Abstract: Provided is a wearable, self-contained drug infusion or medical device capable of communicating with a host controller or other external devices via a personal area network (PAN). The medical device utilizes a PAN transceiver for communication with other devices in contact with a user's body, such as a physiological sensor or host controller, by propagating a current across the user's body via capacitive coupling. The wearable nature of the medical device and the low power requirements of the PAN communication system enable the medical device to utilize alternative energy harvesting techniques for powering the device. The medical device preferably utilizes thermal, kinetic and other energy harvesting techniques for capturing energy from the user and the environment during normal use of the medical device. A system power distribution unit is provided for managing the harvested energy and selectively supplying power to the medical device during system operation.

Abstract: An infusion system having an integrated inserter and infusion set (10) for containing and placing a flexible catheter (40), and a retractable introducer needle (26), wherein the catheter (40) is isolated from movement after placement. The integrated inserter and infusion set (10) includes a hub (20), having a user push button (30) to activate the device for catheter (40) placement. An adhesive liner (34) can be provided to cover an adhesive layer (36), such as pressure sensitive adhesive (PSA), on the bottom of the device (10).

Abstract: An infusion set, patch pump, or elements thereof, having an exemplary catheter (14) provided with one or more channels, grooves and coatings (24, 34, 44), configured and arranged to provide a degree of strength and flexibility. The catheter (14) can also have an exemplary flexible union with the hub (12) having at least one of a ball-and-socket joint (66, 68), a sliding plate (86), and a flexible bushing (106), and which is sealed to allow even further movement of the catheter (14) while preventing leakage of medication through the junction. In doing so, a number of benefits associated with the use of rigid materials in catheter construction can be provided while at the same time, benefits associated with the use of flexible materials in catheter construction and/or flexible engagement with the hub can also be provided.

Abstract: An infusion set, patch pump, or elements thereof, having an exemplary catheter (14) provided with one or more channels, grooves and coatings (24, 34, 44), configured and arranged to provide a degree of strength and flexibility. The catheter (14) can also have an exemplary flexible union with the hub (12) having at least one of a ball-and-socket joint (66, 68), a sliding plate (86), and a flexible bushing (106), and which is sealed to allow even further movement of the catheter (14) while preventing leakage of medication through the junction. In doing so, a number of benefits associated with the use of rigid materials in catheter construction can be provided while at the same time, benefits associated with the use of flexible materials in catheter construction and/or flexible engagement with the hub can also be provided.

Abstract: A catheter for use in medical applications is disclosed. The catheter comprises tubing with a tip hole at one end and an end portion at the other end. Fluid exits the catheter at the tip hole thereof. One or more alternative fluid pathway(s) are provided on the sidewall of the catheter to permit outflow of fluid medication from the catheter to ensure proper delivery of the medication to the intended target area, particularly when the tip opening is occluded or restricted for any reason.

Abstract: Provided is a flexible and conformal wearable, self-contained medical device. The medical device comprises an integral housing formed by a flexible upper portion and a flexible lower portion joined along their perimeters. The medical device is also provided in a plurality of shapes and configurations for increasing the flexibility and conformability of the housing. The components contained within the housing, such as a drug reservoir, printed circuit board, and power supply are preferably constructed from flexible materials and are formed, connected and positioned according to the configuration of the housing in a manner for enhancing flexibility of the housing. A thermal bubble micropump is provided for controlling flow of a drug from the flexible reservoir, that utilizes a thermal resistor provided locally to a thermal expansion fluid that causes a surrounding membrane to expand and displace a volume of drug to be provided to the user.

Abstract: A drug delivery device (100) for administering a low dose of a medicament includes a housing (111) and a drug reservoir (101) disposed in the housing (111). A needle (135) is connected to the drug reservoir (101). A pressure applying member (113) is movably connected to the housing (111) and is movable between first and second positions. The pressure applying member (113) does not apply pressure to the drug reservoir (101) in the first position and applies pressure to the drug reservoir (101) in the second position to dispense medicament stored in the drug reservoir (101). A method of administering a low dose of insulin to simulate a first-phase insulin response of a pancreas is also disclosed.

Abstract: A catheter for use in medical applications is disclosed. The catheter comprises tubing with a tip hole at one end and an end portion at the other end. Fluid exits the catheter at the tip hole thereof. One or more alternative fluid pathway(s) are provided on the sidewall of the catheter to permit outflow of fluid medication from the catheter to ensure proper delivery of the medication to the intended target area, particularly when the tip opening is occluded or restricted for any reason.

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: Provided is an extended use self-contained, wearable medical device. The device is preferably configured with an infusion deployment mechanism for variably inserting and retracting an infusion needle to different depths, or completely retracting the infusion needle from the infusion site and then re-inserting the infusion needle after a predetermined period of time, throughout an infusion cycle for extending the viability of the infusion site. Another embodiment comprises dual needle deployment mechanisms which may also variably insert and retract the infusion needles. A flow sensor is preferably provided for detecting the stoppage of flow through the infusion cannula and signaling the needle deployment mechanism to attempt infusion at a different depth or to deploy a second infusion needle. A re-fillable reservoir assembly is preferably provided for supplying a drug over the extended use of the device.

Abstract: Apparatuses, systems and methods for the wireless communication of medical devices in a subcutaneous fluid delivery system are disclosed. A system for subcutaneous fluid delivery includes a primary patch pump adapted to attach a first infusion cannula to a user and to perform a plurality of primary patch pump functions, and a secondary patch pump adapted to attach a second infusion cannula to a user. The secondary patch pump is further adapted to perform a plurality of secondary patch pump functions substantially similar to the plurality of primary patch pump functions if an error condition associated with the primary patch pump is determined.

Abstract: A catheter for use in medical applications is disclosed. The catheter comprises tubing with a tip hole at one end and an end portion at the other end. Fluid exits the catheter at the tip hole thereof. One or more alternative fluid pathway(s) are provided on the sidewall of the catheter to permit outflow of fluid medication from the catheter to ensure proper delivery of the medication to the intended target area, particularly when the tip opening is occluded or restricted for any reason.

Abstract: In one aspect, a safety pen needle assembly is provided herein which 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. The assembly further includes a shield and a biasing member disposed between the hub and the shield configured to urge the shield distally. A protrusion extends from at least one of the hub and the shield with a channel being formed in at least the other of the hub and the shield. The channel is formed to accommodate the protrusion. The shield is movable from a first position to a second position. In the first position, the shield is spaced from the distal end of the needle such that the distal end of the needle is exposed. In the second position, the shield covers the distal end of the needle. The channel guides the protrusion as the shield moves from the first position to the second position. With this arrangement, a shield may be directed to move in a desired path with stability.

Abstract: In one aspect, a safety pen needle assembly is provided herein which 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. The assembly further includes a shield and a biasing member disposed between the hub and the shield configured to urge the shield distally. A protrusion extends from at least one of the hub and the shield with a channel being formed in at least the other of the hub and the shield. The channel is formed to accommodate the protrusion. The shield is movable from a first position to a second position. In the first position, the shield is spaced from the distal end of the needle such that the distal end of the needle is exposed. In the second position, the shield covers the distal end of the needle. The channel guides the protrusion as the shield moves from the first position to the second position. With this arrangement, a shield may be directed to move in a desired path with stability.

Abstract: Improved systems and methods for medicine delivery, and in particular, improved insulin pen needles and related devices are provided. Smart injection devices record and transfer data including medicine level, delivered dose, dose confirmation, and dose time and date. Additional data captured may include glucose concentration, insulin level, carbohydrates ingested, stress level, exercise, blood pressure, and glucose high and low excursion events. Various means of data collection and analysis are provided and systems can identify and flag patients who require intervention. Smart sleeves and add sensing capability to standard insulin pens. Pen needles are provided with sensing capability to confirm and measure doses delivered by insulin pen. A two-part pen cap include a primary sleeve that connects to the insulin pen and an end cap that provides for capturing the time of dose delivery, and monitoring the hold time for a dose delivery after plunger movement.

Abstract: Provided is a wearable, self-contained drug infusion or medical device capable of communicating with a host controller or other external devices via a personal area network (PAN). The medical device utilizes a PAN transceiver for communication with other devices in contact with a user's body, such as a physiological sensor or host controller, by propagating a current across the user's body via capacitive coupling. The wearable nature of the medical device and the low power requirements of the PAN communication system enable the medical device to utilize alternative energy harvesting techniques for powering the device. The medical device preferably utilizes thermal, kinetic and other energy harvesting techniques for capturing energy from the user and the environment during normal use of the medical device. A system power distribution unit is provided for managing the harvested energy and selectively supplying power to the medical device during system operation.

Abstract: Provided is a flexible and conformal wearable, self-contained medical device. The medical device comprises an integral housing formed by a flexible upper portion and a flexible lower portion joined along their perimeters. The medical device is also provided in a plurality of shapes and configurations for increasing the flexibility and conformability of the housing. The components contained within the housing, such as a drug reservoir, printed circuit board, and power supply are preferably constructed from flexible materials and are formed, connected and positioned according to the configuration of the housing in a manner for enhancing flexibility of the housing. A thermal bubble micropump is provided for controlling flow of a drug from the flexible reservoir, that utilizes a thermal resistor provided locally to a thermal expansion fluid that causes a surrounding membrane to expand and displace a volume of drug to be provided to the user.

Abstract: An infusion system comprising a base, a pump, a fluid tubing set that connects the pump and the base, and a collapse-resistant catheter extending from the base and comprising a swellable inner element including one or more indents, and a non-swellable flexible outer sleeve covering an outer wall of the inner element, wherein when the swellable inner element absorbs liquid, the swellable inner element swells and the one or more indents control a direction of the swelling by causing the swellable inner element to fold inwardly.

Abstract: An infusion set, patch pump, or elements thereof, having an exemplary catheter (14) provided with one or more channels, grooves and coatings (24, 34, 44), configured and arranged to provide a degree of strength and flexibility. The catheter (14) can also have an exemplary flexible union with the hub (12) having at least one of a ball-and-socket joint (66, 68), a sliding plate (86), and a flexible bushing (106), and which is sealed to allow even further movement of the catheter (14) while preventing leakage of medication through the junction. In doing so, a number of benefits associated with the use of rigid materials in catheter construction can be provided while at the same time, benefits associated with the use of flexible materials in catheter construction and/or flexible engagement with the hub can also be provided.

Abstract: Provided is a flexible and conformal wearable, self-contained medical device. The medical device comprises an integral housing formed by a flexible upper portion and a flexible lower portion joined along their perimeters. The medical device is also provided in a plurality of shapes and configurations for increasing the flexibility and conformability of the housing. The components contained within the housing, such as a drug reservoir, printed circuit board, and power supply are preferably constructed from flexible materials and are formed, connected and positioned according to the configuration of the housing in a manner for enhancing flexibility of the housing. A thermal bubble micropump is provided for controlling flow of a drug from the flexible reservoir, that utilizes a thermal resistor provided locally to a thermal expansion fluid that causes a surrounding membrane to expand and displace a volume of drug to be provided to the user.