, 720a-b, 722 may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein.
• the modular BFS vial 710 (and/or portion and/or component 710-1, 710-2, 712, 714, 716, 718a-b, 720a-b, 722 thereof) may be utilized in accordance with the methods 800, 900 of FIG. 8 and/or FIG. 9 herein, and/or portions or combinations thereof.
• FIG. 8 is a perspective flow diagram of a method 800 according to some embodiments.
• the method 800 may, for example, illustrate an exemplary use of the various drug agent delivery systems and/or components thereof, as described herein.
• the process diagrams and flow diagrams described herein do not necessarily imply a fixed order to any depicted actions, steps, and/or procedures, and embodiments may generally be performed in any order that is practicable unless otherwise and specifically noted. While the order of actions, steps, and/or procedures described herein is generally not fixed, in some embodiments, actions, steps, and/or procedures may be specifically performed in the order listed, depicted, and/or described and/or may be performed in response to any previously listed, depicted, and/or described action, step, and/or procedure.
• the drug agent delivery system may be provided with a pack of BFS vials 802 and a corresponding number of fully assembled delivery assemblies 826 (e.g., with safety covers 828 and/or including solid or dry active ingredient disposed therein), at 801.
• a user may then, according to some embodiments, simply tear away one of the vials 810 from the pack 802 when ready to deliver the single dose of fluid agent, at 803.
• the user may then attach the removed vial 810 to one of the delivery assemblies 826 by pressing ⁇ e.g., axially) them together, e.g., until the vial 810 snaps, clicks, and/or locks into place in the delivery assembly 826, at 805.
• the mating or coupling of the one of the vials 810 with the delivery assembly 826 may cause a piercing or removal of one or more seals.
• an active ingredient is stored in the delivery assembly 826
• the delivery assembly 826 may comprise an element that pierces a seal (or portion of) the vial 810 to expose the fluid stored therein.
• the user may shake the coupled vial 810 and delivery assembly 826 to introduce the fluid from the vial 810 with an active ingredient in the delivery assembly 826 (or vice versa).
• the user may then remove the safety cover 828 from the combined vial 810 and delivery assembly 826, thereby exposing the needle 880 (or other appropriate administration member), at 807.
• the user may then administer the fluid agent (either self-administration or administration to another person), at 809.
• the safety cover 828 may be placed back on to the delivery assembly 826 and the contents can be discarded in the appropriate biohazard waste receptacle, at 811.
• the delivery assembly 826 is generally configured to allow delivery of the agent to the patient in a relatively simple manner, without requiring specialized training for administering the agent.
• the delivery assembly 828 is designed such that a person administering the fluid agent ⁇ e.g., administrator), which could also include self-administration, need only position the device upon the administration site ⁇ e.g., shoulder, arm, chest, nose, ear, eye, etc.), and then fully compress the BFS vial 810 (and/or a fluid reservoir thereof) containing the dose of fluid agent, thereby delivering the correct predefined dosage to the patient.
• the delivery assembly 826 may be further configured such that, in the event that a needle 880 is required ⁇ i.e., because the delivery method is an injection), needle penetration is limited to the correct length and orientation within the administration site.
• the needle 880 is positioned substantially perpendicular relative to a plane along which the distal end of the insert lies, such that the needle 880 is configured to be inserted into a patient's skin at a substantially perpendicular angle and the distal end of the insert is configured to contact the patient's skin indicating adequate depth of penetrating for injection of the fluid agent.
• the delivery assembly 826 may not require a trained, skilled healthcare profession for administration of vaccines or drugs.
• the delivery assembly 826 may be particularly useful in situations in which vaccines or drugs are being administered in non-healthcare related facilities ⁇ e.g., outside of clinics or hospitals) and given to large numbers of individuals over a short period of time by a non-professional.
• the method 900 may comprise, for example, separating a BFS vial from a BFS manifold, at 902. A user may grab an individual vial and twist or bend it to separate it from the BFS manifold at one or more preconfigured breakage or junction points, for example. According to some embodiments, the method 900 may comprise coupling the BFS vial to a delivery hub, at 904.
• the coupling may comprise, for example, applying axial force ⁇ e.g., via a grip plate of the BFS vial and an assembly flange of the assembly hub) that urges a BFS vial axially into a bore of a modular assembly hub ⁇ e.g., as described herein), e.g., until engagement elements integral to the BFS vial click or snap into appropriately indexed retention features of the assembly hub.
• one or more seals may be removed or broken during or prior to the coupling and/or the coupled assembly may be shaken to mix ingredients stored separately in the different components thereof.
• the method 900 may comprise removing a safety cap, at 906.
• Axial force may be applied to separate the cap from the assembly hub, for example, exposing an administration member such as a needle, nozzle, dropper, or the like.
• the method 900 may comprise administering a dose of fluid ⁇ e.g., a fluid drug agent or a drug agent comprising a reconstituted or dissolved active ingredient in a carrier fluid or diluent), at 908.
• the administration element of the assembly hub may be engaged with a patient, for example, and a collapsible and integral reservoir of the BFS vial may be squeezed ⁇ e.g., via application of inward radial force) to force fluid therefrom(and/or to cause a mixing or dissolving of a separately-stored active ingredient).
• the fluid may be forced in an antegrade axial direction such that it displaces a valve flap of a one-way valve, thereby allowing the fluid to proceed axially into the administration element and be delivered to the patient.
• the method 900 may comprise replacing the safety cap, at 910.
• the method 900 may comprise disposing of the delivery system, at 912. In such a manner, for example, a low-cost, easily transported and more easily stored fluid delivery system may be provided that allows unskilled users to administer and/or self-administer.
• FIG. 10 shows perspective views of modular delivery or hub assemblies 1026a-d configured for different methods of delivery ⁇ e.g., intramuscular, subcutaneous, intravenous, and intradermal injection).
• each modular hub assembly 1026a-d may comprise a respective modular hub element 1030a-d ⁇ e.g., that may house or contain a dry or solid active ingredient), a modular valve element 1050a-d, a modular insert element 1070a-d, and/or a modular needle (or other administration) element 1080a-d.
• the various respective needle elements 1080a-d may be configured for different delivery/administration requirements.
• the needle elements 1080a-d may have varying lengths in the range of about one and one half millimeters (1.5 mm) to twenty-five millimeters (25 mm) - e.g., with a first needle element 1080a being the longest, a second needle elements 1080b being shorter than the first needle element 1080a, a third needle elements 1080c being shorter than the second needle element 1080b, and/or a fourth needle elements 1080d being shorter than the third needle element 1080c.
• lengths of the needle elements 1080a-d may be in the range of one-half millimeter (0.5 mm) to fifty millimeters (50 mm).
• the only structural differences between the various hub assemblies 1026a-d may be the lengths (and/or thicknesses) of the needle elements 1080a-d.
• Each of the other modular components 1030a-d, 1050a-d, 1070a-d may, for example, be identical. Accordingly, the modular construction of the delivery assemblies 1026a-d may allow for rapid manufacturing reconfigurations of one or more components with minimal costs to create new delivery assembly configurations that meet specific needs (/.e., different modes of delivery depending on agent to be delivered, such as subcutaneous, intramuscular, intradermal, intravenous injection, spray, or droplet delivery).
• the modular hub element 1030a-d and the modular valve element 1050a-d may remain the same construction (dimensions and material), while the modular insert element 1070a-d may be changed to account for different sized needle elements 1080a-d and/or nozzle types, depending on the type of delivery and/or type of fluid agent to be delivered.

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• 2019
  • 2019-06-20 WO PCT/US2019/038302 patent/WO2019246435A1/en unknown
  • 2019-06-20 KR KR1020217001595A patent/KR20210049084A/ko not_active Application Discontinuation
  • 2019-06-20 JP JP2020571495A patent/JP2021527535A/ja active Pending
  • 2019-06-20 EP EP19823345.4A patent/EP3810230A4/en active Pending
  • 2019-06-20 CN CN201980052817.4A patent/CN112543654B/zh active Active

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