A pre-filled blow-fill-seal (BFS) IntraDermal (ID) medical agent injection system assembled and configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a BFS vial to a patient in an auto-disable fashion.
The invention provides for a delivery system including a delivery assembly configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient.
A61J 1/18 - Arrangements for indicating condition of container contents, e.g. sterile condition
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
A61M 5/162 - Needle sets, i.e. connections by puncture between reservoir and tube
A61M 5/24 - Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
A61M 5/28 - Syringe ampoules or cartridges, i.e. ampoules or cartridges provided with a needle
A61M 5/30 - Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or cartridges
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/34 - Constructions for connecting the needle
Systems, methods and articles of manufacture provide for an injection management platform that allows the verification and management of injection event transactions involving injectors equipped with NFC or RFID chips utilizing a distributed and secure technology such as blockchain. An injection event transaction ledger allows for digital receipts of injection event transactions to be securely verified and updated. In accordance with some embodiments, injectors may comprise blow-fill-seal (BFS) injectors that are pre-filled with a single dose of a fluid agent comprising a vaccine or medicament, allowing for tracking of individual doses of the fluid agent via the injection event transaction ledger.
H04L 9/00 - Arrangements for secret or secure communicationsNetwork security protocols
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
5.
SYSTEMS AND METHODS FOR ROTARY BLOW-FILL-SEAL (BFS) MACHINE MOLD POSITIONING
Systems and methods for rotary Blow-Fill-Seal (BFS) mold positioning that utilize fixed-position filling mandrels and upward moving molds to form mandrel-molded BFS product features utilizing a modified mold positioning path profile.
A syringe cartridge assembly includes a syringe housing, a compressible Blow-Fill-Seal (BFS) cartridge at least partially positionable within the syringe housing, and having a fluid agent. In at least some embodiments, the compressible cartridge includes a compressible bellows segment configured to transition between an initial condition and an at least partially compressed condition. A plunger is configured for movement within the syringe housing to cause transition of the compressible bellow segment from the initial condition to the at least partially compressed condition to and push the cartridge into a double-ended cannulated needle of a deliver assembly attached to the syringe housing, causing one end of the needle to penetrate the compressible BFS cartridge and dispense the fluid agent into a patient via the opposing end thereof.
A61M 5/24 - Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
7.
SYSTEMS AND METHODS FOR DYNAMIC ROTARY BLOW-FILL-SEAL (BFS) MACHINE COOLING
Systems and methods for automatic and dynamic temperature adjustment and over-cooling of a rotary Blow-Fill-Seal (BFS) manufacturing device to reduce the fill product temperature such as for filling of BFS vials with cold-temperature vaccines.
B65B 3/00 - Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans or jars
B65B 63/08 - Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged for heating or cooling articles or materials to facilitate packaging
8.
SYSTEMS AND METHODS FOR RADIALLY COMPRESSIBLE BLOW-FILL-SEAL (BFS) DEVICES
Systems and methods for Blow-Fill-Seal (BFS) vials configured to expel a desired quantity of medicament in response to a designed range of radially inward squeeze-force applications received via a compressible fluid reservoir.
In some embodiments, an Al agent may be operable to conduct a pre-injection interview with a patient (e.g., as part of a self-injection process) prior to authorizing an injection for the patient. The interrogation may be designed to identify whether the patient is at an increased risk of adverse side effects, based on historical data accessible to the Al agent. In accordance with some embodiments, the Al agent may be programmed to learn and improve the questions to ask patient (e.g., for a given fluid agent, in particular circumstances, for specific types of questions, or otherwise), based on inputs received from patients who have previously received injections and experienced adverse side effects. In some embodiments, the Al agent may further be programmed to implement one or more mitigation measures based on a result of such an interrogation.
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
A pre-filled blow-fill-seal (BFS) vial can have a fluid seal at one end thereof that can be breached by a piercing element within a connector when a neck of the BFS vial is fully inserted into the connector. The piercing element can comprise or define one or more fluid conduits that allow fluid to flow from an interior of the BFS vial to an outlet port of the connector, thereby allowing the contents to be dispensed from the BFS vial. The connector can facilitate coupling of the BFS vial for subsequent administration of the contents therein to a patient. For example, the outlet port of the connector can be coupled to an administration assembly, such as a syringe, nozzle, intravenous (IV) therapy device, or another device.
A pre-filled medical delivery assembly assembled and configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient may include a multi-bevel cannula piercing element such as for rotational axial engagement to pierce a seal of the BFS vial.
Systems and methods for altering the typical rotary Blow-Fill-Seal (BFS) machine manufacturing process to implement a staged or phased vacuum application to the BFS molds.
B29C 49/42 - Component parts, details or accessoriesAuxiliary operations
B65B 3/02 - Machines characterised by the incorporation of means for making the containers or receptacles
B65B 3/00 - Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans or jars
B65B 47/10 - Apparatus or devices for forming pockets or receptacles in or from sheets, blanks, or webs, comprising essentially a die into which the material is pressed or a folding die through which the material is moved by application of fluid pressure by vacuum
13.
BLOW-FILL-SEAL (BFS) ASSISTED VIAL DISPENSING SYSTEMS AND METHODS
Systems and methods for dispensing Blow-Fill-Seal (BFS) vials such as pre-filled vials containing a vaccine or other medicament via utilization of an assistive dispensing device to selectively compress the fluid reservoir of the BFS vial is shown and described. The assistive dispensing device includes one or more protrusions to aid in applying compressive force to assist in dispensing the liquid from the vial, and may also include a first dosage setting member and a second dosage setting member, that engage each other to limit movement of the one or more protrusions when the proper compression force has been reached.
Systems and methods for disabling Blow-Fill-Seal (BFS) vials such as pre-filled vials containing a vaccine or other medicament via utilization of an assistive dispensing device to selectively compress the fluid reservoir of the BFS vial. The assistive dispensing device can aid in applying compressive force to assist in dispensing the liquid from the vial, and may also be utilized to lock in a mated position so that the BFS vial may not be reused and/or is otherwise readily identifiable as having already been administered.
A61M 5/28 - Syringe ampoules or cartridges, i.e. ampoules or cartridges provided with a needle
A61M 5/50 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
e.g.e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly generally includes a modular design consisting of separately constructed components cooperatively arranged and coupled to one another. In accordance with some embodiments, the medical delivery assembly comprises a hub connector that includes at least one alignment track on an interior portion thereof, configured to receive a corresponding wing of a BFS vial which it is designed to couple with.
A61J 1/20 - Arrangements for transferring fluids, e.g. from vial to syringe
A61M 5/28 - Syringe ampoules or cartridges, i.e. ampoules or cartridges provided with a needle
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A pre-filled medical delivery assembly can have first and second blow-fill-seal (BFS) modules and first and second connectors. Each BFS module can have a reservoir with a fluid agent and a neck with a seal. Each connector can have a respective recess with a piercing element. The first connector can have an outlet port, and the second connector can have an inlet/outlet (I/O) port. The connectors can be coupled together via the outlet and I/O ports. The neck of each BFS module can be inserted into the recess of the respective connector such that the piercing element breaches the seal, thereby providing a fluid path between the reservoirs. The disclosed assemblies can allow the combination of separate fluid agents via the coupled connectors and subsequently delivery of the combination as a single dose of a therapeutic agent to a patient by replacing the first connector with an administration hub.
An inspection system is provided for a pre-filled blow-fill-seal (BFS) product. The BFS product comprises a neck that extends along a longitudinal direction and has a coupling portion that protrudes laterally outward with respect to adjacent portions of the neck. The inspection system comprises a controller and a first inspection station, which includes illumination and detection assemblies. Interrogating light from one or more light sources of the illumination assembly is directed at a perimeter of the coupling portion of the neck. The detection assembly has an input optical axis that extends along the longitudinal direction and comprises an imaging device to detect light emitted from the neck. The controller is configured to determine compliance of the BFS product with respect to predetermined criteria based at least in part on the light detected by the imaging device.
A pre-filled medical delivery assembly can have a blow-fill-seal (BFS) module, a manifold, and a casing. The BFS module can have a pair of reservoirs, and a pair of sealed ports. Each reservoir can have a respective liquid agent therein. Each port can be in fluid communication with a respective one of the reservoirs. Part of the BFS module can be inserted into the manifold, and the casing can protect part of the BFS module exposed from the manifold. An orientation of the casing can be reversed, and the casing can be used to push the BFS module into the manifold to breach the seals and/or to compress the reservoirs to dispense the liquid agents. The disclosed assemblies can combine the liquid agents from the BFS module and deliver the combination as a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) to a patient.
A pre-filled medical delivery assembly assembled and configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly generally includes a modular design consisting of separately constructed components cooperatively arranged and coupled to one another.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
20.
PRE-FILLED MULTI-FLUID MEDICAL DELIVERY ASSEMBLIES
A pre-filled medical delivery system can have a blow-fill-seal (BFS) module and a mixing assembly. The BFS module can have first and second chambers, first and second sealed ports, and first and second actuation members. Each chamber can have a respective liquid agent therein. Each sealed port and each actuation member can be in fluid communication with a respective one of the chambers. The mixing assembly can be constructed for coupling to the BFS module. When coupled to the BFS module, the mixing assembly can breach the seals of the first and second ports and provide fluid communication therebetween. The disclosed systems, when assembled, can combine the liquid agents from the first and second chambers of the BFS component and deliver the combination as a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) to a patient.
A61M 5/34 - Constructions for connecting the needle
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
21.
SYSTEMS AND METHODS FOR ROTARY BLOW-FILL-SEAL (BFS) MACHINE MOLD POSITIONING
Systems and methods for rotary Blow-Fill-Seal (BFS) mold positioning that utilize fixed-position filling mandrels and upward moving molds to form mandrel-molded BFS product features utilizing a modified mold positioning path profile.
B29C 49/30 - Blow-moulding apparatus having movable moulds or mould parts
B29C 49/32 - Blow-moulding apparatus having movable moulds or mould parts moving "to and fro"
B29C 49/38 - Blow-moulding apparatus having movable moulds or mould parts mounted on movable endless supports
B65B 3/02 - Machines characterised by the incorporation of means for making the containers or receptacles
B65B 9/24 - Enclosing successive articles or quantities of material, in preformed tubular webs, or in webs formed into tubes around filling nozzles, e.g. extruded tubular webs the tubes being formed in situ by extrusion
B29C 49/34 - Blow-moulding apparatus having movable moulds or mould parts moving "to and fro" the mould parts moving "hand-over-hand"
B29C 49/36 - Blow-moulding apparatus having movable moulds or mould parts rotatable about one axis
B29C 49/40 - Blow-moulding apparatus having movable moulds or mould parts mounted on movable endless supports on co-operating drums
A fluid delivery manifold system assembled and configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly generally includes a modular manifold design consisting of separately constructed components cooperatively arranged and coupled to one another. The modular manifold construction allows for rapid manufacturing reconfigurations of one or more components with minimal costs to create new delivery manifold 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).
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
A61M 5/28 - Syringe ampoules or cartridges, i.e. ampoules or cartridges provided with a needle
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
24.
SYSTEMS AND METHODS FOR DYNAMIC ROTARY BLOW-FILL-SEAL (BFS) MACHINE COOLING
Systems and methods for automatic and dynamic temperature adjustment and over-cooling of a rotary Blow-Fill-Seal (BFS) manufacturing device to reduce the fill product temperature such as for filling of BFS vials with cold-temperature vaccines.
e.g.e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) bottle to a patient utilizing one or more BFS injection or connection assemblies.
A pre-filled medical delivery system assembled and configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) bottle to a patient utilizing one or more BFS injection or connection assemblies.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
27.
PRE-FILLED BLOW-FILL-SEAL INTRADERMAL INJECTION SYSTEM
A pre-filled blow-fill-seal (BFS) IntraDermal (ID) medical agent injection system (600) assembled and configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a BFS vial (610) to a patient in an auto-disable fashion.
A blow-fill-seal (BFS) vial, such as a pre-filled container containing a vaccine or other medicament, includes a modified fluid seal along a parting line of the vial. For example, the modified fluid seal can be an end portion of the BFS vial that has been thickened or otherwise strengthened during the BFS molding process. Molding systems and methods for thickening and/or strengthening the fluid seal along the parting line of the vial are also provided.
Systems, methods and articles of manufacture provide for an injection management platform that allows the verification and management of injection event transactions involving injectors equipped with NFC or RFID chips utilizing a distributed and secure technology such as blockchain. An injection event transaction ledger allows for digital receipts of injection event transactions to be securely verified and updated. In accordance with some embodiments, injectors may comprise blow-fill-seal (BFS) injectors that are pre-filled with a single dose of a fluid agent comprising a vaccine or medicament, allowing for tracking of individual doses of the fluid agent via the injection event transaction ledger.
H04L 9/00 - Arrangements for secret or secure communicationsNetwork security protocols
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
30.
SYSTEMS AND METHODS FOR PRE-FILLED MULTI-LIQUID MEDICAL DELIVERY DEVICES
A pre-filled medical delivery system can have a blow-fill-seal (BFS) component and a connection assembly. The BFS component can have first and second chambers, and first and second sealed ports. Each chamber can have a respective liquid agent therein. Each sealed port can be in fluid communication with a respective one of the chambers. The connection assembly can be constructed for coupling to the BFS component. When coupled to the BFS component, the connection assembly can breach the seals of the first and second ports and provide fluid communication therebetween. The disclosed systems, when assembled, can combine the liquid agents from the first and second chambers of the BFS component and deliver the combination as a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) to a patient.
A pre-filled medical delivery assembly (100) comprising a blow-fill-seal (BFS) bottle (110) with a collapsible reservoir (120), a neck portion (112), and a side flange (118), an administration assembly (130) comprising a collar (132) with a mounting socket with an interior seat into which the neck portion is axially inserted, a needle hub (150) coupled to a double-ended needle (170) comprising a piercing end within the mounting socket and an administration end. A needle shield (200) covers the needle after use and includes a shield base (220), a shield element (224), and a hinge (218) flexibly connecting the shield base and the shield. The shield base further comprises at least one circumferential notch (228) that couples to at least one side flange of the BFS bottle.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
32.
SYSTEMS AND METHODS FOR PRE-FILLED MEDICAL DELIVERY DEVICES
A pre-filled medical delivery assembly assembled and configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly generally includes a modular design consisting of separately constructed components cooperatively arranged and coupled to one another.
The invention provides for a delivery system including a delivery assembly configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient.
A61M 5/24 - Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
A61M 5/28 - Syringe ampoules or cartridges, i.e. ampoules or cartridges provided with a needle
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/34 - Constructions for connecting the needle
A61J 1/18 - Arrangements for indicating condition of container contents, e.g. sterile condition
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
A61M 5/162 - Needle sets, i.e. connections by puncture between reservoir and tube
A61M 5/30 - Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or cartridges
Systems and methods for dispensing and disabling Blow-Fill-Seal (BFS) vials such as pre-filled vials containing a vaccine or other medicament via utilization of an assistive dispensing device to selectively compress the fluid reservoir of the BFS vial. The assistive dispensing device can aid in applying compressive force to assist in dispensing the liquid from the vial, and may also be utilized to lock in a mated position so that the BFS vial may not be reused and/or is otherwise readily identifiable as having already been administered.
A61M 5/28 - Syringe ampoules or cartridges, i.e. ampoules or cartridges provided with a needle
A61M 5/50 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
35.
BLOW-FILL-SEAL (BFS) ASSISTED VIAL DISPENSING SYSTEMS AND METHODS
Systems and methods for dispensing Blow-Fill-Seal (BFS) vials such as pre-filled vials containing a vaccine or other medicament via utilization of an assistive dispensing device to selectively compress the fluid reservoir of the BFS vial is shown and described. The assistive dispensing device includes one or more protrusions to aid in applying compressive force to assist in dispensing the liquid from the vial, and may also include a first dosage setting member and a second dosage setting member, that engage each other to limit movement of the one or more protrusions when the proper compression force has been reached.
Systems and methods for altering the typical rotary Blow-Fill-Seal (BFS) machine manufacturing process to implement a staged or phased vacuum application to the BFS molds.
A pre-filled medical delivery assembly can have first and second blow-fill-seal (BFS) modules and first and second connectors. Each BFS module can have a reservoir with a fluid agent and a neck with a seal. Each connector can have a respective recess with a piercing element. The first connector can have an outlet port, and the second connector can have an inlet/outlet (I/O) port. The connectors can be coupled together via the outlet and I/O ports. The neck of each BFS module can be inserted into the recess of the respective connector such that the piercing element breaches the seal, thereby providing a fluid path between the reservoirs. The disclosed assemblies can allow the combination of separate fluid agents via the coupled connectors and subsequently delivery of the combination as a single dose of a therapeutic agent to a patient by replacing the first connector with an administration hub.
A pre-filled blow-fill-seal (BFS) vial can have a fluid seal at one end thereof that can be breached by a piercing element within a connector when a neck of the BFS vial is fully inserted into the connector. The piercing element can comprise or define one or more fluid conduits that allow fluid to flow from an interior of the BFS vial to an outlet port of the connector, thereby allowing the contents to be dispensed from the BFS vial. The connector can facilitate coupling of the BFS vial for subsequent administration of the contents therein to a patient. For example, the outlet port of the connector can be coupled to an administration assembly, such as a syringe, nozzle, intravenous (IV) therapy device, or another device.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
39.
SYSTEMS AND METHODS FOR ROTATIONAL PIERCING OF PRE-FILLED MEDICAL DELIVERY ASSEMBLIES
e.ge.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient may include a multi-bevel cannula piercing element such as for rotational axial engagement to pierce a seal of the BFS vial.
A61J 1/20 - Arrangements for transferring fluids, e.g. from vial to syringe
A61M 5/28 - Syringe ampoules or cartridges, i.e. ampoules or cartridges provided with a needle
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/34 - Constructions for connecting the needle
40.
SYSTEMS AND METHODS FOR BLOW-FILL-SEAL (BFS) PRODUCT INSPECTION
An inspection system is provided for a pre-filled blow-fill-seal (BFS) product. The BFS product comprises a neck that extends along a longitudinal direction and has a coupling portion that protrudes laterally outward with respect to adjacent portions of the neck. The inspection system comprises a controller and a first inspection station, which includes illumination and detection assemblies. Interrogating light from one or more light sources of the illumination assembly is directed at a perimeter of the coupling portion of the neck. The detection assembly has an input optical axis that extends along the longitudinal direction and comprises an imaging device to detect light emitted from the neck. The controller is configured to determine compliance of the BFS product with respect to predetermined criteria based at least in part on the light detected by the imaging device.
An inspection system is provided for a pre-filled blow-fill-seal (BFS) product. The BFS product comprises a neck that extends along a longitudinal direction and has a coupling portion that protrudes laterally outward with respect to adjacent portions of the neck. The inspection system comprises a controller and a first inspection station, which includes illumination and detection assemblies. Interrogating light from one or more light sources of the illumination assembly is directed at a perimeter of the coupling portion of the neck. The detection assembly has an input optical axis that extends along the longitudinal direction and comprises an imaging device to detect light emitted from the neck. The controller is configured to determine compliance of the BFS product with respect to predetermined criteria based at least in part on the light detected by the imaging device.
A pre-filled medical delivery assembly can have a blow-fill-seal (BFS) module, a manifold, and a casing. The BFS module can have a pair of reservoirs, and a pair of sealed ports. Each reservoir can have a respective liquid agent therein. Each port can be in fluid communication with a respective one of the reservoirs. Part of the BFS module can be inserted into the manifold, and the casing can protect part of the BFS module exposed from the manifold. An orientation of the casing can be reversed, and the casing can be used to push the BFS module into the manifold to breach the seals and/or to compress the reservoirs to dispense the liquid agents. The disclosed assemblies can combine the liquid agents from the BFS module and deliver the combination as a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) to a patient.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/34 - Constructions for connecting the needle
B65D 81/32 - Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
A61M 5/24 - Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
43.
PRE-FILLED MULTI-FLUID MEDICAL DELIVERY ASSEMBLIES
A pre-filled medical delivery system can have a blow-fill-seal (BFS) module and a mixing assembly. The BFS module can have first and second chambers, first and second sealed ports, and first and second actuation members. Each chamber can have a respective liquid agent therein. Each sealed port and each actuation member can be in fluid communication with a respective one of the chambers. The mixing assembly can be constructed for coupling to the BFS module. When coupled to the BFS module, the mixing assembly can breach the seals of the first and second ports and provide fluid communication therebetween. The disclosed systems, when assembled, can combine the liquid agents from the first and second chambers of the BFS component and deliver the combination as a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) to a patient.
A pre-filled medical delivery assembly assembled and configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly generally includes a modular design consisting of separately constructed components cooperatively arranged and coupled to one another.
A61M 5/24 - Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
A61M 5/20 - Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
A61M 5/28 - Syringe ampoules or cartridges, i.e. ampoules or cartridges provided with a needle
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/34 - Constructions for connecting the needle
45.
SYSTEMS AND METHODS FOR PRE-FILLED MULTI-LIQUID MEDICAL DELIVERY DEVICES
A pre-filled medical delivery system can have a blow-fill-seal (BFS) component and a connection assembly. The BFS component can have first and second chambers, and first and second sealed ports. Each chamber can have a respective liquid agent therein. Each sealed port can be in fluid communication with a respective one of the chambers. The connection assembly can be constructed for coupling to the BFS component. When coupled to the BFS component, the connection assembly can breach the seals of the first and second ports and provide fluid communication therebetween. The disclosed systems, when assembled, can combine the liquid agents from the first and second chambers of the BFS component and deliver the combination as a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) to a patient.
A61J 1/20 - Arrangements for transferring fluids, e.g. from vial to syringe
B65D 35/22 - Pliable tubular containers adapted to be permanently deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid materialHolders therefor with two or more compartments
46.
MEDICAL INJECTORS AND SYSTEMS AND METHODS FOR AN INJECTION MANAGEMENT PLATFORM
Systems, methods and articles of manufacture provide for an injection management platform that allows the verification and management of injection event transactions involving injectors equipped with NFC or RFID chips utilizing a distributed and secure technology such as blockchain. An injection event transaction ledger allows for digital receipts of injection event transactions to be securely verified and updated. In accordance with some embodiments, injectors may comprise blow-fill-seal (BFS) injectors that are pre-filled with a single dose of a fluid agent comprising a vaccine or medicament, allowing for tracking of individual doses of the fluid agent via the injection event transaction ledger.
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G06Q 10/08 - Logistics, e.g. warehousing, loading or distributionInventory or stock management
G16H 10/20 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
G16H 40/20 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
G16H 80/00 - ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
47.
SYSTEMS AND METHODS FOR PRE-FILLED MEDICAL DELIVERY DEVICES
e.ge.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly generally includes a modular design consisting of separately constructed components cooperatively arranged and coupled to one another.
A pre-filled dual-chamber medical agent delivery system assembled and configured to allow delivery of a single dose of a combined therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly generally includes a modular design consisting of separately constructed components cooperatively arranged and coupled to one another, such as to facilitate delivery of a reconstituted lyophilized agent to a patient.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
The invention is a single use delivery device configured to enable reconstitution of a lyophilized agent (e.g., vaccine, drug, medicament, etc.) stored within for subsequent delivery of the reconstituted fluid agent to a patient in a controlled manner and without requiring specialized skill in reconstituting the agent or administering delivery of such agent. The delivery device is prefilled with an individual dose of a lyophilized agent and configured to be filled on-site and in the field with a dose of diluent for reconstitution of the lyophilized agent, while remaining sterile and preventing the potential for contamination during the filling process. The delivery device is further configured to be rendered incapable of reuse followings its intended use of delivering the fluid agent to a patient, thereby preventing reuse of the device and reducing the risk of the spreading blood-borne diseases through reuse.
A61M 5/24 - Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
A61M 5/28 - Syringe ampoules or cartridges, i.e. ampoules or cartridges provided with a needle
A61M 5/50 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/30 - Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or cartridges
A61M 5/46 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for controlling depth of insertion
A fluid delivery manifold system assembled and configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly generally includes a modular manifold design consisting of separately constructed components cooperatively arranged and coupled to one another. The modular manifold construction allows for rapid manufacturing reconfigurations of one or more components with minimal costs to create new delivery manifold 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).
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
A61M 5/28 - Syringe ampoules or cartridges, i.e. ampoules or cartridges provided with a needle
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
51.
SYSTEMS AND METHODS FOR DUAL-COMPONENT DRUG AGENT DELIVERY
A delivery system may include a delivery assembly configured to allow delivery of a single dose of a drug agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly may generally include a modular design consisting of separately constructed components cooperatively arranged and coupled to one another. The drug agent may comprise a fluid agent, diluent, or carrier fluid disposed in a first module of the delivery assembly (e.g., the BFS vial) and an active ingredient disposed in a second module of the delivery assembly such that the two components are combined or introduced upon use, thereby creating a drug agent to be administered to the patient.
A fluid delivery manifold system assembled and configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly generally includes a modular manifold design consisting of separately constructed components cooperatively arranged and coupled to one another. The modular manifold construction allows for rapid manufacturing reconfigurations of one or more components with minimal costs to create new delivery manifold 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).
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
The invention provides for a delivery system including a delivery assembly configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly generally includes a modular design consisting of separately constructed components cooperatively arranged and coupled to one another. The modular construction allows 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). The delivery assembly is generally configured to be filled on-site and in the field and is further capable of delivery of the agent in a controlled manner and without requiring specialized skill in administering delivery of such agent.
A61M 5/28 - Syringe ampoules or cartridges, i.e. ampoules or cartridges provided with a needle
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/30 - Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or cartridges
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
A61J 1/18 - Arrangements for indicating condition of container contents, e.g. sterile condition
A61M 5/162 - Needle sets, i.e. connections by puncture between reservoir and tube
54.
Single use delivery device prefilled with a reconstitutable agent
The invention is a single use delivery device configured to enable reconstitution of a lyophilized agent (e.g., vaccine, drug, medicament, etc.) stored within for subsequent delivery of the reconstituted fluid agent to a patient in a controlled manner and without requiring specialized skill in reconstituting the agent or administering delivery of such agent. The delivery device is prefilled with an individual dose of a lyophilized agent and configured to be filled on-site and in the field with a dose of diluent for reconstitution of the lyophilized agent, while remaining sterile and preventing the potential for contamination during the filling process. The delivery device is further configured to be rendered incapable of reuse followings its intended use of delivering the fluid agent to a patient, thereby preventing reuse of the device and reducing the risk of the spreading blood-borne diseases through reuse.
A61M 5/24 - Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
A61M 5/28 - Syringe ampoules or cartridges, i.e. ampoules or cartridges provided with a needle
A61M 5/50 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/30 - Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or cartridges
A61M 5/46 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for controlling depth of insertion
The invention is a delivery system including a delivery assembly configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a blow-fill-seal (BFS) vial to a patient. The delivery assembly includes a modular design consisting of separately constructed components cooperatively arranged and coupled to one another. The modular construction allows 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). The delivery assembly is configured to be filled on-site and in the field and is further capable of delivery of the agent in a controlled manner and without requiring specialized skill in administering delivery of such agent.
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