Abstract: Various embodiments of a “smart” drug delivery pen are provided which include a drug delivery pen having an inertial sensor or accelerometer. A system is also provided that includes the smart drug pen in conjunction with a data management unit(s) DMU. Various exemplary methods for use of the pens and systems are also described and illustrated.

Abstract: Described herein are various methods to ensure safety and the compliance of therapeutic diabetes protocols. The method can be achieved by performing safeguards against hypoglycemia of the user prior to any change in basal insulin dosage based on the plurality of data.

Abstract: Various embodiments of a medical module are provided which includes a primary module housing, a secondary module housing, a dosage sensor, a power source, and a microcontroller. The module is configured to be attached to a disposable drug delivery pen or a reusable drug delivery pen so that the module may: determine dosage selected, injection of selected dosage, duration of injection, time of injection, whether the pen has been primed or shaken to thoroughly mix up insulin mixtures, transmit information relating to insulin dosage and injection to a data management unit, provide reminders, error warning or messages on improper usage or reusage of needles, track amount of drug remaining on board the pen or duration of usage of pen with respect to expiry of the drug on board, or provide an audible alarm for locating misplaced pen and module.

Abstract: Various embodiments of a “smart” drug delivery system are provided which includes an add-on module and a reusable or disposable drug pen. Upon attachment to the pen, the add-on module may: determine dosage selected, injection of selected dosage, duration of injection, time of injection, whether the pen has been primed or shaken to thoroughly mix up insulin mixtures, transmit information relating to insulin dosage and injection to a data management unit, provide reminders, error warning or messages on improper usage or reusage of needles, track amount of drug remaining on board the pen or duration of usage of pen with respect to expiry of the drug on board, or provide an audible alarm for locating misplaced pen and module.

Abstract: Various embodiments of a “smart” drug delivery system are provided which includes an add-on module and a reusable or disposable drug pen in conjunction with a data management unit(s) DMU. Upon attachment to the pen, the add-on module may: determine dosage selected, injection of selected dosage, duration of injection, time of injection, whether the pen has been primed or shaken to thoroughly mix up insulin mixtures, transmit information relating to insulin dosage and injection to a data management unit, provide reminders, error warning or messages on improper usage or reuse of needles, track amount of drug remaining on board the pen or duration of usage of pen with respect to expiry of the drug on board, or provide an audible alarm for locating misplaced pen and module. Methods of using the drug delivery system are also described.

Abstract: Various embodiments of a “smart” drug delivery system are provided which includes an add-on module and a reusable or disposable drug pen in conjunction with a data management unit(s) DMU. Upon attachment to the pen, the add-on module may: determine dosage selected, injection of selected dosage, duration of injection, time of injection, whether the pen has been primed or shaken to thoroughly mix up insulin mixtures, transmit information relating to insulin dosage and injection to a data management unit, provide reminders, error warning or messages on improper usage or reuse of needles, track amount of drug remaining on board the pen or duration of usage of pen with respect to expiry of the drug on board, or provide an audible alarm for locating misplaced pen and module. Methods of using the drug delivery system are also described.

Abstract: Various embodiments of a “smart” drug delivery pen are provided which include a drug delivery pen having an inertial sensor or accelerometer. A system is also provided that includes the smart drug pen in conjunction with a data management unit(s) DMU. Various exemplary methods for use of the pens and systems are also described and illustrated.

Abstract: Various embodiments of a “smart” drug delivery system are provided which includes an add-on module and a reusable or disposable drug pen. Upon attachment to the pen, the add-on module may: determine dosage selected, injection of selected dosage, duration of injection, time of injection, whether the pen has been primed or shaken to thoroughly mix up insulin mixtures, transmit information relating to insulin dosage and injection to a data management unit, provide reminders, error warning or messages on improper usage or reusage of needles, track amount of drug remaining on board the pen or duration of usage of pen with respect to expiry of the drug on board, or provide an audible alarm for locating misplaced pen and module.

Abstract: Various embodiments of a medical module are provided which includes a primary module housing, a secondary module housing, a dosage sensor, a power source, and a microcontroller. The module is configured to be attached to a disposable drug delivery pen or a reusable drug delivery pen so that the module may: determine dosage selected, injection of selected dosage, duration of injection, time of injection, whether the pen has been primed or shaken to thoroughly mix up insulin mixtures, transmit information relating to insulin dosage and injection to a data management unit, provide reminders, error warning or messages on improper usage or reusage of needles, track amount of drug remaining on board the pen or duration of usage of pen with respect to expiry of the drug on board, or provide an audible alarm for locating misplaced pen and module.

Abstract: Described herein are various methods to ensure safety and the compliance of therapeutic diabetes protocols. The method can be achieved by performing safeguards against hypoglycemia of the user prior to any change in basal insulin dosage based on the plurality of data.

Abstract: A method for measuring and managing an analyte (e.g., blood glucose) in a bodily fluid includes storing a therapeutic administration protocol in a memory module of an analyte measurement and management device and measuring the analyte in the bodily fluid sample using an analyte measurement module of the device. The method also includes calculating, with a processor module of the device, a recommended therapeutic agent dosage (for example, an insulin dosage) and a recommended administration time for user-activated delivery of the dosage by employing the therapeutic administration protocol. The method further includes displaying the recommended therapeutic agent dosage and administration time to a user on a visual display of the device, delivering a therapeutic agent dosage to the user via a user-activated therapeutic agent delivery device, and detecting the user-activated administration of the therapeutic agent using a delivery device communication module of the device.

Abstract: Various embodiments of a diabetes management system are provided. One exemplary system may include an analyte measurement device and a therapeutic agent delivery device. The measurement device includes a measurement unit, display, and first wireless module. The therapeutic agent delivery device has a delivery device housing, delivery mechanism disposed in the housing that delivers a dosage of the agent to the user upon actuation by the user or health care provider, and a second wireless module. The second module, automatically, without prompting from a user or any active input or action by the user, transmits a signal to the first wireless module indicative of: (a) type of therapeutic agent delivered; and (b) amount of therapeutic agent delivered to the user; or (c) type of therapeutic agent device from which the therapeutic agent was administered. Also described are diabetes management devices and methods.

Abstract: A medical device pump with a housing with a compartment for removably receiving a cartridge containing a therapeutic agent, a conduit configured to operatively provide a fluid flow path for therapeutic agent to exit from the cartridge, a user activated delivery button, a trigger mechanism, and a mechanical pump mechanism. The trigger mechanism, user activated delivery button and mechanical pump mechanism of the medical device pump are configured such that the trigger mechanism is activated by a user fully activating the user activated delivery button. Moreover, such full activation generates mechanical power employed by, and sufficient for, the mechanical pump mechanism to pump a predetermined volume of therapeutic agent from the cartridge and through the fluid flow path.

Abstract: A flexible medical device conduit includes an elongated framework formed from a flexible material (e.g., Nitinol) with a body portion, sharp head, distal end and proximal end. The flexible medical device conduit also includes a flexible tube at least partially jacketing the elongated framework between the distal end and the proximal end. Moreover, the sharp head is disposed at the distal end and is configured for subcutaneous skin insertion and the elongated framework and flexible tube define at least one conduit between the elongated framework and the flexible tube, the conduit having an opening at the distal end.

Abstract: The present invention is directed to small, low profile, antenna-transmitter systems that attach to exterior of the body and focus electromagnetic (EM) wave energy onto one or more precise regions inside the body. The antenna-transmitter system may also deliver energy to the surface of the body without focusing. The present invention is further directed to a method of focusing energy, such as electromagnetic radiation, onto a single nerve to effect selective neurostimulation, super- or sub-threshold, using a small, low profile, antenna-transmitter system that attaches to the body exterior and focuses electromagnetic wave energy onto the nerve.

Abstract: In one example, the present invention is directed to wound-healing patche that passively or actively draw fluids from a wound using an internal, integral vacuum source. The patches may also include electrodes and electronics for electrostimulation, and bioactive compounds that promote healing, such as anti-inflammatory agents.

Abstract: Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism's reaction to the introduction of the medical device to the organism. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the formation of blood clots. The drugs, agents, and/or compounds may also be utilized to treat specific diseases, including vulnerable plaque. Therapeutic agents may also be delivered to the region of a disease site.

Abstract: A medical detecting device including at least one miniature probe/lance (hereinafter microprotrusion) containing an integrated sensor which is covered with a protective coating to shield the sensor from fouling and other interactions with a host prior to its desired use is provided. In accordance with the present invention, the protective coating is selectively removed from the sensor prior to using the same. The present invention also provides a method for detecting a selected agent using the medical detecting device of the present invention.

Abstract: Various methods and devices are provided for delivering an infusion liquid using an electrokinetic infusion pump. The electrokinetic infusion pump can generally include an infusion housing having an infusion reservoir. The infusion reservoir has an infusion outlet and is capable of containing an infusion liquid. A plunger is movably coupled to the infusion housing and is adapted to be manually displaced relative to the infusion housing to load the infusion reservoir with infusion liquid. A movable partition can be disposed within the infusion housing and has a first surface in communication with an electrokinetic solution and a second surface, isolated from the first surface, in communication with the infusion reservoir.

Abstract: Various methods of micro-fabricating 2-dimensional and 3-dimensional medical devices comprised of bio-degradable materials. The various methods use conventional photo-lithographic techniques commonly used in the semi-conductor or integrated circuit industry and translate those techniques to process bio-degradable medical devices. The devices may be active, passive or combination active-passive devices for controlling the release of drugs or other bio-active agents contained within the devices. Such devices may be used externally or internally for drug delivery, wound healing, tissue re-generation or the like.