WO2017053175A1 - Stylo d'injection à reconstitution de substance sèche par voie humide - Google Patents

Stylo d'injection à reconstitution de substance sèche par voie humide Download PDF

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Publication number
WO2017053175A1
WO2017053175A1 PCT/US2016/052024 US2016052024W WO2017053175A1 WO 2017053175 A1 WO2017053175 A1 WO 2017053175A1 US 2016052024 W US2016052024 W US 2016052024W WO 2017053175 A1 WO2017053175 A1 WO 2017053175A1
Authority
WO
WIPO (PCT)
Prior art keywords
chamber
drive rod
stops
plunger
state
Prior art date
Application number
PCT/US2016/052024
Other languages
English (en)
Inventor
Annaniy Berenshteyn
Jeffrey C. GIVAND
Original Assignee
Merck Sharp & Dohme Corp.
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 Merck Sharp & Dohme Corp. filed Critical Merck Sharp & Dohme Corp.
Publication of WO2017053175A1 publication Critical patent/WO2017053175A1/fr

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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
    • A61M5/28—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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/3157—Means providing feedback signals when administration is completed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M2005/3132—Syringe barrels having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
    • 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
    • A61M5/31501—Means for blocking or restricting the movement of the rod or piston
    • A61M2005/31508—Means for blocking or restricting the movement of the rod or piston provided on the 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback

Definitions

  • the present invention relates generally to the field of injection pens designed to deliver a single dose of a drug, and more particularly to single-dose injection pens that use dual chamber cartridges.
  • Dual chamber cartridges also known as dual chamber syringes, are cylindrically shaped glass or plastic vessels containing three partitions that are spaced apart to provide two air- and water-tight chambers.
  • a front partition configured to accept and hold a hypodermic needle.
  • a lyophilized substance chamber which contains a lyophilized (or "fireeze- dried") compound, such as a drug.
  • a middle partition which separates the lyophilized substance chamber from a diluent chamber containing a diluent for the lyophilized drug, such as sterilized water.
  • the purpose of the middle partition is to isolate the lyophilized drug in the lyophilized substance chamber from the diluent in the diluent chamber until just before the drug is to be administered to a patient.
  • a rear partition is located behind the diluent chamber, on the end of the cartridge opposite from the front partition.
  • the dual chamber cartridge also includes a bypass channel, which fluidly couples the diluent chamber to the lyophilized substance chamber, which permits the diluent in the diluent chamber to flow into the lyophilized substance chamber when the middle and rear partitions are forced to slide toward the front partition as a result of an external force applied to the rear partition.
  • a dual chamber cartridge that is pre-filled with a diluent and lyophilized drug compound is inserted into an injection pen, which can then be operated by a patient or healthcare provider to produce the external forces required to push the rear and middle partitions toward the front partition.
  • the movement of the middle and rear partitions toward the front partition causes the middle partition to pass underneath the bypass channel in the wall of the cartridge so that the diluent in the diluent chamber flows around the middle partition via the bypass channel and mixes with the lyophilized substance in the lyophilized substance chamber.
  • dual chamber cartridges are considered to have at least three operational states during administration.
  • the dual chamber cartridge when the diluent flows into the lyophilized substance chamber to mix with the lyophilized substance, the dual chamber cartridge is considered to be in a reconstitution state.
  • the dual chamber cartridge When a sufficient amount of the reconstituted solution is forced out of the lyophilized substance chamber and into the needle, thereby removing all of the air from the needle, the dual chamber cartridge is considered to be in the primed state.
  • a significant amount of the reconstituted solution remains in the lyophilized substance chamber while the dual chamber cartridge is in the primed state.
  • the dual chamber cartridge when substantially all of the reconstituted solution has been forced out of the lyophilized substance chamber and into the patient, the dual chamber cartridge may be considered to be in the injected state, which means the patient has received a complete dose of the reconstituted solution.
  • Conventional injection pens for use with pre-filled dual chamber cartridges typically include a considerable number of complex mechanical parts that must be precisely manufactured, assembled and calibrated to interact with each other in order to safely and reliably mix the drug solutions inside the cartridges and deliver the proper doses of medication to patients.
  • Conventional automatic injectors also called “auto-injectors”
  • auto-injectors are typically spring-loaded, and usually include half a dozen or more other precision-molded and/or machined parts that must be carefully assembled and tuned with the spring mechanism in order to reliably operate as intended in the hands of patients. Consequently, manufacturing, assembling and testing all of the complex parts for conventional manual injection pens and auto-injectors is both time consuming and expensive.
  • an injection pen for use with a dual chamber cartridge, the dual chamber cartridge having a chamber and partition system with a plurality of operational states, including at least a reconstitution state, a primed state and an injected state (although more operational states are possible).
  • the injection pen includes a tubular housing, a plunger slidably supported within the tubular housing, and a state control system, the state control system comprising one or more detents and a plurality of stops configured to temporarily suspend the axial travel of the plunger as the plunger moves axially though the body of the tubular housing in response to an external force applied to one end of the plunger.
  • the state control system suspends the axial travel of the plunger as the axial travel of the plunger through the tubular housing causes the dual chamber cartridge to successively change operational states.
  • the tubular housing comprises an internal cavity configured to receive and hold both the dual chamber cartridge and a substantial portion of the plunger.
  • the plunger which comprises a drive rod and a thumb rest, is slidably supported within the tubular housing so that the drive rod abuts the rear end of the chamber and partition system inside the internal cavity.
  • the tubular housing and the plunger are also configured to permit the drive rod of the plunger to travel through the axis of the tubular housing from a starting position within the internal cavity to a final position within the internal cavity in response to an external force applied to the thumb rest.
  • the external force is supplied by a human user using his or her thumbs or fingers to press on the thumb rest, thereby forcing the drive rod and the body of the plunger to slide further into the body of the tubular housing while pressing against and moving the rear partition of the chamber and partition system, and thereby forcing the dual chamber cartridge to change operational states.
  • the axial travel of the drive rod from the starting position to the final position inside the internal cavity forces the dual chamber cartridge inside the internal cavity to undergo changes in in its operational state because the drive rod constantly abuts the chamber and partition system of the dual chamber cartridge as it travels further into the internal cavity of the tubular housing.
  • the travel of the drive rod forces the dual chamber cartridge to successively enter at least three operational states, including a reconstitution state, a primed state and an injected state (although other operational states are also possible).
  • the travel of the drive rod may force the dual chamber cartridge to enter and/or pass through four, five or more distinct operational states, depending on the particular geometry of the dual chamber cartridge and/or the particular steps required to reconstitute and administer a particular drug.
  • the state control system comprises at least one detent and a plurality of stops.
  • the detent and the plurality of stops may be located on the inside wall of the tubular housing, on the outside wall of the plunger, or both on the inside wall of the tubular housing and the outside wall of the plunger.
  • the detent is configured to engage with and disengage from each stop in the plurality of stops as the drive rod travels axially through the body of the tubular housing from the starting position to the final position inside the internal cavity.
  • the axial_travel of the drive rod is temporarily suspended (halted) in order to permit the dual chamber cartridge to perform a necessary step, such as mixing the diluent with the lyophilized drug, or to permit the user to perform a necessary step, such as attaching the needle or inserting the tip of the needle into the user's body.
  • the detent and the plurality of stops are precisely spaced apart on opposite facing walls of the tubular housing and the plunger so that the detent will engage each stop in the plurality of stops, and therefore suspend the axial travel of the drive rod and plunger, whenever the drive rod has traveled a sufficient distance to force the chamber and partition system of the dual chamber cartridge into a new operational state.
  • the plurality of stops includes at least three stops that are positioned at the three specific locations on the tubular housing or the plunger to cause the axial travel of the drive rod to be temporarily suspended at least three times; the first time being when the chamber and partition system of the dual cartridge chamber reaches the reconstitution state, the second time being when the chamber and partition system of the dual cartridge chamber reaches the primed state, and the third time being when chamber and partition system of the dual cartridge chamber reaches the injected state.
  • the engagement between the detent and the stops temporarily suspends the axial travel of the drive rod and does not necessarily suspend or affect the rotational movement of the drive rod relative to the tubular housing.
  • the plurality of stops in the state control system of the present invention may also include additional stops that are positioned on the tubular housing or the plunger so as to engage with the detent to suspend the axial travel of the drive rod and plunger based at least in part on the relative positions of the tubular housing and plunger, or predefined steps to be carried out by the user. Such predefined steps may need to be carried out while the chamber and partition system of the dual chamber cartridge remains in the current operational state, or otherwise carried out while the chamber and partition system is in transition between two operational states.
  • the plurality of stops may include a stop that suspends the axial travel of the drive rod and plunger when the primary parts of the injection pen (i.e., the tubular housing and the plunger) are correctly assembled.
  • the plurality of stops includes a "ready" stop that engages with the detent to stop the axial travel of the drive rod and the plunger when the dual chamber cartridge and the plunger have been properly inserted and secured inside the interior cavity of the tubular body by the user.
  • the engagement of the detent with the ready stop effectively secures the plunger inside the tubular housing without permitting the axial travel of the drive rod to alter the operational state of the dual chamber cartridge.
  • the injection pen, the dual chamber cartridge, or both the injection pen and dual chamber cartridge may be considered to be in a "ready to use" operational state.
  • injection pens configured to operate in accordance with the present invention may also include stops to suspend the axial travel of the drive rod and plunger for purposes other than readiness, reconstitution, priming or injection.
  • an additional stop may be necessary or desirable so that the axial travel of the drive rod will be temporarily suspended at a position corresponding to the time when the user should attach the hypodermic needle to the front partition of the dual chamber cartridge.
  • the hypodermic needle should be attached after the chamber and partition system has completed the reconstitution step and before the chamber and partition system begins the priming step.
  • embodiments of the injection pen of the present invention may include a needle attachment stop configured to temporarily halt the axial travel of the drive rod after the chamber and partition system of the dual chamber cartridge leaves the reconstitution state and before it enters the primed state.
  • the detent of the state control system may be implemented using a variety of different mechanical engagement devices and constructs, including without limitation, a protruding ring, or rib, or rail, or flange, or outcrop, or catch, or latch, or hook, or step, or ridge, or notch, or some combination of two or more of such devices or constructs.
  • the plurality of stops in the state control system may be implemented using a variety of different mechanical engagement devices or constructs, including without limitation, a plurality of depressions, a plurality of grooves, a plurality of holes, a plurality of pockets, a plurality of channels, a plurality of tracks, a plurality of cutouts, a plurality of dimples, a plurality of gaps, a plurality of notches, a plurality of openings, a plurality of recesses, a plurality of slots, a plurality of slits, or some combination of two or more of such devices or constructs.
  • the plurality of stops is located on an inward-facing wall of the internal cavity of the tubular housing, and the detent is connected to an outward- facing wall of the plunger, so that the axial travel of the drive rod on the plunger will stop when the detent on the plunger catches against the stops on the tubular housing.
  • the locations of the detent and stops may be reversed, so that the detent is connected to an inward-facing wall of the internal cavity of the tubular housing, and the plurality of stops is located on an outward-facing wall of the plunger.
  • the state control system may comprise a single detent configured to engage with each stop in the plurality of stops as the drive rod travels axially through the internal cavity of the tubular housing from the starting position to the final position.
  • the state control system may include a plurality of detents configured to engage with and disengage from a plurality of stops, respectively, as the drive rod travels axially from the starting position to the final position inside the internal cavity of the tubular housing.
  • the detent, or the plurality of detents may be attached to the tubular housing or the plunger via one or more resilient and flexible arms configured to force the detent to engage with and disengage from each stop in the plurality of stops as the detent passes over each stop.
  • the state control system of detents and stops is further configured to prevent the drive rod from backtracking, i.e., moving back toward the starting position of the drive rod inside the internal cavity, after the chamber and partition system has entered the reconstitution state, or the needle attachment state, or the primed state, or the injected state.
  • the part of the detent that comes into contact with the stops may be suitably tapered and suitably angled to allow the detent to disengage from the stops if the plunger is moving in a forward direction (i.e., toward the needle end of the injection pen), but preventing the detent from disengaging from the stops if the plunger is moving in the opposite direction (away from the needle end of the injection pen). This feature prevents the user from accidently pulling air into the needle after the needle is primed and before injection, and also prevents the user from pulling a portion of the drug or bodily fluids out of the injection site on the patient's body during or after delivery of the full dose.
  • the detents and stops of the state control system are further configured to provide audible, visual or tactile signals or cues for the user whenever the detent engages with a stop in the plurality of stops.
  • the audible, visual and/or tactile feedback indicates to the user that the device has achieved, or is ready to achieve, the next step in the process of administering the drug.
  • the geometries of the detent and the stops may be constructed so that the engagement of the detent with the stops produces a "snapping" or "clicking" sound of sufficient volume to be heard by the user. Materials of various construction, elasticity and strength may be specifically selected for their abilities to produce and/or magnify these sounds.
  • the detents and stops could also have contrasting shapes, colors or textures such that, when the detent is engaged with a stop, a highly visible change in shape, color or texture will occur in or around the area of the stop to alert the user that the detent and a particular stop (as opposed to a previous stop) is now engaged.
  • the materials and construction of the detent and stops are also suitably selected and configured so that the engagement of the detent with each stop will necessarily cause vibrations or perturbations (i.e., snapping or clicking sensations) in the injection pen, wherein the vibrations and perturbations are easily detected by any user holding and manipulating the injection pen in his or her hands.
  • the tubular housing may also include one or more openings (i.e., windows or voids) that permit the user to visually inspect at least a portion of the dual chamber cartridge while the chamber and partition system is in the reconstitution state and/or the injected state so that the user will be able to tell, based on visual inspection, whether the drug solution has been fully reconstituted (i.e., the lyophilized substance is fully dissolved in the diluent) and/or fully injected.
  • openings i.e., windows or voids
  • embodiments of the present invention may further include one or more longitudinal rails disposed along an inward-facing wall of the internal cavity, and one or more longitudinal grooves disposed along an outward-facing wall of the plunger.
  • the plunger is slidably supported within the tubular housing by coupling the one or more longitudinal rails of the internal cavity to the one or more longitudinal grooves of the plunger.
  • the longitudinal grooves may instead be disposed along an inward-facing wall of the internal cavity, while the longitudinal rails are disposed along an outward-facing wall of the plunger.
  • injection pen is assembled by coupling the longitudinal groove of the interior cavity to the longitudinal rail of the plunger.
  • FIGs. 1 and 2 show a perspective view and a front elevation view
  • FIGs. 3 A and 3B show a perspective view and a cross-sectioned view, respectively, of a dual chamber cartridge that might be used in an injection pen configured to operate in accordance with one embodiment of the present invention.
  • FIGs. 4A and 4B show a perspective view and a side elevation view, respectively, of the tubular housing in one embodiment of the injection pen of the present invention.
  • FIGs. 5 A and 5B show a perspective view and a side elevation view, respectively, of a plunger in one embodiment of the injection pen of the present invention.
  • FIG. 6 shows a perspective view of an embodiment of the injection pen in its disassembled condition according to one embodiment of the present invention.
  • FIG. 7 shows a cross-sectioned view of an embodiment of the injection pen in its disassembled condition according to one embodiment of the present invention.
  • FIG. 8 shows a cross-sectioned view of an embodiment of the injection pen in its assembled condition according to one embodiment of the present invention.
  • FIG. 9 shows an embodiment of the injection pen of the present invention, in which the detent on the plunger is engaged with the "ready" stop on the tubular housing.
  • FIG. 10 shows an embodiment of the injection pen of the present invention, in which the detent on the plunger is engaged with the "mix" (reconstitution) stop on the tubular housing.
  • FIG. 11 shows an embodiment of the injection pen of the present invention, in which the detent on the plunger is engaged with the "primed” stop on the tubular housing.
  • FIG. 12 shows an embodiment of the injection pen of the present invention, in which the detent on the plunger is engaged with the "injected" stop on the tubular housing.
  • FIGs. 1 and 2 show a perspective view and a front elevation view, respectively, of an injection pen configured to operate according to one embodiment of the present invention.
  • the injection pen 100 includes a tubular housing 200 and a plunger 300.
  • the tubular housing 200 has an internal cavity 210 configured to receive and hold a pre-filled dual chamber cartridge 500, as well as a substantial portion of the plunger 300.
  • FIGs. 3 A and 3B show a perspective view and a cross-sectioned view, respectively, of an exemplary dual chamber cartridge 500 that could be used in the injection pen 100 depicted in FIGs. 1 and 2. As shown in FIGs.
  • the dual chamber cartridge 500 comprises cylindrically shaped glass or plastic vessel having a chamber and partition system 510.
  • the chamber and partition system 510 includes three partitions, which are spaced apart to provide two individual air- and water-tight chambers.
  • a front partition 580 configured to accept and hold a hypodermic needle 520 in place.
  • a lyophilized substance chamber 530 which contains a lyophilized (or “freeze-dried") compound 545, sometimes called a "lyo-cake.”
  • a middle partition 550 which separates the lyophilized substance chamber 530 containing the lyo-cake 545 from a diluent chamber 540 containing a diluent, such as sterilized water (not shown).
  • the middle partition 550 isolates the lyo-cake 545 contained in the lyophilized substance chamber 530 from the diluent contained in the diluent chamber 540 until just before the drug is to be administered to a patient.
  • a rear partition 560 is located behind the diluent chamber 540, on the end of the dual chamber cartridge 500 opposite from the front partition 580 holding the needle 520.
  • the dual chamber cartridge 500 also includes a bypass channel 570 configured to permit the diluent in the diluent chamber 540 to flow around the middle partition 550 and into the lyophilized substance chamber 530 when the middle partition 550 and rear partition 560 are forced to slide forward in the cylindrical vessel toward the front partition 580 and the needle 520 as a result of an external force F applied to the rear partition 560 lodged in the rear end 565 of the dual chamber cartridge 500.
  • a bypass channel 570 configured to permit the diluent in the diluent chamber 540 to flow around the middle partition 550 and into the lyophilized substance chamber 530 when the middle partition 550 and rear partition 560 are forced to slide forward in the cylindrical vessel toward the front partition 580 and the needle 520 as a result of an external force F applied to the rear partition 560 lodged in the rear end 565 of the dual chamber cartridge 500.
  • FIGs. 4A and 4B show a perspective view and a side elevation view, respectively, of the tubular housing 200.
  • the tubular housing 200 has a plurality of stops 470, 472, 476 and 478, each stop comprising a triangular hole or notch extending through the wall of the tubular housing 200 to intersect with the internal cavity 210.
  • three of the stops (stops 472, 476 and 478) on the tubular housing 200 are ideally labeled with words or abbreviations to show the operational states of the dual chamber cartridge 500 when those three stops are engaged by the detent 410 connected to an outside wall 305 of the plunger 300, as will be described below. See FIGs.
  • FIG. 3 A and 3B for larger and more detailed illustrations of the dual chamber cartridge 500. See FIGs. 5A and 5B for larger and more detailed illustrations of the plunger 300 and detent 410.
  • the plunger 300, the detent 410 and dual chamber cartridge 500 are all depicted together in FIG. 6.
  • stop 472 contains the label "MIX,” to indicate that the dual cartridge chamber 500 will be in the mixing (or reconstitution) state when stop 472 is engaged by the detent 410.
  • Stop 476 is labeled with the word “PRIME” to show that the needle 520 of the dual chamber cartridge 500 is primed when stop 476 is engaged (i.e., the operational state of the dual chamber cartridge 500 is primed).
  • stop 478 is labeled with the word "INJECT" to show that the dual chamber cartridge 500 will be in the injected operational state when stop 478 is engaged with the detent 410 on the plunger 300.
  • the inject stop 478 is positioned along the body of the tubular housing 200 so that, when the inject stop 478 is engaged, the full dose of the drug will have already been injected and it is time to remove the needle from the patient's body. It is understood, however, that alternative embodiments of the present invention may locate the inject stop 478 in a position along the body of the tubular housing so that the position of the inject stop 478 corresponds to the point where the needle is primed and the drug is ready to be injected. In these embodiments, the engagement of the detent with the inject stop 478, combined with the "INJECT" label next to the inject stop 478, are intended to inform the user that it is time to insert the tip of the needle into the patient's body to start the injection. In this case, an additional stop, such as a stop labeled "DONE,” may be added to the body of the tubular housing 200 to indicate when the injection is completed and it is safe to remove the needle from the patient's body.
  • a stop labeled "DONE” may be added to the
  • the tubular housing 200 may also include a fourth label 474, namely "ATTACH NEEDLE,” to remind the user to attach the needle to the injection pen after the mix stop 472 is engaged and before the prime stop 476 is engaged.
  • the attach needle label 474 may (or may not) be accompanied by a physical stop configured to suspend the axial travel of the drive rod 310.
  • the tubular housing 200 also has a finger flange 260 configured to provide leverage to help the user exert force on the plunger 300 to push the plunger 300 further into the internal cavity 210 of the tubular housing 200 in order to reconstitute (mix) the drug, prime the needle and inject the drug into the user's body.
  • FIGs. 5A and 5B show a perspective view and a side elevation view, respectively, of the plunger 300.
  • the plunger 300 has a thumb rest 320 and a drive rod 310.
  • the drive rod 310 extends from the thumb rest 320 substantially through the center of the plunger 300 along the major axis of the plunger 300.
  • the plunger 300 also has an outside wall 305 that is somewhat longer than the drive rod 310, and therefore extends further out from the thumb rest 320 than the drive rod 310.
  • the cylindrically shaped opening created by longer outside wall 305 provides a stable pocket for receiving, surrounding and securing the rear end 565 of the dual chamber cartridge 500 while the drive rod 310 abuts and pushes against the rear partition 560 on the rear end 565 of the dual chamber cartridge 500.
  • the outside wall 305 of the plunger 300 has one or more windows 350 that permit the user to inspect the tip of the drive rod 310 and/or the rear end 565 of the dual chamber cartridge 500.
  • FIG. 6 which shows a perspective view of the injection pen 100 and dual chamber cartridge 500 in their
  • FIG. 7 shows a cross-sectioned view of the disassembled injection pen 100 and dual chamber cartridge 500, together illustrate how the product is to be assembled.
  • the injection pen 100 may be assembled by first inserting the dual chamber cartridge 500 into the internal cavity 210 of the tubular housing 200. Then the end of the plunger 300 that contains the drive rod 310 is inserted into the internal cavity 210 behind the dual chamber cartridge 500 so that the plunger 300 is slidably supported inside the internal cavity 210, and so that the drive rod 310 of the plunger 300 abuts the rear partition 560 inserted into the rear end 565 of the pre-filled dual chamber cartridge 500.
  • a longitudinal groove 340 extends along the length of the outside wall 305 of the plunger 300.
  • the longitudinal groove 340 is configured to receive and engage with a complimentary longitudinal rail 260 extending along the inward-facing wall 240 of the internal cavity 210 of the tubular housing 200. See FIG. 7.
  • the tubular housing 200 also includes a ready stop 470, which, when engaged by the detent 410 on the plunger 300, will tell the patient or health care professional that the plunger 300 is properly inserted into and supported by the internal cavity 210 of the tubular housing 200, and the injection pen 100 is therefore ready to be used to administer the drug contained in the dual chamber cartridge 500.
  • FIGs. 5 A, 5B and 6 show that the detent 410 is connected to the outside wall 305 of the plunger 300 via a resilient arm 415.
  • the resilient arm 415 is flexible enough to bend inward toward the central axis of the plunger 300 whenever the detent 410 is compressed in that direction by virtue of its contact with the inward-facing wall 240 of the tubular housing 200 (i.e., whenever the detent 410 is not engaged with one of the stops 470, 472, 476 or 478 in the inward-facing wall 240 of the internal cavity 210 of the tubular housing 200).
  • the resilient arm 415 is also rigid enough to force the detent 410 to pop back out to its original position whenever the detent 410 slides into one of the stops 470, 472, 476 and 478 in the inward-facing wall of the internal cavity 210 of the tubular housing 200.
  • the detent 410, the resilient arm 415 and the stops 470, 472, 476 and 478 are suitably shaped and constructed from suitably rigid material so as to provide an audible "pop" or "click,” as well as a tactile snapping sensation every time the detent 410 on the plunger 300 engages with one of the stops 470, 472, 476 and 478.
  • the detent 410 also has a color that stands out from the color of the wall of the tubular housing 200, so that users may easily determine with the naked eye which one of the stops 470, 472, 476 and 478 are currently engaged by the detent 410.
  • FIG. 8 shows a cross-sectioned view the injection pen 100 after the injection pen 100 has been assembled and before the injection pen 100 has been activated to alter the operational state of the dual chamber cartridge 500 located inside the interior cavity 210 of the tubular housing 200.
  • the plunger 300 has been inserted into the interior cavity 210 of the tubular housing 200 just far enough so that the detent 410 engages with the ready stop 470 in the inward-facing wall 240 of the tubular housing 200 by snapping into the hole provided by ready stop 470.
  • the snapping action ideally creates an audible click and a perturbation that lets the user know that the plunger 300 is properly set into the tubular housing 200 and that the injection pen 100 is ready to use.
  • the tip of the drive rod 310 is located in the starting position 220 of the internal cavity 210.
  • the user applies a sufficient amount of external force F to the thumb rest 320 on the plunger 300, it increases the pressure applied by the edge of the inward-facing wall 240 of the internal cavity 210 on the tapered wall of the detent 410. This increase in pressure on the tapered wall of the detent 410, combined with the flexibility of the resilient arm 415, causes the detent 410 and the resilient arm 415 to retract into the outside wall 305 of the plunger
  • the resilient arm 415 forces the detent 410 to snap into the hole provided by the reconstitution stop 472, thereby arresting the axial travel of the drive rod 310 and the plunger 300 again.
  • the drive rod 310 of the plunger 300 will have traveled far enough into the internal cavity 210 to force the rear partition 560 and the middle partition 550 far enough along the inside of the dual chamber cartridge 500 to permit the diluent in the diluent chamber 540 to flow into the lyophilized substance chamber 530 to dissolve the lyophilized substance 545.
  • the drive rod 310 will have forced the chamber and partition system of dual chamber cartridge 500 to enter into the reconstitution state.
  • the tip of the drive rod 310 of the plunger 300 will travel all the way to the final position 230 of the internal cavity 210, with the detent 410 successively engaging with the primed stop 476 and the injected stop 478, which correspond with the primed and injected operational states, respectively, of the dual chamber cartridge 500.
  • the exact location of the detent 410 along the body of the plunger 300, as well as the exact locations and spacing of the stops 470, 472, 476 and 478 along the inward-facing wall 240 of the internal cavity 210, are precisely determined in accordance with the geometry of the dual chamber cartridge 500, so that, as the detent 410 engages with each stop in the plurality of stops, the drive rod 310 of the plunger 300 will be precisely positioned so as to put the dual chamber cartridge 500 in the operational state corresponding to the word labels next to each one of the stops on the outside wall of the tubular housing 200.
  • the exact locations of the detent 410 along the body of the plunger 300, and the exact locations of the stops 470, 472, 476 and 478 along the inward-facing wall 240 of the internal cavity 210 may vary significantly depending on the geometry of the dual chamber cartridge 500 to be used in the injection pen 100.
  • dual chamber cartridges containing larger amounts of lyophilized drugs, or larger volumes of diluent may have longer chamber and partition systems. Longer chamber and partition systems require longer dual chamber cartridges, which in turn may require larger spacing between the stops 470, 472, 476 and 478 in the wall of the tubular housing.
  • detents may also comprise, for example, a flexible protruding ring running around the circumference of the plunger, the ring being configured to engage with and disengage from a series of
  • FIG. 9 shows another view of the injection pen 100, wherein the detent 410 attached to the plunger 300 is engaged with the ready stop 470 on the tubular housing to indicate that the injection pen 100 is ready to be operated to administer a drug to a patient.
  • the drive rod 410 in the tubular housing 200 will be located in the starting position 220 of the interior cavity 210.
  • FIG. 10 shows the injection pen 100 from FIG. 9 again, except that, as a result of external force F applied to the thumb rest 320 of the plunger 300, the drive rod 410 and the plunger 300 have moved far enough into the interior cavity for the detent 410 to reach and engage with the reconstitution (mix) stop 472 in the wall of the tubular housing 200.
  • FIG. 11 shows another view of the injection pen 100, in which the detent 410 on the plunger 300 is engaged with the prime stop 476 on the tubular housing 200.
  • FIG. 12 shows the injection pen 100, in which the detent 410 on the plunger 300 is engaged with the injected stop 478 on the tubular housing 200.

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

Abstract

La présente invention concerne un stylo d'injection destiné à être utilisé avec une cartouche à double chambre ayant une chambre et un système de séparation avec une pluralité d'états de fonctionnement, dont au moins un état de reconstitution, un état amorcé et un état injecté. Le stylo d'injection comprend un boîtier tubulaire, un piston, et un système de commande d'état comprenant un ou plusieurs crans et une pluralité d'arrêts. Le piston est supporté de manière coulissante à l'intérieur du boîtier tubulaire, de sorte que la tige d'entraînement du piston vient en butée contre une extrémité de la chambre et du système de séparation et force la cartouche à double chambre à changer d'état de fonctionnement lorsque la tige d'entraînement se déplace axialement dans le boîtier en réponse à une force externe appliquée à l'extrémité opposée du piston. Le cran et la pluralité d'arrêts dans le système de commande d'état suspendent temporairement la course axiale du piston lorsque la cartouche à double chambre entre dans chaque nouvel état de fonctionnement.
PCT/US2016/052024 2015-09-21 2016-09-16 Stylo d'injection à reconstitution de substance sèche par voie humide WO2017053175A1 (fr)

Applications Claiming Priority (2)

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US201562221291P 2015-09-21 2015-09-21
US62/221,291 2015-09-21

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023174668A1 (fr) * 2022-03-14 2023-09-21 Shl Medical Ag Sous-ensemble destiné à un dispositif d'administration de médicaments

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4968299A (en) * 1987-07-02 1990-11-06 Kabivitrum Ab Method and device for injection
US20090287161A1 (en) * 2008-05-15 2009-11-19 Allergan, Inc Metered, multiple dose/aliquot syringe
WO2012118687A1 (fr) * 2011-02-28 2012-09-07 Merck Sharp & Dohme Corp. Injecteur actionné manuellement avec séquence d'injection limitée
US20130035664A1 (en) * 2011-08-05 2013-02-07 Unitract Syringe Pty Ltd Dual chamber mixing device for a syringe
WO2013132192A1 (fr) * 2012-03-08 2013-09-12 Stemcis Seringue pour application médicale
US20140288507A1 (en) * 2013-03-24 2014-09-25 Bensson Samuel Self-Locking Syringe

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4968299A (en) * 1987-07-02 1990-11-06 Kabivitrum Ab Method and device for injection
US20090287161A1 (en) * 2008-05-15 2009-11-19 Allergan, Inc Metered, multiple dose/aliquot syringe
WO2012118687A1 (fr) * 2011-02-28 2012-09-07 Merck Sharp & Dohme Corp. Injecteur actionné manuellement avec séquence d'injection limitée
US20130035664A1 (en) * 2011-08-05 2013-02-07 Unitract Syringe Pty Ltd Dual chamber mixing device for a syringe
WO2013132192A1 (fr) * 2012-03-08 2013-09-12 Stemcis Seringue pour application médicale
US20140288507A1 (en) * 2013-03-24 2014-09-25 Bensson Samuel Self-Locking Syringe

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023174668A1 (fr) * 2022-03-14 2023-09-21 Shl Medical Ag Sous-ensemble destiné à un dispositif d'administration de médicaments

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