Abstract: A cartridge for containing and dispensing a medicament, the cartridge including a cartridge body having an interior cavity therein, a stopper movably disposed within the interior cavity, and a septum disposed at an opposite end of the interior cavity from the stopper, for containing the medicament within the interior cavity. The cartridge also includes a connection thread integrally formed as a unitary construction of the cartridge body, the thread being disposed at a first end of the cartridge body for connecting a pen needle directly to the cartridge body to pierce the septum and provide communication between the medicament and a patient end of the pen needle.

Abstract: A removal device (121, 221) for removing and disposing of a pen needle (113, 213) connectable to a drug delivery device (111, 211) includes a body (123, 223) having a cavity (141, 241) for receiving the pen needle of the drug delivery device such that a patient end (116, 216) of a needle (115, 215) of the pen needle is covered by the body. An ejector (151, 251) is movably connected to the body (123, 223) for engaging the received pen needle (113, 213) and selectively ejecting the engaged pen needle from the body. The pen needle (113, 213) is securely retained within the removal device (121, 221) without exposing the needle (115, 215) of the pen needle until the pen needle (113, 213) can be properly disposed of, such as in a sharps container, thereby substantially preventing an accidental needle stick.

Abstract: In one embodiment, a member for securely dispensing a substance to an intended user includes a first member configured to threadedly engage with a housing containing the substance; a second member coupled to the first member, the second member configured to fixedly secure the first member to the housing; a third member including a cavity sized and shaped to selectively receive the second member; and a valve coupled to the first member such that: when the second member is received within the cavity, the valve is in an open state that allows the substance to be dispensed from the housing to the intended user in response to a processor determining that a unique biometric attribute of the intended user is detected, and when the second member is not received within the cavity, the valve is in a closed state that prevents the substance from being dispensed from the housing.

Abstract: A medication injection pen, including a housing, a dose set knob (DSK) comprising an internal thread and an internal key proximate to a distal end of the internal thread, and a dose stop member comprising an external thread engaging the internal thread of the dose set knob. Rotation of the dose set knob to set a medication dose causes lateral translation of the dose stop member with respect to the dose set knob, and when the dose set knob is rotated to a last dose setting position, the dose stop member rotationally abuts the internal key thereby preventing further rotational movement of the dose set knob in a dose setting direction.

Abstract: Computerized oral prescription administration with refillable medication dispensing devices and associated systems and methods are provided. In one embodiment, a method of dispensing a substance to an intended user is provided. The method comprises receiving an input from a biometric sensor; determining, based on the received input, whether an intended user's unique biometric attribute is detected by the biometric sensor; receiving an input from an environmental sensor; determining, based on the received input, whether a mouthpiece is positioned within a user's mouth; receiving an input from a capacitive sensor array of the mouthpiece; determining, based on the received input, whether an intended user's unique dentition is positioned within a recess of the mouthpiece; and dispensing a substance from a reservoir to a mouth of the intended user in response to determining that the intended user's unique biometric attribute is detected by the biometric sensor.

Abstract: A medical injector, including a body with a displaceable plunger, which has at least one set of ratchet teeth, each set having a plurality of spaced-apart ratchet teeth disposed along the length thereof. At least one indexer is formed to engage the plunger. The indexer is configured to allow the plunger to displace distally toward the distal end of the body but not proximally toward the proximal end of the body. An actuator has a rocker pivotally connected thereto, the rocker being of single-piece construction and having an engagement portion formed to engage the ratchet teeth. The indexer and the rocker engage the same set of ratchet teeth. The rocker is pivotally connected at a first portion thereof to the body to rotate about an axis disposed on the body and pivotally connected at a second portion thereof to a link to rotate about an axis disposed on the link.

Abstract: The subject invention provides a drug delivery device for injecting medicament which includes a tubular reservoir; a stopper slidably disposed in the reservoir; a spring for moving the stopper in the reservoir; at least one needle, the needle having a distal end for insertion into a patient, and a lumen extending proximally from the distal end, the lumen being in direct or indirect communication with the reservoir; a needle driver for displacing the needle; and an actuator. Activation of the actuator causes the spring to move the stopper and the needle driver to displace the needle. The needle moves relative to, and separately from, the reservoir with the needle being displaced. Advantageously, with the subject invention, a drug delivery device is provided wherein a needle is moved, relative to the reservoir, in being displaced for injection. This permits control of the needle displacement separate from the reservoir.

Abstract: The subject invention provides a drug delivery device for injecting medicament which includes: a tubular reservoir; a stopper slidably disposed in the reservoir; a spring for moving the stopper in the reservoir; at least one needle, the needle having a distal end for insertion into a patient, and a lumen extending proximally from the distal end, the lumen being in direct or indirect communication with the reservoir; a needle driver for displacing the needle; and, an actuator. Activation of the actuator causes the spring to move the stopper and the needle driver to displace the needle. The needle moves relative to, and separately from, the reservoir with the needle being displaced. Advantageously, with the subject invention, a drug delivery device is provided wherein a needle is moved, relative to the reservoir, in being displaced for injection. This permits control of the needle displacement separate from the reservoir.

Abstract: A device for delivering a fluid includes a housing defining an interior space and having a bottom surface configured for contacting a patient. The bottom surface defines a needle opening. The device also includes a reservoir disposed within the interior space of the housing for containing a fluid therein, a needle carrier disposed within the housing, and an injection needle supported by the needle carrier and defining a lumen. The lumen of the injection needle is configured to be placed in fluid communication with the reservoir. The injection needle is transitionable from an initial position in which the injection needle is disposed within the housing, to a use position in which the injection needle extends through the needle opening, and a substantially shielded position in which the injection needle is disposed within the housing and the lumen of the needle is blocked by a portion of the housing.

Abstract: Computerized oral prescription administration with refillable medication dispensing devices and associated systems and methods are provided. In one embodiment, a substance dispensing apparatus includes a housing sized and shaped for handheld use, the housing having at least one wall and a biometric sensor coupled to the at least one wall; a processor in communication with the biometric sensor, the processor configured to determine whether an intended user's unique biometric attribute is detected by the biometric sensor based on input received from the biometric sensor; and a pump in communication with the processor, the pump configured to dispense a substance from a reservoir to a mouth of the intended user in response to the processor determining that the intended user's unique biometric attribute is detected by the biometric sensor.

Abstract: Computerized oral prescription administration with refillable medication dispensing devices and associated systems and methods are provided. In one embodiment, a substance dispensing apparatus includes a housing sized and shaped for handheld use, the housing having at least one wall and a biometric sensor coupled to the at least one wall; a processor in communication with the biometric sensor, the processor configured to determine whether an intended user's unique biometric attribute is detected by the biometric sensor based on input received from the biometric sensor; and a pump in communication with the processor, the pump configured to dispense a substance from a reservoir to a mouth of the intended user in response to the processor determining that the intended user's unique biometric attribute is detected by the biometric sensor.

Abstract: A device (10) for delivering a fluid includes a housing (12) defining an interior space (22) and having a bottom surface (18) configured for contacting a patient. The bottom surface (18) defines a needle opening (56). The device (10) also includes a reservoir (26) disposed within the interior space (22) of the housing (12) for containing a fluid therein, a needle carrier (30) disposed within the housing (12), and an injection needle (28) supported by the needle carrier (30) and defining a lumen. The lumen of the injection needle (28) is configured to be placed in fluid communication with the reservoir (26).

Abstract: A method for creating a sterile connection with a fluid in a container. The container has a sealing member sealing a first end of the container, and a barrier sealing a chamber in fluid communication with the sealing member. The method includes providing a valve sleeve assembly that includes a flexible sleeve having a barrier portion at an end of the flexible sleeve, a hollow first penetrator disposed within the flexible sleeve, and a hollow second penetrator at least partially disposed within the first penetrator. An interior of the flexible sleeve is sterile. The method also includes piercing the barrier portion and the barrier with the first penetrator, and displacing the second penetrator relative to the first penetrator and the sealing member to pierce the sealing member and establish the sterile connection with an interior of the container.

Abstract: An injection pen (1) includes a housing (2), a lead screw (75), a dose set member (6), a setback member (17), and a rotatable driver (60). The lead screw (75) is axially moveable in the housing (2). The dose set member (6) is connected to the housing (2) for dose setting and dose correcting. The setback member (17) is operatively connected to the dose set member (6). The rotatable driver (60) is operatively connected to the setback member (17) and the lead screw (75). The driver (60) is prevented from rotating during dose setting and dose correcting, and the driver (60) rotates during an injection to axially move the lead screw (75).

Abstract: An injection pen, comprising a housing, a lead screw axially moveable in the housing, a dose set member for dose setting and dose correcting, threadably connected to the housing and having a first mating feature, a setback member having a second mating feature for engaging the first mating feature, a clicker that generates an audible or tactile indication during operation, the clicker being operatively connected to the dose set member, and a push button operatively connected to the setback member to cause the second mating feature to engage the first mating feature during an injection, the push button receiving the clicker, wherein the first mating feature is disengaged from the second mating feature during dose setting and dose correcting and engaged with the second mating feature during an injection.

Abstract: An injection pen (1) includes a housing (2), a lead screw (75), a dose set member (6), a setback member (17), and a rotatable driver (60). The lead screw (75) is axially moveable in the housing (2). The dose set member (6) is connected to the housing (2) for dose setting and dose correcting. The setback member (17) is operatively connected to the dose set member (6). The rotatable driver (60) is operatively connected to the setback member (17) and the lead screw (75). The driver (60) is prevented from rotating during dose setting and dose correcting, and the driver (60) rotates during an injection to axially move the lead screw (75).

Abstract: An adapter assembly for establishing bidirectional fluid connection between a cartridge and a vial includes a housing having an open first end adapted to engage the cartridge and a second open end adapted to engage the vial. The adapter includes a needle assembly having a first tip and a second tip, with the needle assembly disposed within the housing and at least partially supported by a needle holder. The needle assembly is movable relative to the housing from an initial position in which the first and second tip are isolated from the cartridge and vial, to an end of use position, in which first tip is engaged with the vial and the second tip is engaged with the cartridge, establishing fluid communication therebetween. The needle assembly is maintained in the initial position by a locking structure which is released by rotationally advancing the needle holder relative to the housing.

Abstract: In one aspect, a medical injector is provided herein having a body and an overcap releasably attached to the body configured to prevent mounting of a needle prior to mixing of components within the body. In a further aspect, a slidable collet may be provided useable to urge resilient members from an outward disrupted state inwardly to collectively define a needle mount. Advantageously, a medical injector is provided which ensures proper sequence in preparation of the device, particularly with respect to the step of allowing mounting of a medical needle to the device subsequent to preparation of the medicament to be administered.

Abstract: A system includes an access cannula, a deployment cannula having a plurality of engagement arms, and a containment bag. The deployment cannula is slidable within the access cannula between an initial condition, wherein the engagement arms are retained in a contracted configuration, and a deployed condition, wherein the engagement arms are disposed in an expanded configuration. The containment bag includes an open end portion configured to receive the first elongated tubular member and the second elongated tubular member. In the initial condition, a portion of the containment bag towards the open end portion is positioned adjacent at least one of the first elongated tubular member or the second elongated tubular member. In the deployed condition, the portion of the containment bag is expanded such that the portion of the containment bag is spaced-apart from the at least one of the first elongated tubular member or the second elongated tubular member.

Abstract: An adapter assembly for establishing bidirectional fluid connection between a cartridge and a vial includes a housing having an open first end adapted to engage the cartridge and a second open end adapted to engage the vial. The adapter includes a needle assembly having a first tip and a second tip, with the needle assembly disposed within the housing and at least partially supported by a needle holder. The needle assembly is movable relative to the housing from an initial position in which the first and second tip are isolated from the cartridge and vial, to an end of use position, in which first tip is engaged with the vial and the second tip is engaged with the cartridge, establishing fluid communication therebetween. The needle assembly is maintained in the initial position by a locking structure which is released by rotationally advancing the needle holder relative to the housing.