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.

Abstract: A medication delivery device (MDD) (e.g., injection pen, wearable pump) is paired with an external device (e.g., smart phone, iPad, computer) via wireless link or wireline connection. The MDD provides to the external device captured data from the flow sensor relating to medicine delivery to a patient to ensure complete delivery and minimize MDD misuse or malfunction or inaccuracies in dosing. The MDD can have Bluetooth™ and/or near field communication (NFC) communication circuits for proximity-based pairing and connectivity with the external device for real-time or deferred transfer of captured data to the external device, depending on memory and power availability at the MDD. The MDD or external device can use captured data and corresponding time stamps to determine flow infomatics such as flow rate, total dose delivered, and dose completion status. An LED on the MDD indicates states such as powered on, paired, delivery in progress and delivery completion.

Abstract: A system and method is provided for a continuous glucose monitoring (CGM) system and the processing of data collected thereby. An internet gateway chip (140, 240, 340, 440) is included in elements of a CGM system to facilitate direct data communication with cloud network storage (150, 250, 350, 450) to thereby communicate and store data of a CGM sensor (110, 210, 310, 410) of the CGM system. The internet gateway chip can be included in a receiver (130, 230, 330), such as an existing wireless receiver and display device of the CGM; in a smart phone or similar device, where the smart phone is also the wireless receiver and display device of the CGM; or in the sensor, such as an existing sensor and/or transmitter (410, 420) of the CGM to facilitate direct data communication between the CGM system and cloud network storage.

Abstract: Systems and methods encourage users to rotate injection sites and avoid lipodystrophy. Sleeves and/or lost-tooth gear dials and/or microswitches in or on injection pens or their caps, on vials, and on other portable devices manually adjust an indicator before or after an injection to show a current or next injection site in accordance with a site rotation plan. Injected medicine packaging and related printed indicia encourage site rotation. Optical devices employing optical mouse or projection technology help locate and/or distribute injection sites within a body area. A mobile phone app tracks injections and locations to select next injection site, and can use imaging to locate a target injection site and optionally diagnose lipodystrophic conditions and record them. Tactile and print media educational tools are presented to help users palpate and identify lipos in body areas having injection sites.

Abstract: A pen needle assembly apparatus includes a housing (30), a movable gripping assembly (32) for gripping a pen needle assembly (18), and an actuator (108). The housing (30) has a top end (34), a bottom end (36), and an inner cavity (38) for storing used pen needle assemblies. The gripping assembly (32) in one embodiment includes two movable jaws (58) that are movable to engage and grip the outer cover (22) of the pen needle assembly (18) so that the needle hub (16) can be separated from the outer cover (22) and placed back in the outer cover (22) after use of the pen needle. The actuator (108) is connected to the jaws (58) where movement of the actuator separates the jaws to release the outer cover of the pen needle assembly. The housing (30) has an opening 160) for engaging the inner shield (24) of the pen needle assembly to remove the inner shield (24) from the needle hub (16).

Abstract: A container (20) for storing pen needles (10) comprises a plurality of cavities (30), each cavity (30) having a closed end (32) and an open end (34), and a plurality of rings (40), each ring (40) including a plurality of arms (42) that is configured to retain the pen needle (10) in a first position and in a second position, wherein the open end (34) is flared outwardly, and the plurality of arms (42) are flared outwardly when the pen needle (10) is in the first position.

Abstract: A pen needle (30, 110) is disclosed for coupling to a delivery device (10) and piercing a septum on the delivery device. The pen needle includes a collar (32, 112) having a side wall (36, 116), an open proximal end (38), and a distal end (40, 118) having a coupling member (50). The pen needle also includes a needle hub (34, 114) having a proximal end (50, 124) and a distal end (58, 126), where the proximal end of the needle hub has a coupling member coupled to the distal end of the collar. The needle hub rotates independently of the collar. A needle (52) extends from the distal end of the needle hub, and a projection (76, 126) extends from the proximal end of the needle hub for piercing a septum (106) of a delivery device. The collar (32, 112) rotates independently from the needle hub (34, 114) so that the collar screws onto the threaded end of the delivery device while the needle hub does not rotate and the projection advances to pierce the septum (106) without rotating.

Abstract: Systems and methods encourage users to rotate injection sites and avoid lipodystrophy. Sleeves and/or lost-tooth gear dials and/or microswitches in or on injection pens or their caps, on vials, and on other portable devices manually adjust an indicator before or after an injection to show a current or next injection site in accordance with a site rotation plan. Injected medicine packaging and related printed indicia encourage site rotation. Optical devices employing optical mouse or projection technology help locate and/or distribute injection sites within a body area. A mobile phone app tracks injections and locations to select next injection site, and can use imaging to locate a target injection site and optionally diagnose lipodystrophic conditions and record them. Tactile and print media educational tools are presented to help users palpate and identify lipos in body areas having injection sites.