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WO2025235758A1 - Système et méthode d'injection - Google Patents

Système et méthode d'injection

Info

Publication number
WO2025235758A1
WO2025235758A1 PCT/US2025/028399 US2025028399W WO2025235758A1 WO 2025235758 A1 WO2025235758 A1 WO 2025235758A1 US 2025028399 W US2025028399 W US 2025028399W WO 2025235758 A1 WO2025235758 A1 WO 2025235758A1
Authority
WO
WIPO (PCT)
Prior art keywords
distal
stopper member
needle
proximal
ball
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/028399
Other languages
English (en)
Inventor
Stephen H. Diaz
Allyson Jade Weiss
Alan E. Shluzas
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
Publication of WO2025235758A1 publication Critical patent/WO2025235758A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—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
    • A61M5/31—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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • 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
    • 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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3221—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3228—Constructional features thereof, e.g. to improve manipulation or functioning the needle being retracted by a member protruding laterally through a slot in the barrel, e.g. double-ended needles
    • 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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3221—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/323—Connection between plunger distal end and needle hub proximal end, e.g. stud protruding from the plunger
    • 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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3221—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3231—Proximal end of needle captured or embedded inside piston head, e.g. by friction or hooks
    • 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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • A61M2005/3241—Needle retraction energy is accumulated inside of a hollow plunger 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/24—Check- or non-return valves
    • A61M2039/2473—Valve comprising a non-deformable, movable element, e.g. ball-valve, valve with movable stopper or reciprocating element
    • A61M2039/248—Ball-valve
    • 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

Definitions

  • the present disclosure 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 injection systems, with or without safety features, 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 possibly malfunction and activate before desirable, loss of accuracy in giving fulldose 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 and/or a combination thereof.
  • 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 transferring 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 multicomponent injection systems that simplify the manual accessing and mixing of multiple components from multiple containers.
  • 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 includes an injection system body defining a proximal opening at a proximal end thereof and a distal needle interface at a distal end thereof.
  • the system also includes a proximal stopper member and a distal stopper member disposed in the injection system body, wherein the proximal stopper member, the distal stopper member, and the injection system body form a proximal drug chamber between the proximal stopper member and the distal stopper member, and a distal drug chamber between the distal stopper member and the distal end of the injection system body.
  • the system further includes a plunger member configured to insert the proximal stopper member relative to the injection system body.
  • the system includes a needle hub assembly coupled to the syringe body at the syringe body distal end, and including a needle hub, and a needle removably coupled to the needle hub and having a sharp needle distal end and a needle proximal end feature.
  • the distal stopper member includes a ball having a lodged state and a dislodged state. When the ball is in the lodged state, the ball forms an openable barrier between the proximal and distal drug chambers. The distal stopper member is configured to selectively allow flow from the proximal drug chamber to the distal drug chamber.
  • the distal stopper member defines a ball trap disposed proximal of the ball when the ball is in the lodged state.
  • the distal stopper member may include a plurality of ball trap flaps separated by ball trap slots. The ball trap flaps may be configured to retain the ball in the ball trap when the ball is in the dislodged state.
  • the distal stopper member defines a longitudinal space configured to hold the ball in a proximal end thereof when the ball is in the lodged state.
  • the distal stopper member may include a plurality of inwardly extending exit ribs at the proximal end of the longitudinal space.
  • the plurality of inwardly extending exit ribs may be configured to hold the ball in the proximal end of the longitudinal space when the ball is in the lodged state.
  • the distal stopper member defines a plurality of flow channels along an interior wall of a distal end of the longitudinal space.
  • the distal stopper member may include a plurality of inwardly extending centering ribs between corresponding pairs of flow channels.
  • the plurality of inwardly extending centering ribs may be configured to align the needle in the longitudinal space.
  • the plurality of inwardly extending centering ribs may be configured to retain the ball in the proximal end of the longitudinal space when the ball is in the lodged state.
  • Each of the plurality of inwardly extending centering ribs may define a respective rib recess configured to retain the ball in the proximal end of the longitudinal space when the ball is in the lodged state.
  • the distal stopper member may define a distally opening funnel at a distal end thereof. The distally opening funnel may be configured to guide the needle proximal end feature and the needle into a distal opening of the longitudinal space. While the distal stopper member in some embodiments include a plurality of inwardly extending centering ribs, in other embodiments the distal stopper does not include centering ribs.
  • the plunger member includes a plunger member body defining a plunger interior.
  • the plunger member may include a needle retention member disposed in the plunger interior and configured to couple to the needle proximal end feature.
  • the plunger member may include an energystorage member disposed in the plunger interior and configured to withdraw the needle retention member proximally in the plunger interior.
  • the plunger member may include an energy-storage member latching member disposed in the plunger interior and having a latched state in which the energy-storage member latching member holds the energy-storage member in an energized state, and an unlatched state in which the energy-storage member latching member does not restrain the energy-storage member and the energy-storage member transforms into a released state.
  • the energy-storage member latching member is transformed from the latched state to the unlatched state, and the energy-storage member pulls needle proximally such that the sharp needle distal end is disposed in an interior of the injection system body.
  • the energy-storage member latching member When the distal stopper member is inserted to the syringe body distal end, the energy-storage member latching member may be transformed from the latched state to the unlatched state, and the energy-storage member may pull the needle proximally via the needle retention feature coupled to the needle proximal end feature.
  • the distal stopper member includes a distally opening funnel insert at a distal end thereof.
  • the distally opening funnel insert is configured to guide the needle proximal end feature and the needle into a distal opening of the longitudinal space.
  • the distally opening funnel insert may define a central opening sized and shaped to allow the needle proximal end feature to pass therethrough.
  • the distally opening funnel insert may include a plurality of ribs configured to support the distally opening funnel insert in the distal stopper member.
  • the distally opening funnel insert and the distal stopper member may define a plurality of arcuate slots adjacent an outer circumference of the distally opening funnel insert configured to provide low liquid flow resistance through the distal stopper member.
  • the distally opening funnel insert may be formed from a polymer material such as cyclic olefin polymer (COP) or cyclic olefin copolymer (COC).
  • COP cyclic olefin polymer
  • COC cyclic olefin copolymer
  • the distally opening funnel may be formed from other polymer materials, metal, ceramic, or glass, materials, or a combination thereof.
  • a method for injecting includes providing a prefilled injection system.
  • the injection system includes an injection system body defining a proximal opening at a proximal end thereof and a distal needle interface at a distal end thereof.
  • the injection system also includes a proximal stopper member and a distal stopper member disposed in the injection system body, wherein the proximal stopper member, the distal stopper member, and the injection system body form a proximal drug chamber between the proximal stopper member and the distal stopper member, and a distal drug chamber between the distal stopper member and the distal end of the injection system body.
  • the injection system further includes a plunger member configured to insert the proximal stopper member relative to the injection system body.
  • the injection system includes a needle hub assembly coupled to the syringe body at the syringe body distal end, and including a needle hub, and a needle removably coupled to the needle hub and having a sharp needle distal end and a needle proximal end feature.
  • the injection system includes a first drug component disposed in the proximal drug chamber, and a second drug component disposed in the distal drug chamber.
  • the distal stopper member includes a ball having a lodged state and a dislodged state.
  • the method also includes moving the plunger and the proximal stopper member coupled thereto distally into the injection system body to move the distal stopper member distally into the injection system body and to dispose the needle proximal end feature in the distal stopper member adjacent the ball.
  • the method further includes moving the plunger and the proximal stopper member coupled thereto distally further into the injection system body to dislodge the ball from the distal stopper member using the needle proximal end feature.
  • the method includes moving the plunger and the proximal stopper member coupled thereto distally yet further into the injection system body to transfer the first drug component from the proximal drug chamber to the distal drug chamber to form a mixed drug with the second drug component.
  • the method includes moving the plunger and the proximal stopper member coupled thereto distally still further into the injection system body to eject the mixed drug from the distal drug chamber through the needle.
  • the method includes automatically retracting the needle proximally after ejecting the mixed drug from the distal drug chamber such that the sharp needle distal end is disposed in an interior of the injection system body.
  • Figures 1A to 5C illustrate various aspects of conventional injection syringe configurations.
  • Figure 6 and 6A are perspective and detailed perspective views illustrating various aspects of syringe based dual chamber safe injection systems according to some embodiments.
  • Figures 7A to 7F are side views illustrating various aspects of safe syringe based dual chamber safe injection systems during steps in methods for mixing and injecting using same according to some embodiments.
  • Figures 8 to 20 are longitudinal cross-sectional and detailed longitudinal cross-sectional views illustrating various aspects of safe syringe based dual chamber safe injection systems during steps in methods for mixing and injecting using same according to some embodiments.
  • Figure 21 is a detailed longitudinal cross-sectional view illustrating various aspects of stopper members with a ball disposed therein for use with safe syringe based dual chamber injection systems according to some embodiments.
  • Figure 22 is a detailed longitudinal cross-sectional view illustrating various aspects of stopper members for use with safe syringe based dual chamber injection systems according to some embodiments.
  • Figures 23A and 23B are detailed distal and proximal axial views illustrating various aspects of stopper members for use with safe syringe based dual chamber injection systems according to some embodiments.
  • Figures 24A and 24B are a detailed distal perspective cross-sectional view and a detailed distal axial view illustrating various aspects of stopper members for use with safe syringe based dual chamber injection systems according to some embodiments.
  • Figure 25 is a distal perspective view illustrating various aspects of syringe based dual chamber safe injection systems according to some embodiments.
  • Figure 26 is a detailed distal perspective cross-sectional view illustrating various aspects of syringe based dual chamber safe injection systems according to some embodiments.
  • Figure 27 is a distal perspective view illustrating various aspects of syringe based dual chamber safe injection systems according to some embodiments.
  • Figure 28 is a proximal perspective view illustrating various aspects of stopper members for use with safe syringe based dual chamber injection systems according to some embodiments.
  • Figure 29 is a proximal axial view illustrating various aspects of stopper members for use with safe syringe based dual chamber injection systems according to some embodiments.
  • Figure 30 is a distal perspective view illustrating various aspects of stopper members for use with safe syringe based dual chamber injection systems according to some embodiments, with various components omitted for clarity.
  • Figure 31 is a side view illustrating various aspects of a needle for use with safe syringe based dual chamber injection systems according to some embodiments.
  • Figure 32 is a side view illustrating various aspects of a needle and a stopper member insert for use with safe syringe based dual chamber injection systems according to some embodiments.
  • Figures 33 and 33A are distal and detailed distal perspective views illustrating various aspects of safe syringe based dual chamber injection systems and stopper members for use with same according to some embodiments.
  • Figure 34 is a distal axial view illustrating various aspects of stopper members for use with safe syringe based dual chamber injection systems according to some embodiments.
  • Figure 35 is a detailed perspective cross-sectional view illustrating various aspects of safe syringe based dual chamber injection systems and stopper members for use with same according to some embodiments.
  • Figure 36 is a distal perspective view illustrating various aspects of funnel inserts for use with stopper members in safe syringe based dual chamber injection systems according to some embodiments.
  • Figures 37 and 38 are proximal perspective views illustrating various aspects of funnel inserts for use with stopper members in safe syringe based dual chamber injection systems according to some embodiments.
  • Figure 39 is a distal axial view illustrating various aspects of stopper members for use with safe syringe based dual chamber injection systems according to some embodiments.
  • Figures 40 and 41 are detailed perspective and detailed perspective cross-sectional views illustrating various aspects of stopper members having ball valves for use in safe syringe based dual chamber injection systems according to some embodiments.
  • FIG. 6A a perspective and a detailed perspective view of a dual chamber safe injection system (600) are shown, with a conventional off-the-shelf pre-filled syringe body (34) with a conventional proximal stopper member (32) and a distal stopper member (36) disposed therein.
  • the proximal and distal stopper members (32, 36) together with the syringe body (34) define proximal and distal drug chambers (40, 42).
  • the proximal and distal stopper members (32, 36) define the proximal and distal ends of the proximal drug chamber (40).
  • the distal stopper member (36) defines a proximal end of the distal drug chamber (42).
  • a needle hub assembly (606) is disposed at the distal end of the distal drug chamber (42) with a needle cover member (63) installed for storage.
  • the dual chamber safe injection system (600) controls transfer of a first drug component from the proximal drug chamber (40) to the distal drug chamber (42) and exit of a combined/mixed drug from the distal drug chamber (42) distally subject to sequential insertion of a plunger member (44) relative to the syringe body (34) to various degrees by a user.
  • the plunger member (44) includes the proximal stopper member (32), a plunger housing member (69) and a plunger manipulation interface (128) (see e.g., Figure 8).
  • the first drug component (252) located in the proximal drug chamber (40) may be a liquid such as aqueous or oil based medicine solutions, a gel, or the first drug component may be a diluent for mixing with the second drug component (254) in the distal drug chamber (42).
  • the second drug component (254) in the distal drug chamber (42) may be a dry form medicine such as a powder, microspheres, emulsion, lyophilized or freeze dried medicine, or a cake like solid medicine.
  • the plunger member (44) may be configured to be manually manipulated to insert the proximal stopper member (32) relative to the syringe body (34). In some embodiments, the plunger member (44) may be configured to be inserted using a spring or a motor of an injection device such as an auto injector. In some embodiments, the plunger member (44) may be configured to be inserted using a pen injection system.
  • the dual chamber safe injection system (600) has a staked needle configuration wherein upon presentation to the user, a needle hub assembly (606), comprising a needle hub and a needle member (50), including a sharp needle distal end/tip (48, see e.g., Figure 8), a needle joining member (51) and a needle proximal end (53), 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 the sharp needle distal end (48) or the needle hub during storage.
  • a needle hub assembly (606) comprising a needle hub and a needle member (50), including a sharp needle distal end/tip (48, see e.g., Figure 8), a needle joining member (51) and a needle proximal end (53), 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 the sharp needle distal end (48) or the needle hub during
  • the needle cover member (63) may comprise a vent (not shown) for allowing pressure resulting from the transfer and mixing of the drug components to escape from inside the syringe body (34) while preventing contamination from entering the syringe body (34).
  • the staked needle is depicted as mounted in position, the needle may be removably coupled to the syringe body (34) using a Luer interface (not shown), with the needle proximal end (53) of the needle member (50) extending through the Luer interface and into the distal drug 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 (69).
  • FIGS 7A-7F various aspects of configurations designed to facilitate injection of multi-part medications and retractions of a needle into a syringe body (34) 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 drug component/diluent (252) may be combined with a substantially non-liquid second drug 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-7F 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.
  • FIGs 7A-7F illustrate a sequence of actions for an injection procedure utilizing a dual chamber safe injection system (600) such as that described herein.
  • a dual chamber safe injection system (600) 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 nonliquid drug component (254), both within a syringe body (34) on opposite sides of a distal stopper member (36).
  • proximal and distal drug 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 drug chamber (42) contains an air or gas gap, as well as a non-liquid medication (254); a proximal drug 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.
  • distal drug chamber (42) is described as containing a non-liquid medicine (254) as a preferred embodiment, the distal drug chamber (42) may contain a liquid, solid, or gel medicine intended to be mixed with the liquid diluent (252) in the proximal drug chamber (40).
  • Figure 7B illustrates initial insertion movement of the plunger member (44), advancing the distal (36) and proximal (32) stopper members together relative to the syringe body (34). With advancement sufficient to stab the needle proximal end (53) of the needle assembly across the distal stopper member (36), a fluid pathway is formed between the two previously isolated chambers (40, 42) of the syringe body (34) (see Figures 12 and 12A, described below).
  • Figures 7C illustrates that with further insertion of the plunger member (44) until the stopper members (36, 32) are immediately adjacent each other, the liquid first drug component/diluent (252) has moved into the distal drug chamber (42) to join the non-liquid second drug component (254).
  • Figure 7D illustrates 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 syringe body (34) includes a visual mixed configuration indicator (304).
  • the mixed configuration indicator (304) is a ring disposed (e.g., painted, etched, etc.) on the syringe body (34) that indicate the approximate optimal location of the distal edge of the distal stopper member (36) when the system is in a mixed configuration in which the mixed medication solution (272) has been formed (compare Figure 7A to Figure 7D).
  • 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 drug 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 member (44).
  • Mixed configuration latches or “mix clicks” in the plunger member (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 I or tactile indication that the transfer of liquid first drug component (252) has been completed.
  • the distal drug chamber (42) may also include an agitation device (not shown), which assists in mixing of the drug 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 member (44) and associated stopper members (36, 32) as shown in Figure 7E.
  • the sharp needle distal end/point (48, see e.g., Figure 7E) may automatically retract to a safe position within the syringe body (34), the needle hub assembly (606), or the plunger member (44).
  • the sharp needle distal end/point (48, see e.g., Figure 7E) may automatically retract into the plunger member (44).
  • Figures 8 and 8A depict a safe dual chamber injection system (800) having a ball valve (2100) disposed therein according to some embodiments.
  • Figures 8 and 8A depict the injection system (800) in a storage/transport configuration. While the injection system (800) is depicted without dual chamber components for clarity, the ball valve (2100) is configured for use with any multiple chamber injection systems.
  • the injection system (800) as shown includes an injection system body (34), a proximal stopper member (32), a distal stopper member (36), a plunger member (44), and an elongate needle member (50).
  • the elongate needle member (50) may be constructed of metal such as stainless steel.
  • the proximal and distal stopper members (32, 36) together with the injection system body (34) defines a proximal drug chamber (40).
  • the distal stopper member (36) together with the injection system body (34) defines a distal drug chamber (42).
  • the injection system body (34) includes a needle hub assembly (606) at a distal end thereof.
  • the needle hub assembly (606) includes a needle hub and a needle member (50).
  • the needle member (50) includes a sharp needle distal end/tip (48), a needle joining member (51) and a needle proximal end (53), which are mounted in position ready for injection after removal of a needle cover member (63).
  • the distal stopper member (36) includes a ball valve (2100).
  • the ball valve (2100) includes a ball (2110), a ball trap (2120), and a longitudinal space (2130).
  • the ball (2110) has lodged and dislodged states corresponding to respective closed and open states of the ball valve (2100).
  • the ball (2110) In the lodged state, the ball (2110) is disposed/held in a proximal end of the longitudinal space (2130).
  • the ball (2110) occludes the longitudinal space (2130), thereby preventing fluid flow therethrough and effectively closing the ball valve (2100).
  • the dislodged state see Figures 12 and 12A
  • the ball (2110) is disposed in the ball trap (2120).
  • the ball (2110) no longer occludes the longitudinal space (2130), allowing fluid flow through the distal stopper member (36) and effectively opening the ball valve (2100).
  • the longitudinal space (2130) and the ball trap (2120) form a flow path through the distal stopper member (36).
  • the distal stopper member (36) may be formed from an elastic material, which may include one or more of the following materials: rubber, butyl rubber, chlorobutyl rubber, bromobutyl rubber, thermoplastic elastomer (TPE), thermoplastic urethane (TPU) silicone rubber, thermoplastic, Polytetrafluoroethylene (PTFE), thermoset plastic.
  • the distal stopper member (36) may be coated with a lubricious polymer such as PTFE, silicone oil, and/or other lubricious coatings.
  • the ball (2110) may be formed from a material impermeable to liquid which may include one or more of the following materials: polymers, cyclic olefin polymer (COP), cyclic olefin copolymer (COC), PTFE, elastomers, TPE, thermoplastic urethane (TPU), rubber, butyl rubber, chlorobutyl rubber, bromobutyl rubber, metal, stainless steel, titanium, ceramic, glass or a combination thereof.
  • COP cyclic olefin polymer
  • COC cyclic olefin copolymer
  • PTFE cyclic olefin copolymer
  • elastomers elastomers
  • TPE thermoplastic urethane
  • TPU thermoplastic urethane
  • rubber butyl rubber, chlorobutyl rubber, bromobutyl rubber, metal, stainless steel, titanium, ceramic, glass or a combination thereof.
  • the injection system (800) also includes a needle retraction system (1000) configured to withdraw/pull/retract the sharp distal end (48) of the needle member (50) to a safe position within the syringe body (34), the needle hub assembly (606), or the plunger member (44) (see e.g., Figure 20).
  • the needle retraction system (1000) includes a needle retention member (1010) configured to capture the needle proximal end (53), and energy-storage member/spring (1020), an energy-storage member/spring latching member (1030), and an actuating member (1040).
  • the needle retraction system (1000) may automatically retract the sharp needle distal end/point (48, see e.g., Figure 7E) into the plunger member (44).
  • FIGs 9 and 9A depict the safe dual chamber injection system (800) after the plunger member (44) and the proximal stopper member (32) coupled thereto have been advanced into the injection system body (34). Due to the in compressibility of the liquid in the proximal drug chamber (40), advancing the plunger member (44) and the proximal stopper member (32) distally advances the distal stopper member (36) distally into the injection system body (34). As shown in Figure 9A, the needle proximal end (53) is partially positioned in the longitudinal space (2130) adjacent the ball (2110). The ball (2110) is still in the lodged state, and the ball valve (2100) is in the corresponding closed state.
  • FIGs 10 and 10A depict the safe dual chamber injection system (800) after the plunger member (44), the proximal stopper member (32) coupled thereto, and the distal stopper member (36) have been advanced further into the injection system body (34).
  • the needle proximal end (53) is pushing the ball (2110) partially out of the longitudinal space (2130).
  • the ball (2110) is transitioning from the lodged state to the dislodged state, and the ball valve (2100) is transitioning from the corresponding closed state to the corresponding open state.
  • FIGs 11 and 11A depict the safe dual chamber injection system (800) after the plunger member (44), the proximal stopper member (32) coupled thereto, and the distal stopper member (36) have been advanced still further into the injection system body (34).
  • the needle proximal end (53) has pushed the ball (2110) out of the longitudinal space (2130).
  • the ball (2110) is still in the flow path through the distal stopper member (36) and partially occludes the flow path.
  • the ball valve (2100) is continuing to transition from the corresponding closed state to the corresponding (fully) open state.
  • FIGs 12 and 12A depict the safe dual chamber injection system (800) after the plunger member (44), the proximal stopper member (32) coupled thereto, and the distal stopper member (36) have been advanced yet further into the injection system body (34).
  • the needle proximal end (53) has pushed the ball (2110) out of the longitudinal space (2130), and fluid flow through the flow path in the distal stopper member (36) has pushed the ball (2110) out of the flow path and into a side of the ball trap (2120).
  • the ball (2110) no longer occludes the flow path.
  • the ball (2110) has transitioned from the lodged state to the dislodged state, the ball valve (2100) has transitioned from the corresponding closed state to the corresponding open state. In this configuration, there is very low resistance to fluid flow through the ball valve (2100).
  • Figure 13 depicts the safe dual chamber injection system (800) after the plunger member (44) and the proximal stopper member (32) coupled thereto have been advanced still further into the injection system body (34). Due to the opening of the ball valve (2100) the fluid in the proximal drug chamber (40, see Figure 12) moves through the flow path in the distal stopper member (36). In Figure 13, all of the fluid in the proximal drug chamber (40) has moved through the ball valve (2100) and the flow path in the distal stopper member (36) to the distal drug chamber (42).
  • Figures 14 and 14A depict the safe dual chamber injection system (800) after the plunger member (44), the proximal stopper member (32) coupled thereto, and the distal stopper member (36) have been advanced yet further into the injection system body (34). As shown in Figure 14A, the needle proximal end (53) has advanced further into the ball trap (2120), thereby retaining the ball (2110) in a side of the ball trap (2120).
  • FIGs 15 and 15A depict the safe dual chamber injection system (800) after the plunger member (44), the proximal stopper member (32) coupled thereto, and the distal stopper member (36) have been advanced still further into the injection system body (34). Advancement of the distal stopper member (36) ejects a mixed liquid from the distal drug chamber (42) out of the injection system (800) through the sharp needle distal end (48). As shown in Figure 15A, the needle proximal end (53) has pierced the proximal stopper member (32).
  • Figure 16 depicts the safe dual chamber injection system (800) after the plunger member (44), the proximal stopper member (32) coupled thereto, and the distal stopper member (36) have been advanced yet further into the injection system body (34).
  • the distal stopper member (36) continues to eject a mixed liquid from the distal drug chamber (42) out of the injection system (800) through the sharp needle distal end (48).
  • the needle proximal end (53) continues to advance into the plunger member (44) and the needle retraction system (1000) contained within the plunger housing member (69).
  • Figure 17 depicts the safe dual chamber injection system (800) after the plunger member (44), the proximal stopper member (32) coupled thereto, and the distal stopper member (36) have been advanced still further into the injection system body (34).
  • the distal stopper member (36) continues to eject substantially all of the mixed liquid from the distal drug chamber (42) out of the injection system (800) through the sharp needle distal end (48).
  • the needle proximal end (53) continues to advance into the plunger member (44) and the needle retraction system (1000) contained within the plunger housing member (69).
  • the needle proximal end (53) has been captured by the needle retention member (1010) and is in contact with the actuating member (1040).
  • Figure 18 depicts the safe dual chamber injection system (800) after the plunger member (44), the proximal stopper member (32) coupled thereto, and the distal stopper member (36) have been advanced yet further into the injection system body (34).
  • the needle proximal end (53) continues to advance into the plunger member (44) and the needle retraction system (1000) contained within the plunger housing member (69).
  • the needle proximal end (53) has been captured by the needle retention member (1010) and has moved the actuating member (1040) to release the energy-storage member/spring latching member (1030) and the energy-storage member/spring (1020) operatively coupled thereto.
  • Figure 19 depicts the safe dual chamber injection system (800) after the released the energy-storage member/spring latching member (1030) allows the energy-storage member/spring (1020) operatively coupled thereto to begin retracting the needle member (50) proximally via the interaction between the needle proximal member (53) captured by the needle retention member (1010).
  • Figure 20 depicts the safe dual chamber injection system (800) after the released energy-storage member/spring (1020) has completely retracted the needle member (50) proximally via the interaction between the needle proximal member (53) captured by the needle retention member (1010).
  • the sharp needle distal end (48) is disposed in the injection system body (34), thereby rendering the injection system (800) safe for disposal.
  • Figures 21 and 22 are detailed longitudinal cross-sectional views illustrating various aspects of a distal stopper member (36) with a ball (2110) disposed therein for use with a safe dual chamber injection system (800, see e.g., Figure 8) according to some embodiments.
  • the ball (2110) is omitted for clarity.
  • the distal stopper member (36) includes a ball valve (2100), which in turn includes a ball (2110), a longitudinal space (2130), and a ball trap (2120).
  • the ball (2110) is a conventional 2 mm metal ball available through medical device supply channels.
  • the longitudinal space (2130) includes a plurality of inwardly extending centering ribs (2122) and a corresponding plurality of flow channels (2124).
  • the plurality of centering ribs (2122) are configured to align the needle proximal end (53) in the longitudinal space (2130) to aim the needle proximal end (53) at a center of the ball (2110) to facilitate dislodging the ball (2110) from the proximal end (2121) of the longitudinal space (2130) without the needle proximal end (53) slipping off center.
  • Each of the plurality of flow channels (2124) is defined between a pair of adjacent centering ribs (2122) as shown in Figures 23A and 24B.
  • the plurality of flow channels (2124) facilitate fluid flow around an outer diameter of the needle member (50) when the ball valve (2100) is in an open state.
  • the plurality of centering ribs (2122) also define a corresponding plurality of rib recesses (2126) at respective proximal ends thereof.
  • the longitudinal space (2130) also includes a plurality of inwardly extending exit ribs (2128) at a proximal end (2121) of the longitudinal space (2130) .
  • the rib recesses (2126) and the exit ribs (2128) cooperate to hold the ball (2110) in the proximal end (2121) of the longitudinal space (2130) when the ball is in the lodged state and the ball valve (2100) is in the closed state.
  • the distal stopper member (36) also defines a distally facing funnel
  • each flow channel (2124) is configured to push the needle proximal end (53) radially out of the flow channel (2124) and into the radial center of the longitudinal space (2130) defined by the centering ribs (2122). While the distal stopper member (36) depicted in some Figures 21 to 24B include a plurality of centering ribs (2122), in other embodiments the distal stopper does not include centering ribs.
  • the ball trap (2120) is defined by a plurality of ball trap flaps (2132) at a proximal end thereof.
  • the plurality of ball trap flaps (2132) also define a corresponding plurality of ball trap slots (2134), with each ball trap slot (2134) disposed between a pair of ball trap flaps (2132) as shown in Figure 23B.
  • the plurality of ball trap flaps (2132) are configured to hold the ball (2110) in the ball trap (2120) when the ball (2110) is in the dislodged state, and the ball valve (2100) is in the corresponding open state.
  • the ball trap flaps (2132) and ball trap slots (2134) are also configured to facilitate removal of a metal core used in the molding process to form the ball trap (2120) after completion of the molding process.
  • Figures 25 to 32 depict various aspects of syringe based dual chamber safe injection systems including a ball valve according to some embodiments.
  • Figures 25 to 27 are distal perspective, detailed distal perspective cross-sectional, and detail distal perspective views illustrating various aspects of a syringe based dual chamber safe injection system (2500) according to some embodiments.
  • the injection system (2500) depicted in Figures 25 to 27 is almost identical to the injection system (800) depicted in Figures 8 to 20.
  • injection system (2500) includes a conventional off-the-shelf pre-filled syringe body (34) with a conventional proximal stopper member (32) and a distal stopper member (2536) disposed therein.
  • the proximal and distal stopper members (32, 2536) together with the syringe body (34) define proximal and distal drug chambers (40, 42).
  • the proximal and distal stopper members (32, 2536) define the proximal and distal ends of the proximal drug chamber (40).
  • the distal stopper member (2536) defines a proximal end of the distal drug chamber (42).
  • a needle hub assembly (606) is disposed at the distal end of the distal drug chamber (42) with a needle cover member (63) installed for storage.
  • the dual chamber safe injection system (2500) controls transfer of a first drug component from the proximal drug chamber (40) to the distal drug chamber (42) and exit of a combined/mixed drug from the distal drug chamber (42) distally subject to sequential insertion of a plunger member relative to the syringe body (34) to various degrees by a user.
  • the plunger member includes the proximal stopper member (32), a plunger housing member (69) and a plunger manipulation interface (128) (see e.g., Figure 7A).
  • the only difference between injection systems (2500, 800) is the ball valve (2600) in the injection system (2500) depicted in Figures 25 to 27.
  • the distal stopper member (2536) in the injection system (2500) includes a ball (2610), a ball trap (2620), a longitudinal space (2630), and a funnel insert (2640).
  • the ball (2610) and the ball trap (2620) are similar to the corresponding ball (2110) and ball trap (2120) in the ball valve (2100) depicted in Figures 21 to 24B.
  • the ball trap (2620) includes ball trap flaps (2622) separated by ball trap slots (2624) as shown in Figures 28 and 29.
  • Figure 26 depicts another centering/alignment embodiment including a funnel insert (2640) configured to guide a needle proximal end (53) into the longitudinal space (2630) and align the needle proximal end (53) therein during use of the injection system (800).
  • the funnel insert (2640) grips the needle proximal end (53) tightly to accurately guide/center/align it in the longitudinal space (2630).
  • this close grip between the funnel insert (2640) and the needle proximal end (53) partially blocks liquid flow during liquid transfer.
  • a large space (2650) is provided between the funnel insert (2640) and the elastic/rubber distal stopper member (2536) to allow the liquid to flow around this partial blockage.
  • the funnel insert (2640) depicted in Figures 25-27 grips the needle proximal end (53) tightly
  • the funnel insert defines a central opening having an inner diameter larger than an outer diameter of the needle proximal end (53). In such other embodiments, the funnel insert does not grip the needle proximal end tightly.
  • the funnel insert is configured to further increase liquid flow (see e.g., Figures 37- 40).
  • ball valve (2600) includes a funnel insert (2640).
  • the body of the distal stopper member (2536) may be made from an elastic material and the funnel insert (2640) may be made from a rigid material (e.g., plastic) to facilitate placement of the funnel insert (2640) into an annular channel (2550) in the distal stopper member (2536) as shown in Figures 26 and 30.
  • the funnel insert is configured to be placed in the distal stopper member using other mechanisms (see e.g., Figures 37-40).
  • the funnel insert (2640) includes a plurality of funnel flaps (2642) defining and separated by a respective plurality of funnel channels (2644).
  • the pluralities of funnel flaps (2642) and funnel channels (2644) are configured to guide a needle proximal end (53) into the longitudinal space (2630) to dislodge the ball (2610) in a similar manner as shown for the ball valve (2100) in Figures 11 to 12A. Dislodging the ball (2610) moves the ball from a lodged state to a dislodged state and the ball valve (2600) from a closed state to an open state.
  • the funnel channels (2644) in the funnel insert (2640) of ball valve (2600) allow the funnel flaps (2642) to deform around a needle proximal end (53) to center and align the needle proximal end (53).
  • the funnel channels (2644) also provide a flow path for the fluid to flow out of the space (2650) between the distal stopper member (2536) and the funnel insert (2640).
  • Embodiments including a funnel insert (2640) may be used for delivering viscous liquids, where a larger flow channel is preferred, and a larger ball and longitudinal space may be used.
  • the funnel insert is configured to further increase liquid flow (see e.g., Figures 37-40).
  • Figure 31 is a side view illustrating various aspects of a needle (50) for use with safe syringe based dual chamber injection systems (700, 800, 2500) according to some embodiments.
  • Figure 32 is a side view illustrating various aspects of a needle (50) and a funnel insert (2640) for use with safe syringe based dual chamber injection systems (2500) according to some embodiments.
  • Figures 33, 33A, 34, 35, and 36 depict various aspects of a syringe based dual chamber safe injection system (3300) including a ball valve (2100’) according to some embodiments.
  • Figures 33 and 33A are distal and detailed distal perspective views illustrating various aspects of the safe syringe based dual chamber injection system (3300) and a distal stopper member (3336) for use with same according to some embodiments.
  • Figure 34 is a distal axial view illustrating various aspects of the distal stopper member (3336) for use with the safe syringe based dual chamber injection system (3300) according to some embodiments.
  • Figure 35 is a detailed perspective cross-sectional view illustrating various aspects of the safe syringe based dual chamber injection system (3300) and distal stopper member (3336) for use with same according to some embodiments.
  • Figure 36 is a distal perspective view illustrating various aspects of a funnel insert (3340) for use with the distal stopper member (3336) in the safe syringe based dual chamber injection system (3300) according to some embodiments.
  • the injection system (3300) depicted in Figures 33-36 is almost identical to the injection system (2500) depicted in Figures 25 to 27 and the injection system (800) depicted in Figures 8 to 20.
  • injection system (3300) includes a conventional off-the-shelf pre-filled syringe body (34) with a conventional proximal stopper member (32) and a distal stopper member (3336) disposed therein.
  • the proximal and distal stopper members (32, 3336) together with the syringe body (34) define proximal and distal drug chambers (40, 42).
  • the proximal and distal stopper members (32, 3336) define the proximal and distal ends of the proximal drug chamber (40).
  • the distal stopper member (3336) defines a proximal end of the distal drug chamber (42).
  • a needle hub assembly (606) is disposed at the distal end of the distal drug chamber (42) with a needle cover member (63) installed for storage.
  • the dual chamber safe injection system (3300) controls transfer of a first drug component from the proximal drug chamber (40) to the distal drug chamber (42) and exit of a combined/mixed drug from the distal drug chamber (42) distally subject to sequential insertion of a plunger member relative to the syringe body (34) to various degrees by a user.
  • the only difference between injection systems (3300, 2500) is the funnel insert (3340) in the injection system (3300) depicted in Figures 33 to 36 (vs. the funnel insert (2640) in injection system 2500).
  • the funnel insert (3340) includes a plurality of funnel flaps (3342) defining and separated by a respective plurality of funnel channels (3344).
  • the pluralities of funnel flaps (3342) and funnel channels (3344) are configured to guide a needle proximal end (53) into the longitudinal space (2130) to dislodge the ball in a similar manner as shown for the ball valve (2100) in Figures 11 to 12A.
  • the funnel channels (3344) in the funnel insert (3340) of ball valve (2100’) allow the funnel flaps (3342) to deform around a needle proximal end (53) to center and align the needle proximal end (53).
  • the funnel channels (3344) also provide a flow path for the fluid to flow out of the space between the distal stopper member (3336) and the funnel insert (3340).
  • the difference between the funnel inserts (3340, 2640) is that the funnel insert (3340) includes a plurality of flow channels (3346) to provide an additional flow path for fluid to flow from the proximal drug chamber (40) to the distal drug chamber (42), thereby increasing fluid flow.
  • the fluid flows from the proximal drug chamber (40) out of the space between the distal stopper member (3336) and the funnel insert (3340) and distally through the pluralities of funnel channels (3344) and flow channels (3346).
  • Figures 37, 38, 39, 40, and 41 depict various aspects of a stopper member (3736, see Figures 39, 40, and 41) in a syringe based dual chamber safe injection system including a ball valve (2100”) and a distally facing funnel insert (3740, see Figures 37 and 38) for use with same according to some embodiments.
  • Figures 37 and 38 are proximal perspective views a funnel insert (3740) for use with a stopper member (3736, see Figures 39, 40, and 41) in safe syringe based dual chamber injection systems according to some embodiments.
  • Figure 39 is a distal axial view illustrating various aspects of a stopper member (3736) for use with safe syringe based dual chamber injection systems according to some embodiments.
  • Figure 40 and 41 are detailed perspective and detailed perspective cross-sectional views illustrating various aspects of a stopper member (3736) having ball valves (2100”) for use in safe syringe based dual chamber injection systems according to some embodiments.
  • the funnel insert (3740) and the stopper member (3736) may be used with various safe syringe based dual chamber injection systems (e.g., 3300; see Figures 33 and 35).
  • Injection systems with which the funnel insert (3740) and the stopper member (3736) may be used, include a conventional off-the-shelf prefilled syringe body (34) with a conventional proximal stopper member (32) and a distal stopper member (3736) disposed therein (see Figures 33 and 35).
  • the proximal and distal stopper members (32, 3736) together with the syringe body (34) define proximal and distal drug chambers (40, 42).
  • the proximal and distal stopper members (32, 3736) define the proximal and distal ends of the proximal drug chamber (40).
  • the distal stopper member (3736) defines a proximal end of the distal drug chamber (42).
  • a needle hub assembly (606) is disposed at the distal end of the distal drug chamber (42) with a needle cover member (63) installed for storage.
  • the dual chamber safe injection system (3300) controls transfer of a first drug component from the proximal drug chamber (40) to the distal drug chamber (42) and exit of a combined/mixed drug from the distal drug chamber (42) distally subject to sequential insertion of a plunger member relative to the syringe body (34) to various degrees by a user.
  • funnel insert (3740) and the stopper member (3736) depicted in Figures 37-41 are similar to the funnel insert (3340) and the stopper member (3336) in Figures 33 to 36.
  • a difference between funnel inserts (3340 and 3740) is that funnel insert (3740) defines a central opening (3748) sized and shaped to allow a needle proximal end feature to pass therethrough, whereas the central opening in the funnel insert (3340) is sized and shaped to prevent a needle proximal end feature (53, see e.g., Figure 35) from passing therethrough until the funnel flaps (3342) open.
  • the funnel insert (3740) includes a continuous cone (3742), which does not need to open to allow the needle proximal end feature (53) to pass through the central opening (3748).
  • the central opening (3748) affects alignment of the needle proximal end feature (53)
  • the central opening (3748) is sized and shaped to allow the needle proximal end feature (53) to pass therethrough while directing the needle proximal end feature (53) toward the ball (2110, see e.g., Figure 35) to dislodge the ball (2110) in a similar manner as shown for the ball valve (2100) in Figures 11 to 12A.
  • the funnel insert (3740) also has a plurality (e.g., three) of ribs (3741) configured to support the funnel insert (3740) in the distal stopper member (3736, see Figures 40 and 41).
  • the funnel insert (3740) and the distal stopper member (3736) together define a plurality of arcuate slots (3746) adjacent an outer circumference of the funnel insert (3740) configured to provide low liquid flow resistance through the distal stopper member (3736).
  • the funnel insert (3740) may be formed from a plastic material while the distal stoper member (3736) may be formed form an elastic material (e.g., rubber) such that the plurality of ribs (3741 ) can elastically deform the distal stopper member to form a cylindrical space (2125) behind the plurality of arcuate slots (3746) to facilitate liquid flow (3748, see Figure 40). Forming the funnel insert (3740) from a plastic material also minimizes cracking.
  • an elastic material e.g., rubber
  • Plastic materials from which the funnel insert (3740) may be formed include polymer material such as cyclic olefin polymer (COP) or cyclic olefin copolymer (COC).
  • the funnel insert (3740) may be formed from other polymer materials, metal, ceramic, or glass, materials, or a combination thereof.
  • Elastic materials from which the distal stopper member (3736) may be formed include one or more of the following materials: rubber, butyl rubber, chlorobutyl rubber, bromobutyl rubber, thermoplastic elastomer (TPE), thermoplastic urethane (TPU) silicone rubber, thermoplastic, Polytetrafluoroethylene (PTFE), thermoset plastic.
  • the distal stopper member (3736) includes a ball valve (2100”).
  • the ball valve (2100”) includes a ball (2110), a ball trap (2120), a longitudinal space (2130), and the cylindrical space (2125).
  • the ball (2110) has lodged and dislodged states corresponding to respective closed and open states of the ball valve (2100”). In the lodged state, the ball (2110) is disposed/held in a proximal end of the longitudinal space (2130). In the lodged state, the ball (2110) occludes the longitudinal space (2130), thereby preventing fluid flow therethrough and effectively closing the ball valve (2100”).
  • the ball (2110) In the dislodged state (see Figures 40 and 41), the ball (2110) is disposed in the ball trap (2120). In the dislodged state, the ball (2110) no longer occludes the longitudinal space (2130), allowing fluid flow through the distal stopper member (3736) and effectively opening the ball valve (2100”). With the ball 2110) in the dislodged state, the longitudinal space (2130) and the ball trap (2120) form a flow path (3748) through the distal stopper member (36).
  • prefilled dual chamber safety injection systems depicted and described herein include syringes with staked needles
  • the various configurations/embodiments described herein e.g., serial injection, detent dual chamber, threaded plunger member, and shielded and vented needle cover
  • cartridges can be used with cartridges, auto injectors, and injection systems with Luer connectors, transfer pipes, 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 may be used in connection with 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.
  • hydrophilic polymers such as polyvinylpyrrolidone-based compositions, fluoropolymers such as tetrafluoroethylene, PTFE, ETFE, hydrophilic gel or silicones

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

Abstract

Un système d'injection comprend un corps de système d'injection, un élément d'arrêt proximal et un élément d'arrêt distal, l'élément d'arrêt proximal, l'élément d'arrêt distal et le corps de système d'injection formant des chambres de médicament proximale et distale. Le système comprend en outre un élément de piston conçu pour insérer l'élément de butée proximale par rapport au corps de système d'injection. De plus, le système comprend un ensemble raccord d'aiguille accouplé au corps de seringue au niveau de l'extrémité distale du corps de seringue, et comprenant un raccord d'aiguille et une aiguille. L'élément d'arrêt distal comprend une bille ayant un état logé et un état délogé. Lorsque la bille est dans l'état logé, la bille forme une barrière ouvrable entre les chambres de médicament proximale et distale. L'élément d'arrêt distal est conçu pour permettre sélectivement l'écoulement de la chambre de médicament proximale vers la chambre de médicament distale.
PCT/US2025/028399 2024-05-10 2025-05-08 Système et méthode d'injection Pending WO2025235758A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463645709P 2024-05-10 2024-05-10
US63/645,709 2024-05-10

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2688966A (en) * 1951-10-06 1954-09-14 Huber Jennie Compartmented ampoule
US3326215A (en) * 1963-12-16 1967-06-20 Sarnoff Two compartment syringe with vapor seal between compartments
US20160296703A1 (en) * 2013-11-05 2016-10-13 3P Innovation Limited A Pharmaceutical Component-Mixing Delivery Assembly
WO2023196173A1 (fr) * 2022-04-04 2023-10-12 Becton, Dickinson And Company Seringue multi-chambres avec valve de pression pour l'administration successive de fluides et procédés d'utilisation
US11844931B2 (en) * 2018-06-08 2023-12-19 Credence MedSystems System and method for safety syringe
WO2024042068A1 (fr) * 2022-08-22 2024-02-29 Kevin Abbott Dispositif pour récipient de distribution de fluide

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2688966A (en) * 1951-10-06 1954-09-14 Huber Jennie Compartmented ampoule
US3326215A (en) * 1963-12-16 1967-06-20 Sarnoff Two compartment syringe with vapor seal between compartments
US20160296703A1 (en) * 2013-11-05 2016-10-13 3P Innovation Limited A Pharmaceutical Component-Mixing Delivery Assembly
US11844931B2 (en) * 2018-06-08 2023-12-19 Credence MedSystems System and method for safety syringe
WO2023196173A1 (fr) * 2022-04-04 2023-10-12 Becton, Dickinson And Company Seringue multi-chambres avec valve de pression pour l'administration successive de fluides et procédés d'utilisation
WO2024042068A1 (fr) * 2022-08-22 2024-02-29 Kevin Abbott Dispositif pour récipient de distribution de fluide

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