Abstract: Provided herein are fluid delivery systems including an inner screw having a pusher disposed at a distal end of the inner screw to engage and linearly translate a plunger within a reservoir to dispense a medication from the reservoir; an outer screw concentrically surrounding the inner screw, wherein an inner surface of the outer screw engages with an outer surface of the inner screw such that a rotational movement of the outer screw advances the inner screw from a nested configuration to an extended configuration; and a screw support configured to engage with the outer screw; and an anti-rotation sleeve (ARS) engaged with the screw support and the inner screw, such that, when the outer screw is rotated, the inner screw is advanced without rotating. The fluid delivery systems can be used in connection with fluid delivery devices.

Abstract: A pen needle magazine (10) comprising a plurality of compartments (14) each carrying a pen needle (40), and a pen needle carrier (60) disposed in each of the plurality of compartments (14), the pen needle (40) disposed in the pen needle carrier (60), wherein the pen needle carrier (60) includes a first pen needle path (62) and a second pen needle path (64), the first pen needle path (62) aids in removing the pen needle (40), and the second pen needle path (64) aids in discarding a used pen needle (40).

Abstract: A dosing module includes an outer shell having a stem and a spline hole plate having a spline hole, where the spline hole plate is positioned within the stem and sized to receive a spline shaft extending from a shaft spring, such that the spline hole plate and the shaft spring rotate together. The dosing module includes an encoder wheel coupled to the spline hole plate and positioned within the stem and sensors positioned within the stem configured to detect rotation of the encoder wheel. The dosing module is removably couplable to a dose knob of a delivery pen, where the stem is received within an internal well of the dose knob. The shaft spring is directly coupled to a component of a drive mechanism of the delivery pen, and the dosing module is configured to measure a size of a dose administered from the delivery pen.

Abstract: A pen needle (10) includes a hub (12) supporting a needle (30), an inner shield (14) enclosing the distal end of the needle, and an outer cover (16). The outer surface of the hub can include ribs (66) that cooperate with ribs (72) on the inner surface of the outer cover to assist in attaching the pen needle to a delivery device while preventing over torqueing or over tightening. In one embodiment, the inner shield (14) has a dimension to attach to the distal end of the hub (12) after use to enclose the proximal, non-patent end of the needle. In another embodiment, the outer cover (16) includes a closure member that can be removed during use and re-attached after use to cover the proximal end of the needle.

Abstract: A pen needle (10) includes a hub (12) supporting a needle (30), an inner shield (14) enclosing the distal end of the needle, and an outer cover (16). The outer surface of the hub can include ribs (66) that cooperate with ribs (72) on the inner surface of the outer cover to assist in attaching the pen needle to a delivery device while preventing over torqueing or over tightening. In one embodiment, the inner shield (14) has a dimension to attach to the distal end of the hub (12) after use to enclose the proximal, non-patent end of the needle. In another embodiment, the outer cover (16) includes a closure member that can be removed during use and re-attached after use to cover the proximal end of the needle.

Abstract: The present disclosure relates to devices, systems and processes for delivering therapeutic fluids. Embodiments disclosed herein are directed to medical devices for housing a therapeutic fluid, and methods and systems for monitoring in an infusion delivery device, using a pressure sensor of the device, one or more of: (A) fill event detection; (B) fill volume detection; (C) mechanical compliance calibration/air detection of an infusion management system after fill event and priming; (D) occlusion detection after removal of insertion seal assembly; (E) detecting fluid path deployment of an infusion delivery device; (F) monitoring for occlusion detection during pump use; and (G) detecting an empty reservoir.

Abstract: A pen needle (10) includes a hub (34) supporting a needle (28) and a distal needle shield (14) that can retract to expose the needle during injection and return to the extended position after use and locked in the extended position cover the needle. A proximal needle shield (16) moves to an extended position with respect to the hub (34) to cover a proximal end (34) of the needle. A spring (64) extends between the distal needle shield (14) and the proximal needle shield (16) to bias each needle shield to the respective extended position. A locking member (78) on the distal needle shield cooperates with the hub to lock the needle shields in the extended position. An indicator (94) in the hub engages and couples to the distal needle shield (14) when moved to the retracted position. The indicator (94) moves with the distal needle shield (14) to the extended position where the indicator is visible through the distal needle shield (14) indicating that the pen needle is no longer usable.

Abstract: A pen needle (30) for a delivery device includes a hub (32) supporting a needle (54) and a distal needle shield (70) that can retract to expose the needle during injection and return to the extended position after use and lock in the extended position to cover the needle. A proximal needle shield (0.102) moves from a retracted position to an extended position with respect to the hub to shield or cover a proximal end of the needle when the needle hub is separated from the delivery device. A spring (130) extends between the distal needle shield and the proximal needle shield to bias each needle shield to the respective extended position. The distal needle shield (70) is coupled to the proximal needle shield (102) in an initial position to retain the spring (130) in a compressed state. The distal needle shield (70) is depressed to disengage the distal needle shield from the proximal needle shield (102) so that the spring expands to an extended state and moves the shields to the extended positions.

Abstract: A pen needle includes a hub supporting a needle and a distal needle shield that can retract to expose the needle and return to an extended position to cover the needle. A proximal needle shield moves to an extended position to cover a proximal end of the needle. A spring extends between the distal and proximal needle shields to bias the distal and proximal needle shields to their respective extended positions. A locking member on the distal needle shield cooperates with the hub to lock the proximal and distal needle shields in their respective extended positions. An indicator in the hub couples to the distal needle shield when the distal needle shield is moved to a retracted position. The indicator moves with the distal needle shield to the extended position of the distal needle shield where the indicator indicates that the pen needle is no longer usable.

Abstract: A device for delivering fluid and an inserter in a device for delivering fluid, the device comprising an annular guide configured to engage a pen or a syringe injection needle, a main body enclosed by a base and a cover, and an inserter for expelling the fluid, wherein the inserter includes a glucose monitoring sensor disposed coaxially with the inserter. The inserter comprising a cannula configured to deliver the fluid, and a glucose monitoring sensor disposed coaxially to and surrounding the cannula, wherein the glucose monitoring sensor includes a biosensor layer that monitors glucose in the fluid and provides feedback to the device.

Abstract: The present disclosure relates to devices, systems and processes for delivering therapeutic fluids. Embodiments disclosed herein are directed to medical devices for housing a therapeutic fluid, and methods and systems for monitoring in an infusion delivery device, using a pressure sensor of the device, one or more of: (A) fill event detection; (B) fill volume detection; (C) mechanical compliance calibration/air detection of an infusion management system after fill event and priming; (D) occlusion detection after removal of insertion seal assembly; (E) detecting fluid path deployment of an infusion delivery device; (F) monitoring for occlusion detection during pump use; and (G) detecting an empty reservoir.

Abstract: The present disclosure relates to devices, systems and processes for delivering therapeutic fluids. Embodiments disclosed herein are directed to medical devices for housing a therapeutic fluid, and methods and systems for monitoring in an infusion delivery device, using a pressure sensor of the device, one or more of: (A) fill event detection; (B) fill volume detection; (C) mechanical compliance calibration/air detection of an infusion management system after fill event and priming; (D) occlusion detection after removal of insertion seal assembly; (E) detecting fluid path deployment of an infusion delivery device; (F) monitoring for occlusion detection during pump use; and (G) detecting an empty reservoir.

Abstract: The present disclosure relates to devices, systems and processes for delivering therapeutic fluids. Embodiments disclosed herein are directed to medical devices for housing a therapeutic fluid, and methods and systems for monitoring in an infusion delivery device, using a pressure sensor of the device, one or more of. (A) fill event detection; (B) fill volume detection; (C) mechanical compliance calibration/air detection of an infusion management system after fill event and priming; (D) occlusion detection after removal of insertion seal assembly; (E) detecting fluid path deployment of an infusion delivery device; (F) monitoring for occlusion detection during pump use; and (G) detecting an empty reservoir.

Abstract: The present disclosure relates to devices, systems and processes for delivering therapeutic fluids. Embodiments disclosed herein are directed to medical devices for housing a therapeutic fluid, and methods and systems for monitoring in an infusion delivery device, using a pressure sensor of the device, one or more of: (A) fill event detection; (B) fill volume detection; (C) mechanical compliance calibration/air detection of an infusion management system after fill event and priming; (D) occlusion detection after removal of insertion seal assembly; (E) detecting fluid path deployment of an infusion delivery device; (F) monitoring for occlusion detection during pump use; and (G) detecting an empty reservoir.

Abstract: The present disclosure relates to devices, systems and processes for delivering therapeutic fluids. Embodiments disclosed herein are directed to medical devices for housing a therapeutic fluid, and methods and systems for monitoring in an infusion delivery device, using a pressure sensor of the device, one or more of. (A) fill event detection; (B) fill volume detection; (C) mechanical compliance calibration/air detection of an infusion management system after fill event and priming; (D) occlusion detection after removal of insertion seal assembly; (E) detecting fluid path deployment of an infusion delivery device; (F) monitoring for occlusion detection during pump use; and (G) detecting an empty reservoir.

Abstract: The present disclosure relates to devices, systems and processes for delivering therapeutic fluids. Embodiments disclosed herein are directed to medical devices for housing a therapeutic fluid, and methods and systems for monitoring in an infusion delivery device, using a pressure sensor of the device, one or more of: (A) fill event detection; (B) fill volume detection; (C) mechanical compliance calibration/air detection of an infusion management system after fill event and priming; (D) occlusion detection after removal of insertion seal assembly; (E) detecting fluid path deployment of an infusion delivery device; (F) monitoring for occlusion detection during pump use; and (G) detecting an empty reservoir.

Abstract: An integrated disease management system provides patients with simple, quick, and readily available counseling regarding a healthy diabetic lifestyle. The system can include an interactive engine with predictive analytics and machine learning to provide a customized experience for a user. The system can be configured to transmit data to a remote server to perform analysis of received data (e.g., disease management data), to provide feedback to the user (e.g., customized feedback with curated content based on a user's data and interface interactions) and send all or a portion of the data and/or curated content to another user device or remote health management access point (e.g., as cloud storage) where the information can be accessed by healthcare stakeholder.

Abstract: A needle hub (10) for a pen needle is provided with an enlarged surface for contact with the skin of a patient. The enlarged surface is provided with a surface having a dimension and shape to enable a needle or cannula to penetrate the skin to a desired depth and permit substantially the entire exposed length of the needle or cannula to penetrate the skin to the desired depth. The surface of the needle hub can be formed by an inner cone shaped member (26) forming a first contact surface with a surface area of about 1-5 mm2 and an outer ring (28) at a peripheral edge forming a second contact surface with a combined surface area of about 15 to 50 mm2.