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 fluid pathway connection includes a piercing member, a connection hub, and a sliding pierceable seal, wherein the sliding pierceable seal is configured to move from a first position, where the piercing member is initially retained within a sterile cavity between the connection hub and the sliding pierceable seal, to a second position, where the pierceable seal has been penetrated by the piercing member. A filter may be utilized to enclose the sterile cavity from the outside environment. The fluid pathway connection may further be configured to move to a third position where one or more interconnects and/or one or more corresponding contacts are permitted to transmit a signal to the user. Such fluid pathway connections may be integrated into a drug container having a barrel and a plunger seal. A drug delivery pump includes such integrated fluid pathway connections and drug containers.

Abstract: An insertion mechanism for a drug pump includes an insertion mechanism housing; a sleeve; a rotational biasing member 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 sleeve. The needle is inserted into a target tissue by the rotational biasing member and interaction between the hub and housing. Retraction of the needle is caused by decompressing or de-energizing of the retraction biasing member. A drug delivery pump includes an activation mechanism, a drive mechanism, a sterile access connection, and the insertion mechanism. Assembly and operation methods are provided.

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.

Abstract: Devices and methods for establishing aseptic connections between a drug container and a fluid pathway connection for a drug pump are provided. A fluid pathway connection includes a connection hub, a piercing member, a piercing member retainer, and a drug container. The drug container includes a cap, a pierceable seal, and a barrel. The piercing member is at least partially disposed in a sterile chamber defined by the connection hub, and the connection hub is configured to be connected to the drug container while maintaining an aseptic condition of a fluid pathway from the sterile chamber to an interior of the drug container.

Abstract: A replaceable fluid restriction mechanism 500, 1500 includes: an aperture 520A residing adjacent to a fluid pathway connection and configured to permit flow of a drug fluid through the aperture 520A when the fluid pathway connection is open; an entry point 520B of a fluid channel 520C configured such that the flow of drug fluid can travel through aperture 520A to the entry point 520B and through the fluid channel 520C to an exit point 520D; and an outlet aperture 514 of a port 512 through which the flow of drug fluid may travel after exiting the exit point 520D, wherein a fluid conduit 30 is connected to the fluid restriction mechanism at the outlet aperture. A configurable fluid restriction mechanism 500, 1500 includes a plurality of fluid channels 520C, 521C, 522C, 523C, selectable to align with the entry point 520B and an exit point 520D of the fluid restriction mechanism.

Abstract: A drive mechanism having integrated status indication includes a drive housing, a status switch interconnect, a drive biasing member, a piston, and a drug container having a cap, a pierceable seal, a barrel, and a plunger seal, wherein the drive biasing member is configured to bear upon an interface surface of the piston. Drive mechanism may include an incremental status stem having a stem interconnect, wherein the stem resides within the drive housing and the piston, and wherein the stem has an interconnect which engages one or more contacts on the piston to provide incremental feedback. A drug delivery pump with integrated status indication includes a housing and an assembly platform, upon which an activation mechanism, an insertion mechanism, a fluid pathway connection, a power and control system, and the drive mechanism having a drug container may be mounted.

Abstract: An insertion mechanism having a vented fluid pathway includes an insertion biasing member 210, a hub 212, a needle 214, a retraction biasing member 216, and a manifold 240 having a septum 230 and a cannula 234, wherein the annular space between the septum 230 and the cannula 234 defines a manifold header 242. The manifold and fluid conduit are ventable through the membrane prior to or just after needle 214 and cannula 234 are inserted into the user. Such insertion is caused by the insertion biasing member(s) 210, after which only the needle 214 or another occlusion element is retracted. Such retraction may open a fluid pathway from the manifold header 242 to the body through the cannula 234 and/or needle 214. A drug delivery pump 10 includes such an insertion mechanism 200 having a vented fluid pathway. The drug delivery pump 10 may contain the insertion mechanism 200 having a vented fluid pathway in either an internally i or an externally tethered configuration.

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: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device includes a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector defines a sterile fluid flowpath between the container and the insertion mechanism. A cannula initially disposed about the needle is included.

Abstract: An insertion mechanism for a drug pump includes an insertion mechanism housing; a sleeve; a rotational biasing member 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 sleeve. The needle is inserted into a target tissue by the rotational biasing member and interaction between the hub and housing. Retraction of the needle is caused by decompressing or de-energizing of the retraction biasing member. A drug delivery pump includes an activation mechanism, a drive mechanism, a sterile access connection, and the insertion mechanism. Assembly and operation methods are provided.

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: The present invention provides devices and methods for establishing aseptic connections between two or more components or subassemblies. The devices may be used in medical devices such as drug delivery pumps (10). In some embodiments, a connection is made between a drug container (50, 1050, 2050) and a fluid pathway connection assembly (300, 1300, 2300). The fluid pathway connection assembly may include a connection hub (312, 1312, 2312), a piercing member (316, 1316, 2316), and a piercing member retainer (314, 1314, 2314). The assembly may further include a first film (318, 1318, 2318) covering a cavity (312A, 1312A, 2312A), thereby maintaining the aseptic condition of the cavity. The drug container may hold a fluid drug and include a pierceable seal (326, 1326, 2326). A second film (322, 1322, 2322) may cover a recess (328, 1328, 2328) formed by the seal and thereby maintain the aseptic condition of the interior of the chamber.

Abstract: An insertion mechanism (200) for a drug pump (10, 1300) includes an insertion mechanism (200) housing (202, 1202, 2202, 3202); a sleeve (220, 1220, 2220, 3220); a rotational biasing member (210, 1210, 2210, 3210) initially held in an energized state; a retraction biasing member (216, 1216, 2216, 3216) and a hub (212, 1212, 2212, 3212) connected to a proximal end of a needle (214, 1214, 2214, 3214), wherein the retraction biasing member (216, 1216, 2216, 3216) is held initially in an energized state between the hub (212, 1212, 2212, 3212) and the sleeve (220, 1220, 2220, 3220). The needle (214, 1214, 2214, 3214) is inserted into a target tissue by the rotational biasing member (210, 1210, 2210, 3210) and interaction between the hub (212, 1212, 2212, 3212) and housing (202, 1202, 2202, 3202). Retraction of the needle (214, 1214, 2214, 3214) is caused by decompressing or de-energizing of the retraction biasing member (216, 1216, 2216, 3216).

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: The present invention provides devices and methods for establishing aseptic connections between two or more components or subassemblies. The devices may be used in medical devices such as drug delivery pumps (10). In some embodiments, a connection is made between a drug container (50, 1050, 2050) and a fluid pathway connection assembly (300, 1300, 2300). The fluid pathway connection assembly may include a connection hub (312, 1312, 2312), a piercing member (316, 1316, 2316), and a piercing member retainer (314, 1314, 2314). The assembly may further include a first film (318, 1318, 2318) covering a cavity (312A, 1312A, 2312A), thereby maintaining the aseptic condition of the cavity. The drug container may hold a fluid drug and include a pierceable seal (326, 1326, 2326). A second film (322, 1322, 2322) may cover a recess (328, 1328, 2328) formed by the seal and thereby maintain the aseptic condition of the interior of the chamber.

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 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 device for delivering fluid to a user includes a housing, a drive motor assembly in the housing, a force sensor, and an electronics module. The drive motor assembly regulates delivery of fluid by actuating a piston of a fluid reservoir, and the force sensor generates output levels in response to force imparted thereto during, for example, fluid delivery operations. The electronics module processes the output levels of the force sensor to assess the operating health of the force sensor, to check for occlusions in the fluid delivery path, and to monitor the seating status of the fluid reservoir.