Abstract: An insertion mechanism and methods of assembly and operation of a drug pump may include an insertion mechanism housing; a housing cap; a manifold guide; an insertion biasing member initially held in an energized state; a retraction biasing member connected to a hub connected to a proximal end of a needle; and, optionally, a clip retainer. The retraction biasing member is held initially in an energized state between the hub and manifold guide. A manifold has a manifold body and one or more septa defining a manifold header. The retraction biasing member may be held initially energized between the hub and the clip retainer. The needle is advanced by the insertion biasing member(s) from the initial configuration to an administration configuration, opening a fluid pathway from the manifold header to the target. The pump may include an activation mechanism, a drive mechanism, a fluid pathway connection, and the insertion mechanism.

Abstract: An insertion mechanism for a drug pump includes an insertion mechanism housing; a manifold guide; an insertion biasing members initially held in an energized state; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the manifold guide; and a manifold having a septum and a cannula, wherein the annular space between the septum and the cannula defines a manifold header. The needle and cannula are inserted into the body of a user by the insertion biasing member(s), after which only the needle is retracted. Retraction of the needle may open a fluid pathway from the manifold header to the body through the cannula. A drug delivery pump includes an activation mechanism, a drive mechanism, a fluid pathway connection, and the insertion mechanism. Assembly and operation methods are provided.

Abstract: Systems for drug delivery devices include a temperature control system and an identification system. A temperature control system configured to sense and control temperature of a cartridge containing a drug includes a heater, one or more temperature sensors, and a control unit. An identification system configured to identify a cartridge containing a drug includes a control unit and a tag sensor that is electrically coupled to the control unit, wherein the tag sensor is activated upon detecting a presence of the cartridge. A drug delivery device includes both the temperature control system and the identification system such that the control unit of the device may process the information of the drug that is received from the tag sensor of the identification system, and based on at least a portion of the processed information, determine and control the temperature of the drug within a cartridge.

Abstract: A controlled delivery drive mechanism includes a drive housing, a piston, and a biasing member initially retained in an energized state and is configured to bear upon an interface surface of the piston. The piston is configured to translate a plunger seal and a barrel. A tether is connected between the piston and the winch drum to restrain the free expansion of the biasing member and the free axial translation of the piston upon which the biasing member bears upon. The drive mechanism may further include a gear assembly and an escapement regulating mechanism configured to control the rotation of the gear assembly to release the tether from the winch drum. The metering of the tether by the escapement regulating mechanism controls the rate or profile of drug delivery to a user.

Abstract: A replaceable fluid restriction mechanism includes: an aperture residing adjacent to a fluid pathway connection and configured to permit flow of a drug fluid through the aperture when the fluid pathway connection is open; an entry point of a fluid channel configured such that the flow of drug fluid can travel through aperture to the entry point and through the fluid channel to an exit point; and an outlet aperture of a port through which the flow of drug fluid may travel after exiting the exit point, wherein a fluid conduit is connected to the fluid restriction mechanism at the outlet aperture. A configurable fluid restriction mechanism includes a plurality of fluid channels, selectable to align with the entry point and an exit point of the fluid restriction mechanism.

Abstract: A skin sensing system for a drug delivery device includes a control unit and a skin sensor comprising one or more electrodes. The skin sensor may be configured to store a threshold value associated with skin sensing, receive one or more sensed signal values from the one or more electrodes, compare the one or more sensed signal values with the threshold value, and based on the comparison, transmit a resultant signal to the control unit. The resultant signal is used by the control unit to determine whether a skin surface of a user is substantially proximate to the skin sensor upon receiving the resultant signal. A drug delivery device for sensing contact with the skin includes the skin sensing system. When the skin sensor senses that the drug delivery device is in contact with a patient's skin surface, drug delivery from the device may be permitted.

Abstract: A drive mechanism includes a housing, a piston adapted to impart movement to a plunger seal within a drug container, a plurality of biasing members disposed in parallel, and a retainer. The biasing members are disposed to release energy to cause movement of the piston from a retracted first position to the extended second position, the piston bearing against the plunger seal to dispense medicine. The retainer is disposed to maintain the biasing members in the energized position and to release the biasing members to permit the piston to dispense the medicine. The drive mechanism may also include an end-of-dose indicator to identify at least one of when the sleeve assembly is disposed subjacent a window in the housing the relative motion of the sleeve assembly with reference to the window or another reference component, the stoppage of such motion, and the rated or change of rate of motion.

Abstract: A vial adapter is provided for interconnecting a vial having a closure and a fluid delivery device such as a safety syringe. The vial adapter comprises an adapter housing having a base, a shroud extending or projecting from the base and a cannula extending or projecting from the base for penetrating a rubber seal on the vial closure to thereby establish fluid communication between the vial and the vial adapter. The shroud may comprise a plurality of latitudinal slits or windows within each of which resides a flexion arm connected to the shroud, each flexion arm capable of engaging and/or retaining vial closures of any of a variety of different sizes. The vial adapter may comprise a conduit tip in fluid communication with the cannula to allow transfer of fluid to or from the safety syringe while also preventing inadvertent activation of a safety syringe needle retraction mechanism.

Abstract: An expanding plunger rod for a syringe is configured to transition from a packaged configuration to an expanded configuration for operation. The rod includes a substantially cylindrical outer sleeve having a closed-off bottom end and an open upper end, and an inner rod having a lower end and an upper end. The inner rod is slidably disposed coaxially within the outer sleeve. In the packaged configuration, the inner rod is nested within the outer sleeve. In the expanded configuration, the inner rod is disposed substantially axially above the outer sleeve, and the inner rod locks axially in place to prevent transition from the expanded to the packaged configuration.

Abstract: A retainer for a needle assembly of a retractable syringe that includes a plunger assembly and a barrel having a mounting member. The needle assembly includes a retractable needle, a needle hub, and a retainer. The retractable needle is engageable by the plunger assembly to facilitate retraction thereof. The needle hub is mountable to the mounting member of the barrel. The retainer includes a body and at least one retaining member that extends distally from the body. The retaining member includes an inwardly projecting lateral projection to engage the retractable needle and thereby prevent inadvertent proximal movement of said retractable needle prior to retraction. A retractable needle assembly includes the retainer, and a retractable syringe includes the retractable needle assembly including the retainer. A syringe kit includes a retractable syringe, a plurality of retractable needle assemblies, and a vial adapter.

Abstract: A user-initiated fluid pathway connection includes: a connection hub, a piercing member, a sterile sleeve, and a drug container having a cap, a pierceable seal, a barrel, and a plunger seal, wherein the piercing member is initially retained within the sterile sleeve between the connection hub and the pierceable seal of the drug container. The connection hub may include an internal aperture within the connection hub which functions as a flow restrictor and wherein a piercing member is connected to one end of the internal aperture and a fluid conduit is connected to another end of the internal aperture. A drug delivery pump with integrated sterility maintenance features includes a housing, upon which an activation mechanism, an insertion mechanism, a fluid pathway connection as described above, a power and control system, and a drive mechanism connected to a drug container are mounted. Methods of assembly and operation are also provided.

Abstract: A barrel adapter mountable to a syringe barrel includes a barrel tip, a needle assembly, a stylet assembly slidably disposed within a needle lumen of the needle assembly, and a plug within the lumen of the needle. An implant delivery syringe includes a barrel, a plunger assembly, and the barrel adapter. The syringe may include a needle retraction mechanism having a biasing member and an actuable locking arrangement. When the actuable locking arrangement is actuated, the biasing member causes the needle to axially translate over the stylet during retraction to dislodge the plug and cause delivery of an implant to a target location. The plug may be a biodegradable polymer plug such as a water-soluble polymer, PLGA, and/or CARP. The stylet may be retracted following delivery. Methods of assembling implant delivery syringes with drug implants are also provided.

Abstract: An automatic accurate dose syringe includes a barrel, a plunger seal, a barrel adapter assembly having a barrel tip and a needle, and a dose control mechanism having a plunger having a coarse pitch screw on its exterior surface, a housing having a corresponding coarse pitch guide along the interior surface of the housing, a screw having a fine pitch screw which interfaces with a fine pitch nut of an adapter, wherein the plunger has an internal annular space within which screw at least partially resides. The syringe further includes a locking mechanism, an activation button, and a biasing member such as a compression and/or a torsional spring. The components are configured such that actuation of the activation button by the user manipulates the locking mechanism to permit the biasing member to move from an initial energized state to a lower energy state, thereby automating drug delivery from the syringe.

Abstract: A drive mechanism includes a housing, a piston adapted to impart movement to a plunger seal within a drug container, a plurality of biasing members disposed in parallel, and a retainer. The biasing members are disposed to release energy to cause movement of the piston from a retracted first position to the extended second position, the piston bearing against the plunger seal to dispense medicine. The retainer is disposed to maintain the biasing members in the energized position and to release the biasing members to permit the piston to dispense the medicine. The drive mechanism may also include an end-of-dose indicator to identify at least one of when the sleeve assembly is disposed subjacent a window in the housing, the relative motion of the sleeve assembly with reference to the window or another reference component, the stoppage of such motion, and the rated or change of rate of motion.

Abstract: A low retraction activation force plunger sub-assembly for an automatic injector includes: a plunger outer having one or more engagement prongs, a plunger inner having a shoulder, and a plunger biasing member retained in a first energized state between said plunger outer and plunger inner when the engagement prongs of the plunger outer are releasably engaged with the shoulder of the plunger inner. An automatic injector includes a housing, an activation mechanism, an actuation mechanism, and a syringe cartridge having the plunger sub-assembly and a needle assembly, wherein the actuation mechanism includes comprises an actuation biasing member residing in an initial energized state substantially within an upper portion of an actuation pill. A method of assembling the automatic injector includes the steps of: assembling the plunger sub-assembly and inserting the plunger sub-assembly into the housing such that a proximal end of the plunger sub-assembly contacts the actuation pill.

Abstract: A mixing device and a retractable syringe comprising same are provided. The mixing device comprises concentric outer and inner barrels that form an outer chamber, the inner barrel having an inner chamber. A mixing plunger is slidably located in the outer chamber. A seal located in the outer chamber is capable of axial movement, in response to depression of the mixing plunger, from a first position in sealing engagement with one or more apertures in the inner barrel to a second position intermediate the apertures and vents in the outer barrel. This allows depression of the mixing plunger to force a first substance from the outer chamber through the apertures to mix with a second substance in the inner chamber. The mixed substance in the inner barrel is then delivered by the syringe with subsequent needle retraction.

Abstract: A barrel adapter for a syringe having a barrel and plunger. The adapter comprises a barrel tip and a needle retraction mechanism having a needle subassembly with a needle and a lumen, actuator subassembly, and biasing member. The needle subassembly moves from an injection to a retracted position within the barrel tip. The actuator subassembly includes a retainer connected to the barrel tip, a stylet held in a stylet disc, and a prong passing into the retainer. The stylet slides within the needle lumen and is spaced from the needle tip in the injection position. The biasing member biases the NOM from the retainer. A locking arrangement compresses the biasing member when locked and releases the biasing member when actuated by depression of the plunger, which moves the prong against the retainer. The biasing member moves the needle and stylet from the injection position to the retracted position when released.

Abstract: A variable rate controlled delivery drive mechanism includes a drive mechanism housing, at least partially within which initially resides a biasing member positioned in an initially energized state within an inner cavity of a piston. The drive mechanism may include a gear drive having one or more screws and one or more corresponding nuts. The piston contacts a plunger seal and is configured to axially translate the plunger seal, by force asserted upon it from the biasing member, from a first position to a second position within a drug container for drug delivery. The biasing member is metered from free expansion from its energized state by the gear drive and a gear assembly mechanism having a motor. A drug delivery pump utilizes such variable rate controlled delivery mechanisms. A status reader configured to recognize one or more corresponding status triggers is utilized to provide feedback to a user.