WO2019058382A1 - An automated multi-use injecting system for administration of injectable medicaments - Google Patents

An automated multi-use injecting system for administration of injectable medicaments Download PDF

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Publication number
WO2019058382A1
WO2019058382A1 PCT/IN2018/050529 IN2018050529W WO2019058382A1 WO 2019058382 A1 WO2019058382 A1 WO 2019058382A1 IN 2018050529 W IN2018050529 W IN 2018050529W WO 2019058382 A1 WO2019058382 A1 WO 2019058382A1
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WO
WIPO (PCT)
Prior art keywords
dosage
dose
housing
spring
content
Prior art date
Application number
PCT/IN2018/050529
Other languages
French (fr)
Inventor
Dr. Gautam DAFTARY
Suresh Kumar Natarajan
Vasanthan Mani
Dr. Anita SAMAGOD
Mahesh GAVASANE
Cyril FERNANDEZ L J
Original Assignee
Bharat Serums And Vaccines Ltd
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 Bharat Serums And Vaccines Ltd filed Critical Bharat Serums And Vaccines Ltd
Publication of WO2019058382A1 publication Critical patent/WO2019058382A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31535Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/3155Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31551Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/3155Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31553Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe without axial movement of dose setting member
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/31556Accuracy improving means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566Means improving security or handling thereof
    • A61M5/3157Means providing feedback signals when administration is completed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A61M5/31585Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by axially moving actuator, e.g. an injection button
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3125Details specific display means, e.g. to indicate dose setting
    • A61M2005/3126Specific display means related to dosing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31535Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31541Means preventing setting of a dose beyond the amount remaining in the cartridge
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31535Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31543Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose piston rod reset means, i.e. means for causing or facilitating retraction of piston rod to its starting position during cartridge change
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159Dose expelling manners
    • A61M5/31593Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir

Definitions

  • the present invention relates to automatic delivery of specific quantity of medicaments. More specifically, the present invention is directed to develop a simple automated multi-use disposable injector system containing medicament/injecting content which would enable its user to automatically inject different per-defined volumes of the medicament/injecting content from said injector system till complete depletion of the medicament/injecting content and then completely restrict further use of the injector system for subsequent injecting applications.
  • US 5674204 discloses a medication delivery pen comprising of a med ication ca rtridge assembly, a pen body assembly a nd a ca p.
  • the pen body assembly includes a dose setting mechanism and a dose delivery mechanism that a re selectively disconnected and connected by attaching and removing, respectively, the cap of the medication delivery pen .
  • the cap When the cap is attached to the medication delivery pen the user can easily dial in and correct the dialed in dosage a nd when the cap is removed the medication delivery pen is ready to d ispense the d ialed in dosage.
  • US 2014/0350478 relates to a n a utomatic torsion spring based injection device having a dial-up/dia! -down mechanism by which a dose can be set by rotating a dose setting member in a first direction and which dose size ca n be reduced by rotating the same dose setting member in a second and opposite direction ,
  • the d ial-up/dial-down mechanism operates a torsion spring which is strained when setting a dose a nd unstained when rotating the dose setting element in the second direction .
  • US 2016/0058950 refers to a handheld injection device comprising a housing and a dose indicator positioned within and axiaily constra ined to the housing and rotatable with respect to the housing during dose setting and during dose d ispensing .
  • the dose ind icator may comprise a flexible clicker arm which, only d uring dispense, is displaced in a first radial direction and, when the device reaches its minimum dose (zero) position, in a second, opposite radial direction.
  • US 8083711 relates to an injection device comprising a housing, a resilient member ada pted to provide a force in the axial direction of the injection device for ejecting a dose from the injection device.
  • the injection device further comprises a dose setting member operatively connected to a dose indicator barrel positioned within the housing, the dose setting member and the dose indicator barrel being movable relative to each other and cooperating to set the dose to be ejected from the injection device.
  • the dose indicator ba rrel undergoes, during dose setting and delivery, a combined rotational and translationai movement within the housing and relative to the housing .
  • the basic construction of the above reported pen type injector systems thus includes (i) a replaceable medicament cartridge containing the medicament (ii) a rotatable dose setting means whereby rotation of said dose setting means causes setting of the dose and storing energy in a resilient element (iii) a dose delivery means which push a plunger or a piston into the medicament cartridge upto a certain length for delivering the medicament as per the set dose by using the stored energy in the resilient element upon application of an unlocking or disengagement device.
  • a dose delivery means which push a plunger or a piston into the medicament cartridge upto a certain length for delivering the medicament as per the set dose by using the stored energy in the resilient element upon application of an unlocking or disengagement device.
  • US 5938642 discloses a multi-use pen-shaped medication dispensing device comprising of a housing, a dial assembly, a generally cylindrical button assembly located within the proximal end of the dial assembly, an internally threaded nut, and an externally threaded lead screw.
  • the device is arranged so that the dial must be rotated to the zero dose position prior to setting a dose.
  • the device includes a lockout mechanism that prevents the dial from being depressed during dosing.
  • the device further includes a mechanism that limits the maximum dosage that can be dialed up and a mechanism that prevents the user from dialing up a dosage greater than that remaining in the cartridge.
  • US 20160058950 discloses an injection device comprising a last dose protection mechanism for preventing the setting of a dose, which exceeds the amount of liquid left in a cartridge, which last dose protection mechanism comprises a nut member located interposed between a drive member and a dose indicator or between a dial member and a clicker sleeve, which is rotationally constrained to the housing.
  • the above reported pen type injector systems including the modified pen type injector systems with last dose limiting mechanism fail to provide any operative integration of the dose setting and delivery means with the plunger or the piston that moves within the med icament ca rtridge and also, the reported last dose limiting mechanism essentially includes moving nut on the drive stem of the injection system resulting additional mechanical complexity in the in dose setting and delivery mea ns construction .
  • Another object of the present invention is to develop an automated multi -use d isposable injector system which would be ada pted to automatically inject d ifferent user defined volumes of liquid/injecting content from a n injection ca rtridge/conta iner in the injector system till complete depletion of the liquid/injecting content in said injection cartridge/container and thereafter restrict further use of the injecting system for any subsequent injecting applications involving the exhausted cartridge/container.
  • Another object of the present invention is to develop an automated multi-use disposable injector system which would be adapted to allow automatic injection of different user defined volumes of liquid/injecting content from the injection cartridge till complete depletion of the liquid/injecting content in said injection cartridge and then restrict further use of the injecting system for any subsequent injecting applications involving the exhausted cartridge with simple mechanical construction by providing an operative integration of the dose setting and delivery means with the plunger or the piston that moves within the injection cartridge.
  • Yet another object of the present invention is to develop a n injector system which would be reusable till complete depletion of the liquid/injecting content in the injection cartridge and after complete depletion of the liquid/injecting will be locked restricting its further use by the user.
  • Another object of the present invention is to develop an injector system which would be easy to operate, low cost and adapted to dispense accurate amount of liquid/injecting content from the injection cartridge during injection.
  • Another object of the present invention is to develop an injector system which would comprises operative feedback integration between the dose setting means, delivery means and the plunger or the piston that moves within the medicament cartridge enabling the dose setting means to operational till complete depletion of the liquid/injecting content in the injection cartridge through gradual injections.
  • an automated and end of content blocking disposable injector system comprising : a housing having an injection container with injecting content for delivery at a dispensing end; injecting content pusher means in axial operative communication with said injection container adapted for dosage dependent delivery of atleast one dosage of the injecting content under forward axial advancement motion of said pusher means with respect to the housing; pusher means forward axial advancement motion actuator means including a dosage setter and dosage actuator selectively cooperating with a resiliently /spring biased control enabling axial compression of a spring/resilient means and holding upon end of dosage setting and releasing said spring/resilient means by the dosage actuator enabling corresponding dosage based pushing forward of the pusher means alongwith a cooperative end of content blocker; said dosage setter and said dosage actuator upon end of administration of each select dosage adapted for resetting based on availability of remaining injecting content in said injection container for subsequent multi dose administration involving said dosage setter and said dosage actuator ; said end of content blocker operatively disposed
  • a n automated and end of content blocking disposable injector system comprising : a housing having an injection container with injecting content for delivery at a dispensing end; injecting content pusher means in axial operative communication with said injection container adapted for dosage dependent delivery of atleast one dosage of the injecting content under forward axial advancement motion of said pusher means with respect to the housing; pusher means forward axial advancement motion actuator means including a rotatable knob based dosage setter and dosage actuator selectively cooperating with a resiliently /spring biased control enabling axial compression of a spring/resilient means wherein measure rotary dose setting motion of the rotatable knob actuates a corresponding spring/resilient means bias loading with respect to said pusher means as stored spring energy and holding upon end of dosage setting and said dosage actuator adapted for releasing said spring/resilient means bias enabling working of the stored spring energy upon said pusher means for corresponding dosage based pushing forward of the pusher means alongwith a cooperative end of content block
  • the housing comprises a barrel shaped housing enclosure which at front accommodates the injection container and at back integrates the dosage setter and the dosage actuator.
  • the pusher means comprises a lead screw axially disposed within the barrel shaped housing enclosure and rotationally constrained relative to the barrel shaped housing enclosure; said lead screw is configured to axially engage cooperatively with the injection container's content for delivery of the content by pushing forward within the injection container with forward axial advancement of the lead screw with respect to the barrel shaped housing enclosure having said injection container for dosage administration.
  • the dosage setter and the dosage actuator include dosage setting measure unit configured to permit users to set a measured dosage volume of the injecting content to be delivered prior to each of the dose administration .
  • the pusher means forward axial advancement motion actuator means operatively engages with the lead screw based on the dosage setter and the dosage actuator to translate the set dosage volume into corresponding forward axial advancement of the lead screw within the injection container for every dosage setting and administration to push a piston within the injection container forward and deliver the injecting content as per set dosage volume.
  • the end of content blocker is supported on the lead screw and includes an usually outwardly resiliently biased lock which is inwardly press fitted with respect to a stationary coaxial sleeve enclosure surrounding said lead screw and adapted to move the said lead screw with respect to said stationary coaxial sleeve enclosure during dosage administration under said inwardly press fitted condition restrained by said stationary coaxial sleeve enclosure and when said lead screw axial traverse reaches end of content in the injection container actuably engage with the pusher means forward axial advancement motion actuator means in a manner blocking any further motion of the lead screw with respect to its surrounding stationary coaxial sleeve enclosure thereby also rendering the dosage setter and dosage the actuator non operative when the forward axial advancement of the lead screw within the injection container has been reached corresponding to complete depletion of the injecting content in the injection container.
  • the housing accommodating the injection container includes a cartridge holder coaxially accommodated at front end of the housing ; wherein the cartridge holder contains an injection cartridge having its dispensing end towards front end of the cartridge holder and a piston at back end of the cartridge holder cooperatively mating with front end of the lead screw; said cartridge holder adapted to accommodate an injecting needle at its front end connected to said dispensing end of the injection cartridge with a removable cap covering the injecting needle.
  • the housing at its back end includes a housing top rotationally constrained relative to the housing and supporting the dosage setter and the dosage actuator external to the housing .
  • the dosage setter comprises a dose knob rotationally coupled with the housing top at its back end involving ratchet teeth at inner surface of the dose knob engaging with pawl features on outer surface of the housing top to constitute two-way ratchet arrangement between the housing top and the dose knob enabling clockwise/anticlockwise rotation of the dose knob with respect to the housing top and also the around the housing axis overhauling said two-way ratchet-pawl arrangement which cooperate with the pusher means forward axial advancement motion actuator means to correspondingly activate resiliently /spring biased control enabling axial compression of a spring /resilient means relative to the housing and holding upon end of dosage setting and maintained so arrested under desired axial compression of a spring /resilient means based on the set dosage and wherein rotation of the dose knob in clockwise/counter clockwise direction enables selecting increasing/decreasing the dose amount based upon corresponding spring compression for generating spring/resilient means based stored spring/resilient means energy and preferably where
  • the dose knob at its back end includes the dosage actuator comprising of a press spring loaded push button having protruding portion within the housing top which cooperate to release the dose setter form further arresting the spring /resilient means for effecting dose delivery through said cooperative pusher means forward axial advancement motion actuator means under release of corresponding spring/ resilient means energy.
  • the pusher means forward axial advancement motion actuator means comprises a hollow control tube coaxially accommodated within the housing and spaced apart from inner surface of the housing, said control tube is configured to exhibit rotational movement relative to the housing and axial movement between its dispositions at the front end and back end of the housing; said stationary coaxial sleeve enclosure coaxially accommodated within the control tube surrounding the lead screw carrying said end of content blocker; a dial sleeve coaxially disposed between the stationary coaxial sleeve enclosure and the control tube ensuring inner surface of the dial sleeve is engaged with outer of the stationary coaxial sleeve enclosure while outer surface of the dial sleeve is engaged with inner surface of the control tube; an energy spring/resilient means coaxially disposed between the stationary coaxial sleeve enclosure and the control tube facing back end of the dial sleeve; a drive nut coaxially accommodated within the housing facing front ends of the control tube and the stationary coaxial s
  • the end of content blocker is disposed at back end of the lead screw enabled to be under resiliently biased and press fitted condition between the stationary coaxial sleeve enclosure and the lead screw and move with forward axial advancement of the lead screw under the press fitted condition during dosage delivery.
  • the end of content blocker actuates though openings defined on peripheral surface of the stationary coaxial sleeve enclosure to engage with corresponding mating slots defined in the inner surface of the dial sleeve covering the stationary coaxial sleeve enclosure; wherein said openings on the stationary coaxial sleeve enclosure are selectively disposed to ensure the end of content blocker reaches exactly below the openings for actuation when the axial advancement of the lead screw within the injection cartridge has been reached corresponding to complete depletion of the injecting content in the injection cartridge.
  • the end of content blocker includes atleast one EOL spring loaded EOL lock; said EOL spring loaded EOL lock is enabled to press fit within the stationary coaxial sleeve enclosure under compression of the EOL spring and adapted to moves linearly along within the stationary coaxial sleeve enclosure with the lead screw during every dosage administration; said EOL spring is enabled to actuate EOL lock through the stationary coaxial sleeve enclosure opening and engage with anyone of the mating slot in the inner surface of the dial sleeve to arrest any motion of the dial sleeve with respect to the stationary coaxial sleeve enclosure.
  • the end of content blocker includes atleast one resilient steel plate supported on the back of the lead screw through a steel plate base; said resilient steel plate is enabled to press fit within the stationary coaxial sleeve enclosure under compression and adapted to move linearly along within the stationary coaxial sleeve enclosure with the lead screw during every dosage administration; said resilient steel plate is enabled to actuate through the stationary coaxial sleeve enclosure opening and engage with anyone of the mating slot in the inner surface of the dial sleeve to arrest any motion of the dial sleeve with respect to the stationary coaxial sleeve enclosure.
  • control tube engaged with the dose knob and the dial sleeve, transfer dose setting rotation of the dose knob to the dial sleeve in the same direction and the same number of turns as that of the dose knob.
  • the dial sleeve which is rotating with the control tube and the dose knob, is adapted for a trans- rotational motion with respect to the stationary coaxial sleeve enclosure due to its threaded engagement with the outer surface of the stationary coaxial sleeve enclosure and the tongue groove engagement with the inner surface of the control tube; whereby dial sleeve move towards back end of the housing compressing the energy spring to thereby store the rotational energy of the dose knob during dose increasing rotation of the dose knob; wherein the dial sleeve is adapted to move towards front end of the housing releasing the energy spring from its existing compressing state during dose decreasing rotation of the dose knob from a set dose; and wherein unwanted releasing of the compressed energy spring is arrested by the two way Ratchet - pawl arrangement between the dose knob and the housing top.
  • a protruding portion of press spring biased push button under pressed condition by the user after setting of the dose extends the within the housing top to thereby push the control tube in forward direction to its disposition at the front end of the housing disengaging it from the dose knob upon pressing, whereby disengagement of the control tube from the dose knob enables release of the compressed energy spring which pushes the dial sleeve to move towards front end of enclosure exhibiting the trans-rotational motion with respect to the stationary coaxial sleeve enclosure due to its threaded engagement with the outer surface of the stationary coaxial sleeve enclosure; wherein the dial sleeve rotates the control tube opposite to its dose setting rotation through the tongue groove engagement acting between the dial sleeve and the control tube.
  • control tube under pushed forward disposition at the front end of the housing , engages with the drive nut through the gear-clutch based engagement enables co-rotation of the control tube and the drive nut with the rotating dial sleeve independent from the dose knob.
  • the lead screw exhibits the forward axial advancement through the rotating drive nut involving its threaded engagement with the inner surface of the drive nut, thus pushing the piston within the cartridge.
  • the dial sleeve includes dose indications printed on its outer surface in multiple equally spaced helical divisions to sequentially appeared on dose window on the barrel surface with the energy spring compressing trans-rotational motion of the dial sleeve during dose setting informing the user about the dose being set for dispensing corresponding to the amount of compressing of the energy spring .
  • a method of operation of the injector system for administration of injectable select dosage comprising : exposing the injection needle by removing the cap and pierced at the injection sight, and then the spring loaded push button of said dosage actuator is pushed against the press spring enabling the protruding portion of the push button to push the control tube to its disposition at the front end of the housing ensuring (i) engagement of the control tube with the drive nut and (ii) disengagement of the control tube from the dose knob leaving the control tube free to rotate and thereby the dial sleeve also free to rotate; whereby spring force of the compressed energy spring continuously act on the dial sleeve for desired dose setting till dose actuator is applied through said push button for complete releasing of the compressed energy spring enabling the dial sleeve to rotates opposite to the dose setting rotation and moves forward over the stationary coaxial sleeve enclosure, whereby the rotational motion of the dial sleeve is transferred to the control tube due to its cooperative engagement; wherein the control
  • Figure 1 shows an embodiment of the injector system with (a) protective cap in close position covering injection needle and cartridge; (b) protective cap in open position exposing injection cartridge in accordance with the present invention.
  • Figure 2 shows (a) exploded view of a preferred embodiment of the present injector system and (b) system elements associated with the preferred injector system embodiment in accordance with the present invention.
  • Figure 3 shows exploded view of an alternate embodiment of the present injector system in accordance with the present invention.
  • Figure 4a and 4b show complete assembly of the present injector system along with different engagements of the system elements associated with the present injector system in accordance with the present invention.
  • Figure 4c shows line diagram of the complete assembly of the present injector system in accordance with the present invention .
  • Figure 5 shows setting of injecting dose in the present injector system in accordance with the present invention.
  • Figure 6 shows delivery of set injecting dose by the present injector system in accordance with the present invention.
  • Figure 7 shows enablement of the End-of-level mechanism in the present injector system in accordance with the present invention.
  • Figure 8 shows enablement of the End-of-level mechanism involving the alternate embodiment of the present injector system in accordance with the present invention.
  • the present invention relates to a pen type injector system for multiple injection applications which permits its user to set an liquid/injecting content dose as per the requirement and facilitates automatic dispensing of said liquid/injecting content as per the set dose from an injection cartridge/container contained with the injector system embodiment.
  • the present pen type injector system also include means which allows its reuse for injecting application till complete depletion of the liquid/injecting content in the injection cartridge/container and after complete depletion of the liquid/injecting content it restrict further use of the injector system.
  • the injector system essentially includes a housing to accommodate an injection container with injecting content at its dispensing end, an injecting content pusher enabled to axially engage with the injection container for dosage dependent delivery of atleast one dosage of the injecting content under its forward axial advancement relative to the housing.
  • the forward axial advancement amount of the injecting content pusher is basically controls the dosage of the injecting content to be dispensed.
  • a pusher means forward axial advancement motion actuator means is provided which includes a dosage setter and dosage actuator to selectively cooperating with a resiliently /spring biased control enabling axial compression of a spring / resilient means relative to the housing.
  • the compression amount varies according to the dosage of the injecting content to be dispensed. In particular, more compression is required for higher dosage.
  • the compression of the spring is maintained by the dosage setter and the dosage actuator till end of the dosage setting and thereafter the spring bias is being released by the dosage actuator enabling corresponding dosage based pushing forward of the pusher means alongwith a cooperative end of level or content blocker.
  • the end of level or cartridge content blocker is basically an actuable locking means which is operatively disposed on the pusher means under non-actuating condition and particularly configured to actuate only the pusher means disposition at end of the content in said injection container to block any subsequent dosage setting and actuation dosage dependent delivery.
  • the present injector system comprises the following elements i. pen cap ( 1), ii. cartridge holder (2), iii. liquid/injecting content cartridge (3), iv. D-lock nut (4), v. drive nut (5), vi. EOL sleeve (6), vii. lead screw (7), viii. EOL spring (8), ix. EOL lock (9), x. Dial sleeve (10), xi. spring rest ( 11), xii. energy spring ( 12), xiii. control tube (13), xiv. housing (14), xv. housing-top ( 15), xvi. dose knob ( 16), xvii. press spring ( 17), xviii. press button ( 18), xix. liquid/injecting content delivery opening/needle (19) and xx. dose window (20) .
  • FIG. 3 shows an alternative embodiment of the present injector system comprising i. pen cap ( 1), ii. cartridge holder (2), iii. liquid/injecting content cartridge (3), iv. D-lock nut (4), v. drive nut (5), vi. EOL sleeve (6), vii. lead screw (7), viii. Steel plate base (8a), ix. Steel Spring plate (9a), x. Dial sleeve (10), xi. spring rest ( 11), xii. energy spring (12), xiii. control tube (13), xiv. housing ( 14), xv. housing -top
  • the injecting content pusher comprises the lead screw (7) whereas the dosage setter comprises the dose knob
  • the pusher means forward axial advancement motion actuator means comprises the drive nut (5), EOL sleeve (6), Dial sleeve (10), control tube ( 13), the energy spring (12), D-lock nut (4) and the spring rest (11) .
  • the injector system embodiment as shown in the figure 2 includes EOL spring (8) and EOL lock (9) to constitute the end of content blocker, whereas the alternative injector system embodiment as shown in the figure 3, includes Steel plate base (8a) and Steel Spring plate (9a) to constitute the end of content blocker.
  • the injector system housing (14) is basically a barrel shaped enclosure which at front accommodates an injection container (3) and at back integrates the dosage setter (16) and the actuator (17, 18).
  • the pusher means i.e. a lead screw (7) axially disposed within the barrel shaped enclosure ( 14) and is configured to axially engage with the injection container's (3) content for delivery of the content by pushing forward it within the injection container (3) with forward axial advancement of the lead screw (7) with respect to the barrel shaped enclosure (14) for dosage administration .
  • the injection container accommodated at front end of the housing includes a cartridge holder (2) coaxially accommodated at front end of the housing ( 14).
  • the cartridge holder (2) contains an injection cartridge (3) having its dispensing end towards front end of the cartridge holder (2) and a piston (21) at back end of the cartridge holder (2) cooperatively mating with front end of the lead screw (7).
  • the cartridge holder (2) is also adapted to accommodate an injecting needle/applicator (19) at its front end connected to the dispensing end of the injection cartridge (3) with a removable cap (1) covering the injecting needle/applicator (19) .
  • the dosage setter and the actuator constitute a dosage setting measure unit permitting users to set a measured dosage volume of the injecting content to be delivered prior to each of the dose administration.
  • the dosage setter which comprises the dose knob (16), operates as 'user input device' of the present injector system and enables the user to set an injection dose to be dispensed.
  • the dose knob (16) is rotationally coupled at back of housing top (15) and front of the housing top (15) is integrated with back end of the housing (14).
  • the housing top (15) is rotationally constrained with respect to the housing ( 14), however the dose knob ( 16) can exhibit bi directional rotation with respect to the housing top ( 15) .
  • engaging outer surface of the housing top ( 15) and inner surface of the dose knob ( 16) include triangular toothed textures for constituting a two-way ratchet arrangement between the housing top ( 15) and the dose knob ( 16).
  • the dose knob (16) can be rotated in both clockwise/anticlockwise direction with respect to the housing top (15) and also the around the housing axis by overhauling the two-way ratchet-pawl arrangement between the housing top ( 15) and the dose knob ( 16).
  • the dose knob (16) at its back end includes the actuator comprising of the press spring (17) loaded push button ( 18).
  • the pusher means forward axial advancement motion actuator means which includes the drive nut (5), EOL sleeve (6), Dial sleeve ( 10), control tube (13), the energy spring ( 12) , D-lock nut (4) and the spring rest (11) systematically operates in combination to each other to operatively engages with the dose knob ( 16) and the press spring (17) loaded push button ( 18) and enables translation of the set dosage volume into corresponding forward axial advancement of the lead screw (7) within the injection container (3) for every dosage administration to push the piston forward within the injection cartridge and deliver the injecting content as per set dosage volume.
  • the hollow control tube (13) is coaxially accommodated within the housing ( 14) and spaced apart from inner surface of the housing.
  • the control tube (13) is particularly configured to exhibit bi-directional rotational movement relative to the housing (14) axis and axial movement between its dispositions at the front end and back end of the housing (14).
  • the back end of the control tube (13) is disposed in operative connection with front end of the dose knob (16) through a detachable tongue - groove engagement at its disposition in the back end of the housing (14) (as shown in the cross section X5) .
  • the drive nut (5) is coaxially accommodated within front end of the housing (14) and rotationally coupled with inner surface of the housing ( 14) through one-way ratchet arrangement enabling only one way rotation of the drive nut (5) with respect to the housing (14).
  • Back end of the drive nut (5) which faces front ends of the control tube (13) and the EOL sleeve (6) comprises gear features (As shown in the X6) for clutch engagement and disengagement with front end of the control tube (13) at its disposition in the front end of the housing (14) .
  • the control tube ( 13) coaxially accommodates the EOL sleeve (6) within it and front end of the EOL sleeve (6) is rotationally coupled with the drive nut (5).
  • the rotational coupling between the EOL sleeve (6) and the drive nut (5) enables rotation of the drive nut (5) with respect to the EOL sleeve (6), however the axial movement of the EOL sleeve (6) within the housing (14) is constrained by the rotational coupling between the EOL sleeve (6) and the drive nut (5).
  • the lead screw (7) has a threaded arrangement within the drive nut (5) causing the lead screw (7) to move forward in direction of the housing ( 14) with the rotation of the drive nut (5).
  • the D lock nut (4) which is fixed within the housing ( 14) between the cartridge holder (2) and the drive nut (5) comprises tongue - groove engagement with the lead screw (7) (As shown in the cross section XI) to arrest any rotational motion of the lead screw (7) with respect to the housing ( 14) during its forward movement. With the forward movement of the lead screw (7), it push the piston (21) within the cartridge (3) in forward direction to dispense the medicament from the cartridge (3) through applicator/ needle (19) disposed in front of the cartridge holder (2) .
  • the dial sleeve ( 10) is coaxially disposed between the EOL sleeve (6) and the control tube (13) wherein inner surface of the dial sleeve (10) includes a threaded engagement with outer surface of the EOL sleeve (6) and outer surface of the dial sleeve (10) includes a tongue - groove engagement with the inner surface of the control tube (13) (as shown in the cross section X2) .
  • the spring rest (11) is provided on the back end of the dial sleeve (10) to bias the dial sleeve (10) with the housing ( 14) through the energy spring (12).
  • the EOL sleeve (6) coaxially covers the lead screw (7) and the lead screw (7) includes tongue-groove arrangement with inner surface of the EOL sleeve (6) (as shown in the cross section X4) enabling only axial linear motion of the lead screw (7) within the EOL sleeve (6) and with respect to the EOL sleeve (6).
  • the EOL sleeve (6) is also constrained to rotate with respect to the housing ( 14) due to its engagement with the lead screw (7) which is constrained to rotate with respect to housing ( 14) due to its engagement with the housing (14) through the D lock nut (4) .
  • the EOL sleeve (6) is thus can be regarded as stationary coaxial sleeve enclosure which surrounds lead screw (7) .
  • the end of content blocker is supported on the lead screw and includes an usually outwardly biased lock which is inwardly press fitted with respect to the stationary coaxial EOL sleeve enclosure (6) surrounding the lead screw (7) .
  • the end of content blocker moves with lead screw (7) and with respect to the stationary coaxial EOL sleeve enclosure (6) during dosage administration under inwardly press fitted condition restrained by stationary coaxial EOL sleeve enclosure (6).
  • the end of content blocker is configured to actuably engage with the pusher means forward axial advancement motion actuator means in a manner blocking any further motion of the lead screw (7) with respect to its surrounding stationary coaxial EOL sleeve enclosure (6) when the forward axial advancement of the lead screw within the injection container is reached corresponding to complete depletion of the injecting content in the cartridge.
  • This engagement of the end of content blocker with the pusher means forward axial advancement motion actuator means rendering the dosage setter and the actuator non operative for further dose setting.
  • the housing ( 14) is to be held fixed with one hand and the dose knob (16) is to be rotated in the clockwise/anticlockwise direction overhauling the two-way ratchet feature.
  • the dose setting is bi-directional in nature.
  • the dose knob ( 16) is to be rotated clockwise (CW) for increasing dose amount and to reduce the value of set dose the dose knob ( 16) can be rotated in counter clockwise (CCW) direction.
  • the Pawl feature on the housing top slips one Ratchet tooth on the dose knob providing an audible feedback (click sound) to the user.
  • the dose setting rotation of the dose knob ( 16) is transferred to the dial sleeve ( 10) through the control tube ( 13) in the same direction and the same number of turns as that of dose knob (16) due to the tongue - groove engagement between the control tube (13) and the dose knob ( 16) and tongue - groove engagement between the control tube (13) and the dial sleeve (10).
  • the dial sleeve (10) With the rotation of the dial sleeve (10), it moves axially within the control tube (13) exhibiting a trans- rotational motion due to its threaded engagement with the threaded outer surface of the stationary EOL sleeve enclosure (6).
  • the dial sleeve (10) moves towards back end of the housing ( 14) within the control tube (13) and compress the energy spring (12) through the spring rest (11) .
  • the dose knob (16) rotational energy is stored within it for dose dispensing operation while the spontaneous release of the compressed energy spring (12) force acting on the dial sleeve ( 10) is resisted by the two way Ratchet - pawl arrangement between dose knob ( 16) and housing top (15) to prevent accidental dose- delivery during dose-setting.
  • the user torque required to rotate the dose knob ( 16) in the dose set direction e.g . clockwise/anticlockwise
  • Dose indications are printed on the dial sleeve ( 10) in multiple equally spaced helical divisions which sequentially appeared on the dose window (20) on the housing ( 14) with trans-rotational motion of the dial sleeve ( 10) during dose setting informing the user about the dose being set for dispensing.
  • dose value can be set from 0 IU to 450 IU in the increments of 12.5 IU, which will be visible to the user through the dose window (20).
  • the dose knob ( 16) includes 18 Ratchet teeth, hence the dose knob ( 16) has to be rotated with 2 complete revolutions in CW direction to set 450IU dose.
  • the push button (18) After holding the push button (18) in the pushed position till the dial sleeve (10) rotates back to the initial position to display ⁇ IU' in the dose window (20) indicating the completion of the dose dispensing, the push button (18) is to be released, during this action the following events takes place : a . the gear feature at the front end of the control tube (13) will get disengaged from the mating gear feature on the drive nut (5) b. pulling the control tube ( 13) back to its original position and again engaging the tongue and groove arrangement between the dose knob (16) and the control tube ( 13) The injector system is again restored to its initial condition for further dose setting and dispensing as per requirement, until it delivers complete labeled volume of the injecting content.
  • the lead screw (7) at its back end includes the EOL spring (8) loaded EOL lock (9) which is press fitted within the stationary coaxial EOL sleeve enclosure (6) under compression of the EOL spring (8).
  • the EOL lock (9) moves linearly along within the stationary coaxial EOL sleeve enclosure (6) with the lead screw (7) towards the front end during every injection and delivery of the injecting content from the cartridge (3).
  • the stationary coaxial EOL sleeve enclosure (6) comprises opening corresponding to the EOL lock (9) disposed on the peripheral surface of the EOL sleeve (6).
  • the opening is selectively disposed to ensure that the EOL lock (9) reaches exactly below the opening when the cartridge (3) becomes empty. In this condition the EOL lock (9) is actuated by the EOL spring (8).
  • the dial sleeve (10) covering the stationary coaxial EOL sleeve enclosure (6) includes mating slots in its inner surface wherein the actuated EOL lock (9) through the opening on the EOL sleeve (6) gets engaged. Once, the EOL lock (9) engages with any of the mating slots of the dial sleeve ( 10) any motion of the dial sleeve ( 10) with respect to the stationary coaxial EOL sleeve enclosure (6) gets arrested .
  • the lead screw (7) at its back end includes the steel plate base (8a) with loaded steel plate spring (9a) which is inwardly press fitted within the stationary coaxial EOL sleeve enclosure (6) under compression of the steel plate spring (9a) .
  • the EOL lock (9) moves linearly along within the stationary coaxial EOL sleeve enclosure (6) with the lead screw (7) towards the front end during every injection and delivery of the injecting content from the cartridge (3).
  • the stationary coaxial EOL sleeve enclosure (6) comprises opening corresponding to the EOL lock (9) disposed on the peripheral surface of the EOL sleeve (6).
  • the opening is selectively disposed to ensure that the steel plate spring (9a) reaches exactly below the opening when the cartridge (3) becomes empty. In this condition the steel plate spring (9a) is actuated .
  • the dial sleeve ( 10) covering the stationary coaxial EOL sleeve enclosure (6) includes mating slots in its inner surface wherein the actuated steel plate spring (9a) through the opening on the EOL sleeve (6) gets engaged. Once, the steel plate spring (9a) engages with any of the mating slots of the dial sleeve ( 10) any motion of the dial sleeve (10) with respect to the stationary coaxial EOL sleeve enclosure (6) gets arrested .
  • the present pen type injector system advantageously performs repetitive automatic delivery of user defined volumes of liquid/injecting content from the injection cartridge till complete depletion of the liquid/injecting content in said injection cartridge and then restrict further use of the injector system for subsequent injecting application through EOL lock and sleeve based integration of the dose setting and delivery means with the lead screw that moves within the injection cartridge.
  • the embodiments of the invention have been illustrated as a unique pen type injector system which advantageously performs repetitive automatic delivery of user defined volumes of liquid/injecting content from the injection cartridge till complete depletion of the liquid/injecting content in said injection cartridge and then restrict further use of the injector system for subsequent injecting application through EOL lock and sleeve based feedback integration of the dose setting and delivery means with the lead screw that moves within the injection cartridge
  • the present pen type injector system or any part thereof in fact can be used for other suitable applications through changes and modifications. Such changes and modifications known to those of ordinary skill are intended to be included within the scope of the present invention.

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Abstract

The present invention is disclosing an automated and end of content blocking disposable injector system comprising a housing having an injection container with injecting content for delivery at a dispensing end, an injecting content pusher means in axial operative communication with the injection container for dosage dependent delivery of the injecting content under forward axial advancement motion of the pusher means with respect to the housing, and an end of content blocker operatively disposed on pusher means such that the pusher means disposition at end of the content in the injection container actuates the end of content blocker to block any subsequent dosage setting and actuation dosage dependent delivery.

Description

Title: AN AUTOMATED MULTI-USE INJECTING SYSTEM FOR ADMINISTRATION OF INJECTABLE MEDICAMENTS.
FIELD OF THE INVENTION: The present invention relates to automatic delivery of specific quantity of medicaments. More specifically, the present invention is directed to develop a simple automated multi-use disposable injector system containing medicament/injecting content which would enable its user to automatically inject different per-defined volumes of the medicament/injecting content from said injector system till complete depletion of the medicament/injecting content and then completely restrict further use of the injector system for subsequent injecting applications.
BACKGROUND OF THE INVENTION: Different medical dispensing devices or medicament injecting systems have been reported in the art over the years. These medical dispensing devices or the medicament injecting systems are designed for serving different injection requirements. Of late, among such different medicament injecting systems, there has been an increasing interest in recyclable medicament injecting systems which are developed to permit user to set different dose of the medicament to be dispensed and thereafter inject the medicament as per the set dose. These recyclable medicament injecting systems are broadly defined as pen type injector systems and particularly suitable for self treatment of the patients suffering from diseases/ ailments which require multiple injection of precise volume of any medicament over a time period .
Recently, different pen type injector systems have been reported in the art which include multi-dose injection cartridge in the injector systems and means for permitting users to set the medicament dose to be d isposed and thereafter d ispense the medicament as per the set dose, e.g .
US 5674204 discloses a medication delivery pen comprising of a med ication ca rtridge assembly, a pen body assembly a nd a ca p. The pen body assembly includes a dose setting mechanism and a dose delivery mechanism that a re selectively disconnected and connected by attaching and removing, respectively, the cap of the medication delivery pen . When the cap is attached to the medication delivery pen the user can easily dial in and correct the dialed in dosage a nd when the cap is removed the medication delivery pen is ready to d ispense the d ialed in dosage.
US 2014/0350478 relates to a n a utomatic torsion spring based injection device having a dial-up/dia! -down mechanism by which a dose can be set by rotating a dose setting member in a first direction and which dose size ca n be reduced by rotating the same dose setting member in a second and opposite direction , The d ial-up/dial-down mechanism operates a torsion spring which is strained when setting a dose a nd unstained when rotating the dose setting element in the second direction .
US 2016/0058950 refers to a handheld injection device comprising a housing and a dose indicator positioned within and axiaily constra ined to the housing and rotatable with respect to the housing during dose setting and during dose d ispensing . The dose ind icator may comprise a flexible clicker arm which, only d uring dispense, is displaced in a first radial direction and, when the device reaches its minimum dose (zero) position, in a second, opposite radial direction.
US 8083711 relates to an injection device comprising a housing, a resilient member ada pted to provide a force in the axial direction of the injection device for ejecting a dose from the injection device. The injection device further comprises a dose setting member operatively connected to a dose indicator barrel positioned within the housing, the dose setting member and the dose indicator barrel being movable relative to each other and cooperating to set the dose to be ejected from the injection device. The dose indicator ba rrel undergoes, during dose setting and delivery, a combined rotational and translationai movement within the housing and relative to the housing .
The basic construction of the above reported pen type injector systems thus includes (i) a replaceable medicament cartridge containing the medicament (ii) a rotatable dose setting means whereby rotation of said dose setting means causes setting of the dose and storing energy in a resilient element (iii) a dose delivery means which push a plunger or a piston into the medicament cartridge upto a certain length for delivering the medicament as per the set dose by using the stored energy in the resilient element upon application of an unlocking or disengagement device. Recently, some modified pen type injector systems have also been reported in the art which incorporate last dose limiting mechanism, e.g.
US 5938642 discloses a multi-use pen-shaped medication dispensing device comprising of a housing, a dial assembly, a generally cylindrical button assembly located within the proximal end of the dial assembly, an internally threaded nut, and an externally threaded lead screw. The device is arranged so that the dial must be rotated to the zero dose position prior to setting a dose. The device includes a lockout mechanism that prevents the dial from being depressed during dosing. The device further includes a mechanism that limits the maximum dosage that can be dialed up and a mechanism that prevents the user from dialing up a dosage greater than that remaining in the cartridge.
US 20160058950 discloses an injection device comprising a last dose protection mechanism for preventing the setting of a dose, which exceeds the amount of liquid left in a cartridge, which last dose protection mechanism comprises a nut member located interposed between a drive member and a dose indicator or between a dial member and a clicker sleeve, which is rotationally constrained to the housing.
However, the above reported pen type injector systems including the modified pen type injector systems with last dose limiting mechanism fail to provide any operative integration of the dose setting and delivery means with the plunger or the piston that moves within the med icament ca rtridge and also, the reported last dose limiting mechanism essentially includes moving nut on the drive stem of the injection system resulting additional mechanical complexity in the in dose setting and delivery mea ns construction . Thus, there has been a continuing need in the art for developing a new pen type injector system with simple mecha nical construction which would allow automatic injection of d ifferent user defined volumes of liquid/injecting content from a cartridge/container till complete depletion of the liq uid/injecting content in said cartridge/container and thereafter restrict further use of the injecting system for subsequent injecting applications involving the exha usted ca rtridge/container through an operative integration of the dose setting and delivery means with the plunger or the piston that moves within the med icament cartridge.
OBJECTS OF THE INVENTION: It is thus the basic object of the present invention to develop a n automated multi-use disposable injector system containing medicament/injecting content a nd having dose setting and delivery mea ns which would be adapted to permit the user to set injecting dose as per the req uirement and automatically dispense the medicament/injecting content as per the set dose from the injector system by involving the energy provided by the user d uring setting the injecting dose.
Another object of the present invention is to develop an automated multi -use d isposable injector system which would be ada pted to automatically inject d ifferent user defined volumes of liquid/injecting content from a n injection ca rtridge/conta iner in the injector system till complete depletion of the liquid/injecting content in said injection cartridge/container and thereafter restrict further use of the injecting system for any subsequent injecting applications involving the exhausted cartridge/container. Another object of the present invention is to develop an automated multi-use disposable injector system which would be adapted to allow automatic injection of different user defined volumes of liquid/injecting content from the injection cartridge till complete depletion of the liquid/injecting content in said injection cartridge and then restrict further use of the injecting system for any subsequent injecting applications involving the exhausted cartridge with simple mechanical construction by providing an operative integration of the dose setting and delivery means with the plunger or the piston that moves within the injection cartridge.
Yet another object of the present invention is to develop a n injector system which would be reusable till complete depletion of the liquid/injecting content in the injection cartridge and after complete depletion of the liquid/injecting will be locked restricting its further use by the user.
Another object of the present invention is to develop an injector system which would be easy to operate, low cost and adapted to dispense accurate amount of liquid/injecting content from the injection cartridge during injection.
Another object of the present invention is to develop an injector system which would comprises operative feedback integration between the dose setting means, delivery means and the plunger or the piston that moves within the medicament cartridge enabling the dose setting means to operational till complete depletion of the liquid/injecting content in the injection cartridge through gradual injections.
SUMMARY OF THE INVENTION:
Thus according to the basic aspect of the present invention there is provided an automated and end of content blocking disposable injector system comprising : a housing having an injection container with injecting content for delivery at a dispensing end; injecting content pusher means in axial operative communication with said injection container adapted for dosage dependent delivery of atleast one dosage of the injecting content under forward axial advancement motion of said pusher means with respect to the housing; pusher means forward axial advancement motion actuator means including a dosage setter and dosage actuator selectively cooperating with a resiliently /spring biased control enabling axial compression of a spring/resilient means and holding upon end of dosage setting and releasing said spring/resilient means by the dosage actuator enabling corresponding dosage based pushing forward of the pusher means alongwith a cooperative end of content blocker; said dosage setter and said dosage actuator upon end of administration of each select dosage adapted for resetting based on availability of remaining injecting content in said injection container for subsequent multi dose administration involving said dosage setter and said dosage actuator ; said end of content blocker operatively disposed with said pusher means such that the pusher means disposition at end of the content in said injection container actuates said end of content blocker to block any subsequent dosage setting and dosage actuation involving said dosage setter and said dosage actuator.
According to another aspect in the present invention, there is provided a n automated and end of content blocking disposable injector system comprising : a housing having an injection container with injecting content for delivery at a dispensing end; injecting content pusher means in axial operative communication with said injection container adapted for dosage dependent delivery of atleast one dosage of the injecting content under forward axial advancement motion of said pusher means with respect to the housing; pusher means forward axial advancement motion actuator means including a rotatable knob based dosage setter and dosage actuator selectively cooperating with a resiliently /spring biased control enabling axial compression of a spring/resilient means wherein measure rotary dose setting motion of the rotatable knob actuates a corresponding spring/resilient means bias loading with respect to said pusher means as stored spring energy and holding upon end of dosage setting and said dosage actuator adapted for releasing said spring/resilient means bias enabling working of the stored spring energy upon said pusher means for corresponding dosage based pushing forward of the pusher means alongwith a cooperative end of content blocker; said dosage setter and said dosage actuator upon end of administration of each select dosage adapted for resetting based on availability of remaining injecting content in said injection container for subsequent multi dose administration involving said dosage setter and said dosage actuator; said end of content blocker operatively disposed with said pusher means such that the pusher means disposition at end of the content in said injection container actuates said end of content blocker to block any subsequent dosage setting and dosage actuation involving said dosage setter and said dosage actuator.
In a preferred embodiment of the present injector system, the housing comprises a barrel shaped housing enclosure which at front accommodates the injection container and at back integrates the dosage setter and the dosage actuator.
In a preferred embodiment of the present injector system, the pusher means comprises a lead screw axially disposed within the barrel shaped housing enclosure and rotationally constrained relative to the barrel shaped housing enclosure; said lead screw is configured to axially engage cooperatively with the injection container's content for delivery of the content by pushing forward within the injection container with forward axial advancement of the lead screw with respect to the barrel shaped housing enclosure having said injection container for dosage administration.
In a preferred embodiment of the present injector system, the dosage setter and the dosage actuator include dosage setting measure unit configured to permit users to set a measured dosage volume of the injecting content to be delivered prior to each of the dose administration .
In a preferred embodiment of the present injector system, the pusher means forward axial advancement motion actuator means operatively engages with the lead screw based on the dosage setter and the dosage actuator to translate the set dosage volume into corresponding forward axial advancement of the lead screw within the injection container for every dosage setting and administration to push a piston within the injection container forward and deliver the injecting content as per set dosage volume.
In a preferred embodiment of the present injector system, the end of content blocker is supported on the lead screw and includes an usually outwardly resiliently biased lock which is inwardly press fitted with respect to a stationary coaxial sleeve enclosure surrounding said lead screw and adapted to move the said lead screw with respect to said stationary coaxial sleeve enclosure during dosage administration under said inwardly press fitted condition restrained by said stationary coaxial sleeve enclosure and when said lead screw axial traverse reaches end of content in the injection container actuably engage with the pusher means forward axial advancement motion actuator means in a manner blocking any further motion of the lead screw with respect to its surrounding stationary coaxial sleeve enclosure thereby also rendering the dosage setter and dosage the actuator non operative when the forward axial advancement of the lead screw within the injection container has been reached corresponding to complete depletion of the injecting content in the injection container.
In a preferred embodiment of the present injector system, the housing accommodating the injection container includes a cartridge holder coaxially accommodated at front end of the housing ; wherein the cartridge holder contains an injection cartridge having its dispensing end towards front end of the cartridge holder and a piston at back end of the cartridge holder cooperatively mating with front end of the lead screw; said cartridge holder adapted to accommodate an injecting needle at its front end connected to said dispensing end of the injection cartridge with a removable cap covering the injecting needle.
In a preferred embodiment of the present injector system, the housing at its back end includes a housing top rotationally constrained relative to the housing and supporting the dosage setter and the dosage actuator external to the housing .
In a preferred embodiment of the present injector system, the dosage setter comprises a dose knob rotationally coupled with the housing top at its back end involving ratchet teeth at inner surface of the dose knob engaging with pawl features on outer surface of the housing top to constitute two-way ratchet arrangement between the housing top and the dose knob enabling clockwise/anticlockwise rotation of the dose knob with respect to the housing top and also the around the housing axis overhauling said two-way ratchet-pawl arrangement which cooperate with the pusher means forward axial advancement motion actuator means to correspondingly activate resiliently /spring biased control enabling axial compression of a spring /resilient means relative to the housing and holding upon end of dosage setting and maintained so arrested under desired axial compression of a spring /resilient means based on the set dosage and wherein rotation of the dose knob in clockwise/counter clockwise direction enables selecting increasing/decreasing the dose amount based upon corresponding spring compression for generating spring/resilient means based stored spring/resilient means energy and preferably wherein with every dose increment/decrement rotation of the dose knob, the Pawl feature on the housing top slips one Ratchet tooth on the dose knob providing an audible feedback for said dosage setting to the user.
In a preferred embodiment of the present injector system, the dose knob at its back end includes the dosage actuator comprising of a press spring loaded push button having protruding portion within the housing top which cooperate to release the dose setter form further arresting the spring /resilient means for effecting dose delivery through said cooperative pusher means forward axial advancement motion actuator means under release of corresponding spring/ resilient means energy.
In a preferred embodiment of the present injector system, the pusher means forward axial advancement motion actuator means comprises a hollow control tube coaxially accommodated within the housing and spaced apart from inner surface of the housing, said control tube is configured to exhibit rotational movement relative to the housing and axial movement between its dispositions at the front end and back end of the housing; said stationary coaxial sleeve enclosure coaxially accommodated within the control tube surrounding the lead screw carrying said end of content blocker; a dial sleeve coaxially disposed between the stationary coaxial sleeve enclosure and the control tube ensuring inner surface of the dial sleeve is engaged with outer of the stationary coaxial sleeve enclosure while outer surface of the dial sleeve is engaged with inner surface of the control tube; an energy spring/resilient means coaxially disposed between the stationary coaxial sleeve enclosure and the control tube facing back end of the dial sleeve; a drive nut coaxially accommodated within the housing facing front ends of the control tube and the stationary coaxial sleeve enclosure, said drive nut includes threaded portion at its inner surface for a threaded engagement with outer surface of the lead screw enabling its forward axial advancement with the rotation of the drive nut to push the piston within the injection cartridge; and a D lock nut fixed within the housing between the cartridge holder and the drive nut having tongue - groove based engagement with the outer surface of the lead screw to arrest any rotational motion of the lead screw with respect to the housing ; said control tube at its disposition in the back end of the housing operatively connected with front end of the dose knob through a detachable tongue groove based engagement while the control tube with clutch features on its front end detachably engage with corresponding gear features on the drive nut at the control tube's disposition in the front end of the housing; said drive nut being rotationally coupled with inner surface of the housing through one-way ratchet arrangement enabling only one way rotation of the drive nut with respect to the housing, whereby front end of the stationary coaxial sleeve enclosure is rotationally coupled with the back end of the drive nut enabling rotation of the drive nut with respect to the stationary coaxial sleeve enclosure and constraining axial movement of the stationary coaxial sleeve enclosure relative to the housing and whereby inner surface of the stationary coaxial sleeve enclosure includes tongue-groove engagement with the outer surface of the lead screw enabling only axial linear motion of the lead screw with respect to the stationary coaxial sleeve enclosure and further constraining the stationary coaxial sleeve enclosure to rotate with respect to the housing; said energy spring being operatively connected with back end of the dial sleeve through a spring rest to resiliently bias the dial sleeve with the enclosure whereby rotational motion of the dose knob for dose setting is acted upon said pusher means forward axial advancement motion actuator means through said control tube and said dial sleeve to activate the energy spring to its compressed state and retain the said state of compression and upon pressing the press button of said dosage actuator operatively disconnecting the dose setter and the said pusher means forward axial advancement motion actuator means to thereby allow the energy spring to uncoil and release its stored energy to initiate the dose delivery with said forward axial motion of said lead screw alongwith said end of blocker to act on said cartridge content and upon complete dosage delivery and release of said press button of said dosage actuator said control tube of said pusher means forward axial advancement motion actuator means operatively reconnecting with said dose knob for subsequent dose setting.
In a preferred embodiment of the present injector system, the end of content blocker is disposed at back end of the lead screw enabled to be under resiliently biased and press fitted condition between the stationary coaxial sleeve enclosure and the lead screw and move with forward axial advancement of the lead screw under the press fitted condition during dosage delivery.
In a preferred embodiment of the present injector system, the end of content blocker actuates though openings defined on peripheral surface of the stationary coaxial sleeve enclosure to engage with corresponding mating slots defined in the inner surface of the dial sleeve covering the stationary coaxial sleeve enclosure; wherein said openings on the stationary coaxial sleeve enclosure are selectively disposed to ensure the end of content blocker reaches exactly below the openings for actuation when the axial advancement of the lead screw within the injection cartridge has been reached corresponding to complete depletion of the injecting content in the injection cartridge.
In a preferred embodiment of the present injector system, the end of content blocker includes atleast one EOL spring loaded EOL lock; said EOL spring loaded EOL lock is enabled to press fit within the stationary coaxial sleeve enclosure under compression of the EOL spring and adapted to moves linearly along within the stationary coaxial sleeve enclosure with the lead screw during every dosage administration; said EOL spring is enabled to actuate EOL lock through the stationary coaxial sleeve enclosure opening and engage with anyone of the mating slot in the inner surface of the dial sleeve to arrest any motion of the dial sleeve with respect to the stationary coaxial sleeve enclosure.
In a preferred embodiment of the present injector system, the end of content blocker includes atleast one resilient steel plate supported on the back of the lead screw through a steel plate base; said resilient steel plate is enabled to press fit within the stationary coaxial sleeve enclosure under compression and adapted to move linearly along within the stationary coaxial sleeve enclosure with the lead screw during every dosage administration; said resilient steel plate is enabled to actuate through the stationary coaxial sleeve enclosure opening and engage with anyone of the mating slot in the inner surface of the dial sleeve to arrest any motion of the dial sleeve with respect to the stationary coaxial sleeve enclosure.
In a preferred embodiment of the present injector system, the control tube, engaged with the dose knob and the dial sleeve, transfer dose setting rotation of the dose knob to the dial sleeve in the same direction and the same number of turns as that of the dose knob.
In a preferred embodiment of the present injector system, the dial sleeve, which is rotating with the control tube and the dose knob, is adapted for a trans- rotational motion with respect to the stationary coaxial sleeve enclosure due to its threaded engagement with the outer surface of the stationary coaxial sleeve enclosure and the tongue groove engagement with the inner surface of the control tube; whereby dial sleeve move towards back end of the housing compressing the energy spring to thereby store the rotational energy of the dose knob during dose increasing rotation of the dose knob; wherein the dial sleeve is adapted to move towards front end of the housing releasing the energy spring from its existing compressing state during dose decreasing rotation of the dose knob from a set dose; and wherein unwanted releasing of the compressed energy spring is arrested by the two way Ratchet - pawl arrangement between the dose knob and the housing top. In a preferred embodiment of the present injector system, a protruding portion of press spring biased push button under pressed condition by the user after setting of the dose extends the within the housing top to thereby push the control tube in forward direction to its disposition at the front end of the housing disengaging it from the dose knob upon pressing, whereby disengagement of the control tube from the dose knob enables release of the compressed energy spring which pushes the dial sleeve to move towards front end of enclosure exhibiting the trans-rotational motion with respect to the stationary coaxial sleeve enclosure due to its threaded engagement with the outer surface of the stationary coaxial sleeve enclosure; wherein the dial sleeve rotates the control tube opposite to its dose setting rotation through the tongue groove engagement acting between the dial sleeve and the control tube.
In a preferred embodiment of the present injector system, the control tube under pushed forward disposition at the front end of the housing , engages with the drive nut through the gear-clutch based engagement enables co-rotation of the control tube and the drive nut with the rotating dial sleeve independent from the dose knob.
In a preferred embodiment of the present injector system, the lead screw exhibits the forward axial advancement through the rotating drive nut involving its threaded engagement with the inner surface of the drive nut, thus pushing the piston within the cartridge.
In a preferred embodiment of the present injector system, the dial sleeve includes dose indications printed on its outer surface in multiple equally spaced helical divisions to sequentially appeared on dose window on the barrel surface with the energy spring compressing trans-rotational motion of the dial sleeve during dose setting informing the user about the dose being set for dispensing corresponding to the amount of compressing of the energy spring . According to a further aspect in the present invention there is provided a method of operation of the injector system for administration of injectable select dosage comprising : exposing the injection needle by removing the cap and pierced at the injection sight, and then the spring loaded push button of said dosage actuator is pushed against the press spring enabling the protruding portion of the push button to push the control tube to its disposition at the front end of the housing ensuring (i) engagement of the control tube with the drive nut and (ii) disengagement of the control tube from the dose knob leaving the control tube free to rotate and thereby the dial sleeve also free to rotate; whereby spring force of the compressed energy spring continuously act on the dial sleeve for desired dose setting till dose actuator is applied through said push button for complete releasing of the compressed energy spring enabling the dial sleeve to rotates opposite to the dose setting rotation and moves forward over the stationary coaxial sleeve enclosure, whereby the rotational motion of the dial sleeve is transferred to the control tube due to its cooperative engagement; wherein the control tube engaged with the drive nut, rotates the drive nut whereby rotation of the drive nut moves the lead screw in forward direction and thus pushing the piston within the cartridge to deliver the pre-set dose volume; wherein after delivery of the dose volume, the push Button is released which is adapted to pull the control tube to its disposition at the back end of the housing ensuring (i) disengagement of the control tube from the drive nut and (ii) engagement of the control tube with the dose knob for further use till complete deletion of the injection cartridge; wherein the end of content blocker disposed at the back of the lead screw moves with every injecting forward axial advancement of the lead screw in press fitted condition under the stationary coaxial sleeve enclosure and actuably engage with corresponding mating slots with the inner surface of the dial sleeve trough the openings in the stationary coaxial sleeve enclosure when the axial advancement of the lead screw within the injection cartridge has reached corresponding position indicative of complete depletion of the liquid/injecting content in the injection cartridge.
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS:
Figure 1 shows an embodiment of the injector system with (a) protective cap in close position covering injection needle and cartridge; (b) protective cap in open position exposing injection cartridge in accordance with the present invention.
Figure 2 shows (a) exploded view of a preferred embodiment of the present injector system and (b) system elements associated with the preferred injector system embodiment in accordance with the present invention.
Figure 3 shows exploded view of an alternate embodiment of the present injector system in accordance with the present invention.
Figure 4a and 4b show complete assembly of the present injector system along with different engagements of the system elements associated with the present injector system in accordance with the present invention.
Figure 4c shows line diagram of the complete assembly of the present injector system in accordance with the present invention .
Figure 5 shows setting of injecting dose in the present injector system in accordance with the present invention.
Figure 6 shows delivery of set injecting dose by the present injector system in accordance with the present invention. Figure 7 shows enablement of the End-of-level mechanism in the present injector system in accordance with the present invention.
Figure 8 shows enablement of the End-of-level mechanism involving the alternate embodiment of the present injector system in accordance with the present invention.
DESCRIPTION OF THE INVENTION WITH REFERENCE TO THE ACCOMPANYING DRAWINGS:
As stated hereinbefore, the present invention relates to a pen type injector system for multiple injection applications which permits its user to set an liquid/injecting content dose as per the requirement and facilitates automatic dispensing of said liquid/injecting content as per the set dose from an injection cartridge/container contained with the injector system embodiment. The present pen type injector system also include means which allows its reuse for injecting application till complete depletion of the liquid/injecting content in the injection cartridge/container and after complete depletion of the liquid/injecting content it restrict further use of the injector system.
The injector system essentially includes a housing to accommodate an injection container with injecting content at its dispensing end, an injecting content pusher enabled to axially engage with the injection container for dosage dependent delivery of atleast one dosage of the injecting content under its forward axial advancement relative to the housing.
The forward axial advancement amount of the injecting content pusher is basically controls the dosage of the injecting content to be dispensed. In the present injector system, a pusher means forward axial advancement motion actuator means is provided which includes a dosage setter and dosage actuator to selectively cooperating with a resiliently /spring biased control enabling axial compression of a spring / resilient means relative to the housing. The compression amount varies according to the dosage of the injecting content to be dispensed. In particular, more compression is required for higher dosage. The compression of the spring is maintained by the dosage setter and the dosage actuator till end of the dosage setting and thereafter the spring bias is being released by the dosage actuator enabling corresponding dosage based pushing forward of the pusher means alongwith a cooperative end of level or content blocker.
The dosage setter and dosage actuator upon end of administration of each selected dosage reset for subsequent multi dose administration .
The end of level or cartridge content blocker is basically an actuable locking means which is operatively disposed on the pusher means under non-actuating condition and particularly configured to actuate only the pusher means disposition at end of the content in said injection container to block any subsequent dosage setting and actuation dosage dependent delivery.
Reference is first invited from the accompanying figures 1 and 2 which show an external view of a preferred embodiment of the present injector system and a detailed exploded view of the system elements associated with said preferred injector system embodiment respectively.
As shown in the figure 2, the present injector system comprises the following elements i. pen cap ( 1), ii. cartridge holder (2), iii. liquid/injecting content cartridge (3), iv. D-lock nut (4), v. drive nut (5), vi. EOL sleeve (6), vii. lead screw (7), viii. EOL spring (8), ix. EOL lock (9), x. Dial sleeve (10), xi. spring rest ( 11), xii. energy spring ( 12), xiii. control tube (13), xiv. housing (14), xv. housing-top ( 15), xvi. dose knob ( 16), xvii. press spring ( 17), xviii. press button ( 18), xix. liquid/injecting content delivery opening/needle (19) and xx. dose window (20) .
Reference is also invited from the accompanying figure 3 which shows an alternative embodiment of the present injector system comprising i. pen cap ( 1), ii. cartridge holder (2), iii. liquid/injecting content cartridge (3), iv. D-lock nut (4), v. drive nut (5), vi. EOL sleeve (6), vii. lead screw (7), viii. Steel plate base (8a), ix. Steel Spring plate (9a), x. Dial sleeve (10), xi. spring rest ( 11), xii. energy spring (12), xiii. control tube (13), xiv. housing ( 14), xv. housing -top
( 15) , xvi. dose knob (16), xvii. press spring (17), xviii. press button ( 18), xix. liquid/injecting content delivery opening/needle (19) and xx. dose window (20).
As shown in the above referred figures 2 and 3, the injecting content pusher comprises the lead screw (7) whereas the dosage setter comprises the dose knob
( 16) and the dosage actuator comprises the press spring ( 17) loaded press button ( 18) . The pusher means forward axial advancement motion actuator means comprises the drive nut (5), EOL sleeve (6), Dial sleeve (10), control tube ( 13), the energy spring (12), D-lock nut (4) and the spring rest (11) . The injector system embodiment as shown in the figure 2, includes EOL spring (8) and EOL lock (9) to constitute the end of content blocker, whereas the alternative injector system embodiment as shown in the figure 3, includes Steel plate base (8a) and Steel Spring plate (9a) to constitute the end of content blocker.
The complete assembly of the present injector system along with engagements of the above system elements is further illustrated in the accompanying figure 4a and 4b. A line diagram of the complete assembly of the present injector system is also shown in the accompanying figure 4c. As shown in the referred figures 4a, 4b and 4c, the injector system housing (14) is basically a barrel shaped enclosure which at front accommodates an injection container (3) and at back integrates the dosage setter (16) and the actuator (17, 18).
The pusher means i.e. a lead screw (7) axially disposed within the barrel shaped enclosure ( 14) and is configured to axially engage with the injection container's (3) content for delivery of the content by pushing forward it within the injection container (3) with forward axial advancement of the lead screw (7) with respect to the barrel shaped enclosure (14) for dosage administration . According to a preferred embodiment of the present injector system, the injection container accommodated at front end of the housing includes a cartridge holder (2) coaxially accommodated at front end of the housing ( 14). The cartridge holder (2) contains an injection cartridge (3) having its dispensing end towards front end of the cartridge holder (2) and a piston (21) at back end of the cartridge holder (2) cooperatively mating with front end of the lead screw (7). The cartridge holder (2) is also adapted to accommodate an injecting needle/applicator (19) at its front end connected to the dispensing end of the injection cartridge (3) with a removable cap (1) covering the injecting needle/applicator (19) .
As shown in the figures 4a and 4b, the dosage setter and the actuator constitute a dosage setting measure unit permitting users to set a measured dosage volume of the injecting content to be delivered prior to each of the dose administration. The dosage setter which comprises the dose knob (16), operates as 'user input device' of the present injector system and enables the user to set an injection dose to be dispensed.
The dose knob (16) is rotationally coupled at back of housing top (15) and front of the housing top (15) is integrated with back end of the housing (14). The housing top (15) is rotationally constrained with respect to the housing ( 14), however the dose knob ( 16) can exhibit bi directional rotation with respect to the housing top ( 15) .
As shown in the figures 4a and 4b, engaging outer surface of the housing top ( 15) and inner surface of the dose knob ( 16) (referred by cross-section X3) include triangular toothed textures for constituting a two-way ratchet arrangement between the housing top ( 15) and the dose knob ( 16). Thus, the dose knob (16) can be rotated in both clockwise/anticlockwise direction with respect to the housing top (15) and also the around the housing axis by overhauling the two-way ratchet-pawl arrangement between the housing top ( 15) and the dose knob ( 16). The dose knob (16) at its back end includes the actuator comprising of the press spring (17) loaded push button ( 18). As shown in the above figures 4a and 4b, the pusher means forward axial advancement motion actuator means, which includes the drive nut (5), EOL sleeve (6), Dial sleeve ( 10), control tube (13), the energy spring ( 12) , D-lock nut (4) and the spring rest (11) systematically operates in combination to each other to operatively engages with the dose knob ( 16) and the press spring (17) loaded push button ( 18) and enables translation of the set dosage volume into corresponding forward axial advancement of the lead screw (7) within the injection container (3) for every dosage administration to push the piston forward within the injection cartridge and deliver the injecting content as per set dosage volume.
The hollow control tube (13) is coaxially accommodated within the housing ( 14) and spaced apart from inner surface of the housing. The control tube (13) is particularly configured to exhibit bi-directional rotational movement relative to the housing (14) axis and axial movement between its dispositions at the front end and back end of the housing (14).
The back end of the control tube (13) is disposed in operative connection with front end of the dose knob (16) through a detachable tongue - groove engagement at its disposition in the back end of the housing (14) (as shown in the cross section X5) . The drive nut (5) is coaxially accommodated within front end of the housing (14) and rotationally coupled with inner surface of the housing ( 14) through one-way ratchet arrangement enabling only one way rotation of the drive nut (5) with respect to the housing (14).
Back end of the drive nut (5) which faces front ends of the control tube (13) and the EOL sleeve (6) comprises gear features (As shown in the X6) for clutch engagement and disengagement with front end of the control tube (13) at its disposition in the front end of the housing (14) .
The control tube ( 13) coaxially accommodates the EOL sleeve (6) within it and front end of the EOL sleeve (6) is rotationally coupled with the drive nut (5). The rotational coupling between the EOL sleeve (6) and the drive nut (5) enables rotation of the drive nut (5) with respect to the EOL sleeve (6), however the axial movement of the EOL sleeve (6) within the housing (14) is constrained by the rotational coupling between the EOL sleeve (6) and the drive nut (5).
The lead screw (7) has a threaded arrangement within the drive nut (5) causing the lead screw (7) to move forward in direction of the housing ( 14) with the rotation of the drive nut (5). The D lock nut (4) which is fixed within the housing ( 14) between the cartridge holder (2) and the drive nut (5) comprises tongue - groove engagement with the lead screw (7) (As shown in the cross section XI) to arrest any rotational motion of the lead screw (7) with respect to the housing ( 14) during its forward movement. With the forward movement of the lead screw (7), it push the piston (21) within the cartridge (3) in forward direction to dispense the medicament from the cartridge (3) through applicator/ needle (19) disposed in front of the cartridge holder (2) .
The dial sleeve ( 10) is coaxially disposed between the EOL sleeve (6) and the control tube (13) wherein inner surface of the dial sleeve (10) includes a threaded engagement with outer surface of the EOL sleeve (6) and outer surface of the dial sleeve (10) includes a tongue - groove engagement with the inner surface of the control tube (13) (as shown in the cross section X2) . The spring rest (11) is provided on the back end of the dial sleeve (10) to bias the dial sleeve (10) with the housing ( 14) through the energy spring (12).
The EOL sleeve (6) coaxially covers the lead screw (7) and the lead screw (7) includes tongue-groove arrangement with inner surface of the EOL sleeve (6) (as shown in the cross section X4) enabling only axial linear motion of the lead screw (7) within the EOL sleeve (6) and with respect to the EOL sleeve (6). The EOL sleeve (6) is also constrained to rotate with respect to the housing ( 14) due to its engagement with the lead screw (7) which is constrained to rotate with respect to housing ( 14) due to its engagement with the housing (14) through the D lock nut (4) .
The EOL sleeve (6) is thus can be regarded as stationary coaxial sleeve enclosure which surrounds lead screw (7) . In the present injector system, the end of content blocker is supported on the lead screw and includes an usually outwardly biased lock which is inwardly press fitted with respect to the stationary coaxial EOL sleeve enclosure (6) surrounding the lead screw (7) . The end of content blocker moves with lead screw (7) and with respect to the stationary coaxial EOL sleeve enclosure (6) during dosage administration under inwardly press fitted condition restrained by stationary coaxial EOL sleeve enclosure (6). The end of content blocker is configured to actuably engage with the pusher means forward axial advancement motion actuator means in a manner blocking any further motion of the lead screw (7) with respect to its surrounding stationary coaxial EOL sleeve enclosure (6) when the forward axial advancement of the lead screw within the injection container is reached corresponding to complete depletion of the injecting content in the cartridge. This engagement of the end of content blocker with the pusher means forward axial advancement motion actuator means rendering the dosage setter and the actuator non operative for further dose setting.
Reference is now invited from the accompanying figure 5, which shows setting of injecting dose in the present pen injector system. As shown in the referred figure 5, to set the dose, the housing ( 14) is to be held fixed with one hand and the dose knob (16) is to be rotated in the clockwise/anticlockwise direction overhauling the two-way ratchet feature. The dose setting is bi-directional in nature. In a preferred embodiment, the dose knob ( 16) is to be rotated clockwise (CW) for increasing dose amount and to reduce the value of set dose the dose knob ( 16) can be rotated in counter clockwise (CCW) direction. With every dose increment/decrement of dose, the Pawl feature on the housing top slips one Ratchet tooth on the dose knob providing an audible feedback (click sound) to the user.
The dose setting rotation of the dose knob ( 16) is transferred to the dial sleeve ( 10) through the control tube ( 13) in the same direction and the same number of turns as that of dose knob (16) due to the tongue - groove engagement between the control tube (13) and the dose knob ( 16) and tongue - groove engagement between the control tube (13) and the dial sleeve (10). With the rotation of the dial sleeve (10), it moves axially within the control tube (13) exhibiting a trans- rotational motion due to its threaded engagement with the threaded outer surface of the stationary EOL sleeve enclosure (6). For dose increasing rotation of the dose knob ( 16), the dial sleeve (10) moves towards back end of the housing ( 14) within the control tube (13) and compress the energy spring (12) through the spring rest (11) . With the compression of the energy spring ( 12), the dose knob (16) rotational energy is stored within it for dose dispensing operation while the spontaneous release of the compressed energy spring (12) force acting on the dial sleeve ( 10) is resisted by the two way Ratchet - pawl arrangement between dose knob ( 16) and housing top (15) to prevent accidental dose- delivery during dose-setting. Thus, to set a dose the user torque required to rotate the dose knob ( 16) in the dose set direction (e.g . clockwise/anticlockwise) should be greater than sum of the dial sleeve (10) rotation torque required to compress the energy spring ( 12), and the torque required to overhaul the two way ratchet feature.
Dose indications are printed on the dial sleeve ( 10) in multiple equally spaced helical divisions which sequentially appeared on the dose window (20) on the housing ( 14) with trans-rotational motion of the dial sleeve ( 10) during dose setting informing the user about the dose being set for dispensing. In the preferred embodiment of the present injector system, dose value can be set from 0 IU to 450 IU in the increments of 12.5 IU, which will be visible to the user through the dose window (20). The dose knob ( 16) includes 18 Ratchet teeth, hence the dose knob ( 16) has to be rotated with 2 complete revolutions in CW direction to set 450IU dose.
Reference is next invited from the accompanying figure 6 which shows the automatic dose dispensing operation. As shown in the referred figure 6, to dispense the dose, the needle is to be pierced into the patient at the injection sight, and then the press spring ( 17) biased push button ( 18) is to be pressed which push the control tube ( 13) in front direction of the housing ( 14) disengaging it from the dose knob (16). The pushing of the control tube (13) also engages its front end with the drive nut (5) establishing clutch based engagement. In this configuration, the Control tube (13), the dial sleeve ( 10) and the drive nut (5) can co-rotate independent from the dose knob (16). After disengagement of the control tube ( 13) from the dose knob ( 16), the spring force of the compressed energy spring (12) acting on the dial sleeve (10) which is not resisted by the two way Ratchet - pawl arrangement dives dial sleeve ( 10) to move towards front end of the housing (14) . The dial sleeve (10) while moving in the front direction within the control tube ( 13) under the spring force of the compressed energy spring ( 12) exhibits trans-rotational motion due to its threaded engagement with the threaded outer surface of the stationary EOL sleeve enclosure (6), whereby rotational motion of the dial sleeve ( 10) is transferred to the drive nut (5) through the control tube ( 13) due to their mutual engagement. Since the drive nut (5) is completely constrained of linear movement, its rotation causes the lead screw (7) to advance linearly in the forward direction without any rotation, thus pushing the Rubber piston (21) of the Cartridge (3) to deliver the pre-set dose volume.
After holding the push button (18) in the pushed position till the dial sleeve (10) rotates back to the initial position to display Ό IU' in the dose window (20) indicating the completion of the dose dispensing, the push button (18) is to be released, during this action the following events takes place : a . the gear feature at the front end of the control tube (13) will get disengaged from the mating gear feature on the drive nut (5) b. pulling the control tube ( 13) back to its original position and again engaging the tongue and groove arrangement between the dose knob (16) and the control tube ( 13) The injector system is again restored to its initial condition for further dose setting and dispensing as per requirement, until it delivers complete labeled volume of the injecting content. Reference in this context invited from the accompanying figure 2 and 7 which shows operation of the end of content blocker comprising of the EOL spring (8) loaded EOL lock (9) . As shown in the figures, the lead screw (7) at its back end includes the EOL spring (8) loaded EOL lock (9) which is press fitted within the stationary coaxial EOL sleeve enclosure (6) under compression of the EOL spring (8). The EOL lock (9) moves linearly along within the stationary coaxial EOL sleeve enclosure (6) with the lead screw (7) towards the front end during every injection and delivery of the injecting content from the cartridge (3). The stationary coaxial EOL sleeve enclosure (6) comprises opening corresponding to the EOL lock (9) disposed on the peripheral surface of the EOL sleeve (6). The opening is selectively disposed to ensure that the EOL lock (9) reaches exactly below the opening when the cartridge (3) becomes empty. In this condition the EOL lock (9) is actuated by the EOL spring (8). The dial sleeve (10) covering the stationary coaxial EOL sleeve enclosure (6) includes mating slots in its inner surface wherein the actuated EOL lock (9) through the opening on the EOL sleeve (6) gets engaged. Once, the EOL lock (9) engages with any of the mating slots of the dial sleeve ( 10) any motion of the dial sleeve ( 10) with respect to the stationary coaxial EOL sleeve enclosure (6) gets arrested . Reference in this context also invited from the accompanying figure 3 and 8 which shows operation of the end of content blocker comprising of the steel plate base (8a) and steel plate spring (9a) . In this embodiment, the lead screw (7) at its back end includes the steel plate base (8a) with loaded steel plate spring (9a) which is inwardly press fitted within the stationary coaxial EOL sleeve enclosure (6) under compression of the steel plate spring (9a) . The EOL lock (9) moves linearly along within the stationary coaxial EOL sleeve enclosure (6) with the lead screw (7) towards the front end during every injection and delivery of the injecting content from the cartridge (3). The stationary coaxial EOL sleeve enclosure (6) comprises opening corresponding to the EOL lock (9) disposed on the peripheral surface of the EOL sleeve (6). The opening is selectively disposed to ensure that the steel plate spring (9a) reaches exactly below the opening when the cartridge (3) becomes empty. In this condition the steel plate spring (9a) is actuated . The dial sleeve ( 10) covering the stationary coaxial EOL sleeve enclosure (6) includes mating slots in its inner surface wherein the actuated steel plate spring (9a) through the opening on the EOL sleeve (6) gets engaged. Once, the steel plate spring (9a) engages with any of the mating slots of the dial sleeve ( 10) any motion of the dial sleeve (10) with respect to the stationary coaxial EOL sleeve enclosure (6) gets arrested .
Thus, the present pen type injector system advantageously performs repetitive automatic delivery of user defined volumes of liquid/injecting content from the injection cartridge till complete depletion of the liquid/injecting content in said injection cartridge and then restrict further use of the injector system for subsequent injecting application through EOL lock and sleeve based integration of the dose setting and delivery means with the lead screw that moves within the injection cartridge. It is important to note that, although the embodiments of the invention have been illustrated as a unique pen type injector system which advantageously performs repetitive automatic delivery of user defined volumes of liquid/injecting content from the injection cartridge till complete depletion of the liquid/injecting content in said injection cartridge and then restrict further use of the injector system for subsequent injecting application through EOL lock and sleeve based feedback integration of the dose setting and delivery means with the lead screw that moves within the injection cartridge, the present pen type injector system or any part thereof in fact, can be used for other suitable applications through changes and modifications. Such changes and modifications known to those of ordinary skill are intended to be included within the scope of the present invention.

Claims

CLAIMS:
1. An automated and end of content blocking disposable injector system comprising : a housing having an injection container with injecting content for delivery at a dispensing end; injecting content pusher means in axial operative communication with said injection container adapted for dosage dependent delivery of atleast one dosage of the injecting content under forward axial advancement motion of said pusher means with respect to the housing; pusher means forward axial advancement motion actuator means including a dosage setter and dosage actuator selectively cooperating with a resiliently /spring biased control enabling axial compression of a spring/resilient means and holding upon end of dosage setting and releasing said spring/resilient means by the dosage actuator enabling corresponding dosage based pushing forward of the pusher means alongwith a cooperative end of content blocker; said dosage setter and said dosage actuator upon end of administration of each select dosage adapted for resetting based on availability of remaining injecting content in said injection container for subsequent multi dose administration involving said dosage setter and said dosage actuator ; said end of content blocker operatively disposed with said pusher means such that the pusher means disposition at end of the content in said injection container actuates said end of content blocker to block any subsequent dosage setting and dosage actuation involving said dosage setter and said dosage actuator.
2. An automated and end of content blocking disposable injector system comprising : a housing having an injection container with injecting content for delivery at a dispensing end; injecting content pusher means in axial operative communication with said injection container adapted for dosage dependent delivery of atleast one dosage of the injecting content under forward axial advancement motion of said pusher means with respect to the housing; pusher means forward axial advancement motion actuator means including a rotatable knob based dosage setter and dosage actuator selectively cooperating with a resiliently /spring biased control enabling axial compression of a spring/resilient means wherein measure rotary dose setting motion of the rotatable knob actuates a corresponding spring/resilient means bias loading with respect to said pusher means as stored spring energy and holding upon end of dosage setting and said dosage actuator adapted for releasing said spring/resilient means bias enabling working of the stored spring energy upon said pusher means for corresponding dosage based pushing forward of the pusher means alongwith a cooperative end of content blocker; said dosage setter and said dosage actuator upon end of administration of each select dosage adapted for resetting based on availability of remaining injecting content in said injection container for subsequent multi dose administration involving said dosage setter and said dosage actuator; said end of content blocker operatively disposed with said pusher means such that the pusher means disposition at end of the content in said injection container actuates said end of content blocker to block any subsequent dosage setting and dosage actuation involving said dosage setter and said dosage actuator.
3. The injector system as claimed in claim 1 or 2, wherein the housing comprises a barrel shaped housing enclosure which at front accommodates the injection container and at back integrates the dosage setter and the dosage actuator.
4. The injector system as claimed in anyone of claims 1 to 3, wherein the pusher means comprises a lead screw axially disposed within the barrel shaped housing enclosure and rotationally constrained relative to the barrel shaped housing enclosure; said lead screw is configured to axially engage cooperatively with the injection container's content for delivery of the content by pushing forward within the injection container with forward axial advancement of the lead screw with respect to the barrel shaped housing enclosure having said injection container for dosage administration .
5. The injector system as claimed in anyone of claims 1 to 4, wherein the dosage setter and the dosage actuator include dosage setting measure unit configured to permit users to set a measured dosage volume of the injecting content to be delivered prior to each of the dose administration.
6. The injector system as claimed in anyone of claims 1 to 5, wherein the pusher means forward axial advancement motion actuator means operatively engages with the lead screw based on the dosage setter and the dosage actuator to translate the set dosage volume into corresponding forward axial advancement of the lead screw within the injection container for every dosage setting and administration to push a piston within the injection container forward and deliver the injecting content as per set dosage volume.
7. The injector system as claimed in anyone of claims 1 to 6, wherein the end of content blocker is supported on the lead screw and includes an usually outwardly resiliently biased lock which is inwardly press fitted with respect to a stationary coaxial sleeve enclosure surrounding said lead screw and adapted to move the said lead screw with respect to said stationary coaxial sleeve enclosure during dosage administration under said inwardly press fitted condition restrained by said stationary coaxial sleeve enclosure and when said lead screw axial traverse reaches end of content in the injection container actuably engage with the pusher means forward axial advancement motion actuator means in a manner blocking any further motion of the lead screw with respect to its surrounding stationary coaxial sleeve enclosure thereby also rendering the dosage setter and dosage the actuator non operative when the forward axial advancement of the lead screw within the injection container has been reached corresponding to complete depletion of the injecting content in the injection container.
8. The system as claimed in claim 1 to 7, wherein the housing accommodating the injection container includes a cartridge holder coaxially accommodated at front end of the housing; wherein the cartridge holder contains an injection cartridge having its dispensing end towards front end of the cartridge holder and a piston at back end of the cartridge holder cooperatively mating with front end of the lead screw; said cartridge holder adapted to accommodate an injecting needle at its front end connected to said dispensing end of the injection cartridge with a removable cap covering the injecting needle.
9. The system as claimed in anyone of claims 1 to 8, wherein the housing at its back end includes a housing top rotationally constrained relative to the housing and supporting the dosage setter and the dosage actuator external to the housing .
10. The system as claimed in anyone of the claims 1 to 9, wherein the dosage setter comprises a dose knob rotationally coupled with the housing top at its back end involving ratchet teeth at inner surface of the dose knob engaging with pawl features on outer surface of the housing top to constitute two-way ratchet arrangement between the housing top and the dose knob enabling clockwise/anticlockwise rotation of the dose knob with respect to the housing top and also the around the housing axis overhauling said two-way ratchet-pawl arrangement which cooperate with the pusher means forward axial advancement motion actuator means to correspondingly activate resiliently /spring biased control enabling axial compression of a spring /resilient means relative to the housing and holding upon end of dosage setting and maintained so arrested under desired axial compression of a spring /resilient means based on the set dosage and wherein rotation of the dose knob in clockwise/counter clockwise direction enables selecting increasing/decreasing the dose amount based upon corresponding spring compression for generating spring/resilient means based stored spring/resilient means energy and preferably wherein with every dose increment/decrement rotation of the dose knob, the Pawl feature on the housing top slips one Ratchet tooth on the dose knob providing an audible feedback for said dosage setting to the user.
11. The system as claimed in anyone of the claims 1 to 10, wherein the dose knob at its back end includes the dosage actuator comprising of a press spring loaded push button having protruding portion within the housing top which cooperate to release the dose setter form further arresting the spring /resilient means for effecting dose delivery through said cooperative pusher means forward axial advancement motion actuator means under release of corresponding spring/resilient means energy.
12. The system as claimed in anyone of the claims 1 to 11, wherein the pusher means forward axial advancement motion actuator means comprises a hollow control tube coaxially accommodated within the housing and spaced apart from inner surface of the housing, said control tube is configured to exhibit rotational movement relative to the housing and axial movement between its dispositions at the front end and back end of the housing; said stationary coaxial sleeve enclosure coaxially accommodated within the control tube surrounding the lead screw carrying said end of content blocker; a dial sleeve coaxially disposed between the stationary coaxial sleeve enclosure and the control tube ensuring inner surface of the dial sleeve is engaged with outer of the stationary coaxial sleeve enclosure while outer surface of the dial sleeve is engaged with inner surface of the control tube; an energy spring/resilient means coaxially disposed between the stationary coaxial sleeve enclosure and the control tube facing back end of the dial sleeve; a drive nut coaxially accommodated within the housing facing front ends of the control tube and the stationary coaxial sleeve enclosure, said drive nut includes threaded portion at its inner surface for a threaded engagement with outer surface of the lead screw enabling its forward axial advancement with the rotation of the drive nut to push the piston within the injection cartridge; and a D lock nut fixed within the housing between the cartridge holder and the drive nut having tongue - groove based engagement with the outer surface of the lead screw to arrest any rotational motion of the lead screw with respect to the housing ; said control tube at its disposition in the back end of the housing operatively connected with front end of the dose knob through a detachable tongue groove based engagement while the control tube with clutch features on its front end detachably engage with corresponding gear features on the drive nut at the control tube's disposition in the front end of the housing; said drive nut being rotationally coupled with inner surface of the housing through one-way ratchet arrangement enabling only one way rotation of the drive nut with respect to the housing, whereby front end of the stationary coaxial sleeve enclosure is rotationally coupled with the back end of the drive nut enabling rotation of the drive nut with respect to the stationary coaxial sleeve enclosure and constraining axial movement of the stationary coaxial sleeve enclosure relative to the housing and whereby inner surface of the stationary coaxial sleeve enclosure includes tongue-groove engagement with the outer surface of the lead screw enabling only axial linear motion of the lead screw with respect to the stationary coaxial sleeve enclosure and further constraining the stationary coaxial sleeve enclosure to rotate with respect to the housing ; said energy spring being operatively connected with back end of the dial sleeve through a spring rest to resiliently bias the dial sleeve with the enclosure whereby rotational motion of the dose knob for dose setting is acted upon said pusher means forward axial advancement motion actuator means through said control tube and said dial sleeve to activate the energy spring to its compressed state and retain the said state of compression and upon pressing the press button of said dosage actuator operatively disconnecting the dose setter and the said pusher means forward axial advancement motion actuator means to thereby allow the energy spring to uncoil and release its stored energy to initiate the dose delivery with said forward axial motion of said lead screw alongwith said end of blocker to act on said cartridge content and upon complete dosage delivery and release of said press button of said dosage actuator said control tube of said pusher means forward axial advancement motion actuator means operatively reconnecting with said dose knob for subsequent dose setting.
13. The system as claimed in anyone of the claims 1 to 12, wherein the end of content blocker is disposed at back end of the lead screw enabled to be under resiliently biased and press fitted condition between the stationary coaxial sleeve enclosure and the lead screw and move with forward axial advancement of the lead screw under the press fitted condition during dosage delivery.
14. The system as claimed in anyone of the claims 1 to 13, wherein the end of content blocker actuates though openings defined on peripheral surface of the stationary coaxial sleeve enclosure to engage with corresponding mating slots defined in the inner surface of the dial sleeve covering the stationary coaxial sleeve enclosure; wherein said openings on the stationary coaxial sleeve enclosure are selectively disposed to ensure the end of content blocker reaches exactly below the openings for actuation when the axial advancement of the lead screw within the injection cartridge has been reached corresponding to complete depletion of the injecting content in the injection cartridge.
15. The system as claimed in anyone of the claims 1 to 14, wherein the end of content blocker includes atleast one EOL spring loaded EOL lock; said EOL spring loaded EOL lock is enabled to press fit within the stationary coaxial sleeve enclosure under compression of the EOL spring and adapted to moves linearly along within the stationary coaxial sleeve enclosure with the lead screw during every dosage administration; said EOL spring is enabled to actuate EOL lock through the stationary coaxial sleeve enclosure opening and engage with anyone of the mating slot in the inner surface of the dial sleeve to arrest any motion of the dial sleeve with respect to the stationary coaxial sleeve enclosure.
16. The system as claimed in anyone of the claims 1 to 15, wherein the end of content blocker includes atleast one resilient steel plate supported on the back of the lead screw through a steel plate base; said resilient steel plate is enabled to press fit within the stationary coaxial sleeve enclosure under compression and adapted to move linearly along within the stationary coaxial sleeve enclosure with the lead screw during every dosage administration ; said resilient steel plate is enabled to actuate through the stationary coaxial sleeve enclosure opening and engage with anyone of the mating slot in the inner surface of the dial sleeve to arrest any motion of the dial sleeve with respect to the stationary coaxial sleeve enclosure.
17. The system as claimed in anyone of the claims 1 to 16, wherein the control tube, engaged with the dose knob and the dial sleeve, transfers dose setting rotation of the dose knob to the dial sleeve in the same direction and the same number of turns as that of the dose knob.
18. The system as claimed in anyone of the claims 1 to 17, wherein the dial sleeve, which is rotating with the control tube and the dose knob, is adapted for a trans-rotational motion with respect to the stationary coaxial sleeve enclosure due to its threaded engagement with the outer surface of the stationary coaxial sleeve enclosure and the tongue groove engagement with the inner surface of the control tube; whereby dial sleeve move towards back end of the housing compressing the energy spring to thereby store the rotational energy of the dose knob during dose increasing rotation of the dose knob; wherein the dial sleeve is adapted to move towards front end of the housing releasing the energy spring from its existing compressing state during dose decreasing rotation of the dose knob from a set dose; and wherein unwanted releasing of the compressed energy spring is arrested by the two way Ratchet - pawl arrangement between the dose knob and the housing top.
19. The system as claimed in anyone of the claims 1 to 18, wherein a protruding portion of press spring biased push button under pressed condition by the user after setting of the dose extends the within the housing top to thereby push the control tube in forward direction to its disposition at the front end of the housing disengaging it from the dose knob upon pressing, whereby disengagement of the control tube from the dose knob enables release of the compressed energy spring which pushes the dial sleeve to move towards front end of enclosure exhibiting the trans-rotational motion with respect to the stationary coaxial sleeve enclosure due to its threaded engagement with the outer surface of the stationary coaxial sleeve enclosure; wherein the dial sleeve rotates the control tube opposite to its dose setting rotation through the tongue groove engagement acting between the dial sleeve and the control tube.
20. The system as claimed in anyone of the claims 1 to 19, wherein the control tube under pushed forward disposition at the front end of the housing engages with the drive nut through the gear-clutch based engagement enables co-rotation of the control tube and the drive nut with the rotating dial sleeve independent from the dose knob.
21. The system as claimed in anyone of the claims 1 to 20, wherein the lead screw exhibits the forward axial advancement through the rotating drive nut involving its threaded engagement with the inner surface of the drive nut, thus pushing the piston within the cartridge.
22. The system as claimed in anyone of the claims 1 to 21, wherein the dial sleeve includes dose indications printed on its outer surface in multiple equally spaced helical divisions to sequentially appeared on dose window on the barrel surface with the energy spring compressing trans-rotational motion of the dial sleeve during dose setting informing the user about the dose being set for dispensing corresponding to the amount of compressing of the energy spring .
23. A method of operation of system as claimed in anyone of the claims 1 to 22, for administration of injectable select dosage comprising : exposing the injection needle by removing the cap and pierced at the injection sight, and then the spring loaded push button of said dosage actuator is pushed against the press spring enabling the protruding portion of the push button to push the control tube to its disposition at the front end of the housing ensuring (i) engagement of the control tube with the drive nut and (ii) disengagement of the control tube from the dose knob leaving the control tube free to rotate and thereby the dial sleeve also free to rotate; whereby spring force of the compressed energy spring continuously act on the dial sleeve for desired dose setting till dose actuator is applied through said push button for complete releasing of the compressed energy spring enabling the dial sleeve to rotates opposite to the dose setting rotation and moves forward over the stationary coaxial sleeve enclosure, whereby the rotational motion of the dial sleeve is transferred to the control tube due to its cooperative engagement; wherein the control tube engaged with the drive nut, rotates the drive nut whereby rotation of the drive nut moves the lead screw in forward direction and thus pushing the piston within the cartridge to deliver the pre-set dose volume; wherein after delivery of the dose volume, the push Button is released which is adapted to pull the control tube to its disposition at the back end of the housing ensuring (i) disengagement of the control tube from the drive nut and (ii) engagement of the control tube with the dose knob for further use till complete deletion of the injection cartridge; wherein the end of content blocker disposed at the back of the lead screw moves with every injecting forward axial advancement of the lead screw in press fitted condition under the stationary coaxial sleeve enclosure and actuably engage with corresponding mating slots with the inner surface of the dial sleeve trough the openings in the stationary coaxial sleeve enclosure when the axial advancement of the lead screw within the injection cartridge has reached corresponding position indicative of complete depletion of the liquid/injecting content in the injection cartridge.
PCT/IN2018/050529 2017-09-19 2018-08-14 An automated multi-use injecting system for administration of injectable medicaments WO2019058382A1 (en)

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IN201721033179 2017-09-19
IN201721033179 2017-09-19

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EP3181169A1 (en) * 2015-12-14 2017-06-21 Sanofi-Aventis Deutschland GmbH Drive mechanism for an injection device

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US5938642A (en) 1995-03-07 1999-08-17 Eli Lilly And Company Multiple dose medication dispensing device
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WO2009141005A1 (en) * 2008-05-20 2009-11-26 Tecpharma Licensing Ag Device for administering an injectable product comprising a residual amount display
EP2201975A1 (en) * 2008-12-23 2010-06-30 Sanofi-Aventis Deutschland GmbH Medication delivery device
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