WO2020257799A1 - Injection system and method - Google Patents

Injection system and method Download PDF

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Publication number
WO2020257799A1
WO2020257799A1 PCT/US2020/039013 US2020039013W WO2020257799A1 WO 2020257799 A1 WO2020257799 A1 WO 2020257799A1 US 2020039013 W US2020039013 W US 2020039013W WO 2020257799 A1 WO2020257799 A1 WO 2020257799A1
Authority
WO
WIPO (PCT)
Prior art keywords
distal
proximal
needle
configuration
transfer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2020/039013
Other languages
English (en)
French (fr)
Inventor
Stephen H. Diaz
Gary Steese-Bradley
Alan E. Shluzas
Conor Edward SHANLEY
Mina M. Leung
Jeff Tillack
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.)
Credence Medsystems Inc
Original Assignee
Credence Medsystems Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Credence Medsystems Inc filed Critical Credence Medsystems Inc
Priority to JP2021576023A priority Critical patent/JP7423089B2/ja
Priority to CA3143804A priority patent/CA3143804C/en
Priority to EP20740120.9A priority patent/EP3986506A1/en
Publication of WO2020257799A1 publication Critical patent/WO2020257799A1/en
Anticipated expiration legal-status Critical
Priority to JP2024001621A priority patent/JP7772396B2/ja
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2066—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/284—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3286—Needle tip design, e.g. for improved penetration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/329—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3294—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2459—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
    • A61M2005/2462—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst by displacing occluding plugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/286—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
    • A61M2005/287—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst by displacing occluding plugs
    • 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
    • A61M2205/19—Constructional features of carpules, syringes or blisters
    • 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
    • A61M2205/27—General characteristics of the apparatus preventing use
    • A61M2205/276—General characteristics of the apparatus preventing use preventing unwanted use
    • 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
    • A61M5/31596—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3295—Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel

Definitions

  • the present invention relates generally to injection systems, devices, and processes for facilitating various levels of control over fluid infusion, and more particularly to systems and methods related to multiple chamber safety syringes in healthcare environments.
  • a typical syringe (2) comprises a tubular body (4), a plunger (6), and an injection needle (8). As shown in Figure 1 B, such a syringe (2) may be utilized not only to inject fluid into a patient, but also to withdraw or expel fluid out of or into a container such as a medicine bottle, vial, bag, or other drug containment system (10).
  • FIG. 2A three Luer-type syringes (12) are depicted, each having a Luer fitting geometry (14) disposed distally, so that they may be coupled with other devices having similar mating geometry, such as the Luer manifold assembly (16) depicted in Figure 2B.
  • the Luer manifold assembly of Figure 2B may be used to administer liquid drugs to the patient intravenously with or without the use of an intravenous infusion bag.
  • the Luer fittings (14) of the syringes of Figure 2A may be termed the“male” Luer fittings, while those of Figure 2B (18) may be termed the“female” Luer fittings; one of the Luer interfaces may be threaded (in which case the configuration may be referred to as a“Luer lock” configuration) so that the two sides may be coupled by relative rotation, which may be combined with compressive loading.
  • rotation may be utilized to engage threads within the male fitting (14) which are configured to engage a flange on the female fitting (18) and bring the devices together into a fluid-sealed coupling.
  • tapered interfacing geometries may be utilized to provide for a Luer engagement using compression without threads or rotation (such a configuration may be referred to as a“slip-on” or“conical” Luer configuration). While such Luer couplings are perceived to be relatively safe for operators, there is risk of medicine spilling/leaking and parts breakage during assembly of a Luer coupling.
  • needle injection configurations carries with it the risk of a sharp needle contacting or stabbing a person or structure that is not desired. For this reason, so called“safety syringes” have been developed.
  • FIG. 3 One embodiment of a safety syringe (20) is shown in Figure 3, wherein a tubular shield member (22) is spring biased to cover the needle (8) when released from a locked position relative to the syringe body (4).
  • FIGs 4A-4B Another embodiment of a safety syringe (24) is shown in Figures 4A-4B. With such a configuration, after full insertion of the plunger (6) relative to the syringe body (4), the retractable needle (26) is configured to retract (28, 26) back to a safe position within the tubular body (4), as shown in Figure 4B.
  • Such a configuration which is configured to collapse upon itself may be associated with blood spatter/aerosolization problems, the safe storage of pre-loaded energy which may possible malfunction and activate before desirable, loss of accuracy in giving full-dose injections due to residual dead space within the spring compression volume, and/or loss of retraction velocity control which may be associated with pain and patient anxiety.
  • FIGs 5A and 5B which generally comprise a syringe body, or “drug enclosure containment delivery system”, (34), a plunger tip, plug, or stopper (36), and a distal seal or cap (35) which may be fitted over a Luer type interface
  • Figure 5A shows the cap 35 in place; Figure 5B has the cap removed to illustrate the Luer interface 14
  • Liquid medicine may reside in the volume, or medicine reservoir, (40) between the distal seal and the distal end (37) of the plunger tip (36).
  • the plunger tip (36) may comprise a standard butyl rubber material and may be coated, such as with a biocompatible lubricious coating (e.g., polytetrafluoroethylene (“PTFE”)), to facilitate preferred sealing and relative motion characteristics against the associated syringe body structure and material.
  • PTFE polytetrafluoroethylene
  • the proximal end of the syringe body (34) in Figure 5B comprises a conventional integral syringe flange (38), which is formed integral to the material of the syringe body (34).
  • the flange (38) is configured to extend radially from the syringe body (34) and may be configured to be a full circumference, or a partial circumference around the syringe body (34).
  • a partial flange is known as a“clipped flange” while the other is known as a “full flange.”
  • the flange is used to grasp the syringe with the fingers to provide support for pushing on the plunger to give the injection.
  • the syringe body (34) preferably comprises a translucent material such as a glass or polymer.
  • a plunger tip (36) may be positioned within the syringe body (34).
  • the syringe body (34) may define a substantially cylindrical shape (i.e. , so that a plunger tip 36 having a circular cross-sectional shape may establish a seal against the syringe body (34)), or be configured to have other cross-sectional shapes, such as an ellipse.
  • Such assemblies are desirable because they may be standardized and produced with precision in volume by the few manufacturers in the world who can afford to meet all of the continually changing regulations of the world for filling, packaging, and medicine/drug interfacing materials selection and component use.
  • Such simple configurations generally will not meet the new world standards for single-use, safety, auto-disabling, and anti-needle-stick.
  • certain suppliers have moved to more “vertical” solutions, such as that (41 ) featured in Figure 5C, which attempts to meet all of the standards, or at least a portion thereof, with one solution; as a result of trying to meet these standards for many different scenarios, such products may have significant limitations (including some of those described above in reference to Figures 3-4B) and relatively high inventory and utilization expenses.
  • multi-component injection systems may mix injectable components (e.g., liquids and/or powders) before injection.
  • injectable components e.g., liquids and/or powders
  • Some systems utilize a single injection device to draw a component liquid from one container and inject the liquid component into another container to solubilize the dry component therein. The solubilized dry component is then drawn into the injection device for injection into a patient.
  • Such systems require much handling of unsheathed needles, leading to unnecessary exposure of a user to one or more uncapped needles.
  • manually the liquid component from one container to another can result in incomplete transfer of the liquid component and affect the ratio of the components in the final mixed injectable.
  • accessing and manipulating multiple containers of components complicates the injection process, thereby increasing the risk of user error. Accordingly, there exists a need for multi-component injection systems that simplify the manual accessing and mixing of multiple components from multiple containers.
  • an increasing number of injectable liquids e.g., medicines
  • have yet another requirement that time of exposure of the injectable liquid to metals e.g., stainless steel of a needle
  • metals e.g., stainless steel of a needle
  • needle stick prevention technology is also desirable to incorporate needle stick prevention technology into the injection system. The ability to retract the sharp end of the needle at least partially inside of the syringe protects the person giving the injection and the patient from inadvertent needle stick injuries.
  • Embodiments are directed to injection systems.
  • the embodiments are directed to multiple chamber safe injection systems with precise control of handling, mixing, and delivery of multi-component injectables.
  • an injection system in one embodiment, includes a syringe body defining a proximal opening at a proximal end thereof and a distal needle interface at a distal end thereof.
  • the system also includes proximal and distal stopper members disposed in the syringe body, forming a proximal drug chamber between the proximal and distal stopper members and a distal drug chamber between the distal stopper member and the distal end of the syringe body.
  • the system further includes a plunger member configured to be manually manipulated to insert the proximal stopper member relative to the syringe body.
  • the system includes a fluid conveying assembly including a penetrating member configured to penetrate the distal stopper member to fluidly couple the proximal and distal drug chambers.
  • the fluid conveying assembly also includes a distal exit tube, wherein a distal end of the penetrating member is disposed in the distal exit tube.
  • the fluid conveying assembly further includes a transfer member disposed at least partially around a portion of the penetrating member, wherein the distal transfer member defines a fluid passage.
  • the transfer member includes a sleeve disposed on the portion of the penetrating member.
  • the sleeve may define the fluid passage on the surface of the portion of the penetrating member.
  • the transfer member may include a chamfered corner at a proximal end thereof.
  • a diameter of the distal end of the geometric feature may be substantially the same as or larger than a diameter of the proximal end of the distal exit tube.
  • the penetrating member may be configured to pierce the distal stopper member and the transfer member may be configured to dilate the distal stopper member and maintain an open fluid passage.
  • the portion of the penetrating member has a reduced diameter relative to a geometric feature at a distal end of the penetrating member and the distal exit tube at a proximal end of the portion of the penetrating member.
  • a distal end of the geometric feature and a proximal end of the distal exit tube may form proximal and distal shoulders at proximal and distal ends of the portion of the penetrating member respectively.
  • the transfer member has a closed configuration wherein the transfer member is disposed around the portion of the penetrating member between the proximal and distal shoulders, the transfer member having a first diameter, and an open configuration wherein the transfer member has a second diameter larger than the first diameter such that the penetrating member and the distal exit tube are slidable within the transfer member.
  • the transfer member may be converted from the closed configuration to the open configuration by the application of between approximately 6 Ibf and approximately 10 Ibf on the distal exit tube provided by hydraulic pressure on the distal stopper member from the plunger member.
  • the transfer member includes a distally directed funnel at a distal end thereof.
  • a proximal end of the distal exit tube may be disposed in the distally directed funnel when the transfer member is in the closed configuration.
  • the proximal end of the distal exit tube may be configured to wedge open the transfer member with distal movement of the distal exit tube relative to the transfer member to transform the transfer member from the closed configuration to the open configuration.
  • the first diameter is less than or equal to a diameter of the distal end of the geometric feature.
  • the second diameter may be greater than a diameter of the proximal end of the distal exit tube.
  • the transfer member may be configured to transform from the closed configuration to the open configuration with application of a pre-determ ined amount of force to the distal exit tube.
  • the pre-determ ined amount of force may be approximately 6 Ibf to approximately 10 Ibf of distally directed force.
  • the transfer member includes a living hinge.
  • the transfer member may include an elongate side opening.
  • the distal stopper member may include a funnel configured to guide a proximal end of the penetrating member toward a center of the distal stopper member.
  • the transfer member may include a radially extending member configure to physically interfere with the funnel to halt proximal movement of the transfer member relative to the funnel and the distal stopper member when the radially extending member contacts the funnel.
  • the penetrating member may include a geometric feature at a proximal end thereof. The geometric feature may be configured to penetrate the distal stopper member.
  • the distal exit tube includes a split open distal end.
  • the distal exit tube may include a proximal side opening and a proximal end opening.
  • the penetrating member may have a length greater than a distance between the proximal side opening and the proximal end opening.
  • the system may also include a ring welded to the distal exit tube. The ring may be configured to prevent a distal end of the distal exit tube from extending more than a predetermined distance toward a distal end of the distal needle interface.
  • the system has a transport configuration wherein the penetrating member is entirely disposed in the distal drug chamber, a transfer configuration wherein the penetrating member has at least partially pierced the distal stopper member, and wherein the penetrating member and the transfer member are at least each partially disposed in the proximal drug chamber, and a mixed configuration wherein the proximal and distal stopper members are in contact with each other, thereby transferring a first drug component from the proximal drug chamber to the distal drug chamber to mix the first drug component with a second drug component in the distal drug chamber.
  • the fluid passage may form a fluid path between the proximal and distal chambers when the system is in the transfer configuration.
  • the transfer member may not fully penetrate the proximal stopper member in the mixed configuration or during injection. After the system has reached the mixed configuration, the distal exit tube wedges open the transfer member and slides proximally within the transfer member with further distal movement of the distal stopper member.
  • the system is configured to transform from the transport configuration to the transfer configuration with application of a pre-determ ined amount of force to the distal stopper member.
  • the pre determined amount of force is approximately 3-5 Ibf of distally directed force.
  • the distal exit tube may include a distal end opening at a distal end thereof, and a proximal side opening disposed in the distal drug chamber.
  • First and second sizes of the respective proximal and distal drug chambers may be modified by movement of the proximal and distal stopper members relative to the syringe body.
  • the proximal and distal drug chambers may respectively contain first and second components of a drug to be mixed together prior to injecting into a patient.
  • the transfer member may be formed from metal or polymer.
  • the transfer member includes a latch having latched and unlatched states.
  • the latch prevents axial movement of the penetrating member and distal exit tube relative to the transfer member in the latched state, and the latch allows axial movement of the penetrating member and distal exit tube relative to the transfer member in the unlatched state.
  • the latch may include a plastic hinge.
  • the plastic hinge may open to transform he latch from the latched to the unlatch state.
  • the plastic hinge may open in response to application of a predetermined amount of force to the latch.
  • the predetermined amount of force may be approximately 6 Ibf to approximately 10 Ibf of distally directed force.
  • the latch may include a frangible link to hold the transfer member in the latched state until a predetermined amount of force is applied to the latch.
  • the predetermined amount of force may be approximately 6 Ibf to approximately 10 Ibf of distally directed force.
  • a syringe modifying device in another embodiment, includes a fluid conveying assembly.
  • the fluid conveying assembly includes a penetrating member configured to penetrate a distal stopper member of a syringe to fluidly couple proximal and distal drug chambers of the syringe.
  • the fluid conveying assembly also includes a distal exit tube configured to couple to a proximal end of a needle of the syringe, wherein a distal end of the penetrating member is disposed in the distal exit tube.
  • the fluid conveying assembly further includes a transfer member disposed at least partially adjacent a portion of the penetrating member, wherein the distal transfer member defines a fluid passage configured to fluidly couple the distal and proximal drug chambers upon penetration of the distal stopper member by the penetrating member.
  • the distal exit tube may include a slot configured to couple the distal exit tube to the proximal end of the needle.
  • an injection system includes a syringe body defining a proximal opening at a proximal end thereof and a distal needle interface at a distal end thereof.
  • the system also includes proximal and distal stopper members disposed in the syringe body, forming a proximal drug chamber between the proximal and distal stopper members and a distal drug chamber between the distal stopper member and the distal end of the syringe body.
  • the system further includes a plunger member configured to be manually manipulated to insert the proximal stopper member relative to the syringe body.
  • the system includes a fluid conveying assembly.
  • the system includes a finger flange including an anti-retraction mechanism.
  • the anti retraction mechanism has a brake tab configured to provide an opposing force to the plunger member to prevent proximal movement thereof relative to the brake tab, and a retention feature configured to maintain the anti-retraction mechanism in a recess in the finger flange.
  • the finger flange also includes another recess configured to mount the finger flange on a flange of the syringe body.
  • the anti-retraction mechanism may also include a plurality of fit tabs configured to reduce a tolerance between the recess and a dimension of the anti-retraction mechanism.
  • the anti-retraction mechanism may be a metal clip.
  • the brake tab is an elastic and self energizing pawl.
  • the brake tab may be disposed at an acute angle in a distal direction relative to a plane of the anti-retraction mechanism.
  • the acute angle and an elasticity of the brake tab may increase a frictional force against the plunger member upon retraction in a proximal direction.
  • the acute angle of the brake tab also creates a reaction force parallel to the plunger member, exerted by a sharp curved edge of the brake tab contacting the surface of the plunger member. This force also prevents the plunger member from moving in the proximal direction.
  • the acute angle and an elasticity of the brake tab may cause the brake tab to exert an outward force through the anti-retraction mechanism to an inner wall of the finger flange when the plunger member is retracted in a proximal direction.
  • the finger flange also includes an opening having an edge configured to interfere with and retain the anti-retraction mechanism in the recess.
  • the anti-retraction mechanism may have a“C” or“0” shape.
  • the anti-retraction mechanism may prevent removal of the plunger member from the syringe body after the plunger member has been inserted into the syringe body.
  • the opposing force may include a frictional force and a reaction force.
  • an injection system in yet another embodiment, includes a syringe body defining a proximal opening at a proximal end thereof and a distal needle interface at a distal end thereof.
  • the system also includes proximal and distal stopper members disposed in the syringe body, forming a proximal chamber between the proximal and distal stopper members and a distal chamber between the distal stopper member and the distal end of the syringe body.
  • the system further includes a plunger member configured to be manually manipulated to insert the proximal stopper member relative to the syringe body.
  • the system includes a fluid conveying assembly.
  • the fluid conveying assembly includes a piercing tube configured to penetrate the distal stopper member.
  • the assembly also includes a solid elongate member, where the piercing tube is disposed at least partially around a portion of the solid elongate member.
  • the assembly further includes a distal tube, where a distal end of the solid elongate member is disposed in a proximal end of the distal tube.
  • the piercing tube includes a pair of vacuum stops configured to increase a force required for a proximal end of the piercing tube to penetrate fully through the distal stopper member. After the proximal end of the piercing tube has penetrated fully through the distal stopper member, the piercing tube defines a fluid passage between the proximal and distal chambers.
  • each of the vacuum stops include a radially outward and distally extending tab.
  • The may also include a funnel insert disposed in the distal stopper member and configured to interfere with the vacuum stops on the piercing tube to halt proximal movement of the piercing tube relative to the funnel insert and the distal stopper member when the radially extending member contacts the funnel insert.
  • the funnel insert may be configured to guide a proximal end of the piercing tube toward a center of the distal stopper member.
  • the piercing tube also includes a tubular member, and a disc disposed orthogonal to a longitudinal axis of the tubular member at a distal end thereof.
  • the disc may define a plurality of radially inward telescoping stops connecting the disc to the tubular member.
  • the plurality of radially inward telescoping stops may define an adjustable opening in an approximate center of the disc.
  • the adjustable opening may have a smaller configuration configured to prevent the solid elongate member from passing completely through the disc and the piercing tube, and a larger configuration configured to allow the solid elongate member to pass completely through the disc and the piercing tube.
  • the distal tube includes a proximally facing shoulder at a proximal end thereof configured to interfere with the plurality of radially inward telescoping stops when the adjustable opening is in the smaller configuration to prevent proximal movement of the distal tube relative to the piercing tube.
  • a diameter of the adjustable opening in the smaller configuration may be smaller than an outer diameter of the shoulder.
  • a diameter of the adjustable opening in the larger configuration may be larger than the outer diameter of the shoulder. Moving the tubular member proximally away from the disc may transform the adjustable opening from the smaller configuration to the larger configuration. Moving the disc distally away from the tubular member may transform the adjustable opening from the smaller configuration to the larger configuration.
  • the adjustable opening is converted from the smaller configuration to the larger configuration by the application of a predetermined amount of proximally directed force on the piercing tube provided by hydraulic pressure on the distal stopper member from the plunger member.
  • the predetermined amount of proximally directed force may be between approximately 7.5 Ibf and approximately 10 Ibf.
  • the tubular member penetrating the distal stopper member may exert a radially inward force on the plurality of radially inward telescoping stops to hold the adjustable opening in the smaller configuration.
  • the piercing tube further including a pair of radially inward and proximally extending tabs configured to limit distal movement of the solid elongate member relative to the piercing tube.
  • the solid elongate member may include a distally facing shoulder configured to interfere with the radially inward and proximally extending tabs to limit distal movement of the solid elongate member relative to the piercing tube.
  • the piercing tube defines a proximal end opening, a middle opening, and a distal opening. After the proximal end of the piercing tube has penetrated fully through the distal stopper member, the fluid passage between the proximal and distal chambers includes the proximal end opening, the middle opening, and the distal opening.
  • the system may also include a vacuum in the distal chamber.
  • the piercing tube may include a chamfered corner at a proximal end thereof.
  • the system has a transport configuration where the piercing tube is entirely disposed in the distal chamber and the distal stopper member, a transfer configuration where the piercing tube has partially pierced the distal stopper member, and where an open proximal end of the piercing tube is disposed in the proximal chamber, and a mixed configuration where the proximal and distal stopper members are in contact with each other, thereby transferring a first drug component from the proximal chamber to the distal chamber to mix the first drug component with a second drug component in the distal chamber.
  • the piercing tube may form a fluid path between the proximal and distal chambers when the system is in the transfer configuration.
  • the piercing tube may not fully penetrate the distal stopper member.
  • the solid elongate member may be released from the piercing tube with further distal movement of the distal stopper member.
  • the system may be configured to transform from the transport configuration to the transfer configuration with application of a pre-determ ined amount of force to the distal stopper member.
  • the pre-determ ined amount of force may be between approximately 7.5 Ibf and approximately 10 Ibf of distally directed force.
  • the proximal and distal chambers may respectively contain first and second components of a drug to be mixed together prior to injecting into a patient.
  • Figures 6A and 6B illustrate various aspects of syringe based dual chamber safe injection systems wherein a distal needle end/tip may be withdrawn into a protected configuration after use according to some embodiments.
  • Figures 7A to 7P illustrate various aspects of syringe based dual chamber safe injection systems during steps in methods for mixing and injecting using same according to some embodiments.
  • Figures 8 and 9 depict dual chamber injection systems according to some embodiments.
  • Figure 10 depicts components of a fluid conveying assembly for use in dual chamber injection systems according to some embodiments.
  • Figures 11 to 14 depict assembly of components of a fluid conveying assembly for use in dual chamber injection systems according to some embodiments.
  • Figures 15 to 21 A depict a fluid conveying assembly in a dual chamber injection system according to some embodiments.
  • Figures 21 B to 21 E depict a fluid conveying assembly and components thereof for use in dual chamber injection systems according to some embodiments.
  • Figures 22 to 29H depict a fluid conveying assembly and components thereof for use in dual chamber injection systems according to some embodiments.
  • Figures 31 to 34 depict a dual chamber injection system conversion kit and its use in converting a single chamber injection system to a dual chamber injection system according to some embodiments.
  • Figures 35 to 43 depict an anti-retraction mechanism for use in dual chamber injection systems according to some embodiments.
  • Figures 44A to 44E depict needle hub assembly with an elastic needle latch for use with safe needle retraction injection systems according to some embodiments.
  • Figures 45A to 45D depict needle hub assembly with an elastomeric needle retention system for use with safe needle retraction injection systems according to some embodiments.
  • Figures 46A to 47H injection systems having needle hub attachment mechanisms according to some embodiments.
  • Figures 48 to 63 depict a dual chamber injection system including a fluid transfer assembly and components of same according to some embodiments.
  • FIG. 6A and 6B a perspective and a longitudinal cross- section view of a prefilled dual chamber safe injection system (100) are shown, with a conventional off-the-shelf prefilled syringe body (34) with conventional proximal and distal stopper members (32, 36) disposed therein.
  • the proximal and distal stopper members (32, 36) together with the syringe body (34) define proximal and distal chambers (40, 42).
  • the proximal and distal stopper members (36, 37) occlude the proximal and distal ends of the proximal chamber (40).
  • the distal stopper member (36) occludes a proximal end of the distal chamber (42).
  • the distal end of the proximal stopper member (32) and the proximal end of the distal stopper member (36) may be coated with a lubricious polymer coating (e.g., PTFE), the first and second polymer coatings of the proximal and distal stopper members (32, 36), together with the syringe body (34) define the proximal chamber (40).
  • a lubricious polymer coating e.g., PTFE
  • the lubricious polymer coating also serves to isolate the rubber of the proximal and distal stopper members (32, 36) from the second liquid (254).
  • proximal and distal stopper members (32, 36) may be oriented as shown in Figures 6A and 6B or the distal stopper (36) may be flipped so the lubricious coating faces the distal chamber (42) such that the first liquid (252) in the distal chamber (42) contacts the lubricious coating for storage.
  • a needle coupling assembly (606) is disposed at the distal end of the distal chamber (42) with a needle cover member (63) installed for storage.
  • the dual chamber safe injection system facilitates sequential injection of a first liquid (252) from the distal chamber (42) followed by injection of a second liquid (254) from the proximal chamber subject to sequential insertion of a plunger assembly (44) relative to the syringe body (34) to various degrees by a user.
  • the plunger assembly (44) includes the proximal stopper member (32), a plunger housing member (69) and a plunger manipulation interface (128).
  • the first and second liquids located in the distal and proximal chambers (42, 40) respectively may be any liquid or gel, such as aqueous or oil based medicine solutions.
  • the dual chamber safe injection system (100) has a staked needle configuration wherein upon presentation to the user, a needle assembly, including a needle spine assembly (“needle”) (76) and a needle coupling assembly (606) are mounted in position ready for injection after removal of a needle cover member (63) which may comprise an elastomeric sealing material on its internal surface to interface with a needle distal end (78) and/or a distal housing portion during storage.
  • a needle cover member (63) may comprise a vent (not shown) for allowing pressure resulting from the transfer of the liquids (252, 254) to escape from inside the syringe body (34) while preventing contamination from entering the syringe body (34).
  • the staked needle may be removably coupled to the syringe body (34) using a Luer slip or a Luer lock interface (not shown), with the proximal end (50) of the needle member extending through the Luer interface and into the distal chamber (42).
  • the needle may be fixedly or removably mounted to the flange on a cartridge body instead of a syringe.
  • a significant portion of the safe needle retraction hardware resides within a plunger housing.
  • FIGS 7A-7P various aspects of configurations designed to facilitate injection of multi-part medications and retractions of a needle into a syringe body are illustrated, wherein two or more medication components are combined to form an injection combination or solution shortly before delivery into the patient.
  • a liquid first medicine component/diluent (252) may be combined with a substantially non-liquid second medicine component (254), such as a powdered form, of a drug agent, such as a freeze-dried or lyophilized drug component, shortly before injection.
  • the configurations described herein in reference to Figures 7A-7P relate to dual-chamber configurations, wherein two or more chambers within the same syringe body (34) are utilized to carry, mix, and inject an injection solution.
  • proximal and distal medicine chambers (40, 42) are formed by a distal stopper member (36) in between two portions of the interior of a syringe body (34), such that the distal medicine chamber (42) contains an air or gas gap, as well as a non-liquid medication (254); a proximal medicine chamber (40), on the opposite side of the distal stopper member (36) contains a liquid diluent (252), which is proximally contained by a proximal stopper member (32).
  • the liquid diluent (252) is a first component of a medicine and the non-liquid medication (254) is a second component of the medicine.
  • a needle coupling assembly here a so-called “staked” needle coupling assembly (606) is illustrated, but other needle assemblies as described below, including Luer-coupled as well as staked configurations, may be utilized).
  • Lug features (258) are configured to assist with coupling the needle coupling assembly (606) to a needle cover member (63), as shown in Figure 7A, for example.
  • a small O-ring may be utilized as a sealing member (260) around the needle shaft, while a larger O-ring may be utilized as a sealing member (262) at the syringe body (34) / needle coupling assembly (606) interface.
  • the small O-ring (260) and the large O-ring (262) may be combined into a single seal that performs both of the O-ring sealing functions.
  • the small O-ring (260) may be used to seal both around the needle shaft and to the syringe body (34).
  • the needle includes a plurality (e.g., four) of proximal openings/ports (270) configured to allow for entry of a liquid diluent, to be expelled out of a more distally-located middle opening/aperture (266); a lumen plug (268) occludes the needle lumen to create the flow path from the proximal openings (270) to the middle opening (266) under conditions such as those described above in reference to Figures 6N and 7H.
  • the needle also includes a distal opening (264) on the opposite side of the lumen plug (268) from the middle opening (266). The distal opening (264) is fluidly coupled to the needle distal end (48) through the needle to inject liquid into a patient.
  • a proximal harpoon interface (84) is configured to serially penetrate proximal and distal stopper members (32, 36), and couple with a coupling feature (such as a needle retention feature are illustrated, for example, in Figures 7N and 7P, element (712)) in the plunger rod.
  • Figure 7F illustrates a spike style harpoon coupling interface (85) that is configured to serially pierce both proximal and distal stopper members (32, 36) and couple with a coupling feature in the plunger rod to retract the needle member at least partially into the plunger rod after the injection has been given to the patient.
  • Figures 7A, 7B, and 7G-7P illustrate a sequence of actions for an injection procedure utilizing a dual chamber safe injection system such as that described above.
  • an injection assembly is in a stable configuration wherein it may be shipped or brought to an injection patient care scenario; a first drug component/liquid diluent (252) is isolated from a second non-liquid drug component (254), both within a syringe body on opposite sides of a distal stopper member (36).
  • Figures 7G and 7H illustrate initial insertion movement of the plunger assembly (44), advancing the distal (36) and proximal (32) stopper members together relative to the syringe body (34).
  • a fluid pathway is formed between the two previously isolated chambers (40, 42) of the syringe body (34), such that the liquid first drug component (252) in the proximal medicine chamber (40) may flow into at least one of the proximal openings (270), through the transfer pipe (46), and exit the more distal middle opening (266), to reach the non-liquid second drug component (254) in the distal medicine chamber (42).
  • Figures 71 and 7J illustrate that with further insertion until the stopper members (36, 32) are immediately adjacent each other, the liquid first drug component/diluent (252) has moved into the distal medicine chamber (42) to join the non-liquid second drug component (254).
  • Figures 7K and 7L illustrate that with time and/or manual agitation, the liquid first drug component/diluent (252) and previously non-liquid second drug component (254) become mixed to form a mixed medication solution (272).
  • the mixed medication solution (272) may be formed with minimal or no agitation or time passage.
  • vigorous shaking may be necessary to facilitate mixing. In the case of vigorous shaking it is useful to the user to be able to remove their thumb from the plunger manipulation interface (128).
  • pressure may build up in the distal medicine chamber (42). This pressure acts upon the proximal and distal stopper members (32, 36) to resist stopper motion.
  • the pressure buildup may also move the stopper members (32, 36) and plunger manipulation interface (128) proximally if the user does not have their thumb restraining the plunger assembly (44).
  • Mixed configuration latches or“mix clicks” in the plunger assembly (44) may be utilized to provide resistance to plunger manipulation interface (128) motion due to pressure buildup and allow the user to release their thumb from the plunger manipulation interface (128) for shaking or mixing of the drug.
  • the mix clicks may also provide an audible and / or tactile indication that the transfer of liquid first medicine component (252) has been completed.
  • the distal medicine chamber (42) may also include an agitation device, which assists in mixing of the medicine components.
  • the needle cover member (63) may be removed and the patient may be injected with the exposed needle distal end (48) with depression/insertion of the plunger assembly (44) and associated stopper members (36, 32) as shown in Figures 7M and 7N.
  • the sharp needle distal end/point (48) may automatically retract at least partially through the distal and proximal stopper members (36, 32) to a safe position within either the syringe body (34), the needle coupling assembly (606), or at least partially within the plunger assembly (44).
  • Figure 8 depicts a dual chamber injection system 800 including a fluid transfer assembly configured to provide precise control of the handling, mixing, and delivery of the components of a multi-component injectable according to some embodiments.
  • the dual chamber injection system 800 includes a syringe body 810, proximal and distal stopper members 812, 814, and a plunger member 816.
  • the plunger member 816 is inserted into an interior 818 of the syringe body 810 via a proximal opening in the syringe body.
  • the syringe body 810 also includes a distal needle interface 820 at the distal end thereof.
  • the syringe body 810 has a Luer lock type distal needle interface 820.
  • the distal needle interface 820 is not limited to Luer lock and may be any other type of needle/tubing interface.
  • the proximal and distal stopper members 812, 814 together with the syringe body 810 define a proximal drug chamber 822.
  • the distal stopper member 814 and the syringe body 810 define a distal drug chamber 824.
  • the plunger member 816 may be manually manipulated to insert the proximal stopper member 812 relative to the syringe body 810. If a non-compressible fluid is disposed in the proximal drug chamber 822, inserting the proximal stopper member 812 also inserts the distal stopper member 814 relative to the syringe body 810.
  • the dual chamber injection system 800 includes a fluid conveying assembly 830 for fluid transfer and delivery.
  • the fluid conveying assembly 830 includes a penetrating member 840, a distal exit tube 850, and a transfer member 860.
  • the penetrating member 840 is partially disposed within the distal exit tube 850 and partially disposed within the transfer member 860.
  • the distal exit tube 850 is generally an elongate tubular member including a jam ring 852 welded thereon to prevent distal movement of the distal exit tube 850 during use of the dual chamber injection system 800.
  • the position of the jam ring 852 on the distal exit tube is configured to leave a seal clearance 853 between the distal end of the distal exit tube and the distal end of the syringe body 810.
  • the seal clearance 853 prevents the syringe cap from leaking during storage and transport.
  • Figure 10 depicts the penetrating member 840 inserted into the distal exit tube 850 without the overlying transfer member 860 omitted for clarity according to some embodiments.
  • the junction 842 between the penetrating member 840 and the distal exit tube 850 is welded to form a watertight seal 842 to prevent unintended fluid flow.
  • the penetrating member 840 is generally an elongate solid member including a geometric feature 844 at a proximal end thereof.
  • the geometric feature 844 depicted in Figure 10 has a three- dimensional arrowhead shape that is configured to penetrate the distal stopper member 814.
  • the outer diameter of the penetrating member 840 is substantially consistent and configured to fit snugly within an interior of the distal exit tube 850.
  • the outer diameter of the penetrating member 840 is slightly less than an inner diameter of the distal exit tube 850.
  • the distal end of the geometric feature 844 has an outer dimension/diameter that is larger than the outer diameter of the penetrating member 840.
  • the proximal end of the distal exit tube 850 also has an outer dimension/diameter that is larger than the outer diameter of the penetrating member 840.
  • the distal end of the geometric feature 844 and the proximal end of the distal exit tube 850 form proximal and distal shoulders 846, 854 surrounding an annularly recessed portion 848 of the penetrating member 840.
  • the annularly recessed portion 848 is sized and shaped to hold the transfer member in a closed configuration (described below).
  • the penetrating member 840 is of sufficient length to substantially fill the interior of the distal exit tube 850 between a proximal opening/junction/watertight seal 842 and a side opening 856 formed in the side wall of the distal exit tube 850 near the jam ring 852.
  • the distal end of the penetrating member 840 extends to point X adjacent to and proximal of the side opening 856.
  • the penetrating member 840 has sufficient additional length to form the annularly recessed portion 848.
  • the distal exit tube also includes a distal opening having a split end 858, and is hollow between the side opening 856 and the distal opening 858.
  • the distal tube between the side opening 856 and the distal opening 858 form a flow path Y through which fluid can exit from the distal drug chamber and out the distal opening 858.
  • the split end at the distal opening 858 is configured to couple the distal exit tube 850 to a tubular member that forms a distal exit from the dual chamber injection system 800.
  • Exemplary tubular members include but are not limited to needles and tubing, both of which may be attached to Luer connectors.
  • Figures 11 to 14 depict the transfer member 860 as it is being mounted onto the annularly recessed portion 848 of the penetrating member 840 according to some embodiments.
  • Figure 11 depicts the transfer member 860 before it is mounted.
  • the transfer member 860 may be cut from a sheet of metal.
  • the transfer member 860 includes two plastic/living hinges 862 and a longitudinal opening 864 sized and shaped to facilitate conversion of the transfer member 860 between a closed and an open configuration (described below).
  • the plastic/living hinges 862 and the longitudinal opening 864 can be modified to modulate a gripping force of the transfer member 860 on the penetrating member 840.
  • the transfer member 860 also includes a funnel 866 at a distal end thereof.
  • the transfer member 860 further includes two radially extending members 868 each in the shape of a wing that are configured to interfere with the distal stopper member 814 to prevent distal movement of the distal stopper member 814 relative to the transfer member 860.
  • Figure 12 depicts the relative positions of the penetrating member 840 (which is already coupled to the distal exit member 850) and the transfer member 860 before the fluid conveying assembly 830 is assembled.
  • the transfer member 860 is aligned with the annularly recessed portion 848 of the penetrating member 840.
  • Figure 13 depicts movement of the penetrating member 840 and the transfer member 860 toward each other such that the transfer member 860 is disposed over the annularly recessed portion 848 of the penetrating member 840.
  • Figure 14 depicts crimping of the transfer member 860 around the annularly recessed portion 848 of the penetrating member 840.
  • the crimping may be performed manually or by a machine/robot.
  • Crimping the transfer member 860 seats the transfer member 860 in the annularly recessed portion 848 of the penetrating member 840. Once seated, the transfer member 860 is in its closed configuration. In the closed configuration, the proximal shoulder 846 interferes with a proximal end of the transfer member 860 to prevent distal movement of the penetrating member 840 relative to the transfer member 860. Further, in the close configuration, the distal shoulder 854 interferes with the funnel 866 at the distal end of the transfer member 860 to prevent proximal movement of the penetrating member 840 relative to the transfer member 860.
  • Figure 15 depicts an exploded view of select components of a dual chamber injection system 800 according to some embodiments.
  • the assembled fluid conveying assembly 830 is inserted through a proximal opening in the syringe body 810 until the jam ring 852 interferes with a distal end of the syringe body 810 to prevent further distal movement of the fluid conveying assembly 830 relative to the syringe body 810.
  • the distal stopper member 814 includes a guide/funnel 813 configured to direct the geometric feature 844 at a proximal end of the penetrating member 840 to a center of the distal stopper member 814.
  • the distal stopper member 814 including the guide/funnel 813 is then inserted through the proximal opening in the syringe body 810 until the geometric feature 844 at the proximal end of the penetrating member 840 is seated in the center of the guide/funnel 813 adjacent the center of the distal stopper member 814. Inserting the distal stopper member 814 defines the distal drug chamber 824.
  • the proximal stopper member 812 is inserted through the proximal opening in the syringe body 810 to define the proximal drug chamber 824 (see Figure 8).
  • the plunger member 816 is then inserted through the proximal opening in the syringe body 810 and coupled to the proximal stopper member 812 (e.g., by screwing the plunger member 816 into the proximal stopper member 812; see Figure 8).
  • Figure 16 depicts a dual chamber injection system 800 in a transport/as shipped configuration according to some embodiments.
  • a proximal end of the geometric feature 844 of the penetrating member 840 rests in respective centers of the guide/funnel 813 and the distal stopper member 814.
  • the proximal end of the geometric feature 844 rests on an inner surface of the distal stopper member 814 and is ready to pierce the distal stopper member 814 in response to a distally directed force applied to the distal stopper member 814.
  • the proximal and distal drug chambers 822, 824 are isolated from each other, and any drug components contained therein are also isolated from each other. Further, any drug component contained in the proximal drug chamber 822 is only exposed to the glass sides of the syringe body 810 and the proximal and distal stopper members 812, 814, which may facilitate transport of metal sensitive drug components in the proximal drug chamber 822.
  • Figure 17 depicts a dual chamber injection system 800 in a transfer configuration according to some embodiments.
  • the geometric feature 844 has pierced the distal stopper member 814 in response to a distally directed force applied to the distal stopper member 814 (e.g., originally applied through the plunger member 816, the proximal stopper member 812, and an incompressible fluid in the proximal drug chamber 822).
  • An amount of distally directed force required to drive the geometric feature 844 through the distal stopper member 814 may be approximately 3 Ibf to approximately 5 Ibf.
  • a proximal end of the transfer member 860 is disposed in the proximal drug chamber 822.
  • the transfer member 860 defines a fluid passage (e.g., trench) 861 on top of the annularly recessed portion 848 (see Figures 10 and 14) of the penetrating member 840.
  • the fluid passage 861 is a fluid flow path between the proximal and distal drug chambers 822, 824. Accordingly, with increased pressure in the proximal drug chamber 822, which may be provided by distal movement of the plunger member 816 and the proximal stopper member 812 coupled thereto, fluid is transferred from the proximal drug chamber 822 to the distal drug chamber 824.
  • the transfer member 860 also includes chamfered corners and a proximal end thereof configured to reduce resistance to liquid flow through the fluid passage 861.
  • the user may apply distally directed force to the plunger member 816 to transfer a liquid drug component in the proximal drug chamber 822 to a distal drug chamber 824 to solubilize a powdered drug component therein.
  • the liquid drug component is transferred through the fluid passage 861 formed in the distal stopper member 814 by the transfer member 860 of the fluid conveying assembly 830.
  • Figure 18 depicts the forces acting on the transfer member 860 while the fluid conveying assembly 830, led by the geometric feature 844, penetrates completely through the distal stopper member 814 (see Figure 17) according to some embodiments.
  • the friction of the distal stopper member material exerts a distally directed force F1 on the transfer member 860.
  • Flowever the distally directed force F1 is countered by a reaction force F2 generated by the interference between the distal shoulder 854 and the funnel 866 on the distal end of the transfer member 860.
  • the balancing of forces F1 and F2 results in the transfer member 860 remaining in the annularly recessed portion 848 (see Figures 10 and 14) of the penetrating member 840 as the fluid conveying assembly 830 penetrates the distal stopper member 814.
  • the distal stopper member 814 and the geometric feature 844 are configured such that the amount of force that the distal stopper member 814 exerts on the geometric feature 844 necessary to cause the fluid conveying assembly 830 to penetrate the distal stopper member 814 is between approximately 3 Ibf to approximately 5 Ibf.
  • Figure 19 depicts a dual chamber injection system 800 after the dual chamber injection system 800 has reached a mixed configuration according to some embodiments.
  • the proximal stopper member 812 has advanced distally such that the proximal and distal stopper members 812, 814 are in contact with each other, thereby substantially collapsing the proximal drug chamber 822.
  • any liquid drug component in the proximal drug chamber 822 has been transferred through the fluid passage 861 formed in the distal stopper member 814 by the transfer member 860 to the distal drug chamber 824.
  • the dual chamber injection system 800 may be agitated (e.g., by inverting) to mix the drug components in the distal drug chamber 824. After mixing the drug components, the multi-component injectable drug is ready for delivery/injection.
  • the radially extending members/wings 868 abut an inner surface of the guide/funnel 813 thereby preventing further distal movement of the distal stopper member 814 (see Figures 19 and 20) relative to the transfer member 860.
  • the interference between the radially extending members/wings 868 and the guide/funnel 813 allow additional force to be applied to the transfer member 860 by the guide/funnel 813. This additional force (i.e. , approximately 6 Ibf to approximately 10 Ibf) is sufficient to transform the transfer member 860 from the closed configuration (see Figure 18) to the open configuration depicted in Figure 20.
  • the distal shoulder 854 formed by the proximal end of the distal exit tube 850 wedges against the funnel 866 at the distal end of the transfer member 860, thereby opening the tubular transfer member 860.
  • the transfer member 860 When the transfer member 860 is wedged open, it transforms from its closed configuration to its open configuration.
  • the distal exit tube 850 and the penetrating member 840 coupled thereto can move proximally relative to the proximal and distal stopper members 812, 814. With such distal movement, the penetrating member 840 penetrates the proximal stopper member 812. Because the transfer member 860 penetrates only the distal stopper member 814 and not the proximal stopper member 812, there is no fluid leak path into the plunger member 816. The proximal stopper member 812 will seal around the penetrating member 840 and the distal exit tube 850 as they penetrate the proximal stopper member 812.
  • Figure 20 depicts the relative positions of the fluid conveying assembly 830 and the guide/funnel 813 in the distal stopper member (not shown for clarity) after a dual chamber injection system 800 has reached the mixed configuration and the a transfer member 860 has reached an open configuration according to some embodiments.
  • the radially extending members/wings 868 of the transfer member 860 interfere with the guide/funnel 813 to prevent distal movement of the guide/funnel 813 and the distal stopper member 814 relative to the transfer member 860.
  • Figure 21 A depicts a fluid conveying assembly 830 with a transfer member 860 in an open configuration according to some embodiments.
  • the guide/funnel 813 and the distal stopper member are omitted for clarity.
  • the dual chamber injection system 800 has moved beyond the mixed configuration by ejecting some of the mixed multi-component injectable from the dual chamber injection system 800.
  • the distal shoulder 868 formed by the proximal end of the distal exit tube 850 wedges the transfer member 860 into the open configuration starting from the funnel 866 at the distal end of the transfer member 860. With the transfer member 860 in the open configuration, the transfer member 860 can move proximally relative to the distal exit tube 850.
  • Figures 21 B to 21 E depict a fluid conveying assembly 2130 (see Figure 21 E) according to some embodiments.
  • the fluid conveying assembly 2130 includes a penetrating member 2140, a distal exit tube 2150, and a transfer member 2160.
  • the penetrating member 2140 and the distal exit tube 2150 are similar to the penetrating member 840 and the distal exit tube 850 depicted in Figures 7 to 21 A and described above.
  • One difference is that the penetrating member 2140 in Figure 21 E is shorter than the penetrating member 840 depicted in Figures 7 to 21 A. The shorter length of the penetrating member is to accommodate the transfer member 2160, which is described below.
  • Figures 21 B to 21 D depict the transfer member 2160 in a top, side, and perspective views.
  • the transfer member 2160 in Figures 21 B to 21 D is similar to the transfer member 860 in Figure 11.
  • the transfer member 2160 has plastic hinges 2162, a longitudinal opening 2164, and a pair of radially extending member/wings 2168.
  • These components of the transfer member 2160 are almost identical to the corresponding components in transfer member 860 depicted and described above.
  • One difference between the transfer members 2160, 860 is that the transfer member 2160 depicted in Figures 21 B to 21 D does not have a funnel/guide such at a distal end thereof as the funnel/guide 866 at the distal end of the transfer member 860 depicted in Figure 11.
  • transfer member 2160 depicted in Figures 21 B to 21 D has a pair of detents 2166 at a proximal end thereof configured to interfere with the distal shoulder 2154 formed at a proximal end of the distal exit tube 2150 (see Figure 21 E).
  • the detents 2166 are configured to prevent proximal movement of the distal exit tube 2150 and the penetrating member 2140 coupled thereto relative to the transfer member 2160 when the transfer member 2160 is in the closed configuration depicted in Figures 21 A to 21 E.
  • the transfer member 2160 is configured to remain in its closed configuration until a predetermined amount of distally directed force (e.g., approximately 6 Ibf to approximately 10 Ibf) is applied to the transfer member 2160.
  • a predetermined amount of distally directed force e.g., approximately 6 Ibf to approximately 10 Ibf
  • the distal shoulder 2154 pushes past the detents 2162, thereby prying open the transfer member 2160 and converting it to an open configuration.
  • the transfer member 2160 With the transfer member 2160 in its open configuration the distal exit tube 2150 and the penetrating member 2140 coupled thereto are free to move distally relative to the transfer member 2160.
  • the amount of force required to drive the geometric feature 844 through the distal stopper member 814 may be approximately 3 Ibf to approximately 5 Ibf.
  • additional force drives fluid from the proximal chamber 822 to the distal chamber 824 (see Figure 17).
  • the dual chamber injection system 800 is in the mixed configuration.
  • the fluid conveying assemblies 830, 2130 depicted in Figures 8 to 21 E facilitates piercing of the distal stopper member 814 to transform the dual chamber injection system 800 from the transport configuration depicted in Figure 16 to the transfer configuration depicted in Figure 17 with the application of a smaller (e.g., approximately 3 Ibf to approximately 5 Ibf) of force.
  • the fluid conveying assembly 830 also facilitates transfer of a fluid from the proximal drug chamber 822 to the distal drug chamber 824 during while the dual chamber injection system 800 is in the transfer configuration depicted in Figure 17.
  • the fluid conveying assembly 830 further facilitates wedges open of the transfer member 860 with the application of a larger (e.g., approximately 6 Ibf to approximately 10 Ibf) of force to transform the transfer member 860 from its closed configuration to its open configuration.
  • the fluid conveying assembly 830 facilitates increased control during transfer of the fluid from the proximal drug chamber 822 to the distal drug chamber 824, mixing of the fluid with a second drug component in the distal drug chamber 824, and ejection of the mixed multi-component injectable from the dual chamber injection system 800.
  • the fluid conveying assemblies 830, 2130 depicted in Figures 8 to 21 E and described above may be used with off-the-shelf components such as stopper members, syringe bodies, cartridge bodies, and Luer connectors.
  • the fluid conveying may also be used with safety needle retraction components such as plunger members and needle hubs.
  • the fluid conveying assembly 830 can be modified to vary the amount of force needed to penetrate the distal stopper member 814, to transfer the fluid from the proximal drug chamber 822 to the distal drug chamber 824, and to eject the mixed multi- component injectable. Varying the amounts of force needed to accomplish various functions of the dual chamber injection system 800 provides increased control of system 800.
  • Figure 22 depicts a fluid transfer assembly 2230 and a distal stopper member 814 for use in a dual chamber injection system according to some embodiments.
  • Other components of the dual chamber injection system can be identical to those in the dual chamber injection system 800 depicted in Figure 8 and described above. These other components may be off-the-shelf components such as stopper members, syringe bodies, cartridge bodies, and Luer connectors. Other components may also be safety needle retraction components such as plunger members and needle hubs.
  • the fluid transfer assembly 2230 depicted in Figure 22 includes a penetrating member 840 and a distal exit tube 850. Both of these components are identical to those depicted in Figures 8 to 21 E and described above.
  • the difference between the fluid transfer assembly 2230 and the fluid transfer assembly 830 described above is the transfer member 2260.
  • the transfer member 2260 is formed from a polymer. In some embodiments, the transfer member 2260 is molded from polymer.
  • the fluid transfer assembly 2230 and the distal stopper member 814 and the guide/funnel 813 are in a transport configuration in Figure 22. In that configuration, a geometric figure 844 is disposed in respective centers of the guide/funnel 813 and the distal stopper member 814.
  • Figure 23 depicts the fluid transfer assembly 2230 and the distal stopper member 814 in a transfer configuration according to some embodiments.
  • the fluid transfer assembly 2230 and the distal stopper member 814 are configured such that a predetermined amount of distally directed force (e.g., approximately 3 Ibf to approximately 5 Ibf) applied to the distal stopper member 814 will cause the geometric figure 844 to pierce the distal stopper member 814.
  • a predetermined amount of distally directed force e.g., approximately 3 Ibf to approximately 5 Ibf
  • a recess in a longitudinal section of the transfer member 2260 forms a fluid passage (e.g., trench) 2261 through the distal stopper member 814.
  • a fluid passage e.g., trench
  • Figure 24 depicts the fluid transfer assembly 2230 and the distal stopper member 814 after the dual chamber injection system has reached a mixed configuration according to some embodiments.
  • the transfer member 2260 includes a pair of latches 2262, which prevent movement of the distal exit tube 850 proximally past the latches 2262 when the latches 2262 are biased in a closed state (see Figures 22 and 23).
  • the latches 2262 are actuated when they abut a surface of the guide/funnel 813 and are acted on by a proximal end of the distal exit tube 850.
  • Actuating the latches 2262 transforms the latches 2260 open state allowing the distal exit tube 850 to move proximally past the latches 2262, as shown in Figure 24.
  • the latches 2262 are configured such that the amount of force applied to the distal stopper member 814 sufficient to actuate the latches 2262 may be approximately 6 Ibf to approximately 10 Ibf.
  • the transfer member 2260 also includes a funnel 2263 to provide a smoother transition (i.e., minimize force/resistance variation) as the proximal end of the distal exit tube 850 passes through the transfer member 2260.
  • Figures 25 to 27 depict a proximal end of a fluid transfer assembly 2230 according to some embodiments.
  • the transfer member 2260 and its latches 2262 are shown in Figures 25 and 26.
  • the latches are configured such that they will remain in their biased closed state when the amount of force (e.g., approximately 3 Ibf to approximately 5 Ibf) for the penetrating member 840 to pierce the distal stopper member is applied. This prevents premature release of the distal exit tube 850 and the penetrating member 840 from the transfer member 2260 until sufficient force (e.g., approximately 6 Ibf to approximately 10 Ibf) is applied to actuate the latches 2262.
  • the latches 2262 in the fluid transfer assembly 2230 depicted in Figures 22 to 27 provide a mechanism of control over the distal stopper penetration, fluid transfer, and fluid ejection steps in multi-component injectable delivery as described above.
  • Figure 28 depicts a fluid transfer assembly 2830 for use in a dual chamber injection system according to some embodiments.
  • the fluid transfer assembly 2830 is similar to the fluid transfer assembly 2230 depicted in Figures 22 to 27.
  • the difference between the fluid transfer assemblies 2230, 2830 is the design of the latching mechanisms in the transfer members 2260, 2860.
  • the transfer member 2860 depicted in Figure 28 also includes a pair of frangible links 2864 (see Figure 29A).
  • the frangible links 2864 prevents the latches 2862 from transforming to their opened state until a sufficient force (e.g., approximately 6 Ibf to approximately 10 Ibf) is applied to the distal stopper member.
  • This additional mechanism provides another control over the distal stopper penetration, fluid transfer, and fluid ejection steps in multi- component injectable delivery as described above.
  • Figures 29B to 29D depict a transfer member 2960 for use with a fluid transfer assembly according to some embodiments.
  • the transfer member 2960 is very similar to the transfer member 2860 depicted in Figure 29A.
  • the transfer member 2960 depicted in Figures 29B to 29D also has a pair of latches 2962 forming a latching mechanism.
  • the difference between the transfer members 2860, 2960 is that the transfer member 2960 depicted in Figures 29B to 29D has only one frangible link 2964.
  • the frangible link 2964 prevents the latches 2962 from transforming to their opened state until a sufficient force (e.g., approximately 6 Ibf to approximately 10 Ibf) is applied to the distal stopper member.
  • FIGS 29E to 29H depict a transfer member 2960’ that includes a distal end, a proximal end, and a frangible link 2964’.
  • the transfer member has interior flow channels 2966 that are define by an interior surface of the transfer member 2960’ and may extend through the transfer member 2960’ to facilitate fluid flow.
  • the transfer member 2960’ may be configured with a single flow channel or a plurality of flow channels.
  • the interior flow channels 2966 may extend from a proximal end to a distal end of the transfer member 2960’. Alternatively, the interior flow channels 2966 may extend over part of the length of the transfer member 2960’.
  • the proximal end of the transfer member 2960’ is configured to surround the proximal end of a penetrating member (2968; see Figure 29G) circumferentially by forming a complete ring with no breaks.
  • the circumferential nature of the proximal end of the transfer member 2960’ increases the radial stiffness of the transfer member 2960’, resisting collapsing forces which are generated as the proximal end of the transfer member 2960’ penetrates the rubber material of stopper members.
  • the transfer member 2960’ may be constructed of a polymer such as COC, COP, Polypropylene, or other medical grade polymer. Installation of the transfer member 2960’ onto the penetrating member 2968 may be accomplished by sliding the transfer member 2960’ over proximal end of the penetrating member 2968.
  • the proximal end of the transfer member 2960’ is configured to expand elastically to allow the proximal end of the penetrating member 2968 to pass through a proximal end opening of the transfer member 2960’.
  • the proximal end opening of the transfer member 2960’ elastically snaps back to a smaller diameter preventing the transfer member 2960’ from being uncoupled from the penetrating member 2968.
  • Figure 30 depicts a fluid transfer assembly 3002, which can form part of a dual chamber injection system conversion kit 3000 (see Figures 31 to 34).
  • the fluid transfer assembly 3000 can be used with an off the shelf syringe such as the one shown in Figure 31 to convert a single chamber injection system to a dual chamber injection system, as shown in described below.
  • the fluid transfer assembly 3002 includes a penetrating member 840, a transfer member 2260, and a distal exit member 3050, which are similar to the corresponding components described above.
  • a latch 3051 in the distal exit member 3050 allows the fluid transfer assembly 3002 to couple to a proximal end of a needle.
  • a split distal and 3058 in the distal exit member 3050 allows the fluid transfer assembly 3002 to couple to a variety of exit modalities (e.g., needles, Luer connectors, tubing).
  • Figures 31 to 34 depict a method for converting a single chamber injection system using the dual chamber injection system conversion kit 3000.
  • the fluid transfer assembly 3002 is inserted through a proximal opening of an off the shelf syringe body 3010.
  • the distal exit tube 3050 of the fluid transfer assembly 3002 is inserted over a proximal end of a needle 3072 from a needle hub assembly 3070, thereby coupling the fluid transfer assembly 3002 to the needle 3072 and the needle hub assembly 3070.
  • Figure 32 depicts the result of coupling the fluid transfer assembly 3002 to the needle hub assembly 3070.
  • Figure 33 depicts addition of a dry/lyophilized component 3015 of a multi-component injectable into the syringe body 3010 through the proximal opening therein. Then an off-the-shelf distal stopper member 3014 is inserted through the proximal opening in the syringe body 3010 until a proximal end of the penetrating member 840 (see Figure 30) is disposed in the center of the distal stopper member 3014. Placing the distal stopper member 3014 in the syringe body 3010 and forms the distal drug chamber 3024 in which the dry/lyophilized component 3015 is disposed.
  • Figure 34 depicts addition of a liquid/diluent component 3017 of the multi-component injectable into the syringe body 3010 through the proximal opening therein. Then an off-the-shelf proximal stopper member 3012 is inserted through the proximal opening in the syringe body on top of the liquid/diluent component 3017. Placing the proximal stopper member 3012 in the syringe body 3010 and forms the proximal drug chamber 3022 in which the liquid/diluent component 3017 is disposed. Next a finger flange 3080 and a plunger member 3016 are added to the now dual chamber injection system.
  • the needle hub assembly 3070 and the plunger member 3016 may include safety needle retraction components such as plunger members and needle hubs.
  • the fluid transfer assembly 3002 has been described as including a penetrating member 840, a transfer member 2260, and a distal exit member 3050, which are similar to the corresponding components described above, the fluid transfer assembly in the dual chamber safe injection system conversion kit can include various equivalent components, such as the transfer member 860 and/or the distal exit member 850 described above.
  • Multiple chamber multi-component mixing injection systems may build up pressure in a first chamber when fluid from another one of the chambers is forced into the first chamber. Pressure in the first chamber may push a plunger member backwards/proximally, thereby interfering with the function of the multiple chamber multi-component mixing injection systems.
  • Figure 35 to 43 depict the addition of a one-way ratchet to the dual chamber injection systems described herein.
  • the one-way ratchet enables the plunger member to be moved distally with minimal drag force and prevents the plunger member from moving proximally by the engagement of ratchet teeth onto the outer surface of the plunger member.
  • air pressure accumulates in the distal chamber as the liquid is transferred. This pressure builds and produces a proximally directed reaction force on the user’s thumb.
  • the addition of a toothless ratchet counteracts this reaction force, preventing the plunger member from moving proximally.
  • the ratchet may be toothless, where the plunger member is smooth on the outside surface and the ratchet arms are configured to dig into the plunger member. In this case the position of the plunger member is maintained in infinitely small increments.
  • the ratchet may engage with annular grooves in or threads on the outside surface of the plunger member, providing an incremental position stop. The annular grooves may provide a tactile and/or audible click or feedback to the user that the ratchet is engaged.
  • Figure 35 depicts a dual chamber injection system 3500 with a finger flange 3580 having an anti-retraction feature 3590 according to some embodiments.
  • the anti-retraction feature 3590 prevents proximal movement of the plunger member 3516 relative to the syringe body 3510, while allowing distal movement.
  • the dual chamber injection system 3500 also includes proximal and distal stopper members 3512, 3514, and a needle hub assembly 3570.
  • the plunger member 3516 is inserted into an interior 3518 of the syringe body 3510 via a proximal opening in the syringe body.
  • the proximal and distal stopper members 3512, 3514 together with the syringe body 3510 define a proximal drug chamber 3522.
  • the distal stopper member 3514 and the syringe body 3510 define a distal drug chamber 3524.
  • the plunger member 3516 may be manually manipulated to insert the proximal stopper member 3512 relative to the syringe body 3510. If a non- compressible fluid is disposed in the proximal drug chamber 3522, inserting the proximal stopper member 3512 also inserts the distal stopper member 3514 relative to the syringe body 3510.
  • Figures 36 to 39 depict the finger flange 3580, which is configured to be mounted onto a small flange 3511 formed at the proximal end of the syringe body 3510 (see Figure 39).
  • the finger flange 3580 defines a first recess 3582 configured to receive the small flange 3511 to couple the finger flange 3580 to the syringe body 3510.
  • the finger flange 3580 also defines a second recess 3584 configured to receive the anti-retraction mechanism 3590.
  • the anti-retraction mechanism 3590 includes a pair of brake tabs 3592 configured to provide an opposing force with proximal movement of the plunger member 3516 relative to the anti-retraction mechanism 3590, while allowing distal movement.
  • the opposing force may include a frictional force as the brake tabs 3592 contact an outer surface 3517 of the plunger member 3516 and a reaction force as the brake tabs 3592 dig into an outer surface 3517 of the plunger member 3516.
  • the acute angle of the brake tabs 3592 creates the reaction force parallel to the plunger member 3516, exerted by a sharp curved edge of each of the brake tabs 3592 contacting the surface 3517 of the plunger member 3516. This reaction force along with the frictional force prevents the plunger member 3516 from moving in the proximal direction.
  • the finger flange 3580 further defines a “C” shaped opening 3586 configured to receive the plunger member 3516 (see Figure 35).
  • the finger flange 3580 can be slid onto the small flange 3511 from the side of the small flange 3511 after the plunger member 3516 is inserted during assembly.
  • The“C” shaped finger flange 3580 and anti-retraction mechanism 3590 depicted in Figures 35 to 39 can be slid/snapped on to the small flange 3511 of the syringe body 3510 after the plunger member 3516 is inserted.
  • Syringe bodies 3510 with plunger members 3516 screwed into proximal stopper members 3514 are able to pack more tightly into shipping trays for transportation.
  • the finger flange 3580 with is the anti-retraction mechanism 3590 is snapped after shipping, and snaps around both the syringe body 3510 and the plunger member 3516.
  • the anti-retraction mechanism 3590 is a generally“C” shaped clip.
  • the anti-retraction mechanism 3590 is cut or stamped from a sheet of metal and then certain portions thereof are bent to the final shape.
  • the anti-retraction mechanism 3590 includes a pair of brake tabs 3592 configured to provide an opposing frictional force with proximal movement of the plunger member 3516 as described above.
  • the brake tabs 3592 are the elastically deformable and self-energizing.
  • the brake tabs 3592 extend at an acute angle in a distal direction relative to the plane of the anti-retraction mechanism 3590 (i.e. , the brake tabs 3592 are bent downwards).
  • the angle and elasticity of the brake tabs 3592 allows the plunger member 3516 to slide past the break tabs 3592 in the in distal direction.
  • the brake tabs 3592 make contact with and dig into an outer surface 3517 of the plunger member 3516 and prevent proximal plunger member 3516 movement relative to the break tabs 3592.
  • the brake tabs 3592 are self energizing, with attempted proximal movement, the brake tabs 3592 engages with the plunger member 3516 by increasing a frictional force applied to the plunger member 3516 and an amount of digging into the plunger member 3516 to prevent its proximal movement.
  • the brake tabs 3592 form a pair of pawls to engage the plunger member 3516 and prevent proximal movement thereof.
  • the plunger member (not shown) may have annular grooves threads and/or formed thereon to increase the ratcheting effect of the brake tabs 3592.
  • the anti-retraction mechanism 3590 and the brake tabs 3592 prevent removal of the plunger member 3516 from the dual chamber injection system 3500 after use.
  • the anti-retraction mechanism 3590 also includes a pair of retention tabs 3594 configured to hold the anti-retraction mechanism 3590 in the second recess 3584 of the finger flange 3580.
  • the retention tabs 3594 are bent inward so that they are configured to grip the inside of the second recess 3584 in the finger flange 3580 with a frictional force and a reaction force to prevent removal of the anti-retraction mechanism 3590 from the second recess 3584.
  • the retention tabs 3594 are also self-energizing to provide increasing frictional and reaction force as the anti-retraction mechanism 3590 is pulled from the second recess 3584.
  • the finger flange 3580 includes a pair of openings 3588 configured to receive the retention tabs 3594 from the anti-retraction mechanism 3590 to retain the anti-retraction mechanism 3590 in the second recess 3584 by interference instead of friction.
  • the anti-retraction mechanism 3590 also includes four fit tabs 3596 configured to reduce a tolerance between the second recess 3584 and the anti-retraction mechanism 3590 thereby providing a tighter fit of the anti-retraction mechanism 3590 in the second recess 3584.
  • the original tolerance is larger because, in some embodiments, the finger flange 3580 is molded from a polymer, and therefore has minimum size limitations for recesses that can be accurately and precisely formed therein.
  • the anti- retraction mechanism 3590 is cut from a sheet of metal, and therefore has a thinner profile then the height of the second recess 3584.
  • the fit tabs 3596 increase the thickness/height of the anti-retraction mechanism 3590, thereby providing a tighter fit in the second recess 3584.
  • the fit tabs 3596 also provide rigidity to the anti-retraction mechanism 3590. Accordingly, when the plunger member 3516 is pulled proximally, the brake tabs 3592 (because of their elasticity and angle) exert an outward force on the anti-retraction mechanism 3590. This outward force is transferred through the anti-retraction mechanism 3590 and the fit tabs 3596 to push against the inside of the second recess 3584 of the finger flange 3500 due to the rigidity of the anti-retraction mechanism 3590. This outward force is the reactive force to the frictional and reaction forces applied to the plunger member 3516 to prevent its proximal movement.
  • Figures 40 to 43 depict a dual chamber injection system 4000 with a finger flange 4080 having an anti-retraction feature 4090 according to some embodiments.
  • the dual chamber injection system 4000 has many of the same components as the dual chamber injection system 3500 depicted in Figures 35 to 39 and described above. Those components have the same reference numerals as the corresponding components in the dual chamber injection system 3500. The difference between the dual chamber injection systems 3500, 4000 is in the finger flanges 3590, 4090.
  • the finger flange 4090 depicted in Figures 41 and 42 has an“O” shaped opening 4086 for receiving the plunger member 3516.
  • The“O” shaped opening 4086 provides an additional mechanism for preventing removal of the plunger member 3516 from the dual chamber injection system 4000 after use.
  • the anti-retraction mechanism 4090 in the finger flange 4080 has an “O” and/or rectangular shape.
  • the anti-retraction mechanism 4090 can be cut from a sheet of metal. Due to the“O” and/or rectangular shape of the anti-retraction mechanism 4090, the anti-retraction mechanism 4090 is inserted into the finger flange 4080, and the finger flange 4080 with the anti-retraction mechanism 4090 is snapped onto the small flange 3511 before the plunger member 3516 is inserted into the syringe body 3510 (see Figures 40 and 43). In such embodiments, the plunger member 3516 is inserted through the“O” shaped opening 4086 in the finger flange 4080.
  • the finger flange 3580 depicted in Figures 35 to 40 which has a“C” shaped opening 3586 can be slid/snapped onto the small flange 3511 from the side of the small flange 3511 at any time during assembly.
  • The“O” shaped opening 4086 in the finger flange 4080 also aligns the plunger member 3516 in the syringe body 3510.
  • the brake tabs 4092 in the anti-retraction mechanism 4090 depicted in Figure 42 are identical to the brake tabs 3592 in the anti-retraction mechanism 3590 depicted in Figure 37, which are described above.
  • the retention tab 4094 in the anti-retraction mechanism 4090 depicted in Figure 42 are similar to the retention tabs 3594 in the anti-retraction mechanism 3590 depicted in Figure 37, which are described above. The difference is that there is a single retention tab 4094 in anti-retraction mechanism 4090, while there is a pair of retention tabs 3594 in anti-retraction mechanism 3590.
  • fit tabs 4094 in the anti-retraction mechanism 4090 depicted in Figure 42 are similar to the fit tabs 3596 in the anti retraction mechanism 3590 depicted in Figure 37, which are described above. The difference is that there are three fit tabs 4094 in anti-retraction mechanism 4090, while there are four fit tabs 3594 in anti-retraction mechanism 3590.
  • the anti-retraction mechanism 4090 depicted in Figures 40 to 43 is symmetrical, simplifying high volume assembly whether manual or automated.
  • the anti-retraction mechanism 4090 may prevent removal of plunger member 3516 from the dual chamber injection system 4000.
  • the pair of long beams in the “O” shaped anti-retraction mechanism 4090 are deformable, allowing the anti-retraction mechanism 4092 bow outward, thereby transferring an outside reactive force to the interior walls of the second recess 4084 via the outside/long fit tabs 4096.
  • Figures 44A to 45B depict a needle latching mechanism 4490 for use with safe injection needle retraction systems 4400 according to some embodiments.
  • An elastic needle latch 4490 is disposed in a needle hub 4474 and retains a needle 4472 in the distal end of a syringe body 4410 during injection and releases the needle 4472 for retraction after the injection is complete.
  • Figure 44A is a semi-cross sectional view of the injection system 4400 depicting the needle 4472 in the latched state in which the needle latch 4490 couples the needle 4472 to the needle hub 4474.
  • the needle 4472 has an annular latching groove 4476 which couples to the elastic needle latch 4490.
  • the elastic needle latch 4490 is configured such that it has a latched state (see Figure 44A) where a pair of latching arms 4492 are restrained and/or compressed into engagement with the needle annular latching groove 4476 and an unlatched state (see Figure 44B) where the latching arms 4492 are free to spring open, disengaging from the annular latching groove 4476 and releasing the needle 4472 for retraction.
  • the needle hub 4474 defines a recess 4478 with an inner diameter and a restraining surface configured to restrain the elastic needle latch 4490 in the latched configuration.
  • Figure 44B is another semi-cross sectional view that illustrates the needle unlatching process.
  • the needle 4472 and the coupled elastic needle latch 4490 are pushed distally by the advancing a plunger member (not shown).
  • the elastic needle latch 4490 is configured such that the needle latch 4490 is pushed distally after the injection is substantially complete.
  • the distal movement of the elastic needle latch 4490 moves it out of the recess 4478 and allows the latching arms 4492 to slide distal of the restraining surface in the recess 4478, allowing the latching arms 4492 to expand radially (as the latching arms 4492 are biased to expand).
  • the latching arms 4492 expanding radially dis-engages the latching surfaces of the latching arms 4492 from the needle annular latching groove 4476, thereby releasing the needle 4472 to be retracted proximally relative to the needle hub 4474 and the syringe body 4410. Needle retraction mechanisms may be used with the elastic needle latch 4490.
  • Figure 44C and 44D are semi-cross sectional views (rotated 90 degrees from Figures 44A and 44B on the longitudinal axis) that illustrate a pair of flexible unlatch force arms/retaining tabs 4494 on the elastic needle latch 4490.
  • Figure 44C depicts the needle 4472 in the latched state
  • Figure 44D depicts the needle 4472 in the unlatched state.
  • the desired force to unlatch the needle 4472 is between approximately 2 Ibf and approximately 4 Ibf.
  • the retaining tabs 4494 engage a generally proximally facing annular shelf 4471 in the inside of the nose cone of the needle hub 4474.
  • the retaining tabs 4494 are in a straight state, wherein they prevent the elastic needle latch 4490 from moving distally out of the recess (see Figure 44A).
  • the retaining tabs 4494 are configured so that upon application of a distally directed force onto the needle assembly (which transmit distally directed force to the elastic needle latch 4490), the retaining tabs 4494 engage the annular shelf 4471. The retaining tabs 4494 react the distally directed needle unlatch force until desired unlatch force is reached.
  • FIG. 44E and 44F are isometric views of the elastic needle latch 4490 of Figures 44A to 44D with the latching arms 4492 in the unlatched state and the retaining tabs 4494 in the straight state.
  • Figures 45A to 45D are a semi cross-section views depicting a mechanism for retaining a needle 4572 during injection and allowing the needle 4572 to be retracted after the injection has been completed according to some embodiments.
  • the safe injection system 4500 includes a needle hub 4574, an elastomeric seal 4590, and a needle 4572 with an annular seal seat 4576 (Figure 45B).
  • the elastomeric seal 4590 (Figure 45C) has an internal sealing surface, a syringe sealing surface, and a needle hub sealing surface.
  • the elastomeric seal 4590 is configured to provide a pressure seal between the inside of the syringe body 4510, the needle hub 4574, and the outside of the needle 4572.
  • the elastomeric seal 4590 is also coupled to the outside of the needle 4572 by a frictional and/or mechanical engagement mechanism, which provides resistance to proximal movement of the needle 4572 into the interior of the syringe body 4510 during injection.
  • the resistance to proximal movement is tuned such that it is sufficient to perform the injection while not strong enough to prevent the needle retraction mechanism from grasping and retracting the needle 4572 into the syringe body 4510 and/or into the plunger member.
  • Proximal movement resistance forces above approximately 1.5 Ibf and below approximately 3.0 Ibf provide sufficient movement resistance to allow assembly and injection while also allowing the retraction spring to overcome the needle retention force and retract the needle 4572 (see Figure 45D).
  • the elastomeric seal may be an O-Ring or a slab of elastomer (not shown) that is pierced by the needle 4572 upon assembly.
  • the needle 4572 has a distally facing surface that engages with a proximally facing surface inside the needle hub 4574 to prevent distal movement of the needle 4572 during cap removal, handling, injection of medication, and/or during removal of the needle 4572 from the patient.
  • Figures 46A to 46E depict an attachment mechanism for coupling a needle hub 4674 to a polymeric syringe body 4610 according to various embodiments.
  • the polymeric syringe body 4610 may be molded from Cyclic Olefin Copolymer or Cyclic Olefin Polymer.
  • the polymeric syringe body 4610 has a needle retention ledge 4611.
  • the needle hub 4674 has a latch 4675 configured to allow the needle retention ledge 4611 to pass in a distal direction then snap into a space 4617 (see Figure 46E) proximal of the needle retention ledge 4611 , thereby coupling the needle hub 4674 to the polymeric syringe body 4610.
  • the injection system also includes a gasket 4615 (see Figure 46B) inside of the needle hub 4674 distal to the polymeric syringe body 4610.
  • Figures 47A to 47H depict an attachment mechanism for coupling a needle hub 4774 to a polymeric syringe body 4710 according to various embodiments.
  • Figure 47A is an exploded view of a needle hub assembly including a needle 4772, a needle hub 4774, a needle retaining ring 4790, and a gasket 4715. While the embodiment depicted in Figure 47A includes a needle latch and a needle latch actuator, these components are optional in a needle hub assembly for use with molded polymer injection system bodies, and other needle hub assembly embodiments may omit the needle latch and the needle latch actuator.
  • the polymeric syringe body 4710 may be molded from Cyclic Olefin Copolymer or Cyclic Olefin Polymer. As shown in Figure 47D, the polymeric syringe body 4710 has a smooth needle coupling member 4711 at a distal end thereof.
  • the needle hub 4774 has a retaining ring
  • the metal retaining ring 4775 includes teeth 4777 (see Figures 47G and 47H) that are biased in such a way to bend more readily in one direction compared to the opposite direction. As such, the retaining ring 4775 can slip proximally over the needle coupling member 4711 (see Figure 47E) more easily at the distal end of the molded polymer syringe body 4710, while providing relatively more substantial resistance to removing the retaining ring 4775 distally over the needle coupling member 4711. In fact, the teeth 4777 of the retaining ring 4775 may even gouge/dig into the needle coupling member 4711 when the needle hub 4774 is pulled away from the polymer syringe body 4710.
  • the teeth 4777 tend to bind harder to the needle coupling member 4711 as more removal force is applied. This is due to the non-shallow angle that is formed between the teeth 4777 and the needle coupling member 4711 after assembly, which increases friction between the teeth 4777 and the needle coupling member 4711 with increasing removal force, thereby preventing the teeth 4777 from releasing the needle coupling member 4711.
  • the domed curvature of the teeth 4777 and the surrounding metal of the retaining ring 4775 lend structural strength to the teeth 4777, which thereby squeeze the needle coupling member 4711 with substantial radial force, and help to reinforce the self-braking action and help the teeth 4777 to resist releasing the needle coupling member 4711.
  • the metal retaining ring 4775 has greater hardness and elasticity compared to the polymer syringe body 4710 due to its metallic composition.
  • Figures 48-63 depict a dual chamber injection system 5100 including a fluid transfer assembly configured to provide precise control of the handling, mixing, and delivery of the components of a multi-component injectable according to some embodiments.
  • the dual chamber injection system 5100 includes a syringe body 5110, proximal and distal stopper members 5114, 5112, and a plunger member 5116.
  • the plunger member 5116 is inserted into an interior 5118 of the syringe body 5110 via a proximal opening in the syringe body 5110.
  • the syringe body 5110 also includes a capped distal needle interface 5120 at the distal end thereof. While the dual chamber injection systems 100 depicted in Figures 6A-7B and 7G-7P have a staked needle, the syringe body 5110 has a Luer lock type distal needle interface 5120.
  • the distal needle interface 5120 is not limited to Luer lock and may be any other type of needle/tubing interface.
  • the distal needle interface 5120 is capped to minimize contamination and to facilitate retention of an optional vacuum in the interior 5118 of the syringe body 5110.
  • Benefits of an optional vacuum include reduced drug exposure to air, force assist in transferring liquid drug components from the proximal drug chamber 5122 to the distal drug chamber 5124, and eliminating the need to vent the distal drug chamber during drug mixing thereby allowing a capped distal needle interface 5120.
  • a capped distal needle interface 5120 minimizes user exposure in embodiments with toxic drug components.
  • the proximal and distal stopper members 5114, 5112 together with the syringe body 5110 define a proximal drug chamber 5122.
  • the distal stopper member 5112 and the syringe body 5110 define a distal drug chamber 5124.
  • the plunger member 5116 may be manually manipulated to insert the proximal stopper member 5114 relative to the syringe body 5110. If a non-compressible fluid is disposed in the proximal drug chamber 5122, inserting the proximal stopper member 5114 also inserts the distal stopper member 5112 relative to the syringe body 5110.
  • the dual chamber injection system 5100 includes a fluid conveying assembly 5130 for fluid transfer and delivery.
  • the fluid conveying assembly 5130 includes a spine assembly 5000 and a piercing tube 4800.
  • the spine assembly 5000 includes a distal tube 5010 and a solid elongate member 5020 partially disposed within the distal tube 5010 and partially disposed within the piercing tube 4800.
  • the distal tube 5010 is generally a tubular member that is sealed by hermetic welds between the solid elongate member 5020 and the distal tube 5010.
  • the solid elongate member 5020 may be coupled to the distal tube 5010 by a weld. As shown in Figure 55, a proximal end of the distal tube 5010 forms a proximally facing shoulder 5012 at a junction with the solid elongate member 5020.
  • the solid elongate member 5020 may be formed from various wires and bands. Alternatively, the solid elongate member 5020 may be formed from a single piece of material. In any case, the solid elongate member 5020 defines a recessed area and a distally facing shoulder 5022 near a proximal end thereof.
  • the piercing tube 4800 includes a tubular member 4810 movably coupled to a disc member 4830.
  • the tubular member 4810 defines a pair of vacuum stops 4814 that extend radially outward and distally from an exterior surface of the tubular member 4810.
  • the vacuum stops 4814 are configured to interfere with a funnel surface 4910 of a funnel insert 4900 (see Figure 49) to stabilize the relative positions of the piercing tube 4800 and the funnel insert 4900 in a transport configuration and to tune an amount of force needed to move the funnel insert 4900 distally past the piercing tube 4800.
  • the tubular member 4810 also defines a pair of middle openings 4816 into an interior of the tubular member 4810 adjacent respective ones of the pair of vacuum stops 4814.
  • the tubular member 4810 further defines a pair of anti-retraction tabs 4818 that extend radially inward and proximally from an exterior surface of the tubular member 4810.
  • the anti-retraction tabs 4818 are configured to interfere with the distally facing shoulder 5022 on the solid elongate member 5020 to limit distal movement of the solid elongate member 5020 relative to the piercing tube 4800.
  • the tubular member 4810 also defines a pair of distal openings 4820 into an interior of the tubular member 4810 adjacent respective ones of the pair of anti-retraction tabs 4818.
  • the piercing tube 4800 may be formed by bending a piece of sheet metal.
  • the disc member 4830 defines a plurality of radially inward telescoping stops 4832.
  • the radially inward telescoping stops 4832 movably connected and disposed adjacent to the disc member 4830 to the tubular member 4810.
  • One of the radially inward telescoping stops 4832 includes a connection member 4836 that connects the disc member 4830 to the tubular member 4810.
  • the radially inward telescoping stops 4832 define an adjustable opening 4834 in an approximate center of the disc member 4830.
  • the adjustable opening 4834 is adjustable between a small configuration (shown in Figure 48) and a large configuration (shown in Figure 62 and described herein).
  • the proximally facing shoulder 5012 on the distal tube 5010 interferes with the radially inward telescoping stops 4832 to prevent proximal movement of the distal exit to 5010 relative to the disc member 4830 of the piercing tube 4800.
  • the adjustable opening 4834 is in the large configuration, the distal tube 5010 is free to move proximally relative to the piercing tube 4800 as described.
  • the radially inward telescoping stops 4832 are prevented from opening. Flowever, when the tubular member 4810 is no longer pushed distally against the disc member 4830, then the radially inward telescoping stops 4832 are free to deform and change the adjustable opening 4834 from the small configuration to the large configuration (see Figure 62 described herein).
  • Figures 48 to 50 depicted the piercing tube 4800, the funnel insert 4900, and the spine assembly 5000 as separate components.
  • the increased amount of distally directed force required by the vacuum stops 4814 and funnel surface 4910 facilitate device stability with a vacuum in the distal drug chamber 5124, which is present in some embodiments.
  • Figure 54 depicts assembly of the dual chamber injection system 5100. First a spine assembly 5000 is inserted into an interior 5118 of the syringe body 5110. Then a piercing tube 4800 is threaded over a proximal end of the spine assembly 5000 to form the fluid conveying assembly 5130.
  • Figure 55 depicts the piercing tube 4800 after it has been snapped over the spine assembly 5000.
  • proximal movement of the spine assembly 5000 relative to the piercing tube 4800 is limited by interference between the proximally facing shoulder 5012 of the distal tube 5010 and the radially inward telescoping stops 4832 of the disc member 4830.
  • distal movement of the spine assembly 5000 and relative to the piercing tube 4800 is limited by interference between the distally facing shoulder 5022 of the solid elongate member 5020 and the anti-retraction tabs 4818 of the tubular member 4810.
  • Figure 55 depicts the piercing tube 4800 walked onto the spine assembly 5000.
  • Figure 55 also depicts a sharp piercing tip 4812 of the piercing a proximal opening 4822 defined thereby.
  • Figure 56 depicts the next step in assembly of the dual chamber injection system 5100 following Figure 54.
  • a funnel insert 4900 is inserted into a distal stopper member 5112 (e.g., screwed or pressed into). Then the distal stopper member 5112 with the funnel insert 4900 is inserted through a proximal opening and into the interior 5118 of the syringe body 5110 until the vacuum stops 4814 of the piercing tube 4800 interfere with the funnel surface 4910 of the funnel insert 4900 (see Figures 48 and 49) to hold the distal stopper member 5112 in the transport configuration of the dual chamber injection system 5100 as described herein.
  • a proximal stopper member 5114 is inserted through the proximal opening into the interior 5118 of the syringe body 5110. Finally, a plunger member 5116 is coupled to the proximal stopper member 5114 (e.g., screwed into).
  • a liquid drug component can be introduced into the proximal drug chamber 5122 before the proximal stopper member 5114 is inserted into the syringe body 5110.
  • the incompressibility of the liquid drug component maintains the position of the proximal stopper member 5114 relative to the distal stopper member 5112 until an exit flow path is opened into the proximal drug chamber 5122.
  • a liquid or dry/lyophilized drug component can be introduced into the distal drug chamber 5124 before or after the distal stopper member 5112 is inserted into the syringe body 5110.
  • a liquid drug component in the distal drug chamber 5124 may be lyophilized in place using a vacuum, which can then be maintained in the distal drug chamber using a capped distal needle interface 5120. If a dry/lyophilized drug component is introduced into the distal drug chamber 5124, a vacuum can still be generated in the distal drug chamber 5124 and maintained using a capped distal needle interface 5120.
  • Figure 57 depicts the distal stopper member 5112, the funnel insert 4900, the piercing tube 4800, and the spine assembly 5000 with the dual chamber injection system 5100 in the transport configuration as described above.
  • the vacuum can generate approximately 6.5 Ibf of distally directed force on the distal stopper member 5112.
  • the vacuum stops 4814 of the piercing tube 4800 and the funnel surface 4910 of the funnel insert 4900 can be configured such that more than 6.5 Ibf of distally directed force is required to overcome the interference between these components and to allow the piercing tube 4800 to enter into the funnel insert 4900 and pierce the distal stopper member 5112.
  • the vacuum stops 4814 of the piercing tube 4800 and the funnel surface 4910 of the funnel insert 4900 can be configured such that 7.5 Ibf of distally directed force is required to overcome the interference between these components and to allow the piercing tube 4800 to enter into the funnel insert 4900 and pierce the distal stopper member 5112.
  • the extra 1 Ibf of distally directed force can be provided by a user applying that force to the plunger member 5116.
  • the sharp piercing tip 4812 of the piercing tube 4800 pierces the distal stopper member 5112 until the proximal opening 4822 of the piercing tube 4800 is in fluid communication with the proximal drug chamber 5122 as shown in Figures 58 and 59.
  • An exemplary amount of force to drive the sharp piercing tip 4812 through the distal stopper member 5112 is approximately 4 Ibf to approximately 5 Ibf.
  • Figures 58 and 59 show the dual chamber injection system 5100 in a transfer configuration in which an exit flow path is open between the proximal and distal drug chambers (5122, 5124).
  • the exit flow path includes the proximal opening 4822 of the piercing tube 4800, and interior of the piercing tube 4800, and the distal openings 4820 of the piercing tube.
  • the spine assembly 5000 only occupies the very distal end of the exit flow path, there is very little resistance to fluid flow through the exit flow path.
  • the force needed to drive the fluid flow is less than about 2.2 Ibf.
  • the distally directed force generated by the vacuum e.g., 6.5 Ibf
  • the proximal stopper member 5114 may also be pulled distally relative to the syringe body 5110.
  • Figure 60 depicts a next step in the multiple component drug injection method.
  • the proximal drug chamber 5122 depicted in Figure 56 has substantially or completely collapsed either by action of the vacuum in the distal drug chamber 5124 and/or user applied distally directed force to the plunger member 5116. Any liquid drug component in the proximal drug chamber 5122 as flow through the exit flow path into the distal drug chamber 5124. Lyophilized drug components in the distal drug chamber 5124 will be dissolved by the liquid drug component.
  • the dual chamber injection system 5100 can be agitated to facilitate solubilization of any lyophilized drug components. At this point the dual chamber injection system 5100 is in a mixed configuration.
  • the various components of the dual chamber injection system 5100 can be configured such that the vacuum is fully expended by moving the liquid drug component into the distal drug chamber 5124.
  • the mixed drug in the distal drug chamber 5124 is ready for injection.
  • the syringe body 5100 includes distal end openings 5030 (see Figure 52) to allow fluids such as the mixed drug to exit the distal drug chamber 5124.
  • Figure 52 depicts an embodiment of a the dual chamber injection system 5100 including a capped distal needle interface 5120, which blocks the outflow path from the distal drug chamber 5024 through the distal end openings 5030 until transfer of a liquid drug component and/or mixing of the mixed drug is completed.
  • a capped distal needle interface 5120 is uncapped before injection.
  • a needle assembly including a needle may be coupled to the uncapped distal needle interface 5120 before injection.
  • tubing may connect the uncapped distal needle interface 5120 to an IV bag before injection.
  • the injection can begin. Further application of distally directed force to the plunger member 5116 will now moves both the proximal and distal stopper members 5114, 5112 distally relative to the syringe body 5110 and forces the mixed drug from the distal drug chamber 5124 out the uncapped distal needle interface 5120 to perform the injection.
  • Figures 61 and 62 show that after the dual chamber injection system 5100 is in the mix configuration and the proximal and distal stopper members 5114, 5112 are in contact with each other.
  • Figure 61 shows that is pushing the tubular member 4810 against the disc member 4830 pushes the radially inward telescoping stops 4832 together and holds the adjustable opening 4834 in its small configuration, which latches the spine assembly 5000 to the piercing tube 4800.
  • the relatively thick metal from which the piercing tube 4800 is made e.g., 0.009”
  • a narrow sliding clearance e.g., 0.0025
  • Figure 63 depicts the dual chamber injection system 5100 after injection of the mixed drug from the distal drug chamber 5124. At this point the dual chamber injection system 5100 is in the completed configuration.
  • the proximal stopper member 5114 is in contact with the distal stopper member 5112 which is in contact with a distal end of the syringe body 5110.
  • a proximal end of the spine assembly 5000 has penetrated both the distal and proximal stopper members 5114, 5112 and entered the plunger member 5116.
  • the piercing tube 4800 does not completely penetrate the proximal stopper member 5112, thereby minimizing the risk of retrograde flow into the plunger member 5116.
  • the spine assembly 5000 and a needle attached thereto may be retracted inside of the syringe body 5110 to provide a safe injection system.
  • the dual chamber injection system 5100 and its components depicted in Figures 48 to 63 prevent accidental and/or premature dispensing of drugs before transfer of a liquid drug component and/or mixing of the mixed drug is completed.
  • the dual chamber injection system 5100 includes a low resistance to injection after the mixed drug is prepared and ready for injection.
  • the dual chamber injection system 5100 accomplishes this by the spine assembly 5000 stay locked to the piercing tube 4800 during transfer of liquid drug from the proximal drug chamber 5122 to the distal drug chamber 5124 and mixing of the drug thereby preventing incomplete mixture and fluid transfer.
  • the resistance to distal movement of the proximal and distal stopper members 5114, 5114 over the spine assembly 5000 is minimal.
  • vacuum has been described in distal drug chambers of various embodiments, a vacuum is an optional feature of the injection system. Alternatively, vacuums may be present in both the proximal and distal drug chambers of some embodiments.
  • the dual chamber injection system 5100 is compatible with needle retraction systems, but it may also be used without needle retraction systems.
  • the dual chamber injection system 5100 is compatible with a wide variety of syringe sizes (e.g., 20 cc syringe).
  • prefilled dual chamber safety injection systems depicted and described herein include Luer lock connectors, the injection configurations and dual chamber configurations, including the anti-retraction mechanisms, the safe injection needle retraction systems, and the needle hub attachment mechanisms described herein can be used with cartridges an auto injector, and injection systems with syringes with staked needles or Luer slip connectors, and no needles.
  • kits may further include instructions for use and be packaged in sterile trays or containers as commonly employed for such purposes.
  • the invention includes methods that may be performed using the subject devices.
  • the methods may comprise the act of providing such a suitable device. Such provision may be performed by the end user.
  • the "providing" act merely requires the end user obtain, access, approach, position, set-up, activate, power-up or otherwise act to provide the requisite device in the subject method.
  • Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as in the recited order of events.
  • one or more lubricious coatings e.g., hydrophilic polymers such as polyvinylpyrrolidone-based compositions, fluoropolymers such as tetrafluoroethylene, PTFE, hydrophilic gel or silicones
  • hydrophilic polymers such as polyvinylpyrrolidone-based compositions, fluoropolymers such as tetrafluoroethylene, PTFE, hydrophilic gel or silicones
  • various portions of the devices such as relatively large interfacial surfaces of movably coupled parts, if desired, for example, to facilitate low friction manipulation or advancement of such objects relative to other portions of the instrumentation or nearby tissue structures.
  • additional acts as commonly or logically employed.
  • any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein.
  • Reference to a singular item includes the possibility that there are plural of the same items present. More specifically, as used herein and in claims associated hereto, the singular forms “a,” “an,” “said,” and “the” include plural referents unless the specifically stated otherwise.
  • use of the articles allow for "at least one" of the subject item in the description above as well as claims associated with this disclosure.
  • claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.

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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)
PCT/US2020/039013 2019-06-21 2020-06-22 Injection system and method Ceased WO2020257799A1 (en)

Priority Applications (4)

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JP2021576023A JP7423089B2 (ja) 2019-06-21 2020-06-22 注入システム
CA3143804A CA3143804C (en) 2019-06-21 2020-06-22 INJECTION SYSTEM AND METHOD
EP20740120.9A EP3986506A1 (en) 2019-06-21 2020-06-22 Injection system and method
JP2024001621A JP7772396B2 (ja) 2019-06-21 2024-01-10 注入システムおよび方法

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US62/864,509 2019-06-21

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023533477A (ja) * 2020-06-30 2023-08-03 クリーデンス メドシステムズ，インコーポレイテッド 安全シリンジのためのシステム

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113456490A (zh) * 2021-06-29 2021-10-01 文青 一种细胞毒性药物安全配药针
WO2023201292A1 (en) * 2022-04-13 2023-10-19 Credence Medsystems, Inc. Needle cover and needle hiding devices for injection systems and methods
EP4598611A1 (en) * 2022-10-07 2025-08-13 Credence Medsystems, Inc. Injection system and method

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1358143A (fr) * 1962-05-29 1964-04-10 Bristol Myers Co Seringue hypodermique
EP0817654A2 (en) * 1995-03-22 1998-01-14 Abbott Laboratories Pre-filled syringe drug delivery system
US20180117261A1 (en) * 2016-11-01 2018-05-03 Credence Medsystems, Inc. System and method for safety syringe

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3941128A (en) * 1970-11-10 1976-03-02 Affiliated Hospital Products, Inc. Fluid dispensing arrangement
US5562626A (en) * 1995-09-11 1996-10-08 Sanpietro; Joseph A. Safety syringe
AU2002259265B2 (en) 2001-07-27 2008-06-05 Becton, Dickinson And Company Luer connector assembly
US7115114B2 (en) 2003-05-02 2006-10-03 Becton, Dickinson And Company Medical device having releasable retainer
US8012132B2 (en) * 2009-02-24 2011-09-06 Becton, Dickinson And Company Luer-snap connection and luer-snap syringe
JP2013506462A (ja) 2009-09-30 2013-02-28 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 薬物送達システム、薬物送達デバイス、ニードルアセンブリ及びプライミング方法
US8597252B2 (en) * 2010-07-15 2013-12-03 Becton, Dickinson And Company Removable flash chamber
US9272099B2 (en) * 2012-04-09 2016-03-01 Becton, Dickinson And Company Syringe with visually coded needle hub
AU2014305922A1 (en) * 2013-08-07 2016-02-25 Unitract Syringe Pty Ltd Luer connection adapters for retractable needle syringes
US11116905B2 (en) * 2018-06-08 2021-09-14 Credence Medsystems, Inc. System and method for safety syringe

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1358143A (fr) * 1962-05-29 1964-04-10 Bristol Myers Co Seringue hypodermique
EP0817654A2 (en) * 1995-03-22 1998-01-14 Abbott Laboratories Pre-filled syringe drug delivery system
US20180117261A1 (en) * 2016-11-01 2018-05-03 Credence Medsystems, Inc. System and method for safety syringe

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3986506A1 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023533477A (ja) * 2020-06-30 2023-08-03 クリーデンス メドシステムズ，インコーポレイテッド 安全シリンジのためのシステム
JP7799324B2 (ja) 2020-06-30 2026-01-15 クリーデンス メドシステムズ，インコーポレイテッド 安全シリンジのためのシステム

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JP7423089B2 (ja) 2024-01-29
JP7772396B2 (ja) 2025-11-18
CA3284445A1 (en) 2025-11-29
US11712525B2 (en) 2023-08-01
CA3143804A1 (en) 2020-12-24
JP2024041872A (ja) 2024-03-27
CA3143804C (en) 2025-12-02
EP3986506A1 (en) 2022-04-27
US20240024584A1 (en) 2024-01-25
US20200398000A1 (en) 2020-12-24

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