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.

Abstract: A method for tracking injection site information includes displaying, on a user interface, a plurality of injection zones, each of the plurality of injection zones representing a segment of the body suitable for medication injection and including a graphical indicator indicating a period of time since a most recent previous injection in the injection zone. The method also includes receiving, via the user interface, injection information relating to a new injection in a particular injection zone. The method also includes updating a graphical indicator of the particular injection zone on the user interface to indicate a new date and time of injection to the particular injection zone.

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 pen needle assembly apparatus (60) includes a housing (30), a movable support (40) for supporting a pen needle (18), an ejector (80) for ejecting a used pen needle from the support, and an actuator (56). The support (40) is rotated relative to the housing (30) to index the pen needles to a position where the pen needle can be accessed and coupled to a delivery device (10). The used pen needle (18) is returned to the well (42) in the support and the support rotated toward the ejector (80) where the used pen needle is ejected to a compartment (50) in the housing for disposal. A cover (60) on the housing includes at least one opening (65) for accessing the pen needle when the support is rotated to position a pen needle relative to the opening in the cover.

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 multiple pen needle or syringe needle storage and dispensing system where a plurality of needle devices such as pen needles including a cover can be disposed on strip, where the strip serves a seal for multiple needle devices. Each needle device can be peeled off the strip unsealed for immediate use for example in an injections device, or separated from the strip sealed for later use.

Abstract: A passive safety needle shield is provided. The needle shield comprises a base fixed to a proximal end of a needle, and an enclosure housing initially disposed at a distal end of the needle and enclosing the end of the needle. A hinged arm connects the base and the enclosure housing. The enclosure housing is slidable along the needle length, and the hinged arm flexes to permit the enclosure housing to move along the needle as the needle is inserted into a user, thereby hiding the needle end, and providing support to the needle to avoid bends or buckles in the needle. The hinged arm is biases in the initial position so that the enclosure housing returns to the end of the needle as the needle is withdrawn.

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) 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: A needle-bearing hub for a pen needle is provided with a distal patient-facing side having an enlarged surface for contact with the subject's skin. The enlarged surface is provided with a radius of curvature that increases the likelihood that the needle reaches full injection depth when an injection is performed at an inclined angle with respect to the surface of the skin and with to the desired depth less discomfort to the patient.

Abstract: A storage device (30) for storing a pen needle assembly (10) includes a housing (30) having first wells (44) with a dimension for receiving the pen needle assembly and second wells (46) for receiving an inner shield (24) of the pen needle assembly. The second wells (46) have a diameter less than a diameter of the first wells (44). An ejector (40) in the housing (34) can be actuated to eject the used needle hub (16) and outer covers (22) from the first well (44) and the inner shield (24) from the second well (46) for disposal. A method of coupling a pen needle delivery device to a needle hub positions a needle hub assembly (18) in the first well (44) and inserts the coupling end of the delivery device (10) into the first well (44) and is coupled to the needle hub. The needle hub is pulled from the outer cover (22). The inner shield (24) is inserted into the second well (46) to remove the inner shield from the needle hub.

Abstract: User-friendly attachment mechanisms for pen needles provide improved handling and ease of use, including locking installation and removal features and sensory feedback when a needle-bearing hub is seated on a pen.

Abstract: A passive safety needle shield (300) is provided. The needle shield comprises a base (302) fixed to a proximal end of a needle, and an enclosure housing (304) initially disposed at a distal end of the needle, and enclosing the end of the needle. A hinged arm (306) connects the base (302) and the enclosure housing (304). The enclosure housing (304) is slidable along the needle length, and the hinged arm (306) flexes to permit the enclosure housing (304) to move along the needle as the needle is inserted into a user, thereby hiding the needle end, and providing support to the needle to avoid bends or buckles in the needle. The hinged arm (306) is biases in the initial position so that the enclosure housing (304) returns to the end of the needle as the needle is withdrawn.

Abstract: A needle hub assembly for a pen needle includes a needle hub, a cannula or needle coupled to the needle hub, a retractable and compressible sleeve covering at least one end of the cannula, and an outer cover. The outer cover encloses the needle hub and the retractable sleeve. The retractable sleeve is coupled to the hub to cover the end of the cannula where the sleeve can pass through or can be pierced by the cannula and the sleeve retracts axially on the cannula. The sleeve is resilient and returns to an original configuration when an insertion force is released. The needle hub can have a first sleeve to cover a patient end of the cannula, and second sleeve to cover a non-patient end of the cannula where the sleeves retract onto the cannula or hub and expand to the original configuration to cover the ends of the cannula.

Abstract: A pen needle shield assembly comprising a hub fixed to a needle cannula, and a movable shield surrounding the hub, the movable shield comprising an upper portion having an outer diameter, a lower portion having an outer diameter greater than the outer diameter of the upper portion, and a distal opening, wherein the movable shield moves from a first position where the needle cannula is retracted in the movable shield prior to use, to a second position where the needle cannula is extended out of the movable shield through the distal opening for medication delivery and to a third position where the needle cannula is retracted in the movable shield and locked to prevent further use.

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 safety pen needle assembly includes a hub with a needle fixed to the hub, the needle having a distal end, formed for insertion into a patient, and a proximal end, a shield and a biasing member disposed between the hub and the shield configured to urge the shield distally. The shield is movable from a first position, when the needle is exposed, to a second position, when the needle is covered. The distal end of the needle may be initially exposed to permit visual confirmation of priming, while allowing the shield to cover a majority of the needle to minimize any needle-related anxiety.

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: An injection sensing device (ISD) (e.g., wearable patch) is paired with an external device (e.g., a medication delivery pen and/or smart phone, iPad, computer) via wireless link or wireline connection. The ISD senses fluctuations in local skin temperature during an injection and provides to the external device captured data from the sensor relating to medicine delivery to a patient to ensure complete delivery and minimize MDD misuse or malfunction or inaccuracies in dosing. The ISD or external device can use captured data and corresponding time stamps to determine flow informatics such as flow rate, total dose delivered, and dose completion status. An LED on the ISD indicates delivery in progress and/or delivery completion.

Abstract: A multiple carrier injection system includes an adapter, having at least one arm, and a pen needle assembly. The pen needle assembly includes a hub retaining a needle and a bullet having a cover to seal the bullet, where the bullet encloses the hub in a first position. The arm engages the adapter to the hub, and the arm causes the hub to rotate within the bullet to move the hub into a second position.