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WO2025193871A1 - Injecteurs et systèmes de commande pour injecteurs avec indication de fin d'injection de dose - Google Patents

Injecteurs et systèmes de commande pour injecteurs avec indication de fin d'injection de dose

Info

Publication number
WO2025193871A1
WO2025193871A1 PCT/US2025/019634 US2025019634W WO2025193871A1 WO 2025193871 A1 WO2025193871 A1 WO 2025193871A1 US 2025019634 W US2025019634 W US 2025019634W WO 2025193871 A1 WO2025193871 A1 WO 2025193871A1
Authority
WO
WIPO (PCT)
Prior art keywords
chamber
plunger
housing
canister
pressurized gas
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/019634
Other languages
English (en)
Inventor
Gavin Li
John C. DUNNE, Jr.
Eric Anderfaas
Matthew MCCAWLEY
Cho Kin CHIU
Jack R. Auld
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Altaviz LLC
Original Assignee
Altaviz LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Altaviz LLC filed Critical Altaviz LLC
Publication of WO2025193871A1 publication Critical patent/WO2025193871A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/3157—Means providing feedback signals when administration is completed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2053—Media being expelled from injector by pressurised fluid or vacuum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion

Definitions

  • TECHNICAL FIELD [0002] The present application relates generally to devices and methods for delivering agents into a subject’s body and, more particularly, to auto-injectors and/or gas- powered drive systems for injection devices, and to methods for making and using such devices.
  • BACKGROUND [0003]
  • auto-injectors are available that include a predetermined dose of the agent that may be delivered automatically into the patient’s body, e.g., after placement against the patient’s skin and activation.
  • Manual injectors are also available that allow a user to manually deliver a desired dose of the agent.
  • injectors include an indicator to inform the user when the dose has been delivered.
  • ISO 11608-7 specifies requirements to make needle-based drug delivery systems accessible for persons with visual impairments, whether the user is the patient themselves or a medical professional or other caregiver. Thus, it may be useful to provide information in visual formats or non-visual formats that may be understood by persons with visual impairments. [0005] Therefore, improved devices and methods for delivering agents into a patient’s body, e.g., to provide a user one or more indications when a desired dose has been delivered by an injector would be useful.
  • a drive module for delivering one or more agents into a patient’s body from an injector module comprising an agent chamber containing one or more agents, an outlet, and a piston.
  • the drive module may include a drive housing including a first end and a second end, a first chamber adjacent the first end communicating with a second chamber adjacent the second end; an opener mechanism within the first chamber adjacent the first end including an actuator pin; a canister containing pressurized gas including an outlet disposed adjacent the actuator pin; an actuator configured to move one of the opener mechanism and the canister to cause the actuator pin to open the outlet and cause the gas within the canister to flow from the first chamber into the second chamber; a plunger slidably disposed within the second chamber such that pressurized gas entering the second chamber causes the plunger to move from an initial position to an extended position, the plunger configured to be coupled to the piston of the injector module to advance the piston of the injector module to deliver the one or more agents from the agent chamber through the outlet; and an end-of-dose indicator configured to receive pressurized gas from the canister to generate an audible sound when the plunger reaches the extended position corresponding to a desired dose of the one or more agents from the agent chamber.
  • a device for delivering one or more agents into a patient’s body that includes a drive module comprising an elongate drive housing including a first end and a second end, a first chamber adjacent the first end communicating with a second chamber adjacent the second end; an opener mechanism within the first chamber adjacent the first end including an actuator pin; a canister containing pressurized gas including an outlet disposed adjacent the actuator pin; an actuator configured to move one of the opener mechanism and the canister to cause the actuator pin to open the outlet and cause the gas within the canister to flow from the first chamber into the second chamber; and a plunger slidably disposed within the second chamber such that gas entering the second chamber causes the plunger to move from an initial position to an extended position wherein a distal end of the plunger extends from the second end of the drive housing.
  • the device also includes an injector module comprising an injector housing coupled to the drive housing carrying an agent chamber containing one or more agents, and a piston slidably disposed within the agent chamber and coupled to the distal end of the plunger for delivering the one or more agents from the agent chamber through an outlet when the plunger moves from the retracted position to the extended position, thereby advancing the piston within the agent chamber.
  • the device also includes an end-of-dose indicator configured to receive pressurized gas from the canister to generate an audible sound when the plunger reaches the extended position corresponding to a desired dose of the one or more agents from the agent chamber.
  • a drive module for delivering one or more agents into a patient’s body from an injector module comprising an agent chamber containing one or more agents, an outlet, and a piston.
  • the drive module may include a drive housing including a first end and a second end, a first chamber adjacent the first end communicating with a second chamber adjacent the second end; an opener mechanism within the first chamber adjacent the first end including an actuator pin; a canister containing pressurized gas including an outlet disposed adjacent the actuator pin; an actuator configured to move one of the opener mechanism and the canister to cause the actuator pin to open the outlet and cause the gas within the canister to flow from the first chamber into the second chamber; a plunger slidably disposed within the second chamber such that pressurized gas entering the second chamber causes the plunger to move from an initial position to an extended position, the plunger configured to be coupled to the piston of the injector module to advance the piston of the injector module to deliver the one or more agents from the agent chamber through the outlet; and an end
  • the strain energy release feature comprises a flange or tab extending radially outwardly from the plunger including a weakened region such that, when the plunger reaches the extended position, the flange or tab contacts the stop feature, thereby causing the flange or tab to fracture at the weakened region to generate the audible sound.
  • the strain energy release feature comprises a bistable element on the plunger configured such that, when the plunger reaches the extended position, the bistable element contacts the stop feature and moves from a first stable position to a second stable position to generate the audible sound.
  • the device also includes an injector module comprising an injector housing coupled to the drive housing carrying an agent chamber containing one or more agents, and a piston slidably disposed within the agent chamber and coupled to the distal end of the plunger for delivering the one or more agents from the agent chamber through an outlet when the plunger moves from the retracted position to the extended position, thereby advancing the piston within the agent chamber.
  • the device also includes an end-of-dose indicator comprising a strain energy release feature on the plunger and a stop feature on the drive housing configured such that, when the plunger reaches the extended position, the strain energy release feature contacts the stop feature and releases strain energy to generate an audible sound.
  • a drive module for delivering one or more agents into a patient’s body from an injector module comprising an agent chamber containing one or more agents, an outlet, and a piston.
  • the drive module may include a drive housing including a first end and a second end, a first chamber adjacent the first end communicating with a second chamber adjacent the second end; an opener mechanism within the first chamber adjacent the first end including an actuator pin; a canister containing pressurized gas including an outlet disposed adjacent the actuator pin; an actuator configured to move one of the opener mechanism and the canister to cause the actuator pin to open the outlet and cause the gas within the canister to flow from the first chamber into the second chamber; a plunger slidably disposed within the second chamber such that pressurized gas entering the second chamber causes the plunger to move from an initial position to an extended position, the plunger configured to be coupled to the piston of the injector module to advance the piston of the injector module to deliver the one or more agents from the agent chamber through the outlet; and an end
  • a device for delivering one or more agents into a patient’s body that includes a drive module comprising an elongate drive housing including a first end and a second end, a first chamber adjacent the first end communicating with a second chamber adjacent the second end; an opener mechanism within the first chamber adjacent the first end including an actuator pin; a canister containing pressurized gas including an outlet disposed adjacent the actuator pin; an actuator configured to move one of the opener mechanism and the canister to cause the actuator pin to open the outlet and cause the gas within the canister to flow from the first chamber into the second chamber; and a plunger slidably disposed within the second chamber such that gas entering the second chamber causes the plunger to move from an initial position to an extended position wherein a distal end of the plunger extends from the second end of the drive housing.
  • the device also includes an injector module comprising an injector housing coupled to the drive housing carrying an agent chamber containing one or more agents, and a piston slidably disposed within the agent chamber and coupled to the distal end of the plunger for delivering the one or more agents from the agent chamber through an outlet when the plunger moves from the retracted position to the extended position, thereby advancing the piston within the agent chamber.
  • the device also includes an end-of-dose indicator configured to receive pressurized gas from the canister to generate tactile feedback when the plunger reaches the extended position corresponding to a desired dose of the one or more agents from the agent chamber.
  • a drive module for delivering one or more agents into a patient’s body from an injector module comprising an agent chamber containing one or more agents, an outlet, and a piston.
  • the drive module may include a drive housing including a first end and a second end, a first chamber adjacent the first end communicating with a second chamber adjacent the second end; an opener mechanism within the first chamber adjacent the first end including an actuator pin; a canister containing pressurized gas including an outlet disposed adjacent the actuator pin; an actuator configured to move one of the opener mechanism and the canister to cause the actuator pin to open the outlet and cause the gas within the canister to flow from the first chamber into the second chamber; a plunger slidably disposed within the second chamber such that pressurized gas entering the second chamber causes the plunger to move from an initial position to an extended position, the plunger configured to be coupled to the piston of the injector module to advance the piston of the injector module to deliver the one or more agents from the agent chamber through the outlet; a needle
  • a device for delivering one or more agents into a patient’s body that includes a drive module comprising an elongate drive housing including a first end and a second end, a first chamber adjacent the first end communicating with a second chamber adjacent the second end; an opener mechanism within the first chamber adjacent the first end including an actuator pin; a canister containing pressurized gas including an outlet disposed adjacent the actuator pin; an actuator configured to move one of the opener mechanism and the canister to cause the actuator pin to open the outlet and cause the gas within the canister to flow from the first chamber into the second chamber; and a plunger slidably disposed within the second chamber such that gas entering the second chamber causes the plunger to move from an initial position to an extended position wherein a distal end of the plunger extends from the second end of the drive housing.
  • the device also includes an injector module comprising an injector housing coupled to the drive housing carrying an agent chamber containing one or more agents, and a piston slidably disposed within the agent chamber and coupled to the distal end of the plunger for delivering the one or more agents from the agent chamber through an outlet when the plunger moves from the retracted position to the extended position, thereby advancing the piston within the agent chamber.
  • the device also includes a needle guard slidably carried by the drive housing; and a secondary chamber between the drive housing and the needle guard configured to receive pressurized gas from the canister when the plunger reaches the extended position, the pressurized gas advancing the needle guard distally to cover the outlet of the injector module.
  • a drive module for delivering one or more agents into a patient’s body from an injector module comprising an agent chamber containing one or more agents, an outlet, and a piston.
  • the drive module may include a drive housing including a first end and a second end, a first chamber adjacent the first end communicating with a second chamber adjacent the second end; an opener mechanism within the first chamber adjacent the first end including an actuator pin; a canister containing pressurized gas including an outlet disposed adjacent the actuator pin; an actuator configured to move one of the opener mechanism and the canister to cause the actuator pin to open the outlet and cause the gas within the canister to flow from the first chamber into the second chamber; a plunger slidably disposed within the second chamber such that pressurized gas entering the second chamber causes the plunger to move from an initial position to an extended position, the plunger configured to be coupled to the piston of the injector module to advance the piston of the injector module to deliver the one or more agents from the agent chamber through the outlet; and cooperating
  • a device for delivering one or more agents into a patient’s body that includes a drive module comprising an elongate drive housing including a first end and a second end, a first chamber adjacent the first end communicating with a second chamber adjacent the second end; an opener mechanism within the first chamber adjacent the first end including an actuator pin; a canister containing pressurized gas including an outlet disposed adjacent the actuator pin; an actuator configured to move one of the opener mechanism and the canister to cause the actuator pin to open the outlet and cause the gas within the canister to flow from the first chamber into the second chamber; and a plunger slidably disposed within the second chamber such that gas entering the second chamber causes the plunger to move from an initial position to an extended position wherein a distal end of the plunger extends from the second end of the drive housing.
  • the device also includes an injector module comprising an injector housing coupled to the drive housing carrying an agent chamber containing one or more agents, and a piston slidably disposed within the agent chamber and coupled to the distal end of the plunger for delivering the one or more agents from the agent chamber through an outlet when the plunger moves from the retracted position to the extended position, thereby advancing the piston within the agent chamber.
  • the device also includes cooperating elements on the plunger and drive housing that generate an audible sound as the plunger advances from the initial position to the extended position, the audible sound discontinuing when the plunger reaches the extended position to provide an end-of-dose indication.
  • Any of the injector devices described herein may include any of the actuators disclosed in the patents incorporated by reference herein.
  • an actuation sleeve may be provided that is retracted when the needle is inserted into a patient’s skin, thereby activating the opener mechanism to release the gas.
  • a screw, lever, button, or other actuator may be provided on the drive module that may be manually activated by a user to actuate the opener mechanism to release the gas.
  • FIGS. 2A and 2B are longitudinal cross-sections of an exemplary auto- injector device including a front and rear housing, and a safety cap. showing internal components of the device including a syringe carrying one or more agents.
  • FIGS. 3A and 3B are details of the distal end of the device of FIGS. 2A and 2B before use, showing a safety cap covering an activation cap and needle of the device.
  • FIGS. 4A-4C are cross-sections of the device of FIGS.
  • FIGS. 5A-5C are details of the proximal end of the device as shown in FIGS. 4A-4C, respectively.
  • FIGS. 6A and 6B are cross-sections of the device of FIGS.
  • FIGS. 7A and 7B are cross-sectional schematics of an exemplary injector device showing an end-of-dose feature configured to generate an audible sound after the plunger moves from its initial position (FIG. 7A) to its extended position (FIG. 7B) due to pressurized gas within the injector.
  • FIGS. 7A and 7B are cross-sectional schematics of an exemplary injector device showing an end-of-dose feature configured to generate an audible sound after the plunger moves from its initial position (FIG. 7A) to its extended position (FIG. 7B) due to pressurized gas within the injector.
  • FIGS. 7C and 7D are details of FIGS. 7A and 7B, respectively, showing pressurized gas venting to atmosphere in the extended position to generate the audible sound.
  • FIGS. 8A and 8B are cross-sectional schematics of an exemplary injector device showing another end-of-dose feature configured to generate an audible sound after the plunger moves from its initial position (FIG. 8A) to its extended position (FIG. 8B) due to pressurized gas within the injector.
  • FIG. 8C is a detail of FIG. 8B showing pressurized gas venting into a resonance chamber in the extended position to generate the audible sound.
  • FIGS. 10A and 10B are cross-sectional schematics of an exemplary injector device showing yet another end-of-dose feature configured to generate an audible sound after the plunger moves from its initial position (FIG. 9A) to its extended position (FIG. 9B).
  • FIG. 9C is a detail of FIG. 9B showing pressurized gas venting to atmosphere to vibrate a reed in the extended position to generate the audible sound.
  • FIGS. 10A and 10B are cross-sectional schematics of an exemplary injector device showing another end-of-dose feature including a strain energy release feature configured to generate an audible sound after the plunger moves from its initial position (FIG. 10A) to its extended position (FIG. 10B).
  • FIGS. 10C and 10D are details of FIGS. 10A and 10B, respectively, showing an exemplary strain energy release feature on the plunger and a stop feature on the drive housing configured such that, when the plunger reaches the extended position, the strain energy release feature contacts the stop feature and releases strain energy to generate an audible sound.
  • FIGS. 11A and 11B are cross-sectional schematics of an exemplary injector device showing still another end-of-dose feature including a strain energy release feature configured to generate an audible sound after the plunger moves from its initial position (FIG. 11A) to its extended position (FIG. 11B).
  • FIGS. 11C and 11D are details of FIGS.
  • FIGS. 12A and 12B are cross-sectional schematics of an exemplary injector device showing another end-of-dose feature configured to generate tactile feedback after the plunger moves from its initial position (FIG. 12A) to its extended position (FIG. 12B) due to pressurized gas within the injector.
  • FIG. 12C is a detail of FIG.
  • FIGS. 13A and 13B are cross-sectional schematics of an exemplary injector device showing yet another end-of-dose feature configured to generate tactile feedback after the plunger moves from its initial position (FIG. 13A) to its extended position (FIG.
  • FIGS. 14A and 14B are cross-sectional schematics of an exemplary injector device showing still another end-of-dose feature configured to generate tactile feedback after the plunger moves from its initial position (FIG. 14A) to its extended position (FIG. 14B) due to pressurized gas within the injector.
  • FIG. 14C is a detail of FIG.
  • FIGS. 15A-15C are cross-sectional views of another injector device including a needle guard that automatically advances after the plunger moves from its initial position (FIG. 15A) to its extended position (FIG. 15B), whereupon pressurized gas within the injector is released to advance the needle guard (FIG. 15C).
  • FIGS. 15A-15C are cross-sectional views of another injector device including a needle guard that automatically advances after the plunger moves from its initial position (FIG. 15A) to its extended position (FIG. 15B), whereupon pressurized gas within the injector is released to advance the needle guard (FIG. 15C).
  • FIG. 16A and 16B are details showing a secondary chamber between the drive housing and the needle guard configured to receive pressurized gas from the canister when the plunger reaches the extended position, the pressurized gas advancing the needle guard distally to cover the outlet of the injector module.
  • FIG. 17A is a cross-sectional schematic of another exemplary injector device including cooperating elements on the plunger and drive housing that generate an audible sound as the plunger advances from the initial position to the extended position, the audible sound discontinuing when the plunger reaches the extended position to provide an end-of- dose indication.
  • FIG. 17B is a detail of FIG.
  • FIG. 18A is a cross-sectional schematic of yet another exemplary injector device including cooperating elements on the plunger and drive housing that generate an audible sound as the plunger advances from the initial position to the extended position, the audible sound discontinuing when the plunger reaches the extended position to provide an end-of-dose indication.
  • FIG. 18B is a detail of FIG.
  • FIG. 19A is a cross-sectional schematic of still another exemplary injector device including cooperating elements on the plunger and drive housing that generate an audible sound as the plunger advances from the initial position to the extended position, the audible sound discontinuing when the plunger reaches the extended position to provide an end-of-dose indication.
  • FIG. 19B is a detail of FIG.
  • FIG. 1 shows an example of an auto-injector device 6 that includes an outer housing 8 including a front housing 10 carrying a syringe 70 containing one or more agents within an agent chamber, and a rear housing 12 including a drive assembly for automatically delivering the agent(s) from the syringe 70 when the device 6 is activated.
  • a safety cap 86 is provided on the front housing 10 to prevent premature activation of the device 6, which may be removed immediately before an injection, as described further elsewhere herein.
  • One or more internal components of the device 6 may move axially, i.e., proximally and/or distally relative to the longitudinal axis 18 when the device 6 is activated, as described further elsewhere herein.
  • the syringe 70 may be a pre-filled syringe, e.g., formed from glass, plastic, and the like, filled with a predetermined volume of agent, e.g., corresponding to a single dose for a patient.
  • the agent chamber and needle may be integrated into the forward housing 10 if desired (not shown).
  • an exemplary auto-injector device 6 that includes an outer housing 8 including a front housing 10 carrying a syringe 70 containing one or more agents within an agent chamber 73, and a rear housing 12 including a drive assembly for automatically delivering the agent(s) from the syringe 70 when the device 6 is activated.
  • a safety cap 86 is provided on the front housing 10 to prevent premature activation of the device 6, which may be removed immediately before an injection, as described further elsewhere herein.
  • One or more internal components of the device 6 may move axially, i.e., proximally and/or distally relative to the longitudinal axis 18 when the device 6 is activated, as described further elsewhere herein.
  • the syringe 70 may be a pre-filled syringe, e.g., formed from glass, plastic, and the like, filled with a predetermined volume of agent, e.g., corresponding to a single dose for a patient.
  • the agent chamber and needle may be integrated into the forward housing 10 if desired (not shown).
  • the syringe 70 (or integral agent chamber) may include a distal port (not shown) without a needle, such that a separate needle (also not shown) may be coupled to the port, e.g., using a Luer fitting, mating threads, and/or other cooperating connectors, immediately before an injection or otherwise as desired.
  • the syringe 70 includes a barrel 72 containing the agent(s) within agent chamber 73, a needle 78 extending from a distal end 72a of the barrel 72, and a piston or stopper 74 slidable within a proximal end 72b of the barrel 72 for directing the agent(s) through the needle 78 into the subject’s body (not shown).
  • the device 6 also includes a gas canister or other source of pressurized gas 40 to power the device 6, e.g., to advance a plunger 50 coupled to the piston 74 to deliver the agent(s).
  • the device 6 also includes an activation cap 80 and an opener mechanism 60 for opening the canister 40 to release pressurized gas within the canister 40 into a set of chambers of the device 6.
  • an inner housing 20 may be mounted within the outer housing 8 that includes a first or proximal chamber 22, e.g., within which the gas canister 40 is mounted, and a second or distal chamber 24, e.g., in which the plunger 50 is slidably received.
  • the device 6 is configured such that, when a contact surface 84 of the activation cap 80 is pressed against a subject’s skin to insert the needle 78, the activation cap 80 retracts proximally into the outer housing 8 and automatically activates the opener mechanism 60 to release the pressurized gas from the canister 40 into the first and second chambers 22, 24, which generates a distal force to advance the plunger 50 to deliver the agent(s) from the syringe 70 into the subject. After the injection is completed and the device 6 is withdrawn away from the skin, the activation cap 80 may automatically advance to cover the needle 78.
  • a spacer 30 may be provided that extends between the activation cap 80 and a release cap 34 of the opener mechanism 60, e.g., such that proximal movement of the activation cap 80 is translated by the spacer 30 to the direct the release cap 34 proximally within the rear housing 12, which releases a spring perch assembly or carriage 64 of the opener mechanism 60, as described further elsewhere herein.
  • the spacer 30 may be biased distally, e.g., by spring 32, which may, in turn, bias the activation cap 80 distally after completing the injection, also as described further elsewhere herein.
  • the outer housing 8 includes a proximal end 8a, e.g., provided on the rear housing 12, an open distal end 8b, e.g., provided on the forward housing 10, and an inner wall extending therebetween to enclose the interior of the device 6.
  • the outer surface between the proximal and distal ends 8a, 8b may be sized and/or shaped to facilitate manipulation of the device 6, e.g., to facilitate placing and pressing the activation cap 80 against a subject’s skin to activate the device 6 and inject the agent(s).
  • the outer surface may have a generally cylindrical shape optionally including one or more textures or grip features to facilitate an operator (the subject themselves or a third party) holding the device 6 in one hand and pressing the activation cap 80 against the subject’s skin, as described further elsewhere herein.
  • the proximal end 8a of the housing 8 may include a wall 8c enclosing the proximal end 8a and, optionally, one or more pockets or other features 8d for locking the release cap 34, as described further elsewhere herein.
  • the outer housing 8 may be formed from multiple, separate components, e.g., clamshell halves, e.g., formed from metal, such as stainless steel, aluminum, and the like, plastic, and/or composite material, by one or more of cold drawing, molding, casting, machining, and the like, that are substantially permanently attached together, e.g., by one or more of welding, soldering, fusing, bonding with adhesive, interference fit, and the like.
  • the outer housing 8 is formed as separate forward and rear housings 10, 12, which may be assembled separately with respective internal components, and then coupled together, e.g., after loading a syringe 70 into the forward housing 10.
  • the forward housing 10 may be assembled with the activation cap 80 and safety cap 86, and a syringe 70 may be loaded into an interior of the forward housing 10, e.g., during manufacturing or during assembly of the device 6 any time before performing an injection.
  • the syringe 70 may include a rigid needle shield 79, e.g. formed from conventional materials, that may be removably secured to the distal end 72a of the barrel 72 to protect the needle and prevent accidental sticks.
  • the safety cap 86 may include features 86a that engage the needle shield 79 such that, when the safety cap 86 is removed, the needle shield 79 is also removed.
  • the proximal end of the safety cap 86 may include one or more fingers 86a that fall into one or more corresponding cutouts, recesses, or other features on the needle shield 79 when the syringe 70 is inserted into the forward housing 10, thereby coupling the needle shield 79 to the safety cap 86, as described elsewhere herein.
  • the rear housing 12 may be assembled with the inner housing 20, the spacer 30, the release cap 34, the gas canister 40, the plunger 50, and the opener mechanism 60 (and any other incidental components), and the rear housing 12 may be coupled to the forward housing 10 at any time.
  • a syringe 70 may be loaded into the interior of the forward housing 10, and the assembled rear housing 12 may be immediately coupled to the forward housing 10.
  • a distal end 54 of the plunger 50 may be coupled to the piston 74 within the syringe 70, e.g., such that distal movement of the plunger 50 is translated to the piston 74, as described further elsewhere herein.
  • the outer housing 8 may include a mount 11, e.g., on one of the forward and rear housings 10, 12, for guiding and/or securing the syringe 70 during loading.
  • the proximal end 72b of the barrel 72 may include one or more flanges, e.g., a radial flange or a pair of opposing flanges, that may abut and/or be received within the mount 11 to secure the syringe 70 relative to the forward housing 10.
  • one or more detents, ridges, or other features may be provided on the forward housing 10 for securing the syringe 70.
  • the forward housing 10 may include one or more windows 10c in the sidewall, which may facilitate observing the syringe 70 during an injection, e.g., to allow visual confirmation when the piston 74 is fully advanced.
  • the device 6 may include a syringe spacer or adapter 75 that may provide an interface between a distal end 54 of the plunger 50 and the piston 74, e.g., to provide connectors therebetween and/or ensure proper spacing such that the piston 74 is advanced in conjunction with the plunger 50.
  • a syringe spacer or adapter 75 may be provided to allow different length syringes to be loaded into the forward housing 10 while properly positioning the needle 78 adjacent the distal end 8b of the outer housing 8 and allowing the plunger 50 to be properly coupled to the piston 74.
  • a syringe 70 may be selected that may be inserted into the housing 8, e.g., through the opening in the distal end 8b and coupled to the distal end 16 of the drive assembly 12.
  • a syringe spacer 75 may be selected and its distal end 75a may be coupled to the piston 74, e.g., by one or more cooperating threads, as shown, one or more detents or other connectors, and the like.
  • the distal end 54 of the plunger 50 may be inserted into a recess 75b in the syringe spacer 75 when the rear housing 12 is coupled to the forward housing 10.
  • the distal end 54 of the plunger 50 and the recess 75b may include cooperating locking features, e.g., one or more threads, detents, and the like (not shown) or the distal end 54 may simply be inserted into the recess 75b to coupled subsequent distal movement of the piston 74 to the plunger 50, as described further elsewhere herein.
  • the assembled housings 10, 12 may be packaged, stored, and/or otherwise prepared for subsequent assembly.
  • the housing 10, 12 may be shipped or otherwise provided to a manufacturer of the syringe 70, who may load the syringe 70 and couple the housings 10, 12 together to provide the finished device 6.
  • the assembled housings 10, 12 may be provided to a hospital, physician, or other medical professional, and final assembly may be completed immediately before performing an injection, which may allow a syringe including a specific agent to be loaded before an injection.
  • the proximal end 10a of the forward housing 10 and the distal end 12b of the rear housing 12 may include one or more cooperating connectors (not shown) to couple the housings 10, 12 together to provide the fully-assembled device 6.
  • the housings 10, 12 may include one or mating threads, detents, and the like, which may permanently couple the housings 10, 12 together.
  • the connectors may allow the housings 10, 12 to be subsequently separated, e.g., after performing an injection, to remove the syringe 70, e.g., to allow the device 6 to be cleaned and reused with a new syringe.
  • the housings 10, 12 may be permanently attached together by one or more of an interference fit between the ends 10a, 12b, bonding with adhesive, fusing, sonic welding, and the like.
  • the outer housing 8 may be formed as a single, integral component into which the components of the device 6 may be assembled. In these alternatives or even with a two-part housing, the device 6 may be a single use device, which may be disposed of after a single injection.
  • the inner housing 20 includes a proximal cylinder 20a including the first chamber 22 and a distal cylinder 20b including the second chamber 24.
  • Each of the proximal and distal cylinders 20a, 20b may have an elongate cylindrical wall or other cross-sectional shape along their lengths.
  • the proximal and distal cylinders 20a, 20b may be permanently attached together to provide the inner housing 20, e.g., by one or more of cooperating threads, as shown, detents or other connectors, force fit, bonding with adhesive, sonic welding, fusing, and the like.
  • the inner housing 20 may be formed as a single, unitary structure including the first and second chambers 22, 24.
  • the proximal and distal cylinders 20a, 20b may be formed from materials similar to or different from the outer housing 8.
  • the inner housing 20 may be mounted within the outer housing 8 such the inner housing 20 remains substantially stationary within the outer housing 8.
  • the gas canister 40 may be mounted within the inner housing 20, e.g., within the first chamber 22, such that the gas canister 40 also remains substantially stationary relative to the outer housing 8.
  • one or more struts, supports, or other structures may be provided on the inner and/or outer housings 20, 8 to secure the inner housing 20 and/or the gas canister 40 relative to the outer housing 8.
  • the proximal cylinder 20a may include an annular wall surrounding the first chamber 22 that includes a uniform diameter first region 22a within which the gas canister 40 is mounted, and second and third regions 22b, 22c within which the carriage 64 is slidably mounted, as described further elsewhere herein.
  • the distal cylinder 20b may have a length such that a distal end 21b of the distal cylinder 20b may abut the syringe 70 when the device 6 is assembled.
  • the distal end 21b may include one or more features that contact the proximal end 72b of the syringe 70, e.g., an O-ring 20d secured on or around the distal end 21b formed from resilient and/or relatively flexible material.
  • the O-ring 20d may prevent the distal end 21b from damaging the syringe 70, e.g., if the barrel 72 is made from glass.
  • the canister 40 includes a body 42 including a first closed end 42a, a second outlet end 42b, and a cap 44 welded or otherwise attached to the outlet end 42b to provide an enclosed cavity 48 filled with a fluid containing pressurized gas, such as carbon dioxide or fluorocarbon gases, compressed to sufficient pressure to least partially liquefy the gas within the cavity 48.
  • a fluid containing pressurized gas such as carbon dioxide or fluorocarbon gases
  • fluids containing gases such as argon, nitrogen, helium argon, or other combinations thereof that remain in gaseous form may be stored within the cavity 48.
  • the pressurized fluid contained within the cavity 48 may be used to generate the forces to operate the device 6, e.g., to inject one or more agents from the syringe 70 into a subject’s body.
  • the body 42 and cap 44 may be formed from stainless steel or other desired or suitable metal, plastic, or composite material, e.g., formed by one or more of drawing, stamping, machining, casting, molding, and the like.
  • the body 42 may be deep drawn from sheet metal, e.g., a round sheet metal blank of Type 305 stainless steel, using one or more dies and punches (not shown), to form a main barrel region, the enclosed end 42a, an optional tapered shoulder region, and the outlet end 42b defining an opening to which the cap 44 is attached.
  • the canister 40 may be oriented with the outlet end 42b proximal to the enclosed end 42a, and the carriage 64 may be provided proximal to the outlet end 44.
  • the cap 44 may be an enclosed cap including a septum or other weakened region (not shown) that may be opened by the opener mechanism.
  • the carriage 64 may include an opener pin 62 configured to puncture or preferentially tear the septum, as described elsewhere herein. Additional information regarding canisters that may be used and methods for making them may be found in U.S. Publication No. 2017/ 0258583, the entire disclosure of which is expressly incorporated by reference herein.
  • the cap 44 may include other closer mechanisms, such as a ball or other member (not shown) that may be biased or otherwise configured to close an outlet in the cap 44 yet may be directed away from the cap 44, e.g., into the canister 40, by the carriage 64 to open the outlet and release the pressurized gas within the cavity 48.
  • the opener pin 62 may include a tapered tip (not shown) sized to enter the outlet and push the closure away from the outlet.
  • the plunger 50 may be an elongate rod or other member including a proximal end 52 that is slidably disposed within the second chamber 24, e.g., initially immediately adjacent the first chamber 22, and a distal end 54 coupled to the piston 74.
  • the plunger 50 is movable from an initial or retracted position (e.g., shown in FIGS. 2A and 2B) to a final or extended position (e.g., shown in FIGS.
  • flange or other guide member 53 may be provided on the proximal end 52 of the plunger 50 that slidably engages a wall of the second chamber 24. Consequently, when pressurized gas enters the second chamber 24 (via the first chamber 22), the pressure generates a distal force to direct the plunger 50 distally from the initial position towards the extended position to advance the piston 74 and deliver the one or more agents from the agent chamber 73 through the needle 78 into the subject, as described further elsewhere herein.
  • a wall, orifice, or intermediate passage may be provided between the first and second chambers 22, 24.
  • the intermediate passage may have a relatively small diameter to provide a restrictor to reduce pressure rise time within the second chamber 24.
  • the intermediate passage may i) slow down the transient flow of gas, slowing the rise of pressure imparted to the plunger 50, e.g., providing a soft-start to the injection, reducing/eliminating pressure shock waves in the fluid to be injected in the syringe and possibly reducing patient pain as the drug injection is gently initiated; and/or ii) slow down the steady state flow of gas, reducing the otherwise pressure imparted to the plunger 50, providing a limiting effect to the flow rate of the drug injected into the patient.
  • the plunger 50 may also include a plunger chamber 56, e.g., extending from an open proximal end 52 of the plunger 50 to a closed distal end 54.
  • the plunger chamber 56 may taper inwardly from the proximal end 52 to the distal end 54, as shown, or may have a uniform diameter or other cross-sectional shape along its length.
  • the proximal end 52 of the plunger 50 may include a closed wall and/or the plunger 50 may be a solid rod between the proximal and distal ends 52, 54.
  • the flange 53 on the proximal end 52 of the plunger 50 may include one or more passages (not shown) that extend between proximal and distal surfaces of the flange 53.
  • the flange 53 may include a plurality of circular or other enclosed passages spaced apart from one another around a circumference of the flange 53, each extending between the proximal and distal surfaces.
  • the flange 53 may be sized and/or shaped to slidably engage an inner wall of the second chamber 24, e.g., to allow the plunger 50 to move from the initial to the extended position, but may not require O-rings or other seals.
  • one or more O-rings or other seals may be provided within and/or adjacent the inner housing 20 to seal the first and second chambers 22, 24 and/or otherwise a flow path from the gas canister 40 to the plunger 50.
  • a first O-ring 58a may be provided between the inner housing 20 and the carriage 64
  • a second O-ring 58b may be provided between a distal end 21b of the inner housing 20 and the plunger 50
  • a third O-ring 58c may be provided between the proximal and distal cylinders 10a, 10b, if provided as separate components secured together.
  • the plunger 50 includes a flange 53 formed as a cylindrical head having a larger outer diameter than the plunger 50, which may be integrally molded or otherwise formed with the plunger 50, or that is manufactured separately and permanently attached to the plunger 50, with one or more passages (not shown) extending between proximal and distal surfaces of the flange 53.
  • the change in volume that the gas must fill increases only minimally (e.g., the volume the plunger 50 occupies within the second chamber 24 that is displaced out of the distal end 16 of drive assembly 12). Consequently, because the volume change is minimized, the resulting force applied by the pressure on the plunger 50 may remain substantially constant or reduce only slightly. Thus, the resulting force drop applied to the plunger 50 may be minimized, which may provide a more uniform delivery rate of the agent from the syringe 70. Additional information regarding plungers that may provide reduced pressure drop can be found in co-pending U.S. application, Serial Nos. 17/965,707, the entire disclosure of which is expressly incorporated by reference herein.
  • the proximal end 52 of the plunger 50 may have a larger diameter or other cross-section than the distal end 54 of the plunger 50.
  • the outer diameter or cross-section may taper between the proximal and distal ends 52, 54 of the plunger 50.
  • Such a tapered shape may increase the cross-sectional area of the plunger 50 as it advances from the initial position towards the extended position, which may minimize the change in the distal force applied to the syringe stopper due to volume change, which may be particularly useful for applications where consistent rates of delivery are desired. It will be appreciated that any of these optional features related to the plunger 50 may be combined together or omitted, as desired. [00090] Returning to FIGS.
  • the opener mechanism 60 includes a release cap 34 and a spring perch assembly or carriage 64 slidably coupled to the rear housing 12, e.g., within the second and third regions 22b, 22c of the first chamber 24.
  • the carriage 64 carries the opener pin 62, e.g., mounted along the axis 18 and oriented distally towards the cap 44.
  • the carriage 64 and release cap 34 include one or more features that disengage when the release cap 34 is directed proximally (by the activation cap 80 and spacer 30), and the carriage 64 may be biased to move distally, when released, to direct the opener pin distally to open the outlet in the cap 44 of the canister 40.
  • the rear housing 12 and the carriage 64 may include cooperating features that prevent the carriage 64 from moving until the device 6 is activated.
  • the carriage 64 includes locking tabs or other features 64a on its proximal end that engage the proximal end 13a of the rear housing 12, and a flange 64b on its distal end slidable within the second region 22b of the first chamber 24.
  • a puncture spring 66 is also provided within the second region 22b around the carriage 64, e.g., a coil spring provided in an initially compressed state between the rear housing 12 and the flange 64b.
  • one or more flanges on the distal end 34b may slide proximally along the inner surface of the outer housing 8, e.g., until they abut a ridge on the outer housing 8 to prevent further proximal movement of the release cap 34, as described further elsewhere herein.
  • a central hub 36 is provided on the proximal end 34a of the release cap 34 aligned along the axis 18 distally towards the opener pin 62.
  • the carriage 64 includes a plurality of tabs or release fingers 65, e.g., arranged concentrically around the axis 18 such that the tabs 65 may slide along the hub 36 as the release cap 34 is directed proximally.
  • the tabs 65 are biased to move radially inwardly (towards the central axis 18), thereby directing the locking features 64a inwardly.
  • the spring 66 may automatically direct the carriage 64 distally, thereby directing the opener pin 62 distally to penetrate the septum in the cap 44 of the canister 40 (or otherwise opening the outlet).
  • the device 6 may be provided initially with the safety cap 86 attached to the distal end 8b of the housing 8, e.g., as shown in FIGS. 1-2B.
  • the safety cap 86 may be removed, e.g., by simply pulling the safety cap 86 distally away from the outer housing 8, to expose the contact surface 84 of activation cap 80, e.g., as shown in FIG. 4A.
  • the safety cap 86 may include inner and outer cylindrical members with the proximal end 86a of the inner member coupled to the needle shield 79 and a proximal end 86b of the outer member slidably received over the distal end 8b of the outer housing 8.
  • the safety cap 86 and/or outer housing 8 may include one or more connectors, locks, and the like (not shown) that may be disengaged before removing the safety cap 86.
  • the safety cap 86 may prevent the activation cap 80 from being directed proximally, e.g., by preventing the activation cap 80 from being contacted.
  • the safety cap 86 may include features that engage the needle shield 79 such that, when the safety cap 86 is removed, the needle shield 79 is also removed. The safety cap 86 and needle shield 79 may prevent the needle 78 from being exposed from the housing 8 prior to use. Once the safety cap 86 and needle shield 79 are removed, the device 6 is ready to be used to perform an injection.
  • the contact surface 84 may be placed against a subject’s skin (not shown) and then the device 6 may be pressed against the skin to insert the needle 78, thereby causing the activation cap 80 to slide proximally from the initial position shown in FIG. 4A to the retracted position shown in FIG. 4B as the needle 78 enters the subject’s skin.
  • this action may activate the opener mechanism 60 to cause the opener pin 62 to open the outlet of the gas canister 40 to release pressurized gas into the first chamber 22, whereupon the pressurized has may advance the plunger 50 and, consequently, the piston 74 to deliver the agent(s) through the needle 78 into the subject.
  • the proximal end 82 of the activation cap 80 may abut or otherwise engage a distal end 30a of the spacer 30, and a proximal end 30b of the spacer 30 may abut or otherwise engage the distal end 34b of the release cap 34.
  • the spring 32 may be compressed, e.g., between features on the distal end 30a of the spacer 30 and the inner housing 20, thereby biasing the spacer 30 subsequently to move distally.
  • the spacer 30 is unable to move distally.
  • the carriage 64 moves distally, it causes the opener pin 62 to advance and penetrate the septum in the cap 44 (or otherwise open the outlet), thereby releasing the pressurized gas within the canister 40.
  • the released pressurized gas then enters the first chamber 22, e.g., around the canister 40, and passes to the second chamber 24, thereby pressurizing the second chamber 24 to generate a distal force to direct the plunger 50 distally from the initial position towards its extended position to deliver the one or more agents from the syringe 70 through the needle 78 into the subject, e.g., as shown in FIG. 6A.
  • the proximal end 30b of the spacer may pass distally beyond features 34d on the distal end 34b of the release cap 34.
  • the features 34b may include one or more fingers or tabs that slide along the interior of the spacer 30 until the proximal end 30b passes distally, whereupon the tabs may resiliently move radially outwardly, e.g., such that the tabs 34d are located proximal to the proximal end 30b of the spacer 30, thereby preventing the spacer 30 from subsequently moving proximally.
  • an exemplary injector device 106 includes an inner drive housing 120 including a first or proximal chamber 122 including a gas canister 40 therein and a second or distal chamber 124 including a plunger 150 for delivering one or more agents from an agent chamber 73 of a syringe 70, e.g., generally similar to the device 6. Also similar to the device 6, the device 106 may include one or more other components, e.g., an outer housing containing the housing 120 and syringe 70, an opener mechanism for opening an outlet of the canister 40 to release pressurized gas into the chambers 122, 124, a needle guard and/or spacer, a manual actuator, and the like, which are not shown in FIGS.
  • an outer housing containing the housing 120 and syringe 70 an opener mechanism for opening an outlet of the canister 40 to release pressurized gas into the chambers 122, 124, a needle guard and/or spacer, a manual actuator, and the like, which are not shown in FIGS.
  • the plunger 150 is initially provided in a proximal or initial position before use (FIG. 7A) and, when pressurized gas is released from the canister 40 (after pressing a needle guard against the patient’s skin to insert the needle to automatically activate the device 106, and/or using a manual actuator, not shown), the pressurized gas passes through the first chamber 122 into the second chamber 124, thereby advancing the plunger 150 to its distal or extended position (FIG.
  • the plunger 150 includes one or more lateral or side ports, e.g., port 152a (best seen in FIGS. 7C and 7D) adjacent the proximal end 152 of the plunger 150.
  • the port(s) 152a communicate between an interior plunger passage 156 within the plunger 150 and an annular space 125 surrounding the plunger 150 within the second chamber 124.
  • pressurized gas introduced into the second chamber 124 may enter the plunger chamber 156 and pass through the port(s) 152a into the annular space 125, e.g., as best seen in FIG. 7C. Because the second chamber 124 is sealed, e.g., by one or more O-rings (not shown), the pressurized gas may fill these spaces without escaping while the plunger 150 is in its initial position (FIG. 7A) and while the plunger 150 advances partially towards its extended position.
  • FIG. 7A initial position
  • the housing 120 also includes an end-of-dose indicator 159 adjacent the distal end 121b of the housing 120, e.g., including a “sound- generating” chamber 159a at least partially surrounding the plunger 150 and a vent opening 159b that communicates between the sound-generating chamber 159a and atmosphere, i.e., the area surrounding the housing 120 (e.g., within an interior of an outer housing of the device 106).
  • an end-of-dose indicator 159 adjacent the distal end 121b of the housing 120, e.g., including a “sound- generating” chamber 159a at least partially surrounding the plunger 150 and a vent opening 159b that communicates between the sound-generating chamber 159a and atmosphere, i.e., the area surrounding the housing 120 (e.g., within an interior of an outer housing of the device 106).
  • the sound-generating chamber 159a is an annular chamber surrounding the plunger 150 that is isolated from the second chamber 124 by one or more seals, e.g., O-rings 158, such that the O-rings 158 slide along the outer surface of the plunger 150 as the plunger 150 advances from the initial position to the extended position, while maintaining a fluid-tight seal.
  • O-rings 158 e.g., O-rings 158
  • the piston 74 has been advanced to deliver a desired dose volume from the syringe 70.
  • the port(s) 152a in the plunger 150 become aligned with the sound-generating chamber 159a.
  • pressurized gas within the plunger chamber 156 is free to pass through the port(s) 152a, into the sound-generating chamber 159a and out the vent 159b.
  • the chamber 159a and vent 159b are configured such that, as the pressurized gas passes therethrough, the gas generates an audible sound, which informs the user that the plunger 150 has reaches its extended position and the desired dose of agent (s) has been delivered.
  • the sound-generating chamber 159a and/or vent 159b may include one or more features that vibrate or otherwise enhance the sound generated as the pressurized gas passes through, e.g., similar to features on a whistle. [000111] Turning to FIGS.
  • an alternative example of an injector device 106’ is shown that generally includes similar features and operates similar to the device 106.
  • the device 106’ includes a plunger 150’ including a proximal end 152’ within the second chamber 124’ and a distal end 154’ coupled to the piston 74 of the syringe 70, and a plunger chamber 156’ including one or more side ports, e.g., port 152a’ communicating between the plunger chamber 156’ and the surrounding annular space 125.’
  • the proximal end 152’ of the plunger 150’ includes an axial port 153a’ communicating between the second chamber 124’ and the plunger chamber 156’, rather than being entirely open at the proximal end 152.’
  • the housing 120’ does not include a separate sound-generating chamber at the distal end 121b’ of the housing 120.’ Instead, the housing 120’ includes a seal, e.g., a
  • the port(s) 152a’ may located on the plunger 150’ such that, when the plunger 150 is advanced fully to its extended position, the port(s) 152a’ passes distally beyond the O-ring 158’ and exits the distal end 121b’ of the housing 120’ to communicate with a resonance chamber adjacent the housing 120,’ e.g., within an outer housing (not shown) of the device 106.’ Consequently, in this position, as best seen in FIG. 8C, the port(s) 152a’ is exposed to the area surrounding the device 106’, i.e., to atmosphere (or within an outer housing, not shown), allowing pressurized gas within the plunger chamber 156’ to escape through the port(s) 152a.’.
  • pressurized gas released from the canister 40 may pass through the first and second chambers 122” 124” into the plunger chamber 156,” through the port 152a” into the annular space 125” surrounding the plunger 150.” Again the O-ring 158” (or other seal(s)) may prevent the gas from escaping while the plunger 150” advances partially from its initial position. [000115] When the plunger 150” reaches its extended position, shown in FIG.9B, the port 152a” may pass distally through the O-ring 158” and out of the distal end 121b” of the housing 120,” thereby allowing the pressurized gas within the plunger chamber 156” to pass freely through the port 152a” to the surrounding atmosphere.
  • FIGS. 10A-10D another example of an injector device 206 is shown that includes an inner drive housing 220 including a first or proximal chamber 222 including a gas canister 40 therein and a second or distal chamber 224 including a plunger 250 for delivering one or more agents from an agent chamber 73 of a syringe 70, e.g., generally similar to the other devices herein.
  • the device 206 may include one or more other components, e.g., an outer housing containing the drive housing 220 and syringe 70, an opener mechanism for opening an outlet of the canister 40 to release pressurized gas into the chambers 222, 224, a needle guard and/or spacer, a manual actuator, and the like (not shown).
  • an outer housing containing the drive housing 220 and syringe 70 e.g., a handle, a proximal or initial position before use (FIG.
  • the plunger 250 includes an end-of-dose indicator including a strain energy release feature on the plunger 250 and a stop feature on the drive housing 220 configured such that, when the plunger 250 reaches its distal or extended position, the strain energy release feature contacts the stop feature and releases strain energy to generate an audible sound.
  • the strain energy release feature comprises a flange or tab 253 extending radially outwardly from the plunger 250, e.g., a flange 253 on the proximal end 252 of the plunger 250, that includes a weakened region or stress-concentration point 253a, e.g., at an intermediate location on the flange 253, e.g., as best seen in FIG.
  • an injector device 306 that includes a drive housing 320 including first and second chambers 322, 324 with a canister 40 and plunger 350 for advancing a piston 74 of a syringe 70, similar to the previous devices.
  • a strain energy feature i.e., a bistable element or ring 359 is provided in the drive housing 320, e.g., adjacent its distal end 321b, as best seen in FIG. 11C.
  • the bistable feature 359 may be in a first stable position, such as that shown in FIG. 11C.
  • the bistable feature may be an annular ring 359 received within an annular recess 321c within the distal end 321b of the drive housing 320, which is shaped to have a nonplanar shape, e.g., a frustoconical shape.
  • the ring 359 may be formed from material, e.g., metal, plastic, or composite material, whose properties allow the ring 359 to shift between a first stable position where the ring 359 tapers inwardly in a proximal direction (FIG. 11C) within the recess 321c and a second stable position where the ring 359 tapers inwardly in a distal direction (FIG. 11D).
  • a stop or annular ridge 353a may be provided around the proximal end 352 of the plunger 350, e.g., formed on or adjacent the flange 353.
  • the stop 353a may interact with the ring 359 to direct the ring 359 from the first stable position to the second stable position.
  • an injector device 406 includes an inner housing 420 including first and second chambers 422, 424 with a canister 40 and plunger 450 for advancing a piston 74 of a syringe 70, similar to the previous devices.
  • an outer housing 408 is shown, which may contain the components of the device 406, e.g., the inner housing 420 and syringe 70 and an actuator (not shown), which may be activated to open an outlet of the syringe, e.g., similar to the device 6 shown in FIGS. 2-6.
  • an actuator not shown
  • the plunger 450 is initially provided in a proximal or initial position before use and, when pressurized gas is released from the canister 40 (after pressing a needle guard against the patient’s skin to insert the needle to automatically activate the device 406, and/or using a manual actuator, not shown), the pressurized gas passes through the first chamber 422 into the second chamber 424, thereby advancing the plunger 450 to its distal or extended position to advance a piston 74 of the syringe 70 to deliver the agent(s) within the agent chamber 73, as shown in FIG. 12B.
  • the plunger 450 includes one or more lateral or side ports, e.g., port 452a (best seen in FIG.
  • the port(s) 452a communicates between an interior plunger passage 456 within the plunger 450 and an annular space 425 surrounding the plunger 450 within the second chamber 424.
  • pressurized gas introduced into the second chamber 424 may enter the plunger chamber 456 and pass through the port(s) 452a into the annular space 425, e.g., as best seen in FIG. 12A.
  • the second chamber 424 is sealed, e.g., by one or more O-rings 458, the pressurized gas may fill these spaces without escaping while the plunger 450 is in its initial position (FIG.
  • the inner housing 420 also includes an end-of-dose indicator 459 adjacent the distal end 421b of the inner housing 420, e.g., a pin chamber 459a at least partially surrounding the plunger 450 and a pin or other displacement member 459b that floats within or is otherwise movable radially relative to the pin chamber 459a.
  • an end-of-dose indicator 459 adjacent the distal end 421b of the inner housing 420, e.g., a pin chamber 459a at least partially surrounding the plunger 450 and a pin or other displacement member 459b that floats within or is otherwise movable radially relative to the pin chamber 459a.
  • the pin chamber 459a is an annular chamber that surrounds the plunger 450 and is isolated from the second chamber 424 by one or more seals, e.g., O-rings 458, such that the O-rings 458 slide along the outer surface of the plunger 450 as the plunger 450 advances from the initial position to the extended position while maintaining a fluid-tight seal.
  • O-rings 458 e.g., O-rings 458
  • the piston 74 has been advanced to deliver a desired dose volume from the syringe 70.
  • the port(s) 452a in the plunger 450 become aligned with the pin chamber 459a.
  • pressurized gas within the plunger chamber 456 is free to pass through the port(s) 452a, into the pin chamber 159a.
  • the pressurized gas within the pin chamber 459a acts on the pin 459b to direct the pin 459b radially outwardly, e.g., through an opening 459c in the inner housing 420, until the pin 459b contacts an inner surface 408a of the outer housing 408a.
  • the pin 459b may scrape or slide along the inner surface 408a, e.g., causing vibration or a scraping or clicking sound, i.e., thereby generating an audible end-of dose indicator, which informs the user that the plunger 450 has reaches its extended position and the desired dose of agent (s) has been delivered.
  • the pin 459b may include a relatively large base within the pin chamber 459b and a relatively narrow shaft that may extend through the opening 459c in the inner housing 420.
  • the surface area of the base exposed within the pin chamber 459a and/or the cross-section of the pin chamber 459a may be adjusted to provide a desired radially outward force on the pin 459b (due to the gas pressure acting on the base) to cause a desired amount of contact and resulting audible sound being generated when the plunger 450 completes its final distal advancement.
  • an injector device 406’ may be provided that is constructed generally similar to the device 406 but with a tactile end-of- dose indicator.
  • the device 406’ may include an inner housing 420’ (including first and second chambers 422,’ 424,’a canister 40, and a plunger 450’) and syringe 70 within an outer housing 408.
  • the inner housing 420’ may include an end-of-dose indicator 459’ adjacent its distal end 421b,’ e.g., a pin chamber 459a’ at least partially surrounding the plunger 450’ and a pin or displacement member 459b’ that floats within or is otherwise movable radially relative to the pin chamber 459a,’ also similar to the device 406.
  • the pin chamber 459a’ is an annular chamber that surrounds the plunger 450’ and is isolated from the second chamber 424’ by one or more seals, e.g., O-rings 458’ that slide along the outer surface of the plunger 450’ as the plunger 450’ advances from the initial position to the extended position.
  • the plunger 450’ includes one or more lateral or side ports, e.g., port 452a’ adjacent the proximal end 452’ of the plunger 450,’ which communicates between an interior plunger passage 456’ within the plunger 450’ and an annular space 425’ surrounding the plunger 450’ within the second chamber 424.’
  • the port(s) 452a’ in the plunger 450 become aligned with the pin chamber 459a.’ Consequently, pressurized gas within the plunger chamber 456’ is free to pass through the port(s) 452a,’ into the pin chamber 159a.’
  • the pressurized gas within the pin chamber 459a’ then acts on the pin 459b’ to direct the pin 459b’ radially outwardly, e.g., through an opening 459c’ in the inner housing 420,’ until the pin 459b’ contacts an inner surface 408a’ of the outer housing 408a.’ [
  • an injector device 406 may be provided generally similar to the device 406’ except that, rather than having a deflectable region on the outer housing, the outer housing 408” includes a hole or opening 409a” therethrough that is aligned with the pin 459b.” Consequently, when the pin 459b” is directed radially outwardly, the pin 459b” may move through the opening 459c” in the inner housing 420” and pass through the opening 409a” in the outer housing 408.” A user holding the outer housing 408” may feel the pin 459b” as it passes through the opening 409a” and contacts the user’s hand holding the outer housing 408,” thereby providing a tactile end-of-dose indication.
  • FIGS. 15A-15C another example of an injector device 506 is shown that includes an outer housing 408 containing the internal components of the device 506, e.g., an inner housing 520 and a syringe 70, generally similar to other devices herein.
  • the inner housing 520 includes first and second chambers 522, 524 with a canister 40 and plunger 550 for advancing a piston 74 of the syringe 70, similar to the previous devices.
  • the device 506 includes a needle guard or shield 580, which may initially cover a needle 78 of the syringe, which is movable proximally, e.g., when a contact surface 584 of the needle guard 580 is placed against tissue and the device 506 is advanced to insert the needle 78 into the patient’ skin (not shown), similar to the other devices herein.
  • the needle guard 780 may be coupled to an opener mechanism (not shown) provided within the outer housing 508, e.g., adjacent an outlet of the canister 40, e.g., proximal to or within the inner housing 520, e.g., similar to the opener mechanism 60 shown in FIGS.
  • the needle guard 580 may include a spacer or extension 530 that extends proximally around the inner housing 520, which may be integrally formed with the needle guard 580, as shown, or may be a separate tubular member, e.g., similar to the spacer 30 of the device 6.
  • the inner housing 520 includes an annular shoulder 523 extending radially outwardly from the inner housing 520 at a location proximal to the distal end 521b and the spacer 530.
  • the spacer 530 may have a first diameter between the spacer 530 and the distal end 521b of the inner housing such that there is minimal space between the spacer 530 and the inner housing 520, and then the spacer 530 may transition to a proximal region 532 having a second larger diameter such that the proximal region 532 may slide over the shoulder 523.
  • One or more seals may be provided between the spacer 530 and the inner housing 520, e.g., a proximal O-ring 523a on the shoulder 523 and a distal O-ring 523b on the distal end 521b of the inner housing 520, thereby isolating a secondary chamber 534 between the spacer 530 and the inner housing 520.
  • the volume of the secondary chamber 534 i.e., the volume isolated by the O-rings 523a, 523b may be minimal given that the transition to the proximal region 532 of the spacer 530 is immediately adjacent the shoulder 523.
  • the inner housing 520 includes a chamber 559 adjacent the distal end 521b that at least partially surrounds the plunger 550 and communicates with the secondary chamber 534, which is sealed by one or more seals, e.g., O-rings 558, that isolate the chamber 559 from the second chamber 524 of the inner housing 520. Consequently, as shown in FIGS.
  • the gas when pressurized gas is released from the canister 40, e.g., by the needle guard 580 and spacer 530 moving proximally when the contact surface 584 is pressed against the subject’s skin to release the opener mechanism (not shown), the gas may pass through the first and second chambers 522, 524 and may enter the plunger chamber 556 within the plunger 550.
  • the released gas may apply a distal force to advance the plunger 550 and, consequently, the piston 74, as shown in FIG. 15B, to deliver the agent(s) within the agent chamber 73 through the needle 78 into the subject’s body.
  • the plunger 550 may include one or more side ports or vents, e.g., ports 552a adjacent the proximal end 552 of the plunger 552 that communicate between the plunger chamber 556 and the annular space 525 surrounding the plunger 550. Because the distal chamber 559 is isolated from the second chamber 520, the released gas does not enter the distal chamber 559. However, once the plunger 550 reaches its extended position, e.g., as shown in FIGS. 15B and 16A, the ports 552a become aligned with the distal chamber 559, consequently exposing the distal chamber 559 to pressurized gas. [000139] As shown in FIGS.
  • the pressurized gas is then free to pass through the distal chamber 559 into the secondary chamber 534 between the spacer 530 and the inner housing 520.
  • the gas may direct the spacer 530 distally as the gas expands within the secondary chamber 534, thereby automatically advancing the needle guard 580 distally to cover the needle 78 when the needle 78 is withdrawn or automatically direct the needle 78 out of the subject’s skin if the gas pressure generates sufficient distal force on the needle guard 580.
  • This distal force may provide a tactile and/or visual indication to the user that the desired dose has been delivered and the device 506 may be removed.
  • any of the other end-of-dose features may be added to the device 506, e.g., to provide further audible, tactile, and/or visual indications that the desired dose has been delivered.
  • FIGS. 17A and 17B still another example of an injector device 606 is shown that includes an inner drive housing 620 including a first or proximal chamber 622 including a gas canister 40 therein and a second or distal chamber 624 including a plunger 650 for delivering one or more agents from an agent chamber 73 of a syringe 70, e.g., generally similar to the other devices herein.
  • the device 606 may include one or more other components, e.g., an outer housing containing the inner drive housing 620 and syringe 70, an opener mechanism for opening an outlet of the canister 40 to release pressurized gas into the chambers 622, 624, a needle guard and/or spacer, manual actuator, and the like (not shown).
  • the plunger 650 includes a proximal end 652 received within the second chamber 624 and a distal end 654 that is coupled to the piston 74 such that distal movement of the plunger 650 advances the piston 74 to deliver agent(s) within the agent chamber 73 of the syringe 70.
  • the plunger 650 and inner drive housing 620 include cooperating elements that generate an audible sound as the plunger 650 advances from its initial position to its extended position, with the audible sound discontinuing when the plunger 650 reaches its extended position to provide an end-of-dose indication.
  • the cooperating elements may include a plurality of ratchet elements on one of the plunger 650 and the inner drive housing 620 and one or more pawl elements on the other of the plunger 650 and the inner drive housing 620 such that the one or more pawl elements move along the ratchet elements as the plunger advances to generate the audible sound.
  • a plurality of ratchet elements 623 are provided along an inner wall of the inner drive housing 620, e.g., spaced apart axially from one another, and the proximal end 652 of the plunger 650 includes a pawl element 658, e.g., including an elastic tab extending outwardly from the proximal end 652 of the plunger 650 such that the pawl 658 is received in one of the ratchet elements 623.
  • the pawl 658 When the plunger 650 is advanced distally (due to pressurized gas from the canister 40 passing through the chambers 622, 624 into the plunger chamber 656), the pawl 658 may deflect in and out as it passes into each successive ratchet element 623. This motion of the pawl 658 may generate an audible sound as the pawl 658 snaps into each successive ratchet 623, and/or may cause a vibration providing a tactile indication to the user that the plunger 650 is advancing and the agent(s) are being delivered.
  • the pawl 658 may include a tapered distal edge and/or the ratchet elements 623 may include tapered proximal edges to allow the pawl 658 to move distally, thereby minimizing resistance to distal advancement of the plunger 650.
  • the pawl 658 may include a blunt proximal edge and the ratchet elements 623 may include blunt proximal edges, thereby preventing proximal movement of the plunger 650 once the pawl 658 has passed over each ratchet 623.
  • the plunger 650 may include a stop 653 on the proximal end 652 that may abut the distal end 621b of the inner drive housing 620 in the extended position, thereby preventing further distal movement of the plunger 650, or other stops may be provided between the plunger 650 and the inner drive housing 620 to limit distal movement of the plunger 650 to its extended position.
  • the pawl 658 remains stationary within a final ratchet element 623, discontinuing further sound and/or vibration, and thereby providing an end-of-dose indication to the user.
  • an injector device 706 that includes an inner drive housing 720 including a first or proximal chamber 722 including a gas canister 40 therein and a second or distal chamber 724 including a plunger 750 for delivering one or more agents from an agent chamber 73 of a syringe 70, e.g., generally similar to the other devices herein.
  • the plunger 750 includes a proximal end 752 received within the second chamber 724 and a distal end 754 that is coupled to the piston 74 such that distal movement of the plunger 750 advances the piston 74 to deliver agent(s) within the agent chamber 73 of the syringe 70.
  • the plunger 750 and inner drive housing 720 include cooperating elements that generate an audible sound as the plunger 750 advances from its initial position to its extended position, with the audible sound discontinuing when the plunger 750 reaches its extended position to provide an end-of-dose indication, similar to the device 650.
  • the inner drive housing 720 includes an internal shaft 728 that extends axially through the second chamber 724 into a plunger chamber 756 of the plunger 750.
  • the shaft 728 includes a proximal end that is axially fixed relative to the inner drive housing 720 and includes an axial passage 729 therethrough that communicates between the second chamber 724 and the plunger chamber 756.
  • pressurized gas released from the canister 40 may pass through the chambers 722, 724, through the passage 729 in the shaft 728, and into the plunger chamber 756, thereby applying a distal force to advance the plunger 750 from the initial or proximal position shown in FIG. 18A to its extended or distal position (not shown).
  • the shaft 728 may include one or more side ports, e.g., port 729a that communicates between the passage 729 and the second chamber 724 to allow the released pressurized gas to fill the annular space 725 around the plunger 750 within the second chamber 724.
  • the shaft 728 and the plunger 750 include cooperating elements that generate an audible sound as the plunger 750 advances.
  • the shaft 728 may include a plurality of ratchet elements 723 spaced apart from one another along an outer surface of the shaft 728 and the proximal end 752 of the plunger may include a pawl or other elastic element 758 that may be received in the ratchet elements 758, similar to the device 606. Consequently, as the plunger 750 advances, the pawl 758 may pass in and out of the sequential ratchet elements 758 to generate a clicking or snapping sound and/or vibratory indication to the user.
  • a bistable element 758’ may be provided on the proximal end 752’ of the plunger 750’ that may engage with ratchet elements 723’ on the shaft 728’ to provide a continuous audible and/or vibratory indication to the user as the plunger 750’ advances, which discontinues once the plunger 750’ reaches the extended position and stops moving.

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

Abstract

Des modules de commande et des auto-injecteurs comprennent un boîtier renfermant des première et seconde chambres ; un mécanisme d'ouverture à l'intérieur de la première chambre présentant une pointe d'actionnement ; une cartouche contenant un gaz pressurisé comportant une sortie disposée adjacente à la pointe d'actionnement ; un actionneur conçu pour libérer le mécanisme d'ouverture afin d'amener la pointe d'actionnement à ouvrir la sortie et d'amener le gaz à l'intérieur de la cartouche à s'écouler à travers la première chambre et pour s'introduire dans la seconde chambre, et un piston disposé de manière coulissante à l'intérieur du boîtier de sorte que le gaz pénétrant dans la seconde chambre amène le piston à se déplacer d'une position initiale à une position étendue dans laquelle une extrémité distale du piston s'étend à partir du boîtier. Les dispositifs comprennent une ou plusieurs fonctionnalités de fin d'injection de dose qui garantissent une confirmation audible, tactile et/ou visuelle lorsqu'une dose souhaitée a été administrée.
PCT/US2025/019634 2024-03-12 2025-03-12 Injecteurs et systèmes de commande pour injecteurs avec indication de fin d'injection de dose Pending WO2025193871A1 (fr)

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
US202463564436P 2024-03-12 2024-03-12
US63/564,436 2024-03-12
US202463565131P 2024-03-14 2024-03-14
US202463565127P 2024-03-14 2024-03-14
US202463565129P 2024-03-14 2024-03-14
US63/565,131 2024-03-14
US63/565,129 2024-03-14
US63/565,127 2024-03-14
US202463566232P 2024-03-16 2024-03-16
US63/566,232 2024-03-16

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080228143A1 (en) * 2004-01-23 2008-09-18 The Medical House Plc Injection Device
US20140114250A1 (en) * 2012-10-24 2014-04-24 Nuance Designs, LLC Autoinjector
US11071824B2 (en) * 2017-11-04 2021-07-27 Altaviz, Llc Injection devices and methods for making and using them
US20230414875A1 (en) * 2015-08-27 2023-12-28 E3D A.C.A.L Ltd Reusable automatic injection device
US20240033434A1 (en) * 2022-08-01 2024-02-01 Altaviz, Llc Manual insertion auto-injectors and methods for use

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080228143A1 (en) * 2004-01-23 2008-09-18 The Medical House Plc Injection Device
US20140114250A1 (en) * 2012-10-24 2014-04-24 Nuance Designs, LLC Autoinjector
US20230414875A1 (en) * 2015-08-27 2023-12-28 E3D A.C.A.L Ltd Reusable automatic injection device
US11071824B2 (en) * 2017-11-04 2021-07-27 Altaviz, Llc Injection devices and methods for making and using them
US20240033434A1 (en) * 2022-08-01 2024-02-01 Altaviz, Llc Manual insertion auto-injectors and methods for use

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